Patient Specific Directions (PSDs) and Patient Group Directions (PGDs)
Patient Specific Directions (PSDs)
The Medicines Act 1968 does not permit nurses who are not qualified prescribers to administer or supply prescription only medicines (POMs) unless one of three types of instruction are in place
- signed prescription
- signed Patient Specific Direction (PSD)
- Patient Group Direction (PGD)
If non-prescribing health care professionals are to administer a medicine on the instruction of a GP, the GP must be able to show that they have appropriate mechanisms in place to ensure that their practice meets statutory requirements. Since these mechanisms for supply and administration are statutory, the fact that a practice has followed them is mitigation to any ensuing liability.
A Patient Specific Direction is a written instruction from a doctor or dentist or other independent prescriber for a medicine to be supplied or administered to a named patient.
primary care: a prescription or simple written or electronic instruction in the patient's notes (NB. This includes a letter from a consultant to the GP requesting that the patient commence on zoladex )
secondary care: instructions on a patient's ward drug chart
PSDs do not limit those who can supply or administer the medicine. For example, a suitably trained health care assistant can do so, even though they cannot work under a PGD.
PSDs are also often used in relation to the administration of vaccinations for named patients as well as Depo-Provera, B12 and Zoladex.
Template PSD available for use if you wish
Patient Group Directions (PGDs)
PGDs in the South West (includes Dorset, BaNES, Swindon & Wiltshire)
The GPC’s guidance on Patient Group Directions (PGD) and Patient Specific Directions (PSD) in General Practice has been updated to clarify the rules surrounding private PGDs. Please click here to read the latest guidance: Patient Group Directions and Patient Specific Directions in General Practice January 2016
Guidance is also available on the Drugs and Prescribing page https://www.bma.org.uk/advice-and-support/gp-practices?
Patient Group Direction use in Primary Care Networks - https://www.sps.nhs.uk/articles/patient-group-direction-use-in-primary-care-networks/
The BMA/GPC advice changed in August 2010.
A Patient Group Direction is a written instruction for the supply and/or administration of a named licensed medicine for a defined clinical condition. PGDs allow a range of specified registered health care professionals to supply and/or administer a medicine directly to a patient with an identified clinical condition without them necessarily seeing a prescriber. The health care professional working within the PGD is responsible for assessing that the patient fits the criteria set out in the PGD.
PGDs are intended to improve patient care by enabling registered health professionals other than doctors to supply and/or administer medicines to patients.Examples of where PGDs may be appropriate are services where assessment and treatment follows a clearly predictable pattern (eg immunisation, family planning).
In general practice they can be used to enable registered nurses to administer a prescription only medicine to a group of patients who fit the criteria specified in the PGD, for example, to administer vaccinations.
The following may supply or administer medicines under a patient group direction
- registered nurses
- health visitors
- ambulance paramedics
- occupational therapists
- speech and language therapists
- prosthetists and orthotists
Note that they can only do so as named individuals.
Particulars to be included in a patient group direction
- The period the Direction shall have effect
- The description or class of POM (Prescription Only Medicine) to which the direction applies
- Whether there are any restrictions on the quantity of medicine which may be supplied on any one occasion, and if so, what restrictions
- the clinical situations which POMs of that description or class may be used to treat
- the clinical criteris under which a person shall be eligible for treatment
- whether any class of person is excluded from treatment under the Direction and, if so,what class of person
- whether there are circumstance in whigh further advice whould be sought from a doctor or dentist and,if so, what circumstances
- the pharmaceutical form or forms in which POMs of that description or class are to be administered
- the strength or maximum strength at which POMs of that description or class are to be administered
- the applicable dosage or maximum dosage
- the route of administration
- the frequency of administration
- any minimum or maximum period of administration applicable to prescription only medicines of that description or class
- whather there are any relevant warnings to note and, if so, what warnings
- whether there is any follow up action to be taken in any circumstances and, if so what action and in what circumstances
- Arrangements for referral for medical advice
- Details of the records to be kept of the supply, or the administration , of medicines under the Direction
Frequently asked questions
Who in the practice needs to sign a PGD?
