Assembly Responds to Arkansas Law on ‘Therapeutic Substitution’

The APA Assembly has requested that the Association revisit its existing position statement on medication substitution, which addresses the substitution of lower cost generic medications for prescribed brand-name drugs by pharmacists.

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An action paper approved at the Assembly meeting in May seeks to address concerns raised by a 2013 Arkansas law that authorizes a pharmacist to dispense a lower cost drug in the same “therapeutic class” as the prescribed drug. According to the state law, the pharmacist must have authorization from the prescriber for every prescription in order to make the substitution and must notify the prescriber within 24 hours after the substitution has been dispensed; however, the law does not require the pharmacist to consult with the prescriber before making the specific substitution.

The Arkansas law appears to be the only one of its kind authorizing “therapeutic exchange”—which is distinct from the much more common and widely legal “generic substitution.” The latter is the substitution of a brand-name drug with its generic equivalent; therapeutic substitution is the substitution of a different molecule in the same “therapeutic class” as the prescribed brand-name drug.

According to the Assembly action paper, “This Act enables prescribers in Arkansas to authorize pharmacists to substitute medications with similar mechanisms of action, with dosages determined by the pharmacist, and with notification to (and not necessarily in consultation with) the prescriber after the drug has already been dispensed.”

APA’s current position on medication substitution, first approved by the Board of Trustees in 1995 and reaffirmed in 2009, states that APA “opposes the practice of therapeutic interchange of psychoactive medication, including the interchangeability of generic and brand medications, without the express consent of the prescribing psychiatrist.”

APA’s Joint Reference Committee (JRC) referred the Assembly action paper to the Council on Quality Care, Council on Healthcare Systems and Financing, and the Council on Advocacy and Government Relations and asked for a report on the issue for review at the JRC’s October meeting.

Eugene Lee, M.D., Assembly representative from the Arkansas Psychiatric Society (APS), said, “My concern is that this is a practice that might not be safe for our patients if prescribers, including psychiatrists, are delegating the authorization for such substitution to the pharmacist.” Lee told Psychiatric News, “It’s a patient safety issue and is not consistent with the doctrine of informed consent.”

Lee added that he believes it is possible the language in the law allowing substitution of “lower cost” drugs could enable pharmaceutical companies to use vouchers and other tools to lower the cost to the patient, while still reaping reimbursement from insurance companies for the market cost of the drug.

In 2015, the APS, with the support of APA, supported state legislation exempting psychiatric medications from therapeutic exchange at the pharmacy.

“[T]hese regulations de facto grant pharmacists, albeit with ‘physician consent,’ inappropriately broad prescribing authority without a full patient medical history or medical training,” APA CEO and Medical Director Saul Levin, M.D., M.P.A., and then APS President Erick L. Messias, M.D., wrote in a letter to the Public Health, Welfare, and Labor Committee of the Arkansas House of Representatives outlining objections to the 2013 law authorizing therapeutic substitution. “[I]ndividual drugs within the therapeutic classes used to treat individuals with psychiatric disorders have very different clinical indications, mechanisms of action, and side-effect profiles. Drug prescribing is therefore complicated given the nature of medications in the classes for the treatment of psychiatric disorders. In short, these drugs are not clinically interchangeable. Pharmacists simply will not have the requisite medical history of the patient, and therefore are not equipped to make a clinically appropriate decision.”

The legislation supporting the exemption of psychiatric medications from therapeutic exchange was not approved. ■