Non-prescription supply of medicines 2 Flashcards
What is a Patient Group Direction?
1) 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
- Used in both primary and secondary care settings
In general, the majority of clinical care should be provided on an individual, patient-specific basis. however PGDs may be appropriate in situations when using it offers an advantage. discuss when PGD’s could be useful
1) Medicines use follows a predictable pattern
2) Patients seek unscheduled care
3) Supplying or administering a medicines for a discrete treatment episode
4) There is a homogeneous patient group
discuss the Legal framework for PGDs
1) Legislation for PGDs is included in the Human Medicines Regulations 2012. it States requirements for:
- Developing PGDs, Authorising PGDs, Using PGS’s…
2) Legislation for labelling of medicines applies to PGDs.
3) 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.
4) Legislation relating to prescription charges and exemptions (including pandemic influenza exemptions) also applies to patients receiving a supply of medicine(s) under a PGD from the NHS.
5) Prescription charges do not apply when medicines are administered under a PGD
explain how you would Set up and authorise a PGD?
- list the authorising bodies
1) Consider the need for a PGD. Is it necessary?
2) Obtain the agreement of the authorising body before proceeding to develop a PGD. Also identify the appropriate person who can sign the PGD on behalf of the authorising body
- NHS bodies: CCG, NHS England, hospital trusts/foundation trusts, local authorities
- Non-NHS bodies: Independent medical agencies (eg. Pharmacies), independent hospitals & clinics
3) Construct the proposal document for seeking agreement, and ensure it has all the information necessary i.e where the PGD will be used, condition treated, benefits and risks
4) identify the appropriate senior doctor (or dentist), senior pharmacist who will sign the PGD
5) Ensure PGDs are consistent with the relevant summary of product characteristics (SPC)
6) A PGD must be: Signed on behalf of the authorising body, Signed by a doctor, Signed by a pharmacist,
Both pharmacist and doctor must have been involved in developing the PGD.
7) When acting as a signatory, establish that the clinical and pharmaceutical content is accurate and supported by the best available evidence
outline who can use a PGD
1) Nurses
2) Midwives,
3) Pharmacists
4) Radiographers, Optometrists, Orthoptists
5) Physiotherapists, Ambulance paramedics
6) Dieticians
7) OT, SALT
8) Dental hygienists, Dental therapists
- They can only act under the PGD as NAMED individuals
what must healthcare professionals ensure before working under a PGD?
1) They have undertaken appropriate training and CPD
2) Been assessed as competent and authorised to practice by provider organisation
3) Have signed appropriate documentation
4) Are using a copy of the most recent and in date final signed version of the PGD
5) Have read and understood the context and content of the PGD
list some of the information that needs to be in a PGD
1) name of business to which the direction applies
2) date it comes into force and expires
3) description of medication to which it applies
4) signature by appropriate organisation
5) relevant warnings and adverse effects
6) arraignments for referral if necessary
7) details of follow up action if necessary
what types of medication are included in the 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. However azithromycin available on PGD for chlamydia
2) Black triangle and off-label 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. follow NICE guidlines
3) some CD’s
which controlled drugs can be included in PGD’s?
1) Sch 2 – morphine and diamorphine (only registered nurses and pharmacists for the immediate, necessary treatment of a sick or injured person (not for addiction))
2) Sch 3 – only midazolam
3) Sch 4 – except anabolic steroids and injectables used for treating addiction
4) Sch 5 - all
which items are excluded from PGDs
1) Unlicensed medicines
2) Medicines needing frequent dosage adjustments or frequent complex monitoring (e.g anticoagulants or insulin)
3) Special manufactured medicines
4) Dressings, appliances and devices
5) Radiopharmaceuticals
6) Abortifacients, such as mifepristone
7) Carefully consider the inclusion of more than one medicines in a PGD
- PGD’s are not to be used for managing long-term conditions
explain how you would go about practising under a PGD
1) Healthcare professionals may not delegate their responsibility.
2) Ensure that you can determine that the patient meets the inclusion criteria as set out in the PGD.
3) Ensure you can determine that no exclusion criteria apply.
4) Be able to discuss alternative options for treating the patient if appropriate.
5) Assess each individuals circumstances and preferences.
6) Recognise when you need to signpost or refer to another HCP as defined in the PGD.
7) Understand relevant information about the medicines in the PGD – e.g. dosage calculations, interactions, etc.
8) Be able to advise patient/carer about the medicine.
9) Document the supply or administration
Most PGDs require a record of the supply or administration, but not always specified in a PGD. outline what needs to be documented as part of Good practice.
1) Date and time of supply and/or admin
2) Patient details and how the patient met the criteria of the PGD
3) Details of medicine
4) Statement that supply or admin is by using a PGD
5) Name and signature of HCP administering or supplying
6) Relevant info provided to the patient
7) If consent was obtained (when relevant)
how long would you keep a PGD record for?
- adult
- child
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.
When are PGD’s reviewed and updated?
1) Usually done in response to approaching the expiry date of the PGD or when – change in legislation, new NICE guidance, changes in SPC, changes to the local formulary
2) When reviewing the PGD, conduct an appropriate literature search to identify new literature
3) Determine whether the PGD remains the most appropriate option to deliver the service. Is it still needed?
4) If updating a PGD, it will need to be re-authorised as per normal requirements
what are the two types of PGD’s.
1) NHS
2) Private:
- Healthcare providers registered with the Care Quality Commission as ‘independent medical agencies’, have the authority to write PGDs
- Generally require pharmacists to undertake training
- Individual pharmacists use PGDs to assess patients and supply medication
- 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 or funding is required.
- Private PGD services are paid for directly by patients
