Pharmacy Practice + Business - November 2019 by ensembleiq

NOVEMBER 2019

Hello, Iâ&#x20AC;&#x2122;m here to help you.

Pharmacists supporting cardiovascular care

HIV TREATMENT UPDATE Assessing common eyelid conditions

THE VIRTUAL PHARMACIST

HOW REMOTE ACCESS TECHNOLOGY IS IMPROVING CARE, SAVING COSTS AND CREATING NEW BUSINESS OPPORTUNITIES FOR PHARMACY

1.0 CEU

Integration of New Treatment Options for Patients with Severe Asthma

CanadianHealthcareNetwork.ca

ADOLESCENTS AND YOUNG ADULTS MAY BE AT RISK FOR

MenB

Because they share

In Canada between 2011 and 2015:2 • Individuals 10-24 years of age accounted for 1 out of 4 cases of invasive meningococcal disease (IMD) • MenB caused the majority (63%) of IMD cases

Serogroup B %

37%

All other Serogroups

MenB = serogroup B IMD

Help protect your adolescent and young adult patients from MenB with TRUMENBA® 1 TRUMENBA is indicated for active immunization to help prevent invasive meningococcal disease (IMD) caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age.

Please consult the Product Monograph at www.pfizer.ca/ pm/en/Trumenba.pdf for contraindications, warnings, precautions, adverse reactions, interactions, dosing, and conditions of clinical use. The Product Monograph is also available upon request by calling 1-800-463-6001.

References: 1. TRUMENBA® Product Monograph. Pfizer Canada ULC. 2. Public Health Agency of Canada. Vaccine Preventable Disease Surveillance Report to December 31, 2015. Available at: https://www.canada.ca/ content/dam/phac-aspc/documents/services/publications/healthy-living/vaccine-preventable-disease-surveillance-report-december-31-2015/vaccine-preventable-disease-eng.pdf. Accessed on June 20, 2019.

PP-TRU-CAN-0047-EN

Contents

NOVEMBER 2019 [VOL.6 NO.9] PAGES 27-30 CE LESSON

Hello, I’m here to help you.

Integration of new treatment options for patients with severe asthma

1.0 CEU

MADE POSSIBLE BY ASTRAZENECA

23 17

EDITOR’S MESSAGE

THE BUZZ

8 13 17

Here comes the future BY VICKI WOOD

What pharmacists are talking about on CanadianHealthcareNetwork

DRUG NEWS

A review of new launches, new indications, new dosage forms, discontinued drugs and Health Canada Advisories

BY LU-ANN MURDOCH

PRACTICE EXPERTS

Therapeutic Issues BY JILLIAN REARDON Adverse Reactions BY SANDRA KNOWLES

CLINICAL FEATURE HIV treatment update for community pharmacists

37 38

BY MICHELLE FOISY

ON THE COVER

The Innovators: The Virtual Pharmacist— How remote access technology is improving care, saving costs and creating new business opportunities for pharmacy BY ROSALIND STEFANAC

FINDING YOUR NICHE Cardiovascular care

BY ROSALIND STEFANAC

SELF-CARE REVIEW

OTC Issues: Don’t cry, it’s just a stye! A review of common eyelid conditions BY NARDINE NAKHLA

OTC COUNSELLING TIP SHEET Dandruff—An opportunity in self-care BY NOOR REHMAN

CLASSIFIEDS

Employment opportunities and services

BACK TALK

Managing: “Flu shots? They make me sick!” BY CARLENE OLEKSYN ILLUSTRATION BY SPENCER FLOCK

www.CanadianHealthcareNetwork.ca @Ppr_plus

@PharmacyPracticePlusBusiness

[Vol.6 No.9] NOVEMBER 2019

NO MATTER HOW YOU SEE IT, THE NUMBERS ARE ALWAYS RIGHT.

TOP SAFETY PICK+

Legacy, Crosstrek, Outback, Impreza: on models with EyeSight® & speciﬁc headlights. Ascent: on models with speciﬁc headlights.

2019 ASCENT

2019 LEGACY

2019 CROSSTREK

SUBARU

BEST RESALE VALUE OF ALL MAINSTREAM BRANDS

5 years in a row

2019 IMPREZA

2019 OUTBACK

98.3% of our vehicles sold in Canada over the last 10 years are still on the road today.

And for the 5th consecutive year, ALG named Subaru as the Top Mainstream Brand for Residual Value. The numbers speak for themselves. They are proof of Subaru’s reliability. We know there’s a lot to consider when looking for a fleet vehicle to fit your company’s needs. So add low cost of ownership, responsible engineering, legendary safety and capability features into the equation. You’ll find out that Subaru is always a great solution.

Visit us at subaruﬂeet.ca 1. Safety ratings are awarded by the Insurance Institute for Highway Safety (IIHS). Please visit www.iihs.org for testing methods. 2. ALG named Subaru the Top Mainstream Brand for Residual Value in the 2019 Canadian Residual Value Awards. ALG is the benchmark for residual value projections in North America, publishing residual values for all vehicles in the United States and Canada. For more information, visit www.alg.com. 3. Based on IHS Markit Vehicles in Operation as of June 30, 2018 for Model Years 2009 to 2018 vs Total New Registrations of those vehicles.

EDITOR’S MESSAGE

Here comes the future

TOMORROW MARKS THE START of a

much-anticipated week of pharmacy education. First stop is Pharmacy U Vancouver, our one-day business-focused CE event. Pharmacy U is always a great chance to catch up with practising pharmacists and become inspired by creative practitioners with forward-thinking ideas. Next, I head to the National Community Pharmacist Association (NCPA) conference, the largest convention for U.S. independent pharmacy owners and pharmacists. Being immersed in NCPA sessions is like catching a sneak peek at our future. It never fails to deliver exciting new trends and concepts that will eventually trickle into Canada. A decade ago, the excitement at NCPA was about medication synchronization (the appointment-based pharmacy model). I was enthralled by stories of how the med sync system freed pharmacists from the hamster wheel of typical community practice so they could perform the pharmacy services they enjoyed—and could bill for. I wrote about the concept, excited to PHARMACY PRACTICE + BUSINESS GROUP BRAND DIRECTOR, HEALTHCARE Donna Kerry dkerry@ensembleiq.com VICE PRESIDENT/ GENERAL MANAGER EVENTS Michael Cronin mcronin@ensembleiq.com EDITOR Vicki Wood vwood@ensembleiq.com

CONSULTING CLINICAL EDITOR Lu-Ann Murdoch, BScPhm VICE PRESIDENT, PRODUCTION Derek Estey CREATIVE DIRECTOR Nancy Peterman

PRODUCTION MANAGER Lisette Pronovost

share an idea that could transform community pharmacy workflow. The initial silence was deafening, but a few years later, the appointment-based model began to make inroads in some pharmacies here. In 2017, the dominant theme among U.S. community pharmacists was the emergence of Community Pharmacy Enhanced Services Networks (CPESN). The CPESN concept involves networks of pharmacies co-operating to offer patientcentred services as a way to differentiate themselves from the dominant PBMowned pharmacy retail chains. Aready, these networks span all but a handful of U.S. states and are recognized as viable alternatives to corporate pharmacies by governments and other payers seeking cost-saving, medically effective healthcare, particularly for complex patients. One of the lynchpins of the CPESN model is pharmacy specialty services. Ideally, a local network includes pharmacies offering a range of specialized patient care services, so that any patient care needs can be met within each network

DIRECTOR OF MARKETING Alex Voulu

ACCOUNT MANAGERS, QUÉBEC Ted Georgaros CONTINUING EDUCATION/ tgeorgaros@ensembleiq.com PROJECT MANAGER/PROOFREADER Nancy Dumont Rosalind Stefanac ndumont@ensembleiq.com WEB OPERATIONS MANAGER COLUMNISTS AND Valerie White CONTRIBUTING/CONSULTING SENIOR DIRECTOR EDITORS AUDIENCE STRATEGY Derek Desrosiers, BSc(Pharm), Lina Trunina RPEBC, RPh; Shelley Diamond, ltrunina@ensembleiq.com BScPhm; Sherilyn Houle, BSP, PhD; Sandra Knowles, BScPhm; SALES & EVENTS COORDINATOR Lu-Ann Murdoch, BScPhm; Nardine Claudia Castro Nakhla, PharmD; Carlene Oleksyn, BSP Pharm, CTH; Vikas Parihar, BRAND DIRECTOR BScBiochem, BScPharm, PharmD; Martin Rissin Jillian Reardon, BSc(Pharm), ACPR, mrissin@ensembleiq.com PharmD, RPh; Rosalind Stefanac; SENIOR ACCOUNT MANAGERS, Karen Welds TORONTO Norman Cook ncook@ensembleiq.com Scott Tweed stweed@ensembleiq.com

of independent pharmacies. High-volume chain pharmacies can undercut fees, but when it comes to keeping plan members well and managing complex and chronic conditions, specialty care is often the answer, and payers are beginning to acknowledge its value. To pique interest in specialty pharmacy here in Canada, we launched the Finding Your Niche series (see page 31), which provides an overview of the options for specialty practice in pharmacy. Pharmacists with a specialty often feel more satisfied in their work and have greater ability to practise on their own terms. Perhaps it’s an option more will consider as a way to break free and “own” their careers. Niche specialization could also be a way for community pharmacies to survive in this cost-cutting era. All this to say, no doubt this year’s NCPA event will influence what you read about in this magazine in the future. So buckle your seatbelts: the theme of this year’s conference is “Changing the Pharmacy Payment Model.”

vwood@ensembleiq.com @Ppr_plus @PharmacyPracticePlusBusiness

CORPORATE OFFICERS CHIEF EXECUTIVE OFFICER Jennifer Litterick CHIEF FINANCIAL OFFICER Dan McCarthy

CHIEF INNOVATION OFFICER Tanner Van Dusen

CHIEF HUMAN RESOURCES OFFICER Ann Jadown EXECUTIVE VICE PRESIDENT, EVENTS & CONFERENCES Ed Several

Pharmacy Practice + Business, established in 1985, is published 10 times a year by EnsembleIQ, 20 Eglinton Ave. West, Suite 1800, Toronto, ON, M4R 1K8 Phone: 877.687.7321 Fax: 888.889.9522. Website: CanadianHealthcareNetwork.ca. Montreal Office: 1425 René Lévesque ouest, 2e étage, Montréal Quebec, H3G 1T7. Pharmacy Practice + Business is abstracted in International Pharmaceutical Abstracts (IPA). Subscriptions: $98.00 per year, 2 year $156.00, Outside Canada $156.00 per year, Single Copy $12.00, Groups $69.00, Outside Canada Single Copy $16.00. Pharmacy Practice + Business is published 10 times per year except for occasional combined, expanded or premium issues, which count as two subscription issues. Mail Preferences: Occasionally we make our subscriber list available to reputable companies whose products or services may be of interest to you. If you do not want your name to be made available please contact us at contactus@canadianhealthcarenetwork.ca. Contents copyright © 2019 by EnsembleIQ; may not be reprinted without permission. EnsembleIQ does not assume liability for content. Pharmacy Practice + Business receives unsolicited materials (including letters to the editor, press releases, promotional items and images) from time to time. 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. ISSN 08-29-2809.

SUBSCRIPTION SERVICES To subscribe or renew, go online to www.CanadianHealthcareNetwork.ca/subscribe, phone toll-free 1.844.694.4422 between 9 a.m. to 5 p.m. EST weekdays or email contactus@canadianhealthcarenetwork.ca CONTINUING EDUCATION All CCCEP-accredited continuing education lessons featured in Pharmacy Practice + Business are available for credit online at eCortex.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 REPRINTS, PERMISSIONS, AND LICENSING Please contact Wright’s Media Email: ensembleiq@wrightsmedia.com Phone: 1.877.652.5295 FIND US ONLINE The online home for Pharmacy Practice + Business is CanadianHealthcareNetwork.ca. Registration is easy and free to qualified pharmacy professionals.

@Ppr_plus

@PharmacyPracticePlusBusiness

CONTACT US: 20 Eglinton Ave. West, Suite 1800, Toronto, ON, M4R 1K8; Phone: 1.844.694.4422; Fax: 1.844.815.0700; Email: pharmacypractice@canadianhealthcarenetwork.ca; Publications mail agreement no. 42940023.

[Vol.6 No.9] NOVEMBER 2019

“THE BUZZ

THE FIRST WORD IS YOURS

Here’s what pharmacists are talking about on CanadianHealthcareNetwork.ca this month:

THE HIDDEN RISKS OF MINOR AILMENT PRESCRIBING Pharmacist and now fourth-year medical student Arman Zereshkian cautions that, although after proper training, many pharmacists could definitely take on the role of assessing and prescribing minor ailments. But whether this is realistic—and safe— within the confines of the typical community pharmacy is debatable.

YOUR COMMENTS “ The Minor Ailments program details in Ontario have not been fleshed out as yet, only the permissionto-plan part. With the experience gained by other provinces already, we have a good chance of moving this forward in a positive way for patients and for the healthcare system. Thank you for the cautions and your perspective.”

“ There could be a fine line between what most might call minor ailments and conditions of greater significance. Pharmacists are trained in therapeutics, but not in diagnosis. How many times have you received an MD’s order for UTI or Strep throat ahead of a definitive lab result? Are you prepared to do this? We also enter a new scope of increased liability.”

“ [In Saskatchewan] there is data already indicating UTIs prescribed by a pharmacist are just as effectively treated with better drug selection (pharmacists were found to follow guidelines much closer than physicians). Not to mention that patients absolutely love that they are able to be seen and treated faster. Like any skill, it requires a little practice but our new grads are coming out prepared to offer the service and the uptake has been seen in almost every pharmacy in the province.”

AND THE LAST WORD IS YOURS

Don’t forget to check out current news, blogs and expert columns! 6

NOVEMBER 2019 [Vol.6 No.9]

Getty Images

“This article is the exact opposite of what’s needed in pharmacy right now. The negativity towards improved patient care via improved access with knowledgeable professionals who are already trained to perform these types of basic assessments is what we heard from physicians 10 years ago. We need to find ways to help improve morale in pharmacy, not do the opposite.”

Do something amazing ®

Help them quit – for good – with the latest in smoking cessation delivered right to your inbox

82% One study found that 82% of smokers wanted their physician to talk about smoking often, or at every visit.1 In fact, seeing a GP but not getting advice to quit can significantly decrease their odds of quitting.2

Even 3 minutes of your time can boost their odds by 30%.3 Get quick counselling tips, NRT dosing information, NICORETTE® & NICODERM® sample ordering opportunities and more in your inbox.

NRT=nicotine replacement therapy NICORETTE® and NICODERM® are smoking cessation aids that can reduce withdrawal symptoms and nicotine cravings in adults 18 years and older. For cautions and warnings, please visit https://www.helpthemquit.ca/treatment/overview. Always direct the patient to read the label. References: 1. Quinn VP, et al. Tobacco-cessation services and patient satisfaction in nine nonprofit HMOs. Am J Prev Med 2005;29(2):77-84. 2. West R. The science, economics and politics of tobacco control. University College London clinical presentation 2013. 3. Fiore MC, et al. Clinical practice guideline: Treating tobacco use and dependence: 2008 update. © Johnson & Johnson Inc. 2019

DRUG NEWS

A REVIEW OF NEW LAUNCHES, NEW INDICATIONS, NEW DOSAGE FORMS AND HEALTH CANADA ADVISORIES

CLINICAL EDITOR

LU-ANN MURDOCH, RPh, BScPhm, ACPR, is a

consulting clinical editor for Pharmacy Practice +Business and drug information consultant for Pharmacist’s Letter.

NEW PRODUCTS

Dovato: two-drug complete regimen for HIV dolutegravir 50 mg (as dolutegravir sodium) and lamivudine 300 mg tablets, ViiV Healthcare.

INDICATIONS A complete regimen

for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents 12 years of age or older and weighing at least 40 kg. Safety and efficacy have not been studied in HIV-1-infected patients who have failed previous antiretroviral therapy and are currently not virologically suppressed. Should not be used in patients with known or suspected resistance to dolutegravir or lamivudine. ACTION Dolutegravir is an integrase strand transfer inhibitor (INSTI). Lamivudine is a nucleoside reverse transcriptase inhibitor (NRTI). DOSAGE Adults and adolescents weighing at least 40 kg: One tablet once daily, taken with or without food. Not recommended for use in patients with a creatinine clearance < 50 mL/min. No dosage adjustment is required in mild or moderate hepatic insufficiency; not recommended in severe hepatic insufficiency. See also Drug Interactions section for situations where an additional dose of dolutegravir is required. ADVERSE EFFECTS MOST COMMON: Headache. Possible increase in serum 8

lipid and blood glucose levels. MOST SERIOUS: Potential to cause hepatotoxicity (including elevated serum liver enzymes, hepatitis and acute liver failure), severe acute exacerbations of hepatitis B in patients co-infected with HIV-1 and hepatitis B virus, lactic acidosis and severe hepatomegaly with steatosis, hypersensitivity reactions (e.g., severe rash or rash with fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial edema, hepatitis, eosinophilia, angioedema), immune reconstitution inflammatory syndrome, opportunistic infections. DRUG INTERACTIONS Contraindicated with dofetilide (potential life-threatening toxicity caused by increased dofetilide concentrations). Certain medications may decrease dolutegravir concentrations (e.g., oxcarbamazepine, carbamazepine, phenytoin, phenobarbital, St. John’s wort, rifampin); in these situations, an additional 50 mg dose of dolutegravir (Tivicay) should be taken, separated by 12 hours from Dovato. May increase metformin concentrations; consider metformin dose adjustments when starting or stopping Dovato treatment to maintain glycemic control. Medications containing polyvalent cations (magnesium or aluminum in antacids, sucralfate, buffered medications) may decrease dolutegravir concentrations: administer Dovato two hours before or six hours after these medications. Dovato can be taken at the same time as calcium and/or iron supplements or multivitamins containing calcium and/or iron if taken with food; under fasting conditions, Dovato should be taken two hours before or six hours after taking supplements containing calcium and/or iron.

