JAC Advance Access originally published online on February 8, 2007
Journal of Antimicrobial Chemotherapy 2007 59(3):333-341; doi:10.1093/jac/dkl502
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Garrod lecture |
The 2005 Garrod Lecture: The changing access of patients to antibiotics – for better or worse?
Department of Medical Microbiology, Southmead Hospital, North Bristol NHS Trust, Westbury-on-Trym, Bristol BS10 5NB, UK
* Tel: +44-117-959-5651; E-mail: davidreeves2{at}aol.com
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Abstract |
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 Top Abstract IntroductionClassification of medicines in...Increasing the range of...Self-purchase of antimicrobialsEffect of changes in...Mixed messagesTransparency declarationsReferences |
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Expanding the range of health professionals who can supply prescription medicines has been a policy of the UK National Health Service (NHS) since 2000, the most recent change being the establishment of nurse and pharmacist independent prescribers. In addition, patients now have a wider choice of how they access treatment for infections, particularly through the availability of antibiotics through community pharmacists under Patient Group Directions and Supplementary Prescribing. There is also a drive to reclassify medicines where possible from Prescription Only to Pharmacy Medicines. Patients can easily obtain antibiotics via the Internet, now available in more than half of UK households, and from their own and others' leftovers of prescribed courses. The first of these has considerable hazards for individual patients. The benefits to patients of the regulatory changes are largely ease of access to treatment for relatively minor illnesses, and their increased awareness and self-reliance that comes from this. More informed self-care should encourage the better use of healthcare resources. There could also be financial savings for the NHS if more patients purchased their medicines. Information on whether the changes in access have led to increased usage is scanty, since information on some of the supply is not collected. No doubt some of the usage from non-medical sources will be substitution, although there may well be an increase overall. It is possible that supply by non-medical professionals could lead to a closer adherence to protocols for the use of antibiotics. Whether the changes in access will have an impact on the prevalence of antimicrobial resistance is even harder to determine, especially as there is still much uncertainty about which parameters of antibiotic consumption encourage resistance. Within the context of the widespread use of antibiotics from extra-regulatory sources, it is hard to see how a modest increase in usage resulting from the changes in the regulations would have a significant impact on resistance. One issue to emerge from these changes is the mixed message given by official sources on antibiotic usage, with on the one hand placing an emphasis on containing resistance (and hence restricting antibiotic use) and on the other widening access and encouraging the reclassification of antimicrobials.
Keywords: prescribing , antibiotic resistance , reclassification , self-medication
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Introduction |
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TopAbstractIntroductionClassification of medicines in...Increasing the range of...Self-purchase of antimicrobialsEffect of changes in...Mixed messagesTransparency declarationsReferences |
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Until the past few years the supply of a full range of oral antimicrobials to patients in the UK was restricted to prescriptions written by medically qualified practitioners. However, since 2000 there have been considerable and accelerating changes in the supply of previously prescription-only medicines (POMs) in general, and the supply of antimicrobials has been included in them. The result is that there are now potentially many more health professionals other than doctors involved in antimicrobial prescribing. Most of the changes have taken place in primary care, and many professionals working in hospital-based infection services may not be aware of them and their possible implications. It is thus opportune to review changes in the supply of medicines so far and also possible future changes. The compatibility of what has happened to antimicrobial supply with the Government's initiatives to contain and reduce antibacterial resistance also demands examination.
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Classification of medicines in the UK |
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TopAbstractIntroductionClassification of medicines in...Increasing the range of...Self-purchase of antimicrobialsEffect of changes in...Mixed messagesTransparency declarationsReferences |
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A medicine in the UK is placed into one of three categories (see ref. 1):
- Prescription-only medicine (POM) – traditionally could only be supplied on a prescription from a medical or dental practitioner, although this was widened in 2006 to include other health practitioners.
- Pharmacy (P) medicine – can be supplied by a registered pharmacist from a registered pharmacy. Self-selection of the medicine in the shop by the public is not allowed.
- General Sales List (GSL) medicine – can be sold from any lockable shop [e.g. filling (petrol) station kiosk, newsagent, etc.].
- Pharmacy (P) medicine – can be supplied by a registered pharmacist from a registered pharmacy. Self-selection of the medicine in the shop by the public is not allowed.
