Medical Post- June 2022

THE MISTAKES ISSUE

Getting over a big mistake that had a negative outcome

Preventing mistakes: tips and tricks doctors can use

Planning for a long retirement

SPECIAL SECTION INSIDE

OTC ANNUAL SURVEY 2022

JUNE 2022

Physicians’ most-recommended brands

INTRODUCING THE NEW

Fights pain in 2 ways Acetaminophen

BLOCKS PAIN SIGNALS

Ibuprofen

TARGETS PAIN AT THE SOURCE

Two different mechanisms of action delivering UP TO 8 HOURS OF PAIN RELIEF1

LOWER MAXIMUM DAILY DOSES Effective pain relief When patients take Advil Plus Acetaminophen they are taking:2*

37.5% 62.5% LESS IBUPROFEN

LESS ACETAMINOPHEN

In pivotal clinical studies published in the Clinical Journal of Pain, Advil Plus Acetaminophen provided patients with:1,2 Fast onset of action Demonstrated analgesic efficacy Long lasting pain relief for up to 8 hours

Advil + Acetaminophen demonstrated A FAVOURABLE SAFETY PROFILE Consistent with the established safety profiles of each active ingredient3-5

IN CLINICAL STUDIES EVALUATING SAFETY AND EFFICACY:2 • All TRAEs were mild or moderate • No new safety concerns were identified† With a well-established safety and efficacy profile — you can trust the pain and fever relief of Advil Plus Acetaminophen3,4

TRAE: treatment related adverse event; OTC: over the counter. * With Advil Plus Acetaminophen, the maximum daily dose is 750 mg ibuprofen and 1500 mg acetaminophen vs. 1200 mg and 4000 mg, which are the maximum daily doses for OTC ibuprofen and acetaminophen alone (respectively).6,7 † Compared to each ingredient alone.

Advil Plus Acetaminophen is indicated for the temporary relief of migraine pain, headaches, including tension headache, muscle aches and pain, joint and body pain, backache, muscle sprains and strains, aches and pain due to the common cold, pain from inflammation associated with arthritis and physical or athletic overexertion (e.g., sprains or strains), dental pain, and pre-menstrual and menstrual pain. Advil Plus Acetaminophen is also indicated for the reduction of fever.

Advil Plus Acetaminophen contains acetaminophen. Patients should not take more than 6 tablets within 24 hours (maximum daily amount), with other drugs that contain acetaminophen, and should not take it while drinking 3 or more alcoholic drinks every day.

Please consult the Product Monograph at https://health-products.canada.ca/dpd-bdpp/index-eng.jsp for information to assist in benefit-risk assessment. Always direct the patient to read the label.

References: 1. Advil Plus Acetaminophen Product Monograph. GSK Consumer Healthcare ULC. March 4, 2021. 2. Searle S, et al. Clin J Pain. 2020;36(7):495-504.

3. Tanner T, et al. BMC Clin Pharmacol. 2010;10:10. 4. Dickman A. Pharm J. 2008;281:631. 5. Perrott DA, et al. Arch Pediatr Adolesc Med. 2004;158(6):521-526.

6. Advil Tablets, Caplets, Gel Caplets, Extra Strength Caplets, Muscle and Joint and 12 Hour Product Monograph. GSK Consumer Healthcare ULC. June 18, 2020.

7. Government of Canada. Acetaminophen. 2021. Retrieved November 16, 2021. Available at: https://www.canada.ca/en/health-canada/services/drugs-medicaldevices/acetaminophen.html.

Scan this QR code to see the detailed clinical data

©2022 GSK group of companies or its licensor. Trademarks are owned by or licensed to the GSK group of companies.

PM-CA-ADV-22-00013

Contents UPFRONT

OTC SECTION

Editorial

OTC: Physicians’ mostrecommended brands

7

The Mistakes Issue: Navigating the errors in our lives

8

Feedback

Doctors’ input on April’s The Anti-Paperwork Issue

10

Rounds

Med school accreditation issues; ‘One issue per visit’ downsides

33

14

Only human

Mistakes are one of the hardest things you face as a physician

19

Ditching the shame and blame

Cover: Gracia Lam, Photo: supplied by Gracia Lam

Hospital critical incident reviews a work in progress

26

Complaints and resolution

By the numbers for seven provinces

29

Preventing mistakes

Common language, increased communication and situational awareness key

76

Solve my problem

Handling patients with somatic symptom disorder

75

Classifieds

OTC counselling: an integral part of your role

BACK PAGES

43

Column: Dr. Raj Waghmare Overnight stay

50

Column: Dr. Ginevra Mills THEME

VOLUME 58 NO. 3

When the worst happens

57 Law

Reverse thinking not allowed

62

Column

When a treatment goes wrong: two lawyers run down what to do

67

Finance

Cover artist

We asked Gracia Lam, the Toronto illustrator, who is creating all the covers of the magazine this year, about the theme of this issue: mistakes Q: Any professional mistakes you made and what did you learn?

Starting out as a young illustrator is a vulnerable position to be in when you are a queer Asian woman. The mistake I made was allowing myself to be convinced that my interests and aesthetics didn’t fit into the industry of many other voices.

Fourteen years later, I’m grateful my blind passion for drawing has allowed me to create something of my own and stopped me from stepping away from the industry.

Q: Any mistakes in life generally?

Over the pandemic, I realized a daily mistake I made was overworking and sitting at my desk seven days a week. What I thought was productivity I now recognize as a numbing burnout. I’m actively changing this—giving myself back full weekends, specifying work hours and not responding to emails beyond those hours—to create a work-life balance.

Q: Did you ever have an illustration that just never worked?

By my own standards, tons! I am my own worst critic.

Fortunately, I can rely on a set of strategies and methods learned over the years to resolve an image most of the time.

Live longer, retire longer

70

Clinic

5 clinical pearls to help patients dealing with hair loss

73

Practice management Staff job-sharing tips

Next Issue

THE FAMILY DOCTORS ISSUE: The next issue focusing on family physician issues will hit doctors’ mailboxes in early September. We’ll look at the mid-level providers, such as nurse practitioners and physician assistants, in terms of how they can help family doctors and what threats they pose to family doctor jobs? As well, we’ll have lots of great content about primary care delivery issues.

THE MEDICAL POST JUNE 2022 5

Break • through: (noun) An advance in knowledge as a result of research and perseverance

Areas of exploration include:

Atopic Dermatitis

Alopecia

It’s what we strive for in our relentless pursuit of innovative e research in chronic inflammatory skin diseases.

Pfizer Inflammation & Immunology’s unwavering commitment to research in dermatology sees us building on our pioneering science and expertise as we work to better understand chronic inflammatory skin conditions.

© 2021 Pfizer Canada ULC Kirkland, Quebec H9J 2M5 PP-ABR-CAN-0032-EN

Vitiligo

Psoriasis

EDITORIAL

The Mistakes Issue We’re only human: navigating the errors in our lives “The single greatest impediment to error prevention in the medical industry is that we punish people for making mistakes.”

—DR. LUCIAN LEAPE

Humans make mistakes but the price in medicine can be so huge.

A journalist makes a mistake: We try to learn from it and quickly fix it online or run a correction notice in the next issue of the magazine. No one died—and we did the best we could at the time. It is not great but sokay.

On the other hand, the costs of mistakes in medicine can be the highest.

This is not easy stuff for doctors.

For this—The Mistakes Issue—our writers interviewed doctors across the country to get their take on how clinicians are thinking about these issues today and how doctors can manage when the inevitable happens. Those articles run from page 14 to page 31.

I also want to highlight Dr. Ginevra

THE MEDICAL POST EDITOR-IN-CHIEF Colin Leslie cleslie@ensembleiq.com MANAGING EDITOR Martha Porado mporado@ensembeiq.com DIGITAL REPORTER Marjo Johne mjohne@ensembeiq.com CREATIVE DIRECTOR Nancy Peterman npeterman@ensembleiq.com ART DIRECTOR Josephine Woertman jwoertman@ensembleiq.com

PRODUCTION MANAGER Lisette Pronovost lpronovost@ensembleiq.com SENIOR VICE PRESIDENT, CANADA Donna Kerry dkerry@ensembleiq.com VICE PRESIDENT, EVENTS Megan Judkins mjudkins@ensembleiq.com SENIOR DIRECTOR AUDIENCE STRATEGY Lina Trunina ltrunina@ensembleiq.com

Mills’ stellar essay—“When the worst happens” on page 50—wherein she grapples with the aftermath of the worst outcome of her career. It is a stunning and powerful piece of writing.

man and so smart about this stuff—so we left them in. Enjoy.

MISTAKES AS FEATURES

SURVEY SAYS!

Sometimes in journalism we turn mistakes . . . into features! We assign different reporters to look at different aspects of whatever issue we’re examining in the magazine and for this issue it happened that several of the reporters and writers ended up quoting or referring to Dr. Brian Goldman. That isn’t too surprising. Dr. Goldman, author and host of CBC’s Radio’s White Coat, Black Art and veteran emergency room physician, has done a lot of thinking and candid writing about medical errors.

Normally we’d view it as a mistake to have one person quoted in multiple articles in the same magazine and we’d edit it down. But Dr. Goldman is a lovely

SENIOR DIRECTOR, DIGITAL CANADA & SPECIAL PROJECTS Valerie White vwhite@ensembleiq.com SALES SENIOR ACCOUNT MANAGER Norman Cook ncook@ensembleiq.com SENIOR ACCOUNT MANAGER Scott Tweed stweed@ensembleiq.com

ACCOUNT MANAGER Nancy Dumont ndumont@ensembleiq.com SALES & BILLING COORDINATOR Sylvie Graveson sgraveson@ensembleiq.com PROJECT COORDINATOR Kalli Sagos ksagos@ensembleiq.com

CHIEF HUMAN RESOURCES OFFICER Ann Jadown EXECUTIVE VICE PRESIDENT, OPERATIONS Derek Estey EXECUTIVE VICE PRESIDENT, CONTENT AND COMMUNICATION Joe Territo

CORPORATE OFFICERS CHIEF EXECUTIVE OFFICER Jennifer Litterick CHIEF FINANCIAL OFFICER Jane Volland

PHYSICIAN ADVISORY BOARD DR. BENJAMIN BARANKIN dermatology DR. MELANIE BECHARD pediatrics DR. ALI DAMJI family medicine

DR. MARIO ELIA family medicine DR. FERRUKH FARUQUI family medicine DR. SARAH GILES family medicine DR. COURTNEY HOWARD emergency medicine

DR. ALAN KAPLAN family medicine DR. CHRISTINE NICHOLAS plastic surgery DR. BRIDGET REIDY family medicine

DR. FRANCO RIZZUTI public health DR. DUNCAN ROZARIO general surgery DR. DAVID SATOK family medicine DR. PUNEET SETH hospitalist

DR. MIKE SIMON family medicine DR. CHRISTOPHER SUN family medicine DR. HIROTAKA YAMASHIRO pediatrics

COLIN LESLIE EDITOR-IN-CHIEF

We do an annual survey of almost 200 doctors, and this year we asked for written answers to the question: “What have you learned from mistakes in your career?” I read through all the answers and I can summarize the advice of the readers as this: Document, document, document.

Lastly, here’s what the doctors in our survey said in response to the following statement: “I believe sensitive communication skills are innate and cannot be taught.”

• 24% Agree • 17% Neither agree nor disagree • 59% Disagree Enjoy reading this issue!

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Contents copyright © 2022 by Stagnito Partners Canada Inc., may not be reprinted without permission. The Medical Post receives unsolicited features and materials (including letters to the editor) from time to time. The Medical Post, its affiliates and assignees may use, reproduce, publish, re-publish, distribute, store and archive such submissions in whole or in part in any form or medium whatsoever, without compensation of any sort. The Medical Post, ISSN-0025-7435, PM Agreement No. PM42940023, established 1965, is published 6 times per year except for occasional combined, expanded or premium issues, which count as two subscription issues by EnsembleIQ, 20 Eglinton Avenue West, Suite 1800, Toronto, Ontario, M4R 1K8.

Printed in Canada at Transcontinental Printing.

THE MEDICAL POST JUNE 2022 7

Feedback The Anti-Paperwork Issue underlined how forms have become a brutal burden for doctors

The burnout drain (April) “It has never been more convenient for patients to receive care,” wrote Dr. Christine Renz of Calgary.

“Many of us continue to provide phone call appointments, e-faxed prescriptions, secure EMR communication for messages, documents and results. And yet, as mentioned, patients are ruder, more demanding and aggressive than ever.”

Others wrote in online comments about physician burnout of the need to have an escape hatch. “All of us must learn to live on much less than we can afford.

Simplify your consumption.

Put your spouse and family first, charity next and yourself last when spending money,” Dr. Leslie MacMillan of Toronto wrote. “Invest wisely and with discipline in order that

8 JUNE 2022 THE MEDICAL POST

you can fully retire several years early if you have to or want to. You must commit to this early in your career so that your family can come to terms with it early.

The person you marry must not expect to live like a rich doctor’s spouse.”

Dr. MacMillan further argued: “Merely cutting back hours doesn’t do it. If you work four days a week instead of 6.5 (patient care plus paperwork), you will just dread and resent the return to the office all the more for having been away from it for a day or two.”

Dr. David Lounsbury of Edmonton replied to Dr. MacMillan’s comment saying: “Along the same lines, if possible, don’t put all your eggs in one basket. I try to keep active in three systems (provincial, federal and private).”

Don’t get them started: Canada’s worst forms (April) Dr. Raymond Simkus of Langley, B.C., wrote to say he agreed with all the examples of bad forms listed in the article. “My particular peeve are forms that are designed for EMR use but they do not pull in data that is already in the EMR. The two reasons for this are that the form designers do not understand that the data may already be

“The fees should always be paid by the third party requesting the form.”

in the EMR. The other part of the problem is that the EMR is designed in an idiosyncratic way so the data needed for the form is poorly named and stored in idiosyncratic places so the form designers do not know how to pull in that data.

This also happens when forms are designed ‘by doctors for doctors.’”

Dr. Adam Chen of Oakville, Ont., noted: “At least a paper form allows you to paste a label, punch a stamp, or write ‘see attached’ across lined fields. Once we ‘axe the fax,’ and you have to complete it online, filling all those blocks marked by little red asterisks*—along with proving ‘I am human,’ ‘new password required,’ and ‘one-time verification code’—forms will morph into a different level of evil.”

Cutting off the flow upstream (April) Our coverage of attempts to make system changes to reduce the burden of paperwork provoked this from Dr. Paul Johnson of Halifax. “Here’s hoping— hopefully more specialist referrals get integrated into Alberta Netcare system— rather than the blizzard of faxes that one referral often generates—i.e., fax back to physician stating referral received, then referral accepted—has to be a simpler way for both family physicians and patients . . . so much for EMR’s saving paperwork thus far!”

“The fees should always be paid by the third party requesting the form,” Dr. Stephen Barron of Port Coquitlam, B.C. “The fees should be per page, and should be much higher than they are now. That would force all these institutions to simplify their forms and request them less often.

Patient’s should never have to pay for a form that someone else wants. Patient’s should only pay for off-work notes or other forms that they are requesting on their own, not ones that their employers require. For example, if an employer wants a note, they should have to request it in writing and pay for it.”

Get to the heart of the matter.

Echocardiogram of the right heart can reveal pulmonary arterial hypertension (PAH).1 Time is a factor.

Prompt referral to a PH Centre ensures timely diagnosis and can make a difference in patient outcomes.1,2

1. Galiè N, Vachiery JL, Gibbs S, et al. Eur Respir J 2015;46:903–975.

2. Humbert M, Coghlan J and Khanna D. Eur Respir Rev 2012;21:306–312.

Janssen Inc. 19 Green Belt Drive Toronto, Ontario M3C 1L9 www.janssen.com/canada © 2021 Janssen Inc. All trademarks used under license.

CP-208103E

Rounds MED SCHOOL ACCRED VITALS

1 in 17 hospital stays in Canada

BY ABIGAIL CUKIER

A partnership between the Canadian Institute of Health Information and Healthcare Excellence Canada (formerly the Canadian Patient Safety Institute)—the Hospital Harm Project—aims to answer the question, “How often do patients experience harm in hospital?” According to its latest report, in 2020/21, one in 17 hospital stays in Canada involved at least one harmful event. These events crossed four categories: 4%

20% 46% 30%

4 categories of harmful events 46% involved healthcare and medications, such as bedsores or a patient getting the wrong medication 30% involved infections, such as surgical-site infection 20% were procedure related—for example, bleeding after surgery 4%

were patient accidents, such as falls

10 JUNE 2022 THE MEDICAL POST

Supervisors and residents: ‘run off their feet’ In late April, a CBC News headline warned that the

University of Manitoba could lose accreditation of three post-graduate medical school programs if improvements weren’t made. Yet the Royal College of Physicians and Surgeons of Canada often puts residency programs on notice as it strives for continuous quality improvement. Instead, the headline should have highlighted how supervisors and residents across Canada are scrambling to balance learning and teaching as they deal with increased workloads.

As part of a scheduled review, supervisors and residents alike told the Royal College that they were being “run off their feet,” Dr. Brian Postl, dean of the Rady Faculty of Health Sciences, told the CBC. This left little time to mentor or be mentored.

“I think these have been very tense environments for the last several years in terms of enormous workloads,” Dr. Postl said.

With the pandemic, increasing workloads have left residents focusing more on providing medical services than on their education, Dr. Josh Aquin, president of the Professional Association of Residents and Interns of Manitoba told the CBC. “The magnitude of the workload and what residents have had to experience over time has resulted in fatigue and burnout,” he said. This is then reflected in accreditation reviews.

The Royal College doesn’t share results of its regular reviews; the University of Manitoba chose to be transparent about the outcome. The Royal College conducts a full review of each residency program every eight years, and it was the University of Manitoba’s turn, as well as other postgraduate medical programs.

The programs in question will remain accredited until a follow-up review occurs. Approximately 20% of the programs assessed each year are scheduled to have a follow-up review sooner than the regular eight-year cycle, the Royal College told the Medical Post. —KYLIE TAGGART

ROUNDS

AUSCULTATIONS

“There are a large number of doctors who have a voracious appetite for something other than FFS.” —Dr. Ramneek Dosanjh, president of Doctors of BC, while acknowledging that many doctors want to keep fee-for-service (FFS) but want it to “be more fair (and) more accurate for today’s economic climate.”

“Usually, we would be disappointed if we had five unmatched spots. So, 12 is an unusually high number.”

—Dr. Cathy Risdon, chair of the department of family medicine at McMaster University, on the number of unfilled family medicine spots in Hamilton after the second iteration of this year’s CaRMS match.

“I’m not saying (NPs) can provide better primary care, but for many people, they do.”

—Adrian Dix, B.C. health minister, in a comment that came under fire from Doctors of BC and others, with some saying he was purposely pitting nurse practitioners against physicians.

Source: Vancouver Sun | Hamilton Spectator | Victoria Times-Colonist

‘LAUNDRY LIST’

One issue per visit: deep downsides ​A common doctors’ complaint is the patient who

comes to an appointment with a never-ending list of issues. A doctor may fear that this will prevent them from focusing enough on the most important concern or worry about being able to attend to a waiting room full of patients.

This has led some physicians to institute a “one issue per visit” rule. But in a recent online Medical Post column, Dr. Marcus Greatheart, a family physician in Campbell River, B.C., said the average outpatient has about 1.7 concerns, and research shows that the first concern is usually not the primary concern.

“Eliciting a list takes about 32 seconds, and significantly reduces the frequency of ‘doorknob’ issues, which are more common when an exhaustive list is not elicited early on,” Dr. Greatheart wrote.

“We want to hear the laundry list of issues, because therein lies not only the primary issue but some

of the pertinent diagnostic facts. Our patients aren’t necessarily going to know that their urinary frequency and back pain are related, but it will surely inform our differential.”

The Canadian Medical Protective Association warns that a one issue per visit rule could expose a doctor to medico-legal risk, as the chance of not detecting serious health problems may increase if patients are limited to one issue per visit. The CMPA says such a policy asks patients to “triage their own symptoms without the knowledge, skills, and judgment to do so.” The association also says it could lead patients to feel like their doctor is too busy or does not care.

The CMPA suggests putting up signage that encourages patients to respect the time of others who are waiting, as well as educating patients on how appointments are scheduled and the implications of appointments that are longer than anticipated.

Dr. Greatheart suggests asking your patient for their list, while telling them that you want only the issues without the details. “Then you and your patient can prioritize what will be discussed at that appointment and which of the other issues are potentially relevant,” he said. “The other issue you save and book follow-up appointments for.” —ABIGAIL CUKIER

THE MEDICAL POST JUNE 2022 11

Rx

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about What is BLEXTEN indicated for?

BLEXTEN® (bilastine) is indicated for the symptomatic relief of nasal and non-nasal symptoms of seasonal allergic rhinitis (SAR) and for the relief of the symptoms associated with chronic spontaneous urticaria (CSU) (e.g. pruritus and hives), in patients 4 years of age and older with a body weight of at least 16 kg.1 Pr

What are the pediatric formats?

BLEXTEN offers the flexibility of two pediatric dosage formats. The pediatric formats are suitable for children 4-11 years old with a body weight of at least 16 kg.1 BLEXTEN Orodispersible Tablets (ODT) • Grape flavour, • 10 mg tablet once daily • To be placed in the mouth where it disperses rapidly in saliva, so it can be easily swallowed • Convenient tablet formulation that can be taken without water BLEXTEN Oral Solution • Raspberry flavour in a clear, colourless liquid • 2.5 mg/mL oral solution; 4 ml equivalent to 10 mg bilastine per dose • A convenient dosing cup is provided with a mark of 4 mL Ages 12+ 20 mg tablet once daily • No dose adjustments needed for elderly patients, kidney disease or liver disease.

Administraton1 • BLEXTEN should be taken without food or grapefruit juice or other fruit juices, as these dietary compounds may decrease the effect of bilastine.

• The BLEXTEN ODT is to be placed in the mouth where it disperses rapidly in saliva, so it can be easily swallowed. Alternatively, the ODT may be dispersed in water before administration. Grapefruit juice or any other fruit juice should not be used for dispersion.

Counselling tips for parents

• If it is difficult to ensure that your child does not eat anything for one hour after taking BLEXTEN, try administering it before bedtime.

• Patients should be instructed to take BLEXTEN and wait for one hour before taking food or fruit juice; or if food or fruit juice has been taken to wait for two hours before taking the medication.

• The maximum daily dose for pediatrics (ages 4-11) is 10 mg (1 orodispersible tablet or 4 mL oral solution); for ages ≥12, the maximum daily dose is 20 mg (1 tablet).

See the Product Monograph for complete dosing and administration information Demonstrated efficacy data in adults and adolescents - Seasonal allergic rhinitis Blexten 20 mg significantly reduced Total Symptom Score area under the curve (TSS AUC) from baseline to day 14 vs. placebo (98.4 vs. 118.4, p<0.001), but did not differ from the active comparator.1‡ BLEXTEN Tolerability ProfileAdults and Adolescents BLEXTEN was generally well tolerated with treatment emergent adverse events equal to placebo.1à Treatment-emergent adverse reactions reported in ≥1% of subjects treated with BLEXTEN 20 mg in Phase 2 and 3 trials Adverse Event

BLEXTEN n=931

Placebo n=950

Gastrointestinal disorders

28 (3.01%)

28 (2.95%)

Abdominal pain upper

10 (1.07%)

4 (0.42%)

Nervous system disorders

81 (8.70%)

55 (5.79%)

Dizziness

10 (1.07%)

4 (0.42%)

Headache

40 (4.30%)

28 (2.95%)

Somnolence

38 (4.08%)

25 (2.63%)

What is the worldwide patient exposure for BLEXTEN?* BLEXTEN 10 mg • More than 2.2 million patients treated • Available in 58 countries • Pediatric formats available in Canada since February 2022 BLEXTEN 20 mg • More than 213 million patients treated • Available in 121 countries • Available in Canada since December 2016

Aralez Pharmaceuticals Canada Inc.* 6733 Mississauga Road, Suite 800, Mississauga, Ontario L5N 6J5

BLEXTEN is covered under most private insurance plans.

Clinical use: BLEXTEN should not be administered to children below 4 years of age and under 16 kg due to limited data in this population.

Contraindication: • History of QT prolongation and/or torsade de pointes, including congenital long QT syndromes.

Relevant warnings and precautions: • QTc interval prolongation, which may increase the risk of torsade de pointes.

• Use with caution in patients with a history of cardiac arrhythmias; hypokalemia, hypomagnesaemia; significant bradycardia; family history of sudden cardiac death; concomitant use of other QT/ QTc- prolonging drugs.

