Effect of Pharmaceutical Intervention in Pharmacologically Treated Hypertensive Patients-A Cluster-Randomized Clinical Trial: AFPRES-CLM Study.

BACKGROUND: Evaluate the effect of a community pharmaceutical intervention on the control of blood pressure in hypertensive patients treated pharmacologically. METHODS: A cluster-randomized clinical trial of 6 months was carried out. It was conducted in the Autonomous Community of Castilla-La Mancha (Spain). Sixty-three community pharmacies and 347 patients completed the study. Intervention patients received the community pharmaceutical intervention based on a protocol that addresses the individual needs of each patient related to the control of their blood pressure, which included Health Education, Pharmacotherapy Follow-up and 24 h Ambulatory Blood Pressure Measurement. Control patients received usual care in the community pharmacy. RESULTS: The pharmaceutical intervention resulted in better control of blood pressure (85.8% vs. 66.3% p < 0.001), lower use of emergencies (p = 0.002) and improvement trends in the physical components of quality of life, measured by SF-36 questionnaire, after 6 months of pharmaceutical intervention. No significant changes were observed for any of these variables in the control group. There were also detected 354 negative medication-related outcomes that were satisfactorily resolved in a 74.9% of the cases and 330 healthcare education interventions and 29 Ambulatory Blood Pressure Monitorings were performed in order to increase adherence to pharmacological treatment and minimize Negative Outcomes associated with Medication and prevent medication-related problems. CONCLUSIONS: Community pharmaceutical intervention can increase hypertensive patients with controlled blood pressure, after 6 months, compared with usual care.

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

No disponible

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.

Evaluating an implementation programme for medication review with follow-up in community pharmacy using a hybrid effectiveness study design: translating evidence into practice.

OBJECTIVES: To evaluate an implementation programme of a community pharmacy medication review with follow-up (MRF) service using a hybrid effectiveness-implementation study design, and to compare the clinical and humanistic outcomes with those in a previously conducted cluster randomised controlled trial (cRCT). SETTING: Community pharmacies in Spain. PARTICIPANTS: 135 community pharmacies and 222 pharmacists providing MRF to polymedicated patients aged 65 or over. INTERVENTION: The intervention was an implementation programme for the MRF service. A national level group was established, mirrored with a provincial level group. A series of interventions were defined (1) to engage pharmacy owners with the implementation model and (2) to provide training to pharmacists consisting of clinical case studies, process of MRF, communication skills and data collection methods and (3) practice change facilitators. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcomes for the implementation programme were progress, reach, fidelity and integration. The secondary outcomes were number of medications, non-controlled health problems, emergency visits, hospitalisations and health-related quality of life, which were compared with a previous 6-month cluster RCT. RESULTS: 55% of pharmacies reached the implementation phase and 35.6% remained in the testing phase at 12 months. A reach of 89.3% (n=844) was achieved. Fidelity average score was 8.45 (min: 6.2, max: 9.3) out of 10. The integration mean score was 3.39 (SD: 0.72) out of 5. MRF service outcomes were similar to the cluster RCT study; however, the magnitude of the outcomes was delayed. CONCLUSIONS: The implementation of pharmacy services is a complex multifactorial process, conditioned by numerous implementation factors. In the absence of remuneration, the implementation of the MRF service is a slow process, taking at least 12 months to complete. TRIAL REGISTRATION NUMBER: CGFTRA-2017-01.

Primary health care policy and vision for community pharmacy and pharmacists in Spain.

From a political and governance perspective Spain is a decentralized country with 17 states [comunidades autónomas] resulting in a governmental structure similar to a federal state. The various state regional health services organizational and management structures are focused on caring for acute illnesses and are dominated by hospitals and technology. In a review by the Interstate Council, a body for intercommunication and cooperation between the state health care services and national government, there is a move to improve health care through an integrative approach between specialized care and primary care at the state level. Community pharmacy does not appear to have a major role in this review. Primary health care is becoming more important and leading the change to improve the roles of the health care teams. Primary care pharmacists as the rest of public health professionals are employed by the respective states and are considered public servants. Total health care expenditure is 9.0% of its GDP with the public health sector accounting for the 71% and the private sector 29% of this expenditure. Community pharmacy contracts with each state health administration for the supply and dispensing of medicines and a very limited number of services. There are approximately 22,000 community pharmacies and 52,000 community pharmacists for a population of 47 million people. All community pharmacies are privately owned with only pharmacists owning a single pharmacy. Pharmacy chain stores are not legally permitted. Community pharmacy practice is based on dispensing of medications and dealing with consumer minor symptoms and requests for nonprescription medications although extensive philosophical deep debates on the conceptual and practical development of new clinical services have resulted in national consensually agreed classifications, definitions and protocolized services. There are a few remunerated services in Spain and these are funded at state, provincial or municipal level. There are no health services approved or funded at a national level. Although the profession promulgates a patient orientated community pharmacy it appears to be reluctant to advocate for a change in the remuneration model. The profession as a whole should reflect on the role of community pharmacy and advocate for a change to practice that is patient orientated alongside the maintenance of its stance on being a medication supplier. The future strategic position of community pharmacy in Spain as a primary health care partner with government would then be enhanced.

