PGD Flashcards
what is Patient group direction (PGD)?
Written instructions for the supply or administration of medicines to a pre-defined group of patients who may not be individually identified before presentation for treatment
By named, authorised, registered health professionals
Using a PGD is not a form of prescribing.
The PGD guides the registered health professional in assessing the patients’ suitability for a specific drug without reference to an independent prescriber
Different to a patient specific direction (PSD) e.g in-patient drug chart or NHS prescription
what is the use of PGD?
-In general, the majority of clinical care should be provided on an individual, patient-specific basis
-PGDs may be appropriate in situations when using it offers an advantage for patient care without compromising patient safety
-PGDs are useful when:
-medicines use follows a predictable pattern
-patients seek unscheduled care
-supplying or administering a medicine for a discrete treatment episode
-there is a homogeneous patient group
what is the legal framework for PGD?
Legislation for PGDs is included in the Human Medicines Regulations 2012
Legislation for the labelling of medicines applies to all supplies of medicines, including those supplied under PGDs
A manufacturer’s patient information leaflet must be provided to patients who have a medicine supplied under a PGD. This is not required by legislation when a medicine is administered
Legislation relating to NHS prescription charges and exemptions (including pandemic influenza exemptions) also applies to patients receiving a supply of medicine(s) under a PGD from the NHS
NHS prescription charges do not apply when medicines are administered under a PGD, or where a person is exempt for paying NHS prescription charges
what is the process of setting up and authorising a PGD
1)Consider the need for a PGD. Is it necessary to have one?
2)Obtain the agreement of the authorising body before proceeding to develop a PGD.
3)Also identify the appropriate person who can sign the PGD on behalf of the authorising body
Authorising bodies include:
NHS bodies: CCG, NHS Commissioning Boards (NHS England), hospital trusts/foundation trusts, local authorities, special health authorities
Non-NHS bodies: Independent medical agencies, independent hospitals & clinics, police force etc
4)Construct the proposal document for seeking agreement, and ensure it has all the information necessary i.e
title of PGD, details of people involved in developing and authorising, the setting where the PGD will be used, condition treated, benefits and risks, details of medicine supplied and/or administered, health professional groups working under PGD, evidence, resources…
5)At an early stage, identify the appropriate senior doctor (or dentist), senior pharmacist (if not you) who will sign the PGD, or representative of the professional group(s) practising under the PGD
6)Ensure PGDs are consistent with the relevant summary of product characteristics (SPC)
7) A PGD must be:
Signed on behalf of the authorising body
Signed by a doctor (or, if appropriate, a dentist)
Signed by a pharmacist
Both a pharmacist and a doctor (or dentist) must have been involved in developing the PGD
When acting as a signatory, establish that the clinical and pharmaceutical content is accurate and supported by the best available evidence
what info needs to be in PGD?
- the name of the business to which the direction applies
-the date the directions come into force and the date it expires
Description of the medicines to which the directions apply
-class of health professional who may supply or administer the medicine
-signature of doctor or dentist as appropriate and pharmacist
-signature by the appropriate organisation
-the clinical condition or situation to which the directions apply
-description of those patients excluded from treatment under the directions
-description of the circumstances in which further advice is sought from a doctor
-dosage, max dose, quantity, form strength, route, frequency and max or min period in which the medicine should be administered.
-relevant warnings - potential adverse effects
-necessary follow-ups and circumstances
-statement of the records and kept for audit purposes
what medicines are included with CAUTION in PGD
1) Antimicrobials – only when their inclusion is absolutely necessary and will not interfere with strategies designed to combat antimicrobial resistance. Will need to involve a microbiologist. Example, azithromycin available on PGD for chlamydia
2) Black triangle and off-label use of drugs – only in exceptional circumstances and when justified by current best clinical practice
- PGD must clearly indicate the status of these drugs and why such use is necessary
- National guidance e.g NICE should be followed to ensure that use of these medicines is justified
- Practitioners should consider informing the patient or their carer when a medicine is being used off-label
what professions cannot administer controlled drugs (1-5) under the PGD?
Dietitians, Speech & language therapists, Dental therapists, Dental hygienists
Dietitians, Speech & language therapists, Dental therapists, Dental hygienists cannot prescribe any CD, what CD can other professions administer under PGD?
Schedule 2: Morphine and diamorphine – only by registered nurses and pharmacists for the immediate necessary treatment of a sick or injured person. Not for treating addiction
what medication is included wth caution in the PGD?
Schedule 2: Ketamine
Schedule 3: Midazolam
Schedule 4: All drugs except anabolic steroids and injectable medications used for treating addiction.
Schedule 5: All drugs
Tramadol, gabapentin and pregabalin may not be supplied and administered under a PGD.
what are exclusion from the PGD?
- Unlicensed medicines (need to have a UK marketing authorisation)
- Medicines needing frequent dosage adjustments or frequent complex monitoring (e.g anticoagulants or insulin)
- Special manufactured medicines
- Dressings, appliances and devices
- Radiopharmaceuticals
- Abortifacients, such as mifepristone
-Carefully consider the inclusion of more than one medicine in a PGD
PGD’s are not to be used for managing long-term conditions
who can you use in PGD?
List of qualified health professionals who may supply or administer medicines under a PGD
They can only act under the PGD as NAMED individuals
Nurses
Midwives
Optometrists
Pharmacists
Chiropodists and podiatrists
Radiographers
Orthoptists
Physiotherapists
Ambulance paramedics
Dieticians
Occupational therapists
Speech and language therapists
Prosthetists
Orthotists
Dental hygienists
Dental therapists
Before working under a PGD, healthcare professionals must ensure:
-They have undertaken appropriate training and CPD
-Been assessed as competent and authorised to practice by the provider organisation
-Have signed appropriate documentation
-Are using a copy of the most recent and in date final signed version of the PGD
-Have read and understood the context and content of the PGD
practising under a PGD
Healthcare professionals may not delegate their responsibility.
Ensure that you can determine that the patient meets the inclusion criteria as set out in the PGD and that no exclusion criteria apply.
Be able to discuss alternative options for treating the patient if appropriate.
Assess each individuals circumstances and preferences.
Recognise when you need to signpost or refer to another HCP as defined in the PGD.
Understand relevant information about the medicines in the PGD – e.g. dosage calculations, interactions, etc.
Be able to advise patient/carer about the medicine.
Document the supply or administration.
documentations of PGD?
Most PGDs require a record of the supply or administration, but not always specified in a PGD
Good practice to include:
-Date and time of supply and/or admin
-Patient details and how the patient met the criteria of the PGD
-Details of medicine
-Statement that supply or admin is by using a PGD
-Name and signature of HCP administering or supplying the medicine
-Relevant info provided to the patient or carer
-If consent was obtained (when relevant)
For adults, all PGD documentation must be kept for eight years and for children until the child is 25 years old, or for eight years after a child’s death.
how long should PGD documentations be kept for ?
For adults, all PGD documentation must be kept for eight years and for children until the child is 25 years old, or for eight years after a child’s death.
