Pharmacy practice research assignment

University Degree Subjects allied to Medicine

PJ 2001 Rayad Chater

Pharmacy Practice Research Assignment

The authors sought to establish whether the incorporation of a medicine review and education programme would result in improved patient medicine compliance and knowledge in the general practice setting for patients aged 65 years or older. The authors set out to achieve this by selectively acquiring patients from one general practice who were 65 years or older and taking three or more medicines. Patients were unable to participate if they lived in nursing or residential care homes, were unable to self-administer their medication or suffered from a terminal illness with a life expectancy less than one year. Patients were randomly allocated to a control or intervention group following sequential recruitment from a patient list. A clinical pharmacist was appointed as the investigator who visited both groups on three occasions.

Successive reviews conducted have estimated that as much as 50% of older patients may not be taking their medicines as prescribed. This may be done intentionally due to concerns and beliefs patients have over their medication, unintentionally, or a combination of both. Numerous approaches were proposed from a previous study with the aim of improving patient medicine compliance. Such propositions have proved successful when adopted under a hospital-based self-medication scheme for hospital patients upon discharge. However, the authors want to test the possibility of extending this scheme to older patients in primary care – many of whom are treated in the general practice setting.

While the method section describes the sequence of events following each visit from the clinical pharmacist and the restricted involvement of the control group patients in visits 1 and 2, the hypothesis is not explicitly presented. For example, the authors fail to describe the associated impact the independent variable (rationalization of patients’ medication and medicines education for intervention group only) will have on the dependent variable (degree of compliance). The aim of the study is clearly stated in one sentence in the abstract section of the journal.

The question the researcher poses is applicable to pharmacy practice because pharmacists are ideally placed to reinforce educational aspects of prescribed and non-prescribed medication to patients, modify medication packaging to tailor patient needs and can instigate medication change when liaising with GPs. The study found a significant improvement in short-term patient knowledge and compliance with their medication when a clinical pharmacist educated intervention patients on appropriate medicines use. Such advice may be facilitated in the pharmacy practice setting via MURs for example. Pharmacists are also able to follow the patient’s progress over time.

This study assumes a positivist approach. This approach assumes that the relationship between observable and measurable things can be identified by careful observation, (Taylor et al 2001). In this study one of the methods used to assess compliance was tablet count which in theory indicates the extent of compliance and so gives meaning to the investigator. Furthermore, the study adopts the principle of causality in which the state of one variable – medicine review and education programme may cause the state of the other variable – improved medicine compliance, an exposure-outcome association. The study also adopts the standard research ...

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The study adopted an Intervention design which is a prospective cohort study (Karwowski 2001). Participants received three visits from the clinical pharmacist. On visit 1, the investigator tested the patients’ understanding of their medication via a structured questionnaire followed by rationalisation of the intervention patients’ medication. The second visit involved one month’s medication supply being issued to all patients while intervention patients received education on medicines use by the investigator. The final visit took place three weeks after visit 2 where patients again received one month’s medication supply and education on medicines use. Data was acquired qualitatively using a structured questionnaire and quantitatively by tablet count. The data was analysed by comparing overall mean compliance of both groups using the Mann-Whitney U-test while participants who were aware of the purpose of their medicines from visits 1 and 3 were compared by the Chi-squared test.

The study received approval from the Local Research Ethics Committee and gained informed consent from participants although the author does not describe how consent was obtained.

The evidence provided by the study is direct, i.e. the use of the intervention and the resultant outcome occurred in the same study, in contrast to indirect evidence where at least two bodies of evidence are required to relate the integration of the intervention to the observed outcome, (Eddy 1997). The authors reported an increase in compliance on the basis of one study. Ideally, the health care intervention would be evaluated over multiple studies. This would provide a larger sample size and increase the likelihood of establishing whether the increase in compliance was attributable to chance.

