Patient Safety - Health Committee Contents

Memorandum by Professor David Webb (PS 89)


  Professor Webb trained as a cardiovascular physician and clinical pharmacologist in London, before moving to Edinburgh where he was appointed to the Christison Chair of Therapeutics and Clinical Pharmacology in 1995. He subsequently led Edinburgh's Department of Medical Sciences (1998-2001), Wellcome Trust Cardiovascular Research Initiative (1998-2001), and Centre for Cardiovascular Science (2000-04). He currently runs a Wellcome Trust-funded Scottish Translational Medicine & Therapeutics Initiative.

  He was Clinical Vice-President to the British Pharmacological Society (BPS: 1996-98), Chair of the Royal College of Physicians Committee on Clinical Pharmacology (1998-99), Chair of the BPS Committee of Heads and Professors of Clinical Pharmacology (2004-07) and Chairman of the Scottish Medicines Consortium (2004-08). He is currently a member of the Executive Committee of the International Union for Pharmacology (IUPHAR: 2004-), and Vice-President of the Royal College of Physicians of Edinburgh (2006-).


1.   What are the risks to patient safety in relation to use of medicines and to what extent are they avoidable?

  It is perhaps not surprising that medication errors occur. Prescribing is a high-level task integrating complex diagnostic skills, clinical judgement and an understanding of therapeutics. It is a skill practiced by virtually every doctor in their routine work, and yet is a task that carries significant risks as well as benefits. Matters are complicated because, year on year, there are more medicines available, with an increasing evidence base for their use. With an ageing population there are more patients to treat, requiring more complicated drug regimens that increase the risk of drug interactions, in potentially vulnerable patients. Standardised protocols now exist for the routine treatment of many conditions, but many patients either do not meet the criteria for these protocols, or have a number of conditions that may produce conflicting requirements. In this situation clinical judgement is crucial.

  Prescribing errors are common in UK hospitals. One study from a London teaching hospital detected 135 errors each week, one-quarter of which were potentially serious, with most made by junior doctors [Dean et al., 2002a]. The National Patient Safety Agency database receives >50 000 reports annually of medication incidents from acute and general hospitals [2007]—very likely a small fraction of all events. An Audit Commission report [2001] has suggested that adverse medication events were responsible for the death of 1100 hospital patients in 2001 in the UK, a 5-fold increase over the previous 10 years. Approximately 6.5% of admissions to hospital are related to adverse drug reactions, with an associated mortality of 0.15%; this costs the NHS £466m annually [Pirmohamed 2004]. Most reactions were judged to be "definitely" or "probably" avoidable.

  Some errors are "system" based whereas others relate to the knowledge or skills of prescribers. System errors include the risk of receiving the wrong medicine when different medicines have similar names, the risk of receiving the wrong medicine when different medicines are presented with similar packaging, and the risk of giving a medicine by an inappropriate or dangerous route when they are presented in ways that allow such mistakes (such as the potentially fatal risk of intra-thecal administration of anti-cancer drugs designed for intravenous use). These issues need to be addressed through systems approaches. In particular, a blame-free approach to reporting of critical incidents, a robust means of responding to system failures, and electronic support for prescribing may assist in reducing some of these system-based errors. The clinical pharmacist has a key role in this area of work.

  In this evidence, I will focus on those errors related to lack of knowledge or skills. There is evidence that inadequate training is often a contributory factor in prescribing errors [Dean 2002b; Leape 1995]. An analysis of 88 serious medication errors in a UK hospital has suggested that a deficit in "skills and knowledge" was a factor in 60% of cases [Dean, 2002b].

  In 2008, Heaton [Heaton 2008] reported the results of a web-based survey which sought the opinions of 2,413 students graduating in 2006-08 from the 25 UK medical schools (mean 96.5 per school) about their undergraduate training to prescribe and their confidence about meeting the relevant competencies identified by the GMC. Distinct courses and assessments in "clinical pharmacology & therapeutics (or equivalent)" were identified by only 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.

  Subsequently, the GMC Education Committee has undertaken its own study on preparedness to practice. This involved three diverse medical schools (Glasgow, Newcastle and Warwick) with different approaches to undergraduate teaching (problem-based learning, systems-based integrated curriculum, and graduate entry respectively). The study was multi-method, cross sectional and prospective, involving in-depth interviews and questionnaires. Newcastle and Warwick Foundation year 1 doctors also completed a safe prescribing assessment. Qualitative triangulating data were collected from nearly 100 clinicians (undergraduate tutors, educational supervisors, key managers and members of clinical teams). Illing and colleagues [GMC website Dec 2008] have now "published" the report of the study on how prepared medical graduates are to begin practice. This document clearly shows that a crucial concern is prescribing ability, as follows:

    "There was a consistent thread, from primary sample data throughout the year, and from triangulation data, of under-preparedness for prescribing. Weaknesses were identified both in the pharmacological knowledge underpinning prescribing, and the practical elements of calculating dosage, writing up scripts, drug sheets, etc. While there was some feeling from triangulating data that F1s were prepared for prescribing, pharmacists did identify severe gaps. Prescribing was also the main area of practice in which errors were reported by respondents, indicating a significant potential risk. Risks were reduced, but not removed, by support from colleagues, with F1s speaking particularly highly about the help received from pharmacists."

