Clinical, economic, and humanistic impact of a multidisciplinary medication review with follow-up for anticoagulated patients treated with vitamin K antagonists in primary care: A cluster randomised controlled trial.

BACKGROUND: Interdisciplinary collaboration between general practitioner, nurses and pharmacists can favour the control of patients treated with vitamin K antagonists (VKA), increasing their safety and effectiveness. The aim of the study was to evaluate the impact of pharmaceutical interventions on patients treated with VKA within the framework of a Pharmacotherapeutic Follow-up service on clinical, economic and humanistic outcomes. METHODS: Controlled and randomized study in patients from two health areas of Zaragoza in treatment with VKA with Time in Therapeutic Range (TTR) according to the Rosendaal method less than 70% in the last 6 months. Patients were recruited at the pharmacy and assigned to two groups: control and intervention. A Pharmacotherapeutic Follow-up Program was established for the intervention group for 6 months. The outcome variables were INR stability, pharmacological adherence, vitamin K intake, knowledge about the use of acenocoumarol, quality of life, satisfaction with treatment, associated costs and avoided costs. A descriptive analysis was performed, and the Students' T test or Mann-Whitney U test was used for the association between quantitative variables and Chi-square or Fisher's test for qualitative variables. RESULTS: A total of 123 patients were included, 65 in the intervention group (IG) and 58 in the control group (CG). A total of 108 interventions were conducted (1.7 interventions/patient) and the most common were those related to the proper taking of medications (41.0%). In IG, TTR (p = 0.019), adherence to treatment (p = 0.038) and knowledge about acenocoumarol (p = 0.031) improved, compared to CG. A higher proportion of patients in IG achieved a TTR>65% (p = 0.024). In addition, patients whose interventions were accepted by the physician (p = 0.027) and those who received vitamin K optimization interventions (p = 0.003) achieved TTR>65% in greater proportion. CONCLUSIONS: Community pharmacist medication review, in collaboration with general practitioners improve knowledge and adherence of patients treated with oral anti-vitamin K agents and enhances the achievement of their therapeutic INR ranges. Investment needed to achieve this clinical impact is low and patient satisfaction is high. TRIAL REGISTRATION: This study has been registered with Clinical Trials.gov dated 25/05/2017: NCT03154489.

Importance of Pharmacogenetics and Drug-Drug Interactions in a Kidney Transplanted Patient.

Tacrolimus (TAC) is a narrow-therapeutic-range immunosuppressant drug used after organ transplantation. A therapeutic failure is possible if drug levels are not within the therapeutic range after the first year of treatment. Pharmacogenetic variants and drug-drug interactions (DDIs) are involved. We describe a patient case of a young man (16 years old) with a renal transplant receiving therapy including TAC, mycophenolic acid (MFA), prednisone and omeprazole for prophylaxis of gastric and duodenal ulceration. The patient showed great fluctuation in TAC blood concentration/oral dose ratio, as well as pharmacotherapy adverse effects (AEs) and frequent diarrhea episodes. Additionally, decreased kidney function was found. A pharmacotherapeutic follow-up, including pharmacogenetic analysis, was carried out. The selection of the genes studied was based on the previous literature (CYP3A5, CYP3A4, POR, ABCB1, PXR and CYP2C19). A drug interaction with omeprazole was reported and the nephrologist switched to rabeprazole. A lower TAC concentration/dose ratio was achieved, and the patient's condition improved. In addition, the TTT haplotype of ATP Binding Cassette Subfamily B member 1 (ABCB1) and Pregnane X Receptor (PXR) gene variants seemed to affect TAC pharmacotherapy in the studied patient and could explain the occurrence of long-term adverse effects post-transplantation. These findings suggest that polymorphic variants and co-treatments must be considered in order to achieve the effectiveness of the immunosuppressive therapy with TAC, especially when polymedicated patients are involved. Moreover, pharmacogenetics could influence the drug concentration at the cellular level, both in lymphocyte and in renal tissue, and should be explored in future studies.

