The Ryan Haight Online Pharmacy Consumer Protection Act of 2008

Ryan Haight was a 18 year-old from California who died after ingesting a fatal dose of Vicodin, which he had ordered and received from an online pharmacy, without having been examined by a physician.

The Ryan Haight Online Consumer Protection Act of 2008 (RHA) represents an appropriate attempt on the part of the US Government to limit access to controlled substances over the internet - without legitimate physician oversight. The Act's intent is to limit the online pharmacy industry and to control the prescribing of unlimited quantities of dangerous, addictive substances, "by means of the internet". In so doing, the federal government has for the first time defined a "valid prescription" as requiring at least one in-person evaluation - with a number of exceptions, telemedicine being an important one.

[By coincidence, the RHA was passed in the same month (October 2008) that my Letter to the Editor was published regarding the treatment of patients with buprenorphine without an in-person evaluation.]

In April of 2009, the DEA released its Final Rule regarding the implementation of the RHA and some have been concerned about the implications this law may have with regard to the prescribing of controlled substances via Skype telepsychiatry, i.e. in the absence of an in-person evaluation.

[Recall that Skype telepsychiatry allows for maintenance of the standard of care for traditional in-person evaluation - including the documentation of vitals signs ($40 pressure cuff on patient side) and mental status examination. An associated visit to a primary care provider can be made a prerequisite for continued treatment, as indicated. Patients may also be required to participate in random urine toxicology screening and more traditional psychosocial treatments for addiction.]

So how damaging is the RHA to the notion of prescribing a Schedule III controlled substance without an in-person evaluation?

In my view the answer will depend on case law which does not yet exist, so is now up for interpretation...

Since the clear intent of the RHA is appropriately and specifically to target the rogue internet pharmacy industry (and not the legitimate practice of telemedicine), it therefore has no relevance whatever to Skype telepsychiatry as defined here, which by definition meets standard of care by allowing for a bona fide medical evaluation.

Allowing that there is relevance (likely through the "valid prescription" argument), the language in the RHA still refers only to prescriptions "issued by means of the internet" and does not refer to prescriptions issued by traditional means i.e. telephone, fax, hard copy. In the model we have been describing, the internet is used to facilitate the examination, not the prescription.

And still there is the telemedicine exception. See the following text taken from the Final Rule:

The definition of the ‘‘practice of telemedicine’’ includes seven distinct categories that involve circumstances in which the prescribing practitioner might be unable to satisfy the Act’s in-person medical evaluation requirement, yet nonetheless has sufficient medical information to prescribe a controlled substance for a legitimate medical purpose in the usual course of professional practice. In these circumstances, provided certain safeguards are in place to ensure that the practitioner who is engaged in the practice of telemedicine is able to conduct a bona fide medical evaluation of the patient at the remote location, and is otherwise acting in the usual course of professional practice, the Act contemplates that the practitioner will be permitted to prescribe controlled substances by means of the Internet despite not having conducted an in-person medical evaluation.

I therefore believe that the RHA has no relevance to the prescribing of controlled substances without an in-person evaluation, providing that the prescriber has completed a bona fide medical evaluation of the patient at the remote location.

I invite discussion on this topic because I predict it will be the treatment of opioid dependence with buprenorphine that will eventually propel this model of treatment to wide acceptance, thus revolutionizing telepsychiatry and in the process providing treatment for a myriad of patients who would otherwise go without this effective treatment.