Non Prescription Supply of Medicines - PGDs

Question 1

What is a patient group direction?

Answer 1

• 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

Question 2

What does the PGD guide register pharmacists to do?

Answer 2

• 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.

Question 3

When are PGDs useful?

Answer 3

• supplying medicine for treatment of episode
• medicines use follows discrete pattern
• homogenous patient group
• unscheduled care

Question 4

Who can use a PGD?

Answer 4

nurses, midwives, optometrists, pharmacists, radiographers, dieticians etc.

Question 5

Legal Framework for PGDs

Answer 5

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)

Question 6

PGD and NHS charge

Answer 6

NHS exemptions/charges also apply PGDs
Prescription charges do not apply when meds are administered under a PGD

Question 7

Setting up a PGD in your pharmacy

Answer 7

• 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

Question 8

Authorising bodies who can sign PGD include

Answer 8

• NHS bodies: CCG, hospital trust and funds, local authorities
• Non NHS bodies: independent medical agencies, independent hospitals

Question 9

Legal requirements of a PGD

Answer 9

• 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

Question 10

Legal MEDICINES requirements of a PGD

Answer 10

• 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

Question 11

Exclusion from PGDs

Answer 11

• 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

Question 12

Medicines included with caution in PGD

Answer 12

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

Question 13

CD included with PGD

Answer 13

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

Question 14

Which CDs cannot be supplied and administered under a PGD

Answer 14

Sch 3:
Tramadol
Gabapentin
Pregabalin

Question 15

Before working under a PGD, healthcare professional must ensure:

Answer 15

• 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

Question 16

Practising Under a PGD

Answer 16

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.

Question 17

Documentation

Answer 17

Most PGD require a record of supply or administration but not always specified in a PGD

Question 18

What is good practice for documentation in PGD?

Answer 18

• 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

Question 19

Reviewing and updating PGDs

Answer 19

• 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

Question 20

Types of PGD

Answer 20

NHS: all of previous information applies

Private

Question 21

Private PGD

Answer 21

• 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

Question 22

Examples of Private PGDs

Answer 22

• 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

Question 23

Examples of NHS PGD

Answer 23

• nappy rash
• impetigo (fusidic acid)
• Oral thrush (nystatin suspension)
• Emergency contraception

Question 24

PGD - Off label

Answer 24

• 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

Question 25

Pandemic Treatment PGD

Answer 25

• 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.

Question 26

Authorising PGD

Answer 26