The Pharmaceutical Journal
Vol 270 No 7230 p19-20
4 January 2003

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Pharmacist prescribing summary

Supplementary prescribing — a groundbreaking opportunity

Gul Root, principal pharmaceutical officer, public health and community services, Department of Health, looks at what supplementary prescribing will mean for pharmacists

On 21 November 2002, Lord Hunt announced new powers that will allow pharmacists and nurses in England to prescribe a wide range of drugs from early in 2003, following diagnosis by a doctor and within an individual clinical management plan. The development of supplementary prescribing has only been possible since the passing of the Health and Social Care Act in May 2001. Further regulations will be laid before Parliament early this year to enable the concept to become a clinical reality.

Supplementary prescribing is based on the recommendations in the final report of the Review of Prescribing, Supply and Administration of Medicines (Crown Report 1999). It provides a groundbreaking opportunity for the pharmacy profession as a whole to enhance its contribution to primary care. Pharmacists have long asked why, with their extensive knowledge of pharmacology and therapeutics, they have not been able to prescribe. Now hospital clinical pharmacists who have been actively involved in the care of patients for many years will be empowered to make prescribing decisions without having to refer back to the doctor every time. Supplementary prescribing will legitimise practice in NHS trusts across the country. Highly experienced pharmacists who work in areas such as intensive care, paediatrics, HIV, cancer and liver transplant units have for some considerable time advised senior doctors about the medicines to be prescribed for patients, the dose, side effects and the monitoring that may be required. Their frustrations because in effect they have been making prescribing decisions but have had to get doctors to sign prescriptions before the prescriptions can be dispensed or administered will be elimin-ated. More recently primary care pharmacists and community pharmacists have played an increasingly important role by providing prescribing advice to GPs. And pharmacists are running clinics for the management of hypertension, hyperlipidaemia, anticoagulation and ulcer healing.

Definition

The working definition of supplementary prescribing is a voluntary prescribing partnership between an independent prescriber and a supplementary prescriber, to implement an agreed patient-specific clinical management plan with the patient's agreement.

The aims of supplementary prescribing are to improve patient experience through better access to care, better quality of care and improved patient safety. Patient safety is and will remain paramount.

Key features

Amendments to the POM Order and NHS Regulations will be laid early in 2003 to enable the introduction of supplementary prescribing. These will set out the criteria for lawful supplementary prescribing, which are:

• The independent prescriber (IP) must be a doctor or dentist

• The supplementary prescriber (SP) must be a registered pharmacist, nurse or midwife

• The IP and SP must share access to the same common patient record

• There must be a written individual clinical management plan (CMP) which must be agreed by the IP and the SP and the patient

Some key principles underpin supplementary prescribing. The importance of effective communication between the independent and supplementary prescriber is fundamental, as is access to the same common patient record, and the need for patients to be involved in decision making.

The scope of supplementary prescribing

There will in effect be no legal restrictions placed on the clinical conditions for which supplementary prescribers will be able to prescribe. However, because investing some time in putting together a simple CMP is needed, it is likely that supplementary prescribing will be most useful in dealing with long-term medical conditions, such as asthma, hypertension, diabetes and some neurological diseases. It will be for the independent prescriber and supplementary prescriber to decide, in agreeing the CMP, when supplementary prescribing will be appropriate. Supplementary prescribing is unlikely to be used solely for acute conditions.

Supplementary prescribers will be able to prescribe medicines from the whole of the British National Formulary providing the medicines can be prescribed by the IP at NHS expense. This means that they will be able to prescribe the following:

• All general sales list (GSL) medicines, pharmacy medicines (P), appliances and devices, and borderline substances

• All prescription only medicines (POMs)

• Medicines for use outside licensed indications ("off-label")

• "Black triangle" drugs, drugs marked "less suitable for prescribing" in the BNF

• Unlicensed medicines but only as part of clinical trials where there is a clinical trial certificate or an exemption certificate

Supplementary prescribers will not be able to prescribe Controlled Drugs for the immediate future. Home Office legislation will need to change to allow this to happen.

