Background
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

Proposal
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

Pharmacist-led refill authorization programs can yield monetary benefits through cost-savings.  One 30-day study serving 32 patients in a pharmacist refill clinic calculated a $1235 cost savings, not including the benefits offset by employing a pharmacist rather than a physician.6

This amounts to $38.59 saved per patient per month. Furthermore, a 2001-2002 study of a Navy Hospital showed a total $70,691 savings for the 573 patients that were cared for by a pharmacist versus a physician.8 In addition, since medication nonadherence contributes to 10% of hospitalizations and up to $300 billion in health care spending, the role of pharmacists in improving adherence rates through refill authorizations can help to reduce hospitalization-related costs as well.20

As with any move towards change, there are deterrents hindering the implementation of pharmacist-led refill authorizations. For example, doctors and patients are skeptical of pharmacist involvement due to the belief that they are not sufficiently qualified to make clinical decisions. However, this doubt is rooted in the lack of knowledge on the roles and responsibilities of pharmacists.

One study surveyed patients’ beliefs on the competence of pharmacists before and after a public service announcement video, which found that patients significantly increased their ratings on the capability of pharmacists to manage medications after being informed of their duties.21 In addition, an annual poll conducted by Gallup has found that Americans consider pharmacists among the most trusted professionals, having consistently ranked them among the top 3 most honest and ethical professionals over the last 14 years.22

This trust can help pharmacists establish new clinical roles and relationships with patients. Although some say that providers are also unwilling to trust pharmacists to refill medications, this has been refuted through experiments in which pharmacists’ decisions were consistently supported and trusted by physicians.3,15,23

Moreover, physicians may develop trust in pharmacists’ patient care involvement by first initiating a working rapport with each other and by establishing certain limits on pharmacists’ clinical scope within mutually agreed upon CDTM protocols. Furthermore, the strictly collaborative nature of a pharmacist-led refill authorization program can serve to remove any doubts about pharmacists potentially disrupting physician duties.

Another hindrance to expansion is the lack of access to patient's electronic medication administration records (EMAR). This can be solved by making EMAR available for pharmacists.23-25

A study conducted by Price et al designed a program that added pharmacists into the EMAR system so that they were privy to patient information as their health status changed.24

This study design can be applied to the community setting in the same way that electronic prescriptions have become prevalent in community pharmacies.25 The availability of EMAR is so crucial to health care that the Center for Medicare and Medicaid Services has announced recommendations on how to “support health information exchange (HIE) and interoperable systems” through funds from the Health Information Technology for Economic and Clinical Health Act.26  

Among the most prevalent arguments against pharmacist-led refill authorizations is the prospect of increasing workload for community pharmacists. Some argue that community pharmacists already struggle to keep up with current demands in the pharmacy.6,27

Although it is true that refill authorizations would be another addition to the pharmacist’s daily tasks, the time commitment can be managed by reorganizing responsibilities within the pharmacy. As technicians are being encouraged to increase their knowledge and obtain licensure, they become an ideal resource to delegate administrative and production tasks in the pharmacy when new services are implemented.28

In addition, a study conducted by Dosea et al found that community pharmacists were happy to expand their services in an effort to “consolidate” their responsibilities with the clinical knowledge they were taught in training.29

The current lack of reimbursement to pharmacies for patient care interventions is a crucial deterrent against the implementation of pharmacist-led refill authorizations. Since pharmacists are not designated with provider status within the legislature, they are unable to bill Medicare for patient care.30

Without the ability to produce revenue from a refill authorization program, pharmacies lack a monetary incentive to implement such a program. The American Society of Health-Systems Pharmacists advocates for legislative change by asserting that the payment needed to reimburse pharmacists for their services is “less than the average monthly salary of a pharmacist,” while the amount of health care costs saved through pharmacists’ clinical services is “two to three times greater than their annual salary.”30

Conclusion
Pharmacist-led refill authorizations can benefit many components of our current health care system. A multitude of evidence demonstrates that pharmacist-led refill authorizations optimize patients’ therapies and yield cost-savings.32

Access to patients’ medical records and reimbursement for services would therefore enable pharmacists to not only improve the quality of patient care, but also reduce overall health care costs. These programs also benefit physicians by allowing them to better focus on more complex patient cases. Hence, expanding the role of pharmacists in authorizing prescription refills is a logical step in improving health care for Americans.

About the Authors
Todd A Brown is clinical instructor and vice chair, Bouvé College of Health Sciences, Department of Pharmacy Education, Northeastern University, 617-373-4175, Email t.brown@neu.edu
 
Riza Usta and Nazmin J Khalifa are PharmD students, Bouvé College of Health Sciences, Northeastern University.
 
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