Identification of and Intervention to Address Therapeutic Gaps in Care

A program identifying and resolving care gaps involving community pharmacists resulted in increased adherence and omission gaps closure and fewer adherence gap reopenings.
Published Online: October 23, 2012
Daniel R. Touchette, PharmD, MA; Sapna Rao, BPharm, MS; Purna K. Dhru, PharmD; Weihan Zhao, PhD; Young-Ku Choi, PhD; Inderpal Bhandari, PhD; and Glen D. Stettin, MD
Objectives: To determine if therapeutic gap identification, notification of community pharmacists, and intervention results in increased gap closure, reduced gap closure time, and fewer adherence gaps reopening.

Study Design: Prospective, controlled, clusterrandomized study.

Methods: State of Illinois employees and beneficiaries of State health plans filling prescriptions at independently owned community pharmacies were included. For selected chronic conditions and medications, gaps in medication adherence and omitted essential therapies were identified from prescription claims and sent as alerts for resolution with the patient and/or physician. Adherence and omission gap closure at 90 days were analyzed with Kaplan-Meier (KM) survival curve approach and Cox proportional hazards models including covariates.

Results: A total of 1433 intervention and 1181 control adherence gaps were identified, while 677 intervention and 534 control omission gaps were generated. Pharmacists intervened on 639 (44.6%) adherence and 506 (74.7%) omission gaps. Gaps were closed more often in intervention than control at 30 days (55.5% in intervention vs 50.6% in control), 45 days (61.1% vs 58.4%, respectively), 60 days (66.1% vs 65.2%, respectively), and 90 days (73.0% vs 72.9%, respectively; adjusted hazard ratio [HR] = 1.242; P = .022; 95% confidence interval [CI] 1.115-1.385). Adherence gaps reopened less frequently in the intervention group (HR = 0.863; P = .012; 95% CI 0.769-0.968). A total of 89 (13.1%) intervention and 29 (5.4%) control omission gaps closed within 90 days (adjusted HR = 1.770; P = .005; 95% CI 1.182-2.653).

Conclusions: Independent community pharmacists reduced gaps in care and had fewer reopened adherence gaps, suggesting improvement in adherence. A continuation study will examine the impact of the program on long-term adherence.

(Am J Manag Care. 2012;18(10):e364-e371)
This targeted patient outreach program involved identifying patients with poor adherence and omitted therapies (referred to as gaps in care) and notifying independent community pharmacists of these gaps in care.

  • Prior to the program, community pharmacists underwent case-based training focused on disease management, motivational interviewing, and communication.

  • The program resulted in increased adherence and omission gap closure and fewer adherence gaps reopened. An indicator of adherence was also improved by the program.

  • This evaluation of our program can be used to develop more effective, targeted, evidence- based strategies to improve patient adherence and reduce errors of omission.
Underutilization of medications, exemplified by poor medication adherence and errors of omission, is a significant barrier to optimizing patient care. Adherence to chronic medications is reported to be as low as 50% after 1 year of therapy, thereby reducing the clinical effectiveness of drug therapy.1,2 Medication non-adherence is commonly associated with cost, number of medications, duration of treatment, regimen complexity, and patient cognition.3 Likewise, omission gaps, where essential drug therapies are underutilized, are also common. In 1 Veterans Affairs study, omission errors accounted for 20% of all identified medication errors.4 Omissions in therapy have been shown to increase morbidity and mortality with greater potential to cause harm than unjustified prescribing.5

In patients with diabetes, hypertension, hypercholesterolemia, and heart failure, poor adherence has been associated with increased hospitalizations and emergency department visits.6 Poor adherence to medications has been shown to increase mortality, as exemplified by increased post–myocardial infarction fatality in patients with low adherence to statins and beta-blockers.7 In patients with diabetes and dyslipidemia, poor adherence has also been associated with increased medical and total costs of care.6 Overall, non-adherence to medications is believed to cost the United States healthcare system an estimated $100 billion annually.8 While there are no available direct estimates for the implications and cost associated with omitted therapies, these costs could be greater because indicated, evidence-based therapies are not being used at all.4

Automated physician notifications of needed omitted therapies have also been tried to increase use of these medicines.9 While many notifications were either ignored or perhaps were not true gaps, automated physician notification did result in increased use of omitted therapies. The involvement of a pharmacist to screen out these unnecessary notifications may be more efficient, but has not been evaluated.