The authorising GP needs to sign a PGD naming the specific health care professionals who the PGD will apply to. In addition, the GPC and NMC recommend that the health care professional acting under the PGD must also sign the PGD.
Can electronic signatures be used on a PGD?
The Specialist Pharmacy Service (SPS) have a webpage giving details about electronic systems and PGDs. It says that "The MHRA have confirmed that electronic systems can be used to authorise a PGD". You are recommended to read the guidance in full on the SPS website.
Can nurses who are not qualified prescribers administer or supply a prescription only medicine?
Yes. A GP can instruct a named practice nurse to supply or administer medicines to a patient. However medicines may only be administered by a practice nurse if one of three types of instruction are in place
- a signed prescription
- a signed Patient Specific Direction (PSD)
- a Patient Group Direction (PGD).
If one of these three options is not in place then the Medicines Act (1968) has been breached
Can a nurse independent prescriber administer a POM without a PSD or PGD in place?
Yes. Nurse independent prescribers do not require a PSD or PGD in order to administer a POM. Under the Medicines Act a nurse independent prescriber is able to administer any licensed medicine for any medical condition within their competence, including some controlled drugs for specified medical conditions.
What needs to be included in a PSD?
There is no set format for PSDs written into the legislation and you do not have it define an instruction as one. However a PSD must:
- state the name of the patient
- state the name and dose of the prescription only medicine to be administered
- show evidence to confirm that the patient has been considered as an individual.
A PSD may be a written or electronic instruction from the GP to the nurse in the patient record, relating to a specific individual patient.
Thus a verbal instruction or letters of invitation to a patient are not suitable.
A list of individually named patients to be treated with a named POM, signed by a doctor/prescriber would constitute a PSD in general practice, providing that each patient on the list has been considered individually by the doctor.
Practices must have protocols in place for their staff to follow to administer a POM using a PSD.
Can a nurse prescriber authorise a PSD?
Yes. Nurses may prescribe from the formulary linked to their recorded qualification. Nurse prescribers may issue a PSD and instruct another health care professional to administer the medicine.
When can PGDs be used in general practice?
In some circumstances, where assessment and treatment follows a clearly predictable pattern (for example where nurses are administering travel or childhood vaccinations) practices may find it beneficial to have an agreed PGD in place so that a GP does not have to give a specific instruction for each individual patient.
Nurses using PGDs must have been assessed as competent to use them and must comply with the standards set by their professional regulatory body the NMC (The Standards for Medicine Management1).
A PGD enables a nurse to supply and / or administer prescription-only medicines to patients using his / her own assessment of patient need, in accordance with the criteria set out in Schedule 7, Part I of Statutory Instrument 2000 No. 1917 - The Prescription Only Medicines (Human Use) Amendment Order 2000 (see below).
If there is no PGD in place then the nurse must have an individual instruction for that patient. This can be a PSD, or signed prescription.
Do PGDs apply to HCAs?
No. The Medicines Act does not allow HCAs to administer POMs under a PGD, as they are not included in the list of 'authorised' persons . An authorised person is one who is professionally regulated - HCAs therefore have to use a PSD or signed prescription as authority.
Can PGDs be used in General Practice to administer non-NHS treatment?
Under the Medicines Act GP practices are not permitted to use PGDs to enable nurses to administer treatment in NHS GP practices in non-NHS circumstances, for example providing private travel vaccinations such as Yellow Fever, Rabies, Meningitis etc.
Patient Specific Directions must be used in these circumstances unless they are independent prescribers. The National Travel Health Network and Centre (NaTHNaC) has proposed an amendment to the Medicines Act 1968 to the Department of Health to allow the use of PGDs in non-NHS circumstance, and the GPC supports this amendment.
Can PGDs be used for travel clinics?
PGDs are useful for NHS travel health services as in many practices these are delivered by practice nurses who have a special expertise in that field. However they can only be used for those treatments which are provided on the NHS and not for private treatment.
