What has been the impact of the Traditional Herbal Registration (THR) scheme in the UK on information provided with herbal products bought over the counter?

BACKGROUND: In 2011 there was a strengthening of European Union (EU) legislation on the licencing of herbal products which, in the UK, resulted in the introduction of the Traditional Herbal Registration (THR) scheme. This scheme sets out standards for the safety and quality of herbal medicines and includes the provision of information to the customer on the safe use of the product. The aim of this study is to replicate a survey undertaken in 2011, prior to the implementation of the THR scheme, and evaluate the impact of this scheme on the information provided with herbal products bought over-the-counter. METHODS: We undertook a survey on 5 herbal products commonly available over-the-counter (St John's wort, echinacea, Ginkgo biloba, Asian ginseng, garlic). The information was searched for key safety messages identified by the National Center for Complementary and Integrative Health (NCCIH). We also explored the presence of risk of harm information. RESULTS: We recorded a rise in the number of products registered with the THR scheme (37% in 2016 compared to 7% in 2011). We also identified a reduction in the number of products that did not contain key safety information (75% in 2011 compared to 20% of products obtained in 2016). Risk of harm information was only communicated in products containing a PIL. We identified more products containing frequency of risk of harm information but this was not statistically significant. CONCLUSION: The introduction of the THR scheme appears to be associated with an increase in the provision of information about key safety messages on the safe use of herbal products. However, it is important to note that at least half of the products on the market that are not included in the THR scheme do not contain any information about their safe use; this includes information about precautions, interactions and side effects. The use of NCCIH herbal monographs replicated the methods used in the previous study; we recognise that the use of a different resource might effect the appraisal of the information provided. We also acknowledge that surveying presence of information does not assure that the latter is effectively communicated to patients, for which a close textual analysis would be required. While it is promising that more information is available after the introduction of the THR scheme, the public needs to be informed about ways to optimise safe use of all herbal products.

User Testing to Improve Retrieval and Comprehension of Information in Guidelines to Improve Medicines Safety.

OBJECTIVE: The aim of the study was to investigate the effectiveness of user testing for improving healthcare professionals' retrieval and comprehension of information in medicines guidelines. METHODS: The United Kingdom's Injectable Medicines Guide was selected as a case study. This gives guidance to nurses on preparing and administering intravenous medicines on hospital wards, in line with standard UK practice. Three rounds of user testing were completed with 10 hospital nurses per round, using the Injectable Medicines Guide for voriconazole and aminophylline. Participants used the guidelines to answer 17 questions related to the administration of these medicines. Answers were scored for "finding" and "understanding" the required information. Semistructured interviews explored participants' opinions of guideline content, design, and wording, with responses analyzed thematically. The guidelines were revised between rounds. RESULTS: In round 1, 8 of 17 questions were answered correctly by all participants. Participants had difficulty with dose, dilution, administration rate, and adverse effects questions. Revisions included new subsections and increased calculation support. In round 2, 14 of 17 questions were answered correctly by all participants. Difficulty persisted with dose and administration rate questions and further revisions made. In round 3, 15 of 17 questions were answered correctly by all participants. Across all rounds, participants considered appropriate subheadings and information order as important for fast location of information. Specific, detailed, and practical instructions were perceived as important to improve understandability and usefulness. CONCLUSIONS: Key information in medicines guidelines may not be found and/or understood by healthcare professionals. User testing increased information retrieval and comprehension and could have an important role in improving the safety of medicines use.

Costs and Cost-Effectiveness of User-Testing of Health Professionals' Guidelines to Reduce the Frequency of Intravenous Medicines Administration Errors by Nurses in the United Kingdom: A Probabilistic Model Based on Voriconazole Administration.

