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Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use (2020)

Chapter: 3 Fundamentals, Use, and Common Ingredients in Compounded Topical Pain Creams

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Suggested Citation:"3 Fundamentals, Use, and Common Ingredients in Compounded Topical Pain Creams." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
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3

Fundamentals, Use, and Common Ingredients in Compounded Topical Pain Creams

This chapter opens with brief descriptions of the fundamentals of the practice of compounding in the United States. It then provides an overview of the market and demand for compounded preparations in general, as well as patient use and pain conditions generally associated with compounded topical pain creams. The chapter concludes by identifying a set of active pharmaceutical ingredients (APIs) that are commonly used in formulations of compounded topical pain creams.

FUNDAMENTALS OF COMPOUNDING

In general, compounding can be defined as “the process of combining, mixing, or altering ingredients to create a sterile or nonsterile medication tailored to the needs of a patient” (FDA, 2017).1 Compounded preparations represent therapeutic alternatives for patients with clinical needs that cannot be met by drugs approved by the U.S. Food and Drug Administration (FDA) (FDA, 2017; Glassgold, 2013; Gudeman et al., 2013; IACP, 2019). Customized formulations can be compounded to (1) create alternate dosage strengths or forms, or (2) omit components of FDA-approved drugs that a patient cannot tolerate (Glassgold, 2013; USP, 2017). Patient populations that have

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1 In an effort to provide additional guidance, the United States Pharmacopeia (USP) offers a more detailed definition of compounding: “the preparation, mixing, assembling, altering, packaging, and labeling of a drug, drug-delivery device, or device in accordance with a licensed practitioner’s prescription, medication order, or initiative based on the practitioner/patient/pharmacist/compounder relationship in the course of professional practice” (USP, 2017).

Suggested Citation:"3 Fundamentals, Use, and Common Ingredients in Compounded Topical Pain Creams." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
×

traditionally benefited from customized compounded preparations include pediatric patients, people living with chronic pain, people at end of life, and people with rare medical or physical conditions (e.g., patients who cannot swallow pills might be provided with a liquid version of their medication) (Kochanowska-Karamyan, 2016; USP, 2017).

The process of compounding can produce sterile or nonsterile preparations and is conducted within a wide range of pharmaceutical and medical settings.2 For example, compounding commonly occurs in community pharmacies, physicians’ offices,3 mail-order compounding pharmacies, hospital pharmacies, and specialty compounding facilities. United States Pharmacopeia (USP) standards suggest that compounded preparations should be developed in designated areas that are adequately designed to support the sterile or nonsterile processes; this includes providing proper storage for those preparations under the appropriate conditions, such as designated temperature, light, moisture, and ventilation (USP, 2018).4,5

Compounding remains an important component of pharmacy practice, particularly in smaller, independent community pharmacies (McPherson et al., 2006). Studies have found that compounding preparations at community pharmacies may strengthen the patient–pharmacist relationship, improve pharmacists’ professional satisfaction and perceived quality of patient care, and imbue pharmacists with a greater responsibility to provide patient-centered care (McPherson and Fontane, 2010; Yancey et al., 2008).

Due in part to the historical nature of patient-specific small-scale compounding and the ad hoc processes it involves, compounded preparations have not been subject to stringent federal and state-level regulatory policies to inform and enforce good compounding practices or procedures to ensure the safety, effectiveness, or quality of the preparations prior to their being marketed to patients (Takaoka et al., 2018). As a critical comparison, FDA maintains a rigorous, multistep drug development, approval, and postmarketing surveillance process for FDA-approved drug products in order to inform medical practice and to protect the patient. Efforts have been made over recent decades to regulate compounding more rigorously in an attempt to

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2 In sterile compounding, medications are prepared in a clean-room environment using aseptic techniques to ensure solutions are free of microorganisms. Sterile compounding is primarily used for injectable, parenteral, and ophthalmic preparations. In nonsterile compounding, medications are prepared in a clean environment without sterile techniques required, mainly for oral and topical (skin) formulations: capsules, solutions, suspensions, ointments, creams, and suppositories.