Clinical impact of a pharmacist-led medication review with follow up for aged polypharmacy patients: a cluster randomized controlled trial

BACKGROUND: Medication review with follow-up (MRF) is a service where community pharmacists undertake a medication review with monthly follow-up to provide continuing care. The ConSIGUE Program assessed the impact and implementation of MRF for aged polypharmacy patients in Spanish Community Pharmacies. The present paper reports on the clinical impact evaluation phase of ConSIGUE. OBJECTIVE: The main objective of the study was to measure the effect of MRF on the primary outcome of the number of uncontrolled health problems. Secondary objectives were to analyze the drug-related problems (DRPs) identified as potential causes of ineffective or unsafe medications and the pharmacists' interventions implemented during MRF provision. METHODS: An open-label multi-centered cluster randomized study with comparison group (CG) was carried out in community pharmacies from 4 provinces in Spain during 6 months. The main inclusion criteria were patients over 64 years old, using 5 or more medicines. The intervention group (IG) received the MRF service (advanced medication review-type 3 MR) whereas patients in the CG received usual care. RESULTS: 178 pharmacies recruited 1403 patients (IG= 688 patients; CG= 715 patients). During the 6 months of the study 72 patients were lost to follow up. The adjusted multi-level random effects models showed a significant reduction in the number of uncontrolled health problems over the periods in the IG (-0.72, 95% CI: -0.80, -0.65) and no change in the CG (-0.03, 95%CI: -0.10, 0.04). Main DRPs identified as potential causes of failures of uncontrolled health problems' treatment were undertreated condition (559 DRPs; 35.81%), lack of treatment adherence (261 DRP; 16.67%) and risk of adverse effects (207 DRPs; 13.53%). Interventions performed by pharmacist to solve DRP mainly included the addition (246 interventions; 14.67%) and change (330 interventions; 19.68%) of a medicine and educational interventions on medicine adherence (231 interventions; 13.78%) and non-pharmacological interventions (369 interventions; 22.01%). CONCLUSIONS: This study provides evidence of the impact of community pharmacist on clinical outcomes for aged patients. It suggests that the provision of an MRF in collaboration with general medical practitioners and patients contributes to the improvement of aged polypharmacy patients' health status and reduces their problems related with the use of medicines

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Clinical impact of a pharmacist-led medication review with follow up for aged polypharmacy patients: A cluster randomized controlled trial.

BACKGROUND: Medication review with follow-up (MRF) is a service where community pharmacists undertake a medication review with monthly follow-up to provide continuing care. The ConSIGUE Program assessed the impact and implementation of MRF for aged polypharmacy patients in Spanish Community Pharmacies. The present paper reports on the clinical impact evaluation phase of ConSIGUE. OBJECTIVE: The main objective of the study was to measure the effect of MRF on the primary outcome of the number of uncontrolled health problems. Secondary objectives were to analyze the drug-related problems (DRPs) identified as potential causes of ineffective or unsafe medications and the pharmacists' interventions implemented during MRF provision. METHODS: An open-label multi-centered cluster randomized study with comparison group (CG) was carried out in community pharmacies from 4 provinces in Spain during 6 months. The main inclusion criteria were patients over 64 years old, using 5 or more medicines. The intervention group (IG) received the MRF service (advanced medication review-type 3 MR) whereas patients in the CG received usual care. RESULTS: 178 pharmacies recruited 1403 patients (IG= 688 patients; CG= 715 patients). During the 6 months of the study 72 patients were lost to follow up. The adjusted multi-level random effects models showed a significant reduction in the number of uncontrolled health problems over the periods in the IG (-0.72, 95% CI: -0.80, -0.65) and no change in the CG (-0.03, 95% CI: -0.10, 0.04). Main DRPs identified as potential causes of failures of uncontrolled health problems' treatment were undertreated condition (559 DRPs; 35.81%), lack of treatment adherence (261 DRP; 16.67%) and risk of adverse effects (207 DRPs; 13.53%). Interventions performed by pharmacist to solve DRP mainly included the addition (246 interventions; 14.67%) and change (330 interventions; 19.68%) of a medicine and educational interventions on medicine adherence (231 interventions; 13.78%) and non-pharmacological interventions (369 interventions; 22.01%). CONCLUSIONS: This study provides evidence of the impact of community pharmacist on clinical outcomes for aged patients. It suggests that the provision of an MRF in collaboration with general medical practitioners and patients contributes to the improvement of aged polypharmacy patients' health status and reduces their problems related with the use of medicines.