AIM: In the UK, injectable medicines are often prepared and administered by nurses following the Injectable Medicines Guide (IMG). Our earlier study confirmed a higher frequency of correct administration with user-tested versus standard IMG guidelines. This current study aimed to model the cost-effectiveness of user-testing. METHODS: The costs and cost-effectiveness of user-testing were explored by modifying an existing probabilistic decision-analytic model. The adapted model considered administration of intravenous voriconazole to hospital inpatients by nurses. It included 11 error types, their probability of detection and level of harm. Model inputs (including costs) were derived from our previous study and other published data. Monte Carlo simulation using 20,000 samples (sufficient for convergence) was performed with a 5-year time horizon from the perspective of the 121 NHS trusts and health boards that use the IMG. Sensitivity analyses were undertaken for the risk of a medication error and other sources of uncertainty. RESULTS: The net monetary benefit at £20,000/quality-adjusted life year was £3,190,064 (95% credible interval (CrI): -346,709 to 8,480,665), favouring user-testing with a 96% chance of cost-effectiveness. Incremental cost-savings were £240,943 (95% CrI 43,527-491,576), also favouring user-tested guidelines with a 99% chance of cost-saving. The total user testing cost was £6317 (95% CrI 6012-6627). These findings were robust to assumptions about a range of input parameters, but greater uncertainty was seen with a lower medication error risk. CONCLUSIONS: User-testing of injectable medicines guidelines is a low-cost intervention that is highly likely to be cost-effective, especially for high-risk medicines.

User-testing guidelines to improve the safety of intravenous medicines administration: a randomised in situ simulation study.

BACKGROUND: User-testing and subsequent modification of clinical guidelines increases health professionals' information retrieval and comprehension. No study has investigated whether this results in safer care. OBJECTIVE: To compare the frequency of medication errors when administering an intravenous medicine using the current National Health Service Injectable Medicines Guide (IMG) versus an IMG version revised with user-testing. METHOD: Single-blind, randomised parallel group in situ simulation. Participants were on-duty nurses/midwives who regularly prepared intravenous medicines. Using a training manikin in their clinical area, participants administered a voriconazole infusion, a high-risk medicine requiring several steps to prepare. They were randomised to use current IMG guidelines or IMG guidelines revised with user-testing. Direct observation was used to time the simulation and identify errors. Participant confidence was measured using a validated instrument. The primary outcome was the percentage of simulations with at least one moderate-severe IMG-related error, with error severity classified by an expert panel. RESULTS: In total, 133 participants were randomised to current guidelines and 140 to user-tested guidelines. Fewer moderate-severe IMG-related errors occurred with the user-tested guidelines (n=68, 49%) compared with current guidelines (n=79, 59%), but this difference was not statistically significant (risk ratio: 0.82; 95% CI 0.66 to 1.02). Significantly more simulations were completed without any IMG-related errors with the user-tested guidelines (n=67, 48%) compared with current guidelines (n=26, 20%) (risk ratio: 2.46; 95% CI 1.68 to 3.60). Median simulation completion time was 1.6 min (95% CI 0.2 to 3.0) less with the user-tested guidelines. Participants who used user-tested guidelines reported greater confidence. CONCLUSION: User-testing injectable medicines guidelines reduces the number of errors and the time taken to prepare and administer intravenous medicines, while increasing staff confidence. TRIAL REGISTRATION NUMBER: researchregistry5275.

The recording of drug sensitivities for older people living in care homes.

AIMS: The aims of this study were to determine the recording of drug sensitivities of elderly care home residents, to describe the nature of sensitivities and to identify and describe discrepancies in the documentation of drug sensitivity status in general practices, pharmacies and care homes. METHODS: A random sample of residents within a purposive sample of care homes (nursing and residential) was selected. A clinical pharmacist inspected the GP medical record, the medicines administration record, and the care home record for each resident to identify drug sensitivities and discrepancies between records and to describe the nature of the recorded sensitivities. RESULTS: The records of 121 residents in 31 care homes were studied. Thirty-one (26%) residents had at least one documented drug sensitivity in one of the sources inspected, with 48 sensitivities in total recorded. There was no description of the nature of the sensitivities recorded in 39/48 (81%) cases. The number of sensitivities recorded on the medicines administration record, care home record and the GP record were 3 (6%), 29 (60%) and 35 (73%), respectively. Only two sensitivities were simultaneously recorded on all three records. CONCLUSIONS: It was of concern that over 90% of drug sensitivities were not recorded on the medicines administration record which is the final checking document when administering medication. The reason for this was that the dispensing pharmacy was responsible for generating the medicines administration record; however, drug sensitivity status is seldom shared between the GP and the dispensing pharmacy. Printing sensitivities on prescriptions would help to resolve this.

