Select Committee on Science and Technology Seventh Report


Over-the-counter (OTC) antibiotics

  2.26     In the United Kingdom at present, generally speaking, systemic antibiotics (i.e. taken internally, as opposed to "topical") are licensed as "POM": i.e. prescription-only medicines, available only on prescription from a doctor, dentist or veterinary surgeon (not from a nurse-prescriber). There is however a general trend to deregulate medicines, moving them from POM to "P" (pharmacy); and there is discussion of treating antibiotics in this way.

  2.27     The RCGP believe that there is pressure for OTC antibiotics from consumers and from industry. However they have no doubt that OTC availability would mean more use, and they consider it possible that this would mean more resistance. Therefore, "We do not think it is a good idea" (Q 306).[20] Neither does Professor Petrie (Q 659). The ABPI are "generally opposed" to OTC antibiotics, with the possible exception of treatments for uncomplicated lower urinary tract infection (cystitis) (p 177, Q 338). They object because pharmacists do not have the necessary training or suitable premises for the confidential consultations which would sometimes be needed to advise customers on the right choice of medicine, nor access to the microbiology services which would sometimes be needed for diagnosis; and because the imprudent use which contributes to resistance would probably increase.

  2.28     Professor Finch (p 186, QQ 364-376), who is a member of the Committee on Safety of Medicines and co-chairman of a BSAC working party on OTC antibiotics, told us that the pressure to deregulate the supply of antibiotics comes not just from industry, but from the regulators themselves, in particular at EU level. He explained that what is under consideration is not a free-for-all, but OTC supply of single doses or short courses for particular indications. In his view, much depends on what drugs are to be deregulated, and for what conditions; he too identified cystitis as one which "seems to be reasonable at first view", along with minor infections of the skin or eye.[21] It would be necessary to give pharmacists robust guidelines, possibly access to medical records, and perhaps a surveillance role. OTC antibiotics would make commercial sense only if they resulted in increased use; but this would not necessarily mean more resistance, and might even mean less, if P medicines with a lower tendency to induce resistance took market share from POM drugs with a higher tendency. He concludes that more research and consideration is needed before any major change.

  2.29     One systemic antimicrobial is already available OTC in the United Kingdom: the antifungal fluconazole, sold in a one-capsule course for Candida vaginitis. In Spain and Greece fluconazole is available OTC, and seems to have given rise to significant resistance. According to Professor Finch, "In the United Kingdom there is no evidence to date that the use in the community of a single capsule for Candida vaginitis is associated with resistance" (Q 375); but this may be because no survey has been undertaken. According to Dr David Denning of the University of Manchester (p 402), fluconazole-resistance in Candida is now common, but the causes are "not known entirely"; any effects of OTC supply are "not being studied".

  2.30     The Department of Health drew to our attention the concern of the Medical Devices Agency about wound dressings which incorporate antibiotics (p 345). Under EU law and the Medical Devices Regulations, there is no provision for such dressings to be POM, and they have therefore been available OTC since 1995. The Agency are concerned that uncontrolled use will give rise to resistance. However they have no evidence yet that this is happening; and they have received little support from other Member States "because many antibiotics are already available OTC in a number of EU countries and there seems to be general acceptance of this practice". As to actual OTC antibiotics, however, the Department are confident that they can hold the line. The Chief Medical Officer, Sir Kenneth Calman, has raised the issue with his EU counterparts (Q 757); he considers a ministerial decision to permit OTC availability "very unlikely" (Q 794). Under EU law, any medicine may be confined to the POM category if it presents "danger to health" if used without supervision; and Sir Kenneth assured us that "health" for this purpose included public health (p 371).

Medical education: undergraduate, postgraduate and vocational

  2.31     The undergraduate medical curriculum is crowded, and several witnesses told us that it tends to devote little time to antimicrobial therapy (e.g. Petrie, McGavock Q 681—though Professor Finch disagrees, p 187).[22] This would be understandable, since oral antimicrobials are relatively easy to prescribe, being relatively non-toxic and unlikely to harm the patient directly. As the AMM put it, "antibacterials are victims of their own success". They point out that "antimicrobials are the only class of drugs the prescription of which can have adverse consequences outside individual recipients"—i.e. the selection of resistant strains. They recommend, "priority should be given by the medical profession, universities and the General Medical Council to ensuring that a definitive slot on antibacterial use is in all curricula, and that this includes not only technicalities of antibacterials but puts their use into sociological and world contexts" (p 10). Implementing this recommendation would of course involve taking time from other subjects, whose advocates would no doubt make their case with equal vigour.

Continuing professional development

  2.32     In medicine as in other walks of life, one of the most effective forms of professional development is participation in teaching. In Oxfordshire, Dr Mayon-White reports, "the teaching and training practices tend to prescribe less of the expensive antibiotics—and indeed fewer antibiotics overall—than the non-teaching, non-training practices" (Q 158, cp Davey p 155 and Q 250). In the context of prescribing, another effective form of professional development is participation in the process of creating local formularies and policies (Petrie Q 679).

