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Not what the doctor ordered?

Pharmacists assume greater role in dermatology patient care


Not what the doctor ordered?

Pharmacists assume greater role in dermatology patient care


By Jan Bowers, contributing writer

A critical member of the health care team, the pharmacist not only dispenses medication, but can also serve patients as a trusted source of information and advice about the drugs they provide. Many dermatologists enjoy generally good relationships with their patients’ pharmacists. If a prescribed drug is not covered by a patient’s insurance, for example, “the pharmacist will communicate with me and say, ‘these are the other options for this patient. How would you like to proceed?’” said Christine Jaworsky, MD, a dermatologist with the MetroHealth system in Cleveland and professor of dermatology at Case Western Reserve University School of Medicine. But there can be bumps in the road due to miscommunication, lack of communication, and inadequate education of pharmacists about dermatologic conditions.

DW spoke with four dermatologists to discuss areas where pharmacists impact the care of dermatology patients: topical corticosteroids (TCs), substitution of prescribed drugs with generics or biosimilars, drug compounding rules (see sidebar), communication with dermatologists, and knowledge about dermatologic conditions and treatment. 

Fighting steroid phobia

Patients are often scared away from using one of the dermatologist’s most trusted weapons against a plethora of skin disorders, topical steroids. “The physicians in my department gather regularly to talk about clinical issues, and the theme that kept popping up was frustration surrounding patients who had been prescribed topical steroids by dermatology but who later returned for visits minimally better because their pharmacist had either scared them from using the topical steroid as directed or told them they needed to stop the topical steroid two weeks after starting,” said Erik J. Stratman, MD, chairman of the department of dermatology for Marshfield Clinic Health System in central Wisconsin.

Dr. Stratman set out to examine what he called the “interprofessional practice gaps” between dermatologists and pharmacists with regard to how each group views TCs, counsels patients on their use, and communicates modifications to TC prescriptions. He sent a 17-question survey to dermatologists and pharmacists throughout Wisconsin and published an analysis of the survey results (JAMA Dermatol. 2019;155(7):838-43) with co-author Ashley N. Millard, MD. Among his key findings:

> Nearly half (46.4%) of pharmacists advised patients to limit TC use to two weeks or less, compared to 6.1% of dermatologists.

> Dermatologists were more likely to perceive that pharmacists modified TC prescriptions or instructions without communication within the past year (83.7%), while only 30% of pharmacists reported making such modifications.

> Dermatologists reported that the most frequently encountered prescription modifications were advice to prematurely discontinue TCs at two weeks (75.5%) and an emphasis on rare adverse effects (61.2%); pharmacists reported making these modifications at lower rates, 6.4% and 10.9% respectively.

> When pharmacists felt that TCs were prescribed incorrectly, 62.7% reported usually or always communicating with the prescribing dermatologist, while 57.1% of dermatologists said they never communicate with pharmacists when changes to prescriptions or instructions occur.

> Pharmacists estimated that dermatologists encounter TC adverse events, including skin atrophy, frequently (at least 11 events per year), but very few dermatologists reported this level of frequency.

Dr. Stratman had no ready explanation for why pharmacists and dermatologists have such widely different perceptions as to how frequently pharmacists are modifying prescriptions, or why more communication between the two is not occurring. He advised that the first step dermatologists should take when they discover a prescription has been changed is to contact the pharmacist. “Sometimes there may be a very simple explanation,” he remarked. “Perhaps the pharmacy only had a small quantity in stock and did not want to make the patient wait an extra day or two to get the topical medication ordered. Perhaps there was a cost issue, so a more limited start-up supply was ordered. My advice is to not go into these conversations assigning blame or motive, but rather to find out the perspective of the pharmacist on the particular matter.” Pharmacists are trusted professionals trying to do their best for the patient, he maintained, and “having a straightforward conversation about your rationale for use can have a significant impact on the pharmacist’s future counseling behavior. It just takes time and reaching out.”

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Stephanie K. Fabbro, MD, a dermatologist in Columbus, Ohio, believes that conservative counseling techniques from pharmacists may perpetuate “steroid phobia” among patients “and causes increased reluctance, possibly hindering compliance.” While she takes the time to explain to the patient the different strengths among steroids and how she chooses the appropriate one, “if the patient gets contradictory information from the pharmacist it leads to increased distrust the patient has for the doctor, the pharmacist, or both.” Addressing topical medications in general, Dr. Fabbro said that when she prescribes a 60- or 100-gram tube of medicine to treat a large amount of body surface area for a disorder like psoriasis or eczema, “I can’t tell you how many times the patient has returned to show me a 15-gram tube of the medicine that was not authorized by me. The most likely explanation for this behavior is insurance denial, but most of the time I am not informed of the change, and as a result of that the patient may go for weeks without the treatment that I ordered.” If the pharmacist had contacted her, “I could have suggested another treatment that may have been more effective at covering their significant body area.”