When the BSAC OTC Working Party was preparing its report in the mid- and late-1990s there was already a trend in the UK to down-regulate medicines as far as possible, but compatible with safety. At that time there was the precedent in antimicrobials of topical antifungals and antivirals, and of oral fluconazole, previously POMs. It was in this context that the Working Party was set up and reported. Since re-classification of antimicrobials to GSLs was considered to be undesirable, the report solely considered re-classification from POMs to P medicines, the so-called POM-to-P switch. P medicines are almost always the result of a switch from prior POM status. While it is possible to give a P licence directly to a new medicine, it is generally acknowledged that this is a difficult regulatory path to follow.
A positive note was sounded by the European Economic Commission (EEC) in 1992 in a directive (EU Council Directive 92/26/EEC) which stated that medicines should be available without prescription unless there was a good reason why this should not be the case. The trend for re-classification in Europe and particularly the UK, apparent in the 1990s, has continued. Since 2002, 36 products have been switched in the UK, including important examples such as simvastatin. Data on POM-to-P switches that were considered or unsuccessfully attempted in the UK during the 1990s are hard to acquire because of commercial confidentiality. It seems likely that local ophthalmic chloramphenicol, topical mupirocin, oral trimethoprim and fosfomycin were considered.
The political climate in the 1990s was against antibiotics as P medicines,2–4 but this changed after 2000. The Wanless reports emphasized the need for change in the way that health services are delivered.5,6 More specifically, the Review of Prescribing, Supply and Administration of Medicines7 suggested that a new form of prescribing by non-medical health professionals, now called supplementary prescribing, should be introduced. This became possible for pharmacists and nurses through changes in the regulations in 2003.
Perhaps the most significant indication of governmental thought in respect of widening the supply of medicines was in Building on the Best (2003)8 ‘We will expand the range of medicines pharmacists can provide without prescription ... and increase the range of healthcare professionals who can prescribe.’ The Medicine and Healthcare products Regulatory Agency (MHRA) set up a reclassification steering group in 2002, with representatives from industry associations and professional pharmacists.9,10
Additional incentives to apply for POM-to-P switches have been the recent changes to allow a company a year of exclusivity if new data are generated to support the re-classification application,11 and the removal of some advertising restrictions.12,13
The Government's sentiments were taken up in the MHRA's business plan for 2004–05.14 ‘The increasing availability of medicines ... over the counter in pharmacies and other retail outlets is providing the public with far greater freedom of choice in the self-diagnosis and treatment of diseases ... . We aim to expand the range of treatments available without prescription in for example, ... eye infections.
The theme was continued in the MHRA business plan for 2005–06:15 ‘We will continue to encourage companies to submit applications ... . New applications we expect during 2005–6 include a popular anti-infective eye drop, an antibiotic for recurrent urinary tract infections in women...’.
A chronology of changing medicine from POM to P is given in the Proprietary Association of Great Britain (PAGB) document Realising the Vision.16
Interestingly, the policy steer from governmental and other sources has been accompanied by an increase in access to the BSAC OTC Working Party report of 1999. After a negligible number of downloads from the Journal of Antimicrobial Chemotherapy web site for many years there was a huge increase in 2004 from 380 in first 6 months to 1100 in the second (Figure 1). This threefold increase was far greater than that of the general increase in downloads from the site. It is also of interest that the report has been cited only 9 times in 6 years, a reflection perhaps on the limited usefulness of the citation index as a measure of the value of a paper to the public good!
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In view of the policy statements from governmental sources, it is not surprising that there has been a re-kindled interest by pharmaceutical companies in making applications to switch antibacterials from POM to P, following the disappointments and rebuffs of earlier years. In 2004 an application was made for chloramphenicol eye-drops, which was approved in mid-2005.17 In 2005 an application was made for trimethoprim in acute urinary tract infection in women of childbearing years. This has undergone public consultation in 2005,18 and the outcome of the review is awaited in November 2006.