  2.33     Not every doctor can be a trainer or policy-maker; and various ways have been found to deliver professional development to the wider medical community. Dr Jeremy Grimshaw of the Health Services Research Unit at the University of Aberdeen gave us an overview drawn from the findings of the Cochrane Collaboration on Effective Professional Practice, of which he is the co-ordinating editor (Q 672). He indicated that there are no "magic bullets"; which interventions are most effective at changing behaviour depends on the behaviour in question, and on the context (e.g. hospital or general practice), and best results are obtained by intervening in several ways at once. Dr Grimshaw's findings may be crudely summarised as follows:

We have received further evidence about (iii) and (iv), as follows.

Audit and feedback

  2.34     GPs may already opt to receive detailed information ("PACT" data) on their own prescribing from the PPA; and some may have access to additional information from their own IT system. The AMM, who recommend wider use of formularies and policies, call for these to be supported by audit (p 10).[23] They acknowledge that audit is especially difficult in the isolated conditions of general practice; on the other hand, GPs are ahead of hospitals in computerising their records of diagnosis and prescription. They acknowledge that the cost to the NHS of the staff and IT required for a proper system of audit would be high; and they assess the impact, even after 5-10 years, as "Some effect, but not major". Professor Petrie is an advocate of audit (Q 663): "By doing audit of what people are doing, you can get the `outliers' and bring them into the middle group of prescribers voluntarily. If you start going out with guns and statutory controls, people hide." Box 4 gives examples of good practice in this area which have come to our notice.

Box 4
Northern Ireland—COMPASS
Dr McGavock told us about COMPASS—Computerised On-line Monthly Prescribing Analysed for Science and Stewardship (p 281, Q 635). COMPASS is an evidence-based, computerised prescribing interrogation system, run by the Drug Utilisation Research Unit of The Queen's University, Belfast. "COMPASS compares each practice's prescribing every month in Northern Ireland against best practice and it then prints a clear report showing the ways in which the doctors did prescribe and recommends changes to improve the quality of their prescribing". For a cost of £2 per copy, COMPASS typically identifies possible savings of 15 per cent. "COMPASS is taken to every practice annually by the Area Prescribing Advisers, for detailed discussion, but fundholding practices often request this document quarterly, to drive their cost-effectiveness efforts. COMPASS has saved over £11m in Northern Ireland in the past three years, but could save up to £25m annually, if fully utilised, with a striking improvement in the quality of medical treatment". In the first quarter of 1997, 60 non-fund-holding GPs saved £1.23m using COMPASS, backed up with lectures and visits. Dr McGavock finds the results of COMPASS overall "disappointing". He believes that, if it is to change behaviour significantly, such a system requires to be backed up by educational outreach, and by some direct "incentive", e.g. such that a proportion of the money saved on drugs is returned to the practice (QQ 638, 684).
Dr Mayon-White told us (p 111) that Oxfordshire Health Authority has begun a programme to improve antibiotic use in general practice. Guidelines have been issued to GPs, recommending first-choice empirical treatments for various infections. The guidelines are supported by prescription monitoring; results are fed back to GPs in general by means of a newsletter, and to individual practices through visits by the Authority's Medical Adviser.

Educational outreach

  2.35     Dr Grimshaw defined educational outreach thus: "This is where you have a professional, often a pharmacist, going to visit a general practice or hospital to give a number of very selective messages about good prescribing behaviour, which often use the marketing techniques of the pharmaceutical industry, to try and identify the specific barriers to the behaviour they want to happen, and modify their message based on these barriers and reinforce that message throughout that contact". He mentioned that the Department of Health is currently funding a large-scale trial of this method, expected to report in 1999 (QQ 672, 683). The USA is ahead of the United Kingdom in this field: see Box 5.