Lokelma: new potassium binder for hyperkalemia sodium zirconium cyclosilicate powder for oral suspension; 5 g and 10 g sachets, AstraZeneca.

NOVEMBER 2019 [Vol.6 No.9]

INDICATIONS Treatment of hyperkalemia

in adults, including elderly patients. Should not be used for life-threatening hyperkalemia because of its delayed onset of action; starts to reduce serum potassium one hour after administration in patients with hyperkalemia. ACTION A nonabsorbable, nonpolymer inorganic powder with a uniform micropore structure. Selectively captures potassium (rather than calcium or magnesium) in exchange for hydrogen and sodium cations. Increases fecal potassium excretion through binding of potassium throughout the lumen of the gastrointestinal tract. This reduces potassium absorption, thereby lowering serum potassium levels. DOSAGE Correction phase: If serum potassium level is > 5.0 mmol/L, the recommended starting dose is 10 g, administered three times daily for up to 48 hours. When potassium levels normalize (3.5–5.0 mmol/L), start with maintenance dosage. If normokalemia is not achieved by the start of Day 3, consider other treatment approaches. Maintenance dosage: Use minimal effective dose to prevent recurrence of hyperkalemia. Adjust dose based on the serum potassium level and desired target range. Recommended dose is 5 g once daily, with possible titration (in increments of 5 g once daily) up to 10 g once daily, or down to 5 g once every other day, as needed, to maintain a normal potassium level. No more than 10 g once daily should be used for maintenance therapy. ADMINISTRATION Can be taken with or without food. Instruct patient to empty the entire contents of the sachet into a drinking glass containing about 45 mL of water. Stir well and drink immediately after mixing, while the powder (which does not dissolve) is still suspended. Suspension is tasteless. Advise to stir mixture again if the powder settles and to

use additional water to ensure the entire dose is taken. ADVERSE EFFECTS MOST COMMON: Peripheral edema (each 5 g of sodium zirconium cyclosilicate powder contains ~ 400 mg of sodium); monitor for signs of edema, particularly in patients who should restrict their sodium intake or are prone to fluid overload associated with comorbidities (e.g., heart failure or renal disease). Muscle spasms, constipation. Avoid in patients with severe constipation, bowel obstruction or impaction, including abnormal postoperative bowel motility disorders. MOST SERIOUS: Hypokalemia; dose titration may be required to prevent moderate to severe hypokalemia. DRUG INTERACTIONS Not absorbed or metabolized by the body. Can transiently increase gastric pH; oral medications with gastric pH-dependent bioavailability should be administered at least two hours before or two hours after sodium zirconium cyclosilicate. The following drugs should be administered at least two hours before or two hours after sodium zirconium cyclosilicate: atorvastatin, azole antifungals (e.g., ketoconazole itraconazole, posaconazole), dabigatran, protease inhibitors (e.g., atazanavir, nelfinavir, indinavir, ritonavir, saquinavir, raltegravir, ledipasvir, rilpivirine), and tyrosine kinase inhibitors (e.g., erlotinib, dasatinib, nilotinib).

OTHER NEW PRODUCTS pdp-Amlodipine amlodipine 1 mg/mL oral solution (as amlodipine besylate); 150 mL bottle, Pendopharm.

INDICATIONS 1. Treatment of mild

to moderate essential hypertension. 2. Management of chronic stable angina (effort-associated angina) in patients who remain symptomatic despite adequate doses of beta-blockers and/or organic nitrates or who cannot tolerate those agents. DOSAGE Hypertension or angina in adults: Recommended initial dose is 5 mg (5 mL) once daily. Dose can be increased after one to two weeks (if necessary) to a maximum of 10 mg (10 mL) once daily. Hypertension in children (6–17 years of age): Usual effective dose is 2.5–5 mg (2.5–5 mL) once daily. Doses above 5 mg (5 mL) daily have not been studied. ADMINISTRATION Do not shake prior to administration. Take at the same time

every day (e.g., with breakfast, lunch or at bedtime). Do not mix with food or beverages before use. STORAGE Store upright in the refrigerator (2–8 ºC). Discard 30 days after opening. COMMENTS First amlodipine oral solution to be marketed in Canada. An alternative to pharmacy-compounded product.

NEW INDICATIONS

Revestive (teduglutide for injection), Shire/Innomar Strategies.

Actemra (tocilizumab for injection), Hoffmann-La Roche.

NEW INDICATION Intravenous (IV)

formulation is now approved for the treatment of patients with chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome, in accordance with patient populations specified for authorized CAR T cell products. (The IV formulation of Actemra is also indicated for use in the treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis.) DOSAGE Cytokine release syndrome: 8 mg/kg (patients weighing ≥ 30 kg) or 12 mg/kg (patients weighing < 30 kg), given as a 60-minute IV infusion. If no clinical improvement in signs and symptoms is seen after the first dose, up to three additional doses may be administered.

Inflectra (infliximab for injection), Celltrion/Pfizer.

NEW INDICATION Now indicated

for use in children: 1. For reducing signs and symptoms, and for inducing and maintaining clinical remission in children ≥ 9 years of age with moderately to severely active Crohn’s disease who have had an inadequate response to

conventional therapy. 2. For reducing signs and symptoms, inducing and maintaining clinical remission and inducing mucosal healing in children ≥ 6 years of age with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy (i.e., aminosalicylate and/or corticosteroid and/ or an immunosuppressant). (Formerly indicated only for several therapeutic indications in adults.) DOSAGE Crohn’s disease in children ≥ 9 years of age: 5 mg/kg given as an induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every eight weeks. Patients who do not respond by week 14 are unlikely to respond with continued therapy; consider discontinuing Inflectra in these patients. Ulcerative colitis in children (≥ 6 years of age): 5 mg/kg given as an induction regimen at 0, 2 and 6 weeks followed by 5 mg/kg every eight weeks thereafter. Administered by IV infusion over a period of at least two hours.

EXPANDED INDICATION Now indicated for the treatment of children (≥ 1 year of age who weigh ≥ 10 kg) with short bowel syndrome who are dependent on parenteral support. (Formerly approved for this use only in adults.) DOSAGE Adults and children: 0.05 mg/kg administered by subcutaneous injection once daily. Alternate injection sites (thighs, arms, and the 4 quadrants of the abdomen).

Trulicity (dulaglutide injection), Eli Lilly.

EXPANDED INDICATION Now indicated

for the once-weekly treatment of adults with type 2 diabetes to improve glycemic control, in combination with a sodium glucose co-transporter 2 inhibitor with metformin. (Formerly approved only for use alone [when metformin is inappropriate] or for use in combination with metformin; metformin and a sulfonylurea; a basal insulin with metformin; or a prandial insulin with metformin.) DOSAGE Recommended starting dose is 0.75 mg once weekly, administered subcutaneously. Dose may be increased to 1.5 mg once weekly for additional glycemic control.

[Vol.6 No.9] NOVEMBER 2019

(New Indications continued)

NEW DOSAGE GUIDELINES

Zerbaxa

Kyprolis (carfilzomib for injection), Amgen.

(ceftolozane and tazobactam powder for injection), Merck.

NEW INDICATION Now indicated for

the treatment of adults with nosocomial pneumonia, including ventilatorassociated pneumonia caused by the following susceptible Gram-negative microorganisms: Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa and Serratia marcescens. (Originally indicated only for the treatment of complicated intraabdominal infections and complicated urinary tract infections in adults.) DOSAGE Nosocomial pneumonia: Recommended dosage regimen is 3 g (ceftolozane 2 g and tazobactam 1 g) administered every eight hours by IV infusion over one hour. The duration of therapy ranges from eight to 14 days, depending on the severity of infection and the patient’s clinical progress.

When used in combination with dexamethasone alone in the treatment of patients with relapsed multiple myeloma, a new once-weekly dosing regimen has been approved as an alternative to the traditional twice-weekly dosing regimen. The once-weekly regimen is intended for patients who cannot adhere to the twice-weekly regimen due to the burden of dosing frequency. Note that the onceweekly regimen has not been compared with the twice-weekly regimen within a clinical trial. DOSAGE Once-weekly regimen (first cycle): Carfilzomib is given by IV infusion once weekly for three weeks (Days 1, 8, and 15), followed by a 13-day rest period (Days 16 to 28). The dosage of carfilzomib is 20 mg/m2 on Day 1, increasing to the target dose of 70 mg/m2 on Day 8. Dexamethasone 40 mg orally or IV is administered on Days 1, 8, 15 and 22; it should be given 30 minutes to four hours before carfilzomib. Consult product monograph for dosages in subsequent cycles.

oxycodone, hydromorphone, tramadol, tapentadol, hydrocodone, methadone, buprenorphine). Taking a gabapentinoid and an opioid at the same time also increases the risk of serious side effects, including respiratory depression, increased sedation, dizziness, fainting and death.

Vaping products: risk of pulmonary illness

Health Canada is warning about recent cases of acute pulmonary illnesses and several deaths possibly linked to the use of vaping products in the United States. The cause is under investigation, but is likely due to chemical exposure after vaping tetrahydrocannabinol (THC) and/or nicotine-containing products. Canadians who use vaping products should seek medical attention promptly if they develop symptoms of pulmonary illness (e.g., cough, shortness of breath, chest pain). 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-healthproducts/medeffect-canada.html and https:// www.canada.ca/en/health-canada/services/ drugs-health-products/medeffect-canada/ safety-reviews.html.

HEALTH CANADA ADVISORIES

NEW GENERICS

Opioids and gabapentinoids: increased risks when used together

• Sandoz Gefitinib

(gefitinib 250 mg tablets), Sandoz. Generic alternative to Iressa.

Health Canada is warning about the increased risk of opioid overdose when taking gabapentinoids (i.e., gabapentin [Neurontin, generics] or pregabalin [Lyrica, generics]) with an opioid (codeine, fentanyl, morphine,

DON’T MISS OUT! Are you staying informed of all the important Canadian pharmacy news and updates? Sign up for our twice-weekly e-newsletters and never miss a thing. PHARMACY NEWS

TUESDAYS

AND

PHARMACY NEWS

THURSDAYS

To sign up, simply register at CanadianHealthcareNetwork.ca/pharmacists, and opt-in to receive the newsletter.

NOVEMBER 2019 [Vol.6 No.9]

THANK YOU for making Blistex the

#1 recommended lip balm 8 years in a row!

Pharmacist developed, pharmacist recommended.

RECOMMEND A SUPERFRUIT INFUSION FOR YOUR PATIENTS’ LIPS NEW Blistex Superfruit Soother ® Lip Balm • Cloudberry and Acai berry extracts provide lips with a nourishing dose of Vitamins C and E, helping to protect and revive damaged lips. • With a combination of antioxidants and fatty acids, Blistex Superfruit Soother works to ensure moisturized and healthy lips. • SPF 15 sun protection. • A hint of mint helps soothe and refresh lips stressed by our Canadian winter.

About Superfruits • Superfruits, a term coined by nutrition scientists, are packed with antioxidants, vitamins, minerals and other nutrients, contributing to overall good health. • Acai berries are extremely high in vitamin C, and therefore have antioxidant properties, beneficial to maintaining healthy lips. • Cloudberries, also known as Nordic Berries, are part of a newly emerging class of powerful superfruits that can thrive in extreme Arctic temperatures, making them extremely resilient.

All our medicated products also provide hydrating ingredients to help moisturize, soften and condition dry lips.

COUNSELLING OPPORTUNITY Lip care is often overlooked in a skincare regimen; however, the lips are one of the most exposed parts of the body and one of the most delicate. Watch for prescriptions being filled for medications that tend to dry the skin. Advise your patients to treat irritated, cracked lips. Suggest Blistex as part of a “healing arsenal” during cough and cold season. Encourage your patients to be proactive and protect their lips, particularly when exposed to the sun … lips burn easily!

Blistex Medicated Lip Ointment

Blistex Lip Medex

Blistex Ultra Protection

• Helps hydrate and soften dry, cracked lips • Helps relieve lip sores and blisters

• Quickly cools, comforts and helps protect sore lips • Also available in jar and tube varieties

• Helps protect against harsh elements – sun, wind and cold • Waterproof, SPF 30

Blistex has been in the business of taking care of lips for more than 70 years. For complete product information and lip care tips, visit www.Blistex.com. © 2019 Blistex Corporation. All rights reserved.

Pharmacy Practice + Business and Profession Santé 2019 on OTC Counselling and Recommendations

STRONGLY RECOMMENDED BY NACI

The National Advisory Committee on Immunization (NACI) recommends that SHINGRIX should be offered to adults 50 years of age and older (strong recommendation)1 According to NACI, a strong recommendation applies to most individuals and should be followed unless a clear and compelling rationale for an alternative approach is present.1 Refer to the NACI statement on the Public Health Agency website for further information. Recommend SHINGRIX to your patients as young as 50 years of age. Indication: SHINGRIX is indicated for prevention of herpes zoster (HZ, or shingles) in adults 50 years of age or older. Contraindications: • Patients with a known hypersensitivity to the active substance or to any component of the vaccine. Most serious warnings and precautions: • Administration: Do not administer the vaccine intravascularly, intradermally or subcutaneously. Other relevant warnings and precautions: • A protective immune response may not be elicited in all vaccinees • Not for prevention of primary varicella infection or treatment of HZ or postherpetic neuralgia • Postpone in those with acute severe febrile illness • Use with caution in those with thrombocytopenia or any coagulation disorder • Syncope following or before any vaccination as a psychogenic response • Use in special populations such as pregnant or nursing women or pediatrics (<18 years of age) has not been established • Limited data in immunocompromised adults 50 years of age or older

Adverse events: • Solicited local and general adverse reactions that occurred in clinical trials within 7 days of vaccination in subjects aged 50–69 and ≥70 years respectively were: pain (85.6%, 69.2%), redness (38.5%, 37.7%), swelling at the injection site (28.5%, 23.0%), myalgia (53.0%, 35.1%), fatigue (51.3%, 36.6%), headache (45.2%, 29.0%), shivering (33.1%, 19.5%), fever (25.9%, 14.3%), gastrointestinal symptoms (20.5%, 13.5%) • Unsolicited adverse reactions that occurred in clinical trials within 30 days of vaccination in ≥1% of subjects and ≥2-fold higher than placebo recipients included chills (3.5%), injection site pruritus (2.2%), and malaise (1.7%) For more information: Please consult the product monograph at gsk.ca/SHINGRIX/PM for important information relating to dosing and administration, adverse reactions, and drug interactions which have not been discussed in this piece. To request a product monograph, or to report an adverse event please call 1-800-387-7374.

Learn more about SHINGRIX at ThinkSHINGRIX.ca References: 1. Public Health Agency of Canada. An Advisory Committee Statement (ACS), National Advisory Committee on Immunization (NACI) – Updated Recommendations on the Use of Herpes Zoster Vaccines. Ottawa, Ontario: Public Health Agency of Canada; June 2018. https://www.canada.ca/en/services/health/ publications/healthy-living/updated-recommendations-use-herpes-zoster-vaccines.html. 2. SHINGRIX Product Monograph. GlaxoSmithKline Inc., October 13, 2017. Trademarks are owned by or licensed to the GSK group of companies. ©2018 GSK group of companies or its licensor.

02923 12/18

PRACTICE EXPERTS

OUR PHARMACIST EXPERTS SHARE INFORMATION AND IDEAS TO SUPPORT YOUR DAILY PRACTICE

THERAPEUTIC ISSUES

JILLIAN REARDON, ACPR, PharmD, RPh,

is a clinical pharmacist and lecturer at the Pharmacists Clinic, Faculty of Pharmaceutical Sciences, University of British Columbia.