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Increasing the range of health professionals who can prescribe antimicrobials |
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TopAbstractIntroductionClassification of medicines in...Increasing the range of...Self-purchase of antimicrobialsEffect of changes in...Mixed messagesTransparency declarationsReferences |
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In recent years a number of changes have been introduced to allow health professionals other than doctors and dentists to prescribe. These include supplementary prescribing, nurse formulary prescribing, nurse and pharmacist independent prescribing, and patient group directions. (see Table 1)
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Supplementary prescribing
Alongside the developments in POM to P switching, other Government-led initiatives have widened the range of health professionals who can prescribe POMs. The Review of Prescribing, Supply and Administration of Medicines proposed prescribing by non-medical health professionals after a diagnosis is made and a clinical management plan signed off by a doctor for the individual patient.7 Originally termed ‘dependent’ prescribing (the doctor being the ‘independent’ prescriber) this is now called, less pejoratively, ‘supplementary’ prescribing. The allied healthcare professional is termed a supplementary prescriber.
The current arrangements are that following diagnosis by a doctor or dentist (independent prescriber), a registered nurse, midwife or pharmacist (supplementary prescriber) is able to prescribe POMs, P medicines or GSL medicines (including any antibiotic) as part of a clinical management plan agreed with the independent prescriber for an individual patient.19,20 Supplementary prescribers have to undertake specific training for the role, having demonstrated core competencies in specific therapeutic areas. In November 2005 there were about 5700 trained nurses and 450 pharmacists acting as supplementary prescribers.21 Supplementary prescribing was extended in 2005 to include physiotherapists, chiropodists/podiatrists and radiographers.22
Some 29 000 district nurses and health visitors could prescribe from the Nurse Prescribers' Formulary (NPF) in November 2005. It contains 13 POMs (2 local antifungal preparations and no systemic antimicrobials) and some P and GSL medicines.
The Nurse Prescribers' Extended Formulary (NPEF) listed specific medical conditions for which nurses can prescribe after they are trained to use the NPEF. The formulary contained about 180 POMs and all P and GSL medicines, including 12 systemic antibacterials. The UK Department of Health's aim has been to achieve greater uptake of nurse prescribing and to extend the NPEF to more conditions, and by April 2006 there were nearly 7000 independent nurse prescribers.23,24 It is not clear from the figures provided how many of the nurses using the NPEF were also supplementary prescribers or previously NPF prescribers. Most independent nurse prescribers work in general practices, either contracted to the practice or seconded from the local Primary Care Trust (PCT). Others work independently, such as in National Health Service (NHS) walk-in centres.
Nurse and pharmacist independent prescribing
From 1 May 2006, Extended Formulary Nurse (EFN) Prescribers became Nurse Independent Prescribers, being able to prescribe within their competence any licensed medicine for any medical condition, including some Controlled Drugs,25 a change that had a somewhat guarded reception from the general practice establishment when originally announced.26 The Extended Formulary was discontinued on 30 April 2006.25
A new category of prescriber, the Pharmacist Independent Prescriber, was also created on 1 May 2006.22 Once qualified, Pharmacist Independent Prescribers will be able to prescribe any licensed medicine for any medical condition within their competence, with the exception of Controlled Drugs. It is anticipated that the first Pharmacist Independent Prescribers will be trained by the end of 2006. It remains to be seen how many community pharmacists take up training since, looked at commercially, there has to be a potential pay-back in increased revenue to compensate for the time taken in training, although funding may be made available.27
In 2000 legislation involving medicines was amended to allow the supply of medicine under Patient Group Directions (PGDs) by a wide range of healthcare professionals. A PGD is a locally developed protocol defining the condition to which the PGD applies (e.g. acute dysuria/frequency in women), the medicine to be used and its dosage, included and excluded patients, and relevant warnings, counselling and advice. It defines the type of health professional that may supply or administer the medicine, and it must be signed by a senior doctor and a pharmacist. The NHS PGD authorizing organization is often a PCT. More detailed guidance on implementing PGDs is available from the MHRA.28 This specifically highlights antimicrobials, warning of the risks of antimicrobial resistance and stating that a microbiologist should be involved in designing the protocol. A number of templates for creating protocols are available, which include the administration of antibacterials, oral, injectable and local.29 An example of a PGD is a cystitis management service by the Rotherham PCT. This has been running since July 2005. Its objectives (to provide alternative access to appropriate advice and treatment; to promote and encourage self-care; to reduce GP minor ailment workload; to facilitate inter-professional collaboration between community pharmacy and GPs) are in line with Government policy. Part of its flow chart (Figure 2) shows the flexibility of the care offered, including the option of going directly to a pharmacist. Clearly, provision of a POM by this last route is similar to that of a P medicine. The differences are that the medicine is provided under a well-defined protocol and documentation of the consultation has to be returned to the PCT, for reimbursement purposes and monitoring. With a P medicine the patient pays the pharmacist for it and there is no mandatory documentation.