• P-glycoprotein inhibitors may increase plasma levels of BLEXTEN in patients with moderate or severe renal impairment; co-administration should be avoided.

• BLEXTEN should be avoided during pregnancy unless advised otherwise by a physician.

• A study was performed to assess the effects of BLEXTEN and bilastine 40 mg on real time driving performance compared to placebo. Bilastine did not affect driving performance differently than placebo following day one or after one week of treatment.

However, patients should be informed that very rarely some people experience drowsiness, which may affect their ability to drive or use machines.

For more information: Please consult the product monograph at www.miravohealthcare.com/wp-content/uploads/ 2021/08/ Blexten-PM-ENG-Aug2021.pdf for important information relating to adverse reactions, drug interactions, and dosing information which have not been discussed in this piece. The product monograph is also available by calling 1-866-391-4503.

References 1. Blexten Product Monograph. Aralez Pharmaceuticals Canada Inc. 2021. ‡ Double-blind, placebo-controlled, randomized, activecontrolled parallel-group trial of 720 patients with SAR, 12-70 years old. Patients were randomized to BLEXTEN 20 mg, desloratadine 5 mg or placebo once daily for 14 days. Primary endpoint was change in AUC of the TSS from baseline to day 14. TSS was comprised of the reflective total nasal symptom score (rTNSS) and the reflective total non- nasal symptom score (rTNNSS). * As of August 31, 2021, the estimate from internal data of patient exposure is based on units sold of the defined daily dose of 10 mg (pediatric) and 20 mg (adult) bilastine and the mean treatment duration of 3 weeks.

BLEXTEN is a registered trademark of FAES used under license by Aralez Pharmaceuticals Canada Inc.

*A wholly owned subsidiary of Searchlight Pharma Inc. This Q&A is published by Ensemble IQ, 20 Eglinton Avenue West, Suite 1800, Toronto, ON M4R 1K8, Telephone: 416-256-9908.

No part of this Q&A may be reproduced, in whole or in part, without the written permission of the publisher. © 2023

2023

The Medical Post

AWARDS THE 2023 MEDICAL POST AWARD CATEGORIES: Media Engagement Award – Changemaker Honours a Canadian doctor who is leading change in healthcare through media and social media communications and has the backing of a large organization.

Media Engagement Award – Trailblazer Honours a Canadian doctor who is leading change in healthcare through media and social media communications as an individual doctor at the grassroots level.

Media Engagement Learner Award

Innovative Practice Award

Honours a med student or resident who is leading change in healthcare through media and social media communications.

Honours a physician or team whose practice has found new ways to improve patient care.

Making a Difference Award – Urban

Interprofessional Team Award

Honours a physician in recognition of their work for marginalized communities in a city.

Honours a team (must include at least once physician) with different health professionals working effectively to advance patient care.

Making a Difference Award – Rural Honours a physician in recognition of their work for marginalized communities in a rural area.

Celebrating Canada’s doctors: The Medical Post Awards support national independent physician voices, contribution to community and practice innovation.

AWARDS 2023 A GALA IN THE FALL IN TORONTO WILL CELEBRATE AWARD RECIPIENTS. COVERAGE OF THE AWARD RECIPIENTS WILL ALSO APPEAR IN THE MAGAZINE. THE JURY ENTRIES WILL BE SUBMITTED TO A PANEL OF JUDGES MADE UP OF PEERS.

Presented by

HOW TO ENTER: NOW ACCEPTING NOMINATIONS.

FOR MORE DETAILS AND TO ENTER VISIT: TheMedicalPostAwards.ca

Deadline to enter: May 31

FEATURE

ONLY HUMAN

Mistakes are one of the hardest things you can face as a physician.

But you are not alone.

BY LOUISE LEGER

14 JUNE 2022 THE MEDICAL POST

FEATURE

“Being a doctor is being vulnerable at the best of times,”

said Ottawa psychiatrist Dr. Mamta Gautam.

Vulnerable? The public, and even physicians themselves, might think of doctors as more powerful than vulnerable. But a culture of perfectionism in medicine, along with high-stakes decision-making and treatments, and increasing medical complexities, sets physicians up to feel devastation and extreme shame when mistakes inevitably happen, many physicians say.

“We are high achievers, perfectionists, push ourselves hard, with a goal of always doing the right thing,” said Dr. Gautam, who treats physicians in her psychiatric practice. “We work in a culture with high expectations and constant pressure. When we ‘fail’ there is a sense of shame. . . . That makes us vulnerable.”

Dr. Gautam believes mistakes in medicine should be normalized. “The culture of medicine supports perfectionism, creates great pressure to be right, know everything, stay strong and never fail. With a mistake, we feel we have failed, are not worthy and do not deserve to be included in the culture/group.

It can be very isolating. Yet making mistakes is human.”

Dr. Brian Goldman is an ER doctor at Toronto’s Mount Sinai Hospital, author of The Power of Teamwork, and creator of the TED Talk, “Doctors make mistakes. Can we talk about that?”

He has made mistakes and has spoken to many physicians who have too.

“My own experience is, as a frontline clinician, I’m human, which means that I will make mistakes, especially given the fact that medicine is increasingly complex,” he said. “It’s difficult to marshal the facts, to know everything about a patient, to know everything all at once.”

Of the experience of making a mistake, he said, “It’s awful.

You’ll not be able to sleep for weeks and maybe months, and in some cases, years. It’s not a happy feeling, waking up at 4 o’clock in the morning, thinking about the patient you’ve harmed, thinking about how their family feels.”

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REFRAMING AND NORMALIZING

Dr. Dennis Desai, a general surgeon, is director of physician support and wellness at the Canadian Medical Protective Association (CMPA), which offers advice and assistance when medico-legal difficulties arise and compensates patients when needed.

Dr. Desai agrees that a culture of perfectionism drives physicians and contributes to the shame and sometimes isolation physicians experience when a mistake has been made.

“Do we start as perfectionists or does the medical system expect perfection? I know if most of us get 80% on a test, that’s pretty good, but for physicians if they get 99.9% in the day’s chores, that’s still not good enough, because one patient may not have been diagnosed perfectly.”

The CMPA’s physician support and wellness team works with doctors who have contacted them regarding a mistake, helping them process what has happened and supporting them, whether or not there is any kind of litigation.

Dr. Desai said the first step is “reframing” the situation.

“Sometimes physicians take accountability for something that they’re not responsible for,” he said. “They wake up planning to go in and do good for the day and then harm

“It’s what you do about mistakes that defines you, not the actual mistake.”

occurs, and they are devastated. They can’t even think straight, they take responsibility for things that (may not have been their fault). We provide them that support and that understanding . . . and talk them down a bit.”

The CMPA also reviews if it is safe for them to continue working at that time, ensuring physicians have been debriefed, and can see the incident in context.

“They’re often ready to just quit, saying, ‘I can’t go on like that. I feel terrible.’ We tell them, ‘Think of your 20 years of service and how many patients you’ve helped, how much good you’ve done and will continue to do.’”

As a general surgeon who practiced for 20 years, Dr. Desai says that he too has made mistakes.

“We have to come to grips with it—we are human. We reframe it for physicians and say . . . ‘Guess what? You’re human.

We’re all human.’”

At the heart of the reframing, said Dr. Desai, is the reality that many mistakes are systemic, with more than one contributor. Perhaps there were not enough checks and balances and system approaches were lacking. He points to the airline industry, where pilots are not automatically the object of blame, and investigations examine the whole system.

MISTAKES IN AN ERA OF BURNOUT

Unfortunately, today’s reality is that stress, overwork and burnout are a part of life for many physicians. This on its own is driving an increasing number of physicians to quit or retire, and contributing to mental health issues among doctors.

When a physician makes a mistake, it compounds those stressors already in place.

“A physician who is not overworked and is doing well may make a mistake,” said Dr. Desai. “With peer support and guidance, and their own support systems, they will recover from a certain event. But when it’s compounded by burnout, overwork and stress, a physician may quit or retire, change their practice, or no longer provide that service.”

That’s a real tragedy, said Dr. Desai, and something he and

THE MEDICAL POST JUNE 2022 15

FEATURE

his team address when reframing and offering support.

Dr. Gautam agrees that for some physicians, making an error can be a tipping point, and can lead to serious mental health consequences.

“Some develop serious psychiatric symptoms, like anxiety, depression, eating disorders, substance abuse and suicidality,” said Dr. Guatam. “This is such a difficult thing to go through.

Colleagues start out in shock and can feel shame, guilt and fear. The shame makes them withdraw from others. This used to be reinforced by legal counsel years ago, but fortunately, now colleagues are encouraged to reach out to others without disclosing the details of the case.”

Regarding his TED Talk, which received more than two million views online, Dr. Goldman said: “I can tell you that residents, physicians and allied health professionals have contacted me after watching and said, ‘Thank you for doing that because I thought I was the only one.’ And that’s the thing about shame culture—people think they’re the only ones who made a mistake.”

WHEN THE INEVITABLE HAPPENS

Dr. Gautam recommends physicians who think they have made a mistake or need medico-legal assistance contact the CMPA (www.cmpa-acpm.ca, 1-800-267-6522).

She also recommends physicians accept that it will take time to process an incident, depending on how serious it was.

“Expect stages similar to grief: denial, anger/protest, sadness, acceptance, integration,” she advised. “Allow your feelings, but remember that just because you feel it does not make it true.

Know that you are not alone—it will happen to all of us at some point in our career. Reach out to family, friends (and) a trusted colleague.”

Dr. Gautam also reminds her doctor patients in this situation: • Debrief as soon as possible after the incident—minutes or hours, not days or weeks • Document what you remember of what happened • Normalize it • Stay humble and learn from it • When you are ready in the future, share with others and be available to support colleagues in the same situation “I remind them of the S words that go together: When we feel Shame, we are Silent,” said Dr. Gautam. “Yet, when we Share, we get Support the very time that we need it.”

Dr. Goldman believes that, “It’s what you do about mistakes that defines you, not the actual mistake.” He recommends talking about those mistakes, supporting others going through it, connecting with the impacted patient and their family, learning what you can from the situation and seeing that appropriate system changes are made.

In addition to reaching out to the CMPA, Dr. Desai recommends physicians seek out the organization’s many online resources, including its Physician Wellness page, and in particular, the video “The Emotional Toll of Medical-Legal issues.”

Dr. Desai said he thinks the culture of silence is slowly changing, as physicians are encouraged to speak up more and share their experiences.

“Medicine is really trying to move away from that shame and blame,” he said. “We’re looking at it as a system issue. Systems can harm people, and there may be multiple providers who are affected parties, along with, of course, the patient who’s been harmed.

“We don’t say, ‘The nurse screwed up, the physician screwed up.’ We see a system that doesn’t allow healthcare providers to do their best. So we ask, ‘How do we make the system better?’”

THE MISTAKES ISSUE

The power of critical thinking One key to preventing errors is education in critical thinking, starting in medical school and continuing throughout medical practice, according to Dr. Pat Croskerry, a professor in emergency medicine and director of the critical thinking program at Dalhousie University Medical School.

When it comes to diagnostic errors, much emphasis is placed on gaining more knowledge to fix the problem. But Dr. Croskerry says knowledge can only get you so far. “A major challenge in the diagnostic process is cognitive failure of the clinician. The human brain predictably fails in many aspects of cognition: in the interpretation of our perceptions, in our memory and recall, in our vulnerability to numerous logical fallacies and because of various cognitive and affective biases,” Dr. Croskerry wrote in a letter along with

16 JUNE 2022 THE MEDICAL POST

Dr. Mike Clancy in the British Medical Journal earlier this year.

To develop critical thinking skills and improve patient safety, Dr. Croskerry recommends that physicians read books and articles on critical thinking, decision-making and identifying biases.

He suggests learning about judgment and decision-making biases, such as overconfidence, the tendency to overestimate one’s ability or the my-side bias, where people process information in a way that is biased toward their prior beliefs and opinions. Once aware of these biases, physicians can be mindful of them and engage in self-judgment.

He also recommends that physicians make diagnosis a team effort with other members of the care team. Even just the act of discussing issues around diagnosis can help with decision-making.

He also recommends using maxims like

“always develop a differential diagnosis” or “consider the opposite,” as well as checklists, alerting diseases commonly missed.

“The most crucial factor in diagnosis is knowing something about how you think, how you are influenced by the patient, how you’re influenced by your colleagues, how you’re influenced by the environment you are working in,” he said.

“Most of the time, most of us are getting it right. But we must accept the reality of medicine, which is that it’s a highly complex and complicated business.

People have to understand just how much of the diagnostic process is vulnerable to failure. And that’s what we haven’t appreciated in the past. We haven’t talked enough about those failures. We haven’t looked at them and tried to understand them and learn from them.”

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FEATURE

Ditching the shame and blame Hospital critical incident reviews a work in progress

BY KYLIE TAGGART

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A

decade ago, Dr. Brian Goldman stood on a stage in Toronto and asked: Why don’t physicians talk about their mistakes?

“Here’s the problem: If I can’t come clean and talk about my mistakes, if I can’t find the still small voice that tells me what really happened, how can I share it with my colleagues? How can I teach them about what I did so they don’t do the same thing?” he asked as part of his TED Talk, now viewed more than two million times. Dr. Goldman is an emergency physician in Toronto and host of CBC Radio’s White Coat, Black Art. “That’s the system that we have: It’s a complete denial of mistakes.”

Whether that was the situation 10 years ago, it’s certainly not the case now.

Every hospital has always had a process for reviewing critical incidents of patient harm, but the tenor of the discussion has changed. Physicians no longer have to don a dunce cap—or a sign reading “bad doctor”—and sit in the corner, shunned. Instead of denying mistakes, there are layers upon layers of processes designed to lean into critical incidents, examine them and learn.

Even the term mistake is frowned upon, because if there is patient harm in a hospital, it is often due to a systemsrelated problem, not an individual’s error. “It is usually as a result of multiple, multiple actions or inactions,” explained

Dr. Lucas Chartier, an emergency physician and medical director of quality and safety at the University Health Network (UHN) in Toronto.

PROTECTING MEANINGFUL CONVERSATIONS

Legislation has helped shift the culture from finger-pointing to quality improvement. Since Dr. Goldman’s TED Talk, Canadian provinces and territories have made progress in mandating elements of critical incident reviews in hospitals, such as what must be reported and what must be disclosed. Legislation also allows physicians to apologize and share information without fear of it being used in legal proceedings.

THE MEDICAL POST JUNE 2022 19

FEATURE

Dr. Chartier said a piece of Ontario legislation, called the Quality of Care Information Protection Act (QCIPA), plays a role in helping healthcare professionals feel safe when discussing critical incidents. It ensures that information shared during critical incident reviews can’t be used in legal proceedings.

UHN invokes QCIPA in all critical incident reviews. “The fact that it is protected under the auspices QCIPA allows providers to feel safe—and that’s the whole point of QCIPA, to be able to engage in these meaningful discussions in a way where they don’t feel repercussions, whether it is medical, legal or employment-based,” Dr. Chartier said. Otherwise, healthcare professionals wouldn’t participate and it would nullify the benefit they could potentially glean from the reviews.

In April 2021, Healthcare Excellence reviewed patient safety legislation across Canadian provinces and territories.

“That legislation has commonalities but is not exactly the same everywhere,” explained Jennifer Zelmer, president and CEO of Healthcare Excellence, a body formed a year ago to bring the Canadian Patient Safety Institute and Canadian Foundation for Healthcare Improvement together under one roof.

Quality assurance legislation like QCIPA, that prevents information from critical incident reviews from being used in legal proceedings, is in place in all Canadian jurisdictions, but Healthcare Excellence noted several areas where it can be improved. It called for more clarification on what information revealed in the critical incident review process is protected and what is not.

Harmonizing these laws across the country would benefit patients by bringing clarity and consistency to the critical incident review process.

For example, while quality assurance legislation still allows findings from critical incident reviews to be disclosed to affected patients and their families, there’s the tricky issue of how far transparency goes. In a publicly funded healthcare system, the public is understandably invested in patient safety incidents, but how far the information

20 JUNE 2022 THE MEDICAL POST

The focus is on making sure everyone feels safe in discussing quality and safety issues.

flows must be well-defined in legislation to protect patients and providers alike.

Another piece of legislation that allows physicians to speak freely focuses on apologies. In 12 out of 13 jurisdictions in Canada, the legislation is the same: an apology is not an admission of fault or liability. This means healthcare professionals can express sympathy without it being taken legally as an admission of culpability. The thinking is that this not only improves communication, but leads to quicker resolutions, Healthcare Excellence notes in their report. Only the Yukon has no legislation protecting apologies.

EFFECTIVE CRITICAL INCIDENT REVIEWS

Despite laws regulating certain aspects of critical incident reviews, how the reviews are carried out often differs from hospital to hospital. For example, in Saskatchewan, the amalgamation of 12 former health regions has meant there’s a lot of variation on how critical incident reviews are conducted. It’s something the Saskatchewan Health Authority (SHA) is actively working to change. “We recognize the opportunity to standardize processes provincially and this is our focus over the next one to two years,” the SHA told the Medical Post.

Hospitals and health authorities can look to the Canadian Incident

Analysis Framework, which outlines best practices on understanding what happened, how it happened, why it happened, and what can be done to reduce the risk of recurrence to make care safer. The World Health Organization also has guidelines on how to conduct a review. Yet there is no one set way to analyze an incident: the Canadian framework includes multiple methods to use when conducting a critical incident analysis. The outcome of the incident is only one factor that decides what method is used, explained a spokesperson for Alberta Health Services (AHS).

“The general process for reviewing events has not changed fundamentally, although, recently it has been recognized that alternative review methodologies or processes other than the traditional approaches could support quality improvement and learning as they take more of a non-linear and systems-based view,” she said. The focus is on making sure everyone feels safe in discussing quality and safety issues.

At the UHN, reports of critical incidents land on several desks, including the staff involved in the incident and the health quality and safety team. A review happens quickly with team members—when memory of the incident is fresh—and then the case may go on to a more formal analysis.

“There are multiple layers depending on the specifics of the case,” Dr. Chartier said. “There will be an interprofessional discussion and then we will determine the root causes of the issues and if there are opportunities for recommendations for the hospital, for the providers, for the system: we try to be as fulsome as possible.”

Including as many perspectives as possible also helps capture the best understanding of the event, the AHS spokesperson reported. This includes hearing the patient’s point of view.

“There has been a fair bit of learning in that set of processes,” Zelmer said.

“There’s also typically more involvement of patients and families now, in the vein of ‘nothing about us without us.”’

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FEATURE

evaluate an individual’s performance, the AHS spokesperson noted. The World Health Organization’s (WHO) guidelines note that successful reviews must shine the spotlight on systems and processes rather than on individual performances.

Improvement of patient safety cannot exist if there’s fear and blame, Zelmer explained. “It is being able to understand what does a safe and just culture look like, that marries learning and accountability and engagement all together.”

Learning should always be the outcome of a critical incident review. In that light, near-misses or “good catches” could also be analyzed. In 2009, the WHO suggested that near-misses in maternal death should be scrutinized for learning opportunities as well as true incidents of maternal death. This can lead to a better understanding of what contributes to actual or potential harm, and can inform changes to improve patient safety.

Like diagnosis without treatment, analyzing a critical incident alone does not result in patient safety. It’s only when hospitals adopt recommendations that better outcomes can occur.

Some could be very floor- or clinicspecific recommendations of a systems change, while others may affect the larger healthcare system. Healthcare Excellence works with many partner groups to help spread the word on best practices for patient safety. Zelmer notes that patient safety starts with good design, not luck.

IMPROVING THE PROCESS

The work to improve the critical incident review process is ongoing. The SHA just completed guidance for clinical leaders on post-critical incident analysis disclosure, helping them with follow-up conversations with patients and family.

SHA has also revised three provincial policies about critical incident reporting, disclosure and responses set to go out for broader consultation.

The UHN is currently working on how to incorporate non-physical harm into their model of patient safety. “We have a renewed focus that there are significant other emotional, psychological harms—community harm as well, with patients who go back to their community and may have had trauma as a result of their experiences,”

Dr. Chartier said. “How can we best capture this in a way that will be fulsome and wholesome to the patient experience and allow us to improve not only the medical care that we provide, but on all of the other aspects that have an impact on patients?”

There’s also a renewed push to help those involved in the incident. A critical incident or a near-miss weighs heavy on healthcare professionals, as Dr. Goldman recounted in his TED Talk. Zelmer said this toll on healthcare workers is being recognized. “There’s an emerging focus on healing after harm, not just what happened at the time, but how can we look forward in terms of healing for all of the individuals who might have been involved in the incident.”

The changes in the critical incident review process have perhaps increased the number of incidents or near-misses reported at the UHN, Dr. Chartier said.

Whereas five to 10 years ago, these scenarios may have gone unreported, “I think now we have a culture of safe reporting where people believe that the over-reporting of events is something that is going to lead to better care for all,” he said.

THE MISTAKES ISSUE

How to talk to patients and their families when you’ve made a mistake Physicians used to be advised to be careful in apologizing to patients for errors as it could be used against them legally. But all Canadian jurisdictions, with the exception of Yukon, have now adopted “apology legislation.”

“If a physician has actually caused that harm, absolutely we recommend apology,” said Dr. Dennis Desai, director of physician support and wellness at the CMPA. “That’s the best way for the patient, the family, and the provider to move forward,” he said.

“And it’s the right thing to do.”

As outlined on the CMPA website, the legislation means that an apology: • does not constitute an admission of fault or liability • must not be taken into consideration in determining fault or liability • is not admissible as evidence of fault or liability What is the best way to approach an apology?

The CMPA shares detailed guidelines on its website, called “Disclosure of Patient Safety Incidents—Good Practices.”

In a nutshell, said Dr. Desai, a patient apology involves “sitting down, taking the time, making eye contact, discussing the events

22 JUNE 2022 THE MEDICAL POST

with empathy and compassion and letting them know that you’re going to help them and be with them.

“If you’ve caused harm, then be frank and say, ‘I apologize. I made this diagnosis and it was an error given this evidence,’ or whatever it is. But, there’s no point belabouring it. The patient just wants to connect with you, know that you care.”

At the same time, Dr. Desai cautions that physicians often take responsibility when it is a system problem, not their sole responsibility. “Apologize when appropriate, but an apology may be incomplete on its own. Patients often say, ‘I don’t want this to happen to anyone else.’ Consider investigating the situation and coming back to patients . . . explaining why it won’t happen again.”

Ottawa psychiatrist Dr. Mamta Gautam, who treats physicians, said: “We feel guilt, and want to apologize to make it better.”

In the face of a mistake, she said she teaches colleagues the 4 As: • Agree/Admit—that a mistake occurred • Acknowledge—the impact on the patient and family • Apologize—for what has occurred • Act—to make things better “Colleagues will come back to tell me how well that works, and how much better it helped them feel,” Dr. Gautam said. “They tell me they were able to have a difficult conversation with the patient, and hope to move forward with them to address it.”—LOUISE LEGER

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SUNOSI 150 mg: -5.4, p < 0.0001d (95% CI: -3.8 (-5.6, -2.0))

A negative change from baseline represents improvement in excessive daytime sleepiness.

a mITT Population included all randomized patients who received at least one dose of study medication and had a baseline and at least one post-baseline evaluation of the MWT or ESS. b Statistically significant difference between SUNOSI and placebo based on the pre-specified hierarchical testing strategy and after adjusting for multiplicity. c The MWT co-primary endpoint failed to show a statistically significant difference (a=0.05) between SUNOSI and placebo, based on the pre-specified hierarchical testing strategy. d Statistically significant difference between SUNOSI and placebo based on the pre-specified hierarchical testing strategy and after adjusting for multiplicity at a=0.05. e The percentage of patients improved on the PGIc includes those who reported very much, much and minimal improvements.

MWT=Maintenance Wakefulness Test; LS Mean = Least Square Mean; Difference From Placebo = LS Mean Difference on change from baseline between active drug and placebo.

