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Rapid Responses: Rapid Responses published:
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Extreme caution perhaps
- Lindy Williams (1 April 2008)
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Proceed with GREAT caution.
- Alexander SD Spiers (2 April 2008)
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Systemic antibiotics should remain POMs
- Robin A Howe (2 April 2008)
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Reclassification and OTC medicines under continual review
- Dr June Raine (8 April 2008)
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Poisons Centres’ role in monitoring drug safety: the future.
- Heather M Wiseman, JN Edwards, N Bates, A Campbell, G Cullen, E Dauncey, A Dines, C Farrow, R Fitzpatrick, A Jones, K Kennedy, L Hawkins, M McParland, J Monaghan, FS Northall, K Sturgeon, N Sutton, D Shaw, Z Tizzard (10 April 2008)
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Updated:- Reclassification and OTC medicines under continual review
- Dr June Raine (10 April 2008)
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Re: Poisons Centres’ role in monitoring drug safety: the future.
- Simon H Thomas, D Nicholas Bateman, John P Thompson, Allister Vale (18 April 2008)
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Lindy Williams, Independent researcher/writer BD23 4QH
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We must hope that members of the All Party Parlimanetary Group on Primary Care and Public Health will act with integrity and impartiality in this matter of OTC medicines. It is important to note that the secretariat for this group is provided by the Proprietary Association of Great Britain (PAGB). Clearly stated on its website, its mission is to ' 'promote responsible consumer healthcare'. This encapsulates our aims of developing the market for safe and effective OTC medicines and food supplements through a favourable regulatory climate, gaining increased recognition for the role of self-medication in health care, and educating the public that the use of OTC's can help them to take more responsibility for their own health'. The group's 'Goal 4' states, 'Consistent with public safety and a responsible approach, OTC products will be able to be marketed as consumer goods, allowing the marketplace to develop in line with people's expectations'. All very laudable, but it is hard not to conclude that there could be conflicts of interest here. Combine this with the possible direct-to- consumer 'information' from pharmaceutical companies currently under discussion in the EU, and the result is an increasingly medicalised population. Good for business but with an uncertain effect on the NHS. http://www.pagb.co.uk/pagb/primarysections/selfcare/appginquiry.htm http://www.pagb.co.uk/pagb/primarysections/aboutpagb/missiongoals.htm Competing interests: None declared |
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Alexander SD Spiers, Professor of Medicine (retired) N/A.
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One must agree with Ferner and Beard that increasing the list of over the counter (OTC) medicines has risks, while reducing the list may be controversial. Some would find it disturbing that a group of parliamentarians is to make decisions on a primarily medical matter. There is an unfortunate tendency to think of doctors uncharitably, and if we insist on a highly restricted OTC list we lay ourselves open to charges of elitism and self-promotion. On the other hand, placing on the OTC list potent medicines with important side effects is certainly not doing the general public a favour. The list of OTC medicines should contain non-opioid analgesics, antihistamines, antacids, laxatives, antidiarrhoeals, post-coital contraceptives and a variety of topical preparations for cold sores, sunburn and antiseptic treatment of cuts and abrasions. The drugs chosen should have been in use for at least several years, so that unexpected side effects are less likely. There are OTC cough suppressants, but the more effective opioid-containing cough mixtures should be restricted. There is a major problem with antibiotic resistance in hospitals and the community, due to use and overuse of antibiotics by the medical profession. Therefore OTC antibiotics should not be available. There is an inherent danger in OTC medicines that relieve symptoms and delay diagnosis but do not treat disease. There is also a danger in OTC medicines that contain less than the standard doses of active agents, so the patient is undertreated. Surely the best way to regulate drug use is a prescription-only list, a small and well-chosen OTC list, and a pharmacist's list that ensures that patients buying more potent drugs or larger supplies have the benefit of professional advice. Competing interests: None declared |
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Robin A Howe, Head, Welsh Antimicrobial Resistance Programme, National Public Health Service for Wales Cardiff Microbiology (Velindre NHS Trust), University Hosp. of Wales, Heath Park, Cardiff. CF14 4XW
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The analysis by Ferner & Beard provides a timely reminder of the issues relating to the wider availability of medicines as the MHRA moves to recommend, for the first time, that a systemic antibiotic (trimethoprim) should have its license reclassified from Prescription Only Medicine (POM) to pharmacy (P) availability. In the case of systemic antibiotics, there are particular concerns that do not apply to other medicines, and could be more thoroughly explored.
