Compounded Topical Pain Creams Review of Select Ingredients for Safety, Effectiveness, and Use (2020) / Chapter Skim
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7 Additional Concerns Related to the Use of Compounded Topical Pain Creams
7 Additional Concerns Related to the Use of Compounded Topical Pain Creams
Pages 213-234
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From page 213... ...
. In other unique clinical circumstances in which pain cannot be managed by any of the available FDA-approved products, FDA regulations allow for medications to manage pain to be compounded for an individual patient.1 While compounded topical pain creams are options in the pain management toolbox, it is critical to note that compounded medications are not necessarily safer or more effective alternatives to commercial FDA-approved products.
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From page 214... ...
, education about compounding practices in pharmacy schools began declining. Indeed, much compounding pedagogy has now been phased out of pharmacy school curricula in favor of clinical pharmacy instruction (Kochanowska-Karamyan, 2016)
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From page 215... ...
Particular concern is warranted about the safety and effectiveness of compounded topical pain creams, given the vast range of options available 3 It is notable that the written North American Pharmacist Licensing Examination includes compounding among its evaluated competencies (NAPLEX, 2019) ; however, at the time of this report, only two U.S.
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From page 216... ...
. Specifically, clinicians who prescribe compounded topical pain creams may not be adequately educated about the complex practice of compounding, the potential risks it can entail, or the lack of evidence to support the effectiveness of many compounded preparations.6 Furthermore, there is a dearth of clinical guidance and best practices to aid clinicians in prescribing these preparations.
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From page 217... ...
. Lack of Clinical Guidance for Clinicians Who Prescribe or for Physicians Who Compound Topical Pain Creams Very limited guidance is available for clinicians who prescribe or for licensed physicians who compound topical pain creams.10 In fact, the committee only found a single clinical guideline or suggested best practice for prescribing compounded preparations to potential patient populations: an algorithm published by the American College of Clinical Pharmacy to aid pharmacists (and presumably extrapolatable to prescribers)
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From page 218... ...
. As a potential consequence, paper- or web-based preformulated prescription forms for compounded topical pain preparations seem to appeal to prescribers by making the compounding prescription process "quick and easy." These forms often list options for treating specific pain conditions and may offer preset ingredients or combinations at set or variable concentrations.
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ADDITIONAL CONCERNS 219 FIGURE 7-1 Sample prescription form distributed by a local pharmacy to physician offices in February 2019.
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Congress has sought to address financial conflicts of interest through enhanced disclosure via the Physician Payments 11 As previously addressed in this report, individuals who compound are exempt from per forming tests on the safety and efficacy of compounded preparations, in general, and based on the findings from the literature review in Chapter 6, there are limited data on the safety and effectiveness of APIs commonly used in compounded topical pain creams.
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From page 221... ...
SAFETY CONCERNS FOR PATIENTS From the patient's perspective, compounded topical pain creams are associated with safety concerns including risks associated with unstandardized formulations, polypharmacy and drug–drug interactions, misuse of compounded preparations, and potential adverse events. Unstandardized Formulations for Compounded Topical Pain Creams Like all pain medication, each compounded topical pain cream has some potential for adverse effects or intolerance among certain populations of patients.
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From page 222... ...
Carbamazepine Concurrent use of TRAMADOL and SEROTONERGIC CYP3A4 INDUCERS may result in increased risk of serotonin syndrome and reduced TRAMADOL plasma concentrations. 14 In a small survey of national pharmacies, the Professional Compounding Centers of America estimated that greater than 80 percent of dispensed compounded topical pain creams contained two or more APIs and greater than 50 percent contained three or more APIs.
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From page 223... ...
Memantine Concurrent use of MEMANTINE and SELECTED N-METHYL D-ASPARATE ANTAGONISTS may result in increased adverse events of N-methyl-D-asperate agonists. Naproxen Concurrent use of NSAIDS and TRICYCLIC ANTIDEPRESSANTS may result in an increased risk of bleeding.
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From page 224... ...
Patients would be better equipped to make their own risk–benefit assess ents about using a compounded preparation if they were provided m with information on its risks and potential adverse events and if they were made aware that compounded preparations have not been approved or tested by a regulatory agency. Similarly, including clear directions for use and storage of compounded drugs would likely reduce adverse events occur ing from patient misuse.
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However, owing to the voluntary nature of reporting and the limitations in the data entry process, it is uncertain whether these cases are a true representative sample of adverse effects related to use of compounded topical pain creams.16 Also in 2019, the committee submitted a data request to the American Association of Poison Control Centers to review potential concerns related to the safety of compounded topical pain creams. It was difficult to accurately track which reported events were related to FDA-approved 16 FDA identified 38 adverse events reports that related to the use of a compounded topi cal drug by reading through report descriptions of all entries marked as compounded.
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Additional efforts to increase the surveillance, data collection, and adverse event reporting for compounded topical pain creams is needed. 17 These data may include both FDA-approved products and compounded formulations.
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According to a retrospective analysis of prescription claims data, ingredients commonly used in compounded topical pain creams were the most expensive ingredients used in compounded drugs for adults by total cost billed in 2013 (McPherson et al., 2016) .18 A recent survey of almost 500 patients of compounded preparations found that almost all (95 percent)
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From page 228... ...
Each of these prescriptions resulted in substantial charges to TRICARE that in some cases amounted to tens of thousands of dollars per prescription, dependng on the number and type of APIs included in the compounded for i mulation. These compounded preparations were formulated with the intent of maximizing the amount that the pharmacist could charge to the insurer, rather than meeting patients' needs (Philpott, 2018)
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From page 229... ...
For example, some patients may no longer have access to compounded topical pain creams they need to manage their pain, because the out-of-pocket costs are prohibitive. Even if patients can afford the out-of-pocket cost, they run the risk of paying high prices for compounded topical pain creams that have little or no evidence of safety and effectiveness.
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2019. Presentation to the assessment of the available scientific data regarding the safety and effectiveness of ingredients used in compounded topical pain creams meet ing 2: American Chronic Pain Assocation topical cream survey.
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https://web.archive.org/web/20121031091347/http://www.fda.gov/ICECI/Enforcement Actions/WarningLetters/2008/ucm1048443.htm (accessed March 13, 2020)
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2019. Presentation to the Assessment of the Available Scientific Data Regarding the Safety and Effectiveness of Ingredients Used in Compounded Topical Pain Creams Meet ing 1.
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https:// www.usp.org/compounding/general-chapter-797 (accessed March 3, 2020)
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