* Efficacy was assessed by two co-primary endpoints: change from baseline in mean sleep latency measured by the MWT and mean ESS total score at Week 12. The MWT measures an individual’s ability to remain awake during the daytime, based on the duration of sleep latency (i.e., time to sleep onset) when placed in a darkened, quiet environment. The ESS is a validated 8-item questionnaire by which patients rate their perceived likelihood of falling asleep in usual daily life activities. The total score ranges from 0 to 24, with higher scores reflecting greater sleepiness. † TONES 3: 12-week, multi-centre, randomized, double-blind, placebo-controlled, parallel-group trial conducted in adults with OSA. 474 patients were randomized in a 1:1:2:2:2 ratio to receive SUNOSI 37.5 mg (n=56), 75 mg (n=58), 150 mg (n=116), 300 mg (n=115) or placebo (n=114) once daily.1 The maximum recommended daily dose is 150 mg. Dosages above 150 mg daily do not confer increased effectiveness sufficient to outweigh dose-related adverse reactions. ‡ TONES 2: 12-week, randomized, double-blind, placebo-controlled, parallel-group trial conducted in adults with narcolepsy (with or without cataplexy). 236 patients were randomized in a 1:1:1:1 ratio to receive SUNOSI 75 mg (n=59), 150 mg (n=60), 300 mg (n=60) or placebo (n= 60) once daily.1 The maximum recommended daily dose is 150 mg. Dosages above 150 mg daily do not confer increased effectiveness sufficient to outweigh dose-related adverse reactions. ¶ The PGIc is a 7-point scale ranging from “very much improved” to “very much worse,” which assesses the patient’s report of change in symptoms and clinical condition relative to the start of the study.

QA What is the recommended dosing for SUNOSI? OSA The recommended starting dose is 37.5 mg once daily, upon awakening. Depending on clinical response and tolerability, the dose can be titrated to a higher level by doubling the dose at intervals of at least 3 days. The recommended maximum daily dose is 150 mg once daily. Doses above 150 mg once daily did not confer additional benefit to outweigh dose-related adverse events.1 Narcolepsy The recommended starting dose is 75 mg once daily, upon awakening. Depending on clinical response and tolerability, the dose can be titrated to a higher level by doubling the dose after an interval of at least 3 days. The recommended maximum daily dose is 150 mg once daily. Doses above 150 mg once daily did not confer additional benefit to outweigh dose-related adverse events.1 • Administer SUNOSI orally upon wakening, with or without food. Avoid taking SUNOSI within 9 hours of planned bedtime because of the potential to interfere with sleep if taken too late in the day.1 • SUNOSI can be taken with or without food.1 • Prior to initiating treatment, assess blood pressure and heart rate and ensure that blood pressure is adequately controlled.

Monitor blood pressure and heart rate, during titration and periodically during treatment.1 See the Product Monograph for complete information on dosing and administration considerations, including for patients with renal impairment.

What is the safety profile for SUNOSI? SUNOSI has as an established safety and tolerability profile. In the pooled 12-week placebo-controlled clinical trials in OSA and narcolepsy, the most common treatment emergent adverse events reported in patients treated with SUNOSI 37.5 mg/day (OSA only), 75 mg/day or 150 mg/day (incidence ≤2% and greater than placebo) were: headache (11.1%), decreased appetite (6.8%), nausea (6.6%), anxiety (4.3%), diarrhea (4.0%), dry mouth (3.5%), insomnia (3.3%) and dizziness (2.3%).1 The maximum recommended daily dose is 150 mg. Dosages above 150 mg daily do not confer increased effectiveness sufficient to outweigh dose-related adverse reactions.

Dosing of 37.5 mg/day is only recommended for OSA patients.

• The definitions for headache (i.e., headache=‘headache’, ‘tension headache’ and ‘head discomfort’) and insomnia (i.e., insomnia=‘insomnia’, ‘initial insomnia’, ‘middle insomnia’ and ‘terminal insomnia’) as per the Product Monograph.

• Patients with myocardial infarction within the past year, unstable angina pectoris, uncontrolled hypertension, serious cardiac arrhythmias and other serious heart problems were excluded from the clinical studies.

Potential for abuse1 • The potential for abuse should be considered when prescribing SUNOSI. Physicians should carefully evaluate patients for a history of drug abuse, especially those with a history of drug/stimulant abuse (e.g., methylphenidate, amphetamine or cocaine) or alcohol abuse, and follow such patients closely. Patients should be observed for signs of misuse/abuse (e.g., incrementation of doses or drug-seeking behavior).

• In an open-label, cross-over human abuse potential study in subjects with a history of alcohol and drug/stimulant abuse, on average, the peak Drug Liking (VAS) scores for SUNOSI (300 mg, 600 mg and 1200 mg) were significantly greater than placebo, similar to phentermine 45 mg and lower than phentermine 90 mg. All three SUNOSI doses had lower Overall Drug Liking scores compared to both phentermine doses. Based on a scale, interpreted as a measure of euphoric effects, both doses of phentermine and all doses of solriamfetol showed statistically significant greater effects compared to placebo. The maximum recommended daily dose is 150 mg. Dosages above 150 mg daily do not confer increased effectiveness sufficient to outweigh dose-related adverse reactions.

Dependence/withdrawal1 • Abrupt discontinuation of SUNOSI was evaluated in a long-term trial as well as during the two-week follow up periods of phase 3 controlled studies. The available data do not suggest physical dependence or a consistent pattern of withdrawal symptoms.

See the Product Monograph for complete details on dose-dependent adverse events, drug-drug interactions and other safety information.

Clinical use: Pediatrics (<18 years): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.

• with myocardial infarction within the past year, unstable angina pectoris, uncontrolled hypertension, serious cardiac arrhythmias and other serious heart problems.

• who have end-stage renal disease.

Relevant warnings and precautions: • The potential for abuse should be considered when prescribing SUNOSI. Physicians should carefully evaluate patients for a history of drug abuse, especially those with a history of drug/stimulant abuse (e.g., methylphenidate, amphetamine or cocaine) or alcohol abuse, and follow such patients closely. Patients should be observed for signs of misuse/abuse (e.g., incrementation of doses or drug-seeking behavior).

• Exercise caution when treating patients at higher risk of MACE, particularly patients with known cardiovascular and or cerebrovascular disease, pre-existing or hypertension and patients with advanced age. Use caution when treating patients with SUNOSI, who are also taking other drugs that increase blood pressure and heart rate.

• Patients with excessive daytime sleepiness, including those taking solriamfetol, should be frequently reassessed for their degree of sleepiness and, if appropriate, advised to avoid driving or any other potentially dangerous activity, especially at the start of the treatment or when the dose is changed.

• Mydriasis may occur in patients taking SUNOSI. Caution is advised in patients with increased ocular pressure or risk of angle closure glaucoma.

• Patients should be monitored for adverse reaction such as anxiety, insomnia and irritability, which may exacerbate pre-existing psychiatric disorders or symptoms.

• SUNOSI is not recommended during pregnancy or in women of childbearing potential not using effective contraception.

• Decisions regarding breast-feeding and continued use of SUNOSI must consider the potential benefit to the patient as well as the risk to the breast-feeding infant.

Breastfed infants should be monitored for adverse events such as, but not limited to, agitation, insomnia, anorexia, reduced weight gain, diarrhea and constipation.

For more information: Consult the SUNOSI Product Monograph at: https://www.axsome.com/sunosi-product-monographen-ca.pdf for important information relating to adverse reactions, drug interactions, and dosing information that have not been discussed in this piece. The Product Monograph is also available by calling our medical department at: 1-888-858-9666.

References 1. SUNOSI Product Monograph, Axsome Malta Ltd., August 24, 2022.

2. Schweitzer PK, Rosenberg R, Zammit GK, et al. Solriamfetol for excessive sleepiness in obstructive sleep apnea (TONES 3).

Am J Respir Crit Care Med 2019;199(11):1421–1431.

3. Thorpy MJ, Shapiro C, Mayer G, et al. A randomized study of solriamfetol for excessive sleepiness in narcolepsy.

Ann Neurol 2019;85:359–370.

SUNOSI® is a registered trademark of Axsome Malta Ltd. or its affiliates .

Geriatrics (>65 years): Limited data are available from patients 65 years of age or older. Physicians who choose to treat geriatric patients with SUNOSI should consider treatment in the context of greater frequency of reduced renal function, other concomitant diseases and concomitant drug therapies, which may necessitate dose adjustments and additional or more frequent monitoring.

Contraindications: SUNOSI is contraindicated in patients: • who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.

• who are receiving concomitant treatment with monoamine oxidase inhibitors (MAOI) or within 14 days after MAOI treatment has been discontinued due to the risk of hypertensive crisis.

This Q&A is published by Ensemble IQ, 20 Eglinton Avenue West, Suite 1800, Toronto, ON M4R 1K8, Telephone: 416-256-9908.

No part of this Q&A may be reproduced, in whole or in part, without the written permission of the publisher. © 2022

FEATURE

Complaints and resolutions: by the numbers A cross-Canada look at seven provinces

BY MARJO JOHNE

•

•

•

the previous year—and 988 complaints concluded.

Of the complaints concluded, close to 50% were about clinically related conduct—such as case management, diagnosis and surgical complications— while just over 40% had to do with physician’s conduct. About one-third of these conduct-related complaints were focused on a communication issue.

Just over half of the 988 concluded cases resulted in little or no criticism, while about 40% led to advice or written criticism. Remediation with consent occurred in 66 cases, while either a reprimand or citation was issued in 13 cases. Four cases resulted in consent agreements. Thirty-four were withdrawn or abandoned, and six were dismissed by the registrar.

The highest cost ever imposed on a doctor in B.C. was $75,000.

NEW BRUNSWICK We’ve gathered data on patient complaints and investigations from select physician regulators across the country.

ALBERTA

11,153 registered physicians Annual licensing fee $1,792 (after a onetime fee deduction) • The College of Physicians and Surgeons of Alberta saw its total number of complaints decrease over the last three years—from 857 complaints received in 2019 to 617 in 2021.

• In 2021, 311 complaints were directed to investigations and 23 hearing tribunals were convened. Once a file goes into investigation and—if it warrants it—into hearing, it can take between 150 days to almost 1,000 days for a file to close.

• What patients seem to complain about the most has stayed consistent over the last five years, with quality of care topping the list based on the nature of complaints, followed by practice management, medical reporting and ethics.

• The highest cost that the CPSA has ever imposed on a physician was $717,421—costs associated with a merit hearing, a sanction hearing and an appeal to council.

BRITISH COLUMBIA

14,564 registered physicians Annual licensing fee $1,725 • In 2021, the College of Physicians and Surgeons of British Columbia saw 1,046 complaints filed—up from 993 in

26 JUNE 2022 THE MEDICAL POST

1,830 registered physicians (2020) Annual licensing fee $580 • It was a “very different year” in 2021 for the Picture Province, which saw a 50% increase in patient complaints from the previous year (which saw 45 complaints). “And most of these weren’t specific to COVID, more a general irritability among patients and docs,” said Dr. Ed Schollenberg, registrar for the College of Physicians and Surgeons of New Brunswick.

• Quality of care has consistently been the top reason why patients in New Brunswick complain, according to statistics that date back to 2013.

Complaints rarely advance to a formal inquiry—many conclude with counsel or caution and a very few with censures.

• Four guilty findings were handed down between 2013 and 2020, a period that saw 381 complaints and four formal inquiries.

NEWFOUNDLAND AND LABRADOR

1,451 registered physicians Annual licensing fee $1,850 • The College of Physicians and Surgeons of Newfoundland and Labrador received 103 complaints in 2021—a significant jump from the previous year, which saw 63 complaints. Of the 2021 total, 80% were investigated, 20% were resolved at the initial stage and 5% were referred to the discipline panel.

• In the past 10 years, the highest cost imposed on a physician in Newfoundland and Labrador was $75,000. The median number of months from receipt of a complaint to final decision has ranged from 12 to 14 months in recent years.

NOVA SCOTIA

2,961 registered physicians Annual licensing fee $1,950 • In its 2021 annual report, the College of Physicians and Surgeons of Nova Scotia noted a 44% increase in volume of complaints from the previous year— an indication, wrote the college, of the pressures building in the healthcare system and not necessarily a reflection of the quality of care in the province.

• The CPSNS received 417 complaints in 2021, compared to 289 in 2020 and 205 in 2016. Just under one-third of the complaints in 2021 had to do with communication, while a similar percentage were about quality of care or treatment. Complaints about ethics and medical reporting each account for about 15% of complaints in 2021.

• Of the 359 complaints closed in 2021, 151 were dismissed by the registrar and 89 were dismissed by the investigation committee. Four ended in suspension of the physician’s registration, six with consensual retirement and one with consensual revocation. Forty-one complaints were withdrawn.

ONTARIO

44,223 registered physicians Annual licensing fee $1,725 • The latest available data from the College of Physicians and Surgeons of Ontario show 3,483 complaints received in 2020—a decrease of 281 from the previous year. These complaints were directed at 2,832 of the province’s 44,223 registered physicians.

• Close to 77% of complaints in 2020 were related to clinical practice, while 42% had to do with professionalism and 7% with practice management.

• Almost half of all 2020 complaints were dealt with by early resolution and 34% required no action. Just under 15% led to advice or remedial agreement and 5% to a caution or undertaking. A mere 1% was referred to the discipline tribunal.

• All 46 discipline tribunal cases completed in 2021 were proven in favour of the complainant.

QUEBEC

22,247 registered physicians Annual licensing fee $1,625 • Between 2020 and 2021, the Collège des médecins du Québec received 1,544 complaints and completed 1,582 investigation requests. Of the latter, 486 were deemed to be ineligible requests, and 176 were withdrawn or abandoned by the complainant. A total of 12 complaints were filed with the disciplinary board.

• The largest fine ever imposed on a physician in Quebec was $106,000.

PRECISION WHERE IT MATTERS. PERFORMANCE IN

ACNE CARE.

The 1st topical retinoid indicated to treat facial and truncal acne.1-3 • Trifarotene molecule precisely binds to the most relevant RAR in acne (RAR-ɣ)1 • Patients may see significant results in facial acne in four weeks 3 • Patients reported substantial improvements in self-confidence, social life, and emotional well-being4 with improvement of their acne www.AKLIEF.ca Indication and clinical use: AKLIEF® (trifarotene 50 mcg/g) cream is indicated for the topical treatment of acne vulgaris of the face and/or trunk in patients 12 years of age and older.

Safety and effectiveness have not been established in geriatric patients (≥65 years).

Contraindications: • Eczema or seborrheic dermatitis • Pregnancy or women planning a pregnancy Most serious warnings and precautions: • For external use only, not for ophthalmic use • Pregnancy or planning a pregnancy: Rare reports of birth defects associated with topical retinoids during pregnancy. Women of child-bearing potential should be informed of potential risks and use effective birth-control measures

Other relevant warnings and precautions: • Discontinue use if allergic/hypersensitivity reactions occur • Avoid contact with eyes, lips, angles of the nose, mucous membranes, abraded skin, open wounds, cuts, and eczematous and sunburned skin • Avoid use of other dermatologic medications and potentially irritating topical products that have a strong skin-drying effect and products with high concentrations of alcohol, astringents, spices, or limes • Non-comedogenic cosmetics should be used • Treatment area should not be covered with dressings or bandages • Weather extremes, such as wind or cold, may be more irritating • Exposure to excessive sunlight, including sunlamps, should be avoided or an effective sunscreen and protective clothing are recommended

• Certain cutaneous signs and symptoms can be expected with use • Use of electrolysis, “waxing,” and chemical depilatories for hair removal should be avoided • Caution when taking drugs with known photosensitizers • Avoid use on chest during breastfeeding For more information: Please consult the AKLIEF® Product Monograph at https://pdf.hres.ca/dpd_pm/00054047.

PDF for important information relating to adverse reactions, interactions, and dosing information, which have not been discussed in this advertisement.

The Product Monograph is also available by calling us at 1-800-467-2081.

References: 1. AKLIEF® Product Monograph. Galderma Canada Inc. November 25, 2019. 2. Aubert J, et al. Nonclinical and human pharmacology of the potent and selective topical retinoic acid receptor-γ agonist trifarotene. Br J Dermatol.

2018;179(2):442-456. 3. Tan J, et al. Randomized phase 3 evaluation of trifarotene 50 μg/g cream treatment of moderate facial and truncal acne. J Am Acad Dermatol. 2019;80(6):1691-1699. 4. Blume-Peytavi U, et al. Long-term safety and efficacy of trifarotene 50 μg/g cream, a first-in-class RAR-γ selective topical retinoid, in patients with moderate facial and truncal acne. J Eur Acad Dermatol Venereol. 2021;34(1):166-173.

RAR-ɣ, retinoic acid receptor gamma AKLIEF® is a registered trademark of Galderma Canada Inc. Galderma Canada Inc. Thornhill, Ontario CA-AFC-2100112

Considering NORVASC? Hypertension NORVASC (amlodipine besylate) is indicated for the treatment of mild to moderate essential hypertension.

Combination of NORVASC with a diuretic, a beta-blocking agent, or an angiotensin converting enzyme inhibitor has been found to be compatible and showed additive antihypertensive effect.

Chronic stable angina NORVASC is indicated for the management of chronic stable angina (effort-associated angina) in patients who remain symptomatic despite adequate doses of beta-blockers and/or organic nitrates or who cannot tolerate those agents. NORVASC may be tried in combination with beta-blockers in chronic stable angina in patients with normal ventricular function. When such concomitant therapy is introduced, care must be taken to monitor blood pressure closely since hypotension can occur from the combined effects of the drugs.

When you purposely prescribe the Viatris original brand NORVASC, help your patient get it.

Some insurers limit full-cost coverage for higher-cost interchangeable drugs to patients who meet certain criteria, and in some instances, documentation from the prescriber is required. There is a possibility that the patient may need to contribute out-of-pocket where those conditions are not met.

1 2

3

Write the Viatris original brand name, NORVASC, and include “no sub,” when appropriate, on your patient’s prescription.

Encourage your patients to visit ViatrisOriginals.ca so they can: • Download a payment assistance card to help patients who have no insurance or whose insurance co-payment amount might be a barrier to obtaining the Viatris original brand medication. This card can help patients obtain the Viatris original brand medication at little or no additional cost compared to the generic version.* Remind your patient to ask for the Viatris original brand NORVASC at the pharmacy.

Consult the Product Monograph at https://pfizer.ca/pm/en/NORVASC.pdf for contraindications, warnings, precautions, adverse reactions, interactions, dosing, and conditions of clinical use. The Product Monograph may also be obtained by calling 1-800-463-6001.

Viatris and the Viatris logo are trademarks of Mylan Inc., licensed use by Upjohn Canada ULC, a Viatris Company. © 2022 Viatris Inc. All rights reserved.

NORVASC is a registered trademark of Viatris Specialty LLC, licensed use by Upjohn Canada ULC, a Viatris company.

ViatrisOriginals.ca

NORV-2022-0204E - AL2022

* Subject to change. The Viatris Originals Program is available in all provinces except Quebec.

Availability and level of payment assistance vary by brand medication and province.

FEATURE

Preventing mistakes

Common language, increased communication and situational awareness central to Caring Safely program

Getty Images

W

BY ABIGAIL CUKIER

hen an emergency room physician at University Health Network in Toronto asks a nurse to provide a 50-milligram dose of medication, they will say “Five-Zero” instead of “50” to ensure the proper number is heard and prevent underdosing or overdosing.

When spelling the name of a patient or a medication, they will use the NATO alphabet (Alpha, Bravo, Charlie) to ensure clarity for whoever is listening.

In an urgent situation, they are trained to pause and think of STAR (Stop, Think, Act, Review). This reminds them to slow down and ensure they have the right patient and the right equipment.

“These may appear to be trivial, but if you magnify 17,000 employees and thousands of patients who are cared for every day and communications that are a little bit imperfect, if you magnify this by the volume, that’s where mistakes can happen,” said Dr. Lucas Chartier, deputy medical director of the emergency department and medical director of quality and safety at UHN. “None of these examples will make a magical difference to our overall system. But if you have one extra person doing one extra thing for one patient, that leads to the prevention of harm.

It’s time and resources well spent.”

The steps ER staff take are part of a UHN-wide program called Caring Safely. Implemented in 2015 in partnership with the Hospital for Sick Children, Caring Safely has one goal: to reduce the number of preventable harmful events to zero.

UHN is facing the same challenge as hospitals, doctors’ offices, nursing homes and pharmacies across the country— how to prevent medical errors.

DAILY SAFETY HUDDLE

Jennifer Zelmer, president and CEO of Healthcare Excellence Canada, says while the number of incidents has remained stable over the past few years, over the longer term, there have been improvements to hospital safety due to efforts focused on specific areas, such as preventing post-operative infections.

Zelmer said further improvement will come through measuring and monitoring adverse events and reviewing “good catches.”

“Once we identify and understand what contributed to these events, we can reduce risk. And then we can shift to a more proactive approach by creating a culture of safety instead of just responding to history,” Zelmer said.

This is the goal of UHN’s Caring Safely, which borrowed principles from organizations such as airlines, nuclear power plants and chemical facilities.

“The goal was to fundamentally change how we approach issues and improvements and how we review adverse events. It was also to create more situational awareness to prevent these events from happening. Having tools and a common language across the organization allows us to be a high-reliability organization,” Dr. Chartier said.

When creating the program, the health network focused on some common preventable hospital-acquired conditions, including C. difficile, central line infections, adverse events from medications, surgical site infections, bedsores and falls.

UHN also focused on workplace safety for its staff including musculoskeletal injuries, workplace violence and falls.

Specific steps were created for each of these situations.

THE MEDICAL POST JUNE 2022 29

Advertisement

SUVEXX®: ONE pill that takes on migraine attacks with BOTH a triptan and an NSAID1 SUVEXX (sumatriptan succinate and naproxen sodium) is indicated for the acute treatment of migraine attacks with or without aura in adults.1 2-in-1 SUVEXX

Formulated with a triptan and an NSAID fixed-dose combination:1 • Triptan – sumatriptan 85 mg • NSAID – naproxen sodium 500 mg

Demonstrated efficacy in migraine pain relief

% of patients who achieved headache pain relief at 2 hours post-dose

SUVEXX demonstrated pain relief at 2 hours post-dose in a single-dose study.1,2*† 2 hour headache pain relief

70% – 60% –

SUVEXX

65%

Placebo

50% –

p< 0.001 vs. placebo

40% – 30% –

28%

62% – 10% – 0% –

Adapted from Product Monograph.

% of patients with sustained pain-free response 2 to 24 hours after dosing

SUVEXX delivered sustained pain-free (2-24 hour) response (secondary endpoint)1,3‡§

45 – 40 –

Sustained 2-24 hour pain-free response (secondary endpoint)

45%

SUVEXX Placebo

p< 0.001 vs. placebo

35 – 30 – 25 – 20 – 15 – 10 –

12%

5– 0–

(n = 280)

(n = 296)

Adapted from Product Monograph.

• 45% of patients who were pain free at 2 hours post-dose, remained pain-free at 24 hours without the use of additional rescue medication.

Pharmacokinetics—Median Tmax¶

• Median Tmax for sumatriptan when given as a component of SUVEXX was 1 hour (range 0.3 to 4 hours) versus a median Tmax of 1.5 hours for sumatriptan succinate 100 mg alone.1 • Median Tmax of the naproxen when given as SUVEXX was 6 hours (range 0.3 to 12 hours), approximately 5 hours later than from naproxen sodium tablets (550 mg).1 Tmax =time to maximum plasma concentration

Recommended dose: 1 tablet1£

COUNSELLING TIPS

▶ It is advisable that SUVEXX be taken as early as possible during the migraine attack. SUVEXX is effective when administered at any stage of the attack.

▶ Maximum recommended dosage in a 24-hour period is 2 tablets, taken at least 2 hours apart.

▶ Tablets should not be split, crushed or chewed. ▶ SUVEXX can be taken with or without food.

See Product Monograph for complete dosing and administration information.

Clinical use: SUVEXX is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic, basilar, or ophthalmoplegic migraine. Safety and efficacy of SUVEXX has not been established for cluster headache, which is present in an older, predominantly male population.

SUVEXX should only be used if a clear diagnosis of migraine headache has been established.

(n = 1461)

• Significantly more SUVEXX patients achieved 2-hour headache pain relief vs. placebo (p<0.001).1,2 • SUVEXX significantly decreased migraine associated symptoms of photophobia and phonophobia at 2 hours postdose vs. placebo:2 ▶ Photophobia: SUVEXX 58% vs. placebo 36%, p < 0.001 ▶ Phonophobia: SUVEXX 61% vs. placebo 38%, p < 0.001

50 –

Dosing

The safety and efficacy of SUVEXX in pediatric patients (<18 years) and the elderly population (>65 years of age) have not been established. SUVEXX is not indicated for use in pediatric patients.

Contraindications: • Ischemic coronary artery disease (CAD) (angina pectoris, history of myocardial infarction, or documented silent ischemia) or coronary artery vasospasm, including Prinzmetal’s angina.

• In the setting of coronary artery bypass graft surgery.

• Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders.

• History of stroke or transient ischemic attack or history of hemiplegic, basilar, or ophthalmoplegic migraine because these patients are at a higher risk of stroke.

