Patient Group Direction (PGD) Development Policy - NHS Borders

What is a Patient Group Direction?

A Patient Group Direction (PGD) provides a legal framework that allows defined registered health professionals to supply and/or administer a specified medicine(s) following assessment of suitability to a pre-defined group of patients, without them having to see a registered independent prescriber.

The PGD is a specific written instruction for the supply and/or administration of medicines to groups of patients (subject to specified exclusions) who cannot be individually identified before presentation for treatment. 

• A PGD can be used instead of a prescription when treatment is provided by a NHS health board, GP, dental practice, or NHS funded family planning clinic.  Rationale for using a PGD must be evidence- based.
• A PGD must be signed by a senior doctor (or, if appropriate, dentist), nurse and pharmacist, all of whom have been involved in developing the PGD.
• PGDs are NOT intended as a substitute for individual prescribing where there is an opportunity in the care pathway for medicine or medicines to be prescribed.

The majority of clinical care however should be provided on an individual, patient specific basis and not via a PGD.

Who can use them?

The law states that registered nurses, midwives, health visitors, podiatrists/chiropodists, pharmacists, pharmacy technicians, ambulance paramedics, optometrists, radiographers, orthoptists, and physiotherapists can supply and administer specified medicines using a PGD.

It is important to note that the above professionals may only supply or administer medicines under a PGD as named individuals.  A record of named individuals eligible to use each PGD must be recorded on the PGD master copy, which is held by the responsible person for that location.

In Primary Care, before individual practitioners sign the master copy of the PGD, they must ensure the Practice Authorisation section has been signed by a local GP with relevant interest and involvement in the PGD development.

Health professionals should refer to their own regulatory or professional bodies standards/guidance where available, including:

• GMC Prescribing Guidance
• GPhC Standards
• HCPC Standards
• NMC Standards

The PGD Template is available on the NHS Borders Patient Group Directions intranet microsite.

What can they be used for?

PGDs should be used in situations where patients can receive additional benefit; this includes –

• Timely access to treatment.
• Reduction in patient waiting times.
• Avoidance of hospital admissions.
• Maximise the use of resources.
• Fully utilise professional skills.

In most cases, care will be provided on an individual patient basis by a specific prescriber to a specific individual patient. 

Medicines may be supplied or administered under PGDs in limited situations where this offers an advantage for patient care without compromising safety, and where it is consistent with appropriate professional relationships and accountability.

What can’t they be used for?

The use of any medicine should be consistent with the product license i.e. Summary of Product Characteristics (SPC) for the relevant products and any relevant guidance.

PGDs can be used to supply specific Controlled Drugs.

(Please see Appendix 5 for the list of controlled drugs that can be provided under PGD)

PGDs should not be used by trainees or for training purposes.

PGDs cannot be legally used to allow

- registered health professionals to undertake their joint injector training/competency as they are not fully trained and competent. A Patient Specific Directive (PSD) would be required.

- registered healthcare professional to undertake LNG-IUD fitting as part of their competency training to obtain a College of Sexual and Reproductive Healthcare (CoSRH) Letter of Competence in Intrauterine Techniques as they are not fully trained and competent.  A prescription or PSD would be required.

PGDs should only be used in exceptional circumstances for:

• Black triangle drugs.
• ‘Off Label’ use of Medicines. If using off-label, status must be clearly documented within the PGD.
• Antimicrobials (refer to Frequently Asked Questions)

What are the alternatives to PGDs?

Other ways of providing medicines should also be considered:

• Individual Patient Prescription, including Non-Medical Prescribing.
• Patient Specific Directions.
• Exemptions to the Medicines Act.
• Individualised Care Pathways (ICPs) or clinical protocols.
• Symptomatic Relief Policy.

How do I begin a PGD?

The clinical team who will use the PGD should be involved in its development. This will be a multi-disciplinary approach and should be driven by an identified service/patient need and aligned to Health Board non-medical prescribing strategy.

The professionals involved comprise the local Clinical Team and line management support.  A clinical pharmacist may be used to provide pharmacy expertise but should not author the document as they will be required to engage in the review process.

How should I go about it?

Use the PGD template to ensure that the PGD contains the legally required information.  This is available on the Patient Group Directions intranet microsite.

As the PGD author you will be expected to identify and to ensure PGD Sign Off by the following individuals:

• Author of the PGD: discussion and agreement of PGD within local clinical team.
  
  
• Person responsible for Audit & Training: this should be defined for each clinical area as the most appropriate person by the author. More than one person may require to be identified.
  
  
• Specialist Clinician: defined by the author as the most appropriate local Clinical Specialist with the relevant expertise (must not be the author and should be a prescriber).
  
