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Transcript
Our reference: MLX 313 Date: 19 October 2004 | Dear Sir/Madam PROPOSAL FOR AMENDMENTS TO MEDICINES LEGISLATION TO ALLOW SUPPLY OF WATER FOR INJECTION BY PEOPLE EMPLOYED IN NEEDLE EXCHANGE SCHEMES Introduction 1. We are writing to consult you in accordance with section 129(6) of the Medicines Act 1968 about proposals to allow people employed in needle exchange schemes and other legitimate drug treatment services to supply Water for Injection (WFI) to drug users. This would be achieved by amendments to the Prescription Only Medicines (Human Use) Order 1997 (the POM Order), the Medicines (Pharmacy and General Sale -Exemption) Order 1980 and the Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1980. 2. The proposals are intended to allow needle exchange schemes and other drug treatment services to supply WFI as a means of reducing harm to drug users. Application to England, Wales, Scotland and Northern Ireland 3. This consultation is also being made available in Wales, Scotland and Northern Ireland. The proposed changes to legislation would apply throughout the United Kingdom. Current Legal Position 4. Under the Medicines Act 1968, all medicines for parenteral administration are classified as Prescription Only (POM). POMs may only be sold or supplied only through registered pharmacies by or under the supervision of a pharmacist against an appropriate practitioner’s prescription. An “appropriate practitioner” is a doctor, a dentist, and, within the terms of the legislation covering their prescribing, a supplementary prescriber or independent nurse prescribers. POMs may also be supplied by nurses and other specified groups of health professional under a patient group direction (PGD). A PGD is a written direction for the supply and/or administration of a named medicine in a defined clinical situation and must be signed by a doctor and a pharmacist. It applies to groups of patients who may not be identified before presenting for treatment. Background 5. Water for Injection is a sterile water injection. Needle exchange and drugs agency staff sometimes supply WFI among other items of drug injecting articles (known as “paraphernalia”) as a means of reducing harm caused by drug misusers using dirty or potentially contaminated water. 6. Until last year, the Misuse of Drugs Act 1971, which is the responsibility of the Home Office, made it an offence to supply any article (apart from a syringe) used for preparation or administration of a controlled drug. This included WFI. Following a request from the Government, the Advisory Council on Misuse of Drugs (ACMD), an independent advisory body on drug misuse, considered whether there was a case for amending the misuse of drugs legislation to permit the supply of various articles of paraphernalia to drug users for harm reduction purposes. Research evidence confirmed that blood borne viral infections such as HIV and Hepatitis C may be transmitted through both the sharing of needles and other injecting equipment such as water, swabs and filters. There was evidence that the supply of WFI, swabs, mixing utensils such as spoons and bowls and citric acid had significant potential harm minimising benefits. The Council recommended that the law should be amended to permit the supply of these items. Proposals 7. Following a public consultation conducted by the Home Office, the Misuse of Drugs Act was amended with effect from August 2003 to decriminalise the supply of WFI and other paraphernalia by practitioners, pharmacists and people engaged in the lawful provision of drug treatment services. However, under medicines legislation WFI could still only be supplied against a prescription or by a health professional under a PGD. In order to clarify the position it is therefore proposed to amend the POM Order so that people working in drug treatment services may also supply WFI to drug users for harm reduction purposes. We would welcome views on this proposal. 8. To minimise possible health risks from sharing excess water, it is proposed that individual ampoules of WFI should be restricted to a maximum volume of 2mls. However, we should welcome views on whether it would be more appropriate, from the harm reduction perspective, to further restrict the maximum volume. We welcome views on this proposal. 