Evaluation of an enhanced service for medication review with follow up in Swiss community pharmacies: Pre-post study protocol.

BACKGROUND: In Switzerland, 20,000 people are hospitalized each year as result of drug related problems (DRPs). The sources of DRPs can be related to patients' behavior (i.e., wrong administration) or to health processes (i.e., drug-drug interaction). No community pharmacy (CP) service focus on DRPs related to patients' behavior is currently recognized or remunerated in Switzerland. A medication review with follow up (MRF) has been developed to evaluate prescription and non-prescription medication. OBJECTIVE: To evaluate the impact of MRF service for the identification and management DRPs associated to patients' behavior and to describe pharmaceutical interventions carried out through MRF. METHODS: A pre-post intervention study with a cluster design and one intervention group will be carried out in CPs in the canton of Vaud (Switzerland) for 15 months. Volunteer pharmacists will be trained on the identification and management of DRPs related to patients' behavior. After training, they will include randomly selected adults taking four or more chronic drugs prescribed for at least three months prior to recruitment. Then, they will conduct three pharmacist-patient face-to-face consultations at 6-month intervals. Tasks will be differentiated by pharmacy technician or pharmacist to triage expired medication or to manage DRPs in a structured manner, respectively. The primary outcome is the identification of DRPs associated to patients' behavior. Secondary outcomes are to assess patients' medication knowledge, number of expired medications, interventions carried out by pharmacists and pharmacists' satisfaction. The study will begin in April 2023 in 19 to 35 pharmacies that will recruit at least 162 patients. A sub analysis will be carried out for patients with 65 years old or over. CONCLUSIONS: The MRF intervention features a training designed for an enhanced evaluation of patient's behavior towards their medication. The study will allow the assessment and management of DRPs in Swiss CPs with the support of the local health authorities and pharmacist association. TRIAL REGISTRATION: Clinicaltrials.gov NCT05348538.

Documentation of drug related problems and their management in community pharmacy: Data evolution over six years.

BACKGROUND: Documentation of pharmacists' activities, such as drug related problems (DRPs) management, is necessary to estimate fair remuneration but is rarely done in community pharmacies. OBJECTIVE: To document and evaluate the evolution of DRPs prevalence and management over six years. METHODS: Observational study carried out since 2016 in a community pharmacy. Documentation was made yearly for 21 days (depending on seasons, holidays and medical internship rotations) using the ClinPhADoc tool. Pharmacists documented: medication, DRP type, intervention, implied partner and time for DRP management. A subanalysis was made depending on the medical rotation. RESULTS: A total of 171 437 prescriptions were received and 6 844 (4.0%) documented with 1 550 DRPs. Most frequent DRPs were procedural (n = 506, 32.6%), dosage/posology (n = 263, 17.0%) and drug-drug interaction (n = 153, 9.9%). Mean time dedicated to DRP management was 6.9 min, the longest time was for clinical DRPs (11.0 min, SD = 6.6). Most DRPs (n = 726, 44.6%) were managed by the pharmacist alone taking less working time than when involving other stakeholders (p < 0.01). Statistically significant differences were found in DRPs between the beginning and end of medical rotation (p < 0.05). CONCLUSIONS: Documentation of DRP management allowed consistent results over the years. Patterns of DRPs can be used to develop inter-professional interventions to prevent DRPs.

Domiciliary medication review (ReMeDo): development, reliability and acceptability of a tool for community pharmacists.

OBJECTIVES: Polymedication and medication hoarding in patients' homes may increase the risk of drug-related problems (DRPs). Community pharmacists can prevent DRPs through medication reconciliation and review. This study aims to (1) develop a tool for community pharmacists to perform domiciliary medication review (ReMeDo) and (2) assess the interrater and test-retest reliability and acceptability of the tool. METHODS: The ReMeDo tool was first developed 6 years before this study to perform medication review during pharmacist home visits. A literature review was performed to update the content of the existing tool. Ten pharmacy students participated in the assessment of the interrater and test-retest reliability using three vignettes based on former ReMeDo patients. Test-retest reliability coefficients were calculated for the entire tool and each segment. Global and individual interrater reliability coefficients were also computed. Acceptability was assessed through a satisfaction survey. KEY FINDINGS: The ReMeDo tool was structured to guide the collection of information before, during and after the pharmacist home visit. The global kappa coefficients for interrater and test-retest reliability were 0.70 (95% confidence interval (CI), 0.67 to 0.73) and 0.71 (95% CI, 0.68 to 0.74), respectively. The test-retest reliability coefficients for each segment and the interrater reliability coefficients for participants were higher than 0.60 (except for one participant), demonstrating a moderate to substantial level of agreement. The tool was deemed acceptable by participants. CONCLUSIONS: The ReMeDo tool proved to be reliable and acceptable for use by community pharmacists to perform medication review in patients' homes.

