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8 Recommendations Regarding the Treatment of Patients with Compounded Topical Pain Creams
Pages 235-240

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From page 235...
... In its review of available scientific evidence within the study scope, the committee concluded that the vast majority of APIs commonly used in compounded topical pain creams have little to no scientific evidence to support their claims of effectiveness in the treatment of various pain conditions when applied to intact skin. Furthermore, potential for systemic absorption and toxicity of many of APIs reviewed remains largely unknown.
From page 236...
... the nonstandardized surveillance procedures and protocols for ensuring appropriate reporting of adverse events underpin a substantial public health concern related to the use of these preparations. From their research findings, the committee puts forth three overarching conclusions: Conclusion 8-1: There is limited evidence to support the use of com pounded topical pain creams to treat pain conditions in the general adult population.
From page 237...
... Pain researchers, public and private funding agencies, and relevant patient advocacy organizations should prioritize research efforts to examine ­ the safety and effectiveness of compounded topical pain creams, including but not limited to • Randomized, double-blind, placebo-controlled clinical trials with sufficient numbers of patients to study, both in isolation and in combinations, APIs and inactive ingredients commonly used in compounded topical pain cream formulations • Clinical research on APIs with demonstrated effectiveness to treat pain in preclinical animal models, which may indicate a potential therapeutic effect in humans (e.g., cannabidiol) • Obtaining high-quality evidence to inform the safety profile for all APIs that act transdermally • Research on potential new topical or transdermal therapeutic agents to treat pain Funding agencies that could drive these efforts include the Agency for Healthcare Research and Quality, National Center for Complementary and Integrative Health, other relevant institutes or centers of the National Institutes of Health, and Patient-Centered Outcomes Research Institute.
From page 238...
... Interprofessional organizations that could drive these efforts include the American Academy of Physician Assistants, American Association of Nurse Practitioners, American Cancer Society, American Medical Asso ­ ­ ­ ciation, American Society of Anesthesiologists, and American Society of ­ Interventional Pain Physicians. State boards of pharmacy, local and regional schools of pharmacy, and nonprofit professional societies and organizations within the medical and pharmaceutical sectors should support and incentivize more in-depth training on compounding delivered by schools of medicine and pharmacy, as well as relevant nonprofit professional societies and organizations.
From page 239...
... should collaboratively develop standard processes for testing APIs (in solitude and combinations) and excipients commonly used in compounded topical pain creams.


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