Download Application to England, Wales, Scotland and Northern Ireland

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:
……………………………………