The Cutaneous Procedures Adverse Events Reporting (CAPER) Registry is a patient safety database that collects data on adverse events associated with procedures performed by dermatologists, non-dermatologist physicians, and non-physicians. Included procedures are skin cancer surgery, laser, and cosmetic procedures. A steering committee composed of board-certified dermatologists, clinicians, and researchers from the American Society for Dermatologic Surgery Association (ASDSA) and the Northwestern Department of Dermatology developed the CAPER Adverse Event Report Form by adapting existing similar data entry forms used in other medical registries. A total of 54 cases and 83 adverse events (AEs) associated with 18 types of cutaneous procedures were reported from March 2021 to November 2022. The AEs associated with non-physician-conducted procedures included large, circular, hypopigmented scars; second degree burns; permanent discoloration; and bullae developing into ulcers. The adverse events associated with non-dermatologist physician-conducted procedures included erosion and ulcers, and excessive swelling and bluish discoloration of the tear trough. Non-physician-conducted and non-dermatologist physician-conducted procedures were associated with a higher proportion of severe AEs (31.3%) compared to dermatologist-conducted procedures (11.8%).

To the Editor: The Cutaneous Procedures Adverse Events Reporting (CAPER) Registry is the only voluntary national reporting registry specifically for adverse events (AEs) associated with dermatologic procedures. 1 Kang B.Y. Ibrahim S.A. Poon E. Hellquist K. Avram M.M. Alam M. The Cutaneous Procedures Adverse Events Reporting (CAPER) registry. Arch Dermatol Res. 2022; 314: 987-989https://doi.org/10.1007/s00403-021-02265-4 Crossref PubMed Scopus (2) Google Scholar Prior to CAPER's inception, relevant AEs were typically reported through the US Food and Drug Administration Adverse Event Reporting System. 2 Alatawi Y.M. Hansen R.A. Empirical estimation of under-reporting in the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS). Expert Opin Drug Saf. 2017; 16: 761-767https://doi.org/10.1080/14740338.2017.1323867 Crossref PubMed Scopus (87) Google Scholar However, events may have been under-reported due to concerns about involving a governmental entity. 3 Barach P. Small S.D. Reporting and preventing medical mishaps: lessons from non-medical near miss reporting systems. BMJ. 2000; 320: 759-763https://doi.org/10.1136/bmj.320.7237.759 Crossref PubMed Scopus (829) Google Scholar

Background After Congress passed the Drug Quality and Security Act (DQSA) in 2013, new rules led to increased oversight of compounding pharmacies and also draft guidance relating to compounding in physicians’ offices. Objective To gather information from state medical board directors about the nature and frequency of reported adverse events associated with compounding in physicians’ offices, and board policies regarding the regulation of such compounding. Design Cross-sectional survey study. Participants were surveyed regarding: (1) the number of compounding-associated adverse events in physician offices; and (2) the extent to which their board implements United States Pharmacopeia (USP) standards on physician office compounding. Setting Remote data collection at an academic medical center. Participants Executive directors or comparable executives of state medical and osteopathic boards. Measurements Adverse event reports associated with medications compounded in physician offices. State board rules consistent with USP compounding standards for physician offices. Results Seventy percent of state boards (47/67) responded, with 42 complete responses analyzed. The majority (71%) of boards able to provide information on compounding errors had received no reports of these. None of the reported errors were known to have resulted in patient harm. Ninety percent of respondents had not incorporated any USP compounding standards into their regulations. Conclusion These findings suggest that the incidence of adverse events associated with in-office compounding is low, and that this may be limiting the propensity of state medical and osteopathic boards to implement strict regulations, such as USP compounding standards, that would further restrict such compounding. Therefore, regulatory agencies and legislators would better serve their mission by reallocating resources to ensure the integrity of other aspects of the drug supply chain.

The CAPER Registry is a voluntary, national safety reporting program that gathers patients' adverse events encountered during dermatologic procedures. This registry is intended as an aid for practitioners, patients, industry, and government regulators, and aims to facilitate safety monitoring for the specialty by identifying resource, process, education, and other systemic gaps associated with adverse events, as well as any potential risk factors for adverse events. CAPER will provide new or corroborating information to help dermatologists improve clinical practices, improve safety and effectiveness, and treat and prevent adverse events. The data generated will also help industry partners and regulatory bodies prevent adverse events from going unnoticed.

BACKGROUND:Medications may be specially prepared, or "compounded," to meet the needs of patients who cannot use standard formulation. The United States Pharmacopeia (USP) Convention is a private, nongovernmental organization which independently develops guidelines for pharmaceuticals. The purpose of this survey study is to better understand the extent to which state boards of pharmacy currently incorporate relevant USP guidelines into their compounding regulations. METHODS AND FINDINGS:Executive directors or other administrative representatives of each state board of pharmacy were invited to respond to six open-ended questions. Their free text responses were analyzed by two reviewers (KR, SI) using qualitative research techniques. The response rate was 71% (36/51). Almost all (35/36, 97%) indicated that they implement USP compounding standards at least in part. Eighteen boards (18/28, 64%) reported that 'some, but not all standards' are enforced, most commonly < 795 > and < 797 > , but not < 800 > (9/28, 32%). Ten (10/28, 36%) indicated that 'all' USP compounding standards are enforced. Eighteen (18/21, 86%) only implement finalized USP standards, whereas three consider newly proposed chapters (3/21, 14%). Over half (22/36, 61%) employ a committee or similar process to select standards. CONCLUSIONS:Almost all responding state boards of pharmacy incorporate finalized USP compounding standards into their regulations, usually via a formal rulemaking process, with boards commonly implementing some standards but not all. Chapters < 795 > and < 797 > are implemented more commonly than < 800 > . Since Congress passed the Drug Quality and Security Act (DQSA), pharmacy boards are becoming increasingly observant of USP compounding standards.