Online Prescribing and Telepharmacy
What is telepharmacy?
Telepharmacy is the integration of pharmacy software, remotely controlled dispensing cabinetry and telecommunications technologies to enable the provision of pharmaceutical services from a distance. Telepharmacy expands access to quality health care to communities nationwide, primarily in rural, medically-underserved areas (36).
In many rural communities, it is more difficult to recruit a pharmacist than a physician. As a result, communities are often without pharmacy services and small rural hospitals are at risk of closing because they do not have a licensed pharmacist on staff. Telepharmacy systems, allow oversight by licensed pharmacists of pharmaceutical dispensing by individuals other than pharmacists. Each state’s boards of pharmacy determine who can dispense pharmaceuticals, and in most cases, it must be a licensed pharmacist, unless an exception has been made for telepharmacy services (37).
Telepharmacy can be conducted over secure private networks or over the public internet. The greatest legal controversies have arisen regarding on-line prescribing and on-line pharmacies. Some of these issues are discussed in a separate section. A more detailed discussion of telepharmacy is being developed as a separate module.
What are the legal issues involved in dispensing of pharmaceuticals over the Internet?
Pharmaceuticals are bought and sold over the Internet much in the same way as other commercial goods. A customer places an order, often through a questionnaire or order form, and then the goods are shipped to their home state from a multitude of possible locations. However, pharmaceuticals differ from other goods in that they are highly regulated by the Federal and state governments in both product and means of dispensation. Pharmaceuticals cannot be legally purchased without proof of a valid prescription. Safely purchasing pharmaceuticals over the internet requires the purchaser to carefully ensure the integrity of both the drugs she is purchasing and the pharmacist dispensing the product. Additionally, on the dispensation side, the pharmacist must comply with a host of legal requirements inapplicable to traditional brick and mortar pharmacies.
To be a licensed pharmacy that dispenses drugs, both the pharmacy and pharmacist must be licensed by the state board of pharmacy. Internet sales complicate this requirement because of the likelihood that the requested drugs will be shipped out of state. The pharmacist and pharmacy must comply with the home state as well as shipping state’s laws for the interstate sale of pharmaceuticals. Additionally, there are a variety of other legalities complicated by internet sales. For example, pharmacists are traditionally charged with ensuring the integrity of the prescription and the authority of the prescribing practitioner. However, the reality that the prescribing doctor, patient and pharmacist may be in three different states is a challenge and a potential threat to meeting this duty.
Additionally, prescribing pharmaceuticals on the internet has become a forum for “patients” to abuse prescription drugs. Pharmaceutical abuse is a growing problem in the United States, partly attributed to the ease of purchasing drugs over the internet. Pharmacists practicing telepharmacy have a duty to ensure that they are controlling dispensation so as not to aid in any illegal activity.
What are the rules for pharmacists dispensing pharmaceuticals on the Internet?
If you are a State licensed pharmacist or pharmacy using telecommunications or other electronic technology to dispense pharmaceuticals, you must be licensed in the state in which you practice.
Intrastate pharmaceutical sales:
If you are a pharmacist located outside of the state where you wish to provide services and are providing pharmacist care services outside of a licensed pharmacy to individuals located in this state, then you comply with the foreign state’s registration requirements.
- See specific state requirements.
- For further reading see the National Association Board of Pharmacy, Model Rule for the Practice of Pharmacy, § 3 at http://www.nabp.net/government-affairs/model-actrules/.
If you are a pharmacy licensed outside of the state where you wish to practice, you must be licensed to do business in the foreign state.
- See specific state requirements.
- For further reading see the National Association Board of Pharmacy, Model Rule for the Practice of Pharmacy, Article V§ 501 § 3 at http://www.nabp.net/government-affairs/model-actrules/.
What is the Ryan Haight Online Pharmacy Consumer Protection Act for Telemedicine?
In October 2008, the Ryan Haight Online Pharmacy Consumer Protection Act (38) was signed into law, amending the Controlled Substances Act (CSA) by defining legally permissible activities for physicians prescribing controlled substances over the Internet. The above provisions in the CSA were amended as follows:
- A valid prescription for controlled substances dispensed by means of the internet by a practitioner for a legitimate medical purpose in the usual course of professional practice [requires] at least one in-person medical evaluation of the patient.
- An exception to the requirement for an in-person medical evaluation was made for practitioners who are engaged in the practice of telemedicine.
- The Act provides a temporary definition of the “practice of telemedicine,” pending issuance of separate regulations no later than January 15, 2010.
- It is unlawful to “fill a prescription for a controlled substance based solely on a consumer’s completion of an online medical questionnaire.”
- Violations punishable under the current penalty provisions of § 841 of the CSA are amended to include offenses committed by doctors or pharmacists involving dispensing, distributing or aiding and abetting the distribution of controlled substances by means of the Internet.
What are the implications of the Ryan Haight Online Pharmacy Consumer Protection Act for Telemedicine?
The Drug Enforcement Administration (DEA) issued a Final Rule on April 6, 2009 that spells out its policies in implementing the statute (39). In accordance with the Act, the current Rule defines telemedicine as follows: “The term “practice of telemedicine” means the practice of medicine in accordance with applicable Federal and State laws by a practitioner (other than a pharmacist) who is at a location remote from the patient and is communicating with the patient, or health care professional who is treating the patient, using a telecommunications system referred to in section 1834(m) of the Social Security Act (40), if the practitioner is using an interactive telecommunications system that satisfies the requirements of section 410.78(a)(3) of title 42,Code of Federal Regulations. Thus, the interactive telecommunications requirement would preclude use of certain store-and-forward systems, such as those used in Alaska. Future regulations are under development to refine this definition, but currently, telemedicine practitioners prescribing controlled substances must satisfy the requirement of at least one interactive video consultation with the patient prior to prescribing. The telemedicine practitioner remains subject to the requirement that every prescription for a controlled substance be issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice.
(39) http://edocket.access.gpo.gov/2009/pdf/E9-7698.pdf (Federal Register/ Vol. 74, No.64, pages 15603-15604 April 6, 2009).