Clinical Pharmacy Activities Documented (ClinPhADoc): Development, Reliability and Acceptability of a Documentation Tool for Community Pharmacists.

Documentation of community pharmacists' clinical activities, such as the identification and management of drug-related problems (DRPs), is recommended. However, documentation is not systematic in Swiss community pharmacies, and relevant information about DRPs, such as consequences or involved partners, is frequently missing. This study aims to evaluate the interrater and test-retest reliability, appropriateness and acceptability of the Clinical Pharmacy Activities Documented (ClinPhADoc) tool. Ten community pharmacists participated in the study. Interrater reliability coefficients were computed using 24 standardized cases. One month later, test-retest reliability was assessed using 10 standardized cases. To assess the appropriateness, pharmacists were asked to document clinical activities in their own practice using ClinPhADoc. Acceptability was assessed by an online satisfaction survey. Kappa coefficients showing a moderate level of agreement (>0.40) were observed for interrater and test-retest reliability. Pharmacists were able to document 131 clinical activities. The good level of acceptability and brief documentation time (fewer than seven minutes) indicate that ClinPhADoc is well-suited to the community pharmacy setting. To optimize the tool, pharmacists proposed developing an electronic version. These results support the reliability and acceptance of the ClinPhADoc tool.

Beliefs influencing community pharmacists' interventions with chronic kidney disease patients: A theory-based qualitative study.

BACKGROUND: Drug-related problems (DRPs) are highly prevalent in chronic kidney disease (CKD) patients. Community pharmacists are ideally positioned to manage these DRPs. However, little is known about the factors influencing their interventions with CKD patients. OBJECTIVES: Using the theory of planned behavior (TPB), this qualitative study sought to: (1) explore the behavioral beliefs (perceived advantages and disadvantages), normative beliefs (perceived expectations of significant others) and control beliefs (perceived barriers and facilitators) influencing community pharmacists' interventions related to identifying and managing DRPs in CKD; and (2) compare these beliefs among three DRPs prevalent in CKD patients. METHODS: Community pharmacists in Quebec, Canada participated in face-to-face individual semi-structured interviews. The topic guide was based on the TPB. Three vignettes were presented to stimulate community pharmacists' thoughts about their interventions regarding: (1) the use of an inappropriate over-the-counter laxative; (2) prescriptions of anti-inflammatory medications; and (3) non-adherence to antihypertensive medication. Integral transcripts of audio recordings were analyzed using thematic analysis. The findings on each of the three DRPs were systematically compared. RESULTS: Fifteen community pharmacists participated in the study. All expressed a positive attitude toward DRP management, mentioning advantages such as gaining the patient's loyalty as a client and avoiding CKD complications. Participants mentioned that patients and physicians generally approve their interventions, but the dynamics of these relationships may vary depending on the DRP. Common barriers in the management of the three DRPs were the pharmacists' limited time and heavy workloads. The pharmacists felt that the main disadvantage is that these interventions interrupt the workflow in the pharmacy. CONCLUSION: Community pharmacists hold positive views of their interventions in CKD. However, enhancing community pharmacists' involvement in CKD care may require measures to facilitate pharmacists' proactivity, inter-professional collaboration and a work organization adapted to clinical activities.

Prevalence and Management of Drug-Related Problems in Chronic Kidney Disease Patients by Severity Level: A Subanalysis of a Cluster Randomized Controlled Trial in Community Pharmacies.

BACKGROUND: Drug-related problems (DRPs) are prevalent among chronic kidney disease (CKD) patients. However, little is known about their severity and management by community pharmacists. OBJECTIVES: To (a) describe the prevalence of DRPs by severity level in CKD patients and (b) assess the effect of a training-and-communication network program in nephrology (ProFiL) on these DRPs. METHODS: This is a secondary analysis of a cluster randomized controlled trial evaluating the effect of the ProFiL-program. In 6 CKD clinics, patients at CKD stage 3 or 4 and their community pharmacists were recruited and assigned to the ProFiL group or a usual care (UC) group. Using validated criteria, 2 pharmacists identified DRPs and assessed their severity at baseline and after 12 months. The mean annual change in the number of DRPs per patient by severity level was assessed using a 2-level multivariable linear mixed-effects model. RESULTS: A total of 494 pharmacists and 442 patients participated. At baseline, the prevalence (mean number of DRPs per patient [SD]) of mild DRPs (e.g., requiring dosage adjustment) and moderate DRPs (e.g., drug adherence requiring a monitoring plan) were 0.55 (0.98) and 1.04 (1.51), respectively. After 12 months, an unadjusted incremental annual reduction of 0.34 moderate DRPs (95% CI = -0.66 to -0.01) was observed in the ProFiL group compared with the UC group. After adjustment, no between-group differences were observed. CONCLUSIONS: Among patients followed in CKD clinics, most DRPs have a moderate severity requiring specific monitoring by pharmacists. The benefit of continuing education programs, such as ProFiL, to reduce moderate DRPs remains to be determined. DISCLOSURES: This study was supported by the Canadian Institutes of Health Research (grant number: MOP-230207). Part of the study was also funded by Pfizer Canada, Leo Pharma, and Amgen. The authors declare that they have no relevant financial interests. Study concept and design were contributed by Quintana-Bárcena, Lord, and Lalonde. Quintana-Bárcena, Lord, and Lizotte were responsible for the data analysis, and Quintana-Bárcena and Berbiche performed the statistical analysis. The manuscript was written by Quintana-Bárcena and Lalonde and revised by Quintana-Bárcena and Lalonde, along with the other authors.