Could the problem be averted if dermatologists included more explicit instructions in the prescription? Due to character limits, “lengthy instructions on labels are rarely allowed,” Dr. Stratman pointed out. “We provide patients with handouts on the way out the door from the dermatology clinic, but the final counselor about our medicines is usually the pharmacist, so they often are the biggest influence.” If a pharmacist purposefully makes changes, “most states would require a communication permitting the change. Our experience was that this communication with pharmacists was rarely happening, particularly when they altered the quantity of topical steroids dispensed.”

State pharmacy boards crack down on compounding

In a classic case of unintended consequences, a horrendous scandal linking the New England Compounding Center to an outbreak of meningitis in 2012 that killed more than 100 people has led some state pharmacy boards (as well as the U.S. Congress and FDA) to adopt stringent rules around drug compounding that are hampering the practice of dermatology. In Ohio, for example, the pharmacy board in 2017 introduced regulations that require physicians who compound drugs to obtain a Terminal Distributor of Dangerous Drugs (TDDD) license and restrict how long a compounded drug can be stored before it must be administered or discarded. Other rules dictate the need for a sterile setting and vented hood to mix certain medicines such as bleomycin, used by some dermatologists to treat warts.

“The compounding pharmacy in New England had terrible conditions. Their compounded steroid was contaminated and was being injected into the spinal column and into joints,” said Timothy T. Chang, MD, a dermatologist at the MetroHealth system in Cleveland and clinical assistant professor of dermatology at Case Western Reserve University School of Medicine. “In 2017, the Ohio Board of Pharmacy, trying to be proactive, enacted regulations to ensure that compounding was done safely. But they defined compounding as mixing two substances together, so dermatologists suddenly became compounders.” Diluting steroids with saline for intralesional injection and adding bicarbonate to lidocaine to reduce stinging both qualify as compounding under the rules, explained Dr. Chang, who is also president of the Ohio Dermatological Association. 

“For decades, we’ve been mixing bicarb with lidocaine, refrigerating the vials and using them throughout the week,” he said. “Now it has to be used within six hours or thrown away. For a while, we had a nationwide shortage of bicarb, so pitching it was a problem. The other consequence, intended or unintended, is that once you have the TDDD license, it theoretically allows the pharmacy board to come in and inspect you.”

 Dr. Chang said he has been notified of one such inspection by a large dermatology practice in the Columbus area. “They were cited for a certain number of things, but there was no fine or anything punitive,” he added.

The AADA “continues to have a big issue with the pharmacy boards that want to inspect physician offices to make sure they’re compliant with the compounding regulations, where our argument is that we’re physicians, under the purview of the medical board, and it should be the medical board that does the inspections,” said Lisa Albany, JD, the AADA’s director of state policy. She pointed out, however, that in Virginia pharmacists are inspecting compounding practices in physicians’ offices.

Dr. Chang noted that the USP is in the process of revising its compounding guidelines, which will likely impact state policies. The USP finalized its compounded sterile preparation chapter in June 2019 but it has not yet gone into effect due to an appeal unrelated to in-office preparations. The AADA is working with state dermatology and medical societies to make sure that the practice of dermatology is not adversely affected once USP chapters go into effect. In a warning to dermatologists in other states, he said that by the time Ohio dermatologists got wind of the compounding regulations, “it was already too late. We just did not see this on the radar at all. You have to have some organization looking at what’s on the horizon, because if you don’t pay attention then something like this can happen. I feel like it’s hurt us, and it’s just unfortunate.”

Learn more from the AADA about access to compounded medications at staging.aad.org/member/advocacy/priorities/drugs/compounding.

Biosimilar and generic substitution

State law determines a pharmacist’s authority to substitute generic drugs for a brand-name equivalent. In 12 states and one territory, they are required to do so if all other prescribing requirements are met. According to the National Conference of State Legislatures’ (NCSL) Prescription Drug Resource Center (www.ncsl.org/portals/1/documents/health/Generic_Drug_Substitution_Laws_32193.pdf), all states allow prescribers options to block pharmacist substitutions. Mostly this involves the prescriber “stating that the brand-name drug is ‘medically necessary’ for the patient. The prescriber must use language such as ‘no substitution should be made,’ ‘do not interchange,’ or ‘dispense as written.’” The dermatologists reported few problems with how pharmacists dispense generics but urged vigilance. Dr. Jaworsky, who worked as a pharmacist during medical school, recalled dispensing a generic for furosemide, “and I look at the bottom and it was just powder. This is the responsibility that we delegate to our colleagues, the pharmacists, to make sure that it’s a reputable drug house providing the generics. But as much as everything’s a big corporate industry, they may not have a say in terms of which generics are purchased for them.”