Subclinical hypothyroidism – are we overtreating?

ubclinical hypothyroidism (SCH) affects 4%–20% of the general population, with women, the elderly and Caucasians most afflicted.(1) It is defined as elevated serum thyroid stimulating hormone (TSH) with normal serum free thyroxine levels.(1) The true prevalence of SCH in those over age 70 is likely overestimated, as TSH can naturally rise with age, surpassing the upper limit of normal.(1) Approximately 90% of patients with SCH have a TSH between the upper end of normal (4.5–5 mU/L) and 10 mU/L (Table 1).(1) Causes of SCH are the same as overt hypothyroidism, the most common being chronic autoimmune thyroiditis (Hashimoto’s disease).(2)

Clinical implications

Progression to overt hypothyroidism The majority of patients with SCH and TSH < 10 mU/L are asymptomatic. While some patients have vague nonspecific symptoms, such as fatigue and cognitive deficits, these complaints are common even in euthyroid individuals.(1,2) When TSH is < 10 mU/L, annual progression to overt hypothyroidism is 2%–5%, with risk increased if thyroid peroxidase antibodies are present and/or TSH ≥ 10 mU/L.(1) Conversely, in 60% of patients with SCH and TSH < 10 mU/L, TSH will decline to normal within five years.(1) Cardiovascular disease A meta-analysis of observational studies, including more than 75,000 participants, did not find an association between SCH

Pharmacists can play a role in educating patients and prescribers on the lack of evidence to justify levothyroxine use in the vast majority of SCH cases.

and adverse cardiovascular outcomes.(3) However, when only individuals with TSH > 10 mU/L were analyzed, there was a statistically significant association with increased risk of coronary artery disease, heart failure and cardiovascular mortality.(3) Cognitive impairment A meta-analysis of observational studies, including more than 18,000 participants, demonstrated a positive association between SCH and cognitive impairment or dementia in patients under age 75; however, this finding may have been confounded by degree of TSH elevation.(4) No statistical association was seen in patients older than 75 years.(4)

Evidence for thyroid replacement therapy

The TRUST trial is the largest prospective study evaluating SCH treatment.(5) It randomized 737 patients age 65 or older (mean age 74) with SCH (mean TSH 6.4 mU/L) to receive levothyroxine (median dose 50 µg daily adjusted to target a normal TSH) or placebo.(5) At 12 months, no difference was seen in the primary outcome of hypothyroid symptoms and fatigue scores. Additionally, treatment did not affect any secondary outcomes, which included quality of life, cognitive function, metabolic parameters, carotid intima media

thickness and carotid plaque thickness.(5) Adverse events did not differ between groups at two years.(5) A subsequent meta-analysis of 21 trials (including TRUST), with a total of 2,192 patients with SCH, found no improvement in quality of life or other clinical outcomes with levothyroxine compared to placebo.(6) Results were unchanged when only patients under age 65 were analyzed.(1,6)

Approach to treatment

TSH can be transiently elevated in acute illness; therefore, a repeat measurement should occur in one to three months to confirm a diagnosis of SCH.(1) For nonpregnant adults with repeat TSH values between the upper limit of normal and 10 mU/L, treatment with levothyroxine is not recommended based on lack of demonstrated clinical benefits, risk of iatrogenic hyperthyroidism and burden of adhering to long-term

TABLE 1

Laboratory findings in euthyroid, subclinical and hypothyroid adults(8)* SUBCLINICAL HYPOTHYROID

LAB TEST

NORMAL

TSH

0.4–4.5 mU/L

Free T4 (thyroxine)

8.5–15.2 pmol/L Normal

Low

3.5–6.5 pmol/L

Low

Free T3 (triiodothyronine)

Typically: > 4.5–10 mU/L Rarely: > 10 mU/L

Normal

HYPOTHYROID

Typically: > 10 mU/L

*Reference ranges will vary depending on laboratory

[Vol.6 No.9] NOVEMBER 2019

medication and monitoring.(1,2) When TSH is ≥ 10 mU/L, clinical practice guidelines recommend considering treatment with levothyroxine based on higher risk of progression to overt hypothyroidism and association with increased cardiovascular events.(1-3) Other groups with SCH in whom treatment with levothyroxine may be considered, despite magnitude of TSH elevation, include patients with severe symptoms, under age 30, or women who are pregnant or attempting pregnancy. Robust data are lacking to inform best practices in these patient groups and each case must be evaluated individually.(1)

ADVERSE REACTIONS

SANDRA KNOWLES, BScPhm, is a drug

information pharmacist with Sunnybrook Health Sciences Centre in Toronto.

Pharmacist’s role

REFERENCES 1. Bekkering GE, Agoritsas T, Lytvyn L, et al. Thyroid hormones treatment for subclinical hypothyroidism: a clinical practice guideline. BMJ 2019;365:l2006. 2. Biondi B, Cappola AR, Cooper DS. Subclinical hypothyroidism: a review. JAMA 2019;322:153-60. 3. Rodondi N, den Elzen WP, Bauer DC, et al; Thyroid Studies Collaboration. Subclinical hypothyroidism and the risk of coronary heart disease and mortality. JAMA 2010;304:1365-74. 4. Pasqualetti G, Pagano G, Rengo G, et al. Subclinical hypothyroidism and cognitive impairment. J Clin Endocrinol Metab 2015;100:4240-8. 5. Stott DJ, Rodondi N, Kearney PM, et al. TRUST Study Group. Thyroid hormone therapy for older adults with subclinical hypothyroidism. N Engl J Med 2017;376:2534-44. 6. Feller M, Snel M, Moutzouri E, et al. Association of thyroid hormone therapy with quality of life and thyroid-related symptoms in patients with subclinical hypothyroidism: a systematic review and meta-analysis. JAMA 2018;320:1349-59. 7. IQVIA, CompuScript. Pharmaceutical trends - top 20 dispensed drugs in Canada, 2018. https://www.iqvia.com/-/ media/iqvia/pdfs/canada-location-site/2018-trends/ top20dispensed_en_18.pdf?la=en&hash=437C8A723BEF8D3D585878CBB1FE1044DF1EABF9&_=1565063321716 (accessed August 1, 2019). 8. Medical Council of Canada. Clinical laboratory tests – normal values. https://mcc.ca/objectives/normal-values/ (accessed August 28, 2019).

Pregnancies continue to occur during isotretinoin therapy

sotretinoin, a systemic retinoid, is the most effective medication for the management of severe acne. However, it is a potent teratogen, with an 18%–28% risk of embryopathy in live births. Pregnancy prevention programs have been developed in Canada and the United States in order to reduce fetal exposure to isotretinoin. The US iPLEDGE program requires registration of clinicians, whole salers and pharmacies that provide isotretinoin, as well as patients with a prescription for isotretinoin; it also requires females of childbearing potential to have a pregnancy test with negative results and to verify two forms of contraception monthly. Despite the restrictions on clinicians and patients, it is unknown whether the program has reduced pregnancy rates. An analysis of reports of pregnancyrelated adverse events (i.e., pregnancies, abortions, fetal defects) associated with isotretinoin from January 1, 1997 to December 31, 2017, was done using the US Food and Drug Administration Adverse Event Reporting System. Over the 21-year period, 6,740 pregnancies occurred among women exposed to isotretinoin, peaking in 2006 with 768 pregnancies. A total of 69% were reported after the introduction of the iPLEDGE program in 2006. Since 2010, the number of pregnancies reported annually ranged from 218–265 per year.

NOVEMBER 2019 [Vol.6 No.9]

Implications for pharmacists

Although the number of pregnancies initially decreased following implementation of the iPLEDGE program in the United States, a substantial number of pregnancies and other pregnancyrelated adverse events continue to occur despite strict requirements for prescribing isotretinoin. The Canadian Pregnancy Prevention Program is similar to iPLEDGE, but has the additional requirement of two pregnancy tests before starting isotretinoin treatment and a pregnancy test one month after discontinuation; however, similar to the US program, pregnancies continue to occur. In Canada, over a 15-year study period, 1,473 pregnancies were recorded during isotretinoin treatment (24.9/1000 users) of which 90.4% terminated spontaneously or by medical intervention. Of the 118 live births, 9.3% had congenital malformations. Changes are needed to current pregnancy prevention programs to safely maintain access to isotretinoin for patients who require it. REFERENCES Tkachenko E, Singer S, Sharma PR, et al. US Food and Drug Administration Reports of pregnancy and pregnancyrelated adverse events associated with isotretinoin. JAMA Dermatol [published online July 17, 2019]. doi:10.1001/ jamadermatol.2019.1388.

Henry D, Dormuth C, Winquist B, et al. CNODES (Canadian Network for Observational Drug Effect Studies) Investigators. Occurrence of pregnancy and pregnancy outcomes during isotretinoin therapy. CMAJ 2016;188:723-30.

Getty Images

Levothyroxine consistently ranks among the most frequently dispensed medications in Canada and utilization is rising, likely in part to SCH treatment.(7) The common and nonspecific nature of hypothyroid symptoms, coupled with frequency of TSH testing, may lead patients to instinctively request treatment for mild TSH elevations. Pharmacists can play a role in educating patients and prescribers on the lack of evidence to justify levothyroxine use in the vast majority of SCH cases. When treatment is deemed appropriate, suggest using low-dose levothyroxine (typically 25–50 µg daily), which is often sufficient to normalize mild TSH elevations. Recommend checking TSH six weeks after starting levothyroxine, with dose adjustments to target the normal TSH reference range (Table 1). In untreated patients, monitor for progression or SCH resolution with annual thyroid function tests.

Cough and cold medications in young children

ough and cold medications include a combination of several drugs including expectorants, antihistamines, antitussives, decongestants and/or antipyretics. In 2008, Health Canada recommended against the use of all over-the-counter cough and cold medicines in children under six years of age, due to lack of benefit and potential harm. Similar recommendations by the American Academy of Pediatrics were made in the United States. In order to observe how these recommendations have impacted prescribing, a recent US study examined 3.1 billion pediatric visits from 2002–2015. They analyzed all physician visits for cough and cold medications containing antitussives, decongestants or expectorants (with or without opioids) as

well as antihistamines as a comparator. Recommendations for opioid- and nonopioid-containing cough and cold preparations declined substantially after the 2008 recommendations, especially in children two years of age or younger. Prescriptions for nonopioid cough and cold medications decreased by 70% for children less than two years of age, and cough and cold medications with opioids dropped by 90% in children under six years of age. In contrast, prescriptions for antihistamines increased by 10-fold in children under four years and more than five times in children four to five years of age.

Implications for pharmacists

Cough and cold medications are not recommended in children under the age of six. The Canadian Paediatric Society has provided guidance on therapies for symptom relief for the common cold in children. Therapies with demonstrated benefit (and only rare adverse events) include: fluid intake, nonsteroidal antiinflammatory drugs (e.g., ibuprofen) and honey (safe in children older than 1 year

In 2008, Health Canada recommended against the use of all over-the-counter cough and cold medicines in children under six years of age, due to lack of benefit and potential harm.

of age). Therapies with possible benefit but associated with rare adverse events include: humidified air and vitamin C. Antihistamines, echinacea and zinc are therapies that are unlikely to provide benefit. REFERENCES Horton DB, Gerhard T, Strom BL. Trends in cough and cold medicine recommendations for children in the United States, 2002-2015. JAMA Pediatrics [published online July 29, 2019]. Jul 29. doi: 10.1001/jamapediatrics.2019.2252.

Goldman RD; Canadian Paediatric Society, Drug Therapy and Hazardous Substances Committee. Treating cough and cold: guidance for caregivers of children and youth (reaffirmed February 25, 2019). Paediatr Child Health 2011;16:564-6. https://www.cps.ca/en/documents/position/treating-coughcold (accessed August 21, 2019).

ce ce FREE! Approved for Answer online at ·ca www.eCortex.ca 1.5 Continuing Education CEUs L E S S O N

FREE! Approved for Answer online at ·ca www.eCortex.ca 1.0 Continuing Education CEU L E S S O N

CCCEP #1002-2019-2848-I-P • Please consult this course online at eCortex.ca for expiry dates

CCCEP #1329-2019-2736-I-P • Please consult this course online at eCortex.ca for expiry dates

Optimizing Diabetes Pharmacy Consultations In the Digital Age

Chronic Migraine:

Comprehensive Management. Collaborative Care.

By Farah Mussa, BSc. Pharm, CDE, CRE, CBE, APA

By Karen Agro, BScPhm, PharmD, MSc Faculty: Rose Giammarco, MD, FRCPC, Nardine Nakhla, PharmD, RPh

Upon completion of this program, the pharmacist will be able to: 1. Review the 2018 Diabetes Canada Clinical Practice Guidelines to provide practical management of diabetes for self-management education (SME) with self-management support (SMS). 2. Apply the use of self-management blood glucose (SMBG) devices and mobile applications for diabetes management to facilitate in decision-making, as well as improvements in healthy behaviours and clinical outcomes. 3. Outline how pharmacists can play a key role in optimizing care for diabetes patients by using technological aids to efﬁciently manage time during consultations.

At the completion of this program, pharmacists will be able to: 1. Recognize episodic versus chronic migraine and identify patients requiring prophylaxis. 2. Differentiate chronic daily headache disorders and their characteristic features. 3. Explore chronic migraine treatments, including self-management, natural health products, and prescription, both oral and injectable options when needed. 4. Identify self-management strategies to empower patients on appropriate medication use, including utilization of headache diaries and avoidance of medication overuse headache. 5. Discuss the elements of a comprehensive migraine management program, including the pharmacist’s role in self-management and collaborative care to optimize patient health outcomes.

Supported by an educational grant from LifeScan Canada Ltd.

Supported by educational funding from Allergan Inc.

[Vol.6 No.9] NOVEMBER 2019

Patients are now aging with HIV infection and new challenges are arising in treating comorbidities such as cardiovascular, bone and renal disease. Given the numerous challenges in preventing and treating HIV and associated comorbidities, an interdisciplinary team care approach is required. Pharmacists working in all sectors (community, ambulatory clinics and institutional care) are well-positioned to contribute significantly to patient care. This article reviews the etiology, pathophysiology, clinical presentation, diagnosis, treatment and role of community pharmacists in managing HIV.

Etiology/pathophysiology/clinical presentation

CLINICAL FEATURE

HIV INFECTION Treatment update for community pharmacists

MICHELLE FOISY, BScPharm, PharmD, ACPR, FCSHP, AAHIVP

Getty Images

WITH THE ADVENT OF COMBINATION ANTIRETROVIRAL THERAPY (ART), human

immunodeficiency virus (HIV) infection has become a chronic manageable disease. Patients are now aging with HIV infection and new challenges are arising in treating comorbidities such as cardiovascular, bone and renal disease.(1) Despite advances in pharmacotherapy, HIV infection continues to be a public health concern, with 36.9 million people infected globally and 1.8 million new infections in 2017.(2) In Canada, 2,402 new HIV diagnoses were reported in 2017 with a cumulative total of over 84,000 cases since 1985.(3) While the national average rate of HIV infection in Canada was 6.5 cases per 100,000 population in 2017, Saskatchewan had much higher rates of 15.5 per 100,000 population due to the population demographics.(3)

There are two types of HIV: HIV-1 and HIV-2. HIV-1 infection is the predominant type worldwide. HIV-2 infection is endemic in West Africa and is generally less aggressive with a longer latent phase, lower viral loads and lower mortality.(4) This article focuses on HIV-1. HIV is transmitted via infected bodily fluids such as blood, semen, rectal fluid, vaginal fluid and breast milk. Therefore, it can be transmitted through unprotected sexual intercourse (vaginal, anal), use of contaminated needles or equipment to inject drugs, to the fetus during pregnancy and to the newborn at birth (vertical transmission), and to infants via breastfeeding.(5) In serodifferent (one partner HIV-positive, the other HIV-negative) heterosexual and gay couples, studies show that patients who are adherent to ART and maintain an undetectable HIV viral load have no risk of transmitting HIV to their seronegative sexual partners during condomless intercourse.(6-8) This concept is known as U=U (undetectable=untransmittable).(9) HIV is an RNA virus that preferentially infects and destroys CD4 lymphocytes (T-helper or T4 cells), a type of white blood cell required for immunity against various bacteria, viruses and parasites. When a person is first infected with HIV (primary infection), the virus replicates quickly, resulting in a very high viral load and a decreased CD4 count in the blood. Acute symptoms of HIV infection may include flu-like illness, fever, swollen lymph nodes, headache and rash. During this stage, newly infected persons are highly infectious.(10) After primary infection, a period of clinical latency (chronic infection) occurs and most people are asymptomatic for a prolonged period. However, over a period of 10 years or longer, the CD4 count gradually decreases to a critical point (< 200 cells/ÂľL) resulting in a higher risk of acquiring opportunistic infections, some of which can be life-threatening. This stage is known as advanced disease or AIDS (acquired immunodeficiency syndrome).(10) Examples of more common opportunistic infections include oropharyngeal/esophageal Candida (thrush), Pneumocystis pneumonia, toxoplasma encephalitis, cryptococcal meningitis, cytomegalovirus, and mycobacterial diseases (e.g., tuberculosis and Mycobacterium avium complex).(10,11) As well, certain cancers such as Kaposi sarcoma and cerebral lymphoma can occur at late stages of HIV.(4)

[Vol.6 No.9] NOVEMBER 2019

The average window period is 18 days from the time of new infection to the time of first being able to detect antigen/antibody.

TABLE 1

Recommended Initial Antiretroviral Therapies (4) NRTI BACKBONE (TWO DRUGS)

• Abacavir + lamivudinea • Tenofovir disoproxil fumarate (TDF) + emtricitabineb

• Tenofovir alafenamide (TAF) + emtricitabineb

THIRD DRUG RECOMMENDED IN MOST PEOPLE WITH HIV

INSTI Class

• Bictegravir

• Dolutegravir • Raltegravir

Diagnosis

The US Centers for Disease Control recommends that HIV testing be offered as part of routine clinical care for people ages 13–64 years at least once, with the option for the patient to decline HIV testing. In addition, pregnant women, patients with tuberculosis, symptomatic patients, those seeking treatment for sexually transmitted infections, and healthcare workers with an HIV exposure should be screened. Persons with ongoing high risk for HIV infection should be tested annually.(12) The diagnosis of HIV involves several steps. The initial screening test uses a fourth-generation assay, which is a combination test that detects the presence of both the HIV-1/2 antibody and p24 antigen with high sensitivity (99.8%) and specificity (99.5%). The average window period is 18 days (up to 1.5 months) from the time of new infection to the time of first being able to detect antigen/antibody. Specimens with a positive screening test result then undergo an antibody immunoassay test, which distinguishes between HIV-1 and HIV-2. If the test is reactive for HIV-1, a final confirmatory test is performed using the HIV-1 nucleic acid test, which detects the presence of HIV RNA.(13,14) Currently only one rapid (point-of-care) HIV test is available in Canada—the INSTI test. This test detects HIV-1/2 antibodies in the blood, yields results in as little as one minute, and has a high sensitivity and specificity (> 99%) when fingerstick blood is used.(14) A second antibody test (OraQuick), which uses saliva for testing, is available in the United States.(13) Since neither of these tests are fourth-generation combined antibody/antigen tests, a longer window period (3–12 weeks) is required from the time of new infection to testing positive.(13) A positive rapid test requires follow-up confirmatory testing.

