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.

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.

Worlds apart? An exploration of prescribing and medicine-taking decisions by patients, GPs and local policy makers.

UNLABELLED: Current healthcare policy in the UK has been shaped by two major forces; increasing accountability to evidence-based standards and increasing patient involvement. Shared decision-making brings the patient into prescribing decisions, and guidelines introduce a third decision-maker, the policy maker, into the doctor-patient consultation. This study explored the decision-making processes used by patients and GPs in comparison to local policy makers. METHOD: Qualitative interviews with 8 GPs, 14 patients and 2 PCT Prescribing Advisers, followed by quantitative questionnaires completed by 305 GPs and 533 patients. RESULTS: Patients made individual medicine-taking decisions based on experience, personal financial and human cost, trust and the relational aspects of their interactions with doctors over time. In contrast local implementation of prescribing guidelines was based on consideration of financial costs, efficacy and risks, based on objective clinical evidence at a population level. GPs adopted a mid-position between these two polar views. Guidelines are written from a different perspective to the worldview of patients, and they tend to downplay the criteria most important to patients. This has the potential to have a harmful effect on patients' medicine-taking and adherence. Paradoxically, enforcing the use of guidelines could inhibit the achievement of guideline targets.

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)'.

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.

Randomised controlled trial of clinical medication review by a pharmacist of elderly patients receiving repeat prescriptions in general practice.

OBJECTIVE: To determine whether a pharmacist can effectively review repeat prescriptions through consultations with elderly patients in general practice. DESIGN: Randomised controlled trial of clinical medication review by a pharmacist against normal general practice review. SETTING: Four general practices. PARTICIPANTS: 1188 patients aged 65 or over who were receiving at least one repeat prescription and living in the community. INTERVENTION: Patients were invited to a consultation at which the pharmacist reviewed their medical conditions and current treatment. MAIN OUTCOME MEASURES: Number of changes to repeat prescriptions over one year, drug costs, and use of healthcare services. RESULTS: 590 (97%) patients in the intervention group were reviewed compared with 233 (44%) in the control group. Patients seen by the pharmacist were more likely to have changes made to their repeat prescriptions (mean number of changes per patient 2.2 v 1.9; difference=0.31, 95% confidence interval 0.06 to 0.57; P=0.02). Monthly drug costs rose in both groups over the year, but the rise was less in the intervention group (mean difference 4.72 pound sterling per 28 days, - 7.04 pound sterling to - 2.41 pound sterling); equivalent to 61 pound sterling per patient a year. Intervention patients had a smaller rise in the number of drugs prescribed (0.2 v 0.4; mean difference -0.2, -0.4 to -0.1). There was no evidence that review of treatment by the pharmacist affected practice consultation rates, outpatient consultations, hospital admissions, or death rate. CONCLUSIONS: A clinical pharmacist can conduct effective consultations with elderly patients in general practice to review their drugs. Such review results in significant changes in patients' drugs and saves more than the cost of the intervention without affecting the workload of general practitioners.