Box 5
Dr Jerry Avorn of Harvard Medical School is a world expert on educational outreach. His approach is modelled on that of the pharmaceutical industry. He began with focus groups of physicians. These revealed two groups of doctors: some who overprescribe out of ignorance; and others who consciously overprescribe in order to satisfy their patients. For the second group, like Dr Schwartz, he provides "paper placebos". For the first, he sends out "academic detailmen": pharmacists from the medical school who meet physicians one-to-one, on the same basis as salesmen, to talk about prudent prescribing. He has shown that every $1 spent on these actions saves $2 on the drugs bill. His approach has been taken up in various places around the USA; similar approaches have been tried in various parts of the United Kingdom, and adopted nationwide in Australia. He acknowledged that some doctors require to be persuaded that prudent use is not just a euphemism for cutting costs at the expense of patient care.
Dr Ben Schwartz, of the Centers for Communicable Disease Control and Prevention (CDC) in Atlanta, has worked on educating community physicians and their patients, with a view to controlling the rise of penicillin-resistant pneumococcus. In focus groups, physicians acknowledged overusing antibiotics by as much as 50 per cent. They blamed pressure from patients, and shortage of consultation time: it is quicker to prescribe, than to explain why a prescription would be inappropriate. Dr Schwartz has therefore produced the following aids for physicians: professional information sheets; a simple patient information leaflet for the waiting room, explaining that unnecessary antibiotics are bad for the patient; a "non-prescription" form; question-and-answer sheets for parents; and a letter for parents to give to their child-carer. Pilot projects are now under way in five States; CDC is equipping the local health department to train senior doctors to disseminate the concepts and materials to their peers. Evaluation will show whether these approaches reduce inappropriate use, and whether this in turn affects the level of resistance.


Educating the public

  2.36     One major factor affecting the prescribing behaviour of GPs is the expectations of their patients[24]—or GPs' perception of patients' expectations, which is not necessarily the same thing.[25] Patients' expectations are not uniform; according to Dr Grimshaw, they "vary across different areas, socio-economic groups and cultures" (p 301).

  2.37     It may not be the case that people in poorer communities have a higher expectation of receiving antibiotics. Rather, it may be that GPs in such communities are more pressed for time, and therefore inclined to prescribe rather than explain. However a GP under pressure of time may do various things to terminate the consultation besides prescribing. First, he may simply say No: Dr Grimshaw cited evidence from a randomised trial that this reduces the likelihood that the patient will attend again with the same complaint (Q 674). Saying No is not always easy: Dr Grimshaw recommended training for GPs in communication skills (p 301). Dr Davey mentioned two alternative approaches (Q 273): give the patient an information leaflet; or say, "I do not think you need an antibiotic, but if you want to get a prescription you can come back any time, you do not have to make another appointment". Of the latter approach, he commented, "Most of the people who were given that option did not come and get the antibiotics". Dr Taylor of the RCGP mentioned another: a delayed-action prescription, for use if symptoms persist. "The result of that is that many patients do not in fact take the prescription" (Q 303); this strategy is also known to reduce the rate of follow-up appointments.

  2.38     Rather than waiting until the patient is in the surgery, the professions may take the message of prudent use out to the public at large. The AMM recommend that the health and education departments, the health professions and the media should all do more to convey the message (p 11). Dr Mayon-White similarly calls for public education; he recommends that health authorities' health education departments should prepare material for schools, while adult education should be delivered through the media (QQ 159-163).

  2.39     The RCGP observe that GPs work within, and are to an extent constrained by, a "cultural framework" (Q 281). A GP who unilaterally defies this framework may simply lose his patients. However the culture can be changed, as in the cases of barbiturates and amphetamines. Changing the culture requires public education and consensus-building, based on evidence. In this matter, they feel, the evidence will have to be compelling: "Whether or not, and how far, antibiotic use for relief of symptoms of self-limiting illness should be limited should not be a matter for doctors to decide, but the subject of public policy. In a context in which antibiotics are much more freely used in agriculture and food production, it seems unlikely that there would be much public support for such restriction...Antibiotic use in the United Kingdom is already lower than in many other European countries; in that context it would be difficult to operate a more restrictive policy" (p 167). The RCGP observe that typically the sort of patients who are most insistent on antibiotics belong to the social groups who are hardest to reach with educational material (Q 299, cp Petrie Q 677).

Are antibiotics bad for you?

  2.40     Persuading the public of the case for reduced use of antibiotics will be much easier if it can be shown that unnecessary use carries risks not only to public health in general, but also to the particular patient under treatment.[26]

  2.41     Professor Finch said (in the context of OTC antibiotics), "It is uncommon for resistance to arise in an individual receiving an antibiotic and for this to cause him/her harm" (p 189). (TB is an exception, as are viruses such as HIV.) However he went on, "Agents can affect the susceptibility of the bacteria which make up the normal flora of the skin and gastrointestinal tract. This in turn could give rise to subsequent infection in an individual". Dr Ben Schwartz of the US Centers for Communicable Disease Control and Prevention (CDC) and Dr Michael Bennish of Boston both believe they can show that previous treatment with antibiotics is a risk factor for infection with resistant strains. Dr McGavock cited evidence that, in cases of otitis media, withholding antibiotics for two to three days reduced the rate of recurrence by four fifths (QQ 659, 677).