So where Hepatitis B vaccination can be given for travel and the patient is charged, a PGD cannot be used, but if it is given on the NHS then it can be administered under a PGD. This presents difficulties for some practices as many PCOs are trying to get practices to give Hepatitis B for travel as a private service which would make them ineligible for administration under a PGD and thus make the administration of the travel service more complex.
Can a GP sign off a PGD?
Not in the NHS. A PGD can only be signed off by a PCO when it applies to an NHS practice; if it is not signed off by the PCO, then it is not valid. This means that NHS practices are dependent on PCOs for the signing off of PGDs and can lead to PCOs using them to control or influence medicines use.
However GPs can be commissioned to provide clinical governance sign off for a PGD for a private practice or a private travel clinic (even though they cannot do so for their own NHS practice or clinic).
Can a PCO demand that a practice adopts a PGD for a particular POM?
No. The practice can determine how it wishes to organise the administration of medicines.
Can a PCO withdraw PGDs for certain medicines?
PCOs may try to do this in order to influence medicines use in the area. There is nothing in the legislation that states that PCOs have to develop PGDs, they merely have to authorise them.
If GP practices develop their own PGDs it would be difficult for a PCO to justify not approving it if all the conditions listed above have been met and there is a clinical need for the service. In this situation they would not be adhering to their obligations and duties to administer and provide health care to the public as set out in the NHS Act 2006.
Practices should, with LMC support, raise this with the PCO in writing justifying why a PGD is needed and clinical evidence of the need and quoting the PCO's duties under the NHS Act and the amendment to the Prescription Only Medicines (Human Use) Order 1997 The Prescription Only Medicines (Human Use) Amendment Order 2000.
LMCs in their turn should support practices whose reasonable needs for a PGD are not being met by PCOs, especially where this is being done not on clinical grounds, but to manage prescribing. Please contact the GPC firstname.lastname@example.org for assistance this.
If there are difficulties with the use of or production of PGDs then the practice can use patient specific directions where possible in order to continue providing the service though this may be a far less suitable and flexible method.
Can PCOs use PGDs as a performance management tool by putting unreasonable terms in them, for example excessive training requirements?
PGDs were intended to improve patient care by enabling registered healthcare professionals other than doctors to supply and / or administer medicines to patients.
It is unreasonable and obstructive for PCOs to use PGDs to manage the way practices provide services. Only information listed above in Schedule 7, Part I of Statutory Instrument 2000 No. 1917 - The Prescription Only Medicines (Human Use) Amendment Order 2000 needs to be included in a PGD and if anything else is added by a PCO the practice should contact their LMC and raise these concerns before signing it.
Can PGDs be used to administer Botox?
No. The administration of medicines (such as Botox®, Vistabel® or Dysport®) to paralyse muscles which cause wrinkles requires assessment of individual patients' suitability and (if the administration is to be delegated to a nurse or other person) patient specific directions. PGDs or general directions which would apply to any patient with an appointment on a particular day are not sufficient. In any case PGDs cannot be used to for private services in an NHS practice.
How long do you need to retain PGDs?
“PGD documentation includes master authorised (signed) copies of PGDs, lists of authorised practitioners and patient supply/administration records, including electronic records/agreements.
The same rules apply to PGD records as to all other patient records:
- For adults all PGD documentation in a patient’s clinical record must be kept for eight years.
- For children all PGD documentation in a patient’s clinical record must be kept until the child is 25 years old or for eight years after a child’s death.
- Where a PGD is for an implant in an adult then all PGD documentation in a patient’s clinical record must be kept for 10 years. For example this would apply to contraceptive and sexual health PGDs for contraceptive implants or drug eluting coils.
- Staff authorisation records should be kept for 8 years after the expiry date of the PGD if the PGD relates to adults only (10 years if relates to an implant) and for 25 years after the expiry date of the PGD if the PGD relates to children.
