APhA coronavirus watch: APhA, pharmacy groups refine therapeutic interchange recommendation

Pharmacists should be allowed to make therapeutic substitutions without consultation with a prescriber in order to mitigate coronavirus-related shortages, except for drugs within one of Medicare’s six protected classes—anticonvulsants, antidepressants, antineoplastics, antipsychotics, antiretrovirals, and immunosuppressants—according to an updated joint statement from APhA and 11 other pharmacy groups. A previous version of the statement did not specify in what cases authorization from a physician should still be required. The statement was updated on April 3, 2020.

The joint statementoriginally released in March 2020, called for pharmacists to conduct therapeutic interchange and substitution without authorization from a physician when product shortages arise. The statement also urged FDA to continue identifying and reporting drugs that are in or at risk of shortage, as well as working with firms to extend drug expiration dates.

The updated statement also recommends that pharmacists should be allowed to “evaluate and manage medications through therapeutic interchange, chronic care dose adjustment, refill authorizations, quantity modifications (e.g., 90-day fills), and other forms of prescription adaptation." For medications within one of Medicare’s six protected classes ... [pharmacists should be allowed], in consultation with the patient’s prescriber, to make therapeutic interchanges.”

In a letter to APhA, the American Epilepsy Society emphasized the importance of keeping patients with epilepsy on their current antiseizure medication (ASM) regimens. Pharmacists should make therapeutic substitutions only in consultation with the patient’s prescriber or health care provider, the letter said. Generic substitution, on the other hand, has proven to be safe and appropriate for patients with epilepsy.

Patients with epilepsy must balance seizure control with ASM adverse effects and drug–drug interactions. ASMs have a wide range of mechanisms of action, pharmacokinetics, adverse effect profiles, and drug interactions, and while almost all ASMs have similar FDA-approved indications, individual patients with the same seizure classification may have very different clinical responses to the same medication. Many patients require multiple adjustments of ASM, particularly when given in combination, to achieve optimal outcomes.

Mental Health America raised similar concerns about therapeutic interchange and substitution.

In addition to APhA, the joint statement was signed by the American Society of Health-System Pharmacists, National Alliance of State Pharmacy Associations, National Association of Chain Drug Stores, Hematology/Oncology Pharmacy Association, National Community Pharmacists Association, American Society of Consultant Pharmacists, American Association of Colleges of Pharmacy, American College of Clinical Pharmacy, National Association of Specialty Pharmacy, College of Psychiatric and Neurologic Pharmacists, and Accreditation Council for Pharmacy Education.

The joint statement also makes policy recommendations on testing and immunization, telehealth, and removal of barriers to access to pharmacists’ care.