As custodians of controlled substances and hazardous substances, hospital and independent pharmacists bear a great deal of responsibility and accountability. As part of this trust they must keep their drug inventory secure from theft and abuse. In the U.S., the DEA enforces the regulation, maintenance and physical security of controlled substances. This chain of custody—and the pharmacist’s many links in it—are outlined in the DEA’s Controlled Substance Act (CSA). However, it can take considerable time out of a pharmacist’s already-busy schedule to cross-reference each guideline as well as their state board of pharmacy’s regulations. With that in mind, this article briefly details the CSA, a few state-specific drug policies, and rising national trends.
Top Drivers of Federal and Statewide Drug Compliance
The DEA’s Controlled Substance Act outlines the healthcare provider’s many responsibilities in the chain of custody from ordering through dispensing to disposal. To begin with, in order to legally dispense a prescription for a controlled substance, your facility must first label the package with compliance data including fill date, serial number, patient name and prescribing practitioner. The CSA also has extensive provisions to follow for record-keeping and inventorying all stored controlled substances and hazardous materials. CSA mandates that ‘complete and accurate’ records always be maintained (for a two-year minimum) for all controlled substances in your custody. These records must include an initial inventory, a biennial inventory, and a newly-scheduled controlled substance inventory.
Naturally, security is foremost among pharmacists’ responsibilities as custodians of the protected medications trusted to their care. The CSA recognizes this duty by requiring providers to guarantee adequate physical security of all controlled substances in their facility. CSA provisions also extend to all transfer and disposal of controlled substances and hazardous materials. Each transfer requires a new record be made, as does each disposal. However, healthcare providers are permitted to hire a third-party vendor registered with the DEA to perform inventories, disposal and other duties.
Be aware that some states require pharmacists and other providers to follow additional regulations beyond the CSA. A few of the states which define many of our nation-wide drug policies include:
- California: The California Medical Association’s bill, AB 149, which came into law January 1st of this year, will mandate that “prescription forms for controlled substances include a uniquely serialized number.” Providers are given until January 1st, 2021 to enact this requirement, intended to curb the loss of controlled substances and quickly spot losses. Providers must also provide quarterly reconciliation reports of their Schedule II medications.
- Texas: September 1 of 2018 saw the introduction of a new version of the state’s ‘Official Prescription Form,’ which contains additional security features. Providers are given the June 1, 2019 date until all previous versions of the form are invalid.
- New York: New York allows controlled substances to be prescribed and dispensed. Practitioners can electronically prescribe Schedules II through V drugs and can also accept these prescriptions. However, providers must use proprietary American Society for Automation in Pharmacy (ASAP) software. New York also limits opioid prescriptions for acute pain to a 7-day supply.
You can find your state board of pharmacy at the National Association of Boards of Pharmacy website.
With the rise of the opioid epidemic, there are trends emerging in how pharmacies, and the entities that govern them, are handling controlled substances.
- Increasingly, pharmacists are participating in interstate practice models. This collaboration could help bridge the gap between regulatory drug law and its practice.
- The online sale of counterfeit medications is rapidly worsening the opioid epidemic in the United States. State board of pharmacy task forces are more aggressively reviewing existing state and federal laws and regulations regarding suspicious orders of controlled substances placed by pharmacies to wholesale distributors.
- State pharmacy boards are also reviewing the practices of “white-bagging” and “brown-bagging” methods of medication delivery as targets of additional regulations. White-bagging deliveries are left with the provider, while brown bagging deliveries are made directly to the patient’s address. This review is prompted due to uncertainties about whether specialty medications were always handled and stored safely.
Every link of the chain of custody has its own array of responsibilities, but your pharmacy can help to ensure compliance by understanding and enacting the main drivers in each area of the CSA. With best practices at top of mind, your facility can be a responsible steward of the drugs and hazardous substances in its custody.
For more information visit the DEA’s website.
Founded in 1996, Pharma Logistics is the trusted, proven industry leader in reverse pharmaceutical distribution services, including rapid credit, box and ship, onsite and drug take back programs. Pharma Logistics clients include hospital pharmacies, the DOD and VA Health System, independent pharmacies, pharmacy chains and physicians’ offices.