To: Interested Parties. Our reference: MLX 310 Date: 2 August Dear Sir/Madam

Transcription

1 To: Interested Parties Our reference: MLX 310 Date: 2 August 2004 Dear Sir/Madam PROPOSALS TO ENABLE THE USE OF ELECTRONIC SIGNATURES ON PRESCRIPTIONS AND PROPOSED AMENDMENTS TO THE PRESCRIPTION ONLY MEDICINES (HUMAN USE) ORDER 1997 INTRODUCTION 1. We are writing to consult you, in accordance with section 129(6) of the Medicines Act 1968, on proposals to amend the Prescription Only Medicines (Human Use) Order 1997 (the POM Order) so as to allow the use of advanced electronic signatures on prescriptions that are to be transmitted electronically. This would be achieved by amendments to the POM Order. This consultation abides by the six consultation criteria as set out in the revised Code of Practice on Consultation published by the Cabinet Office ( Application to England, Wales, Scotland and Northern Ireland 2. The proposed changes to the POM Order would apply throughout the United Kingdom. This consultation is being made available in Scotland, Wales and Northern Ireland. BACKGROUND 3. Under current legislation, prescriptions have to be signed in ink by an appropriate practitioner. This means that prescriptions have to be in paper form. We are, however, looking to allow prescriptions to be transmitted electronically. In the case of NHS prescriptions, the prescription might also be transmitted electronically to the relevant reimbursement authority. 4. Legislation was amended in 2001, specifically to allow electronic signatures to be used for three pilots for the electronic transmission of prescriptions in England. These pilots finished in 2003 and, as this legislation was particular to the needs of the pilots, we need now to put in place a permanent provision suitable for enabling electronic prescriptions across the UK. 5. Transmitting prescriptions electronically is expected to introduce significant benefits for patients, prescribers and dispensers. It will be more convenient for patients, as they will need

2 to make fewer trips to the GP surgery to collect repeat prescriptions. There will be benefits for patient safety as there will be fewer illegible or incomplete prescriptions. Other improvements to patient safety, such as better patient medication records, may also be derived from the integration of the electronic transmission of prescriptions with other IT functionalities, such as the NHS Care Records Service in England. There will also be efficiency improvements for prescribers and dispensers. PROPOSALS 6. We propose to amend the POM Order to allow the use of advanced electronic signatures (as defined by the Electronic Signatures Regulations 2002 see Annex A) on prescriptions that are to be transmitted electronically. Other types of electronic signature will not be acceptable. 7. We propose an advanced electronic signature rather than an electronic signature, as the former is more secure than an electronic signature. As outlined in Annex A, an advanced electronic signature is uniquely linked to the signatory, is capable of identifying the signatory, is created using a means that the signatory can maintain under his sole control and is linked to the data to which it relates in such a manner that any subsequent change of data is detectable. An electronic signature does not have to have these security characteristics. 8. Before NHS prescriptions can be transmitted electronically, amendments will also be need to be made to the relevant NHS legislation in each of the UK administrations. These changes will not effect the proposals outlined above in relation to the POM Order. It maybe that there will be additional requirements under the NHS legislation for NHS prescriptions transmitted electronically. 9. The proposal does not intend to force prescribers to transmit prescriptions electronically. Prescribers will still be able to sign paper prescriptions by hand in ink as now. 10. However, the proposal does not intend to provide for prescribers to print an electronic signature onto a paper prescription. 11. For clarification, the proposals outlined above do not apply to a prescription for a controlled drug specified in Schedules 1, 2 and 3 of the Misuse of Drugs Regulations. In March 2003, the Home Office consulted on proposals to allow all details on prescriptions for Schedule 2 and 3 controlled drugs except for the signature to be generated by computer. Amendments to the Misuse of Drugs Regulations are awaited. 12. We would welcome comments on the proposals set out in paragraphs 6-7 and 9-10 above to allow for an advance electronic signature on those prescriptions transmitted electronically. REGULATORY IMPACT 13. A draft regulatory impact assessment is at Annex B. We would welcome comments on this assessment. COMMENTS ON PROPOSALS 14. You are invited to comment on: the proposal to amend the POM Order to allow the use of advanced electronic signatures on prescriptions that are to be transmitted electronically;