WHEN TO START

Therapy is life-long; therefore, determining the patient’s overall stability, readiness to start ART, medication preferences and commitment to chronic treatment are essential factors for longterm success. Therapy is recommended in all patients; however, it should be started more urgently in the following situations: 18

NOVEMBER 2019 [Vol.6 No.9]

PI Classc • Atazanavir • Darunavir NNRTI Class • Doravirine • Efavirenz • Rilpivirine

TABLE 2

Single Tablet Regimens (STRs) for HIV (4,18,19)a BRAND NAME

COMPOSITION

COMMENTS

Bictegravir + TAF + emtricitabine

Take with or without food Avoid if CrCl < 30 mL/min

Elvitegravir/cobicistat + TAF + emtricitabine

Take with food Avoid if CrCl < 30 mL/min

Elvitegravir/cobicistat + TDF + emtricitabine

Take with food Avoid if CrCl < 70 mL/min

Dolutegravir + abacavir + lamivudine

Take with or without food Avoid if CrCl < 50 mL/min

Atripla, generics

Efavirenz + TDF + emtricitabine

Take on an empty stomach Avoid if CrCl < 50 mL/min

Odefsey

Doravirine + TDF + lamivudine

Take with or without food Avoid if CrCl < 50 mL/min

Rilpivirine + TAF + emtricitabine

Take with a meal Avoid if CrCl < 30 mL/min

Rilpivirine + TDF + emtricitabine

Take with a meal Avoid if CrCl < 50 mL/min

Darunavir + cobicistat + TAF + emtricitabine

Take with food Avoid if CrCl < 30 mL/min

INSTI-BASED

Biktarvy

Genvoya Stribild Triumeq NNRTI-BASED

Delstrigo

Complera Symtuza

HIV treatment guidelines from the US Department of Health and Human Services are widely used in North America and provide current and comprehensive information on HIV treatment.(4) The goals of therapy include suppressing HIV RNA (HIV viral load < 20–40 copies/mL in plasma), increasing and preserving immune function (increased CD4 cell count), reducing morbidity (preventing certain cancers and opportunistic infections), increasing survival and preventing HIV transmission to others.(4)

INSTI Class • Elvitegravirc

INSTI–integrase strand transfer inhibitor; NNRTI–non-nucleoside reverse transcriptase inhibitor; NRTI–nucleoside reverse transcriptase inhibitor; PI–protease inhibitor a. Abacavir + lamivudine has limited use and is only recommended in combination with dolutegravir, raltegravir or boosted darunavir. HLA-B*5701 testing should be done before starting abacavir. b. In most cases, tenofovir (as TDF or TAF) + emtricitabine is the recommended NRTI backbone. TAF or TDF plus emtricitabine or lamivudine also provides coverage for hepatitis B virus (HBV) coinfection. Abruptly stopping antiretrovirals in patients with HIV/HBV is not recommended as this may result in a flare of HBV and acute hepatitis. c. PIs are boosted with ritonavir or cobicistat to improve the pharmacokinetic profile and allow for once-daily dosing. Elvitegravir is boosted with cobicistat.

PI-BASED

Treatment GOALS OF THERAPY

THIRD DRUG RECOMMENDED IN CERTAIN CLINICAL SITUATIONS

NEW TWO-DRUG STRs

Dovatob Julucab

Dolutegravir + lamivudine

Take with or without food Avoid if CrCl < 50 mL/min

Dolutegravir + rilpivirine

Take with a meal

CrCl–creatinine clearance; INSTI–integrase strand transfer inhibitor; NNRTI–non-nucleoside reverse transcriptase inhibitor; PI–protease inhibitor; TAF–tenofovir alafenamide; TDF–tenofovir disoproxil fumarate a. The STRs listed are all complete regimens and are dosed as one tablet once daily. Except for efavirenz-based regimens, ART is generally better absorbed and/or tolerated when taken with food. b. Although two-drug regimens are not currently considered first-line therapy, specific combinations may be suitable in some patients who have intolerances to nucleosides (NRTIs). The combination of dolutegravir + lamivudine was recently marketed in Canada as a complete regimen for the treatment of HIV infection in adults and adolescents (≥ 12 years of age and weighing ≥ 40 kg).(18) In contrast, the combination of dolutegravir + rilpivirine is only recommended as switch therapy in patients who are already stable on ART with an undetectable viral load for > 6 months and with no underlying drug resistance.(19) A new monthly injectable dual ART regimen (cabotegravir/rilpivirine) may be approved in Canada in the first half of 2020.

TABLE 3

Fixed-Dose Combination (FDC) Tablets for HIV(4)a BRAND NAME

COMPOSITION

COMMENTS

Kivexa, generics

Abacavir + lamivudine

Truvada, generics

Take with or without food Avoid if CrCl < 50 mL/min

TDF + emtricitabine

Descovy

Take with or without food Avoid if CrCl < 50 mL/min

Combivir, generics

TAF + emtricitabine (2 strengths)

Take with or without food Avoid if CrCl < 30 mL/min

Zidovudine + emtricitabine

Take with or without food Avoid if CrCl < 50 mL/min

Abacavir + lamivudine + zidovudine

Take with or without food Avoid if CrCl < 50 mL/min

Prezcobix

Darunavir + cobicistat

Take with food Avoid if CrCl < 70 mL/min (only when used with TDF)

Kaletra

Lopinavir + ritonavir

Take with or without food

Atazanavir + cobicistat

Take with food Avoid if CrCl < 70 mL/min (only when used with TDF)

NRTI-BASED

Trizivir

PI-BASED

Evotaz

NRTI–nucleoside reverse transcriptase inhibitor; PI–protease inhibitor; TAF–tenofovir alafenamide; TDF–tenofovir disoproxil fumarate a. The FDC tablets listed should be taken with other antiretrovirals to make a complete regimen. Most antiretrovirals are better absorbed and/or tolerated when taken with food.

pregnancy; primary/early infection; immunosuppression (CD4 count < 200 cells/µL or with AIDS-defining conditions); coinfection with hepatitis B or C; and HIV-associated nephropathy.(4) A strategy that is garnering more attention is rapid ART initiation on the day of HIV diagnosis in order to achieve virologic suppression more quickly, decrease HIV transmission and engage patients in care. This is a resource-intensive approach that requires a well-developed implementation plan to be successful.(4,16)

WHAT TO START

This article focuses on recommended initial therapies in ART-naïve patients with no underlying ART resistance. While regimens usually consist of three active drugs from two or more drug classes, an emerging option is newer oral and injectable dual ART, which may be suitable for certain patients.(4) Therapy is highly tailored and selected based on: • patient characteristics—formulation preferences, presence of comorbidities, hepatitis B and C coinfection, immune function, pregnancy status (some ART should be avoided in pregnancy) • drug factors—potency of regimen, drug interactions, adverse effects, pill burden/size, dosing frequency • virologic factors—underlying drug resistance, viral burden. Several drug classes are used to treat HIV initially, including nucleoside reverse transcriptase inhibitors (NRTIs), integrase strand transfer inhibitors (INSTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs) and protease inhibitors (PIs). A typical three-drug regimen consists of two NRTIs combined with an INSTI in most patients. In some cases, an NNRTI or a boosted PI may be used instead of an INSTI.(4) Many of these combinations are co-formulated as single tablet regimens (STRs), which contain a complete regimen in one tablet; other formulations may contain one or two drugs and need to be combined with other agents. Thus, the pill burden can vary

depending on the regimen selected. Some of the drugs are also available as generics, which allows for less expensive regimens and cost-savings to the healthcare system.(17) Table 1 provides a summary of recommended initial regimens. Tables 2 and 3 outline STRs and other fixed-dose combination tablets.

Adverse effects

In general, newer ART classes such as the INSTIs and more modern NRTIs (e.g., tenofovir alafenamide [TAF], emtricitabine, lamivudine, abacavir) are well-tolerated, with some short-term effects such as nausea and diarrhea, and long-term effects which are monitored for clinically and via laboratory testing. Table 4 summarizes common or important adverse effects.

Drug interactions

There are many drug interactions with ART and co-medications. Interactions that affect ART absorption involve drug–food requirements (see Tables 2 and 3), gastric pH and chelation. The absorption of both rilpivirine and atazanavir is impaired by agents that increase gastric pH (i.e., antacids, H2-receptor antagonists and proton pump inhibitors). The INSTI class has chelation interactions with polyvalent minerals such as calcium, iron and magnesium (found in mineral supplements, vitamins with minerals, antacids); therefore, spacing of these agents is required.(4) Dosing and spacing vary for specific ART–comedication combinations; an interaction checker should be consulted for appropriate management (see Box 1). Metabolic and elimination interactions are complex and involve the cytochrome P450 system (most commonly CYP3A4 and to a lesser extent CYP2D6 and other cytochromes), hepatic glucuronidation, and drug transporters (e.g., P-glycoprotein, organic cation transporter 2 [OCT2]).(4) Although a detailed overview of drug interactions is beyond the scope of this review, several free specialized resources and interaction checkers are recommended to assist clinicians in screening and managing interactions (Box 1).(22-24) Table 5 highlights key principles of metabolic drug interactions with ART.(4,25,26)

Monitoring patients on antiretroviral therapy

Drug efficacy parameters include routinely monitoring the HIV viral load, the CD4 lymphocyte count and ART adherence. After starting ART, the viral load is measured within two to eight weeks and then every three to six months. The goal is to achieve a viral BOX 1

Specialized Resources and Interaction Checkers for Screening and Managing HIV Drug Interactions(22-24) • University Health Network–Toronto General Hospital, Immunodeficiency Clinic. HIV/HCV drug therapy guide; 2016. http://app.hivclinic.ca/ • University of Liverpool. HIV drug interactions. https://www.hiv-druginteractions.org/ • CHUM–Centre Hospitalier de l’Université de Montréal. HIV/HCV medication guide. http://www.hivmedicationguide.com/Default.asp

[Vol.6 No.9] NOVEMBER 2019

Drug safety parameters are reviewed every three to 12 months, depending on the medications and the overall stability of the patient.

TABLE 4

Adverse Effects of Antiretrovirals(4,20,21) ADVERSE EFFECT

Gastrointestinal: nausea, diarrhea

Pharmacist’s role

Community pharmacists are key healthcare professionals to address and support patients’ medication-related needs. The clinical efficacy of ART depends on excellent adherence (> 95%),(27) although newer regimens with longer durations of action and increased potency may be more forgiving. It is important to explore factors that may affect ART adherence and to tailor adherence strategies according to the needs of each patient. Examples of potential barriers to adherence include lack of readiness to commit to chronic therapy, stigma of HIV, the ART regimen (pill burden/size, dosing schedule, adverse effects), social conditions (medication coverage, homelessness, food security), comorbidities (addictions, psychological factors, polypharmacy) and transitions in care/gaps in drug supply.(4,28,29) When counselling patients, it is important to respect privacy and confidentiality while providing a nonjudgmental and caring environment. Key points to cover in a counselling session include: performing medication reconciliation; assessing drug coverage; reviewing how to take ART and any other medications (i.e., food and drug interaction spacing requirements, best time of day to remember medications); discussing the importance of adherence, assessing barriers to adherence and finding solutions (e.g., blister packing medications, directly observed ART with other daily observed medications such as opioid replacement therapy); reviewing common adverse effects; screening for drug interactions; and discussing missed doses, ART storage and the refill process.(4,28,29) It is important to ensure the pharmacy has adequate ART inven tory to prevent interruptions in therapy. Patient follow-up may involve a call-back in one to two weeks to check on adherence and medication tolerability. Antiretroviral refills provide the opportune time for pharmacists to assess ART efficacy (viral load, CD4 count), safety (adverse effects, drug interactions) and adherence (based on patient recall, ART refill history). Community pharmacists can also collaborate with the healthcare team in the management of chronic comorbidities (e.g., dyslipidemia, diabetes, hypertension, osteoporosis, smoking cessation) and co-infections (e.g., hepatitis B and C, 20

NOVEMBER 2019 [Vol.6 No.9]

More common with PIs, but may be seen with all ART

MANAGEMENT

•T ake with food; take at bedtime to “sleep off” effects

•E at small, frequent bland snacks; increase fibre intake for diarrhea

•P harmacologic: antiemetics, loperamide, psyllium

Central Nervous System:

load below the level of detection of the assay (< 20–40 copies/mL) after eight to 24 weeks of therapy. The CD4 count is measured every three to 12 months to assess for immune reconstitution/ preservation. A CD4 count > 200 cells/µL is desirable to minimize the chance of developing opportunistic infections.(4) Drug safety parameters are reviewed every three to 12 months, depending on the medications and the overall stability of the patient. This would include assessing laboratory parameters (e.g., renal/hepatic function, lipids, glucose/A1C), reviewing tolerability of medications and screening for drug interactions.(4)

DRUG

depression, sleep disturbances; efavirenz can also cause abnormal dreams, dizziness and impaired concentration

Renala

Hepatic

NNRTIs (efavirenz > rilpivirine > doravirine)

INSTIs (dolutegravir > other INSTIs)

•C aution with these ARTs in patients with insomnia and/ or depression • Take efavirenz at bedtime •T ake dolutegravir in the morning if experiencing insomnia

Tenofovir disoproxil fumarate, certain PIs

•M onitor for increased serum creatinine/decreased eGFR, proteinuria

PIs, NNRTIs

•M onitor for elevations in liver transaminases (AST, ALT)

•M ay require a switch in therapy

Bone:a decreased BMD

TDF > other ART

Abacavir, certain Cardiovascular: myocardial infarction PIs or other CV events

•B MD testing may be indicated in older patients with other underlying risk factors for low BMD •M ay require a switch in therapy and treatment of low BMD if indicated

•C onsider other alternatives in high CV risk patients when possible

Dyslipidemia

PIs, efavirenz, elvitegravir/ cobicistat

• Monitor lipid panel

Diabetes and Insulin resistance

Older PIs (e.g., indinavir, lopinavir/ ritonavir); INSTIs (rarely)

•M onitor fasting glucose and/or A1C

•M anagement includes either switching ART and/or treating elevated lipids

•M anagement includes switching ART and treating underlying diabetes as indicated

A1C–glycated hemoglobin; ALT–alanine aminotransferase; ART–antiretroviral therapy; AST–aspartate aminotransferase; BMD–bone mineral density; CV–cardiovascular; eGFR–estimated glomerular filtration rate; INSTI– integrase strand transfer inhibitor; NNRTI–non-nucleoside reverse transcriptase inhibitor; PI–protease inhibitor a. The newer formulation of tenofovir known as tenofovir alafenamide (TAF) is associated with significantly less bone and renal toxicity than TDF. Note: some ART (e.g., dolutegravir, cobicistat, bictegravir) can cause a small increase in serum creatinine without affecting the glomerular function after the first four weeks due to inhibition of tubular secretion of creatinine (median ~ 10 µmol/L ).(4)

opportunistic infection treatment and prophylaxis).(28,29) When indicated and within scope of practice, immunizations can be administered. It is important to consult immunization guidelines and the HIV care team to ensure certain vaccines are safe to give in HIV infection and to avoid duplication of administered vaccines and extra costs.(30-32) Finally, pharmacists can play a role in HIV prevention by educating patients on safer sexual practices, condom use, use of sterile needles/needle exchange programs, and encourage HIV testing in high-risk patients.(28,29,33) Pharmacists can also provide medication education and support for uninfected patients taking antiretrovirals for HIV prevention (pre- and post-exposure prophylaxis [PrEP and PEP]). Recent Canadian guidelines provide a comprehensive review of PEP and PrEP and the pharmacist’s role in this evolving field.(34,35)

TABLE 5

Principles of Metabolic Drug Interactions with Antiretrovirals(4,25,26) DRUG CLASS

NRTIs

NNRTIs

PIs, Boosters (ritonavir,a cobicistat)

INSTIs

METABOLISM

EXAMPLES OF INTERACTIONS

Note: TAF is a P-gp substrate

TAF should be avoided with P-gp inducers and requires a reduced dose with P-gp inhibitors

Mostly renally eliminated

CYP3A4 substrates

CYP3A4 inducers (efavirenz, nevirapine)

PIs: CYP3A4, P-gp substrates and inhibitors Note: Boosters inhibit CYP3A4, CYP2D6 and P-gp

UGT substrates (also CYP3A4 substrates for certain INSTIs) Note: • elvitegravir is boosted with cobicistat (CYP3A4/2D6/P-gp inhibitor); therefore, has more interactions • dolutegravir is an inhibitor of renal OCT2

Fewer interactions with co-medications compared with other ARTs

i concentrations of NNRTIs when given with CYP3A4 inducers (e.g., rifampin, anticonvulsants) i concentrations of CYP3A4 substrates (e.g., methadone)

i concentrations of PIs when given with CYP3A4 and P-gp inducers (e.g., rifampin, anticonvulsants)

h concentrations of CYP3A4/2D6/ P-gp substrates (e.g., statins, PDE5 inhibitors, CCBs, psychotropics, corticosteroids) i concentrations of INSTIs when given with UGT and CYP3A4 inducers (e.g., rifampin, anticonvulsants) See boosters above

h concentrations of OCT2 substrates (e.g., metformin)

CCBs–calcium channel blockers; INSTI–integrase strand transfer inhibitor; NNRTI–non-nucleoside reverse transcriptase inhibitor; NRTI–nucleoside reverse transcriptase inhibitor; OCT2–organic cation protein 2; PDE5– phosphodiesterase type 5; P-gp–P-glycoprotein; PI–protease inhibitor; TAF–tenofovir alafenamide; UGT–uridine glucuronosyltransferase. a. Ritonavir also induces CYP2B6, CYP2C9, CYP2C19, CYP1A2 and UGT. Cobicistat is not an enzyme inducer.

Summary

With the advent of combination ART, HIV is now a chronic manageable disease, with an increasing proportion of older patients. The aging population means multiple comorbidities are more common and add to the overall complexity of care. While triple ART is the cornerstone of treatment, emerging therapies include oral and injectable dual ART. The selection of drug therapy is based on patient, medication and viral factors. To simplify therapy, numerous co-formulations are available, including single-tablet regimens. While newer ARTs are better tolerated than older regimens, ongoing monitoring for adverse effects and patient adherence is critical. Drug interactions are very common with ART; therefore, screening for interactions is recommended at each visit/ART refill. Community pharmacists can have a significant positive impact on the overall care of people living with HIV by supporting antiretroviral adherence, assisting in managing comorbidities, screening for drug interactions, and providing patient education on HIV treatment and prevention. MICHELLE FOISY (Michelle.Foisy@ahs.ca) is an HIV clinical pharmacist with the Northern Alberta Program, Royal Alexandra Hospital site in Edmonton, AB. Michelle has been working as a clinician, educator and consultant in the HIV field for almost 30 years.

