Randomised evaluation of the Italian medicines use review provided by community pharmacists using asthma as a model (RE I-MUR)

Background The 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/Design This 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. Discussion This 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 number ISRCTN72438848. Keywords Asthma – Medicines use review – Cluster randomised controlled trial (RCT) – Community pharmac

A cluster randomised control trial to evaluate the effectiveness and cost-effectiveness of the Italian medicines use review (I-MUR) for asthma patients

Background The economic burden of asthma, which relates to the degree of control, is €5 billion annually in Italy. Pharmacists could help improve asthma control, reducing this burden. This study aimed to evaluate the effectiveness and cost-effectiveness of Medicines Use Reviews provided by community pharmacists in asthma. Methods This cluster randomised, multi-centre, controlled trial in adult patients with asthma was conducted in 15 of the 20 regions of Italy between September 2014 and July 2015. After stratification by region, community pharmacists were randomly allocated to group A (trained in and delivered the intervention at baseline) or B (training and delivery 3 months later), using computerised random number generation in blocks of 10. Each recruited up to five patients, with both groups followed for 9 months. The intervention consisted of a systematic, structured face-to-face consultation with a pharmacist, covering asthma symptoms, medicines used, attitude towards medicines and adherence, recording pharmacist-identified pharmaceutical care issues (PCIs). The primary outcome was asthma control, assessed using the Asthma-Control-Test (ACT) score (ACT ≥ 20 represents good control). Secondary outcomes were: number of active ingredients, adherence, cost-effectiveness compared with usual care. Although blinding was not possible for either pharmacists or patients, assessment of outcomes was conducted by researchers blind to group allocation. Results Numbers of pharmacists and patients enrolled were 283 (A = 136; B = 147) and 1263 (A = 600; B = 663), numbers completing were 201 (A = 97; B = 104) and 816 (A = 400; B = 416), respectively. Patients were similar in age and gender and 56.13% (458/816) had poor/partial asthma control. Pharmacists identified 1256 PCIs (mean 1.54/patient), mostly need for education, monitoring and potentially ineffective therapy. Median ACT score at baseline differed between groups (A = 19, B = 18; p < 0.01). Odds ratio for improved asthma control was 1.76 (95% CI 1.33–2.33) and number needed to treat 10 (95% CI 6–28). Number of active ingredients reduced by 7.9% post-intervention (p < 0.01). Adherence improved by 35.4% 3 months post-intervention and 40.0% at 6 months (p < 0.01). The probability of the intervention being more cost-effective than usual care was 100% at 9 months. Conclusions This community pharmacist-based intervention demonstrated both effectiveness and cost-effectiveness. It has since been implemented as the first community pharmacy cognitive service in Italy

Medicines use reviews: a potential resource or lost opportunity for general practice?

Background: Patient non-adherence to medicines represents a significant waste of health resource and lost opportunity for health gain. Medicine management services are a key health policy strategy to encourage patients to take medicines as they are prescribed. One such service is the English Medicines Use Review (MUR) which is an NHS-funded community pharmacy service involving a patient-pharmacist consultation aiming to improve patients’ knowledge of medicines and their use. To date the evidence for MURs to improve patient health outcomes is equivocal and GPs are reported to be sceptical about the value of the service. This paper presents the patient’s perspective of the MUR service and focuses on the importance of GP-pharmacist collaboration for patient care. Suggestions on how MURs may have value to GPs through the delivery of increased patient benefit are discussed. Method: A qualitative study involving ten weeks of ethnographic observations in two English community pharmacies. Observations were made of all pharmacy activities including patient-pharmacist MUR consultations. Subsequent interviews with these patients were conducted to explore their experience of the service. Interviews with the pharmacy staff were conducted after the period of observations. A thematic approach was used to analyse the data. Results: Fifty-four patients agreed to have their MUR observed of which thirty-four were interviewed. Seventeen pharmacy staff were also interviewed. Patients reported positive views about MURs. However, there was little evidence suggesting that pharmacists and GPs were working collaboratively or communicating outcomes resulting from MURs. MURs were conducted in isolation from other aspects of patient care. Patients considered GPs to have authority over medicines making a few wary that MURs had the potential to cause tensions between these professionals and possibly adversely affect their own relationship with their doctor. Conclusions: This study reveals the potential for effective GP-pharmacist collaboration to improve the capacity of the MUR service to support patient medicine taking. Closer collaboration between GPs and pharmacists could potentially improve patients’ use of medicines and associated health care outcomes. The current lack of such collaboration constitutes a missed opportunity for pharmacists and GPs to work together with patients to improve effective prescribing and optimise patient use of medicines