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VOL 16. NO 2 JULY 2019

July 2019

PHARMACY JOURNAL OF NEW ENGLAND

Pharmacists and pharmacy students kick off day two of CPA's Women in Pharmacy Summit with some yoga.

BE MINDFUL

PAGE 4 THE ART OF MINDFULNESS PAGE 9 CLINICAL PEARLS PAGE 17 PJNE HEADLINES


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Table of Contents From the Desk of New England................................................................PAGE 2 MPhA Pharmacist Spotlight......................................................................PAGE 3 Mindfulness...............................................................................................PAGE 4 Rx and the Law.........................................................................................PAGE 6 CT Legislative Update...............................................................................PAGE 7 Clinical Pearls and More…………………………........................................PAGE 9 CPA Photo Montage………………….....................…............…................PAGE 15 PJNE Headlines........................................................................................PAGE 17 Sneak Peek: 2019 NEPC..........................................................................PAGE 19 Save the Date in New England.................................................................PAGE 20

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Take a Breath — and Try Mindfulness in Your Practice Dear Readers, Happy Summer! As we enjoy these longer days of sunlight in New England, now is the time to start thinking about that summer vacation—or at least a long weekend. In the world of pharmacy, we understand that 12-hour shifts coupled with greater work demands can make time off challenging. But taking a break from the pharmacy for a little while is beneficial for your well-being, your job satisfaction and your work productivity. We often hear a common word that pharmacists seem to be experiencing these days: burnout. A new survey released by the American Society of Health-System Pharmacists (ASHP) revealed that one in four Americans said they believe hospital pharmacists (26%) and community pharmacists (25%) are often burnt out. As state associations committed to helping pharmacists of all practice settings advance in their careers, we take this data to heart. That’s why the feature story in this issue focuses on mindfulness—being in the present moment. Mindfulness is a simple tool you can use any time of the day whether you’re behind the pharmacy counter or at home—as you’ll learn from CPA President Lisa Bragaw in this feature article. This summer also is the opportune time to reflect on how you want to advance your role in the health care industry. Save the date for the following fall events that will help you reach your career goals while creating meaningful networking experiences: • September 12-13: 15th Annual New England Pharmacists Convention, presented by the Connecticut Pharmacists Association at the Hartford Marriott • November 14-15: Massachusetts Pharmacists Summit, presented by the Massachusetts Pharmacists Association at MGM Springfield/Mass Mutual Center Sincerely,

Lindsay De Santis Executive Vice President Massachusetts Pharmacists Association

Editors:

Lindsay De Santis, Nathan Tinker

Nathan Tinker, PhD CEO Connecticut Pharmacists Association

Creative Editor: Carla Eisenstein Design & Production: Kathy Harvey-Ellis

The Pharmacy Journal of New England is owned and published by the Massachusetts Pharmacists Association and the Connecticut Pharmacists Association. Opinions expressed by those of the editorial staff and/or contributors do not necessarily reflect the views or policies of the publisher.Readers are invited to submit their comments and opinions for publication. Letters should be addressed to the Editor and must be signed with a return address. For rates and deadlines, contact the Journal at (860) 563-4619. Pharmacy Journal of New England 35 Cold Spring Road, Suite 121 Rocky Hill, CT 06067-3167 members@ctpharmacists.org

Submitting Articles to the Pharmacy Journal of New England™

The Pharmacy Journal of New England™ is the product of a partnership between the Connecticut Pharmacists Association and the Massachusetts Pharmacists Association. The Journal is a quarterly publication. All submitted articles are subject to peer review. In order to maintain confidentiality, authors’ names are removed during the review process. Article requirements must conform to the Uniform Requirements for Manuscripts Submitted to Biomedical Journals (Ann Intern Med 1982;96 (1part1):766-71). We strongly encourage electronic submissions. PJNE does not assume any responsibility for statements made by authors.

Please submit manuscripts to: PJNE, 35 Cold Spring Rd., Suite 121, Rocky Hill, CT 06067 or email to: lcapobianco@ctpharmacists.org

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Pharmacy Journal of New England • July 2019

MPhA Pharmacist Spotlight: Anita Young, EdD, RPh MPhA is proud to share that longtime member and pharmacy educator Anita Young was named honorary president of the National Association of Boards of Pharmacy for 2019 in recognition of her dedication to the Association’s mission and goals. NABP named Dr. Young as its honorary president for her commitment to the boards of pharmacy, to protecting public health, and to her significant involvement with NABP.

Annual Spring conference. Her insight and support of the Association is invaluable. Dr. Young earned her Bachelor of Science degree in pharmacy from the Massachusetts College of Pharmacy; her Master of Education degree from the University of Massachusetts, Boston; and her Doctorate in Education from Northeastern University.

Dr. Young is devoted to increasing pharmacist engagement with community health and making health care more accessible. For over 50 years, Dr. Young has been an active leader in the field of pharmacy. She is currently the NABP District 1 secretary/treasurer and serves on the Meeting Planning Committee for District 1 and 2. She also served on NABP’s 2017 Task Force on Best Practices for Veterinary Compounding and has served on NABP’s Advisory Committee on Examinations since 2015. She was also a member of the Massachusetts Board of Registration in Pharmacy from 2012 to 2014. Dr. Young works hard to ensure that people dealing with drug abuse have access to necessary resources. She advocated for standing orders for intranasal Naloxone for Massachusetts pharmacists, and she regularly does outreach to destigmatize addiction, especially among pharmacists and other health care providers. Dr. Young also lobbied for an academic seat on the Board to facilitate collaboration between the pharmacy, the Board and the schools of pharmacy. Due to her efforts, the board now includes a designated seat for a representative of the schools of pharmacy. In 1990 the Association honored Dr. Young with the Pharmacist of the Year Award. For the past 15 years, Dr. Young has been the director of continuing pharmacy education at Northeastern University. In recognition for her lifelong dedication to community pharmacy, Dr. Young was awarded the MPhA Bowl of Hygeia Award in 2017. Dr. Young serves as Director to the MPhA Foundation Board of Directors, has played an integral role in the development of pharmacy programs for the Association and serves as Program Chair for our

