Key Learning Outcomes for Clinical Pharmacology and Therapeutics Education in Europe: A Modified Delphi Study.

Harmonizing clinical pharmacology and therapeutics (CPT) education in Europe is necessary to ensure that the prescribing competency of future doctors is of a uniform high standard. As there are currently no uniform requirements, our aim was to achieve consensus on key learning outcomes for undergraduate CPT education in Europe. We used a modified Delphi method consisting of three questionnaire rounds and a panel meeting. A total of 129 experts from 27 European countries were asked to rate 307 learning outcomes. In all, 92 experts (71%) completed all three questionnaire rounds, and 33 experts (26%) attended the meeting. 232 learning outcomes from the original list, 15 newly suggested and 5 rephrased outcomes were included. These 252 learning outcomes should be included in undergraduate CPT curricula to ensure that European graduates are able to prescribe safely and effectively. We provide a blueprint of a European core curriculum describing when and how the learning outcomes might be acquired.

Prescribing Safety Assessment 2016: Delivery of a national prescribing assessment to 7343 UK final-year medical students.

AIMS: Newly graduated doctors write a large proportion of prescriptions in UK hospitals but recent studies have shown that they frequently make prescribing errors. The prescribing safety assessment (PSA) has been developed as an assessment of competence in relation to prescribing and supervising the use of medicines. This report describes the delivery of the PSA to all UK final-year medical students in 2016 (PSA2016). METHODS: The PSA is a 2-hour online assessment comprising eight sections which cover various aspects of prescribing defined within the outcomes of undergraduate education identified by the UK General Medical Council. Students sat one of four PSA 'papers', which had been standard-set using a modified Angoff process. RESULTS: A total of 7343 final-year medical students in all 31 UK medical schools sat the PSA. The overall pass rate was 95% with the pass rates for the individual papers ranging from 93 to 97%. The PSA was re-sat by 261 students who had failed and 80% of those candidates passed. The internal consistency (Cronbach's alpha) of the four papers ranged from 0.74 to 0.77 (standard error of measurement 4.13-4.24%). There was a statistically significant variation in performance between medical school cohorts (F = 32.6, P < 0.001) and a strongly positive correlation in performance for individual schools between PSA2015 and PSA2016 (r = 0.79, 95% CI 0.61-0.90; P < 0.01). CONCLUSIONS: PSA2016 demonstrated the feasibility of delivering a standardized national prescribing assessment online. The vast majority of UK final-year medical students were able to meet a prespecified standard of prescribing competence.

Development and Validation of the McMaster Prescribing Competency Assessment for Medical Trainees (MacPCA).

BACKGROUND: Prescribing is an essential skill for all physicians, built on knowledge of clinical pharmacology, therapeutics and toxicology across the life cycle. The decline in organized clinical pharmacology training in medical schools, combined with an expanding pharmacopeia and increasing complexity of patient care, makes prescribing competency difficult for medical students to master. OBJECTIVES: To develop and validate the McMaster Prescribing Competency Assessment (MacPCA), an online tool suitable for evaluating clinical pharmacology knowledge and prescribing skills of medical trainees in Canada. METHODS: The MacPCA was developed using an online examination platform scalable to multiple sites across Canada. Questions represented 8 domains of safe and effective prescribing with level of difficulty aimed at a final year medical student. Validation assessment concentrated on face and construct validity. RESULTS: 58 participants (7, 12 and 21 medical students in Years 1, 2, and 3, respectively and 8 undergraduate controls) were recruited. Mean scores were 31% (SD 13.6), 46% (SD 14.9), 75% (SD 8.3) and 81% (SD 10.5) for the controls, Year 1, Year 2, and Year 3 (final year) students, respectively. Combined Year 2/Year 3 scores were significantly better than control/Year 1 scores (p<0.0001). Final year student feedback indicated the test was fair, clear and unambiguous, aimed at the right level, with sufficient time for completion. CONCLUSIONS: The MacPCA demonstrated good face validity and successfully discriminated between upper year medical students and their junior colleagues. Further expansion of testing and validation is warranted.

The contribution of prescription chart design and familiarity to prescribing error: a prospective, randomised, cross-over study.

