New Medicines Act legislation effective throughout the United Kingdom from August 9 paves the way for the supply and administration of prescription-only medicines (POMs) and pharmacy (P) medicines by designated health care professionals under patient group directions. Among other things, it specifies that a pharmacist must be one of the signatories of any patient group direction. Guidance on patient group directions for the National Health Service in England was expected to be issued in the form of a Health Service Circular on August 10 (after The Journal had gone to press). The new legislation takes the form of amendments to the Prescription Only Medicines (Human Use) Order 1997 and the Medicines (Pharmacy and General Sale - Exemption) Order 1980. Between them the amending Orders allow the supply of both POMs and P medicines by specified NHS bodies for administration by a designated health professional in accordance with a patient group direction, subject to certain conditions.

Midwives, nurses, pharmacists and other health care professionals will be able to administer and supply medicines under patient group directions

A patient group direction is defined as a written direction, signed by a doctor or dentist and by a pharmacist, relating to supply and administration, or administration only, of a prescription-only medicine or pharmacy medicine to persons generally, subject to any exclusions that may be set out in the direction.
Both amending Orders also allow the supply of medicines by specified NHS bodies, or by designated health professionals in arrangement with such a body, where the product is supplied for the purpose of being administered in accordance with the patient specific directions of a doctor or dentist.
The NHS bodies to which the legislation applies are listed as health authorities, special health authorities, NHS trusts, primary care trusts and the Common Services Agency for the Scottish Health Service. "Health authority" is interpreted as including health boards in Scotland and health and social services boards in Northern Ireland in addition to health authorities in England and Wales. "Special health authority" has an equivalent interpretation for Scotland and Northern Ireland. "NHS trust" is interpreted as including health and social services trusts in Northern Ireland as well as NHS trusts in England, Wales and Scotland.
The conditions for supply or administration by an NHS body are: that the patient group direction must be in effect at the time of supply or administration; that the direction contains specified particulars (see panel below); that the direction is signed on behalf of the "authorising person"; that the individual who supplies or administers the medicine belongs to one of the designated health professions and is designated in writing, on behalf of the authorising person, for the purpose of the supply or administration of medicines under the direction; and that the medicine is a licensed medicinal product or a registered homoeopathic preparation.
Similar conditions apply to supply or administration under a patient group direction to assist one or more doctors or dentists in providing NHS primary care service. In this case, the direction must be signed by the doctor or dentist in question and on behalf of the relevant health authority, and the health professional must be designated in writing by the doctor or dentist. (Where the direction relates to more than one doctor or dentist, then any of the doctors or dentists may sign the direction or designation.)
The particulars to be included in a patient group direction are set out in a new schedule added to each of the principal Orders. The schedule also specifies who may sign a patient group direction on behalf of an NHS body and lists the classes of health professional eligible to supply and administer medicines under direction. As well as pharmacists, the designated health professionals are health visitors, midwives, nurses, ophthalmic opticians, chiropodists, orthoptists, physiotherapists, radiographers and paramedics, provided such person are appropriately registered or certificated.
The two amending Orders are accompanied by a necessary amendment to the Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1980. This allows wholesalers to supply POMs and P medicines to health authorities, special health authorities and primary care trusts and to those who supply or administer medicines by arrangement with a health authority, a special health authority, an NHS trust, a primary care trust or the Common Services Agency.

The Prescription Only Medicines (Human Use) Amendment Order 2000, SI 2000 No 1917. Stationery Office, price £2.50.
The Medicines (Sale or Supply) (Miscellaneous Provisions) Amendment (No 2) Regulations 2000, SI 2000 No 1918. Stationery Office, price £1.50.
The Medicines (Pharmacy and General Sale - Exemption) Amendment Order 2000, SI 2000 No 1919. Stationery Office, price £2.

Essential particulars of a patient group direction

The particulars to be included in a patient group direction are as follows:

• The period during which the direction shall have effect
• The description or class of medicine to which the direction relates
• Details of any restrictions on the quantity of medicine which may be supplied on any one occasion
• The clinical situations which the medicine may be used to treat
• The clinical criteria under which a person shall be eligible for treatment
• Details of any class of person excluded from treatment under the direction
• Details of any circumstances in which further advice should be sought from a doctor or dentist
• The pharmaceutical form(s) in which the medicine is to be administered
• The strength, or maximum strength, at which the medicine is to be administered
• The applicable dosage or maximum dosage
• The route of administration
• The frequency of administration
• Any minimum or maximum period of administration
• Any relevant warnings
• Details of any follow-up action and the circumstances in which it is to be taken
• Arrangements for referral for medical advice
• Details of the records to be kept of the supply or administration of medicines under the direction