9. Two options were considered around how WFI should be supplied to drug users. The first (option A) was that it should be supplied pre-packed and that the pack size should contain no more than 10 unit doses. The second (option B) was to remove the requirement that the product should be pre-packed which would allow drug workers to supply a quantity from a larger pack. 10. There are currently a number of exemptions under medicines legislation which allow the supply of POMs without the requirement that the product is pre-packed. However, all of these apply either to specified registered health professions or to emergency situations. The current proposals for the supply of WFI will not always involve supply by a health professional. Also, given that WFI’s status as a POM will be unaltered as well as from the harm reduction perspective, there is a case for requiring more control over its supply. Therefore we are provisionally proposing that option A is the most suitable way forward. We welcome views on this proposal. Regulatory Impact Assessment 11. A draft regulatory impact assessment is at Annex A. comments on this assessment. We would welcome Comments 12. You are invited to comment on the proposed changes set out at paragraphs 7, 8 and 10 above. Circulation of Proposals 13. This consultation letter is being sent in hard copy to those organisations listed. Copies of the consultation are also available from our website - www.mhra.gov.uk and replies are welcome from all interested parties. A form is attached for your reply. Comments should be addressed to Mrs Anne Ryan, MHRA, 16-142, Market Towers, 1, Nine Elms Lane, London SW8 5NQ (or e-mail to [email protected] to arrive no later than 11 January 2005. Comments received after this date will not be taken into account. The DH/MHRA will not enter into any correspondence concerning these proposals. 14. The Committee on Safety of Medicines will be asked to consider the proposals in the light of comments received and their advice will be conveyed to Ministers. Subject to the agreement of Ministers, we plan to implement the changes by Statutory Instrument in 2005. Statutory Instruments are available from the Stationary Office and may also be viewed on their website http://www.hmso.gov.uk Making copies of the replies available to the public 15. To help informed debate on the issues raised by this consultation, and within the terms of the Code of Practice on Access to Government Information, the Agency intends to make publicly available copies of comments that it receives. Copies will be made available as soon as possible after the public consultation has ended. 16. The Agency’s Information Centre at Market Towers will supply copies on request. An administrative charge, to cover the cost of photocopying and postage, may be applied. Alternatively, personal callers can inspect replies at the Information Centre by prior appointment (telephone 0207 084 2351). 17. It will be assumed that your comments can be made publicly available in this way, unless you indicate that you wish all or part of them to be treated as confidential and excluded from this arrangement. Yours faithfully Anne Ryan Executive Support MHRA To : Anne Ryan MHRA 16-142 Market Towers 1 Nine Elms Lane LONDON SW8 5NQ From : ______________________________ ______________________________ ______________________________ ______________________________ CONSULTATION LETTER MLX 313 : Supply of Water for Injection by people engaged in needle exchange schemes and drug treatment services * 1. I support the proposals contained in the MLX * 2. I have no comment to make on the proposals in the MLX *3. My comments on the proposals in the MLX are below/attached. * My reply may be made freely available. * My reply is confidential. * My reply is partially confidential (indicate clearly in the text any confidential elements) Signed: _____________________________________________ * Delete as appropriate MLX 313: HARD COPY CONSULTATION LIST NB: this list is not intended to be exhaustive. Copies of the consultation are also available from our website - www.mhra.gov.uk – and replies are welcome from all interested parties. Advisory Council on Misuse of Drugs All Party Pharmaceutical Group Association of British Health Care Industries Association of British Pharmaceutical Industries Association of Independent Multiple Pharmacies British Association of Pharmaceutical Wholesalers British Dental Association British Generic Manufacturers Association British Institute of Regulatory Affairs British Medical Association British Pharmacological Society Chemist & Druggist College of Health College of Pharmacy Practice Community Pharmacy Magazine Company Chemists Association Consumers Association Co-operative Pharmacy Technical Panel Dispensing Doctors Association Doctor Magazine Drug & Therapeutics Bulletin Drug Information Pharmacists Group European Association of Hospital Pharmacists General Dental Council General Medical Council General Practitioners Committee Guild of Healthcare Pharmacists Health & Safety Executive Health Development Agency Health Professions Council Health Promotion England Health Service Commissioner Health Which? Independent