Perhaps the main issue regards the spread of antimicrobial resistance. There is conclusive evidence regarding the link between antibiotic use in the community and the emergence of antibiotic resistance. In this respect, unlike other medicines, the use of antibiotics may have an adverse effect, not only on the specific patient, but on the public health of the community. Quantification of the relationship between antibiotic exposure and resistance is difficult, but a case-control study of risk of an antibiotic-resistant Escherichia coli urinary tract infection found that the risk of a trimethoprim-resistant infection was significantly associated with a trimethoprim prescription in the last month; odds ratio 13.91 (3.32-58.31) if the prescription was for >=7 days, and 4.03 (1.69-9.59) if the prescription was for <7 days. (1) Because resistance to multiple agents is often linked, the selective pressure of using one antibiotic will frequently select for resistance to other unrelated agents. Resistance rates for community urinary coliform isolates from the Cardiff area (table) show that trimethoprim-resistant coliforms are significantly more resistant to second-line treatments such as ciprofloxacin. Thus trimethoprim use will select for ciprofloxacin resistance.
There is also an issue of selecting resistance in organisms other than those targeted by therapy since the majority of commensal flora will also be exposed to some degree to a systemic antibiotic. Trimethoprim is acknowledged as an oral option for the treatment of a variety of infections caused by MRSA.(2) Although rates of resistance are significant (35%) in UK bacteraemia isolates,(2) resistance among community isolates of MRSA in some areas (e.g. South Wales) remains low at 12%. Increased trimethoprim use within the community is likely to select for resistance in MRSA and hence remove a valuable oral therapeutic option. For these reasons, and for the growing concern about Clostridium difficile-associated disease in the community, it is imperative that antibiotic use is regulated to ensure that inappropriate use is kept to a minimum. The close regulation of antimicrobial availability has been recommended by the European Commission Council Recommendation on the prudent use of antimicrobial agents in human medicine (2002/77/EC) which states that member states should "...implement control and preventive measures to support the prudent use of antimicrobial agents and contribute to limiting the spread of communicable diseases by ... restricting systemic antibacterial agents to prescription-only use." Indeed the 7th Report of the House of Lords Select Committee on Resistance to Antibiotics and other Antimicrobial Agents stated "We commend the Government and the ABPI for their firm stand against over-the-counter antibiotics, and urge them not to give way."(3) Given the continuing concern about antibiotic resistance and the ever-increasing restrictions on antibiotic use in Hospitals that are being encouraged by the Department of Health in an effort to control resistance and C. difficile, it appears paradoxical that we should choose this time to "give way" and reclassify trimethoprim. References 1. Hillier S, Roberts Z, Dunstan F, Butler C. Prior antibiotics and risk of antibiotic-resistant community-acquired urinary tract infection: a case-control study. J Antimicrob Chemother 2007; 60: 92-99. 2. Gemmell CG, Edwards DI, Fraise AP, Gould FK, Ridgway GL, Warren RE; Joint Working Party of the British Society for Joint Working Party of the British Society for Antimicrobial Chemotherapy, Hospital Infection Society and Infection Control Nurses Association. Guidelines for the prophylaxis and treatment of methicillin-resistant Staphylococcus aureus (MRSA) infections in the UK. J Antimicrob Chemother 2006; 58: 220. 3. Resistance to antibiotics and other antimicrobial agents. Report of the House of Lords Select Committee on Science and Technology. London: Stationery Office, 1998. Competing interests: None declared |
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Dr June Raine, Director of Vigilance and Risk Managagement of Medicines Medicines and Healthcare products Regaulatory Agency, SW8 5NQ
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Sir We welcome the focus on over the counter medicines (Analysis, BMJ 29 March 2008 p 694-696). The regulatory systems for making medicines available over the counter are robust and do indeed “proceed with caution”. Only after a rigorous safety review, independent expert scientific advice from the Commission on Human Medicines and a period of public consultation, is a proposed reclassification of a medicine from Prescription only to Pharmacy availability approved or refused. For a number of sound reasons, the optimal dose authorised for OTC use may differ from that authorised for prescription only supply. The indication may be restricted, as for this week’s switch of naproxen 250mg for period pain; the patient population may be more narrowly defined, as in the case of simvastatin 10mg for people at moderate risk of coronary heart disease (10-15% risk of a major event in 10 years). The evolving role of pharmacy, set out in the White Paper published on 3 April 1, ensures that the safety net of professional controls continues to adapt to the introduction of new OTC medicines. The pharmacy profession’s successful handling of reclassified medicines as varied as chloramphenicol eye drops and levonorgestel for emergency hormonal contraception is evidence of this. In the case of the switch of levonorgestrel, the study by Marston showed that reclassification did not seem to have resulted in an increase in use of emergency hormonal contraception, to an increase in unprotected sex, or to a decrease in use of more reliable methods of contraception2. Patients increasingly expect equal involvement in decisions about their health and there is a growing body of evidence that educated self- management brings improved health outcomes. The NHS plan published in 2000 (reference) gave a commitment to make more medicines available OTC where it is safe to do so, as an important plank in empowering patients3. At MHRA we keep the safety of OTC medicines under continual review and are ready to take action if new evidence emerges, including via patient Yellow Card reports. Our conclusion is that the benefits of wider access to medicines overwhelmingly outweigh the risks. 