Developing and testing a patient information booklet for thrombolysis used in acute stroke.

Objective Thrombolysis decreases the chance of post-stroke dependence, although its use carries significant risk, notably of intra-cerebral haemorrhage. Patients (and families) face an important risk/benefit decision before consenting. We drafted a patient information booklet for this purpose, and applied performance-based readability testing with the aim that the most important information in the booklet could be found and understood. Methods The booklet was developed with reference to best practice in information writing and design. We User-Tested its performance on 56 people without prior experience of stroke. After reading the booklet they were asked to find and explain 15 pieces of information. The booklet was revised according to its performance and re-tested, until each item was found and understood by at least 80% of participants. Key findings The four-page information booklet contained approximately 900 words, organised into six sections. A risk-palette graphic showed the chance of positive and negative outcomes. The booklet was tested on four participant cohorts and revised, including more bold text, re-wording, changing the title and changing the graphic to a coloured bar chart. Testing the final version on the fourth cohort of 20 people showed that each of the 15 tested items of information met the target of at least 80% participants being able to find and understand it. Conclusions The use of information design and User Testing produced a booklet that is understandable by people with no prior experience of stroke. User Testing is an inexpensive and quick method to ensure that information intended for patients is usable.

Written information about individual medicines for consumers.

BACKGROUND: Medicines are the most common intervention in most health services. As with all treatments, those taking medicines need sufficient information: to enable them to take and use the medicines effectively, to understand the potential harms and benefits, and to allow them to make an informed decision about taking them. Written medicines information, such as a leaflet or provided via the Internet, is an intervention that may meet these purposes. OBJECTIVES: To assess the effects of providing written information about individual medicines on relevant patient outcomes (knowledge, attitudes, behaviours and health outcomes) in relation to prescribed and over-the-counter medicines. SEARCH STRATEGY: We searched MEDLINE, EMBASE, CINAHL, The Cochrane Library, PsycINFO and other databases to March 2007. We handsearched five journals' tables of contents, and the reference lists of included studies, and contacted experts in the field. SELECTION CRITERIA: Randomised controlled trials (RCTs) of medicine users, comparing written medicines information with no written medicines information; or trials that compared two or more styles of written medicines information. We only included trials that measured a knowledge, attitudinal or behavioural outcome. There were no language restrictions. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data relating to the interventions, methods of the trials, and outcome measures; and reconciled differences by discussion. Heterogeneity of interventions and outcomes measured meant that data synthesis was not possible. The results are presented in narrative and tabular format. MAIN RESULTS: We included 25 RCTs involving 4788 participants. Six of twelve trials showed that written information significantly improved knowledge about a medicine, compared with no written information. The inability to combine results means we cannot conclude whether written information was effective for increasing knowledge. The results for attitudinal and behavioural outcomes were mixed. No studies showed an adverse effect of medicines information. AUTHORS' CONCLUSIONS: The combined evidence was not strong enough to say whether written medicines information is effective in changing knowledge, attitudes and behaviours related to medicine taking. There is some evidence that written information can improve knowledge. The trials were generally of poor quality, which reduces confidence in the results. Trials examining the effects of written information need to be better designed and use consistent and validated outcome measures. Trials should evaluate internet-based medicines information. It is imperative that written medicines information be based on best practice for its information design and content, which could improve its effectiveness in helping people to use medicines appropriately.

Performance-based readability testing of participant materials for a phase I trial: TGN1412.

BACKGROUND: Concern has been expressed about the process of consent to clinical trials, particularly in phase I "first-in-man" trials. Trial participant information sheets are often lengthy and technical. Content-based readability testing of sheets, which is often required to obtain research ethics approval for trials in the USA, is limited and cannot indicate how information will perform. METHODS: An independent-groups design was used to study the user-testing performance of the participant information sheet from the phase I TGN1412 trial. Members of the public were asked to read it, then find and demonstrate understanding of 21 key aspects of the trial. The participant information sheet was then rewritten, redesigned and tested on 20 members of the public, using the same 21-item questionnaire. RESULTS: On the original TGN1412 participant information sheet, participants could not find answers and some of the found information was not understood. Six of 21 questions, including those relating to placebo, follow-up visits and the emergency phone number, were found by eight or fewer of 10 participants. The revised information sheet performed better, with the answers to 17 of 21 questions found and understood by all 20 participants. CONCLUSIONS: Tests showed that the TGN1412 participant information sheet may not inform participants adequately for consent. Revising its content and design led to significant improvements. Writers of materials for trial participants should take account of good practice in information design. Performance-based user testing may be a useful method to indicate strengths and weaknesses in trial materials.