Reflexiones sobre "Visión crítica y argumentación sobre los programas de atención de la cronicidad en Atención Primaria y Comunitaria" / Reflection on "Critical view and argumentation on chronic care programs in Primary and Community Care"

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Assessment of a screening protocol for type 2 diabetes in community pharmacy. The DiabNow Study.

The aim of this study was to assess the performance and feasibility of a protocol for screening type 2 diabetes in community pharmacy. Performance was primarily assessed by measuring stakeholders' adherence (pharmacists, patients and physicians) to the protocol's components.

Cost-utility analysis of a medication review with follow-up service for older adults with polypharmacy in community pharmacies in Spain: the conSIGUE program.

BACKGROUND: The concept of pharmaceutical care is operationalized through pharmaceutical professional services, which are patient-oriented to optimize their pharmacotherapy and to improve clinical outcomes. OBJECTIVE: The objective of this study was to estimate the incremental cost-effectiveness ratio (ICER) of a medication review with follow-up (MRF) service for older adults with polypharmacy in Spanish community pharmacies against the alternative of having their medication dispensed normally. METHODS: The study was designed as a cluster randomized controlled trial, and was carried out over a time horizon of 6 months. The target population was older adults with polypharmacy, defined as individuals taking five or more medicines per day. The study was conducted in 178 community pharmacies in Spain. Cost-utility analysis adopted a health service perspective. Costs were in euros at 2014 prices and the effectiveness of the intervention was estimated as quality-adjusted life-years (QALYs). In order to analyze the uncertainty of ICER results, we performed a non-parametric bootstrapping with 5000 replications. RESULTS: A total of 1403 older adults, aged between 65 and 94 years, were enrolled in the study: 688 in the intervention group (IG) and 715 in the control group (CG). By the end of the follow-up, both groups had reduced the mean number of prescribed medications they took, although this reduction was greater in the IG (0.28 ± 1.25 drugs; p < 0.001) than in the CG (0.07 ± 0.95 drugs; p = 0.063). Older adults in the IG saw their quality of life improved by 0.0528 ± 0.20 (p < 0.001). In contrast, the CG experienced a slight reduction in their quality of life: 0.0022 ± 0.24 (p = 0.815). The mean total cost was 977.57 ± 1455.88 for the IG and 1173.44 ± 3671.65 for the CG. In order to estimate the ICER, we used the costs adjusted for baseline medications and QALYs adjusted for baseline utility score, resulting in a mean incremental total cost of -250.51 ± 148.61 (95 % CI -541.79 to 40.76) and a mean incremental QALY of 0.0156 ± 0.004 (95 % CI 0.008-0.023). Regarding the results from the cost-utility analysis, the MRF service emerged as the dominant strategy. CONCLUSION: The MRF service is an effective intervention for optimizing prescribed medication and improving quality of life in older adults with polypharmacy in community pharmacies. The results from the cost-utility analysis suggest that the MRF service is cost effective.

Evidence of the clinical effectiveness of cognitive pharmaceutical services for aged patients.