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Implementing the Art of Mindfulness in Your Practice by LIsa Bragaw, President of CPA Board of Directors We’ve all heard the saying before throughout our pharmacy careers: It’s all about balance--balance between work and time with family and friends. Balance between giving back to others and making time for yourself. In the pharmacy profession, we all know that’s easier said than done. As pharmacists, balancing the needs between ourselves and our job can be a challenge that we know all too well. In 2018, a study in the American Journal of Health-System Pharmacy revealed that 53% of pharmacists self-reported a high degree of burnout caused by increasing stresses and demands. I can attest to this earlier in my career as a pharmacist, when I experienced repetitive strain injuries in my neck and back related to work. It was one of the most unpleasant experiences in my life. But out of this experience grew a new passion that helped me practice that “balance”: yoga and mindfulness.

of

Lisa Bragaw Most importantly, mindfulness meditation can help reduce distractions, snap judgments and inadvertent stereotyping in the pharmacy, fostering practitioners to motivate patients to make significant health changes. The more you focus on the present moment, the more you can troubleshoot potential prescription errors—and enhance your interactions with patients.

Yoga was a great way to relieve stress, reduce pain and create balance in both my body and life. It also was a source of healing that helped me get right back up behind the pharmacy counter. After receiving my Doctorate of Pharmacy, my passion for yoga grew so much that I decided to open my own yoga and cycling studio called “Zen and Now.” Today I am a business owner, yoga instructor and a clinical pharmacist. I even recommend breathing techniques when providing medication management counseling services to patients.

Besides meditation, I recommend other mindfulness exercises, such as the 4-square breath. Here’s how you can try it:

Through yoga, I also was able to practice the art of mindfulness. Jon Zabbat Zinn, the founder of the University of Massachusetts Center for Mindfulness, defines mindfulness in a nutshell: “paying attention to the present moment, on purpose, and in a nonjudgmental way.”

So how can mindfulness help you find that balance, especially as work stresses and demands continue? First, mindfulness takes practice, so cut yourself some slack. All it takes is a few minutes to practice these exercises, and if you incorporate just one exercise per day, you are on your way to staying in the present moment.

You do not have to be a yoga guru to practice the art of mindfulness. With mindfulness comes a wealth of techniques, including meditation. Meditation is not a reli-

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gion, but rather a way of maintaining awareness in a moment by moment experiential practice. It means disengaging from strong attachment to beliefs, thoughts or emotions in a way that generates a greater sense of emotional balance and well-being.

• Breath in slowly through your nose for a count of 4. • Hold your breath for a count of 4. • Breath out through your mouth for a count of 4. • Hold for a count of 4.

Second, discover a mindfulness technique that works best for you. Like shoe sizes, one mindfulness exercise may


Pharmacy Journal of New England • July 2019

not fit all. There is no “right” technique to master the art of mindfulness. This summer, I challenge you try a mindfulness exercise. Whether you’re walking outside to your car or sitting at your kitchen table, take a few moments to make time for you. Check out this list of resources that can help you in your practice.

Pocket Mindfulness

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Mindfulness Exercises

Positive Psychology

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Lisa Bragaw (far right) leads a yoga session at the CPA’s Women in Pharmacy Summit June 1st.

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Pharmacy Marketing Group Rx and the Law By: Don R. McGuire Jr., R.Ph, JD

Partial Fills Partial filling of prescriptions has been going on for a long time in pharmacies. So long in fact that most pharmacists don’t think about the legalities of doing so. When you search for laws or regulations about partial filling, you get few results addressing partial filling for non-controlled substances. One of the few that is found is in West Virginia. This code section allows the partial filling of any prescription if the pharmacy is unable to supply the entire amount or if the patient requests a lesser amount. Many states just don’t address partial filling for non-controlled substances in their laws or regulations. Almost all states have a regulation regarding the partial filling of controlled substances, particularly Schedule II. Many of them are worded similarly to the DEA regulation on this subject. What is different about the DEA regulation is that it only allows partial filling in situations where the pharmacy is unable to supply the entire amount of the prescription. It doesn’t permit the patient to request a partial fill of a Schedule II substance. One of the unforeseen results of these regulations has been its potential contribution to the opioid crisis. In response to the crisis, Congress passed the Comprehensive Addiction and Recovery Act of 2016 (CARA). One of the many provisions of the law allows the patient or the prescriber to request a partial fill of a prescription for Schedule II controlled substances. Although the DEA hasn’t rewritten its regulations, the interpretation of the law has been that CARA supersedes the DEA regulations to allow the patient or the prescriber to request the partial fill. For non-controlled substances, what is the legal status of partial filling in those states whose laws and regulations are silent on the issue? The answer depends on your view of how the law works. Some would say that there is nothing prohibiting it, so I can proceed to partially fill the prescription. The other view would say that there is nothing permitting it, so I can’t do it. Given the history of partial filling, I would agree with the former view. It is such an ingrained part of pharmacy practice, with little apparent risk to the public, that regulators haven’t felt the need to address it. However, there are risks when partial filling a prescription. There have been claims reported when the remaining portion of the prescription has been filled incorrectly. Partial filling is a deviation from the normal workflow, so there is

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an increased chance of error in that situation. Errors occur most often with look-alike, sound-alike pairs. There can also be interruptions in therapy if the remainder is overlooked or misplaced. There is also a risk that the patient will not come back to finish the course of their treatment. It is important to make sure that there is accurate documentation of what was dispensed and when. On top of the treatment risks, there are also contractual issues. Partial filling may be addressed in your contracts with third party payers. These provisions may address when partial filling may occur, how it is to be documented, and how to charge for the prescription. Failure to follow the contractual requirements could result in an audit and recoupment of third party payments. It is especially important to follow the contractual requirements in cases of partial filling when the patient fails to pick up the remainder of the prescription. Failure to adjust billings in those cases could end up as cases of unjust enrichment or fraud. At first glance, the issue of partially filling a prescription seems pretty benign. However, it does present some pitfalls for the unwary. The legal and/or contractual requirements may be contradictory to what is seen as good patient care. For example, the patient presents with a new prescription for an expensive medication. It may make sense to dispense a few days’ supply to make sure that the patient can tolerate the new treatment. But this can be problematic if regulations or contractual requirements do not allow partial fills. Unfortunately the world is not always rational or logical. Because of these complexities, partial filling should be addressed in your pharmacy’s policy and procedure manual.


