Electronically transmitted prescriptions - a good idea?
It seems obvious to say that the internet will be of great benefit to the health service by helping to create a more efficient and seamless system. However, it is important that everyone involved is made aware of the law that has an impact on the electronic transmission of health care data and also on the use of those data
The internet is already revolutionising the health care industry in Britain. Launching the Information for Health Strategy1 in 1998, the former Health Secretary Frank Dobson said that “information technology has a central role in the Government’s ambition to renew and modernise the National Health Service”. The strategy includes the development and application of such things as electronic health records, electronic patient records, a national electronic library for health, telemedicine and telecare.
In addition, the strategy promotes the NHSnet as the best medium for the transfer of clinical information.2,3 The implementation of electronically transmitted prescriptions in community health care will be introduced between 2000 and 2002 and in hospitals by 2005. Electronically transmitted prescriptions have already been tested with general medical practitioners4 and also in many hospitals in the United Kingdom.5 Is electronic prescribing a good thing?
The use of electronic prescriptions has the potential to benefit the health care system in many ways as it has advantages not only for prescribers and pharmacists, but for patients, as well.
Patients would be assured of error free prescriptions as the system would set the drug dosage and check for drug interactions. However, the correct clinical diagnosis and drug selection still has to be made, and the prescription still has to be dispensed and the medication administered correctly. These things are by no means certain, as various court cases have shown.6-9 It has been found that around one in 20 admissions to hospital is for treatment of side effects related to drugs or the results of drug interactions,10 perhaps due to difficulties in calculating drug doses11 or other prescribing problems.12 An electronic prescribing system should help to optimise the level of care received by the patient. Although the prescription is just one factor in the process, electronic prescribing and transfer of prescriptions is a step towards optimising the clinical outcome of the drug treatment.
The system would also provide for the prescription to be transmitted, at the time of prescribing, straight to a nominated community pharmacy. Research undertaken on behalf of Pharmed has shown that over 80 per cent of patients would be happy to nominate one pharmacy where their prescriptions could be sent. The medicine would then be ready for collection by the time the patient arrived at the pharmacy or the prescription could be held at the pharmacy until the patient requested a supply. This method could speed up drug delivery in community care and also in hospitals, where the prescriptions would be transmitted from wards or clinics to the hospital pharmacy. The service would be more convenient for patients. It is likely that pharmacists would still spend time on prescription queries, for example, regarding the choice of a drug in a clinical situation. But the goal of seamless care between hospitals, GPs and community care would be a step nearer, if not a reality, with the electronic transmission of information.
Doctors and pharmacists
Electronic prescription services can save significant time and money by providing efficient data exchange between doctors and pharmacists, thus giving them more time to spend on their other professional duties. A survey has shown that GPs would welcome electronic links with pharmacists and can see the benefits it would bring.13
Doctors owe a duty to their patients to write prescriptions clearly. A pharmacist who misreads a prescription and dispenses the wrong drug to a patient is liable in negligence where there has been sufficient information on the prescription as a whole to alert him to the fact that he was dispensing the wrong drug.14 In the past, there has been litigation involving the prescribing and ordering of drugs over the telephone.15
An important benefit, therefore, is that electronic prescribing should diminish the potential for disciplinary hearings and litigation arising from prescribing and the interpretation of prescriptions. For example, when an electronic prescribing system was put in place in Wirral Hospital NHS trust, the number of complete and correct dosages charted increased from 17.7 to 100 per cent. It also minimised omission of doses by nurses. The system increased the need for pharmacists as it uncovered drug-related problems that had previously gone unnoticed.16
Prescription fraud is a major concern. It is usually carried out by a person who:
- Obtains many prescriptions for the same drug from various doctors
- Uses a stolen prescription pad and writing his/her own prescription17
- Calls in for a prescription for himself while posing as a doctor
The total losses to the NHS from prescription fraud are unknown, but it is estimated that the theft, counterfeit and forgery of prescription forms cost some £15m each year.18 The doctors and pharmacists involved may be legally liable. A pharmacist who supplies medicines on the basis of a forged prescription commits an offence whether or not he is aware that the prescription is a forgery.19 It is also dangerous to the person taking the drugs as it can lead to the misuse of medicines.20 The Government is attempting to fight fraud,21 but the widespread use of an electronic system will remove the use of stolen prescription pads and people posing as doctors to write prescriptions for themselves, and will make obtaining the same prescription from various doctors much more difficult as the patient’s past drug history will be easily accessible.
