This guide has been written in response to the many enquiries that we have received about the development and use of PGDs in radiology services. It has been written in consultation with and agreed by the SPS Website PGD Board and the Society & College of Radiographers.
The article is intended to be read as a whole to help provide the full context in practice and to inform and support decision making when considering whether a PGD is a safe and appropriate mechanism in radiology services, particularly where contrast media are being used. An update to this advice issued in December 2016 has been added in Spring 2018 – this has been added towards the end of the document (in bold type).
Before a patient may receive a medical exposure of ionising radiation, there are specific clinical circumstances that must be considered at each stage of the patient pathway.
There are separate legal frameworks to consider – the authorisation of the medical exposure to ionising radiation and the authorisation of the supply and administration of medicines. One does not confer legal authority for the other.
The Ionising Radiation (Medical Exposure) Regulations (IR(ME)R) 2000 (1) is legislation which provides a framework intended to protect patients from the hazards associated with ionising radiation.
Responsibility for compliance with IR(ME)R firmly rests with the Employer and all of the “entitled” duty holders as defined in the Regulations. Specific individuals will be named and entitled to undertake these roles within each radiology department.
Both IR(ME)R Referrers and Practitioners are required to assess the patient’s clinical needs and suitability for a particular medical exposure.
Before a request for clinical imaging is accepted, the IR(ME)R Practitioner, who must be a registered healthcare professional, makes a judgement to justify and authorise the exposure of a patient to ionising radiation. To perform this action, the request for the exposure is assessed against the clinical data supplied by the Referrer. The Practitioner must have had adequate training and be competent to consider the potential detriment of the exposure against the potential benefits for that individual. (2)
The practitioner may allocate the task of authorisation of a requested medical exposure to an entitled IR(ME)R Operator (Regulation 6) but the practitioner retains responsibility for its justification. This requires the Operator to follow precisely the authorisation guidelines provided by the Practitioner. (2) After reviewing the referral form and if the referral is accepted, the IRMER Practitioner justifies the medical radiation exposure required.
If the examination requires the use of contrast media or other adjunct medicines, then the Operator must also have a legal authority to be able to administer that medicine. This requires careful consideration.
A locally agreed clinical imaging protocol does not in itself confer any legal authority to the Radiographer or any other healthcare professional to administer any medicines specified within that protocol.
The preferred way for patients to receive medicines is for a prescriber to provide care for an individual patient on a one to one basis.
At the time of patient presentation to the radiology department, further assessment is required such as confirmation of current renal status, allergies and pregnancy status. This is over and above the normal IR(ME)R checks being undertaken by the IR(ME)R Operator (normally a Radiographer).
The Faculty of Clinical Radiology Standards for Intravascular Contrast Agents (Third Edition 2015) state that “a formal record for the decision to inject contrast should be made before administration and that how this will be achieved depends on local circumstances and pathways of care”. PGDs are mentioned as one of the options available.
Some organisations looking to improve local medicines governance arrangements in response to changing pathways of service delivery in radiology services have developed PGDs. PGDs have been used as a bridging mechanism to support the transition of service delivery models following local review of current arrangements, including prescribing, whilst working to maintain safe medicines optimisation practices.
The Specialist Pharmacist for PGDs has received several requests for PGDs for administration of contrast media and other medicines for administration in radiology services.
Following discussions with the Society & College of Radiographers, members of the PGD Board and other networks, a number of PGDs from various NHS Trusts were obtained.
During the course of sourcing practice examples, it became apparent that the development and the decision making around contrast media PGDs was often problematic. The PGDs had generally proved very difficult to write which could be a reflection that a PGD is not the most suitable framework to support the provision of medicines within the current patient pathway.
Patients who are referred to a radiology service require assessments at different stages of the care pathway even when the procedure is routine.
Whilst the processes and steps that are considered necessary when making decisions about exposure to radiation and the safe administration of contrast media are sometimes compared, they do not lend themselves to the requirements of to the specification required by PGD legislation and PGDs NICE Medicines Practice Guideline 2 2013.
A PGD must be a stand alone written instruction for the registered health professional to follow and all the information that they need should be within it to make the decision to administer the medicine. If practice requires clinical judgement beyond the written instruction within the PGD, then a PGD is not appropriate.
In conclusion, whilst PGDs for administration of contrast media are currently being used in radiology services to bridge a gap created by service model change, they should only be used as an interim solution and as part of an agreed plan towards individualised patient medicines optimisation. Current local systems and processes should be reviewed by a multi-disciplinary team during this interim period to identify an opportunity in the patient pathway for these medicines to be prescribed with utilisation of medical or radiologist or independent non-medical prescribing.
In addition, PGDs used for the supply and/or administration of other medicines in radiology should be carefully considered in line with PGDs NICE Medicines Practice Guideline 2 2013 to ensure that patients receive all of their medicines in the most appropriate, safe and timely, manner.
In March 2018 the Royal College of Radiologists (RCR), the Society and College of Radiographers (SCoR), NHS England, the MHRA, the Specialist Pharmacy Service (SPS) and other professionals within the field of radiology met to discuss the practical implications of this SPS guidance and how the supply and administration of contrast media can be managed without compromising patient access and care.
The SPS guidance released in 2016 advised that PGDs were not a suitable mechanism for the administration of contrast media for the reasons detailed within the guidance. This position remains unchanged.
However it is appreciated that the impact of this guidance may lead to service delivery issues as no other mechanisms for administration had been determined at the time the guidance was released.
At the March 2018 meeting, NHS England agreed to explore further work to scope alternative mechanism to enable the safe and effective administration of contrast media by radiographers focusing on the potential use of exemptions within the Human Medicines Regulations (2012). However such mechanisms require legislative change which will take time to be realised.
Therefore it was determined that a pragmatic interim approach was required. SPS have worked with the RCR and SCoR and specialist radiographers and pharmacists to produce exemplar PGD templates for commonly used contrast media which can then be adopted by NHS organisations. The aim of these templates is to produce a consistent presentation which has been reviewed by specialists within the field who will ensure that the legislative and clinical parameters have been fully considered and accomplished as far as is possible. It is intended that these PGDs will remain available (and will be updated as required) until other mechanisms for administration are in place.
Five iodine contrast PGD templates were released in January 2019 and five gadolinium contrast PGD templates in April 2019 – these can be accessed via the link below.
Advice on the preparation and/or administration of contrast agents supplied under a Patient Group Direction (linked below) was published in August 2020 (see below).
1 The Ionising Radiation (Medical Exposure) Regulations 2000, Statutory Instrument No. 1059. London, UK: HMSO 2000. http://www.legislation.gov.uk/uksi/2000/1059/made (Accessed Sept 2016)
2 A guide to understanding the implications of the Ionising Radiation (Medical Exposure) Regulations in diagnostic and interventional radiology. A joint document by the Society and College of Radiographers, British Institute of Radiology and The Royal College of Radiologists (2015) The Royal College of Radiologists, http://www.sor.org (Accessed Sept 2016)