PGD CHECKLIST FOR DIRECTORATE CLINICAL GOVERNANCE COMMITTEES

Transcription

1 The purpose of the Trust Patient Group Direction (PGD) Protocol is to ensure compliance with PGD legislation and NICE Medicines Practice Guidelines (MPG2) PGDs 2013 recommendations for the systems and processes used when considering the need for, developing, authorising, using and updating Patient Group Directions (PGDs). The Trust must provide the majority of clinical care involving supplying and/or administering medicines on an individual, patient-specific basis. This tool should be used in conjunction with the Trust PGD Protocol and supports monitoring both governance arrangements and use of PGDs at directorate level, with the aim of ensuring patients receive safe and appropriate care and timely access to medicines, in line with legislation. Checklist outcomes: o To ensure that PGDs are only used in the limited situations in which this offers an advantage for patient care. o To ensure that PGDs deliver effective patient care that is appropriate in a pre-defined clinical situation, without compromising patient safety. o To ensure compliance with NICE Medicines Practice Guidelines (MPG2) PGDs 2013 recommendations The Trust PGD Protocol Appendix 3 states that the Directorate Clinical Governance Committee should establish and manage a structured PGD work programme for ensuring adherence to the PGD Protocol. Not all Directorates use (or would be expected to use) PGDs within their services but discussions may arise. Any discussions within services regarding the feasibility or potential use of PGDs should be captured by the committee and any outcomes noted. Measures and resource required will depend on number of PGDs in the directorate. Some directorates may have several services using PGDs (e.g. community /GRIDA). Service leads must provide the clinical governance committee with the relevant documentation in order to monitor proposals, submissions and PGDs in practice within their service. Committees may consider the frequency of any agenda items below based on PGD workload and activity within the directorate. Where several PGDs are in practice, at minimum there should be monitoring on a bi-monthly basis. DTC may request updates from Clinical Governance committees on a periodic basis. Page 1 of 8 PGD checklist for clinical governance committees. Version 1 March 2016

2 Is there a named committee responsible for keeping an up to date list of all PGD activity in the Directorate? Is there a named committee member who is responsible for keeping an up to date list of all PGD activity in the Directorate? Is there a named committee member who is responsible for ensuring that PGDs are a regular agenda item? Has the committee ensured that any PGD proposals are agreed and correctly completed prior to submission to DTC? A local clinical governance committee should be responsible for monitoring PGD activity in the Directorate. Named person should keep list of PGDs for each service with approval reference/expiry and review dates/notes on current status/name of service lead. If there is one or more PGDs or one or more PGD proposals in the directorate, this must be an agenda item. PGD proposal forms are a checklist and they must be supported by feasibility discussions to ensure that PGD use will be legal and appropriate. Page 2 of 8 PGD checklist for clinical governance committees. Version 1 March 2016

3 For PGD proposals, can standards for safe administration be met if the medicine is supplied and/or administered under the PGD? For PGD proposals, can standards for safe supply and storage be met if the medicine is supplied and/or administered under the PGD? Have any PGD proposals submitted to DTC been returned to author without approval i.e. rejected? Medicines Policy and Codes of Practice standards apply and PGD proposal discussions must ensure standards can be met. Medicines Policy and Codes of Practice standards apply and PGD proposal discussions must ensure standards can be met. Standard = no If DTC has rejected a proposal, this means there are concerns that a PGD is not legal or appropriate. Clinical governance committees should be aware of this rejection and ensure steps are taken to investigate any concerns/withdraw or re-submit the proposal. Page 3 of 8 PGD checklist for clinical governance committees. Version 1 March 2016

4 For PGD proposals are adequate resources, such as finance, training, medicines procurement and diagnostic equipment available? For every PGD which is reviewed or developed, has the committee received a PGD checklist which has been correctly completed by the lead author? Is progress of PGDs in development or under review recorded and monitored? Whilst a PGD may have been agreed as an appropriate option, there needs to be adequate resource to write the PGD and put the PGD into practice. This may need additional finance for medicines procurement for over-labelled packs. Lead author should complete a checklist to demonstrate that they have followed due process and to ensure that all legal requirements have been met. This includes progress prior to submission and also progress after submission via WaFR. Note status and monitor progress/ check reasons for delay. Page 4 of 8 PGD checklist for clinical governance committees. Version 1 March 2016

5 Does a PGD under review or in development consider views of all stakeholders who should be involved in the process? Do the people who are developing or reviewing a PGD have relevant knowledge and understanding of PGDs? This includes being able to write a PGD and an understanding of the legal framework. Does the committee monitor review dates and expiry dates of PGDs to ensure that PGDs remain legal and valid? Has the committee carried out a local risk assessment and have an action plan for PGDs due to expire in the next three months? Have any PGDs had an expiry date extension? E.g. the committee may want to consider whether to include more than one consultant in review of a PGD if they have an interest in the service. Antimicrobial Stewardship Committee must be consulted when a PGD is being developed for an antimicrobial. PGD e learning package is available and should be completed by new PGD authors at a minimum. Standard = no If yes, see below Page 5 of 8 PGD checklist for clinical governance committees. Version 1 March 2016

6 If answer to above question is yes, has the service provided an action plan for review and update of the PGDs? Have there been any IR1s related to any PGDs? Extensions should be exceptional and supported by an action plan to ensure that the PGD is submitted at least 3 months before extended expiry date. This should also be noted on the risk register. Standard= no If yes, an immediate review of the PGD and audit of practice should have taken place alongside any IR1 investigation. IR1 record should state the medicine was supplied/administered under PGD Page 6 of 8 PGD checklist for clinical governance committees. Version 1 March 2016

7 Have any PGDs been submitted to DTC and returned to author without approval? Standard = no Clinical governance committees should seek to understand why the PGD has been rejected. Reasons are generally because PGD does not conform to template or guidance notes or has been rejected by a clinical author. Committees should ensure steps are taken to amend the PGD to the required standard or to withdraw the submission as required. Total number compliant standards = % compliance (Total of compliant standards/18) x 100 = Page 7 of 8 PGD checklist for clinical governance committees. Version 1 March 2016

8 Page 8 of 8 PGD checklist for clinical governance committees. Version 1 March 2016