Delegation of supply or administration of medicines using a PGD

Sarah Cavanagh, Deputy Director, Medicines Use and Safety Division, Specialist Pharmacy ServicePublished

Summary

This page explains why delegation of supply or administration using a PGD is not possible.  A set of common scenarios are given to illustrate the point.

National guidance on delegation

NICE guidance

NICE MPG 2 Patient Group Directions 2017 states: When practising under a PGD, health professionals should not delegate their responsibility.

MHRA guidance

The Medicines and Healthcare Regulatory Agency (MHRA) has confirmed ((can we give a date for this)) that:

  • Administration of an injectable medicine must not be delegated under a PGD. The only exception to this is where a medicine has been supplied under a PGD and is to be administered for the purpose of saving life in an emergency (as listed in Human Medicines Regulations Schedule 19, Regulation 238).
  • If the PGD only covers supply of a non-injectable medicine by the health professional named in it, then it can be given to the patient for self-administration or for administration by another person. The law requires that administration of the supplied medicine is in accordance with the PGD and so the PGD should specify that the medicine is supplied for subsequent administration and it is labelled appropriately.

Scenarios

The following scenarios provide examples to help interpret the law into practice.

Scenario: Medicines supplied using a PGD for administration by relatives or carers

Injectable medicines:

Relatives and carers cannot administer injectable medicines under a PGD.

It is not within the law to inject prescription only medicines to another person unless you are a prescriber or acting under the directions of a prescriber. If an injectable medicine needs to be supplied for a parent/carer or other health practitioner to administer, a prescription or Patient Specific Direction from a prescriber will be required to authorise the administration.

Other medicines:

Relatives and carers can administer non-injectable medicines under a PGD.

The law does restrict who may administer non-injectable medicines supplied under a PGD (e.g. a “to take home” (TTO) pack for a non-injectable medicine) providing they are administered with the patient’s consent.

The PGD should contain details of the relevant advice that must be provided to the patient and/or their relative/carer to ensure that the medicine is administered as intended by the practitioner making the supply. Medicines that are supplied for subsequent administration outside the clinic setting must be appropriately labelled and contain a product information leaflet.

Scenario: A community nurse using a PGD to supply a medicine for subsequent administration by a care worker in another organisation (e.g. a care home)

Injectable medicines:

An injectable medicine cannot be supplied under a PGD for another person to administer.

It is not within the law to inject prescription only medicines to another person unless you are a prescriber or acting under the directions of a prescriber. If an injectable medicine needs to be supplied for a parent/carer or other health practitioner to administer, a prescription or Patient Specific Direction from a prescriber will be required to authorise the administration.

Non-injectable medicines:

Where the PGD clearly covers supply only by the healthcare professional of a non-injectable medicine, then it can be given to the patient for self-administration or for administration by another person.  However, the PGD should specify that the medicine is supplied for subsequent administration. The PGD should also contain details of the relevant advice that must be provided to the patient and/or their relative/carer.

Care worker location:

In the scenario (where a non-injectable medicine is supplied under PGD for administration within another care setting) the organisation providing the care must decide who may be authorised to administer medicines within their local medicines policies and governance arrangements.

Those authorised by their employing organisation to subsequently administer medicines supplied under the PGD (e.g. care home workers) must be appropriately trained and competent to do so. NICE SC1 Managing Medicines in Care Homes 2014 gives further information on managing medicines in care homes.

Scenario: Supplying low molecular weight heparin (LMWH) injection to patients in a pre-operative assessment clinic prior to hospital admission

A PGD is suitable here, but only if the patient will self-administer the injections.

It is not within the law to inject prescription only medicines to another person unless you are a prescriber or acting under the directions of a prescriber. If an injectable medicine needs to be supplied for a parent/carer or other health practitioner to administer, a prescription or Patient Specific Direction from a prescriber will be required to authorise the administration.

Scenario: A student nurse, practising injection technique under supervision, and administering an injection supplied by a healthcare professional using a PGD

A PGD is not suitable here.  This scenario represents delegation by the registered, authorised health professional to the student nurse. Delegation is not allowed under a PGD under any circumstance.

In addition, NICE MPG 2 Patient Group Directions 2017 2017 states that PGDs are not suitable for health professionals who are undergoing relevant training, for example, for administering intramuscular injections.

We’ve also produced some guidance on this issue

Scenario: A nurse identifies a patient need for oral bowel cleansing medicines (prior to a procedure) and instructs a hospital secretary to post the product to the patient using a PGD

A PGD is not suitable here, since this is delegation of supply and is not allowed.

