  Can pharmacists influence the health-related quality of life of patients with asthma? The New Zealand Pharmaceutical Care experience *Nadir Kheir, Lynne Emmer ton, John Shaw Division of Pharmacy, Faculty of Medical and Health Sciences, The University of Auckland, Private Bag , Auckland, New Zealand *To whom correspondence should be addressed. E-mail: n.kheir@auckland.ac.nz A B S T R AC T. Background: The newly emerging practice of Pharmaceutical Care requires that pharmacists take responsibility for the outcomes of drug therapy. Improvement in Quality of Life (QoL) represents the final outcome of the care process and indicates the success of interventions. Objectives: To assess the impact of a Pharmaceutical Care specialist asthma service provided by community pharmacists to a sample of patients with asthma, the outcome indicators being changes in health status and QoL. Method: Sixty-two adult asthma patients ( years and older) living in two rural regions of New Zealand, were segregated into two groups for phased introduction to the service. The patients acted as their own controls before they received the pharmacists’ service. They had been diagnosed with asthma at least six months previously, and their asthma was symptomatic and not considered optimally controlled prior to the study. Results: There was significant improvement in asthma-related QoL (as measured by the Asthma Quality of Life Questionnaire) following introduction of the service, and pharmacists were able to identify, prevent or resolve over  drug-related problems. Conclusion: The results suggest that with appropriate training and support, New Zealand pharmacists can help asthma patients achieve greater quality of life. This research has implications for the introduction of Pharmaceutical Care services in other countries and for patients with other conditions who require ongoing management. Key words: Pharmaceutical Care, Quality of Life, asthma, pharmacists, T      morbidity and mortality has increased worldwide, representing a challenge to healthcare providers.1,2 Consequently, clinical services are sought to help patients manage their condition effectively. New Zealand pharma- cists have formally embraced the internationally recog- nised practice of Pharmaceutical Care, and New Zealand has now probably the largest number of Pharmaceutical Care trained pharmacists per capita in the world.3,4 In a widely publicised article, Hepler and Strand defined the process of Pharmaceutical Care as ‘the responsible provision of drug therapy intended to achieve definite outcomes that will improve a patient’s quality of life.’5 is definition suggests that, as healthcare professionals, pharmacists take responsibility for the outcomes of drug therapy by adopting an active role in patient management. As the ultimate goal of drug therapy should be to improve the patient’s health-related quality of life (QoL), it     :   , : , : , – ©   Asthma New Zealand ����� ���� ����� ������ ������� ��� ������� ������� ���� ��: ������ ������������� ���� ������ ���� ������ ��� ������:�����:����� ����� ������� �������� �������� ������� ������ ������ �������� ������� ����� ����������� �������. �������:����� ������������ ����� ���� �� ���� )������� ���� (������� �� ������� ������� ����� �������� �������� ��� ������� � �������� ������ .����� ����� �������� ������ ������������ ���� ��� ������ ��� ����� .��� ��� ������ ����� ����� �� ��� ��� ��� ������ ����� ����� ������� ��� �� ����� ������ ����� ���� ����� ����� �� ����.�������:�������� ��� �� ���� ���� � �� ���� ���� ����� �� �������� ���� ��� ������ ����� ��� ����� ���� ���� ����� ����������������� ���� ��� �����.������:��� � ���� ����� ��� ������ �� ����� ���� ������ �������� ������� ���� ������� ������� ����� ��� ���������� .��������� ����� ��� ������ ������ ����� ���� ����� ����� ���� ����� �� �������� ������� �����.   is imperative to assess the impact of medical interventions on QoL. While considerable evidence exists demonstrat- ing the worth of Pharmaceutical Care on a variety of patient outcomes, little has been provided on the impact of Pharmaceutical Care on QoL as an end-point in the healthcare process. For example, Fischer et al suggested that Pharmaceutical Care appears to increase the informa- tion given to patients about medications, promote more effective self-administration of medications by encourag- ing patients to use systematic reminders, and increase awareness of medication side effects.6 In another study, patients receiving Pharmaceutical Care reported receiving more information about asthma self-management, were more likely to monitor peak flow readings, and had increased satisfaction with care.7 Munroe and colleagues reported that pharmacists’ inter- ventions in a community pharmacy-based disease man- agement model substantially reduced monthly healthcare costs in patients with hypertension, hypercholesterolaemia, diabetes, and asthma.7 More evidence is needed on the impact of Pharmaceutical Care on subjective outcomes, specifically QoL. is paper outlines the findings of a Pharmaceutical Care specialist asthma service conducted as a demonstra- tion project by the pharmacists in New Zealand. Although the paper does not provide data pertaining to the impact of the service on economical outcomes, the research has implications for other countries faced with rising second- ary care costs due to asthma and other chronic conditions. M E T H O D S e 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. is study was conducted in five community pharmacies in Otago/Southland regions of New Zealand over a two- year period. e 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. e study was approved by the local ethics committee and patients gave informed written con- sent 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  