Compounded Topical Pain Creams Review of Select Ingredients for Safety, Effectiveness, and Use (2020) / Chapter Skim
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3 Fundamentals, Use, and Common Ingredients in Compounded Topical Pain Creams
3 Fundamentals, Use, and Common Ingredients in Compounded Topical Pain Creams
Pages 45-62
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From page 45... ...
The chapter concludes by identifying a set of active pharmaceutical ingredients (APIs) that are commonly used in formulations of compounded topical pain creams.
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From page 46... ...
United States P harmacopeia (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)
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. 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)
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. Given the evidence for the substantial use of compounded preparations and the current 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.
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They may also be unaware of the potential risks reported by patient health surveys or of adverse events that have been reported. 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.
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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.
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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 gastro intestinal 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 Pain Conditions for Which Compounded Topical Pain Creams Type of Pain Were Used Neuropathic pain • Peripheral neuropathy (diabetic, chemotherapy-induced) • 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 • Fibromyalgia (mixed pain)
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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.
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From its research efforts, the committee has found that many APIs formulated in compounded topical pain creams include those found in FDAapproved 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.
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54 COMPOUNDED TOPICAL PAIN CREAMS TABLE 3-2 FDA-Approved and Off-Label Indications Limited to Pain Indications for Which Topical Pain Creams Are Often Used FDA-Approved Pain Drug Product Formulation(s) Drug Class Indications Amitriptyline Oral Tricyclic None antidepressants Baclofen Oral, intrathecal Skeletal muscle Muscle spasms relaxant Bupivacaine Injection Local anesthetic None Cannabidiol Oral Cannabinoid None Carbamezapine Oral Anticonvulsants Trigeminal neuralgia Clonidine Transdermal Alpha-2 adrenergic None agonist Clonidine HCl Epidural, oral Alpha-2 adrenergic None agonist Cyclobenzaprine Oral Skeletal muscle Skeletal muscle spasm relaxant
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Trigeminal Drowsiness, dizziness, Gastrointestinal bleeding neuralgia, and weakness (Metacel peripheral Pharmaceuticals, LLC, 2019) neuropathy Pain Excitation and/or depression Cardiac arrest, respiratory of the CNS system as well as depression cardiovascular adverse reactions (Pfizer, 2012)
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56 COMPOUNDED TOPICAL PAIN CREAMS TABLE 3-2 Continued FDA-Approved Pain Drug Product Formulation(s) Drug Class Indications Dexamethasone Oral, ophthalmic, Adrenal None injection corticosteroid Doxepin Oral, topical Tricyclic None antidepressants 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 None antagonist Naproxen Oral NSAID Rheumatoid arthritis, osteoarthritis Nifedipine Oral Calcium channel None blocker
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peripheral neuropathy Acute pain Cardiovascular, respiratory, Bradyarrhythmia, cardiac ocular, genitourinary, dysrhythmia, respiratory psychological, neurological, depression and gastrointestinal adverse reactions (JHP Pharmaceuticals, 2012) Diabetic Application site reactions such -- neuropathy, as irritation, erythema, and acute pain pruritus (Scilex Pharmaceuticals, Inc., 2018)
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Food and Drug Administration; HCl = hydrochloride; IM = intramuscular injection; IV = intravenous injection; NMDA = N-methylD-aspartate; NSAID = nonsteroidal anti-inflammatory drug; REMS = Risk Evaluation and Mitigation Strategy. REFERENCES ACPA (American Chronic Pain Association)
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2019. Presentation to the assessment of the available scientific data regarding the safety and effectiveness of ingredients used in compounded topical pain creams meet ing 2: American Chronic Pain Association topical cream survey.
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U.S. compounding pharmacies market size.
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2019. Presentation to the assessment of the available scientific data regarding the safety and effectiveness of ingredients used in compounded topical pain creams meeting 1: Uses, common types, and costs of compounded topical pain creams and patient pref erences regarding compounded topical pain creams.
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2014. A brief survey on prescriber beliefs regarding compounded topical pain medications.
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