Legislative Update

Pharmacy Journal of New England • July 2019

Legislative Sessions Ends with Important Wins for CT Pharmacy Connecticut lawmakers ended the 2019 Legislative Session on June 5 with a new biennial budget, more PBM transparency and expanded collaborative practice opportunities for pharmacists statewide. Under the new budget that passed, legislators eliminated the sales tax on non-prescription drugs that Governor Ned Lamont initially proposed. The budget also expands Husky A eligibility for adults while limiting the costs of co-pays and deductibles that providers charge in group health insurance plans. Here is a synopsis of other passed legislation that will have a profound impact on the pharmacy practice in Connecticut. Public Act 19-199: “An Act Prohibiting Recoupment Provisions in Pharmacy Services Contracts & Concerning A Prevailing Rate of Wages Exemption” Just when we thought pharmacy DIR reform was brought to a standstill at the national level, the CPA was very pleased when Connecticut legislators passed restrictions on pharmacy benefit manager (PBM) clawbacks and direct and indirect remuneration (DIR) fees during the final hours of the Legislative Session. The act specifically prevents “[a] health carrier or pharmacy benefits manager to recoup, directly or indirectly, from a pharmacy or pharmacist any portion of a claim that such health carrier or pharmacy benefits manager has paid to the pharmacy or pharmacist.” The act, which takes effect in January 2020 pending Governor Lamont’s signature, marks a big win for Connecticut pharmacists, even though it is only a first step. Recently, the Centers for Medicare and Medicaid Services’ final drug pricing rule failed to reform DIR fees, which have left community pharmacists in an unpredictable and unsustainable financial situation. CPA’s policy team has been working closely with legislators, along with Comptroller Kevin Lembo’s office and other agencies, to address PBM reform. The Association is proud to see this issue gaining the statutory attention it deserves, and will continue to fight for broader reforms that create a more pharmacist-friendly environment in Connecticut and beyond.

agreements with physicians since 2006. Research shows that nurse practitioner-pharmacist collaborations can improve patient care while making healthcare more affordable and accessible for consumers, especially in underserved communities. Allowing pharmacists and APRNs to collaborate in Connecticut can address the 41 Health Professional Shortage Areas (HPSAs), where primary care needs are not being met. With over 2,800 highlytrained pharmacists statewide, this bill, which currently sits on Governor Lamont’s desk for signature, presents a huge opportunity to address this crisis. HB 7159: An Act Addressing Opioid Use This bill requires pharmacists to provide counseling to all patients when dispensing prescription medications—a standard practice that Connecticut pharmacists already incorporate. Another section of this bill also alleviates pharmacist workload by allowing pharmacists to authorize a trained pharmacy technician to access the state prescription drug monitoring program (PDMP). The bill currently sits on the governor’s desk for signature.

SB 921: An Act Concerning the Scope of Practice of Advanced Practice Registered Nurses Sections 22 and 23 of this bill gives pharmacists an opportunity to extend their formal practice relationships, to include APRNs. CPA made this bill a major legislative priority, and is proud to see this become a reality for Connecticut pharmacists, who have already established collaborative practice

SB 1006: An Act Concerning Revisions to the Pharmacy & Drug Control Statutes This bill requires sterile compounding pharmacies in Connecticut to comply with federal compounding standards, including USP Chapters <800> and <797>. The bill requires

7


Legislation

continued

that all sterile compounding facilities designate a pharmacist to be responsible for overseeing the pharmacy. The bill also requires sterile compounding pharmacies to report to the Connecticut Department of Consumer Protection (DCP) any administrative or legal action they receive from a state or federal agency. Governor Lamont is expected to sign this bill. New DCP Regulations: Return of Prescription Drugs to Pharmacies The Regulations Review Committee recently approved CT DCP’s proposed regulations that provide guidelines for the safe collection and handling of unused prescription drugs that the public returns to licensed Connecticut pharmacies. This regulation requires participating pharmacies and disposal locations to be registered annually with the DCP Commissioner, reinforces compliance with federal regulations, and establishes requirements for the collection and handling methods at pharmacies as well as for the transportation and destruction of materials collected by disposal locations. Bills at a Standstill By the end of the session, some proposed bills came to a standstill, including the legalization of adult use marijuana and a proposal to reform Connecticut’s health care environment. In the final two weeks of the legislative session, the Insurance Committee tried to pass a bill that aimed to: 1. Establish a public insurance option (aka the “Connecticut Option”)--a state-sponsored plan offered to individuals and small businesses that don’t have employer-subsidized coverage. 2. Impose a tax on opioid manufacturers at the first point of sale. 3. Seek approval from the federal government to import prescription drugs from Canada at “greatly reduced prices.” Although the CPA shares the goals of Governor Lamont and the legislature to provide Connecticut residents more afford

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able, high-quality health care, several elements of this controversial proposal sparked concern about its potential adverse impact on pharmacists and their patients. The Connecticut Option plan not only would severely damaged the shrinking number of independent pharmacies statewide, but also would hurt patients who suffer from debilitating pain and other conditions for which only opioids are a suitable therapy. CPA also was concerned that safety would be compromised by proposals to import medications from Canada, as these drugs would not be FDA-approved and would create additional legal and financial liability for pharmacists who dispense counterfeits. Ultimately, a water-downed version of the bill passed the House, but did not make it to the Senate floor. CPA will keep a close eye on this legislation, which is expected to return next year. Keeping Up the Pressure Two proposals that the CPA championed this year did not receive floor votes. Among these bills was HB 6543: An Act Permitting Pharmacists to Prescribe Tobacco Cessation Products. Research shows that patients who use a tobacco cessation medication are more likely to quit—and pharmacists are a great solution for increasing access to these medications. As the most accessible health care providers, pharmacists are well-equipped to help people quit smoking, and can respond quickly to modify cessation therapies. Meanwhile, SB 94: An Act Allowing Pharmacists to Administer the Influenza Vaccine to Children Twelve Years of Age and Older, also did not receive floor votes. This bill allows pharmacists to provide the flu vaccine to patients age 12 and older with parental permission, and will make it easier, faster and less expensive to protect Connecticut’s children from the flu.


