Many health care systems own outpatient facilities in addition to hospitals and other inpatient settings. Managing diversion prevention and compliance with DEA regulations in hospital-owned outpatient clinics, physicians’ offices, and ambulatory care settings can be a challenging task for the hospital-based pharmacist. However, as the medication experts, the pharmacy department must take ownership of managing medications used in these environments.
It is important that pharmacy be cognizant of the more commonly encountered challenges in those settings. Please note that the regulatory concerns addressed herein are based on federal requirements; nonetheless, some states have additional requirements, making familiarity with local regulations equally important.
Best Practices for Controlled Substance Security
Controlled substance compliance begins with DEA registration. One method health systems commonly employ is to have clinics and other outpatient care settings dispense controlled substances under the main hospital’s DEA registration. Often, this practice has been established for many years and has never been questioned. However, according to the DEA:
The Controlled Substance Act (CSA) requires that a separate registration be obtained for each principal place of business or professional practice where controlled substances are manufactured, distributed, or dispensed. DEA has historically provided an exception that a practitioner who is registered at one location, but also practices at other locations, is not required to register separately for any other location at which controlled substances are only prescribed. If the practitioner maintains supplies of controlled substances, administers, or directly dispenses controlled substances at the separate location, the practitioner must obtain a separate DEA registration for that location.1 (emphasis added)
Besides violating regulations, having a single registration subsume several locations creates a problem with drug security. Controlled substances are received at the registered location, usually the hospital, and must then be transported to the outpatient sites where they will be dispensed and utilized. Any time controlled substances are transported, additional risks of diversion are created. The means of transportation often is not secure; pharmacy technicians or other staff may carry controlled substances in unsealed boxes, bags, or totes. This creates opportunities for diversion as well as tampering.
Nevertheless, outlying registrants, such as clinics, may be supplied with controlled drugs by the hospital pharmacy, subject to certain limits. According to the Five Percent Rule:
The total number of dosage units of all controlled substances distributed by a pharmacy may not exceed five percent of all controlled substances dispensed by the pharmacy during a calendar year. If at any time the controlled substances distributed exceed five percent, the pharmacy is required to register as a distributor.2
The transportation of controlled substances during the supply process creates additional risks. If a location obtains controlled substances from the main hospital pharmacy by use of DEA Form 222, the drugs must be transported in a secure box with a numbered lock to ensure a chain of custody.
In all settings, blank DEA 222 Forms must be stored as securely as a controlled substance. Serial numbers should be logged and, when the forms are used, the details of the order should be logged next to the serial number. In the clinic setting, there may be temptation to pre-sign the forms; this risky practice should be absolutely prohibited.
Separation of Duties
Due to staffing limitations, in clinic settings without automated drug storage there is often a single person, typically a nurse, who oversees drug ordering, receives the drugs, and stocks them. However, separation of ordering, receiving, and stocking duties is considered a best practice to prevent diversion during the procurement process. Having a separate person witness each stage of procurement or independently verify ordering and stocking records may be a solution if complete separation is not feasible.
Automated Drug Storage
Utilizing automated drug storage is ideal for promoting security and accountability, although it is not always an option in the outpatient setting. Nevertheless, the storage location must be secure, access must be limited to authorized personnel, and the quantity of the inventory must be verified at the beginning and end of each business day using a two-person process. Records of inventory, use, and disposal must be maintained, and usage should be reviewed by an independent entity on a regular basis. Controlled substances that require refrigeration must be kept in a separate lock box in the refrigerator.
Samples of controlled substances must be secured and accounted for in the office setting exactly as any other controlled substance. Prescribers must stay current as to which samples are scheduled drugs. For example, some providers are unaware that eluxadoline (Viberzi) and suvorexant (Belsomra) are Schedule IV drugs. If patients are to pick up samples of controlled substances outside of regular visits, the drugs must remain in locked drug storage until the moment of collection.
Prescription Pads and Printers
Prescription pads and prescription printer paper present a particular risk in offices and clinics. Blank pads and prescription printer paper should be kept in small quantities and stored securely. Printed and signed prescriptions should be delivered directly and immediately to the patient, rather than left to accumulate on counters and printers. Non-prescribers should not be allowed to complete any portion of the prescription. Ideally, the prescriber always hands the prescription to the patient.
Prescriptions Awaiting Pickup
On occasion, patients may need to pick up a prescription for a controlled substance outside of a normal office visit. Prescriptions awaiting pickup should be tracked in a log, kept in a locked location, and should be destroyed if not collected within 7 days. Some states require that uncollected prescriptions be returned to a state regulatory board.