Accurate, cost-effective prescribing is more likely and quicker with electronic transfer of prescriptions, patient data and other health care information. The prescriber can instantaneously access background information about the drug, its side effects and drug interactions, formulary status, cost and patient’s medical and drug history. The prescriber will be more adequately informed, which should lead to better decision making. The system saves time as patients’ paper notes will not have to be located and there will be less need to refer to hardcopy sources such as the British National Formulary. This means that the prescriber has more time to spend with patients or can see more patients in a given time. This is likely to save time for other surgery staff, too.
Formulary and treatment protocol compliance will increase without the need for interventions by pharmacists. Patient outcomes should improve and drug spending is likely to decrease (or allow for spending on other previously unaffordable drugs). Pharmacists will be able to concentrate their time on such things as drug monitoring, drug information queries, patient counselling, clinical pharmacy, clinical trials, audit, financial management, other pharmaceutical management and, perhaps, prescribing.
A project in Denmark studying the electronic transmission of prescriptions showed that the workload for pharmacists became more evenly spread over the day and both GPs and pharmacists appreciated time gains. One of the main advantages was not needing to spend so much time on telephone calls or waiting for telephone calls and handling of prescriptions was easier and less time consuming.22
Research on behalf of Pharmed has shown that 75 per cent of GPs think it would be useful to know whether all or some of their patients had collected their medicine from the pharmacy, and 80 per cent would like to know if specific patients did not collect their medicines. Moreover, 55 per cent of GPs would also find it useful to know about any over-the-counter medicines patients take in order to reduce side effects, although community pharmacists are perhaps in a better position to monitor this. Also, research has found that 90 per cent of GPs have said that they would be happy for pharmacists to take responsibility for repeat prescription management. Repeat prescriptions account for approximately 75-80 per cent of all prescribing.4 All these things would be possible with electronic links between doctors and pharmacists.
Both the doctor and pharmacist will easily be able to access a patient’s medical and drug history, the drugs the patient is currently taking and any previous allergic reactions. This is important to enable potential problems to be spotted and handled accordingly. In the event of a drug recall, patient contact information will be available straight away.
The system will help in the collection and analysis of drug usage and patient data, which will be useful in the formulation of treatment protocols and care plans, and therefore help to improve health care outcomes. This will be subject to provisions in the Data Protection Act 1998 and Human Rights Act 1998, which are discussed later in this article.
To put an electronic data exchange system like this in place means a commitment to large start-up costs for software and hardware. The Government recognises that, without a significant increase in the current levels of investment, the NHS cannot deliver its “Information for health” strategy and has formed a modernisation fund, which includes support for the strategy.23 In March, 1999, the Scottish NHS management executive circulated a paper24 to health boards telling them that local initiatives for electronic prescribing should be discouraged because of national plans,25 which include the investment of £4m.26 The Department of Health in Northern Ireland has secured over £2m funding direct from the Treasury to support a major project to establish electronic prescribing in the province.27 The money that the system is likely to save by reducing fraud will help to cover the cost of introducing the system.
Health care staff must be positive about the increasing use of information technology. Time will have to be spent training staff to use the system to its full capabilities in order to give maximum benefit to themselves and to patients as well as maximum cost savings to the health care industry. The high number of locums working within the NHS could cause problems. It is important that locums are able to use the system even if they are only in a particular hospital or clinic for a relatively short time.