Perceived risk of medicine side effects in users of a patient information website: a study of the use of verbal descriptors, percentages and natural frequencies.

OBJECTIVES: Research into the provision of patient information has demonstrated that, under certain conditions, patients overestimate the risks of medicine side effects. Gigerenzer and Edwards (2004) argue that 'natural frequencies' are a less confusing way of expressing risk information. Two experiments with users of an existing high profile patient information website, investigate the effectiveness of presenting medicine side-effect risk information in different forms. DESIGN: In both experiments participants were randomly allocated to one of the three conditions for representing risk information (a form of 'natural frequency', percentages and verbal descriptors). METHOD: Participants were recruited from users of the Cancer Research UK patient information website (Cancer Help UK). In Experiment 1, participants (N=148) were asked to imagine that they had to take a chemotherapy drug (Taxol) and were asked to estimate the risks of two side-effects occurring. In Experiment 2 participants (N=137) estimated the risk for three different side-effects occurring with the painkiller ibuprofen. RESULTS: In both experiments, verbal descriptions led to significantly higher estimations of risk compared to the other two formats. There was some evidence that people given information as frequencies were more accurate in their estimates than those given percentage information. CONCLUSIONS: These findings provide partial support for the advantages of a form of 'natural frequencies' when presenting side-effects to patients. They also add weight to the growing body of research highlighting the deficiencies in using verbal descriptions of side-effect risk alone.

Adequacy of patient information on adverse effects: an assessment of patient information leaflets in the UK.

BACKGROUND: One of the most important categories of information that patients want to know about the drug they are taking is the likelihood or probability of adverse effects. All patients should receive such information in the patient information leaflet that is supplied with all drugs. Anecdotal evidence suggests that most leaflets give little indication of the likelihood of adverse effects. The UK Medicines and Healthcare products Regulatory Agency (MHRA) suggests using a combination of words and numbers to convey this information. However, an EU guideline suggests using five verbal descriptors on a scale from common to rare, the use of which has been shown to lead to gross overestimation of the risk of adverse effects. METHODS: We assessed the leaflets supplied with the 50 most frequently prescribed drugs in England, to determine the extent to which the likelihood of adverse effects was described, and whether it met the requirements of the EU guidance and/or best practice. We examined both the method used to describe the likelihood of adverse effects, and the format of this information in the leaflet. RESULTS: Twenty of the 50 leaflets (40%) gave no indication of the likelihood of adverse effects occurring. Six (12%) used the recommended EU terms and a further 20 (40%) used a wide range of other verbal descriptors. Only four leaflets (8%) provided any form of numerical indication of risk. Over half (52%) presented long lists of adverse effects in paragraphs of continuous text. CONCLUSIONS: Patient need is not being met in terms of the provision of usable information about the likelihood of adverse effects. Most patients receive no information, whereas some are given verbal descriptors, both of which lead to overestimation of the risk. Very few of the patient information leaflets assessed used currently described best practice, i.e. to present verbal descriptions alongside numerical information in the form of natural frequencies, e.g. 'rare (affects less than 1 in 1000 people)'.

Clinical Trial Results Summary for Laypersons: A User Testing Study.