As separate DEA registrants, clinics must comply with all DEA requirements, including conducting a complete biennial controlled substance inventory, which includes physical quantitation of Schedule II drugs. Records of the inventories and of disposition of scheduled drugs must be maintained onsite in a readily retrievable form for 2 years; records of Schedule II drugs must be kept separately from other schedules. Because the staff at offices and clinics does not typically include pharmacists, they may be unaware of the requirements for inventories and record maintenance. The requirements should be explicitly delineated in each facility’s policies and procedures.
Some clinics may only keep controlled substances on hand in small quantities for emergency administration, such as benzodiazepines for seizure management. In lieu of having staff physically count the drugs twice a day, the drugs may be stored in a lock box with an external serialized lock. Each day, staff must verify on the inventory record that the lock is intact and that the number on the lock is correct. The box should be opened and inventoried on a monthly basis to be certain the drugs are present and unexpired.
Controlled substance disposal can be challenging in the outpatient setting. Wasting of partial doses should be performed and recorded with a witness, whose name must be part of the disposal record. Although sharps containers often are used for disposal of controlled drugs, they do not meet the DEA standard of rendering the waste non-retrievable. To minimize the risk of diversion, the use of a specialized controlled substance waste receptacle is an excellent option. Sewering (flushing or disposal into a drain) is a commonly utilized method; however, the DEA has stated that it does not consider sewering alone to meet the standard of non-retrievability.3 Also, concerns about the environment may inspire staff reluctance to sewer medication. Certain substances used in the outpatient setting, notably testosterone, may require special handling due to a proposed rule making them hazardous substances in addition to scheduled drugs.
The ideal method of disposal for expired and unneeded stock is through a registered reverse distributor. If that is not a practical solution, then destruction on-site, using a two-person process (the same method as for partial doses), must be used. A separate log should be kept to record destroyed medication; DEA Form 41 provides a template for recording destruction of controlled medication.
Drugs that are inventoried continue to require tracking until they are destroyed or physically removed from the premises by the reverse distributor. A common practice is to eliminate the drug from the inventory once it is set aside for removal. However, drugs designated for disposal are still vulnerable to diversion and must be accounted for. Ideally, a separate inventory record should be maintained for expired medications and any other drugs awaiting destruction or removal, and drugs should remain on that inventory record until they are no longer physically present at the site.
Managing Unwanted Medications
Patients often wish to return unwanted medications, including controlled substances, to the prescribing office. However, staff in clinics and other outpatient practices must be aware that, per DEA regulations, they are not allowed to collect unwanted medications from end users. If such requests are encountered regularly, offices should keep on hand a list of registered take-back sites. As a courtesy to patients, practices also may provide commercially available products that patients can use to return or destroy their own controlled substances.
Just as in hospitals, staff that works in outpatient settings must be educated on diversion prevention and understand the process for reporting concerns, including concerns about medical providers in their offices. At a minimum, a formal, annual in-service covering the scope of the problem, what to look for, and how to report concerns is essential. Physicians and mid-level providers also must receive annual education on prescribing practices to minimize the risk of abetting abuse.
Although pharmacists may spend limited time in clinics and physicians’ offices, they are responsible for managing medications utilized in these settings. Proper management includes preventing diversion by ensuring controlled substances are stored securely and utilized in compliance with DEA regulations.
- Drug Enforcement Administration Final Rule. Clarification of Registration Requirements for Individual Practitioners. (DEA clarification of 21 U.S.C. 822(e)). Federal Register. 21 CFR Part 1301 [Docket No. DEA-244F] RIN 1117-AA89 (2006).
- Drug Enforcement Administration. Diversion Control Division. Pharmacist’s Manual (Section XIII: Other Controlled Substance Regulations). Controlled Substance Distribution by a Pharmacy – “Five Percent Rule”. DEA; Springfield, VA.
- Drug Enforcement Administration. Secure and Responsible Drug Disposal Act of 2010. Disposal of Controlled Substances Final Rule. Federal Register. 2014;79(174):53520-53570.
Kimberly New, JD, BSN, RN, is the founder of Diversion Specialists, LLC, a consulting service providing solutions for all aspects of institutional drug diversion. She is a specialist in controlled substance security and DEA regulatory compliance, working with health systems across the country to establish and expand drug diversion programs, with the overriding goal of improving patient safety. Kim is also the cofounder and executive director of the International Health Facility Diversion Association.
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