Abstract

BackgroundThe Italian Ministry of Health decided to introduce community professional services in 2010. This trial provides an opportunity to evaluate the outcomes of a new professional pharmacy service: Italian Medicines Use Review (I-MUR) aimed at reducing the severity of asthma and its associated costs.Methods/DesignThis is a cluster randomised controlled trial of the I-MUR service. Data will be collected over time before, during and after pharmacists’ intervention. Fifteen Italian regions will be involved and it is aimed to recruit 360 community pharmacists and 1800 patients. Each pharmacist will receive training in medicines use review, recruit five patients, administer the Asthma Control Test and provide the I-MUR service. Pharmacists will be allocated to different groups, one group will be trained in and provide the I-MUR service immediately after completion of the baseline ACT score, the other group will receive training in the I-MUR and provide this service three months later. Group allocation will be random, after stratification by region of Italy. The I-MUR service will involve gathering data following each patient consultation including demographic details, patients regular medications, including those used for asthma, their attitude towards their medications and self-reported adherence to treatments. In addition, pharmacists will identify and record pharmaceutical care issues and any advice given to patients during the I-MUR, or recommendations given to doctors. Pharmacists will upload trial data onto a web platform for analysis. The primary outcome measure is the severity of asthma before, during and after the I-MUR assessed using the Asthma Control Test score. Secondary measures: number of all active ingredients used by patients during and after the I-MUR, number of pharmaceutical care issues identified during the I-MUR, patients’ self-reported adherence to asthma medication during and after the I-MUR, healthcare costs based on the severity of asthma, before, during and after the I-MUR service provision.DiscussionThis study has been developed because of the need for a new way of working for pharmacists and pharmacies; it is the first trial of any community pharmacy-based pharmaceutical care intervention in Italy. The results will inform future policy and practice in Italian community pharmacy.Trial registration numberISRCTN72438848.

Highlights

  • The Italian Ministry of Health decided to introduce community professional services in 2010

  • The results showed that reliever therapy costs dropped by 22.7%, emergency admissions due to asthma reduced by 50%, deaths fell by 75% and hospital inpatient costs fell by 66%

  • In Italy no other work has been conducted on asthma involving community pharmacists, this current study is needed to determine whether the I-medicines use review (MUR) can contribute to improve asthma outcomes and to demonstrate whether the service provides clinical and cost benefits, as these were not included in pilot work

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Summary

Discussion

This study has been developed because of the need for a new way of working for pharmacists and pharmacy in Italy. If the results are positive, the study has the potential to open up a new professional perspective for Italian community pharmacists, providing this is accepted by all stakeholders: Italian medicine control agency (AIFA = Agenzia Italiana del Farmaco), Italian Ministry of Health, Italian general practitioners and hospital doctors. It is important internationally, as it is one of the largest studies ever conducted in community pharmacy and the first and largest study ever conducted in Italy, involving 75% of Italian regions

Background
Improving patients’ adherence to asthma medications?
Findings
Strengths and limitations
Full Text
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