3 The frequency of compounding performed in a physician’s office tends to vary by specialty.

4 The United States Pharmacopeial Convention is a nonprofit organization that works to ensure the quality of compounded medicines by setting public standards for identity, strength, quality, and purity. USP has developed three types of standards for compounding: United States Pharmacopeia-National Formulary (USP-NF) monographs for bulk drug substances, USP-compounded preparation monographs, and essential General Chapters.

5 USP does not have regulatory or enforcement authority, but its standards are enforceable by state law.

Suggested Citation:"3 Fundamentals, Use, and Common Ingredients in Compounded Topical Pain Creams." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
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ensure patient safety while preserving patients’ access to compounded preparations (FDA, 2017). See Chapter 4 for a discussion on the current federal and state-level oversight of compounding practices.

OVERVIEW OF THE USE AND DEMAND FOR COMPOUNDED PREPARATIONS

In recent years, the increasing demand for personalized medical care—coupled with the lack of regulations and oversight for the development of compounded preparations—has catalyzed a resurgence in compounding for treating a much broader patient population than traditionally intended (Burch, 2017; Glassgold, 2013). More specifically, the increased supply and demand for compounded preparations is driven by a host of factors that include

  • Frequent shortages of commercially produced drugs (particularly sterile generic injectables);
  • Preferences among patients and prescribing clinicians for personalized formulations;
  • The growing aging population; and
  • Evolving business strategies in the pharmaceutical sector toward marketing compounded preparations for specific indications, rather than case-by-case clinical needs (Glassgold, 2013).

The growing demand for compounded preparations is reflected in their use to treat a wide spectrum of conditions across a range of therapeutic areas, including pain management, hormone therapy, sports medicine, weight loss, dental care, veterinary care, pediatrics, and hospice care (Glassgold, 2013; McPherson et al., 2016). Indeed, the use of compounded preparations has become common in the fields of allergy, dermatology, immunology, otolaryngology, oncology, ophthalmology, neurology, and rheumatology specialties (NABP, 2017).

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6 This text has changed since the prepublication release of this report. Here and in other instances throughout the report, “commercially available product(s)” was replaced with “FDA-approved drug product(s).”

Suggested Citation:"3 Fundamentals, Use, and Common Ingredients in Compounded Topical Pain Creams." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
×

The Compounding Market

There are no federal reporting requirements for compounding pharmacists or pharmacies to disclose data on use or demand of compounding preparations, and as a result, it is difficult to secure an accurate estimate of the compounding market (Glassgold, 2013). However, available data, largely produced by surveys, suggest that the compounding industry has expanded quite considerably over the past few decades and has become increasingly lucrative (HHS OIG, 2016; McPherson et al., 2016). Several private marketing reports have estimated the global market revenue for compounded preparations to fall between $2 and $9 billion. Those analyses all predict growth in the next few years, ranging from 3 to 7 percent.

A caveat is that these estimates come from private marketing reports and are based on data sources that are publicly unverifiable (Bourne Partners, 2018; Global Market Insights, 2018; Market Research Engine, 2018; ReportsnReports, 2018; Zion Market Research, 2018). Private marketing reports have also analyzed the pain management segment of the compounding market. They estimate that the pain management market held the greatest revenue share of the U.S. compounding market in 2017 ($1.6 billion) and predict steady growth and consumer demand in that market through 2025 (Global Market Insights, 2018).7

Data on compounded preparations are also available from national data on workers’ compensation claims. Compounding is a growing trend in workers’ compensation programs; prescriptions for compounded preparations increased almost 5-fold between 2007 and 2012, from 6,416 to 30,669 (Walls et al., 2014). Several surveys of pharmacists and prescribing clinicians have sought to elicit information about the use of compounded preparations, but the information obtained has been limited owing to low response rates (McPherson et al., 2019; Ness et al., 2002; Warner and Tuder, 2014).