• Peripheral vascular disease.

• Ischemic bowel disease.

• Uncontrolled hypertension.

• Recent use (i.e., within 24 hours) of ergotamine-containing medication, ergottype medication (such as dihydroergotamine or methysergide), or another 5-hydroxytryptamine1 agonist.

• Concurrent administration of a monoamine oxidase (MAO)-A inhibitor or recent (within 2 weeks) use of an MAO-A inhibitor.

• History of asthma, urticaria, or allergic-type reactions after taking acetylsalicylic acid (ASA) or other nonsteroidal anti-inflammatory (NSAID).

Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients. The potential for cross-reactivity between different NSAIDs must be kept in mind.

• Third trimester of pregnancy because of risk of premature closure of the ductus arteriosus and prolonged parturition.

• Breastfeeding women.

• Moderate or severe hepatic impairment or active liver disease.

• Severe uncontrolled heart failure.

• Active gastric/duodenal/peptic ulcer, active GI bleeding.

• Cerebrovascular bleeding or other bleeding disorders.

• Inflammatory bowel disease. * Randomized, phase 3, double-blind, parallel-group, single-dose study of 1,461 patients with acute migraine with or without aura utilizing placebo and each individual active component of SUVEXX as comparisons (SUVEXX, n=370; placebo, n=365; sumatriptan succinate 85 mg, n=365; naproxen sodium 500 mg, n=361). Co-primary endpoints were superiority of SUVEXX over placebo at 2h post-dose for the following endpoints: pain relief (no or mild pain); incidence of photophobia, phonophobia and nausea; and superiority of SUVEXX vs. the individual components for sustained pain-free at 24 hours. † Headache relief was defined as a reduction in headache severity from moderate to severe pain to mild or no pain. ‡ In a randomized, double-blind, parallel group, placebo controlled, single attack study of patients with a migraine attack with or without aura (n=576). SUVEXX or placebo was taken within 1 hour of onset of migraine head pain and while pain was mild. Rescue medication was allowed at any point 2 hours after study drug ingestion. The primary endpoint was the percentage of patients who became pain-free (grade 0 on pain scale with no rescue) 2 hours after treatment. Secondary endpoints included the percentage of patients who were pain-free at 0.5, 1, and 4 hours post-dose. § Defined as pain-free at 2 hours with no return of pain or use of rescue medication through 24 hours. ¶ Comparative clinical significance has not been established. £ The safety of treating an average of more than 5 migraine headaches in a 30-day period has not been established. See the Product Monograph for complete dosing and administration instructions.

This Counselling Corner is published by Ensemble IQ, 20 Eglinton Avenue West, Suite 1800, Toronto, ON M4R 1K8, Telephone: 416-256-9908. No part of this Counselling Corner may be reproduced, in whole or in part, without the written permission of the publisher. © 2022

FEATURE • •

Severe renal impairment (creatinine clearance <30 mL/ min or 0.5 mL/ sec) or deteriorating renal disease (individuals with lesser degrees of renal impairment are at risk of deterioration of their renal function when prescribed NSAIDs and must be monitored).

Known hyperkalemia.

Most serious warnings and precautions: Risk of cardiovascular adverse events: Sumatriptan, a component of SUVEXX, can cause coronary artery vasospasm. SUVEXX is contraindicated in patients with uncontrolled hypertension, ischemic CAD, cardiac arrhythmias, and those with history of myocardial infarction. SUVEXX is not recommended in patients with family history or risk factors predictive of CAD. Naproxen sodium, a component of SUVEXX, is an NSAID. Use of some NSAIDs is associated with an increased incidence of cardiovascular adverse events (such as myocardial infarction, stroke or thrombotic events) which can be fatal. The risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.

Caution should be exercised in prescribing NSAIDs such as naproxen sodium, which is a component of SUVEXX, to any patient with ischemic heart disease (including but NOT limited to acute myocardial infarction, history of myocardial infarction and/or angina), cerebrovascular disease (including but NOT limited to stroke, cerebrovascular accident, transient ischemic attacks and/or amaurosis fugax) and/or congestive heart failure (NYHA II-IV).

Use of NSAIDs, such as naproxen sodium, which is a component of SUVEXX, can promote sodium retention in a dose-dependent manner, through a renal mechanism, which can result in increased blood pressure and/or exacerbation of congestive heart failure.

Risk of gastrointestinal (GI) adverse events: Use of NSAIDs, such as naproxen sodium, which is a component of SUVEXX, is associated with an increased incidence of gastrointestinal (GI) adverse events (such as peptic/duodenal ulceration, perforation and obstruction of the upper and lower gastrointestinal tract, and gastrointestinal bleeding). These events can occur at any time during use and without warning symptoms. Elderly patients and those with history of peptic ulcer disease and/ or GI bleeding are at greater risk for serious Gl events.

Risk in pregnancy: Caution should be exercised in prescribing SUVEXX during the first and second trimesters of pregnancy. Use of NSAIDs at approximately 20 weeks of gestation or later may cause fetal renal dysfunction leading to oligohydramnios and neonatal renal impairment or failure. SUVEXX is contraindicated for use during the third trimester because of risk of premature closure of the ductus arteriosus and uterine inertia.

Other relevant warnings and precautions: • Use only when a clear migraine • Masking of inflammation and fever. diagnosis has been established.

• Excluding other neurologic • Use in cluster headache. conditions.

• Psychomotor impairment.

• History of seizures.

• Use in medication overuse • Serotonin syndrome; monitor headache. patients on other serotonergic • Not recommended for use with treatments. other NSAIDs, except low• Blurred and/or diminished vision. dose ASA for cardiovascular • Renal impairment; use with prophylaxis. caution in patients with severe • Serious cardiac events and dehydration or pre-existing kidney fatalities associated with 5-HT1 disease. agonists.

• Sodium retention and • Cerebrovascular events and hyperkalemia. fatalities with 5-HT1 agonists.

• ASA-induced asthma.

• Other vasospasm-related events. • May impair fertility; not • Increased blood pressure; use recommended in women trying to with caution in patients with conceive. controlled hypertension.

• Serious skin reactions (e.g., drug • Congestive heart failure and edema. reaction with eosinophilia and • Interference of platelet function. systemic symptoms (DRESS), • Use with anticoagulants.

Stevens-Johnson syndrome, • Anti-platelet effects. toxic epidermal necrolysis, • Blood dyscrasias. exfoliative dermatitis and • Increased liver enzymes; evaluate erythema multiforme). patients with signs of liver • Use with caution during first and dysfunction. second trimesters; evaluate risk• Hypersensitivity and benefit. anaphylactoid reactions.

• Not recommended during labour • Do not use in ASA-intolerance. and delivery.

• Cross-sensitivity to other NSAIDs. • Use in breastfeeding women.

For more information: Please consult the Product Monograph at: https://www.miravohealthcare. com/wp-content/uploads/2022/01/Suvexx-PM-ENG-Dec2021.pdf for adverse reactions, interactions, dosing and conditions of clinical use.

The Product Monograph is also available by calling Miravo Medical Information at 1-866-391-4503.

References: 1. SUVEXX® Product Monograph. Aralez Pharmaceuticals Canada Inc., December 2021.

2. Brandes J et al. Sumatriptan-naproxen for acute treatment of migraine: a randomized trial. JAMA 2007 Apr 4;297(13):1443-54. 3. Silberstein S et al. Multimechanistic (sumatriptan-naproxen) early intervention for the acute treatment of migraine. Neurology 2008;71:114-121.

Aralez Pharmaceuticals Canada Inc.* 6733 Mississauga Road, Mississauga, Ontario L5N 6J5 *d/b/a Miravo Healthcare

For example, preventing surgical site infections requires the participation of many people, including the medical secretary who gives the patient their pre-op instructions, the assistant who preps the surgical area, the operating room nurses and technicians who drape the patient, the surgical team who administers preventive antibiotics and makes sure the patient is warmed to a certain temperature before the stitches are done and the post-op and home care team.

Another element of Caring Safely is the daily safety huddle, which takes place in every patient care unit. Staff meet quickly each day to talk about any issues from the previous day and concerns about the next day. ER staff hold hot debriefs. At the end of a case, within an hour, everyone involved gathers for a five-to-10-minute huddle to review what went well and what didn’t and decide if any follow-up is needed. For example, if a piece of equipment had not been readily available, they decide what steps are needed to ensure that it is fixed for next time.

THE MISTAKES ISSUE

Teamwork and the art of avoiding mistakes In his recently released book The Power of Teamwork, Dr. Brian Goldman, an ER doctor at Toronto’s Mount Sinai Hospital, talks about how teamwork can make for happier staff, more efficient operations—and fewer medical errors.

In the first chapter, he writes about a woman who went in for routine sinus surgery who ended up with irreversible brain damage, because three eminent clinicians, one surgeon and two anesthetists failed to recognize a recognizable emergency for which there were guidelines.

Through teamwork, such errors can be reduced, writes Dr. Goldman.

One avenue of errorreducing teamwork, he said, is group problem-solving using questions (originally designed for medical students): “What do you see?” “What do you see that makes you say that?” and “What more can we find?”

Teamwork requires leadership, said Dr. Goldman, and a leader is needed to ask the questions, and to get all different team members, including nurses, involved in the discussion.

“One of the problems with

an acute emergency is that you develop tunnel vision when you’re anxious,” Dr. Goldman said in an interview. “These questions widen the tunnel out. This approach widens out your fields of view by making available to you things that you might not have seen yourself.

You’re calling on the wisdom of the room. It’s about reducing errors through team cognition.”

Another way a teamwork approach can prevent errors, said Dr. Goldman, is being on the lookout for others’ cognitive overload. So many healthcare workers are overloaded with medical cases—and also with the daily hassles of computer work.

“Imagining a physician is given an EKG that shows an obvious heart attack, but the doctor misses it completely.

That is an error that could have dire consequences.”

But, said Dr. Goldman, with teamwork, the person who handed the doctor the EKG would look into their eyes to make sure the doctor had really seen it and that their eyes aren’t glazed over. “Or if that nurse sees a heart attack there, they will feel free to say, ‘I think there’s an ST-segment elevation MI there.’ And in the teamwork model, the doctor will say, ‘Let me look at that again. I wasn’t looking at this properly. Thank you.’”—LOUISE LEGER

F-SUV-012-04192022 EN

THE MEDICAL POST JUNE 2022 31

Lean on LYRICA LYRICA (pregabalin) is indicated in adults for: • The management of neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, and spinal cord injury.

• The management of pain associated with fibromyalgia.

The efficacy of LYRICA in the management of pain associated with fibromyalgia for up to 6 months was demonstrated in a placebo-controlled trial in patients who had initially responded to LYRICA during a 6-week open-label phase.

When you purposely prescribe the Viatris original brand LYRICA, help your patient get it.

Some insurers limit full-cost coverage for higher-cost interchangeable drugs to patients who meet certain criteria, and in some instances, documentation from the prescriber is required. There is a possibility that the patient may need to contribute out-of-pocket where those conditions are not met.

1 2

3

Write the Viatris original brand name, LYRICA, and include “no sub,” when appropriate, on your patient’s prescription.

Encourage your patients to visit ViatrisOriginals.ca so they can: • Download a payment assistance card to help patients who have no insurance or whose insurance co-payment amount might be a barrier to obtaining the Viatris original brand medication. This card can help patients obtain the Viatris original brand medication at little or no additional cost compared to the generic version.* Remind your patient to ask for the Viatris original brand LYRICA at the pharmacy.

* Subject to change. The Viatris Originals Program is available in all provinces except Quebec.

Availability and level of payment assistance vary by brand medication and province.

Viatris and the Viatris logo are trademarks of Mylan Inc., licensed use by Upjohn Canada ULC, a Viatris Company. © 2022 Viatris Inc. All rights reserved.

LYRICA is a registered trademark of Viatris Specialty LLC, licensed use by Upjohn Canada ULC, a Viatris company.

ViatrisOriginals.ca

LYR-2022-0826E - AL2022

Consult the Product Monograph at http://pfizer.ca/pm/en/LYRICA.pdf for contraindications, warnings, precautions, adverse reactions, interactions, dosing, and conditions of clinical use. The Product Monograph may also be obtained by calling 1-800-463-6001.

OTC

ANNUAL SURVEY 2022 PHYSICIANS’ MOST-RECOMMENDED BRANDS PAGES 33-41

2022 OTC COUNSELLING & RECOMMENDATIONS SURVEY

Survey methodology

OTC counselling: an integral part of your role When Canadians have questions about the appropriate use of nonprescription over-the-counter (OTC) products, they often enough ask a doctor for advice.

As it has for many years, the Medical Post Survey on OTC Counselling & Recommendations continues to highlight the role of physicians as counsellors, advisors and influencers in the area of nonprescription products.

This important survey tracks and monitors the OTC products that community clinicians are recommending when they advise patients—providing helpful insights used by your fellow doctors.

Throughout the pandemic patients have been asking doctors during virtual care visits about nonprescription self-care. And all signs indicate that your importance as a trusted source of information and advice for patients seeking products to help them or their family members treat symptoms, manage self-limiting conditions and support their good health will only continue to grow.

In the following pages, you can see how you compare to other Canadian physicians in terms of the nonprescription products you recommend.

Thank you to all who participated in the 2022 OTC Counselling & Recommendations Survey.

34 JUNE 2022 THE MEDICAL POST

The 2022 Survey on OTC Counselling & Recommendations was an online survey fielded between October 2021 and January 2022 by the research division of EnsembleIQ. A total of 552 Canadian physicians responded to the survey for a margin for error of +/- 4.16%, 19 times out of 20. In total, 26 product categories were presented to the overall sample of physicians.

To establish the OTC brand rankings, respondents were asked the following questions: 1) How often do you make recommendations on this product category? 2) Do you recommend brand names, house brands/generic items, and 3) What brand(s) do you usually recommend?

Reponses for store brands, prescription drugs, products not belonging in a category and generic suggestions (eg., Vitamin C, acetaminophen, etc.) were removed from the outcome.

The resulting lists for each product category were then ranked by the number of recommendations, resulting in a winner for the category.

Have you seen this logo?

Only the OTC products voted #1 by you, in the Medical Post’s annual survey, can use this logo or claim to be the “Physician’s #1 Recommended Brand.”

How to read the charts Category

Brands, ranked in order of the percentage of physicians who recommend them to patients.

Antibiotic Eye and Ear Drops

Polysporin

70%

Responses less than 1% not shown; n=220; 40% recommend in category. Results may total >100% due to multiple brand recommendations.

Average number of times per month physicians make a recommendation on this category.

AVERAGE RECOMMENDATIONS/MONTH BASE: Make at least 1 recommendation/month

5

2022 OTC COUNSELLING & RECOMMENDATIONS SURVEY

Antibiotic Eye and Ear Drops

Thank you for your continued support!

Polysporin

70%

Eliminates bacteria causing the infection.

Responses less than 1% not shown; n=220; 40% recommend in category. Results may total >100% due to multiple brand recommendations.

AVERAGE RECOMMENDATIONS/MONTH

5

Pharmacy Practice + Business and Profession Santé 2022 Survey on OTC Counselling and Recommendations, The Medical Post and Profession Santé 2022 Survey on OTC Counselling and Recommendations To be sure this product is right for your patients, always read and follow the label. © Johnson & Johnson Inc. 2022

BASE: Make at least 1 recommendation/month

Antinauseant

Gravol

THANK YOU 95%

FOR VOTING GRAVOL THE #1 ANTI-NAUSEANT BRAND IN CANADA! NEW

Responses less than 1% not shown; n=346; 63% recommend in category. Results may total >100% due to multiple brand recommendations.

AVERAGE RECOMMENDATIONS/MONTH

5

Pharmacy Practice + Business and Profession Santé 2022 Survey on OTC Counselling and Recommendations (re: pharmacists) and The Medical Post and Profession Santé 2022 Survey on OTC Counselling and Recommendations (re: physicians)

BASE: Make at least 1 recommendation/month

THE MEDICAL POST JUNE 2022 35

2022 OTC COUNSELLING & RECOMMENDATIONS SURVEY

Thank you for your continued confidence in OMRON Among Canadian physicians, OMRON was chosen as the #1 recommended brand of home blood pressure monitors.

Blood Pressure Monitor

Omron LifeSource

39%

4%

Bios

1%

Welch

1%

Responses less than 1% not shown; n=279; 51% recommend in category. Results may total >100% due to multiple brand recommendations. © 2022 OMRON Healthcare, Inc. OMR086B 04/22

OmronHealthcare.ca

The Medical Post and Profession Santé 2022 Survey on OTC Counselling and Recommendations (re: physicians)

CANADIAN BUMS THANK YOU FOR NAMING ANUSOL #1

BASE: Make at least 1 recommendation/month

Hemorrhoid Treatment

Anusol

66%

Preparation H

Thank you for naming Anusol the #1 Physician-and-Pharmacist-recommended hemorrhoid treatment brand in Canada.

Pharmacy Practice + Business and Profession Santé 2022 Survey on OTC Counselling and Recommendations (re: pharmacists) and The Medical Post and Profession Santé 2022 Survey on OTC Counselling and Recommendations (re: physicians).

21%

Venixxa

6%

Hemovel

2%

Hemcort

2%

Responses less than 2% not shown; n=296; 54% recommend in category. Results may total >100% due to multiple brand recommendations.

AVERAGE RECOMMENDATIONS/MONTH BASE: Make at least 1 recommendation/month

36 JUNE 2022 THE MEDICAL POST

8

AVERAGE RECOMMENDATIONS/MONTH

4

2022 OTC COUNSELLING & RECOMMENDATIONS SURVEY

Iron Supplement

FeraMAX

FeraMAX® is the #1 recommended iron supplement nationally by Physicians and Pharmacists† 42%

Palafer

17%

Proferrin

4%

Fer-In-Sol

4%

OptiFer

3%

Responses less than 3% not shown; n=314; 57% recommend in category. Results may total >100% due to multiple brand recommendations.

8

AVERAGE RECOMMENDATIONS/MONTH

www.FERAMAX.com † Pharmacy Practice + Business and Profession Santé 2022 Survey on OTC Counselling and Recommendations; The Medical Post and Profession Santé 2022 Survey on OTC Counselling and Recommendations. BioSyent Pharma Inc. © 2022

BASE: Make at least 1 recommendation/month

Laxative

Lax-A Day

43%

RestoraLAX

30%

Senokot

Thank you for your support.

17%

Metamucil

Thank you for making Lax-A Day® the #1 pharmacist and physician recommended laxative brand in Canada1

12%

Colace

7%

Peg 3350

6%

For more information, visit:

www.laxasolutions.com Responses less than 6% not shown; n=414; 75% recommend in category. Results may total >100% due to multiple brand recommendations.

AVERAGE RECOMMENDATIONS/MONTH

9

This product may not be suitable for everyone.

Always read and follow the label.

1. Pharmacy Practice + Business and Profession Santé 2022 Division of Pharmascience inc. ® registered trademark of Pharmascience Inc.

Survey on OTC Counselling and Recommendations (re: pharmacists) and The Medical Post and Profession Santé (re: physicians)

BASE: Make at least 1 recommendation/month

THE MEDICAL POST JUNE 2022 37

2022 OTC COUNSELLING & RECOMMENDATIONS SURVEY

MDI Spacer

Thank y you!

AeroChamber

54%

TM

Inhaler + AeroChamber VHC ®

Responses less than 1% not shown; n=131; 24% recommend in category. Results may total >100% due to multiple brand recommendations.

The Medical Post and Profession Santé 2022 Survey on OTC Counselling and Recommendations (re: physicians) MD-189A-0522. * trade-marks and registered trade-marks of Trudell Medical International (TMI). © TMI 2022. All rights reserved.

AVERAGE RECOMMENDATIONS/MONTH

6

BASE: Make at least 1 recommendation/month

Probiotic

THANK YOU! YOUR #1 CHOICE OF PROBIOTIC*

Align

35%

Bio-K+

17%

Probaclac

13%

BioGaia

9%

Florastor

7%

Gluten Free Soy Free Vegetarian

Responses less than 7% not shown; n=300; 54% recommend in category. Results may total >100% due to multiple brand recommendations.

*The Medical Post and Profession Santé 2022 Survey on OTC Counselling and Recommendations (re: physicians)

AVERAGE RECOMMENDATIONS/MONTH

© 2022 P&G

BASE: Make at least 1 recommendation/month

38 JUNE 2022 THE MEDICAL POST

6

2022 OTC COUNSELLING & RECOMMENDATIONS SURVEY

Scar/Stretch Marks Therapy

Bio-Oil

25%

La RochePosay/Cicaplast

14%

Mederma

5%

CICA-Care

5%

Dermatix

Thank you for your continued support and confidence in Bio-Oil®

3%

#1 Recommended scar and stretch mark product in Canada Responses less than 3% not shown; n=108; 20% recommend in category. Results may total >100% due to multiple brand recommendations.

5

AVERAGE RECOMMENDATIONS/MONTH

www.bio-oil.com Celebrating 15 years in Canada Pharmacy Practice + Business and Profession Santé 2022 Survey on OTC Counselling and Recommendations (re: pharmacists) and The Medical Post and Profession Santé (re: physicians).

BASE: Make at least 1 recommendation/month

Smoking Cessation Aids

6494_BioOil_ThankYou_MedicalPost_2022_EN_ad_r3.indd 1

YOU RAISED THE CONVERSATION & MADE THE RECOMMENDATION

Nicoderm

44%

Nicorette

43%

Habitrol

3%

Thrive

1%

2022-04-19 9:44 PM

Nicoderm and Nicorette are statistically tied as the #1 brands.

Thank you for making Nicoderm® and Nicorette® the #1 recommended OTC smoking cessation brands*† With nicotine replacement therapy and your support, smokers are 5X more likely to quit vs. willpower alone1 For more ways to make the quitting conversation count, Join the Help Them Quit Community.

Responses less than 1% not shown; n=313; 57% recommend in category. Results may total >100% due to multiple brand recommendations.

AVERAGE RECOMMENDATIONS/MONTH

6

*Tied for #1 †The Medical Post and Profession Santé 2022 Survey on OTC Counselling and Recommendations (re: physicians) 1. Sutherland G. Smoking: Can We Really Make a Difference? Heart 2003;89:ii25-7. © Johnson & Johnson Inc. 2022

BASE: Make at least 1 recommendation/month

THE MEDICAL POST JUNE 2022 39

2022 OTC COUNSELLING & RECOMMENDATIONS SURVEY

Sunscreen

NEW!

Ombrelle

33%

Neutrogena

THE SUN MADE SAFER FOR OVER 30 YEARS

La Roche-Posay/ Anthelios (NET)

Thank you

Aveeno

for your continuous support that has made us the #1 recommended sunscreen brand

since 1994.

21%

17%

6%

Coppertone

4%

Avene

4%

Responses less than 4% not shown; n=252; 46% recommend in category. Results may total >100% due to multiple brand recommendations.

HYPOALLERGENIC. COLORANT FREE. FRAGRANCE FREE.

Pharmacy Practice + Business and Profession Santé 2022 Survey on OTC Counselling and Recommendations (re: pharmacists) The Medical Post and Profession Santé 2022 Survey on OTC Counselling and Recommendations (re: physicians)

AVERAGE RECOMMENDATIONS/MONTH

11

BASE: Make at least 1 recommendation/month

Therapeutic Skin Cleanser

Cetaphil

45%

CeraVe

24%

Spectro

22%

Aveeno

5%

Neutrogena

3%

THANK YOU FOR MAKING CETAPHIL YOUR

#1 PHARMACIST AND PHYSICIAN

RECOMMENDED THERAPEUTIC SKIN CLEANSER Pharmacy Practice + Business and Profession Santé 2022 Survey on OTC Counselling and Recommendations (re: pharmacists) , The Medical Post and Profession Santé 2022 Survey on OTC Counselling and Recommendations (re: physicians)

Responses less than 3% not shown; n=201; 36% recommend in category. Results may total >100% due to multiple brand recommendations. ®

AVERAGE RECOMMENDATIONS/MONTH BASE: Make at least 1 recommendation/month

40 JUNE 2022 THE MEDICAL POST

7

2022 OTC COUNSELLING & RECOMMENDATIONS SURVEY

Topical Anti-Infective

Thank you for your continued support!

Polysporin

75%

Bactroban

10%

Bacitracin

2%

Baciguent

2%

Neosporin

1%

HEAL-FAST® Formula helps prevent infection to speed healing of minor cuts, scrapes and burns.

Responses less than 1% not shown; n=343; 62% recommend in category. Results may total >100% due to multiple brand recommendations.

