NONPRESCRIPTION AVAILABILITY OF SELF-ADMINISTERED INFLUENZA ANTIVIRALS

To support a behind-the-counter practice model that expands access to self-administered influenza antivirals.

Rationale

Oseltamivir (Tamiflu), zanamivir (Relenza), and baloxavir (Xofluza) are self-administered drugs used for the treatment and chemoprophylaxis of influenza. ASHP supports the availability of self-administered influenza antivirals via a behind-the-counter practice model. Use of this practice model, which has already been adopted for medications such as pseudoephedrine and emergency contraception, would facilitate appropriate use of those antivirals and provide patients with an opportunity to receive assessment and professional consultation from a pharmacist.

There are several perceived advantages and disadvantages of the nonprescription designation for self-administered influenza antivirals. Potential benefits include quicker and improved access for patients, public health value by reducing exposure of sick individuals at provider visits, unlikely development of antiviral resistance (based on currently available data), and experience with oseltamivir as a nonprescription medication in New Zealand since 2007. Potential concerns include stockpiling, shortages, questionable effectiveness, adverse effects, potential reduction of influenza vaccination rates because of perceived antiviral availability, dosing considerations (e.g., renal function, pediatric weight-based dosing), costs, reimbursement for clinical services provided by pharmacists (e.g., point-of-care influenza testing, questionnaire screening tool for oseltamivir dispensing), blunting of other more severe underlying conditions without a provider visit, and overextension of pharmacist responsibilities and duties. Furthermore, potential public health benefits and risks of expanded access must also be considered. With availability over or behind the counter, patients may bypass visiting their primary care providers to obtainantivirals, and pharmacists will therefore need to assume an active role in promoting public health by reporting positive cases to local health departments, should rapid testing and reporting be a requirement of dispensing.

Given the interest in expanding patient access to self-administered influenza antivirals, ASHP advocates that any reclassification should not result in increased costs to patients or pharmacies. Modifications to national, regional, and local drug coverage decisions are needed to ensure that payer policies do not unintentionally restrict or prevent access. In addition, the reclassification will likely result in an increased workload and potential liability associated with pharmacist provision of this care, which includes patient screening (and point-of-care testing, if applicable), patient education, dosing, counseling, and documentation of the care provided in the pharmacy and medical record. ASHP policy 2020, Care-Commensurate Reimbursement, states that pharmacists should be compensated for these kinds of clinical and patient care services.