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The status of biosimilars in dermatology is more complex. According to a National Psoriasis Foundation fact sheet, the FDA has approved five biosimilars for the treatment of psoriasis and psoriatic arthritis. However, Lisa Albany, JD, the AADA’s director of state policy, said that, “there aren’t any approved interchangeable biosimilars for dermatology patients right now. Biosimilars have been approved for dermatologic conditions but have not come to market due to patent disputes. The FDA finalized its guidance on interchangeability last year, and the delay in approval could be due to the standards set forth in the guidance.” Anticipating that it is only a matter of time before such drugs do enter the marketplace, the AADA has been waging a multi-front battle in state legislatures to advocate for a dermatologist’s right to be notified before biosimilar substitutions are made.

According to the NCSL website, 47 states have passed biosimilar substitution laws, which “usually include allowing doctors to block the substitution by writing that the brand is medically necessary, the pharmacist notifying the prescriber about the change, and only making the substitution for a cheaper drug alternative.” The AADA “spent a bit of time in Idaho battling a proposal that would not have required any communication of the substitution between the pharmacist and the physician,” Albany noted. “It’s been a challenge. Most states are requiring communication, but it’s always after the fact, usually within three to five days.”

With a front-row seat to developments at the state level, Albany views the biosimilar issue as part of a broader effort by pharmacists to expand their autonomy and scope of practice. “In Idaho, a couple of years ago, we were successful in changing a rule that would have allowed pharmacists to prescribe any drug approved by the FDA for mild acne,” she said. “At the time, we were happy that we managed to get it limited to topical drugs only. In Florida, a new law just took effect that allows pharmacists to screen for and treat minor, non-chronic health conditions, including skin conditions. It does stipulate that pharmacists must work within the framework of a written protocol with a supervising physician, but it doesn’t have to be a dermatologist. It could be a family physician, and we would argue that they don’t have as much knowledge about skin conditions.”

Addressing a need for education

As a medical student at Northeast Ohio Medical University, Dr. Fabbro had discussions with her mentor, Robert T. Brodell, MD, about his frequent interaction with pharmacists who clearly lacked an understanding of basic dermatologic treatment. At the same time, he was hearing from pharmacists “expressing concerns when patients would ask them about skin lesions or dermatoses because access to dermatologists was so difficult. It seemed like both sides of the care continuum had concerns that could be improved upon.” Their solution: organize a dermatology symposium for pharmacists. With the support of an educational grant from Galderma, the university held a 10-hour symposium in 2011, attended by 83 pharmacists and six physicians. The format featured seven lectures on clinical topics, with case-based test questions presented before and after each lecture, and panel discussions on such topics as improving relationships between pharmacists and dermatologists and barriers to optimizing care. A report on the symposium published in Currents in Pharmacy Teaching and Learning indicated that attending pharmacists significantly improved their grasp of the clinical topics, particularly the dosage of systemic steroids. Surveyed at the end of the symposium, the overwhelming majority of pharmacists agreed that it helped them close knowledge gaps and motivated them to pursue further coursework in dermatology.

Eight years later, Dr. Fabbro said the need to educate pharmacists about dermatology is still apparent. “For instance, I have heard from colleagues of pharmacists denying off-label systemic treatments for rare dermatologic diseases because use of such medications was ‘outside the realm of dermatology.’ Furthermore, pharmacists serve a critical role on formulary boards for many insurance companies, and better understanding of dermatologic conditions could help ensure patients get access to the most effective treatments.” The AAD could help by making a basic dermatology curriculum available to pharmacists through its website, and state dermatologic societies could invite pharmacists to their annual meetings, she suggested. (The AAD does have basic dermatology curricula for medical students, internists, and pediatricians at staging.aad.org/member/education/residents/bdc.) “Both dermatologists and pharmacists could probably be better at making the entire process of obtaining and using dermatologic treatments more seamless for the patient from start to finish,” she remarked. Dr. Jaworsky agreed, noting that “we’re all in this for the patient. Absolutely the best communication possible between all professionals taking care of patients is essential for good treatment outcomes.”