The majority of health care should be carried out on a patient specific basis. When the development of a PGD is considered the developers should also take into account whether independent or supplementary prescribing would be more appropriate
There are certain exemptions from the Medicines Act 1968 (Ref: HMSO. Gov - legislation) which cover some professional groups and also cover emergency situations in order to save a life. In these cases a PGD may not be required. Please check the exemptions before developing a PGD.
A PGD is not a patient specific direction (PSD). A PSD is a
written instruction from a doctor or dentist or non-medical
prescriber for a medicine or appliance to be supplied or
administered to a named patient or to several named patients (e.g.
patients on a clinic list). (Ref:
Assessment for PGD Development
A PGD should only be developed where it will:
1 Improve access to
2 Offer an advantage to patient care without compromising patient safety
3 Reduce patient waiting times
4 Ensure the appropriate use and extension of the skills used by the various healthcare professionals detailed in the legislation
To identify if a PGD is appropriate in a particular situation follow link to To PGD or not to PGD, Scottish version.
Each Health Board in Scotland has a local process for PGD development. It is recommended prior to developing a PGD to identify the local process and contacts for the Health Board area. Some areas require a PGD development group to complete a proforma in order to obtain a PGD template. Other areas have their own website or intranet site where PGDs and the process for development and approval are explained. A general development flowchart is available (pdf).
The Development Group for a PGD must include a doctor (or dentist), a pharmacist and a health professional to which the PGD will apply. It is good practice to appoint a lead author who will ensure all required information is entered on the template and revisions are made and submit the final version for approval. Also the lead would ensure any revisions are collated, agreed and written into the PGD before a final version is submitted for approval.
The availability of local sample PGDs will help to identify the information that should be included.
Specific Product Characteristics (SPC)
It is important in a PGD that reference is made to the Specific Product Characteristics (SPC). The SPC defines the licensed indication(s), dosage(s) and administration for the use of the medicine and includes contraindications and cautions. Any cautions contained in the SPC can be added to the exclusion criteria. This does not mean the patient will not receive the medicine if any cautions apply, only that a PGD is not suitable in this instance. Advice would be sought from an appropriately trained prescriber who can assess the patient and prescribe appropriately for them.
Contra-indications should be included in the exclusion criteria of the PGD. Staff members using the PGD must screen the patients and not give the medicine in circumstances involving contra-indications. If the medicine is to be used `off-license' that is for an indication not listed in the SPC, this must be defined within the PGD. Evidence to support the use of the medicine outside the licensed indication should be available to those administering and/or supplying under the PGD, and to those authorising the PGD. Sources of evidence to support use outside the product license may be from national or local guidelines i.e. SIGN, NICE, BHS guidelines or the BNF and Children's BNF. It is important to check the SPC, which can be found on the http://www.medicines.org.uk website.
Pharmacy Only (P) and General Sales List (GSL) Medicines
Medicines legislation states that a PGD is not required to administer a P or GSL medicine. The use of a simple protocol is advisable for best practice and from a governance perspective. All medicines administered must be recorded in the patient's medical record. Where a GSL medicine is to be supplied it must be taken from lockable premises and supplied in a pre-pack which is fully labelled and meets the GSL requirements.
A PGD will be necessary for the supply of P medicines by anyone other than a registered pharmacist. Recommend further advice to be sought from a pharmacist. (Ref: http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingofmedicines/Legalstatusandreclassification/index.htm
PGDs for children
Care should be taken in developing PGDs for children as the medicines for some of these will fall outside the SPC or be 'off license'. PGDs can be developed outside the licensed indication, but evidence must be available to support this use. This evidence should be stated in the PGD. For example many children's medicines are not licensed indications but are contained in the Children's BNF, which provides recommendations for dosing in children and is evidence based.
Where PGD development is required for a medicine that may be supplied to children or adults it is good practice to have two separate PGDs, one for children and one for adults. This approach reduces the risk of giving an adult dose to a child and provides greater clarity regarding dosage and amounts to be supplied. There is also greater transparency regarding the inclusion and exclusion criteria.
When developing a PGD for an antimicrobial the advice of a microbiologist should be sought to ensure the appropriate use of antimicrobials. Each Health Board has a multidisciplinary antimicrobial management team which includes a lead Doctor and Pharmacist, a microbiologist and / or infectious disease physician, and a senior management representative (normally the Infection Control manager) (more information).
Please see the relevant Health Board link for further information as there will be different systems in place within each Health Board.
PGDs can be developed for certain controlled drugs. The legislation supports the use of PGDs for Schedule 4 Part 1 drugs (provided that it is not in a parenteral form for the treatment of addiction) and Schedule 5 drugs. Recent legislation has changed the classification of midazolam from a Schedule 4 Part 1 to a Schedule 3 drug. The legislation however, states that midazolam can continue to be supplied and administered under a PGD and is the only Schedule 3 allowed under PGD legislation.
Legislation has now been enacted enabling diamorphine and
morphine to be supplied or administered by nurses and pharmacists
under a PGD for the immediate and necessary treatment of sick or
injured persons in any setting.
Black Triangle ▼
Drugs for the first two years post licensing are marked with a `black triangle` and have special reporting of reactions and interactions. PGDs containing `black triangle` drugs should be marked to identify their status to ensure staff are aware and vigilant regarding reporting of any reactions or interactions. Examples include the current new childhood immunisation vaccines.
Authorisation of PGDs
It is recommended that the development team develop link with the PGD authorisation group within the Health Board area. This communication link will provide a degree of support through the process of submitting a PGD for approval and authorisation. The authorising group is usually linked to the local Area Drug and Therapeutics Committee (ADTC). The contacts for PGD processes within Scotland can be found in the Health Board section.
Templates for PGDs
There are a number of templates that have been developed to support staff in the development of PGDs. Please check locally before developing a PGD to ensure the correct template is used. While there are templates provided on the website, this may not be the current one in use for your area. Some templates will give advice on the content and the necessary legal requirements for a PGD. These can be found on the Health Board section.