The National Academies Press

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1 Introduction
Pages 15-30

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From page 15... ... . For many years, topical pain creams have served a role in pain management by providing a level of versatility not available via oral alternatives. Read the entire page →
From page 16... ... Although there may be some advantages to using compounded topical pain creams in pain treatment, it is important to consider key differences that exist between the regulation of compounded preparations and FDA-approved medications. Under current U.S. Read the entire page →
From page 17... ... As a result, labeling for compounded topical pain creams is often insufficient to educate patients and clinicians about their use and potential risks. Together, these issues are a cause for public health concern, especially given the more recent evolution toward precision medicine and personalized care and resultant resurgence of compounding in recent years (McPherson et al., 2019) Read the entire page →
From page 18... ... These issues range from accidental exposures to local irritation of skin to unintended overdoses that sometimes resulted in coma and even death.3 These diverse and complex safety and effectiveness issues related to development, marketing, and use of compounded topical pain creams create a public health concern for a multitude of stakeholders including medical practitioners, patients, health advocacy organizations, and federal and state public health agencies. CHARGE TO THE COMMITTEE To explore issues regarding the safety and effectiveness of the ingredients used in compounded topical pain creams, FDA requested that the National Academies of Sciences, Engineering, and Medicine appoint an ad hoc committee to conduct a study of the ingredients used in compounded topical pain creams. Read the entire page →
From page 19... ... Based on this assessment, the committee will develop a report that summarizes its findings, including addressing the following specific items: • Identify the ingredients that the available scientific data suggest may not be safe and effective to treat pain topically, • Describe the concentrations and combinations of ingredients that may raise significant safety issues, and • Comment on the level of benefit expected for the various ingredi ents given their likelihood of absorption through the skin. Based on these findings, the report will offer recommendations regard ing the treatment of patients with compounded topical pain creams. Read the entire page →
From page 20... ... Uniquely, lidocaine can be considered a positive control for other topical ingredients because there is an FDA-approved lidocaine gel patch. It is important to note that the omission of a category, or mechanism, does not imply safety or effectiveness, or potential usefulness of drugs in that category used in compounded topical pain creams. Read the entire page →
From page 21... ... and their associated chemical class: • Amitriptyline -- antidepressant • Baclofen -- muscle relaxant • Clonidine -- alpha-2-adrenergic receptor agonist • Cyclobenzaprine -- muscle relaxant • Gabapentin -- antiepileptic • Meloxicam -- nonsteroidal anti-inflammatory drug (NSAID) • Memantine -- NMDA receptor antagonist • Orphenadrine -- antispasm • Topiramate -- antiepileptic • Tramadol -- opioid agonist Committee-selected ingredients, associated drug class, and reason for inclusion: • Bupivacaine -- long-acting local anesthetic; significant potential t oxicity if absorbed • Cannabidiol -- commonly available cannabinoid with rapid growth in use • Carbamazepine -- sodium channel antiepileptic; toxicity profile from oral use • Dexamethasone -- potent steroid widely used for treatment of pain and itch; significant toxicity with systemic absorption over long periods of time • Doxepin -- antidepressant, chosen to expand this class beyond a mitriptyline; also used as an antihistamine to treat itch • Ketamine -- anesthetic agent used to treat pain and high potential toxicity when absorbed • Lidocaine -- short-acting local anesthetic with FDA-approved prod ucts but also used in compounded topical creams; may account for significant degree of effectiveness in multidrug compounded creams • Naproxen -- short-acting commonly used predominately COX-1 non teroidal, chosen to expand NSAID group beyond meloxicam, s which is predominately COX-2 and long acting • Nifedipine -- calcium channel blocking agent; known vascular side e ffects with oral use • Pentoxifylline -- improves local blood flow; may enhance absorp tion of other agents, which could increase local effectiveness and systemic blood levels Read the entire page →
From page 22... ... This important distinction will continue to be noted throughout the report. Focus on Intact Skin Furthermore, in the committee's review of the literature on the safety and effectiveness of ingredients in compounded topical pain creams, the Read the entire page →
From page 23... ... There remains a substantial literature base that reviews the safety, effectiveness, and use of topical pain creams on membrane or mucosal surfaces; however, this evidence was not explicitly reviewed or discussed in this report. Focus on Human Populations The committee did not examine the use, safety, or effectiveness of compounded topical pain creams that were explicitly formulated to address health indications relevant to the fields of veterinary science or animal care. Read the entire page →
From page 24... ... As a result, many of the research findings discussed throughout the report assess outcomes related to the potential effectiveness or efficacy of compounded topical pain creams. Given its broader application to the body of research reviewed, the term effectiveness is used more generally across the report. Read the entire page →
From page 25... ... 5 Of note, the committee identified several other published studies with tangential relevance to the committee's charge (e.g., use of compounded topical pain creams to treat itch) ; however, only the studies with the most direct relevance were reviewed in this report. Read the entire page →
From page 26... ... Chapter 2 provides a brief overview of the role of compounded topical pain creams in pain management, complexity of pain, and pain treatments. In that chapter, the committee describes the complexity of pain and pain management, reviews standards of care and pharmacological approaches related to pain treatment, and highlights the advantages of using topical pain creams in pain management plans. Read the entire page →
From page 27... ... The ingredi ents reviewed are organized by their primary drug class. Chapter 7 describes a selection of concerns associated with the use of compounded topical pain creams that are faced by individuals who compound, clinicians who prescribe compounded preparations, and patients. Read the entire page →
From page 28... ... 2019. US market study on animal drug compounding. Read the entire page →
From page 29... ... industry analysis report, application potential, price trends, competitive market share & forecast, 2018–2025. Selbyville, DE: Global Market Insights. Read the entire page →

From page 15...

... . For many years, topical pain creams have served a role in pain management by providing a level of versatility not available via oral alternatives.

1 Introduction Pages 15-30

1 Introduction
Pages 15-30