There are provisions in the Human Medicines Regulations 2012 that can be used in a pandemic, unfortunately none of them specifically involve PGDs. At this point in time we do not expect that the legislation relating to PGDs will be changed during a pandemic.
Organisations will need to consider local governance arrangements and perform local risk assessments if there is any divergence from their usual PGD related processes during a pandemic to ensure that PGD use remains within the legislation and that patient safety is protected.
This document summarises and links to resources which may support organisations using PGDs during a pandemic.
|If changes are made to a PGD does it need re-authorising and re-signing?||All amendments made to a PGD, including minor ones require a PGD to be reauthorised. Even where review of a PGD results in no changes it must still be reauthorised and re-dated accordingly. Reauthorising requires the agreement of, and resigning by, the development signatories (i.e. the doctor/dentist, pharmacist and member of professional group using the PGD) and the signatory responsible for authorising PGDs on behalf of the organisation. The process for review and reauthorisation should be described in the local PGD policy and procedure and the process should be supported by the organisation’s multidisciplinary PGD working group or local equivalent. Local arrangements should be in place to ensure that all healthcare professionals working under a PGD are made aware of any changes made and when a new version is released and that they are reauthorised to operate under the updated version. Any changes to a local PGD authorisation process must be locally risk assessed and documented through
the organisation’s usual governance procedure. See full supporting advice at link to the left
|Patient Group Direction (PGD) use in remote consultations||The legal framework for PGDs does not state the patient must be present for a supply of a medicine to be made. Therefore remote consultation prior to making a supply under a PGD is permissible and a supply can also be made in the absence of the patient. Where remote consultation is undertaken and supply is made without the patient being present
organisations are encouraged to have relevant governance and operating procedures for such practice in place.
See full supporting advice at link to the left.
|Can bank and agency staff operate under an organisation’s Patient Group Directions (PGDs)?||Organisations who utilise bank or agency staff may consider allowing these staff members to operate under PGDs to maintain service provision. Whilst there is nothing in PGD legislation that would prevent agency or bank nurses from being authorised to use PGDs there are governance issues which need to be considered.
See full supporting advice at link to the left.
|Can a PGD be used to supply and/or administer medicines to patients in their own homes or in more than one location?||A PGD need not to relate to specific premises. If no specific location for use has been specified on the PGD the supply or administration could take place at a variety of locations including a patient’s home, a surgery or health centre, a pharmacy or an Urgent Care Centre. However, if a PGD does specify the location of use (i.e. Administration of lidocaine 1% injection within the Minor Injuries Unit’) then this PGD can only be used within this setting. It could, however, be changed, reauthorised and re-signed as detailed above. See full supporting advice at link to the left.|
|When Patient Group Directions (PGDs) are not required. Guidance on when PGDs should not be used and advice on alternative mechanisms for supply and administration of medicines||This guidance is designed to assist organisations in identifying when a Patient Group Direction (PGD) is not required and should not be used. It describes alternative mechanisms which can be used to administer and supply medicines. See full supporting advice at link to the left.Template protocols have been developed for self-administration of GSL medications which can be locally adapted/adopted by organisations. These templates can be found using the link to the left.|
|Medicines Shortages and Patient Group Directions||Medicine Shortages can occur for many reasons including manufacturing and quality control problems, delays in supply chains and discontinuations. Where a medicine supplied and/or administered under a PGD is subject to an interruption in supply a
review of the PGD may be required. This Q&A provides support on the use of PGDs during a medication shortage. See full supporting advice at link to the left
|Is extension of an expiry date of a PGD allowed without review and re-authorisation of the PGD?||This Q&A details the guidance on PGD expiry dates and the recommended process to be followed if an expiry date extension is being considered.|
|Questions about electronic systems and PGDs||This Q&A supports organisations in using electronic systems to develop, approve and authorise PGDs and to authorise individual practitioners to work under PGDs.|
|To PGD or not to PGD? – that is the question||This tool “To PGD or not to PGD” is intended to be the first stage in the process to help colleagues consider whether a PGD is appropriate. The aim of this tool is to ensure that patients receive safe and appropriate care and timely access to medicines, in line with legislation. See full supporting advice at link to the left|
National PGDs and template PGDs have been developed for some services including reproductive health and ambulance trusts.
See links at Medicines Governance Do Once Programme for further information.