Healthcare Association Information and Statistics Division Joint Consultants Committee Joint Formulary Committee Joint Royal Colleges Ambulance Service Liaison Committee Long Term Medical Conditions Alliance Medical Defence Union Medical Protection Society Ltd Medical Research Council MIMS Ltd National Board for Nursing, Midwifery and Health Visiting National Consumer Council National Care Standards Commission National Patient Safety Agency National Pharmaceutical Association National Treatment Agency Neonatal and Paediatric Pharmacists Group NHS Alliance NHS Confederation Northern Ireland Consumer Council OTC Bulletin Patients Association Pharmaceutical Contractors Committee (Northern Ireland) Pharmaceutical Journal Pharmaceutical Services Negotiating Committee Pharmaceutical Society for Northern Ireland Prescription Pricing Authority Primary Care Pharmacists Association Proprietary Association of Great Britain Public Health Laboratory Service Royal College of Anaesthetists Royal College of General Practitioners Royal College of Midwives Royal College of Midwives (Scottish Board) Royal College of Midwives (Northern Ireland Board) Royal College of Nursing Royal College of Nursing (Northern Ireland) Royal College of Nursing (Scotland) Royal College of Nursing (Wales) Royal College of Obstetricians & Gynaecologists Royal College of Ophthalmologists Royal College of Paediatrics and Child Health Royal College of Pathologists Royal College of Physicians (Edinburgh) Royal College of Physicians (London) Royal College of Physicians & Surgeons (Glasgow) Royal College of Psychiatrists Royal College of Radiologists Royal College of Speech & Language Therapists Royal College of Surgeons (England) Royal College of Surgeons (Edinburgh) Royal College of Surgeons (Faculty of Dental Surgery) Royal College of Surgeons of England (Faculty of General Dental Practitioners (UK)) Royal Colleges of Physicians : Faculty of Pharmaceutical Medicine Royal Colleges of Physicians : Faculty of Public Health Medicine Royal Pharmaceutical Society of Great Britain Royal Pharmaceutical Society of Great Britain (Scottish Department) Royal Pharmaceutical Society of Great Britain (Welsh Department) Royal Society of Chemistry Royal Society for the Promotion of Health Scrip Ltd Small Business Service Social Audit Unit Specialist Advisory Committee on Antimicrobial Resistance Unison Welsh Scientific Advisory Committee Welsh Pharmaceutical Committee Welsh Medical Committee Health Professions Wales ANNEX A REGULATORY IMPACT ASSESSMENT – DRAFT Title 18. Amendments to the Prescription Only Medicines (Human Use) Order 1997 (the POM Order), the Medicines (Pharmacy and General Sale -Exemption) Order 1980 and the Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1980. to allow people employed or engaged in needle exchange to supply Water for Injection (WFI) to drug users. Issue: 19. Under the Medicines Act 1968, all medicines for parenteral administration are classified as Prescription Only (POM). POMs may only be sold or supplied only through registered pharmacies by or under the supervision of a pharmacist against an appropriate practitioner’s prescription. An “appropriate practitioner” is a doctor, a dentist, and, within the terms of the legislation covering their prescribing, a supplementary prescriber or independent nurse prescribers. POMs may also be supplied by nurses and other specified groups of health professional under a patient group direction (PGD). Objective: 3. Water for Injection is a sterile water injection. Needle exchange and drugs agency staff sometimes supply WFI among other items of drug injecting articles (known as “paraphernalia”) as a means of reducing harm caused by drug misusers using dirty or potentially contaminated water. In August 2003 the Home Office amended Misuse of Drugs Regulations to permit the supply of various articles of paraphernalia to drug users for harm reduction purposes by a practitioner, a pharmacist or a person employed or engaged in the lawful provision of drug treatment services. However, under medicines legislation WFI could still only be supplied against a prescription or by a health professional under a PGD (see paragraph 2 above). In order to clarify the position it is therefore proposed to amend the POM Order so that people working in drug treatment services may also supply WFI to drug users for harm reduction purposes. Scope of this RIA 4. Health services provided outside the NHS are regarded as businesses and the RIA therefore concentrates on the impact of the proposed changes on these groups (referred to from now on as the independent healthcare sector) who are employed or engaged in the lawful provision of drug treatment services. However, the proposal does not create a new regulatory