6

AVERAGE RECOMMENDATIONS/MONTH

Pharmacy Practice + Business and Profession Santé 2022 Survey on OTC Counselling and Recommendations, The Medical Post and Profession Santé 2022 Survey on OTC Counselling and Recommendations To be sure this product is right for your patients, always read and follow the label. © Johnson & Johnson Inc. 2022

BASE: Make at least 1 recommendation/month

Vaginal Lubricant

Replens

51%

K-Y

26%

RepaGyn

7%

Astroglide

7%

Gynatrof

4%

Vagisil

4%

THANK YOU FOR MAKING REPLENS THE #1 VAGINAL LUBRICANT IN CANADA. TM

Responses less than 4% not shown; n=242; 44% recommend in category. Results may total >100% due to multiple brand recommendations.

AVERAGE RECOMMENDATIONS/MONTH

5

The Medical Post and Profession Santé 2022 Survey on OTC Counselling and Recommendations (re: physicians)

BASE: Make at least 1 recommendation/month

THE MEDICAL POST JUNE 2022 41

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COLUMN

Stay overnight Instinct told Dr. Raj Waghmare to ask his recovering patient to stay overnight in the hospital—the next day his admission diagnosis surprised

Getty Images

C

an you see this patient?” a nurse says. “I put him in room 26. He’s in agony. He needs something for pain.”

I take the chart and meet James Chin (patient’s name changed). He’s in a wheelchair, hunched over. His clenched fist is pushed into his gut and an empty vomit bag is lying across his lap. His triage note is detailed, so I already know his tale of woe. Beginning earlier in the day, James developed abdominal pain that radiated into his back. He’s in his early 60s, so the most important thing to consider is a ruptured abdominal aneurysm, but many of his details are reassuring.

Firstly, this isn’t the first time James has had this pain. He’s had it several times—it began a few years earlier and initially attacks were two or three times a year. Now, the pain returns every few weeks and although he’s been investigated, no cause has been identified. He was even seen by a gastroenterologist a year earlier and had a normal upper endoscopy.

Although most episodes resolve within a day, this one has lasted three days during which he hasn’t been able to eat, nor drink, and has had intermittent bouts of vomiting. James’s vital signs also don’t suggest a ruptured aneurysm. They’re normal: his temperature is 36 degrees, his

BY DR. RAJ WAGHMARE

blood pressure 140 over 90, his heart rate 80 and his oxygen saturation 100%.

“I’ll get you something for pain in just a minute,” I say. “But tell me first, in your words, what’s going on.”

He repeats his story—recurrent episodes of abdominal pain, investigated

THE MEDICAL POST JUNE 2022 43

Remind your migraine patients about RELPAX

RELPAX is indicated for the acute treatment of migraine with or without aura in adults.

RELPAX is a registered trademark of Viatris Specialty LLC, licensed use by Upjohn Canada ULC, a Viatris company.

Viatris and the Viatris logo are trademarks of Mylan Inc., licensed use by Upjohn Canada ULC, a Viatris Company. © 2022 Viatris Inc. All rights reserved.

RELP-2022-0056E - MA2022

Consult the Product Monograph at http://pfizer.ca/pm/en/RELPAX.pdf for contraindications, warnings, precautions, adverse reactions, interactions, dosing, and conditions of clinical use.

The Product Monograph is also available by calling 1-800-463-6001.

RELEASE

01

BACK PAGES

25/05/22

19470_16503_VIT_TP_Relpax_MP_En_01

When you purposely prescribe the Viatris original brand RELPAX, help your patient get it.

Some insurers limit full-cost coverage for higher-cost interchangeable drugs to patients who meet certain criteria, and in some instances, documentation from the prescriber is required. There is a possibility that the patient may need to contribute out-of-pocket where those conditions are not met.

1 Write the Viatris original brand name, RELPAX, and include “no sub,” when appropriate, on your patient’s prescription.

2 Encourage your patients to visit ViatrisOriginals.ca so they can: • Download a payment assistance card to help patients who have no insurance or whose insurance co-payment amount might be a barrier to obtaining the Viatris original brand medication.

This card can help patients obtain the Viatris original brand medication at little or no additional cost compared to the generic version.*

3 Remind your patient to ask for the Viatris original brand RELPAX at the pharmacy.

* Subject to change. The Viatris Originals Program is available in all provinces except Quebec.

Availability and level of payment assistance vary by brand medication and province.

yet unexplained. He stops and breathes x 10.75continuing. in heavily,Format panting2.625 before “They usually subside after 12 hours but Safety 2.125 x 9.75 in this has been steady for three days.” He Bleed trying 2.875to x 11catch in stops again, his breath. “I just need something for pain to get me Spread YES through this episode.”

“I can your pain,” I say. “But Copycontrol 19470_Relpax_Campaign_HC_Ad_V07 what happens after that? Do you have Public.follow-up?”

The Medical Post any further “Well, ” he says.

Language EN “I was hoping to get another CT scan today. I had one a few [ CG ] Graphic designer weeks ago, but my familyRDdoctor didn’t order it with contrast for someCORRECTION(S) reason.”

APPROVED Because his nurse had handed me the chartGDand asked me to see him immediately, I didn’t have a chance to look up James’s history on our EMR. “I’ll lookADat the CT report,” I say before taking the rest of his history. Other than the abdominal pain, James is relatively BL has high blood pressure and healthy. He type 2 diabetes—both controlled with oral medication. He isn’t on insulin, PR hasn’t ever had any surgery, hasn’t smoked in 20 years and doesn’t drink.

He does use weed occasionally, and PROD I wonder whether or not anyone has suggested cannabinoid hyperemesis syndrome as the cause for his pain.

CS “One of the doctors had mentioned it,” he says, “but really, I rarely use it.

Maybe just once or twice a week.”

01 01 01 01

A history of stones

James groans in pain, and I leave to find his nurse. She’s standing just outside the door with morphine and gravol in hand.

“Tell him I’ll be right back,” I say, as I log on to a computer and look at his recent scan. Minutes later, I’m back in the room. “You’re right, your CT scan was non-contrast—your doctor was looking for a kidney stone.”

“Oh yeah,” he says, “I have a history of stones too, but they didn’t find anything.”

I examine him in the wheelchair as he’s too sore to move to the exam table. He’s pale and his lips and tongue are chapped. He looks sick. He’s tender everywhere and his abdominal muscles tighten when I palpate. “I’ll order the contrast CT scan,” I say. “But no guarantees that I’ll find any answers today.”

“I just need something for pain today,” he says. “Just to get me through this episode. My family doctor is arranging another scope with a GI. This time upper and lower.”

“Did they only do the upper scope before?”

“It was really only upper abdominal pain before. Pain in my upper gut radiating to the back.”

“Is that what it is again today?”

“Mostly,” he says. “Sharp and going straight to my back. But I feel it all over my abdomen.”

“You’ve never been told you have an aneurysm, have you?”

“No,” he says. “Why? Do you think that’s what it is?”

I look at his vital signs again. “No.” It’s unlikely, but when I fill in the CT requisition and write his history, I don’t forget to leave out rule-out AAA. Just as I’m about to leave the room, I remember to ask for a medication list. “I don’t have a list,” he says, pointing to a plastic bag on the floor beside him. “But all my pills are in there.”

I take the bottles out and scribble quickly—he’s on Nexium for his stomach, Norvasc and Ramipril for his blood pressure and two medications for diabetes: Metformin and Jardiance.

“Nothing else?” I say.

“Just Tylenol for my pain,” he says.

“But that’s not touching it.”

“The pain meds should kick in soon,” I say. “We’re going to get some blood work, the CT scan and give you some I.V. fluids.”

‘Your scan is normal’

It’s busy in the department and it’s five hours before the scan is complete.

“Your scan, Mr. Chin,” I say, “is normal.

No cause identified for your recurrent episodes of pain.”

“I’m not surprised,” he says.

“How’s your pain?”

“Almost gone.”

I look at his blood tests. “Do you feel well enough to go home?”

“I do,” he says. “Can I get a prescription for a few tablets just in case my pain comes back?”

His creatinine is slightly elevated at one-fifteen, likely due to dehydration,

ViatrisOriginals.ca THE MEDICAL POST JUNE 2022 45

For your patients with chronic migraine,

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BOTOX® (onabotulinumtoxinA) for the prophylaxis of headaches in adults with chronic migraine (≥15 days per month with headache lasting 4 hours a day or longer) For more information: Please consult the Product Monograph at: pdf.hres.ca/ dpd_pm/00060199.PDF for contraindications, warnings, precautions, adverse reactions, interactions, dosing and conditions of clinical use.

The Product Monograph is also available by calling: 1-800-668-6424.

REFERENCE: BOTOX® Product Monograph, Allergan Inc.March 11, 2021.

All trademarks are the property of their respective owners.

ALLERGAN® and its design are trademarks of Allergan Inc. © 2022 AbbVie. All rights reserved.

BACK PAGES

but the blood tests were drawn before he received I.V. fluids. Other than that, his white count is elevated slightly and his sodium is down a few points.

“Do you think you can keep fluids down when you go home?”

“I should be fine now,” he says. “And if I’m not, I’ll just come back.”

I’m ready to agree with him and write him a prescription. His CT is normal, his vital signs are normal, and his blood tests are OK. But he still looks sick. While his pain is controlled, his lips and tongue are still parched and although his respiratory rate is documented as normal, he pants between words.

“I don’t know,” I say. “How would you feel about getting more hydration, and maybe staying overnight until things settle?”

He sighs. “If you think I should, then I will.”

“I think you should.”

Minutes later, I’m describing his case to the admitting doctor—recurrent abdominal pain, blood tests more or less normal, normal CT scan. “He needs admission?” my colleague asks.

“He doesn’t look well,” I say. “His vitals are normal but he’s dry as a bone.

And that’s after two litres of fluid.

If nothing else, he needs hydration overnight.”

“OK.” The next day, I’m back in the ER and James is still in the ER here, this time lying in a monitored bed. I check the screen and again, and his vital signs are normal. I check his chart—and his admission diagnosis surprises me: diabetic ketoacidosis (DKA). Although it doesn’t explain his abdominal pain, it explains everything else—the dehydration, the rapid respiratory rate (his body’s way of blowing off the excess acid in his blood), the normal blood work. Had I considered the diagnosis at the outset, I would have ordered a blood gas, but I was focused on his abdominal pain.

“How long have you been on Jardiance?” I ask him, identifying the culprit-medication that causes acidosis—a severe complication of diabetes that until recently was almost exclusively associated with insulin. What makes this such a tough diagnosis is

“I don’t know.

How would you feel about getting more hydration, and maybe staying overnight until things settle?”

that while patients become dehydrated and acidotic, their glucose levels don’t skyrocket as they do when insulin causes this same, sometimes fatal condition.

“Just a couple of weeks,” he says. “My doctor put me on it to help control my sugars.”

“Well,” I say. “I’m happy I didn’t send you home.”

I text the admitting doctor: Great call on the euglycemic DKA. I didn’t think of it, even though I knew he was on Jardiance.

Text came back: I didn’t think of it either until I was dictating my note.

Things didn’t sit well. I’m glad he’ll be OK. Had I sent him home, he may not have fared as well. I text him again: me too. Thx. Two weeks after discharge, he sees the GI specialist and is scoped again, up and down. No clear cause for his recurrent episodes of pain is found.

DR. RAJ WAGHMARE is an ER physician in

Newmarket, Ont.

CA-BCM-220004A - March 2022

THE MEDICAL POST JUNE 2022 47

FOR WHEN A

MIGRAINE STRIKES Pr

CAMBIA® (diclofenac potassium) is indicated for the acute treatment of migraine attacks with or without aura in adults 18 years and older.

30 mL = 2 Tbsp

Completely dissolve one sachet of CAMBIA® in 30–60 mL of water only and drink immediately1* Significantly measurable plasma levels were observed within 5 minutes of CAMBIA dosing, in fasted healthy individuals1† Tmax was achieved1,2†: • After ~15 minutes under fasting conditions‡ • After ~10 minutes under fed conditions§

Tmax: Time to reach maximum plasma levels. *No other liquids should be used with CAMBIA. †Clinical significance is unknown. ‡Range: 10–40 minutes. §Range: 5 minutes–4 hours.

Please refer to the Product Monograph for complete administration information.

Indication and clinical use: Pr CAMBIA® (diclofenac potassium) is indicated for the acute treatment of migraine attacks with or without aura in adults 18 years and older.

Efficacy and safety of CAMBIA beyond a single dose have not been studied.

CAMBIA is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic, basilar or ophthalmoplegic migraine. Safety and efficacy have not been established for cluster headache which is present in an older, predominantly male population.

Geriatrics (> 65 years of age): Safety and efficacy of CAMBIA have not been studied in individuals over 65 years of age, and its use in this population is not recommended.

Pediatrics (< 18 years of age): Safety and efficacy of CAMBIA have not been in patients below the age of 18 years, and its use in this population is contraindicated.

Contraindications: • Perioperative pain setting of coronary artery bypass graft surgery; • Third trimester of pregnancy; • Nursing women; • Severe uncontrolled heart failure; • History of asthma, urticarial, or allergic-type reactions after taking ASA or other NSAIDs; • Active gastric/duodenal/peptic ulcer, active GI bleeding; • Cerebrovascular, or other bleeding disorders; • Inflammatory bowel disease; • Severe liver impairment or active liver disease; • Severe renal impairment or deteriorating renal disease; • Known hyperkalemia; • Children and adolescents less than 18 years of age Most serious warnings and precautions: Risk of CV adverse events: Diclofenac is associated with an increased risk of cardiovascular adverse events (such as myocardial infarction, stroke or thrombotic events) that is comparable to COX-2 inhibitors and which can be fatal. The risk may increase with duration of use. Metaanalysis of randomized clinical trials comparing several difference NSAIDs suggest that diclofenac, particularly at higher doses, is associated with an increased risk of cardiovascular adverse events that is comparable to COX-2 inhibitors. Large population-based observational studies conducted in the general population also support these findings.

Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. To minimize the potential risk for adverse CV event, CAMBIA should be used for the shortest possible duration.

Treatment with CAMBIA is not recommended in patients with preexisting cardiovascular disease (congestive heart failure NYHA II--IV, ischemic heart disease, peripheral arterial disease), cerebrovascular disease, uncontrolled hypertension, and caution should be exercised in patients with risk factors for cardiovascular disease (e.g. hypertension, hyperlipidemia, diabetes mellitus and smoking). These patients should be treated with CAMBIA only after careful consideration.

Use of NSAIDs, such as CAMBIA can promote sodium retention in a dose dependent manner, which can result in increased blood pressure and/or exacerbation of congestive heart failure.

Risk of GI adverse events: Use of NSAIDs such as CAMBIA is associated with an increased incidence of gastrointestinal adverse events (such as peptic/duodenal ulceration, perforation, obstruction and GI bleeding) which can be fatal. Elderly patients are at a greater risk.

Risk in pregnancy: Caution should be exercised in prescribing CAMBIA during the first and second trimesters of pregnancy. Use of NSAIDs at approximately 20 weeks of gestation or later may cause fetal renal dysfunction leading to oligohydramnios and neonatal renal impairment or failure. CAMBIA is contraindicated for use during the third trimester because of risk of premature closure of the ductus arteriosus and uterine inertia.

Other relevant warnings and precautions • CAMBIA cannot be replaced by any other diclofenac formulations, nor is it possible to convert dosing from any other formulation of diclofenac to CAMBIA; • Not recommended in individuals over 65; increased risk of adverse events; safety and efficacy have not been studied; • Special care in frail or debilitated patients; • Caution in the treatment of elderly patients who are more likely to be suffering from impaired renal, hepatic or cardiac function; • Hepatic, renal and genitourinary impairment; • Patients with a history of peptic/duodenal ulcer disease or gastrointestinal bleeding; • Use in phenylketonurics patients; • Use in women attempting to conceive, first and second trimesters of pregnancy; • Caution in patients with Helicobacter pylori infection, prolonged use of NSAID therapy, excess alcohol intake, smoking, poor general health status; • Observation for patients with hemophilia or platelet disorders; • Monitor patients taking warfarin; • Blood dyscrasias and antiplatelet effects; • Use in patients with asthma, seasonal allergic rhinitis, swelling of the nasal mucosa, chronic obstructive pulmonary diseases or chronic infections of the respiratory tract, Quicke’s edema or urticarial, and patients who are allergic to other substances; • Serious skin reactions; • May mask signs and symptoms of infectious disease; • May cause photosensitivity and vision changes upon exposure to sunlight or UV light; • Neurological adverse events including blurred or diminished vision, decreased alertness or depression; • Concomitant use with: other NSAIDs, with the exception of low-dose ASA for cardiovascular prophylaxis; diclofenac sodium containing products; anti-coagulants; anti-platelet agents; oral corticosteroids; Selective Serotonin Reuptake Inhibitors; drugs that are known to be potentially hepatotoxic (e.g. acetaminophen, certain antibiotics, antiepileptics) For more information: Please consult the Product Monograph at: https://www.miravohealthcare. com/wp-content/uploads/2021/12/Cambia-PM-ENG-Dec2021.pdf for adverse reactions, interactions, dosing and conditions of clinical use.

The Product Monograph is also available by calling Miravo Medical Information at 1-866-391-4503.

REFERENCES: 1. CAMBIA® Product Monograph, Aralez Pharmaceuticals Canada Inc. December, 2021. 2. Diener HC, Montagna P, Gacs G, et al. Efficacy and tolerability of diclofenac potassium sachets in migraine: a randomized, double-blind, cross-over study in comparison with diclofenac potassium tablets and placebo. Cephalagia 2006:26:537–547.

Aralez Pharmaceuticals Canada Inc.* 6733 Mississauga, Ontario L5N 6J5 *d/b/a Miravo Healthcare F-CAM-071-04112022

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COLUMN

When the worst happens Dr. Ginevra Mills shares her long journey of healing

golden hour just before dusk. I’ve just finished a run along the water and through a patch of forest near my house.

As I walk between massive, old-growth cedars towering above and listen to the birds rustling and chirping in the dense canopy, I breathe in the crisp fresh air and think to myself that, in this moment, I feel contented.

If you were to peek into my life 18 months ago to ask me if I ever believed that I would find myself in such a moment, I would have crumpled to the floor in a heap of despair. This is because on a cold and snowy November night a year-and-a-half ago, while working a locum on labour and delivery, I

50 JUNE 2022 THE MEDICAL POST

experienced the worst outcome of my short career.

The ward was busy, as it always is, and everything was going as well as one can expect. Until suddenly it wasn’t. I was called urgently to a room where a heartbeat was suddenly lost. For a second, I panicked. But then, I did exactly what I knew to do. Everything moved quickly and before I knew it, I was cutting faster than I’d ever done before. In less than 60 seconds a baby was in the world and in the capable hands of the pediatrics team. However, it wasn’t enough. We weren’t enough.

I wasn’t enough.

A colleague came in to take over the rest of my shift, but the hours that

followed in the early morning went by in a blur of mental anguish and torment.

I will never, ever, forget the harrowing moment when I faced a woman, tears running down both our faces, while she held her still child, with nothing to offer but a deep and regretful apology. As I left the hospital that morning with absolutely nothing left inside of me, the only thing I could think was, “This is all my fault. I should have done better.”

Shame and guilt

In the days following, I went through all the necessary actions—the debriefing with the unit staff, talking with the family, all the mountains of paperwork and documentation, and finally a trip

Getty Images

It’s a seasonable May evening in the

BACK PAGES

BY DR. GINEVRA MILLS

back home where I was expected to resume my normal clinical duties.

Despite all the talking, all the debriefing, and all the reassurance that I had done everything I could, I could not erase the shame and guilt I felt over what had happened.

My nights were haunted with nightmares reliving the night over again in different permutations and combinations of scenarios. I couldn’t sleep for the incessant selfinterrogations, sifting through the events with a fine-toothed comb, wondering where I made a mistake (did I even make a mistake?), or where I could have done something differently, or if any other course of action might have changed the outcome anyway. I found myself begging for the impossible chance to re-do that night over again.

My days were filled with flashes of memories: the mother and her baby, the moment I pulled the baby out and handed her over, and even the flashbacks of somehow competently completing a surgery as tears clouded my vision, and likely dropped into the surgical field to become part of the woman with whose life I tragically collided.

Barely a week went by when I realized that this outcome, this tragedy, this “mistake,” was consuming me, and I needed help if I was ever going to survive the torment I was experiencing.

Even that thought—that I would survive this point in my life—felt like an impossibility.

I started by talking to some trusted colleagues—my friends from residency— those I knew would understand the medical side of things and would understand the gravity of what I was experiencing. I shared my self-torment with a few close friends whom I felt could be trusted with the ugliest and

scariest parts of myself. Finally, I reached out to the physician support program in my province to speak with a therapist about my grief and trauma.

Despite making these connections, I still felt very alone, as if I was on the other side of grief itself. I felt as if I was standing on the wrong side of a two-way mirror: I felt that as a physician, with the need to move forward and to remain professional and respect confidentiality, I was an impermeable silver wall of compassionate stoicism. Yet behind my reflection was a vast expanse of emptiness, where I ultimately still sat alone with a grief that I had to bring myself through.

The next most helpful step in my journey to recovery was understanding that the process to healing would take time—and likely more time than I wanted or felt that I was able to give.

Feeling less alone

One physician friend recommended that I watch Dr. Brian Goldman’s 2010 TED talk about doctors making mistakes. The talk starts by comparing all-star baseball stats (batting 4/10 safe hits is legendary) with the expected “batting average” of the average doctor or surgeon being nothing less than 10/10—100%. And Dr. Goldman asks, where does that leave us physicians who are human beings, who err just as everyone else—and who then hold in ourselves the shame and guilt of never being good enough? Although I was weeks into my rather ineffective healing journey, this talk was the first time I began to feel like maybe I wasn’t completely alone in navigating the after-

math of a terrible outcome in medicine.

The next most helpful step in my journey to recovery was understanding that the process to healing would take time—and likely more time than I wanted or felt that I was able to give.

Once I accepted that reality, I let myself focus on the journey one step at a time. I was grateful to reconnect with a therapist with whom I’d had a previous therapeutic relationship. There was also space within the physician support program to lengthen the services to provide the support I required over the time I needed.

Gradually, months passed. Although the rawness of the experience faded and I was able to allow the memories to blend into the background of my life, hardly a day passed when I didn’t think about the family inextricably weaved into my history. As the anniversary of that night approached, I relapsed into a new sense of grief. I longed for something I didn’t think would ever be possible—closure, a final acceptance.

As the one-year mark approached, I found myself standing in a card store, attempting to choose the perfect card to send a family who, like me, were barreling towards the anniversary of an event that changed their lives forever.

Once I settled on one, I constructed a simple thought to let a family know that I always think about them and the time I spent crossing their path has never been forgotten. I opened a long-ago folded scrap of paper in my wallet—the only piece of information I saved from that fateful night—an address.

Sending a card was the most closure I could ever ask for. In that moment, I feared that I was selfish in sending this small token of my own healing journey; I worried that perhaps in doing something to help myself move forward, I was causing more pain for someone else. But I did it anyway, and I accepted this as the book end on this tragic event in my life.

A letter from the family

I believed my healing journey as complete as possible, and I never expected a response from the family. But a few months later, there it was, sitting on the counter in a thick envelope with their

THE MEDICAL POST JUNE 2022 51

For patients with moderate-to-severe plaque psoriasis

Consider

for the

BACK PAGES

I have traversed a path from a place of darkness, unfathomable shame and devastation, to where I am now: a place of contentment in where my life has taken me.

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Enrol your patients in the Sun Patient Support Program for ILUMYA™ – designed to help you and your patients every step of the way

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ILUMYA™ (tildrakizumab injection) is indicated for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

For more information: Please consult the Product Monograph at: info.ilumya.ca/Product_Monograph for important information relating to contraindications, warnings, precautions, adverse reactions, interactions, dosing and conditions of clinical use.

The Product Monograph is also available by calling our medical information department at: 1-844-924-0656.

REFERENCE: Current ILUMYA™ Product Monograph, Sun Pharma. © 2022 Sun Pharma, or its subsidiaries and affiliates. All rights reserved.

ILUMYA™ is a trademark of Sun Pharmaceutical Industries Limited.

Used under license.

family name printed heavily across the top left corner. I stared at the envelope for a long time before opening it. Inside was a card, complete with pictures of their whole family, and a beautifully handwritten note. In it, they thanked me for my kindness in sending them a card, and for the role I played in their lives. They filled me in on little details of the past year, including findings from their baby’s autopsy, in case I didn’t know what was found (I never knew the outcome, so this was instrumental for me), and the admission that they think fondly of me when they remember their time in the hospital.

