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Implementation

All PGDs must be authorised prior to implementation by the organisation which is to use them. In Scotland the local NHS Health Board process is the standard route for PGD authorisation for managed services

The process is usually linked to the ADTC. Authorisation for PGDs used by independent contractors such as GP practices and community pharmacies is usually also through their local NHS Health Board.  If any independent contractors are unsure of the process for themselves please check with the local contact listed on the website for your Health Board area.

The Scottish Prison Service Health is now managed through the local Health Boards and therefore any PGDs for the prison service should be approved through the local Health Board process and enquiries directed to the contacts for the Health Boards.

The Scottish police services in some areas are going into contractual arrangements with their local Health Board and may be using local PGDs.  Please check with your local Health Board contact.

Local approval

Following organisational authorisation, certain facts require verification where used locally. The local staff managers need to ensure staff required to use a PGD are competent to operate the PGD and that they belong to the authorised group of professionals named in the legislation. The PGD must not exceed the named expiry date at the time of administration or supply of medicines. In addition, the manager must ensure that the necessary processes are in place to support the legal framework for the use of PGDs. Individuals must be named on the PGD and which they must sign in order to supply or administer medicines under the PGD.

Safe and secure handling of medicines

In the PGD documentation reference should be made to local policies and procedures for the security, storage and labelling of medicines for use under a PGD. There is an expectation that audit processes should be in place to ensure a system of recording medicines administered or supplied under a PGD. These should identify the supply of medicine on an individual patient basis, so it is possible to identify what medicine(s) had been given to which patient, and by which named health professional. Staff must have access to Patient Information Leaflets (PIL) for the relevant medicines as it is a legal requirement for them to be available for patients who are administered or supplied medicines.

Supply

Where the medicine is to be supplied, the packs must be labelled according to the EU Labelling and Leaflet Directive 2001/83 (Ref: Dale and Appelbe's Pharmacy Law and Ethics, 8th Edition, 2005 and MHRA) by the dispensing pharmacy. The named professional supplying the medicine will add the patient name and date of supply.  The NMC Medicines Management Standards explains clearly the difference between dispensing and supply of medicines and when it is appropriate for nurses to dispense medicines.

Storage

Medicines administered or supplied under a PGD must be stored safely and securely with reference to local policies and procedures for handling and storing of medicines (Ref :The Safe and Secure Handling of Medicines: A Team Approach - A Revision of the Duthie Report (1988) led by the Hospital Pharmacists' Group of the Royal Pharmaceutical Society) . For certain medicines this will require maintenance of the cold chain, please refer to your local policy. It is good practice that these records should also be auditable.

Recording, Administration or Supply under a PGD

Safe and secure systems for recording and monitoring medicines should be in place with a process available to reconcile receipt and supply on a patient by patient basis. At a minimum the following should be recorded:

  • The date of supply or administration
  • The patient's name and address
  • Unique patient identifier (e.g. Chi number)
  • The practitioner's name and signature
  • The name, form, quantity, batch number and expiry date of the medicine supplied or administered

Audit of the supply and administration of medicines by PGDs

It is good practice that each PGD should be audited at regular intervals to check the quality of supply of medicines under the PGD.

The aims of audit are to:

  • Provide a means of monitoring performance against agreed standards
  • Ensure a specified standard, as agreed, with national and/or local policy and guidelines are reviewed
  • Identify and initiate action to rectify deficiencies surrounding the administration of medicines under the PGD
  • Aid in the continuous improvement of the service
  • Fulfil clinical governance criteria as set out by local or national organisations/committees

All PGDs have expiry dates and cannot be used beyond their expiry date.  Generally a PGD should be reviewed every two years. The PGD can be reviewed at any time prior to the expiry date and renewed by the authorising group that originally authorised the PGD.  An example of a PGD audit tool and guidance can be accessed at the following link.