SUMMARY OF RESPONSES TO CONSULTATION MLX310

Transcription

1 SUMMARY OF RESPONSES TO CONSULTATION MLX Consultation MLX 310 was issued with a deadline for comments of 29 October. It was circulated to a range of interested organisations throughout the UK and copies appeared on the MHRA website. The MHRA received 91 responses. The replies can be broadly categorised as follows: Medical and Nursing Organisations: 23 NHS Bodies: 37 Pharmaceutical Interests: 15 E-signature Interests: 3 Other Organisations: 11 Individuals: 2 2. Eighty three (83) of the replies expressed support for the proposals. The BMA and Boots Pharmacists Association were amongst those particularly supportive. Six (6) made no comment or expressed no preference. Two (2) opposed the proposals. 3. The majority of the replies were supportive. Correspondents mentioned a number of benefits that could flow from the electronic transmission of prescriptions (ETP), which would be enabled by the change to the POM order. These benefits included an increase in patient safety, making collecting prescriptions more convenient for patients and freeing up time for doctors and pharmacists. Advantages in clinical audit and the prevention of fraud were also expected. A number of correspondents felt that the proposals and their implementation were long overdue. 4. Some correspondents, including some community pharmacy organisations, thought that efforts should be made to make ETP the norm as this would result in the greatest benefit. 5. Several organisations welcomed the fact that the amendment to the POM order would not force prescribers to use an advanced electronic signature (AES) instead of an ink signature. 6. The proposal for the use of an AES, as opposed to an electronic signature, met with the approval of a large number of correspondents. 7. There were a number of requests for clarification of the exact extent of the proposal. The Company Chemist s Association Ltd (CCA) and National Pharmaceutical Association (NPA) asked whether the proposal would allow all prescribers to use an AES to issue a prescription. Both organisations thought that this should be the case, with the CCA particularly keen that pharmacists should be included. Other correspondents were interested in how the proposals would apply to hospitals, since the RIA only covered GP prescribers and PCT dispensers. 8. Lloyds Pharmacy, the CCA, Boots the Chemist, BMA, PSNC and the NPA all made comment on the fact that the proposal excludes Schedule 1,2 and 3 drugs. Although most of them welcomed this cautious approach, all

2 remarked that in order to gain the greatest benefits from ETP the scheme would need to be expanded to included these drugs (only schedule 2 and 3 drugs in the case of Lloyds). 9. A number of correspondents enquired as to whether the proposals covered the prescription of phenobarbitone and temazepam. These are schedule 3 drugs but are exempt from the prescription requirements of the Misuse of Drugs Act. In addition, Lloyds asked for clarification that it would be possible to prescribe schedule 4 and 5 drugs using ETP. 10. Correspondents sought reassurance / requested clarification on a number of issues surrounding the implementation of any AES system. Some correspondents were concerned that people who work in more than one institution or who change work places regularly (such as locum pharmacists or trainee doctors and nurses) might have to register their electronic signature more than once, which would make the system less secure and more bureaucratic. 11. Boots the Chemist and the PSNC pointed out that any AES database should be time sensitive, so that if a prescriber is removed from the database for any reason then the prescriptions already signed by their AES will still be valid after their ability to sign their AES will have expired. 12. The Association of Pharmacy Technicians UK said that there should be a regulator with the power to withdraw the ability of a prescriber to use an AES. 13. The Royal College of Anaesthetists thought that the audit of prescriptions transmitted electronically should only be possible with the consent of the AES signatories. They also argued that regulations should ensure NHS adopters of AES are certified under The Electronic Signatures Regulations 2002 statutory instrument 2002 No. 318 (EU Law). 14. Some correspondents, including the PSNC, pointed out that under article 15(3) of the POM Order pharmacists must be able to demonstrate all due diligence in checking the validity of prescriptions. They asked whether in future the presence of an AES on the prescription would be sufficient to confirm that it is valid. Boots the Chemists argued that if this was the case then article 15(3) should be removed from the POM order. 15. Boots the Chemists argued that the legislation to allow electronic signatures should become effective from an agreed date that is notified well in advance, allowing the majority of pharmacy contractors to have received the necessary equipment and training to become fully operational. They believe that if this is not the case then there will be distortions of competition between pharmacy contractors during the implementation phase. 16. A large number of replies asked about the specific nature of an AES and how it would be used: whether it would involve a scanned signature, a swipe card, a password, or something different entirely. Concerns were expressed that all AES s should be to the same standard even if they were issued by different