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. e 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-assess- ment and by the frequency of visits to collect asthma medication. e patients were phased into the study in groups of  per pharmacy for stepwise introduction to the service. is avoided the pharmacies being overwhelmed by large num- bers 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  included patients whom the research team felt were in need of immediate intervention. e study design dictated that Group  receive the intervention first. It was consid- ered unethical to deny these patients the opportunity for immediate care. At baseline (T), face-to-face interviews were con- ducted with all the patients. Data collected included QoL, specific symptoms, utilisation of health services, and beta-agonist (‘reliever’ medication) use. Group  patients          ���������Classification of Medication-Related Problems ������ ��������������������� �������������������������� ���������������������������������������������������������������������������������������������������������������������������� ����������������������� ��������������������������������������������������������������������������������������������������������������� ������� �������������������������������������������������������������������������������������������������������������������� ����������� ������������������������������������������������������������������������������������������������������������������������������������ ������������������������������ �������������� ������������������������������������������������������������� �   then underwent a one-month run-in period during which standard pharmacy services were delivered (prescription- related counselling, basic monitoring, advice on request). Immediately aer the run-in period, the service was intro- duced to Group . Group  continued their run-in period for another four months, during which they received no intervention. Only the data pertaining to adult patients (aged  years and over) in Groups  and  (year  of the study) are cov- ered 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 proto- cols, 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 inter- views with their patients at monthly intervals or as needed. e process was based on the guidelines of Strand et al, given below.9 . 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. e pharmacist also performs peak flow measurements, acquires the medication history, contacts other health professionals where necessary, checks compli- ance with asthma medication standards including inhaler technique, and documents the data using the soware ‘Cognicare’, a window-based pharmaceutical care pro- gram designed for point-of-care cognitive services provi- sion. . Assessment 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 (‘pre- venter’ medicines), and poor inhaler technique [Table ]. . Care Plan Based on the findings of steps  and  the pharmacist devel- ops a plan to eliminate or minimise medication-related problems and maximise desired outcomes. is may involve written recommendations and an Asthma Action Plan based on peak flow readings and symptom diaries. . Patient education, recommendation and referral e 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. . 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. e medication-related problems were categorised for descriptive analysis. e 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- (SF-) and the Asthma Quality of Life Questionnaire (AQLQ).11,12 e SF- is a general health questionnaire used interna- tionally 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 e responses are transformed to a scale of –, where  denotes extreme impairment and  no impairment. e AQLQ is an asthma-specific QoL questionnaire, which has  items that address QoL in four domains: activity limitation, symptoms, emotional function, and environmental stimuli. e response options are on a seven- point scale, where  indicates maximal impairment and  indicates no impairment. e 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 e 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.                                    Statistical Analysis Quantitative data for analysis included general and asthma- specific QoL data at baseline (T) and following four months of provision of the service (T). e significance of change in QoL at T was expressed using analysis of vari- ance, and p<. was considered statistically significant. e 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 (T) to follow-up (T) by the standard deviation of the score at baseline.15 An Effect Size of  was considered small,  moderate and  large.16 e outcomes of medication-related problems and asthma symptoms were expressed qualitatively using the documentation system available, and detailed results have been published elsewhere.3 R E S U L T S Of the  adult asthmatics ( males) recruited, one with- drew for personal reasons. Demographics of the patients and their QoL status at baseline (T) are shown in Table . In summary, there were no significant differences between the two groups in their mean age, asthma duration, asthma severity, asthma-specific QoL, and general QoL as meas- ured by the PCS and the MCS.           Table  shows the change in QoL of Group  aer receiving the service for four months. With the exception of the envi- ronmental domain, all domains of the AQLQ, including the overall AQLQ, indicated different levels of statistically significant changes at T with a corresponding Effect Size. Neither the PCS nor the MCS of the SF- indicated significant change at T (p=., and ., respectively). e AQLQ scores of Group  patients were also meas- ured at T, at which time, this group were still receiving their baseline service [Table ]. Apart from the Activity domain (p = .), all domains of the AQLQ indicated small, non-significant improvements. Again, general health, as measured by the PCS and the MCS, did not show significant difference at T in both the groups of patients.           