1.Pharmacy in England: Building on strengths - delivering the future:http://www.official-documents.gov.uk/document/cm73/7341/7341.asp2. Marston C et al BMJ 2005;331:271 (30 July), doi:10.1136/bmj.38519.440266.8F (published 11 July 2005) 3. NHS Plan: a plan for investment, a plan for reform http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4002960 Competing interests: None declared |
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Heather M Wiseman, clinical scientist Guy's and St Thomas' Poisons Unit, Guy's and St Thomas' NHS Foundation Trust, London SE14 5ER, JN Edwards, N Bates, A Campbell, G Cullen, E Dauncey, A Dines, C Farrow, R Fitzpatrick, A Jones, K Kennedy, L Hawkins, M McParland, J Monaghan, FS Northall, K Sturgeon, N Sutton, D Shaw, Z Tizzard
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Poisons centres receive reports of the inappropriate use of medicines and make a useful contribution to the review of safety. With reference to examples quoted by Ferner and Beard,1 poisons centre workers were among the first to provide evidence of the toxicity of the dextropropoxyphene/paracetamol combination: the review by Proudfoot2 records that Volans had warned of the dangers in 1976. Poisons centres also have a valuable role in continuing to monitor the effectiveness of pack size regulations in limiting intentional and unintentional self- poisoning with paracetamol,3 they have provided useful evidence of the effects of reclassification and wider availability of medicines such as ibuprofen,4 and as recipients of adverse drug event reports could develop a greater a role in pharmacovigilance.5 It is timely to draw attention to the importance of poisons centres in monitoring drug safety.Users of the National Poisons Information Service(NPIS) may not be aware that arrangements for provision of poisons information in the UK are about to change following the decision by the Health Protection Agency (HPA) that there is sufficient capacity in the UK to provide a poisons information service without Guy’s and St Thomas’ Poisons Unit. In July, Guy’s and St Thomas’ will stop providing a telephone poisons information service and the knowledge and experience of the Unit’s Specialists in Poisons Information will no longer be available to support the management of acute poisoning. This decision is in line with the NPIS strategy to reduce access to the telephone service and promote the use of TOXBASE.6 It is unclear how this will affect the capability and effectiveness of NPIS surveillance, which is important not only for monitoring drug safety, but also for detection of chemical threats, to enhance HPA’s ability to respond to chemical incidents. There is a short-term risk to the capacity of centres in Newcastle and Birmingham to monitor, follow-up and assess case reports when they receive all the calls previously directed to Guy’s and St Thomas’, but plans for overall reduction in telephone enquiries may have a more significant impact on surveillance. Analysis of TOXBASE accesses can provide useful information, but does not substitute for monitoring and following up telephone enquiries. Although Guy’s and St Thomas’ Poisons Unit will no longer have an opportunity for prospective surveillance of cases reported to the NPIS, their database of 2.5 million cases will continue to be available for retrospective search. The Unit will continue to contribute to pharmacovigilance and toxicovigilance by exploring new data collection methods and by continuing to work with EU poisons centres to develop a surveillance system to detect syndromes caused by exposure to chemicals.7 1. Ferner RE, Beard K. Over the counter medicines: proceed with caution. BMJ 2008; 336: 694-696.(29 March). 2. Proudfoot AT. Clinical features and management of Distalgesic overdose. Hum Toxicol 1984; 3,85S-94S. 3 Morgan O, Hawkins L, Edwards N, Dargan P. Paracetamol (acetaminophen) pack size restrictions and poisoning severity: time trends in enquiries to a UK poisons centre. J Clin Pharm Ther 2007; 32:449-455. 4. Volans G, Fitzpatrick R. Human toxicity of ibuprofen. In Rainsford KD (ed) Ibuprofen a Critical Bibliographic Review. London, Taylor & Francis, 1999, 541-559. 5. Volans GN, Karalliedde L, Wiseman HM. Poisons Centres and the reporting of adverse drug events. Drug Saf 2007 30(4): 191-194. 6. National Poisons Information Service. National Poisons Information Service Annual Report 2006/7. Health Protection Agency, 2007 http://www.camr.org.uk/web/HPAweb&HPAwebStandard/HPAweb_C/1196942160030. 7. Europa, website of the European Commission, DG Health and Consumer Protection, Public Health website. ASHT - Development of an alerting system and the criteria for development of a health surveillance system, for the deliberate releases of chemicals by terrorists. http://ec.europa.eu/health/ph_projects/2004/action2/action2_2004_03_en.htm. accessed 4th April 2008. Competing interests: None declared |
