Careers

Your Pharm Aid

Amoxicillin Shortage

As many of us are aware, the United States is currently in the midst of a shortage of amoxicillin products. The shortage started this summer in several countries around the world and is now affecting us here at home. The unfortunate timing in tandem with the current surge of RSV and other upper respiratory infections nationwide makes this a significant issue for patients, families, and primary care providers.

As of the writing of this piece, the shortage is primarily affecting pediatric oral powders for reconstitution, although some manufacturers are reporting a short supply of oral solids dosage forms as well. This problem is expected to persist across all wholesalers and pharmacies worldwide well into 2023.  

The causes of the shortage are multifactorial and appear to stem from scaled-back production in response to decreased demand for the drug over the past 2 years amid lower disease transmission related to social distancing and masking. There are currently 4 primary amoxicillin manufacturers worldwide. United Kingdom-based Hikma Pharmaceuticals and Israeli company Teva did not offer explanations for the shortfall to the American Society of Health-System Pharmacists (ASHP), which maintains the most accurate, up-to-date database for drug shortages in the United States. Sandoz attributes the problem to “a rapid succession of the pandemic impact and consequent demand swings, manufacturing capacity constraints, scarcity of raw materials, and the current energy crisis.” US-based Rising Pharmaceuticals filed for bankruptcy in 2019 but does report the availability of some tablet and capsule formulations.

Only a handful of countries, primarily China, produce the active ingredient for amoxicillin. Regulatory sanctions resulting from poor manufacturing practices have been placed on several overseas pharmaceutical manufacturers (e.g., India-based Aurobindo Pharmaceuticals) producing raw ingredients or amoxicillin itself and are likely to be contributory as well.

Because amoxicillin is such an inexpensive medication, drug manufacturers are essentially disincentivized from allocating and/or investing resources in its production. As a result, we should anticipate long-term scarcity in the United States and worldwide.

Pharmacies and health systems are addressing the issue by pausing the standard practice of rounding up to the next stock bottle size based on the duration of therapy (e.g., dispensing a commercially available 150mL bottle for 5mL PO TID x 7 days). Rather, exact quantities may be mixed and dispensed based on the prescribed duration of therapy. Since tablets and capsules are still currently available, pharmacies can extemporaneously compound amoxicillin if necessary. However, it is possible, if not likely, that oral solid amoxicillin dosage forms may be affected in the future.

Moving forward, prescribers should be especially mindful of antimicrobial stewardship practices to avoid subsequent development of resistance to amoxicillin alternatives. Careful diagnostic approaches are emphasized, and watchful waiting is encouraged in cases where viral upper respiratory infections are possible.

 

References:

ASHP Drug Shortage Database. https://www.ashp.org/drug-shortages/current-shortages/drug-shortage-detail.aspx?id=875.

https://www.cidrap.umn.edu/news-perspective/2022/10/doctors-pharmacists-coping-amoxicillin-shortage.

TIME Study Reveals Indifference to Dosing Time for Antihypertensives

Some ambiguity has existed as to what is the best time of day for patients to take their antihypertensive medications. Diurnal blood pressure variations often lead to a greater frequency of cardiovascular (CV) events occurring during the morning hours. Whether the timing of medication administration can positively impact this has led to studies attempting to answer this question.

Previously, only two randomized trials had studied whether cardiovascular outcomes were impacted by morning versus nighttime administration of antihypertensive medications. Both the MAPEC study and the Hygia Chronotherapy Trial showed a reduction in cardiovascular outcomes when medications were taken at nighttime. Significant controversy surrounded the design and outcomes reported in these studies calling into question their conclusions. As a result, the answer to this clinical question has been felt to be unanswered by many clinicians.

A recent study in Lancet sought to clarify if the time of day when antihypertensive medications are administered (morning vs. nighttime) had any effect on cardiovascular outcomes. The TIME study took place in Great Britain, following over 21,000 adults during a median follow-up of 5 years. Patients were randomized to take all their antihypertensive medications either in the morning (6:00 am - 10:00 am) or all at night (8:00 pm - 12:00 am). Medication adherence, side effects, and cardiovascular events were monitored via periodic questionnaires. Primary cardiovascular outcomes monitored included CV-related death, non-fatal myocardial infarction, and stroke. Morning dosing found a higher rate of side effects such as dizziness, indigestion, diarrhea, and myalgia, while evening dosing had a higher rate of bothersome nocturia (as would be expected with nighttime administration of diuretics used for hypertension). Rates of medication adherence were better in the morning compared with nighttime dosing. At the study’s conclusion after a median follow-up of five years, both morning and evening administration times had similar rates of cardiovascular outcomes.

