CLINICAL PROTOCOL FOR THE DEVELOPMENT AND IMPLEMENTATION OF PATIENT GROUP DIRECTIONS (PGD) DEFINITION A Patient Group Direction (PGD) is a specific written instruction for the supply and administration of a named medicine to a group of patients in an identified clinical situation. The majority of clinical care should be provided on an individual, patient specific basis. The supply and administration of medicines under PGD must therefore be reserved for those limited situations where they offer advantages for patient care without compromising patient safety. TARGET GROUP All health professionals employed by the Trust who are required to supply or administer medicines using PGDs as part of their role. TRAINING All staff in the Trust are required to comply with the Trust s Training Matrix which specifies mandatory training; in addition clinical staff are required to comply with their service level training matrix which outlines the training and competencies required for their specific role. A senior health professional within each service utilising PGDs is responsible for ensuring only qualified competent professionals use each PGD. Health professionals delivering care authorised by PGDs must be able to demonstrate to their senior colleague; an understanding of working within the limitations of the PGD, an understanding of the clinical condition(s) treated via the PGD and knowledge of the medicines authorised by the PGD. 1/6
LEGAL FRAMEWORK FOR PGD The current legislation for PGDs is outlined within The Human Medicines Regulations 2012. This legislation was amended in April 2013 to reflect changes in the NHS organisational structures in England. The original legislation establishing PGDs was Health Service Circular 2000/026 Healthcare organisations need to ensure that any current or new patient group directions comply with the legal requirements and guidance set out in the current regulations. Failure to comply with the legal requirements could result in a criminal prosecution under the Medicines Act. PEER REVIEW FOR PGDs The Trust s Group will oversee the development and updates of all PGDs. To ensure consistency in format there is a standard PGD layout for use within the Trust. All PGDs are updated after 3 years or earlier if clinical evidence based practice indicates a need for an earlier update The specialist lead in the service responsible for supporting updating the PGD must comply with the agreed time scales for the updating process If a PGD is not updated with the agreed time frame, this would need to be recorded on the service at risk register and an action put in place for its timely update PGD SAFETY CONCERNS Safety concerns must be a priority, notably: Security, storage and labelling arrangements must be in place for any medicine administered or issued via a PGD. Medicines supplied and taken away by the patient for self administration or administration by a carer must be labelled. In the majority of cases the medicine must be overlabelled by a licensed unit. In the case of oral contraceptives, original manufacturer s packs with dosing instructions can be supplied where the service adds the patient s name and date of supply. All medicines issued by PGDs should be labelled with the address of the supplying clinic. There must be secure recording and monitoring systems so that in-coming and outgoing stock may be reconciled on a patient-by-patient basis. Names of those providing treatment, patient identifiers and medicines provided must all be recorded. 2/6
Provision must comply with; section 20 regulations of the Health and Social Care Act 2008. and European Community Labelling and Leaflet directive 92/27. Medicine use must be consistent with their Summary of Product Characteristics and any relevant NHS guidance. DEVELOPING NEW PGDS WITHIN THE TRUST Approval from the Service Lead or Divisional Manager and the Trust s Medicines Management Group is needed before developing new PGDs. There must be an identified budget to meet costs of new PGDs. If there is no identified budget this should be discussed with the Director of Development prior to any further development taking place. Storage of medicines must comply with Trust Policy and section 20 regulations of the Health and Social Care Act 2008. Clinical expertise for developing PGDs will come from the service developing the PGD in partnership with a Trust Pharmacist. WHO CAN ADMINISTER FROM A PGD IN THE TRUST The qualified practitioners who may supply or administer medicines under a Patient Group Direction are Nurses, Midwives, Health Visitors, Optometrists, Pharmacists, Podiatrists, Physiotherapists, Dental Hygienists and Dental Therapists. They can only do so as named individuals. REQUIRED SIGNATURES FOR THE TRUST The Patient Group Directions must be signed by:- A senior trust pharmacist A senior doctor (or, if appropriate a dentist) A senior representative of the professional group expected to supply or administer medicines under the PGD (All of whom should have been involved in developing the direction.) Head of Nursing, Quality and Governance Responsibility for signing PGDs can be delegated e.g. in cases of prolonged absence SIGNATURES OF QUALIFIED PRACTITIONERS The individual qualified practitioners who are to follow the PGDs must sign to agree to comply with the PGD. In addition the signature of each individual practitioner must be countersigned by their line manager to confirm that the practitioner is fully competent, qualified and trained to 3/6
