There are several sections in this chapter. This chapter addresses the committee's charge to identify and analyze available scientific data relating to the ingredients used in compounded topical pain creams. In the context of the somewhat recent rise in the supply and demand of compounded preparations, this gap in knowledge creates a substantial public health concern.

Currently, little is known about the safety and effectiveness of compounded topical pain creams. Given this context, clear, evidence-based conclusions on the safety and effectiveness of pain medications helps to inform clinical guidelines for the use of pain medications and to mitigate risks of adverse effects in specific patients. Inappropriate use of opioids in pain management plans has contributed to a substantial increase in the rates of opioid addiction and consequential deaths from overdose ( Solomon et al., 2010 Wehrwein, 2010).

The ongoing opioid epidemic in the United States serves as another cautionary example of the potential risks of pain medication. Based on clinical studies and the product's label, pharmacists and prescribing clinicians know to exercise certain cautions when treating certain populations with NSAIDs, including older populations, patients on anticoagulants or steroid drugs, and women in early pregnancy. For example, chronic use of nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen may cause gastrointestinal effects (e.g., ulcers, bleeding) as well as be linked to kidney and liver damage. Food and Drug Administration (FDA)-approved pain medications-have some potential for adverse effects or intolerance among certain populations of patients. Whether these systemic actions are intended or not, they are critically important considerations in the review of a compounded topical preparation's safety and effectiveness profile.ĭespite their many benefits, all pain medications-including U.S. However, distal responses to topical applications may also occur ( Glinn et al., 2017 Leppert et al., 2018). In theory, topical APIs intended to treat local or regional pain act on nerves in the skin or in underlying muscles or joints by blocking nerve signals, reducing inflammation, relaxing muscle spasms, or increasing the effects of other substances ( Cline and Turrentine, 2016 Leppert et al., 2018). First, the API should have a mechanism of action to treat pain, and second, the topical formulation must deliver the API to the site of action in an amount that is sufficient to achieve an effect but is also appropriate to be safe. The safety and effectiveness of each active pharmaceutical ingredient (API) in a compounded topical pain cream depends on two factors.

Versapro cream ingredients