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A useful review of non-medical prescribing, including such information on outcomes as exists, on can be found in the Drug and Therapeutics Bulletin.30
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Self-purchase of antimicrobials |
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TopAbstractIntroductionClassification of medicines in...Increasing the range of...Self-purchase of antimicrobialsEffect of changes in...Mixed messagesTransparency declarationsReferences |
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For individuals with access to the Internet there are a large number of sources that supply medicines by mail order. More than half of homes in the UK now have Internet access, with a substantial proportion of these on broadband.31,32 People can also access the Internet in libraries, Internet cafes and at work. A few minutes of searching on the name of an antimicrobial, or generically on ‘online pharmacies’ quickly provides the web sites of numerous suppliers.33,34 The range of antimicrobials available is impressive and would satisfy the needs of a hospital, let alone an ambulant patient. Some suppliers seem to be entirely reputable, at least within the confines of good trading practices, providing a geographical address. Others have no geographical address, offering contact only by email; at least one of these companies offers medicines that are illegal without prescription in the UK (opiates; anabolic steroids). Companies based in the USA offer by mail what would be classified as POMs, either if a doctor's prescription is provided (i.e. a mail order version of a community pharmacy), or they ship the medicines from Mexico or other countries where they are available equivalent to the UK P medicines. It is legal to ship them into the USA to individuals, and presumably the same applies to the UK. Some companies offer a ‘consultation’ with a doctor based on a completed questionnaire. Interestingly, antibiotic capsules and tablets (including ampicillin and tetracyclines) are readily obtainable in the USA itself from stores supplying aquarists,35 although this does not seem to be the case in the UK.
Clearly this situation is potentially dangerous to patients who might use an antimicrobial for an indication for which it would be ineffective or mask the infection. They might also be exposed to serious adverse effects. Purchase prices are higher than those for UK pharmacies, in some instances substantially so. With the less reputable suppliers there is no guarantee that the medicine contains what it states on the label, with little or no chance of redress.36 Alarm has been expressed about the situation.37,38 The risk to individual members of the public is considerable, since some antimicrobials (e.g. zidovudine, rifampicin) might be used alone in conditions where the chance of selecting resistant strains is high (HIV infection, tuberculosis).
It is difficult to see what governments and, more specifically, drug regulatory authorities could do to control the situation, short of making it illegal to order from online pharmacies, which would be virtually unenforceable. Given the natures of the Internet and international trade in the 21st Century, control of the suppliers would be difficult. The risks have been recognized by the Royal Pharmaceutical Society, which is setting up a pilot scheme for a logo for approved web sites registered in the UK.39
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Effect of changes in access to antibiotics |
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TopAbstractIntroductionClassification of medicines in...Increasing the range of...Self-purchase of antimicrobialsEffect of changes in...Mixed messagesTransparency declarationsReferences |
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Although it is relatively easy to set out the changes that have occurred, it is far more difficult to find information on the effect they are having, and still more difficult to predict any likely future effect.
Benefits for patients and healthcare systems
On the positive side from the individual patient's point of view, there is now an increasingly wide choice of how treatment can be accessed for the more minor illnesses. In the current culture it is perceived that there should be more self-reliance, which has been supported by the information revolution, largely via the Internet.8,16 From the point of view of healthcare providers, from the Government down to the PCTs and GPs, the trend towards more informed self-care relieves some of the burden of relatively minor illnesses from healthcare services and professionals, enabling GPs to concentrate on the priorities in the Quality and Outcomes Framework. Potentially there are also some direct financial savings to be made for health services if patients purchase some medicines themselves. Across the EU, reclassifying medicines to P status or its equivalent in other countries could potentially realize huge savings.40
Will the changes significantly increase usage?