3 the draft regulatory impact assessment. CIRCULATION OF PROPOSALS 15. This consultation letter is being sent in hard copy to those organisations listed. A form is attached for your reply. This list is not intended to be exhaustive. Copies of the consultation are also available from our website - and replies are welcome from all interested parties. Comments should be addressed to Roy Drepaul, MHRA, Market Towers, 1, Nine Elms Lane, London SW8 5NQ (or roy.drepaul@mhra.gsi.gov.uk) to arrive no later than 29 October Comments received after that date will not be taken into account. 16. 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. The proposal is that the statutory instrument necessary to make the proposed change will come into effect in early Once made and published, statutory instruments are available from the Stationery Office and may also be viewed on their website MAKING COPIES OF THE REPLIES AVAILABLE TO THE PUBLIC 17. 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. 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. 18. 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 ). Yours faithfully Anne Thyer Joanna Warner Executive Support Medicines, Pharmacy and Industry Group Medicines and Healthcare products Department of Health Regulatory Agency

4 ANNEX A The Electronic Signatures Regulations 2002 Paragraph 2 of the Electronic Signatures Regulations 2002 states the following: "advanced electronic signature" means an electronic signature (a) which is uniquely linked to the signatory, (b) which is capable of identifying the signatory, (c) which is created using means that the signatory can maintain under his sole control, and (d) which is linked to the data to which it relates in such a manner that any subsequent change of the data is detectable

5 ANNEX B REGULATORY IMPACT ASSESSMENT - DRAFT Title 1. The Prescription Only Medicines (Human Use) Amendment Number (**) Order Issue: 2. We propose to amend the Prescription Only Medicine (Human Use) Order 1997 (the POM Order) to allow the use of advanced electronic signatures (as defined in the Electronic Signatures Regulations 2002) on prescriptions that are to be transmitted electronically. Objective: 3. To enable the electronic transmission of prescriptions, which is a significant development in technology that cannot be implemented without the change in regulation. Electronic transmission of prescriptions is expected to introduce significant benefits for patients, prescribers and dispensers. 4. Firstly, the electronic transmission of prescriptions will be more convenient for patients, as they will need to make fewer trips to the GP surgery to collect repeat prescriptions. Secondly, there will be benefits for patient safety as there will be fewer illegible or incomplete prescriptions. Other improvements in patient safety, such as better patient medication records, may also be derived from the integration of the electronic transmission of prescriptions with other IT functionalities, such as the NHS Care Records Service in England. Thirdly, there will be efficiency improvements for prescribers and dispensers using the electronic transmission of prescriptions. Scope of this RIA 5. These regulatory changes will not force prescribers to transmit prescriptions electronically. Prescribers will still have the option of issuing paper prescriptions, signed by hand. 6. The extent to which the electronic transmission of prescriptions is adopted within national health organisations within the UK, is a matter for each of the devolved administrations and will require further regulatory changes. Issues of Equity or Fairness 7. The proposed amendments to the POM Order will enable prescriptions to be transmitted electronically in the independent healthcare sector, with an advanced electronic signature, if prescribers so wish. 8. If each of the UK administrations so chooses, subject to further regulatory changes, the amendments will also enable NHS prescriptions to be transmitted electronically with an advanced electronic signature. Risk Assessment 9. Without this change electronic transmission of prescriptions is not possible. The associated risk is therefore that a technology development that can offer significant benefits (see paragraphs 3 and 4 above) will not be adopted.

