Complementary therapies, the placebo effect and the pharmacist

Pharmacists need to know about complementary therapies so they can advise patients on their suitability, and also their compatibility with conventional drugs. This article discusses, from a pharmaceutical perspective, the types of therapies available, their applications and indications, and issues surrounding the placebo effect.

Protocol for the PINCER trial: a cluster randomised trial comparing the effectiveness of a pharmacist-led IT-based intervention with simple feedback in reducing rates of clinically important errors in medicines management in general practices

Background: Medication errors are an important cause of morbidity and mortality in primary care. The aims of this study are to determine the effectiveness, cost effectiveness and acceptability of a pharmacist-led information-technology-based complex intervention compared with simple feedback in reducing proportions of patients at risk from potentially hazardous prescribing and medicines management in general (family) practice. Methods: Research subject group: "At-risk" patients registered with computerised general practices in two geographical regions in England. Design: Parallel group pragmatic cluster randomised trial. Interventions: Practices will be randomised to either: (i) Computer-generated feedback; or (ii) Pharmacist-led intervention comprising of computer-generated feedback, educational outreach and dedicated support. Primary outcome measures: The proportion of patients in each practice at six and 12 months post intervention: - with a computer-recorded history of peptic ulcer being prescribed non-selective non-steroidal anti-inflammatory drugs - with a computer-recorded diagnosis of asthma being prescribed beta-blockers - aged 75 years and older receiving long-term prescriptions for angiotensin converting enzyme inhibitors or loop diuretics without a recorded assessment of renal function and electrolytes in the preceding 15 months. Secondary outcome measures; These relate to a number of other examples of potentially hazardous prescribing and medicines management. Economic analysis: An economic evaluation will be done of the cost per error avoided, from the perspective of the UK National Health Service (NHS), comparing the pharmacist-led intervention with simple feedback. Qualitative analysis: A qualitative study will be conducted to explore the views and experiences of health care professionals and NHS managers concerning the interventions, and investigate possible reasons why the interventions prove effective, or conversely prove ineffective. Sample size: 34 practices in each of the two treatment arms would provide at least 80% power (two-tailed alpha of 0.05) to demonstrate a 50% reduction in error rates for each of the three primary outcome measures in the pharmacist-led intervention arm compared with a 11% reduction in the simple feedback arm. Discussion: At the time of submission of this article, 72 general practices have been recruited (36 in each arm of the trial) and the interventions have been delivered. Analysis has not yet been undertaken.

PINCER trial: a cluster randomised trial comparing the effectiveness and cost-effectiveness of a pharmacist-led IT-based intervention with simple feedback in reducing rates of clinically important errors in medicines management in general practices

