Non Prescription Supply of Medicines - PGDs Flashcards
What is a patient group direction?
- Written instructions for the supply or administration of med to patients usually in planned circumstances
- By named, authorised, registered health professionals
- Using PGD is not a form of prescribing
What does the PGD guide register pharmacists to do?
- PGD guide register health professionals in assessing the patients suitability for a specific drug without reference to an independent prescriber
- Pharmacist can only supply medicines on a PGD if there is an advantage for the pt.
When are PGDs useful?
- supplying medicine for treatment of episode
- medicines use follows discrete pattern
- homogenous patient group
- unscheduled care
Who can use a PGD?
nurses, midwives, optometrists, pharmacists, radiographers, dieticians etc.
Legal Framework for PGDs
Legislation for PGDs included in HMR 2012
States requirements for:
- Developing/ authorising PGDs
- Information to be included in a PGD
- Reviewing and updating PGD
- Using PGD
- Labelling PGDs (normal legislation applies)
- PIL must be provided with PGDs (not required by legislation)
PGD and NHS charge
NHS exemptions/charges also apply PGDs
Prescription charges do not apply when meds are administered under a PGD
Setting up a PGD in your pharmacy
- consider need for PGD
- obtain the agreement of the authorising body before proceeding to develop PGD
- identify appropriate person who can sign PGD on behalf of authorising body
- construct the proposal document for seeking agreement, and ensure it has all the info necessary
Authorising bodies who can sign PGD include
- NHS bodies: CCG, hospital trust and funds, local authorities
- Non NHS bodies: independent medical agencies, independent hospitals
Legal requirements of a PGD
- Name of business who owns the direction
- Start and end date of PGD
- Description of medicines
- Class of HCP who can supply or administer
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
Legal MEDICINES requirements of a PGD
- Clinical conditions to which the direction applies
- Exclusion criteria
- Referral criteria
- Details of appropriate dose, max total dose, qty, form, strength, route, frequency
- Max/min period to administer meds
- Relevant warnings
- Details of any necessary follow up actions
- Statement of records to be kept for audit
Exclusion from PGDs
- Supply or administration of abortifacients
- As part of training
- Care homes and independent schools providing healthcare entirely outside the NHS
- Certain controlled drugs (see Part 2 lecture)
- Meds needing frequent dose adjustments or monitoring (anticoagulants and insulin)
- Dressings or medical devices (they don’t have a MA)
- Mixing of medicines (it produces an unlicensed medicine)
- Radiopharmaceuticals
- Unlicensed medicines
Medicines included with caution in PGD
Abx:
- Only when their inclusion is necessary and won’t interfere with strategies to combat AMR.
- Will need to involve microbiologist.
e.g. Example azithromycin available as 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 Cleary 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)
- Ketamine
Schedule 3:
- midazlolam
Schedule 4:
- except anabolic steroids and injectables used for treating addiction
Schedule 5:
- all including codeine
Which CDs cannot be supplied and administered under a PGD
Sch 3:
Tramadol
Gabapentin
Pregabalin
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
HCPs cannot delegate their responsibility
They must:
- Determine that patient meets inclusion criteria/no exclusion criteria apply.
- Assess each individuals circumstances and preferences.
- Understand relevant information about the medicines in the PGD – e.g. dosage, interactions, etc.
- Be able to advise patient/carer about the medicine.
- Document the supply or administration.
Where appropriate they should also:
- Be able to discuss alternative options for treating the patient.
- Recognise when you need to signpost or refer to another HCP as defined in the PGD.
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 kept for eight years and for children it is until they are 25 or eight years after a child’s death
Reviewing and updating PGDs
- Usually done close to expiry date of PGD (max 3 years) OR when there are changes in legislation e.g. NICE guidance/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
Types of PGD
NHS: all of previous information applies
Private
Private PGD
- Healthcare providers registered with the Care Quality Commission as ‘independent medical agencies’
- 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
Examples of Private PGDs
- Antimalarials (Malarone, doxycycline, Lariam)
- Cystitis treatment (trimethoprim)
- Erectile dysfunction (Viagra, Cialis, Levitra)
- Emergency contraception (Levonelle and ellaOne)
- Hair loss (Propecia)
- Stop smoking (Champix)
- Salbutamol inhalers (for repeat supply)
- Vaccines (rabies, yellow fever
Examples of NHS PGD
- nappy rash
- impetigo (fusidic acid)
- Oral thrush (nystatin suspension)
- Emergency contraception
PGD - Off label
- Clearly state the product is being used outside the terms of it’s MA
- Why this is recommended
- Reference to supporting evidence/guidance.
- Inform pt when use is off-label
Pandemic Treatment PGD
- Supply of a POM for the prevention or treatment of a disease that is, or is anticipated to be, pandemic.
- Must be done in accordance with a Pandemic Treatment Protocol (PTP) or Pandemic Treatment Patient Group Direction (PTPGD), if and when one is issued.
Authorising PGD
