Development and testing of practicable strategies for professional pharmacy services, with medication adherence as an illustrative example

INTRODUCTION
To fulfill the newly defined role of a primary care provider, pharmacists must define and implement professional pharmacy services that are aimed at improving patients' health outcomes. One area in which the whole pharmacy team can provide valuable support to the patient is medication adherence. Depending on the source consulted, 25-50% of patients do not take their medication as agreed upon. Despite some promising medication adherence services that have already been implemented, few are sustained. The final step of scaling up an intervention from a few motivated patients in a controlled trial setting to a routinely provided service often fails. In general, implementation success is defined by three determinants: the service, the setting, and the process. However, in recent years, most research in pharmacy practice has been consistently focused on developing and evaluating new services rather than on the mechanism for successful implementation of existing services. Successful implementation and delivery of services for pharmacy teams depend on changing multiple behaviors and working processes. In addition, the pharmacy teams’ experience in implementing new services is limited. Therefore, a focus should be on the successful implementation and delivery of professional pharmacy services. We hypothesize that the pharmacy team should be provided with a toolkit of practical strategies for each step during these processes that is, when taking medication adherence as an illustrative example, from screening for nonadherent patients to follow-up after the intervention. This thesis focuses on developing and testing practicable strategies for screening nonadherent patients, and implementing professional pharmacy services.
GOAL
The goal of this thesis was the development and testing of practicable strategies for professional pharmacy services, with medication adherence as an illustrative example.
- Project A was developed to refine the groundwork for medication adherence screening in community pharmacies.
- Project B was developed to use implementation concepts in order to establish professional pharmacy services in community pharmacies.
Project A
Project A focused on collecting and assessing patient data on medication adherence.
Project A1 aimed at deriving a new adherence estimate from dispensing data of patients of direct oral anticoagulants (DOAC). The new estimate ΔT represents the difference between the calculated and effective refill day. With ΔT we characterized 2204 refill events from 116 DOAC patients with 19 refills. The medication possession ratio was high (0.975 ± 0.129) and showed a positive correlation with mean ΔT. Refills occurred on average 17.8 ± 27.9 days “too early”, with a mean of 75.8 ± 20.2% refills being “on time”. Four refill behavior patterns were identified, including constant gaps within or at the end of the observation period, which were critical.
Project A2 aimed at investigating medication adherence thresholds in relation to clinical outcomes. We conducted a systematic literature search. Six articles were included that assessed clinical outcomes linked to adherence rates in 7 chronic disease states. Five studies defined adherence thresholds between 46 and 92%. One study confirmed the 80% threshold as valid to distinguish adherent from nonadherent patients.
Project A3 aimed at translating the Medication-Related Burden Quality of Life tool (MRB-QoL) into German and assessing its practicality in primary health care. The MRB-QoL allows for measuring the burden of medication on patients' psychological, social, physical, and financial well-being. The translation and adaptation for primary health care resulted in a final 17-item German tool. For stakeholders, its practicality is in primary patient care as a screening tool for the general practitioner who initiate targeted interventions in collaboration with nurses and pharmacists.
The aim of Project A4 was to develop and test a framework that allows pharmacy teams to define and apply a strategy to address medication adherence in community pharmacies. A framework based on the principles of social marketing was developed. It consisted of 3 items: the target patient (“Who”), the target plan (“How”), and the target goal (“How many”). Pharmacy teams tested the framework by developing strategies based on the three items and applying them during one pilot day. The pharmacy teams generated strategies that consisted of 18 different target patients and 20 different target plans. A total of 325 encounters were observed, of which 208 patients (64%) corresponded to the predefined target patients. Medication adherence was addressed with 73 patients (22.5%), and adherence counseling was performed with 50 patients (15%). The framework was accepted by the pharmacy teams who judged it feasible and adaptable to their needs.