To be effective, it is essential that the implementation of electronic prescribing is a national initiative rather than one differing in various primary care groups, trusts, hospitals, departments or community pharmacies. Pharmed has undertaken an electronic prescribing trial with a four-partner general practitioner practice and is looking to launch a national pilot in accordance with NHS guidelines once NHS approval has been obtained. The European Committee for Standardisation has been set up with European Union funding in order to establish a common European standard for electronic health care.4
Electronic prescriptions have been sent for several years in Denmark and now more than 35 per cent of prescriptions are sent electronically. The Danish Pharmacy Association has shown that the number of employees in all Danish pharmacies decreased by 6.3 per cent in 1996 and 1997.22 As electronic communication saves time, it could be assumed that this is related to the decrease in staff required. However, this can be looked on in a more positive way by saying that, here in the UK, once doctors and pharmacists are trained in electronic communication, the time saved can be used more effectively by them in other ways to improve the health care of patients.
There is the possibility that the computer system may crash so the maintenance of a hard copy of all information will be essential. Users may experience network failures or inability to contact an internet service provider. The cost of maintenance, upgrading and IT support also needs to be considered.
At first pharmacists are likely to want to verify the legitimacy of transmissions. This will take time although it is debatable if this will be significant when compared as a whole with the system currently in place.
Many people are not confident about the security of information on computers and the internet, and would be concerned about having their personal health details transferred electronically. Confidence is further undermined by highly publicised security breaches, such as that uncovered in 1999 on Microsoft’s hotmail system where hackers could read other people’s e-mails.28 Even the British Medical Association has said that the NHSnet is not secure without encryption and there is no guarantee of communications not being intercepted. As an illustration, when the Wirral Hospital NHS trust set up its electronic prescribing systems it encountered the problem of a nurse using a doctor’s password to prescribe illegally.29
Most professional health care workers and the courts recognise and respect the importance of patient confidentiality, including the confidentiality of patient medical records and data. Data exchange systems need to be secure to protect patient privacy.
The duty of medical confidentiality is not an absolute duty. Certain Acts and common law provide for exceptions subject to certain conditions. Examples can be found in the following acts
- Road Traffic Act 1988
- Police and Criminal Evidence Act 1984
- Public Interest Disclosure Act 1998
- Public Health (Control of Disease) Act 1984
and the following circumstances
- Disclosure to comply with a court order, eg, in the course of criminal or civil litigation
- Disclosure in the public interest, eg, serious adverse reactions to a medicine or a person suffering from a mental illness or infectious disease and who is likely to cause harm to others
- Disclosure in the overriding interest of protecting a third party, eg, a pharmacist knows the partner of someone who is mentally ill and not taking medication and is at risk of injury
Cases for breach of confidence do not reach the courts very often.30?33 In 1969, the courts identified the requirements needed for an action for breach of confidence in Coco v A. N. Clark (Engineers) Ltd.34 These are:
- The information has the necessary quality of confidence about it
- Imparting that information in circumstances importing an obligation of confidence
- Unauthorised use of that information
- Use of the information to the detriment of the party communicating it
In 1999, the courts considered these requirements again in the case of Source Informatics Limited.35 Two main issues arose in the hearing: (i) whether anonymised prescription data provided by pharmacists to the applicant (a data collecting company) with the consent of the prescribing doctor but not the patient constituted unauthorised use of confidential information, and (ii) the potential detriment to the patient if the (anonymised) information were to be used by the applicant
At first instance, Lord Latham held that the above “will result in a clear breach of confidence unless the patient gives consent… Nor is it suggested that the patient can be said to have given implied consent.”
This judgment seemed to remove the need for a claimant to show detriment as here all the information was anonymised and so surely there could not have been an invasion of privacy or of public interest to constitute detriment. This decision also meant that it would be necessary to obtain a patient’s consent before anonymised data relating to the patient’s care was used for any purpose other than that for which consent had been obtained. Therefore, there would be practical problems if the data from electronic prescriptions and electronic patient records was used by the NHS for audit, clinical governance, planning, development of treatment protocols, postmarketing surveillance, education of health professionals, etc.
