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Community pharmacy based provision of pharmaceutical care to older patients |
Sturgess I K, McElnay J C, Hughes C M, Crealey G |
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Record Status This is a critical abstract of an economic evaluation that meets the criteria for inclusion on NHS EED. Each abstract contains a brief summary of the methods, the results and conclusions followed by a detailed critical assessment on the reliability of the study and the conclusions drawn. Health technology The study investigated a harmonised, structured pharmaceutical care programme provided to elderly patients by community pharmacists. Those patients attending pharmacies providing this intervention received education on medical conditions, implementation of compliance strategies, rationalisation of drug regimens and appropriate monitoring. This intervention was compared with routine community pharmacy, whereby patients received normal services.
Economic study type Cost-effectiveness analysis.
Study population The study population comprised elderly patients aged 65 years or older who were community dwelling, taking four or more prescribed medications, and who were regular visitors to the participating community pharmacy and oriented to self, time and place. Patients were excluded if they were housebound or living in a nursing or residential home.
Setting The setting was the community. The economic study was carried out at the School of Pharmacy, Queen's University Belfast, UK.
Dates to which data relate The effectiveness and resource use data were collected over an 18-month period, although the authors did not report the precise dates. The price year was 1999.
Source of effectiveness data The effectiveness data were derived from a single study.
Link between effectiveness and cost data The costing was undertaken prospectively on the same patient sample as that used in the effectiveness study.
Study sample No sample size appeared to have been determined in the planning phase of the study. In addition, no power calculations were performed retrospectively. A letter was circulated to all registered community pharmacies in Northern Ireland (n=506) inviting pharmacists to participate in the study. Fifty-seven pharmacies expressed an initial interest. Following the provision of further information, 24 remained interested and, after a personal visit from the project facilitator, 10 community pharmacies were selected according to certain criteria reported by Bernsten et al. (2001). Half of the participating pharmacies were then randomly assigned as intervention sites and the other half as control sites. Intervention pharmacies recruited only intervention patients, while control sites recruited control patients.
Eligible patients were identified via computerised patient medication records kept within the pharmacy, with the pharmacy approaching these patients. A total of 191 elderly patients were recruited into the study, 110 for the intervention group and 81 for the control group. The patients in the intervention group had a mean age of 73.1 (standard deviation, SD=5) years and 36.4% were men. The patients in the control group had a mean age of 74.2 (SD=6.3) years and 39.0% were men.
Study design The study was a randomised, controlled, longitudinal, clinical trial that was carried out in 10 community pharmacies throughout Northern Ireland. The recruited pharmacies were matched into pairs as closely as possible according to size (i.e. the total number of patients served and number of staff), situation (city versus village) and type (single proprietor versus large national chain) using a restricted randomisation technique. The groups were followed up for 18 months. The number of patients assessed was 147 (86 intervention, 61 control) at 6 months, 119 (76 intervention, 43 control) at 12 months and 110 (75 intervention, 35 control) at 18 months. Patients dropped out for a variety of reasons: unwillingness to continue with the study (15 intervention, 26 control), too ill to participate (1 intervention, 1 control), death (4 in each group), and pharmacy withdrawal due to a lack of time or higher priority activities to be performed within the pharmacy (15 intervention, 15 control). Patients who completed the study were taking significantly fewer medicines than those who dropped out, (p=0.021).
Analysis of effectiveness The authors did not report whether the analysis of the clinical study was conducted on an intention to treat basis or for treatment completers only. The health outcomes used were:
the health-related quality of life,
the number of hospitalisations,
sign and symptom control,
patient knowledge of medicines,
drug use (prescription and non-prescription),
the number of changes in medicine,
compliance with the dosage regimens, and
the number of contacts with health care professionals (nurses, general practitioners, specialist physicians).
The patients' satisfaction with the services and the pharmacists' perception of the study and care were also investigated. Both self-completed and interview-administered questionnaires were employed to collect data throughout the study. Where possible, the data were collected via an interview performed by a member of staff other than the pharmacist (e.g. pharmacy assistant). Health-related quality of life was assessed using the SF-36. Using self-completed questionnaires patients were asked if they were experiencing problems with their medicines. More specifically, problems relating to swallowing medicines, opening containers, getting medicines out of packaging, unpleasant taste of medicines, troublesome side effects, difficulty reading labels and information leaflets, and confusion on when to take medicines.
There were some differences between the two groups at baseline. For example, the intervention patients were prescribed more medications, (p<0.05). The intervention patients also reported better quality of life than control patients in all dimensions, and significant differences were observed in the mental health, physical functioning and vitality dimensions of the SF-36, (p<0.05).