Background: Medication errors in general practice are an important source of potentially preventable morbidity and mortality. Building on previous descriptive, qualitative and pilot work, we sought to investigate the effectiveness, cost-effectiveness and likely generalisability of a complex pharm acist-led IT-based intervention aiming to improve prescribing safety in general practice. Objectives: We sought to: • Test the hypothesis that a pharmacist-led IT-based complex intervention using educational outreach and practical support is more effective than simple feedback in reducing the proportion of patients at risk from errors in prescribing and medicines management in general practice. • Conduct an economic evaluation of the cost per error avoided, from the perspective of the National Health Service (NHS). • Analyse data recorded by pharmacists, summarising the proportions of patients judged to be at clinical risk, the actions recommended by pharmacists, and actions completed in the practices. • Explore the views and experiences of healthcare professionals and NHS managers concerning the intervention; investigate potential explanations for the observed effects, and inform decisions on the future roll-out of the pharmacist-led intervention • Examine secular trends in the outcome measures of interest allowing for informal comparison between trial practices and practices that did not participate in the trial contributing to the QRESEARCH database. Methods Two-arm cluster randomised controlled trial of 72 English general practices with embedded economic analysis and longitudinal descriptive and qualitative analysis. Informal comparison of the trial findings with a national descriptive study investigating secular trends undertaken using data from practices contributing to the QRESEARCH database. The main outcomes of interest were prescribing errors and medication monitoring errors at six- and 12-months following the intervention. Results: Participants in the pharmacist intervention arm practices were significantly less likely to have been prescribed a non-selective NSAID without a proton pump inhibitor (PPI) if they had a history of peptic ulcer (OR 0.58, 95%CI 0.38, 0.89), to have been prescribed a beta-blocker if they had asthma (OR 0.73, 95% CI 0.58, 0.91) or (in those aged 75 years and older) to have been prescribed an ACE inhibitor or diuretic without a measurement of urea and electrolytes in the last 15 months (OR 0.51, 95% CI 0.34, 0.78). The economic analysis suggests that the PINCER pharmacist intervention has 95% probability of being cost effective if the decision-maker’s ceiling willingness to pay reaches £75 (6 months) or £85 (12 months) per error avoided. The intervention addressed an issue that was important to professionals and their teams and was delivered in a way that was acceptable to practices with minimum disruption of normal work processes. Comparison of the trial findings with changes seen in QRESEARCH practices indicated that any reductions achieved in the simple feedback arm were likely, in the main, to have been related to secular trends rather than the intervention. Conclusions Compared with simple feedback, the pharmacist-led intervention resulted in reductions in proportions of patients at risk of prescribing and monitoring errors for the primary outcome measures and the composite secondary outcome measures at six-months and (with the exception of the NSAID/peptic ulcer outcome measure) 12-months post-intervention. The intervention is acceptable to pharmacists and practices, and is likely to be seen as costeffective by decision makers.

A pharmacist-led information technology intervention for medication errors (PINCER): a multicentre, cluster randomised, controlled trial and cost-effectiveness analysis

Background: Medication errors are common in primary care and are associated with considerable risk of patient harm. We tested whether a pharmacist-led, information technology-based intervention was more effective than simple feedback in reducing the number of patients at risk of measures related to hazardous prescribing and inadequate blood-test monitoring of medicines 6 months after the intervention. Methods: In this pragmatic, cluster randomised trial general practices in the UK were stratified by research site and list size, and randomly assigned by a web-based randomisation service in block sizes of two or four to one of two groups. The practices were allocated to either computer-generated simple feedback for at-risk patients (control) or a pharmacist-led information technology intervention (PINCER), composed of feedback, educational outreach, and dedicated support. The allocation was masked to general practices, patients, pharmacists, researchers, and statisticians. Primary outcomes were the proportions of patients at 6 months after the intervention who had had any of three clinically important errors: non-selective non-steroidal anti-inflammatory drugs (NSAIDs) prescribed to those with a history of peptic ulcer without co-prescription of a proton-pump inhibitor; β blockers prescribed to those with a history of asthma; long-term prescription of angiotensin converting enzyme (ACE) inhibitor or loop diuretics to those 75 years or older without assessment of urea and electrolytes in the preceding 15 months. The cost per error avoided was estimated by incremental cost-eff ectiveness analysis. This study is registered with Controlled-Trials.com, number ISRCTN21785299. Findings: 72 general practices with a combined list size of 480 942 patients were randomised. At 6 months’ follow-up, patients in the PINCER group were significantly less likely to have been prescribed a non-selective NSAID if they had a history of peptic ulcer without gastroprotection (OR 0∙58, 95% CI 0∙38–0∙89); a β blocker if they had asthma (0∙73, 0∙58–0∙91); or an ACE inhibitor or loop diuretic without appropriate monitoring (0∙51, 0∙34–0∙78). PINCER has a 95% probability of being cost eff ective if the decision-maker’s ceiling willingness to pay reaches £75 per error avoided at 6 months. Interpretation: The PINCER intervention is an effective method for reducing a range of medication errors in general practices with computerised clinical records. Funding: Patient Safety Research Portfolio, Department of Health, England.

