This website places cookies on your device to help us improve our service to you. To find out more, see our Privacy and Cookies statement.

Skip to page content

Guidance

Guidance on Development and Review of PGDs

Gather Essential Organisational Information

  • Which group or individuals lead on PGD development in your organisation?
  • How and where can the PGD policy or procedure for your organisation be accessed?
  • Does your organisation have a PGD template and how can you access it?
  • Identify at the earliest stages of development if there is any parallel pieces of work being undertaken within the organisation. This will minimise potential for duplication, delays in the approval process and maximise benefit to the organisation of any PGD produced.
  • Consider any planned re-design of services for potential effect on the need for a PGD.
  • Look at local examples of PGDs.
  • Is a similar PGD already developed in your organisation? If not, is there an example on this site?

PGD Development Team

  • Who in the pharmacy team should be approached for advice?
  • Identify a lead author and their associated responsibilities?
  • Identify all necessary co-authors. This needs to include a pharmacist and a doctor (or dentist) who has the relevant clinical and pharmacy skills.
  • Identify the person who during the development process will ensure agreed comments on the draft PGD are incorporated?

Questions for PGD Development Team To Ask?

  • Development (or ongoing use) of the PGD is in patients best interests
  • Ensure the professional group wishing to work under PGDs is included within current legislation
Nurses Midwives
Chiropodists/Podiatrists Physiotherapists
Prosthetists and Orthotists Speech and Language Therapists
Optometrists Occupational Therapists
Pharmacists Health Visitors
Dieticians Paramedics or holders of a certificate of proficiency in paramedic skills (issued by the Secretary of State)
Orthoptists Dental Therapists and Dental Hygienists
  • The medicine(s) for supply / administration have Medicines and Healthcare Regulatory Authority (MHRA) (unlicensed or clinical trial medicines cannot be covered by PGD).
  • Medicines administered / supplied under PGD will usually be used within the terms of their UK product license.  If a PGD is required for a medicine outwith the product license, the reasons and evidence for use should be clearly specified within the PGD.
  • For advice on PGDs for antimicrobials seek advice from relevant personnel within organisation. i.e. Antimicrobial Management Team, Microbiologist.
  • Where possible, PGDs should be written in a generic format (e.g. not specific for one clinical area or clinical group of patients). This could facilitate cross-sector use of PGDs.


Sample Core Information Required

Clinical Condition PGD
Indication:

This must be clear, unambiguous and, if possible, generic, e.g.

Like:

Influenza vaccine for at risk individuals.

But not like:

Influenza vaccine for patients in general medical wards at hospital

Inclusion criteria: Must reflect data in current SPC and BNF and any other guidelines in use e.g. SIGN

Most PGDs for CHILDREN should be submitted as separate PGDs (as this facilitates audit purposes). If your PGD is intended to cover adults and children please discuss this with a member of your Health Board PGD Group who will advise on the appropriateness of this
Exclusion criteria: Must reflect contra-indications in SPC / BNF and be relevant to your clinical practice.

Include statement on concomitant medication or other disease states that are contra-indicated - this list must be relevant to clinical practice and not simply a list of any possible interactions lifted form the BNF or SPC.

Always include a statement on allergy e.g. "Known allergy or sensitivity the drug or any excipients in the product"

Include a statement on patients who are pregnant or breast feeding, if excluded.

If any haemodynamic parameters are exclusion criteria e.g. renal dysfunction, the parameter must be defined as tightly as possible (e.g. eGFR less than or equal to 30 ml/min).
Cautions/Need for further advice/ Circumstances when further advice should be sought from the doctor:

Cautions / Need for advice - this must reflect any Cautions in the SPC / BNF or other recognised guidelines or other clinical situations that may necessitate caution in using the PGD.

Some "cautions" are best placed in exclusion criteria as this may require a clinical judgement by a prescriber.


Action if patient declines or is excluded:
Usually this means informing the consultant / GP / local doctor and documenting this in the patient notes / medical record. This is to ensure patients can be treated by a different clinician.

(Sentences in italicsare intended for automatic inclusion in most PGDs).


