The aim of the study was to assess the health-related and QoL outcomes in a group of asthma patients receiving a pharmacy-based asthma management service.
This study was conducted in five community pharmacies in Otago/Southland regions of New Zealand over a two-year period. The School of Pharmacy, University of Otago, co-ordinated the study, which was funded by the Health Funding Authority with support from GlaxoWellcome New Zealand Limited. The study was approved by the local ethics committee and patients gave informed written consent to participate.
In consultation with the patients’ general practitioners, who were kept informed about the aims and progress of the study, pharmacists from the five pharmacies recruited 20 medically-diagnosed asthma patients each. Inclusion criteria were that (i) the patients had been diagnosed with asthma at least six months previously, (ii) their asthma was symptomatic and not optimally controlled, and (iii) they did not suffer other co-morbidity. The latter criterion was based on the assumption that other chronic conditions could interfere with health outcomes measured, including the patient’s QoL, and could make it difficult to identify the effect of the intervention on asthma. However, to simulate real-life situations, it was decided that if a concomitant condition were identified during the study, the patient continued participation. Prior to the study, the status of the patients’ asthma was estimated by subjective self-assessment and by the frequency of visits to collect asthma medication.
The patients were phased into the study in groups of 5 per pharmacy for stepwise introduction to the service. This avoided the pharmacies being overwhelmed by large numbers of patients at one time, and allowed variable baseline measurement periods for the pre- and post-intervention measures.
Based on a preliminary rating of asthma that used input from patients and their pharmacists, the patients were divided into two groups. While all patients recruited had what appeared to be poorly controlled asthma, Group 1 included patients whom the research team felt were in need of immediate intervention. The study design dictated that Group 1 receive the intervention first. It was considered unethical to deny these patients the opportunity for immediate care.
At baseline (T1), face-to-face interviews were conducted with all the patients. Data collected included QoL, specific symptoms, utilisation of health services, and beta-agonist (‘reliever’ medication) use. Group 1 patients then underwent a one-month run-in period during which standard pharmacy services were delivered (prescription-related counselling, basic monitoring, advice on request). Immediately after the run-in period, the service was introduced to Group 1. Group 2 continued their run-in period for another four months, during which they received no intervention.
Only the data pertaining to adult patients (aged 17 years and over) in Groups 1 and 2 (year 1 of the study) are covered in this review.
Patient training in both asthma management and the provision of the service was provided by the staff from the School of Pharmacy, University of Otago, in co-ordination with other specialists. Specific material was provided on asthma presentation, aetiology, diagnosis, treatment protocols, therapies, devices, monitoring and features in special populations, such as children and pregnant women. An asthma educator attended the three training sessions.
Pharmacists initiated the service by arranging interviews with their patients at monthly intervals or as needed. The process was based on the guidelines of Strand et al,
1. Patient consultation
At this initial step, pharmacists elicit information on the patients’ asthma and other relevant history, including their concerns and understanding of their condition and their medication. The pharmacist also performs peak flow measurements, acquires the medication history, contacts other health professionals where necessary, checks compliance with asthma medication standards including inhaler technique, and documents the data using the software ‘Cognicare’®, a window-based pharmaceutical care program designed for point-of-care cognitive services provision.
At this stage, the pharmacist assesses the patient’s entire therapy, seeking potential or actual medication-related problems, such as overuse of bronchodilators (‘reliever’ medicines), under-use of inhaled corticosteroids (‘preventer’ medicines), and poor inhaler technique .
Classification of Medication-Related Problems
3. Care Plan
Based on the findings of steps 1 and 2 the pharmacist develops a plan to eliminate or minimise medication-related problems and maximise desired outcomes. This may involve written recommendations and an Asthma Action Plan based on peak flow readings and symptom diaries.
4. Patient education, recommendation and referral
The pharmacist provides individualised education to the patient on drug therapy and usage of medication, and demonstrates inhaler technique and the ways to identify and avoid asthma ‘triggers’. If necessary, the pharmacist refers the patient to a general practitioner for specific assessment and management.
5. Patient monitoring and follow-up
Monitoring enables the pharmacist and the patient to assess the progress towards therapeutic goals, and assures that new medication-related problems are avoided, and that the outcomes are evaluated and documented. Both prevention and resolution of medication-related problems are a focus of the service.
The medication-related problems were categorised for descriptive analysis. The classification system was based on a widely used United States system, with emphasis on asthma management.10
Quality of Life Measures
Two questionnaires were used to quantify quality of life (QoL): the Short Form-36
(SF-36) and the Asthma Quality of Life Questionnaire
The SF-36 is a general health questionnaire used internationally and previously validated for use in New Zealand. It has eight domains of health that are generally summarised into Physical and Mental Component Summaries (PCS and MCS, respectively).13
The responses are transformed to a scale of 0–100, where 0 denotes extreme impairment and 100 no impairment.
The AQLQ is an asthma-specific QoL questionnaire, which has 32 items that address QoL in four domains: activity limitation, symptoms, emotional function, and environmental stimuli. The response options are on a seven-point scale, where 1 indicates maximal impairment and 7 indicates no impairment. The participants are shown their previous answers before they give their new responses to the same questions (an ‘informed response’ strategy). Responses to the AQLQ were analysed as the mean for the overall AQLQ and its separate domains.
Self-completed Asthma Symptoms Diary
The patients were asked to keep daily diaries documenting their asthma symptoms and peak flow monitoring record, based on the variables and scales used in existing asthma diaries.14
Diaries were brought to the pharmacist at each subsequent appointment.
Quantitative data for analysis included general and asthma-specific QoL data at baseline (T1) and following four months of provision of the service (T2). The significance of change in QoL at T2 was expressed using analysis of variance, and p<0.05 was considered statistically significant. The magnitude of the post-intervention change in scores was assessed by calculating the Effect Size of the overall and individual domain scores. Effect Size was calculated by dividing the change in the mean scores from baseline (T1) to follow-up (T2) by the standard deviation of the score at baseline.15
An Effect Size of 2 was considered small, 4 moderate and 8 large.16
The outcomes of medication-related problems and asthma symptoms were expressed qualitatively using the documentation system available, and detailed results have been published elsewhere.3