PURPOSE OF STUDY: Initiatives to standardise hospital paper-based prescription charts are underway in various countries in an effort to reduce prescribing errors. The aim of this study was to investigate the extent to which prescribing error rates are influenced by prescription chart design and familiarity. STUDY DESIGN: In this prospective, randomised, cross-over study, Foundation Year 1 doctors working in five Scottish National Health Service (NHS) Boards participated in study sessions during which they were asked to prescribe lists of medications for five fictional patients using a different design of paper prescription chart for each patient. Each doctor was timed completing each set of prescriptions, and each chart was subsequently assessed against a predefined list of possible errors. A mixed modelling approach using three levels of variables (design of and familiarity with a chart, prescribing speed and individual prescriber) was employed. RESULTS: A total of 72 Foundation Year 1 doctors participated in 10 data-collection sessions. Differences in prescription chart design were associated with significant variations in the rates of prescribing error. The charts from NHS Highland and NHS Grampian produced significantly higher error rates than the other three charts. Participants who took longer to complete their prescriptions made significantly fewer errors, but familiarity with a chart did not predict error rate. CONCLUSIONS: This study has important implications for prescription chart design and prescribing education. The inverse relationship between the time taken to complete a prescribing task and the rate of error emphasises the importance of attention to detail and workload as factors in error causation. Further work is required to identify the characteristics of prescription charts that are protective against errors.

eDrugCalc: an online self-assessment package to enhance medical students' drug dose calculation skills.

AIMS: Dose calculation errors can cause serious life-threatening clinical incidents. We designed eDrugCalc as an online self-assessment tool to develop and evaluate calculation skills among medical students. METHODS: We undertook a prospective uncontrolled study involving 1727 medical students in years 1-5 at the University of Edinburgh. Students had continuous access to eDrugCalc and were encouraged to practise. Voluntary self-assessment was undertaken by answering the 20 questions on six occasions over 30 months. Questions remained fixed but numerical variables changed so each visit required a fresh calculation. Feedback was provided following each answer. RESULTS: Final-year students had a significantly higher mean score in test 6 compared with test 1 [16.6, 95% confidence interval (CI) 16.2, 17.0 vs. 12.6, 95% CI 11.9, 13.4; n= 173, P < 0.0001 Wilcoxon matched pairs test] and made a median of three vs. seven errors. Performance was highly variable in all tests with 2.7% of final-year students scoring < 10/20 in test 6. Graduating students in 2009 (30 months' exposure) achieved significantly better scores than those in 2007 (only 6 months): mean 16.5, 95% CI 16.0, 17.0, n= 184 vs. 15.1, 95% CI 14.5, 15.6, n= 187; P < 0.0001, Mann-Whitney test. Calculations based on percentage concentrations and infusion rates were poorly performed. Feedback showed that eDrugCalc increased confidence in calculating doses and was highly rated as a learning tool. CONCLUSIONS: Medical student performance of dose calculations improved significantly after repeated exposure to an online formative dose-calculation package and encouragement to develop their numeracy. Further research is required to establish whether eDrugCalc reduces calculation errors made in clinical practice.

Medication errors: problems and recommendations from a consensus meeting.

Here we discuss 15 recommendations for reducing the risks of medication errors: 1. Provision of sufficient undergraduate learning opportunities to make medical students safe prescribers. 2. Provision of opportunities for students to practise skills that help to reduce errors. 3. Education of students about common types of medication errors and how to avoid them. 4. Education of prescribers in taking accurate drug histories. 5. Assessment in medical schools of prescribing knowledge and skills and demonstration that newly qualified doctors are safe prescribers. 6. European harmonization of prescribing and safety recommendations and regulatory measures, with regular feedback about rational drug use. 7. Comprehensive assessment of elderly patients for declining function. 8. Exploration of low-dose regimens for elderly patients and preparation of special formulations as required. 9. Training for all health-care professionals in drug use, adverse effects, and medication errors in elderly people. 10. More involvement of pharmacists in clinical practice. 11. Introduction of integrated prescription forms and national implementation in individual countries. 12. Development of better monitoring systems for detecting medication errors, based on classification and analysis of spontaneous reports of previous reactions, and for investigating the possible role of medication errors when patients die. 13. Use of IT systems, when available, to provide methods of avoiding medication errors; standardization, proper evaluation, and certification of clinical information systems. 14. Nonjudgmental communication with patients about their concerns and elicitation of symptoms that they perceive to be adverse drug reactions. 15. Avoidance of defensive reactions if patients mention symptoms resulting from medication errors.

Undergraduate preparation for prescribing: the views of 2413 UK medical students and recent graduates.

