The challenges of prescribing isotretinoin


Isotretinoin prescriptions are a challenging endeavor, requiring collaboration between providers, office administrative staff, pharmacists, insurance companies, and laboratory facilities.

Prescription of isotretinoin is a challenging endeavor, requiring collaboration between providers, office administrative staff, pharmacists, insurance companies, and laboratory facilities.

As the administrative burden is not well elucidated, a group of researchers conducted a study aiming to quantify the workload required to manage patients on isotretinoin compared to non-isotretinoin medications for acne treatment.

“We wanted to explore this topic because often in the clinic we encountered issues with processing isotretinoin prescriptions and many patients faced difficulty with the process,” said Anna Kirkorian, MD, chief of dermatology at Children’s National in Washington, D.C. “For example, our nurses would have to spend hours on the phone explaining the iPLEDGE process and how to complete the online questionnaires to patients, as well as speak with insurance companies regarding medication prior authorizations.”

In the paper, “The administrative burden of prescribing and treating with isotretinoin,” Kirkorian and the research team explored he effectiveness of the iPLEDGE program, and found it decreased patient access and increased administrative burden.

The study included all patients under the age of 21 years who received both isotretinoin and non-isotretinoin medications for acne treatment at Children’s National Hospital in the time period of 2012 to 2019.

“We performed a retrospective chart review of all patients who received isotretinoin for the treatment of acne,” said Nidhi Shah, MD, candidate at George Washington University’s school of medicine and health sciences, who served as lead author on the paper. “Patients generally have to fail other medications such as topicals and oral antibiotics prior to receiving isotretinoin, hence, we compared the administrative burden associated with prescribing these other acne medications (pre-isotretinoin) and for prescribing isotretinoin in the same patient cohort.”

From the chart review, the researchers extracted information such as patient demographics, patient treatment information, as well as the number and type of communications made by the nursing staff.

“We explored the nursing communications which provided insight on the number of calls that the staff had to make to different stakeholders, including patient, pharmacy, insurance company, physician, and iPLEDGE,” Shah said. “Additionally, we explored the reasons behind the communications which allowed us to understand the biggest hurdles to isotretinoin prescription.”

The data showed a total of 1,609 communications occurred during isotretinoin treatment; 40 percent were calls with patients, 24 percent were calls with pharmacies, 13 percent were calls with insurance, and 19 percent were messages with providers. And the majority of the calls involved prior authorization processing and patient education about iPLEDGE.

“By comparing the number of communications required for non-isotretinoin medication and isotretinoin within the same patient population, we were able to control for variables and appreciate the vast difference in workload required for isotretinoin vs. other medications,” Shah said.

One notable takeaway of the data is that despite having similar lengths of treatment of non-isotretinoin and isotretinoin, prescription of isotretinoin resulted in significant more workload for the administrative staff (10.70±8.54 communications/patient occurred during isotretinoin treatment versus 1.72±2.66 communications/patient during non-isotretinoin treatment (p<0.01)).

Another was that significantly more communications/patient occurred for patients with public insurance (2.24±1.72) than private insurance (1.58±1.28) (p=0.033) and when a prior authorization (PA) was required (2.38±1.34) than when no PA was required (1.64±0.97) (p<0.001).

“Although we were not surprised to learn that isotretinoin prescriptions required a greater workload than non-isotretinoin acne medications, we were definitely surprised by the significant difference in the amount of workload,” Kirkorian said. “Additionally, when translating the call lengths to the cost on the healthcare system, we were surprised that the cost to process one isotretinoin prescription could range from $6.15-$147.80 in non-reimbursable staff hours.”

One of the biggest challenges for the administrative staff that was gleaned during the study was the coordination of prior authorization process between the pharmacy and the insurance company, especially within the 7-day prescription window which added a time urgency.

The administrative staff served as an intermediary between stakeholders, investigating why the physician sign-off is not displaying on the pharmacy’s iPLEDGE portal or coordinating PAs between the pharmacy and insurance company.

After all, the iPLEDGE program requires involvement of all stakeholders (patient, physician, pharmacy, insurance company, laboratory facility, and iPLEDGE) to successfully prescribe isotretinoin.

“iPLEDGE requires each stakeholder to complete their own set of required tasks (ex. physician must sign off in iPLEDGE, patient must take an online questionnaire, pharmacy must verify patient’s iPLEDGE status),” Shah said. “The multiple steps required especially for childbearing patients poses a lot of obstacles for patients and the nursing staff is in the center to coordinate all of the items. The administrative staff is racing against time to ensure successful prescription of isotretinoin and this orchestration is burdensome, costly, and takes away time from other duties.”

Since the implementation of iPLEDGE, there has been a shift in isotretinoin prescription pattern from low-volume general providers to high-volume specialist providers, which may be secondary to the administrative burden associated with isotretinoin prescription.

“Given that many of the patient barriers to accessing isotretinoin—for example patient delays in insurance prior authorization or inability to find an iPLEDGE-participating pharmacy—align with the reasons for the significant administrative burden,” Kirkorian said. “Our study sheds light on the implications of iPLEDGE from a physician/administrative perspective, with hopes that future changes in the program both work towards decreasing the burden on both patients and providers to increase access and treatment adherence.”

While the study was limited to a single site and pediatric population, Shah noted that by comparing the workload for isotretinoin and non-isotretinoin in the same cohort, the research team could control for patient variables, contributing to workload differences.

Therefore, the findings underestimate the actual administrative burden as non-phone communications and time spent on documentation, iPLEDGE portal activities, and electronic PA submissions were not included.

“The administrative staff is racing against time to ensure successful prescription of isotretinoin, and this orchestration is burdensome, costly, and takes away time from other duties,” she said. “While iPLEDGE serves an important role in preventing fetal exposure to isotretinoin, streamlining the process of prescription could decrease both the administrative and patient workload, thereby reducing potential treatment barriers.”

Originally published on our sister brand, Dermatology Times.


Shah N, Smith E, Czermak J, Ferris M, Kirkorian A. The administrative burden of prescribing and treating with isotretinoin. Journal of the American Academy of Dermatology. April 23, 2021.

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