OBJECTIVE: To apply "user testing" to maximize readability and acceptability of a Clinical Trial Results Laypersons Summary-a new European requirement. METHODS: "User testing" (using questionnaire and semistructured interview) assessed whether people could find and understand key points. Findings were used to improve content and design, prior to retesting. Participants had a range of levels of health literacy and there was a higher education group. Participants accessed the summary on screen. In round 1 we tested 12 points of information. In round 2 a revised summary addressing round 1 findings was tested, leading to a third final version. RESULTS: In round 1, 2 of 12 points of information did not reach the target and interviews raised further format and content issues (some distracting technical explanations and inability to find or understand the 2 main study purposes). These findings informed revisions for the version tested in round 2, with 2 different points not reaching the target (inclusion criteria relating to duration of seasonal allergies and how researchers found out about participants' symptoms). Identified problems in both rounds were addressed and reflected in the final version. Despite improvements, participants did not consistently understand that summaries were intended for the public, or to only interpret results of single trials in the context of additional trials. All readers, including those with higher education, found the clear and straightforward language acceptable. CONCLUSIONS: Applying "user testing" resulted in a largely health-literate summary suitable for people across a range of backgrounds.

A systematic review of quantitative and qualitative research on the role and effectiveness of written information available to patients about individual medicines.

OBJECTIVES: To establish the role and value of written information available to patients about individual medicines from the perspective of patients, carers and professionals. To determine how effective this information is in improving patients' knowledge and understanding of treatment and health outcomes. DATA SOURCES: Electronic databases searched to late 2004, experts in information design, and stakeholder workshops (including patients and patient organisations). REVIEW METHODS: Data from selected studies were tabulated and the results were qualitatively synthesised along with findings from the information design and stakeholder workshop strands. RESULTS: Most people do not value the written information they receive. They had concerns about the use of complex language and poor visual presentation and in most cases the research showed that the information did not increase knowledge. The research showed that patients valued written information that was tailored to their individual circumstances and illness, and that contained a balance of harm and benefit information. Most patients wanted to know about any adverse effects that could arise. Patients require information to help decision-making about whether to take a medicine or not and (once taking a medicine) with ongoing decisions about the management of the medicine and interpreting symptoms. Patients did not want written information to be a substitute for spoken information from their prescriber. While not everyone wanted written information, those who did wanted sufficient detail to meet their need. Some health professionals thought that written information for patients should be brief and simple, with concerns about providing side-effect information. They saw increasing compliance as a prime function, in contrast to patients who saw an informed decision not to take a medicine as an acceptable outcome. CONCLUSIONS: The combination of a quantitative and qualitative review, an exploration of best practice in information design, plus the input of patients at stakeholder workshops, allowed this review to look at all perspectives. There is a gap between currently provided leaflets and information which patients would value and find more useful. The challenge is to develop methods of provision flexible enough to allow uptake of varying amounts and types of information, depending on needs at different times in an illness. This review has identified a number of areas where future research could be improved in terms of the robustness of its design and conduct, and the use of patient-focused outcomes. The scope for this research includes determining the content, delivery and layout of statutory leaflets that best meet patients' needs, and providing individualised information, which includes both benefit and harm information. In particular, studies of the effectiveness and role and value of Internet-based medicines information are needed.

Consumer medication information in the United States, Europe, and Australia: a comparative evaluation.

OBJECTIVE: To evaluate the quality of patient information leaflets provided with dispensed medications in the United States, United Kingdom, and Australia. DESIGN: Quantitative survey by an expert panel. SETTING: United States, United Kingdom, and Australia. PARTICIPANTS: Not applicable. INTERVENTION: Patient information leaflets for atenolol, glyburide (glibenclamide), atorvastatin, and nitroglycerin (glyceryl trinitrate) from the United States, United Kingdom, and Australia. MAIN OUTCOME MEASURES: Leaflets were evaluated against U.S. consensus criteria for both clinical information and general criteria, including the design of the leaflets. RESULTS: Leaflets from Australia received a mean overall score of 90% (range 83%-94%) adherence with criteria, those from the United Kingdom a score of 81% (range 73%-84%), and those from the United States a score of 68% (range 65%-77%). The U.S. leaflets achieved 50% or less adherence for contraindication and precaution information. Omissions included warnings about preexisting allergy and illness and information about drug interactions. The U.S. leaflets also scored poorly (60%) for legibility and comprehensibility. The lower U.K. score reflected shortcomings in information about how to use and monitor the medications (46% adherence) and on adverse drug reactions (64%), largely due to the lack of clear advice about urgency of action in relation to adverse drug reactions. CONCLUSION: Leaflet quality varied more among the three countries than within each country, reflecting the regulatory context. The Australian leaflets performed well across all criteria, whereas the U.S. leaflets had significant shortcomings with the omission of vital information for the safe and effective use of the medications. A repeat survey is needed to assess whether new legislation and guidance in all three countries successfully addresses the shortcomings identified.

