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Appendix

Key legislation and definition of terminology

Medicines use in the UK is controlled by the terms of the  Human Medicines Regulations 2012 which provide the legislative framework for medicines use in the UK. Radiographer prescribers must understand the various medicines frameworks available to them.

Administration framework

The Patient Specific Direction (PSD) – A PSD is a written or electronic instruction from a prescriber for a medicine to be administered to a named patient. It relates to the relationship between the prescriber and another professional. A radiographer must only administer the medicine in accordance with the instructions that are written by the prescriber. Instructions should be written, although in a genuine life threatening emergency an oral instruction may be given.

Supply and administration frameworks

The Patient Group Direction (PGD) –This is not a prescribing tool for the radiographer. A senior doctor and a senior pharmacist, in conjunction with the radiographers who will use the tool, define in writing the named medicines that may be supplied and/or administered to groups of patients who may, or may not, have been individually identified prior to treatment. The PGD must be drawn up in a specific way in order to be legally valid. The radiographer, who must be named in the PGD, must supply and administer the medicine in accordance with the instructions that are written within the PGD. PGDs are not valid in all healthcare delivery settings.

Exemptions – This is not a prescribing tool. Specific pieces of law allow certain listed medicines to be supplied and administered to patients by certain health professional groups without the need for another appropriate prescribing or supply/administration framework. There are no Exemptions that apply specifically to radiographers.

Prescribing frameworks

Supplementary prescribing – This allows a radiographer to prescribe in partnership with a doctor or dentist. The medicines to be used must be defined in writing within a Clinical Management Plan (CMP) and be appropriate to the needs of the named patient. Supplementary prescribing requires the involvement of a doctor or dentist, the supplementary prescriber and the patient. The terms of use and definition of ‘’Clinical Management Plan‟ are defined in law. For a CMP to be legally valid, the independent prescriber must be a doctor or a dentist. Supplementary prescribing can be used to prescribe licensed medicines, unlicensed medicines, mixed medicines and all controlled drugs.

Independent prescribing – This allows a radiographer to autonomously prescribe, as well as supply and administer medicines to individual named patients appropriate to the needs of the named patient. While the principles of prescribing are the same, non-medical independent prescribers are different from medical prescribers in terms of restrictions and context within which they prescribe, therefore doctors and non-medical independent prescribers are not directly comparable with each other in their activities. 

Categories of medicine

General Sales List medicines (GSL)

These products can be sold with reasonable safety without the supervision or advice of a doctor or pharmacist, and may be obtained through a variety of outlets. All GSL medicines must hold a valid UK product license and all the active ingredients must be listed in the product. Regulations restrict the pack sizes and quantities of the medicine that may be sold without supervision. Larger volumes may only be sold under supervision (P class) or prescription (POM class). An example of this would be paracetamol that is limited to 16 tablets under GSL terms, but may be supplied in larger quantities under P or POM terms.

Pharmacy sale medicines (P)

These products can be sold with reasonable safety from premises that are under the supervision of a pharmacist but without the need for a written prescription. The products may be available for self-selection by the general public but a pharmacist is aware of the purchase at the point of sale.

Both GSL and P class medicines are known as “over-the-counter‟ (OTC) medicines as they can be sold and supplied (in some cases only at certain low volumes) without a written prescription for supply.

Prescription only medicines (POM)

The Human Medicines Regulations 2012 define those medicines that must be classed as POM and include those that: 

  • contain certain listed substances 
  • are controlled drugs 
  • are for parenteral (ie injection) administration (with the exception of insulin) 
  • emit radiation 
  • come under other listed criteria.

POMs may only be sold, supplied and administered in accordance with a written prescription by an appropriate practitioner and dispensed from a registered pharmacy or dispensing doctor’s practice.

The Human Medicines Regulations 2012 defines “appropriate practitioner” for the purposes of issuing written prescriptions as: 

  • doctor, dentist , vet
  • independent nurse prescriber
  • independent pharmacist prescriber 
  • independent optometrist prescriber
  • independent physiotherapist prescriber
  • independent podiatrist prescriber 
  • supplementary prescriber acting under a written Clinical Management Plan (CMP) - nurse, pharmacist, podiatrist, physiotherapist, radiographer, optometrist. 

A radiographer who is annotated on the Health and Care Professions Council (HCPC) register as a Supplementary Prescriber may only prescribe POMs under a written Clinical Management Plan (CMP). Those annotated as both an independent and supplementary prescriber may use both frameworks.  Regulations require that POMs may not be advertised to the general public, only marketed to health professionals, and there is blanket ban on the advertising to the public of certain treatments for certain specified medical conditions such as cancer.

Controlled Drugs

The Misuse of Drugs Act 1971 controls certain types of drugs that may be liable to misuse and abuse because of their effects on users. Schedule 2 of this Act lists the drugs subject to these specific controls and it categorises the drugs into one of three classes: Class A, Class B and Class C. The term “controlled drug” is used to refer to drugs within these three categories.

The Misuse of Drugs Regulations 2001 permits the use of controlled drugs in healthcare and further classifies controlled drugs as one of five Schedules that reflect the differing levels of control required for use of each category of drug. Controlled drugs are also subject to specific regulations pertaining to the storage and documentation required for their use.

Further changes to home office regulations will be required for therapeutic radiographers to independently prescribe controlled drugs.

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