  
• Governance group: you must have agreement and support from your specific local governance group prior to the PGD being shared out with your department

The PGD will reflect best practice and published evidence.  The training needs of the practitioners using the PGD will be identified and any gaps in skills and knowledge addressed.

Arrangements to obtain the medicines required should be made together with any additional supporting equipment. To facilitate an audit trail, you will also need to consider treatment records (refer to section 8) and agree referral pathways.

 A senior representative of each profession should be responsible for ensuring that only fully competent, qualified, and trained persons are authorised to use PGDs.

All professionals involved in the development, review, and operation of the PGD must act within the legal requirements as well as the appropriate code of professional practice and conduct. Any professional signing the PGD must be satisfied that this matter has been addressed appropriately. 

As the author of the PGD you are responsible its review and control.

1. The PGD must be reviewed every three years, this is a legal requirement. Pharmacy Admin Office will notify you when the PGD is due for review, and you will be expected to review the PGD within the required timescale.
   
   
2. It is essential that you inform Area Drugs and Therapeutics Committee (ADTC) of any issues which may delay review and formally request a temporary extension to ADTC, detailing the mitigating circumstances.
   
   
3. Your line manager will be informed at the point of expiry of the PGD and that it is no longer valid.
   
   
4. The PGD will be removed from the microsite and will not be legally valid for staff to operate under if it has not been received in pharmacy by the expiry date.
   
   
5. A short PGD Audit of the PGD’s use in practice should be undertaken following the first 6 months of a new PGD and then as part of the review process every three years. It is the authors responsibility to use this audit tool as appropriate for their area. Evidence and data from audits may be requested by ADTC.
   
   
6. Once the PGD has been received in Pharmacy, the expiry date will be extended for a maximum of 8 weeks to enable review, approval and sign off.

Sign-off legal requirements are a doctor/dentist and pharmacist; NHS Borders requires additional signatures as part of local governance:-

• Medical Director
• Director of Pharmacy
• Profession Lead
• Chair of Area Drug & Therapeutics Committee

Professionals using PGDs assume a duty of care to the patient. If a professional using a PGD acts in any way outside of its terms, for instance in supplying the wrong medication, they are accountable for that decision. If the requirements of the PGD are fulfilled but the patient comes to harm as a result of the supply (e.g. if they experience an adverse drug reaction) then the organisation that has agreed the use of the PGD is accountable.

The persons responsible for assessing the competence of individuals supplying or administering under a PGD may be held partly liable if it were decided that the assessment was not appropriate.

Individuals operating under a PGD are responsible for determining their own competence. All individuals must ensure that the activities they undertake are covered by adequate indemnity arrangements.

What next?

The current list of PGDs that have been approved for use within NHS Borders can be viewed on the Patient Group Directions intranet microsite. If a PGD is needed, the appropriate Local Clinical Team is responsible for writing the PGD. 

Until the approved PGD has been authorised by NHS Borders, (Signed by Medical Director, Director of Pharmacy, Professional Lead and ADTC Chair) the PGD has no legal status and cannot be used.

Who is responsible at NHS Borders?

The NHS Borders Pharmacy Department is responsible for maintaining the organisations list of active PGDs. A list of all the approved PGDs is published and maintained on the PGD Intranet Micro-site.

Local Clinical Teams will be reminded to review their PGDs prior to their expiry, if the PGD is not reviewed in this time it will be removed from the intranet and will no longer be authorised for use.  The Local Clinical Team, who developed the PGD, should retain a master copy and the lead for each clinical area will maintain the PGD folder for that area which will contain the signed master copies of all relevant PGDs.

There is no legal provision for automatic extension beyond the authorised expiry date. Any extension must be explicitly re-authorised by the appropriate organisation.

How often should PGDs be reviewed?

National guidance recommends that PGDs are reviewed every three years or sooner and this is the standard that NHS Borders will strive to maintain.

PGDs must also be reviewed following any changes to the relevant Summary of Product Characteristics of any medicine listed within a PGD, this is the authors’ responsibility.

1. 1^st review is by the local clinical team.
   
   
2. 2^nd review is by an appropriate clinical specialist with relevant expertise (organised by, but must not be, the author).
   
   
3. For subsequent resubmissions a PGD Audit is required as part of the submission to NHS Borders Area Drug & Therapeutics Committee (ADTC).
   
   
4. 3^rd review* is by the Clinical Pharmacist covering clinical area.
   
   
5. 4^th review is by the NMP lead where the PGD will be assessed against a PGD risk matrix (Appendix 6). All drugs considered to be high risk or with indentified concerns will be discussed at a local multidisciplinary working group with medical and pharmacy representation.
   