While the current study design specifically addressed changes in QoL in the two groups, other outcomes were collated and analysed in a more quasi-experimental and qualitative manner in the whole sample. Individual case studies were used to provide evidence for the potential effectiveness of the service in different outcomes.3 A total of  medication-related problems were identi- fied by the pharmacists, and all were documented using          �������� Change in AQLQ Scores (Group 1 patients, n=34) ������� ��������� ����� ����� �������� ���������� ����������� �� ��������� ���� ��������� ���������� ���������� ���������� ����� ���� ��������� ���������� ���������� ���������� ����� ���� ���������� ���������� ���������� ���������� ����� ���� �������������� ���������� ���������� ���������� ����� ���� ������������� ���������� ���������� ���������� ����� ���� �� ����������������������� ��� ������������������������������������������������������������������������������� �� ����������������������������������������������������������������������������� � � � ���������Baseline (T1) characteristics of Group 1 and Group 2 patients (n=62) � ��������������� ��������������� ���������� ��������������� ���������� � ������������ ����� ������ ����� ������ ����� ������������������������ ����� ������ ����� ������ ����� ���������� ���� ������ ���� ����� ����� ������������� ���� ����� ���� ����� ����� ����������� ����� ������ ����� ������ ����� ����������� ����� ����� ����� ������ ����� �� ������������������������������������������������������������������ ������������������������������� � � ���������Change in AQLQ Scores (Group 2 patients, n=28) � ������� ��������� ���������� ������������� ����������� �� ��������� ����� ��������� ���������� ����������� ���������� ����� ���� ��������� ���������� ����������� ���������� ����� ���� ���������� ���������� ����������� ���������� ����� ���� �������������� ���������� ����������� ���������� ����� ���� ������������� ���������� ����������� ���������� ����� ���� ��� ����������������������� ����������������������������������������������������������������������������������� �� ����������������������������������������������������������������������������� � � �                                   ���������Examples of problems faced by pharmacists providing Pharmaceutical Care � ����������������� ������������������� ���������������������������������������������� ����������������������� �������������������� ����������������������� ������������������������������ ������������������������������������������������������������� ������������������������������������������������������������� ������������������������������������������ ���������������������������������������������������������������������������������� ������������������������������������������� ������������������������������������������� �� ��������������������������������������������������������������� ��� �������������������������������������������������������������������������������������������������� � the designated computer soware. ere was no important difference between the groups, as these issues had been identified in the initial interview. On average, . medica- tion-related problems were detected per patient, although the range was wide (between  and  per patient). About half of the patients recruited had approximately half of their medication-related problems resolved within the first six months of receiving the service. Ten patients had at least  of their problems resolved. e pharmacists found out that while some problems were easy to resolve with simple interventions, others were more complex, some warranting referral to the general practitioner for more specific man- agement. Table  gives examples of the simple and complex problems faced by the pharmacists. e medication-related problems were classified as per the Hepler and Strand model, and about two-thirds were of ‘compliance/understanding’ type, such as overuse of bronchodilators and under-use of corticosteroids.10 e remaining problems were mostly related to choice of devices and adverse drug effects. Choice of the drug did not feature highly, indicating that in most cases the choice of treatment was correct, but the patient did not know how to use the medication properly, or had chosen not to use it. All patients received some kind of intervention, including revision of Action Plan, referral to the GP, and/or further counselling or education. D I S C U S S I O N is study provided data that suggest that motivated and well-trained pharmacists can influence asthma-related outcomes in the community, with improvement in asthma- related QoL. e pharmacy services in New Zealand are fully com- puterised, both at the community and the hospital levels. e consequent efficiency in in storage and access of medi- cation histories enables quick identification of patients with medication-related problems, such as those failing to collect repeat prescriptions, and those who collect their bronchodilator therapy but not their inhaled corticoster- oid therapy. In the current study, the pharmacists used their computer facilities to identify patients who were potentially suitable for inclusion in the study. Asthma has been chosen in the current study because of its impact on QoL. While it affects all age groups, older asthmatics have reportedly had significantly worse QoL than age- and sex- matched controls, and had more frequent depressive symp- toms.17 During an asthma attack, the patients’ functional capacity, and consequently their capability to lead normal daily