Community Pharmacist Training-and-Communication Network and Drug-Related Problems in Patients With CKD: A Multicenter, Cluster-Randomized, Controlled Trial.

BACKGROUND: Appropriate training for community pharmacists may improve the quality of medication use. Few studies have reported the impact of such programs on medication management for patients with chronic kidney disease (CKD). STUDY DESIGN: Multicenter, cluster-randomized, controlled trial. SETTING & PARTICIPANTS: Patients with CKD stage 3a, 3b, or 4 from 6 CKD clinics (Quebec, Canada) and their community pharmacies. INTERVENTION: Each cluster (a pharmacy and its patients) was randomly assigned to either ProFiL, a training-and-communication network program, or the control group. ProFiL pharmacists completed a 90-minute interactive web-based training program on use of medications in CKD and received a clinical guide, patients' clinical summaries, and facilitated access to the CKD clinic. OUTCOMES: Drug-related problems (primary outcome), pharmacists' knowledge and clinical skills, and patients' clinical attributes (eg, blood pressure and glycated hemoglobin concentration). MEASUREMENTS: Drug-related problems were evaluated the year before and after the recruitment of patients using a validated set of significant drug-related problems, the Pharmacotherapy Assessment in Chronic Renal Disease (PAIR) criteria. Pharmacists' questionnaires were completed at baseline and after 1 year. Clinical attributes were documented at baseline and after 1 year using available information in medical charts. RESULTS: 207 community pharmacies, 494 pharmacists, and 442 patients with CKD participated. After 1 year, the mean number of drug-related problems per patient decreased from 2.16 to 1.60 and from 1.70 to 1.62 in the ProFiL and control groups, respectively. The difference in reduction of drug-related problems per patient between the ProFiL and control groups was -0.32 (95% CI, -0.63 to -0.01). Improvements in knowledge (difference, 4.5%; 95% CI, 1.6%-7.4%) and clinical competencies (difference, 7.4%; 95% CI, 3.5%-11.3%) were observed among ProFiL pharmacists. No significant differences in clinical attributes were observed across the groups. LIMITATIONS: High proportion of missing data on knowledge and clinical skills questionnaire (34.6%) and clinical attributes (11.1%). CONCLUSIONS: Providing community pharmacists with essential clinical data, appropriate training, and support from hospital pharmacists with expertise in nephrology increases pharmacists' knowledge and reduces drug-related problems in patients with CKD who are followed up in clinics incorporating a multidisciplinary health care team.

Development and validation of criteria for classifying severity of drug-related problems in chronic kidney disease: A community pharmacy perspective.

PURPOSE: The development and validation of criteria for classifying severity of drug-related problems (DRPs) in chronic kidney disease (CKD) in the community pharmacy setting are described. METHODS: The Severity Categorization for Pharmaceutical Evaluation (SCOPE) criteria were adapted from an existing tool based on the interventions required to manage DRPs in community pharmacy. Ten community pharmacists reviewed the criteria. An expert panel involving community pharmacists, hospital pharmacists, family physicians, and nephrologists scored the relevance of each criterion. The severity of 487 DRPs identified among 168 patients was rated independently by two evaluators and by one evaluator on two occasions. Kappa reliability coefficients were computed. Severity as assessed by implicit judgment and the SCOPE criteria was compared. RESULTS: Three severity categories were defined (mild, moderate, and severe), each including two levels (for a total of six levels). At each level, specific interventions required to manage DRPs in community pharmacy were listed. The test-retest reliability coefficient by level was 0.85 (95% confidence interval [CI], 0.79-0.90), and the interrater reliability coefficient was 0.77 (95% CI, 0.72-0.82). The test-retest coefficient by category was 0.89 (95% CI, 0.84-0.95), and the interrater coefficient was 0.90 (95% CI, 0.86-0.94). A higher level of SCOPE was associated with more severe DRPs as rated by implicit judgment (p < 0.05). CONCLUSION: A set of criteria developed for use in the community pharmacy setting for evaluating the severity of DRPs in CKD proved to be reliable and correlated with clinical implicit judgment.