It is clear that rates of resistance to antibacterials are increasing worldwide, and so it is natural that concerns have been voiced over the inclusion of more antimicrobials, and antibacterials in particular, with other medicines in the widened access. It is, however, difficult to find information on the extent of the actual changes in antimicrobial supply as a result of widened access. The position is also complicated by differences between the countries of the UK. While amendments to medicines legislation and the decisions of the MHRA apply to all the countries of the UK, implementation depends on the different health bodies in those countries.
There is a presumption in the minds of many people that giving patients a greater variety of means of obtaining antimicrobials will result in a larger number of courses being taken. While some of the access to antibiotics will be a substitution for medical prescription, as has been recently shown for simvastatin,41 it is likely that there will be an overall increase in the number of courses because access will be more readily available. In the case of supplementary prescribers, presumably most of their prescriptions are substitutes for those that would have been provided by doctors, and thus the overall number of courses of antimicrobials from that source has probably not altered greatly. Any change must, however, be put in the context of extensive medical prescribing and also self-medication without prescription.
Apart from purchase via the Internet, it is clear that some patients keep part or all of prescribed courses for future use without a consultation,42,43 and that actual and intended self-medication occurs in the UK44 and elsewhere.45–48 Studies using the detection of antibacterial substances in urine have shown that patients self-medicate with antibiotics more often than they admit to at presentation.49,50 Sometimes blame is put on to the companies that seek POM-to-P switches, but this is wrong in my opinion, since they are pursuing legitimate commercial interests within the climate of re-classification created by the Government and encouraged by the MHRA. Data on PGDs are also hard to find. Information gathered by Actavis indicates that there are, for example, some 14 PCTs that have recently been running PGDs for cystitis. This is out of approximately 230 PCTs in England, each of which covers about 150 000 people on average. In Scotland there are minor ailment schemes which provide reimbursement for P medicines direct from pharmacies supplied according to locally agreed protocols. POM medicines are not supplied and, as far as I am aware, there are few PGDs in operation. The supply of a P medicine outside any formal scheme is purely a transaction between the pharmacist and the purchaser and there is no collection of data on this supply.
It is therefore difficult at present to judge whether there have been more courses of antimicrobials issued as a result of the changes. However, it should not be all about quantity but also quality of courses. Following the 1998 Standing Medical Advisory Committee (SMAC) report51 there was initially a fall of about 27% in the number of prescriptions for antibacterials returned to the NHS Business Services Authority (Figure 3),52 but then the number remained more or less static for 4 years. There may be a good reason for this, such as an irreducible number of patients needing antibiotic treatment and a further reduction not being compatible with the safe management of patients. However, it is disappointing that despite all the publicity about resistance and the need for prudent prescribing the initial progress was not improved upon. More worrying are the ePACT data of EFN prescribing compared with that by GPs. The large majority of courses of trimethoprim in UK general practice are prescribed for cystitis. The SMAC report gave a clear recommendation that the course should generally be for 3 days only (6 tablets). Figure 4 shows that the large majority of courses from GPs are for 5 or 7 days, with an average of 10.9 tablets/course (= 5.5 days). In comparison the EFN prescribers mostly gave courses of 3 days (average 8.5 tablets/course = 4.5 days). Of course, it might be that the GPs saw a greater proportion of difficult cases, but this is unlikely to account for most of the long courses. Nurses and pharmacists are well known to be careful to follow protocols, so it is possible that a greater shift towards their prescribing will improve quality overall. As long as it was mostly a substitute for GP prescribing in the example illustrated above, the number of tablets dispensed for each course given for cystitis should fall. Indeed the Actavis trimethoprim switch proposal mentions using such a protocol to verify appropriateness of supply.18
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It is of interest that of 139 patients accessing the cystitis management service of the Rotherham PGD (Figure 2), only 51% were given trimethoprim by a pharmacist; 23% were given self-help advice and the remainder sold a non-antimicrobial product or referred back to their GP (information from Actavis).
