Pharmacy Practice June 2025

JUNE/JULY 2025

PLUS MENTAL HEALTH Switching antidepressants

“ We have patients saying this is so easy and fast, and they don’t have to wait for a doctor.”

Athena Dhirani, pharmacist/owner, Trinity Bellwoods Pharmacy, Toronto

THE PHARMACIST CAN SEE YOU NOW AT TRINITY BELLWOODS PHARMACY IN TORONTO, PATIENTS CAN USUALLY BE SEEN WITHOUT AN APPOINTMENT

CanadianHealthcareNetwork.ca

5 TIPS Improving outcomes in patients with COPD CLINICAL FEATURE Heart failure: Optimizing therapy in community practice

NKB anta THE FIRST AND ONLY NON-HORMONAL NEUROKININ B (NKB) ANTAGONIST INDICATED IN THE TREATMENT OF VMS ASSOCIATED WITH MENOPAUSE.1-3*

HELP FIGHT MODERATE TO SEVERE VMS, ALSO KNOWN AS HOT FLASHES and NIGHT SWEATS 1,4

WITH NEW VEOZAH VEOZAH (fezolinetant film-coated tablets) is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.1 VEOZAH achieved statistically significant reductions from baseline in the frequency of moderate to severe VMS vs. placebo at week 12 (p<0.001, coprimary endpoint)1† 63.5% reduction in the frequency of moderate to severe VMS per 24 hours with VEOZAH vs. 43.1% with placebo (LS mean change from baseline: -7.5 vs. -5.0, respectively)

DISCOVER A NEW OPTION TO TREAT MODERATE TO SEVERE VMS1 Clinical use: • Pediatrics (<18 years of age): not indicated • Geriatrics (≥65 years of age): no data available; therefore, an indication has not been recommended Contraindications: • Known cirrhosis • Severe renal impairment or end-stage renal disease • Patients using concomitant moderate or strong CYP1A2 inhibitors • Known or suspected pregnancy Relevant warnings and precautions: • Incidence of other malignancies • Benefit-risk consideration to treat women with known or previous breast cancer or other estrogen-dependent malignancies • Risk of endometrial hyperplasia and endometrial carcinoma

• Not recommended in Child-Pugh Class B (moderate) chronic hepatic impairment; not studied in Child-Pugh Class C (severe) chronic hepatic impairment and is not recommended in this population • Risk of hepatic transaminase elevation and hepatotoxicity • Perform baseline bloodwork to evaluate hepatic function and assess for injury (including serum ALT, serum AST, serum ALP, and serum bilirubin [total and direct]) prior to initiating VEOZAH. Perform hepatic laboratory tests monthly for the first 3 months, at 6 months, and 9 months after initiation of therapy • Not recommended in breast-feeding women For more information: Consult the Product Monograph at www.veozahmonograph.ca for important information relating to adverse reactions, drug interactions and dosing information. The Product Monograph is also available by calling 1-888-338-1824.

ALP: alkaline phosphatase; ALT: alanine aminotransferase; AST: aspartate aminotransferase; LS: least squares. *Comparative clinical significance unknown. †SKYLIGHT 2 was a phase 3, randomized double-blind, placebo-controlled, parallel-group study in which post-menopausal women were randomized to VEOZAH 45 mg (n=167) or placebo (n=167) once daily for 12 weeks. After the 12-week, double-blind treatment period, all patients received fezolinetant for a 40-week extension treatment period with women on placebo re-randomized to VEOZAH to evaluate safety for up to 52 weeks total exposure. The study included post-menopausal women who had a minimum average of 7 moderate to severe VMS per day. The coprimary efficacy endpoints were change from baseline in moderate to severe VMS frequency and severity to weeks 4 and 12. Baseline mean frequency of moderate to severe VMS per 24 hours: 11.8 for VEOZAH, 11.6 for placebo.1 REFERENCES: 1. VEOZAH Product Monograph. Markham, ON: Astellas Pharma Canada, Inc. 2. The North American Menopause Society (NAMS). Menopause. 2023;30(6):573-590. 3. Data on file. Astellas Pharma Canada, Inc. 4.Yuksel N, Evaniuk D, Huang L, et al. Guideline No. 422a: Menopause: vasomotor symptoms, prescription therapeutic agents, complementary and alternative medicine, nutrition, and lifestyle. J Obstet Gynaecol Can. 2021 Oct;43(10):1188-1204.e1.

All trademarks are the property of their respective owners. © 2025 Astellas Pharma Inc. or its affiliates.

MAT-CA-VEO-2025-00046 03/25

Contents JUNE/JULY 2025 [VOL.12 NO.4]

2025 Gold Award Winner for Best Brand B2B

5 / Editor’s Message

34

Who’s afraid of AI? / By Vicki Wood

7 / Openers The Starting Point—Your pharmacy is already a clinic / By Jaclyn Katelnikoff

10 / Drug News A review of new launches, new indications, new dosage forms, discontinued drugs and Health Canada advisories / By Lu-Ann Murdoch

17 / Practice Experts Mental Health / By Sunny Wang Cardiovascular Issues / By Arden Barry Practical Diabetes / By Rhonda Roedler

P. 17 P. 20 P. 24

26 / 5 Tips Improving outcomes in patients with COPD / By Jamie Falk

29 / Clinical Feature Heart failure: Optimizing care in community practice / By Emily Cowley

34 / Cover Story Innovator­Athena Dhirani: The pharmacist can see you now / By Rosalind Stefanac / Photography By Mike Ford

CONTINUING EDUCATION

38 / The Closer The Business of Care—Disrupting the PPN: how smart pharmacies win / By Niki Shah

All CCCEP-accredited continuing education lessons featured in this issue are available on eCortex, the online learning home of Pharmacy Practice + Business and part of CanadianHealthcareNetwork.ca. Use your CanadianHealthcareNetwork.ca login for easy access. Registration is free to qualified pharmacy professionals.

For assistance with our CE programs, please email ecortex@canadianhealthcarenetwork.ca

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[Vol.12 No.4] June/July 2025 PHARMACY PRACTICE + BUSINESS

3

Thanks for your vote of confidence.

The #1 recommended OTC oral iron supplement nationally for the 10th year in a row!†

Scan this code to visit the healthcare practitioner page on feramax.com Caution: Keep out of reach of children. There is enough iron in the package to seriously harm a child. At doses greater than 35 mg per day, some people may experience constipation, diarrhea and/ or vomiting. Patient should consult a health care provider prior to use, if they are hypersensitive to iron preparations or any ingredient in these products, if they are pregnant or breastfeeding, or if they have peptic ulcer, regional enteritis, or ulcerative colitis. Discontinue use if the patient experiences nausea, vomiting, abdominal pain, hematemesis (vomiting of blood), or diarrhea. Stop use if hypersensitivity occurs. Store at room temperature (15 - 30 ⁰C). Do not store in areas of high humidity. † Pharmacy Practice + Business and Profession Santé 2025 Survey on OTC Counselling and Recommendations (re: pharmacists). The Medical Post and Profession Santé 2025 Survey on OTC Counselling and Recommendations (re: physicians) ©BioSyent Pharma Inc., 2025. All rights reserved.

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EDITORIAL

EDITOR Vicki Wood vwood@ensembleiq.com

EDITOR, CANADIANHEALTHCARENETWORK Martha Porado mporado@ensembleiq.com CLINICAL CONSULTING EDITOR Lu-Ann Murdoch

CONTINUING EDUCATION / PROJECT MANAGER / PROOFREADER Rosalind Stefanac REPORTER, CANADIANHEALTHCARENETWORK Tom Yun – tyun@ensembleiq.com

COLUMNISTS & CONTRIBUTING / CONSULTING EDITORS Arden Barry, BSc, BScPharm, Pharm D, ACPR Katelyn Halpape, BSP, ACPR, PharmD, BCPP Sherilyn Houle, BSP, PhD Jaclyn Katelnikoff, BSc PMCOL, BSc Pharm, RPh Sandra Knowles, BScPhm Nardine Nakhla, PharmD Rhonda Roedler, BScPharm, ACPR, PharmD, CDE Cheryl A Sadowski, BSc(Pharm), PharmD, BCGP, FCSHP, CHE Niki Shah, B.Pharm, CRE Sunny Wang, RPh, PharmD

EDITORIAL ADVISORY BOARD

Sandra Aylward, Halifax, NS; Naushin Hooda, Vancouver, BC; Ian Lloyd, Victoria, BC; Kara O’Keefe, Newfoundland & Labrador; Barret Procyshyn, Dauphin, MB; Tim Smith, Winnipeg, MB; Andrew Tu, Toronto, ON; Kristen Watt, Southampton, ON; Bruce Winston, Calgary, AB

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Pharmacy Practice + Business, its affiliates and assignees may use, reproduce, publish, re-publish, distribute, store and archive such unsolicited submissions in whole or in part in any form or medium whatsoever, without compensation of any sort. Pharmacy Practice + Business, established in 1985, is published 7 times a year. Pharmacy Practice + Business is abstracted in International Pharmaceutical Abstracts (IPA). ISSN 08-29-2809. Publications mail agreement no. 42940023.

EDITOR’S MESSAGE

Who’s afraid of AI? I am, a little. As someone whose job is to learn about a subject, examine it from many angles, then assess, distill and clearly communicate what’s important about it, artificial intelligence (AI) seems threatening. It’s my new competitor, if you will.

And that fear doesn’t even touch on the staggering environmental impact of generative AI, which is on track to be one of the world’s largest consumers of fossil-fuel-derived power and water.

Still, it’s fascinating to see how ubiquitous this technology has become in pharmacies. As pharmacists are increasingly being tasked with filling healthcare gaps in ways that range from assessing common ailments to monitoring and managing serious chronic conditions, it’s more urgent than ever that they free themselves from all aspects of pharmacy operation that do not require their clinical, license-dependant skills. To that end, AI-dependent tools are now working away in the background of any pharmacy—automating appointment booking, refill requests, billing and documentation, and providing clinical and prescribing support.

Pharmacy Disruptors 2030, the 2025 Canadian Pharmacists Association Pharmacy Summit held in June, was all about the technologies and trends that are both forcing and enabling this transition. The bulk of the program was focused on the ways in which AI is impacting pharmacy and its regulation, as well as on how the new Uber-ized, Amazon-Primed consumer will want to receive their healthcare.

There were many fascinating insights shared that day, but hovering above the “gee-whiz” aspects of cool new technologies was one proven and consistent truth: people still value one-on-one care from a pharmacist. Even though that caring advice may now come via text or a video call, it is still wanted. Wary as we may rightfully be, technology is just a tool— the care still comes from you.

Pharmacy Practice + Business wins Gold!

Pharmacy Practice + Business has won the Gold award for Best Brand in the National Magazine Foundation Awards B2B 2025. This award recognizes a brand’s excellence in serving its audience. The jury said: “Pharmacy Practice + Business demonstrated impressive brand engagement with its audience through a vast array of services, resources and community-building activities. From time-saving resources for clinicians to an awards program and continuing education, the Pharmacy Practice + Business brand delivered.”

We are grateful to our staff, pharmacist contributors, presenters, advisors and especially to our readers who provide us with inspiration, feedback, encouragement and ideas.

VICKI WOOD EDITOR vwood@ensembleiq.com

[Vol.12 No.4] June/July 2025 PHARMACY PRACTICE + BUSINESS

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Scores Epithelial Confluence Scores Epithelial Confluence Scores Higher scores, better epithelial confluence

Hydrocolloids are water-soluble substances that turn into a gel when mixed with liquids.2 In a hydrocolloid dressing, the hydrocolloids mix with fluids from the wound to form a gel. The gel creates a moist, protective environment to help improve healing time and protect tissue growth. 2,3

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Bandages demonstrated significantly improved healing compared to regular bandages for the composite wound -2.0 3.5 healing scores§ andPROHEAL forPROHEAL the Demonstrated individual Better Healing Results thanthan Demonstrated Better Healing Results Demonstrated BetterAlone Healing composite healing PROHEAL score components, Using Bandage Using Bandage AloneResults than Using Bandage Alone wound appearance¶ and epithelial -1.5 7.0 confluence£ (p<0.05).1†

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For use on minor cuts and scrapes on all parts of the body

Adhesive Bandages demonstrated a 60% improvement in wound healing compared to regular bandages based on a 7-day average of the percentage of subjects showing improvement in general wound appearance.1†

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Each subject had 4 laser-induced wounds per forearm.

Bandages were applied once daily and removed after 24 hours.

Healing was evaluated at Days 1-7 and 16. ¥ Photos and scores represent 1 trial patient. § Composite Wound Healing Score Day 0-7: Sum of general wound appearance, smoothness and epithelial confluence scores minus sum of erythema, edema and crusting/scabbing scores. Composite healing score on a 25-point scale (-12 [no healing] to +12 [towards healing]) is indicative of extent of wound healing and was calculated for each wound site on each evaluation day. ¶ Wound Appearance Score: 0=poor (new or fresh wound missing the epithelium layer, with the wound bed appearing raw and possibly oozing); 1=fair (epithelial growth is starting to occur, and the wound bed is dry); 2=good (scabbing may be present, but the epithelial growth is clearly evident and the wound bed color indicating no more than moderate erythema); 3=very good (slight scabbing may be present, but the wound bed indentation is slightly visible, and the wound area is mostly covered with epithelial regrowth); 4=excellent (slight color mismatch may be present, but the wound is fully healed, with skin flush against surrounding skin). £ Epithelial Confluence Score: 0=none (no epithelial coverage); 1=slight (up to 30%); 2=moderate (31-60%); 3=extensive (61-90%); 4=almost complete or complete (91-100%). Higher scores indicate a better outcome.

Notes: * P valueNotes: 95% , PROHEAL is significantly higher score than bandage only * P value 95% , PROHEAL is significantly higher score than bandage only **Other Notes: treatment arms in the clinical study were excluded because these are for another project **Other treatment arms in the clinical study were excluded because these are for another project * P value 95% , PROHEAL is significantly higher score than bandage only **Other treatment arms in the clinical study were excluded because these are for another project

Apply the BAND-AID® Brand PRO HEAL™ adhesive bandage to clean, dry skin, placing the cushion pad over the wound.

• Replace the bandage every 1-2 days until the wound is fully healed.

• To remove the bandage, loosen one end of the pad by stretching it along the skin.

• BAND-AID® Brand PRO HEAL™ adhesive bandages can be used on all parts of the body.

Diabetics and people with poor circulation should use under doctor’s supervision.

If redness, swelling or allergic reaction occurs, discontinue use and consult a healthcare professional. Do not use on deep puncture wounds, fragile skin, burns, stitches, infected areas or on children < 2 yrs.

References 1. RA Study to Assess Wound Healing Efficacies of Different Clean, Treat, and Protect Wound Care Regiments Compare to Standard of Care and Untreated. ClinicalTrials.gov. Clinical Study Number NCT05045183. October 2022. 2. West M. Hydrocolloid dressings: Benefits and how to use. Medical News Today. www.medicalnewstoday.com/articles/hydrocolloid#how-they-work (accessed February 24, 2025). 3. Thomas S. Hydrocolloid dressings in the management of acute wounds: a review of the literature. International Wound Journal 2008;5(5):602-613.

This Counselling Corner is published by Ensemble IQ, 2300 Yonge, Suite 2900, Toronto, ON M4P 1E4, 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. © 2025

7

Openers

AN AT-A-GLANCE LOOK AT WHAT’S HAPPENING IN PHARMACY

THE STARTING POINT

Your pharmacy is already a clinic

JACLYN KATELNIKOFF BSc PMCOL, BSc Pharm, RPh

Shutterstock/charactervectorart

Let’s stop waiting for permission or perfection.

The systems we already have can support clinical care if we design them to.

As the country moves forward with expanding the pharmacist’s scope of practice, I often hear groans from colleagues: “We’re already too busy.” “We don’t have time for more.”

To that I say, yes, we are busy. But what is it that we too busy doing?

Are the tasks filling your day ones that actually require your license? Or could other qualified, less costly team members be doing them?

We often hear that pharmacies need to become more clinical, as if a massive renovation or the addition of expensive new staff is the only way forward. But the truth is, the clinical potential has always been there. You don’t need a full makeover to practise at the top of your game. You need clear roles, a smart workflow, a mindset shift and a chance to look through the window into a pharmacy that is already doing it successfully.

Let’s stop waiting for permission or perfection. The systems we already have can support clinical care if we design them to.

Start with intake. When pharmacists are the first point of contact, we identify clinical opportunities early, build trust and lead care proactively. This is where we practise to our full scope, not in the back corner after the “real work” is done.

This does not mean adding more to an already full plate. It means working differently. It means using the entire team to their full potential.

Regulated pharmacy technicians are trained and licensed to perform final package checks and (depending on the province) injections, patient device instruction and master compound formulation. When they are empowered to fully own this process, it frees up pharmacists to focus on what only pharmacists can do: assess, prescribe, monitor, educate and solve problems.

Pharmacy assistants and frontstore staff also play crucial roles in patient engagement and operational flow. When each person’s role is clear and respected, the workflow becomes smoother, the care more intentional and the outcomes stronger.

A small adjustment in physical layout may be needed. A desk and two chairs near the front—one for the pharmacist and one for the patient—can transform the energy of the space.

It does not have to be fancy. It can be makeshift or built into what already exists. What matters is the signal it sends: we are ready to care for you here, all day, every day. Patients quickly begin to trust that we are there for them; that they have our full attention, each and every visit.

Pulling pharmacists out of community pharmacies to work in external clinics causes more than just opportunity gaps. It creates a vacuum. The socalled “shortage” of pharmacists in the community is not always a numbers issue. Often, it is a design issue. We need to stop exporting clinical skills and start cultivating them right where they are needed most: in the community pharmacy.

Here is the good news—we are already clinical pharmacists.

You do not need to wait for a new policy, a new building, or even a new funding model. If you are a pharmacist, you are already a clinician. If you are in a pharmacy, you are already in a clinic.

You have been doing clinical work all along.

So if your pharmacy owner embraces the wellestablished pharmacist-at-intake model, (as my employers have done for 15 of my 16 years in practice), every pharmacist and technician on staff can practice to their full clinical scope. No added expense. No staffing crisis. Just smart use of the people and space you already have.

Because your pharmacy is already a clinic.

The future of pharmacy is not somewhere else.

It is here. It is now. And we are ready.

Jaclyn Katelnikof, is a passionate community pharmacist, leader, and advocate dedicated to shaping the future of pharmacy through empowerment and innovation.

[Vol.12 No.4] June/July 2025 PHARMACY PRACTICE + BUSINESS

7

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Learn about DAYVIGO® and considerations for use DAYVIGO (lemborexant) is indicated for the treatment of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance1

UNDERSTANDING THE SLEEP CYCLE • The sleep cycle is divided into 4 stages: Non-rapid eye movement (NREM) sleep stages N1–N3 and the rapid eye movement (REM) sleep stage.2,3 • Most people experience 4 to 6 sleep cycles a night.2,3 • The sleep stages are based on analysis of brain activity during sleep, which demonstrates distinct characteristics.2,3

The Stages of Sleep2,3 Stage 1 N1 A few minutes

EEG recording: theta waves - low voltage. The lightest stage of sleep. Muscle tone is present in the skeletal muscle, and breathing occurs regularly.

EEG recording: beta waves - similar to brain waves during wakefulness.

REM is associated with dreaming and not considered restful. Rapid eye movements. Breathing rate is erratic and irregular.

DAYVIGO’S MECHANISM OF ACTION* DAYVIGO is a competitive antagonist of both orexin receptors, OX1R and OX2R, with a higher affinity for OX2R.1 • The orexin neuropeptide signaling system is a central promoter of wakefulness.1 • Blocking the binding of wake-promoting neuropeptides orexin A and orexin B to receptors OX1R and OX2R is thought to suppress wake drive.1

Orexin

Orexin Receptor

The orexin neuropeptide signaling system is a central promoter of wakefulness.

