by Erica D. Lindsay, PharmD, MBA, Esq.
From Compliance Today, a publication for HCCA members.
Recently, pharmacies have been directly impacted by drug shortages across the country. When a drug shortage occurs, facilities are able to purchase the drug through an alternative supplier, (i.e., compound pharmacy) or produce the doses internally. In either case, a higher risk of intravenous (IV) contamination occurs if sterile procedures are not followed on a consistent basis. A recent headline, “Pharmacy owners arrested after meningitis outbreak kills 64,”[1] highlights a situation where purchasing a drug from a compound pharmacy goes wrong due to poor IV compounding procedures. The owners of the New England Compounding Center (NECC) were registered through the state as a compound pharmacy authorized to create customized prescription(s) for a specific patient. In October 2012, an investigation was conducted and NECC was cited for compounding batches of pharmaceuticals and shipping them to facilities, classifying NECC as a drug manufacturer, not a compound pharmacy. During the investigation of NECC, unsanitary conditions were discovered, including fungi growth in steroid solutions.[2]
Contaminated doses of Methylprednisolone Acetate (MPA) were distributed by NECC to patients from May 21 through September 24, 2012. Approximately 750 patients were infected with fungal meningitis and 64 died within 20 states.[3] Glenn Adam Chin, NECC’s pharmacy supervisor, was accused of using improper sterilization and testing techniques, falsifying cleaning logs, and instructing staff to frequently mislabel vials. As a result of the criminal investigation, 14 people were recently arrested, including Chin and the two co-founders Gregory Conigliaro, Barry Cadden..[4]
As a result of this case, a wide range of criminal charges resulted, including mail fraud, racketeering, conspiracy, contempt, structuring violations of the Food, Drug and Cosmetic Act, and second degree murder.[5] In addition to these charges, other civil charges could arise, including breaching the medical standards of care, battery, and violation of state regulations, resulting in fines and penalties.
This case illustrates how IV contamination can bring irreversible harm and death to patients. To prevent and control fungal, bacterial, and viral outbreaks, the United States Pharmacopeial (USP) Convention was formed. The USP is a non-profit scientific organization founded in 1820 designed to develop quality standards for medicine.[6] The USP’s role in federal law is to create and maintain adulteration and misbranding regulations for pharmacy practice. USP <797> was established to reduce and control healthcare-associated infections (HAIs) by creating and maintaining sterility in pharmacy compounding processes. HAIs are defined as infections acquired during the patients’ course of treatment for non-related conditions. Prior to the implementation of USP <797>, there were no consistent guidelines for healthcare facilities to follow in compounding patients’ prescriptions. After the implementation of USP <797>, the Centers for Disease Control and Prevention (CDC) reported a 44% reduction in central-line associated bloodstream infections, a 20% reduction in infections related to 10 surgical procedures tracked from 2008-2012, and a 4% reduction in hospital onset MRSA bloodstream infections from 2011-2012.[7] By following USP <797> regulations, healthcare facilities can ensure patient safety through enforcing proper IV compounding and administration techniques, which can save lives.
Erica D. Lindsay (Erica.lindsay1@gmail.com) is Pharmacy Compliance Officer for RX Compliance Solutions in Chicago, Illinois.
[bctt tweet=”Compounding: How non #compliance can lead to second-degree murder @theHCCA”]
[1] Associated Press: “Pharmacy owners arrested after meningitis outbreak kills 64.” December 17, 2014. Available at http://bit.ly/1wCQl3U
[2] Denise Grady, Andrew Pollack and Sabrina Tavernise: “Scant Drug Oversight in Meningitis Outbreak.” New York Times. October 6, 2012. Available at http://nyti.ms/13ABF9X
[3] CDC: Multistate outbreak of fungal meninigitis and other infections. Available at http://1.usa.gov/1va5S5T
[5] John Bacon: “Meningitis outbreak that killed 64 draws murder charges.” USA Today, December 17, 2014. Available at http://usat.ly/1CBK60P
[6] U.S. Pharmocopeial Convention: USP and its standards. Available at http://bit.ly/1HvrY9C
[7] CDC: Healthcare-associated Infections (HAI) Progress Report. March 26, 2014. Available at http://1.usa.gov/1B1SKnU