Moving Health Care into the Future: Proposal for Pharmacist-led Refill Authorizations

Over recent decades, the role of the pharmacist has grown to include various direct patient care activities as the profession becomes more integrated into health care provider teams.1 With the increasing shortage of primary care physicians in America, the FDA is considering the expansion of pharmacists’ scope of practice. Pharmacists in Canada and the United Kingdom are already permitted to authorize medication refills, which has not only led to a reduction in medication related errors but has also relieved pressure from overwhelmed providers.3

Pharmacists may implement refill authorization services in retail pharmacies by establishing Collaborative Drug Therapy Management (CDTM) agreements with physicians. CDTM is defined as an agreement between physicians and pharmacists whereby pharmacists may initiate, monitor, continue, and adjust drug therapy for certain disease states based on established protocols.4 Of the 50 states, 47 currently allow pharmacists to establish a collaborative practice agreement with physicians;5 however, these agreements have not been extensively established within retail settings.

The workflow models of various refill authorization programs exemplify protocols and procedures that could reasonably be adopted in all retail pharmacies.6-9 Upon receiving a request for additional refills, a pharmacist can first determine whether they can safely evaluate the medication for continuation of therapy.10 Such medications are generally for chronic disease states that have been deemed appropriate for pharmacist management in a collaborative practice agreement.

Examples of chronic diseases that may benefit from pharmacist oversight include hypertension, diabetes, hyperlipidemia, hypothyroidism, asthma/COPD, allergies, epilepsy, and depression.4,6,8 Next, the pharmacist retrieves the patient’s electronic medical record and reviews important lab values, vitals, refill dates, lab dates, and dates of physician visits in order to assess disease progression, medication history, appropriateness of monitoring parameters, and follow-up history.6-9

Afterward, the pharmacist may interview the patient to gather pertinent safety and efficacy-related information about the medication.8,9

Pharmacists may utilize decision algorithms that outline safety and efficacy requirements for each drug class to facilitate consistent and reliable decision-making during a point-of-care service, as done in a US Navy Hospital Refill Clinic.8 Subsequently, if a pharmacist determines that no drug therapy problems exist, they may authorize additional refills for a certain duration, as specified in the CDTM agreement.

Research protocols enabled refill authorizations for durations varying from 30 days to 12 months.6-9 If the patient lacks a lab parameter or provider visit within the past year, the pharmacist may schedule the necessary lab or physician appointment and authorize sufficient refills until that date.6,9

However, if a pharmacist detects a drug therapy problem that would preclude continuation of therapy, they would contact the patient’s doctor and relay the need for reconciliation.6,8,9

Pharmacist-led refill authorizations are advantageous for both health care providers and patients. As a result of diminishing physician supply, the Unites States has “fewer physician visits than the [global] median (4.0 vs 6.5)” respectively.7 Hence, patients are at risk of gaps in care due to delayed appointments with their primary care physician.10-13

Furthermore, requests for refill renewals are inconvenient, causing missed doses for the patient, while disrupting workflow and increasing administrative tasks for both pharmacists and physicians.2,11,12,14-16

Pharmacist-led refill authorization programs can thus bridge gaps in health care as well as “expedite the refill process, alleviate provider time spent on refill requests, and promote patient safety.”17

Pharmacists’ refill services have demonstrated greater optimization of therapy compared with usual care. For example, a Canadian study found that pharmacists identified significantly greater drug-related problems, rectified more regimens and increased the number of routine appointments when evaluating refills.18

A Kaiser Permanente experiment also demonstrated that pharmacist-led refill authorizations yielded a greater percentage of patients with adequate medication monitoring compared with physician-led authorizations (49% vs 29%).6 Another Kaiser Permanente site instituting a new medication refill protocol with pharmacist involvement, demonstrated a 15% increase in medication compliance after initiating the program.19

Furthermore, a US Navy Refill Clinic showed that pharmacists were able to increase quality of care by identifying adverse events and drug interactions while also improving adherence and treatment cost by reducing the number of medications a patient takes and by suggesting lower cost alternatives.8

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