DAYVIGO

Blocking the binding of wakepromoting neuropeptides orexin A and orexin B to receptors OX1R and OX2R is thought to suppress wake drive.

EEG recording: sleep spindles and K complexes.

A deeper sleep than Stage 1. Heart rate and body temperature drops.

Each cycle lasts about 90 minutes.

Stage 4 REM Sleep 10-60 minutes

DAYVIGO (lemborexant) is indicated for the treatment of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.1

10-25 minutes N2 Stage 2

EEG recording: delta waves - lowest frequency, highest amplitude. Also known as slow-wave sleep (SWS).

The deepest stage of sleep.

Most difficult to waken from.

20-40 minutes N3 Stage 3

Explaining how DAYVIGO works to your patients DAYVIGO belongs to a group of medicines called “dual orexin receptor antagonists”.

Orexins are chemicals that bind to certain receptors in your brain to keep you awake.

DAYVIGO temporarily blocks the orexin receptors. This may help you fall asleep faster and stay asleep longer.1 • In the daytime, orexins help us stay awake.

• At night, DAYVIGO temporarily blocks orexin receptors and this may help you fall asleep and stay asleep.

PHARMACOKINETICS: ABSORPTION In healthy patients, the pharmacokinetic profile of DAYVIGO was examined after single doses of up to 200 mg and after once-daily administration of up to 75 mg for 14 days. DAYVIGO is rapidly absorbed, with a time to peak concentration (tmax) of approximately 1 to 3 hours. DAYVIGO exhibits linear pharmacokinetics with multi-exponential decline in plasma concentrations. The extent of accumulation of DAYVIGO at steady-state is 1.5- to 2-fold across the dose range. Ingestion of DAYVIGO with a high-fat meal resulted in a slight decrease in the rate of absorption as demonstrated by 23% decrease in lemborexant Cmax and delay in tmax of 2 hours and 18% increase in total exposure AUC. Time to sleep onset may be delayed if taken with or soon after a meal.1

PHARMACODYNAMICS: SLEEP ARCHITECTURE In patients with insomnia, DAYVIGO led to increases in both non-REM and REM sleep as assessed by polysomnography. The increases in REM sleep were statistically significantly greater

• Each of the 4 to 6 sleep cycles a night lasts about 90 minutes; however, the length of a sleep cycle can vary throughout the night.2,3 • During the first half of the night, most of the time is spent in deep sleep—the N3 stage commonly lasts 20 to 40 minutes.

As the night progresses, however, more time gets spent in REM sleep and less in deep sleep.2,3 Sleep Architecture: The analysis of the different cycles and stages of sleep is commonly referred to as sleep architecture. It provides information about factors that can alter sleep architecture, such as sleep disorders.2

for both doses of DAYVIGO compared to placebo at both the beginning (Days 1 and 2) and end (Days 29 and 30) of treatment.1

EFFECTIVE AS QUICKLY AS NIGHTS 1,2 (calculated as the mean of nights 1 and 2)1† DAYVIGO 5 mg and 10 mg were superior to placebo in time to sleep onset at Nights 1,2. The primary efficacy endpoint was the mean change in latency to persistent sleep (LPS) from baseline to end of treatment, as measured objectively by polysomnography. LPS was defined as the number of minutes from lights off to the first 10 consecutive minutes of non-wakefulness.

Mean change from baseline in LPS at Nights 1,2: DAYVIGO 5 mg: -17 minutes (p<0.01) DAYVIGO 10 mg: -19 minutes (p<0.001) placebo: -6 minutes Significant reduction in wake after sleep onset1† DAYVIGO 5 mg and 10 mg were superior to placebo in reducing time spent awake after sleep onset (WASO) at Nights 1,2. The secondary efficacy endpoint was the mean change from baseline to end of treatment in wake after sleep onset (WASO) measured objectively by polysomnography. WASO was defined as the minutes of wake from the onset of sleep until wake time.

Mean change from baseline in WASO at Nights 1,2: DAYVIGO 5 mg: -51 minutes (p<0.001) DAYVIGO 10 mg: -60 minutes (p<0.001) placebo: -18 minutes * Clinical significance unknown. † A 1-month multicentre, randomized, double-blind, placebo-controlled, parallel-group Phase III study in 1006 patients (263 patients were randomized to active comparator), 55 years and older with insomnia disorder, using both polysomnography and patient sleep diaries.

DAYVIGO 5 mg achieved clinical significance vs. placebo In two studies, DAYVIGO 5 mg achieved clinical significance vs. placebo for both sleep latency and time spent awake after sleep onset as assessed both subjectively by the patient and objectively by polysomnography.1†‡

12-MONTH EFFICACY DATA DAYVIGO demonstrated sustained improvements in sleep over 12 months of treatment.1

SAFETY INFORMATION Somnolence was the most common adverse event In clinical trials of patients with insomnia treated with DAYVIGO 5 mg or 10 mg, the most common adverse reaction (reported in 5% or more of patients treated with DAYVIGO and at a higher rate than placebo) was somnolence (DAYVIGO 5 mg 7%, DAYVIGO 10 mg 11%, placebo 2%). DAYVIGO was associated with a dose-related increase in somnolence.1 Most common adverse event resulting in discontinuation of treatment Somnolence was the most common adverse reaction leading to discontinuation, with an incidence similar to placebo: 1% for DAYVIGO 5 mg, 2% for DAYVIGO 10 mg, and 1% for placebo.1 Drug interactions to talk to your patients about Explain to your patients that the following may interact with DAYVIGO:1 • Alcohol. Alcohol can increase your chances of getting serious side effects. Do NOT drink any alcohol while taking DAYVIGO. • Sedatives. Do NOT take any sedatives or medicines that can make you sleepy. This includes: prescription and over-the-counter sleep products; opioids (used to treat pain); and certain antidepressants (used to treat depression).

• Itraconazole, ketoconazole and posaconazole (used to treat fungal infections).

• Clarithromycin, telithromycin (used to treat bacterial infections).

• Bocepravir, telaprevir (used to treat Hepatitis C Virus (HCV)).

• Fluconazole (used to treat fungal and yeast infections).

• Diltiazem and verapamil (used to treat high blood pressure and chest pain/angina).

• Digoxin (used to treat heart failure).

• Aprepitant (used to treat nausea and vomiting caused by certain anti-cancer medicines).

• Imatinib (used to treat certain types of cancer).

• Nefazodone (used to treat depression).

• Conivaptan (used to treat low sodium levels).

• Rifampin (used to treat bacterial infections).

• Carbamazepine and phenytoin (used to treat convulsions and seizures).

• St. John’s wort (used to treat depression).

• Grapefruit juice.

Long-term safety Over 12 months of continuous treatment, adverse reactions were consistent with those observed during the first month of treatment.1 Physical dependence and withdrawal profile In completed clinical trials with DAYVIGO, there was no clear evidence of physical dependence or withdrawal symptoms upon discontinuation of prolonged use of DAYVIGO as assessed by the Tyrer Benzodiazepine Withdrawal Symptom Questionnaire.1 Caution should be exercised when prescribing DAYVIGO to individuals with a history of substance use disorder, including addiction to, or abuse of, alcohol and other sedative drugs due to risk of misuse or abuse.1

COUNSELLING FOR YOUR PATIENTS TAKING DAYVIGO Dosing 5 mg and 10 mg doses  Start with the lowest effective dose for the patient.1 • The recommended dose of DAYVIGO is one 5 mg tablet taken no more than once per night, within a few minutes before going to bed, with at least 7 hours remaining before the planned time of awakening.1 • The dose may be increased to the maximum recommended dose of 10 mg based on clinical response and tolerability.1 • Response should be evaluated after 7 to 10 days.

If symptoms fail to remit after 7 to 10 days, alternative primary psychiatric or medical illness should be considered.1 Tips for using DAYVIGO1 • Take right before bed: Take DAYVIGO once a day within a few minutes of going to bed.

• Give it time: Only take DAYVIGO when you can get at least 7 hours of sleep.

• Avoid eating close to taking: Time to sleep onset may be delayed if taken with or soon after a meal.

• Don’t mix: Do not take DAYVIGO with alcohol, sedatives, or other medicines that make you sleepy.

• Use as your doctor prescribed: Talk to your doctor if after 7 to 10 days your sleep problems do not get better or get worse; this may mean there is another condition causing your sleep problems.

• Take a missed dose only if you have time to sleep for 7 hours. If you miss a dose and you do have time to sleep for at least 7 hours before you must wake up again, take your dose as usual. If you do not have time to sleep for at least 7 hours before you must wake up again, do not take your dose. Take it the next night when you can ensure at least 7 hours before you must wake up.

See the Product Monograph for complete dosing and administration information.

This Counselling Corner is published by Ensemble IQ, 2300 Yonge Street, Suite 2900, Toronto, ON M4P 1E4, 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. © 2025

LIFESTYLE TIPS FOR PATIENTS WITH INSOMNIA4 1 Maintain routine of going to bed and getting up at the same time (this is where the sleep log can be helpful).

2 Limit or avoid napping during the day.

3 Avoid caffeine, alcohol, or a heavy meal several hours before bedtime.

4 Exercise regularly – however, avoid exercising 1-2 hours before bedtime.

5 Try to start dimming the lights and relax for an hour before bedtime.

6 Don’t watch TV, use the computer or use your phone in bed. Use your bed only for sleeping and intimacy.

7 Keep the bedroom quiet, cool and dark.

8 Don’t lie in bed awake. If you don’t fall asleep within 20 minutes, get up and do something relaxing, like reading, until you feel tired.

FOR MORE PATIENT INFORMATION, VISIT MYDAYVIGO.CA. DAYVIGO is covered by most Canadian private insurance plans.¶ Clinical use: DAYVIGO is not recommended for patients under the age of 18 years.

DAYVIGO is not recommended in patients with severe hepatic impairment.

Contraindications: • Hypersensitivity to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.

• Patients with narcolepsy.

Relevant warnings and precautions: • Abnormal thinking and behavioural changes • CNS depressant effects (including alcohol) and daytime impairment and risk of falls • Complex sleep behaviours • Sleep paralysis, hypnagogic/hypnopompic hallucinations, and cataplexy-like symptoms • Worsening of depression/suicidal ideation • Drug interactions - inhibitors and inducers of CYP3A • Patients with galactose intolerance • Driving and operating machinery • Patients with dependence/tolerance and abuse liability • Rebound insomnia • Patients with hepatic impairment • Patients with compromised respiratory function • Pregnant or breastfeeding women

For more information: Please see the Product Monograph at https://ca.eisai.com/ en-CA/our-products for important information on adverse reactions, drug interactions, and dosing not discussed in this piece. The Product Monograph is also available by calling 1-877-873-4724. ‡ A long-term, randomized, double-blind, placebo-controlled, multi-center trial in adult patients aged 18 or older who met DSM5 criteria for insomnia disorder. The study had 2 periods: a 6month placebo-controlled treatment period (Period 1), followed by a 6-month period (Period 2) where patients who previously received placebo were re-randomized in a double-blind fashion to receive only active treatment: DAYVIGO 5 mg or DAYVIGO 10 mg. ¶ Data on file, Eisai Limited.

References: 1. DAYVIGO Product Monograph, Eisai Limited, January 30, 2025.

2. Suni E. Stages of Sleep: What happens in a Sleep Cycle. The Sleep Foundation 2023. www.sleepfoundation.org/stages-of-sleep (accessed March 10, 2025).

3. Patel AK, et al. Physiology, Sleep Stages. NIH, National Library of Medicine https://www.ncbi.nlm.nih.gov/books/NBK526132/ (accessed March 28, 2025).

4. Hersh E. 12 Healthy Sleep Hygiene Tips. Healthline 2024. www. healthline.com/health/sleep-hygiene (accessed March 26, 2025).

DAYVIGO® is a registered trademark of Eisai R&D Management Co., Ltd. and is licensed to Eisai Inc. Eisai Limited, 6925 Century Avenue, Suite 701, Mississauga, Ontario L5N 7K2

Drug News NEW PRODUCTS Qalsody for SOD1-amyotrophic lateral sclerosis

tofersen 100 mg/15 mL injection; solution for intrathecal use in single-dose glass vials, Biogen Canada.

INDICATIONS Treatment of adults with amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 (SOD1) gene.

Issued market authorization with conditions, pending the results of clinical trials to verify the drug’s clinical benefit.

ACTION Patients with SOD1-ALS have mutations in the SOD1 gene. This causes accumulation of a toxic form of SOD1 protein, resulting in axonal injury and neurodegeneration. This leads to muscle weakness, with difficulty in movement, breathing and swallowing.

Tofersen is an antisense oligonucleotide that reduces the synthesis of SOD1 protein. This may decrease the loss of nerve cells and slow down the loss of muscle strength and function.

DOSAGE 100 mg (15 mL) by intrathecal injection. Give three 100 mg loading doses (Days 0, 14 and Day 28), followed by 100 mg maintenance doses every 28 days thereafter (Days 56, 84, etc.).

ADMINISTRATION Administer as an intrathecal bolus injection (over 1–3 minutes) using a lumbar puncture needle. Should be given by a healthcare professional experienced in performing lumbar punctures. Allow the refrigerated vial to warm to room temperature prior to administration.

ADVERSE EFFECTS MOST COMMON: Pain, arthralgia, myalgia, fatigue, increases in cerebrospinal fluid white blood cells and/ or protein, pyrexia. MOST SERIOUS: Serious neuroinflammatory adverse reactions (e.g., aseptic or chemical meningitis, myelitis and radiculitis, elevated intracranial pressure and/or papilledema). Renal toxicity, including potentially fatal glomerulonephritis, coagulation abnormalities and acute

A review of new launches, new indications, new dosage forms and Health Canada advisories

CLINICAL EDITOR LU-ANN MURDOCH, RPh, BScPhm, ACPR

severe thrombocytopenia have been seen after subcutaneous (SC) and intravenous (IV) administration of antisense oligonucleotides.

DRUG INTERACTIONS No clinical drug interaction studies have been performed.

Not a substrate for, or an inducer or inhibitor of CYP450-mediated metabolism; therefore, it should not interfere with other medications that interact with these metabolic pathways.

STORAGE Store refrigerated at 2°C–8°C in the original package to protect from light.

The vial (in the original carton to protect from light) can be stored for up to 14 days at room temperature (not > 30°C).

COMMENTS SOD1-ALS is an ultra-rare genetic form of ALS, affecting about 2% of people with ALS. Tofersen is the first therapy that targets the root cause of SOD1-ALS.

Rebyota for C. difficile prevention

fecal microbiota, live 1×108 to 5×1010 colony forming units (CFU)/mL; 150 mL rectal suspension, Ferring.

INDICATIONS Prevention of recurrence of Clostridioides difficile infection (CDI) in adults following antibiotic treatment for recurrent CDI. Not indicated for the treatment of CDI. ACTION A microbiome restoration therapy; exact mechanism of action has not been established.

DOSAGE A single dose of 150 mL microbiota suspension by rectal administration, given 24–72 hours after the last dose of antibiotics for CDI. Should not be administered during antibiotic treatment for CDI. No oral antibiotic therapy should be administered for up to eight weeks after administration of the microbiota suspension unless directed by a physician. Additional Rebyota treatment may be administered in the event of CDI recurrence.

ADMINISTRATION Prior to use, the suspension should be thawed completely (see STORAGE below). Administer rectally by gravity flow using the supplied administration set; see product monograph for detailed instructions.

ADVERSE EFFECTS MOST COMMON:

10 PHARMACY PRACTICE + BUSINESS June/July 2025 [Vol.12 No.4]

Abdominal pain, diarrhea, abdominal distension, flatulence, nausea; most are mild to moderate in severity and occur within the first two weeks following treatment. MOST SERIOUS: None specifically attributed to the microbiota suspension.

Manufactured from human fecal matter; it may contain food allergens and may carry a risk of transmitting infectious agents.

DRUG INTERACTIONS Not absorbed into the body; no metabolic drug–drug interactions are expected.

STORAGE/STABILITY Contains live microorganisms; therefore, it is important to follow the storage requirements. Can be stored in an ultracold freezer at -60° to -90°C until the product expiration date or stored in the refrigerator (2°C–8°C) for up to five days (including the 24 hour thawing period). Before use, thaw the suspension completely by placing the carton in a refrigerator for about 24 hours. Must not be thawed at room temperature or using a heat source such as a microwave or hot water. Do not refreeze once thawed. Shelflife is 36 months in an ultracold freezer from date of manufacture.

SUPPLIED Prepackaged single-dose 150 mL microbiota suspension is supplied in a carton containing one single-dose suspension bag. An administration set to facilitate rectal administration is packaged separately.

Skyclarys for Friedreich’s ataxia omaveloxolone 50 mg capsules, Biogen Canada.

INDICATIONS Treatment of Friedreich’s ataxia in patients ≥ 16 years of age.

ACTION Precise mechanism is unknown.

It activates nuclear factor (erythroid-derived 2)-like 2 (Nrf2), which is involved in cellular response to oxidative stress, and may play a role in restoring mitochondrial function. This may help to protect cells, especially those in the brain and nervous system, from damage.

DOSAGE 150 mg (3 x 50 mg capsules) once daily. Dose reductions are required

in mild or moderate hepatic impairment; avoid in severe hepatic impairment.

ADMINISTRATION Take on an empty stomach at least one hour before or two hours after eating. Swallow capsules whole; do not crush or chew. For patients unable to swallow capsules, the capsules may be opened and the contents sprinkled onto two tablespoons (30 mL) of applesauce and mixed well.

Consume drug-applesauce mixture immediately on an empty stomach at least one hour before eating or two hours after eating. Do not mix capsule contents with milk or orange juice.

ADVERSE EFFECTS MOST COMMON: Increases in serum alanine transaminase (ALT) and aspartate aminotransferase (AST), headache, nausea, fatigue, diarrhea.

Low-density lipoprotein cholesterol (LDL-C) elevations may occur. ALT, AST, bilirubin, B-type natriuretic peptide and lipid parameters should be monitored before starting omaveloxolone therapy and during treatment. MOST SERIOUS: Elevation of B-type natriuretic peptide (BNP) may occur, which may indicate cardiac failure; evaluate cardiac function promptly. If transaminases (ALT, AST) increase to levels greater than five times the upper limit of normal (ULN), or greater than three times the ULN with evidence of liver dysfunction (e.g., elevated bilirubin), discontinue omaveloxolone immediately and repeat liver function tests as soon as possible.

DRUG INTERACTIONS Avoid concomitant use with strong CYP3A4 inhibitors (e.g., itraconazole); if concomitant use cannot be avoided, consult product monograph for recommended dose reduction. Caution with moderate CYP3A4 inhibitors (e.g., verapamil); monitor for adverse reactions and reduce dose of omaveloxolone if needed. Avoid concomitant use with strong or moderate CYP3A4 inducers (e.g., efavirenz); they may significantly decrease omaveloxolone exposure, which may reduce its efficacy. May reduce the efficacy of combined hormonal contraceptives (e.g., pill, patch, ring), implants and progestin-only pills. Patients should use an alternate contraceptive method (e.g., nonhormonal intrauterine system) or additional nonhormonal contraceptive (e.g., condom) during concomitant use and for 28 days after discontinuation of omaveloxolone.

COMMENTS First therapy to help slow disease progression in Friedreich’s

ataxia, a rare, progressive, debilitating and life-shortening neurodegenerative disease affecting about one in 40,000 individuals in Canada.