These problems were avoided when the Court of Appeal overturned this decision on December 21, 1999.36 Lord Justice Simon Brown handed down the judgment which said: “The patient has no proprietorial claim to the prescription form or to the information it contains … and no right to control its use provided only and always that his privacy is not put at risk… . the confidence is not breached where the confider’s identity is protected. The patient’s privacy will have been safeguarded, not invaded. The pharmacist’s duty of confidence will not have been breached.”
Data protection and human rights
The Data Protection Act 1998 (DPA), which implements European Council Directive 95/46, means that the use of personal information such as prescription data and other health care records held on manual records as well as computers will be governed by statute. The DPA is concerned with the protection of the individual’s right to privacy. It regulates the data subject’s (eg, patient’s) rights of access to personal information held by a data controller (eg, GP, pharmacist, health care trust). The DPA also states a series of exemptions to the data subject’s rights, which benefit the data controller. The DPA will be implemented in phases.37 The relevant provisions of DPA 1998 came into effect on March 1, 2000. The DPA will not come into force in its entirety until October 24, 2007.
It seems that under the DPA patients must give informed written consent that they are aware of the precise purposes for which release or processing of their sensitive personal data is intended. The DPA contains conditions that permit the processing of sensitive personal data, for example, “the processing is necessary for medical purposes and is undertaken by a health professional or a person who, in the circumstances, owes a duty of confidentiality which is equivalent to that which would arise if that person were a health professional”.
“Medical purposes” includes preventative medicine, medical diagnosis, medical research, provision of care and treatment and the management of health care services.38 It is worth noting that the directive 95/46 did not include medical research in its definition of “medical purposes”.
“Sensitive personal data” includes personal data consisting of information as to an individual’s physical or mental health or condition.39
The “explicit consent” of the data subject (eg, patient) to the processing of the personal data is required.40 Obtaining an individual’s informed consent in writing showing a positive response from the individual would be prudent.
It should also be noted that, under the Computer Misuse Act 1990, a person is guilty of a criminal offence if he accesses any program or data held in any computer when not authorised to do so, and he knows at the time that that is the case.
By reading the judgment handed down by Lord Justice Simon Brown in the Source Informatics court of appeal case,36 it seems that the DPA and the European Council directive 95/46 will have no application to anonymised data. This is because anonymised data do not come within the definition of “personal data” stated in article 2 of the directive. It defines “personal data” as “any information relating to an identified or identifiable natural person (“data subject”). The “processing of personal data” is defined as “any operation or set of operations which is performed on personal data”.
The Human Rights Act 1998, which was given Royal assent on November 9, 1998, comes into force in the UK on October 2, 2000. Article 8 will affect the law of confidentiality as it protects the right to respect for private and family life and a person’s home and his correspondence. Medical information is likely to come within “private life”. Under article 8 there are exceptions: a public authority may interfere with the right to privacy where to do so is within the law and is necessary in a democratic society in the interests of one of a prescribed set of public interests as set out under that article.
An example would be protecting the economic well being of the country41 or the prevention of disorder or crime and the protection of health and morals.42
Draft guidance from the General Medical Council on the use of patients’ records for audit, research and combating fraud is thought to be unlawful as it contravenes the European Convention on Human Rights and the European directive on data protection.44 The GMC is currently reviewing this draft guidance.
