What is the problem to be addressed?
It is estimated that around 300 million people in the world have asthma with an additional 100 million cases predicted by 2025 [
1]. The number of disability-adjusted life years (DALYs) lost to asthma worldwide has been estimated to be around 15 million per year with an estimated one in every 250 deaths worldwide caused by asthma [
1].
Prevalence of asthma in the European adult population, age 18–44, varies from country to country, with the highest value in Sweden (20.62%) and the lowest in Bulgaria and Lithuania (2%); in Italy it is 6.2% [
2].
The total cost of respiratory diseases in the 28 countries of the EU alone amounts to more than €380 billion annually with asthma accounting for €33.9 billion [
3]
. The total bill includes the costs of direct primary and hospital healthcare (around €55 billion), the cost of loss of production (nearly €42 billion) and the monetized DALYs lost (at least €280 billion).
Overall cost of asthma, including individual direct costs, indirect costs and intangible quality of life costs have been related to severity of asthma [
4-
6].
In 2000, a COI (Cost of Illness) study was carried out in Italy in the frame of the Italian Study on Asthma in Young Adults. The mean annual costs for an asthmatic patient was €741 (95% CI: 599–884) ranging from €379 (95% CI: 216–541) for well-controlled asthmatics to €1,341 (95% CI: 978–1,706) for poorly controlled cases that accounted for 46.2% of the total cost [
7].
Pharmacists’ role in asthma management
Pharmacists have the potential to improve asthma severity through interventions, which include counseling on inhaler technique, medicine therapy management and medicines use review (MUR) [
8-
12].
A portrait of the pharmacy profession around the world suggests a wide variation in the practice of pharmacy, not only between countries but also within countries [
13].
In England, the Isle of Wight Respiratory project, involved health care practitioners including community pharmacists. The aim was to reduce respiratory death, hospital admission and the cost of respiratory medication. In this study, general practitioners referred patients to their community pharmacist for inhaler technique training. 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%. A review on the NICE shared database highlighted that the training of health care practitioners carried a cost, which was paid back seven times over with the reduction in cost of bronchodilators within one year of the project [
14].
In Denmark, a prospective controlled multicenter study, aimed to improve asthma severity (status) by increasing the participation of pharmacists and promoting cooperation with patients and the patient’s general practitioner (GP). The study recruited 500 asthmatic patients from primary care, and found improvements in asthma symptoms status, quality of life and days of sickness [
15].
In Finland, a 10-year asthma program was undertaken from 1994 to 2004 to improve asthma care and prevent asthma costs increasing, using general practitioners, nurses, and pharmacists. The main goal of this program was to lessen the burden of asthma to individual and to society. Pharmacists provided patients with written or oral information on preventers and relievers during 98% of asthma medication purchases, plus gave instruction on inhalation technique to 98% of newly diagnosed asthmatic patients and 34% of patients with existing disease. Pharmacists’ intervention combined with the ones provided by GPs and nurses contributed to reduce the number of days patients were in hospital which fell by 54%; the increasing cost of asthma had stopped and the annual cost per patient decreased by 36% from €1,611 to €1,031 [
16].
An Australian multi-site randomised controlled trial compared pharmacist counseling on asthma, asthma medication and associated lifestyle advice with a control group providing usual care. Fifty pharmacies were enrolled and randomly allocated to one of the two groups (randomisation conducted at pharmacy level), the intervention group with 191 patients and the control group with 205 patients. In both groups questionnaires and spirometric testing were carried out at baseline and at six months. The main outcome measure was asthma severity/control status assessed by a tool adapted from the National Asthma Council. The percentage of patients in the intervention group classified as having severe asthma declined from 87.9% to 52.7% (p < 0.01), whilst the change in the control group the change was not significant (71.2% to 67.9%; p = 0.11). These authors used a multilevel logistic regression model to adjust for the difference in asthma severity at baseline and to account for any possible effect from clustering. Both pharmacist groups administered questionnaires and spirometric testing at baseline and six months later; it was found that patients in the intervention group were almost three times more likely to change from the severe asthma category to the not severe category than patients in the control group (OR 2.68, 95% CI 1.64 to 4.37 p < 0.01) [
17].
