The Pharmaceutical Journal
Vol 270 No 7230 p25
4 January 2003

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Pharmacist prescribing summary

Pharmacist prescribing — new rights, new responsibilities

Christopher Newdick, barrister and reader in health law at the University of Reading looks at some of the legal implications that arise from pharmacists being allowed to prescribe

New regulations will extend the rights of pharmacists to prescribe medicines to patients. In this, pharmacists will join nurses and other professionals in the Government's policy to broaden the prescribing base and make it more sensitive to patients' needs. To what extent, however, will these new rights bring new responsibilities? I discuss three aspects of the law of negligence: professional standards of care, "systems" negligence, and the nature of informed consent.

Professional standards of care

Some may say that, among the variety of new prescribers, pharmacists will be the senior partner. Given their training and experience, they will be expected to understand the nature and quality of pharmaceutical interventions in more detail and with greater subtlety. In cases of doubt, or when further advice is needed, the pharmacist may be the party whose opinion is sought first.

If pharmacist prescribers come to acquire authority in this way they should understand the basic principles of the law of negligence. First, the Bolam test of medical negligence, which was developed in 1957 for doctors, will extend to the new prescribers. The test says that a professional person is to be judged against the standards to be expected from a responsible body of his or her peers. Provided their conduct secures the approval of a responsible body, albeit a minority body, they will not be liable in negligence.

Of course, the smaller the minority, the closer the law will scrutinise the logic and reasonableness of the decision. But, at least in theory, even a majority view could be held negligent, for example, for failing to keep up to date with modern developments. And the standard expected of pharmacists will be high. Pharmacists will be expected to understand more about the general characteristics of a medicine, its profile of risks and benefits and its potential for interacting with other medicines, than many of the other new prescribers.

"Systems" negligence

Another requirement of the law of negligence concerns the adequacy of "systems" for maintaining safety. Naturally, as the number of prescribers increases, so does the risk of mixed messages, crossed wires and misunderstandings. Reasonable steps must be taken to recognise and deal with this risk. Systems must be introduced to monitor, manage and minimise the danger.

Patients may visit a number of different prescribers. Systems must exist to enable up-to-date notes to be available to each prescriber. Electronic records (provided they can be made to work) will provide a solution to this problem. Until they are available, however, prescribers should be careful to have a reasonably accurate picture of patients' needs and requirements, and a record of the medicines they are using.

When things do go wrong, new governance requirements insist that mechanisms exist to record and consider the error and the steps taken to avoid it in future. Following the Bristol inquiry, the Department of Health and the National Patient Safety Agency are committed to tracing the patterns of errors that occur in the National Health Service. It is only when we understand the aetiology of error that corrective action can be taken to minimise the same risk happening again in future. Pharmacists will be expected to play a full role in reporting and assessing the patterns of mistakes that occur.

Treatment and "informed consent"

Thirdly, negligence has also made significant changes to the law on informed consent. In a climate where human rights are paramount, patients have the right to refuse treatment for good reason, bad reason or no reason at all. Clinicians may advise patients of the choices available to them but the decision is a matter for the patient alone. So clinicians should disclose information about the risks and benefits of the proposed treatment, the consequences of doing nothing at all and, if they are available, the possibility of alternative treatments. No doubt, like doctors, pharmacists will complain about the time available to comply with these requirements. Pharmacists will also need physical space in which to protect the confidence of their discussions.

Equally, especially if a good relationship is established between doctor and prescriber, a patient is entitled to say: "I trust you to make the decision for me." In this case, patients can waive the right of informed consent and there is no need to force unwanted information upon them. On the other hand, keep a good note of the conversation in the medical records. Remember that for you the consultation may be entirely a matter of day-to-day routine which may quickly be lost from memory. But for patients, it is something out of the ordinary and more likely to be remembered.

Treating children is different. Children are competent to give their consent to treatment from the age of 16. More difficult is the "Gillick competent" child (following the litigation involving Victoria Gillick). Children develop in maturity and understanding over many years. They do not suddenly become competent at 16. Thus, for some simple procedures, children above the age of, say, 13 or 14 may be sufficiently competent to give their informed consent to treatment — without parental consent.

This means that each prescriber must assess each child's capacity to understand the particular information concerned. Serious treatment may be beyond the capacity of any child. Although such circumstances will be uncommon for pharmacists, children are never likely to understand the nature of treatment which is capable of saving their lives. If the child cannot understand the treatment, consent should normally be obtained from the child's parents.

Exceptionally, parental refusal to consent to necessary care may be overridden by the court. Parents are duty-bound to promote the child's "best interests" and there are extreme cases involving, say, Jehovah's Witness parents, where the courts have overruled such a refusal to consent. These cases are rare. However, when they arise pharmacists may need to move with great haste. They need to know whom to turn to for advice within their professional associations and, perhaps, the local authority, to enable appropriate and speedy action to be taken if required. They should have emergency telephone numbers available, just in case.

Conclusion

Unsurprisingly, new rights impose new responsibilities on the profession. These requirements are at the core of the new relationship that will arise between patients and the new prescribers.