The second in a series of articles on developments in telepsychiatry.

Controlled Substances Act

The Controlled Substances Act (CSA) of 1970, a key structural element of the DEA’s authority, combined existing federal drug laws and expanded their scope, changed the nature of federal drug law policies, and expanded federal law enforcement pertinent to controlled substances. Several amendments to CSA followed over the next several decades up through 2010, which together circumscribe the prescription of controlled substances via telemedicine.

Definition of Controlled Substances

Controlled substances may fall under one of five schedules, as described in the following table (state and local laws may be more restrictive):

Schedule I No accepted medical use; high potential for abuse (e.g. heroine, ecstasy)
Schedule II Accepted medical use with severe restrictions; high potential for abuse (e.g., cocaine, morphine)
Schedule III Accepted medical use; moderate to low potential for abuse (e.g., codeine, Vicodin)
Schedule IV Accepted medical use; potential for abuse, but less than Schedule III (e.g., valium, Ambien)
Schedule V Accepted medical use; low potential for abuse (e.g., Robitussin AC)

 

Ryan Haight Online Pharmacy Consumer Protection Act

The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 amends the Controlled Substances Act to prevent the illegal distribution and dispensation of controlled substances by means of the internet. The Act was passed by Senator Feinstein in response to the death of Ryan Haight, a teenager who overdosed on pain killers that he obtained in an illegal manner by exploiting gaps in the U.S. pharmacy system.

The Ryan Haight Act specifies that a prescribed controlled substance, as determined under the Federal Food, Drug, and Cosmetic Act, may not be delivered, distributed, or dispensed by means of the internet without a valid prescription. A valid prescription is a prescription issued for a legitimate medical purpose in the usual course of professional practice by a practitioner who has conducted at least 1 in-person medical evaluation of the patient, or a covering practitioner. A covering practitioner is a practitioner who conducts a medical evaluation (other than an in-person medical evaluation) at the request of a practitioner who has (a) conducted at least one in-person medical evaluation of the patient, or an evaluation of the patient through the practice of telemedicine within the previous 24 months and (b) is temporarily unavailable to conduct the evaluation of the patient. The intent of the Act is to prevent the generation of a prescription by an online pharmacy that also dispenses the medication; in other words, to separate the prescriber from the dispenser.

In addition, the Act exempts practitioners from the in-person exam requirement so long as they meet the federal definition of telemedical practice. A physician who practices telemedicine may prescribe a controlled substance without an in-person evaluation if (a) the patient is treated by and physically located in a hospital or clinic with a valid DEA registration, and (b) the telemedicine practitioner treats the patient in the usual course of professional practice.

DEA Electronic Prescriptions for Controlled Substances Rule

The DEA Electronic Prescriptions for Controlled Substances Rule of 2010 further revises DEA prescription regulations to (i) provide practitioners the option to write prescriptions for controlled substances electronically, (ii) permit pharmacies to receive, dispense, and archive these electronic prescriptions, and (iii) provide pharmacies, hospitals, and practitioners the ability to use modern technology for controlled substance prescriptions while maintaining the closed system of controls on controlled substances. The regulations supplement and do not replace existing DEA rules.

State Policies On Controlled Substance Prescription

In addition to the Ryan Haight Act and Electronic Prescriptions for Controlled Substances Rule, providers must be cognizant of state-specific laws and policies, as published by the National Association of State Controlled Substance Authorities. Further, controlled substances may be prescribed only through an electronic health record (EHR) system. An even split exists between states that require controlled substance registration and states that do not.

The following chart describes recent policy changes by a subset of states:

Arizona Providers do not pay a fee
Delaware Providers must complete 2 hours of controlled substances CME
Florida Prescriber profile designation
Minnesota Providers are exempt from registration
Mississippi Providers are exempt from registration, unless handling a controlled substance
Montana Providers are exempt from registration, but must pay a fee
New Hampshire Providers must participate in a drug monitoring program
North Carolina Solo practitioners are exempt from registration
Ohio Businesses that generate prescriptions must register
Oklahoma Providers must possess state residency

 

Takeaways

Practitioners engaged in the electronic prescription of controlled substances must develop comfort and familiarity with the Ryan Haight Online Pharmacy Consumer Protection Act, DEA Electronic Prescriptions for Controlled Substances Rule, and relevant state and local policies. Further, the variability in laws and policies state to state on this issue suggests that practitioners ought to take an active role in the influence of policymaking, work with EHR vendors to optimize process, and engage with associations and popular press to advance requirements and best practices central to electronic prescription of controlled substances.