  2.42     Dr Davey also has evidence to support this proposition. "Patients with resistant organisms are more likely to have received prior antibiotic therapy than are controls [i.e. patients with susceptible strains of the same organism]"—though, he admits, "Antibiotic use may just be a marker for patients who are more ill" (p 145). Speaking in the context of the successful campaign in Iceland to bear down on penicillin-resistant pneumococci, he added, "The message that we need to get across is that most of the bacteria that live in our bodies do not do us any harm, and if you eliminate them with antibiotics then you allow the bad guys in" (Q 262; cp Q 236, pp 146, 154). He went so far as to say, "Germs are good for you...germs are part of your environment" (Q 274); he admitted that this is "probably not something that people understand".

  2.43     The ABPI observe that effects on the gut flora are checked as part of the process of licensing a new antimicrobial. "Whilst it is true that there are occasional changes in gut flora which are limited to the duration of treatment, generally speaking you find that the gut flora returns to normal quickly after the antibiotics are stopped" (Q 331).

  2.44     If antibiotics do even slight collateral damage, then it would plainly be better not to use them in situations where they can do no good (e.g. the minor viral infections which Dr Davey believes account for more than half of GPs' prescriptions—Q 265). More difficult are situations where antibiotics do a little good, which must then be weighed against the possibility of harm. The RCGP draw attention to the major grey area in general practice: the use of antibiotics to relieve the symptoms of self-limiting illness such as sore throat, bronchitis and otitis media. They concede that there may be a case for limiting use in such cases on public health grounds, but they insist that such use does have direct benefit (p 166). The ABPI, on the other hand, regard prescribing antibiotics for "the majority of sore throats", or for "a banal, self-limiting, mild condition, e.g. an upper respiratory tract infection", as "irresponsible" (p 176).

  2.45     Tessa Jowell MP, the Minister for Public Health, was firmly of the view that the public must not be warned off antibiotics. For her, the issue crystallised around meningitis: nothing must be said to deter parents, in particular, from contacting their doctor at once if they suspected meningitis in their child. She acknowledged that it was difficult to convey the message of appropriate use of antibiotics in a way which was balanced and not confusing; but, she insisted, "We do not want patients to think that antimicrobials are dangerous for the individual...; they are among the safest medicines" (Q 759). The Chief Medical Officer suggested that the problem could be addressed by acknowledging that what was appropriate varied from case to case: for instance, what was appropriate for a young child with a fever was not necessarily appropriate for a middle-aged man with a cold (Q 761).


  2.46     It is usual practice for patients receiving antibiotics to be instructed to "complete the course". Yet the quality of evidence on which the recommended duration of antibiotic treatment is based varies, in fact, greatly from case to case. For some infections, of which tuberculosis is the most notable example, the type and duration of treatment needed to cure the patient (and to prevent resistance in those few patients who are not cured) has been well authenticated by numerous controlled trials. For others, including the many respiratory infections, such as bronchitis, pneumonia, sinusitis and otitis media, which constitute the most frequent occasions of antibiotic use, the optimum duration of courses of treatment is still surprisingly ill-founded. International comparisons reveal these uncertainties vividly, particularly in otitis media, bacterial endocarditis and urinary tract infection (Griffin p 548). There is certainly no virtue in completing the course if the infection was not in fact present in the first place (Davey Q 268), or if the prescribed course was longer than necessary to cure the infection and completing the course only prolongs the selective pressure on the commensal flora.

  2.47     Whether or not the particular recommendations for duration of treatment are well-founded, however, it is clear that compliance with prescribing recommendations is hard to achieve and that non-compliance with treatment can contribute to resistance, especially in the case of tuberculosis and sexually-transmitted infections. The Royal Pharmaceutical Society has addressed this problem in a valuable document entitled From Compliance to Concordance (March 1997). The RCGP observe that compliance can be encouraged by drug and regimen design, and by patient information, on which there is recent EU legislation which they support (p 167). The ABPI are "particularly keen" on improving compliance by means of new formulations (p 176, Q 347); and they support the Patient Pack Initiative on patient information.

20   The RCGP's memorandum (p 167) said, "In principle...we would not object to the direct sale of certain antibiotics". They admitted under oral examination that they would object, up to the point where the Medicines Control Agency licensed antibiotics OTC, at which point "We would have to go along with that" (Q 306). Back

21   Cp Royal Pharmaceutical Society p 463. Back

22   Professor David Greenwood, of Nottingham University Hospital, believes that his department "may be unique" in giving third-year medical students a two-week module on antimicrobial therapy (p 410). Back

23   So do the British Pharmacological Society (p 386). Back

24   For eloquent accounts of this problem from the front line, see the evidence of the Osborne Practice in Southsea (p 440) and Dr John Sterland (p 526). Back

25   "Doctors tend to overestimate the patient's desire for a prescription"-RCGP Q 297, cp Grimshaw Q 674. Back

26   Like all medicines, antibiotics carry risks of direct adverse side-effects in the individual. Although antibiotics are generally safe medicines, unwanted effects do occur, mostly trivial but occasionally life-threatening. Our particular concern, however, is the relationship of antibiotic treatment to the development of resistance. Back

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