THE AUTHOR THANKS PAM NICKEL, HIV CLINICAL PHARMACIST AT THE NORTHERN ALBERTA PROGRAM, KAYE EDMONTON CLINIC SITE, EDMONTON, AB, FOR HER CRITICAL REVIEW OF THIS MANUSCRIPT. REFERENCES 1. McMillan JM, Krentz H, Gill MJ, et al. Managing HIV infection in patients older than 50 years. CMAJ 2018;190(42):E1253-8. 2. UNAIDS. Global HIV & AIDS statistics- 2018 fact sheet. http://www.unaids.org/en/resources/ fact-sheet (accessed April 5, 2019).

3. Haddad N, Li JS, Totten S, et al. HIV in Canada- surveillance report, 2017. Can Commun Dis Rep 2018;44(12):324-32. https://www.canada.ca/content/dam/phac-aspc/documents/services/ reports-publications/canada-communicable-disease-report-ccdr/monthly-issue/2018-44/ issue-12-december-6-2018/ccdrv44i12a03-eng.pdf (accessed June 19, 2019). 4. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for use of antiretroviral agents in adults and adolescents living with HIV. Department of Health and Human Services. Reaffirmed October 25, 2018. https://aidsinfo.nih.gov/contentfiles/lvguidelines/ adultandadolescentgl.pdf (accessed April 5, 2019). 5. Canadian AIDS Treatment Information Exchange (CATIE). HIV basic facts. Reaffirmed 2016. https://www.catie.ca/en/basics/hiv-and-aids (accessed April 5, 2019). 6. Cohen MS, Chen YQ, McCauley M, et al. Antiretroviral therapy for the prevention of HIV-1 transmission. N Engl J Med 2016;375:830-9. 7. Rodger AJ, Cambiano V, Bruun T, et al. Sexual activity without condoms and risk of HIV transmission in serodifferent couples when the HIV-positive partner is using suppressive antiretroviral therapy. JAMA 2016;316:171-81. 8. Rodger AJ, Cambiano V, Bruun T, et al. Risk of HIV transmission through condomless sex in serodifferent gay couples with the HIV-positive partner taking suppressive antiretroviral therapy (PARTNER): final results of a multicentre, prospective, observational study. Lancet 2019; May 2. [Epub ahead of print]. 9. The Lancet HIV. U=U taking off in 2017 (editorial). Lancet HIV 2017;4(11):e475. 10. AIDSinfo. U.S. Department of Health and Human Services. The stages of HIV infection. Reaffirmed July 27, 2018. https://aidsinfo.nih.gov/understanding-hiv-aids/fact-sheets/19/46/ the-stages-of-hiv-infection (accessed April 5, 2019). 11. Panel on Opportunistic Infections in HIV-infected Adults and Adolescents. Guidelines for the prevention and treatment of opportunistic infections in HIV-infected adults and adolescents: recommendations from the Centers for Disease Control and Prevention, the National Institutes of Health, and the HIV Medicine Association of the Infectious Disease Society of America. Reaffirmed May 29, 2018. https://aidsinfo.nih.gov/contentfiles/lvguidelines/adult_oi.pdf (accessed April 5, 2019). 12. Branson BM, Handsfield HH, Lampe MA, et al. Centers for Disease Control and Prevention. Revised recommendations for HIV testing of adults, adolescents, and pregnant women in health-care settings. MMWR Recomm Rep 2006;55(RR-14):1-17. https://www.cdc.gov/mmwr/ preview/mmwrhtml/rr5514a1.htm (accessed April 5, 2019). 13. Canadian AIDS Treatment Information Exchange (CATIE). HIV testing technologies, 2018. https://www.catie.ca/en/fact-sheets/testing/hiv-testing-technologies (accessed April 5, 2019). 14. Centers for Disease Control and Prevention and Association of Public Health Laboratories. Laboratory testing for the diagnosis of HIV infection: updated recommendations. Published June 27, 2014. https://stacks.cdc.gov/view/cdc/23447 (accessed April 5, 2019). 15. bioLytical Laboratories Inc. INSTI HIV-1/HIV-2 Rapid Antibody Test product monograph. Richmond, BC; 2015. https://biolytical.com/products/insti-hiv-1hiv-2/ (accessed April 5, 2019). 16. Boyd MA, Boffito M, Castagna A, et al. Rapid initiation of antiretroviral therapy at HIV diagnosis: definition, process, knowledge gaps. HIV Medicine 2019;20(Suppl. 1):3-11. 17. Krentz HB, Campbell S, Lahl M, et al. De-simplifying single-tablet antiretroviral treatments: uptake, risks and cost savings. HIV Med 2019;20:214-21. 18. ViiV Healthcare ULC. Dovato (dolutegravir/lamivudine) product monograph. Laval, QC; August 22, 2019. https://pdf.hres.ca/dpd_pm/00052819.PDF (accessed August 29, 2019). 19. ViiV Healthcare ULC. Juluca (dolutegravir/rilpivirine) product monograph. Laval, QC; August 27, 2018. https://gskvideo.edgesuite.net/Viiv/viivhealthcare/pdf_files/en-ca/juluca.pdf (accessed April 5, 2019). 20. Canadian AIDS Treatment Information Exchange (CATIE). A practical guide to HIV drug side effects. 2nd ed, 2013. https://www.catie.ca/en/practical-guides/hiv-drug-side-effects (accessed April 5, 2019). 21. Capetti AF, Giambenedetto S, Latini A, et al. Morning dosing of dolutegravir-related insomnia and sleep disorders. HIV Med 2018;19(5):e62-3. 22. University Health Network–Toronto General Hospital, Immunodeficiency Clinic. HIV/HCV drug therapy guide; 2016. http://app.hivclinic.ca/ (accessed April 5, 2019). 23. University of Liverpool. HIV drug interactions. https://www.hiv-druginteractions.org/ (accessed April 5, 2019). 24. CHUM–Centre Hospitalier de l’Université de Montréal. HIV/HCV medication guide. http:// www.hivmedicationguide.com/Default.asp (accessed April 5, 2019). 25. Devanathan AS, Anderson DJC, Cottrell ML, et al. Contemporary drug-drug interactions with HIV treatment. Clin Pharmacol Ther 2019;105:1362-77. 26. Hughes, CA, Tseng A, Cooper R. Managing drug interactions in HIV-infected adults with comorbid illness. CMAJ 2015;187:36-43. 27. Paterson DL, Swindells S, Mohr J, et al. Adherence to protease inhibitor therapy and outcomes in patients with HIV infection. Ann Intern Med 2000;133:21-30. 28. Tseng A, Foisy M, Hughes CA, et al. Role of the pharmacist in caring for patients with HIV/ AIDS: clinical practice guidelines. Can J Hosp Pharm 2012;65:125-44. 29. Schafer JJ, Gill TK, Sherman EM, et al. ASHP guidelines on pharmacist involvement in HIV care. Am J Health-Syst Pharm 2016;73:e72-98. 30. U.S. Department of Health and Human Services. HIV and immunizations. Reaffirmed January 22, 2019. https://aidsinfo.nih.gov/understanding-hiv-aids/fact-sheets/21/57/hiv-andimmunizations (accessed April 5, 2019). 31. U.S. Department of Health and Human Services. Guidelines for the prevention and treatment of opportunistic infections in HIV-infected adults and adolescents. Recommended immunization schedule for adults and adolescents with HIV infection. Reaffirmed September 13, 2017. https://aidsinfo.nih.gov/guidelines/html/4/adult-and-adolescent-opportunisticinfection/365/figure--immunization (accessed April 5, 2019). 32. Public Health Agency of Canada. Canadian Immunization Guide–Immunization of immunocompromised persons. Ottawa, ON: May 2018. Available at: https://www.canada.ca/ en/public-health/services/publications/healthy-living/canadian-immunization-guide-part3-vaccination-specific-populations/page-8-immunization-immunocompromised-persons. html#a29. (accessed April 5, 2019). 33. Weidle PJ, Lecher S, Botts LW, et al. HIV testing in community pharmacies and retail clinics: a model to expand access to screening for HIV infection. J Am Pharm Assoc 2014;54:486-92. 34. Tan DHS, Hull MW, Yoong D, et al. Canadian guidelines on HIV pre-exposure prophylaxis and nonoccupational postexposure prophylaxis. CMAJ 2017;189:E1448-58. http://www.cmaj.ca/ content/189/47/E1448 (accessed April 5, 2019). 35. Hughes C, Yoong D, Giguère P, et al. Canadian guidelines on HIV preexposure prophylaxis and nonoccupational postexposure prophylaxis for pharmacists. Can Pharm J 2019;152:81-91. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6410427/ (accessed May 22, 2019).

[Vol.6 No.9] NOVEMBER 2019

Eczema Control

Effective Itch Relief—from the makers of Canada’s leading hand cream1

Glysomed Eczema Control combines trusted moisturization with effective relief from the itchiness and dryness associated with eczema. ®

•

Contains 2% active colloidal oatmeal, a non-steroidal eczema itch reliever.

•

Enriched with the Glysomed glycerine-chamomile blend plus oat extract and oat kernel oil, the formula is ultra-hydrating and long-lasting to help soften, soothe and deeply moisturize compromised skin.

•

Gentle, non-irritating, fragrance/steroid-free. Suitable for use by the entire family, including children.

Accepted by the Eczema Society of Canada

Canadians trust Glysomed to care for their skin. Glysomed’s hardworking skin care products blend science, quality ingredients and convenience to effectively help soften and relieve dry, itchy skin. The non-irritating, dermatologist-recommended formulas spread easily and penetrate deeply to provide long-lasting hydration and protection, and to help restore skin’s moisture.

PATIENT EDUCATION Help your patients become more engaged in self-managing eczema symptoms and flare-ups by providing them with an understanding of key aspects of the condition.

IMPAIRED SKIN BARRIER FUNCTION

TRIGGERS

Skin affected by eczema has a reduced ability to hold water, which results in dry, irritated skin. The compromised skin is then more sensitive to irritants and eczema flare-ups.2

Examples of the kinds of conditions, irritants and allergens that may provoke eczema symptoms and flare-ups include: cold weather, excessive sweating, frequent hand washing, antibacterial soaps, cleaning products, foods, dust, clothing fibres, plastic and plants.2,3

Self-management strategy Moisturizing is essential to managing eczema. Keeping skin well hydrated is crucial to successfully managing eczema symptoms and flare-ups. A rich moisturizer should be applied frequently throughout the day—particularly in cold weather—to replenish moisture and create a barrier to protect the skin.2,3 Moisturizing should continue even when skin is healthy.3

Self-management strategy Avoid/minimize triggers. Patients should be proactive about • avoiding and/or minimizing factors that trigger eczema symptoms and flare-ups. a trigger diary. Suggest that your patients keep a diary • toKeep track items or situations that seem to provoke symptoms and flare-ups.

For more information about Glysomed skin care products, visit www.glysomed.ca 1. Nielsen, July 2019. 2. Canadian Dermatology Association. Eczema. www.dermatology.ca/skin-hair-nails/skin/eczema/#!/skin-hair-nails/skin/eczema/what-is-eczema-2/ (accessed September 18, 2019). 3. Eczema Society of Canada. About Eczema. Hand Eczema. Treatment. www.eczemahelp.ca/en/index.html (accessed September 18, 2019).

Hello, Iâ&#x20AC;&#x2122;m here to help you.

THE VIRTUAL PHARMACIST

Shutterstock

THE INNOVATORS

How remote access technology is improving care, saving costs and creating new business opportunities for pharmacy BY ROSALIND STEFANAC

[Vol.6 No.9] NOVEMBER 2019

It was an Epi Pen—from British Columbia’s city of Duncan to a rural area in Salt Spring Island. It took less than 11 minutes to travel the six kilometres over the Pacific Ocean, and in one of three test cases that day, the medication was delivered directly to a patient’s home. This first of its kind collaboration between London Drugs, Canada Post and InDro Robotics is testament to a new genre of pharmacy services unfolding in Canada, says Chris Chiew, London Drugs general manager of pharmacy. He believes using drones for medication delivery will be especially beneficial for underserved communities or during natural disasters when medication access becomes a critical issue. “We are always looking at ways to service communities that don’t have pharmacies or where patients have to drive too far for services—this is where telepharmacy fits in.” (If you haven’t heard much about the term telepharmacy yet, see the sidebar.) Next up London Drugs will test drone delivery of highcost Hepatitis C medications from one of its pharmacies to a remote community 55 kms away. “This is the type of medication where if you miss a dose, it can cause real issues,” says Chiew. “We were lucky the first time with perfect weather, so we want to ensure we can keep packages at a constant temperature necessary to maintain the integrity of the medication no matter what.” Future iterations will involve drones with high-definition cameras with facial recognition to ensure medications are reaching the right people, as well as drones with screens to allow pharmacists to counsel patients on site. “The possibilities are pretty incredible,” he says. 24

NOVEMBER 2019 [Vol.6 No.9]

Photo courtesy of London Drugs

ON A SUNNY AUGUST DAY THIS YEAR, A DRONE SUCCESSFULLY DELIVERED A LIFESAVING MEDICATION.

While community-based drone pharmacy services like these are still in their infancy, other telepharmacy services are fast becoming an increasingly common way of providing care in rural hospital and out-patient settings throughout Canada. One example is the pharmacist assisted warfarin-dosing system, initiated by NorthWest Telepharmacy Solutions, that’s been successfully running in under-resourced communities since 2007. Pharmacist and program lead Chole Campbell is based in Ottawa, but assists patients in Moose Factory more than 700 kms away. “Patients on warfarin are registered for the program through their physician and then as a group of pharmacists [working remotely] we have access to their blood work and we determine how to adjust their blood thinner to work with other medication,” she says. “Depending on how stable patients are, we may speak to them by phone once a month or once a week.” Campbell, who works from home and sees her patients in person once a year if that, says telepharmacy programs like these mean patients don’t have to visit their physicians as often, and have continuity of care despite the high turnover of physicians typical in these areas. “We have all their medical history and that’s a key benefit of us looking after them,” she says. “Physicians appreciate having us there to help with that part of their workload.” One of Campbell’s patients, 77-year-old Roy Turner who lives in Moose Factory, says he appreciates the fact he can have his pharmacist check-in from the comfort of home. “I have type 2 diabetes, a pacemaker, and I’m in a wheelchair due to a spinal injury,” he says. “Getting out is not so easy.” Another recent pilot program that patients are appreciating is a pharmacist-led best possible medication discharge plan (BPMDP) via tele-robot. The technology was tested at the Lady Dunn Health Centre, which has only 10 acute care beds and is 225 kms away from the nearest tertiary hospital. The robot was equipped with an iPad so the pharmacist could interview the patient via screen. “The great thing is that the pharmacist could be in Kitchener and driving the robot in Wawa, Ontario,” says Kevin McDonald, director at Northwest. “And overall, patients were satisfied having that conversation with the pharmacist in this way.” In fact, in a post-pilot survey, 80% of patients said it was a positive experience. McDonald says the physicians and clinic staff working in northern communities also appreciate pharmacists’ input. “When we first got into business, it was the communities asking for help because they didn’t have access to care,” he says. “The sites themselves are generally very approachable and willing to innovate if it improves patient care.” Case in point, many rural hospitals do not have on-site pharmacists to support medication reconciliation upon discharge, which significantly increases the probability of medication-related adverse events. Using pharmacists remotely helps reduce the probability of errors happening during that transition of patient to home, which is a win for everyone. By the looks of it Canada’s telepharmacy work isn’t going unnoticed either. Not only have US chains like Walgreens since announced similar drone-testing of health product delivery after the London Drugs pilot, countries like Jordan are looking to replicate Canada’s entire telepharmacy

What is telepharmacy?

Shown on the robot is pharmacist Satvir Bains, speaking with a nurse at the Lady Dunn Hospital in Wawa, ON.

Telepharmacy refers to the provision of pharmacy care through the use of information technologies and telecommunications to patients at a distance. Telepharmacy can be used to clinically review new orders, remotely check sterile IV preparations and provide counselling to patients at discharge from hospital. The term can also refer to using videoconferencing to provide training, education and management to other pharmacists and pharmacy staff.

Photo courtesy of Northwest Telepharmacy Solutions

A telepharmacy operates like a traditional pharmacy except for the fact the pharmacist reviewing and verifying prescriptions is in another location. All remote pharmacies must have a regulated pharmacy technician on site, however. Interestingly, the research shows(1) that telepharmacies experience fewer dispensing errors than traditional pharmacies. 1. https://www.ndsu.edu/fileadmin/telepharmacy/APhA_article_2011_-_Copy.pdf

model. Shadi Al-Hawari, pharmacist/owner of seven B.C. pharmacies, including two telepharmacies in the province, will be taking a group of physician colleagues to Jordan in October to offer advice to government on how to implement some 200 tele-clinics there, which include telepharmacies and labs. In the meantime, Al-Hawari is working on opening up a third telepharmacy site in Williams Lake, B.C., next summer that will service some 3,500 indigenous patients. “Not only does telepharmacy make practical sense in delivering pharmacy services to remote areas, it is a money-saver for government,” he says. “It’s a concept that’s been proven to work.” Future applications of remote pharmacy services could be a game-changer too, especially in dealing with major health issues, such as the opioid crisis in Canada. Paula Newman, research specialist and clinical pharmacist at NorthWest, is currently part of a team working on the implementation of a pharmacist-led opioid stewardship program via videoconference. Funded by the Canadian Foundation for Pharmacy, the pilot is geared to patients with chronic non-cancer pain and will target a rural population near Sudbury where opioid mis-use is particularly high and there are few pharmacy support services. “We’ve developed a comprehensive tool to interview patients and provide a follow-up assessment,” says Newman. “We want to determine if this can be done remotely in a population that isn’t used to having a lot of contact with a pharmacist—and whether patients and providers will be satisfied with the service.”