Talzenna for metastatic prostate cancer

OTHER NEW PRODUCTS Clorotekal

chloroprocaine hydrochloride injection solution, 50 mg/5 mL (10 mg/mL), intrathecal; B. Braun of Canada/Cardinal Health.

INDICATIONS Induction of spinal anesthesia by intrathecal administration, in adults undergoing surgical procedures no longer than 40 minutes in duration.

DOSAGE The recommended dose is 50 mg (5mL) to obtain an effective block to the T-10 level with a single administration in an adult of average height and weight (~70 kg).

talazoparib 0.1 mg and 0.25 mg capsules (as talazoparib tosylate), Pfizer.

Combogesic IV INDICATIONS Treatment of adults with homologous recombination repair genemutated metastatic castration-resistant prostate cancer, in combination with enzalutamide. (Also indicated for use in the treatment of locally advanced or metastatic breast cancer, but Pfizer will not be marketing the drug for this indication.)

ACTION Inhibits poly(adenosine diphosphate ribose) polymerase (PARP) enzymes, resulting in decreased cancer cell proliferation and increased cancer cell death.

DOSAGE Metastatic castration-resistant prostate cancer: 0.5 mg once daily (in combination with enzalutamide 160 mg once daily), until disease progression or unacceptable toxicity occurs. Note: 0.1 mg and 0.25 mg capsules are available for dose reductions in renal impairment or to manage adverse reactions.

ADMINISTRATION Take with or without food at approximately the same time every day.

Swallow capsules whole; do not open, crush, chew or dissolve capsules.

ADVERSE EFFECTS MOST COMMON: (in combination with enzalutamide): Anemia, neutropenia, thrombocytopenia, fatigue, nausea, decreased appetite, diarrhea, dizziness. MOST SERIOUS: Anemia, bone fracture, pneumonia, sepsis, fatigue, ischemic heart disease, spinal cord compression.

DRUG INTERACTIONS Avoid concomitant use of strong P-gp inhibitors (e.g., amiodarone, carvedilol, clarithromycin, itraconazole, verapamil); if concomitant use cannot be avoided, monitor for potential increase in adverse reactions.

Avoid concomitant use of strong BCRP inhibitors (e.g., curcumin, cyclosporine).

acetaminophen 10 mg/mL and ibuprofen 3 mg/mL injection, solution for IV infusion; 100 mL vials, Aft Pharmaceuticals Canada/Accelera Pharma Canada.

INDICATIONS Short-term management of mild to moderate pain, or moderate to severe pain as an adjunct to opioid analgesics. Intended for use in adults when an IV route of administration is considered clinically necessary and/or when other routes of administration are not possible.

DOSAGE Adults weighing > 50 kg: One vial (100 mL) administered as a 15-minute IV infusion every six hours, as necessary.

Maximum total daily dose is four vials (400 mL), equivalent to 4 g acetaminophen and 1.2 g ibuprofen/day. Adults weighing ≤ 50 kg: 1.5 mL/kg (15 mg/kg acetaminophen + 4.5 mg/kg ibuprofen), as a 15-minute IV infusion every six hours, as necessary. Maximum single dose is 75 mL, which would equate to a total daily dose of acetaminophen 3 g and ibuprofen 900 mg.

Note: Combogesic IV has been evaluated in treatment of post-operative pain for up to two days (8 doses) with additional safety data in a small number of patients treated for up to five days (20 doses).

Patients may be dosed to a maximum of five days if justified by ongoing benefit-risk assessments.

COMMENTS Combogesic tablets (acetaminophen 325 mg and ibuprofen 97.5 mg tablets) are marketed by BioSyent Pharma in Canada.

[Vol.12 No.4] June/July 2025 PHARMACY PRACTICE + BUSINESS 11

Iqirvo

elafibranor 80 mg tablets, Ipsen Biopharmaceuticals.

NEW DOSAGE FORMS • Eylea HD (aflibercept 8 mg/0.07 mL

solution for intravitreal injection), Bayer.

Now available in a single-use prefilled syringe with OcuClick dosing system, as well as in the original 8 mg/0.07 mL single-use vial for the treatment of a single eye.

NEW GENERICS • Apo-Levothyroxine (levothyroxine

INDICATIONS Treatment of primary biliary cholangitis, in combination with ursodeoxycholic acid (UDCA), in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA. Issued market authorization with conditions, pending the results of trials to verify the drug’s clinical benefit.

DOSAGE 80 mg once daily, with or without food. Administer at least four hours before or four hours after administering a bile acid sequestrant, or as far apart as possible.

COMMENTS Primary biliary cholangitis affects approximately 13,000 people in Canada. It is a rare, chronic autoimmune liver disease where the immune system attacks the liver causing slow progressive damage to the bile ducts. If not effectively treated, it can lead to liver transplant and in some cases, premature death. Iqirvo is available through the Ipsen Cares program (https://www.ipsencares.ca/).

Talvey

talquetamab solution for SC injection; 3 mg/1.5 mL (2 mg/mL) and 40 mg/1 mL vials, Janssen/ Johnson & Johnson Innovative Medicine.

INDICATIONS Treatment of relapsed or refractory multiple myeloma in adults who have received at least three prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. Intended for patients who have demonstrated disease progression on or after the last therapy. Issued market authorization with conditions, pending the results of trials to verify the drug’s clinical benefit.

DOSAGE Based on body weight.

Administered SC in a three- or fourdose step-up phase, followed by weekly or every-two-weeks dosing; consult product monograph for details.

sodium 25 µg, 50 µg, 75 µg, 88 µg, 100 µg, 112 µg, 125 µg, 137 µg, 150 µg, 175 µg, 200 µg and 300 µg tablets, Apotex.

Generic alternative to Synthroid.

• Apo-Vilazodone (vilazodone 10 mg, 20 mg and 40 mg tablets), Apotex.

Generic alternative to Viibryd.

• Apo-Vortioxetine (vortioxetine 5 mg, 10 mg and 20 mg tablets), Apotex.

Generic alternative to Trintellix.

NEW INDICATIONS Eylea

aflibercept injection, solution for intravitreal injection, Bayer.

NEW INDICATION Treatment of retinopathy of prematurity (ROP) in preterm infants with zone I (stage 1+, 2+, 3 or 3+), zone II (stage 2+ or 3+) or aggressive posterior ROP disease. Issued market authorization with conditions, pending the results of trials to verify the drug’s clinical benefit. (Also approved earlier [without conditions] for use in adults for the treatment of: neovascular [wet] age-related macular degeneration; visual impairment due to macular edema secondary to central retinal vein occlusion; visual impairment due to macular edema secondary to branch retinal vein occlusion; diabetic macular edema; and myopic choroidal neovascularization.)

DOSAGE ROP in preterm infants: aflibercept 0.4 mg (0.01 mL) administered by intravitreal injection. Start with a single injection per eye (may be given on the same day). A total of up to two injections per eye may be administered within six months of treatment initiation if there are any signs of disease activity. The interval between two doses injected into the same eye should be at least four weeks.

HyQvia

normal immunoglobulin (human) and recombinant human hyaluronidase, solution for SC infusion, Takeda.

12 PHARMACY PRACTICE + BUSINESS June/July 2025 [Vol.12 No.4]

NEW INDICATION Maintenance therapy in adults with chronic inflammatory demyelinating polyneuropathy, after stabilization with IV immunoglobulin to prevent relapse of neuromuscular disability and impairment. (Also approved earlier for replacement therapy in primary or secondary humoral immunodeficiency in persons two years of age or older.)

DOSAGE Chronic inflammatory demyelinating polyneuropathy: Consult product monograph for details on how to transition from IV immunoglobulin to HyQvia. The two components must be infused sequentially through the same SC needle, beginning with the hyaluronidase solution followed by the immunoglobulin solution. Can be administered by a caregiver or self-administered by the patient after appropriate training.

Imfinzi

durvalumab for injection, AstraZeneca.

NEW INDICATIONS 1. First-line treatment of adults with metastatic nonsmall cell lung cancer (NSCLC) with no sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) genomic tumour aberrations, in combination with tremelimumab and platinum-based chemotherapy.

2. Monotherapy treatment of adults with limited-stage small cell lung cancer whose disease has not progressed following platinum-based chemoradiation therapy. (Also approved earlier for numerous other indications; consult product monograph for details.)

DOSAGE Consult product monograph for dosage schedules. Administered as an IV infusion over 60 minutes.

Itulatek

standardized allergen extract, white birch (Betula verrucosa), ALK-Abelló.

EXPANDED INDICATION Now indicated as an allergy immunotherapy for the treatment of moderate to severe seasonal allergic rhinitis, with or without conjunctivitis, induced by pollen from birch, alder, hazel and/or oak, in persons five to 65 years of age. Intended for persons with a clinical history of symptoms of allergic rhinitis, despite use of symptom-relieving medication, and a positive test of sensitization to one or more of the pollen of birch, alder, hazel or oak (skin prick test and/or specific IgE). (Oak has been added

to the list of allergens and the product was approved earlier for use in adults only.)

DOSAGE One tablet (12 SQ-Bet) taken sublingually daily. Avoid swallowing for about one minute. Do not take the tablet with food or beverage. Avoid food or beverages for five minutes after taking a tablet.

DOSAGE 200 mg every three weeks or 400 mg every six weeks until disease progression or unacceptable toxicity occurs, or up to 24 months or 35 doses for 200 mg or 18 doses for 400 mg, whichever is longer, in patients without disease progression. Administered as an IV infusion over 30 minutes.

Jemperli

Lynparza

NEW INDICATION Treatment of primary advanced or first recurrent endometrial cancer in adults who are candidates for systemic therapy, in combination with carboplatin and paclitaxel. (Also approved earlier for the treatment of mismatch repair deficient [dMMR] or microsatellite instability-high [MSI-H] recurrent or advanced endometrial cancer; see product monograph for details.)

DOSAGE 500 mg administered as an IV infusion over 30 minutes every three weeks for six doses, followed by 1000 mg every six weeks for all cycles thereafter; consult product monograph for details.

NEW INDICATION Add-on maintenance treatment to bevacizumab in adults with advanced high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer.

Intended for patients who are in response (complete or partial) to prior treatment with first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency-positive status defined by either a deleterious or suspected deleterious BRCA mutation and/or genomic instability. (Also approved earlier for use in the treatment of breast cancer, other situations of ovarian cancer, adenocarcinoma of the pancreas and prostate cancer; consult product monograph for details.)

DOSAGE Add-on maintenance treatment to bevacizumab in adults with advanced high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer: Two 150 mg tablets twice daily (600 mg/day), taken with or without food. Swallow tablets whole; do not chew, crush, dissolve or divide tablets.

dostarlimab for injection, GlaxoSmithKline.

Kevzara

sarilumab injection, Sanofi-aventis.

NEW INDICATION Treatment of polymyalgia rheumatica in adults who have had an inadequate response to corticosteroids, or who have experienced a relapse during corticosteroid taper. (Originally indicated only for the treatment of moderately to severely active rheumatoid arthritis.)

DOSAGE Polymyalgia rheumatica: 200 mg SC every two weeks, in combination with a tapering course of systemic corticosteroids. Can be used as monotherapy following discontinuation of corticosteroids. Dosage modifications may be required to manage adverse effects such as neutropenia, thrombocytopenia or elevated liver enzymes; consult product monograph for details.

Keytruda

pembrolizumab solution for infusion, Merck.

NEW INDICATION First-line treatment of adults with unresectable advanced or metastatic malignant pleural mesothelioma, in combination with pemetrexed and platinum chemotherapy. (Also approved earlier for numerous other indications; consult product monograph for details.)

olaparib tablets, AstraZeneca.

Sarclisa

isatuximab for injection, Sanofi-aventis.

NEW INDICATION Treatment of newly diagnosed multiple myeloma in patients who are not eligible for autologous stem cell transplant (ASCT), in combination with bortezomib, lenalidomide and dexamethasone. (Also approved earlier for the treatment of relapsed and refractory multiple myeloma.)

DOSAGE 10 mg/kg administered by IV infusion, in combination with bortezomib, lenalidomide and dexamethasone; consult product monograph for details.

Tagrisso

osimertinib tablets, AstraZeneca.

NEW INDICATION Treatment of locally advanced, unresectable (stage III) nonsmall cell lung cancer (NSCLC) in

patients whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations (either alone or in combination with other EGFR mutations) and whose disease has not progressed during or following platinumbased chemoradiation therapy. Issued market authorization with conditions, pending the results of trials to verify the drug’s clinical benefit. (Also approved earlier [without conditions] for use in other NSCLC situations; consult product monograph for details.)

DOSAGE 80 mg orally once daily, with or without food, at the same time each day.

Swallow tablets whole with water; do not crush, split or chew tablets.

HEALTH CANADA ADVISORIES Kinase inhibitor–statin interaction

A Health Canada safety review found a possible link between the risk of rhabdomyolysis and a drug interaction between cyclin-dependent kinase inhibitors (abemaciclib, palbociclib, ribociclib) and statins (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin). The review focused on 13 cases (1 Canadian and 12 international) of rhabdomyolysis in patients taking palbociclib or ribociclib and a statin (rosuvastatin or simvastatin).

In all 13 cases, patients had been on statin therapy prior to starting kinase inhibitor therapy. In eight cases, statin therapy was ongoing without reported rhabdomyolysis for more than one year prior to the start of kinase inhibitor therapy; in six of these eight cases, rhabdomyolysis occurred within 30 days of the addition of a kinase inhibitor, suggesting that adding the kinase inhibitor increased statin exposure, leading to rhabdomyolysis. Product monographs for abemaciclib, palbociclib and ribociclib products are being updated to include the risk of rhabdomyolysis due to a drug interaction with statins.

Lu-Ann Murdoch is a consulting clinical editor for Pharmacy Practice + Business and drug information consultant for Pharmacist’s Letter.

Further details about these advisories and safety reviews can be obtained from the MedEffect Canada website: https://www.canada.ca/en/health-canada/ services/drugs-health-products/medeffect-canada. html and the Drug and Health Product Portal https://dhpp.hpfb-dgpsa.ca/review-documents? search=&f%5B0%5D=content_type%3Assr.

[Vol.12 No.4] June/July 2025 PHARMACY PRACTICE + BUSINESS 13

Rx

Advertisement

Medication with indications in both chronic weight management and non-fatal MI risk reduction in adults with established CVD and BMI ≥ 27 kg/m2*

about For adults with obesity ± CVD OR overweight + CVD or additional risk factors

What is Wegovy® indicated for?

Wegovy® (semaglutide injection) is indicated:1 • as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients with an initial BMI of 30 kg/m2 or greater (obesity), or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbidity such as hypertension, type 2 diabetes mellitus, dyslipidemia, or obstructive sleep apnea.

• to reduce the risk of non-fatal myocardial infarction in adults with established CVD and BMI equal to or greater than 27 kg/m2.

Wegovy® should not be used in combination with any other semaglutidecontaining drug (e.g., Ozempic®, Rybelsus®) or any other GLP-1 receptor agonist.

What is the mechanism of action of Wegovy®?** GLP-1 is a physiological regulator of appetite and caloric intake.1 Semaglutide is 94% similar to human GLP-1 and acts as a GLP-1 receptor agonist that binds to and activates GLP-1 receptors. Compared to native GLP-1, semaglutide has a prolonged half-life of around 1 week. The principal mechanism of protraction is albumin binding, which results in decreased renal clearance and protection from metabolic degradation. Furthermore, semaglutide is stabilised against degradation by the DPP-4 enzyme.1

Are there guideline recommendations?

Semaglutide 2.4 mg is recommended as an obesity-management option by the Canadian Adult Obesity Clinical Practice Guidelines.2

What was the efficacy data for Wegovy® in clinical trials?

STEP 5 TRIAL: At week 104, in adults with obesity or overweight and at least one weight-related comorbidity, Wegovy® demonstrated powerful double-digit weight loss at two years vs. placebo.3† * Comparative clinical significance has not been established. ** Clinical significance has not been established. ∆ Based on treatment policy estimand. † STEP 5 study design: 104-week randomized, double-blind, phase 3, placebo-controlled trial in 304 patients with obesity (BMI ≥ 30 kg/m2) or overweight (BMI ≥ 27 to < 30 kg/m2) and at least one weight-related comorbid condition; patients with diabetes were excluded. Patients were randomized 1:1 to once-weekly semaglutide 2.4 mg or placebo, in addition to reduced calorie diet and increased physical activity. The co-primary endpoints were percentage change in body weight from baseline to week 104 and achievement of weight loss of ≥ 5% of baseline weight at week 104.3 ‡ STEP 1 study design: 68-week randomized, double-blind, phase 3, placebo-controlled trial that enrolled 1,961 patients with obesity (BMI ≥ 30 kg/m2), or with overweight (BMI ≥ 27 kg/m2 to < 30 kg/m2) and at least one weight-related complication who were randomized 2:1 to semaglutide 2.4 mg or placebo. Patients with diabetes were excluded. All patients were on a regimen of a reduced calorie diet and increased physical activity throughout the trial. The majority of patients had at least one weight-related complication. The primary efficacy outcomes were percent change in body weight from baseline to week 68 and percentage of patients who achieved ≥ 5% body weight reduction.4

-15.2% mean weight lost achieved with Wegovy® p < 0.0001

Mean change in body weight (%) from weeks 0-104 0 -2

Change in body weight, %

Go with

®

Pr

-2.6%

-4 -6

Wegovy® (n = 152) Placebo (n = 152) +diet and exercise

-8 -10 -12 -14

-15.2%

-16 -18 -20

12 16 20

28

36

44

52

60

68

76

84

92

100 104 104∆ (MI)

Number of participants Wegovy® 152 150 151 151 151 152 Placebo 152 149 146 146 143 141

152 133

149 132

146 131

149 129

136 118

101 89

92 74

140 116

137 117

134 144 107 128

0

4

8

Time from randomization (weeks)

Mean body weight ± SD at week 0 = 105.6 ± 20.8 kg (Wegovy®) and 106.5 ± 23.1 kg (placebo).

ITT population; MI analysis.

Adapted from Garvey, WT et al. (2022)3

The maintenance dose for Wegovy® is 2.4 mg once weekly.1 Please see the Product Monograph or the dosing section in this piece for more details on the recommended dosing protocol.

STEP 1 TRIAL: At week 68, in adults with obesity or overweight and at least one weight-related comorbidity, Wegovy® demonstrated effects across selected cardiometabolic parameters, glycemic control, and physical functioning (2° endpoints).1,4‡ Supportive 2° endpoints were not controlled for multiplicity. Wegovy® is not indicated to treat these cardiometabolic parameters or physical functioning.

Waist circumference

Total cholesterol

Systolic blood pressure

LDL

Diastolic blood pressure

HDL

A1C

Triglycerides

Physical functioning

Cardiometabolic and glycemic effects at week 68 (Wegovy® [baseline], placebo [baseline], % difference vs. placebo [LS mean; 95% CI], respectively): Waist circumference: -13.5 cm (114.6 cm); -4.1 cm (114.8 cm); -9.4 (-10.3, -8.5) p < 0.0001 (unadjusted 2-sided) for superiority. Systolic blood pressure: -6.2 mmHg (126 mmHg); -1.1 mmHg (127 mmHg); -5.1 (-6.3, -3.9) p < 0.001 (unadjusted 2-sided) for superiority. Diastolic blood pressure: -2.8 mmHg (80 mmHg); -0.4 mmHg (80 mmHg); -2.4 (-3.3, -1.6). A1C: -0.5% (5.7%); -0.2% (5.7%); -0.3 (-0.3, -0.2). Total cholesterol: -3.3% (4.9 mmol/L); 0.1% (5.0 mmol/L); -3.3 (-4.8, -1.8). LDL: -2.5% (2.9 mmol/L); 1.3% (2.9 mmol/L); -3.8 (-5.9, -1.5). HDL: 5.2% (1.3 mmol/L); 1.4% (1.3 mmol/L); 3.8 (2.2, 5.4).

