State medical board regulation of compounding in physician offices.

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Drug Quality and Security Act (DQSA) in 2013, new rules led to increased oversight of compounding pharmacies and also draft guidance relating to compounding in physicians' offices.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.

Increased regulation of medication compounding by state boards of pharmacy.

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.

The Cutaneous Procedures Adverse Events Reporting (CAPER) Registry.

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.

What nurse case managers need to know about the Nurse Licensure Compact.

In the late 1990s, the National Council of State Boards of Nursing (NCSBN) began exploring several nurse-licensing models that would simplify government processes and remove regulatory barriers, while increasing access to safe nursing care. The NCSBN decided on the mutual-recognition model (similar to that used for state driver's licenses), which allows a nurse to practice in states other than the one in which the license was issued, usually the state of residency, as long as that individual acknowledges that he or she is subject to each state's practice laws and discipline. Like the driver's license model, nursing practice across state lines is allowed, whether physical or electronic, unless the nurse is under discipline or a monitoring agreement that restricts practice across state lines.