The Electronic Communications Bill, currently under Parliamentary scrutiny, has a diverse range of admirers. Measures in the Bill are supported by Microsoft, Intel, IBM, AOL, BT, the international pharmaceutical industry, and, more curiously, the Worshipful Company of Information Technologists. To that list can be added the Labour Party, Government Ministers, the Opposition, and the Select Committee as well as the governments of the United States of America, Canada and the European Commission. With so many advocates, pharmacists might feel reassured about the advent of e-communication and electronic signatures in particular. But should pharmacists worry?
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Legal recognition of electronic signatures will make paperless prescribing possible . . . |
The Government attaches huge significance to these measures. The Bill was the first to be referred to in the Queen's Speech last November, the first to be introduced into Parliament and the first to have its Second Reading. Ministers have made clear that this Bill is central to delivering their commitments.
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. . . but could force pharmacists to pay for more new technology |
The technology to produce an electronic signature has existed for several years. An electronic signature is an icon that can be attached to a document in the same way as if the signatory had signed it himself. When the electronic version of the document is sent by e-mail, the receiver can click on the signature icon and a further document is displayed from a third party impartial source that confirms the identity, position, professional qualifications, and other details of the signatory. This technology is simple to acquire and relatively cheap at about £6 per name. The signature can then be used indefinitely.
Electronic signatures have long been mooted as a useful way to modernise outmoded working practices. They are now lawful in the US and Germany and increasing numbers of Western countries are following suit. The Electronic Communications Bill allows businesses and consumers to have confidence in electronic signatures as a quick and easy equivalent to paper signatures, records and documents. Cutting down on vast paper records of transactions is obviously attractive to business. For example, online procurement at the Ford Motor Company has cut transaction costs from $65 to under $5. Pharmaceutical companies could save hundreds of thousands of man-hours when a new drug application with an electronic signature attached can be delivered electronically rather than in a truck. And, of course, electronic signatures would make electronic prescribing possible in time to fulfil the Government's pledge to make prescribing by general medical practitioners electronic by 2002.
The will to bring in electronic prescribing has been around since the Government's 1992 IT strategy first proposed a secure system for authorised health professionals to share patient-related information. Since that time, debate has raged about the technical, ethical and practical aspects of electronic prescribing. The arguments have been well rehearsed before (PJ, September 25, 1999, p496-501). One aspect which has received little attention is the timeframe within which the proposed Electronic Communications Act would be brought into force. Section 8 of the Bill provides for individual Government Departments to adopt electronic signatures at their own pace. In other words, there is a strong possibility that the Department of Health will not accept electronic requests for prescription reimbursement for some years yet.
This would require officials to resist strong pressure from the Cabinet Office, something that has happened recently on other IT matters. The Government wants a consistent approach across Departments to prevent confusion and to promote efficiency. If you can file your taxes and pay for your stock online, why not receive reimbursement from the NHS online? The answer is that officials are not convinced that electronic data interchange (EDI) between pharmacies and the pricing authority either saves time or allows pharmacists to take greater clinical responsibility for the prescription process.
The recent Scottish SCRIPTS project demonstrated these objections. The extra data - the prescription serial number and the GP code - that needed to be added increased workload. This was offset by not needing to sort and post forms each month and rapid warnings to the contractor of any disallowed or invalid items. In the event, the electronic system did not speed up payment. These purely technical aspects were not demonstrably overcome by the commercial systems on the market at the time.
On top of this, the question of protocol standards for electronic prescriptions is being investigated. At the moment there is more than one way to describe the name of the medicine, the reasons for prescribing that medicine, the pack size and quantity, and the type of text in which the GP communicates with the pharmacist. There are no universal standards for security, confidentiality, or quality. In other words, there is no standard way of prescribing electronically. Compare this with the current manual system operated by the PPA to cost scripts and produce PACT reports. The paper system is 99.82 per cent accurate on over 500m items a year, as well as being highly efficient in terms of operator keystrokes. This leads to the question: why change?
The Government is committed to electronic prescribing but has so far not decided how to deliver it. Pressure is coming from the Treasury for the large investment needed to establish a national electronic prescribing system to be funded through a public-private partnership with a major telecommunications operator. While several companies have shown interest, most would want the EDI system to capture more information about the patient. A more accurate link between drug quantities, prescribing habits and anonymised patient information would be of considerable commercial use. The Government also would like this information to combat fraud, better monitor medicines use and to cut the large transaction costs of medicine supply.
All sides in this debate are waiting for the appeal against the Source Informatics case to be resolved (PJ, January 1, p5). This decision, expected within weeks from the House of Lords, concerns the right of pharmacists to sell anonymised data to pharmaceutical companies. The Department of Health wants this information for itself. An alternative would be to access the GP data-stream in an anonymised way. This could be done through the existing NHSNet, which has security and confidentiality protocols already in place. This information could be used by the NHS to monitor National Institute for Clinical Excellence guidelines and better to inform the Prodigy prescribing support system. This alternative has so far received less attention but could be examined more closely should the appeal against the Source Informatics case fail.
The Electronic Communications Bill also contains provision for the self-regulation of registration of suppliers of cryptography services. The Government has been working with the Alliance for Electronic Business to establish voluntary regulations and standards. In this, the Government has tended to work with the larger companies such as BT, IBM and the Royal Mail, rather than smaller start-up companies. Discussions are on-going over fees for certification and the regulation and basis of these fees.
This has implications for the future of e-commerce in the pharmacy profession. Ministers have repeatedly made clear that they do not want to stifle innovation nor competitive advantage. Therefore, they have followed the "third way" on regulation and brought forward legislation that favours self-regulation in the first instance backed up by power to intervene directly if standards are not being protected sufficiently. It is unclear how flexible these provisions will be in practice. There are three areas where this flexibility will be tested:
The political direction in this area is clear. The Government is committed to a national system of 24-hour electronic patient records within the next five years. To deliver this target, the variety of questions over electronic prescribing and regulation of the EDI systems employed will need to be solved. A workable financial model for funding the investment in hardware, software, and training will also need to be found. It is also clear that the Electronic Communications Bill introduces the framework legislation fully to enable successful joint working with GPs. In fact, this Bill dovetails well with the Royal Pharmaceutical Society's 1997 "Pharmacy in a New Age" strategy that advocates extended roles for community pharmacists.
These debates come in the context of a much-wider debate about the evolution of the relationship between the patient and health care professionals. Recent or imminent changes include: the Data Protection Act 1988; the Competition Act 1998; the Health Act 1999 and clinical governance; a draft European Directive on e-commerce that affects prescriptions and sale of medicines; and a European Directive on distance selling. The Council of the Royal Pharmaceutical Society is currently considering and consulting on the implications of these wider developments.
However, advances in information and communications technologies tend to leave day-to-day practitioners trailing in their wake. Already tri-band mobile telephones are available with voice recognition that offers electronic voice signatures as standard. Similarly, credit cards can now be used inside a mobile phone to purchase goods, making fraudulent activity potentially much easier. It is likely that there is a long way to go before electronic communication and health care provision will sit comfortably together.
Andrew Tucker is head of policy development at GJW Health Affairs and is working with the Royal Pharmaceutical Society on e-commerce