Possible impact on bacterial resistance
Whether changes either way in the length or dosage of courses of antibiotics will affect bacterial resistance is unclear since we do not know whether it is fostered in individuals by the number of courses (i.e. the number of patients exposed no matter how short or long the courses are) or by the total dosage, or by a combination of the two. In addition, which factor is important in resistance may well vary between the different antibacterial–pathogen combinations. For example, in contrast to a weak or no association between trimethoprim use and resistance at the population level, there is a strong association between fluoroquinolone use and resistance.53 The confusing picture is illustrated by the diverse results of studies that have tried to examine the relationship between antibiotic usage in the community and the resistance of bacterial pathogens from the same community. Kahlmeter54 could find no correlation at country-wide level between the consumption of trimethoprim and resistance to trimethoprim in urinary pathogens, although there were correlations for some other classes of antibiotics, particularly fluoroquinolones. Based on data at group practice level, others have shown a correlation between the prescribing of trimethoprim and resistance to that agent,55,56 but the correlation was relatively low for individual practices and groups and the use of routine microbiological data was thought to be unsatisfactory for this type of study. In particular, it appeared as if a substantial change in prescribing would only result in a small change in resistance rates. Livermore et al. (2000)57 also found only weak correlation between resistance to ampicillin and its analogues or to trimethoprim in Escherichia coli from blood cultures and prescribing patterns of these antimicrobials. The study also highlighted the differences in rate of resistance to trimethoprim (varying from 17 to 29%) among the 12 areas of England studied. In a meta-analysis of studies relating antibiotic usage to resistance to trimethoprim in urinary tract pathogens, Hillier et al. (2002)58 found that only one ecological study showed good evidence of a link. Studies in individual patients were also thought to be weak. For example, Steinke et al.59,60 showed that prior use of trimethoprim increased the likelihood of an individual having a trimethoprim-resistant pathogen (as did exposure to oestrogen), and Hay et al. (2005)61 found an association between resistance and antibiotic use in the previous 2 months. Hillier et al.58 concluded that better-designed studies are needed to define the relationship of use to resistance. Steinke and Davey (2001),62 reviewing the published studies then available, thought that the weight of evidence pointed to a causal relationship between use and resistance, but that future studies needed to be carefully designed to avoid sources of bias and confounding.
While it is clear that presently we only have incomplete knowledge about what factors, if any, in the administration in the community of the more commonly used antibacterials are important in the generation or persistence of resistant strains in individuals, there is another important imponderable to consider. We do not know whether the current level of prescribing antibacterials, even if reduced to a level that could be described as prudent by the most zealous members of the anti-antibacterial lobby, will bring about a reduction in the present prevalence of resistance or, indeed, prevent further increases.63 Within that context it is hard to see how a modest increase in usage might have a significant impact on resistance. In view of our seeming impotence in controlling rises in the prevalence of resistance, more emphasis will have to be placed on non-antimicrobial interventions, such as preventing infection by better infection control methods, boosting immunity and enhancing other body defence mechanisms.64
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Mixed messages |
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TopAbstractIntroductionClassification of medicines in...Increasing the range of...Self-purchase of antimicrobialsEffect of changes in...Mixed messagesTransparency declarationsReferences |
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To those of us with an interest in access to antimicrobials, perhaps the most perplexing aspect of the current situation is the mixed message that has come from Government. On the one hand, bodies such as Specialist Advisory Committee on Antimicrobial Resistance have been created to advise on resistance65 and much publicity has been given to campaigns, such as Andybiotic66 and Antibiotics—Don't wear me out,67 for reducing antimicrobial usage. On the other hand, emphasis has been given in service provision to increasing choice for patients and encouraging responsibility for their own healthcare. Part of that has included widening access to previous POMs, and antimicrobials have been caught up in this. Whether the Government was unaware of the potential conflict between the two policy streams is open to question. The position has been made more confusing by the MHRA, which positively encouraged a switch to P status for an oral antimicrobial for cystitis but now seems to have gone quiet about bringing this into reality, presumably now aware of the political sensitivities involved. For me personally, I am distressed to witness reputable scientists giving advice that seems to be based more on toeing the line politically on resistance rather than expressing a scientifically balanced judgement. Only time will tell whether enhanced access by patients will achieve its full potential, and whether any changes in the prevalence of resistance can be attributed to that. In the meantime, more efforts should be made to monitor resistance in the community in a way that produces valid and interpretable data rather than largely relying on the selected clinical specimens that reach diagnostic laboratories.68
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Transparency declarations |
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The author has, within the past three years, been a consultant to Alpharma/Actavis, Baxter International, Boots Healthcare International, Goldshield Healthcare, and Boehringer Ingelheim.