It is important legally, therefore, that any electronic prescribing system set up must be secure to protect patient confidentiality. There is a general lack of awareness throughout the NHS at all levels of existing guidance on confidentiality and security. This will have to be improved as the use of electronic transfer of prescriptions and other health records will increase the potential for breaches of confidentiality and the law relating to it. The British Medical Association has suggested that a national body on confidentiality be established with the objectives of:
- Policing standards of confidentiality
- Auditing how standards are being met
- Regulating and monitoring the use of patient-identifiable confidential information
- Ensuring that training is provided about the legal and ethical issues surrounding confidential information
- Advising on security issues
- Overseeing training in IT throughout the NHS44
The Government’s chief medical officer asked Dame Fiona Caldicott to chair a committee to undertake a review of the uses made of patient identifiable information for non-clinical purposes, in order to determine the extent to which such flows of information were justified and protected. The Caldicott committee published its report in December, 1997, and made 16 recommendations that were accepted by Ministers.45 The report concluded that all items of information which relate to an attribute of an individual ought to be treated as potentially capable of identifying patients, to a greater or lesser extent, and should be appropriately protected to safeguard confidentiality. Recommendation 14 in the report states: “The design of new systems for electronic transfer of prescription data should incorporate the principles developed in this report.”46
The committee’s recommendations mean that, in most cases, where personal health information is used outside immediate care, the NHS number should replace the patient’s name and address. However, this provides little protection for the patient as the new NHS tracing service enables NHS staff to find out the name and address corresponding to a number and vice versa. This potentially leaves the system open to the corrupt or misinformed health care worker,47 and also the DPA would probably apply to such data since the patient is potentially identifiable.
When a prescription is transmitted electronically to a pharmacist, the doctor will not have signed it. Can such a prescription be dispensed legally?
In America, the court has considered this situation. In the first instance, the Wisconsin pharmacy examining board reasoned that, because statute (in America) does not specifically mention electronic transmissions, but rather defines a “prescription order” as simply “a written or oral order by a [physician] for a drug or device for a particular patient”, an electronic transmission is the equivalent of a written order and thus subject to the signature requirement of the statute.
This decision was appealed and the circuit court reversed, concluding with respect to statute violation that prescriptions transmitted electronically were more analogous to prescriptions ordered by telephone, which, under the statute, a physician need not sign.48 What would an English court decide in these circumstances? As the law in England and Wales stands at present, a prescription-only medicine shall not be taken to be sold or supplied in accordance with a prescription given by an appropriate practitioner unless it is signed in ink with his own name by the appropriate practitioner giving it.49
In America, 21 states allow electronic transmission of prescriptions,50 for example, North Carolina,51 Mississippi52 and Washington State.53 In some states there is no legislation addressing the issue, whereas in others there is; for example, New York State has recently enacted legislation pertaining to this area.54 Various state laws restricting medical privacy have been passed in America, but currently there are no federal laws specifically addressing the confidentiality of health care information. However, it is likely that a federal privacy law that will limit disclosure of medical information and provide for legal remedies in the event of abuse will be passed in the near future.55 Legislation is needed in English law to cover electronic prescribing issues.
European Directive 1999/93 of December 13, 1999, provides a legal framework to guarantee security of electronic signatures.56 Electronic signatures allow someone receiving data over electronic networks to determine the origin of the data and to check that the data have not been altered. The directive defines the requirements for electronic signature certificates and certification services so as to ensure minimum levels of security. It also stipulates that an electronic signature cannot be legally discriminated against solely on the grounds that it is in electronic form. If a certificate and the service provider as well as the signature product used meet a set of specific requirements, there will be an automatic assumption that any resulting electronic signatures are as legally valid as a handwritten signature.
Member states have to bring into force laws, regulations and administrative provisions necessary to comply with this directive before July 19, 2001. The directive mentions the fact that electronic signatures will be used in the public sector, giving the health system as an example. Article 3 of the directive gives member states the option to make the use of electronic signatures in the public sector subject to possible additional requirements. We shall have to wait and see how the UK Government legislates to comply with this directive and what effect it will have on the legal requirements of a prescription.