Primary health care policy and vision for community pharmacy and pharmacists in Spain

From a political and governance perspective Spain is a decentralized country with 17 states [comunidades autónomas] resulting in a governmental structure similar to a federal state. The various state regional health services organizational and management structures are focused on caring for acute illnesses and are dominated by hospitals and technology. In a review by the Interstate Council, a body for intercommunication and cooperation between the state health care services and national government, there is a move to improve health care through an integrative approach between specialized care and primary care at the state level. Community pharmacy does not appear to have a major role in this review. Primary health care is becoming more important and leading the change to improve the roles of the health care teams. Primary care pharmacists as the rest of public health professionals are employed by the respective states and are considered public servants. Total health care expenditure is 9.0% of its GDP with the public health sector accounting for the 71% and the private sector 29% of this expenditure. Community pharmacy contracts with each state health administration for the supply and dispensing of medicines and a very limited number of services. There are approximately 22,000 community pharmacies and 52,000 community pharmacists for a population of 47 million people. All community pharmacies are privately owned with only pharmacists owning a single pharmacy. Pharmacy chain stores are not legally permitted. Community pharmacy practice is based on dispensing of medications and dealing with consumer minor symptoms and requests for nonprescription medications although extensive philosophical deep debates on the conceptual and practical development of new clinical services have resulted in national consensually agreed classifications, definitions and protocolized services. There are a few remunerated services in Spain and these are funded at state, provincial or municipal level. There are no health services approved or funded at a national level. Although the profession promulgates a patient orientated community pharmacy it appears to be reluctant to advocate for a change in the remuneration model. The profession as a whole should reflect on the role of community pharmacy and advocate for a change to practice that is patient orientated alongside the maintenance of its stance on being a medication supplier. The future strategic position of community pharmacy in Spain as a primary health care partner with government would then be enhanced

No disponible

Defining and characterising age-friendly community pharmacies: a qualitative study.

INTRODUCTION: The Global Network of Age-friendly Cities is a project promoted by the World Health Organization as a response to demographic ageing and urbanization process. San Sebastian, Spain, is one of these Age-friendly Cities and community pharmacies of the city joined the initiative. OBJECTIVE: To define and implement the Age-friendly Pharmacy concept to promote active ageing, optimize the contribution of community pharmacies of San Sebastian to the friendliness of the city and to the improvement of quality of life of the ageing population. METHOD: A bottom-up participative approach was undertaken. A focus group was conducted to determine elderly people's opinions and expectations of community pharmacy. The information obtained was analysed using content analysis and validated for reliability, usefulness and applicability through three expert groups of community pharmacy owners and staff. KEY FINDINGS: Fifteen requirements were agreed, covering four main areas: relationships, pharmacy layout, pharmaceutical services and communication of services. Initially, 18 community pharmacies committed to become Age-friendly Pharmacies by pledging to these requirements and the Official Pharmacist Association of Gipuzkoa supported pharmacies in the implementation of the initiative. CONCLUSION: This study suggests that there is demand for a patient-centred community pharmacy to support older people, in which pharmaceutical care services are required. The 18 Age-friendly Pharmacies together with the Official Pharmacist Association of Gipuzkoa have publicly committed to actively work on social and patient-centred care to meet the needs of the ageing population.

Cost analysis and cost-benefit analysis of a medication review with follow-up service in aged polypharmacy patients.

BACKGROUND: Drug related problems have a significant clinical and economic burden on patients and the healthcare system. Medication review with follow-up (MRF) is a professional pharmacy service aimed at improving patient's health outcomes through an optimization of the medication. OBJECTIVE: To ascertain the economic impact of the MRF service provided in community pharmacies to aged polypharmacy patients comparing MRF with usual care, by undertaking a cost analysis and a cost-benefit analysis. METHODS: The economic evaluation was based on a cluster randomized controlled trial. Patients in the intervention group (IG) received the MRF service and the comparison group (CG) received usual care. The analysis was conducted from the national health system (NHS) perspective over 6 months. Direct medical costs were included and expressed in euros at 2014 prices. Health benefits were estimated by assigning a monetary value to the quality-adjusted life years. One-way deterministic sensitivity analysis was undertaken in order to analyse the uncertainty. RESULTS: The analysis included 1403 patients (IG: n = 688 vs CG: n = 715). The cost analysis showed that the MRF saved 97 € per patient in 6 months. Extrapolating data to 1 year and assuming a fee for service of 22 € per patient-month, the estimated savings were 273 € per patient-year. The cost-benefit ratio revealed that for every 1 € invested in MRF, a benefit of 3.3 € to 6.2 € was obtained. CONCLUSION: The MRF provided health benefits to patients and substantial cost savings to the NHS. Investment in this service would represent an efficient use of healthcare resources.

The impact of a medication review with follow-up service on hospital admissions in aged polypharmacy patients.

