Derms Mixing Up Their Own Prescriptions: Do or Dicey?

In the world of dermatology and skin care, there is an ongoing quest to create the “perfect” product. Couple that pursuit with consumer demand and the rising cost of topical prescription medications and you have something known as “compounding”—a sort of “mixing of bespoke concoctions” that many dermatologists do.

“Mixing or compounding products has been a longstanding practice,” says Norwalk, CT, dermatologist Deanne Mraz Robinson, MD. “There are many skin conditions for which there is not an ideal topical readily available or approved by the FDA—either the vehicle is not ideal or the concentration or type of ingredients are not matched for the particular condition we are treating. As such, there is a large practice of either writing multiple prescriptions and having the patient mix and apply them or compounding a new prescription containing the desired ingredients.”

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One big benefit of "mixing" ingredients: You may end up with a more potent, more multitasking product—for less. "Many times, these are not covered by insurance, so patients can get them for less through their physician," New York dermatologist Sapna Westley, MD, says. "It can also be done to combine several synergistic ingredients that may be more beneficial to a condition than one alone. Plus, by doing this, compliance is enhanced if patients can apply multiple ingredients in one product once daily, rather than having to apply multiple creams more frequently."

As Dr. Mraz Robinson explains, usually a compounded topical medication is one that is not available as a standard prescription and needs to be filled at a specialty pharmacy. “Also, given the increased risk of prescription topical medications, many options may be available cheaper through a compounding pharmacy.” 

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While it may be cheaper, Dr. Mraz Robinson does admit it will be a “different” prescription. “It also won’t be FDA-approved, even though the individual ingredients may be FDA-approved,” she says. (The FDA recently issued a statement, document 503A, which gives regulatory guidance on compounding. Patients should inquire whether their mixed prescription is in compliance with this new regulation.) “For example, I may want to use a topical medicine for rosacea that contains topical ivermectin and topical metronidazole, mixed in a calming cream vehicle. This doesn’t exist as a standard prescription available from the pharmaceutical companies, but can be compounded for use.” 

Coral Gables, FL, dermatologist Janice Lima Maribona says she is also a fan of mixing—more specifically, for her patients who have skin conditions like rosacea and acne. “I love to mix retinoic acid with neck creams and moisturizers; vitamin C from SkinCeuticals with different masks; and SkinCeuticals masks with other prescriptions for acne, like Tazorac, and non-prescription ingredients like salicylic acid. There’s definitely been an uptick in compounding recently, especially for us chemical lovers and product fans,” she says, but she does point out that there are some things to consider. “Things like acidity, pH and consistency are really important. Plus, you should be told there is a mix and you should know what to do if a reaction happens.”

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What’s more, Dr. Mraz Robinson says, is that patients should ask what all the ingredients are and the safety of the mixed prescription. “I recommend asking if there is an increased chance for irritation with the compounded medication and how long it should be used. Patients should be aware if their physician is dispensing the compounded medication from their office or if they need to have the prescription filled at a specialty pharmacy.” Dr. Westley stresses that your dermatologist should explain in detail what the compound is in terms of what the ingredients are, how they work together and if this is something that is also available through a commercial pharmacy. "Examples include tretinoin/hydroqunione/topical steroid, which is used for melasma or tretinoin in an emollient base for anti-aging," she says. "Compounds for treating psoriasis—a potent topical steroid compounded with urea or salicylic acid that can enhance penetration of the steroid—are also commonly compounded by physicians, as this is not available through a commercial pharmacy."

Of course, there’s also the option of trying doctor-developed lines, which sort of merge the best of both worlds. “In my practice, my son, Daniel, and I developed an over-the-counter lip and body balm product with 1 percent hydrocortisone, called FixMySkin 1% Hydrocortisone Healing Balm. It helps with skin problems ranging from eczema to psoriasis and dry lips,” says Omaha, NE, dermatologist Joel Schlessinger, MD, but admits it wasn’t easy. “This is something that was difficult to do without working hand in hand with an FDA go-between to make sure the formulation met stringent rules.”

“Costs can be significant, and in our case it costs tens of thousands of dollars to develop the product and that didn't even take into account the significant sums it eventually cost for patent protection,” he says. “This isn't something that many dermatologists have the stomach for, so it has largely been abandoned.”

“The flipside is the joy of knowing you have created something that is unique.”

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1 Comment
  • Sally
    Posted on

    A quick note for clarification, it is incorrect to state that the ingredients in a compounded drug are FDA-approved--they are not. The FDA approves medications in their final formulated dosage form, including packaging. With respect to placing an additional burden on patients to ask their pharmacy about the FDA approval status of a medication after it has been prescribed, medical ethics should dictate that patients be informed whether or not a medication prescribed for them is FDA-approved before they are given the prescription, so they are provided an opportunity to discuss the necessity of the prescription with their doctor. They should also be informed whether or not doctors have a competing financial incentive to prescribe untested medicines, and what, if any, additional precautions or monitoring should be conducted while the patient is exposed to the unapproved drug. This exchange of information and communication is directly relevant to a patient's health and safety, particularly if they are not offered an option to be treated with a drug that has been subjected to multidisciplinary scientific, clinical and medical regulatory science review for safety, effectiveness and manufacturing quality.

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