Clinical Pearls

Pharmacy Journal of New England • July 2019

Dose Verification of Combination Drug Products Prescribed for Children By Margaret M. Burke, Pharm.D., BCPPS

tions in children:

Verifying the correct dose of a combination medicine for a child can be tricky. Whereas doses of combination products for adults are usually expressed as milligrams or grams of the combined product, dosing for children may be expressed as milligrams or grams of the combined product OR on the basis of only one of the product’s components. No standard exists so the approach is at the discretion of the manufacturer of the product.

• Thoughtful design of medication use systems

For example, an adult patient might commonly be prescribed Unasyn® 3 grams IV every 6 hours.1 Unasyn® 3 grams is made up of ampicillin 2 grams and sulbactam 1 gram. The pediatric dose for Unasyn® is commonly 50 mg/kg/dose based on the ampicillin component.2 Therefore, a 5-year-old child weighing 18 kg should receive 900 mg of the ampicillin component which would require 1350 mg of Unasyn® be administered. Examples of combination oral products dosed on the basis of only 1 product component for children include amoxicillin/clavulanate and trimethoprim/sulfamethoxazole. In contrast, dosing for Avycaz® in children is based on the combination product. The drug is made up of ceftazidime 2 grams and avibactam 0.5 grams. A typical adult dose is 2.5 grams every 8 hours3 whereas the pediatric dose is 62.5 mg/kg/dose of Avycaz® which contains 50 mg of ceftazidime and 12.5 mg of avibactam.2 These varying approaches can lead to confusion, miscommunication, and error at any major step in the medication use process - prescribing, dispensing, or administration. In the Unasyn example above, if a prescriber mistakenly ordered 900 mg of Unasyn® the child would be underdosed by 30 percent. This variability in approach must be considered in the design and implementation of technology in the healthcare system. Different rules may need to be written for pediatric vs. adult orders in electronic ordering or compounding systems to calculate doses correctly. Consider the following actions to minimize the likelihood of errors when dealing with orders for combination medica-

• Use of current, reliable pediatric dosing references4 • Verify correct dosing for each medication • Require weight in kg be included on the order or be readily accessible to healthcare providers • Read carefully • Require independent double checks in the medication use process References 1. Unasyn [package insert] New York, NY: Pfizer; 2018. 2. Lexicomp Online, Pediatric and Neonatal Lexi-Drugs Online, Hudson Ohio Wolters Kluwer Clinical Drug Information, Inc.; 2019; May 15 2019. 3. Avycaz [package insert] Irvine, CA: Allergan; 2019. 4. Boucher EA, Burke MM, Johnson PN, Klein KC, Miller JL; Advocacy Committee for the Pediatric Pharmacy Advocacy Group. Minimum Requirements for Core Competency in Pediatric Pharmacy Practice. J Pediatr Pharmacol Ther. 2015;20(6):481–484. doi:10.5863/1551-6776-20.6.481.

Assessment Question: What is the standard for dosing of combination drug products in children? (Answer on page 18) a) The FDA requires dosing be based on mg/kg of the combination product. b) The FDA requires dosing be based on mg/kg of the primary component of the product. c) The FDA requires dosing be listed in the package insert both as mg/kg of the combination product and as mg/kg of the primary component. d) The FDA does not provide a standard and the approach is at the discretion of the drug manufacturer.

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Clinical Pearls

continued

Psoriatic Arthritis Treatment in Patient with Multiple Treament Confounders By Laura Varnum, PharmD Learning Objective: Assess the treatment options for patients with psoriatic arthritis (PsA) while taking into consideration their comorbidities and insurance coverage. Background: Psoriatic arthritis is an autoimmune condition associated with a combination of psoriasis and peripheral and axial joint inflammation. Most patients will exhibit skin symptoms followed by joint involvement. A smaller subset of patients have joint and skin involvement at the same time or joint inflammation prior to psoriasis. Early diagnosis of PsA is imperative to delay disease progression because it can lead to joint damage, higher mortality, and higher healthcare costs. Patient Case: LK is a 75-year-old female with a past medical history of

Drug Class

TNFi1

psoriatic arthritis, asthma, hypertension, osteoarthritis, Crohn’s disease, and Guillain-Barre Syndrome. Her rheumatologist consults the clinic pharmacist regarding what options she has to treat LK’s PsA considering her past medical history. She is currently taking leflunomide 10 mg daily for her PsA, but it has been inadequately controlling her symptoms, and she previously failed methotrexate therapy. She is not on maintenance medication for her Crohn’s disease at this time. Drug Information: The 2018 American College of Rheumatology/National Psoriasis Foundation guidelines recommend the use of biologic agents over oral small molecule (OSM) options (methotrexate, sulfasalazine, cyclosporine, leflunomide, and apremilast) for treatment-naive patients with active disease, and patients with active PsA despite treatment with an OSM. Tumor necrosis factor inhibitor (TNFi) agents are the preferred treatment options when patients have no contraindications. Table 1 outlines the approved biologic treatment options for PsA.

Drugs

Disease-Related Concerns

Etanercept (Endbrel®)

History of demyelinating disease

Infliximab (Remicade®, Inflectra®

Heart fallure

Adalimumab (Humira®)

Seizure disorder (etanercept and infliximab only)

Golimumab (Simpoini®) Certolizumab pegol (Cimzia®)

History of lymphoma and skin cancer

IL 12/23I

Ustekinumab (Stelara®)

History of skin cancer

IL 17i

Secukinumab (Cosentyx®)

Inflammatory bowel disease

Ixekizumb (Taltz®) Brodalumab (Siliq®)

Depression or suicidal ideation (brodamab only)

Abatacept (Orencia®)

COPD

CTLA4-lg JAK Inhibitor2

History of lymphoma Tofacitinib (Xeljanz®)

Hepatic impairment Interstitial lung disease History of lymphoma and skin cancer

1 All biologic medications increase the risk of infection due to immunosuppression. Caution should be used in patients with a history of

tuberculosis and hepatitis B and C. 2 Additional JAK inhibitors are on the market, but only tofacitinib is approved for use in PsA.