FREE! Approved for Answer online at ·ca www.eCortex.ca 1 Continuing Education CEU L E S S O N CCCEP #1329-2019-2868-I-P • Please consult this course online at eCortex.ca for expiry dates

Integration of New Treatment Options for Patients with Severe Asthma By Tom Smiley BScPhm, PharmD, CTE

After completion of this learning activity pharmacists will be better able to: 1. Assess and identify asthma severity as mild, moderate or severe 2. Distinguish uncontrolled asthma from severe asthma 3. Review the consequences/hazards of oral corticosteroid (OCS) overuse in patients with severe asthma 4. Discuss differences between severe allergic asthma and severe eosinophilic asthma and implications for treatment 5. Describe new biologic treatment options for severe asthma and their place in therapy according to 2017 Canadian Thoracic Society (CTS) position statement and 2019 Global Initiative in Asthma (GINA guidelines)

This program was supported in part by an educational grant from AstraZeneca

[Vol.6 No.9] NOVEMBER 2019

A new software program called MedMonitor, launched this fall, is expected to prevent medication risks, lower absenteeism and significantly improve savings when it comes to benefits and disability costs by using pharmacists’ remote intervention. HumanisRx, a division of Remedy Holdings Inc., developed the program which uses some 150 clinical algorithms to identify employee medication risks based on their insurance claims. Then, provided the employee has given consent, it triages these issues and initiates an intervention with a HumanisRx pharmacist. “When someone has a gap in care or a safety issue, an alert is sent to our call centre where a pharmacist will reach out to an employee via phone,” says Jeff May, president of HumanisRx, adding that there is potential for video conferences as well. “Our research finds that employees are not optimizing their use of prescription medications—and that’s a huge cost driver for Canadian employers and insurance companies.” The pharmacist works with the employee and his/her prescriber as needed to resolve medicationrelated issues and reduce overall health risks. That could mean dealing with adherence problems, making medication changes or suggesting behavioural changes to improve outcomes. The service is available across Canada (outside of Quebec).

NOVEMBER 2019 [Vol.6 No.9]

– SHADI AL-HAWARI

Key barriers to telepharmacy growth

While telepharmacy initiatives are proving that remote pharmacy services can have a major impact, some key challenges remain. The lack of adequate bandwidth in remote areas hinders some technologies from operating optimally. Meanwhile, community telepharmacy operators say strict government regulations around licensing and staffing (all remote pharmacies must have a regulated pharmacy technician on site) means setting up these sites is an arduous and expensive endeavour. “It’s a real struggle to get a telepharmacy license and in one case we had to apply four times before we got approved,” says Al-Hawari, noting that in BC, a remote site has to be at least 25 kms away from the nearest pharmacy. “We need more incentives to open in remote areas instead of barriers.” Finding pharmacists to work in telepharmacy settings can be a challenge too, says NorthWest’s Kaminsky. In Nunavut, for example, there are five brick and mortar pharmacies serving the entire population that rely on a remote distribution model. “If there is no pharmacist to oversee that and we have to close down, the whole care model becomes compromised and services go back to the nursing centres,” she says. “A few of our pharmacists and physicians have been with us for 10+ years but it’s rare.” With the cost of doing business in the north at three times the standard in the south, Kaminsky says pharmacists in these positions are paid a premium wage, with additional provisions for housing, food and household supplies. “We try to set up multipleyear contracts, but when they get up north it’s a whole different environment for them and some will take an early leave,” she says. “We also always try and hire local folks and have a tuition reimbursement program if they want to go further and get accredited.” Those pharmacists who do stay for the long-term have been able to practise at the top of their scope and tend to be “everything to their community,” she adds. Ultimately, Kaminsky says she envisions a hybrid model of care with pharmacists in the community and those in remote settings working together to keep up with the “swell of healthcare need” in remote areas “For pharmacists today, it’s about keeping an open mind that technology should never be considered a barrier or threat to the deliverance of healthcare, but rather a way to enhance our service model.”

Photo by Lindsey Donovan

Remote pharmacists mitigate medication risk

“ IT’S A REAL STRUGGLE TO GET A TELEPHARMACY LICENSE AND IN ONE CASE WE HAD TO APPLY FOUR TIMES BEFORE WE GOT APPROVED.”

ce November 2019

Approved for

Answer online at eCortex.ca

Continuing Education L E S S O N

CEU Canadian Council on Continuing Education in Pharmacy

Approved for 1 CE unit by the Canadian Council on Continuing Education in Pharmacy • CCCEP #1329-2019-2868-I-P • Please consult this course online at eCortex.ca for expiry dates

Learning Objectives

Integration of New Treatment Options for Patients with Severe Asthma By Tom Smiley BScPhm, PharmD, CTE

Instructions

Background

1. After carefully reading this lesson, study each question and select the one answer you believe to be correct. Answer online at eCortex.ca. 2. To pass, a grade of at least 70% (6 out of 8) is required. 3. Complete the required feedback form for this lesson online at eCortex.ca.

Asthma is a common respiratory disease that ranges in symptom severity from mild to severe and affects almost 11% of Canadians.(1) Although severe asthma represents approximately five to ten percent of asthma cases, it accounts for up to 50% of direct asthma costs and results in a significant impact on quality of life.(2) Management of asthma over the past number of decades has improved as the mechanisms of impaired breathing associated with airway inflammation have become better understood and addressed with antiinflammatory medications. However, severe asthma is now understood as a heterogeneous syndrome that involves various airway inflammation triggers that are unique to different subsets of patients.(2,3) This has resulted in ongoing research into the development of novel biologic therapies that target these triggers according to a patient’s “phenotype” or “endotype” (e.g., allergic asthma vs. eosinophilic asthma).(2,3) This continuing education lesson reviews the management of severe asthma as recommended by the Canadian Thoracic Society (CTS) and the Global Initiative on Asthma (GINA) with a focus on the biological agents, and discusses the important role of community pharmacists in the assessment and ongoing care of adult and adolescent patients with severe asthma.(2,4)

Please consult this course online at eCortex.ca for expiry dates.

DISCLOSURES The author discloses that in the past he has received funds from the company sponsoring this learning activity, for participation in an advisory board meeting and speaking engagements. One expert reviewer discloses the receipt of funds from the sponsor and other commercial entities for membership on advisory boards, continuing education work and speaking engagements. The second expert reviewer discloses the receipt of funds from other entities for continuing education work. The provider declares no real or potential conﬂict with the sponsor of this lesson.

Answer online at eCortex.ca

·ca

Case: Ben’s Struggles with Asthma Ben is a 39-year-old male who has suffered with asthma since he was a child. Ben’s asthma treatment regimen has gradually increased over the years to the point that he is now using a high dose Inhaled corticosteroid/ long-acting beta-agonist combination and an

inhaled long-acting anticholinergic agent on a chronic basis along with a short-acting betaagonist used prn for symptom relief. Ben has been coming to the pharmacy for a long time, and you have regularly confirmed correct use of his inhalers and adherence to his maintenance medications. Ben has come to the pharmacy for a refi ll and after asking him how his asthma symptoms have been, he tells you that he has visited the hospital for treatment of asthma exacerbation three times in the past year, including six weeks ago. He tells you that he has required a course of oral prednisone each time he has been treated and is worried about the long-term effects of the medication. Ben tells you that at his last emergency visit, the doctor mentioned that he might have to take prednisone on a daily basis. The doctor also said something about new injectable drugs for people with severe asthma. You inform Ben that there are new biological drugs on the market that have been shown to reduce the frequency of asthma exacerbations and the need for oral corticosteroids. Because there are different types of biological medications that are targeted for different causes of severe asthma, testing needs to be conducted to confirm which medication is the most appropriate for a particular person. Ben is very interested in finding out more about these medications and you offer to call his doctor to discuss the possibility of starting the testing and booking a referral to his respiratory specialist. Ben readily agrees and thanks you for taking the time to speak with him about his asthma issues.

Severe Asthma vs. Uncontrolled Asthma In order to manage asthma appropriately, it is extremely important to distinguish severe asthma from uncontrolled asthma.(2) Whereas severe asthma reﬂects asthma symptoms based on optimal treatment of the patient, uncontrolled asthma is a function of issues such as poor inhaler technique and adherence.(4) By regularly checking on inhaler technique and adherence to therapy, and assessing exposure to asthma triggers with the patient, pharmacists have a vital role to play in helping to make the distinction between uncontrolled and severe asthma and to address these issues or refer as appropriate. Figure 1 summarizes levels of asthma based on treatment needed to keep asthma controlled (i.e., Steps 1-5) according to the 2019 GINA Asthma Treatment

This program was supported in part by an educational grant from AstraZeneca

Continuing Education L E S S O N

Integration of New Treatment Options for Patients with Severe Asthma

CE2

November 2019

2019 GINA treatment strategy(1)

FIGURE 1

* For deﬁnitions of low, medium and high dose ICS please refer to 2019 GINA guidelines which can be found at www.ginasthma.org LTRA = leukotriene receptor antagonist; Anti-IgE = Anti-immunoglobulin E; Anti-IL5/5R = anti-interleukin 5/anti-interleukin 5 receptor; Anti-IL4R = Anti-interleukin 4 receptor; OCS = Oral corticosteroid; HDM SLIT = House dust mite sublingual immunotherapy; FEV = forced expiratory volume ©2019 Global Initiative for Asthma, available from www.ginasthma.org, reprinted with permission.

TA B L E 1

Comparison of guideline deﬁnitions of severe vs. uncontrolled asthma(2,4)

Severe asthma

Uncontrolled asthma

2019 GINA guidelines

2017 CTS guidelines

Asthma that requires Step 4 or 5 treatment (see Figure 1) such as high-dose ICS-LABA to prevent it from becoming uncontrolled, or asthma that remains uncontrolled or worsens despite this treatment. Three or four of the following symptoms: • Daytime asthma symptoms more than twice/week • Any night waking due to asthma • Reliever needed for symptoms more than twice/week • Any activity limitation due to asthma The guidelines state the following: Having uncontrolled asthma symptoms is an important risk factor for exacerbations

Asthma which requires treatment with high-dose ICS and a second controller for the previous year, or systemic corticosteroids for 50% of the previous year to prevent it from becoming uncontrolled, or which remains uncontrolled despite this therapy. At least one of the following: 1. Poor symptom control as per CTS guidelines (not meeting criteria as per Table 2) or other standardized questionnaires: (e.g., Asthma Control Questionnaire [ACQ] consistently > 1.5, Asthma Control Test [ACT] < 20) 2. Frequent severe exacerbations: 2 or more courses of systemic corticosteroids (≥ 3 days each) in the previous year 3. Serious exacerbations: at least one hospitalization, intensive care unit (ICU) stay or mechanical ventilation in the previous year. 4. Airﬂow limitation: After appropriate bronchodilator withhold FEV1 < 80% of personal best (or < the LLN in the face of reduced FEV1/FVC deﬁned as less than the LLN).

ICS = Inhaled corticosteroid LABA = long-acting beta-agonist FEV1 = forced expiratory volume in 1 second LLN = lower limit of normal FVC = forced vital capacity

TA B L E 2

CTS criteria for controlled asthma(2)

Characteristic Daytime symptoms Night-time symptoms Physical activity Exacerbations Absence from work or school due to asthma Need for fast-acting beta-agonist inhaler FEV1 or peak expiratory ﬂow (PEF) rate PEF diurnal variation Sputum eosinophils FEV1 = Forced expiratory volume in 1 second

Frequency or Value < 4 days/week < 1 night/week Normal Mild, infrequent None < 4 doses/week (in addition to use prior to exercise) ≥ 90% personal best < 10-15% < 2-3%

Answer online at eCortex.ca

Strategy for Adults and Adolescents 12 years and older.(4) This information is needed in order to determine if an individual has severe asthma according to criteria presented in Table 1. The 2019 GINA guidelines define mild asthma as asthma that is well controlled with Step 1 or Step 2 treatment in Figure 1 and moderate asthma as asthma that is well controlled with Step 3 therapy. Severe asthma is defined as asthma that requires Step 4 or 5 therapy (see Figure 1 and Table 1).(4) Table 1 compares the definitions of severe asthma and uncontrolled asthma according to the 2019 GINA guidelines and the Canadian Thoracic Society (CTS) position statement recommendations on recognition and management of severe asthma published in 2017 (2017 CTS guidelines). Pharmacists should regularly assess asthma control as well as inhaler techniques and adherence to medication in patients with asthma (e.g., at prescription refi lls, medication reviews) and refer for further assessment as appropriate.

Case (continued): Ben returns to the pharmacy Ben returns to the pharmacy three weeks later and presents you with a prescription for prednisone to treat another asthma exacerbation. Ben is upset about taking yet another course of oral corticosteroids. He tells you that he has recently had the laboratory testing done that you had discussed with him and is now waiting to see his respiratory specialist.

Consequences and hazards of oral corticosteroid overuse The 2017 CTS severe asthma management continuum and the 2019 GINA guidelines both recommend chronic oral corticosteroid (OCS) therapy (e.g., prednisone) for patients with severe asthma.(2,4) Higher doses are used for those patients whose symptoms remain uncontrolled despite optimal management with other asthma therapies. Long-term effects of OCS use have been identiﬁed in real-world retrospective cohort population studies.(5,6) In a study comparing patients with severe asthma requiring daily doses of OCS to those using rescue OCS doses only, adverse effects more often reported in association with daily use included dyspeptic disorders, obesity, psychiatric disorders, hypertension, hypercholesterolemia, osteoporosis and osteopenia, type 2 diabetes, cardiovascular disease and sepsis/infection.(5) In a second study that compared patients using low dose prednisone (< 6 mg/day) vs. medium and high doses (6-12 mg and > 12 mg/day), similar results were observed for medium and high-dose patients vs. those using low dose prednisone.(6) Many health professionals may be under the impression that adverse effects associated with use of OCS occur only with long-term use. This assumption would result in patients like Ben being told not to worry about intermittent use of these drugs. However, a retrospective cohort study of 1.5 million adults (18-64 years) with asthma suggests that short-term use

Integration of New Treatment Options for Patients with Severe Asthma

Answer online at eCortex.ca

TA B L E 3

November 2019

Continuing Education L E S S O N CE3

Biologic therapies as add-on therapy for the management of severe asthma*(2,14-20) Severe Allergic Asthma

Severe Eosinophilic Asthma

Omalizumab

Benralizumab

Mepolizumab

Reslizumab

Indication

Adult and pediatric patients (6 years of age and above) with moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids.

As add-on maintenance treatment of adult patients with severe eosinophilic asthma in patients 18 years of age and older.

As add-on maintenance treatment of adult patients with severe eosinophilic asthma who are inadequately controlled with high-dose inhaled corticosteroids and an additional asthma controller(s), and have a blood eosinophil count of ≥ 150 cells/µL at initiation of treatment OR ≥ 300 cells/µL in the past 12 months in patients 18 years and older

As add-on maintenance treatment of adult patients with severe eosinophilic asthma who are inadequately controlled with medium-to-high-dose inhaled corticosteroids and an additional asthma controller(s) and have a blood eosinophil count of ≥400 cells/µL at initiation of the treatment in patients 18 years and older.

Mechanism of Action

Humanized mAb binds to IgE and prevents binding to high-afﬁnity IgE receptor to slow or prevent the allergic cascade.

Humanized mAb that binds IL-5 α receptor expressed on eosinophils and basophils. Inhibits IL-5 mediated eosinophil activation and proliferation and causes antibodydependent natural killer cellmediated cytotoxicity (apoptosis) of basophils and eosinophils

Humanized mAb that binds IL-5 and prevents IL-5 binding to IL-5 receptor.

Dosing

30 mg SC every 4 wks for ﬁrst 3 75 mg – 375 mg SC every 2 or 4 wks based on body doses, then 30 mg sc once every weight and baseline IgE level 8 weeks

100 mg SC every 4 wks

3 mg/kg IV infusion over 20-50 minutes every 4 weeks

Efﬁcacy (results for severe asthma)

Exacerbations ↓ 26 % (p=.042) severe exacerbations ↓ 50 % small or no ↑ in FEV1

Exacerbations ↓28% - 51% 74% of patients exacerbation-free in year 2 of treatment ↑ FEV1 by 100-160 mL

Exacerbations ↓39% - 52% ↑ FEV1 by ~ 100 mL

Exacerbations ↓41% - 50% ↑ FEV1 by 115 - 160 mL

Corticosteroid sparing effect

No signiﬁcant difference in OCS dose

75% ↓ in median OCS dose D/C of OCS in 52% of eligible patients

50% ↓ in median OCS dose Data not available D/C of OCS in 14% of patients in “Intention to Treat” population

Adverse effects

Anaphylaxis in ~ 0.09% Otherwise similar to placebo

Similar to placebo

*Note: All biologic agents listed are to be administered by a qualiﬁed healthcare professional who is experienced in the monitoring of signs and symptoms of hypersensitivity after administration of biologic agents and prepared to manage anaphylaxis that can be life-threatening.