Description and process evaluation of pharmacists’ interventions in a pharmacist-led information technology-enabled multicentre cluster randomised controlled trial for reducing medication errors in general practice (PINCER trial)

Objective To undertake a process evaluation of pharmacists' recommendations arising in the context of a complex IT-enabled pharmacist-delivered randomised controlled trial (PINCER trial) to reduce the risk of hazardous medicines management in general practices. Methods PINCER pharmacists manually recorded patients’ demographics, details of interventions recommended, actions undertaken by practice staff and time taken to manage individual cases of hazardous medicines management. Data were coded and double entered into SPSS v15, and then summarised using percentages for categorical data (with 95% CI) and, as appropriate, means (SD) or medians (IQR) for continuous data. Key findings Pharmacists spent a median of 20 minutes (IQR 10, 30) reviewing medical records, recommending interventions and completing actions in each case of hazardous medicines management. Pharmacists judged 72% (95%CI 70, 74) (1463/2026) of cases of hazardous medicines management to be clinically relevant. Pharmacists recommended 2105 interventions in 74% (95%CI 73, 76) (1516/2038) of cases and 1685 actions were taken in 61% (95%CI 59, 63) (1246/2038) of cases; 66% (95%CI 64, 68) (1383/2105) of interventions recommended by pharmacists were completed and 5% (95%CI 4, 6) (104/2105) of recommendations were accepted by general practitioners (GPs), but not completed at the end of the pharmacists’ placement; the remaining recommendations were rejected or considered not relevant by GPs. Conclusions The outcome measures were used to target pharmacist activity in general practice towards patients at risk from hazardous medicines management. Recommendations from trained PINCER pharmacists were found to be broadly acceptable to GPs and led to ameliorative action in the majority of cases. It seems likely that the approach used by the PINCER pharmacists could be employed by other practice pharmacists following appropriate training.

How was patient empowerment portrayed in information leaflets describing the community pharmacy Medicines Use Review service in the UK?

Objective The Medicines Use Review (MUR) community pharmacy service was introduced in 2005 to enhance patient empowerment but the service has not been taken up as widely as expected. We investigated the depiction of the patient–pharmacist power relationship within MUR patient information leaflets. Methods We identified 11 MUR leaflets including the official Department of Health MUR booklet and through discourse analysis examined the way language and imagery had been used to symbolise and give meaning to the MUR service, especially the portrayal of the patient–pharmacist interactions and the implied power relations. Results A variety of terminology was used to describe the MUR, a service that aimed ultimately to produce more informed patients through the information imparted by knowledgeable, skilled pharmacists. Conclusion The educational role of the MUR overshadowed the intended patient empowerment that would take place with a true concordance-centred approach. Although patient empowerment was implied, this was within the boundaries of the biomedical model with the pharmacist as the expert provider of medicines information. Practice implications If patient empowerment is to be conveyed this needs to be communicated to patients through consistent use of language and imagery that portrays the inclusivity intended.

What is the new medicines use review ‘patient survey’ attempting to capture in the context of existing patient satisfaction with pharmacy questionnaires and a new conceptual framework?