I cried as I read the letter repeatedly. I didn’t realize how much I wanted to hear from this family again—how much I needed it to finally feel a sense of peace. In that moment, I was grateful that I took the risk in reaching out to this family—not only because it provided me with a feeling of contentment after so long, but because it demonstrated the true power of authentic human connection, even in the face of life’s worst moments.

A few months more have now passed, and I have accepted that this fateful outcome will always be part of who I am. Since that morning 18 months ago, I have traversed a path from a place of darkness, unfathomable shame and devastation, to where I am now: a place of contentment in where my life has taken me. If we lived in a world where we could change the past, I would redo that night differently every time, and maybe it would have made a difference. However, in this world where we can only move forward, I am content with the knowledge that my life has forever been changed and I am a better person for that change.

DR. GINEVRA MILLS is a reproductive endocrinologist based in

Victoria.

PM-CA-ILY-0036

THE MEDICAL POST JUNE 2022 53

PEI Clinical Insights Q&A

Pancreatic Exocrine Insufficiency: ‘A Disease We Went to Medical School to Manage’

Gabor Kandel, MD, FRCPC

Gastroenterologist, St. Michael’s Hospital, Associate Professor of Medicine, University of Toronto

This educational supplement aims to provide Canadian clinicians with the latest in clinical thinking and therapeutic practice.

Before recommending any mentioned medication, please refer to the appropriate product monograph. The information and opinions contained herein do not necessarily reflect those of the sponsor.

Do you prioritize conditions easy to diagnose if thought of, easy to treat when found, but disastrous when missed? If yes, it’s worthwhile reviewing pancreatic exocrine insufficiency (PEI). This is a syndrome caused by a wide range of disparate predisposing diseases, all leading to a common insufficiency of pancreatic enzyme activity impairing nutrient absorption. Numerous problems can ensue.

pancreatic cancer, obstruction of the pancreatic duct from tumour, PEI: clinical trauma or inflammation, cystic manifestation fibrosis, and pancreatic surgery.

Recent articles have emphasized • Steatorrhea that non-pancreatic conditions • Unexplained weight loss can also cause PEI, presumably • Malaise because of defects in stimulation • Bloating, flatulence of the exocrine pancreas. For • Abdominal pain example, PEI develops after • Fat-soluble vitamin gastric surgery – bariatric or deficiency syndromes subtotal gastrectomy – and has • Reduced bone density been reported in type 1 diabetes Kidney stones (up to 57%), type 2 diabetes (35%), inflammatory bowel Here, Dr. Gabor Kandel, a disease (14% to 22%), celiac vitamin A deficiency by gastroenterologist at Toronto’s disease (15%), HIV and diarrhea- declining night vision, vitamin St. Michael’s Hospital and predominant IBS (6%).(2-12) D deficiency by bone diseases – associate professor of medicine osteomalacia and osteoporosis at the University of Toronto, HOW DOES IT PRESENT? – and vitamin E deficiency by discusses the practical Dr. Kandel: The traditional muscle weakness, neuropathy, considerations in the diagnosis hallmark of PEI is steatorrhea visual deterioration, and and treatment of PEI. – fatty-appearing, largeimmune compromise. volume, semi-formed stools Steatorrhea can also lead to WHAT ARE THE MOST passed more frequently than kidney stones from urinary COMMON MEDICAL normal, irreversibly staining oxalate crystallization.

CONDITIONS ASSOCIATED the toilet bowl, difficult WITH PEI? WHAT INVESTIGATIONS to flush, and exceptionally ARE USED TO CONFIRM THE Dr. Kandel: It is well known that malodourous. Usually, body DIAGNOSIS OF PEI? chronic pancreatitis is the most weight decreases: Involuntary Dr. Kandel: Fecal elastase (FE-1) common cause of PEI. However, weight loss is another feature has revolutionized the diagnosis virtually any pancreatic disease of PEI. However, both of these of PEI because it is accurate, can cause PEI, including symptoms represent end-stage PEI. In the modern era, PEI can inexpensive and increasingly available, in contrast to previous be – and should be – detected tests. The lower the value, the PEI: possible causes earlier, before steatorrhea higher the likelihood of PEI. becomes clinically evident and • Chronic pancreatitis A systemic study found that weight loss incapacitating.

• Cancer it has a sensitivity of 77% and Another presentation is • Surgery specificity of 88% for PEI(15), vitamin deficiency, particularly • Pancreatic obstruction but sensitivity is probably higher vitamins A, E, D and K – the • Cystic fibrosis when only symptomatic patients fat-soluble vitamins that • Autoimmune-related are considered. False-positive are characteristically poorly • Crohn’s disease low values have been reported in absorbed in PEI. This can • Celiac disease diarrhea from any cause because cause a wide variety of clinical • Diabetes problems. Vitamin K deficiency the large volume of stool simply dilutes the elastase. is suggested by easy bruising, MADE POSSIBLE THROUGH THE FINANCIAL SUPPORT OF VIATRIS

The selection of tests depends on presentation. If the chief complaint is frequent stools, then enteric pathogens should be excluded by stool culture, stool for C. difficile and stool microscopy. Colonoscopy and either celiac serology or small bowel biopsy then follow if these tests do not establish a diagnosis. In all cases, routine bloodwork is helpful. To find a clue to pancreatic disease, pay special attention to the serum glucose, which is elevated

small bowel with active porcine enzymes, is the mainstay of PEI treatment. It has been used for generations and is thoroughly understood, with years of clinical experience behind it. Safety and efficacy are well established. In fact, there is really no downside to an empiric course of PERT in patients for whom we have a high degree of suspicion for PEI. Seeing objective improvement in PEI symptoms with PERT treatment is in fact one of the

The recent introduction of a formulation containing high amounts of pancreatic enzyme (Creon 35®) has simplified therapy.

WHAT DIET SHOULD BE FOLLOWED? Dr. Kandel: Traditionally, a

MADE POSSIBLE THROUGH THE FINANCIAL SUPPORT OF VIATRIS

• Initiate PERT at sufficient dose • Add PPI with nonenteric coated PERT formulation Review for • Resolution of symptoms • Normalization of nutritional parameters Reassess and evaluate for other etiology fecal elastase-1 in type I diabetes mellitus.

Z Gastroenterol. 2001;39(10):823–830.

8. Hardt PD, Krauss A, Bretz L, et al.

Pancreatic exocrine function in patients with type 1 and type 2 diabetes mellitus.

Acta Diabetol. 2000;37(3):105–110.

9. Maconi G, Dominici R, Molteni M, et al.

Prevalence of pancreatic insufficiency in inflammatory bowel diseases. Assessment by fecal elastase-1. Dig Dis Sci. 2008;53(1):262–270.

10. Leeds JS, Hopper AD, Hurlstone DP, et al. Is exocrine pancreatic insufficiency in adult coeliac disease a cause of persisting symptoms?. Aliment Pharmacol.

2007;25(3):265–271.

11. Leeds JS, Hopper AD, Sidhu R, et al. Some patients with irritable bowel syndrome may have exocrine pancreatic insufficiency. Clin Gastroenterol Hepatol.

2010 May 1;8(5):433–438.

12. Ewald N, Bretzel RG. Diabetes mellitus secondary to pancreatic diseases (Type 3c)—are we ease?. Eur J Intern Med. 2013;24(3):203–206.

13. Singh, VK, et al. Less common etiologies of exocrine pancreatic insufficiency. World J Gastroenterol 2017 Oct 21; 23(39): 7059–7076.

14. Domínguez-Muñoz, JE. Pancreatic exocrine insufficiency: diagnosis and treatment. J Gastroenterol Hepatol 2011;26 Suppl 2:12–16.

15. Vanga, RR, Tansel, A, Sidiq S, El-Seraq HB, et al. Diagnostic performance of measurement of fecal elastase-1 in detection of exocrine pancreatic insufficiency. Systemic review and metaanalysis. Clin Gastroenterol Hepatol. 2018; 16: 1220-1228.e4 Senior Vice President, Canada: DONNA KERRY Senior Account Manager: NORMAN COOK Editor: LOUISE LEGER Project Manager: KALLI SAGOS Art Direction: NANCY PETERMAN This supplement is published by EnsembleIQ, 20 Eglinton Ave., W., Suite 1800, Toronto, ON M4R 1K8. Telephone: (416) 256-9908. No part of this publication may be reproduced, in whole or in part, without the written permission of the publisher. Copyright © 2022.

NON-2022-7635E-JN2022

low-fat diet was recommended for PEI patients, but contrary to what physiology suggests (pancreatic enzymes are more required for fat absorption than protein or carbohydrate absorption) and perhaps contrary to what we were “There is really no downside to an empiric course taught in medical school, of PERT in patients for whom we have a high degree diet restriction actually plays of suspicion for PEI. Seeing objective improvement a limited role in PEI. These in PEI symptoms with PERT treatment is in fact patients are often malnourished, one of the best indicators that one has and they have lost weight, so it made the correct diagnosis.” doesn’t make sense to restrict their diet. What we want them to do is eat, and the best way to because the islets of Langerhans best indicators that one has encourage somebody to eat is to become involved in the disease give them food they enjoy. Fat made the correct diagnosis.

In the past, prudent process, and to the serum absorption even when dietary physicians started with low doses fat is included in the diet should alkaline phosphatase, which of PERT because of articles rises because of compression of be sufficient with adequate reporting colon fibrosis with the bile duct as it traverses the PERT. The malnutrition seen higher doses. It turns out that inflamed or fibrotic pancreatic in the past with PEI should this adverse outcome was limited never be allowed to develop in head. Other useful blood tests include serum carotene, calcium, to cystic fibrosis patients using the modern era. daily doses above 750,000 IU of magnesium, phosphate, INR If available, referral to a and PTT (which are elevated in lipase. No convincing evidence dietician is helpful both to vitamin K deficiency) and levels has been presented incriminating encourage optimal weight and high doses of PERT in nonof vitamin D, E, and A. for vitamin supplements. cystic fibrosis patients.

Pancreatic stimulation I recommend initiating tests and 72-hour stool References 1. Durie P, et al. Diagnosis and PERT at a dose of anywhere collection were at one time management of pancreatic exocrine between 40,000 to 80,000 IU considered the investigations insufficiency (PEI) in primary care: that best established PEI (“gold per meal and 50% of that dose consensus guidance of a Canadian expert panel. Curr Med Res Opin 2018 with snacks. This can be taken standard”), but are clumsy, Jan;34(1):25–33. either all with the first bite of unpleasant and time intense.

2. Löhr JM, Dominguez-Munoz E, Rosendahl J, et al. United European food, or one-third immediately They are so rarely necessary Gastroenterology evidence-based guidelines nowadays that most labs are no before eating, one-third for the diagnosis and therapy of chronic with the meal, and one-third longer able to do them. pancreatitis (HaPanEU). United European Gastroenterol J. 2017;5(2):153–199. immediately after the meal is 3. Dumsay V, Myriam D, Frédéric C, HOW IS TREATMENT FOR PEI completed. PERT works best et al. Fat malabsorption screening in INITIATED AND MONITORED? when the pancreatic enzymes chronic pancreatitis. Am J Gastroenterol.

Dr. Kandel: Treatment is reach the duodenum at the same 2004;99(7):1350–1354.

4. Domínguez Muñoz JE. Pancreatic satisfying, because direct time as the food. exocrine insufficiency: diagnosis and treatment. J Gastroenterol Hepatol. correction of the underlying Improvement in symptoms 201;26:12–16. problem is safe, effective, readily and nutritional deficiencies, 5. Durno C, Corey M, Zielenski J, available, and relies on sound weight gain and a rise in fecal et al. Genotype and phenotype correlations in patients with cystic physiological principles. It’s elastase can all be used to and pancreatitis. Gastroenterol. a disease we went to medical monitor response to treatment. fibrosis 2002;123(6):1857–1864. school to manage. Pancreatic A proton pump inhibitor 6. Domínguez Muñoz JE. Pancreatic enzyme replacement therapy: replacement therapy (PERT), (PPI) must be prescribed with exocrine pancreatic insufficiency after which replaces endogenous PERT formulations that are not gastrointestinal surgery. HPB. 2009;11:3–6.

7. Icks A, Haastert B, Giani G, et al. Low enzymes in the lumen of the enteric-coated.

PEI: management steps Confirm dysfunction and clinical symptoms

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PRESCRIPTION ANTIHISTAMINE COVERED BY MOST PRIVATE INSURANCE PLANS Indications: Seasonal Allergic Rhinitis BLEXTEN® (bilastine) is indicated for the symptomatic relief of nasal and non-nasal symptoms of seasonal allergic rhinitis (SAR) in patients 4 years of age and older with a body weight of at least 16 kg.

Chronic Spontaneous Urticaria BLEXTEN® (bilastine) is indicated for the relief of the symptoms associated with chronic spontaneous urticaria (CSU) (e.g. pruritus and hives), in patients 4 years of age and older with a body weight of at least 16 kg.

Contraindication: • History of QT prolongation and/or torsade de pointes, including congenital long QT syndromes Relevant warnings and precautions: • QTc interval prolongation, which may increase the risk of torsade de pointes • Use with caution in patients with a history of cardiac arrhythmias; hypokalemia, hypomagnesaemia; significant bradycardia; family history of sudden cardiac death; concomitant use of other QT/QTc-prolonging drugs

Σ

• P-glycoprotein inhibitors may increase plasma levels of BLEXTEN® in patients with moderate or severe renal impairment; co-administration should be avoided • BLEXTEN® should be avoided during pregnancy unless advised otherwise by a physician • A study was performed to assess the effects of BLEXTEN® and bilastine 40 mg on real time driving performance compared to placebo. Bilastine did not affect driving performance differently than placebo following day one or after one week of treatment. However, patients should be informed that very rarely some people experience drowsiness, which may affect their ability to drive or use machines.

For more information: Please consult the product monograph at https://www.miravohealthcare.com/wp-content/ uploads/2021/08/Blexten-PM-ENG-Aug2021.pdf for important information relating to adverse reactions, drug interactions, and dosing information which have not been discussed in this piece. The product monograph is also available by calling 1-866-391-4503.

As of August 31, 2021, the estimate from internal data of patient exposure is based on units sold of the defined daily dose of 20 mg bilastine and the mean treatment duration of 3 weeks.

Reference: 1. Blexten® Product Monograph. Aralez Pharmaceuticals Canada Inc. 2021.

bilastine tablets 20 mg Aralez Pharmaceuticals Canada Inc.* 6733 Mississauga Road, Suite 800 Mississauga, Ontario L5N 6J5 *d/b/a Miravo Healthcare MA-20-12-16-2021-E

© 2022. BLEXTEN is a registered trademark of FAES used under license by Aralez Pharmaceuticals Canada Inc.

BACK PAGES

BY BILL ROGERS

LAW

Reverse thinking not allowed After an arthroscopic knee surgery, the patient had persistent pain, so the surgeon must have injured an artery, right?

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“The procedure ended in a bad result, so it must be the doctor’s fault!”

Luckily, this kind of logic is not allowed in medical malpractice law. It reared its ugly head recently in the Manitoba Court of Appeal, but the court squashed it down, calling it “clearly impermissible, reverse thinking.”

It all started with arthroscopic knee surgery that seemed to go off without a hitch. The surgeon followed typical methods: He removed a large piece of torn cartilage, used a power shaver to smooth down the surface of the knee cap and trim back some membrane, then closed the wound. Unfortunately, shortly after the operation, the patient began suffering from bad circulation and pain in her lower leg. An ultrasound revealed

a pseudoaneurysm in an artery behind the knee, apparently caused by direct trauma. It was repaired but the pain persisted.

At trial, the surgeon was adamant that none of the instruments he used to perform the surgery had come into contact with the artery. The trial judge accepted this and held him blameless.

The patient appealed, but the appeal court held him blameless too.

It was a close call, though. One of the three appeal judges dissented.

The dissenting judge suggested that at the trial, when the surgeon testified on the witness stand that none of his instruments had made contact with the artery, he was either mistaken or lying. How else could the injury have happened? “This could only have

occurred if the instrument had strayed,” said this judge. “The surgeon denied that he did so. However, that remains the likely explanation for how the injury occurred.”

This judge found support for his conclusion from the patient’s expert, who said injuring an artery during this kind of procedure, while recognized as a “possible” complication, is exceedingly rare and “should not occur at all.” In other words, “the standard of care with respect to this procedure includes the requirement that the surgeon not allow instruments to stray from the knee capsule and strike the artery.” And this must have happened because there was a bad result.

No, said the other two judges. It is not permissible to reason backwards from a bad result and decide that the doctor must have done “X,” even though there is no proof the doctor did “X,” or indeed anything else untoward. This kind of reverse thinking has long been seen as wrong in law. Decision after decision has ruled that doctors cannot be measured solely by their results.

For example, the two majority judges cited a leading malpractice case from a few years ago involving a patient who underwent surgery on her colon, which resulted in injury to her ureter.

Even though there was no proof, the trial judge made the inference that the surgeon must have touched the ureter with a cauterizer. And obviously, the trial judge reasoned, a prudent surgeon would not allow a cauterization instrument within a certain distance of a vulnerable part of a patient’s body. Therefore, he was negligent. But this backward-looking decision was subsequently overruled and reversed.

Reasoning backwards from a bad result is not just bad logic, it amounts to

THE MEDICAL POST JUNE 2022 57

BACK PAGES

BILL ROGERS is a Toronto lawyer and

writer covering medical and pharmaceutical issues.

58 JUNE 2022 THE MEDICAL POST

CARTOON

Contest: Caption the cartoon

WHAT WOULD BE A FUNNY LINE FOR A CHARACTER TO SAY HERE? Use your smartphone to scan the QR code at right—or go online to canadianhealthcarenetwork.ca/caption-junes-cartoon—and you can enter your answer on the Medical Post’s online home. If your answer is selected, you’ll receive a $75 Amazon gift card and this cartoon will re-run in the September issue of the Medical Post magazine with your caption! So you get money—and the doubtless esteem and accolades from your colleagues!

Caption contest winner We had a lot of great entries for the caption-the-cartoon contest in the April issue of the magazine, but we thought Dr. Sherry Rohekar’s entry below was the funniest. Dr. Rohekar, a rheumatologist in London, Ont., will receive a $75 Amazon gift card as a prize.

‘Exactly how many circumcisions are we performing today?’

Johnny Hawkins

applying a standard of perfection. And perfection is, of course, not the correct standard to judge doctors by. It amounts to the expectation of a “guaranteed” outcome and, sadly, there are no guarantees in medicine or anything else for that matter.

Accordingly, the court reiterated several well-settled malpractice principles: The standard of care required of a medical practitioner is not perfection but a reasonable degree of skill and knowledge, similar to what could reasonably be expected of a normal, prudent practitioner of the same experience and standing.

Even the patient’s expert admitted that injuring an artery during knee arthroscopy is a recognized, albeit rare, complication, and “can occur without negligence.” His report included a medical journal article saying, “pseudoaneurysm formation after knee arthroscopy can also appear without a history of penetration of the knee capsule or vessel wall,” possibly because of “the shear stress on the knee structures and arteries during surgery and specifically during arthroscopy.”

This, together with the surgeon’s own testimony, successfully rebutted the inference that the cause of injury was an instrument straying. “The trial judge came to the correct conclusions,” ruled the appeal court majority. “The surgeon did not breach the appropriate standard of care, and it has not been established that he did, or failed to do, anything to cause the injury.”

In the end, the appeal court concluded there was no negligence, and the injury to the knee artery was nothing more than an “unfortunate misadventure.” Those happen. They are not negligence. The only basis for finding negligence here would be to employ hindsight, and “utilize a results-oriented approach and to reason backwards.” In other words: “The procedure ended in a bad result, so it must be the doctor’s fault.” Luckily, this kind of logic is not allowed.

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THE PATIENT

Significantly more SUVEXX® patients achieved headache pain relief at 2 hours vs placebo*†

65% vs 28%, respectively (p<0.001)

SUVEXX pharmacokinetics‡: • Median Tmax for sumatriptan when given as a component of SUVEXX was 1 hour (range: 0.3 to 4 hours) vs a median Tmax of 1.5 hours for sumatriptan succinate 100 mg alone • Median Tmax for naproxen when given as SUVEXX was 6 hours (range: 0.3 to 12 hours), approximately 5 hours later than with naproxen sodium tablets Recommended dosing: • One tablet dosing taken as early as possible during migraine attack • The maximum recommended dosage in a 24-hour period is 2 tablets, taken at least 2 hours apart Tmax: Time to reach maximum plasma levels. * Randomized, phase 3, double-blind, parallel-group, single-dose study of 1,461 patients with acute migraine with or without aura utilizing placebo and each individual active component of SUVEXX as comparisons (SUVEXX, n=370; placebo, n=365; sumatriptan succinate 85 mg, n=365; naproxen sodium 500 mg, n=361). Co-primary endpoints were superiority of SUVEXX over placebo at 2 hours post-dose for the following endpoints: pain relief (no or mild pain); incidence of photophobia, phonophobia and nausea; and superiority of SUVEXX vs the individual components for sustained pain-free at 24 hours. † Headache relief was defined as a reduction in headache severity from moderate-to-severe pain to mild or no pain. ‡ Clinical significance unknown.

Please see the Product Monograph for complete dosing and administration recommendations.

Pr SUVEXX® (sumatriptan succinate and naproxen sodium) is indicated for the acute treatment of migraine attacks with or without aura in adults.

SUVEXX is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic, basilar, or ophthalmoplegic migraine. Safety and efficacy of SUVEXX has not been established for cluster headache, which is present in an older, predominantly male population.

SUVEXX should only be used if a clear diagnosis of migraine headache has been established.

The safety and efficacy of SUVEXX in pediatric patients (<18 years) and the elderly population (>65 years of age) have not been established. SUVEXX is not indicated for use in pediatric patients.

Contraindications: • Ischemic coronary artery disease (CAD) (angina pectoris, history of myocardial infarction, or documented silent ischemia) or coronary artery vasospasm, including Prinzmetal’s angina; • In the setting of coronary artery bypass graft surgery; • Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders; • History of stroke or transient ischemic attack or history of hemiplegic, basilar, or ophthalmoplegic migraine because these patients are at a higher risk of stroke; • Peripheral vascular disease; • Ischemic bowel disease; • Uncontrolled hypertension; • Recent use (i.e., within 24 hours) of ergotamine-containing medication, ergot-type medication (such as dihydroergotamine or methysergide), or another 5-hydroxytryptamine1 agonist; • Concurrent administration of a monoamine oxidase (MAO)-A inhibitor or recent (within 2 weeks) use of an MAO-A inhibitor; • History of asthma, urticaria, or allergic-type reactions after taking acetylsalicylic acid (ASA) or other nonsteroidal anti-inflammatory (NSAID).

Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients. The potential for cross-reactivity between different NSAIDs must be kept in mind.

• Third trimester of pregnancy because of risk of premature closure of the ductus arteriosus and prolonged parturition; • Breastfeeding women; • Moderate or severe hepatic impairment or active liver disease; • Severe uncontrolled heart failure; • Active gastric/duodenal/peptic ulcer, active GI bleeding; • Cerebrovascular bleeding or other bleeding disorders; • Inflammatory bowel disease; • Severe renal impairment (creatinine clearance <30 mL/ min or 0.5 mL/ sec) or deteriorating renal disease (individuals with lesser degrees of renal impairment are at risk of deterioration of their renal function when prescribed NSAIDs and must be monitored); • Known hyperkalemia Most serious warnings and precautions: Risk of cardiovascular adverse events: Sumatriptan, a component of SUVEXX, can cause coronary artery vasospasm. SUVEXX is contraindicated in patients with uncontrolled hypertension, ischemic CAD, cardiac arrhythmias, and those with history of myocardial infarction. SUVEXX is not recommended in patients with family history or risk factors predictive of CAD. Naproxen sodium, a component of SUVEXX, is an NSAID. Use of some NSAIDs is associated with an increased incidence of cardiovascular adverse events (such as myocardial infarction, stroke or thrombotic events) which can be fatal. The risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.

Caution should be exercised in prescribing NSAIDs such as naproxen sodium, which is a component of SUVEXX, to any patient with ischemic heart disease (including but NOT limited to acute myocardial infarction, history of myocardial infarction and/or angina), cerebrovascular disease (including but NOT limited to stroke, cerebrovascular accident, transient ischemic attacks and/or amaurosis fugax) and/or congestive heart failure (NYHA II-IV).