   
6. Once these steps are complete send the PGD via email to pgdadmin@borders.scot.nhs.uk.
   
   
7. 5^th review* by ADTC will be undertaken for NEW PGDs and any PGDs with significant clinical changes (electronic voting is used and a quorate decision based upon minimum review by ADTC members as follows: 1 Primary care physician, 1 Secondary care physician and 2 pharmacists).
   
   
8. Final review is the sign off process by appropriate clinical leads and chair of ADTC (as defined in the signatory section of the PGD).

* the 3^rd and 5^th review is not required for Nationally developed PGDs. Requirement for the 5^th review will be at the discretion of the NMP lead. 

Please refer to the information contained in Appendix 1 and Appendix 2.

Line managers of professionals working under PGDs are responsible for ensuring that only fully competent, qualified, and trained persons are authorised to operate under the PGD.

Professionals signing the PGD must be satisfied that this matter has been addressed appropriately, and that the staff training specified will enable safe operation of the PGD.

It is therefore important that the Local Clinical Team assess the training needs of local practitioners who will be expected to operate within a particular PGD, before they produce a PGD for approval or adapt/adopt an authorised PGD locally.

Advice to Practitioners Operating within a PGD

Practitioners operating within a PGD must:

1. Ensure that they have up-to-date knowledge relating to the clinical situation covered by the PGD, the medicine and its use for the indications specified.
   
   
2. Ensure that they have undertaken any training required for operation of the PGD.
   
   
3. Be satisfied that the PGD is legally valid and that it has been authorised by NHS Borders.
   
   
4. Ensure that when medicines are supplied or administered the agreed protocol is followed and the information specified in the PGD is recorded.  These records must include the identity and signature of the practitioner assuming responsibility for each supply or administration.
   
   
5. Act within the legal requirements of the PGD as well as the appropriate code of professional practice and conduct.
   
   
6. Each individual operating under a PGD is responsible for determining their level of competence.

• All medicines supplied under a PGD must be labelled in accordance with the EC Labelling and Leaflet Directive 92/97.
  
  
• Medicines supplied under a PGD must be labelled as dispensed medicinal products.
  
  
• Vaccines and other medicines administered immediately under a PGD do not require full ‘dispensed’ labelling, provided the product remains in original manufacturer’s packaging and is not supplied to the patient to take away.”
  
  
• A manufacturer’s patient information leaflet must be supplied to the patient when a medicine is supplied or administered.

Labels

The container of a dispensed medicinal product must be labelled to show the following particulars:

• name of the person to whom the medicine is to be administered.
• name and address of the person who supplies the medicinal product.
• date of dispensing.
• the words “Keep out of reach of children”.
• name of the product.
• pharmaceutical form of the product.
• quantity of the product.
• directions for use, including the method and if necessary, the route of administration of the product.
• precautions relating to the use of the product.
• the phrase “For external use only” within a rectangle if the product is not on a general sales list and is an embrocation, liniment, lotion, liquid antiseptic or other liquid preparation or gel and is for external use only.
• any special storage precautions for the product.

Medicines may only be supplied under a PGD if these labelling requirements are met.

Patient Information Leaflets

Patient information leaflets will be supplied each time a medicine is supplied.  The principal reason for supply of a leaflet is to ensure that all information required for safe and effective use of the medicine is conveyed to the patient. Where possible, availability of leaflets in different languages/Braille should be considered.

It is essential that due consideration is given to the arrangements for the supply, security, storage, and stock rotation of all medicines.

NHS guidance has indicated that all medicines should be supplied in pre-packs made up by a pharmacist.  Refer to the NHS Borders Code for the Control of Medicines for additional information.

Record Keeping

Proper audit trails must be in place to demonstrate whether the PGD has been followed, i.e. to show that the healthcare professional has made an appropriate supply to the patient. This requires a robust system for the recording of medicines used under the PGD on an individual patient-by-patient basis.

Stock balances must be reconcilable with receipts, administration, records, and disposals i.e. any non-administration leading to wastage of medication must be documented.  From this it should be possible to identify what patient has had what medicine. 

The names of the health professionals providing treatment must be recorded. The record acts both as a record of the transaction and a prompt for the healthcare professional supplying/administering the medicine.

What should be recorded?

Details of supply and administration of a medicine under a PGD must be recorded as for all medicines supplied/administered to patients. The medicine chart would need to be completed in the hospital.  

