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PGD Development

While all PGDs will differ they will all require to contain common components. The
following sections will look at the essential components of a PGD which require to be
considered when constructing a new PGD

PGD Development

A PGD should only be developed where it will:

  • Improve access to treatment
  • Offer an advantage to patient care without compromising patient safety

Development of PGDs

While this section is about the development of PGDs it is acknowledged that the vast majority of staff will be more involved in using PGDs rather than developing them.

Each Health Board in Scotland has a local process for PGD development. It is recommended that 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. Most Health Boards will have a standard template and if this is the case, this should be adopted by the development group to ensure all the appropriate information required within the
PGD are included.

The development group for a PGD must include a doctor (or dentist), a pharmacist and a health care 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 subit 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.

Areas to be considered when developing a PGD

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 clinically assess the patients and not give the medicine in circumstances involving contra-indications

If the medicine is to be used `off-license' that isfor 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.

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. It is recommended that further advice to be sought from a pharmacist.

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.

Antimicrobial PGDs

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).

Local Health Board regulations should be adhered to as there will be different systems in place within each Health Board.

Controlled Drugs

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 when initially licensed are marked with a `black triangle ▼` and have special
reporting of reactions and interactions. There is now no time limit on how long a medicine will be black triangle (previously 2 years). These new medicines that are under additional monitoring have the ▼symbol displayed in their package leaflet and summary of product characteristics together with a short sentence explaining what the triangle means. It does not mean that the medicine is unsafe. PGDs containing 'black triangle' drug should be marked to identify their status to ensure staff are aware and vigilant regarding reporting of any reactions or interactions.

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.

Can you locate and identify any local PGD templates available within your Health Board