Do themes in consumer medicines information literature reviews reflect those important to stakeholders?

OBJECTIVE: To compare the themes emerging from a stakeholder workshop on consumers' medicines information with themes in relevant published reviews. METHODS: A stakeholder workshop was held to permit consumer orientation of a systematic review of consumer medicines information. Analysis of the workshop outputs was compared to a content analysis of the identified published reviews. RESULTS: The workshop generated a range of responses inductively grouped into 12 over-arching themes. No reviews tackled all of these themes, nor addressed 'informed choice and autonomy'. More recent reviews reflected more workshop themes than older ones, suggesting a temporal trend towards a greater sensitivity to consumer issues. The most common workshop themes were covered by all reviews. Six themes in the reviews were related to traditional professional concerns including compliance, which did not arise in the workshop. CONCLUSION: The results highlight a mismatch between the themes in previous published reviews and the themes emerging from the workshop. The most commonly reflected themes in reviews conform to the 'patient education' model of discourse, while workshop themes less often echoed in reviews reflect the discourse of 'patient empowerment'. PRACTICE IMPLICATIONS: The findings suggest the importance of involving patients in the development of patient literature from the outset.

Community IntraVenous Antibiotic Study (CIVAS): protocol for an evaluation of patient preferences for and cost-effectiveness of community intravenous antibiotic services.

INTRODUCTION: Outpatient parenteral antimicrobial therapy (OPAT) is used to treat a wide range of infections, and is common practice in countries such as the USA and Australia. In the UK, national guidelines (standards of care) for OPAT services have been developed to act as a benchmark for clinical monitoring and quality. However, the availability of OPAT services in the UK is still patchy and until quite recently was available only in specialist centres. Over time, National Health Service (NHS) Trusts have developed OPAT services in response to local needs, which has resulted in different service configurations and models of care. However, there has been no robust examination comparing the cost-effectiveness of each service type, or any systematic examination of patient preferences for services on which to base any business case decision. METHODS AND ANALYSIS: The study will use a mixed methods approach, to evaluate patient preferences for and the cost-effectiveness of OPAT service models. The study includes seven NHS Trusts located in four counties. There are five inter-related work packages: a systematic review of the published research on the safety, efficacy and cost-effectiveness of intravenous antibiotic delivery services; a qualitative study to explore existing OPAT services and perceived barriers to future development; an economic model to estimate the comparative value of four different community intravenous antibiotic services; a discrete choice experiment to assess patient preferences for services, and an expert panel to agree which service models may constitute the optimal service model(s) of community intravenous antibiotics delivery. ETHICS AND DISSEMINATION: The study has been approved by the NRES Committee, South West-Frenchay using the Proportionate Review Service (ref 13/SW/0060). The results of the study will be disseminated at national and international conferences, and in international journals.

Patients' understanding of risk associated with medication use: impact of European Commission guidelines and other risk scales.

Patients want and need comprehensive and accurate information about their medicines so that they can participate in decisions about their healthcare. In particular, they require information about the likely risks and benefits that are associated with the different treatment options. However, to provide this information in a form that people can readily understand and use is a considerable challenge to healthcare professionals. One recent attempt to standardise the language of risk has been to produce sets of verbal descriptors that correspond to specific probability ranges, such as those outlined in the European Commission (EC) Pharmaceutical Committee guidelines in 1998 for describing the incidence of adverse effects. This paper provides an overview of a number of studies involving members of the general public, patients, and hospital doctors, that evaluated the utility of the EC guideline descriptors (very common, common, uncommon, rare, very rare). In all studies it was found that people significantly over-estimated the likelihood of adverse effects occurring, given specific verbal descriptors. This in turn resulted in significantly higher ratings of their perceived risks to health and significantly lower ratings of their likelihood of taking the medicine. Such problems of interpretation are not restricted to the EC guideline descriptors. Similar levels of misinterpretation have also been demonstrated with two other recently advocated risk scales (Calman's verbal descriptor scale and Barclay, Costigan and Davies' lottery scale). In conclusion, the challenge for risk communicators and for future research will be to produce a language of risk that is sufficiently flexible to take into account different perspectives, as well as changing circumstances and contexts of illness and its treatments. In the meantime, we urge the EC and other legislative bodies to stop recommending the use of specific verbal labels or phrases until there is a stronger evidence base to support their use.