It is recommended that a stock record must also be completed each time stock is received for the purposes of supply or administration against a PGD. This will allow reconciliation of receipts and supplies of medicines on an individual patient by patient basis (refer to Appendix 4) which could be a record book rather than separate forms). 

Legal requirements for PGD’s under Human Medicines Regulations (HMR) 2012

Records must include:

• Name of business, practice, area (organisation) owning the PGD.
• Class of health professional authorised.
• Signatures: doctor/dentist + pharmacist. The signature and printed name of the approved healthcare professional who supplied or administered the medicine.
• Authorisation by an appropriate organisation.
• Start & end dates.
• Description of the medicine(s)Patient name, CHI and Clinical condition/situation.
• Exclusion criteria.
• Referral criteria.
• Medicine name, dose, maximum dose, quantity, pharmaceutical form, strength, route, frequency, min/max period.
• Relevant warnings & possible adverse reactions.
• Follow‑up actions.
• Records to be kept, the patient group direction title and/or number, drug batch number and expiry.
• Quantity supplied / received and current stock balance (Appendix 4).

Patients Medical Notes

To ensure all members of the multidisciplinary team are aware that the patient has had a medicine supplied or administered under a PGD, details of this must be recorded in the patient’s paper notes and on the computer records (if available).

This must include whether the patient met the inclusion criteria and whether the exclusion criteria were assessed.

The supply of manufacturer’s patient information leaflet, action taken, and any counselling given to the patient must be recorded.

Details and quantity of drug supplied/administered must be recorded as well as any failed attempt to administer medication under a PGD.

Records must be kept by the clinical area to allow the process to be audited internally (by Local Clinical Team) and externally.  

A PGD Audit should be undertaken after 6 months of a new PGD and at each three yearly review. The following are suggestions of methods that you could employ to check the quality of the supply of medicines under PGDs:

Record Keeping

A simple audit would be to look at the records and ascertain whether they have been completed properly.  Incomplete record keeping could lead to NHS Borders removing the approval for an individual healthcare professional to supply / administer against PGDs.

Inclusion/exclusion criteria

A check on whether healthcare professionals are following the inclusion/exclusion criteria in all cases. A simple review of the records will demonstrate whether this is being followed.

Counselling

If the PGD does not specify the content and quantity of counselling that should be given, then each healthcare professional must decide how much counselling they think is appropriate for each patient. It is good practice to make a formal decision about how much counselling and what areas the healthcare professional would wish to cover with each supply/administration.  It would be useful to produce a counselling checklist.

To audit counselling, the healthcare professional could review the actual counselling noted in the records against their decision about how much counselling was required.  The healthcare professional may then want to reflect on whether they are delivering all the counselling that they thought necessary and decide whether to change their practice.

Significant Events

An important form of auditing practice is to note any significant events that have happened during supply/administration of a medicine under a PGD.  A significant event could be a supply/administration which was particularly difficult or went particularly well. 

Significant events are important in highlighting learning experiences.  If possible, share your experiences, either good or bad, with colleagues and staff so that they can also learn.  If appropriate, complete an InPhase Adverse event report for Medication Events (including “Near-Misses”).

After a supply/administration that you did not handle particularly well, try to reflect on why you had a problem:

• What could you do differently next time?
• How could you have dealt with the client better?
• Could your peers give you some insight into how to improve your techniques?

Similarly, after a supply/administration that you were particularly happy about:

• What did you do particularly well?
• Is there something you could incorporate into future supplies/administrations?

Formal Audit Reporting

To ensure safe and effective mechanisms a formal audit of the PGD will be required during the first year of a PGD and again as part of the 2-year review process. 

This PGD Audit will be the responsibility of the responsible clinician defined in the PGD.  If not completed within a 6-week period the PGD will be withdrawn, and staff will not be covered to work under it.

Can you have a PGD for more than one drug?

PGDs will cover individual drugs, with certain exceptions, e.g. midwifery. Due to the level of information legally required within a PGD, PGDs for more than one drug may be confusing, unless for a combination product. It is unlikely that a different PGD would be required for different brands of the same drug. If there is any doubt please seek advice from Pharmacy.

Is it acceptable to have a dose range specified in the PGD rather than a specific dose?

This is acceptable. The legislation requires that the applicable dose or maximum dose is specified. The PGD may therefore specify a single dose or a range up to a specified maximum.  Healthcare professionals signing the PGD must be satisfied that the dose range is clinically appropriate and within the terms of the medicine’s marketing authorisation. The clinical criteria for selecting a dose within the range must be specified. The healthcare professional supplying/administering under the PGD must be assessed as competent to make the dosage decision. 

Is it allowable to have a PGD for Antimicrobials?