AIMS: The aims were to assess the impact of a medication review with follow-up (MRF) service provided in community pharmacy to aged polypharmacy patients on the number of medication-related hospital admissions and to estimate the effect on hospital costs. METHODS: This was a sub-analysis of a cluster randomized controlled trials carried out in 178 community pharmacies in Spain. Pharmacies in the intervention group (IG) provided a comprehensive medication review during 6 months. Pharmacists in the comparison group (CG) delivered usual care. For the purposes of this sub-analysis, an expert panel of three internal medicine specialists screened the hospitalizations occurring during the main study, in order to identify medication-related hospitalizations. Inter-rater reliability was measured using Fleiss's kappa. Hospital costs were calculated using diagnosis related groups. RESULTS: One thousand four hundred and three patients were included in the main study and they had 83 hospitalizations. Forty-two hospitalizations (50.6%) were medicine-related, with a substantial level of agreement among the experts (kappa = 0.65, 95% CI 0.52, 0.78, P < 0.01). The number of medication-related hospitalizations was significantly lower in patients receiving MRF (IG 11, GC 31, P = 0.042). The probability of being hospitalized was 3.7 times higher in the CG (odds ratio 3.7, 95% CI 1.2, 11.3, P = 0.021). Costs for a medicine-related hospitalization were €6672. Medication-related hospitalization costs were lower for patients receiving MRF [IG: €94 (SD 917); CG: €301 (SD 2102); 95% CI 35.9, 378.0, P = 0.018]. CONCLUSION: MRF provided by community pharmacists might be an effective strategy to balance the assurance of the benefit from medications and the avoidance of medication-related hospitalizations in aged patients using polypharmacy.

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.

Facilitators for practice change in Spanish community pharmacy.

OBJECTIVE: To identify and prioritise facilitators for practice change in Spanish community pharmacy. SETTING: Spanish community pharmacies. METHOD: Qualitative study. Thirty-three semi-structured interviews were conducted with community pharmacists (n = 15) and pharmacy strategists (n = 18), and the results were examined using the content analysis method. In addition, two nominal groups (seven community pharmacists and seven strategists) were formed to identify and prioritise facilitators. Results of both techniques were then triangulated. MAIN OUTCOME MEASURES: Facilitators for practice change. RESULTS: Twelve facilitators were identified and grouped into four domains (D1: Pharmacist; D2: Pharmacy as an organisation; D3: Pharmaceutical profession; D4: Miscellaneous). Facilitators identified in D1 include: the need for more clinical education at both pre- and post-graduate levels; the need for clearer and unequivocal messages from professional leaders about the future of the professional practice; and the need for a change in pharmacists' attitudes. Facilitators in D2 are: the need to change the reimbursement system to accommodate cognitive service delivery as well as dispensing; and the need to change the front office of pharmacies. Facilitators identified in D3 are: the need for the Spanish National Professional Association to take a leadership role in the implementation of cognitive services; the need to reduce administrative workload; and the need for universities to reduce the gap between education and research. Other facilitators identified in this study include: the need to increase patients' demand for cognitive services at pharmacies; the need to improve pharmacist-physician relationships; the need for support from health care authorities; and the need for improved marketing of cognitive services and their benefits to society, including physicians and health care authorities. CONCLUSION: Twelve facilitators were identified. Strategists considered clinical education and pharmacists' attitude as the most important, and remuneration of little importance. Community pharmacists, in contrast, considered remuneration as the most important facilitator for practice change.

Drug related problems identified by European community pharmacists in patients discharged from hospital.

INTRODUCTION: Drug related problems (DRPs) are perceived to occur frequently when patients are discharged from the hospital. Community pharmacists' interventions to detect, prevent and solve DRPs in this population are scarcely studied. OBJECTIVE: To examine the nature and frequency of DRPs in community pharmacies among patients discharged from hospitals in several countries, and to examine several variables related to these drug related problems. METHOD: The study was performed in 112 community pharmacies in Europe: Austria, Denmark, Germany, The Netherlands, Portugal and Spain. Community pharmacists asked patients with a prescription after discharge from hospital between February and April 2001 to participate in the study. A patient questionnaire was used to identify drug related problems. Pharmacists documented drug related problems, pharmacy interventions, type of prescriber and patient and pharmacy variables. RESULTS: 435 patients were included in the study. Drug related problems were identified in 277 patients (63.7%). Uncertainty or lack of knowledge about the aim or function of the drug (133; 29.5%) and side effects (105; 23.3%) were the most common DRPs. Practical problems were reported 56 times (12.4%) by patients. Pharmacists revealed 108 problems (24.0%) concerning dosage, drug duplication, drug interactions and prescribing errors. Patients with more changes in their drug regimens (drugs being stopped, new drugs started or dosage modifications) and using more drugs were more likely to develop DRPs. Community pharmacists recorded 305 interventions in 205 patients with DRPs. Pharmacists intervened mostly by patient medication counselling (39.0%) and practical instruction to the patient (17.7%). In 26.2% the intervention was directed towards the prescriber. In 28 cases (9.2%) the pharmacists' intervention led to a change of the drug regimen. CONCLUSION: This study shows that a systematic intervention by community pharmacists in discharged patients, or their proxies, is able to reveal a high number of DRPs that might be relevant for patient health outcomes. There should be more initiatives to insure continuity of care, since DRPs after discharge from hospital seem to be very common.