- The final authorised copy of the PGD should be kept for 8 years after the expiry date of the PGD if the PGD relates to adults only (10 years if relates to an implant) and for 25 years after the expiry date of the PGD if the PGD relates to children.
- The main content of a PGD (i.e. an unauthorised final copy), which contains no patient identifiable information or staff authorisation records, may be retained by an organisation for up to 20 years for purposes of business planning/continuity if there is reason to do so (i.e. reference for future PGDs).”
Guidance on developing a private PGD
PSD for “group” administration e.g. flu vaccines
We do have to be mindful of the guidance around PGDs & PSDs and ensure we fulfill the recommendations.
What is a PSD?
“A written and authorised instruction to administer a medicine to a list of individually named patients where each patient on the list has been individually assessed by that prescriber. The prescriber must have adequate knowledge of the patient's health and be satisfied that the medicine to be administered serves the individual needs of each patient on that list.
A written instruction applying to a group of patients where the patient/s are not individually identified i.e. a PSD could not state ‘All patients attending the practice’s ‘flu vaccine clinic on date dd/mm/yyyy’ but needs to be a list of all named patients due to attend the clinic who have been individually assessed by the prescriber as suitable for treatment and be signed and dated by a prescriber (this does not need to be completed for each entry but can be once for the entire list).” https://www.sps.nhs.uk/wp-content/uploads/2013/03/PSD-final-July-2018.pdf
This is a link to a group PSD adapted from one written by Diane Coulthard who is an excellent trainer in vaccinations and immunisations. You could adapt this in your practice to allow HCAs and staff not directly employed by the practice and not non-medical prescribers e.g. paramedics/pharmacists to administer flu vaccines.
In addition, we would recommend that the following needs to be put in place;
The PSD must clearly identify which flu vaccine is to be administered under this specific PSD i.e. Quadrivalent or Trivalent as there should be a separate PSD for each vaccine. This may require practices organising separate clinics for administration of each vaccine.
The person signing the PSD must be satisfied that they are not aware of any contraindications to the patients on the list receiving the stated vaccine, as they are taking responsibility for making the clinical decision.
The person signing the PSD must be confident that they are singing that the person administering the vaccine is competent, has received training in administering the flu vaccines, is aware of the cold chain policy, clinically supervised and has attended annual up to date training around basic life support, management of anaphylaxis and use of the defibrillator.
There should be a record in the patients notes that the vaccine has been administered via a PSD. You would benefit from speaking to your IT person to add in a short cut key or read code.
The printed list of patients under the PSD should be retained for at least 2 years and preferably stored electronically.
As with all vaccines the patients name, DOB, type of vaccine, expiry date, vaccine code, method of immunisation and site of injection should be recorded in the patients notes together with patients consent to administration.
HCAs & Immunisations/PSDs
The following is taken form the RCN document Health Care Support Workers Administering Inactivated Influenza, Shingles and Pneumococcal Vaccines for Adults and Live Attenuated Influenza Vaccine (LAIV) for Children
Questions about Patient Specific Directions (SPS, 2018) states the following:-
- The prescriber is responsible for assessment of the patient and the decision to authorise the supply/administration of the medicine(s) in question.
- The prescriber has a duty of care and is professionally and legally accountable for the care they provide.
- The prescriber must be satisfied that the person to whom the administration is delegated has the qualifications, experience, knowledge and skills to provide the care or treatment involved.
This is also clear within the GMC’s (2014) Good medical practice guidance and the NMC’s (2018) The Code for nurses and midwives.
HCSWs must not be placed in a position where they need to make standalone clinical judgment calls in relation to vaccine administration. The HCSW needs to be able to promptly liaise and discuss issues with a registered health care professional who is available on site (whether they are in a primary care, school or hospital setting). For practical and general administration issues, this can be any registered health care professional but for medicines and prescribing clarification the registered prescriber needs to be available.
All registered professionals must adhere to their codes of conduct, standards of practice and delegation principles (NMC, 2018; GMC, 2014; HCPC, 2016; GPhC, 2017).