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Legal Mechanisms of Medicine Use

Use The use of medicines in the UK is controlled by a very clear framework governed by the terms of the Medicines Act (1968). Radiographer supplementary prescribers must be absolutely clear that they understand this framework and the distinctions between the five core frameworks for medicines’ use which are as follows:

Supply and Administration Frameworks:

1. Patient Specific Direction (PSD)
2. Patient Group Directive (PGD)
3. Exemptions

Prescribing Frameworks: 

4. Supplementary Prescribing
5.
Independent Prescribing

1. Patient Specific Direction (PSD)

This relates to the supply and administration of medicines and is not a prescribing tool for the radiographer. A PSD is a written instruction from a prescriber for a medicine to be supplied and/or administered to a named patient or, to several named patients (e.g. patients on a clinic list).

The radiographer must only supply and/or administer the medicine in accordance with the instructions that are written by the prescriber; it does not require an assessment of the patient by the radiographer. It is not good practice for oral instructions to be acted upon except in emergencies.

For example, if a radiologist or oncologist writes the type, strength and amount of contrast agent to be given to a named patient then that is a PSD. A written record of instructions given under a PSD must be maintained.

The radiographer administering the medication is accountable for their actions and should be aware of the professional standards for administration of medicines.

2. Patient Group Direction (PGD)

This relates to the supply and administration of medicines and is not a prescribing tool for the radiographer.

A PGD is defined as

  • ‘ the supply and/or administration of a specified medicine or medicines, by named authorised health professionals, to a well-defined group of patients requiring treatment for the condition described in the PGD. The health professional must be registered. It applies to groups of patients who may not be individually identified before presenting for treatment.’2

PGDs may be used by a range of registered health care professionals (HCPs) acting as named individuals and having signed the PGD documentation. Assistant practitioners are not HPC registered and are not permitted by law to use PGDs.

A PGD provides a legal mechanism by which medicines can be supplied and/or administered to patients by a radiographer without first seeing a doctor or dentist. The radiographer thus:

  • accepts personal responsibility for working within PGDs
  • understands the legal implications of doing so
  • keeps up to date with any emerging safety concerns related to the medicines in the PGD

A radiographer can obtain a stock of medicine ahead of administration of the medicine to a patient when the radiographer is using a PGD as the legal framework of medicines use and the named medicine is listed within the PGD.

Medicines included under the scope of PGDs are most licensed medicines and prescription only medicines (POMs). Unlicensed medicines cannot be supplied and/or administered under a PGD.

The administration of radiopharmaceuticals continues to be regulated by the Medicines (Administration of Radioactive Substances) Regulations 1978 and should not be included in PGDs.

Radiographer Responsibilities regarding PGDs2

  • The radiographer must supply and administer the medicine in accordance with the instructions that are written within the PGD.
  • The radiographer must satisfy specific educational and other criteria laid down within the protocol and which are approved by a senior physician and a pharmacist
  • The radiographer working to a PGD is responsible for assessing that the patient fits the criteria in the PGD.
  • A PGD enables a radiographer 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 20005

PGDs are not valid in all healthcare delivery settings. The application of PGDs in clinical practice varies between the separate UK countries.

3. Statutory Exemptions

This is NOT a prescribing tool; it is a supply and administration framework.

Legislation has provided a number of exemptions to the POM order for named groups of healthcare professionals in order that they can sell, supply or administer to patients named medicinal products within the scope of their clinical practice. When a medicine is covered in the legislation by an exemption then the health professional does not need a Patient Group Direction (PGD), Patient Specific Direction (PSD) nor a prescription from an authorised prescriber. There are no exemptions that apply to radiographers at the present time.

4. Supplementary Prescribing

Supplementary prescribing allows a radiographer to prescribe prescription only medicines (POMs), pharmacy (P) medicines and general sale list (GSL) medicines as part of a clinical management plan (CMP) agreed with the independent prescriber relating to a named patient and to that patient’s specific condition.

The terms of use and definition of a CMP are defined in law and for a CMP to be legally valid, the independent prescriber must be a doctor or a dentist only.

5. Independent Prescribing

Currently this is not an option for radiographers- but it may change in the future. There is a strong case for progression to Independent Prescribing for physiotherapists and podiatrists. There is some evidence supporting a progression to Independent Prescribing for radiographers but less than that which exists for physiotherapists and podiatrists. 5

 

 

 

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