Hello, Teleph(armacy) Line: DEA Seeks Public Comment Concerning Telepharmacy Regulation

With a nod to the Electric Light Orchestra’s 1976 song, “Telephone Line,” the Drug Enforcement Administration (“DEA”) issued an Advanced Notice of Proposed Rulemaking (“ANPR”) regarding the practice of telepharmacy.¹ The Controlled Substances Act (CSA), enforced by the DEA, regulates telepharmacies if they dispense controlled substances.² However, the DEA is seeking comments from specific groups involved with telepharmacy, as well as the general public, to better understand the actual practice of telepharmacy. As telehealth and telepharmacies grow nationwide, the agency intends to promulgate requirements concerning the dispensing of controlled substances. The growth of telepharmacies has helped expand access to pharmacy care for rural and other underserved populations that otherwise may not have been able to employ full-time licensed pharmacists. However, the DEA is weighing this benefit against the heightened risks of an absent pharmacist (e.g., no licensed professional physically monitoring the dispensing of controlled substances). The deadline for submitting comments is January 18, 2022.

Highlights

This Bulletin will discuss the ANPR, the DEA’s questions for the pharmacy industry, and issues to consider. We will not list all of the questions the agency asked of other groups.

• The CSA does not specifically define “telepharmacy,” but it is generally considered to be the provision of pharmacist care by a remote pharmacist, through telecommunications and other technologies, to a patient located at a dispensing site.
  • This practice may include dispensing and distribution of prescription drugs, drug use review, patient counseling services, and drug therapy monitoring.

• Telepharmacy practice may differ from state to state regarding whether the telepharmacy may fill paper or electronic prescriptions.

• Telepharmacies tend to fall into two categories: brick-and-mortar pharmacies or self-service, automated machines.
  • Brick-and-mortar sites consist of traditional pharmacies physically staffed by non-pharmacist employees, such as pharmacy technicians, who are remotely supervised by licensed pharmacists located at a “parent” or “hub” pharmacy through some mode of telecommunication.
    • Under the licensed pharmacist’s remote supervision, the non-pharmacist staff member may receive and input prescriptions into the pharmacy’s information management system and prepare prescriptions for dispensing.
  • Self-service, automated machines are kiosks containing pharmacy prescription medication, labeling equipment, and telecommunication technology to connect the patient to the remote pharmacist through real-time video and audio links.
  • These kiosks may accept prescriptions or refill orders, store prepackaged or repackaged medications, label patient-specific prescriptions, and ultimately dispense the prescription to the patient using the machine.

• The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 requires registration of “Online Pharmacies” that utilize the internet to dispense controlled substances, unless they meet an exception.³
  • An online pharmacy is defined as any “person, entity, or internet site, whether in the United States or abroad, that knowingly or intentionally delivers, distributes, or dispenses, or offers or attempts to deliver, distribute, or dispense, a controlled substance by means of the internet.”⁴

• DEA regulation contains 10 exceptions from the definition of online pharmacy, eight of which overlap with the Ryan Haight Act.

• Three of the exceptions exempt pharmacies whose dispensing of controlled substances by means of the internet consists solely of:
  • filling or refilling prescriptions for controlled substances in Schedules III–V;
  • filling prescriptions that were electronically prescribed; and
  • transmitting prescription information between a pharmacy and an automated dispensing system located in a long-term care facility.
    • Telepharmacies that use the internet to facilitate the dispensing of controlled substances must either be issued a modified regulatory registration as an online pharmacy or fall within one of these exceptions.

• The exception above provides an exemption to the regulation’s definition of an online pharmacy where the “dispensing of controlled substances by means of the internet consists solely of filling prescriptions that were electronically prescribed in a manner authorized by [the regulation] and otherwise in compliance with the [CSA].”⁵  The DEA finds this to be the most applicable exception to telepharmacy.⁶
  • This exception does not exempt telepharmacies from DEA regulations regarding registration, prescriptions, security, recordkeeping, and reporting.

• The DEA is seeking input from state regulatory authorities, national and professional associations, industry, telepharmacy vendors and servicers, and the general public to gain a better understanding of telepharmacy and its current practical operation. It provided the following questions specifically for pharmacy input:
  • Are the remote sites or automated machines typically owned and operated by the owner of the parent or hub pharmacy? If they do not share owners, how is recordkeeping handled
  • How are locations selected for the remote sites or automated machines? If locations are based on the sociodemographic of a region or community, can the firm provide the data or information considered?
  • What additional training, if any, do telepharmacy pharmacists and telepharmacy support staff provide?
  • With the absence of the pharmacist at the remote site and automated machine, how does the pharmacist adequately supervise and oversee telepharmacy technicians and staff?
  • If controlled substances are dispensed at a telepharmacy practice, are they stored and accounted for separately from non-controlled substances?
  • If the practice has not implemented the use of electronic prescriptions, what is preventing the practice from full implementation?
  • For those that have not adopted telepharmacy, what are the reasons or barriers to adopting telepharmacy?
  • How does the pharmacist make the final verification of the filled prescription remotely?
  • Is your remote site or automated machine registered with the DEA? If so, under what business activity?
  • If the entity is a remote pharmacist at a telepharmacy, how many remote sites and automated machines can be adequately supervised during the same period of time?
  • Please provide any information that could be used to help the DEA quantify or discuss qualitatively the potential costs and benefits of a rule that would either promote or restrict the use of telepharmacy.

AGG Observations

• The ANPR does not provide much insight into exactly what changes the DEA has in mind. However, telepharmacies must pay attention to potential developments in the coming year. Some states already have regulations of telepharmacies in place, and the DEA acknowledges the utility of telepharmacies for underserved populations.

• The DEA does not ask for insight from the pharmaceutical or the life sciences industries, but members of any industry involved with controlled substances may also wish to provide comments. Telepharmacy has an innovative role in drug product access and distribution. All facets of the pharmaceutical industry could be ultimately affected by these changes.

• For now, the DEA is asking industry to give it some time (to paraphrase the ELO song) and gather facts to better understand the practice and the risks associated with telepharmacy. Stay tuned, and don’t hang up.

[1] 86 Fed. Reg. 64096-64099 (Nov. 17, 2021).

[2] 21 U.S.C § 811 et seq.

[3] 21 U.S.C. § 801 et seq.

[4] 21 U.S.C. § 802 (52); 21 C.F.R. § 1300.04(h).

[5] 21 C.F.R. § 1300.04(h)(9).

[6] Telepharmacies may fill electronic prescriptions, but not paper prescriptions under the exemption.