6 10. If no action is taken, the existing arrangements for signing and issuing paper prescriptions will remain as at present. However, the proposed changes will prescribers the additional option of signing and transmitting prescriptions electronically. Government, prescribers and dispensing pharmacists are keen to press ahead with the electronic transmission of prescriptions. In England, for example, there is a Government target of 100% roll-out of the Electronic Transmission of Prescriptions in the NHS in England by None of this will be possible without legislative changes to allow electronic signatures. Options 11. Three options have been identified: Option 1 - Option 2 - Option 3 - do nothing. introduce a Code of Practice or voluntary agreement on using electronic signatures for the electronic transmission of prescriptions amend the POM Order as proposed to allow prescriptions which are to be electronically transmitted to be signed with an electronic signature. Benefits and value of options 12. Option 1: This would maintain the status quo but would result in a failure to deliver electronic transmission of prescriptions, thereby losing the benefits to patients, prescribers and dispensers as outlined above. 13. Option 2: This is included for completeness but would not achieve the stated objective. This is because the requirement that a prescription must be signed in ink is contained in legislation and a voluntary agreement or code could not remove or waive that requirement. 14. Option 3: This would facilitate the implementation of the electronic transmission of prescriptions in the independent healthcare sector and, subject to further regulatory changes, in the national health organisations across the UK. COMPLIANCE COSTS FOR BUSINESS, CHARITIES AND VOLUNTARY ORGANISATIONS 15. Option 3 does not create a new regulatory environment for the independent healthcare sector, as the use of electronic signatures, and the subsequent electronic transmission of prescriptions is a voluntary decision in the light of benefits to the organisation, patients and the health professionals employed by those organisations. 16. The POM Order alone will not enable the use of electronic signatures in national health organisations. The extent to which the electronic transmission of prescriptions is adopted within national health organisations is a matter for each of the devolved administrations. These national services are not regarded as a business, charity or voluntary organisation for the purpose of this RIA. It will be for each of the UK administrations to decide whether to make subsequent changes to their national health legislation. These changes may have compliance costs, but this will be a matter for each of the administrations to discuss with interested parties.

7 17. Costs for a typical business if proposals are adopted: as outlined above, this proposal alone does not force businesses to adopt the use of electronic transmission of prescriptions and hence the use of an advanced electronic signature. 18. Should the independent healthcare sector decide to introduce electronic transmission of prescriptions, costs will vary according to any computer equipment or connectivity they may already have (see paragraph 20 below). 19. In the national health organisations across the UK, compliance cost will depend on various factors. These could include whether and how quickly the administrations would like the electronic transmission of prescriptions adopted, any additional requirements (IT and/or service related) which need to be implemented to support the electronic transmission of prescriptions and the advanced electronic signature. vary according to any computer equipment or connectivity that may already be in place and whether it can be modified or needs to be replaced. Such matters will be a matter for each of the administrations to discuss with interested parties as they look to introduce electronic transmission of prescriptions within their national health organisations. 20. Impact on small business: we invited views on the potential costs of drawing up and implementing advanced electronic signatures for electronic transmission of prescriptions in those businesses which may choose to adopt this approach. It needs to be borne in mind that prescribers will still be able to use paper prescriptions as now. [To be completed after consultation ends] 21. Summary of Competition Assessment: As this proposed regulation is an enabling measure to allow the use of new technology in the independent healthcare sector, it is unlikely to have any effect on the competitive process or to provide any detriment to the provision of services. Results Of Consultation 22. [To be completed after consultation ends] SUMMARY AND RECOMMENDATIONS 23. Option 3 is recommended because it best meets the Government's objectives. The benefits of this option in terms of patient care and the effective use of resources are judged to outweigh any costs involved. It will be for businesses outside the national health service to decide whether to implement the electronic transmission of prescriptions, with its associated costs, on the basis of their commercial judgement.

8 Option Disadvantage Benefit Option 1 (Do nothing) Potential benefits of the electronic transmission of prescriptions not realised. Status quo maintained. Option 2 (Introduce a Code of Practice or voluntary agreement on the electronic transmission of prescriptions) Option 3 (Amend regulations) Requirement that prescriptions be signed in ink is contained in legislation. Adopting a non-legislative option could not remove or waive that requirement. These regulatory changes will not force the use of the electronic transmission of prescriptions. Independent healthcare organisations will decide whether to take on any costs associated with the electronic transmission of prescriptions, balanced against its benefits. None Will help to enable the electronic prescriptions, which will increase flexibility and convenience for patients and healthcare professionals. Enforcement, Sanctions, Monitoring and Review 24. The Medicines and Healthcare products Regulatory Agency will be responsible for enforcing medicines legislation. The UK administrations may wish to review arrangements for the electronic transmission of prescriptions in the context of their own national healthcare systems. 25. Declaration: I have read the Regulatory Impact Assessment and I am satisfied that the benefits justify the costs. Signed by the responsible Minister: Date:

