Non Prescription Supply of Medicines 2 Flashcards
What is a patient group direction?
Written direction that allows the supply and/or administration of a specified medicine by named authorised health professionals, to a well-defined group of patients requiring treatment for a specific condition.
Using PGD is not a form of prescribing
PGD guides registered health professionals in assessing the patient’s suitability for a specific drug without reference to an independent prescriber.
When are PGDs useful?
- supplying medicine for the treatment of an episode
- medicines use follows a discrete pattern
- homogenous patient group
- unscheduled care
Legislation for PGDs
Included in Humans Medicines Regulation 2012.
Legislation for the labelling of medicines applies to those supplied under PGDs.
PIL must be given with medicines supplied under a PGD.
- Not required if the medicine is administered.
Legislation relating to prescription charges and exemptions (including pandemic influent exemptions) applies medicines supplied under a PGD from the NHS.
Prescription charges don’t apply when medicines are administered under a PGD.
Setting up and authorising a PGD
Consider need for PGD.
Obtain agreement of an authorising body before proceeding.
Identify appropriate person to sign PGD on behalf of authorising body.
- NHS: CCG, NHS commissioning boards, Hospital/Foundation trusts and local authorities.
- Non NHS: independent medical agencies, hospitals and clinics, police force.
Construct the proposal document for seeking agreement, and ensure it has all the info necessary
Notify the appropriate senior doctor, pharmacist or representative of the professional groups practising under PGD to sign the PGD.
Ensure PGD consistent with the relevant summary of product characteristics.
PGD requirements
- signed on behalf of authorising body
- signed by a doctor
- signed by a pharmacist
- both a pharmacist and doctor must have been involved in developing the PGD
- when acting as a signatory, establish clinical and pharmaceutical content is accurate and can be supported by evidence
Medicines included with caution in PGD
Antibiotics - only when their inclusion is necessary and won’t interfere with strategies used to combat AMR. Will need to involve a microbiologist. E.g. azithromycin available under PGD for chlamydia
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
- NICE guidelines just be used to justify the use of these meds
CD included with PGD
Schedule 2: morphine and diamorphine (only registered nurses and pharmacists for immediate, necessary treatment of a sick or injured person- not for treatment of addiction)
Schedule 3: midazlolam
Schedule 4: except anabolic steroids and injectables used for treating addiction
Schedule 5: all including codeine
Exclusion from PGDs
- unlicensed meds (need to have MA)
- meds needing frequent dose adjustments or monitoring (anticoagulants and insulin)
- special manufactured meds
- dressing, appliances and devices
- radiopharmaceuticals
- PGDs are not used for managing long term conditions
Who can use a PGD?
nurses, midwives, optometrists, pharmacists, radiographers, dieticians etc.
Before working under a PGD, healthcare professional must ensure:
- They have undertaken appropriate training and CPD
- assessed as competent and authorised to practice by provider organisation
- have signed an appropriate documentation
- are using a copy of most recent and in date final signed version of the PGD
- have read and understood context and content of PGD
Practising Under a PGD
- Healthcare professionals may not delegate their responsibility
- Ensure patient meets the inclusion criteria and that no exclusion criteria apply
- Assess individuals circumstances and preferences.
- Be able to discuss alternative options for treating the patient if appropriate.
- 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.
Documentation
Most PGD require a record of supply or administration but not always specified in a PGD
What is good practice for documentation in PGD?
- Date and time of supply/administration
- Patient details and how the patient met the criteria of the PGD
- Details of medicine
- Statement that supply/administration is by using a PGD
- Name and signature of HCP administering or supplying
- Relevant info provided to the patient
- If consent was obtained (when relevant)
- for adults all PG documents must be keptt for eight years and for children it is until they are 25 or eight years after a Childs death
Reviewing and updating PGDs
When PGD is approaching expiry date (3 years).
Done when there is a change in:
- Legislation
- NICE guidelines
- SPC
When reviewing the PGD (at least every 2 years):
- Conduct an appropriate literature search to identify new evidence
- Determine whether the PGD remains the most appropriate option to deliver service; is it still needed?
If updating PGD, it will need to be re-authorised as per normal requirements
Type of PGD
NHS: all of previous information applies
Private:
- Healthcare providers registered with the Care Quality Commission as ‘independent medical agencies’, have the authority to write PGDs (still need to follow the legislation)
- Use of private PGDs generally require pharmacists to undertake training
- Superintendent pharmacists / Pharmacist Owners oversee the use of the PGDs within their organisation, including insurance
- Pharmacies set their own prices for services and medication supplied through private PGDs. No NHS authorisation is required.
- Private PGD services are paid for directly by patients
