Author Interviews, Health Care Systems, JAMA, Pharmacology, University of Pittsburgh / 31.10.2024
UPitt Study Compares Supply Chains and Drug Shortages Between US and Canada
MedicalResearch.com Interview with:
[caption id="attachment_64457" align="alignleft" width="200"] Dr. Suda[/caption]
Katie J. Suda, PharmD, M.S., FCCP
Professor of medicine with tenure
Associate Director, Center for Pharmaceutical Policy and Prescribing
University of Pittsburgh School of Medicine
MedicalResearch.com: What is the background for this study?
Response: Our pharmaceutical supply chain is global where the manufacturing process for one drug may occur in multiple countries. Sometimes there are breakdowns in the pharmaceutical supply chain which may threaten access to medicines. Breakdowns in the supply chain occur for medicines manufactured in the U.S. and by international partners. While breakdowns in the supply chain occur for hundreds of drugs each year, not all result in a decrease in available supply (a “drug shortage”) because of action taken by manufacturers, pharmacies and drug regulators (e.g., the U.S. Food and Drug Administration [FDA]).
Drug shortages are a critical concern to public health as pharmacies, clinicians, and patients struggle to identify safe and effective alternatives. In addition, drug shortages have been associated with adverse patient outcomes and medication safety events. Recently, drug shortages have gotten worse with shortages occurring with increasing frequency and lasting longer. There has also been a shift in the types of medicines in shortage from drugs primarily used in hospitals, such as injectables, to oral medicines frequently used to manage outpatient conditions.
Countries have different regulatory authority and policy which may impact how drug supply chain breakdowns result in drug shortages. We wanted to know if there are differences between the U.S. and Canada in the frequency that national drug shortages occur after supply chain breakdowns are reported in both countries. Canada is a good comparator to the U.S. because Canada has similar drug regulatory standards and manufacturing inspections. Prescription drug coverage is also similar for the two countries where half of prescriptions are reimbursed through public insurance and half through private insurance and out-of-pocket.
Dr. Suda[/caption]
Katie J. Suda, PharmD, M.S., FCCP
Professor of medicine with tenure
Associate Director, Center for Pharmaceutical Policy and Prescribing
University of Pittsburgh School of Medicine
MedicalResearch.com: What is the background for this study?
Response: Our pharmaceutical supply chain is global where the manufacturing process for one drug may occur in multiple countries. Sometimes there are breakdowns in the pharmaceutical supply chain which may threaten access to medicines. Breakdowns in the supply chain occur for medicines manufactured in the U.S. and by international partners. While breakdowns in the supply chain occur for hundreds of drugs each year, not all result in a decrease in available supply (a “drug shortage”) because of action taken by manufacturers, pharmacies and drug regulators (e.g., the U.S. Food and Drug Administration [FDA]).
Drug shortages are a critical concern to public health as pharmacies, clinicians, and patients struggle to identify safe and effective alternatives. In addition, drug shortages have been associated with adverse patient outcomes and medication safety events. Recently, drug shortages have gotten worse with shortages occurring with increasing frequency and lasting longer. There has also been a shift in the types of medicines in shortage from drugs primarily used in hospitals, such as injectables, to oral medicines frequently used to manage outpatient conditions.
Countries have different regulatory authority and policy which may impact how drug supply chain breakdowns result in drug shortages. We wanted to know if there are differences between the U.S. and Canada in the frequency that national drug shortages occur after supply chain breakdowns are reported in both countries. Canada is a good comparator to the U.S. because Canada has similar drug regulatory standards and manufacturing inspections. Prescription drug coverage is also similar for the two countries where half of prescriptions are reimbursed through public insurance and half through private insurance and out-of-pocket.
Lisa-Marie Smale, PharmD
Dr. Lazarus[/caption]
Philip Lazarus, PhD
Boeing Distinguished Professor, Pharmaceutical Sciences
Professor, Dept of Pharmaceutical Sciences
College of Pharmacy and Pharmaceutical Sciences
Washington State University
Spokane, WA 99210
MedicalResearch.com: What is the background for this study?
Response: Smoking and tobacco use remains a major health issue. Smokers use cigarette over the course of the day because the levels of nicotine, the addictive agent in cigarettes and other forms of tobacco, dimmish with time in the bloodstream due to the breakdown of nicotine by enzymes in the body. By inhibiting the breakdown of nicotine in smokers, one would expect that the levels of nicotine would remain higher after smoking a single cigarette, and that these individuals may not require lighting up another cigarette so quickly, reducing the number of cigarettes smoked over the course of a day. This could have a profound effect on reducing the overall harm incurred from smoking or from using other forms of tobacco.
In a single previous study, smokers who used a CBD inhaler exhibited a 40% reduction in cigarette use. In addition, while cannabis users are often smokers, previous studies have indicated that they smoke less cigarettes than non-cannabis-using cigarette smokers. In previous studies published in 2021, we found that major cannabinoids present in cannabis like THC and CBD inhibit major metabolizing enzymes in our body, including several that are important in drug metabolism. We hypothesized that CBD and its major active metabolite, 7-hydroxy (OH)-CBD, may also be inhibiting one or more of the enzymes important in the metabolism (or breakdown) of nicotine.
Sneha Vaddadi[/caption]
Sneha Vaddadi, BS
Department of Medical Education
Geisinger Commonwealth School of Medicine
Scranton, Pennsylvania
MedicalResearch.com: What is the background for this study?
Response: The prescription stimulants methylphenidate, amphetamine, and lisdexamfetamine, classified as Schedule II substances, are sympathomimetic drugs with therapeutic use widely used in the US for Attention Deficit Hyperactivity Disorder. Changes in criteria for diagnosis of Attention Deficit Hyperactivity Disorder in 2013 and approval of lisdexamfetamine for binge eating disorder in 2015 may have impacted usage patterns.
The goal of this study1 was to extend upon past research2 to compare the pharmacoepidemiology of these stimulants in the United States from 2010–2017, including consideration to variation within geographic regions, the Hispanic population, and the Medicaid population.
Dr. Reker[/caption]
Daniel Reker, PhD
Koch Institute for Integrative Cancer Research
Massachusetts Institute of Technology
MedicalResearch.com: What is the background for this study?
Response: We started thinking more about this topic following a clinical experience five years ago that Dr. Traverso was involved in where a patient suffering form Celiac disease received a prescription of a drug which potentially had gluten. This experience really opened our eyes for how little we knew about the inactive ingredients and how clinical workflows do not currently accommodate for such scenarios.
We therefore set up a large scale analysis to better understand the complexity of the inactive ingredient portion in a medication as well as how frequently critical ingredients are included that could potential affect sensitive patients.