Subjects were randomly assigned to either the control or intervention group. This helped ensure that both groups were equivalently matched prior to treatment enhancing the internal validity of the study. The authors avoided asking for volunteers as this would be unrepresentative of the older population as they are likely to have good compliance. The method used to calculate the required sample size of 160 participants was statistically valid so the sample size is sufficient. Exclusion criteria mean results have limited applicability, for example, many older people in population may be reliant on another person to administer their medicines. In addition, elderly carers may also suffer from memory problems.

The authors randomly allocated subjects which ensured the two groups were well matched with regards to age, sex, social circumstances and number of medicines taken so minimising selection bias. However, the refusal of 20 participants to take part may have caused some selection bias, (Aschengrau et al 2003). There were no differences in patient care other than the intervention of regime rationalization and education programme being studied avoiding performance bias. However, the nature of the intervention requires the active participation of the subjects and so the patients may not have been subjected to a blinded trial. This may have affected their subsequent behaviour if they were aware of the purpose of the intervention. Although nine patients dropped out, reducing the sample size slightly, there is no attrition bias because sample attrition was not systematic, i.e. patients who dropped out did not share unique characteristics. The authors confirm this and mention that the remaining subjects remained closely matched. The authors also used a structured questionnaire to minimise observer bias while an independent observer reviewed all subject responses to achieve objectivity as it was not possible to conceal the allocation of the intervention from the investigator.

The study does not state if allowances were made for drop-outs and non-compliance when the sample size of 160 was calculated. The study has the minimum power required (0.8). One of the methods used to measure compliance – tablet count, suffers from poor credibility as it may not reflect compliance behaviour due to medicine dumping and gives little impression of the timing of doses or drug-free intervals. Also, patient knowledge and compliance were assessed three weeks after visit 2 which does not provide a long enough follow up as one month is the standard measure for chronic medication, (Armour et al 2001).

The conclusion makes clear the distinction between the quantitative findings of the study and the translation of the results into meaningful explanation. The authors conclude with respect to the research question that patient knowledge and compliance in the short term significantly increases upon exposure to a medicine review and education programme. This was justified by the study’s results for knowledge of medicines which found a tenfold increase for the intervention patients compared to the increase for the control patients. The mean compliance score was also higher (11.8%) than that of the control group.

The study was conducted in natural settings, i.e. patient homes and so is applicable to wider settings, (Blanche et al 2008). However, the study involved one investigator who educated patients on their use of medicines and so the findings may be researcher dependent, (Smith 2002). Moreover, the study consists of highly specific inclusion and exclusion criteria which limit its applicability to older patients in everyday clinical practice. The study does not suffer from measures of compliance as the nature of the target population dictated that tablet count and patient reports were the only suitable methods available. However, the subjects were selected from one GP practice in a suburban Leeds area which may not be representative of the compliance of older patients elsewhere.

Previous studies have suggested that a compliance figure of 85% is needed for older patients to benefit from treatment, (Raynor et al 1993). This study has found that the implementation of a medicine review and education programme surpassed this compliance figure in the short term. This study is more substantial than a previous one which assessed compliance of elderly patients in the hospital setting, (Lowe et al 1995). Although both studies adopted an identical study design (RCT), this study recruited a sample that is almost twice the size and provided a longer follow up duration allowing more time for the effect of the intervention to be revealed. Furthermore, the experimental population are more representative of the patients who will ultimately receive the intervention as older people are generally treated in general practice more often.

In conclusion, the study highlights a significant improvement in patient compliance and awareness of medicines for older patients in primary care following a medicines review and education programme intervention. The sample size was sufficient to meet the study’s aims while the study design was most appropriate for the purpose of the study. However, several limitations of the study exist including issues of external validity, duration of follow up, number of sites and exclusion criteria.

Word Count: 1650

References

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Aschengrau A, Seage GR, (2003), Essentials of Epidemiology in Public Health. Publisher; Jones & Bartlett Publishers. Edition: illustrated

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