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Pharmacy Journal of New England • July 2019

Discussion: In response to the rheumatologist, tofacitinib and ustekinumab were recommended as treatment options for LK. Ustekinumab is the best option because it is FDA approved to treat both PsA and Crohn’s disease, and it is not contraindicated in demyelinating disease. Tofacitinib is an alternative option because it can also be used with demyelinating disease and IBD comorbidities. It was recently FDA approved for ulcerative colitis but is not approved for use in Crohn’s disease. The other option for LK is abatacept. Unfortunately, LK is insured through Medicare, and her Part D insurance copay was unaffordable. Most drug manufacturers have patient assistance programs that provide free medication to patients who meet financial criteria. The manufacturer of abatacept only utilizes independent charitable foundations to support patients with federal health insurance, and the funds get exhausted quickly. In a specialty where many patients are insured by Medicare or other government subsidized insurance, drug cost and financial burden needs to be taken into consideration. Conclusion:

the drug selection process. Pharmacists can play an integral role by educating providers about drug-disease precautions, so that disease exacerbations can be avoided. Assessment Question: What biologic agent(s) can treat PsA in a patient with a history of Crohn’s disease? (Answer on page 18). References: 1. Janssen Biotech, Inc. STELARA® (ustekinumab) Full Prescribing Information. http://www.janssenlabels.com/packageinsert/product-monograph/prescribing-information/STELARA-pi. pdf. Accessed May 14, 2019. 2. Pfizer Labs. XELJANZ®/XELJANZ XR® (tofacitinib) Full Prescribing Information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203214s018lbl.pdf. Accessed May 14, 2019. 3. Singh JA, Guyatt G, Ogdie A, et al. 2018 American College of Rheumatology/National Psoriasis Foundation Guideline for the Treatment of Psoriatic Arthritis. Arthritis & Rheumatology. 2019;71(1):5-32. doi:10.1002/art.40726.

The author has no conflicts of interest to disclose.

While the development of TNFi and interleukin 17 inhibitor (IL17i) agents have improved the quality of life for many patients with PsA, use is limited to patients without a history of demyelinating disease, IBD, and/or heart failure. These comorbidities need to be taken into consideration in

Case-Based Review: Ahh...There’s nothing like a hot shower! Let’s talk cannabinoid hyperemesis syndrome By Loriel J. Solodokin, PharmD.; Assistant Professor, MCPHS University School of Pharmacy - Boston; Clinical Oncology Pharmacist, Dana Farber Cancer Institute/ Brigham and Women’s Hospital Conflicts of Interest The author does not have any disclosures Learning objectives • Recognize the most common presenting symptoms and diagnostic characteristics of cannabinoid hyperemesis syndrome (CHS) • Describe the treatment modalities used for CHS • Understand a pharmacist’s role in the management of CHS

Background Since 2008, legislation in Massachusetts has significantly increased access to marijuana, with the most recent phase being legalization of recreational use.1 The upward trajectory in marijuana consumption has been met by a low risk perception among users, and an astoundingly low level of preparedness/readiness among clinicians to recommend cannabis and answer related questions.2,3 The medical implications of increased legalization are also palpable, with a doubling in emergency department (ED) visits for CHS.4,5 Patient case A 26-year-old male with a non-significant past medical history presented to the ED with complaints of severe nausea, vomiting (N/V), and abdominal pain. He reported vomiting about 10 times since the previous night, each episode associated with diaphoresis and diffuse, non-radiating, colicky abdominal pain. He had suffered from bouts of intrac-

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Case-Based Review

continued

table vomiting with stomach upset for the past 1.5 years, leading to 4 hospitalizations in the previous 6 months for cyclical vomiting syndrome. Neither ondansetron nor metoclopramide mitigated these symptoms. Symptoms peaked in the morning and were alleviated by repeated hot showers and heating pad applications. The symptoms subsided earlier in the year when he stopped using marijuana for 2 months, but returned upon reinitiating use. He denied fevers, chills, sick contacts, hematemesis, melena/hematochezia, diarrhea, trauma, unusual food ingestion, recent travel, and use of any prescription, over the counter, or other herbal agents. No immediate family members or acquaintances were similarly affected. • Social history: EtOH negative, tobacco negative, marijuana positive o Marijuana use on and off for 8 years o Smoked 6 joints/day and intermittently vaped and consumed marijuana products • No known drug allergies • Physical exam unremarkable (soft, non-tender, non-distended abdomen, with normal bowel sounds) • Hemodynamically stable • Labs normal (no electrolyte/acid-base abnormalities, normal hepatic and pancreatic enzymes) • Urine toxicology (+) Cannabidiol

• Imaging studies ruled out gastric etiologies Diagnosis: CHS Drug information Marijuana is a product of the Cannabis plant (sativa, indicia, ruderalis) and has a myriad of phytocannabinoids and active cannabinoids.3,6 Variations in Cannabis chemovars (i.e. chemical varietals), formulations, usage techniques, and general dietary considerations impact the pharmacologic and pharmacokinetic properties of the product (Table 1). Marijuana is metabolized via the CYP450 enzymatic system to its primary active metabolite, delta-tetrahydrocannabinol (∆-THC), responsible for mediating psychoactive and gastrointestinal effects, and cannabidiol (CBD), responsible for mediating analgesic, anti-inflammatory, anti-anxiety, and antipsychotic effects via pre-synaptic involvement of the endogenous cannabinoid receptors, CB-1 and CB-2. THC and CBD work synergistically and should, preferably, be used in conjunction. Optimal cannabinoid dosing has not been firmly established and is highly personalized. Generally, the “start low and go slow” approach is implemented and usually results in therapeutic efficacy, with minimal adverse events. As cannabis has a high potential for dependence, tolerance, and addiction, users and clinicians should be aware of the utility of implementing a drug holiday, as well as the withdrawal symptoms associated with cannabis abstinence, such as anxiety, depression, decreased appetite/nausea, headaches, insomnia, irritability, and vivid dreams/nightmares.