Studies in the community setting aimed at improving patient adherence using mailings10 and telephone reminder systems11-14 have metwith mixed results. Those programs that focus solely on reminders tend to be less effective, since medication adherence is generally considered to be multifaceted and affected by system and health barriers, patient behaviors and beliefs, and patient self-efficacy.15 As such, multifaceted interventions are more likely to be successful in changing patient

behavior and improving adherence. 16 More comprehensive interventions addressing adherence have generally shown better results.17-19

Pharmacists are in an optimal position to address therapeutic gaps in care. Community pharmacists are knowledgeable about potential barriers and solutions to adherence issues. They have frequent contact with their patients, know them well, and when needed, reach out to physicians on their behalf. They are also widely considered a trusted source for providing information to patients and practitioners about medication therapies.20 Therefore, with the right supportive infrastructure, the community pharmacist may be very effective at validating and addressing therapeutic gaps in care related to underutilization of medications. Such an infrastructure includes pharmacists having access to evidence-based gaps in care alerts and comprehensive medication and fill history at the point of care.

The objective of this study was to determine if the identification of therapeutic gaps in care from prescription claims data, notification of community pharmacists of gaps through alerts, and intervention on those alerts results in higher gap closure, reduced time to closure, and reduced proportion of gaps reopening in the case of adherence gaps.


This study was a prospective, cluster-randomized, controlled quality assurance study. The study was approved by the University of Illinois at Chicago institutional review board and conducted in compliance with all regulations of the Health Insurance Portability and Accountability Act of 1996.

Pharmacy Selection and Random Assignment

All pharmacies were required to 1) service members in the State of Illinois network, 2) be located in Illinois, 3) be independently owned, 4) utilize a commercially available web-based clinical documentation platform capable of relaying real-time gap information from Medco to pharmacists and capturing pharmacists’ documentation of gap causes and status, patient disposition, and comments, and 5) have 10 or more patients with identified care gaps over the 13-week period prior to randomization. In all, 96 independently owned community pharmacies met inclusion criteria and were invited to participate. Pharmacies were randomized to either provide the intervention or not (usual care control).

Population and Patient Inclusion Criteria

State of Illinois employees and beneficiaries (spouses, children, and retired workers) with continuous eligibility during the study period, and all of their pharmacy claims, were included. Patients were assigned to a particular pharmacy based on where the patient was filling the majority of their prescriptions in the 6 months prior to the study. Patient assignment was solely for the purpose of providing the intervention. Specifically, gap alerts were sent to the assigned intervention pharmacy. Control pharmacies did not receive gap in care alerts. At the start of the project, a letter was sent to the intervention pharmacy patients to inform them of the services being offered. Patient participation was optional; patients were not informed about the study. Patients were not required to fill medications at the assigned pharmacy.

Therapeutic Gaps in Care

Adherence and omission gaps in care were identified daily, using Medco’s prescription claim warehouse and defined clinical criteria. Gaps in care were transmitted as alerts to the pharmacy via the web-based platform. Adherence gaps occurred when a patient on selected chronic medications had a medication possession ratio (MPR) of less than 80% over the last 18 months and was late to fill the medication. Omission gaps occurred when a patient with a selected chronic condition was missing a medication on their profile. Omission gaps were selected based on documentation of clinical evidence and general consensus supporting the medication’s use for a particular condition. The alert definitions and situations for which they were generated are shown in Table 1.

Intervention Pharmacy Training and Practice

Control pharmacies and pharmacists continued to provide the services normally provided to their patients and did not receive gap in care alerts. Beyond the usual patient services, intervention pharmacies provided the additional service of addressing care gaps identified by Medco and communicated via a web-based clinical documentation and communication platform. All participating pharmacists at intervention pharmacies were required to undergo a certified continuing education program comprising 7.5 hours of online and 3.5 hours of in-person case-based training conducted by residencytrained clinical pharmacists with experience in medication therapy management and ambulatory care specialty clinics. Training focused on disease management (see Table 1 for conditions), motivational interviewing, and communication. Program sponsors held monthly telephone conferences with the intervention pharmacists to gather feedback on process improvement and best practice sharing and provide updates. Additional education and communication materials were provided when requested, such as the American Diabetes Association treatment guidelines.

The approach to addressing therapeutic gaps depended on the type of gap identified, as well as patient-, pharmacist-, and pharmacy-specific factors. In-person communication was encouraged for the first patient visit, with follow-up visits being in-person or by telephone. Communication with prescribers by telephone or facsimile was encouraged. However, pharmacists were allowed to conduct the intervention as appropriate, according to the pharmacy’s policies, procedures, and established relationships.

An adherence gap was considered “closed” once a prescription was filled for the medication in question. An adherence gap was considered “reopened” if an alert was generated for the gap for a second time during the study period. An omission gap was considered closed when a new prescription was written for an appropriate medication. Typically, adherence gaps were addressed directly with the patient, while omission gaps were addressed with the patient’s primary care or other provider as appropriate.

Pharmacists documented their interventions for the identified gap in care using the web-based clinical platform. All pharmacist activities were within the scope of practice, as defined by Illinois State and national pharmacy organizations and by the Illinois State practice laws. Pharmacies were reimbursed $30 for the initial session and $15 for each of up to 2 follow-up sessions to a maximum of $60 per gap addressed.

Sample Size and Data Analysis

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