Aralez Pharmaceuticals Canada Inc.* 6733 Mississauga Road, Mississauga, ON L5N 6J5 * d/b/a Miravo Healthcare F-SUV-012-03242022

Use of NSAIDs, such as naproxen sodium, which is a component of SUVEXX, can promote sodium retention in a dose-dependent manner, through a renal mechanism, which can result in increased blood pressure and/or exacerbation of congestive heart failure.

Risk of gastrointestinal (GI) adverse events: Use of NSAIDs, such as naproxen sodium, which is a component of SUVEXX, is associated with an increased incidence of gastrointestinal (GI) adverse events (such as peptic/duodenal ulceration, perforation and obstruction of the upper and lower gastrointestinal tract, and gastrointestinal bleeding).

These events can occur at any time during use and without warning symptoms. Elderly patients and those with history of peptic ulcer disease and/or GI bleeding are at greater risk for serious Gl events.

Risk in pregnancy: Caution should be exercised in prescribing SUVEXX during the first and second trimesters of pregnancy. Use of NSAIDs at approximately 20 weeks of gestation or later may cause fetal renal dysfunction leading to oligohydramnios and neonatal renal impairment or failure. SUVEXX is contraindicated for use during the third trimester because of risk of premature closure of the ductus arteriosus and uterine inertia.

Other relevant warnings and precautions: • Use only when a clear migraine diagnosis has been established; • Use in cluster headache; • Psychomotor impairment; • Use in medication overuse headache; • Not recommended for use with other NSAIDs, except low-dose ASA for cardiovascular prophylaxis; • Serious cardiac events and fatalities associated with 5-HT1 agonists; • Cerebrovascular events and fatalities with 5-HT1 agonists; • Other vasospasm-related events; • Increased blood pressure; use with caution in patients with controlled hypertension; • Congestive heart failure and edema; • Interference of platelet function; • Use with anticoagulants; • Anti-platelet effects; • Blood dyscrasias; • Increased liver enzymes; evaluate patients with signs of liver dysfunction; • Hypersensitivity and anaphylactoid reactions; • Do not use in ASA-intolerance; • Cross-sensitivity to other NSAIDs; • Masking of inflammation and fever; • Excluding other neurologic conditions; • History of seizures; • Serotonin syndrome; monitor patients on other serotonergic treatments; • Blurred and/or diminished vision; • Renal impairment; use with caution in patients with severe dehydration or pre-existing kidney disease; • Sodium retention and hyperkalemia; • ASA-induced asthma; • May impair fertility; not recommended in women trying to conceive; • Serious skin reactions (e.g., drug reaction with eosinophilia and systemic symptoms [DRESS], Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis and erythema multiforme); • Use with caution during first and second trimesters; evaluate risk-benefit; • Not recommended during labour and delivery; • Use in breastfeeding women For more information: Please consult the Product Monograph at: https://www.miravohealthcare. com/wp-content/uploads/2022/01/Suvexx-PM-ENG-Dec2021.pdf for adverse reactions, interactions, dosing and conditions of clinical use. The Product Monograph is also available by calling Miravo Medical Information at 1-866-391-4503.

SUVEXX® Product Monograph, Aralez Pharmaceuticals Canada Inc. December, 2021.

BACK PAGES

4. Record everything

If there was ever a time to take meticulous notes, this is it. You want to describe in detail the treatment you gave, how long it took, the problem that arose, your observations, what the patient told you or said and what you told the patient. Often, it is not only the issue that arose during treatment but how the problem was handled that becomes an issue. Ensuring this is all well documented will assist in determining whether an appropriate approach was followed.

5. Review the standards of care

If you are unsure what the standards of care are for the adverse outcome your patient is experiencing, review your professional conduct handbook or other standard of care manuals and resources.

Refer to that review in your notes, including the specific provisions reviewed and the steps you took as a result.

What to do when a treatment goes wrong?

Two lawyers run down the steps

BY CLAIRE IMMEGA AND HARPREET DOSANJH

Y

ou’ve performed this treatment thousands of times without incident. You have seen it help patients time again. But this time, you see that this patient has an adverse reaction to the treatment or maybe you become careless and make a mistake.

Do not panic. We are all human and mistakes happen. Here is what you should do when a treatment goes wrong:

1. Stop the treatment

Do not continue treating the patient if a problem arises. You do not want to make a bad situation worse. Immediately stop treatment.

2. Inform the patient

Tell the patient that they have had an

62 JUNE 2022 THE MEDICAL POST

adverse reaction to the treatment and then what steps they should or should not take.

3. Do not admit liability

While you may feel responsible, something outside of your control may have occurred.

Do not tell the patient you have done something wrong or apologize for doing something wrong. It is OK to express sympathy and under the right circumstances say “sorry that this happened” or “sorry the procedure/ treatment did not work,” but do not admit that you made a mistake. Doing so can harm your legal defense, and in some cases can void your professional liability insurance.

6. Refer

If the patient is experiencing adverse reactions that are at all serious, refer them to their family physician, a walk-in clinic or urgent care for further care.

7. Follow-up

It is important to followup with the patient a day or two following the treatment to ensure they are following the post-treatment recommendations.

This helps ensure you are being diligent and highlights the advice you have provided the patient to follow.

8. Report it to your insurer

If you have concerns that a complaint will be lodged with your regulatory body, a lawsuit may be filed or that you have done something wrong to cause damage to the patient, reporting ahead of time to your insurer is a good idea. This does not mean you are liable but provides your insurer notice that a claim may be made and take steps to protect you. When in doubt, check your reporting obligations in your insurance policy.

Claire Immega and Harpreet Dosanjh are lawyers with Singleton Urquhart Reynolds Vogel.

Getty Images

COLUMN

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The Dexcom G6 Urgent Low Soon alert can even warn patients in advance of serious hypoglycemia—allowing them time to take steps to prevent it.

Dexcom CGM use is also clinically proven to lower A1C, reduce hyper- and hypoglycemia, and increase time in range.2,3 To learn more about the Dexcom G6, visit: ca.provider.dexcom.com Smart devices sold separately

* If glucose alerts and readings from the G6 do not match symptoms or expectations, use a blood glucose meter to make diabetes treatment decisions. † Conditions apply. Visit dexcom.com for more information. ‡ Smart devices sold separately. For a list of compatible devices, visit dexcom.com/compatibility.

1. Shah VN, et al. Diabetes Technol Ther. 2018;20(6):428-33.

2. Beck, RW, et al. JAMA. 2017;317(4):371-378.

3. Welsh JB, et al. Diabetes Technol Ther. 2019;21(3):128-32.

Dexcom and Dexcom G6 are registered trademarks of Dexcom Inc. in the United States and may be registered in other countries. ©2021 Dexcom Canada, Co. All rights reserved. LBL021882 Rev002

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What was was the the efficacy efficacy of of Ozempic Ozempic®® in in clinical clinical trials? trials?

What DEMONSTRATED A1C A1C REDUCTION REDUCTION DEMONSTRATED At week week 56, 56, both both as as add-on add-on to to metformin metformin and/or and/or TZD, TZD, Ozempic Ozempic®® demonstrated demonstrated At statistically signifi cantly greater A1C reduction vs.

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† p<0.0001 vs. Januvia® † p<0.0001 vs. Januvia®

Januvia®® Januvia 100mg mg 100

Ozempic®® Ozempic 0.5mg mg 0.5

Ozempic®® Ozempic mg 11mg

n =407 n =407

n =409 n =409

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Adapted from Product Monograph and Ahrén et al.

Adapted from Product Monograph and Ahrén et al.

Mean baseline A1C = 8.1%; baseline A1C (%) Ozempic® 0.5 mg = 8.0; Ozempic® 1 mg = 8.0; Januvia® 100 mg = 8.2.

Mean baseline A1C = 8.1%; baseline A1C (%) Ozempic® 0.5 mg = 8.0; Ozempic® 1 mg = 8.0; Januvia® 100 mg = 8.2.

TZD = thiazolidinedione.

TZD = thiazolidinedione.

DEMONSTRATED WEIGHT WEIGHT REDUCTION REDUCTION DEMONSTRATED At week 56, both as add-on to metforminand/or and/orTZD TZD(2° (2°endpoint), endpoint),Ozempic Ozempic®® At week 56, both as add-on to metformin ® 1‡ demonstrated statistically signifi cant weight reduction vs.

Januvia demonstrated statistically significant weight reduction vs. Januvia®..1‡ Change Change from from baseline baseline in in weight weight at at week week 56 56 0 0

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How is is Ozempic Ozempic®® supplied? supplied?

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Ozempic®® Ozempic 0.5mg mg 0.5

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n =407 n =407

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WITH OZEMPIC® V.S JANUVIA® WITH OZEMPIC® V.S JANUVIA® (Both as add ons to metformin and or TZD; (Both as add ons ndto metformin and or TZD; 2 endpoint) 2nd endpoint)

Adapted from Product Monograph and Ahrén et al.

Adapted from Product Monograph and Ahrén et al.

Mean baseline weight: 89.5 kg; TZD= thiazolidinedione.

Mean baseline weight: 89.5 kg; TZD= thiazolidinedione.

Ozempic®® isis not not indicated indicated for for weight weight reduction. reduction.

Ozempic ‡ A 56-week, randomized, double-blind, double-dummy, active-controlled, parallel-group, multicentre trial to compare the efficacy and safety of Ozempic®® vs. ‡ A 56-week, randomized, double-blind, double-dummy, active-controlled, parallel-group, multicentre trial to compare the efficacy and safety of Ozempic vs.

Januvia®. A total of 1,231 patients with T2DM inadequately controlled on metformin and/or thiazolidinediones were randomized to receive once-weekly Januvia®. ®A total of 1,231 patients with T2DM inadequately controlled on metformin and/or thiazolidinediones were randomized to receive once-weekly Ozempic 0.5 mg (n=409), once-weekly Ozempic® 1 mg (n=409), or once-daily Januvia® 100 mg (n=407). At week 56, the primary endpoint was change Ozempic® 0.5 mg (n=409), once-weekly Ozempic® 1 mg (n=409), or once-daily Januvia® 100 mg (n=407). At week 56, the primary endpoint was change in A1C and the secondary endpoint was change in mean body weight at week 30. in A1C and the secondary endpoint was change in mean body weight at week 30.

Apis bull

Clear sPaCe rules Our logo must have enough free space – a 'clear space' zone – around it to ensure its impact. This means no element should be placed closer than two n's to the logo.

The clear space from the bottom of the page to the bottom of the logo is 5x the height of the n, or 5n, in the wordmark.

ByliNe It is optional, but recommended where practically possible, to insert the following byline in materials featuring the Apis bull logo: 'The Apis bull logo is a registered trademark of Novo Nordisk A/S'.

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DEMONSTRATED CARDIOVASCULAR OUTCOMES In addition to standard of care (SOC)£ in patients with T2DM and at high risk of CV events, Ozempic® demonstrated a CV outcome (MACE) safety endpoint at 2 years.1,2§ Time to first confirmed major adverse CV event (MACE)

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8.9% Placebo + SOC 6.6% Ozempic® + SOC

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(95% CI [0.58, 0.95]; -26%) vs. placebo

p<0.0001 for non-inferiority. p=0.017 for superiority.

Time from randomization (week)

CV=cardiovascular; MACE=major adverse cardiovascular event; HR=hazard ratio; CI=confidence interval; MI=myocardial infarction

What is the dosing and administration for Ozempic®?

Ozempic® provides convenient once-weekly dosing—any time of the day, with or without meals.1

OPTION TO ESCALATE

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0.25 mg

0.5 mg

for 4 weeks (not a therapeutic dose)

1 mg

for 4 weeks (maintenance dose)

if additional glycemic control is needed after 4 weeks

• Dose escalation: The starting dose of 0.25 mg is not a therapeutic dose. After 4 weeks, the dose should be increased to 0.5 mg once weekly.

If additional glycemic control is needed after 4 weeks, the dose may be increased to 1 mg once weekly to further improve glycemic control.1 • Dosage adjustment: No dosage adjustments are required for patients with renal impairment.1 See Product Monograph for complete dosing and administration information.

What is the mechanism of action of Ozempic®?¶ Ozempic® (semaglutide injection) is a GLP-1 receptor agonist that selectively binds to and activates the GLP-1 receptor. It is a GLP-1 analogue with 94% sequence homology to human GLP-1.1 Ozempic®:1

PANCREAS

GLP-1=glucagon-like peptide-1

Counselling tips to help manage GI side effects: Eat smaller, more frequent meals Eat slowly Drink plenty of water (stay hydrated) Avoid fatty food

Delays gastric emptying

LIVER

STOMACH

Clinical use: Not a substitute for insulin. Not for use in type 1 diabetes or for the treatment of diabetic ketoacidosis. Ozempic® is not indicated for use in pediatric patients.

Contraindications: • Personal or family history of medullary thyroid carcinoma (MTC), or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) • Pregnancy or breastfeeding • Hypersensitivity to Ozempic or any of the product components Most serious warnings and precautions: Risk of thyroid C-cell tumours: In both genders of rats and mice, semaglutide causes treatment-dependent thyroid C-cell tumours. Patients should be counselled regarding the risk and symptoms of thyroid tumours.

Other relevant warnings and precautions: • Should not be administered intramuscularly • Pancreatitis • Hypoglycemia with concomitant use of insulin secretagogues or insulin • Use with other incretin drugs • Diabetic retinopathy: in patients with history of disease monitor for progression • Renal impairment: severe GI adverse reactions warrant monitoring of renal function; use in end-stage disease • CV effects: increased heart rate; PR interval prolongation • Hepatic insufficiency For more information: Please consult the Product Monograph at OzempicPM-E.ca for more information relating to adverse reactions, drug interactions, and dosing information which have not been discussed in this advertisement. The Product Monograph is also available by calling us at 1-800-465-4334. £ Standard of care included oral antihyperglycemic treatments, insulin, antihypertensives, diuretics, antithrombotic and lipid-lowering therapies. § A 2-year, randomized, double-blind, placebo-controlled, parallel-group trial to evaluate CV and other long-term outcomes of Ozempic®. A total of 3,297 patients with T2DM and high risk of CV events were randomized based on evidence of CV disease, insulin treatment and renal impairment to once-weekly Ozempic® 0.5 mg (n=826), Ozempic® 1 mg (n=822) or placebo (n=1,649) in addition to standard of care treatments, such as oral antihyperglycemic treatments, insulin, antihypertensives, diuretics and lipid-lowering therapies at investigator discretion. The primary endpoint was time from randomization to first occurrence of a major adverse CV event (MACE) defined as CV death, non-fatal myocardial infarction, or non-fatal stroke. Secondary endpoints included first occurrence from baseline to week 104 of the individual components of the composite outcomes and diabetic retinopathy complications; change from baseline to week 104 in body weight and A1C. ¶ Clinical significance has not been established.

References 1. Ozempic® (semaglutide injection) Product Monograph. Novo Nordisk Canada Inc., 2022.

2. Marso SP, et al. Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. N Engl J Med. 2016;375(19):1834-1844

All trademarks and registered trademarks are the property of their respective owners. Ozempic® and NovoFine® Plus are registered trademarks of Novo Nordisk A/S and used under license by Novo Nordisk Canada Inc. Novo Nordisk Canada Inc., Tel: (905) 629-4222 or 1-800-465-4334. www.novonordisk.ca This Q&A is published by Ensemble IQ, 20 Eglinton Avenue West, Suite 1800, Toronto, ON M4R 1K8, Telephone: 416-256-9908.

No part of this Q&A may be reproduced, in whole or in part, without the written permission of the publisher. © 2022

CA22OZM00008E

Lowers glucagon secretion (in a glucosedependent manner)

Stimulates insulin secretion (in a glucosedependent manner)

The most common GI adverse reactions were nausea (Ozempic® 0.5 mg= 17.0%, Ozempic® 1 mg =19.9%, comparator=6.3%), diarrhea (Ozempic® 0.5 mg=12.2%, Ozempic® 1 mg=13.3%, comparator=5.7%), abdominal pain (Ozempic® 0.5 mg=8.7%, Ozempic® 1 mg=8.1%, comparator= 4.7%), vomiting (Ozempic® 0.5 mg=6.4%, Ozempic® 1 mg=8.4%, comparator=3.3%) and constipation (Ozempic® 0.5 mg=6.9%, Ozempic® 1 mg=6.2%, comparator=2.7%). The majority of the nausea, vomiting and diarrhea events occurred during dose escalation. Investigators graded the severity of gastrointestinal adverse reactions occurring on 0.5 mg and 1 mg of Ozempic® as “mild” in 38.8% and 36.5% of cases, respectively, “moderate” in 9.8% and 12.5% of cases, respectively, or severe in 1.7% and 1.8% of cases, respectively.1

See Product Monograph for complete information on adverse events.

The components of MACE are CV death, non-fatal stroke and non-fatal MI.1 No increased risk for MACE was observed with Ozempic®.1 Ozempic® is not indicated to reduce the incidence of CV (MACE) outcomes.

START

What were the most common gastrointestinal (GI) adverse reactions associated with Ozempic®?

For Canadian healthcare professionals only

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SH

1

BREO ELLIPTA (fluticasone furoate/vilanterol) 100/25 mcg and BREO ELLIPTA 200/25 mcg are indicated for the once-daily maintenance treatment of asthma ma in patients aged 18 years and older der with reversible obstructive airways ys disease.1 Please see the Product Monograph aph for complete dosing and administration instruction.

Consult the Product Monograph at ca.gsk.com/media/6157/breo-ellipta.pdf k com/media/6157/breo-ellipta.pdf for important information about: t ins; and primary treatment of statu • Contraindications in patients with severe hypersensitivity to milk proteins; status asthmaticus or other acute episodes of asthma.

• Relevant warnings and precautions regarding risk of serious asthma-related events (hospitalizations, intubations, death) with fixed-dose ICS/LABA combinations; not for relief of acute asthma symptoms; discontinuing regular use of rapid onset, short-duration inhaled bronchodilators; not to be used in acutely deteriorating asthma; asthma-related adverse events and exacerbations; do not use higher than recommended dose/frequency, or use with other LABAs; cardiovascular disease; Candida albicans infection; systemic effects; hypercorticism and adrenal suppression; risk of death due to adrenal insufficiency in systemic steroid replacement; hypokalemia and hyperglycemia; co-existing conditions; eosinophilic conditions, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/ or neuropathy; hypersensitivity; paradoxical bronchospasm, wheezing, pneumonia; coadministration with other medications; monitoring recommendations: serum potassium levels in patients predisposed to low levels of serum potassium; blood glucose in diabetic patients; bone and ocular effects (cataract, glaucoma, and central serous chorioretinopathy) for patients at risk; and corticosteroid effects for patients with hepatic impairment.

• Conditions of clinical use, adverse reactions, drug interactions and dosing instructions The Product Monograph is also available by calling 1-800-387-7374.

To report an adverse event, please call 1-800-387-7374 REFERENCES: 1. BREO Product Monograph. GlaxoSmithKline Inc. January 7, 2019.

Trademarks are owned by or licensed to the GSK group of companies.

BREO Ellipta was developed in collaboration with © 2022 GSK group of companies or its licensor.

04901-03/2022 GlaxoSmithKline Inc. 100 Milverton Drive, Mississauga, Ontario L5R 4H1

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It’s understandable, says Rubach.

Doctors are busy and gathering the information needed to put together a financial plan can be time-consuming.

“But if you don’t address it you might spend the next several years worrying that you’re not going to have enough money to retire,” she said. “So why not do it today?”

MISTAKE #2: Giving too much away to help the kids buy their first home

FINANCE

Live longer, retire longer And make it easier by avoiding these 5 mistakes BY MARJO JOHNE

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anadians own bragging rights to having one of the world’s best prospects for longevity, with a life expectancy at birth of 79.8 years for men and 83.9 years for women. If you happen to be a physician—and there’s a good chance you are, if you’re reading this—you might want to recalibrate your expectations by adding four or five years to your anticipated lifespan.

That’s what some studies in the past have suggested anyway, albeit with the caveat that data on physician death is sparse and more studies are needed.

The point is, there’s a good chance you’re going to live longer than your parents did simply because Canadians as a whole are living longer, plus an extra chance you’ll live longer than other Canadians simply because you’re a doctor.

“It’s not like it used to be where you retire at 65 and die at 75,” said Elke Rubach, a certified financial planner and

founder of Rubach Wealth in Toronto.

“Now, retirement can take up a third, or even more, of your lifetime. So the whole concept of retirement really needs to be revisited entirely.”

MISTAKE #1: Failing to crunch the numbers

When retirement starts at 65 and lasts for 20, 30 or even more years, financial planning mistakes or oversights can have significant and often painful impacts.

Rubach pointed out a common mistake that can be remedied easily: making assumptions without first crunching the numbers.

“I can’t tell you the number of times we’ve done financial planning for doctors and they’re convinced that if they stop working they’re going to be destitute,” she said. “But then we sit down and go through all their numbers and we find money. And they’re like, ‘Really?’”

There was a time when a $50,000 loan or gift was enough to ensure your adult children had enough of a down payment to put toward a real estate purchase.

Today, helping the kids get into their first home could require an outlay of about $100,000 or more.

Before you give that money away, take some time to figure out—ideally with your financial planner—if you can actually afford it.

“Do what they tell us to do on an airplane: Put your oxygen mask on first before helping others with theirs,” said Rubach. “You may have that extra money today but if you give it away, could you end up being financially strapped 20 years down the road?”

If that financial helping hand you’re extending to your child today is intended as a loan, make sure you have that stated in writing and signed by the recipient, said Laroux Peoples, a wills and estates lawyer in Toronto. As an added measure of protection, you may want to register a mortgage on the title of the property in question. This puts you—or, upon your death, your estate—in line as a priority creditor.

MISTAKE #3: Not keeping track of those ‘living inheritances’

Whether you’re giving or lending money toward a child’s first home, or paying for your grandkids’ private school education, it’s a good idea to keep an accounting of these “living inheritances” you’re passing down while you’re still walking on this earth, said Peoples.

Another good idea? Add a hotchpot clause to your will—a provision designed to help ensure equal division of your estate among your beneficiaries. With

THE MEDICAL POST JUNE 2022 67

Consider XALATAN and XALACOM

When you purposely prescribe the Viatris original brand XALATAN or XALACOM, help your patient get it.

1

Write the Viatris original brand name, XALATAN or XALACOM, and include “no sub,” when appropriate, on your patient’s prescription.

2

Encourage your patients to visit ViatrisOriginals.ca so they can: • Download a payment assistance card to help patients who have no insurance or whose insurance co-payment amount might be a barrier to obtaining the Viatris original brand medication. This card can help patients obtain the Viatris original brand medication at little or no additional cost compared to the generic version.*

3

Remind your patient to ask for the Viatris original brand XALATAN or XALACOM at the pharmacy.

* Subject to change. The Viatris Originals Program is available in all provinces except Quebec.

Availability and level of payment assistance vary by brand medication and province.

ViatrisOriginals.ca

XALB-2022-0143E - MA2022

Some insurers limit full-cost coverage for higher-cost interchangeable drugs to patients who meet certain criteria, and in some instances, documentation from the prescriber is required. There is a possibility that the patient may need to contribute out-of-pocket where those conditions are not met.

XALATAN is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

XALATAN may be used for the reduction of intraocular pressure in patients with chronic angle-closure glaucoma who underwent peripheral iridotomy or laser iridoplasty.

XALACOM is indicated for the reduction of IOP in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-adrenergic blocking agents, prostaglandins, or other IOP lowering agents AND when the use of XALACOM (the combination drug) is considered appropriate.

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“If you keep a proper tally, itYESwould be easy for the estate trustee Spread to show, for example, that one child 19470_Xalabrands_Campaign_HCP_ Copy Ad_V06_Cln got so much over the years while Public.

The Medical Post another didn’t get as much help.”

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a hotchpot clause, any financial gifts or loans you give your beneficiaries while you’re still alive gets deducted from BL their share of your estate. Hence, the importance of tracking what you give your heirs.

AD “If you keep a proper tally, it would be easy for the estate trustee to show, for example, that one child got so much over PR the years, while another didn’t get as much help,” said Peoples. “This can really go PROD a long way toward preventing hurt feelings and legal disputes later on.”

CS MISTAKE #4: Foregoing the pre-nup or cohab agreement

Viatris and the Viatris logo are trademarks of Mylan Inc., licensed use by Upjohn Canada ULC, a Viatris Company. © 2022 Viatris Inc. All rights reserved.

XALATAN is a registered trademark of PFIZER PFE US HOLDINGS 4 LLC, licensed use by Upjohn Canada ULC, a Viatris company.

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Consult the Product Monographs at http://www.pfizer.ca/pm/en/XALATAN.pdf and http://www.pfizer.ca/pm/en/ XALACOM.pdf for contraindications, warnings, precautions, adverse reactions, interactions, dosing, and conditions of clinical use. The Product Monographs are also available by calling 1-800-463-6001.