Triglycerides: -21.9% (1.4 mmol/L); -7.3% (1.4 mmol/L); -15.8 (-18.8, -12.7).1,4 Proportion of patients achieving clinically meaningful improvements in physical functioning defined as a proportion of patients achieving A1C: glycated hemoglobin; BMI: body mass index; CI: confidence interval; CVD: cardiovascular disease; GLP-1: glucagon-like peptide-1; HDL: high-density lipoprotein; ITT: intent-to-treat; LDL: low-density lipoprotein; LS: least squares; MI analysis: multiple imputation analysis; MI: myocardial infarction; SD: standard deviation.

an improvement in score of at least 3.7 and 14.6 for SF-36v2 and IWQOL-Lite-CT, respectively, (Wegovy® vs. placebo): SF-36v2: 39.8% vs. 24.1%. IWQOL-Lite-CT: 51.8% vs. 28.3%.# SELECT TRIAL1,5§ • Of 17,604 patients enrolled in SELECT, the mean follow-up time was 39.8 ± 9.4 months.

• The primary endpoint was the time from randomization to the first occurrence of major adverse cardiovascular events (MACE), defined as a composite endpoint consisting of CV death, non-fatal myocardial infarction, or non-fatal stroke.

• A primary cardiovascular endpoint (MACE) event occurred in 569 patients (6.5%) in the Wegovy® group and in 701 patients (8.0%) in the placebo group (HR = 0.80; 95% CI [0.72, 0.90]; p < 0.001).

Patients with events (%)

In adults with established CVD and overweight or obesity taking CV SoC, Wegovy® demonstrated powerful non-fatal MI relative risk reduction vs. placebo (supportive 2° endpoint, both with standard of care).1,5§

28

%

4

relative risk reduction of non-fatal MI

3

HR = 0.72 (95% CI [0.61, 0.85]); supportive 2° endpoint.

2 1 0

Wegovy® +SoC Placebo + SoC

0

Patients at risk Wegovy® 8,803 Placebo 8,801

6

12

18

24

30

36

42

48

54

8,484 8,332 8,398 8,258

7,309 7,206

5,862 5,742

4,200 4,089

1,774 1,712

73 62

Months since randomization

8,713 8,598 8,674 8,534

Wegovy®: 2.7% (234/8,803 vs. placebo: 3.7% (322/8,801 events, both with standard care.

Data from the in-trial period. Cumulative incidence estimates are based on time from randomisation to first EAC-confirmed non-fatal myocardial infarction with all-cause death modelled as competing risk using the Aalen–Johansen estimator. Subjects without events of interest were censored at the end of their in-trial observation period.

Time from randomization to first MACE, MACE components, and selected secondary confirmatory endpoints.

HR (95% CI) 0.80 (0.72, 0.90)

Wegovy® N (%) 569 (6.5)

Placebo N (%) 701 (8.0)

CV death

0.85 (0.71, 1.01)

223 (2.5)

262 (3.0)

Non-fatal MI

0.72 (0.61, 0.85)

234 (2.7)

322 (3.7)

Non-fatal stroke

0.93 (0.74, 1.15)

154 (1.7)

165 (1.9)

Heart failure composite£

0.82 (0.71, 0.96)

300 (3.4)

361 (4.1)

All-cause death

0.81 (0.71, 0.93)

375 (4.3)

458 (5.2)

Components of MACE

Secondary confirmatory endpoints

Favours Wegovy®

0.6

0.8

1.0

1.2

Wegovy® has a convenient, once-weekly dosing schedule. The 16-week dose escalation helps reduce the likelihood of GI-related AEs.1 MONTH 5

MONTH 4

MONTH 3

MONTH 1

(weeks 1 to 4) 0.25 mg once weekly DIN: 02528509

START

at the lowest dose

(weeks 9 to 12) 1 mg once weekly DIN: 02528525

MONTH 2

(weeks 5 to 8) 0.5 mg once weekly DIN: 02528517

(weeks 13 to 16) 1.7 mg once weekly DIN: 02528533

STEP UP

(weeks 17 and onwards) 2.4 mg once weekly (maintenance dose) DIN: 02528541

STAY

the dose gradually

at the maintenance dose

If your patient does not tolerate the 2.4 mg dose of Wegovy®: • Temporarily decrease the dose to 1.7 mg weekly, for a maximum of 4 weeks.

• Patients should re-escalate to the 2.4 mg dose.

If your patient misses a dose, instruct them to: • Take Wegovy® as soon as possible if the next scheduled dose is at least 2 days (48 hours) away.

• Not to take Wegovy® and resume once-weekly dosing as scheduled if the next scheduled dose is less than 2 days (48 hours) away.

For complete dosing information, please refer to the Product Monograph.

How is Wegovy® administered?

Adapted from the Wegovy® Product Monograph.

Primary endpoint

What is the dosing schedule for Wegovy®?

Favours placebo

Adapted from the Wegovy® Product Monograph.

Wegovy is not indicated to reduce the risk of MACE, CV death, non-fatal stroke, heart failure, or all-cause death.

Data are from the in-trial period. Time from randomization to each endpoint were analyzed using a Cox proportional hazards model with treatment as categorical fixed factor. Patients without events of interest were censored at the end of their in-trial period. For the primary endpoint the HR and CI were adjusted for the group sequential design using likelihood ratio ordering. Secondary endpoints are not under multiplicity control. CV death includes both cardiovascular death and undetermined causes of death. # Baseline SF-36v2 physical function scores: 51.0 (Wegovy®) and 50.8 (placebo). Baseline IWQOLLite-CT physical function scores: 65.4 (Wegovy®) and 64.0 (placebo). § SELECT study design: A randomized, double-blind, placebo-controlled, event driven trial in 17,604 patients with BMI ≥ 27 kg/m2 and established CVD (prior myocardial infarction, prior stroke, and/or PAD). Patients with a history of diabetes were excluded. Patients were randomized 1:1 to either semaglutide 2.4 mg or placebo in addition to CV SoC. At baseline, 92.0% of patients were receiving CV medication (70.2% beta blockers, 45.0% ACE inhibitors, 29.5% angiotensin receptor blockers and 26.9% calcium-channel blockers); 90.1% were receiving lipidlowering agents (primarily statins [87.6%]); and 86.2% were receiving anti-platelet agents. The primary endpoint was the time from randomization to first occurrence of MACE, defined as a composite of: CV death, non-fatal MI, or non-fatal stroke.1 £ The composite heart failure endpoint was defined as time to the first occurrence of either heart failure hospitalization, urgent heart failure visit, or CV death.

Wegovy® comes in a pre-filled FlexTouch® pen designed for ease of use.

Wegovy® is injected subcutaneously.

Audible click: Signals dose delivery is complete Colour-coded: Helps to identify a pen's dose

Single dose, multi-use: Four once-weekly, preset doses in every pen

Each Wegovy® package includes: • 1 multi-use, prefilled FlexTouch® pen containing 4 fixed doses of one Wegovy® strength (either 0.25 mg, 0.5 mg, 1 mg, 1.7 mg, or 2.4 mg) • 4 NovoFine® needles A new prescription is required for each dose strength. Each pen strength (0.25 mg, 0.5 mg, 1 mg, 1.7 mg, 2.4 mg) has a unique DIN, and therefore requires a separate prescription to be dispensed. Needles are included with every pen (no separate Rx needed).

Watch this step-by-step video to help your patients learn how to use and store Wegovy® in a pre-filled FlexTouch® pen.

How is Wegovy® stored?

Before first use: Store in a refrigerator (2 to 8°C).

After first use: Store below 30°C or in a refrigerator (2 to 8°C) for up to 8 weeks.

• Protect from excessive heat and light (keep the pen cap on). Do not freeze.

• Always remove the injection needle after each injection and store the pen without a needle attached.

• After the final dose of Wegovy® the pen should be discarded in accordance with local requirements.

CV: cardiovascular; EAC: event adjudication committee; GI: gastrointestinal; HR: hazard ratio; MACE: major adverse cardiovascular events; IWQOL-Lite-CT: Impact of Weight on Quality of LifeLite for clinical trials; SF-36v2: Short Form Health Survey Version 2; SoC: standard of care.

What is the safety profile for Wegovy®?

STEP 1-3 trials: In three 68-week, placebo controlled trials, Wegovy® established a safety profile in over 2,000 patients in weight-management clinical trials.1 The most frequently reported adverse reactions (occurring in ≥ 10% of Wegovy® patients) were:1 Wegovy® N = 2,116 (%)

Placebo N = 1,261 (%)

Nausea

44

16

Diarrhea

30

16

Constipation

24

11

Vomiting

24

6.3

Abdominal Pain

20

10

Headache

16

11

Fatigue

11

5.1

Most GI events were mild or moderate, of short duration, and did not lead to discontinuation.

Permanent discontinuation of treatment due to GI AEs occurred in 4.3% of people treated with Wegovy® vs.

0.7% placebo.

SELECT trial: The safety profile for Wegovy® in the SELECT trial was generally similar to that reported in the weight-management Phase 3a trials with some exceptions (n = 8,803 taking Wegovy®). Please refer to the Product Monograph for more information on such AEs, including fractures of the femoral neck, femur, hip, and pelvis occurring in 1.0% (24/2,488) vs. 0.2% (5/2,424) of female patients treated with Wegovy® vs. placebo, respectively.1 Wegovy® established a safety profile in over 2,000 patients across weight-management clinical trials and over 8,000 patients in the CV outcomes trial.1 Help your patients manage GI side effects with lifestyle tips by encouraging them to:6 • Reduce meal size.

• Stop eating when full or when not hungry.

• Drink more water and eat high-fibre foods.

• Avoid spicy or high-fat foods.

• Drink fewer carbonated or alcoholic beverages.

Is there a patient support program for Wegovy®?

Yes—before your patients fill their first prescription of Wegovy®, encourage them to enrol in the FREE Novo Nordisk Care® for Wegovy® patient support program by visiting wegovy.ca¶ and entering the DIN: 02528509.

With Novo Nordisk Care® for Wegovy® your patients will have access to: • A savings card¥ • Drug coverage navigation support • Live support with a program educator (RN, RD, or pharmacist) • Helpful videos • Informative articles • Educational weight-management resources

Clinical use: Wegovy® should not be used in combination with any other semaglutide-containing drug (e.g., Ozempic®, Rybelsus®) or any other GLP-1 receptor agonist. Efficacy and safety in combination with other products intended for weight management have not been established. Wegovy® is not indicated in type 1 diabetes mellitus or diabetic ketoacidosis.

Contraindications: • Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2).

• Pregnancy or breast-feeding.

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: • Cardiovascular effects: heart rate increase, PR interval prolongation, and use in heart failure • Theoretical risk of dependence, tolerance, and/or abuse • Risk of hypoglycemia with concomitant use of insulin or an insulin secretagogue (precaution with driving and operating machinery) • Gastrointestinal events leading to dehydration • Delayed gastric emptying • Acute pancreatitis • Acute gallbladder disease • Hypersensitivity • Retinal disorders in patients with type 2 diabetes • Suicidal behaviour and ideation • Aspiration in association with general anesthesia or sedation • Acute kidney injury • Use with caution in hepatic insufficiency • Not for use in end-stage renal disease • Fertility • Contraception use recommended For more information: Please consult the Product Monograph at www.wegovypm-e.ca for more 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 Novo Nordisk at 1-800-465-4334.

AE: adverse event; CV: cardiovascular; DIN: drug identification number; PSP: patient support program; RD: registered dietitian; RN: registered nurse. ¶ The website wegovy.ca is open to the general public. ¥ Exclusions may apply. The user may still be responsible for costs not covered by their Novo Nordisk Care® savings card. Manufacturer reserves all rights to change or stop this program at its discretion.

References: 1. Novo Nordisk Canada Inc. Wegovy® Product Monograph. April 8, 2025.

2. Pedersen S, et al. Canadian Adult Obesity Clinical Practice Guidelines: Pharmacotherapy in Obesity Management. 2020. Available at: https://obesitycanada.ca/guidelines/pharmacotherapy.

Retrieved February 1, 2025.

3. Garvey WT, et al. Two-year effects of semaglutide in adults with overweight or obesity: The STEP 5 trial. Nat Med. 2022;28(10):2083-2091.

4. Wilding JPH, et al. Once-weekly semaglutide in adults with overweight or obesity. N Engl J Med. 2021;384(11):989-1002.

5. Lincoff AM, et al. Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes. N Engl J Med. 2023;389(24):2221-2232.

6. Wharton S, et al. Canadian Adult Obesity Clinical Practice Guidelines: Obesity in Adults: A Clinical Practice Guideline. 2020. Available at: https://www.cmaj.ca/content/192/31/E875.

Retrieved September 10, 2020.

All trademarks and registered trademarks are the property of their respective owners.

Wegovy®, Novo Nordisk Care®, FlexTouch®, NovoFine®, Ozempic®, Rybelsus®, and Apis Bull Design® are registered trademarks of Novo Nordisk A/S used under licence by Novo Nordisk Canada Inc. Novo Nordisk Canada Inc., tel: (905) 629-4222 or 1-800-465-4334. www.novonordisk.ca

Visit wegovy.ca¶ today to learn more about how the Novo Nordisk Care® for Wegovy® PSP can support your patients taking Wegovy®!

Pr

®

This Q&A is published by Ensemble IQ, 2300 Yonge Street, Suite 2900, Toronto, ON M4P 1E4, 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. © 2025

CA25SEMO00064E

Novo Nordisk Care® for Wegovy® is valid for Canadian residents only. Program availability may change or end at any time at the manufacturer’s discretion. For more details, see the Program terms and conditions. Coverage eligibility is determined by the patient’s insurance provider and/or plan sponsor. Novo Nordisk Canada Inc. cannot guarantee coverage approvals.

Practice Experts MENTAL HEALTH

By Sunny Wang / P. 17

CARDIOVASCULAR ISSUES

By Arden R. Barry / P. 20

MENTAL HEALTH

Switching antidepressants SUNNY WANG RPh, PharmD

Shutterstock/Dari-designPie

A

ntidepressants are widely used for a variety of different indications, ranging from depression and anxiety to the treatment of nonpsychiatric conditions such as neuropathic pain and migraine prophylaxis.1 Unfortunately, there often comes a time when an anti­depressant must be switched to an alternate agent due to an unsuccessful trial.2 Unlike many other classes of medication, special care must be taken when switching antidepressants due to the potential for withdrawal symptoms (Table 1), and the risks of drug interactions and serotonin syndrome.3,4 As such, pharmacists play a key role in guiding the switch, providing patient education,

Our pharmacist experts share information and ideas to support your daily practice

and actively monitoring for any potential withdrawal symptoms or adverse effects.

Cross-taper…or not to cross-taper While a variety of strategies are used for switching antidepressants, a ‘cross-taper’ or the simultaneous reduction of the current agent with the gradual titration of the new agent is most often favoured.4 The theory behind using a cross-taper is to minimize potential withdrawal symptoms, and to ensure antidepressant coverage throughout the process.4 There is no standard approach on the speed of the cross-taper as evidence is limited, but resources such as SwitchRx (www. switchrx.com) offer some guidance.5 Generally, the current agent should be tapered at a frequency and by dose increments similar to the initial dosage titration recommended in the product monograph or other resources. For example, sertraline is recommended to be titrated by 25–50 mg

PRACTICAL DIABETES

By Rhonda Roedler / P. 24

increments every week, and can be tapered using the same schedule.6 Nevertheless, it is important for clinicians, including pharmacists, to closely monitor patient response and tolerability. Dose increments and frequency of the cross-taper dose changes may need to be adjusted. It is not uncommon to prolong the frequency, or adjust at smaller dose increments if the patient is experiencing difficulties such as withdrawal symptoms. This may be especially important for agents associated with a higher incidence of withdrawal syndrome, such as duloxetine or venlafaxine XR.7 The new agent should be titrated as per recommendations offered by the product monograph or other resources, and should be titrated simultaneously with each tapering increment of the current agent. For example, if the goal is to cross-taper a patient from sertraline to venlafaxine XR, venlafaxine XR can be increased from a starting dose of 37.5 mg to 75 mg simultaneously with a taper of sertraline from 200 mg to 150 mg (see Table 2). Caution (e.g., increased monitoring, therapeutic intervention on prescribed doses) should be used when the two agents involved carry risks of drug interactions (e.g., CYP enzyme interactions, or pharmacodynamic interactions such as QT-prolongation).4

TABLE 1

FINISH mnemonic for symptoms of antidepressant discontinuation syndrome3 F I

N I

S

H

Flu-like symptoms (lethargy, fatigue, headache, aches, sweating) Insomnia (including vivid dreams and nightmares) Nausea and vomiting Imbalance (dizziness, vertigo, light-headedness) Sensory disturbances (‘burning, tingling, shock-like’ sensations) Hyperarousal (anxiety, irritability, agitation, aggression)

[Vol.12 No.4] June/July 2025 PHARMACY PRACTICE + BUSINESS 17

TABLE 2

Cross-taper example: switching from sertraline to venlafaxine XR5 Timing

Sertraline 200 mg

Venlafaxine XR

Week 1

200 mg

37.5 mg

Week 2

150 mg

75 mg

Week 3

100 mg

112.5 mg

50 mg

150-187.5 mg

Week 5

Discontinue

187.5-225 mg

Week 4 Week 6

187.5-225 mg

Week 7

225 mg+

Stop and start switch method Abrupt discontinuation of the current agent should be avoided unless the patient is experiencing significant adverse effects, due to concerns for triggering withdrawal syndromes.4 A few exceptions exist. Some clinicians may use the ‘stop and start’ method, where the current agent is abruptly discontinued and the new agent is initiated at its usual therapeutic dose. This strategy may be especially relevant when the current and new agents share a similar mechanism of action (e.g., switching from one SSRI to another SSRI).4 Risks associated with the ‘stop and start’ method include withdrawal syndromes and potential adverse effects arising from initiating the new agent at full therapeutic doses.

Another exception is with fluoxetine.

Owing to its long half-life (4–6 days for the parent drug and 4–16 days for its active metabolite, norfluoxetine), some clinicians choose to discontinue fluoxetine abruptly when switching to a new agent due to fluoxetine’s gradual self-tapering, which minimizes risk of withdrawal syndromes.8 Monoamine oxidase inhibitors (MAOIs) Due to significant risks of serotonin syndrome, switching from or to a MAOI requires special considerations. General guidance for all antidepressants is for a ‘washout period’ of two to three weeks depending on the agent when switching to or from a MAOI.4,9 However, when switching from fluoxetine to a MAOI, the recommended washout period can be five to six weeks or longer owing to fluoxetine’s long half-life.4,9 What complicates the matter even more is, when switching from a MAOI

TABLE 3

Symptoms of serotonin syndrome4 Increasing severity

to a new agent, it is recommended to taper the MAOI prior to the washout period to avoid withdrawal symptoms.4 This significantly prolongs the process as the MAOI taper can take several weeks to months, and leaves the patient without adequate antidepressant coverage during this time. One exception is when switching from moclobemide, a reversible MAOI, to another agent. The washout period required is generally recommended to be one to five days in this case.4 Note, however, that the usual two-week or longer washout period applies when switching from an antidepressant to moclobemide.4 Be alert for serotonin syndrome Serotonin syndrome is a severe, potentially life-threatening condition arising from excessive serotonergic activity.4 While serotonin syndrome can occur at any point, including with a single serotonergic agent at therapeutic doses, patients are especially at risk when switching antidepressants due to the simultaneous use of multiple serotonergic agents.4 Clinicians should actively monitor for potential signs and symptoms (Table 3), and advise patients to seek immediate medical attention if there are any suspicions of serotonin syndrome.4 Summary Switching between antidepressants occurs commonly in practice.