Looking at insurance claims data, the number of beneficiaries receiving compounded preparations also increased substantially by 281 percent, from 73,368 in 2006 to 279,873 in 2015 (HHS OIG, 2016). A retrospective analysis of prescription claims data found that the prevalence of eligible members using compounded preparations increased by around 27 percent between 2012 and 2013, with 1.4 percent of eligible members using compounded preparations in 2013. The number of claims for compounded preparations also increased by around 34 percent (from 486,886 to 653,360) during the same period (McPherson et al., 2016). Given the evidence for the substantial use of compounded preparations and the current

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7 Given the limited resources of the committee, it was unable to access the private reports to verify whether the market segment for topical pain creams was reviewed.

Suggested Citation:"3 Fundamentals, Use, and Common Ingredients in Compounded Topical Pain Creams." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
×

gaps in federal and state oversight protections for patients, the committee is concerned that an increasing fraction of drugs used in the United States is consumed without assurance for quality, safety, and effectiveness.8

THE USE OF COMPOUNDED TOPICAL PAIN CREAMS

As described in the previous sections, there is a substantial market for compounded preparations for pain management. However, there is little empirical evidence to describe the individuals who use compounded preparations, the number of preparations that are compounded, the common formulations dispensed, or the conditions they are intended to treat (Glassgold, 2013). The growing supply and demand for compounded preparations provides a compelling rationale to learn more about the clinical use of compounded topical pain creams, as the lack of data poses challenges for risk–benefit assessment of these preparations and for the development of evidence-based public health policy to govern their use.

Data on Patient Use

Clear data are unavailable to describe the use of compounded topical pain creams and patients’ overall experience with those preparations. This is attributable in part to a constantly evolving compounding landscape, which has seen the emergence of large, mail-order compounding pharmacies as well as changes in insurance coverage (McPherson et al., 2019). In recent years, payers have drastically reduced their coverage of compounded preparations (Chavez-Valdez, 2018; DoD, 2017; Silverman, 2014). If insurance companies are tracking compounded preparation prescriptions, these data have not been widely published or analyzed by researchers. Furthermore, no database exists to capture the use of those preparations by customers who pay out of pocket. In the context of tracking patient use, another caveat is that many patients may not be aware that their medication is compounded.

Because both FDA-approved products and compounded preparations are prescribed by their doctors, consumers may not be effectively educated by their prescribing clinicians or pharmacists about the difference between the compounded preparations and FDA-approved medications (Cowan, 2019). This lack of education affects patients’ knowledge about the risks and benefits of the compounded preparations they are taking. They may also be unaware of the potential risks reported by patient health surveys or of adverse events that have been reported.

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8 In Chapter 6 of this report, the committee reviews the scientific evidence to support claims related to the safety and effectiveness of common active pharmaceutical ingredients used in compounded topical pain creams.

Suggested Citation:"3 Fundamentals, Use, and Common Ingredients in Compounded Topical Pain Creams." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
×

Although data sources paint an incomplete picture of the use of compounded topical pain creams, the increasing numbers of prescriptions being written appear to reflect substantial interest in prescribing these preparations (HHS OIG, 2016). To expand the evidence base, much more robust epidemiological data are needed in order to identify

  • the demographics of the patients;
  • the frequency with which the preparations are being used;
  • the conditions for which the preparations are used; and
  • any adverse events that have taken place as a result of use of these preparations.

This type of research and surveillance is needed to understand the prevalence of use of compounded preparations as well as to appropriately inform evidence-based decisions on rationale for use, targeted populations for use, and minimum labeling requirements to help educate patients about the preparations they are consuming.