3 companies or authorities. Other, related questions included: how the signatory would be able to keep the signature under their sole control; whether pharmacists would be able to check the validity of a prescriber s signature and if so, how? 17. Many correspondents wished to emphasize that AES and ETP should be secure so that prescriptions could not be intercepted and the information used for illegal purposes. The Advisory Council on the Misuse of Drugs suggested that the final proposal should refer to the advanced electronic signature being created using a means that the signatory must maintain under his sole control instead of created using a means that the signatory can maintain under his sole control. 18. Correspondents expressed a number of concerns about the implementation of any AES system within the NHS. The Royal College of Anaesthetists said that an AES should only be able to be used for ETP. The National Pharmaceutical Association thought that it should be able to be used to sign other documents in the prescribing process. 19. The CCA and others argued that pharmacists should be allowed to alter prescriptions after they have been signed by a prescriber, noting that appending a signature does not, in itself, make a prescription clinically or technically correct. The CCA stated that this should only happen where pharmacists have taken sufficient steps to be sure of the prescriber s intentions. Another correspondent believed that any guidance should make clear that this is possible. 20. The SPC and CPA both pointed out that at present a patient who is exempt from prescription charging needs to sign the prescription to certify the fact. They mentioned that some system would need to be provided for patients to do this electronically if the current proposals go ahead. 21. The NPA asked that prescribers be allow to sign in ink any token that a patient may take from the prescriber to the dispenser as part of ETP. They believe that patents may suffer a delay in receiving medicines if they present a token at a pharmacy that cannot handle ETP and therefore an ink-signed ETP token ought to be treated as a prescription until all pharmacies can process ETP. 22. The Royal College of Physicians of Edinburgh was interested in what would happen in the event of a systems crash. They were particularly concerned with how patients might be affected. 23. Many organisations were concerned with the expense of hardware and software that would be needed to implement ETP. The Association of Pharmacy Technicians UK were particularly concerned about how small rural pharmacies would be able to fund the cost of implementation. They proposed that some sort of fee incentive could be built into the system for pharmacy services, encouraging small pharmacies to provide the service and thus

4 increasing the implementation rate of the scheme. Other correspondents expressed similar concerns about GP s. 24. Boots the Chemists stated that they were pleased that an agreement had been reached, in principle, to reimburse NHS contractors for the cost of new IT to support ETP. They went on to say that they expected that the associated allowance for maintenance and connectivity would cover all incremental costs. 25. The Scottish Pharmaceutical Council (SPC) and the Co-operative Pharmacy Association (CPA) stated that they believe that the proposals force pharmacies to adopt the use of electronic signatures. They point out that patients demand the right to have their prescriptions dispensed at a community pharmacy of their choosing. To meet this expectation all community pharmacies must be able to process ETP. The SPC and CPA say that this forces pharmacists to adopt ETP and thus AES. The organisations believe that this means the associated costs to contractor pharmacists should be fully funded by the NHS. 26. Two correspondents disagreed with the proposal. The NHSL Acute Operating Division pointed out that advanced should be inserted before electronic in section 11 of the Regulatory Impact Assessment. 27. Mr Stephen Mason, author of Electronic Signatures in Law, had a number of objections. These were enumerated in his submission to the consultation, which he also published as an article in The Pharmaceutical Journal. The Macmillan Cancer Trust, Boots the Chemists and another correspondent all referred to the issues covered in this article as causes for concern. In his concluding remarks Mr Mason summarises his objections by listing the questions he feels the department have not given satisfactory answers to. These are: How much will the software cost? What upgrades will be required to computer systems? Will advanced electronic signatures be compatible across different types of computer? Will users be able to decide which form of advanced electronic signature they use? Who will pay for users to be registered with certificate authorities? Who will pay for the annual costs of maintenance and to replace the private keys each year? Who will be responsible for the additional security measures required to ensure a private key is not compromised on a computer? How will a user know when their private key is compromised, so that they must cancel it? Who will be liable if a private key is used to obtain drugs illegally? Who will be responsible for storing old private keys? How long will they need to be stored for? How will keys be managed? Mr Mason can see no clear answers to the above and believes that there are better and less expensive models available. He gives the example of the Girotel system operated by the Dutch bank, PostBank. In this system a user is given an identification number. The bank then issues a list of transaction

5 codes on paper. Each time the user enters the system, they use the next transaction code. A new list of codes is issued as the old code are used up. Mr Mason states that this system is not foolproof but it does allow the user to know when their paper has been stolen or used without authority.