Yes, but particular caution should be exercised in any decision to draw up a PGD relating to antimicrobials.  Microbial resistance is a public health matter of major importance and great care should be taken to ensure that their inclusion in a PGD is absolutely necessary and will not jeopardise strategies to combat increasing resistance. A local microbiologist/antimicrobial pharmacist should be involved in development of the PGD.  Any such PGDs will be consistent with local policies and subject to external audit which will be considered during the PGD’s development.

Can a medicine be supplied under a PGD from a GP practice if a nurse named in the PGD is not available?

No. Only named individuals, named on the PGD can supply or administer under PGDs. It is therefore essential that when a named nurse is not available, nursing staff are able to refer patients for treatment if required.

Who is responsible for ensuring the competence of the professionals supplying or administering under PGDs?

Line managers/clinical leads of professionals involved in supplying or administering medicines under a particular PGD are responsible for ensuring that personnel are adequately trained and competent to undertake such a role.  Practitioners involved in supply or administration under a PGD are also responsible for ensuring that they have received appropriate training and are competent. (Refer to Section 5). All practitioners supplying or administering under PGDs will have completed the NHS Borders PGD e-learning.

I am a nurse authorised to supply a medicine under a PGD in a different NHS Health Board/Trust. Can I supply under the PGD in NHS Borders?

No. Each PGD is organisation specific.  An individual supplying or administering under a PGD must be named in the PGD (Signed the health professional’s authorisation form).  If a nurse is not named in a particular PGD they cannot supply or administer it regardless of whether they are authorised elsewhere for other PGDs.

Does a medicine supplied under PGD have to be given to the patient in person?

No. A medicine could be supplied to a carer or representative if the patient is unable to present to the practice in person.  However, the healthcare professional has a professional responsibility to ensure that the medicine is suitable, and that the patient has all the information necessary for safe and effective use of the medicine.  If the healthcare professional cannot be satisfied that the supply is appropriate or that all the necessary information will be accurately conveyed, the patient should be referred in line with the referral guidance detailed in the PGD. Ideally the patient should be assessed on a face-to-face basis against the criteria of the PGD.

What is the position if a medicine is being used outside the terms of its Summary of Product Characteristics (SPC)? (‘Off label’)

A medicine with a valid marketing authorisation gives guarantees of safety, quality and efficacy for its licensed indications.  Once a product is used outside the terms of its SPC, no such guarantees exist.  NHS Scotland guidance states that a medicine being used outside the terms of its SPC, can be included in a PGD in exceptional circumstances and where its use is justified by current best clinical practice.  The status of the product must be clearly indicated in the PGD. Those healthcare professionals involved in drawing up PGDs, and those supplying or administering under PGDs as authorised individuals, must use their professional expertise to ensure that the use of a product outside the terms of its SPC is appropriate given that there are no guarantees of safety, quality and efficacy.  Healthcare professionals must ensure that the benefits to patients will outweigh the risks. Practitioners must ensure that patients are informed that the product is being used out-with its license (‘off label’).   

A PGD cannot be used to supply or administer unlicensed medicines. To understand the difference between ‘off-label’ and ‘unlicensed’ use of medicines, please see the appropriate section of the NHS Borders Code for the Control of Medicines and the Prescribing Medicines in NHS Borders not on the East Region Formulary.

Please seek advice from the Pharmacy Department if required.

This could be a form or a specific record book.

The use of controlled drugs continues to be regulated under the Misuse of Drugs Act 1971 and the Misuse of Drugs Regulations 2001.  Currently, the following controlled drugs can be included in PGDs:

Schedule 2: Morphine and Diamorphine (Only registered nurses and pharmacists for the immediate necessary treatment of a sick or injured person (not permitted for treating addiction).  

Schedule 3: Only 1 Schedule 3 CD may be supplied/administered under a PGD (Midazolam).  Tramadol, Gabapentin, pregabalin, buprenorphine, temazepam etc. Cannot be supplied/administered under a PGD. 

Schedule 4(part ii): All Schedule 4 CD’s (Part I and II) except anabolic steroids and injectable CDs used for treating addiction.

Schedule 5: All Schedule 5 CDs permitted without additional restriction. drugs.  

See Appendix- Human Medicines Regulations 2012 – PGD Section

https://www.legislation.gov.uk/uksi/2012/1916/schedule/16/part/4/made

Professional Groups Who Cannot Use CDs Under PGDs

These registered professions cannot supply/administer any CD under ANY PGD (Schedules 1–5):

• Dietitians;
• Speech and language therapists;
• Dental therapists;
• Dental hygienists;
• Pharmacy technicians.

Example:-