Comparison of two methods of presenting risk information to patients about the side effects of medicines.

OBJECTIVE: To determine whether the use of verbal descriptors suggested by the European Union (EU) such as "common" (1-10% frequency) and "rare" (0.01-0.1%) effectively conveys the level of risk of side effects to people taking a medicine. DESIGN: Randomised controlled study with unconcealed allocation. PARTICIPANTS: 120 adults taking simvastatin or atorvastatin after cardiac surgery or myocardial infarction. SETTING: Cardiac rehabilitation clinics at two hospitals in Leeds, UK. INTERVENTION: A written statement about one of the side effects of the medicine (either constipation or pancreatitis). Within each side effect condition half the patients were given the information in verbal form and half in numerical form (for constipation, "common" or 2.5%; for pancreatitis, "rare" or 0.04%). MAIN OUTCOME MEASURE: The estimated likelihood of the side effect occurring. Other outcome measures related to the perceived severity of the side effect, its risk to health, and its effect on decisions about whether to take the medicine. RESULTS: The mean likelihood estimate given for the constipation side effect was 34.2% in the verbal group and 8.1% in the numerical group; for pancreatitis it was 18% in the verbal group and 2.1% in the numerical group. The verbal descriptors were associated with more negative perceptions of the medicine than their equivalent numerical descriptors. CONCLUSIONS: Patients want and need understandable information about medicines and their risks and benefits. This is essential if they are to become partners in medicine taking. The use of verbal descriptors to improve the level of information about side effect risk leads to overestimation of the level of harm and may lead patients to make inappropriate decisions about whether or not they take the medicine.

Official warnings on thromboembolism risk with oral contraceptives fail to inform users adequately.

Following the 1995 "pill scare" relating to the risk of venous thrombosis from taking second- or third-generation oral contraceptives, the Committee on Safety of Medicines (CSM) withdrew their earlier recommended restrictions on the use of third-generation pills and published recommended wording to be used in patient information leaflets. However, the effectiveness of this wording has not been tested. An empirical study (with 186 pill users, past users, and non-users) was conducted to assess understanding, based on this wording, of the absolute and relative risk of thrombosis in pill users and in pregnancy. The results showed that less than 12% of women in the (higher education) group fully understood the absolute levels of risk from taking the pill and from being pregnant. Relative risk was also poorly understood, with less than 40% of participants showing full understanding, and 20% showing no understanding. We recommend that the CSM revisit the wording currently provided to millions of women in the UK.

Patients' views of a pharmacist-run medication review clinic in general practice.

BACKGROUND: Reviewing elderly patients' medication is a requirement of the National Service Framework for Older People. Many general practitioners have insufficient time to review patients' medications in a consultation. Pharmacist review has been offered as an alternative and this will be a new experience for many patients. AIM: To ascertain patients' views of a pharmacist-conducted medication review clinic, run in their general practice surgery. DESIGN OF STUDY: Qualitative study using focus group interviews. SETTING: General practices in Leeds Health Authority area. METHOD: Patients aged 65 years and over, who had attended a medicine review clinic, took part in focus groups that were recorded and transcribed. Units of information representing an idea were identified and similar ideas were grouped together as themes. RESULTS: Patients had a number of prior beliefs about the clinic. Most patients knew that the clinic's purpose was to review repeat medication, to find out more about their medicines, and to ask questions about efficacy and side effects. Some patients were suspicious about the purpose of the clinic but others welcomed the opportunity to have an in-depth review and an explanation of their condition and its treatment; some patients did not accept advice or were disappointed that their expectations were not fulfilled. Most patients were happy to attend a yearly review but some expressed guilt about attending the surgery too frequently. CONCLUSION: Patients who attended the medication review clinics expressed a range of views about the service. Further research into patients' and carers' opinions about medicine review is needed to inform the development of these services.