Special care must be used due to risks of withdrawal symptoms, drug interactions and serotonin syndrome.

Pharmacists should actively guide and monitor the process in collaboration with the patient and other clinicians to ensure a seamless transition.

18 PHARMACY PRACTICE + BUSINESS June/July 2025 [Vol.12 No.4]

Severity

Symptoms

Mild

Insomnia, anxiety, nausea, diarrhea, hypertension, tachycardia, hyper-reflexia

Moderate

Agitation, myoclonus, tremor, mydriasis, flushing, diaphoresis, low fever (<38.5°C)

Severe

Severe hyperthermia, confusion, rigidity, respiratory failure, coma, death

Sunny Wang is a clinical pharmacist at the Centre for Addiction and Mental Health (CAMH) in Toronto, Ont. He is also a clinical instructor at the Leslie Dan Faculty of Pharmacy and serves as an expert hub member for the Addiction Medicine and Psychosocial Interventions Program with Project ECHO. REFERENCES 1. Canadian Pharmacists Association. Tricyclic antidepressants (TCAS). CPhA monograph.

Last revised November 12, 2018.

2. Rush AJ, Trivedi MH, Wisniewski SR, et al. Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report. Am J Psychiatry 2006;163(11):190517. doi: 10.1176/ajp.2006.163.11.1905.

3. Gabriel M, Sharma V. Antidepressant discontinuation syndrome. CMAJ 2017;189(21):E747. doi: 10.1503/cmaj.160991.

4. Taylor D, Barnes TRE, Young AH. The Maudsley prescribing guidelines in psychiatry, 14th ed. Hoboken, NJ: Wiley Blackwell; 2021.

5. Mcintosh D, Procyshyn R. SwitchRx – The online medication switching tool. https:// www.switchrx.com/antidepressants.php/ switch (accessed March 13, 2025).

6. BGP Pharma ULC dba Viatris. Sertraline product monograph. Etobicoke, ON; August 22, 2023. Accessed electronically via Compendium of Pharmaceuticals and Specialties (accessed March 11, 2025).

7. Quilichini JB, Revet A, Garcia P, et al. Comparative effects of 15 antidepressants on the risk of withdrawal syndrome: a real-world study using the WHO pharmacovigilance database. J Affect Disord 2022;297:189-93. https://doi.org/10.1016/j. jad.2021.10.041 (accessed March 13, 2025).

8. Sivem Pharmaceuticals ULC. Fluoxetine product monograph. Saint-Laurent, QC; June 11, 2018. Accessed electronically via Compendium of Pharmaceuticals and Specialties (accessed March 11, 2025).

9. Royal College of Psychiatrists Psychopharmacology Committee. Use of monoamine oxidase inhibitors (MAOIs) in psychiatric practice position statement: RCPsych; July 2020. https://www.rcpsych. ac.uk/docs/default-source/improving-care/ better-mh-policy/position-statements/ps03_20. pdf?sfvrsn=bc814c70_2 (accessed March 13, 2025).

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Beta-blockers post-MI: should we stop using them if patients have normal heart function?

ARDEN R. BARRY BSc, BSc(Pharm), PharmD, ACPR

In contemporary medicine, the extent of evidence needed to stop recommending an existing therapy typically far exceeds the threshold required to introduce a new one. Novel therapies are often implemented in practice based on one or two large-scale randomized controlled trials (e.g., sodium-glucose cotransporter-2 inhibitors). However, multiple studies can demonstrate that a therapy is ineffective for a given condition, yet clinicians are often reluctant to abandon that medication once it has become part of the “usual” regimen. Such is the case with beta-blockers in patients who present with a myocardial infarction (MI) and have normal or near-normal heart function post-MI. Beta-blocker use post-MI Historically, beta-blockers were recommended as part of the typical post-MI cocktail, in addition to a renin-angiotensin-aldosterone system inhibitor, a statin and dual antiplatelet therapy.1,2 This recommendation was primarily based on data before the routine use of reperfusion strategies, such as percutaneous coronary intervention (PCI) and fibrinolysis. Beta-blockers are strongly recommended in patients who have a left ventricular ejection fraction (LVEF) of ≤ 40%, as they have demonstrated a survival benefit in these patients.3 However, the effect of beta-blockers in patients who do not have left ventricular dysfunction after an MI (which is becoming increasingly common due to readily accessible reperfusion therapy) is less clear.

Evidence for long-term use: In 2017, a Doctor of Pharmacy student and I conducted a systematic review to evaluate the evidence for long-term

For patients who present with an MI and have an LVEF ≥ 50% post-vascularization, the benefit of betablockers, if one truly exists, is likely modest at best.

beta-blockers in patients post-MI without left ventricular dysfunction in the modern reperfusion era.4 Of the eight cohort studies we identified, only two demonstrated a reduction in all-cause death with beta-blockers, whereas no difference was observed in the other six studies. Among the eight studies, only four studies reported a major adverse cardiovascular event outcome (e.g., MI, stroke, heart failure hospitalization), none of which demonstrated a benefit with beta-blocker therapy. We concluded that this evidence imparted

20 PHARMACY PRACTICE + BUSINESS June/July 2025 [Vol.12 No.4]

uncertainty regarding the benefit of beta-blockers in this population and suggested that they may be considered for discontinuation after one year.

Following this systematic review, two noteworthy studies were published that both demonstrated futility with beta-blockers post-MI. An open-label trial conducted in Japan of 801 patients with an ST-segment elevation MI who underwent PCI ≤ 24 hours post-MI and had an LVEF ≥ 40%, were randomized to carvedilol or no beta-blocker therapy.5 After three years, the primary composite endpoint of adverse cardiovascular events (death, MI, or hospitalization for heart failure or acute coronary syndrome) was similar between groups (6.8% vs 7.9%, p=0.20), although the trial did not have a sufficient sample size to detect a significant difference.

A well-designed Ontario-based cohort study evaluated exposure to betablocker versus no beta-blocker therapy in 33,811 patients ≥ 65 years of age who experienced an MI.6 Patients with a history of heart failure with reduced ejection (HFrEF) or who were prescribed carvedilol (which is limited to patients with HFrEF in Ontario) were excluded.

The primary composite outcome of death or hospitalization for a recurrent MI or angina at one year was not significantly different between groups (14.8% vs 14.7%, adjusted hazard ratio [HR] 1.00, 95% confidence interval [CI] 0.94–1.07).

Recent randomized controlled trial data: Two open-label randomized controlled trials recently demonstrated conflicting results, which has fueled this debate. The REDUCE-AMI trial randomized 5,020 patients (mostly from Sweden) with an acute MI and LVEF ≥ 50% to either beta-blocker (metoprolol or bisoprolol) or no therapy.7 There was, however, some crossover between groups. After 3.5 years, no difference was seen in the primary outcome (all-cause death or recurrent MI) between patients assigned to a beta-blocker or not (7.9% vs 8.3%, HR 0.96, 95% CI 0.79–1.16), although the event rates were lower than anticipated. Cardiovascular death and all-cause death were similar between groups, as were safety endpoints (e.g., hospitalization for bradycardia).

The ABYSS trial, conducted in France,

Getty Images/FotografiaBasica

PRACTICE EXPERTS / CARDIOVASCUL AR ISSUES

Summary For patients who present with an MI and have an LVEF ≥ 50% post-vascularization, the benefit of beta-blockers (if one truly exists) is likely modest at best. Therefore, it is reasonable to taper and discontinue beta-blockers in these patients, particularly

older persons that are at higher risk of adverse effects, although the timeframe is unclear (e.g., 1-year post-MI). This does not apply to patients with an LVEF < 50% or those who did not undergo revascularization, or patients with another indication for beta-blocker therapy (e.g., atrial fibrillation). The recently published American College of Cardiology/ American Heart Association guideline for the management of patients with acute coronary syndromes continues to recommend beta-blockers in all patients post-MI despite these new trial data, stating that more studies are needed.9 Fortunately, several ongoing (albeit open-label) trials, including one based in Edmonton,10 will provide more insight regarding this clinical question.

Arden Barry is a clinical pharmacy and research specialist in ambulatory cardiology at the Jim Pattison Outpatient Care and Surgery Centre in Surrey, BC, and associate professor (partner) at the Faculty of Pharmaceutical Sciences, University of British Columbia in Vancouver, BC. REFERENCES 1. O’Gara PT, Kushner FG, Ascheim DD, et al.

2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/ American Heart Association Task Force on Practice

Guidelines. Circulation 2013;127:e362-e425.

2. Amsterdam EA, Wenger NK, Brindis RG, et al. 2014 AHA/ACC guideline for the management of patients with non-ST-elevation acute coronary syndromes: a report of the American College of Cardiology/ American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol 2014;64:e139-e228.

3. Ezekowitz JA, O’Meara E, McDonald MA, et al. 2017 Comprehensive update of the Canadian Cardiovascular Society guidelines for the management of heart failure. Can J Cardiol 2017;33:1342-433.

4. Hong J, Barry AR. Long-term beta-blocker therapy after myocardial infarction in the reperfusion era: a systematic review. Pharmacotherapy 2018;38:546-54.

5. Watanabe H, Ozasa N, Morimoto T, et al.

Long-term use of carvedilol in patients with ST-segment elevation myocardial infarction treated with primary percutaneous coronary intervention. PLoS One 2018;13:e0199347.

6. Jackevicius CA, Krumholz HM, Ross JS, et al. Clinical outcomes with beta-blocker use in patients with recent history of myocardial infarction. Can J Cardiol 2020;36:1633-40.

7. Yndigegn T, Lindahl B, Mars K, et al. Beta-blockers after myocardial infarction and preserved ejection fraction. N Engl J Med 2024;390:1372-81.

8. Silvain J, Cayla G, Ferrari E, et al. Beta-blocker interruption or continuation after myocardial infarction. N Engl J Med 2024;391:1277-86.

9. Rao SV, O’Donoghue ML, Ruel M, et al. 2025 ACC/AHA/ACEP/NAEMSP/SCAI guideline for the management of patients with acute coronary syndromes: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.

Circulation 2025;151:e771-e862.

10. ClinicalTrials.gov. De-adoption of beta-blockers in patients with stable ischemic heart disease (ABBREVIATE). https://clinicaltrials.gov/study/ NCT05081999 (accessed March 2, 2025).

APPROVED FOR

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included 3,698 patients with an MI and an LVEF ≥ 40% who underwent revascularization six months or more before randomization.8 Patients were randomized to either continue or discontinue their beta-blocker. The primary outcome of death, nonfatal MI, nonfatal stroke or hospitalization for a cardiovascular reason was lower in the group that continued their betablocker (21.1%) compared to those who interrupted therapy (23.8%) at three years, which did not meet the criteria for noninferiority. However, the main criticism of this trial is that the primary outcome was driven by hospitalizations for a coronary-related reason (e.g., suspected angina) and, due to the open-label design, clinicians who knew their patients were not on a beta-blocker may have been more likely to refer them to hospital.

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Canadian Council on Continuing Education in Pharmacy

The When, Why and How of Using Once-Weekly Insulin

By Nanci Frank, BS Pharm, CDE

Non-hormonal treatment options for vasomotor symptoms

By Cait Luther, MSCP, BSc, PharmD, RPh KEYWORDS:

MENOPAUSE MANAGEMENT

LIFESTYLE INTERVENTION

PHARMACIST COUNSELLING ROLE

VASOMOTOR SYMPTOMS (VMS)

Supported by educational funding from Astellas Pharma Canada, Inc. Take this course on eCortex, the online learning home of Pharmacy Practice + Business and part of CanadianHealthcareNetwork.ca

Upon successful completion of this continuing education lesson, you will be better able to: 1. Explain how once-weekly insulin differs from current once-daily basal insulin therapies.

2. Determine the appropriateness of once-weekly basal insulin in people with type 2 diabetes.

3. Use patient counselling tips to manage Supported by medication use and an unrestricted optimize adherence. educational

grant from Novo Nordisk Canada

[Vol.12 No.4] June/July 2025 PHARMACY PRACTICE + BUSINESS 21

Rx

Advertisement

THE FIRST AND ONLY NON-HORMONAL NEUROKININ B (NKB) ANTAGONIST INDICATED IN THE TREATMENT OF VMS ASSOCIATED WITH MENOPAUSE.1-3*

about new Week 52 data5,6†

What is VEOZAH® indicated for?

Pr

VEOZAH® (fezolinetant film-coated tablets) is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.1

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What is the mechanism of action of VEOZAH?

VEOZAH is a nonhormonal selective NK3 receptor antagonist that blocks neurokinin B (NKB) binding on the kisspeptin/neurokinin B/dynorphin (KNDy) neuron to modulate neuronal activity in the thermoregulatory center in the hypothalamus.1**

What was the efficacy profile of VEOZAH in the SKYLIGHT 2 clinical trial?

4 weeks Baseline (SD) 2.4 (0.34) 2.4 (0.32)

0 -0.4

-0.6 (0.05)

-0.8

-0.3 (0.05)

Difference vs. placebo (SE) -0.3 (0.06), p<0.001‡

Placebo (n=167) LS mean change from baseline (SE)

1,4

LS mean change from baseline (SE)

VEOZAH 45 mg (n=167)

12 weeks Baseline (SD) 2.4 (0.34) 2.4 (0.32)

0 -0.4 -0.8

-0.8 (0.06)

-0.5 (0.06)

Difference vs. placebo (SE) -0.3 (0.08), p<0.001‡

VEOZAH provided statistically significant reductions in the severity of moderate to severe VMS (per 24 hours) at Weeks 4 and 12 vs placebo (p<0.001).‡ Adapted from VEOZAH Product Monograph.

Statistically significant difference between VEOZAH vs. placebo was observed at Week 1 for VMS frequency (secondary endpoint).5-7† Mean (SD) change from baseline in VMS frequency with VEOZAH: 3.91 (4.30) vs. 2.34 (3.34) with placebo.

Baseline (SD) VMS frequency in VEOZAH group 11.8 (8.26) vs. 11.6 (5.02) with placebo.

LS mean difference vs. placebo (SE): -1.71 (0.40); 95% CI: -2.51, -0.91; p<0.001, without multiplicity analysis.

Week 52 data The duration of this study is longer than that of the efficacy data included in the VEOZAH Product Monograph. Mean change in the frequency and severity of moderate to severe VMS from baseline to each visit in the extension period was an exploratory endpoint.

Assessments after the 12-week placebocontrolled period were descriptive only.

5,6†

VEOZAH provided clinically meaningful reductions in the frequency of moderate to severe VMS and provided statistically significant reductions in the severity of VMS symptoms vs. placebo at Weeks 4 and 12.1† FREQUENCY: Weeks 4 and 121† MEAN CHANGE FROM BASELINE TO WEEKS 4 AND 12 IN MODERATE TO SEVERE VMS FREQUENCY PER 24 HOURS1

FREQUENCY

CHANGE IN MODERATE TO SEVERE VMS UP TO WEEK 525

12 weeks

14

Mean baseline (SD) 11.8 (8.26) 11.6 (5.02)

Mean baseline (SD) 11.8 (8.26) 11.6 (5.02)

12

-4.0

-8.0

-3.7 (0.33) -6.3 (0.33)

Difference vs. placebo (SE) -2.6 (0.46), p<0.001‡ FREQUENCY of moderate to severe VMS REDUCED by 53.3%

by Week 4 with VEOZAH vs.

31.8% with placebo (p<0.001)‡

0

-4.0

-7.5 (0.39) Difference vs. placebo (SE) -2.5 (0.55), p<0.001‡ FREQUENCY of moderate to severe VMS REDUCED by 63.5%

by Week 12 with VEOZAH vs.

43.1% with placebo (p<0.001)‡

-8.0

Adapted from VEOZAH Product Monograph.

-5.0 (0.39)

Daily mean frequency (SE)

0

Placebo (n=167)

4 weeks LS mean change from baseline (SE)

LS mean change from baseline (SE)

VEOZAH 45 mg (n=167)

Placebo VEOZAH 45 mg

10

Placebo – VEOZAH 45 mg

8 6 4

Placebocontrolled period

2 0

0

Active extension period''

8 12 16 20 24 28 32 38 40 44 48 52 Weeks Coprimary endpoints 4

Adapted from Johnson et al, 2023.

CI: confidence interval; LS: least squares; PROMIS SD SF 8b: Patient-Reported Outcomes Measurement Information System Sleep Disturbance–Short Form 8b; SD: standard deviation; SE: standard error; VMS: vasomotor symptoms.

SEVERITY

CHANGE IN MODERATE TO SEVERE VMS UP TO WEEK 522-4 3.0

Placebo

2.5

VEOZAH 45 mg

2.0

Placebo – VEOZAH 45 mg

1.5 1.0 Placebocontrolled period Active extension period'' 0 0 4 8 12 16 20 24 28 32 38 40 44 48 52 Coprimary endpoints Weeks

0.5

Adapted from Johnson et al, 2023.

SLEEP DISTURBANCES VEOZAH demonstrated powerful reductions in self-reported sleep disturbances related to VMS, as measured by the PROMIS SD SF 8B (key secondary endpoint). In the management of VMS, VEOZAH improved sleep disturbances vs. placebo at week 12 (p=0.007).5† PROMIS SD SF 8B§

MEAN CHANGE FROM BASELINE TO WEEK 12 TOTAL SCORE5 12 weeks LS mean change from baseline

MEAN CHANGE FROM BASELINE TO WEEKS 4 AND 12 IN MODERATE TO SEVERE VMS SEVERITY PER 24 HOURS1

Daily mean severity (SE)

SEVERITY: Weeks 4 and 121†

0

Baseline 26.2 (6.6) 27.4 (7.0) VEOZAH 45 mg (n=167)

-4.0

-8.0

-3.4 (0.5)

Placebo (n=167)

-5.5 (0.5)

Mean baseline (SD) Difference vs. placebo (SE) -2.0 (0.7), p=0.007 ¶

Adapted from Johnson et al, 2023.

* Comparative clinical significance is unknown. ** Clinical significance unknown. † SKYLIGHT 2: The efficacy of VEOZAH was evaluated in the first 12-week, randomized, placebo-controlled, double-blind portion of the SKYLIGHT 2 phase 3 study. After the first 12 weeks, postmenopausal women on placebo were then re-randomized to VEOZAH for a 40-week extension to evaluate safety for up to 52 weeks of total exposure. The study included post-menopausal women who had a minimum average of 7 moderate to severe VMS per day. Coprimary endpoints were mean change from baseline in moderate to severe VMS frequency and severity at weeks 4 and 12.1 FREQUENCY: Measured as a daily mean and analyzed as weekly average (calculated as the average frequency over nonmissing days from 7 days).5 SEVERITY: Measured as a daily mean and analyzed as weekly average (calculated as the average frequency over nonmissing days from 7 days).5 LS mean: least squares mean estimated from a mixed model for repeated measures analysis of covariance.1 ‡ Statistically significantly superior compared to placebo at the 0.05 level with multiplicity adjustment.1 '' Women previously taking placebo were switched to VEOZAH 45 mg. § PROMIS SD SF 8b assesses self-reported sleep disturbance during the prior 7 days and includes perceptions of restless sleep; satisfaction with sleep; refreshing sleep; difficulties sleeping, getting to sleep, or staying asleep; amount of sleep; and sleep quality. Responses to the 8 items range from 1 to 5, and the range of possible summed raw scores is 8 to 40. Higher scores on PROMIS SD SF 8b indicate more disturbed sleep. ¶ Two-sided unadjusted p-value.5

VEOZAH demonstrated a safety and tolerability profile up to 1 year.1 12–week safety profile Adverse events that occurred in at least 2% in VEOZAH 45 mg and greater than placebo in two trials£ Combined SKYLIGHT 1 and 2 VEOZAH Placebo N=340 N=342 n(%) n(%) Gastrointestinal disorder Abdominal pain# Investigations Liver test elevation¥

7 (2.1%)

7 (2.0%)

11 (3.2%)

9 (2.6%)

Adapted from VEOZAH Product Monograph.