This study is not without limitations. A review of the study revealed some of the following issues:

  • Reported primary CV outcomes occurred at a lower rate than expected which was postulated to be the result of a healthier-than-average study population.
  • Being a prospective, randomized, open-label, blinded-endpoint design, study participants were aware of their assigned dosing time. As a result, participants may have answered questionnaires to reflect this knowledge. 
  • Medication adherence was impacted negatively to a greater extent with nighttime administration.
  • Regarding the applicability to a diverse patient population, participants in this study were over 90% white.

Ultimately, the conclusion made by the study’s authors was not that morning versus nighttime administration of antihypertensive medications was superior to the other in the reduction of cardiovascular outcomes, but rather that patients should be promoted to take these medications at whichever time is best for them to do so. Patient-specific characteristics that consider when a patient may be most adherent to their medication therapy may ultimately be the most important factor.  More research is likely still needed; however, this study does provide some validity to the importance of patient-specific care decisions.

 

To be directed to the TIME study, click here: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)01786-X/fulltext

 

 

November is Diabetes Month and World Diabetes Day is November 14th! Celebrate with a Summary of the New 2022 Algorithms from ADA/EASD

Highlights from the updated 2022 consensus statement by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) published this month: 

  • Graphics have been updated to capture the overall themes well – it is worth checking them out!
  • Holistic Person-Centered Approach has been simplified into 4 areas of management:

Many combos are available too!

References:
Melanie J. Davies, Vanita R. Aroda, Billy S. Collins, Robert A. Gabbay, Jennifer Green, Nisa M. Maruthur, Sylvia E. Rosas, Stefano Del Prato, Chantal Mathieu, Geltrude Mingrone, Peter Rossing, Tsvetalina Tankova, Apostolos Tsapas, John B. Buse; Management of Hyperglycemia in Type 2 Diabetes, 2022. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care 1 November 2022; 45 (11): 2753–2786. https://doi.org/10.2337/dci22-0034

Available here: https://diabetesjournals.org/care/article/45/11/2753/147671/Management-of-Hyperglycemia-in-Type-2-Diabetes

Clinical Pharmacy Practitioner in Primary Care

Mike Grunske, PharmD, BCPS

Mike Grunske is a Board-Certified Pharmacotherapy Specialist (BCPS). Mike transitioned his practice to the Clement Zablocki VA Medical Center where he has since practiced in the Primary Care Clinics as a Clinical Pharmacist Practioner. Within this role, his practice involves direct care and management of patients’ medication regimens. He has worked as an active preceptor for both pharmacy students and residents throughout his entire career. Mike is also Past-President and former Foundation Chair of the Pharmacy Society of Wisconsin (PSW).

Mike is married to a fellow PharmAid contributor (Vanessa Grunske). Together they have a teenage daughter and son. He enjoys traveling with his family, attending his kid’s cheer, baseball, and basketball events, and spending any available leftover time running and hunting.

Pharmacist at Advocate Aurora Health

Vanessa Grunske, PharmD, BCACP

Vanessa practices with Advocate Aurora Health in Milwaukee, where she sees patients at Aurora Sinai Medication Management Clinic and maintains a dispensing practice at St. Luke’s Medical Center. Board-certified in ambulatory care pharmacotherapy, her practice interests include diabetes, hypertension, smoking cessation, geriatrics, improving health literacy, and medication adherence. She particularly enjoys and spends a good share of her work hours teaching and mentoring pharmacy students, family medicine residents and pharmacy residents.  

She and her husband, Mike, live in the Milwaukee area with their two teenage children. In her free time, she enjoys cooking, baking, visiting our national parks with her family or relaxing on a beautiful Caribbean beach.

Professor at Concordia University Wisconsin School of Pharmacy

Beth Buckley, PharmD, CDCES

Beth Buckley, PharmD, CDCES (Certified Diabetes Care and Education Specialist), is a Professor of Pharmacy Practice at the Concordia University Wisconsin School of Pharmacy, where she has a teaching role within all years of the curriculum with a focus on Applied Patient Care Skills Lab, Diabetes Pharmacotherapy, and electives in the areas of diabetes and wellness. Her current role is ambulatory care pharmacist where she works with a Collaborative Practice Agreement to provide chronic disease state management within a primary care clinic.

When not working, she enjoys reading, gardening, traveling with her husband, volunteering within the community, and active fun: hiking, biking, dog walking, practicing yoga, mindfulness, and living with intention and gratitude. 

Disclaimer: The Wisconsin Academy of Family Physicians (WAFP) has entered into a business relationship with Pharm Aid to offer our members discounts and exclusive savings. This or other affinity program relationships presented by the WAFP in no way implies a WAFP endorsement of the program, supplier, or vendor.

Sign up to the
WAFP Email List