Pharmacy Innovation Series: the DEA Steps into Telepharmacy Regulation
(The DEA is accepting comments and responses to specific questions listed in the ANPRM through January 18, 2022, so if you want our help shaping the future of telepharmacy, please click the “get started” link at the bottom of this post.)
For the first time, the Drug Enforcement Agency (“DEA”) is becoming directly involved in the telepharmacy space, an industry that the DEA has not previously regulated aside from the loose application of its existing regulations governing online pharmacies. In the Regulation of Telepharmacy Practice Advanced Notice of Proposed Rulemaking (“ANPRM”) published on November 17, 2021, the DEA requested additional insight from stakeholders regarding how telepharmacies are currently operating, especially in relation to dispensing controlled substances. DEA clarified that although “telepharmacy” is not explicitly defined by the Controlled Substances Act (“CSA”), telepharmacies are subject to the CSA and DEA if they are dispensing controlled substances. This may mean increased restrictions for telepharmacy vendors and servicers who do process and dispense controlled substances; however, it may also help push other agencies to establish clear guidance at the federal level to assist telepharmacies in navigating this gray area.
What is Telepharmacy? How is it different from Online Pharmacy?
Telepharmacy is the practice of providing pharmacist services through telecommunications and information technologies to patients at a distant site. Examples of services that pharmacists may provide via telepharmacy include dispensing and distributing prescription medications, prescription verification, medication review, patient counseling, medication management, and drug therapy monitoring.
It is important to distinguish “telepharmacy” from “online pharmacies”, which, from DEA’s perspective, include individuals, entities, or internet sites that knowingly deliver, distribute, or dispense a controlled substance through the internet; for example, websites selling prescription drugs, such as Pill Pack. The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the "Ryan Haight Act") is the primary law governing online prescribing in the United States and requires online pharmacies to either: (1) obtain a modified DEA pharmacy registration that expressly authorizes such online activity; or (2) meet one of the ten exceptions to an online pharmacy.
Three of these exceptions exempt pharmacies whose dispensing of controlled substances by means of the internet consists solely of: (1) filling or refilling prescriptions for controlled substances in schedules III-V; (2) filling prescriptions that were electronically prescribed; or (3) transmitting prescription information between a pharmacy and an automated dispensing system located in a long-term care facility. It is likely that telepharmacies would fit within one of these exceptions; however, because DEA is taking a look at telepharmacy in general, it is important to be aware of how DEA is thinking about the relationship between telepharmacies and online pharmacies.
Why is DEA considering Telepharmacy regulation?
Telepharmacy started in North Dakota in the early 2000s and continues to expand to meet pharmacy access needs, especially in rural and underserved communities. DEA acknowledges the importance of telepharmacy in resolving the issue of “pharmacy deserts,” where locations with a licensed pharmacist are few and far between, but suggests that the absence of an on-site pharmacist might pose a heightened risk of diversion. The recently published ANPRM indicates that DEA is considering promulgating regulations for a special or modified telepharmacy registration to address these concerns.
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How is Telepharmacy currently regulated?
Telepharmacy is regulated at the state level, often enforced by state boards of pharmacy. It is only an accepted practice in about twenty-five states, and among those states that permit telepharmacy, the scope of permissible services varies. Although there are several varying telepharmacy business models that pharmacists can pursue, telepharmacy generally falls into two categories in states that do recognize the practice of telepharmacy: (1) brick and mortar remote sites; and (2) self-service, automated machines.
Brick and Mortar Remote Sites: traditional pharmacy businesses, physically staffed by non-pharmacist employees such as pharmacy technicians, that utilize a pharmacist located in a separate “parent” or “hub” pharmacy to remotely supervise the technician via continuous, real-time telecommunication modalities (audio and video). Subject to state law, a pharmacy technician may assist the remote pharmacist by receiving and inputting prescriptions into the pharmacy's information management system and preparing prescriptions for dispensing.
Self-service, Automated Machines: kiosks that contain prescription medications/pharmacy inventory, labeling equipment, and the appropriate telecommunication technology to connect the patient-user to the remote pharmacist via real-time audio and video links. These automated machines can accept and process prescriptions or refill orders, store prepackaged or repackaged medications, label and dispense patient-specific prescriptions, and dispense the prescription to the patient-user.
Public Comment on the DEA’s Regulation of Telepharmacy Practice ANPRM
The lack of clarity and understanding of telepharmacy at the federal level is hindering the provision of telepharmacy services. The ANPRM presents an optimal opportunity for entities providing such services to offer guidance based on their “on the ground” experience, thereby helping to shape the future of telepharmacy. The DEA is accepting comments and responses to specific questions listed in the ANPRM through January 18, 2022, and asks to hear specifically from telepharmacy vendors and servicers to gain a more comprehensive understanding of telepharmacy and how it is being implemented. Because state laws regarding telepharmacy remain inconsistent, DEA is also requesting information from state regulatory authorities regarding requirements for telepharmacy licensing and regulations.
Don’t have the resources, expertise, or time to submit stakeholder feedback to the DEA before the deadline of January 18, 2022?
We routinely help clients advocate on behalf of themselves and their industries with regulatory agencies. If you’d like help preparing and submitting comments around the telepharmacy proposals described above, please click this link to get started. We do everything from helping you understand the impact of each regulation to your business to drafting comments to submitting to the DEA on your behalf in a fixed-fee service.
Whether you take advantage of our fixed-fee service or not, we hope you’ll advocate for your company, your patients, and the industry during the public comments period.
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