I was methodically signing off on stack of refill requests, until I find one I don’t recognize. The patient is mine but the prescription (under my name) is not. It’s for a specialty compounded cream with 4 ingredients, but I only recognize the flucatisone ingredient. I call the patient and she says she wonders why I prescribed this for her and is even more surprised to hear that I had not. What’s going on here?
You may have noticed the increasing number of patients receiving “compounded pain creams” (hereafter noted as CPC). The indications are numerous and include diabetic neuropathy, fibromyalgia, postherpetic neuralgia, joint pain, arthritis, etc. The costs and growth is staggering. The California’s workers’ compensation system paid out $10 million for CPCs in 2006, and saw this grow 14 fold to $145 million in 2013. A GAO report found that TRICARE costs for CPC grew from $5 million in 2004 to $259 million in 2013. CPCs are expensive pain meds. But according to a NY Times article, it’s not just “pain” that is being treated; specialty compounds can be a “… $1,600 ointment to treat diaper rash” or the “$8,500 cream to reduce scarring and the $2,300 salve to relieve pain.”
Patients love topicals. Not surprising as they were raised on Vicks Vapo-Rub and Ben-Gay and, well, topicals fall short of the oral or injectable leap to “taking medicine”. Patients also appreciate they are covered by many insurance plans at little or no cost to them. Many patients are unaware of the astronomically high prices attached to these emollient based concoctions of unrelated, potentially analgesic compounds. Often CPCs will have 4, but may have up to 18 ingredients, that may include ketamine, diclofenac, ketoprofen, gabapentin, cyclobenzaprine, baclofen, lidocaine, prilocaine, tramadol, dexamethasone, pentoxifylline, clonidine, tricyclic antidepressants, topical steroids or antihistamines. The combinations of ingredients are endless, as are the number of manufacturers. Sometimes the combinations are guided by the profitability of the ingredients.
In addition to being ubiquitous and overpriced, the business of CPCs has grown with little credible research and often with questionable marketing practices. Typically, doctors or providers buy these creams, prescribe them to their patients, and then fill out the paperwork to have the prescriptions paid for by insurers. Frequent prescribers justify the practice, citing other doctors who purchase, prescribe and administer injectable drugs. Many pain specialists feel that CPCs have allowed them to reduce narcotic use overall in an era of increasing narcotic regulation.
Manufacturers have fallen under scrutiny of the law for incentivizing prescribers to utilize these products. In Southern California, the Orange County grand jury has indicted 15 people involved with defrauding over $100 million from insurance companies. "We believe there were thousands of prescriptions being written and thousands being filled by multiple pharmacies in Orange County," and there were "huge markups billed to insurance companies," said Zidbeck. He said workers' compensation insurers would be billed in "the $1,500 to $3,000 range" for creams that had a wholesale cost of about $70.
Compound creams are not approved by the Food and Drug Administration and are intended for limited use, typically for people who can't take oral medication. CPCs often prescribed by pain clinics but also promoted or sold by other specialties, chiropractors, physiatrists and pharmacists. As these are not regulated by the FDA, a prescription isn’t essential, but it does help when it comes to reimbursement. Compounded drugs may contain FDA approved products. These drugs may also contain bulk drug substances, which are typically raw powders that are generally not FDA approved. Traditionally, the practice of drug compounding has been regulated by state pharmacy regulatory bodies (e.g., boards of pharmacies).
There is little research on the efficacy or safety of CPCs, moreover, little is known about their permeability and pharmacokinetics. Its doubtful that any CPCs are more effective than prescription Voltaren gel, which costs about $50 per 100 gram tube. The FDA has expressed concerns about compounding pharmacies, especially since the 2012 NECC debacle when 60 patients died as a result of sterility issues associated with compounded corticosteroids. While compounding regulations fall under the jurisdiction of the state, the safety of CPCs and anesthetic creams is an area of investigation as there have been reports of adverse events, especially when used inappropriately or in a more susceptible population such as children, the elderly, those with hepatic dysfunction or patients taking orally administered like compounds.