PAIN CONDITIONS FOR WHICH COMPOUNDED TOPICAL PAIN CREAMS ARE COMMONLY USED

The committee reviewed numerous medical position statements, recommendations, and clinical guidance in an attempt to identify the clinical specialties, pain conditions, and types of compounded topical pain cream formulations that are recommended for use. The few professional organizations that explicitly mentioned the clinical use of compounded topical pain creams often cautioned that there was a lack of evidence to support the effectiveness or reliable safety of these treatments (ACPA, 2019; Paterson and Yuen, 2015; Tavares, 2015). Of note, compounded preparations were mentioned as potential treatment options for chronic and neuropathic pain, including chronic cancer pain (Paice et al., 2016); chemotherapy-induced peripheral neuropathy (ACPA, 2019); and peripheral neuropathic pain (Paterson and Yuen, 2015). However, one organization, the International Association for Hospice and Palliative Care, recommended against the use of multidrug compounded preparations to treat chronic pain and instead promoted the administration of different drugs independently (IAHPC, 2013).

Rationale for Patient Use

Although there is a dearth of clinical guidance for use, the medical literature has a number of articles that mention the use of compounded topical pain creams in treatment plans for pain-related medical conditions. The conditions highlighted in Table 3-1 were identified during the committee’s

Suggested Citation:"3 Fundamentals, Use, and Common Ingredients in Compounded Topical Pain Creams." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
×

literature review on the safety and effectiveness of selected ingredients commonly used in compounded topical pain creams (see Chapters 1 and 6 for more information on the committee’s literature review efforts).

To add to the body of knowledge related to the rationale for use, a small survey was recently conducted of patients of compounded topical pain creams (McPherson et al., 2019). The 107 respondents ranged in age from 35 to 96 years, with about 80 percent between 48 and 83 years of age and an average age of 67 years; 77 percent of respondents were female. The most common reasons cited for using the compounded pain creams were arthritis pain (29 percent) and general pain in the feet, knee, hip, shoulder, back, or neck (26 percent); 12 percent said they used the medications for neuropathic pain. Around half of respondents reported using compounded topical pain cream in addition to other medications (McPherson, 2019; McPherson et al., 2019).

Based on the committee’s review of the literature, compounded topical pain creams appear to be used for a variety of different reasons. For example, clinicians and compounding pharmacists commonly associate compounded topical pain cream use with a range of perceived benefits, including

  • selectively delivering drugs to peripheral sites of action;
  • improving tolerability, owing to less contact with the gastrointestinal system;
  • combining multiple drugs with different mechanisms of action at varying dosages to meet individual patient needs; and

TABLE 3-1
Sample of Reported Pain Conditions Treated with Compounded Topical Pain Creams

Type of Pain Pain Conditions for Which Compounded Topical Pain Creams Were Used
Neuropathic pain
  • Peripheral neuropathy (diabetic, chemotherapyinduced)
  • Postherpetic neuralgia
  • Neuropathic pain from spinal cord injury
  • Neuropathic pain from multiple sclerosis
  • Chronic idiopathic axonal polyneuropathy
  • Radicular pain
Nociceptive pain
  • Musculoskeletal pain
  • Rheumatoid arthritis
  • Osteoarthritis
  • Back and neck pain
  • Visceral pain, muscle spasms
  • Abdominal pain
  • Idiopathic proctodynia
Nociplastic pain (mixed pain)
  • Fibromyalgia
  • Trigeminal neuralgia
Suggested Citation:"3 Fundamentals, Use, and Common Ingredients in Compounded Topical Pain Creams." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
×

Although the reported benefits of compounded topical pain creams are intriguing, in general, many of these claims, particularly those related to the safety and effectiveness of the preparations, are not yet supported by a strong body of empirical research.

ACTIVE PHARMACEUTICAL INGREDIENTS COMMONLY USED IN COMPOUNDED TOPICAL PAIN CREAMS

The ad hoc nature of compounding creates a situation in which the formulations of various compounded topical pain creams are not standardized across different compounding pharmacists, compounding pharmacies, or between states. In addition, as discussed in Chapter 7 of this report, there are no central repositories to collect formulations for specific pain conditions or special populations of patients. Much of these data lie in the hands of the individual compounding pharmacies and outsourcing facilities. For example, in an effort to better understand the types of APIs used in the development of compounded topical pain formulations, the committee submitted a research request to FDA. From data provided by outsourcing facilities during required product reporting in 2017 and 2018, FDA supplied the committee with aggregated data for five APIs that were the most commonly used in multidrug combination creams.9,10 The submitted data show that during 2017 and 2018, baclofen and gabapentin were each used in more than 5,200 formulations, cyclobenzaprine in just less than 5,000, clonidine in just more than 1,000, and amitriptyline in 416 formulations.11,12

