Abstract

To the Editor: Treatment with isotretinoin poses many challenges for patients, including locating an iPLEDGE-participating pharmacy.1Shah N. Smith E. Kirkorian A.Y. Evaluating the barriers to isotretinoin treatment for acne vulgaris in pediatric patients.J Am Acad Dermatol. 2020; https://doi.org/10.1016/j.jaad.2020.11.055Abstract Full Text Full Text PDF Scopus (8) Google Scholar We demonstrated in Washington, District of Columbia, that iPLEDGE pharmacies are substantially limited in low-income and racial minority communities.2Shah N. Truong M. Kirkorian A.Y. Relationship between sociodemographic factors and geographic distribution of pharmacies dispensing isotretinoin in Washington, DC.J Am Acad Dermatol. 2020; 83: 930-933https://doi.org/10.1016/j.jaad.2020.01.014Abstract Full Text Full Text PDF PubMed Scopus (3) Google Scholar The current study expands the geographic analysis of iPLEDGE pharmacies across metropolitan cities in the United States. Four cities with a population greater than 500,000 residents, based on the US Census Bureau's 2010 estimates, were randomly selected per geographic region of the country (Northeast, Southeast, Midwest, West, and Southwest). A list of active outpatient pharmacies was obtained from the state's Board of Pharmacy and public sources and verified for iPLEDGE enrollment. A list of dermatologists was obtained from the American Academy of Dermatology. Zip code-specific demographics were extracted from the 2013-2017 American Community Survey estimates. iPLEDGE pharmacy distribution was compared with community demographics and dermatologist density using Poisson regression and simple linear regression, respectively. Of 737 zip codes surveyed across 20 cities, 5470 pharmacies were identified, of which 2961 (54.1%) were enrolled in iPLEDGE. The Southeast had the highest iPLEDGE pharmacy density, whereas the West had the lowest (Fig 1). For every $1000 increase in median household income, the number of iPLEDGE pharmacies increased by 12% and 10% in the West (95% CI 1.10-1.15) and Midwest (95% CI 1.08-1.13), respectively (Fig 2). For every 1% increase in the percentage of individuals living below the poverty line, the overall number of iPLEDGE pharmacies decreased by 22% (95% CI 0.71-0.85), with the largest decrease in the Southwest, ie, 30% (95% CI 0.57-0.86). For every 1% increase in the percentage of non-White individuals, the overall number of iPLEDGE pharmacies decreased by 9% (95% CI 0.87-0.96), with the largest decrease in the Southwest, ie, 30% (95% CI 0.59-0.83). Overall, the iPLEDGE pharmacy density increased by 0.66 units for every unit increase in the dermatologist density (per 10,000 residents) (95% CI 0.64-0.68). The total number of pharmacies was not associated with changes in sociodemographic factors; however, non-iPLEDGE pharmacy distribution decreased by 8% and 13% for every 1% increase in the percentage of non-White individuals and individuals living below the poverty line, respectively.Fig 2Association of the distribution of iPLEDGE-participating pharmacies with sociodemographic variables. The data represent changes in the number of iPLEDGE pharmacies for every $1000 increase in median household income, 1% increase in non-White population, and 1% increase in the percentage of people living below the poverty line. ∗Represents a statistically significant change.View Large Image Figure ViewerDownload Hi-res image Download (PPT) Our study demonstrates the maldistribution of iPLEDGE pharmacies across the United States, with restricted availability in low-income and racial minority communities. Limited access to iPLEDGE pharmacies is associated with poor isotretinoin treatment outcomes, such as more missed prescription windows and early termination of treatment, and contributes to racial and socioeconomic disparities in acne treatment.1Shah N. Smith E. Kirkorian A.Y. Evaluating the barriers to isotretinoin treatment for acne vulgaris in pediatric patients.J Am Acad Dermatol. 2020; https://doi.org/10.1016/j.jaad.2020.11.055Abstract Full Text Full Text PDF Scopus (8) Google Scholar,3Barbieri J.S. Shin D.B. Wang S. Margolis D.J. Takeshita J. Association of race/ethnicity and sex with differences in health care use and treatment for acne.JAMA Dermatol. 2020; 156: 312-319https://doi.org/10.1001/jamadermatol.2019.4818Crossref PubMed Scopus (22) Google Scholar Further, Black women have been reported to face restricted access to pharmacies that have contraception.4Barber J.S. Ela E. Gatny H. et al.Contraceptive desert? Black-white differences in characteristics of nearby pharmacies.J Racial Ethn Heal Disparities. 2019; 6: 719-732https://doi.org/10.1007/s40615-019-00570-3Crossref PubMed Scopus (13) Google Scholar The disproportionate distribution of iPLEDGE pharmacies and dermatologists, coupled with a “contraception desert,” not only places racial minorities at a disadvantage of accessing isotretinoin but also jeopardizes the safe use of isotretinoin. Our results are limited to urban settings and may not be generalizable to rural communities. iPLEDGE presents multiple challenges for pharmacies, such as recertification and retraining requirements, gaining access to the iPLEDGE online portal, and using an interactive voice system.5Barlas S. FDA intensifies drive to reduce REMS burdens.http://dailymed.nlm.nih.gov/Date accessed: December 17, 2020Google Scholar Methods to reduce the regulatory burden of iPLEDGE requirements on pharmacies, such as streamlining the iPLEDGE verification process, may encourage pharmacies with limited resources to enroll in the program and expand access. Supplementary Material are available on Mendeley at https://doi.org/10.17632/wybgpbcbzd.3. None disclosed.

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