FIGURE 2

Recommendations for Conﬁrmation and Management of Severe Asthma

Assume patient with presumed severe asthma is taking high dose ICS + LABA +/- LTRA +/- tiotropium +/- theophylline +/- chronic prednisone (dosing to achieve control) with SABA or ICS/LABA (budesonide/ formoterol) on demand(2) 1. Confirm severe asthma diagnosis (differential diagnoses)(2,12) 2. Assess and address factors that may be contributing to symptoms:(2,12) a) Incorrect inhaler technique and/or suboptimal adherence b) Overuse of SABA relievers c) Medication side effects d) Environmental, including occupational exposures e) Assess comorbidities (e.g., GERD, obesity, chronic rhinosinusitis, vocal cord dysfunction, anxiety and depression, obstructive sleep apnea) 3. Regular (e.g., monthly) follow-up with health professional/asthma educator. Reassess control and confirm correction of reasons for poor control after 3-6 months(2,12) 4. If asthma still uncontrolled, severe asthma is diagnosed(2,12) 5. Assess severe asthma phenotype while on high dose ICS or lowest dose OCS. To identify Type 2 inflammation: a) Blood eosinophils ≥ 150/µL and/or(12) b) FeNO ≥ 20 ppb and/or(11) c) Sputum eosinophils ≥ 2% and/or(12) d) Asthma is clinically allergen-driven and/ or(12) e) Need for maintenance OCS and/or(12) f) Total IgE (30-1300 IU/mL for children 6-11 yrs and 30-700 IU/mL for 12 yrs and older)(2) 6. If NOT type 2 inflammation – review differential diagnosis, inhaler technique, adherence, comorbidities, side-effects, exposures to allergens and irritants; consider add-on therapies as per respiratory specialist(12) 7. If type 2 inflammation:(12) a) consider increasing ICS dose for 3-6 months b) consider biologic therapy (anti-IgE, anti-IL-5, anti-IL-5R as appropriate according to biomarkers)

of oral corticosteroids (< 30 days duration) are associated with increased risk for hospitalization as a result of acute adverse events such as sepsis, venous thromboembolism (VTE) and fracture by two to ﬁve times.(7) Another retrospective study that compared over 72,000 people with asthma that took OCS therapy vs. over 156,000 people with asthma who did not, found that asthma patients exposed to four or more OCS prescriptions in a year were at least 20 percent more likely to experience an adverse event during the year.(8) Adverse events included osteoporosis, hypertension, obesity, type 2 diabetes, gastrointestinal ulcers/bleeds, fractures, and cataracts (OR; 1.21-1.44 depending on the adverse event).(8) In their conclusions, the authors of the study publication stated “OCS-sparing strategies are extremely important to improve patient outcomes.”(8) As will be discussed, the biological agents omalizumab, benralizumab and mepolizumab have all been shown to reduce, or in some cases nullify, the need for OCS in patients with severe asthma. This represents an important treatment beneﬁt that extends beyond the clinical effectiveness associated with exacerbation frequency and clinical symptoms of these agents.

The Pathophysiology of Severe Asthma Various pathophysiologic mechanisms may

Continuing Education L E S S O N

Integration of New Treatment Options for Patients with Severe Asthma

CE4

November 2019

potentially contribute to the inflammation, airway hyper-responsiveness, airway remodelling and mucous hypersecretion that contribute to a diagnosis of severe asthma.(2,9,10) The mechanisms leading to severe asthma have been divided according to the level of involvement of the Th2 pathway (Th2 high or Th2 low).(2) The Th2 high (referred to as Type 2) mechanistic pathway refers to the involvement of the Type 2 helper cell which is largely responsible for eosinophilic airway inflammation and production of type 2 (inflammatory) cytokines such as interleukin (IL)-4, IL-5 and IL-13.(8) This pathway to inflammation which also includes immunoglobulin E (IgE) is the major cause of most cases of asthma and is initially triggered by sensitization to allergens.(10) IgE and the inflammatory cytokines continue to play an important role in symptom severity during the chronic phase of the disease and are targets for monoclonal antibodies (mAbs) such as omalizumab (anti-IgE), mepolizumab and reslizumab (anti-IL-5) and benralizumab (anti-IL-5 receptor ligand or anti-IL-5R).(11) In simplest terms we can think of severe asthma associated with T2 mechanism pathophysiology as being predominantly severe allergic (atopic) asthma or severe eosinophilic asthma.(10) Severe allergic asthma: IgE is the key mediator of severe allergic asthma due to its role in the pathogenesis of chronic allergic inflammation through influence on several immune and structural cells such as mast cells, basophils, dendritic cells, airway smooth muscle cells, epithelial cells, endothelial cells and eosinophils (i.e., the “allergic cascade”).(11) Severe eosinophilic asthma: As the name would suggest, this severe asthma category or “endotype” is characterized by high numbers of blood eosinophils.(2) Eosinophil production is stimulated by IL-5 at the level of the bone marrow.(11) IL-5 is produced by Th2 cells, mast cells and basophils.(11) Eosinophils cause damage to airways by degranulation and release of toxic proteins. This leads to bronchial wall damage airway remodelling through ongoing inflammation and repair.(11) Eosinophils also produce a number of additional inflammatory cytokines (IL-3, IL-4, IL-6 and others) which help to promote heightened airway inflammation and hyper-responsiveness and increased risk of asthma exacerbation.(11)

Answer online at eCortex.ca

Patient Resources for Severe Asthma 1. Asthma Canada - Severe Asthma: www.asthma.ca/get-help/asthma-3/severe-asthma 2. Asthma Canada - Biologics: www.asthma.ca/get-help/asthma-3/treatment/biologics 3. Could your severe asthma be e-asthma? www.e-asthma.ca

Although there is often overlap in these two severe asthma pathways, it is important to identify the predominant pathological mechanism in order to aid in decisions when biologic therapy (i.e., anti-IgE, antiIL5R or anti-IL5) is deemed to be appropriate. Biomarkers used to predict response to biologic therapies include sputum differential cell count, fraction of exhaled nitric oxide (FeNO), blood eosinophils and serum IgE.(2) Indications for speciﬁc therapies based on these biomarkers are presented in Figure 2.

Severe Asthma Management: What the guidelines say In Canada we turn to the 2017 CTS position paper on Recognition and management of severe asthma and the 2019 GINA guidelines on Difficult to treat & severe asthma for guidance on severe asthma management. (2,12) The strategies outlined in Figure 2 incorporate recommendations from both publications. (2,12)

Biologic Therapy for the Management of Severe Asthma Biologic therapies represent a breakthrough in the management of treatment resistant severe asthma. As outlined in Table 3, the anti-IgE agent omalizumab is indicated for management of severe allergic asthma while the anti-IL5R agent benralizumab and the anti-IL5 agents mepolizumab and reslizumab are indicated for management of severe eosinophilic asthma. Approximately 50% of individuals with severe asthma have severe eosinophilic asthma. Note the efﬁcacy and OCS sparing effects of these agents vs. standard therapy for severe asthma when used as add-on therapy.

Case (conclusion): Ben is happy Ben is smiling as he walks into the pharmacy and tells you that his lab results showed that he has severe eosinophilic asthma and that his respiratory specialist has prescribed benralizumab for him. The doctor told him that the subcutaneous administration every eight

weeks makes it a little more convenient than the others. You tell Ben that you would be happy to review the expected beneﬁts and potential adverse effects with him in detail even though he is not able to receive the medication at your pharmacy. Ben says he very much appreciates that, and he comes to your pharmacy because of the great care and personal service he receives.

Key Learnings 1. Severe asthma represents approximately 5-10% of asthma cases, but it accounts for up to 50% of direct asthma costs. 2. In order to manage asthma appropriately, it is extremely important to distinguish severe asthma from uncontrolled asthma. 3. Both chronic and intermittent oral corticosteroid use are associated with significant harmful clinical outcomes. 4. Biologic agents that target type 2 inflammation are associated with OCS sparing effects when used for treatment of severe asthma. 5. Severe asthma associated with type 2 inflammation can be generally classified as severe allergic asthma or severe eosinophilic asthma. 6. The anti-IgE agent omalizumab is indicated for treatment-resistant severe allergic asthma. 7. The anti-IL-5R agent benralizumab and the anti-IL-5 agents mepolizumab and reslizumab are indicated for treatment resistant severe eosinophilic asthma 8. All biologic agents mentioned significantly reduce the rate of asthma exacerbation.

References for this CE lesson are available online at www.ecortex.ca. Find the questions for this CE lesson online at www.ecortex.ca.

Quick Search CCCEP # 1329-2019-2868-I-P

Faculty: Integration of New Treatment Options for Patients with Severe Asthma ABOUT THE AUTHOR Tom Smiley BScPhm, PharmD, CTE, founder of Pharmavision Health Consulting Inc., has developed clinical education programs for pharmacists and other healthcare providers for more than 20 years in many areas, including respiratory care, diabetes and cardiovascular disease.

·ca

He has co-authored a program designed to prepare health professionals to challenge the Certiﬁed Respiratory Educator (CRE) exam.

REVIEWERS All lessons are reviewed by pharmacists for accuracy, currency and relevance to current pharmacy practice.

Answer online at eCortex.ca

CE Project Manager: Rosalind Stefanac CE Designer: Shawn Samson

CE queries: email ecortex@canadianhealthcarenetwork.ca

This lesson is published by EnsembleIQ: 20 Eglinton Ave. West, Suite 1800 Toronto, ON M4R 1K8 Phone: 877.687.7321 Fax: 888.889.9522

No part of this CE lesson may be reproduced, in whole or in part, without the written permission of the publisher.

FINDING YOUR NICHE:

AT THE HEART OF PATIENT HEALTH PHARMACISTS SUPPORTING CARDIOVASCULAR CARE

Getty Imges

BY ROSALIND STEFANAC

nyone who has dealt with cardiovascular issues can appreciate just how complex an organ the heart is, and how critical it is to every function of the body. From ambulatory care to hypertension treatment, pharmacists specializing in heart health say it’s an area that’s as vast as it is complex. And the need for medication expertise extends far beyond the hospital setting. After all, nine in 10 Canadians have at least one risk factor for heart disease, which is the leading cause of death in Canada, according to the Heart Research Institute. Pharmacist Sheri Koshman splits her time between teaching in the cardiology division of the University of Alberta and seeing patients at the Cardiac EASE clinic in Edmonton, which is supported by Alberta Health Services. “I really like the variety of my job as I do a lot of risk factor management in addition to dealing with complex cases,” she says. Patients referred to the clinic are first seen by Koshman, who does a physical exam, reviews their medication and presents each case to the cardiologist so they can work together to come up with an action plan. “The doctors I work with trust me and allow me to work to my full scope.” While she recognizes that the average pharmacist—who doesn’t have a longstanding relationship with a team of physicians—may not have the same opportunities, Koshman says heart disease risk reduction is something all

community pharmacists can be doing. “A lot of people have risk factors that are not identified and not managed and that’s the perfect opportunity for pharmacists to do a blood pressure check or set up a cardiovascular risk reduction screening clinic,” she says. “There is a lot of research out there proving that pharmacists can make a big difference in improving things like hypertension and other cardiovascular issues.”

Winnipeg. “I am very fortunate to be working with a team that includes nurses, occupational therapists, dieticians, cardiologists, endocrinologists and internal medicine physicians,” she says. Right now, a big part of her day is working

“ There is a lot of research out there proving that pharmacists can make a big difference in improving things like hypertension and other cardiovascular issues.” Sheri Koshman, pharmacist, Cardiac EASE clinic in Edmonton

Koshman also advises pharmacists not to shy away from charging for these services as needed, if they can’t bill for them under current provincial legislation. “If people value it they will pay for it, and I personally think there is a business opportunity for those who do it well and consistently.” Focusing on heart health can also be a good opportunity for pharmacists to strengthen their role in the healthcare team—and secure new roles entirely. Kristine Petrasko is one of several clinical case managers on an inter-professional cardio-metabolic team at Cardio 1 in

[Vol.6 No.9] NOVEMBER 2019

collaboratively with the patients and team on tobacco cessation consultations, which is one of the largest heart disease risk factors in this patient population. Given that cardiac care involves complex medication management for patients that often have multiple co-morbidities, Petrasko says the goal at Cardio 1 is to bridge the gap between the usual community and the hospital care settings to help patients prevent cardiac events and promote healthy living options. “These are areas that the government doesn’t pay for, but Cardio 1 saw the value in providing more service offerings into these areas,” she says. “This unique collaborative care team works hard to see patients in a timely fashion to decrease wait times and decrease the burden on the healthcare system. Working together makes us all stronger and enhances the patient care experience all around.” Although there is a pharmacy connected to the clinic, Petrasko says her team works with pharmacists/pharmacies all over Manitoba. Cardiac care is also an optimal way for pharmacists to use their pharmacy training, says Arden Barry, who splits his time teaching at the University of British Columbia and working at the Fraser

HEART HEALTH RESOURCES BC Heart Failure Network Practice Resources: http://www.bcheartfailure. ca/for-bc-healthcare-providers/ practice-resources/

“In cardiovascular care, pharmacists can be helpful in applying evidence in practice to individual patients dealing with heart issues.”

Canadian Cardiovascular Pharmacists Network: https://ccpn.ca

Arden Barry, clinical pharmacist and research specialist, Fraser Health Authority, BC.

Hypertension Canada Guidelines:

Health Authority as a clinical pharmacist and research specialist in a heart failure clinic. “Lots of us are taught to be evidence-based in terms of our approach to patient care, and in cardiovascular care, pharmacists can be helpful in applying evidence in practice to individual patients dealing with heart issues.” While cardiologists know heart medication well, Barry says they look to pharmacists for expertise on other

Cardio 1 team from left to right: Joel Hart (Clinical Pharmacist), Janelle Lussier (Clinical Pharmacist), Kristine Petrasko (Pharmacist Case Manager), Rose Ramm (Director of Research), Dr. Peiman Malek-Marzban (Cardiologist)

How do I specialize?

While there is no cardiology certification for pharmacists in Canada yet, those specializing in the area say staying on top of the latest clinical trials and heartrelated guidelines is essential, as information is being updated constantly. (See list of helpful mobile apps, right.) Those wishing to get formal certification can do so through the American Board of Pharmacy Specialties or the National Certification Board of Anticoagulation Providers. Attending conferences like the annual Canadian Cardiovascular Congress is also a good way to meet others in the field while learning about the latest in clinical updates.

NOVEMBER 2019 [Vol.6 No.9]

Canadian Cardiovascular Society Guidelines: http://www.ccs.ca/

eguidelines/Content/Topics/Home.htm https://guidelines.hypertension.ca

Thrombosis Canada:

http://thrombosiscanada.ca/tools/

CV Risk Calculator:

http://bestsciencemedicine.com/chd/ calc2.html

DAPT Risk Calculator: http://tools.acc.

org/DAPTriskapp/#!/content/calculator/

SPARC (stroke prevention in atrial fibrillation risk calculator): https://www.sparctool.com

drugs and drug interactions. “Cognitively [working in this field] can be very rewarding because at the end of the day, you know you’ve been applying evidence in the way you’ve been trained to do to figure out a sometimes complex issue.” Barry also believes pharmacists can help fill a current gap in care when it comes to cardiovascular risk factors and disease management by ensuring existing drugs are used in a more patient-centred way. “Our attention to detail and ability to monitor patients with a systematic approach to treatment are all benefits of what pharmacists can do.”

USEFUL APPS FOR CARDIOVASCULAR CARE: • • • • •

Aspirin Guide CCPN SPAF iCCS Credible Meds MED-HF

SELF-CARE REVIEW

A PRIMER ON COMMON AILMENTS MANAGED BY NONPRESCRIPTION PRODUCTS

OTC ISSUES

NARDINE NAKHLA, PharmD is a practising community

pharmacist and a clinical lecturer at the University of Waterloo School of Pharmacy. The author thanks Kristi Butt, PharmD, for her contribution to this article.

Don’t cry, it’s just a stye! A review of common eyelid conditions Case

PM, a 58-year-old male, presents to the pharmacy requesting Polysporin Eye & Ear drops for a small, tender lump that spontaneously appeared yesterday in the left lower eyelid. He reports no ophthalmic discharge, changes in vision, eye trauma or chemical exposures, and he does not wear contact lenses. Visual inspection reveals a rounded raised abscess localized to the distal eyelid margin, with surrounding erythema. PM has an important business meeting in a couple of days and desperately wants the “unsightly” eyelid lump gone before then. He is otherwise healthy, with no known medical conditions or allergies.

Background

A red swollen eyelid may accompany a number of disorders, ranging from mild dermatitis to malignant tumours (Table 1).(1,2) To accurately assess the nature and severity of eyelid complaints, a basic understanding of key eyelid structures is necessary. Figure 1 illustrates eyelid anatomy, including the eyelashes, sebaceous (meibomian) glands and sweat glands (glands of Zeis or Moll).(3) Inflammatory reactions in any of these structures, or mass effects (e.g., compression, displacement) from tissues posterior to the orbital septum, can lead to a red swollen eyelid. Prompt and accurate diagnosis is vital to guide appropriate therapy and avoid vision loss.(2) Red flags warranting an immediate

ophthalmology consultation include penetrating trauma through the eyelid or into the globe (eyeball), a change in vision (e.g., diplopia) or loss of extraocular movements.(2) Patients presenting with signs and/or symptoms suggestive of superficial skin processes or orbital cellulitis (Table 1) should also be referred. Hordeola (styes) are among the most common conditions seen in community pharmacy practice. Caused by an acute staphylococcal infection of the eyelash follicle, a hordeolum typically presents unilaterally as red painful swelling of the eyelid margin.(1) External hordeola are more superficial, with the glands of Zeis or Moll involved, while internal hordeola are more diffuse, with the meibomian glands affected.(4) Hordeola generally drain spontaneously and resolve untreated; however, the infection can spread to other ocular glands or tissues (presenting as cellulitis) and recurrences are common.(2) If unresolved, an acute internal hordeolum can become chronic or develop into a chalazion.(5) A chalazion presents as a painless, nonerythematous eyelid nodule.(4) Chalazia are noninfectious, resulting from chronic inflammation of the meibomian glands.(4) Visual distortion is possible, as chalazia gradually enlarge and begin pressing on the eyeball.(6) Blepharitis is also a chronic eyelid condition, but presents bilaterally with eyelid margins that appear greasy, scaly and/or flaky.(7) It is common in patients with rosacea or seborrheic dermatitis, and the eyelid margins are often heavily colonized by staphylococci.(2) Long-term complications include physical damage to the eyelids and cornea.(7)

Pharmacists must be able to differentiate self-care candidates presenting with minor opthalmic concerns from those with serious sightthreatening conditions.