Effectiveness results During the study there was a trend for the quality of life of intervention patients to decline over the 18 months, whilst that of control patients appeared to significantly improve in some of the SF-36 dimensions (physical functioning and vitality, p<0.05). However, these findings were largely driven by patients attending one control site pharmacy who showed marked improvements in SF-36 scores over time.
During the 18-month study, a lower proportion of intervention patients reported one or more hospitalisations than did the control patients (30.9% versus 36.7%). However, the difference was not significant, (p>0.05). Overall, compared with control patients, fewer intervention patients were hospitalised during the study than in the 18 months before the study. Again, this difference did not reach statistical significance.
A significant proportion of intervention patients agreed that they controlled their medical condition better during the study than before participation in the study (87.8% at 6 months 85.1% at 12 months and 83.1% at 18 months).
During the study there was little change in summary measure scores investigating the patients' knowledge of medicines in either the intervention or control patients compared with those scores obtained at baseline, (p>0.05).
The intervention patients were taking significantly more prescribed medicines at 6, 12 and 18 months compared with baseline, (p<0.05), whilst medication use for the control patients remained constant. The use of non-prescribed medicines remained at a similar level throughout the study.
From the self-reported scale, a significantly higher proportion of intervention patients were compliant with their medicine at 12 (40.4% versus 24.4%) and 18 months (47.3% versus 14.7%) than were control patients, (p<0.05). An analysis of change in compliance during the study showed that a significantly higher proportion of intervention patients changed from non compliant to compliant in comparison with the control patients (intervention 13.4% versus control 9.1%). In addition, a significantly higher proportion of control patients changed from compliant to non compliant at 18 months than did intervention patients (control 36.4% versus intervention 4.5%).
Using refill compliance rate, a significantly higher proportion of intervention patients were compliant with their medicines at 6 months than were control patients (46.2% versus 19.1%, p=0.02).
There were no significant differences between the control and intervention patients with medication problems during the first 12 months of the study. However, during the last 6 months, intervention patients reported significantly fewer problems with their medicines than control patients (0.90 +/- 1.27 versus 2.09 +/- 2.38; p<0.05).
The intervention patients reported higher numbers of contacts with their general practitioner during the first (2.89 +/- 4.44 versus 1.88 +/- 2.55) and second (2.97 +/- 2.56 versus 1.97 +/- 4.25) 6-month periods than control patients, (p<0.05). The intervention patients also reported more contact with a specialist during the second (0.89 +/- 1.25 versus 0.16 +/- 0.50) and third (0.87 +/- 2.60 versus 0.10 +/- 0.31) 6-month periods than control patients, (p<0.05).
All of the patients agreed that they were satisfied with pharmacy services. The general practitioners had a positive opinion on pharmaceutical care and its provision by community pharmacists.
Clinical conclusions The pharmaceutical care provision to community dwelling patients resulted in an improvement in medication compliance and a reduction in the number of patient-reported problems. However, the intervention had limited impact on the health-related quality of life and the patients' knowledge of medicines.
Measure of benefits used in the economic analysis The authors did not derive a summary measure of health benefits. The analysis was, in effect, a cost-consequences study.
Direct costs The authors did not report the perspective adopted in the economic analysis, or the categories of costs considered in the economic analysis. They reported that the direct costs included in the analysis were those that occurred as a direct result of the intervention. Other non-health care indirect costs, such as travel costs incurred by the patients, were not included in the analysis. The cost components were detailed elsewhere (Bernsten et al. 2001). The costing analysis was based on treatment completers only. Discounting was not necessary, as all the costs were incurred during an 18-month period, and hence it was not performed. The study reported the average cost per patient. All the costs were updated to January 1999 prices using the Retail Price Index.
Statistical analysis of costs The costs were treated stochastically. Mann-Whitney tests were used to test for statistically significant differences between the two groups, (p<0.05).
Indirect Costs The indirect costs were not included.
Sensitivity analysis No sensitivity analyses were undertaken.
Estimated benefits used in the economic analysis See the 'Effectiveness Results' section.
Cost results During the first 6 months of the study period (i.e. 0 to 6 months), the average cost per patient over the study period was 558.40 for intervention patients and 865.90 for control patients. This resulted in an average cost-saving of 307.49 per patient, but the cost-difference was not statistically significant, (p=0.39).
During the second assessment period (7 to 12 months), the average cost per patient over the study period was 462.83 for intervention patients and 568.33 for control patients, (p=0.18).
During the third assessment period (13 to 18 months), the average cost per patient over the study period was 531.56 for intervention patients and 539.98 for control patients, (p=0.65).
Synthesis of costs and benefits The costs and benefits were not combined.
Authors' conclusions The provision of pharmaceutical care to community dwelling patients resulted in an improvement in medication compliance, a reduction in the number of patient-reported problems and evidence of cost-savings.