Table 1: Marijuana Pharmacokinetics (Adults)3,6 Route

Absorption

Peak Concentration

Bioavailability

Inhalation/smoking

Rapid drug delivery to brain

22 min Duration: 2-4 hours

Variable, 2-56%

Oral

Slow

1-2 hours, up to 8 hours Duration: 6-8 hours

10-20%

Sublingual

Fast

30 min Duration: 6-8 hours

10-20%

Rectal

Fast

15 min

20-40%

Transdermal

Slow

2 hours, maintained for 48 hours

10%

Distribution

Metabolism

T1/2

Elimination

Highly lipophilic Large Vd

CYP450 2C9, 2C19, and 3A4

Infrequent users: 31.2 hours Men: 14.9 hours ±3.7 L/hr Frequent users: 5-13 days Women: 11.8 hours ±3 L/hr Feces: 65%, urine: 20%

Synthetic Forms Dronabinol (Marinol®), nabilone (Cesamet®), cannabidiol (Epidiolex®)

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Semi-Synthetic Forms Nabiximols (Sativex®, Europe; 1:1 THC:CBD ratio)


Pharmacy Journal of New England â&#x20AC;˘ July 2019

Discussion CHS is manifested as a cyclical and paroxysmal onset of N/V and abdominal pain, paradoxically induced by chronic (THC-rich) cannabis use, followed by hot bathing with associated symptom resolution.8,9,10 It is considered a diagnosis of exclusion and consists of prodromal, hyperemetic and recovery phases (Figure 1).7,8,9 Other commonly cited diagnostic characteristics include a history of cannabis use for â&#x2030;Ľ 1 year, severe N/V (cyclical, over months), symptom onset at < 50 years old, and symptom resolution upon cessation of marijuana use.7 The highest incidence is in males who initiated cannabis use in their teenage years and currently use marijuana products weekly. Patients with CHS report multiple ED/clinic visits and hospitalizations, with non-specific diagnoses. Proposed pathophysiologic mechanisms of CHS revolve around endocannabinoid system dysregulation, CB-1 receptor activity changes, cannabinoid metabolite accumulation, CYP450 enzymatic genetic variations, changes in the hypothalamic-pituitary-adrenal axis, and splanchnic vasculature vasodilation.7,8,11,12 Patients should be acutely managed with hydration, electrolyte repletion, hot bathing/heating pad application to the abdomen, and/or alternative and complementary therapies.7,9 While cannabinoid abstinence is effective in > 90% of cases, there are a variety of pharmacotherapeutic modalities with reported efficacy (case reports/ series and retrospective analyses).7,9,12-19 Although most

patients are refractory to conventional antiemetics, such as ondansetron, metoclopramide, prochlorperazine, and promethazine, olanzapine may still have a place in therapy, given its superiority in preventing nausea and vomiting.20 More innovative regimens have also been studied and are reported to mitigate the cyclical nausea, vomiting, and abdominal pain present in those with CHS. Topical capsaicin, applied to the abdomen, back, and/or arms, 3-4 times daily is thought to be effective due to its influence on TRPV-1 receptors, substance P, and correction of cannabinoid-induced hypothalamic temperature dysregulation.12 Varying doses of haloperidol, given every 8 hours as needed, has likely been impactful due to its inhibitory effects on both the CB-1 and D2 receptors.13-15 Other multimodal therapies typically executed for migraines, such as propranolol and tricyclic antidepressants, may also be trialed for CHS.16,18 Furthermore, benzodiazepines, mirtazapine, erythromycin, H-1 blockers, and NK-1 inhibitors have also been utilized with success. Notably, opioids should be reserved for severe pain and used with caution due to their potential for decreased peristaltic motility and substance abuse disorder.7 Symptoms are typically self-limiting and resolve in 1-4 weeks, after cannabis use cessation.8 If acute CHS symptoms are managed appropriately and the dosing ratio of THC:CBD is delicately modulated, it may still be possible for cannabis use to be resumed for those in need (close follow-up by practitioners familiar with cannabis is advised).

Figure 1: CHS Presentation7,8,9

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Case-Based Review

continued

Conclusion Cannabis legalization in Massachusetts is directly impacting recognition of marijuana-induced complications, such as CHS. Although rare, CHS is a manageable complication occurring in some patients with a history of chronic cannabis use. While cannabis abstinence is the most effective CHS management strategy, nuanced pharmacological and non-pharmacological approaches may be used. Pharmacists play a significant role in recognition, management, and long term counseling for CHS patients, as well as monitoring for symptoms of cannabinoid withdrawal and drug interactions.7-9 Implementation of motivational interviewing techniques, referral to a substance abuse specialist, and close follow-up encompass the best practice management for CHS. Future directions for CHS include optimal cannabinoid dosing strategies, established pharmacist-led cannabinoid programs, and increased/more robust evidence regarding its prophylaxis and treatment.

6. Oberbarnscheidt T and Miller NS. Pharmacology of Marijuana. J Addict Res Ther. 2017;S11:012. 7. Sorensen CJ, DeSanto K, Borgelt L, Phillips KT, Monte AA. Cannabinoid hyperemesis syndrome: Diagnosis, pathophysiology, and treatment â&#x20AC;&#x201C; a systematic review. J Med Toxicol. 2017;13:7187. 8. Allen JH, de Moore GM, Heddle R, Twartz JC. Cannabinoid hyperemesis: cyclical hyperemesis in association with chronic cannabis abuse. Gut. 2004;53:1566-1570. 9. Lu ML, Agito MD. Cannabinoid hyperemesis syndrome: Marijuana is both antiemetic and proemetic. Cleve Clin J Med. 2015;82(7):429-434. 10. Stanghellini V, Chan FK, Hasler WL, et al. Gastroduodenal Disorders. Gastroenterology. 2016;150(6):1380-1392.