BACKGROUND: cognitive pharmaceutical services (CPSs) encompass a variety of pharmacists' interventions to optimise pharmacotherapy. The clinical effectiveness of CPSs for aged patients remains controversial. OBJECTIVE: to analyse and describe the evidence of the clinical effectiveness of CPSs in aged patients by means of performing a systematic review of systematic reviews. METHODS: using the recommended methodology by Cochrane, a search was undertaken for systematic reviews of the clinical effectiveness of CPSs in MEDLINE, EMBASE, DOAJ, SCIELO and COCHRANE LIBRARY. Reviews were assessed using the Assessment of Multiple Systematic Reviews (AMSTAR) instrument. Quality of the evidence in the reviews was ranked using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. RESULTS: a total of 14 systematic reviews and one meta-analysis were analysed. The overall quality of the reviews was moderate. High and moderate strength of evidence was found for the positive effect of certain CPSs on reducing the number and improving the appropriateness of medicines. There was conflicting evidence of the effect on adherence. There was limited evidence of high and moderate strength on clinical outcomes. No positive evidence was found on mortality, hospitalisations, functional capacity and cognitive function. No systematic reviews reported the effect on the level of control of health problems. CONCLUSIONS: certain types of CPSs reduce the number of medicines and improve the appropriateness of prescriptions. Longer follow-up periods and/or the use of surrogate clinical variables measuring the short-term impact are required to demonstrate the effect on clinical outcomes.

Terms used in patient safety related to medication: a literature review.

PURPOSE: There is a lack of homogeneity in the terminology used in the context of patient safety related to medication. The aim of this review was to identify the terms and definitions used in patient safety related to medication within the scientific literature. METHODS: Original and review articles that were indexed between 1998 and 2008 in MEDLINE and EMBASE and contained terms used in patient safety related to medication were included. Terms and definitions were extracted and categorised according to whether its definition referred to the process of medication use, or to the clinical outcome of medication use, or both. RESULTS: Of 2564 articles, 147 were included. Sixty terms used in patient safety related to medication with 189 different definitions were identified. Among terms that referred only to the process of medication use (n = 23), medication error provided the greatest number of definitions (n = 29). Among terms that referred only to the clinical outcome of medication use (n = 31), adverse drug event provided the greatest number of definitions (n = 15). Finally, among terms that referred both to the process of use and to the clinical outcome of medication use (n = 13), drug-related problem provided the greatest number of definitions (n = 7). CONCLUSIONS: A multitude of terms and definitions are used in patient safety related to medication. This heterogeneity makes it difficult to compare the results among studies and to appreciate the true magnitude of the problem. Classifying and unifying the terminology is necessary to advance in patient safety strategies.

Adherence: a review of education, research, practice and policy in Spain.

AIMS: To describe medication adherence education, practice, research and policy efforts carried out by pharmacists in Spain in the last decade. METHODS: A literature review using Medline and Embase was conducted covering the last ten years. Additional pharmaceutical bibliographic sources in Spain were consulted to retrieve articles of interest from the last decade. Articles were included if a pharmacist was involved and if medication adherence was measured or there was any direct or indirect pharmacist intervention in monitoring and/or improving adherence. Articles focusing on the development of tools for adherence assessment were collected. Pre- and post-graduate pharmacy training programs were also reviewed through the Spanish Ministry of Education and Science website. Information regarding policy issues was gathered from the Spanish and Autonomous Communities of Education and Health Ministries websites. RESULTS: Pharmacists receive no specific training focused on adherence. There is no specific government policies for pharmacists in Spain related to medication adherence regardless of their practice setting. A total of 24 research studies met our inclusion criteria. Of these, 10 involved pharmacist intervention in monitoring and/or improving adherence and 14 assessed only adherence. Ten studies involved hospital pharmacists working in collaboration with another healthcare professional. CONCLUSIONS: At present in Spain, the investigative role of the pharmacist is not well developed in the area of medication adherence. Adherence improvement services provided to patients by pharmacists are not implemented in a systematic way. However, recent efforts to implement new initiatives in this area may provide the basis for offering new cognitive services aimed at improving patient adherence in the near future.