Issues for pharmacists

Partnership An important principle that underlies supplementary prescribing is that the partnership between the IP and the SP is a voluntary one. Supplementary prescribing can only go forward where the IP is willing to work in partnership with and give responsibility for prescribing to the pharmacist. He or she should be willing to prescribe for the patient within the framework of the CMP and to accept clinical responsibility for those prescribing decisions. The patient has an important role within this partnership. Supplementary prescribing cannot go ahead until the patient agrees to the SP prescribing for him or her within the CMP.

Clinical management plan The prerequisite for supplementary prescribing is for a joint CMP to be developed by the IP and SP. The detail within the CMP will vary. It will depend on the professional relationship between the IP and the SP and the professional expertise of the SP. The IP will set the range of discretion consistent with patient safety, ie, the CMP can be as wide or as prescriptive as the IP wishes, as long as patient safety is not compromised. The CMP should include relevant warnings about any known sensitivities to particular medicines and include arrangements for notification of adverse drug reactions.

Review A joint formal clinical review between the IP and SP should be carried out at an agreed time — normally within at least 12 months of the initial diagnosis. In some circumstances it may be appropriate for the review to be carried out at much more frequent intervals.

Separation of prescribing and dispensing The Department of Health would normally expect separation of the prescribing and dispensing roles where this is feasible, in keeping with the principles of safety and clinical and corporate governance. However, in the context of supplementary prescribing, dispensing and prescribing need not necessarily be separated provided clear accountability arrangements are in place to assure patient safety and probity.

Contemporaneous recording Supplementary prescribers will be required to record clinically relevant facts in the patients' records as soon as possible and preferably contemporaneously. Details of the prescribing and monitoring information should be entered in the patient's notes as soon as possible after the prescription is written. This period should not exceed 48 hours, except in exceptional circumstances.

Professional accountability and clinical responsibility Being aware of one's own limitations and knowing when to refer back to the IP is an important principle of supplementary prescribing and pharmacists will need to pay careful attention to this. The Royal Pharmaceutical Society's Code of Ethics and Standards requires pharmacists to be professionally accountable for all their activities: "Pharmacists must ensure that they only accept work where they have the requisite skills and fitness for the tasks to be performed."

Although the IP will be responsible for clinically assessing the patient and making the diagnosis, the SP will take clinical responsibility for making their own prescribing decisions. It is therefore important that pharmacists do not accept responsibility for managing a condition or for prescribing medicines with which they are unfamiliar; they should prescribe only within the limits of their competence. SPs will be expected to monitor response to therapy.

Training — funding and length Funding for the direct cost of training SPs will be met from central funds allocated from the Department of Health to Workforce Development Confederations (WDCs). The WDCs will commission training probably through higher education institutes including schools of pharmacy. The first pharmacists should be in training by spring 2003.

The length of the programme has not yet been finalised but is expected to be in the region of 25 days of which a significant proportion will be face-to-face contact time plus 12 days of supervised practice. Other ways of learning such as open-learning formats will be considered. The contribution of peer support from face-to-face learning will also need to be taken into account. Nurses who undertook training for extended independent nurse prescribing found this extremely helpful.

Appropriate nominations It will be important to ensure that appropriate pharmacists are nominated. The criteria that should be used are as follows:

• There should be benefit to patients

• Benefit to local NHS services

• Pharmacists should be willing and able to undertake training

• Opportunity to prescribe in their current job

• Best value from training resources

• Employer agreement

Who will be likely candidates for supplementary prescribing? In the first instance, it is likely that the following will undertake training:

• Hospital clinical pharmacists

• Primary care pharmacists and

• Community pharmacists working closely with GPs on chronic disease management, or those doing sessional work in GP practices

Conclusion

Supplementary prescribing promises to deliver improved access to medicines for patients and to make better use of pharmacists' skills. As a supplementary prescriber a pharmacist will be able to prescribe for and monitor patients over a period of months following diagnosis by a doctor or dentist, within a clinical management plan for each patient. That will include altering the dosage or frequency of medicines, changing or adding new medicines or delivery devices, and writing all the necessary prescriptions.

Pharmacists will no longer just advise doctors about what to prescribe, or ask — and wait — for a doctor to sign prescriptions for patients. They will be able to prescribe themselves. This development is truly groundbreaking and it is vital that pharmacists seize the opportunity to enhance patient care.

Further information on supplementary prescribing is available here