This article is a slightly longer version of the one which appears in print, which was edited because of space restrictions
Health authorities and National Health Service trusts in England are being warned that caution is needed in drawing up patient group directions (PGDs) relating to antibiotics, recently licensed drugs subject to special reporting arrangements ("black triangle" drugs) and medicines used outside the terms of their summary of product characteristics (SPC).
The warning comes in a Health Service Circular issued to HA and trust chief executives to coincide with the introduction of legislation permitting the supply and administration of prescription-only medicines and pharmacy medicines under PGDs (PJ, August 12, p219).
So far as antibiotics are concerned, the circular says that they should be included in a PGD only where absolutely necessary and where strategies to combat increasing resistance will not be jeopardised. A microbiologist should be involved in drawing up the PGD and the local drug and therapeutics committee or area prescribing committee should ensure that the PGD is consistent with local policies and subject to regular external audit.
The guidance says that only in exceptional circumstances should a PGD include black triangle drugs or medicines used outside the terms of the SPC. Their inclusion must be justified by current best clinical practice (eg, National Institute for Clinical Effectiveness guidance) and the PGD must clearly describe the status of the product. Black triangle vaccines used in immunisation programmes may be included provided they are used in accordance with the schedules recommended by the Joint Committee on Vaccination and Immunisation.
When a product is being used outside the terms of the SPC, this must be clearly stated in the PGD, the guidance says. Documentation should include the reasons why such use is necessary exceptionally. Where the medicine is for children, particular attention will be needed to specify any restrictions on the age, size and maturity of the child.
The guidance makes the point that most clinical care should be provided on an individual, patient-specific basis. Supply and administration of medicines under PGDs should be reserved for those limited situations where this offers an advantage for patient care (without compromising patient safety), and where it is consistent with appropriate professional relationships and accountability.
In an interpretation of the new legislation, the guidance says that, as well as applying to the NHS, the legislation covers any private and voluntary sector activity funded by the NHS. It therefore cover services such as walk-in centres and NHS-funded family planning clinics as well as those provided by NHS bodies such as NHS trusts, primary care trusts, health authorities and special health authorities or by general medical or dental practices. It adds that further legislation is proposed in due course to cover other activities in the private and voluntary sectors.
Expanding on the legal requirement that a PGD must be signed by a doctor (or dentist) and a pharmacist, the guidance says that both signatories must be in senior positions and both must have been involved in developing the direction. The person best placed to authorise a PGD on behalf of a health authority or trust (or a primary care group in its capacity as a subcommittee of a health authority) would probably be the clinical governance lead, the guidance says.
The circular states that any PGD should be drawn up by a multidisciplinary group involving a doctor, a pharmacist and a representative of any professional group expected to supply medicines under the PGD. It is good practice to involve local drug and therapeutics committees, area prescribing committees and similar advisory bodies.
The guidance says that health professionals may supply or administer medicines under a patient group direction only as named individuals. A senior person in each profession should be designated with the responsibility to ensure that only fully competent, qualified and trained professionals operate within directions. All professions must act within their appropriate code of professional conduct.
Appropriate document(s) should be signed by each member of the multidisciplinary group, the clinical governance lead on behalf of the authorising NHS body and the individual health professionals working under the direction. Generally, a direction should be reviewed every two years.
There must be comprehensive arrangements for the security, storage and labelling of all medicines. Wherever possible, medicines should be supplied in pre-packs made up by a pharmacist. In particular there must be a secure system for recording and monitoring medicines use from which it should be possible to reconcile incoming stock and outgoings on a patient-by-patient basis. Names of the health professionals providing treatment, patient identifiers and medicine provided should all be recorded.
The guidance emphasises that, as well as normally being consistent with the product's SPC, the use of any medicine should conform with any relevant guidance from the National Institute for Clinical Effectiveness. Supplies must meet the requirements of the European Community's labelling and leaflet directive.
The circular includes a reminder that existing legislation prohibits the inclusion of Controlled Drugs and radiopharmaceuticals in PGDs. However, it says that the Medicines Control Agency is initiating discussion with the Home Office about a possible amendment to the Misuse of Drugs Regulations to allow the use of Schedules 4 & 5 CDs under PGDs.
The guidance adds that a website is to be developed to provide examples of model directions. The guidance itself is available on the Department of Health website (www.doh.gov.uk/coinh.htm).