Project A5 was a subanalysis of Project A4. Patients who were counseled about adherence (n = 50) were compared with patients who were not counseled about adherence (n = 275). The encounters with adherence counseling were on average 1.6 minutes longer (7.5 ± 5.2 min vs. 5.9 ± 4.8, p = 0.002). The number of counseling topics (excluding medication adherence counseling) was on average two per encounter and did not differ between both groups (2.04 ± 2.04 vs. 1.93 ± 1.93, p = 0.762). On average, 1.4 ± 0.6 topics of medication adherence were thematized during adherence counseling, mainly addressing patient-related issues (e.g., positive reinforcement, therapy/disease understanding, and motivation)
Findings of Project A
- A new absolute adherence estimate ΔT was developed that characterizes every refill event and highlights the dynamic of the refill behavior of DOAC patients.
- The 80% threshold in adherence calculation was questioned as a general standard for determining patients' medication adherence.
- The MRB-QoL tool was translated in German and adapted to a short version so that in the future, the patient's medication-related burden can be measured in the primary care setting.
- The proposed 3-item framework represents a simple tool that enables pharmacy teams to develop a strategy for addressing medication adherence in community pharmacies.
- Community pharmacy teams are able to counsel on a broad spectrum of patient-related issues when addressing medication adherence. Addressing medication adherence during patient counseling is not time-consuming and does not affect other counseling activities.
Project B
In Project B, implementation concepts were used to establish a new professional pharmacy service in community pharmacies with a focus on implementation strategies and outcomes.
Project B1 aimed at developing an implementation strategy for professional pharmacy services in community pharmacies that is based on the PDCA cycle. The developed implementation strategy named fokus°PDCA was designed to be used repetitively throughout the implementation process. First evaluations of the strategy resulted in good scores for usability, comprehensibility, acceptability, feasibility, and appropriateness.
The aim of Project B2 was to evaluate the implementation of a new professional pharmacy service named TopCompliance with the use of the implementation outcomes defined by Proctor et al. During the 6-month pilot study, the five included pharmacies had on average 3.3 ± 2 active users of the service. At the implementation start, the agreement between pharmacy team members (n = 28) was high for appropriateness (75%) and adoption (92.3%), and discordand for acceptability (50%). After one month (n = 25), the agreement dropped remarkably (appropriateness: 36.5%, adoption: 53.8%, and acceptability: 3.8%). Feasibility was evaluated with 2.8±0.2 on a 4 point Likert scale. After the observation period of 6 months, 4 out of 5 pharmacies were still using the service (penetration: 80%), and two pharmacies planned to continue working with TopCompliance (sustainability: 40%).
Findings of Project B
- An implementation strategy for professional pharmacy services was successfully developed, piloted, and evaluated.
- Proctor et al.'s implementation outcomes were successfully adapted and tested for professional pharmacy services. They are practicable to evaluate the implementation process of professional pharmacy services repeatedly.
CONCLUSION
In the past, pharmaceutical care research has focused mainly on developing and evaluating professional services. The implementation gap (i.e., the poor implementation of these services) has only been acknowledged in the last decade by adapting implementation concepts in the pharmacy setting. To our knowledge, this thesis is one of the first that places a particular focus on the process and the deliverers of professional pharmacy services, i.e., the pharmacy teams:
- by providing the pharmacy team with screening tools for nonadherent patients,
- by applying implementation science concepts with a focus on strategies and outcomes to the pharmacy setting,
- by applying new methods and theories such as social marketing theory or process models to increase the participation of stakeholders in pharmaceutical care research.
OUTLOOK
In the future, the pharmacy teams should have a toolbox of viable methods and strategies to identify nonadherent patients and provide professional pharmacy services to the patient. To realize the full potential of this work, the individual findings and strategies should be linked to the improvement of the process of pharmaceutical care in the area of medication adherence, and the provision of professional pharmacy services to the patient. The findings from Project A should be used to identify potential patients in need of medication adherence intervention. The findings from Project B should be used to implement professional pharmacy services. To link Project A and B and close the process loop of pharmaceutical care, the next step should be to develop tools that allow the pharmacy teams to tailor interventions to the patient. In addition, future projects should pursue the vision of providing pharmacy teams with a toolbox of strategies for screening nonadherent patients and implementing services by developing new strategies and evaluating the existing strategies.