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A longer lifespan could mean a new romantic relationship in your retirement years—one that might lead to marriage or cohabitation. Before you take this step, you may want to talk to your lawyer (and to your new partner, of course) about a marriage contract or cohabitation agreement.

These legal documents can ensure the wealth and assets you’ve spent your lifetime accumulating are passed down according to your wishes, she said. The family cottage, for example, gets to stay with your children as you’d always wanted. Your new spouse or partner, in the meantime, gets looked after as you intended, without having to worry about legal squabbles over your estate.

“The heartache and mistake we often see is when blended families just own everything like a first-marriage family and you assume your surviving partner will take care of your kids from a previous marriage,” said Peoples. “But in a lot

of cases, the surviving partner’s overriding concern is for their own children.”

MISTAKE #5: Focusing too much on the front end, not enough on the back end

In your vision of life after work, you might see yourself spending the most money and energy during your first decade of retirement. There’s all that catch-up travel you’ve been planning to do, all those activities on your bucket list.

But as the saying goes, don’t spend it all in one place.

“There’s the common assumption that as you get to your 80s you’re probably going to start slowing down, so there’s going to be less travel, less going out, and less expenses,” said Mallory McGrath, founder and CEO of Viive Planning Ltd., a Toronto firm that provides legacy and end-of-life planning services. “But what if you develop Alzheimer’s late in life and need to live in long-term care? These are things no one wants to think will happen to them.”

Beyond the financial considerations, it’s important to plan for how you and your family will navigate the latter years of your life, said McGrath.

“Start by having a meeting with your family—the best time to do this is while no one is sick yet or incapacitated—and discuss your concerns, what you’d like to happen if you get sick, who would have the right to make decisions on your behalf if you’re incapacitated and who will take care of you,” she said. “It’s a hard conversation to have, but it will be even harder if you don’t have it.”

XALACOM is a registered trademark of Viatris Specialty LLC, licensed use by Upjohn Canada ULC, a Viatris company.

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THE MEDICAL POST JUNE 2022 69

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concerns seriously. Not only does hair loss have an effect cosmetically, but it has a very high psychological impact on these patients,” Dr. Thuraisingam said.

How physicians react to a patient’s complaint about hair loss, especially early hair loss, is important. “The approach that the family physician takes goes a long way in helping patients come to terms with their hair loss,” Dr. Donovan said.

CLINIC

Hair beware

Five clinical pearls to help patients dealing with hair loss or hair shedding

BY KYLIE TAGGART

I

t’s a funny thing, hair. The fact that it plays a big role in our sense of self often only becomes apparent when it changes: goes grey, becomes brittle, or begins to thin or fall out.

For something that has such a big impact on patients’ well-being, there are surprisingly few Canadian physicians who specialize in hair loss. Physicians should familiarize themselves with common conditions that cause hair loss and feel comfortable prescribing treatments, according to dermatologists Dr. Jeff Donovan and Dr. Thusanth Thuraisingam.

Dr. Donovan is the medical director of Donovan Hair Clinic in Whistler, B.C., and clinical instructor at the University of British Columbia. Dr. Thuraisingam is an assistant professor of medicine at the

70 JUNE 2022 THE MEDICAL POST

University of Ottawa and McGill University and he works at a private clinic in Ottawa and in a hair loss clinic at the Jewish General Hospital in Montreal.

1. Show respect and concern

The first step is to listen to patients when they come in with reports of hair loss.

“I think it is really important to trust patients that if they feel they are losing hair, believe them. It sounds silly, but one of the number one complaints of patients is they really feel dismissed,” Dr. Donovan said.

Complacency could lead to a delay in diagnosis and treatment or lead to inappropriate treatment. It can also impact a patient’s mental health, since hair loss affects self-esteem and selfidentity. “It is important to take these

Drs. Donovan and Thuraisingam said there are three main conditions physicians will see in their offices.

While there are many dermatological conditions that affect hair, Dr. Donovan said if a physician knows how to diagnose and treat the most common three, “you’ll be able to help 98% of patients that come through the door.”

Diagnosing before treating is essential because each condition is treated differently, Dr. Donovan said.

One common complaint physicians may encounter is telogen effluvium (TE), or hair shedding. There are many causes of TE: iron deficiency, thyroid deficiency, other nutritional deficiencies, infection, medications or a major shock or stress such as losing a loved one, or blood loss during surgery.

Order a blood test to help determine the underlying cause. Dr. Donovan said that every patient with concerns about shedding “should leave the office with a blood test requisition so some of these common things are not missed,” Dr. Donovan said.

A good patient history is essential too, including questions about recent illness. Dr. Thuraisingam said he is seeing a lot of patients who are suffering from TE after contracting COVID. Another common condition is androgenetic alopecia, or age-related hereditary hair loss. Dr. Thuraisingam advises physicians to ask: “How long have you been losing hair?” to get clues about a possible trigger and determine if it is new onset or not. For example, if patients had COVID-19 followed by shedding, it could be TE triggered by infection; whereas if hair loss has been

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2. Understand the three most common conditions

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going on for years, it is more likely to be androgenetic alopecia. He said physicians should perform a scalp exam and check for miniaturization of hairs to see if patients are beginning to enter androgenetic alopecia.

The third common complaint is alopecia areata, an autoimmune disorder that affects about 2% of patients. It often appears as coin-shaped bald patches on the scalp. The individual hairs around are thick but then thin closer to the scalp, known as an exclamation mark morphology. Some cases affect other parts of the body, such as eyelashes, eyebrows or beard hair, Dr. Thuraisingam said.

School-aged children may also present with tinea capitis, a fungal infection of the scalp. It often appears with dry scaling of the scalp and a grey patch, according to a handout from McGill University. A fungal culture is needed to confirm diagnosis.

When taking a history, Dr. Donovan advises physicians to ask about the five S’s: the site of the hair loss, the speed of the hair loss, the symptoms, if they are taking supplements or medications, and how much the patient is shedding. Dr. Donovan said it is especially important to ask about the symptoms in detail to understand their severity.

3. Learn how to prescribe and deliver common treatments

Dr. Donovan advises that physicians get familiar with prescribing minoxidil because it can help a number of hair conditions. “We often use it off label for a number of hair conditions, including alopecia areata,” he said.

Patients should be aware that it takes up to six months for minoxidil to take effect and that there may be increased shedding for the first month of treatment. Dr. Thuraisingam tells his patient that the minoxidil “is getting rid of all the bad hairs to make room for the good hairs.” This way patients do not stop the medication.

Physicians need to counsel patients about the possible side-effects of minoxidil, such as hair on the face, headaches or dizziness. “These are fortunately not very common,” Dr.

Donovan said. Patients who plan to become pregnant should avoid oral or topical minoxidil.

First-line treatment for androgenetic alopecia is topical minoxidil and, in men, oral finasteride. A large randomized clinical trial found that finasteride was not effective in women with androgenetic alopecia. Patients expecting to become pregnant should not take finasteride or touch broken pills.

Physicians may want to consider starting patients on lower doses. While 1 mg is the recommended dose for finasteride, physicians may want to consider starting patients on a lower dose, such as 0.5 mg, Dr. Donovan said in a webinar.

First-line therapy for alopecia areata involves topical steroids, intralesion steroid treatments or minoxidil. For the injections, triamcinolone acetonide can be injected at concentrations of 2.5 mg/mL to 10 mg/mL. Treatments are repeated every four to six weeks and patients may wish to apply a numbing cream beforehand, according to a clinical review of alopecia areata treatments published in Canadian Family Physician.

Although some treatments are more successful than others, all include the potential of having a relapse once treatment is stopped.

Dr. Donovan said one of his goals for the next few years is to train family physicians to feel comfortable giving steroid injections so patients don’t need to wait for a dermatology appointment.

“It is not a difficult technique,” he said.

Within a month it can get the hair growing back and “it can dramatically change the way patients feel about themselves.”

Physicians can monitor treatment success using simple photos. Equipment to measure hair density and other factors don’t always capture the benefit of a treatment from a patient’s point of view. “If your photos don’t show an improvement, there’s probably not an improvement,” Dr. Donovan explained.

Patients are often drawn to new treatments to restore hair, but physicians should discuss with patients if the treatments are safe, affordable, feasible and effective, Dr. Donovan said.

4. Watch for red flags

Physicians should be on the watch for worrisome symptoms that merit a referral to a dermatologist. The main red flags are significant scalp itching, burning, bruising, tenderness or pain, Dr. Donovan said. Massive shedding is another red flag. This is shedding where hair is found around the house, not just on their hairbrush.

Some patients have itching due to hairstyling treatments, but tremendous itching or burning, “where people come in with an ice pack on their scalp,” is when patients often need a scalp biopsy, Dr. Donovan said. Scalp biopsies are needed to rule in or rule out conditions such as scarring alopecia, Dr. Thuraisingam said Physicians who practice in remote areas, or where access to a dermatology consult is limited, might consider learning how to perform a scalp biopsy.

“It is not a difficult technique to do,” Dr. Donovan said.

5. Recognize that different people have different patterns of hair loss Physicians should learn to recognize hair loss patterns in different populations.

For example, androgenetic alopecia may look different in women than in men. In women, it often begins in the middle of the scalp.

“For genetic hair loss, it is easy to recognize in men because you’re used to seeing it in the general population,” Dr. Donovan said.

“One of the reasons that we don’t have a lot of good examples of female balding in our society is that women go to great lengths to hide it,” he added.

Hairstyling practices could cause hair loss, such as traction alopecia from pulling forces on the hair. Styles such as braids, twists, weaves or cornrows may cause traction alopecia.

Physicians should also consider haircare practices of different populations before recommending treatment. For example, Black hair needs less washing, and a shampoo treatment may not be appropriate for these patients. The American Academy of Dermatology has resources available for patients with Black hair.

THE MEDICAL POST JUNE 2022 71

Meet Jerry LIPITOR prescriber There are many good reasons to prescribe LIPITOR. LIPITOR (atorvastatin calcium) is indicated in adults as an adjunct to lifestyle changes, including diet, for: • the reduction of elevated total cholesterol (total-C), LDL-C, triglycerides (TG), apolipoprotein B (apo B), the Total-C/HDL-C ratio and for increasing HDL-C in hyperlipidemic and dyslipidemic conditions, including: – Primary hypercholesterolemia (Type IIa); – Combined (mixed) hyperlipidemia (Type IIb), including familial combined hyperlipidemia, regardless of whether cholesterol or triglycerides are the lipid abnormality of concern; – Dysbetalipoproteinemia (Type III); – Hypertriglyceridemia (Type IV); – Familial hypercholesterolemia (homozygous and heterozygous).

For homozygous familial hypercholesterolemia, LIPITOR should be used as an adjunct to treatments such as LDL apheresis,

or as monotherapy if such treatments are not available.

• the prevention of cardiovascular disease, to reduce the risk of myocardial infarction in the following conditions: – hypertensive patients without clinically evident coronary heart disease, but with at least three additional risk factors for coronary heart disease such as age ≥55 years, male sex, smoking, type 2 diabetes, left ventricular hypertrophy, other specified abnormalities on ECG, microalbuminuria or proteinuria, ratio of plasma total cholesterol to HDL-cholesterol ≥6, or premature family history of coronary heart disease.

– patients with type 2 diabetes mellitus and hypertension without clinically evident coronary heart disease, but with other risk factors such as age ≥55 years, retinopathy, albuminuria or smoking.

It also reduced the risk of stroke in this population.

– patients with clinically evident coronary heart disease.

Consult the Product Monograph at http://www.pfizer.ca/pm/en/LIPITOR.pdf for contraindications, warnings, precautions, adverse reactions, interactions, dosing, and conditions of clinical use. The Product Monograph is also available by calling 1-800-463-6001.

For LIPITOR patients, there are many good reasons to join the Viatris Originals Program.

THE VIATRIS ORIGINALS PROGRAM The Viatris Originals Program provides tips and tools to help your patients get the Viatris original brand medication as well as information on their medication and health.

Encourage your patients to visit ViatrisOriginals.ca so they can: • Download a payment assistance card to help patients who have no insurance or whose insurance co-payment amount might be a barrier to obtaining the Viatris original brand medication. This card can help patients obtain the Viatris original brand medication at little or no additional cost compared to the generic version.*

Viatris and the Viatris logo are trademarks of Mylan Inc., licensed use by Upjohn Canada ULC, a Viatris Company. © 2022 Viatris Inc. All rights reserved.

LIPITOR is a registered trademark of Upjohn Manufacturing Ireland Unlimited Company, licensed use by Upjohn Canada ULC, a Viatris company.

ViatrisOriginals.ca

LIPI-2022-0593E - AL2022

* Subject to change. The Viatris Originals Program is available in all provinces except Quebec.

Availability and level of payment assistance vary by brand medication and province.

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PRACTICE MANAGEMENT

Staff job-sharing tips Could staff job sharing help combat office turnover and make staff happier? BY LOUISE LEGER

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he “revolving door” of medical clinic staff is nothing new, but today that door is whirling like a tornado, as demanding workloads, irate patients, pandemic burnout and personal reflection have many workers making a hasty exit.

Job sharing is nothing new, either, and is growing in Canada’s public sector, and physicians themselves often opt to split the load with someone else. But can it work with clinic staff?

According to HR Daily Advisor, flextime and flexspace policies are becoming increasingly popular in the post-pandemic workplace, with job sharing being one variation on flextime.

“With the ‘Great Resignation’ and people leaving in droves, job sharing is one of those things that we’ve got to

try to embrace,” said Marilyn Lawrie, a healthcare human resources consultant at BizShrink in Vancouver. “Staffing is always a problem in healthcare— finding good qualified people. Job sharing is something that government organizations have embraced for a long time, because they know that it works,” said Lawrie, “and it can work well elsewhere, too.”

Advantages of job sharing include: • recruiting, attracting and retaining qualified talent who want work-life balance • reduced absenteeism • trained staff who can temporarily fill in when others go on leave or vacation • two workers can cover high peak workloads

• maximizing skills: job-sharers can each favour their particular likes and talents, increasing productivity and job satisfaction • possibly less burnout • no increased costs Of course, there can be disadvantages, too, such as difficulties scheduling meetings or training where both job-sharers must be present; potential disruption of workflow; and the possible need for more supervisory time and attention.

Two models

There are different ways of setting up a job share, according to HR Advisor Daily.

In the twin model, for example, two workers share the same duties, with one person working on Monday and Tuesday,

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the second person working on Thursday and Friday, and both working part-time on Wednesday, for easy transfer of information and knowledge sharing.

In the islands model, or job-split model, two employees share one fulltime position, but not its responsibilities.

Each specializes in a different area of the position’s duties, enabling them to focus on their strengths. For example, one administrator might be more peoplefocused and do patient outreach; the other may be more suited to handling paperwork and details.

Dr. Chris Sun, a family physician with the Crosstown Family Health Team in Toronto, said his clinic has tried job sharing “with some success.” In his view, the greatest benefit is having two staff members trained on the same job so that if one takes a leave of absence or quits, the practice is not disrupted: The remaining worker knows the job and may be willing to work more hours while a replacement is sought.

“Our RN job share worked out well,” said Dr. Sun. “They collaborate

on projects like Pap clinics and flu shot clinics and cancer screening callbacks with good successes to date,” he said.

Dr. Sun said his clinic employs job sharers with its admin staff as well, who easily cover each other when one is sick or absent. “I’m not sure if it helps with burnout or employees being happier necessarily,” he said, noting that staff dissatisfaction in medicine is currently high across the board. “It definitely makes it easier to cope with temporary absences.”

Dr. John Crosby, a Cambridge, Ont., family physician has seen job sharing work out well, and considers it a “no-brainer” especially when workers, usually women, are wanting to spend more time with family.

“It works well with secretaries and nurses,” he said. “I find especially lately there are nurses who might be semiretired but still want to work some. They can share with someone else and come in only on a certain day or days, for example for all the needles, well-baby checks, prenatal visits, etc. It’s a win-win, and not expensive for the doctor.”

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74 JUNE 2022 THE MEDICAL POST

Sharing means communicating

Experts say the key to successful job sharing is communication—between the workers themselves and with other staff and physicians.

“Job sharing can work out really well if you can get those two people really aligned and they’re making sure that they’re touching base and exchanging information,” said Lawrie. “(There needs to be) a system whereby everybody does email handoffs at the end of the day. Although with EMRs you can assign tasks to people, EMRs really don’t give you the opportunity to do the expanse of information change that’s often needed.”

Lawrie recommends a dedicated form of communication, where job-sharers outline what needs to be done, what needs to be followed up on and what can be left.

“Formalizing communication channels is a really important part of how you manage, not just your human resources, but your daily operations,” said Lawrie.

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THE THE MEDICAL MEDICAL POST POST APRIL JUNE 2022 75

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SOLVE MY PROBLEM

How do you handle patients who have somatic symptom disorder or illness anxiety disorder?

Listen, then reassure

I try to keep in mind that reassurance is the same as dismissal unless the suffering has been seen and respected, and the person’s fears acknowledged.

I would never call the appointments these patients book unnecessary. I take their symptoms seriously and explain why they are unlikely to progress into something known, bad or treatable. I also make it clear that I will gladly re-evaluate if things change.

I normalize uncertainty, and sometimes order tests to rule out bad things while emphasizing that the tests are unlikely to be helpful. I let the patient know that the results are reassuring. If nothing changes, I don’t keep ordering tests. I deal with the anxiety as well as the symptoms.

to prepare lists of anxious thoughts beforehand.

–DR. BRIDGET REIDY

–DR. JABIR JASSAM

Fixed appointments

Acknowledge suffering

I have a few patients with illness anxiety disorder, two in particular with severe cases. These two patients have cost the healthcare system thousands of dollars as a result of their repeated visits to our clinic, the emergency room, and other walk-in clinics for nothing more than reassurance. It became difficult for me to accommodate them when I was busy. Three years ago, I decided to treat them differently by giving them short monthly appointments.

This method has worked miraculously well, to the extent that one of them has not visited another clinic since. Both patients stated that these fixed appointments put them at ease, make them feel safe and give them time

76 JUNE 2022 THE MEDICAL POST

Instead of jumping to reassurance, I focus on validating what the person is sharing and acknowledging their suffering. Reassurance rarely works if a person doesn’t feel seen, heard and at least somewhat understood. When someone comes to us with a physical phenomenon, it is imperative that we perform a physical examination and be transparent about how we’ve settled on our tentative diagnosis. These days, I try to keep in mind that reassurance is the same as dismissal unless the suffering has been seen and respected, and the person’s fears acknowledged. With that in mind, I think of psychologist Karen Treisman’s suggestion that “every interaction is an

intervention” and that it is important to connect before we try to correct.

–DR. CHASE EVERETT MCMURREN

Practice being ‘aware’ DR. BRIDGET REIDY A family physician in Victoria

DR. JABIR JASSAM A family physician in Ottawa

At the outset, I discuss working with both mind and body. I focus on “grounding” and anxiety reduction, through simple breathing practices and acronyms.

One such acronym is “AWARE,” from Aaron Beck and Gary Emery. In a nutshell, “AWARE” is as follows: Accept that anxiety is happening (A), watch the wave of anxiety as it rises and falls (W), act as if the anxiety were not so high (A), repeat the first three steps (R), and expect both the best and that anxiety will come and go (E). I tell the patient that it’s normal to feel anxiety and I am glad to help with that part of their experience.

–DR. ELSPETH MACEWAN

DR. CHASE EVERETT MCMURREN A home-visiting physician and psychotherapist in Toronto

DR. ELSPETH MACEWAN A semi-retired psychiatrist in Ottawa

Next Problem

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Is there a way for virtual appointments to be as respected as in-person?”

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by Aug. 1, 2022. You will receive a $25 gift card if your answer is chosen for the next print edition.

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TRINTELLIX IMPROVED FUNCTION IN WORK, FAMILY AND SOCIAL LIFE IN PATIENTS WITH MDD (secondary endpoints)1*

COVERED by most private insurance plans and public formularies across Canada (restrictions may apply)2

DEMONSTRATED TO TREAT MULTIPLE SYMPTOMS OF MDD3 Depressive symptoms (MADRS total score) Demonstrated 60% improvement from baseline at 8 weeks with Trintellix 20 mg vs 37% with placebo (-18.8 vs -11.7, p<0.0001)1,3*‡

Overall function (SDS) Demonstrated improvement from baseline at 8 weeks with Trintellix 20 mg vs placebo: Up to 87% improvement in overall function (-8.4 vs -4.5; p=0.0005)1*‡ Up to 86% improvement in function at work (-2.6 vs -1.4; p=0.0059)1*‡ Up to 82% improvement in function at home (-3.1 vs -1.7; p<0.0001)1*‡ Up to 82% improvement in function in a social setting (-3.1 vs -1.7; p<0.0001)1*‡ ‡ The starting and recommended dose of Trintellix is 10 mg once daily for adults <65 years of age. See the Product Monograph for complete dosing and administration information.

Pr

Trintellix® (vortioxetine) is indicated for the treatment of MDD in adults.3

MADRS=Montgomery-Åsberg Depression Rating Scale; MDD=major depressive disorder; SDS=Sheehan Disability Scale † Trintellix is eligible for reimbursement by Non-Insured Health Benefits, Veteran Affairs Canada and Correctional Service Canada, and for formulary coverage in the following provinces and territories: Quebec, Ontario, Alberta, Manitoba, Saskatchewan, New Brunswick, Newfoundland and Labrador, Nova Scotia, Prince Edward Island, Northwest Territories, Yukon and British Columbia (special authorization). Refer to provincial formularies for more information.

Visit Trintellix.ca for more information

NEW INDICATION

SHINGRIX IS NOW INDICATED IN ADULT PATIENTS 18 YEARS OF AGE AND OLDER WHO ARE OR WILL BE AT INCREASED RISK OF SHINGLES DUE TO IMMUNODEFICIENCY OR IMMUNOSUPPRESSION CAUSED BY KNOWN DISEASE OR THERAPY SHINGRIX is indicated for the prevention of herpes zoster (HZ, or shingles) in:1 • adults 50 years of age or older; • adults 18 years of age or older who are or will be at increased risk of HZ due to immunodeficiency or immunosuppression caused by known disease or therapy.

There are a variety of risk factors that can put your patients at increased risk of shingles.2 • ≥90% of Canadians have had varicella and are at risk for shingles. 3 • Age-related decline in immunity was shown to be the dominant driver of shingles, with 2/3 of shingles cases occurring in those over the age of 50. The risk and severity of shingles is greatest in the elderly.1,2 • The risk of shingles is higher in adults 18 years and older with immunosuppression due to disease and/or therapy.1 • The risk of hospital-attended shingles (i.e., seen in hospitals or emergency departments) in immunocompromised adults was 2.9 times higher than that of immunocompetent adults, and ranged from 2.6 to 12.3 times higher depending on the immunocompromising conditions.4*

With this new indication, the number of patients eligible for SHINGRIX has increased.

Recommend SHINGRIX to all your eligible patients and help protect them against shingles.

Visit THINKSHINGRIX.ca to learn more.

Consult the Product Monograph at gsk.ca/SHINGRIX/PM for contraindications, warnings and precautions, adverse reactions, interactions, dosing and administration information. To request a Product Monograph, or to report an adverse event, please call 1-800-387-7374. * According to a retrospective cohort analysis design to estimate annual incidence rates, organized by April to March fiscal year. The study included adults 18 years and older who had an emergency department visit or hospitalization for shingles from 1 April 2002 to 31 August 2016 in Ontario. Only Ontario residents with a valid provincial health insurance number were included. Ethics approval was obtained from Public Health Ontario’s Ethics Research Board. The primary outcome was hospital-attended HZ (as defined by seen in hospital or emergency department). 4

Trademarks are owned by or licensed to the GSK group of companies. ©2022 GSK group of companies or its licensor.

04948 04/22

References: 1. SHINGRIX Product Monograph. GlaxoSmithKline Inc., November 24, 2021. 2. Harpaz R, Ortega-Sanchez IR, Seward JF; Advisory Committee on Immunization Practices (ACIP), Centers for Disease Control and Prevention (CDC). Prevention of herpes zoster: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2008;57(RR-5):1-30. 3. National Advisory Committee on Immunization (NACI). Statement on the recommended use of herpes zoster vaccine. Can Commun Dis Rep 2010;36(ACS-1):1-19. 4. Buchan SA et al. Incidence of hospitalizations and emergency department visits for herpes zoster in immunocompromised and immunocompetent adults in Ontario, Canada, 2002–2016. Clin Infect Dis 2020;71(1):22-29.