52–week safety profile Adverse events that occurred in at least 2% in VEOZAH 45 mg and greater than placebo over 52 weeksϕ SKYLIGHT 4

Gastrointestinal disorder Abdominal pain# Diarrhea Nausea General disorders Fatigue Investigations Liver test elevation∆ Nervous system disorders Headache, cluster headache, sinus headache, and tension headache Psychiatric disorders Insomnia, middle insomnia Vascular disorders Hot flush, flushing

VEOZAH N=609 n(%)

Placebo N=610 n(%)

27 (4.4%) 24 (3.9%) 19 (3.1%)

13 (2.1%) 16 (2.6%) 15 (2.5%)

17 (2.8%)

16 (2.6%)

32 (5.3%)

29 (4.8%)

59 (9.7%)

58 (9.5%)

24 (3.9%)

11 (1.8%)

15 (2.5%)

10 (1.6%)

Adapted from VEOZAH Product Monograph.

A numerical imbalance was observed in the incidence of other malignancies between VEOZAH and placebo groups in the long-term safety trial SKYLIGHT 4. A causal relationship between VEOZAH and increased risk of malignancies has not been established.1 Please see the VEOZAH Product Monograph for complete adverse events information.

What is the dosing for VEOZAH?

VEOZAH provides convenient once-daily dosing.

The recommended dose of VEOZAH is 45 mg orally once daily, with or without food.

Take VEOZAH with liquids at about the same time every day, and swallow whole. Do not cut, crush, or chew tablets.1 Missed dose If a dose is missed or not taken at the usual time, patients should take the missed dose as soon as possible, unless there is less than 12 hours before the next scheduled dose. Return to the regular schedule the following day.1

Special populations Hepatic impairment1 VEOZAH is contraindicated in individuals with cirrhosis.

VEOZAH is not recommended for use in individuals with Child-Pugh Class B (moderate) chronic hepatic impairment.

VEOZAH has not been studied in individuals with Child-Pugh Class C (severe) chronic hepatic impairment and is not recommended in this population.

No dose modification is recommended for individuals with Child-Pugh Class A (mild) chronic hepatic impairment.

Renal impairment1 VEOZAH is contraindicated in individuals with severe (eGFR < 30 mL/min/1.73 m2) renal impairment.

VEOZAH has not been studied in individuals with end-stage renal disease (eGFR < 15 mL/ min/1.73 m2) and is contraindicated in this population.

No dose modification is recommended for individuals with mild (eGFR 60 to < 90 mL/ min/1.73 m2) or moderate (eGFR 30 to < 60 mL/ min/1.73 m2) renal impairment.

Dosing considerations1 Perform baseline bloodwork to evaluate hepatic function and assess for injury including serum ALT, serum AST, serum ALP, and serum bilirubin (total and direct) before initiating treatment with VEOZAH. Do not start VEOZAH if ALT or AST is ≥2 x ULN or if the total bilirubin is elevated (≥2 x ULN).

Proceed with caution if ALT or AST is between >1.5 x ULN and <2 x ULN. While using VEOZAH, perform follow-up evaluations of hepatic transaminase concentration monthly during the first 3 months, at 6 months, and 9 months after the initiation of therapy.

Advise patients to discontinue VEOZAH immediately and seek medical attention including hepatic laboratory tests if they experience signs or symptoms that may suggest liver injury.

Signs or symptoms that may suggest liver injury include new onset fatigue, decreased appetite, nausea, vomiting, pruritus, jaundice, pale feces, dark urine, or abdominal pain.

Discontinue VEOZAH if transaminase elevations are ≥5 x ULN and/or transaminase elevations are ≥3 x ULN and the total bilirubin level is ≥2 x ULN. If transaminase elevations ≥3 x ULN occur, perform more frequent follow-up hepatic laboratory tests until resolution.

Exclude alternative causes of hepatic laboratory test elevations.

See the VEOZAH Product Monograph for complete dosing and administration information.

Is there a patient support program for VEOZAH?

Yes—the VEOZAH® Connect Patient Support Program has been designed to help facilitate the treatment journey with VEOZAH. Benefits include an easy enrolment process, financial support, a call centre available 8am-8pm EST, adherence support, and ongoing patient updates and reminders. For more information: Phone: 1-855-283-6924 (1-855-2VEOZAH) Fax: 1-877-298-5167 Email: support@veozahconnect.ca Clinical use: Pediatrics (<18 years of age): not indicated Geriatrics (≥65 years of age): no data available; therefore, an indication has not been recommended Contraindications: Known cirrhosis Severe renal impairment or end-stage renal disease Patients using concomitant moderate or strong CYP1A2 inhibitors Known or suspected pregnancy Relevant warnings and precautions: Incidence of other malignancies Benefit-risk consideration to treat women with previous or known breast cancer or other estrogen-dependent malignancies Risk of endometrial hyperplasia and endometrial carcinoma Not recommended in Child-Pugh Class B (moderate) chronic hepatic impairment; not studied in Child-Pugh Class C (severe) chronic hepatic impairment and is not recommended in this population Risk of hepatic transaminase elevation and hepatotoxicity Perform baseline bloodwork to evaluate hepatic function and assess for injury (including serum ALT, serum AST, serum ALP, and serum bilirubin [total and direct]) prior to initiating VEOZAH. Perform hepatic laboratory tests monthly for the first 3 months, at 6 months, and 9 months after initiation of therapy Not recommended in breast-feeding women For more information: Consult the Product Monograph at www. veozahmonograph.ca for important information relating to adverse reactions, drug interactions and dosing information. The Product Monograph is also available by calling 1-888-338-1824.

ALP: alkaline phosphatase; ALT: alanine aminotransferase; AST: aspartate aminotransferase; eGFR: estimated glomerular filtration rate; ULN: upper limit of normal. £ SKYLIGHT 1 and 2 were identical phase 3 efficacy and safety studies that were randomized, placebo-controlled, double-blind for 12 weeks, followed by re-randomization of women previously receiving placebo to VEOZAH (women on VEOZAH remained on VEOZAH) for an additional 40 weeks of active treatment.1 # Abdominal pain includes abdominal lower pain, abdominal upper pain, and abdominal tenderness.1 ¥ Liver test elevation includes ALT abnormal/increased, AST abnormal/increased, blood ALP abnormal/increased, blood bilirubin increased, gamma-glutamyltransferase increased, hepatic enzyme abnormal/increased, transaminases increased, and liver function test abnormal/increased.1 ϕ SKYLIGHT 4 was a phase 3, 52-week, randomized, placebocontrolled, double-blind, long-term safety study.1 ∆ Liver test elevation includes ALT abnormal/increased, AST abnormal/increased, blood ALP increased, blood bilirubin increased, gamma-glutamyltransferase increased, hepatic function abnormal, hepatic enzyme increased, transaminases increased, and liver function test abnormal/increased.1 All trademarks are the property of their respective owners © 2025 Astellas Pharma Inc. or its affiliates.

References: 1. VEOZAH Product Monograph. Markham, ON: Astellas Pharma Canada, Inc. 2. The North American Menopause Society (NAMS). Menopause. 2023;30(6):573-590. 3. Data on file. First and only claim. 4. Yuksel N, Evaniuk D, Huang L, et al. Guideline No. 422a: Menopause: vasomotor symptoms, prescription therapeutic agents, complementary and alternative medicine, nutrition, and lifestyle. J Obstet Gynaecol Can. 2021;43(10):1188-1204.e1. 5. Johnson KA, Martin N, Nappi RE, et al. Efficacy and safety of fezolinetant in moderate to severe vasomotor symptoms associated with menopause: a phase 3 RCT. J Clin Endocrinol Metab. (Epub) 02-03-2023. 6. Data on file. SKYLIGHT 2 study protocol. 7. Data on file. Clinical efficacy summary.

This Q&A is published by Ensemble IQ, 2300 Yonge, Suite 2900, Toronto, ON M4P 1E4, 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. © 2025

MAT-CA-VEO-2025-00093

What is the safety profile of VEOZAH?

PRACTICE EXPERTS / PRACTICAL DIABETES

Jet injectors provide a needle-free alternative to use of pens or syringes and are associated with reduced pain, making them ideal for those with needle phobia. making them ideal for those with needle phobia.3,6 In one study, 95% of jet-treated patients did not experience anxiety with device use and 93.8% successfully completed the trial with the jet injector.2

RHONDA ROEDLER BScPharm, ACPR, PharmD, CDE

P

atients who do not have the option of managing diabetes with oral hypoglycemics need to rely on exogenous insulin for glycemic control.

Since the development of insulin over 100 years ago, many changes have been made to formulations and administration for patient convenience and better management of diabetes.1 The use of insulin pens and syringes involves skin penetration and has been known to invoke pain and patient anxiety, leading patients to reduce or avoid treatment with insulin altogether.1-3 In addition, patients have been known to reuse needles to reduce cost, which may increase the amount of pain on

injection or the chance of infection at the injection site. This practice can also increase the chance of blood regurgitation into the insulin cartridge, leading to contamination.2 In an attempt to overcome the anxiety of injection, patients may ignore injection site rotation, which may lead to subcutaneous fat hypertrophy and poorer glycemic control.1 Needleless injection system now available in Canada InsuJet, a needleless system that uses a high-pressure stream of liquid instead of a needle to deliver insulin, is now approved by Health Canada and has been marketed as of November 2024.4 InsuJet has been reported to deliver insulin into the subcutaneous adipose tissue with over 90% efficiency.2,5,6 Jet injectors provide a needle-free alternative to use of pens or syringes and are associated with reduced pain,

24 PHARMACY PRACTICE + BUSINESS June/July 2025 [Vol.12 No.4]

What are the benefits?

By improving and accelerating the absorption of bolus insulin from the subcutaneous tissue into the blood, the peak insulin level is achieved within a shorter period of time and the effect of the bolus insulin is similar to that of endogenous insulin.1-3 Treatment with InsuJet showed significant decreases in glucose levels at 30 minutes, one and two hours after administration in comparison to insulin pen use.2,5 As well, it has been noted that administration of insulin by the needleless injection system reduces both time until peak insulin plasma levels and the time to maximal glucose lowering effect by approximately 50% compared to insulin pens/syringes.3 This helps to

Shutterstock/Lightspring

Insulin delivery using a needleless injection system? Inconceivable!

How does the system work?

The InsuJet system is composed of three key constituents: an injection chamber for the medication, a nozzle and a pressure source that produces a high velocity jet stream of liquid.6 By pushing liquid under high pressure through a tiny orifice in the front of a nozzle, placed on the surface of the skin, InsuJet has the ability to deliver insulin at a velocity of more than 100 m/s through the skin and into subcutaneous tissue.1,2,6,7 In doing this, the insulin is distributed over a larger area in comparison to syringes or pens. The diffusion pattern in the subcutaneous tissue helps to enhance the absorption of insulin into the blood circulation; it also helps to achieve a more direct blood glucose lowering effect.1,7

Which patients will benefit from InsuJet? The InsuJet system is suitable for patients with type 1 or type 2 diabetes and can be used to administer any type of insulin, including rapid-acting insulin analogs, regular or NPH insulin, long-acting insulins (glargine, detemir, degludec) and premixtures (e.g., 30/70).8 It is safer than conventional insulin therapy due to the absence of needles and the faster uptake of insulin compared to using pens or syringes. It is suitable for adults and children six years or older of any size or gender. InsuJet can be used in patients with any skin thickness, as there is no correlation between skin thickness and the time for insulin to reach its peak action.

The cost to the patient will be approximately $1 per day (excluding the cost of the insulin). The system can be used for up to 5,000 injections and can deliver between 4 and 50 units of insulin per dose. A separate device is needed for each type of insulin. InsuJet is easy to use by installing the nozzle, charging the device, withdrawing insulin from the vial, cartridge or pen, adding a comfort ring and injecting.

Adapters are available to connect the nozzle to the insulin container; they are customizable to each product format of insulin (vials or cartridges).8 Final thoughts InsuJet shows promise for increasing adherence in patients using insulin, especially those that have needle phobia or experience pain upon injection. In addition, healthcare providers are at no risk for needle stick incidents and the environment benefits as InsuJet use will lead to fewer single-use needles that need to be processed as sharps waste.9 Some patients may feel the cost of the device is a barrier and some may think the device is larger than desired.2

Rhonda Roedler is a pharmacist in Calgary, AB. She maintains an ambulatory clinical practice in diabetes.

REFERENCES 1. Pan Q, Zhang L, Gu A, et al. The absorption of needle-free insulin aspart through jet injector in different body parts of healthy individuals.

Front Endocrinol 2022;13:832726.

2. Guo Lixin, Xiao Xinhua, Sun X, et al. Comparison of a jet injector and insulin pen in controlling plasma glucose insulin concentrations in type 2 diabetic patients. Medicine 2017;96:1(e5482).

3. Engwerda EEC, Tack CJ, Galan BE. Needle-free jet injection of rapid-acting insulin improves early postprandial glucose control in patients with diabetes. Diabetes Care 2013;36:3436-41.

4. Health Canada. Medical devices active licences search. InsuJet. https://health-products.canada.ca/ mdall-limh/information?deviceId=1069060&device Name=INSUJET%20INJECTOR%20 V5&licenceId=109429&type=active&lang=eng (accessed March 31, 2025).

5. McHugh AD, Chase JG, Knopp JL, et al.

Determining losses in jet injection subcutaneous insulin delivery: a model based approach. J Diabetes Sci Technol 2023;17(4):1016-28.

6. de Wit HM, Engwerda EEC, Tack CJ, et al. Insulin administered by needle-free injection corrects marked hyperglycemia faster in overweight or obese patients with diabetes. Diabetes Obes Metab 2015;17:1093-9.

7. Han HS, Hong JY, Kwon TR, et al. Mechanism and clinical applications of needle-free injectors in dermatology: literature review. J Cosmet Dermatol 2021;20:3793-801.

8. Sol-Millennium. InsuJet product information. www. solm.com/insujet (accessed February 28, 2025).

9. Schoppink J, Fernandez Rivas D. Jet injectors: perspectives for small volume delivery with lasers. Adv Drug Deliv Rev 2022;182:114109.

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correct postprandial hyperglycemia, leading to the prevention of serious medical complications including diabetic ketoacidosis and hyperosmolar hyperglycemic state. For those patients on larger doses of insulin, the dose is more readily dispersed into the subcutaneous tissues reducing the need for the patient to repeat the injection, leading to a lower chance of late hypoglycemia.3,7

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Evidence to Action: Managing Obesity in Pharmacy Practice

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PATIENT-CENTRED CARE

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2. Apply current guidelines to manage patients with T2D and comorbid CVD or CKD.

3. Implement practical, patient-centered strategies for holistic care to people with T2D with either CVD or CKD. 4. Optimize pharmacotherapy to improve outcomes in people with type 2 diabetes and CVD or CKD. Supported by an unrestricted educational grant from Novo Nordisk Canada

[Vol.12 No.4] June/July 2025 PHARMACY PRACTICE + BUSINESS 25

5 Tips

PEARLS YOU CAN USE IN YOUR PRACTICE NOW

Improving outcomes in patients with COPD

By Jamie Falk, BScPharm, PharmD

T

1

Periodically assess inhaler technique and adherence Arguably the most recognized role pharmacists play with COPD patients is in helping patients optimize their medications by assessing inhaler technique and gauging adherence. Assessing technique is important not only for patients already using a specific device, but also prior to dispensing a prescription for the first time.

A survey of Canadian outpatient prescribers found that 52% prioritized their own experience when prescribing inhalers, with less attention to what might work best for patients, such as inspiratory flow rate, physical attributes (e.g.,

hand dexterity) or cognitive ability.2 With multiple device options available for most medication classes and combinations, helping to determine whether a particular device makes sense for your individual patient can minimize difficulties down the road. To support your assessments of the “what” and “how,” pharmacists can make use of easily accessible high-quality resources.3-5 While proper technique is essential, we also need to know if patients are actually using their inhalers. Adherence rates in COPD can be as low as 30%–50%.6,7 After determining if they’re using their inhaler(s), keep in mind there are often multiple factors impeding adherence. Community pharmacists tend to be the best equipped to help resolve the “if not, why not” issues, such as side effects, cost, lack of efficacy, or confusion with the device or regimen.

26 PHARMACY PRACTICE + BUSINESS June/July 2025 [Vol.12 No.4]

2

Ask questions to assess need and preference Before we assess adherence with an inhaler, we should first be asking if the inhaler is necessary. As management guru Peter Drucker said, “There is surely nothing quite so useless as doing with great efficiency what should not be done at all.”8 Rational medication decisions for chronic conditions like COPD should be made with the patient, considering potential benefits, harms and patient values. COPD guidelines tend to take the generally reasonable stepwise approach to management,9,10 but we need to recognize that just because a patient can

take a step, it doesn’t mean they should (or will want to).

Beyond the first step up to a long‐acting muscarinic antagonist (LAMA) or long‐ acting beta‐agonist (LABA), the gains of subsequent steps are incremental at best, sometimes with questionable benefit-to-burden balance.11 Although having all-in-one inhalers containing two or three medications allows for fewer inhalers, this still results in multiple ingredients with potential adverse events and greater costs, increasing patient burden.

In order to be on the same page as the patient, ask questions to determine if expectations are being met for symptom improvement, functionality and exacerbation reduction. It’s also important for pharmacists and patients to realize that COPD symptoms can fluctuate

Shutterstock/mi_viri

he trajectory of chronic obstructive pulmonary disease (COPD) tends, unfortunately, to be a downward one. For some patients this is a very gradual slope with minimal day-today symptoms, while for others the burdens of COPD are front and centre much of the time. Wherever a patient is on this trajectory, slowing the decline is a reasonable goal; however, for many patients their primary aim is to live more comfortably with less breathlessness and with as minimal burden as possible.1 The management of COPD, whether through multiple inhaler use, vaccinations or management of multiple comorbidities, places the community pharmacist at the forefront, opening up a variety of important avenues to enhance patient care and minimize burden. Aside from the obvious importance of helping patients with smoking cessation in those continuing to smoke, here are five tips to help ensure COPD patients are achieving the care and outcomes that are best for them.

seasonally, weekly or even daily in many patients,12,13 meaning that asking these questions is necessarily a repetitive process to establish a better overall picture.

Frequent encounters with chronic disease patients make community pharmacists well-placed to have these frequent mini-assessments that help you, your patient and the prescriber take the next steps, either up or down.

3

syncytial virus (RSV) vaccinations are all recommended for most patients with chronic lung conditions;16 however, the bulk of evidence for COPD patients resides with influenza and pneumococcal vaccinations, both resulting in a reduction in exacerbations.17-19 As part of immunization tracking processes in your pharmacy, flagging COPD patients in your system, especially those with more severe disease, is another way to further enhance comprehensive care for this at-risk group.

5

Keep pulmonary rehabilitation on your radar A large body of evidence supports the benefits of pulmonary rehabilitation for improvement in COPD symptoms, quality of life and exercise capacity, and reduction in exacerbations.14,15 If you’re able to be a direct referral source, that’s great, but even prompting your patient’s primary care provider can go a long way to jumpstart the referral process to local programs existing in many regions across the country.