In addition, with reference to the supply of bowel cleansing medicines, organisations should refer to NPSA Rapid Response Report RRR012: Reducing risk of harm from oral bowel cleansing solutions.

Scenario: A pharmacist in community pharmacy instructs a pharmacy assistant or technician to supply varenicline following an assessed using a PGD

A PGD is not suitable here, since this is delegation of supply and is not allowed.

In this scenario, the pharmacist must assess the client and must also supply the medicine according to the PGD. However the assistant or technician could gather background information from the patient to support the pharmacist’s assessment.  They could also provide additional information to the patient.

However an authorised registered healthcare professional should, when supplying under a PGD, personally make the supply of the patient pack to the patient at the time of consultation- the supply cannot be delegated to another person following assessment by the authorised healthcare professional.

Scenario: A registered nurse working in a prison supplies a medicine using a PGD, with administration undertaken subsequently by another healthcare professional

Injectable medicines

An injectable medicine cannot be supplied under a PGD for another person to administer.

It is not within the law to inject prescription only medicines to another person unless you are a prescriber or acting under the directions of a prescriber. If an injectable medicine needs to be supplied for a parent/carer or other health practitioner to administer, a prescription or Patient Specific Direction from a prescriber will be required to authorise the administration.

Non-injectable medicines

If the medicine supplied under the PGD is a take-away pack for a non-parenteral (non-injectable) medicine, it is within the law for the PGD to be used for “supply only”. The PGD should specify that the medicine is supplied for subsequent administration. Another person may administer a non-injectable medicine as necessary.

Scenario: A nurse uses a PGD to supply a medicine and directs a patient to a pharmacy to complete the supply (e.g. using a voucher)

A PGD is not suitable here, since this is delegation of supply and is not allowed.

The nurse may direct a patient to a pharmacist to obtain a recommended product but any decision to supply would only be made once the supplying pharmacist had independently carried out an assessment of the patient and is satisfied that an appropriate medicine is being supplied.

Scenario: A nurse uses a PGD to supply the nasal live attenuated influenza vaccine (LAIV) to a child for subsequent administration by a healthcare support worker

A PGD is suitable here, provided the PGD states supply for subsequent administration. LAIV is a non-injectable medicine. In addition, guidance has been provided ((by whom and when)) that LAIV does not need to be labelled if it is administered to a patient before they leave the clinic setting.

Scenario: A registered nurse in a hospital using a PGD to supply a medicine for an inpatient which will then be administered by another healthcare professional

If the PGD clearly only covers supply of a non-injectable medicine by the health professional named in it, then it can be supplied to the patient for self-administration or for administration by another person; however, this should not be routine practice but reserved for use where it is locally deemed necessary to improve patient care or safety.

The law requires that administration of the supplied medicine is in accordance with the PGD and so the PGD should specify that the medicine is supplied for subsequent administration.

The majority of clinical care should be provided on an individual, patient-specific basis and PGDs reserved for those limited situations where this offers an advantage for patient care without compromising patient safety.  In all environments prescribing on an individual patient basis by medical and non-medical prescribers should be undertaken in preference to PGD use.

If used a PGD should contain details of the relevant advice that must be provided to the patient and/or their relative/carer including administration details.  All relevant documentation must be completed by the person making the supply under the PGD including any clinical records in line with local policy as must associated administration records.

Those authorised by their employing organisation to subsequently administer medicines supplied under the PGD (e.g. nurse or healthcare support worker) must be appropriately trained and competent to do so.

An example of this in practice is the supply of MRSA decolonisation products under a PGD by an infection control specialist nurse in an inpatient environment to prevent a delay in starting treatment although other examples may exist.

Scenario: A pharmacist delegating use of a PGD, that they are named on, to another pharmacist (e.g. a locum covering a day off)

A PGD is not suitable here. Only the qualified professional who has been authorised to operate under a PGD can do so. They cannot delegate this responsibility to another person.

In this scenario, the locum would also need to be authorised to operate under the PGD.

Scenario: A pharmacist remotely assessing patients, then using a PGD to supply medicines via another pharmacist or other member of the pharmacy team (who happen to be in the same location as the patient)

A PGD is not suitable here. This is delegation of supply. An authorised registered healthcare professional should, when supplying under a PGD, personally make the supply of the patient pack to the patient at the time of consultation: the supply cannot be delegated to another person following assessment by the authorised healthcare professional.