life, becomes impaired. Asthma sufferers report a wide range of restrictions due to their condition. ese include difficulties in performing housework, time off work, disruption of social life, avoid- ance of certain foods, and extra expenditure incurred in modifying their environment to suit their condition.18 Emotional problems such as fear, helplessness, dependence and depression have also been identified as consequence of asthma in addition to physical one such as chronic lung diseases.19 erefore the most important goals in asthma management are improving patients’ everyday functioning, their emotional and social lives and subjective well-being. erefore, it would be logical to assume that should a demonstrable improvement in QoL occur, the main objec- tive of this specialist service could be considered achieved. Pharmaceutical Care services seek to add new dimen- sions to pharmacy practice, and to re-direct the focus of pharmacists from the product to the individual patient. Structured and focussed processes have enabled the pharmacists participating in this study to realise improve- ments in daily performance of most patients. is has been demonstrated in the change observed at follow-up (aer four months of provision of the service), and evidenced by Effect Size, a statistical method that has been widely advocated in biomedical research to quantify magnitude of change.15 Effect Size has become popular in the social           and behavioural sciences, but not so much in medicine.16 While traditional clinical measures can estimate concrete phenomena related to change in biological function- ing, they fall short of quantifying change in health status that have no direct biological meaning, such as anxiety, depression, and QoL limitations. Effect Size measures the magnitude of change or ‘the clinically important change’ in health status, and not the statistical significance of the change.15 e larger the Effect Size, the greater the degree to which the phenomenon under study is manifested. e Effect Size therefore serves as an index of the degree of departure from the null hypothesis. In the current study, a moderate Effect Size was observed in the overall QoL and in the symptoms domain of the patients who received the service. e majority reported significantly fewer asthma symptoms, fewer asthma-related emotional problems, and better performance of daily activities. at these changes occured within a short period, could be due in part to the erratic nature of asthma. However, simple interventions like correction of inhaler technique can lead to dramatic improvement in a short time.20 Restrictions due to envi- ronmental triggers were found to be the most resistant to improvement. Identification and avoidance of asthma trig- gers remains the best solution for these patients. e SF- Physical and Mental Component summaries did not reflect significant changes in the patients’ general QoL. However, the SF- taps areas of health that might have only been slightly affected by asthma, while the AQLQ, being specific to asthma, demonstrated greater sen- sitivity in detecting change. e participating pharmacists acquired new commu- nication and cognitive skills in their dealings with both patients and other health practitioners. Indeed, the quality of interaction between the patients and their health pro- fessionals should determine to a large extent whether the desired outcomes are achieved. For example, the patient’s understanding of the importance of treatment influenced compliance more positively than the presence of perceived side effects, which again reflects the importance of com- munication with the patient.21 Good communication, improved education, and tailoring therapy to the indi- vidual needs of the patient are all considered to improve asthma outcomes.22 In cases of mild asthma, rigid adher- ence to long-term daily peak flow measurement without taking into account the individual needs, does not appear to improve outcomes.23,24 As part of the intervention, medication-related prob- lems were identified and acted upon. Results related to medication-related problems were reported in a more qualitative manner, and a brief cross-section of these has been provided in the current article, where the emphasis is more towards the impact of the service on QoL. e study also provided insight into the applicability of the Pharmaceutical Care service, and the difficulties faced by the pharmacists involved. ese have also been reported elsewhere.3 Finally, while the sample size recruited might appear small, it is of the same order as in other QoL studies and was based on calculations by Guyatt et al using the Responsiveness Index approach.25–26,27 C O N C L U S I O N e pharmacist’s role and place in the healthcare structure has changed, and new opportunities have emerged. Results from this study provide evidence that through providing structured, co-operative, patient-oriented Pharmaceutical Care, pharmacists can help asthma patients achieve desired health outcomes.              e authors thank the five pharmacists and the patients who took part in the study, and acknowledge the financial funding provided to the project by the Health Funding Authority of New Zealand and GlaxoWellcome (New Zealand) Limited. R E F E R E N C E S . Lockey RF, DuBuske LM, Friedman B, Petrocella V, Cox F, Rickard K. Nocturnal asthma: effect of salmeterol on quality of life and clinical outcomes [In Process Citation]. Chest , , –. . Barnes PJ, Jonsson B, Klim JB. e costs of asthma. Eur Respir J , , –. . Shaw JP, Emmerton L, Kheir N, Smith N, Clareburt R, Barron P, et al. Otago/Southland Comprehensive Pharmaceutical Care Asthma Project [Final report]. Dunedin: School of Pharmacy, Uni- versity of Otago, . . Hepler CD. 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