Designer pain creams - profitable for compounding pharmacies but risky for patients and children

Certain pharmacies, known as compounding pharmacies, can mix different ingredients together to produce a patient-specific product.

by Michael R. Cohen, RPh

Published March 18, 2015, 5:30 a.m. ET

Certain pharmacies, known as compounding pharmacies, can mix different ingredients together to produce a patient-specific product. For example, they can prepare a special formulation of a needed medication that replaces an ingredient in a commercially available product to which the patient is allergic. On the other hand, some pharmacies have concentrated on making a business out of marketing and selling compounded pain creams and ointments that contain a combination of multiple potent medications. Many include drugs that can cause central nervous system depression, even resulting in slower breathing; cardiac effects such as a low heart rate or irregular heartbeat; and drowsiness or a loss of consciousness, in addition to having some effect on pain. These drugs may include:

Ketamine—a powerful pain reliever that can cause extreme drowsiness
Baclofen and cyclobenzaprine—powerful muscle relaxants that cause drowsiness
Lidocaine and bupivacaine—local anesthetics that can cause heart rate and rhythm changes
Tricyclic antidepressants (i.e., amitriptyline, doxepin)—antidepressant medicines that also treat pain but can cause heart or blood pressure abnormalities
Gabapentin, clonidine, and nifedipine—pain relievers that are primarily used to control seizures or high blood pressure

Although each individual drug is approved by the FDA to treat specific conditions, they are NOT approved when combined to make pain creams or ointments by compounding pharmacies. Consumers are charged per ingredient even though there is really no proof that mixing more drugs together make the product better.

Compounding pharmacies that concentrate in this area often have a large sales force that conducts an elaborate marketing campaign, providing doctors with prescriptions that only require their signature to make prescribing of these creams easier. Prospective patients have received unsolicited calls at home with a promise that the cream can be prescribed after an arranged telephone consultation with a physician. One of our nurses had persistent unsolicited calls from a compounding pharmacy even though she told them she was not in pain. A CBS News investigation identified one patient whose insurance company was billed over $18,000 for unwanted pain creams.

Some compounding pharmacies even entice doctors with financial incentives to prescribe these creams, despite an Anti-Kickback Statute. In one high-profile case, the Federal Bureau of Investigation (FBI) recently announced the arrest of a pharmacist at a compounding pharmacy who paid tens of thousands of dollars in cash bribes to physicians for providing patients with pain cream prescriptions.

As noted in an earlier blog, pain creams can present safety issues for adults and children. Patients may be unaware of potential dangers with these creams, particularly side effects related to central nervous system depression and cardiac effects. There is also concern about some compounding pharmacy statements that may be unproven, such as a pain cream or ointment's safe use with children. Because safety issues can arise with any compounded, unapproved formulations of medications, I believe regulatory oversight is necessary by boards of pharmacy and the FDA, with compounded pain creams needing prominent warnings on labels that describe the potential for toxicity.

If your doctor prescribes a pain cream or ointment for you, ask questions about possible adverse effects and proper use. Make sure you know the symptoms of potential toxicity and when to stop using the cream or seek medical attention. Wash your hands after applying the cream or ointment. Keep the treated area covered with clothing if possible, and avoid skin-to-skin contact between the treated area and others.

The body can absorb too much medicine when exposed to excessive heat, so don't apply heat to the area after applying the pain cream. This includes heat from a heating pad, heat wrap, electric blanket, sauna, hot tub, the sun, or other heat sources. Keep the creams or ointments up and away and out of the sight and reach of children. The creams may not have a safety closure to prevent access by a child. Never allow others to use the cream that was specifically prescribed for you, including family members or friends. You could be putting them in danger!