Drug Details


Name, form & strength of medicine: Ensure clear and unambiguous
Generic name
With new rINN.
Route/Method of administration: Ensure clear and unambiguous
Dosage

(include maximum dose if appropriate):
Ensure clear and unambiguous
If a dose range is included ensure maximum is stated
e.g. 1 mg per kg, capped at a maximum of 90 mg.
Frequency:
Be specific - e.g. 8 hourly rather than TID

If once only dose then state this
Duration of treatment: State maximum time-scale covered by PGD and number of doses this relates to, if relevant

Also, if applicable, state here if the PGD can only be used a certain number of times per patient - e.g. a PGD for steroid injections to the knee might specify that it can be used only twice in any 12 month period per patient.
Maximum or minimum treatment period: Must concur with above information.
Quantity to supply/administer: Must concur with above.  If PGD is for SUPPLY (e.g. A&E out-patient packs of analgesics) ensure that these packs are readily available from pharmacy

Include details of any labels that will be applied to the medication if it is to be supplied to the patient to take away - e.g. Pre-pack supplied by pharmacy with directions "Take one tablet three times daily".  Nurse will complete label with patient name and date of supply.

Remember all medicines supplied require a PIL.
▼Black Triangle Drug:* Yes/No delete whichever is inappropriate
Specify if the drug is a black triangle - check current BNF

Legal Category:

POM/P - delete whichever is inappropriate
Specify if drug is a POM or P or GSL - check Medicines, Ethics and Practice (Usually, PGDs only developed for POM and P medicines)
Is the use outwith the SPC:**
Yes/No delete whichever is inappropriate
If "yes" then explain why and include reference to texts supporting use outwith the SPC (e.g refer to BNF if drug is used routinely in children but not licensed as such.)
Please ensure the SPC has been checked as it may have changed since the last PGD was written or reviewed. SPC available at medicines.org.uk
Storage requirements: Explain local set-up eg locked drug cupboards

 


Warnings including possible adverse reactions and management of these:


Please refer to current BNF or SPC for full details

Common side effects should also be listed individually but there is no need to list ALL side effects.  Any management plans / advice should be stated e.g. patient advised to return to GP if side effects problematic

If reactions can be severe then put in method of summoning assistance.

Use the Yellow Card System to report adverse drug reactions directly to the CSM. Yellow Cards and guidance on its use are available at the back of the BNF or online at http://yellowcard.mhra.gov.uk/


Advice to patient/carer including written information provided:
  • Explain treatment and course of action
  • Give patient a copy of relevant patient information leaflet
  • If condition worsens or symptoms persist then seek further medical advice (specify where advice should be sought from)

Monitoring (if applicable):

Will depend on clinical situation / medication
Follow up: Will patient need to be seen again e.g. by GP?
Will a letter / discharge prescription be sent to GP?

 

Staff Characteristics

Professional qualifications: Registered professional [appropriate qualification to be listed] with a current [professional] registration
Specialist competencies or qualifications:
  • Has undertaken appropriate training to carry out clinical assessment of patient leading to diagnosis that requires treatment according to the indications listed in this PGD
  • Has undertaken appropriate training for working under PGDs for the supply and administration of medicines
  • Has undertaken training to meet local requirements for implementation, e.g. ALS and/or IV & cannulation training

List any other qualifications needed e.g. ALS

Continuing education & training:
The practitioner should be aware of any change to the recommendations for the medicine listed. It is the responsibility of the individual to keep up-to-date with continued professional development.

List any other ongoing needs e.g. ALS renewed every 2 years



Referral Arrangements and Audit Trail

Referral arrangements: Include details of who patients may be referred to post treatment
Records/audit trail:
  • Patient's name, address and consent given
  • Contact details of GP (if registered)
  • Diagnosis
  • Dose and form administered and batch details of the product
  • Advice given to patient (including side effects)
  • Signature/name of staff who administered or supplied the medication, and also, if relevant, signature/name of staff who removed/discontinued the treatment
  • Details of any adverse drug reaction and actions taken including documentation in the patient's medical record
  • Referral arrangements (including self-care)
References/Resources and comments: Include edition of BNF or SPC used (should be most recent) and any other guidelines used e.g. SIGN or professional guidelines e.g. Royal College of Radiologists

Notes:
SPC - Summary of Product Characteristics
BNF - British National Formulary

 

Professionals drawing up PGD / Authors

Designation and Contact details
*Name: Professional representing

group working under PGD



Signature:                                             Date:
Designation :

E-mail address :
Name: Pharmacist



Signature:                                             Date:

Designation :

E-mail address :

Name: Doctor



Signature:                                             Date:
Designation :

E-mail address :
Name:



Signature:                                             Date:
Designation :

E-mail address :


* Lead Author
In the above table, more than one member of each professional group may be in the team that develops the PGD (hence the additional spaces)