operate within the PGD. A copy of this must also be kept on file by the line manger. Overall responsibility for signatures of staff remains with the Service Lead or Divisional Manager. ANTIBIOTICS Particular caution must be exercised in any decision to draw up Patient Group Directions relating to antibiotics. A Wirral University Teaching Hospital Consultant Microbiologist must be involved in drawing up any such direction and the Trust Group must ensure that such directions are consistent with local policies and subject to regular review. WHAT CANNOT BE INCLUDED IN A PATIENT GROUP DIRECTION The following should not normally be included in a Patient Group Direction:- New drugs under intensive monitoring and subject to special adverse reaction reporting requirements [Black Triangle Scheme]. (except when such use is supported by national NHS guidance such as the Joint Committee on Vaccination and Immunisation) Medicines used outside their licensed indications (except when such use is supported by best clinical practice, e.g. NICE Guidance.) The following should never be included in a Patient Group Direction Medicines being used in clinical trials. Unlicensed medicines. MINIMUM CONTENTS OF A PATIENT GROUP DIRECTION The law specifies that each Patient Group Direction must contain the following: A description of the medicine(s) to which the direction applies. The clinical condition or situation to which the direction applies. A description of those patients included and those excluded from treatment under the direction. A description of the circumstances in which further advice should be sought from a doctor (or dentist, as appropriate) and arrangements for referral. Details of appropriate dosage and maximum total dosage, quantity, pharmaceutical form and strength, route and frequency of administration, and minimum or maximum period over which the medicine should be administered. Details of any necessary follow-up action and the circumstances. Relevant warnings, including potential adverse reactions. The date the direction comes into force and the date it expires. Class of health professional who may supply or administer the medicine. Signature of a doctor or dentist, as appropriate, and a pharmacist. Signature of the Trust s Clinical Governance lead. A statement of the records to be kept for audit purposes. Patient Group Directions should be reviewed at least every three years. 4/6
Further guidance is contained in The Human Medicines Regulations 2012 (Amended April 2013) UPDATING AND STORAGE OF PGDS PGDs are held electronically by the. The original signed copies are also held as controlled stationery. All PGDs are updated after 3 years or earlier if clinical evidence based practice indicates a need for an earlier update. Any changes require a reference source or rationale for change. Allow time to obtain necessary signatures to ensure PGD is valid and adheres to Department of Health guidance. Plan for practitioners signatures to be obtained for all those authorised to use the PGD, and for the signatures to be appropriately countersigned, keeping a copy on file. Paper/electronic copies of outdated PGDs must be kept on file for eight years, PGDs relating to children must be kept for 25 years, document control will be managed by the. HEALTH RECORDS Health records must be consistent with the Trust Health Records Policy and service procedures where appropriate It is essential that practitioners have a copy of the PGD to refer to when supplying or administering medication, this will ensure the practitioner will be able to check that all the conditions of the PGD are fully met for that individual. INCIDENT REPORTING Clinical incidents or near misses relating to this protocol must be reported using the Trust Incident Reporting System. EQUALITY ASSESSMENT During the development of this protocol the Trust has considered the clinical needs of each protected characteristic (age, disability, gender, gender reassignment, pregnancy and maternity, race, religion or belief, sexual orientation). There is no evidence of exclusion of these named groups. If staff become aware of any clinical exclusions that impact on the delivery of care, the incident must be reported using the Trust Incident Reporting System and an appropriate action plan put in place. REFERENCES NICE Guidance MPG2 Patient Group Directions August 2013 5/6
European Community Labelling and Leaflet directive 92/27 Health and Social Care Act 2008. Health Service Circular 2000/026 Patient Group Directions (England only) CONTROL RECORD Title Clinical Protocol for the Development and Implementation of Patient Group Directions (PGD) Purpose The purpose of this clinical protocol is to support health professionals when developing, supplying or administering medicines via a PGD Author (QGS) Equality Assessment Integrated into protocol Yes No Subject Experts Lisa Knight Medicines Governance Pharmacist Document Librarian QGS Groups consulted with :- Group Infection Control Approved Not applicable Date formally approved by March 2015 Quality, Patient Experience and Risk Group Method of distribution Email Intranet Archived Date: Location: S Drive QGS Access Via QGS VERSION CONTROL RECORD Version Number Author Status Changes / Comments Version 1 Lisa Knight Annie Baker N To ensure support for all health Professionals who supply or administer medicines via a PGD Version 2 Lisa Knight R To reinforce the need for signatures of individual practitioners to be countersigned Version 3 Lisa Knight R To incorporate NICE guidance on PGDs Status New / Revised / Trust Change 6/6