The community pharmacy service medicines use review (MUR) was introduced in 2005 ‘to improve patient knowledge, concordance and use of medicines’ through a private patient–pharmacist consultation. The MUR presents a fundamental change in community pharmacy service provision. While traditionally pharmacists are dispensers of medicines and providers of medicines advice, and patients as recipients, the MUR considers pharmacists providing consultation-type activities and patients as active participants. The MUR facilitates a two-way discussion about medicines use. Traditional patient–pharmacist behaviours transform into a new set of behaviours involving the booking of appointments, consultation processes and form completion, and the physical environment of the patient–pharmacist interaction moves from the traditional setting of the dispensary and medicines counter to a private consultation room. Thus, the new service challenges traditional identities and behaviours of the patient and the pharmacist as well as the environment in which the interaction takes place. In 2008, the UK government concluded there is at present too much emphasis on the quantity of MURs rather than on their quality.[1] A number of plans to remedy the perceived imbalance included a suggestion to reward ‘health outcomes’ achieved, with calls for a more focussed and scientific approach to the evaluation of pharmacy services using outcomes research. Specifically, the UK government set out the main principal research areas for the evaluation of pharmacy services to include ‘patient and public perceptions and satisfaction’as well as ‘impact on care and outcomes’. A limited number of ‘patient satisfaction with pharmacy services’ type questionnaires are available, of varying quality, measuring dimensions relating to pharmacists’ technical competence, behavioural impressions and general satisfaction. For example, an often cited paper by Larson[2] uses two factors to measure satisfaction, namely ‘friendly explanation’ and ‘managing therapy’; the factors are highly interrelated and the questions somewhat awkwardly phrased, but more importantly, we believe the questionnaire excludes some specific domains unique to the MUR. By conducting patient interviews with recent MUR recipients, we have been working to identify relevant concepts and develop a conceptual framework to inform item development for a Patient Reported Outcome Measure questionnaire bespoke to the MUR. We note with interest the recent launch of a multidisciplinary audit template by the Royal Pharmaceutical Society of Great Britain (RPSGB) in an attempt to review the effectiveness of MURs and improve their quality.[3] This template includes an MUR ‘patient survey’. We will discuss this ‘patient survey’ in light of our work and existing patient satisfaction with pharmacy questionnaires, outlining a new conceptual framework as a basis for measuring patient satisfaction with the MUR. Ethical approval for the study was obtained from the NHS Surrey Research Ethics Committee on 2 June 2008. References 1. Department of Health (2008). Pharmacy in England: Building on Strengths – Delivering the Future. London: HMSO. www. official-documents.gov.uk/document/cm73/7341/7341.pdf (accessed 29 September 2009). 2. Larson LN et al. Patient satisfaction with pharmaceutical care: update of a validated instrument. JAmPharmAssoc 2002; 42: 44–50. 3. Royal Pharmaceutical Society of Great Britain (2009). Pharmacy Medicines Use Review – Patient Audit. London: RPSGB. http:// qi4pd.org.uk/index.php/Medicines-Use-Review-Patient-Audit. html (accessed 29 September 2009).

A retrospective audit of medicines use review forms

The medicines use review (MUR) service was introduced in England and Wales in 2005 to improve patients’ knowledge and use of medicines through a private, patient–pharmacist consultation. The pharmacist completes a standard form as a record of the MUR consultation and the patient receives a copy. The 2008 White Paper, Pharmacy in England[1] notes some MURs are of poor or questionable quality and there are anecdotal reports that pharmacists elect to conduct ‘easy’ MURs with patients on a single prescribed medicine only.[2] In 2009, the Royal Pharmaceutical Society of Great Britain (RPSGB) launched a multi-disciplinary audit template to review the effectiveness of MURs and improve their quality.[3] Prior to this, we conducted a retrospective MUR audit in a 1-month period in 2008. Our aims were to report on findings from this audit and the validity of using MUR forms as data for audit.

The effects of electronic prescribing on the quality of prescribing

Aims To investigate the effects of electronic prescribing (EP) on prescribing quality, as indicated by prescribing errors and pharmacists' clinical interventions, in a UK hospital. Methods Prescribing errors and pharmacists' interventions were recorded by the ward pharmacist during a 4 week period both pre- and post-EP, with a second check by the principal investigator. The percentage of new medication orders with a prescribing error and/or pharmacist's intervention was calculated for each study period. Results Following the introduction of EP, there was a significant reduction in both pharmacists' interventions and prescribing errors. Interventions reduced from 73 (3.0% of all medication orders) to 45 (1.9%) (95% confidence interval (CI) for the absolute reduction 0.2, 2.0%), and errors from 94 (3.8%) to 48 (2.0%) (95% CI 0.9, 2.7%). Ten EP-specific prescribing errors were identified. Only 52% of pharmacists' interventions related to a prescribing error pre-EP, and 60% post-EP; only 40% and 56% of prescribing errors resulted in an intervention pre- and post-EP, respectively. Conclusions EP improved the quality of prescribing by reducing both prescribing errors and pharmacists' clinical interventions. Prescribers and pharmacists need to be aware of new types of error with EP, so that they can best target their activities to reduce clinical risk. Pharmacists may need to change the way they work to complement, rather than duplicate, the benefits of EP.