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Dr June Raine, Director of Vigilance and Risk Managment of Medicines Medicines and Healthcare products Regulatory Agency
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Sir We welcome the focus on over the counter medicines (Analysis, BMJ 29 March 2008 p 694-696). The regulatory systems for making medicines available over the counter are robust and do indeed “proceed with caution”. Only after a rigorous safety review, independent expert scientific advice from the Commission on Human Medicines and a period of public consultation, is a proposed reclassification of a medicine from Prescription only to Pharmacy availability approved or refused. For a number of sound reasons, the optimal dose authorised for OTC use may differ from that authorised for prescription only supply. The indication may be restricted, as for this week’s switch of naproxen 250mg for period pain; the patient population may be more narrowly defined, as in the case of simvastatin 10mg for people at moderate risk of coronary heart disease (10-15% risk of a major event in 10 years). The evolving role of pharmacy, set out in the White Paper published on 3 April 1, ensures that the safety net of professional controls continues to adapt to the introduction of new OTC medicines. The pharmacy profession’s successful handling of reclassified medicines as varied as chloramphenicol eye drops and levonorgestel for emergency hormonal contraception is evidence of this. In the case of the switch of levonorgestrel, the study by Marston showed that reclassification did not seem to have resulted in an increase in use of emergency hormonal contraception, to an increase in unprotected sex, or to a decrease in use of more reliable methods of contraception2. Patients increasingly expect equal involvement in decisions about their health and there is a growing body of evidence that educated self- management brings improved health outcomes. The NHS plan published in 2000 gave a commitment to make more medicines available OTC where it is safe to do so, as an important plank in empowering patients3. At MHRA we keep the safety of OTC medicines under continual review and are ready to take action if new evidence emerges, including via patient Yellow Card reports. Our conclusion is that the benefits of wider access to medicines overwhelmingly outweigh the risks. 1.Pharmacy in England: Building on strengths - delivering the future:http://www.official-documents.gov.uk/document/cm73/7341/7341.asp2. Marston C et al BMJ 2005;331:271 (30 July), doi:10.1136/bmj.38519.440266.8F (published 11 July 2005) 2. Marston C et al BMJ 2005;331:271 (30 July), doi:10.1136/bmj.38519.440266.8F (published 11 July 2005) 3. NHS Plan: a plan for investment, a plan for reform http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4002960 Competing interests: None declared |
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Simon H Thomas, Consultant Physician Newcastle upon Tyne Hospitals NHS Trust, Newcastle NE1 4LP, D Nicholas Bateman, John P Thompson, Allister Vale
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As Directors of the four National Poisons Information Service Units in Birmingham, Cardiff, Edinburgh and Newcastle, we were interested to see this letter from the staff of the Guys & St Thomas's Poisons Unit (GTPU). We agree that, although most adverse drug reactions are best monitored via spontaneous reporting schemes such as the UK Yellow Card Scheme, poisons information services can provide additional information that is useful for monitoring drug safety, especially about toxicity in overdose. While we regret the forthcoming closure of the telephone information service at GTPU, which has not been part of the NPIS since 2005, NPIS has adequate capacity to manage the numbers of telephone enquiries currently being made to UK poisons centres about human poisoning. Since the NPIS poisons information database TOXBASE was made available on-line in 1999, annual product accesses to TOXBASE have increased to almost 1 million, allowing a reduction in the annual total number of telephone enquiries to all UK poisons centres from approximately 250,000 in 2000 to under 80,000 in 2007. There are specific advantages for the collection of data relevant to public health afforded by our current national structure for poisons information provision. These include common governance arrangements and operational policies, a single point of contact, a database shared by all NPIS units allowing rapid access to national information in a common format and common case follow-up arrangements. Information on numbers of accesses is also available from TOXBASE, which also has a mechanism for collecting further information on substances of interest, and is being enhanced to provide the capability of detecting unusual patterns of enquiries. The quality of the service provided by NPIS has recently been endorsed by an independent external clinical governance review and stakeholder feedback has been consistently excellent. NPIS continues to have close ties with the MHRA. For example, NPIS datasets have recently been used to inform policy decisions with respect to co-proxamol withdrawal. All current NPIS units are closely linked to a Yellow Card Centre and 2 of its Directors are current members of the MHRA Pharmacovigilance Expert Advisory Group. We agree that safety of over the counter medications is important, and wholeheartedly agree that the NPIS has a continued important role in this area. Competing interests: The authors are the Directors of the 4 UK National Poisons Information Service Units commissioned by the Health Protection Agency |
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