By Jo Raffaitin, MRPharmS
This article has been prepared in the Royal Pharmaceutical Society's Professional Standards Directorate to help pharmacists understand the new United Kingdom legislation relating to the supply of prescription only medicines under patient group directions. It aims to present a summary of the legal requirements as clearly and concisely as possible. Since it depends to an extent on an interpretation of the legislation, it should be noted that the only authoritative interpretation would be a decision of a court of law
A patient group direction (PGD) is a written direction relating to supply and administration, or just administration, of a prescription-only medicine (POM) to persons generally (subject to specified exclusions) and is signed by a doctor or dentist and by a pharmacist.
A PGD must not be confused with a written direction. Under Article 12 of the POM Order, supply of a POM can be made within the course of the business of a hospital in accordance with the written direction of an appropriate practitioner. Amendments made to Article 12 of the POM Order mean that a written direction must now be patient-specific. In addition, supply on the authority of a patient-specific written direction is now extended to apply to health authorities, trusts and other National Health Service bodies.
In most cases, the most appropriate clinical care will be provided on an individual basis by a specific prescriber to a specific individual patient. A PGD for the supply and/or administration of medicines should only be considered where it would offer a benefit to patient care without compromising safety in any way. This is best achieved by involving representatives of all the relevant health care professions, including the professional group expected to supply or administer medicines under the direction. A senior representative of each profession should be responsible for ensuring the suitability and competence of the professionals operating within the scheme.
Pharmacists involved with PGDs in any way must operate within all the legal requirements as well as the professional requirements of the Code of Ethics.
To be valid, a PGD must contain the following information:
The following is a list of the classes of person permitted under the Regulations to supply or administer medicines under a PGD:
PGDs fall into two main categories. The first category allows the supply of medicines by NHS bodies, including trusts and health authorities. The second circumstance where PGDs are permissible is where it is to assist a doctor or dentist providing national health services. There are different requirements for each type of PGD.
NHS bodies For the purposes of the Regulations, an NHS body means the Common Services Agency, a health authority, a special health authority, an NHS trust or a primary care trust. PGDs for the supply or administration of medicines by, or on behalf of, NHS bodies must:
A patient-specific written direction can lawfully allow the supply of a POM within the course of the business of a private hospital. However, given that the two situations under which PGDs can take place, as detailed above, are both within the context of the NHS, there is no scope as the legislation stands at present, for PGDs in the private sector.
The Medicines Control Agency has indicated that it will consider extensions to non-NHS settings in the future. At present though this may mean that many travel clinics, private hospitals and prisons will need to change their current arrangements.
Certain drugs will require special consideration before inclusion in a PGD and some are restricted by legislation.
Controlled Drugs Controlled Drugs can only be supplied and administered in accordance with the requirements of the Misuse of Drugs Regulations. There is no scope within the legislation, as it currently stands, to allow the inclusion of a Controlled Drug in a PGD. This may change in the future with regard to drugs in Schedule 4 and 5 of the Misuse of Drugs Regulations. However, discussions on this subject are at an early stage and therefore no Controlled Drug may be considered for inclusion in a PGD.
Medicines without a marketing authorisation and those used outside the terms of the SPC Medicines without a United Kingdom marketing authorisation are not considered appropriate for inclusion in a PGD. The Regulations specifically state that a medicine can only be included if it has a current UK marketing authorisation or a homoeopathic certificate of registration. Only medicines with a marketing authorisation can have guarantees of safety, quality and efficacy.
In certain, exceptional circumstances, medicines with a marketing authorisation could be used outside the summary of product characteristics. Areas for consideration might include paediatrics where no licensed version exists. National Institute for Clinical Excellence guidance should be followed to ensure that a medicine used in this way is justified. The PGD must clearly state that the product is being used outside the terms of the SPC and state the reasons why its use is necessary.
Newly licensed drugs subject to special reporting arrangements, ( "black triangle " drugs) should also only be considered in exceptional circumstances. Again good clinical practice guidelines must be followed and the PGD must clearly state the status of the product.
Antimicrobials Antimicrobial resistance is a major public health concern. The use of antibiotics in PGDs must therefore be given careful consideration. Inclusion in a PGD should only be considered where absolutely necessary and justifiable and where measures to combat resistance will not be compromised. Any PGDs involving antibiotics should be audited regularly.
The legislation for PGDs provides for exemptions from Section 52 and 53 of the Medicines Act 1968. This therefore allows the supply of a pharmacy (P) or general sale list (GSL) medicine under a PGD. It is important to remember that all the requirements for a valid PGD, as detailed above, must be adhered to. Only named individuals who belong to one of the classes of persons specified in Section 2 can supply or administer a P or GSL under a PGD.
It is essential that due consideration is given to the arrangements for supply, security and storage of all medicines. NHS guidance for England has indicated that all medicines should be supplied in pre-packs made up by a pharmacist. However, pharmacists asked to supply pre-packs in this manner must be sure to check with the MCA that they have the appropriate licences to allow them to do so. It may be necessary for supplies to be made from regional licensed repackaging centres.
The NHS Executive has produced a document, "Controls assurance standard: medicines management (safe and secure handling) ", that provides guidance on the legislation and best practice that should be followed with regard to the handling of medicines.
Proper audit trails should be in place. This would involve a secure system for the recording of medicines use under the PGD. It would include the reconciliation of receipts and supplies of medicines on an individual patient by patient basis. From this it should be possible to identify what patient has had which medicine. The names of the health professionals providing treatment should also be recorded.
The European Union labelling and leaflet directive (92/27/EEC) was incorporated into UK law in 1994 and, among other provisions, it is now a legal requirement that the manufacturer's patient information leaflet (PIL) is provided each time a medicine is supplied. However, it is not a legal requirement to put a product's batch number and expiry date on a dispensed medicinal product. The particulars required are in Paragraph 3 of Schedule 5 of the Medicines For Human Use (Marketing Authorisations Etc) Regulations 1994 (SI 1994 No 3144). These requirements will apply equally to medicines supplied under PGDs. These requirements are also reproduced in ‘Medicines, ethics and practice: a guide for pharmacists'.
It is essential that pharmacists involved in PGDs in any way have adequate indemnity insurance to cover the tasks they are undertaking. This applies equally to pharmacists involved in the drawing up of PGDs, those responsible for signing them and those responsible for supplies made under a PGD.
| Extra support Although the issues surrounding PGDs are complex, the new legislation provides an opportunity for extending pharmacists’ roles. Some pharmacists will be responsible for drawing up and signing PGDs and named individual pharmacists will supply and/or administer POMs under PGDs. To support pharmacists involved, the Society has set up a working group to identify opportunities for the profession to supply medicines under PGDs and to prepare information, advice and standards to support pharmacists in developing and using PGDs. To this end, the working group is producing a resource pack for pharmacists involved in PGDs. The pack will include this article, in the form of a fact sheet, relevant NHS guidance, professional standards, audit tools, model PGDs for primary and secondary care settings, suggested fields for PGDs and a standard template. It is hoped that the resource pack will be available in the new year. |