Compounded Topical Pain Creams Review of Select Ingredients for Safety, Effectiveness, and Use (2020) / Chapter Skim
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In spite of this, the percentage of clinician training time devoted to pain diagnosis and treatment is relatively small; furthermore, that training generally does not encompass today's full range of treatment modalities for pain. In addition, the large number of patients with chronic pain vastly exceeds the number that can be seen by pain specialists, leaving the difficult task of designing and maintaining pain management plans to other types of clinicians.
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are available to treat acute and chronic pain conditions via targeting various systemic pain mechanisms. Commonly prescribed pain medications include opioid agonists, nonsteroidal anti-inflammatory drugs (NSAIDs)
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The limited number of FDA-approved topical analgesics, coupled with the growing interest in the field of personalized medicine, has led to increasing numbers of customized compounded formulations being prescribed by health care providers in an attempt to individualize and optimize pain management. Certain compounded topical pain creams include APIs that are approved by FDA for oral or systemic use to treat pain, others contain APIs that are used offlabel to treat pain, and still others include APIs that have no demonstrated potential to treat pain at all.
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Benefits and Risks of Compounded Topical Pain Creams Topical pain creams have a range of potential advantages, the most compelling being their nonsystemic route for administering pain medication. Furthermore, when not systemically absorbed, topical application of pain medications is thought to potentially avoid certain adverse side e ffects linked to oral analgesics.
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The skin is a formidable barrier to active ingredients in topical pain therapies and, consequently, compounded pain creams may contain much higher concentrations of APIs than oral formulations. This is not generally a concern when topical pain therapies are used on a restricted local area by adults with healthy intact skin, and the excipient included in the formulation does not result in toxic levels of systemic absorption.
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. To support comprehensiveness across potential pain mechanisms, the committee expanded the scope of its study by including an additional 10 ingredients that are commonly used in compounded topical pain creams: anesthetics (ketamine, bupivacaine, lidocaine)
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Inadequate Regulation and Oversight Owing in part to the historical nature of small-scale compounding and to the patient-specific, ad hoc processes it involves, compounding has not traditionally been subject to rigorous oversight at the federal or state level. Recent decades have seen an emergence of a type of compounding that is not patient specific, as well as greater volumes of compounded drugs sold across state lines, thereby widening the potential patient population receiving compounded topical pain creams.3 Of note, within the current regulatory landscape, FDA does not routinely inspect 503A compounding pharmacies nor does FDA assess the quality, safety, or efficacy of the drugs they compound.
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As a result of fraud and kickback controversies, many insurance companies have become reluctant to cover compounded topical pain creams in recent years, placing patients potentially at financial risk as well. Other risks may be faced by patients who are prescribed and dispensed compounded preparations without evidence of their safety or efficacy.
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Because reporting of adverse events for compounded preparations dispensed by compounding pharmacies is not legally mandated for 503A pharmacies, there are no standardized surveillance procedures or established protocols for ensuring the appropriate reporting of adverse events related to patient use. Education, Training, and Procedural Protocols Pharmacists and other health care providers who perform compounding require theoretical knowledge and practical, hands-on training to ensure the quality, safety, effectiveness, and batch-to-batch reproducibility of compounded formulations.
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These findings raise significant concerns about best practices when prescribing compounded topical pain creams. CONCLUDING STATEMENTS Compounded topical pain creams may have a potential therapeutic role in integrative pain management plans for patients with specific clinical needs.
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From its research findings, the committee drew three overarching conclusions: There is limited evidence to support the use of compounded topical pain creams to treat pain conditions in the general adult population. The few APIs that show potential effectiveness in compounded topical pain creams (doxepin [tricyclic antidepressant]
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Prescribing clinicians, compounding pharmacists, and nonpharmacists who compound should exercise caution when considering inclusion of compounded topical pain creams in pain management plans, given the lack of scientific evidence to support their safety or effectiveness beyond a few limited ingredients. RECOMMENDATIONS TO ADDRESS PUBLIC HEALTH CONCERNS Given the public health concerns related to the use of compounded topical pain creams, the committee recommends additional research, education, and oversight to support safety, effectiveness, and use of these preparations.
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Interprofessional organizations representing pharmacy, nursing, medical sectors, and other professions with prescriber authority to treat pain conditions should advocate for state-level certification of indi iduals who v seek to begin or continue to prescribe compounded topical pain creams. Formal clinical education should be offered in parallel to continuing medical education courses for clinicians who prescribe topical pain creams.
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Additional continuing medical education courses hosted by for-profit organizations should not substitute for this more in-depth training, owing to potential conflicts of interest. Recommendation 4: Additional state-level oversight of compounded topical pain creams is needed to improve safety and effectiveness.
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