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References |
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1 Reeves DS, Finch RG, Bax RP, et al. (1999) Self-medication of antibacterials without prescription (also called ‘over-the-counter’ use): A report of a Working Party of the British Society for Antimicrobial Chemotherapy. J Antimicrob Chemother 44:163–77.
2 House of Lords, Science and Technology—Seventh Report. (1998) Chapter 2: Prudent use in human medicine. Over-the-counter (OTC) antibiotics. http://www.parliament.the-stationery-office.co.uk/pa/ld199798/ldselect/ldsctech/081vii/st0705.htm (22 June 2006, date last accessed).
3 BBC News 10/9/98. EU calls for action over antibiotics. http://news.bbc.co.uk/1/hi/health/background_briefings/antibiotics/168604.stm (22 June 2006, date last accessed).
4 EU Economic and Social Committee. Resistance to antibiotics as a threat to public health. Official Journal of the European Communities 28/12/98 C404/7. http://europa.eu.int/eur-lex/pri/en/oj/dat/1998/c_407/c_40719981228en00070017.pdf (22 June 2006, date last accessed).
5 Wanless Report. (2002) Securing our Future Health: Taking a Long-term View http://www.hm-treasury.gov.uk/Consultations_and_Legislation/wanless/consult_wanless_final.cfm (22 June 2006, date last accessed).
6 Securing Good Health for the Whole Population: Final Report—February 2004 http://www.dh.gov.uk/PublicationsAndStatistics/Publications/PublicationsPolicyAndGuidance/PublicationsPolicyAndGuidanceArticle/fs/en?CONTENT_ID=4074426&chk=c4gJvj (22 June 2006, date last accessed).
7 Review of prescribing, supply and administration of medicines. (1999) http://www.dh.gov.uk/PublicationsAndStatistics/Publications/PublicationsPolicyAndGuidance/PublicationsPolicyAndGuidanceArticle/fs/en?CONTENT_ID=4077151&chk=LKaIV4 (22 June 2006, date last accessed).
8 Building on the Best: Choice, Responsiveness and Equity in the NHS—response document 9/12/2003. http://www.dh.gov.uk/Consultations/ResponsesToConsultations/ResponsesToConsultationsDocumentSummary/fs/en?CONTENT_ID=4068391&chk=K2l%2BzZ (22 June 2006, date last accessed).
9 MHRA. (2006) Legal Status and Reclassification http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=107 (22 June 2006, date last accessed).
10 MHRA. (2002) The reclassification strategy group. http://www.mhra.gov.uk/home/groups/pl-a/documents/websiteresources/con1004382.pdf (22 June 2006, date last accessed).
11 MHRA guidance on the application for exclusivity for change in legal status of a medicine. http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=433&within=Yes&keywords=otc+exclusivity (22 June 2006, date last accessed).
12 MHRA. The Blue Guide. Advertising and Promotion of Medicines in the UK http://www.mhra.gov.uk/home/idcplg?IdcService=GET_FILE&dID=17736&noSaveAs=1&Rendition=WEB (22 June 2006, date last accessed).
13 PAGB. Recent regulatory developments affecting the OTC sector. http://www.pagb.co.uk/pagb/primarysections/selfcare/regulatoryinselfcare.htm (22 June 2006, date last accessed).
14 MHRA. Business Plan for 2004–5, p. 3 http://www.mhra.gov.uk/home/idcplg?IdcService=GET_FILE&dID=1476&noSaveAs=0&Rendition=WEB (1 November 2006, date last accessed).
15 MHRA. Business Plan for 2005–6, p. 16 http://www.mhra.gov.uk/home/idcplg?IdcService=GET_FILE&dID=12344&noSaveAs=1&Rendition=WEB (1 November 2006, date last accessed).
16 PAGB. Annual Self-Care Review 2005. Self-Care: Realising the Vision. http://www.pagb.co.uk/pagb/primarysections/selfcare/publications.htm (22 June 2006, date last accessed).
17 MHRA. (2005) Antibiotic eye drops available over the counter. http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2014984&ssTargetNodeId=389 (22 June 2006, date last accessed).
18 MHRA. Request to reclassify a product from POM to P. http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=433&within=Yes&keywords=trimethoprim (22 June 2006, date last accessed).
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