Q J Med 2002; 95: 181-184
© 2002 Association of Physicians
Commentary |
Medicines management: a sour taste
From the West Midlands Centre for Adverse Drug Reaction Reporting, City Hospital, Birmingham, UK
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Introduction |
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‘Medicines management in hospitals encompasses the entire way that medicines are selected, procured, delivered, prescribed, administered, and reviewed ...’1 states the Audit Commission in its recent report, A spoonful of sugar, which views matters almost entirely from the perspective of clinical pharmacists. We can agree with the Commission that medicines are becoming more expensive, that some hospitals seem to be spendthrift and others parsimonious with drugs, and that drug budgets should, and will, span primary and hospital care. We can also agree that medication errors are unacceptably common, since any error is one too many. Many of the Commission's conclusions, though, seem insecure.
The selection of drugs through hospital formularies is crucial to safe, effective, and economic prescribing. A choice needs to be made, for example, among the 11 angiotensin-converting enzyme inhibitors, or several of the 25 non-steroidal anti-inflammatory drugs, where differences are small. The Commission emphasizes the need for ‘evidence-based formularies’, but does not explain why formularies vary so greatly from one hospital to another. In theory, the same evidence is available to all drug and therapeutics committees, but concentrating and distilling evidence is a skilled, painstaking, and time-consuming task, for which few drug and therapeutics committees have the necessary expertise or resources, so results are patchy. Even if the evidence were presented uniformly, of course, different decisions might be reached, because of differences in temperament, value judgements, or the baleful influence of pharmaceutical marketing.2 An important factor is the local perception of how to balance marginal or potential benefit against increased expenditure. For example, some Trusts perceive an advantage in using tissue plasminogen activator for treating myocardial infarction, even though it costs nearly 10 times as much as streptokinase, and even though its benefits are likely to be marginal and are largely unproven.3 A good drug and therapeutics committee should be made up of representatives from many disciplines, and be active and pro-active. It needs: the authority and resources to make decisions on which drugs are available to prescribers and how they are used; a process for implementing the decisions; a mechanism for appealing against decisions, and for agreeing exceptions for individual patients; and a way to audit its activities.4 The Commission's ‘diagnostic to monitor medicines management arrangements’ assesses these attributes only very obliquely or not at all.
Some central guidance might help. There is, of course, a tension between local autonomy, with the powerful adjunct of local involvement, and national uniformity imposed by some distant bureaucratic hand. One way forward is for drug and therapeutics committees from a wide area to meet and co-operate.5
The National Institute for Clinical Excellence (NICE) takes evidence from diverse sources, but does not sponsor field trials to help assess newly licensed drugs.6 What evidence NICE obtains, it sets against some unseen7 but Procrustean measure of effectiveness that requires budgets to be stretched to accommodate new drug therapies that could hardly hope to be high in the list of priorities for alleviating suffering if they were measured against, say, hip replacement surgery.
The Commission hopes, reasonably enough, that drug and therapeutics committees police drug spending. The present system apparently results in wide inequalities. One example quoted is the expenditure on oral antibiotics as a proportion of total antibiotic expenditure. This varies from under 25% in one Trust to nearly 45% in another. The Commission does not provide an explanation for the disparity, or discuss absolute spending. If the figures do accurately represent the usage of similar antibiotics in similar cohorts of patients, and the arguments are in favour of a high proportion of spending on oral drugs, then what is one to do? That depends on the underlying problem: is it one of a hospital ethos favouring intravenous treatment, perhaps because of ignorance of the evidence;8 or is it the result of indolence, disobedience, or a lack of awareness that giving antibiotics by mouth is safer, makes patients more comfortable, saves nurses' time, and can reduce drug expenditure; or is it the result of ineffective systems for translating the decisions of the drug and therapeutics committee into action? The cure will depend on the diagnosis. Clinical pharmacists may well be involved, as the Commission suggests, in gathering evidence, and in helping to convince prescribers of the need for change, but nurses, managers, finance staff, and senior and junior clinicians must surely be involved, too.
The Commission dwells on medication errors: ‘10000 hospital patients each year have serious adverse reactions to medicines.’ A graph of annual deaths due to the adverse effects of medicines shows an increase from just over 200 to nearly 1100 between 1990 and 2000 in England and Wales. Yet, in the US, with just four times the population, there are 180000 ‘deaths from iatrogenic disease’ a year, of which 36000 are related to medicines use. Professor Woods estimated the frequency of one horrifying error, intrathecal administration of vincristine, as 1 in 30000 vincristine treatments; that is, very rare.9 The disparate numbers are only explicable if there are systematic differences in the assignment or recording of cases in different years and different countries. Both are likely. There are very serious difficulties in framing an operational definition of medication errors,10 for example, and the commission recommends a definition * that is so broad as to be unusable in practice. Even after a satisfactory working definition has been found, the adverse drug reactions and medication errors have to be detected, and detection is both theoretically and practically difficult. Subsequent reporting is never complete, and often whimsical.11
The Commission assumes that iatrogenic disease is wholly bad, but that is to deny one of the truths of therapeutics: some treatments harm some patients. Modern medicine is based more on the Benthamite ideal of the greatest happiness of the greatest number than on the Hippocratic one of ‘primum non nocere’. In practice, therapeutic decisions where known benefits—for example, survival after thrombolysis for acute myocardial infarction—are balanced against known risks—for example, intracranial haemorrhage—are common. We know from large outcome trials that the benefits of thrombolysis greatly outweigh the evident dangers,3 but the latter are real enough for those who suffer as a consequence. The risk of their occurrence can be reduced, but they cannot be eliminated.