In June 2019, the committee submitted a data request to the National Association of Boards of Pharmacy (NABP) to gather information on the most common formulations of compounded topical pain creams. From its 2016–2018 collection of pharmacy inspection application requests, NABP submitted a compiled list of the five most dispensed formulations from both

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9 This text has changed since the prepublication release of this report to clarify the data source.

10 Data were aggregated across all outsourcing facilities in order to keep each outsourcing facility’s production volume confidential.

11 FDA. 2019. Email from G. Cosel to National Academies staff regarding aggregated volume output of products containing ingredients of interest to compounded topical pain medication study. August 30. Available through the National Academies’ Public Access File.

12 Additional outsourcing facility preparation reports can be found at https://www.fda.gov/drugs/human-drug-compounding/information-outsourcing-facilities (accessed April 13, 2020).

Suggested Citation:"3 Fundamentals, Use, and Common Ingredients in Compounded Topical Pain Creams." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
×

503A compounding pharmacies and 503B outsourcing facilities.13 Given the limitations in the data-reporting process, the committee was not able to confidently distinguish between APIs that were used in compounded preparations from those that were dispensed as a manufactured product (NABP, 2019), which prohibited the analysis of these data for this report.

From its research efforts, the committee has found that many APIs formulated in compounded topical pain creams include those found in FDA-approved topical pain products, FDA-approved nontopical pain products, or products approved by FDA for nonpain indications. Moreover, many compounding pharmacies develop compounded topical pain creams formulations that contain four, five, or even more APIs. Using the Micromedex database as a resource, Table 3-2 provides details on APIs selected for the committee’s review and includes information about FDA-approved pain indications, off-label use, and associated major adverse effects.14,15

Again—owing to a lack of a central database and clinical guidance—it is not possible to draw clear, specific conclusions on when and why these multi-ingredient preparations are prescribed to treat specific health indications and the potential adverse effects that may occur. Therefore, because of the limited regulation and oversight for compounding, pharmacists and prescribing clinicians hold enormous privilege and responsibility in determining the appropriate medical formulation and dose to treat the patient.

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13 The majority of these reports came from pharmacies that voluntarily came to NABP requesting an inspection, though some inspections were mandated owing to state disciplinary action.

14 Micromedex is an evidence-based, multidatabase drug search engine that provides comprehensive information on pharmaceutical drugs. See https://www.micromedexsolutions.com/home/dispatch (accessed December 10, 2019).

15 For the purposes of this report a drug is considered off-label when an approved drug product is prescribed for a condition, or in a dose, other than that for which it received its approval.

Suggested Citation:"3 Fundamentals, Use, and Common Ingredients in Compounded Topical Pain Creams." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
×

TABLE 3-2
FDAApproved and OffLabel Indications Limited to Pain Indications for Which Topical Pain Creams Are Often Used

