Enterprise Wide Pharmaceutical Security
For productivity, efficiency, patient safety and staff security, safe pharmaceutical storage is the first priority. And security matters for compliance with DEA regulation too. Pharmacy safety violations are frequently in the headlines.
The largest settlement in DEA history took place in June 2013. Walgreens, the nation’s largest drug store chain, agreed to pay $80 million in civil penalties due to Controlled Substances Act violations with six retail pharmacies and a distribution center in Florida. The pharmacies and distributor committed "an unprecedented number" of record-keeping and dispensing violations, a U.S. attorney said. Most violations were connected to oxycodone and other prescription painkillers.
Security compliance is more important for pharmacies than ever before. Not only is compliance critical for good patient care, it’s also important for avoiding costly violations.
The new Safe Prescribing Act of 2013 will have an immediate impact on drug storage, requiring all pharmacies to use a DEA-approved safe for hydrocodone-based painkillers. Under this act, hydrocodone will become a Schedule II substance, requiring your pharmacy to store these substances in a security-rated safe such as a B-Rated safe, locker or cabinet.
To get compliant with the new legislation, your pharmacy staff should review current hydrocodone storage methods. These new regulations require DEA-approved safes for these painkillers. We your pharmacy’s trusted source for safes that meet the Schedule I – V requirements for drugs and narcotics. DEA-approved safes are critical for security and safety. Pharmacies must store controlled substances classified as Schedule I or II in a Class 5 Narcotics safe or UL Burglary rated equivalent such as a TL-15 or TL-30 security safe.
Federal regulations don’t specifically define the construction requirements for security cabinets. But the intent of the law is that controlled substances must be adequately safeguarded. Some factors considered when the DEA evaluates a pharmacy’s controlled substance security include:
- how many employees, customers or patients have access to the substances
- the location
- use of an effective alarm system
- quantity of controlled substances kept on hand
- prior history of theft or loss
The DEA will use these and other indicators to evaluate secure storage. Bottom line: controlled substances must be stored in a securely locked cabinet of substantial construction.
Plus, the area where the substance is stored should only be accessible to a minimum of authorized employees. Should a non-authorized person pass through the area, like maintenance staff or a business guest, adequate written observation of the area must be made by an authorized employee.
To minimize the threat of theft, loss or diversion, practitioners need to provide not only physical security. It’s also important to implement procedures to keep unauthorized people out and provide an alarm system where necessary. These procedures include:
- not employing an individual who has had his or her application for registration with the DEA denied or revoked at any time
- notifying the nearest DEA Field Office upon discovery of loss or theft
- storing blank prescription forms, as well as DEA order forms, in secure locations to minimize risk of theft
The potential threat of robbery, burglary and internal theft is a true concern for many pharmacies. To combat this threat, many have safety precautions in place, like surveillance and alarm systems. A security safe adds another level of protection. By securing your pharmacy’s medications, the risk of criminal activity – and the risk of costly violations -- is greatly decreased.
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