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Sterile compounding: clinical, legal, and regulatory implications for patient safety
Nabeel Qureshi1, Laurie Wesolowicz, Trish Stievater
1Blue Cross Blue Shield of Michigan, 600 E. Lafayette Blvd., Mail Code 512C, Detroit, MI 48226-2998. nqureshi@bcbsm.com.
Background:
Poor compounding practices by the New England Compounding Center resulted in the 2012-2013 fungal infections outbreak. Contaminated injectable methylprednisolone led to the diagnosis of fungal infections in 751 patients and 64 deaths. In the United States, pharmacy compounding has traditionally been regulated by state boards of pharmacy rather than the FDA. To minimize safety risks related to pharmacy compounding, the Drug Quality and Security Act (DQSA) was signed into law November 27, 2013, to improve regulation of compounding pharmacies.
Objectives:
To (a) review the literature regarding clinical, legal, and regulatory implications of pharmacy compounding for patient safety during the 2012-2013 fungal infections outbreak and (b) discuss strategies that managed care organizations (MCOs) can use to promote safe compounding practices.
Methods:
A literature search was conducted via PubMed for original articles on fungal infections related to drug compounding published October 2012 to March 2014. Specific search terms included "drug compounding and fungal infection" and "fungal meningitis outbreak." The FDA website was also utilized for material related to the Food, Drug, and Cosmetic Act and the DQSA.
Results:
Four articles met inclusion criteria. The 2012-2013 fungal infections outbreak was attributed to 3 lots of preservative-free methylprednisolone acetate, which comprised 17,675 vials distributed to 76 facilities across 23 states. Median incubation period (from time of last injection to initial diagnosis) was 47 days, ranging from 0 to 249 days. According to the FDA, a total of 30 recalls regarding compounded products were issued by pharmacies during March through December 2013.
Conclusions:
Pharmacy compounding has the potential for significant safety risks. The purpose of the DQSA is to improve regulation of compounding pharmacies. Since registration as an outsourcing facility is voluntary, uncertainty still remains regarding advancement in safe compounding practices. MCOs can employ multiple strategies to ensure patient safety and promote appropriate drug therapy.
Insights
The 2012-2013 fungal meningitis outbreak highlighted significant risks in pharmacy compounding. New regulations aim to improve safety, but voluntary registration leaves patient safety concerns unresolved.
Area of Science:
- Pharmaceutical Sciences
- Public Health
- Regulatory Affairs
Background:
- The 2012-2013 fungal infections outbreak, linked to contaminated methylprednisolone acetate, caused 751 cases and 64 deaths in the US.
- Pharmacy compounding in the US was historically regulated by state boards, lacking consistent federal oversight.
- The Drug Quality and Security Act (DQSA) of 2013 was enacted to enhance the regulation of compounding pharmacies and mitigate safety risks.
Purpose of the Study:
- To review the clinical, legal, and regulatory implications of pharmacy compounding during the 2012-2013 outbreak.
- To discuss strategies for managed care organizations (MCOs) to promote safe compounding practices.
Main Methods:
- Literature search of PubMed using terms like "drug compounding and fungal infection" and "fungal meningitis outbreak" (October 2012-March 2014).
- Inclusion of four articles meeting specific criteria.
- Utilized FDA website for information on the Food, Drug, and Cosmetic Act and the DQSA.
Main Results:
- The outbreak involved 17,675 vials of preservative-free methylprednisolone acetate distributed across 23 states.
- Median incubation period for fungal infections was 47 days.
- The FDA reported 30 recalls of compounded products by pharmacies between March and December 2013.
Conclusions:
- Pharmacy compounding presents substantial patient safety risks.
- The DQSA aims to improve compounding pharmacy regulation, but voluntary outsourcing facility registration introduces ongoing uncertainty.
- MCOs can implement strategies to ensure patient safety and appropriate drug therapy through safe compounding practices.
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