environment with which the independent healthcare sector must comply at the outset. Whether businesses, employers and individual health professionals enter into the provision of drug treatment services is entirely a voluntary decision for them based on their commercial and professional judgement. Issues of Equity or Fairness 5. Government wants to ensure that persons using services provided in the NHS and the independent healthcare sectors are treated in the same way with more access to professional skills and timely services. Risk Assessment 6. The risk assessment is neutral – implementing the changes would mean that drug users within drug treatment services provided by the independent sector receive the same range of services as those in schemes within the NHS. However, if the changes are not implemented, the existing arrangements in the independent healthcare sector – by which WFI can only be prescribed by a practitioner or supplied under a PGD will remain unaffected. Options 7. Two options have been identified Option 1 - do nothing. Option 2 - amend medicines regulations as proposed to enable to permit the supply of various articles of paraphernalia to drug users for harm reduction purposes by a person employed or engaged in the lawful provision of drug treatment services. Benefits and value of options 5 Option 1: This would maintain the status quo but would lose the benefit of drug users within drug treatment services provided by the independent sector receiving the same range of services as those in schemes within the NHS. This would not maximise efforts to reduce the harm caused by drug misusers using dirty or potentially contaminated water. 6 Option 2: Will maximise efforts to reduce the harm caused by drug misusers using dirty or potentially contaminated water and will to clarify the supply of WFI in the context of existing misuse of drugs legislation (see paragraph 3 above). COMPLIANCE COSTS FOR BUSINESS, CHARITIES AND VOLUNTARY ORGANISATIONS 7. Business sectors affected: Independent healthcare organisations providing drug treatment services outside any arrangements funded by the NHS. 8. Costs for a typical business and/or impact on small business if proposal accepted: as outlined above, Option 2 does not create a new regulatory environment for businesses. A draft RIA accompanied the joint DH/MHRA formal consultation with a wide range of interests covering the NHS, health professionals, patient and other interest groups and the independent healthcare sector and including the Small Business Service. We invited views on the potential costs of implementing this proposal as part of this formal consultation process. Replies from the consultation suggested…[To be completed after consultation ends] Total costs of proposal 9. Implementation of the proposal will only be in the context of those independent healthcare sector bodies who provide drug treatment services. This provision is voluntary and costs will depend on the actual number of independent healthcare sector organisations who choose to adopt the new arrangements. Views on potential costs were sought as part of the formal consultation (paragraph 8). [To be completed after consultation ends] Competition Assessment 10. The proposal to allow people employed or engaged in needle exchange to supply WFI to drug users has been considered against the Office of Fair Trading’s competition filter. The results show [To be completed after consultation ends] Results Of Consultation 11. [To be completed after consultation ends] SUMMARY AND RECOMMENDATIONS 12. Option 2 is recommended because it best meets the Government's objective. The benefits of this option, taken with existing arrangements for the supply of drug paraphernalia, are judged to outweigh any costs to business. It will be for the businesses concerned to decide whether to implement the proposal, with any associated costs, on the basis of their commercial judgement. Option 1 ("Do Nothing") Healthcare WFI will continue to businesses need to be prescribed carrying out by an appropriate activities practitioner or outwith the supplied under a PGD NHS Citizens (in this context, drug misusers) Option 2 (Amend Regulations) Allows safe and effective supply of WFI to drug users as part of legitimate drug treatment services, resulting in potential longer term savings and benefit to drug misusers, Harm reduction benefits availability of sterile water of Enforcement, Sanctions, Monitoring and Review 13. The Medicines and Healthcare products Regulatory Agency will be responsible for enforcing medicines legislation. 14. Declaration: I have read the Regulatory Impact Assessment and I am satisfied that the benefits justify the costs. Signed by the responsible Minister: …………………………………… Date: ……………………………………