Assessment question

11. Schreck B, Wagneur N, Caillet P, et al. Cannabinoid hyperemesis syndrome: Review of the literature and of cases reported to the French addictovigilance network. Drug Alcohol Depend. 2018;182:27-32.

As the emergency medicine pharmacist, what would be the most appropriate strategy(ies) to treat (select all that apply)?(Answers on page 18).

12. Richards JR, Lapoint JM, Burillo-Putze G. Cannabinoid hyperemesis syndrome: potential mechanisms for the benefit of capsaicin and hot water hydrotherapy in treatment. Clinical Toxicology. 2018;56(1):15-24.

a. Initiate topical capsaicin 0.1% cream 3-4 x daily to the abdomen

13. Inayat F, Hassan Virk HUI, Ullah W, Hussain Q. Is haloperidol the wonder drug for cannabinoid hyperemesis syndrome? BMJ Case Rep. 2017; doi: 10.1136/bcr-2016-218239.

b. Initiate dronabinol 2.5 mg PO TID, 30 min before meals c. Initiate haloperidol 2 mg IV q8hrs PRN N/V, until symptom resolution d. Initiate hydromorphone 0.2 mg IV q3hrs PRN abdominal pain e. Use motivational interviewing to establish goals related to tapering/abstaining from marijuana use References 1. Massachusetts law about marijuana possession; Mass.gov;

https://www.mass.gov/info-details/massachusetts-law-about-marijuana-possession; updated May 8, 2019; accessed May 2019. 2. Lipari RN, Ahrnsbrak RD, Pemberton MR, Porter JD. Risk and protective factors and estimates of substance use initiation: Results from the 2016 national survey on drug use and health. Rockville, MD: Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration; 2017. Retrieved from https://www.samhsa.gov/data/sites/default/ files/NSDUH-FFR1-2016/NSDUH-FFR1-2016.htm. Accessed March 2019. 3. MacCallum CA, Russo EB. Practical considerations in medical cannabis administration and dosing. Eur J Intern Med. 2018;49:12-19. 4. Kim HS, Anderson JD, Saghafi O, Heard KJ, Monte AA. Cyclic vomiting presentations following marijuana liberalization in Colorado. Acad Emerg Med. 2015;22(6):694-699.

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5. Heard K, Monte AA, Hoyte CO. Brief commentary: Consequences of marijuana-observations from the emergency department. Ann Intern Med. 2019;170:124.

14. Hickey JL, Witsil JC, Mycyk MB. Haloperidol for treatment of cannabinoid hyperemesis syndrome. Am J Emerg Med. 2013;3(6):1003.e5-e6. 15. Lee C, Greene SL, Wong A. The utility of droperidol in the treatment of cannabinoid hyperemesis syndrome. Clinical Toxicology. 2019; doi: 10.1080/15563650. 16. Richards JR, Dutczak O. Propranolol treatment of cannabinoid hyperemesis syndrome a case report. J Clin Psychopharmacol. 2017;37(4):482-484. 17. Haghighat M, Dehghani SM, Shahramian I, Imanieh MH, Telmouri A, Noori NM. Combination of erythromycin and propranolol for treatment of childhood cyclic vomiting syndrome: a novel regimen. Gastroenterol Hepatol Bed Bench. 2015;8(4):270-277. 18. Bhandari S, Venkatesan T. Novel treatments for cyclic vomiting syndrome: Beyond ondansetron and amitriptyline. Curr Treat Options Gastro. 2016;14:495-506. 19. Kovacic K, Sood M, Venkatesan T. Cyclic vomiting syndrome in children and adults: What is new in 2018? Curr Gastroenterol Rep. 2018;20(10):46. 20. Chelkeba L, Gidey K, Mamo A, Yohannes B, Matso T, Melaku T. Olanzapine for chemotherapy-induced nausea and vomiting: systematic review and meta-analysis. Pharm Pract. 2017;15(1):877.


Pharmacy Journal of New England • July 2019

CPA in Full Bloom

Clockwise from left: APhA Past President Nicki Hilliard kicks off CPA’s inaugural Women in Pharmacy Summit on May 31 at the Spa at Norwich Inn; The 4th Annual CT Compounding Conference sees a record turnout of attendees on April 24 at the Red Lion Hotel in Cromwell, CT; Erik Tosh presents an update on federal compounding regulations at the Compounding Conference; A portion of Women in Pharmacy’s proceeds benefits the Terri Brodeur Breast Cancer Foundation; Namaste! Women in Pharmacy attendees take part in a morning yoga session led by CPA President Lisa Bragaw on June 1; SCA Pharma, a state-of-the-art 503B outsourcing facility, speaks with attendees at the CT Compounding Conference.

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Game room fun, craft beer, and dozens of raffle prizes take over City Steam Brewery CafĂŠ in Hartford for the Connecticut Pharmacists Foundationâ&#x20AC;&#x2122;s 9th Annual Scholarship Fundraiser. Every year, the event aims to raise money to provide scholarships to promising pharmacy students.

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Pharmacy Journal of New England • July 2019

Big Y Sells 6 In-Store Pharmacies to CVS Citing “dwindling medical reimbursements and fees, along with increased expenses,” Big Y sold six of its in-store pharmacies to CVS Health at the end of June. The Massachusetts-based supermarket chain said it can no longer continue to support the costs of these pharmacies. Big Y sold its East Longmeadow and Southwick stores on June 26, and said customers’ prescriptions will be automatically be transferred to local CVS stores. Source: WWLP-22News

FDA Overlooked Red Flags in Testing of New Depression Drug Although the FDA approved a ketamine cousin called esketamine (Spravato—Janssen) for patients with intractable depression earlier this year, critics claim that Janssen provided the agency at best modest evidence it worked and then only in limited trials. The manufacturer presented no information about the safety of esketamine, a nasal spray, for long-term use beyond 60 weeks. According to an article published in Kaiser Health News, three patients who received the drug died by suicide during clinical trials, compared with none in the control group. After hearing the evidence, Jess Fiedorowicz, MD, director of the Mood Disorders Center at the University of Iowa and a member of the FDA advisory committee that reviewed the drug, described its benefit as “almost certainly exaggerated.” The expert panel, however, cleared the drug based on the evidence that the FDA and Janssen had determined was sufficient. Eskatamine is available only under supervision at a certified facility where patients must be monitored for at least 2 hours after taking the drug to watch for side effects, including dizziness, detachment from reality, and increased blood pressure.

