PainRelief.com Interview with:
Debra A. Schwinn, M.D. (Committee Chair) – President-Elect of Palm Beach Atlantic University; former professor of anesthesiology, pharmacology, and biochemistry at the University of Iowa
Edmund J. Elder, Ph.D., R.Ph. – Director of the Zeeh Pharmaceutical Experiment Station, School of Pharmacy at the University of Wisconsin–Madison
·John T. Farrar, M.D., Ph.D. -Associate Professor of epidemiology and neurology, University of Pennsylvania School of Medicine
PainRelief.com: What is the background for this study?
Response: Compounding is the process of altering or combining ingredients to create medications that are tailored for an individual. Typically, compounded topical pain creams – which are applied to the skin in the form of gels, lotions, or ointments – are used by patients who cannot tolerate oral pain medications.
However, compounded topical preparations are not subject to the same level of extensive testing and stringent regulatory oversight as FDA-approved products. There are a number of safety concerns associated with their use, ranging from minor skin irritations to drug toxicity.
In response, FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to make recommendations for how the available scientific data on safety and effectiveness should inform future prescribing decisions.
PainRelief.com: What are the main findings?
Response: The report found there is limited scientific evidence to support the safety and effectiveness of compounded topical pain creams in adults. The committee assessed 20 Active Pharmaceutical Ingredients (APIs) that are commonly used in compounded topical pain creams. Out of the 20 APIs reviewed, 3 individual APIs and 1 two-drug combination demonstrate potential clinical effectiveness in compounded topical pain creams.
When possible, providers should prescribe FDA-approved products. Pharmacists and providers who prescribe compounded topical pain creams should also educate their patients about how much to use, which conditions to use it for, and the potential risks.
Among the report’s other findings about safety and effectiveness:
· The rate and extent of the drug’s absorption into the skin and beyond is often unknown
· There is no clear clinical rationale for specific combinations of APIs and dosages used
· Labeling requirements for compounded preparations are often inadequate
PainRelief.com: What should readers take away from your report?
Response: Patients may not even know that their medication is compounded, particularly if they’re receiving a medication through a mail or online pharmacy. They should seek guidance and information about the risks and potential adverse events associated with these preparations, and check if there are FDA-approved options available. In addition, clear labelling with directions for use and storage of compounded preparations would likely reduce adverse events from patient misuse.
PainRelief.com: What recommendations do you have for future research as a result of this work?
Response: Substantial high-quality research is needed to examine the effectiveness of the ingredients commonly used in compounded topical pain creams (both individually and in combination with each other); as well as the relative risk for adverse effects if these ingredients are absorbed by the skin, muscles or joints, or body systems.
Public and private funders of research (such as the Agency for Healthcare Research and Quality and the National Institutes of Health) and relevant patient advocacy organizations can help drive these research efforts.
PainRelief.com: Is there anything else you would like to add?
Response: In addition to its findings regarding the safety and effectiveness of compounded topical pain creams, the committee highlighted three areas of concern that should be addressed:
· Increasing federal and state level regulation and oversight of compounded pain creams, with prioritized focus on those containing APIs that, when applied topically, cross the skin and act systemically within the body
· Standardizing data collection and surveillance efforts to better understand the frequency with which compounded topical pain creams are used, the conditions for which they are used, patient demographics, and adverse events resulting from the use of these preparations
· Strengthening training and education for health care providers and individuals who compound
National Academies committee members are chosen for their expertise and experience and serve pro bono to carry out the study’s statement of task. All committee members are screened for conflicts of interest. The reports that result from the study represent the consensus view of the committee and must undergo external peer review before they are released, as did this report.
Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use (2020)
2020 National Academy of Sciences
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