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Sterile Compounding: Clinical, Legal, and Regulatory Implications for Patient Safety
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 tradit...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Academy of Managed Care Pharmacy
2014
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10441022/ https://www.ncbi.nlm.nih.gov/pubmed/25443512 http://dx.doi.org/10.18553/jmcp.2014.20.12.1183 |
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author | Qureshi, Nabeel Wesolowicz, Laurie Stievater, Trish Lin, Alexandra Tungol |
author_facet | Qureshi, Nabeel Wesolowicz, Laurie Stievater, Trish Lin, Alexandra Tungol |
author_sort | Qureshi, Nabeel |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-10441022 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2014 |
publisher | Academy of Managed Care Pharmacy |
record_format | MEDLINE/PubMed |
spelling | pubmed-104410222023-08-21 Sterile Compounding: Clinical, Legal, and Regulatory Implications for Patient Safety Qureshi, Nabeel Wesolowicz, Laurie Stievater, Trish Lin, Alexandra Tungol J Manag Care Pharm Review 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. Academy of Managed Care Pharmacy 2014-12 /pmc/articles/PMC10441022/ /pubmed/25443512 http://dx.doi.org/10.18553/jmcp.2014.20.12.1183 Text en Copyright © 2014, Academy of Managed Care Pharmacy. All rights reserved. https://creativecommons.org/licenses/by/4.0/This article is licensed under a Creative Commons Attribution 4.0 International License, which permits unrestricted use and redistribution provided that the original author and source are credited. |
spellingShingle | Review Qureshi, Nabeel Wesolowicz, Laurie Stievater, Trish Lin, Alexandra Tungol Sterile Compounding: Clinical, Legal, and Regulatory Implications for Patient Safety |
title | Sterile Compounding: Clinical, Legal, and Regulatory Implications for Patient Safety |
title_full | Sterile Compounding: Clinical, Legal, and Regulatory Implications for Patient Safety |
title_fullStr | Sterile Compounding: Clinical, Legal, and Regulatory Implications for Patient Safety |
title_full_unstemmed | Sterile Compounding: Clinical, Legal, and Regulatory Implications for Patient Safety |
title_short | Sterile Compounding: Clinical, Legal, and Regulatory Implications for Patient Safety |
title_sort | sterile compounding: clinical, legal, and regulatory implications for patient safety |
topic | Review |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10441022/ https://www.ncbi.nlm.nih.gov/pubmed/25443512 http://dx.doi.org/10.18553/jmcp.2014.20.12.1183 |
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