(Lydia Zuraw/KHN illustration; Getty Images)

Source: Kaiser Health News

Colorado’s $100 Insulin Cap Sparks Interest in Other States A new law in Colorado capping the price of insulin for insured patients at $100 per month has sparked interest in other states, including California, Minnesota and Pennsylvania. Signed into law in May, the law makes insulin more affordable for insured patients who have not met a high health insurance deductible. Although the insurance industry was officially neutral on the bill, some companies expressed concern that if more laws follow this precedent to price-cap other life-saving medications, the cost of insurance will increase for patients. Lawmakers in Minnesota have proposed an act that would give patients a discounted emergency supply of up to 90 days’ worth of insulin. Source: United Press International

Photo by jwskks5786/Pixabay

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Headlines

continued

Study: Chicken pox vaccine may protect against shingles years later

A study published in the journal Pediatrics indicates that the varicella vaccine not only protects against chickenpox but may also reduce the risk for shingles. The study included 6.4 million children under age 18 years, one-half of whom had received the varicella vaccine. After calculating rates of shingles from 2003 to 2014, researchers found that generally the vaccinated children had a 78% lower rate of shingles compared with their unvaccinated peers. Rates of shingles were even lower among children who had received both doses of the vaccine, according to results of the study. Source: Pharmacy Today

CVS Health to Expand HealthHub to 1500 Locations

Photo by David J. Phillip. Associated Press

worldmercuryproject.org

CVS Health will expand its HealthHUBs to 1,500 locations by the end of 2021. Fifty CVS locations in the Houston, Atlanta, Philadelphia/Southern New Jersey, and Tampa, FL, areas will be converted to offer expanded services. Earlier this year, CVS opened three pilot HealthHUBs in Houston, offering personalized pharmacy support programs and expanded MinuteClinic services, as well as nutrition and weight loss counseling. HealthHUBs also will educate customers about service offerings, connect them to in-store healthcare providers and provide community spaces for group events such as health or yoga classes. Source: Drug Topics

NACDS Guidelines Push for National PDMP Increasing access to naloxone and working towards a national prescription drug monitoring program (PDMP) are among the NACD’s new policy recommendations for opioid abuse prevention. The organization’s new opioid recommendations include state-level legislative and regulatory revisions that would foster the goal of a national PDMP database, NACDS President & CEO Steven Anderson told Drug Topics. Proposed PDMP requirements include daily reporting of controlled substance dispensing information to state PDMPs, data standardization to improve PDMP usefulness, a check to the state PDMP by providers before issuing a controlled substance prescription, and allowing interstate access to PDMP data. Source: Drug Topics

Answers to Clinical Pearls Assessment Questions: Dose Verification of Combination Drug Products Prescribed for Children: d Psoriatic Arthritis Treatment in Patient with Multiple Treatment Confounders: Any biologic except IL17i agents Ahh…There’s nothing like a hot shower! Let’s talk cannabinoid hyperemesis syndrome: a,c,e

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Pharmacy Journal of New England • July 2019

Now in its 15th year, the New England Pharmacists Convention is the premier gathering of pharmacy professionals on the East Coast. Comprising advanced certificate programs, informative breakout sessions, talks by industry thought leaders, and much more, the convention is a source of continuing education tailored specifically to pharmacy professionals and promoting a climate conducive to excellence in pharmacy practice. Don’t miss it! FOR AGENDA, ACCOMMODATIONS, REGISTRATION, EXHIBITION AND SPONSORSHIP OPPORTUNITIES, GO TO

ctpharmacists.org/NEPC Bring the family! The 2019 New England Pharmacists Convention will be held on the banks of the Connecticut River at the beautiful Hartford Marriott Downtown, offering attendees tons of opportunities for extracurricular activities, including the nearby Connecticut Science Center, Dunkin’ Donuts Ballpark (home of the Yard Goats), the Wadsworth Atheneum and much more. Great restaurants, river walks and cruises, and active nightlife await–and Six Flags New England, the MGM SpringÞeld Casino and the Big E are just a short drive away.

• 3 pharmacist certiÞcation programs • 15 CE sessions, including pharmacogenomics and veterinary tracks • Annual awards banquet • Tons of networking and community building • Hundreds of attendees from across New England and beyond • Student career, competition, and poster programs

FOR AGENDA, ACCOMMODATIONS, REGISTRATION, EXHIBITION AND SPONSORSHIP OPPORTUNITIES, GO TO

ctpharmacists.org/NEPC 19


Save the Date in New England! SEPT

12 SEPT

13

New England Pharmacists Convention Now in its 15th year, the New England Pharmacists Convention (NEPC) is the premier gathering of pharmacy professionals on the East Coast. Comprised of advanced certificate programs, informative breakout sessions, networking opportunities and more, NEPC is a source of continuing education that is tailored specifically to pharmacy professionals. This year, NEPC will take place on September 12-13 on the banks of the Connecticut River at the beautiful Hartford Marriott. The two-day event will feature several certificate programs, student programming and three CE tracks on pharmacogenomics, medical marijuana and diabetes. Visit ctpharmacists.org/NEPC for more details.

NOV

14 NOV

15

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Massachusetts Pharmacists Fall Summit The Massachusetts Pharmacists Association's inaugural Fall Pharmacists Summit will take place at the MGM Springfield/MassMutual Center in Springfield, MA. The event will kick off on November 14 with CE tracks on business management and health & disease, a poster session, and networking reception, as well as the MPhA Awards & Installation Banquet. The event will continue with a keynote address from Michael Botticelli of the Boston Medical Center, a panel and CE breakout sessions, including a non-sterile compounding track. Visit masspharmacists.org for more details.


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Profile for CT Pharmacists Association

Pharmacy Journal of New England July 2019  

PJNE 2019

Pharmacy Journal of New England July 2019  

PJNE 2019

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