Not all patients will have the time or desire to commit to a program, but being familiar with the programs in your area allows you to get the ball rolling by providing the necessary information to your interested patients, as well as collaborating with their primary care provider in the referral process.

4

Don’t forget about vaccinations

Considering the oftenunderwhelming benefits of COPD inhaler therapies (despite many ingredients and many devices), comprehensive care beyond inhalers including up-to-date vaccinations is important to help minimize the complications of COPD. Influenza, pneumococcal, COVID and respiratory

Recognize the bigger health picture Up to 50% of all hospitalizations and a quarter to a third of all deaths in patients with COPD are related to cardiovascular disease.20 It’s important to keep in mind the relatively large potential for cardiovascular event reduction that can be accomplished through rational blood pressure control and statin use when appropriate.

Although not directly affecting COPD symptoms, reduction of vascular events can minimize overall health burden and the detrimental effects on overall functioning in a patient with already compromised functional status. Recognizing this and the continual interplay between comorbid conditions in this complex patient population will allow for more nuanced and better prioritized medication decision making.

Summary Pharmacists have a significant opportunity to ensure that comprehensive care is provided for their patients with COPD. Frequent encounters for new inhalers and refills allow for continued points of contact for assessment of inhaler technique, adherence and indication. Be ready to advocate for escalation or deescalation of therapy, including not only inhaler decisions, but also through involvement in

Influenza, pneumococcal, COVID and respiratory syncytial virus (RSV) vaccinations are all recommended for most patients with chronic lung conditions.

the pulmonary rehabilitation process. In addition, ensuring appropriate immunizations and recognizing the importance of multimorbidity in medication management decisions will go a long way to achieving the ultimate goal of patientinformed comprehensive care for the COPD patients in your practice.

Jamie Falk (Jamison.Falk@ umanitoba.ca) is an Associate Professor, Colllege of Pharmacy, Rady Faculty of Health Sciences, University of Manitoba.

REFERENCES 1. Cook NS, Criner GJ, Burgel P-R, et al. People living with moderate-to-severe COPD prefer improvement of daily symptoms over the improvement of exacerbations: a multicountry patient preference study.

ERJ Open Res 2022;8:00686-2021.

2. Frank IR, Falk J, Korownyk C, et al. How patient-centred are inhaler device choices? A survey of Canadian prescribers. Can J Hosp Pharm 2024;77(2):e3507.

3. Cascades. A clinical guide to inhalers in Canada. https:// www.inhalerguide.ca/ (accessed December 4, 2024) 4. RxFiles. How to pick an inhaler. Updated September, 2024. Available at www.rxfiles.ca (accessed December 4, 2024).

5. RxFiles. Asthma & COPD: Inhalation devices chart. Updated November, 2023 http://www.rxfiles.ca/asthma (accessed December 4, 2024).

6. Turégano-Yedro M, Trillo-Calvo E, Navarro I Ros F, et al. Inhaler adherence in COPD: a crucial step towards the correct treatment.

Int J Chron Obstruct Pulmon Dis 2023;18:2887-93.

7. López-Campos LJ, Quintana Gallego E, Carrasco Hernández L. Status of and strategies for improving adherence to COPD treatment. Int J Chron Obstruct Pulmon Dis 2019;14:1503-15.

8. Drucker PF. Managing for business effectiveness. Harv Bus Rev 1963;41(3):53-60.

9. Bourbeau J, Bhutani M, Hernandez P, et al. 2023 Canadian Thoracic Society guideline on pharmacotherapy in patients with stable COPD. Am J Respir Crit Care Med 2023;7(4):173-91.

10. Global Initiative for Chronic Obstructive Lung Disease.

2024 Gold report. https:// goldcopd.org/2024-gold-report/ (accessed December 4, 2024).

11. BC Provincial Academic Detailing (PAD) Service. COPD: triple therapy and device choice. https://www2.gov. bc.ca/gov/content/health/practitionerprofessional-resources/pad-service/ copd-triple-therapy-and-devicechoice (accessed December 4, 2024).

12. Jenkins CR, Celli B, Anderson JA, et al. Seasonality and determinants of moderate and severe COPD exacerbations in the TORCH study.

Eur Respir J 2012;39:38-45.

13. Kessler R, Partridge MR, Miravitlles M, et al. Symptom variability in patients with severe COPD: a pan-European cross-sectional study.

Eur Respir J 2011;37:264-72.

14. McCarthy B, Casey D, Devane D, et al. Pulmonary rehabilitation for chronic obstructive pulmonary disease. Cochrane Database Syst Rev 2015(2):CD003793.

15. Puhan MA, Gimeno-Santos E, Cates CJ, et al. Pulmonary rehabilitation following exacerbations of chronic obstructive pulmonary disease. Cochrane Database Syst Rev 2016(12):CD005305.

16. Government of Canada.

Immunization of persons with chronic diseases: Canadian Immunization Guide. Updated November 12, 2024. https:// www.canada.ca/en/public-health/ services/publications/healthy-living/ canadian-immunization-guide-part3-vaccination-specific-populations/ page-7-immunization-persons-withchronic-diseases.html#p3c6a2.10 (accessed December 4, 2024).

17. Kopsaftis Z, Wood-Baker R, Poole P. Influenza vaccine for chronic obstructive pulmonary disease (COPD). Cochrane Database Syst Rev 2018(6): CD002733.

18. Bao W, Li Y, Wang t, et al. Effects of influenza vaccination on clinical outcomes of chronic obstructive pulmonary disease: a systematic review and meta-analysis. Age Res Rev 2021;68:101337.

19. Walters JAE, Tang JNQ, Poole P, et al. Pneumococcal vaccines for preventing pneumonia in chronic obstructive pulmonary disease. Cochrane Database Syst Rev 2017(1): CD001390.

20. Morgan AD, Zakeri R, Quint JK. Defining the relationship between COPD and CVD: what are the implications for clinical practice?

Ther Adv Respir Dis 2018;12:1-16.

[Vol.12 No.4] June/July 2025 PHARMACY PRACTICE + BUSINESS 27

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CLINICAL FEATURE

Heart failure: Optimizing therapy in community practice

Shutterstock/Rawpixel.com

By Emily Cowley, PharmD, ACPR

Nearly one million Canadians live with heart failure (HF) and often multiple chronic conditions.1 A disparity exists, as indigenous people are disproportionately impacted by heart failure.1 HF remains a frequent reason for hospital admission, despite the advances in pharmacologic and device therapy. Of those admitted, approximately one in five will return to hospital within 30 days of their last visit.1,2 By 2030, it is estimated that national healthcare costs related to heart failure will surpass $2 billion per year.1 Many patients do not achieve maximally tolerated guideline-directed medical therapy.3 This provides a unique opportunity for frontline pharmacists to identify, engage and aid in the management of HF. [Vol.12 No.4] June/July 2025 PHARMACY PRACTICE + BUSINESS 29

PHARMACOLOGIC TREATMENT HFrEF Quadruple therapy is currently the recommended pharmacologic treatment for patients with HFrEF. This drug regimen consists of an angiotensin-converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB) or angiotensin receptor-neprilysin inhibitor (ARNI, i.e., sacubitril-valsartan); a beta-blocker; a mineralocorticoid receptor antagonist (MRA), and a sodiumglucose cotransporter-2 (SGLT2) inhibitor.5 This treatment strategy, commonly known as guideline-directed medical therapy (GDMT), is strongly advocated in the Canadian Cardiovascular Society (CCS) HF guidelines.5 In addition to these four standard therapies, other medications such as ivabradine, vericiguat and digoxin may be prescribed based on specific patient factors. For example, ivabradine can be prescribed in addition to a betablocker, for patients with persistently elevated heart rates (i.e., greater than 70 beats per minute).5 The goal of this therapy is to achieve either the maximally tolerated dose or the targeted doses defined in the clinical trials (Table 3). HFrEF “sequencing” refers to the order of initiation of these medications. If no contraindications or barriers exist, all four classes of foundational therapies at low doses can be initiated simultaneously or in rapid sequence of one another (e.g., standard-dose SGLT2 inhibitor and low-dose beta-blocker initiated, followed by low-dose ACEI/ARB and MRA in 1–2 weeks) and titrated to maximally tolerated doses. Historically, the conventional approach involved the initiation of one drug class (e.g., ACEI) followed by up-titrating to target doses before starting a second drug class (e.g., beta-blocker). This older strategy would require more than six months to achieve appropriate therapy and does not capitalize on the early derived morbidity and mortality benefit from each drug independent of the other. While no one strategy of sequential or rapid-sequence initiation is superior, the order of initiation and titration should remain patient-specific with a goal of reaching maximally targeted doses for each class of medications within three to six months from diagnosis.5 Notably, the STRONG-HF trial demonstrated that even patients admitted to hospital with acute HF can successfully achieve up-titration of all four therapies within 90 days with appropriate follow-up.7 HFpEF and HFmEF HFpEF remains difficult to treat given the limited benefit of GDMT. It often involves treatment of the underlying disease process (i.e., managing hypertension, obesity and type 2 30 PHARMACY PRACTICE + BUSINESS June/July 2025 [Vol.12 No.4]

TABLE 1

Heart Failure Signs and Symptoms5 Signs and Symptoms Fatigue

Breathlessness

Peripheral edema (leg or ankle swelling)

Orthopnea (shortness of breath when lying down) Paroxysmal nocturnal dyspnea (shortness of breath during sleep) TABLE 2

New York Heart Association (NYHA) HF Classification6 NYHA Class

Definition

II

Slight limitation of physical activity but comfortable at rest. Ordinary activity causes symptoms.

I

No symptoms of heart failure (HF).

III

Marked limitation of physical activity, but comfortable at rest. Less than ordinary activity cause symptoms.

IV

Symptoms at rest.

FIGURE 1

Evidence for GDMT across the EF spectrum

Class of Medication

DIAGNOSIS AND HF CLASSIFICATIONS Heart failure is a chronic, progressive clinical syndrome that is diagnosed based on signs, symptoms and imaging. Guidelines have adopted ejection fraction terminology to aid in the classification of HF: HF with reduced ejection fraction (HFrEF) = left ventricular ejection fraction (LVEF) < 40%; HF with preserved ejection fraction (HFpEF) = LVEF > 50%; and HF with mid-range ejection fraction (HFmEF) = LVEF 41%–49%.4,5 The prevalence of HF categorized by ejection fraction varies; however, the majority of patients have either HFrEF or HFpEF.2 Common causes of HF include valvular disease, coronary artery disease, tachyarrhythmias and genetic causes.4 Table 1 includes signs and symptoms of HF,5 while Table 2 outlines the New York Heart Association (NYHA) functional classification of HF.6

Ivabradine SGLT2i MRA Beta blocker

ACEi, ARB or ARNi < 40% = finerenone

41-49%

LVEF %

>50%

= spironolactone ACEi–angiotensin-converting enzyme inhibitor; ARB–angiotensin receptor blocker; ARNi– angiotensin receptor-neprilysin inhibitor; EF–ejection fraction; GDMT–guideline-directed medical therapy; LVEF–left ventricular ejection fraction; MRA–mineralocorticoid receptor antagonist; SGLT2i–sodium-glucose cotransporter-2 inhibitor

diabetes).8 Diuretic therapy is also common to alleviate symptoms from volume overload.4 The benefits of medical therapy vary across the spectrum of ejection fraction as displayed in Figure 1.

Two classes of medications have recently demonstrated a cardiovascular benefit in the HFpEF population, regardless of the patient’s diabetes status:9-12 1. SGLT2 inhibitors: canagliflozin, dapagliflozin, empagliflozin 2. Nonsteroidal MRA: finerenone.

The landmark trials, CANVAS (canagliflozin), DELIVER (dapagliflozin) and EMPEROR-Preserved (empagliflozin), each found a reduction in the risk of hospitalization and cardiovascular death with the SGLT2 inhibitor.9-11 While this benefit was primarily driven by a reduction in total HF

TABLE 3

Guideline-directed Medical Therapy Targeted Dosing for HFrEF4,5 Medication

Initial Dosing

Target Dosing

Candesartan

4–8 mg once daily

32 mg once daily

Enalapril

1.25–2.5 mg bid

10–20 mg bid

ARBs and ACEIs Valsartan

Perindopril Ramipril

Lisinopril ARNI

40 mg bid

2–4 mg once daily 1.25–2.5 mg bid

2.5–5 mg once daily

160 mg bid

4–8 mg once daily 5 mg bid

20–35 mg once daily

Sacubitril-valsartan

50–100 mg bid

200 mg bid

Bisoprolol

1.25 mg once daily

10 mg once daily

Metoprolol tartrate

12.5–25 mg bid

100 mg bid

Beta-blocker Carvedilol MRA

Spironolactone

3.125 mg bid

25–50 mg bid

12.5 mg once daily

25–50mg once daily

Dapagliflozin

10 mg once daily

10 mg once daily

Canagliflozin

100 mg once daily

100–300 mg once daily

Eplerenone

SGLT2 inhibitor Empagliflozin Sinus node inhibitor

25 mg once daily

10 mg once daily

50 mg once daily

10–25 mg once daily

Ivabradine

2.5–5 mg bid

7.5 mg bid

Vericiguat

2.5 mg once daily

10 mg once daily

sGC stimulator

Primary interventions and roles of community pharmacists for patients with HF include medication management, education and immunizations.

ACEI–angiotensin-converting enzyme inhibitor; ARB–angiotensin receptor blocker; ARNI–angiotensin receptor-neprilysin inhibitor; HFrEF–heart failure with reduced ejection fraction; MRA–mineralocorticoid receptor antagonist; sGC–soluble guanylate cyclase stimulator; SGLT2–sodium-glucose cotransporter-2

hospitalizations, SGLT2 inhibitors are considered a treatment option for HFpEF in international societal guidelines for HF.13,14 Similarly, the efficacy of the nonsteroidal MRA, finerenone, was established in HF with EF > 40% in the FINEARTS-HF trial.12-14 Dosing up to 40 mg daily was based on tolerability, renal function and potassium levels. The steroidal MRAs (spironolactone and eplerenone) have not provided a statistically significant benefit in HFpEF; the benefits of finerenone, however, could be related, in part, to higher receptor affinity and cardiac tissue distribution and improved side effect profile.12 Ongoing randomized controlled trials are currently underway with finerenone in HFrEF and initiation during hospitalization (REDEFINE-HF; NCT06008197, CONFIRMATION-HF NCT06024746, FINALITY-HF; NCT06033950).15 PHARMACIST’S ROLE Numerous articles have established the role of pharmacists in managing HF within the ambulatory setting.16 Given the prevalence of heart failure, community pharmacists will surely encounter patients with this complex progressive condition.

Primary interventions and roles of community pharmacists for patients with HF include medication management, education and immunizations.

1. Medication management Optimal medication use and dosing can be challenging in the ambulatory setting. Dose adjustments, monitoring and followup are ideally conducted by specialized outpatient HF clinics across Canada with dedicated HF pharmacists and general cardiologists. Adding the primary contact for HF management (i.e., HF clinic or specific cardiologist) to the pharmacy patient profile can promote ongoing collaboration and communication with the HF team and the community pharmacy. During refills or scheduled medication reviews, community pharmacists should be aware of the four foundational drug classes and the appropriate target doses of each drug class (Table 3).

As HF patients are at high risk of hospitalization, medication reconciliation is crucial for the pharmacy staff to reconcile each patient’s HF regimen prior to and upon discharge. During a HF admission, opportunities for in-hospital initiation of GDMT is now becoming a priority.17 For example, if a patient is switched to sacubitril–valsartan in-hospital, the pharmacist can ensure the patient stops taking their ACEI or ARB. If patients experience adverse reactions or inability to tolerate higher doses, pharmacists can maintain records of these issues. For example, spironolactone can cause gynecomastia in male patients; rather than avoiding the entire class of MRAs, the pharmacist could recommend considering a trial of eplerenone.

2. Patient education Pharmacists can solidify a patient’s understanding of their medications, including specific indication (e.g., for HF). In addition to general HF medication education, community pharmacists should tailor their assessments to include symptom monitoring, routine blood pressure and weight checks, and an understanding of the patient’s baseline functional status. This conversation is ideally initiated with each patient encounter.

Screening tools like The One Minute Clinic for Heart Failure (TOM-C HF) were developed for community pharmacists to identify high-risk HF patients.18 Pharmacists can provide resources or refer patients to the HeartLife Foundation, a patientled HF organization and the Heart Failure Medications: A Patient & Caregiver Guide, a publication supported by the CCS.19,20 Given the chronicity of HF and frequency of hospitalizations, pharmacists can help prevent hospitalizations or worsening HF by providing information on: a) Sick day management During periods of acute illness, complications such as hypotension and acute kidney injury can arise if certain medications are not adjusted or withheld. Community [Vol.12 No.4] June/July 2025 PHARMACY PRACTICE + BUSINESS 31

pharmacists are well-positioned to define parameters and triage to determine the most appropriate clinical action (i.e., referral to family doctor or seek emergency medical attention).21 Pharmacists can utilize tools like the RxFiles ‘Sick Day Management’ templates to personalize and educate patients regarding when to withhold or adjust medications.22 b) Drugs that can worsen heart failure Patients with HF have medication regimens of high complexity, often with up to seven medications prescribed for HFrEF alone; this increases pill burden, risk of drug–drug interactions and adverse reactions.4,23 Pharmacists should engage with their HF patients during each encounter to ensure their prescribed medications, over-the-counter products and natural health products are safe, have minimal direct myocardial toxicity and do not oppose their GDMT.24 For example, post-marketing data have identified that rosiglitazone and saxagliptin, both used in type 2 diabetes, are associated with increased risk of HF events.24 Community pharmacists can identify safer alternatives including the initiation of an SGLT2 inhibitor, which is a foundational therapy for HF across the spectrum of ejection fraction. The American Heart Association has a helpful guide to assist pharmacists with their management of HF.24 3. Medication access Despite evidence-based rationale for GDMT, government authorization for drug coverage can be delayed or may include restrictive eligibility criteria. Barriers also exist with the implementation of GDMT by prescribers due to clinical

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By Sherilyn Houle, BSP, PhD, CTH, AFTM RCPS(Glasg)

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32 PHARMACY PRACTICE + BUSINESS June/July 2025 [Vol.12 No.4]

TABLE 4

Recommended Vaccines in Patients With HF27 Vaccine*

Influenza Pneumococcal (Pneu-C-20 or Pneu-C-21)

COVID-19

RSV (RSVPreF3, RSVpreF or mRNA-1345)

Recommendation

Yearly immunization recommended for all HF patients

Recommended for adults > 50 years with HF to reduce risk of hospitalization. Refer to the Canadian Immunization Guide for timing of Pneu-C-20 in patients previously immunized with Pneu-P-23 or Pneu-C-13.

Recommended for all HF patients

Recommended for all > 75 years old; all ≥ 60 years living in a nursing home/ chronic care facility; those 50–74 with HF may also be considered.**

*Pharmacists should consult the “Canadian Immunization Guide” for the most current recommendations and for additional information regarding each vaccine.27 **Adults 60–74 years of age can receive a single dose of RSVpreF, RSVPreF3 or mRNA-1345. Only RSVPreF3 is authorized for use in adults 50–59 years of age. mRNA-135 – respiratory syncytial virus mRNA vaccine; Pneu-C-13–13-valent pneumococcal conjugate vaccine; Pneu-C-20–20-valent pneumococcal conjugate vaccine; Pneu-P-23–23-valent pneumococcal polysaccharide vaccine; RSV– respiratory syncytial virus; RSVpreF–respiratory syncytial virus prefusion F subunit; RSVPreF3–respiratory syncytial virus prefusion F3 subunit

inertia, unfamiliarity with GDMT and funding/reimbursement issues.25 Medications are costly to patients and can result in significant barriers to accessing appropriate therapy. The CCS has published formulary listings of HF medication coverage across the country.26 Community pharmacists should familiarize themselves with medication coverage in their province or territory, to aid in facilitation of therapy.