Drug Product Formulation(s) Drug Class FDA-Approved Pain Indications
Amitriptyline Oral Tricyclic antidepressants None
Baclofen Oral, intrathecal Skeletal muscle relaxant Muscle spasms
Bupivacaine Injection Local anesthetic None
Cannabidiol Oral Cannabinoid None
Carbamezapine Oral Anticonvulsants Trigeminal neuralgia
Clonidine Transdermal Alpha2 adrenergic agonist None
Clonidine HCl Epidural, oral Alpha2 adrenergic agonist None
Cyclobenzaprine Oral Skeletal muscle relaxant Skeletal muscle spasm
Suggested Citation:"3 Fundamentals, Use, and Common Ingredients in Compounded Topical Pain Creams." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
×
Off-Label/Non-FDA Uses for Pain Example Adverse Effects from FDA-Approved Label Example Serious Adverse Effects from Micromedex (2019)
Fibromyalgia, postherpertic neuralgia Cardiovascular, CNS and neuromuscular, anticholinergic, allergic, hematologic, gastrointestinal, and endocrine adverse reactions (Sandoz, 2014) Black box warning for increased suicidal thoughts; cardiac arrhythmias
Trigeminal neuralgia, peripheral neuropathy Drowsiness, dizziness, and weakness (Metacel Pharmaceuticals, LLC, 2019) Gastrointestinal bleeding
Pain Excitation and/or depression of the CNS system as well as cardiovascular adverse reactions (Pfizer, 2012) Cardiac arrest, respiratory depression
None Somnolence, decreased appetite, diarrhea, transaminase elevations, fatigue, malaise, asthenia, rash, sleep disorders, and infections (GW Pharmaceuticals, 2018) Increased suicidal thoughts; increased liver enzymes
None Dizziness, drowsiness, unsteadiness, nausea, and vomiting adverse reactions. The most severe reactions observed have been in the hemopoietic system, skin, liver, and cardiovascular system (Novartis, 2009) StevensJohnson syndrome, toxic epidermal necrolysis, atrioventricular block, syncope, liver failure
None Dry mouth, drowsiness, fatigue, headache, lethargy, and sedation (Boehringer Ingelheim Pharmaceuticals, Inc., 2011) Atrioventricular block
Muscle spasms Dry mouth, drowsiness, dizziness, constipation, and sedation (Boehringer Ingelheim Pharmaceuticals, 2009) Atrioventricular block
Fibromyalgia Drowsiness, dry mouth, fatigue, and headache (McNeil Consumer Healthcare, 2013) Cardiac dysrhythmia, heart block, myocardial infarction, syncope
Suggested Citation:"3 Fundamentals, Use, and Common Ingredients in Compounded Topical Pain Creams." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
×
Drug Product Formulation(s) Drug Class FDA-Approved Pain Indications
Dexamethasone Oral, ophthalmic, injection Adrenal corticosteroid None
Doxepin Oral, topical Tricyclic antidepressants None
Gabapentin Oral, topical Anticonvulsants Postherpetic neuralgia
Ketamine IV, IM Local anesthesia None
Lidocaine Rectal, topical Local anesthetic Postherpetic neuralgia
Meloxicam Oral NSAID Osteoarthritis, rheumatoid arthritis
Memantine Oral NMDA receptor antagonist None
Naproxen Oral NSAID Rheumatoid arthritis, osteoarthritis
Nifedipine Oral Calcium channel blocker None
Suggested Citation:"3 Fundamentals, Use, and Common Ingredients in Compounded Topical Pain Creams." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
×
Off-Label/Non-FDA Uses for Pain Example Adverse Effects from FDA-Approved Label Example Serious Adverse Effects from Micromedex (2019)
None Allergic reactions, cardiovascular, dermatologic, endocrine, fluid and electrolyte disturbances, gastrointestinal, metabolic, musculoskeletal, neurological/psychiatric, and ophthalmic adverse reactions (Fera Pharmaceuticals, 2004) Cardiomyopathy, hyperglycemia, pancreatitis
Chronic pain Burning/stinging at the site of application, drowsiness, dry mouth, pruritus, and fatigue (Bioglan Pharma, Inc., 2002) Ventricular arrhythmia, thrombocytopenia, suicidal thoughts, kidney damage
Fibromyalgia, Diabetic peripheral neuropathy Dizziness, somnolence, and peripheral edema (Pfizer, 2010a) StevensJohnson syndrome
Acute pain Cardiovascular, respiratory, ocular, genitourinary, psychological, neurological, and gastrointestinal adverse reactions (JHP Pharmaceuticals, 2012) Bradyarrhythmia, cardiac dysrhythmia, respiratory depression
Diabetic neuropathy, acute pain Application site reactions such as irritation, erythema, and pruritus (Scilex Pharmaceuticals, Inc., 2018)
None Diarrhea, upper respiratory tract infections, dyspepsia, and influenzalike symptoms (Boehringer Ingelheim Pharmaceuticals, 2012) Black box warning for increased risk of cardiovascular events, gastrointestinal bleeding and ulceration
None Dizziness, headaches, confusion, and gastrointestinal adverse effects (Forest Pharmaceuticals, 2013) Cerebrovascular accident, seizures, kidney failure
None Gastrointestinal, CNS, dermatologic, cardiovascular and special senses disturbances (visual and hearing) adverse reactions (Roche, 2007) Black box warning for increased risk of cardiovascular events, gastrointestinal bleeding and ulceration
None Peripheral edema, headache, dizziness, fatigue, nausea, and constipation adverse reactions (Bayer Healthcare, 2011; Pfizer, 2010b) Myocardial infarction, ventricular arrhythmia, suicidal thoughts, kidney damage
Suggested Citation:"3 Fundamentals, Use, and Common Ingredients in Compounded Topical Pain Creams." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
×
Drug Product Formulation(s) Drug Class FDA-Approved Pain Indications
Orphenadrine Injection, oral Skeletal muscle relaxant Musculoskeletal pain
Pentoxyifyline Oral Vasoactive phosphodiesterase inhibitor None
Topiramate Oral Anticonvulsants Migraine prophylaxis
Tramadol Oral Opioid agonist Chronic pain

