Pharmaceutical Compounding: a History, Regulatory Overview, and Systematic Review of Compounding Errors
- PDF / 724,214 Bytes
- 21 Pages / 595.276 x 790.866 pts Page_size
- 97 Downloads / 171 Views
REVIEW
Pharmaceutical Compounding: a History, Regulatory Overview, and Systematic Review of Compounding Errors C. James Watson 1,2
&
James D. Whitledge 2 & Alicia M. Siani 3 & Michele M. Burns 1,4
Received: 30 June 2020 / Revised: 13 September 2020 / Accepted: 17 September 2020 # American College of Medical Toxicology 2020
Abstract Introduction Medications are compounded when a formulation of a medication is needed but not commercially available. Regulatory oversight of compounding is piecemeal and compounding errors have resulted in patient harm. We review compounding in the United States (US), including a history of compounding, a critique of current regulatory oversight, and a systematic review of compounding errors recorded in the literature. Methods We gathered reports of compounding errors occurring in the US from 1990 to 2020 from PubMed, Embase, several relevant conference abstracts, and the US Food and Drug Administration “Drug Alerts and Statements” repository. We categorized reports into errors of “contamination,” suprapotency,” and “subpotency.” Errors were also subdivided by whether they resulted in morbidity and mortality. We reported demographic, medication, and outcome data where available. Results We screened 2155 reports and identified 63 errors. Twenty-one of 63 were errors of concentration, harming 36 patients. Twenty-seven of 63 were contamination errors, harming 1119 patients. Fifteen errors did not result in any identified harm. Discussion Compounding errors are attributed to contamination or concentration. Concentration errors predominantly result from compounding a prescription for a single patient, and disproportionately affect children. Contamination errors largely occur during bulk distribution of compounded medications for parenteral use, and affect more patients. The burden falls on the government, pharmacy industry, and medical providers to reduce the risk of patient harm caused by compounding errors. Conclusion In the US, drug compounding is important in ensuring access to vital medications, but has the potential to cause patient harm without adequate safeguards. Keywords Compounding . Pharmacy . Error . Contamination . Toxicology . Regulation
Introduction
Prior Presentations: None Supervising Editor: Michael Hodgman, MD * C. James Watson [email protected] 1
Harvard Medical Toxicology Program, Boston Children’s Hospital, 333 Longwood Avenue, Mailstop 3025, Boston, MA 02215, USA
2
Department of Emergency Medicine, Beth Israel Deaconess Medical Center, Boston, MA, USA
3
School of Law, Boston University, MA Boston, USA
4
Division of Emergency Medicine, Boston Children’s Hospital, Boston, MA, USA
In the modern-day United States (US), medications are by-inlarge manufactured in commercial facilities, and this production is regulated and overseen by the US Food and Drug Administration (FDA). Historically, however, medications were mixed—or compounded—by independent pharmacists for use by individual patients. While traditional compounding is becoming less prevalent, i
Data Loading...