FIGURE 1

Eyelid Anatomy(3) Orbicularis muscle

Tarsal conjunctiva

Gland of Zeis

Tarsum Eyelash

Pharmacist’s role

Meibomian gland Gland of Moll

Pharmacists must be able to differentiate

[Vol.6 No.9] NOVEMBER 2019

self-care candidates presenting with minor ophthalmic concerns from those with serious sight-threatening conditions.(1) A thorough history—including coexisting conditions (e.g., rosacea), changes in vision, the severity and duration of eye discomfort and/or pain, and the presence of eye discharge— should be elicited from the patient in order to rule out more serious causes of the presenting complaint.(1,2) A simple inspection of the eye(s), when possible, can supplement information gathered and assist in the differential diagnosis. For self-treatable conditions, pharmacists should guide patients in management, ensuring strategies used are safe and evidence-based. Pharmacists should also ensure patients know when to expect eyelid conditions to improve/resolve and when to seek further medical attention. Finally, pharmacists should provide education on preventing the recurrence of eyelid conditions.

TABLE 2

General Management Strategies for Common Eyelid Conditions and Timelines for Seeking Further Medical Attention EYELID CONDITION

Hordeolum (stye)

Recommendation

Reassure PM that an external hordeolum (stye) typically resolves spontaneously within 48 hours and it will likely be gone before his business meeting in a couple of days. To facilitate drainage, a warm compress can be applied for 10–15 minutes three or four times daily 34

External hordeola:(8) • Apply warm compress for 10–15 minutes tid-qid

Internal hordeola: • Recent Cochrane review found no evidence for the effectiveness of nonsurgical treatments (e.g., warm compresses, lid massages, lid scrubs).(5)

•R esolve spontaneously within 1–2 weeks

WHEN TO SEEK FURTHER MEDICAL ATTENTION(8) Internal hordeola: • If not resolved in one week External hordeola: • If not resolved in 48 hours

External hordeola: • Resolve spontaneously within 48 hours Internal & external hordeola: • Nonprescription ophthalmic antibacterials are not recommended; they are not associated with faster resolution and hordeola drain spontaneously.(1)

•A n ophthalmic antibacterial ointment (e.g., erythromycin) may be used for hordeola that fail to resolve spontaneously and require incision for drainage.(7)

Chalazion

Initial management: • Same as for external hordeola

•N onprescription ophthalmic antibacterials are not recommended, as chalazia are not associated with infection

• I f no improvement within a few days of using nonpharmacological strategies or if chalazion is large

•C ontinuing eyelid hygiene practices may help prevent exacerbations

• I f presenting with suspected blepharitis for the first time, if unresponsive to eyelid hygiene measures, or if presenting with a severe exacerbation

•S urgical excision and/or steroid injection(s) may be required for large chalazia.(2)

Blepharitis

Long-term eyelid hygiene:(7) • Apply warm compresses for 5–10 minutes •C leanse eyelid margin with warm water, diluted baby shampoo or commercial eyelid wipes

Case analysis

PM is presenting with tenderness, localized swelling and erythema on his left lower eyelid, suggestive of an external hordeolum. Other eyelid conditions can be ruled out, as an internal hordeolum would have more diffuse swelling and erythema, a chalazion would be painless, and blepharitis would likely present bilaterally. The hordeolum has been present for less than 48 hours and PM has no red flags (e.g., vision changes, contact lens use, chemical exposures) that would exclude him from self-management. PM is healthy otherwise, with no known medical conditions or allergies.

COMMENTS

•G ently massage eyelid toward eyelid margin

General treatment approach

In the majority of cases, eyelid conditions like hordeola, chalazia and blepharitis are not sight-threatening and do not require emergent referral. General management strategies for these conditions, as well as recommendations for when patients should seek further medical attention, are outlined in Table 2.

RECOMMENDATIONS FOR MANAGEMENT

• Massage eyelid

•O phthalmic or systemic antibacterials, antiinflammatories, and/or other prescription products may be required for severe exacerbations.(7)

Repeat all of above bid-tid initially and during flares(8)

followed by gentle massaging of the eyelid toward the lid margin. Explain that Polysporin Eye & Ear drops are unlikely to hasten resolution and are not generally recommended for this condition. Advise PM to seek further medical attention if the hordeolum fails to drain within 48 hours or if his signs/symptoms worsen (e.g., increasing pain, changes to vision). To prevent transmission to the other eye, recommend that PM avoid touching the affected eye (or wash hands thoroughly after contact), and change his pillowcases

NOVEMBER 2019 [Vol.6 No.9]

TABLE 1 is available in the

online version of this article. Visit

CanadianHealthcareNetwork.ca/ pharmacists

and towels. Eyelid hygiene practices can also be suggested and may minimize the risk of recurrence. REFERENCES 1. Rutter P. Eyelid disorders. In: Community pharmacy: symptoms, diagnosis and treatment. 4th ed: Elsevier; 2017. p. 63-8. 2. Carlisle RT, Digiovanni J. Differential diagnosis of the swollen red eyelid. Am Fam Physician 2015;92:106-12. 3. McAlinden C, Gonzalez-Andrades M, Skiadaresi E. Hordeolum: acute abscess within an eyelid sebaceous gland. Cleve Clin J Med 2016;83:332-4. 4. Papier A, Tuttle DJ, Mahar TJ. Differential diagnosis of the swollen red eyelid. Am Fam Physician 2007;76:1815-24. 5. Lindsley K, Nichols JJ, Dickersin K. Non-surgical interventions for acute internal hordeolum. Cochrane Database Syst Rev 2017;1:CD007742. 6. Arbabi EM, Kelly RJ, Carrim ZI. Chalazion. BMJ 2012;341:c4044. 7. Amescua G, Akpek E, Farid M, et al. Blepharitis Preferred Practice Pattern®. Ophthalmology 2019;126:P56-93. 8. Friesen AM. Eyelid conditions: hordeolum, chalazion and blepharitis. In: Jovaisas B, ed. Compendium of therapeutics for minor ailments. Ottawa, ON: Canadian Pharmacists Association; 2019.

This is the second in a series of Self-Care Counselling Tip Sheets created for Pharmacy Practice + Business by third-year pharmacy students in the Advanced Patient Self-Care course at the University of Waterloo.

OTC COUNSELLING TIP SHEET

Dandruff An opportunity in self-care BY NOOR REHMAN

Dry, white diffuse scales on scalp ONLY

Pruritus due to dryness

NORMALLY, SHEDDING OF DEAD KERATINOCYTES IS NOT NOTICEABLE

2x + 2x =

Limited or no erythema

the normal turnover rate of keratinocytes

the normal growth of Malassezia yeast

increased shedding of flakes

CAN BE TRIGGERED OR WORSENED BY: dryness

OFTEN CONFUSED WITH OTHER SCALING CONDITIONS SEBORRHEIC DERMATITIS • greasy, yellowish scales, erythematous patches • may have systemic symptoms can also involve

cold weather

poor immune system

AFFECTS ALMOST HALF OF THE WORLD’S POPULATION ABOVE 30 YEARS OLD PSORIASIS • thick, silvery, scaly plaques, erythematous patches

10 years old

• may have systemic symptoms

infrequent shampooing

stress

AFFECTS BOTH SEXES AND ALL RACES EQUALLY

USUALLY STARTS BETWEEN

UNCOMMON IN CHILDREN Further assessment is needed if a CHILD UNDER 10 YEARS shows symptoms

can also involve

years old

Getty Imges

Dandruff may be harmless, but it can be embarrassing and inconvenient for patients Further assessment is needed in patients if symptoms are GENERALIZED or NOT LIMITED TO THE SCALP

[Vol.6 No.9] NOVEMBER 2019

TIP SHEET CONTINUED

Dandruff presents a great opportunity for PHARMACISTS to strengthen OTC sales and PATIENTS to practise self-care

$200

USD MILLION

Approximate value of incremental sales opportunity will be created from anti-dandruff shampoos between 2019 and 2029

According to a global market study released by XploreMR, a leading market research firm that specializes in identifying opportunities in the healthcare industry

1) NON-PHARMACOLOGICAL MEASURES

Recommend frequent rinsing of hair at least

3 TIMES PER WEEK avoid hair sprays & pomades

use a cool air humidifier

use a non-medicated shampoo

2) OTC ANTI-FUNGAL SHAMPOOS

fungicidal agents that decrease colonization of Malassezia 1ST LINE

KETOCONAZOLE Can be used long-term Also slows cell turnover 80% response rate in 4 weeks

More effective with longer contact time

Excessive use can cause oily hair and hair loss

may add to antifungal therapy if response has been inadequate

Sulfur

Coal Tar

•L oosen bonds between keratinocytes and help detach flakes • Increase penetration of other agents • Combination products are more potent, but also more irritating

4) OTC TOPICAL CORTICOSTEROIDS

may add to antifungal therapy if response has been inadequate or lesions are extensive and inflamed Decrease pruritus and inflammation

HYDROCORTISONE

For better adherence, try to strike a balance between shampoo effectiveness and cosmetic appeal

2ND LINE

SELENIUM SULFIDE OR ZINC PYRITHIONE

3) OTC KERATOLYTIC AGENTS

Salicylic acid

with a shampoo that contains surfactants and is indicated for dry hair

Intended for temporary use only

Long-term use can lead to atrophy and poor wound healing Solutions and lotions are best for the scalp

WEEKS

ANTIFUNGALS AND KERATOLYTIC AGENTS BOTH REQUIRE TO SEE FULL EFFECT

WEEKS

MAINTAIN USE UNTIL SYMPTOMS ARE CONTROLLED, THEN TAPER

COUNSELLING TIPS ON USING MEDICATED SHAMPOOS:

1) Part hair into small sections 2) Massage shampoo into scalp at the roots 3) Leave on scalp for at least 5 min 4) Rinse thoroughly 5) Repeat

MONITORING THERAPY:

 Recommend patients keep a symptoms diary  Follow-up in 2-3 weeks C heck for Efficacy: scales, erythema, surface area

involved, spread to other sites, pruritus, impact on ADLs, recurrence  Check for Safety: allergic reactions, irritation  Discontinue therapy if allergic reaction occurs

NOOR REHMAN expects to graduate with a PharmD in 2020 from the University of Waterloo School of Pharmacy. She has previous work experiences at Sunnybrook Health Sciences and Walmart Canada, and is looking forward to completing her experiential rotations in Hamilton, ON. REFERENCES 1. Canadian Dermatology Association. Dandruff. https://dermatology.ca/public-patients/hair/dandruff/. Updated 2019. Accessed February 28, 2019. 2. Pharmaceutical Society of Australia. Dandruff. www.nightingales.net.au/LiteratureRetrieve.aspx?ID=115865. Reviewed August 2008. Accessed February 28, 2019. 3. NBC29. Anti-Dandruff Shampoo Sales Spiral Up as Products with Novel Formulations Come to Fore, finds XploreMR. https://www.nbc29.com/story/40781488/anti-dandruff-shampoo-sales-spiral-up-as- products-with-novel-formulations-cometo-fore-finds-xploremr. Published July 12, 2019. Accessed July 15, 2019. 4. Pierard-Franchimont C, Xhauflaire-Uhoda E, Pierard GE. Revisiting Dandruff. Int J Cosmet Sci. Oct 2006;28(5):311-8. doi: 10.1111/j.1467-2494.2006.00326.x. 5. Sibbald, D. Dandruff and Seborrheic Dermatitis. In: Compendium of Therapeutics for Minor Ailments. Ottawa, ON: Canadian Pharmacists Association. [Updated January 2018; Accessed February 28, 2019]. https://myrxtx.ca.

NOVEMBER 2019 [Vol.6 No.9]

Classified

We are more than our name implies. Check out our new website. www.oconnell.ca

CLASSIFIED ADVERTISING

a great place to work Advance your pharmacy career with Save-On-Foods. We are a Western Canadian company with over 130 pharmacies in over 50 communities across BC, Alberta, Saskatchewan, Manitoba, and the Yukon. We’re looking for pharmacy professionals who share a passion for healthy living and for delivering quality patient-centred care to our customers.

ndumont@ensembleiq.com

1 877 687-7321

113098_Asthma Society-BC:92776_Asthma Society-BC 07/05/09 ext.:1266

Our pharmacists have opportunities to be involved with health screenings, vaccinations and travel health, medication management services, prescribing, and other clinical programs where possible in their province. A career at Save-On-Foods is an opportunity to: • Work in a friendly, professional and supportive work environment • Enjoy flexibility, stability and great compensation packages • Develop your leadership skills, expand your scope of practice and advance your career

Asthma Society of Canada InfoLine 1-866-787-4050 info@asthma.ca

For career opportunities, please forward your resume in confidence to: pharmacyemployment@saveonfoods.com.

4950 Yonge Street, Suite 2306, Toronto, ON, M2N 6K1

www.Asthma.ca

pharmacy

[Vol.6 [Vol.6 No.9] No.2] NOVEMBER MARCH 2019

45 37

BACK TALK

CREATIVE THOUGHTS ON MANAGEMENT FROM AN INNOVATIVE PHARMACY OWNER

MANAGING

CARLENE OLEKSYN, BSP Pharm, CDE, CTH,

“ This shot does not protect you from nausea, vomiting, diarrhea, ‘stomach flu,’ colds or sinus infections. Those are all caused by other viruses.”

“FLU SHOTS? THEY MAKE ME SICK” “The flu shot made me sick.” “I’m really healthy, I don’t need it.” “It doesn’t work anyway, so why bother?“ Talking with people who believe vaccine myths is one of the most challenging aspects of vaccination. A couple years ago I changed how I approach people regarding influenza vaccination. Whether it’s patients refusing the vaccine, or those who come for one somewhat reluctantly, I realized that providing a few scientific facts in simple language vastly increases uptake and acceptance of flu shots. Here are my top 5 points to increase patient uptake of flu shots: 1. Explain what it is. Make a point of telling patients you are protecting them from a “serious lung infection.” This 38

infection, influenza, causes a high fever, likely a cough and makes you feel like you’ve been hit by a truck. It comes on fast and you will likely be sick for at least a week. The danger with influenza is it leaves your lungs vulnerable. Pneumonia can set in, or it can make medical conditions critically worse. This is what puts people in the hospital and causes death. 2. Explain what it is not. It’s essential to tell patients what the flu shot is NOT protecting them from. My usual spiel goes something like: “This shot does not protect you from nausea, vomiting, diarrhea, ‘stomach flu,’ colds or sinus infections. Those are all caused by other viruses. You can, and likely will, get some of those illnesses this winter.” I give this information

NOVEMBER 2019 [Vol.6 No.9]

even as I am giving the shot to people who ask for it. This helps prevent someone who contracts a stomach bug from blaming it on the flu shot. 3. Take away the mystery. Using imagery is a great way to help people understand what vaccines do. “I am giving you a killed-off version of the virus. Your body recognizes it as an invader, even though it is dead, and makes antibodies to protect you against the virus. Antibodies fit like puzzle pieces on the virus. If you get sick with the real thing, those antibodies will fit on the virus and get rid of it before it makes you sick.” Vaccines cause a natural immune response in the body, making the immune system “stronger” against this particular virus. This also helps to explain antigenic shift to a patient and why they need to get the vaccine every year. The virus “changes its shape” and the antibody will not “fit any more. It also explains how sometimes the vaccine is not a good match. Science is not perfect. Experts do their best at matching the circulating strains. But whether it is a

20% match or an 80% match, 20% protection is better than no protection, given the extremely low risk of vaccination and the high risk in getting influenza. Which brings me to my next point: 4. Give a personal example. If it’s suitable, share a personal story of someone you know who encountered influenza and suffered from its consequences. My neighbor and friend, a perfectly healthy 40-yearold mom of two boys, was on life support for over a month and nearly lost her life from influenza. She is lucky to be alive, though she lost her voice permanently from the prolonged intubation and her lungs are irreversibly damaged. If you don’t have a story, feel free to share Jocelyn’s. She has given me permission to share with anyone who will listen. 5. Express empathy—and roll with resistance. I often say, “It’s my job to present to you the science and facts so that you can make an informed decision.” In the end, it is the patient’s choice, but I ensure I’ve done my best to help them make an informed decision based on facts. Expressing empathy and understanding, and providing facts in patientfriendly language can go a long way in increasing vaccination rates and ultimately the health of our patients and our communities.

Illustration by Spencer Flock

is the owner of Meridian Pharmacy in Stony Plain, AB, and owner and director of the Stony Plain Travel Clinic.

NOT ALL PROBIOTICS ARE THE SAME.

IBS SYMPTOM RELIEF SUCH AS: ABDOMINAL DISCOMFORT, GAS & BLOATING

ONLY ALIGN® CONTAINS THE PATENTED PROBIOTIC STRAIN BIFIDOBACTERIUM 35624™ GENUS

SPECIES

SUBSPECIES

Biﬁdobacterium

longum

Strain Designation

STRAIN DESIGNATION

35624™ 35624

Although some store brands compare themselves to Align, none contain the same strain. Only Align contains the patented purestrain probiotic Biﬁdobacterium 35624™, which helps to relieve and manage symptoms of Irritable Bowel Syndrome.

RECOMMENDED BY GASTROENTEROLOGISTS

X MORE THAN ANY OTHER PROBIOTIC*

CAUTION: Keep out of reach of children. In case of accidental ingestion, contact your doctor or a Poison Control Centre. Do not use if you are experiencing nausea, fever, vomiting, bloody diarrhea, or severe abdominal pain. Do not use if you have an immune-compromised condition (e.g., AIDS, lymphoma, patients undergoing longterm corticosteroid treatment). Consult a doctor if symptoms of digestive upsets do not improve, or persistently worsen. To ensure this product is right for your patients, always advise the patient to read and follow the label. * Among gastroenterologists who recommended a brand of probiotic in a ProVoice 2017 survey. © 2018 P&G

Helping patients and caregivers manage their health At Teva Canada, we do more than provide medication: we’re committed to helping Canadians take better control of their health. With one of the country’s broadest range of resources and tools for pharmacies, we’re excited to work with you in helping counsel and treat patients and caregivers, creating true partnerships in people’s health journeys. Learn more about our Caregiver Friendly Pharmacy Program at TevaCaregivers.com

Live Better Days