NOTE: CNS = central nervous system; FDA = U.S. Food and Drug Administration; HCl = hydrochloride; IM = intramuscular injection; IV = intravenous injection; NMDA = NmethylDaspartate; NSAID = nonsteroidal antiinflammatory drug; REMS = Risk Evaluation and Mitigation Strategy.

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ACPA (American Chronic Pain Association). 2019. ACPA resource guide to chronic pain management. https://www.theacpa.org/wp-content/uploads/2019/02/ACPA_Resource_Guide_2019.pdf (accessed January 10, 2020).

Bayer Healthcare. 2011. Adalat CC (nifedipine) extended release tablets for oral use label. https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020198s023lbl.pdf (accessed December 17, 2019).

Bioglan Pharma. 2002. Zonalone (doxepin hydrochloride) cream label. https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20126slr006_Zonalon_lbl.pdf (accessed March 16, 2020).

Boehringer Ingelheim Pharmaceuticals. 2009. Catapres (clonidine hydrochloride, USP) label. https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017407s034lbl.pdf (accessed December 17, 2019).

Boehringer Ingelheim Pharmaceuticals. 2011. Catapres-TTS (clonidine) patch label. https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018891s028lbl.pdf (accessed March 16, 2020).

Boehringer Ingelheim Pharmaceuticals. 2012. Mobic (meloxicam) tablets, oral suspension label. https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020938s022lbl.pdf (accessed December 17, 2019).

Suggested Citation:"3 Fundamentals, Use, and Common Ingredients in Compounded Topical Pain Creams." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
×
Off-Label/Non-FDA Uses for Pain Example Adverse Effects from FDA-Approved Label Example Serious Adverse Effects from Micromedex (2019)
None Dry mouth, tachycardia, palpitation, urinary hesitancy or retention, and blurred vision (3M Pharmaceuticals, 2006) Palpitations, tachyarrhythmia
None Cardiovascular, digestive, and nervous system adverse reactions (Validus Pharmaceuticals, LLC, 2016) Thrombocytopenia
None Paresthesia, anorexia, and weight loss (Janssen Pharmaceuticals, Inc., 2017) Dermatologic: Erythema multiforme, StevensJohnson syndrome, toxic epidermal necrolysis
Cancer pain Constipation, nausea, dizziness, and headache (Johnson & Johnson, 2009) Black box warning for addiction, abuse, misuse. Required REMS by FDA. Respiratory depression, accidental ingestion, sedation, coma, and death if used with benzos or alcohol

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Burch, J. 2017. Compounding pharmacists provide customized care. North Carolina Medical Journal 78(3):191–194.