  The key significance of this report, part from confirming the earlier work from Heaton is that it compared the full range of competencies expected of newly qualified doctors and identified prescribing as the most significant weakness, and one that has the potential to put patients at serious risk. Of 10 competencies that were scored under 3 (out of 5), 4 of these were in the area of prescribing.

  The GMC report concludes that the priorities are to:

    "… address particular weaknesses in prescribing by supporting the development of teaching of prescribing as a skilled procedure which is subject to the time pressures and contingencies of all clinical skills. Such teaching should place greater emphasis on prescribing as an instance of applied pharmacology, and the need for new doctors to engage with prescribing and develop their own expertise rather than relying on others."

  The report also showed problems in a safe prescribing assessment administered to Foundation doctors within two of the schools. Indeed, over 80% of foundation doctors failed the assessment in the first round. Whilst it may be that this assessment had problems, it does highlight the need for continuing reinforcement and reassessment of prescribing skills in the early years after qualification.

  The particular needs for education described by the GMC—in pharmacokinetics (how the body handles medicines), interactions between medicines, and common prescribing skills—are all met by the core curriculum in clinical pharmacology and therapeutics produced by the British Pharmacological Society [Maxwell 2003]. As a result of Tomorrow's Doctors (1993, 2003), time spent on undergraduate teaching in this area has reduced substantially and this now needs to be corrected.

2.   What is the effectiveness of current approaches to patient safety in relation to use of medicines?

  It is widely recognised that newly qualified doctors are at the sharp end of prescribing, and that this work is largely unsupervised. Although junior doctors are protected from undertaking many high-risk practical procedures, they are able to prescribe powerful medicines from their first day of clinical work. Here, clinical pharmacists are well recognised to play a very important support and educational role. Nevertheless, there is a critical need to provide medical students with an undergraduate education and training in therapeutics and prescribing that prepares them effectively to fulfil this role, and to be able to develop as an effective prescriber thereafter. Essential support in prescribing can be provided, and several studies have suggested that the delivery of targeted education can improve prescribing performance and reduce prescription errors [Scobie 2003; Garbutt 2006; Langford 2001; Vollebregt 2006]. However, some of the changes in recent years have served to reduce the preparedness of doctors for prescribing (see below).

  The GMC's recommendations on undergraduate medical training published in Tomorrow's Doctors (1993) heralded a major change in medical training. The focus was on a reduction in the burden of factual learning, a slimming down of the science base taught to medical students and the development of an integrated medical undergraduate curriculum in an organ based structure. There were many potential benefits to this approach, but one of non-organ based areas of teaching that lost out was the vertical theme of pharmacology, clinical pharmacology and therapeutics, which in most medical schools became a much less visible area of teaching. Again, in many medical schools, the assessment of teaching in therapeutics was no longer identifiable and this diminished the demand on students to focus on this area of learning. Another important driver for loss of teaching in this area was the national round of Research Assessment Exercises, which meant that universities placed a higher value on research than teaching and, as a largely academic specialists, clinical pharmacologists were encouraged to focus on this aspect of their work. In some medical schools therapeutics disappeared as a teaching discipline and it has been noted that many nursing schools provide more hours of education in this area than most medical schools [Aronson 2006]. These concerns about teaching in therapeutics and prescribing within in the UK [Maxwell 2006], have been mirrored in Europe [Maxwell 2007] and Australia [Hilmer 2009].

  In the past, medical students were encouraged to prescribe, under supervision, and to have their prescriptions signed off by a more senior member of staff. This is no longer considered an acceptable practice but it has not generally been replaced in medical schools by other means to give students an understanding of the complexity of prescribing, and to thereby ensure that they give this area of learning the time and effort it justifies.

  Interestingly, there have been recent moves by the pharmaceutical industry to fill the void and take on this role [Coombes 2009]. However, there are well-recognised concerns about the ability of industry to provide such information in an unbiased way [House of Commons Health Committee 2005], and in a recent poll in the British Medical Journal around 80% of respondents thought that drug companies should not teach therapeutics to medical undergraduates [This Week 2009]. Indeed, one could argue more broadly, for the same reasons, that the pharmaceutical industry should not be involved in the education of doctors but should focus their efforts on the development of powerful and innovative new medicines.

  Importantly, following a public debate on the preparedness of newly qualified doctors for prescribing [Aronson 2006, Rubin 2006a], the GMC assisted in creating a Safe Prescribing Working Group (SPWG) [Rubin 2006b] established by the Medical Schools Council under the chairmanship of Professor Robert Lechler. The work of SPWG [Lechler 2007] had two important outcomes: first, a description of the prescribing competencies required of a newly qualified doctor; and second, the generation of a major Department of Health E-Learning project on Prescribing.