CRD COMMENTARY - Selection of comparators A justification was given for the comparator used. It represented current practice in the authors' setting. However, the authors did not provide any details of what current practice entailed. They also provided very little information on the intervention, making it difficult for the reader to precisely understand the nature of the services provided by the intervention and current practice.
Validity of estimate of measure of effectiveness The analysis was based on a randomised controlled trial (RCT). This was appropriate for the study question as well-conducted RCTs are considered the 'gold' standard study design when comparing health interventions. However, as the authors acknowledged, before randomisation, pharmacies decided whether or not to enter the study, with very few doing so (approximately 5%). Hence, there is the possibility that these pharmacies will be different from the average pharmacy in Northern Ireland, thus limiting the generalisability of the authors' results. There were some differences between the two groups at baseline. For example, the intervention patients were prescribed more medications (p<0.05). The intervention patients also reported better quality of life than control patients in all dimensions, and significant differences were observed in the mental health, physical functioning and vitality dimensions of the SF-36, (p<0.05). It would appear, although it was unclear, that the clinical study was analysed for treatment completers only. Appropriate statistical analyses were undertaken to test for statistically significant differences between the two groups.
Validity of estimate of measure of benefit The authors did not derive a measure of health benefits. The analysis was, in effect, a cost-consequences study.
Validity of estimate of costs The authors did not report the perspective adopted in the study, or the direct costs included in the analysis. Hence, it was not possible to determine whether there were any important cost omissions. However, it would appear from this paper that relevant details of the costing methodology were reported by Bernsten et al. (2001). As the costs and the quantities were not reported separately, this will limit the generalisability of the authors' results. Appropriate statistical tests were undertaken to detect any statistically significant differences in mean costs between the two groups of patients. However, it would appear that the study was not sufficiently powered to detect any such differences between the two groups. The authors converted all costs into 1999 prices, which will assist any inflation exercises, but they did so using the Retail Price Index instead of the appropriate health index. As health care inflation has been generally higher than average inflation, this will potentially have underestimated the true costs.
Other issues The authors reported that studies investigating the outcomes of community pharmacy-based pharmaceutical care documented improved quality of care and reduced medication costs, more appropriate prescribing in patients receiving polypharmacy, and decreased physician consultations. Such programmes have also been reported to improve outcomes in patients with asthma, diabetes, hypertension and hyperlipidaemia. The issue of generalisability to other settings was not addressed. The authors do not appear to have presented their results selectively and their conclusions reflected the scope of the analysis.
The authors reported that the main limitation of this study was that it was too ambitious, in terms of data collection and outcome measurement, and that this might have resulted in research fatigue on the part of the community pharmacists and recruited patients. Hence there was a big drop-out in patients over the course of the study. Further, the conclusion of the cost analysis (i.e. there is evidence of cost-savings) appears too optimistic since no statistically significant differences in the costs were reported between the two groups. In addition, as information provided on the cost analysis was limited, it was difficult to make an objective assessment of the validity of the results.
Implications of the study The authors reported that further research is needed on new practice implementation and on the impact of new models of care. The authors also reported that future pharmaceutical care studies may benefit from a more focused selective approach to data collection and outcome measurement.
Source of funding Funded by the Northern Pharmacies Trust, Northern Ireland, and the European Commission under the BIOMED 2 programme.
Bibliographic details Sturgess I K, McElnay J C, Hughes C M, Crealey G. Community pharmacy based provision of pharmaceutical care to older patients. Pharmacy World and Science 2003; 25(5): 218-226 Other publications of related interest Bernsten C, Bjorkman I, Caramona M, et al. Improving the well-being of elderly patients via community pharmacy-based provision of pharmaceutical care. Drugs and Aging 2001;18:63-77.
Lobas NH, Lepinski PW, Abramowitz PW. Effects of pharmaceutical care on medication cost and quality of patient care in an ambulatory care clinic. American Journal of Hospital Pharmacy 1992;49:1681-8.
Hammerstrom B, Wessling A, Nilsson JL. Pharmaceutical care for patients with skin diseases: a campaign year at Swedish pharmacies. Journal of Clinical Pharmacy and Therapeutics 1995;20:327-44.
Indexing Status Subject indexing assigned by NLM MeSH Aged; Community Pharmacy Services /economics /standards; Costs and Cost Analysis; Data Collection; Drug Therapy /economics /standards; Drug Utilization; Drug-Related Side Effects and Adverse Reactions; Female; Hospitalization; Humans; Longitudinal Studies; Male; Northern Ireland; Patient Compliance; Patient Education as Topic; Patient Satisfaction; Pharmacists; Quality of Life; Treatment Outcome AccessionNumber 22004006086 Date bibliographic record published 30/11/2005 Date abstract record published 30/11/2005 |
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