AIMS: To gather opinions from UK medical students and recent graduates about their undergraduate training to prescribe and their confidence about meeting the relevant competencies identified by the General Medical Council (GMC). METHODS: We designed a web-based survey that was distributed to UK medical students and first year Foundation doctors (graduation years 2006-2008) via medical schools and postgraduate networks. RESULTS: Analysis was restricted to 2413 responses from students graduating in 2006-2008 from the 25 UK medical schools (mean 96.5 per school) with a complete undergraduate curriculum. Distinct courses and assessments in 'clinical pharmacology & therapeutics (or equivalent)' were identified by 17% and 13%, respectively, with mode of learning described most commonly as 'opportunistic learning during clinical attachments' (41%). Only 38% felt 'confident' about prescription writing and only a minority (35%) had filled in a hospital prescription chart more than three times during training. The majority (74%) felt that the amount of teaching in this area was 'too little' or 'far too little', and most tended to disagree or disagreed that their assessment 'thoroughly tested knowledge and skills' (56%). When asked if they were confident that they would be able to achieve the prescribing competencies set out by the GMC, 42% disagreed or tended to disagree, whereas only 29% agreed or tended to agree. CONCLUSIONS: Many respondents clearly perceived a lack of learning opportunities and assessment related to the safe and effective use of drugs and had little confidence that they would meet the competencies identified by the GMC. There is an urgent need to review undergraduate training in this area.

The influence of primary care prescribing rates for new drugs on spontaneous reporting of adverse drug reactions.

INTRODUCTION: Adverse drug reaction (ADR) reporting makes a vital contribution to pharmacovigilance, although the factors that influence the reporting rate remain unclear. The aim of this study was to investigate whether the variation in the rate of reporting of suspected ADRs in different regions of Scotland was explained by differences in local prescribing practice and to quantify the extent of this influence. METHODS: Population and primary care prescribing data were obtained for ten geographical areas based on the 15 administrative regions of the National Health Service in Scotland. All reports of suspected ADRs received from within Scotland for 2000 and 2001 were available from the regional monitoring centre (Committee on Safety of Medicines, Scotland). The primary analysis was based on 14 medications that appeared in the 'top ten' list for the frequency of reported ADRs for either year. Reporting rates for each area were expressed both in terms of population (reports per million people) and in terms of estimated exposure to those medications in primary care (reports per 1000 prescriptions). For each analysis, the Pearson correlation coefficient between reporting and prescribing data was calculated using SPSS software. RESULTS: The 'top ten' medications accounted for 1715 of 2817 (60.9%, 95% CI 59.1, 62.7) ADR reports but only 2.2 million out of a total of 128 million primary care prescriptions (1.7%). Although there was a 3-fold geographical variation in the per-population ADR reporting rate, there was a close correlation between local reporting of ADRs and prescribing of the index medications (p = 0.66, p = 0.04, respectively). This implies that 44% of the observed variation in reporting rate can be attributed to variation in prescribing within the same population. DISCUSSION: Spontaneous ADR reporting in Scotland over the 2 years studied was highly concentrated on a small number of medications that were under intensive surveillance. Although there was a 3-fold variation in reporting rates from individual geographic areas when corrected for the size of the population, primary care prescribing data showed nearly half of this local variation in reporting rates could be explained by differences in prescribing. This study highlights the importance of considering prescribing practice when interpreting spontaneous ADR reporting data.

Do doctors rely on pharmaceutical industry funding to attend conferences and do they perceive that this creates a bias in their drug selection? Results from a questionnaire survey.

PURPOSE: To determine the sources of funding for doctors attending conferences and meetings and the doctors' perception on whether their involvement with the pharmaceutical industry created a conflict of interest or bias in their drug selection. METHOD: A postal questionnaire was distributed to 622 hospital doctors and 515 general practitioners (GPs) working in the Edinburgh area in Scotland, UK. RESULTS: The pharmaceutical industry funded approximately half of the meetings and conferences attended by doctors. Less than 20% of the doctors funded themselves. One-third of the meetings would not have been attended if funding from the industry had not been available. Hospital doctors and GPs had similar views on conflict of interest and bias. A minority of doctors (40%) thought that industry involvement created a conflict of interest but the majority of doctors (86%) thought that it did not create a bias in their own drug selection. CONCLUSIONS: If continuing medical education (CME) for doctors is going to rely on pharmaceutical industry funding in the future, then we need more explicit codes of conduct. It is of concern that while many doctors recognise the potential for the industry to influence their prescribing habits, few recognise that they themselves are susceptible.