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DEA Relaxes Requirements for Use of Automated Dispensing Systems in Long-Term Care Facilities — Is Illinois Next?

Both federal and Illinois state law expressly allow the use of automated medication dispensing systems in skilled nursing and other long-term care facilities. The registration requirements under federal law are generally easy to meet, but with registration comes a host of recordkeeping obligations that could be onerous for pharmacies that wish to use these systems. In Illinois, restrictions on drug replenishment pose an additional practical barrier to placing automated dispensing systems in long-term care facilities. 

However, recent guidance from the U.S. Drug Enforcement Administration (DEA) removes the registration requirement when automated dispensing systems are used solely as emergency drug kits — and it appears that the Illinois Department of Financial and Professional Regulation (IDFPR) is poised to recommend that the state follow suit. During his presentation, “Making Sense of Sensible Regulation,” at October 26, 2017, “Regulation & Risk in Today’s Health Care Environment” seminar, IDFPR Secretary Bryan Schneider indicated that the department supports a change to the replenishment rule.

Background: Automated Dispensing Systems in Illinois Facilities

An automated dispensing system is conceptually similar to a vending machine: a pharmacy stores bulk drugs in the machine in separate bins or containers, and programs and controls the system remotely. A facility nurse then removes medication from the machines for administration to patients. 

Such systems help to prevent accumulation of unused medications at long-term care facilities, by allowing the pharmacist to dispense small amounts of prescribed drugs (e.g., daily doses) rather than the entire amount indicated on the prescription at one time. They also allow for immediate dispensing of drugs, including controlled substances, in emergency situations, without having to wait for an offsite pharmacy to deliver medications. In fact, many pharmacies and facilities have chosen to use automated dispensing systems only for emergency dispensing. 

For nearly four decades, the DEA has allowed pharmacies to place emergency drug kits in long-term care facilities, which it defines as a nursing home, retirement care, mental care, or other facility or institution that provides extended health care to resident patients. The DEA does not require pharmacies to obtain a controlled substance registration for emergency drug kits or to otherwise notify it of the placement of a kit. 

Since 2005, the DEA has also allowed pharmacies to install automated dispensing systems at long-term care facilities. Unlike with emergency kits, however, the DEA requires the pharmacy to separately register each dispensing machine. Because each machine holds a separate registration, the pharmacy must therefore maintain a separate set of records for drugs placed in and dispensed from the machine and keep separate biennial inventories. Although these documents can be stored at the pharmacy, they cannot be commingled with the pharmacy’s other records. 

These two sets of rules gave rise to an important question: when a pharmacy uses an automated dispensing system solely for dispensing of emergency drugs, does the DEA’s emergency drug kit rule apply, or does its automated dispensing system rule control? Until recently, the answer was unclear, though reasonable arguments could be made to support the application of each rule. 

DEA Issues New Guidance 

In a November 30, 2016, letter to the American Society of Consultant Pharmacists, the DEA provided the clarity that pharmacies have long sought and pronounced that the emergency drug kit rule controls. The DEA explained:

“All emergency kits — whether or not they are electronic — remain subject to the 1980 policy statement (and thus need not be separately registered), provided they satisfy the criteria of the 1980 policy statement at all times. Among other things, it is crucial to bear in mind that an emergency kit is an emergency kit if it is used exclusively for emergencies… If, at any time, a kit is used to administer or dispense controlled substances for a purpose other than an emergency, the kit thereafter ceases to be an emergency kit and, as a result, the separate registration requirement applies.”

The guidance was clear: pharmacies that use automated dispensing systems exclusively for emergency dispensing need not register the machines with the DEA. 

In Illinois, however, a barrier to the widespread use of automated dispensing systems as emergency drug kits still remains. State regulations provide that when an automated dispensing system is used as an emergency drug kit, the use must be in compliance with the automated dispensing system regulation. That regulation, in turn, requires that the stocking and restocking of the system be accomplished by a registrant under the Pharmacy Practice Act — that is, a pharmacist, pharmacy intern or pharmacy technician. 

Generally, automated dispensing systems use removable cartridges or containers to hold drugs. Licensed pharmacy personnel prepackage drugs in secure, tamper-evident cartridges or containers at the pharmacy. Upon arrival at the facility, the cartridge or container is placed directly in the automated dispensing system; no drugs are — or can be — removed from the cartridge or container. 

In many states, this process meets the requirement that replenishment be accomplished by duly licensed pharmacy personnel; in such states, a pharmacy delivery driver or a facility nurse can place the cartridge in the machine. However, IDFPR takes the position that the individual who places drugs in the automated dispensing system must be licensed under the Pharmacy Practice Act, regardless of how drugs were packaged and secured at the pharmacy. As a result, pharmacies must either use licensed technicians as delivery personnel or ensure that their long-term care facility customers have a licensed technician on staff.

In his October 26 presentation, Bryan Schneider acknowledged that there is no logical reason for restricting automated dispensing system replenishment to licensed pharmacy personnel. Director Schneider noted that long-term facility personnel routinely handle drugs; after all, they are the ones who administer medication to patients, and they are licensed as registered and/or practical nurses. In his view, their licenses should be sufficient to qualify them to replenish automated dispensing systems. 

Director Schneider expects that IDFPR will ask the Joint Committee on Administrative Rules (JCAR) to amend the current rule to expand the categories of licensed personnel who may lawfully place drugs in an automated dispensing system at a long-term care facility.

© 2017 Much Shelist, P.C.

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About this Author

Harold Hilborn, Much Shelist, pharmacies attorney, regulatory dispute lawyer, anti-kickback statute, prescription-drug marketing legal counsel
Principal

Harold Hilborn draws on his extensive trial and appellate practice to help pharmacies, pharmacists and other healthcare providers resolve their most pressing business and regulatory disputes. Harold provides effective compliance and litigation counsel in the full range of industry issues, including disciplinary and licensing matters, self-referral, the Stark Law and the Anti-Kickback Statute, prescription-drug marketing laws, and contract disputes.  

Over the course of his career, Harold has argued cases in state and federal district and appeals...

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