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Suggested Citation:"3 Fundamentals, Use, and Common Ingredients in Compounded Topical Pain Creams." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
×

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Suggested Citation:"3 Fundamentals, Use, and Common Ingredients in Compounded Topical Pain Creams." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
×

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Suggested Citation:"3 Fundamentals, Use, and Common Ingredients in Compounded Topical Pain Creams." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
×

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Suggested Citation:"3 Fundamentals, Use, and Common Ingredients in Compounded Topical Pain Creams." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
×
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Suggested Citation:"3 Fundamentals, Use, and Common Ingredients in Compounded Topical Pain Creams." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
×
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Suggested Citation:"3 Fundamentals, Use, and Common Ingredients in Compounded Topical Pain Creams." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
×
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Suggested Citation:"3 Fundamentals, Use, and Common Ingredients in Compounded Topical Pain Creams." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
×
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Suggested Citation:"3 Fundamentals, Use, and Common Ingredients in Compounded Topical Pain Creams." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
×
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Suggested Citation:"3 Fundamentals, Use, and Common Ingredients in Compounded Topical Pain Creams." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
×
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Suggested Citation:"3 Fundamentals, Use, and Common Ingredients in Compounded Topical Pain Creams." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
×
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Suggested Citation:"3 Fundamentals, Use, and Common Ingredients in Compounded Topical Pain Creams." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
×
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Suggested Citation:"3 Fundamentals, Use, and Common Ingredients in Compounded Topical Pain Creams." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
×
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Suggested Citation:"3 Fundamentals, Use, and Common Ingredients in Compounded Topical Pain Creams." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
×
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Suggested Citation:"3 Fundamentals, Use, and Common Ingredients in Compounded Topical Pain Creams." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
×
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Suggested Citation:"3 Fundamentals, Use, and Common Ingredients in Compounded Topical Pain Creams." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
×
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Suggested Citation:"3 Fundamentals, Use, and Common Ingredients in Compounded Topical Pain Creams." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
×
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Suggested Citation:"3 Fundamentals, Use, and Common Ingredients in Compounded Topical Pain Creams." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
×
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Suggested Citation:"3 Fundamentals, Use, and Common Ingredients in Compounded Topical Pain Creams." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
×
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Suggested Citation:"3 Fundamentals, Use, and Common Ingredients in Compounded Topical Pain Creams." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
×
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Suggested Citation:"3 Fundamentals, Use, and Common Ingredients in Compounded Topical Pain Creams." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
×
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Suggested Citation:"3 Fundamentals, Use, and Common Ingredients in Compounded Topical Pain Creams." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
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Pain is both a symptom and a disease. It manifests in multiple forms and its treatment is complex. Physical, social, economic, and emotional consequences of pain can impair an individual’s overall health, well-being, productivity, and relationships in myriad ways. The impact of pain at a population level is vast and, while estimates differ, the Centers for Disease Control and Prevention reported that 50 million U.S. adults are living in pain. In terms of pain’s global impact, estimates suggest the problem affects approximately 1 in 5 adults across the world, with nearly 1 in 10 adults newly diagnosed with chronic pain each year.

In recent years, the issues surrounding the complexity of pain management have contributed to increased demand for alternative strategies for treating pain. One such strategy is to expand use of topical pain medications—medications applied to intact skin. This nonoral route of administration for pain medication has the potential benefit, in theory, of local activity and fewer systemic side effects. Compounding is an age-old pharmaceutical practice of combining, mixing, or adjusting ingredients to create a tailored medication to meet the needs of a patient. The aim of compounding, historically, has been to provide patients with access to therapeutic alternatives that are safe and effective, especially for people with clinical needs that cannot otherwise be met by commercially available FDA-approved drugs.

Compounded Topical Pain Creams explores issues regarding the safety and effectiveness of the ingredients in these pain creams. This report analyzes the available scientific data relating to the ingredients used in compounded topical pain creams and offers recommendations regarding the treatment of patients.

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