4. Immunizations Individuals with chronic heart conditions such as HF are at a higher risk of viral and bacterial-related complications.27,28 They are more likely to require hospitalization and develop cardiac decompensation. Routine vaccinations are recommended for patients with chronic cardiac conditions; pneumococcal, respiratory syncytial virus (RSV), annual influenza, and COVID-19 vaccinations are strongly encouraged by Canada’s National Advisory Committee on Immunization as detailed in the Canadian Immunization Guide and Table 4.27 Pharmacistdelivered immunizations have improved vaccination rates and enhanced accessibility to vaccines. Vaccinations are not a contraindication for patients on anticoagulants and/ or antiplatelets. Our profession has established its role as immunizers and we should continue to advocate and educate to reduce communicable and vaccine-preventable diseases.29 SUMMARY The prevalence of HF and the complexity of drug regimens continues to increase. In addition to clinical signs and symptoms, the patient’s ejection fraction further classifies patients as either HFrEF, HFmEF or HFpEF.4,5 Currently, quadruple therapy consisting of an ACEI, ARB or ARNI, a beta-blocker, an MRA and a SGLT2 inhibitor is the preferred strategy for patients with HFrEF.5 Recently, SGLT2 inhibitors and a nonsteroidal MRA, finerenone, have demonstrated proven benefit in the HFmEF and HFpEF populations and will transform the treatment strategies for these patients.13,14 As pharmacologic management is at the centre of HF, community pharmacists are an important multidisciplinary team member in the management and care of these patients.

Emily Cowley (Emily.cowley@albertahealthservices.ca) is a clinical pharmacist in the cardiovascular intensive care unit at the Mazankowski Alberta Heart Institute in Edmonton, AB. In her practice, she cares for patients with acute heart failure and those requiring mechanical circulatory support.

REFERENCES 1. Heart and Stroke Foundation. Falling short: how Canada is failing people with heart failure – and how we can change that. https://www.heartandstroke.ca/-/ media/pdf-files/canada/2022-heart-month/hs-heart-failure-report-2022-final.pdf (accessed January 7, 2025).

2. Poon S, Leis B, Lambert L, et al. The state of heart failure care in Canada: minimal improvement in readmissions over time despite an increased number of evidencebased therapies. CJC Open 2022;4(8):667-75.

3. Greene SJ, Gonarow GC, DeVore AD. Titration of medical therapy for heart failure with reduced ejection fraction. J Am Coll Cardiol 2019;73(19):2365-83.

4. Ezekowitz JA, O’Meara E, McDonald MA, et al. 2017 Comprehensive update of the Canadian Cardiovascular Society guidelines for the management of heart failure. Can J Cardiol 2017;33(11):1342-433.

5. McDonald M, Virani S, Chan M, et al. CCS/CHFS heart failure guidelines update: defining a new pharmacologic standard of care for heart failure with reduced ejection fraction. Can J Cardiol 2021;37(4):531-46.

6. Dolgin M, Association NYH, Fox AC, et al; New York Heart Association. Criteria Committee. Nomenclature and criteria for diagnosis of diseases of the heart and great vessels. 9th ed. Boston, MA: Lippincott Williams and Wilkins; March 1, 1994.

7. Mebazaa A, Davison B, Chioncel O, et al. Safety, tolerability and efficacy of uptitration of guideline-directed medical therapies for acute heart failure (STRONGHF): a multinational, open-label, randomised, trial. Lancet 2022;400:1938-52.

8. MacDonald B, Virani SA, Zieroth S, et al. Heart failure management in 2023: a pharmacotherapy- and lifestyle-focused comparison of current international guidelines. CJC Open 2023;5(8):629-40.

9. Figtree GA, Radholm K, Barrett TD, et al. Effects of canagliflozin on heart failure outcomes associated with preserved and reduced ejection fraction in type 2 diabetes mellitus. Circulation 2019;139(22):2591-3.

10. Solomon SD, McMurray JJV, Claggett B, et al. Dapagliflozin in heart failure with mildly reduced or preserved ejection fraction. N Engl J Med 2022;387(12):1089-98.

11. Anker SD, Butler J, Filippatos G, et al. Empagliflozin in heart failure with a preserved ejection fraction. N Engl J Med 2021;385(16):1451-61.

12. Solomon SD, McMurray JJV, Vaduganathan M, et al. Finerenone in heart failure with mildly reduced or preserved ejection fraction. N Engl J Med 2024;391(16):1475-85.

13. Heidenreich PA, Bozkurt B, Aguilar D, et al. 2022 AHA/ACC/HFSA guideline for the management of heart failure: a report of the American College of Cardiology/ American Heart Association Joint Committee on Clinical Practice Guidelines.

Circulation 2022;145(18):e895-1032.

14. McDonagh TA, Metra M, Adamo M, et al. 2023 Focused update of the 2021 ESC guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J 2023;44(37):3627-39.

15. Bayer US Medical Affairs. Clinical trials & pipeline. https://cardiorenal. medicalaffairs.bayer.com/clinical-trials-pipeline (accessed January 7, 2025).

16. Cao VFS, Cowley E, Koshman SL, et al. Pharmacist-led optimization of heart failure medications: a systematic review. J Am Coll Clin Pharm 2021;4(7):862-70.

17. Greene SJ, Butler J, Albert NM, et al. Medical therapy for heart failure with reduced ejection fraction: the CHAMP-HF Registry. J Am Coll Cardiol 2018;72(4):351-66.

18. Bleske BE, O Dillman N, Cornelius D, et al. Heart failure assessment at the community pharmacy level: a feasibility pilot study. J Am Pharm Assoc 2014;54(6):634-41.

19. HeartLife Foundation. https://heartlife.ca/ (accessed January 7, 2025).

20. The Heart Hub. Heart failure medications: a patient & caregiver guide. https:// ourhearthub.ca/heart-failure-medications-guide/ (accessed January 7, 2025).

21. Watson KE, Dhaliwal K, Robertshaw S, et al. Consensus recommendations for sick day medication guidance for people with diabetes, kidney, or cardiovascular disease: a modified Delphi process. Am J Kidney Dis 2023;81(5):564-74.

22. RxFiles. What to do with heart failure medications if I’m sick. https://www.rxfiles. ca/rxfiles/uploads/documents/Heart-Failure-Sick-Days.pdf (accessed January 7, 2025).

23. Kwak MJ, Cheng MA, Goyal P, et al. Medication complexity among older adults with heart failure – how can we assess better? Drugs Aging 2022;39(11):851-61.

24. Page II RL, O’Bryant CL, Cheng D, et al. Drugs that may cause or exacerbate heart failure: a scientific statement from the American Heart Association.

Circulation 2016;134(6):e32-69.

25. Swat SA, Helmkamp LJ, Tietbohl C, et al. Clinical inertia among outpatients with heart failure: application of treatment nonintensification taxonomy to EPIC-HF trial.

J Am Coll Cardiol 2023;11(11):1579-91.

26. Canadian Cardiovascular Society. Formulary listings for heart failure medication coverage in Canada. https://ccs.ca/app/uploads/2022/06/CCS-HF-formulary_ May2022.pdf (accessed January 7, 2025).

27. Government of Canada. Immunization of persons with chronic diseases: Canadian Immunization Guide. https://www.canada.ca/en/public-health/services/ publications/healthy-living/canadian-immunization-guide-part-3-vaccinationspecific-populations/page-7-immunization-persons-with-chronic-diseases.html (accessed January 7, 2025).

28. Bhatt AS, DeVore AD, Hernandez AF, et al. Can vaccinations improve heart failure outcomes? Contemporary data and future directions. JACC Heart Fail 2017;5(3):194-203.

29. Isenor JE, Bowles SK. Evidence for pharmacist vaccination. Can Pharm J 2018;151(5):301-4.

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[Vol.12 No.4] June/July 2025 PHARMACY PRACTICE + BUSINESS 33

Athena Dhirani, pharmacist/owner, Trinity Bellwoods Pharmacy

COVER STORY / INNOVATOR PROFILE

The pharmacist can see you now

By Rosalind Stefanac / Photography by Mike Ford

W

alking into Trinity Bellwoods Pharmacy in downtown Toronto you can’t help but be drawn to the pharmacist-led walk-in clinic, the first in Ontario for the Guardian banner. Designed by pharmacist/owner Athena Dhirani, the space is as beautiful as it is functional with a marble-topped check-in counter situated under an eye-catching, lighted wooden arch. “With our large windows and all the natural light “ We have coming in, this section patients actually brings people saying this in to see what we’re all is so easy about,” she says.

Even as a first-time and fast, pharmacy owner and and they manager, Dhirani knew don’t have exactly what she wanted to wait for to achieve in taking over the 2,000-square-foot a doctor.” space in 2024, namely a non-sterile environment where patients would feel “relaxed, cared for and ultimately empowered.” To that end, the pharmacy features natural colours, lots of greenery, books and a heavy focus on clinical services and health and wellness products.

Since launching the walk-in clinic last November, Dhirani says the feedback from the community has been positive. With no appointments needed, patients appreciate being able to consult with a

pharmacist in a private room when dealing with their health concerns. If their conditions are beyond the scope of the pharmacist, the pharmacy has a collaboration with GoToDoctor (gotodoctor.ca) to ensure these patients can be quickly connected with a doctor virtually to get the prescriptions they need. “Sometimes the doctor will ask me to take blood pressure and check temperatures, but then we’ll escort the patient to a private room with a Zoom camera set up where they can speak directly to the doctor,” says Dhirani, adding that she was inspired by the success of pharmacy clinic formats in Nova Scotia. “We have patients saying this is so easy and fast, and they don’t have to wait for a doctor.”

Getting the clinic off the ground was truly a team effort. “We worked hand in hand with the Pharmacy Services team at McKesson Canada led by Kiran Gandhi & Tahira Lallani,” says Dhirani, noting that she is also grateful to Tommy Cheung, leader of the Enhanced Care Group (which operates in-person and telemedicine health facilities across Ontario and Manitoba) for his guidance and support. “A big shout out to everyone at Dhirani Group of Pharmacies, too, as this was an indeed a big win for the entire family.”

(Athena’s father Akhil Dhirani operates a number of pharmacies under the Dhirani Group umbrella.)

So far, the pharmacy sees at least two clinic appointments daily and awareness is steadily growing. “Our goal is to have at least 10 clinic visits daily and with all our signage outside, I have new people coming in every [Vol.12 No.4] June/July 2025 PHARMACY PRACTICE + BUSINESS 35

Trinity Bellwoods Pharmacy team from left to right: Melissa Hubscher, RPh; Athena; Fatima Siddiqui, pharmacy assistant and Cristine Amaral, pharmacy assistant.

day to find out more about it,” says Dhirani who employs three pharmacy technicians and two additional part-time pharmacists.

The pharmacy offers all minor ailment prescribing services available in Ontario, as well as skin care consultations (acne is a popular one). Dhirani also hosts the occasional pop-up event, such as COVID-19 clinic days, as well as reiki sessions and Botox services. “We have a nice range of skincare products, including liquid IV and liquid collagen, which all have benefits for the skin—and I’ll often ask about skincare routines when providing consultations,” she says.

With a wide range of vitamin products, Dhirani eventually plans to add a vitamin drip section in keeping with the pharmacy’s wellness theme to shine a greater focus on the vital 36 PHARMACY PRACTICE + BUSINESS June/July 2025 [Vol.12 No.4]

role of vitamins in improving health. “I also develop dietary and exercise plans for my patients and will follow up in two months to ensure they are still on track.” Most pharmacist services are billed under patients’ provincial plan, plus they are charged a $20 injection administration fee where applicable.

Just over a year in, Dhirani says her biggest takeaway so far in running her own pharmacy has been to adapt to her surroundings. Given the strong Portuguese influence in the neighborhood, for example, she started putting up signs in English and Portuguese to make patients feel more comfortable. “I started learning Portuguese words myself and hired a fully Portuguesespeaking pharmacy technician who lives two minutes from the pharmacy and is immersed in the community,” she says.

Putting a jar of free cookies and granola bars on the counter every day for the homeless predominant in the area—and treating them with respect—has also helped to curb loitering and stealing. “They come in on a daily basis and I know their names and ask them how they’re doing,” she says.

Having grown up in a pharmacy family herself, Dhirani admits that being in a pharmacy every day feels like home. “I pretty much grew up in [the] pharmacy on weekends,” she says, noting that the

Patients appreciate being able to consult with Dhirani or another staff pharmacist in a private room.

Dhirani has created a space where patients would feel “relaxed, cared for and ultimately empowered.”

family now owns five pharmacies across the Greater Toronto Area.

“When I’ve gone back there to work sometimes, some patients still remember me as a baby.”

Yet rather than simply working with her father, Dhirani opted to expand her horizons by heading to the University of Kent in England at the age of 18 to pursue her pharmacy studies. “They actually had a dispensary on site and I was able to do hospital and community pharmacy placements while there,” she says.

“They were far more advanced in practice too at the time as pharmacists were already prescribing.”

When she returned to Canada in 2021, she worked at Village Square Pharmacy in Scarborough (her father’s first pharmacy) while studying for her Ontario qualifying exams. Two months after she got her license, the opportunity to purchase Trinity Bellwoods came up, and her family asked Dhalia if she was ready to take the lead. She agreed wholeheartedly: “I told them not only will I run the dispensary, but I’ll take over as store manager and business manager,” she says. “I also worked with the contractor to make it look exactly as I wanted it to.”

As it is the first time in her career where is she is managing staff, Dhalia says she is always working towards creating an

environment where people are content and thriving. Every Friday she orders in lunch for her staff and they spend a half hour eating together family style. “I think that really helps in team building and every few months staff from all five stores get together for different team-building activities,” she says, noting that pickleball is next on the agenda.

While still in the midst of getting her pharmacy off the ground, Dhirani is excited about what’s to come in growing her practice even further. “Maybe we’ll expand the clinic to have its own separate entrance,” she says. “I also hope our pharmacist scope expands even more so I can prescribe more and help my community.”

Rosalind Stefanac is a Toronto writer specializing in pharmacy and retail journalism.

[Vol.12 No.4] June/July 2025 PHARMACY PRACTICE + BUSINESS 37

The Closer

CREATIVE THOUGHTS AND SMART IDEAS FOR PHARMACY OWNERS AND MANAGERS

THE BUSINESS OF CARE

Disrupting the PPN: How smart pharmacies win “I’ve been with your pharmacy for years, but now my insurance says I have to go somewhere else.”

NIKI SHAH B.Pharm, CRE

PPNs may dictate where drugs go—but only you can decide where care lives.

A decade-long relationship can be erased by a single email from an insurer.

Capitalism at its best drives innovation, competition and efficiency. But in pharmacy? It’s beginning to drive exclusion, fragmentation and depersonalization.

Preferred provider networks (PPNs) are not just business contracts—they are gatekeepers of access, shaping where patients go, how they get care, and what role community pharmacies are allowed to play. It is a tool designed to optimize the insurer’s financials by negotiating lower costs, ensuring rebate capture and tightening control, not patient outcomes.

It also reveals a darker side of healthcare capitalism: one where care is commodified, relationships are severed, and patients become pawns in a corporate strategy.

The human cost: care without a caregiver For independent pharmacies, conversations like this with patients are becoming heartbreakingly common.

And while the decision may seem administrative, its impact runs deep—undermining patient trust, pharmacist-patient relationships, and continuity of care.

These networks turn pharmacy from a healthcare service into a logistics operation—with volume and efficiency prioritized over quality and connection.

We see it every day. Patients confused by insurer jargon. Seniors crying in front of the counter because they must leave the pharmacy that got them through chemotherapy or helped them manage their diabetes.

A 2022 Health Affairs study found that patients forced to switch pharmacies had a drop of up to 24% in medication adherence, with the largest impact seen in chronic conditions like diabetes, asthma and hypertension. Other hallmarks of the PPN system include disrupted care, marginalized pharmacists,

38 PHARMACY PRACTICE + BUSINESS June/July 2025 [Vol.12 No.4]

widened wealth inequity, false savings and increased patient safety risks.

We’ve arrived at the era of contract-first healthcare—where spreadsheets beat relationships.

But here’s the plot twist: you don’t need to be on the list to be at the top.

This isn’t about being cheaper. It’s about being irreplaceable. No PPN pharmacy can do what you do: text a worried patient at 9 p.m., spot the red flag before the doctor does. That’s care. That’s impact.

That’s power. And they don’t have it. Let the PPN fill the meds. You fill the gap.

Package what they can’t steal The prescription is just the hook. The real value is in the care around the script.

If you only sell pills, they can outbid you. But if you sell a relationship, they can’t touch you. You’re not the “pharmacy that fills.” You’re the brand that builds health. Every loss is a boomerang. Serve patients so well that they swing back when the system fails.

Stay relevant outside the network.

Train your team and flip the script—you’re not just a pharmacy, you’re a platform. PPNs treat patients like accounts. You treat them like VIPs. Empathy today can win loyalty tomorrow.

Make every conversation with a patient one they’ll remember when the PPN fails them. Their plan may choose the pharmacy, but patients choose who they trust. And trust isn’t contracted. It’s earned.

Loyalty can be deferred, but not deleted It’s an unavoidable fact that some of your patients may be rerouted today—but they’ll remember how you treated them through the transition to their new provider. Your compassion during this unfair switch could be the reason they come back.

And patients will come back. Not because you had the contract, but because you cared when it didn’t benefit you.

PPNs may dictate where drugs go, but only you can decide where care lives.

So be that pharmacy. Show up anyway. Patients will remember. And when they come back—you’ll be stronger than ever.

Niki Shah is a passionate and dedicated pharmacist with extensive experience as a pharmacy owner.

RSV is nothing to sneeze at

For people ≥60 years of age, those with chronic health conditions or weakened immune systems, RSV can take a serious, even fatal toll.1,2 In older adults hospitalized with RSV: • ~1 in 9 patients ≥65 years of age died within 30 days3* • ~1 in 7 patients ≥60 years of age demonstrated a loss of independence at discharge4†‡

Take action by starting the conversation today

Help avoid the unnecessary toll of RSV.

Scan to get the facts or visit knowthetoll.ca

RSV = respiratory syncytial virus. * All-cause mortality. Retrospective cohort study from Ontario, Canada. Hospitalization data collected from the 2010–11 to 2018–19 respiratory virus seasons. † 14% difference: 40% of patients lived independently pre-hospitalization (n=122/302) vs. 26% at discharge (n=79/302, p<0.01). ‡ 302 adults ≥60 years of age hospitalized with laboratory-confirmed RSV were enrolled. Living situation was assessed 2 weeks pre-hospitalization, at enrollment, and at hospital discharge.

1. Centers for Disease Control and Prevention. RSV in older adults fact sheet. Available at: https://www.cdc.gov/rsv/older-adults. Accessed March 2025. 2. Government of Canada. Respiratory syncytial virus (RSV): for health professionals. Available at: https://www.canada.ca/en/public-health/services/diseases/respiratory-syncytial-virus-rsv/ health-professionals.html. Accessed March 2025. 3. Hamilton MA, et al. Predictors of all-cause mortality among patients hospitalized with infl uenza, respiratory virus, or SARS-CoV-2. Infl uenza Other Respir Viruses 2022;16:1072–1081. 4. Branche AR, et al. Change in functional status associated with respiratory syncytial virus infection in hospitalized older adults. Infl uenza Other Respir Viruses 2022;16:1151–1160.

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