Electronic signatures use technology called public key cryptography. A user has a public key that is made available either through directories or via the web, and a private key. To send a signed and confidential message (eg, a prescription), the user (eg, a GP) encrypts it using the recipient’s public key, digitally signs it using his own private key, and then sends the encrypted massage with the electronic signature to the recipient (eg, the pharmacist). The recipient verifies the electronic signature using the public signature key of the sender (the latter is sent with the document automatically or can be retrieved from the directory). They then decrypt the document using their own private decryption key.57
There is no electronic signature as such, but a digital certificate. These are similar to a passport since they enable the identity to be verified by a recognised authority. The certificate holds certain information about the user and identifies the holder as the owner of the key, which generates an electronic signature. These digital certificates can be bought from certificate authorities such as Royal Mail and BT.
There are still risks with electronic signatures as they only show that someone had access to the token or computer on which the digital certificate and signing process was stored. They do not prove that a signed document came from the claimed sender. Companies are currently assessing other techniques (ie, biometric) for use in confirming the user’s authenticity. A survey has shown that while 76 per cent of large UK companies use the internet and 76 per cent have websites, 71 per cent of large companies in the UK do not use the internet to send confidential or sensitive information.57
According to legal opinion, the Government’s draft e-commerce Bill,58 which was published in August, 1999, would be likely to breach Article 8 of the European Convention on Human Rights Act, ie, respect for private life. This is because law enforcement authorities would be given powers to serve written notice demanding the decryption of electronic communication,59 with a two-year sentence for non-compliance and a five-year sentence for tipping off other users.60 However, in the Queen’s Speech in November, 1999, the Government surprisingly dropped all mention in its e-commerce Bill of measures to give law enforcement authorities powers to gain access to encrypted material. Instead, a separate Regulation of Investigatory Powers Bill will cover the regulation of “the interception of communications and the use of other intrusive techniques”.61
Smart cards were first developed over 22 years ago and offer a possible solution to some of the problems of security and confidentiality mentioned above. A smart card carries a patient’s health care records in an electronic memory requiring a code (held by the card owner) to be used to read the information. An authorised system will be used to read the information. When a system user (eg, doctor or pharmacist) is given the code, a card can be configured to reveal some of the information on the card, depending on the classification of the user. If attempts are made to break into a card, the card locks and becomes useless. There are also provisions if a card is lost or a code is forgotten.
Health care providers in France are already issuing smart cards, and in numerous other countries, including Canada, Germany and the UK, health care smart cards are in use in pilot or operational settings. The use of smart cards would empower patients, as the patients would be in control, if they so wished, over who else had access to their personal health records. Patients could also read them when they wanted to or when they wished to seek an independent review of their care.62
The introduction of smart cards would probably mean an initial increase in workload for GPs and or their surgery staff. Patients will request information from their GP so that it can be entered on to their smart card.63 However, patients may not support the use of smart cards, as they are likely to be seen as the introduction of identity cards.
Electronic prescribing is a daunting task, but it is an opportunity that doctors and pharmacists cannot ignore. The first British pharmacy to open for business on the internet went live on November 22, 1999. Customers can receive price quotes for private prescriptions, but at present prescription orders cannot be placed on line and no dispensing takes place until the prescription has been sent to the pharmacy.64 This is the first step in the process towards an e-pharmacy service including electronic transmission of prescriptions. The Council of the Royal Pharmaceutical Society has set standards of good professional practice for the provision of pharmaceutical services over the internet65 and these standards will be updated in the light of future developments.66
As the internet is so vast and open it has massive potential, but its weakness is that it is hard to make secure. There are many issues of security and law that need to be dealt with at a governmental and health care workforce level to ensure the successful introduction of an electronic prescribing system. The users of the system will need to be educated, not only in the IT skills required, but also and most importantly in the various laws which need to be complied with. The introduction of an electronic prescribing system needs to be a national one in order to be successful.
The benefits of electronic transfer of prescriptions and other patient health care information are too good to ignore. However, it is unlikely that patients or health care workers will accept a system that electronically transfers sensitive patient data until the security is guaranteed.
Helen Middleton is a trainee solicitor at Le Brasseur J. Tickle, London
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Citation: The Pharmaceutical Journal URI: 20002346
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