Audit and Patient Group Directions Sandra Wolper Associate Director Medicines Use and Safety February 2019

Could this be a GP Practice in your CCG? Two of the PGDs, we looked at, had been signed by the practice manager. National guidance state that a PGD must be adopted in the practice by a GP. CQC Report GP Practice Published Oct 2015 23/08/2019

Could this be your Organisation? PGDs had been highlighted as a risk for the department as it had been identified that these had gone out of date. Authorisation had been given for an extension on the current PGDs and new ones were being re-written. Some had been authorised by the PGD committee and were waiting allocation and it was aimed that the remainder would be completed by September 2016. The tests for those who were using PGDs were under review and once they had been completed all eligible staff would retake them. CQC Report Urgent & Emergency Services, Acute Trust July 2016 23/08/2019

Could this be your Organisation? Staff generally followed established patient pathways and national guidance for care and treatment. However, they did not always complete pain assessments and band five nurses were not authorised to administer oral pain relief under the trust’s patient group directions (PGD). This meant patients sometimes experienced a delay in pain relief.  CQC Report Acute Trust April 2017 23/08/2019

Could this be your Organisation? In ophthalmology, a patient specific direction was developed under a patient group direction and healthcare assistants were administering eye drops. This was not in line with the medicines legislation and best practice guidance. CQC Report Acute Organisation Published Apr 2015 23/08/2019

Could this be your Organisation? The service had introduced a Patient Group Direction (PGD) for Buccal midazolam since our last inspection. However, we were unable to locate records to demonstrate that each nurse had agreed to working within the terms of the PGD. CQC Report Substance misuse and eating disorder service July 2017 23/08/2019

Could this be your Organisation? Staff in the XX town service could not produce a signed copy of patient group directions (PGD) form for staff to administer Hepatitis B vaccines. CQC Report Substance misuse service July 2016 23/08/2019

Could this be your Organisation? The service had introduced a Patient Group Direction (PGD) for Buccal midazolam since our last inspection. However, we were unable to locate records to demonstrate that each nurse had agreed to working within the terms of the PGD. July 2017 Substance misuse and eating disorder service 23/08/2019

What could you audit? Clinical governance and audit surrounding PGD use are local responsibilities. Think about specific PGDs, specific medicines, economics of a service think about different types of records & available information What areas of possible audit might be of a high priority? Three main aspects could be considered. Organisational is there a policy what does it cover legal compliance review / audit Central registers etc. Authorship competencies process. Individual clinician audit compliance 23/08/2019

Group Activity Individual Service Organisation Audit Offers 23/08/2019

Discussion 23/08/2019

Individual (1) Is the audit in real time or retrospective ? Is the PGD the most recent, approved and in date? Is the individual authorised? (professional registration) Is clinical knowledge current / PGD within scope of practice? Have they demonstrated competency/attended required training? Have appropriate competencies been assessed and recorded? Is the PGD the most recent, approved and in date? Is the individual authorised? (professional registration) Is clinical knowledge current / PGD within scope of practice? Have they demonstrated competency/attended required training? Have appropriate competencies been assessed and recorded? Do they know how to refer to relevant resources for more information? (Do they have access?) 23/08/2019

Individual (2) Has the patient been treated correctly under the PGD? (E.g. adherence to inclusions/exclusions/referral criteria/correct dosage calculations.) Is any observing of practice undertaken? Are they fulfilling all required steps (including issuing PIL/obtaining consent) Do they know how and where to refer to relevant resources for more information? Have the treated the patient correctly under the PGD? E.g. adherence to inclusions/exclusions/referral criteria/correct dosage calculations. How is this reviewed? (retrospectively or in real time) Any observing of practice undertaken? Are they fulfilling all required steps (including issuing PIL/consent 23/08/2019

Individual (3) Is record keeping in line with requirements? Are supporting SOPs/procedures followed? Are storage requirements adhered to? Is there evidence of delegation? Is there any patient feedback? Career / service development consider NMP training Is record keeping in line with requirements? Are supporting SOPs/procedures followed (e.g. prescription charges) ? Are storage requirements adhered to? Is there evidence of delegation ? Is there any patient feedback? 23/08/2019

Service (1) Is the PGD the most recent, approved in date accessible ? Are all the individuals authorised? (professional registration) How many individuals are authorised? Are lists of authorised staff maintained and if so who by? Does service review and maintain training and competency requirements? Are there prescribers in the service or planned? Benchmark with other services Is there an accessible/in date copy on site? Is this paper or electronic? If paper is it correct version? 23/08/2019

Service (2) How many times has PGD been used? Is PGD still required/ relevant? Are there any PGD related risks on the register? Have there been any PGD related incidents? Are correct appropriately labelled products available? Is storage monitored and correct conditions maintained? Is there product awareness?(varying brands/generics,). Is there an accessible/in date copy on site? Is this paper or electronic? If paper is it correct version? How many times was the PGD used? Low usage may indicate it is not needed or not meeting the needs of the client group. Is there any practice which may be outside of the law of guidance? E.g. delegation/supervision of trainees? Is there anything on the risk register to indicate problems with practice under PGDs? 23/08/2019

Service (3) Are supporting SOPs/protocols in place (valid), accessible and being used? Is there a clear consent policy? Is the service managing prescription charges if required? Do staff have access to supporting resources which are in date? (e.g. BNF) Observation of practice Is there an accessible/in date copy on site? Is this paper or electronic? If paper is it correct version? How many times was the PGD used? Low usage may indicate it is not needed or not meeting the needs of the client group. Is there any practice which may be outside of the law of guidance? E.g. delegation/supervision of trainees? Is there anything on the risk register to indicate problems with practice under PGDs? Observation of practice ensure no delegation or supervision within law 23/08/2019

Organisation (1) Is there a PGD policy? (Does it reflect most recent guidance and legislation) Are there PGD working groups (with terms of reference defined responsibilities, minutes etc.) Are PGDs processes being followed and working efficiently? Is there a register of all PGDs authorised and in date? Are PGDs owned reviewed audited and still required? Is there a PGD policy? Does it reflect most recent guidance and legislation 23/08/2019

Organisation (2) Is there an audit process timetable? Are there any PGD related risks on the register? How many times has PGD been used? Is PGD still required/ relevant? Have there been any PGD related incidents? Are there any commissioned or subcontracted services? Is training provided and competencies assessed? Is 23/08/2019

Useful Links NICE baseline assessment tool https://www.nice.org.uk/guidance/mpg2/resources SPS website PGD Audit tool examples https://www.sps.nhs.uk/?s=&cat[]=4&cat[]=3238&cat[]=8 HQIP Quality improvement methods tools http://www.hqip.org.uk/public/cms/253/625/19/38/Guide-to-quality-improvement-methods-2015-7-1.pdf?realName=3hoUed.pdf 23/08/2019