Errors associated with preparation of adult and paediatric parenteral nutrition in UK hospital pharmacies

Rationale: In UK hospitals, the preparation of all total parenteral nutrition (TPN) products must be made in the pharmacy as TPNs are categorised as high-risk injectables (NPSA/2007/20). The National Aseptic Error Reporting Scheme has been collecting data on pharmacy compounding errors in the UK since August 2003. This study reports on types of error associated with the preparation of TPNs, including the stage at which these were identified and potential and actual patient outcomes. Methods: Reports of compounding errors for the period 1/2004 - 3/2007 were analysed on an Excel spreadsheet. Results: Of a total of 3691 compounding error reports, 674 (18%) related to TPN products; 548 adult vs. 126 paediatric. A significantly higher proportion of adult TPNs (28% vs. 13% paediatric) were associated with labelling errors and a significantly higher proportion of paediatric TPNs (25% vs. 15% adult) were associated with incorrect transcriptions (Chi-Square Test; p<0.005). Labelling errors were identified equally by pharmacists (42%) and technicians (48%) with technicians detecting mainly at first check and pharmacists at final check. Transcription errors were identified mainly by technicians (65% vs. 27% pharmacist) at first check. Incorrect drug selection (13%) and calculation errors (9%) were associated with adult and paediatric TPN preparations in the same ratio. One paediatric TPN error detected at first check was considered potentially catastrophic; 31 (5%) errors were considered of major and 38 (6%) of moderate potential consequence. Five errors (2 moderate, 1 minor) were identified during or after administration. Conclusions: While recent UK patient safety initiatives are aimed at improving the safety of injectable medicines in clinical areas, the current study highlights safety problems that exist within pharmacy production units. This could be used in the creation of an error management tool for TPN compounding processes within hospital pharmacies.

The impact of a closed-loop electronic prescribing and automated dispensing system on the ward pharmacist’s time and activities

Objective To assess the impact of a closed-loop electronic prescribing and automated dispensing system on the time spent providing a ward pharmacy service and the activities carried out. Setting Surgical ward, London teaching hospital. Method All data were collected two months pre- and one year post-intervention. First, the ward pharmacist recorded the time taken each day for four weeks. Second, an observational study was conducted over 10 weekdays, using two-dimensional work sampling, to identify the ward pharmacist's activities. Finally, medication orders were examined to identify pharmacists' endorsements that should have been, and were actually, made. Key findings Mean time to provide a weekday ward pharmacy service increased from 1 h 8 min to 1 h 38 min per day (P = 0.001; unpaired t-test). There were significant increases in time spent prescription monitoring, recommending changes in therapy/monitoring, giving advice or information, and non-productive time. There were decreases for supply, looking for charts and checking patients' own drugs. There was an increase in the amount of time spent with medical and pharmacy staff, and with 'self'. Seventy-eight per cent of patients' medication records could be assessed for endorsements pre- and 100% post-intervention. Endorsements were required for 390 (50%) of 787 medication orders pre-intervention and 190 (21%) of 897 afterwards (P < 0.0001; chi-square test). Endorsements were made for 214 (55%) of endorsement opportunities pre-intervention and 57 (30%) afterwards (P < 0.0001; chi-square test). Conclusion The intervention increased the overall time required to provide a ward pharmacy service and changed the types of activity undertaken. Contact time with medical and pharmacy staff increased. There was no significant change in time spent with patients. Fewer pharmacy endorsements were required post-intervention, but a lower percentage were actually made. The findings have important implications for the design, introduction and use of similar systems.