  The prescribing competencies defined by SPWG, which now provide a yardstick against which undergraduate education in this area can be judged, are that all medical graduates should be able to:

    — Establish an accurate drug history.

    — Plan appropriate therapy for common indications.

    — Write a safe and legal prescription.

    — Appraise critically the prescribing of others.

    — Calculate appropriate doses.

    — Provide patients with appropriate information about their medicines.

    — Access reliable information about medicines.

    — Detect and report adverse drug reactions.

  The Department of Health e-Learning for Healthcare project, led by Dr Simon Maxwell and undertaken in collaboration with the British Pharmacological Society, will provide funds to develop a national e-Learning solution in clinical pharmacology and prescribing for students of medicine and allied professions. The project will be known as Prescribe and is intended to provide e-learning materials that will enable students to develop a firm grounding in the principles of basic and clinical pharmacology, which underpin safe and effective prescribing in the NHS. Prescribe will contain both interactive learning sessions and information covering the pharmacology, clinical pharmacology and therapeutics that a student might expect to encounter within a standard medical curriculum. Also in development is an interactive student formulary, the opportunity to practice skills relevant to prescribing, self-assessment exercises, a library of important publications, a glossary and links to other resources. Prescribe will be available free of charge to students registered with UK universities and NHS-affiliated organisations. Further details are available at

3.   What should the NHS do next regarding patient safety in relation to use of medicines?

  Together with gathering evidence by taking a history from the patient, undertaking a medical examination, and interpreting the results of laboratory investigations, prescribing of treatments is one of the defining activities of the doctor. Prescribing is not an exact science, as it requires the weighing of evidence and the use of clinical judgement about harms and benefits of intervention, but safe, effective and cost-effective prescribing requires training in the principles of pharmacology and its application in therapeutics. In the absence of incontrovertible evidence (which would be hard to obtain) that poor prescribing leads to harm to patients, all of the evidence we have to date would support the risks of poor prescribing skills and the precautionary principle would justify a greater emphasis on improving prescribing quality.

  Addressing this problem requires collaboration between the medical schools, GMC and NHS. The following are important ways in which patient safety in relation to prescribing could be improved.

    1. Undergraduate medical students need to receive a sound grounding in the principles of pharmacology and therapeutics, supported by training in the practical skills of prescribing, and a professional attitude to its performance. The required competencies in prescribing are defined by the Medical Schools Council Safe Prescribing Working Group [Lechler 2007]. Research is needed to define the best way to deliver these competencies.

    2. The next iteration of Tomorrow's Doctors (2009; the last was in 2003), currently in draft form, addresses many of the previous omissions, and is an important development in undergraduate medical training. Nevertheless, it should identify the report from the Medical Schools Council Safe Prescribing Working Group, and include the full list of prescribing competencies required of a newly qualified (Foundation) doctor. In addition, it should identify prescribing as one of the key therapeutic procedures. The opportunity to make an unequivocal statement on this issue should not be missed.

    3. Teaching and training need to be backed up by rigorous methods of assessment of knowledge, skills and attitudes around the time of graduation so that these competencies can be assured. If necessary, these should be undertaken on a national basis.

    4. It should be anticipated that undergraduate teaching and training will be very usefully supplemented by the Department of Health e-Learning for Healthcare package, Prescribe, currently under construction.

    5. In addition, there is a need for continuing medical education in this area, backed up by assessment of prescribing in the foundation period of training, and beyond. Benefits would be gained by having prescribing "champions" in training environments where foundation doctors are placed. The creation of a "prescribing skills test" to be undertaken early in the early postgraduate period might be a helpful step.

    6. Additional benefits might well accrue from introducing a standardised prescribing form across routine UK hospitals so that there is less risk of error associated with doctors moving between centres.

    7. The creation of effective electronic prescribing systems would assist in ensuring that patients received the right medicine at the right dose, would serve to encourage use of the most effective medicines, and would assist in providing alerts to potential contraindications and drug interactions. It should also serve to ensure clarity about current treatment in the movement of patients between primary care and the hospital setting.

    8. Patients need to receive unbiased evidence about the benefits and harms of licensed medicines. In the US, direct-to-patient advertising by the pharmaceutical industry can serve to distort this advice [Berndt 2005], especially in relation to the relative benefits and harms of medicines. Direct-to-patient advertising should be resisted within the EU.

    9. Clinical pharmacologists, and other clinicians with skills, knowledge and a focus on teaching of prescribing skills are required to assist junior clinicians in integrating prescribing into clinical care. Clinical pharmacists have complementary roles in education to ensure safe prescribing, and there are substantial benefits from pharmacists working closely with clinicians in this important area.

    10. The discipline of clinical pharmacology and therapeutics is the only medical specialty within the NHS that is declining in numbers, as other specialities grow. Given that clinical pharmacology is the key medical specialty with a focus on safe and effective prescribing, and its numbers are at a critically low state, urgent work is needed within the Department of Health to increase the numbers of doctors training in clinical pharmacology and therapeutics in the UK.

Professor David Webb MD DSc FRCP FRSE

January 2009


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