Information should be provided electronically to reduce the number of medication errors, in the Commission's view. This has been helpful in a study in the US, and on a renal unit in England,12 in reducing the number of perceived errors. It does, however, require very careful planning and execution, because the workings of the computer are hidden from the prescriber, so errors can go unnoticed. A mistake in using a computer program to calculate radiation doses went undiscovered for a decade, and many patients suffered as a result.13 Automatic warnings of potential problems can be triggered so frequently that an alarm becomes very non-specific, and the information content of any alert is consequently very low.14 Unforeseen difficulties can arise whenever a change is made to a complex system, and so careful testing, in itself difficult and expensive, is essential.
Information is only part of the problem of improving the safe use of medicines. The psychological theory of errors recognizes that in performing a habitual act we follow a ‘schema’ that specifies the nature and order of the steps required to perform the act.15 When we tie our shoe laces, or write a cheque, or give an injection of benzyl penicillin, we follow such a schema. Sometimes we err. We write ‘3 January 2001’ on our cheques on 3 January 2002. Or we are presented with a prescription for ‘Lamisil’ (terbinafine, an antifungal) but read ‘Lamictal’ (lamotrigine, an anti-epileptic agent). Or we automatically draw up penicillin powder and use the potassium chloride solution in the nearest ampoule without realizing it. Such errors, in which steps in the schema are omitted, duplicated, or subverted by those of another schema, are the price we pay for ‘automatic’, learned, behaviour. These slips are unconscious, so that exhortation will not prevent them. Their frequency is increased by distractions, simultaneous and competing demands, and tiredness: just the circumstances of hospital medicine.
Pharmacists are excellent at detecting and correcting ‘clerical’ errors in written prescriptions, as prospective studies show. However, there are two difficulties. The first is that, by and large, pharmacists correct errors without correcting the prescribing of doctors or modifying the dispensing of nurses. This is partly cultural: the time is yet to come when a pharmacist might demand that a prescription chart is rewritten to improve its clarity; or a nurse refuse to dispense a prescription because drug trade names, not approved names, have been used. As clinical governance, and clinical negligence settlements, become more onerous, Trusts may be led to ask for these measures to be taken. Secondly, however meticulously prescriptions are checked, and however carefully drugs are dispensed, there always remains the possibility of a slip in some later part of the process. An obvious example is giving vincristine intrathecally, an error that is usually lethal.9 Unless there is a mechanism for making it physically impossible to attach a syringe containing vincristine to a spinal needle, the error will remain possible. The most we can hope for is that a sufficiently large number of safety checks is interposed to make the eventual failure of all of them unlikely. That has proved hard to do.9 In the meantime, some empirical research, such as the US Food and Drug Administration's scheme to test drug names for potential confusion by presenting handwritten prescriptions, or the Medicines Control Agency's proposed scheme for standard drug labelling, may lead to safer working arrangements without huge investment.
Doctors at all levels have a vital role in selecting, prescribing, administering and reviewing medicines, and in designing and operating safer systems for these processes. It is precisely this primacy of doctors in the therapeutic process that makes it important that they are taught the general topics of therapeutics: the potential benefits of a medicine to an individual patient, the factors that contribute to the interaction between the medicine and the individual, the possible harms, the potential modes of administration, and the economic considerations.16,17
We should now look carefully at the undergraduate curriculum, and postgraduate training, and at the more general trend to teach specific skills rather than assume they have been learned. The General Medical Council should ensure that any doctor who qualifies has demonstrated such basic skills as being able to write a legible and legal prescription, and to give an intramuscular injection safely.18 When doctors appreciate the heavy burden that therapeutics places on them, they will more readily welcome the active support of clinical pharmacists. The Audit Commission's advocacy of clinical pharmacy, flawed by uncertain analysis of unreliable data, will not be enough.
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Notes |
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Address correspondence to Dr R.E. Ferner, West Midlands Centre for Adverse Drug Reaction Reporting, City Hospital, Birmingham B18 7QH. e-mail: r.e.ferner{at}bham.ac.uk
*‘... any preventable event that may cause or lead to inappropriate medication use or patient harm, while the medicine is in the control of the health care professional, patient, or consumer. Such events may be related to professional practice, health care products, procedures, and systems including: prescribing, order communication; product labelling, packaging and nomenclature; compounding; dispensing; distribution; education; monitoring; and use.’ This definition seems to have been taken from the American Association of Hospital Pharmacists' Report on Medication Errors.19
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