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Lisette Hilton is president of Words Come Alive, based in Boca Raton, Florida.
In this article, Dr. Murad Alam, M.D., president elect of the American Society for Dermatologic Surgery, addresses how changes in federal and state regulations that govern compounding medications could impact physicians and patients.
Changes to federal and state legislation that expand oversight of common mixing and compounding practices in dermatology could a have substantial impact on doctors and their patients, according to Murad Alam, M.D., M.B.A., president elect of the American Society for Dermatologic Surgery and vice chair of dermatology at Northwestern University.
Dr. Alam, who was among, the speakers at the “Pharmacy Compounding and the Dermatologist” session at the American Academy of Dermatology annual meeting in February, says two common and simple practices that dermatologists perform daily may be changing under new regulations.
“One is the office use of compounded substances. The other is in-office mixing in which physicians prepare pharmaceuticals for patient use,” he said.
Buying compounded medications in bulk, such as topical anesthesia, allows dermatologists to use these for patients who may need them in the course of routine office procedures. For instance, compounded numbing agents may be purchased and kept in the office for application before laser treatments to reduce perioperative pain.
Dermatologists have been mixing prepackaged products with water or bicarbonate to enhance patient treatments safely for decades.
“We feel [in-office mixing] is not compounding in the classic sense. Usually, you’re just mixing a perfectly safe pharmaceutical product that was packaged appropriately with a very simple and safe diluent, like sterile saline, water or sodium bicarbonate,” Dr. Alam said.
A dermatology practice, for example, may use lidocaine with a pre-packaged epinephrine. It may be mixed with a small amount of sodium bicarbonate out of a sterile vial so that the resulting mixture is at a more neutral pH and doesn’t sting as much on injection.
Kenalog (triamcinolone acetonide) is another example in which patients may require different strengths. “Kenalog comes in two strengths - 10 mg and 40 mg per cc. But sometimes you might want a different strength. You might want just 3mg per cc. Or, you might want 20 mg per cc. These alternative concentrations can be obtained by mixing a standard strength with a measured quantity of sterile water or saline. These safe dilutions are often used for treating hypertrophic scars and keloids, or inflammatory lesions,” Dr. Alam said.
The new regulations were prompted in 2012 after more than 70 patients died in the Boston area from a fungal infection linked to contaminated compounded drugs. An additional 750 cases of infection were reported.
Safety issues are a constant. The FDA has investigated cases in which serious adverse events have occurred as a result of compromised sterile and non-sterile compounded drugs. They’ve also investigated other safety issues in which super potent sterile and non-sterile drugs contained to much active ingredient.
See the related story: FDA moves to regulate medicines produced in bulk
FDA spokesperson Jeremy Kahn said compounded medications can present a greater risk to patients than traditional medications.
Under poor conditions, compounded medications can cause serious patient harm. “Because compounded drugs do not go through FDA’s drug approval process, the FDA does not review them for safety, eff ectiveness and quality before they are marketed,” Kahn said.
Dr. Alam says that once Congress passes legislation that conveys general principles and objectives, the FDA will translate the new language into enforceable rules and regulations.
A private rule and standard setting body called United States Pharmacopeia, or U.S.P., which is led mostly by pharmacists and pharmacologists, works closely with FDA to develop standards that are often used by state boards of pharmacy.
“Since medicine is regulated at the state level, state boards of pharmacy have an outsize role in states’ regulation of pharmaceutical products. State boards of medicine and state legislatures will often defer to state boards of pharmacy,” he said.
Dr. Alam says that by eliminating the minimum risk category of compounded drugs, the U.S.P. and FDA have broadly interpreted the existing federal legislation in a way that inhibits appropriate use of compounded drugs in dermatology practice.
“While compounding pharmacies and physicians remain subject to the Federal Food, Drug, and Cosmetic Act, the FDA conducts surveillance inspections of compounders to verify that they meet applicable provisions of federal law,” Kahn said.
The FDA’s draft guidance suggests that dermatologists may no longer buy compounded products in bulk. Instead, they would need to write prescriptions and use topical anesthetics that are prescribed on an individual basis.
But this may be problematic because dermatologists don’t always know when they’ll need a numbing agent for an in-office procedure. Writing prescriptions for a topical anesthesia, for example, may require rescheduling the medical procedure.
Proposed changes to U.S.P. Chapter 797 would eliminate the minimal risk category that currently governs in-office mixing practices. It would require dedicated pharmacy clean rooms for mixing.
The proposed changes to U.S.P. 797 have generated comments from thousands of physicians sending a clear message to the FDA and U.S.P. that a further revision was necessary, Dr. Alam said. “Now, we are all waiting for the second draft.
Hopefully, they’ll be closer to where we want them to be. Then, we’ll have to comment on those changes,” Dr. Alam says.
PHYSICIAN VIGILANCE NEEDED
Even though the FDA and U.S.P. have not finalized proposed rules on compounding and mixing, some states have already adopted versions of the more restrictive recommendations, he said.
“Some state pharmacy boards have adopted draft rules without waiting for the rule-making process to play out. In some cases, state legislators have enshrined these rules into law, thereby, forcing the state board of medicine to go along. It’s important for dermatologists in affected states to band together to communicate their concerns to their legislators and state medical boards,” said Dr. Alam adding that it is the responsibility of the specialty to educate federal and state authorities before new policies are adopted.
“These are people who are very committed to ensuring the safety of drugs in the U.S. They’re working hard and have limited resources. We might feel it’s overly restrictive, but they have to deal with not just the most ethical dermatologists and dermatologic surgeons, but also with people who are careless.
“We need to remind them that we are committed to patient well-being. We need to continue to show them that in-office mixing is exceedingly safe and that in over-regulating us, they are wasting resources in trying to solve a problem that simply doesn’t exist,” he said.
Dermatologists should monitor new federal and state pharmacy compounding rules. Dr. Alam says dermatologists should be prepared to write to the FDA and state or federal legislators once the new draft guidance is issued.
Dr. Alam has consulting ties with Allergan, Amway Corporation and Pulse Biosciences. He is and investigator with Merz Pharmaceuticals; Dr. Siegfried is an investigator for Allergan, Amgen, Eli Lilly and Company, Janssen Pharmaceuticals, Mayne Pharma Group, Pierre Fabre Dermo-Cosmetique US, Regeneron. She is a consultant to Dermavant Sciences, Novan and Valeant Pharmaceuticals North America; an advisor to Verrica Pharmaceuticals and is on the Data Safety Monitoring Board of GlaxoSmithKline.
“F136 Pharmacy compounding and the dermatologist,” Luke, Siegfried, et al. AAD annual meeting, San Diego. Feb. 19, 2018