9 ANNEX C Roy Drepaul MHRA Market Towers 1 Nine Elms Lane LONDON SW8 5NQ From : CONSULTATION LETTER MLX 310: PROPOSALS TO ENABLE THE USE OF ADVANCED ELECTRONIC SIGNATURES ON PRESCRIPTIONS TRANSMITTED ELECTRONICALLY AND PROPOSED AMENDMENTS TO THE PRESCRIPTION ONLY MEDICINES (HUMAN USE) ORDER I agree the proposals and have no comments to make I agree the proposals and have the following comments to make: I do not agree with the proposals for the following reasons: 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

10 MLX 310: HARD COPY CONSULTATION LIST NB: this list is not intended to be exhaustive. Copies of the consultation are also available from our website - and replies are welcome from all interested parties. Action for Sick Children Advisory Committee on Misuse of Drugs Age Concern All Party Pharmaceutical Group Association of British Cardiac Nurses Association of Nurse Prescribing Association for Palliative Medicine Association for Residential Care Association of Anaesthetists of Great Britain and Northern Ireland Association of British Dispensing Opticians Association of British Health Care Industries Association of British Pharmaceutical Industries Association of Hospice Management Association of Independent Multiple Pharmacies Association of Medical Microbiologists Association of Optometrists Association of Surgeons of Great Britain and Ireland British Association of Dermatologists British Association for A&E Medicine British Osteopathic Association British Association of Pharmaceutical Physicians British Association of Art Therapists British Association of Drama Therapists British Association of Music Therapists British Association of Prosthetists and Orthotists British Cardiac Patients Association British College of Optometrists British Contact Dermatitis Group British Dental Association British Dental Trade Association British Diabetic Association British Dietetic Association British Generic Manufacturers Association British Heart Foundation British Institute of Regulatory Affairs British Medical Association British Medical Journal British Oncological Association British Orthoptic Society British Pharmacological Society Carers National Association Chartered Society of Physiotherapy Chemist & Druggist College of Health College of Occupational Therapists College of Optometrists College of Pharmacy Practice Community Practitioners and Health Visitors Association Community Pharmacy Magazine Community Services Pharmacists Group

11 Company Chemists Association Consumers Association Co-operative Pharmacy Technical Panel Dental Defence Union Dental Formulary Subcommittee of the Joint Formulary Committee Dental Protection Ltd Dispensing Doctors Association Doctor Magazine Drug & Therapeutics Bulletin Drug Information Pharmacists Group Faculty of Homoeopathy Faculty of Pharmaceutical Medicine General Dental Council General Dental Practitioners Association. General Medical Council General Optical Council General Practitioners Committee Guild of Healthcare Pharmacists Health Development Agency Health Professions Council Health Promotion England Health Service Commissioner Health Which? Independent Healthcare Association Joint Consultants Committee JCVI Joint Formulary Committee Joint Royal Colleges Ambulance Service Liaison Committee Long Term Medical Conditions Alliance Macmillan Cancer Care Medical Defence Union Medical Protection Society Ltd MIMS Ltd National Association of GP Co-operatives National Association of Primary Care National Consumer Council National Council for Hospices and Specialist Palliative Care Services National Care Standards Commission National Patient Safety Agency National Pharmaceutical Association Neonatal and Paediatric Pharmacists Group NHS Alliance NHS Confederation Northern Ireland Consumer Council Nursing and Midwifery Council Ophthalmic Group Committee OTC Bulletin Paediatric Chief Pharmacists Group Patients Association Pharmaceutical Contractors Committee (Northern Ireland) Pharmaceutical Journal Pharmaceutical Services Negotiating Committee Pharmaceutical Society for Northern Ireland Prescription Pricing Authority

12 Primary Care Pharmacists Association Proprietary Association of Great Britain 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 for the Promotion of Health Scrip Ltd Small Business Service Social Audit Unit Society of Chiropodists and Podiatrists Society of Homoeopaths Society of Pharmaceutical Medicine Society of Radiographers Specialist Advisory Committee on Antimicrobial Resistance St John Ambulance UK Clinical Pharmacy Association Unison Welsh Nursing & Midwifery Committee Welsh Medical Committee Welsh Optometric Committee Director of Social Services, Wales Society of Directors of Public Protection, Wales Welsh Therapies Advisory Committee All Wales Dietetic Advisory Committee All Wales Professional Heads of Occupational Therapists Services Group All Wales Orthoptics Advisory Committee Chiropody/Podiatry Service Group, Wales All Wales Physiotherapy Managers All Wales Speech & Language Therapy Committee Health Professions Wales