Medicines use reviews in asthma
The Medicines Use Review (MUR) service was first introduced in England in 2005 as an advanced service in the community pharmacy contractual framework. The aim of the MUR is to achieve a concordant consultation about medicine-taking by establishing the patient’s actual use, understanding and experience of taking their medicines, with the ultimate aim of improving the clinical and cost-effectiveness of prescribed medicines, reducing medicines wastage and improving patient outcomes through improved adherence [
18].
Portlock et al. [
19] conducted a study in England in which 965 MURs were undertaken in patients with asthma. Pharmacists identified that 37% of the patient population were primarily non-adherent (i.e. collected < 75% of intended asthma prescriptions in the previous 12 months) and a further 31% had secondary adherence issues (i.e. not taking their medications in the way they had been intended). Pharmacists made 1,787 interventions (mean 1.8 per MUR consultation) of which 41% were device checks, 10% were referral to a GP or nurse and 49% were educational.
Another study involving 154 patients with asthma receiving an MUR found that the proportion of patients whose asthma was not controlled fell from 59% to 45% (p < 0.01), 30% of patients were referred to their GPs or asthma nurse as a result of their MUR and, of those referred, 70% had a treatment or dosage change [
20].
Italian medicines use review (I-MUR)
This study is about developing a similar service in Italy where no such services exist. The I-MUR has been designed as a structured interview, supported by a quantitative questionnaire enabling pharmacists to capture in a systematic way a patient’s demographic data, quantity and type of medicines used, their knowledge about the medicines used, their adherence to the medicines, actual complaints (e.g. shortness of breath, chest tightness, night time waking, need for rescue medicines, limitation on activity including exercise), plus any pharmaceutical care issues identified by the pharmacists, the advice given to physicians and to patients, including healthy living advice, using an online platform (Qualtrics®).
The Italian government is considering introducing the I-MUR service, but at present there is no evidence from Italy on the feasibility, acceptability or effectiveness of such a model. Hence there is a need to gather robust data on all aspects of the potential new service to inform service design and delivery.
A pilot study was carried out between October 2012 and January 2013, to assess the feasibility of Italian community pharmacists delivering I-MURs to patients with asthma [
21]. In this phase, the MUR template used in England was adapted and supplemented with a structured interview to be conducted with patients. The template also included the classification of pharmaceutical care issues (PCIs) which were potentially identifiable by pharmacists during the patient consultation. Pharmaceutical care issues were classified using the method developed by Krska et al. [
22] where they are defined as “an element of a pharmaceutical need which is addressed by pharmacists”. This enabled pharmacists to categorize, using a systematic approach, all issues they found during the consultation.
This pilot study was carried out in four Italian regions and involved 74 pharmacists who provided the I-MUR to 895 patients during a four-month period, following training [
23]. The training provided was evaluated and pharmacists’ views on the service provision sought through focus groups. Poor adherence was found in 45% of the 895 patients and only 18% had either no asthma-related problems – either actual complaints or medicine-related problems. Pharmacists identified pharmaceutical care issues in 60% of patients; they provided 1008 items of medicine-related advice to GPs and 1321 to patients, plus 1219 items of healthy living advice. Pharmacists’ clinical knowledge increased by 24%; following training and I-MUR service provision.
Following this pilot study, which focused on pharmacists, a second study, conducted between October and November 2013, sought to obtain patients’ feedback and GPs’ views on the I-MUR service provision. All patients who had received the I-MUR service previously were invited to complete a feedback questionnaire. Responses were obtained from 246 patients (27% response rate). The questionnaire found that 50% of patients were neither worried nor had problems with their medicines before having the I-MUR, but 75% of them confirmed that they benefited from the service. Seventy-five percent of patients also indicated they felt involved in all the discussion, 37% confirmed that I-MUR found problems with their medications and 27% agreed that changes were made to their medication after the I-MUR. Half the patients would consider having another I-MUR and 85% would recommend the service to other patients [
24]. A focus group was held which was attended by four GPs. GPs’ views about I-MUR was positive. They identified the potential for the I-MUR to improve patients’ adherence, quality of life, result in safer use of medicines and better health care outcomes. GPs suggested developing and sharing training sessions, underlining the fact that GPs and pharmacists should work together, empowering each other, and sending a consistent message to their patients [
25].
In Italy no other work has been conducted on asthma involving community pharmacists, therefore this current study is needed to determine whether the I-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. The study will provide evidence about the practicability and costs of provision and the effectiveness of the I-MUR in asthmatic patients.