A pilot randomised, open, uncontrolled, clinical study of two dosages of St John's wort (Hypericum perforatum) herb extract (LI-160) as an aid to motivational/behavioural support in smoking cessation

There is an association between smoking and depression, yet the herbal antidepressant St John's wort (Hypericum perforatum L.: SJW) herb extract has not previously been investigated as an aid in smoking cessation. In this open, uncontrolled, pilot study, 28 smokers of 10 or more cigarettes per day for at least one year were randomised to receive SJW herb extract (LI-160) 300mg once or twice daily taken for one week before and continued for 3 months after a target quit date. In addition, all participants received motivational/behavioural support from a trained pharmacist. At 3 months, the point prevalence and continuous abstinence rates were both 18%, and at 12 months were 0%. Fifteen participants (54%) reported 23 adverse events up to the end of the 3-month follow-up period. There was no statistically significant difference in the frequency of adverse events for participants taking SJW once or twice daily (p > 0.05). Most adverse events were mild, transient and non-serious. This preliminary study has not provided convincing evidence that a SJW herb extract plus individual motivational/behavioural support is likely to be effective as an aid in smoking cessation. However, it may be premature to rule out a possible effect on the basis of a single, uncontrolled pilot study, and other approaches involving SJW extract may warrant investigation.

A framework for assessing continuing professional development activities for satisfying pharmacy revalidation requirements

The United Kingdom’s pharmacy regulator contemplated using continuing professional development (CPD) in pharmacy revalidation in 2009, simultaneously asking pharmacy professionals to demonstrate the value of their CPD by showing its relevance and impact. The idea of linking new CPD requirements with revalidation was yet to be explored. Our aim was to develop and validate a framework to guide pharmacy professionals to select CPD activities that are relevant to their work and to produce a score sheet that would make it possible to quantify the impact and relevance of CPD. METHODS: We adapted an existing risk matrix, producing a CPD framework consisting of relevance and impact matrices. Concepts underpinning the framework were refined through feedback from five pharmacist teacher-practitioners. We then asked seven pharmacists to rate the relevance of the framework’s individual elements on a 4-point scale to determine content validity. We explored views about the framework through focus groups with six and interviews with 17 participants who had used it formally in a study. RESULTS: The framework’s content validity index was 0.91. Feedback about the framework related to three themes of penetrability of the framework, usefulness to completion of CPD, and advancement of CPD records for the purpose of revalidation. DISCUSSION: The framework can help professionals better select CPD activities prospectively, and makes assessment of CPD more objective by allowing quantification, which could be helpful for revalidation. We believe the framework could potentially help other health professionals with better management of their CPD irrespective of their field of practice.

Training pharmacists to deliver a complex information technology intervention (PINCER) using the principles of educational outreach and root cause analysis

Objective: To describe the training undertaken by pharmacists employed in a pharmacist-led information technology-based intervention study to reduce medication errors in primary care (PINCER Trial), evaluate pharmacists’ assessment of the training, and the time implications of undertaking the training. Methods: Six pharmacists received training, which included training on root cause analysis and educational outreach, to enable them to deliver the PINCER Trial intervention. This was evaluated using self-report questionnaires at the end of each training session. The time taken to complete each session was recorded. Data from the evaluation forms were entered onto a Microsoft Excel spreadsheet, independently checked and the summary of results further verified. Frequencies were calculated for responses to the three-point Likert scale questions. Free-text comments from the evaluation forms and pharmacists’ diaries were analysed thematically. Key findings: All six pharmacists received 22 hours of training over five sessions. In four out of the five sessions, the pharmacists who completed an evaluation form (27 out of 30 were completed) stated they were satisfied or very satisfied with the various elements of the training package. Analysis of free-text comments and the pharmacists’ diaries showed that the principles of root cause analysis and educational outreach were viewed as useful tools to help pharmacists conduct pharmaceutical interventions in both the study and other pharmacy roles that they undertook. The opportunity to undertake role play was a valuable part of the training received. Conclusions: Findings presented in this paper suggest that providing the PINCER pharmacists with training in root cause analysis and educational outreach contributed to the successful delivery of PINCER interventions and could potentially be utilised by other pharmacists based in general practice to deliver pharmaceutical interventions to improve patient safety.