Q1: There is an ongoing debate among therapeutic radiographer independent Non Medical Prescribers as to whether we are allowed to prescribe codeine or Oramorph without a clinical management plan? Some say that we can as it's a schedule 5 drug, others say that we can't as it's a schedule 2 class B drug and nobody seems clear as to whether it's a controlled drug or not. Does it depend on the strength? Or does it depend on the Trust?
A: Codeine and morphine can only be prescribed by a radiographer using supplementary prescribing under a clinical management plan (CMP)
When the legislation was changed to allow for therapeutic radiographer independent prescribing the first piece of legislation (Human Medicines Regulations 2012) was changed to allow a limited list of controlled drugs to be prescribed. However, another piece of legislation called the Misuse of Drugs Regulations 2001 also needs to be amended. Until this change happens therapeutic radiographer independent prescribers cannot independently prescribe controlled drugs from any schedule.
The legislation around controlled drugs is complex. When a medicine is classified as a controlled drug it is then placed into a schedule. For therapeutic purposes these will be schedule 2, 3, 4 or 5. Sometimes the schedule is due to the drug, sometimes the strength or the formulation. This means for example that morphine injection 1mg per 1 ml is a schedule 2 controlled drug but that morphine oral solution 10mg in 5ml is in schedule 5.
The schedules are important because there are different legal requirements associated with them. However, for this particular question it is that fact that the drugs in question are classified as controlled drugs in any schedule that is important. You can find out which drugs are classified as controlled drugs here.
Nevertheless, if there is a clinical management plan (CMP) in place and the medicines are being prescribed under supplementary prescribing then controlled drugs from schedules 2-5 can be prescribed (but not for treating addiction).
The Society and College of Radiographers are actively working with stakeholders to try to get the amendments to the Misuse of Drugs Regulations 2001 agreed.
Q2: I am an independent sector (IS) employer providing additional capacity for CT and MR scans. We are accepting NHS referrals from an NHS radiology department for IS employed radiographers to scan in IS facilities. Can the radiographers use the referring Trust Patient Group Directions (PGDs) or Patient Specific Direction (PSD) to administer medicines such as contrast agents?
A: You will need to discuss with the referring Trust what is required and accordingly put in place a Memorandum of Understanding (MOU) or similar with regards to how this will be managed. It is possible for the independent sector radiographers to work under a Patient Specific Direction (PSD) from a referring Trust. You will need to be clear on lines of accountability. The radiographers must be confident that they understand their professional and legal responsibilities for the patient including where and how to escalate concerns or queries. It should be clear about who is taking clinical responsibility for the patient should there be any issues.
Alternatively they may be able to use the Trust’s PGDs but would need honorary contracts in place with the Trust and also a MOU detailing the issues around where they were working as possibly far wider accountability in terms of equipment, who owns the contrast etc. The IS radiographers will need to complete any PGD training that NHS radiographers complete and policies updated to reflect the addition of IS radiographers to the authorised user of the PGDs. Radiographers should know who is taking clinical responsibility should the patient fall outside of the PGD or there be other queries.
Chief Pharmacists from the involved organisations should be able to advise what constitutes a legal and safe process. Good governance requires both employers recognise any agreement and that this is supported at senior or Board level.
Further information is available here: Patient Group Directions in Complex Commissioning Scenarios
With thanks to Jo Jenkins, Specialist Pharmacist (Patient Group Directions), Medicines Use and Safety Division, Specialist Pharmacy Services in developing this answer.
Q3: What are the rules for 2nd checking of drugs before administration? Can nonregistered staff 2nd check drugs?
A: The MHRA previously advised there is no legal requirement for 2nd checking of medicines, although it is considered good practice. A risk assessment will indicate whether a second checker should be in place. Second checkers, from any background including support staff, should be competent and have the education and training to understand their role in the medicines safety chain.
There is no legal or professional bar to support workers training as second checkers if the employer endorses this through their medicines policies.
In short, any clinical staff can act as second checkers where they have been trained and assessed as competent.
Q4: We are looking for a solution for contrast cover at our CDC and was wondering if you know what others are doing or have any suggestions? How can radiographers support contrast media reactions?
See: Emergency treatment of anaphylactic reactions | SoR for information from SoR, RCR and NHSEI
As with any diagnostic imaging or radiotherapy service development involving a change in practice for a registered radiographer, the radiographer must be suitably educated and trained for their role and assessed as competent. The radiographer should feel capable to perform the function as required and be supported where safety concerns are raised. Employers must provide vicarious liability by recognising the role, usually within a job description or standard operating procedure that clearly identifies who is covered and signed off at a senior level. Other governance processes might include, e.g. formal staff consultation, board-level recognition and support of the change of practice, associated standard operating procedures, risk assessments, training/education requirements with associated training records, and ongoing CPD.
Q5: What legal mechanism covers the administration of carbon dioxide when used to inflate the large bowel during a CTC? Can I use protocol or do I need a prescribing mechanism?
A: CO2 isn't a medicine so can't be administered under a PGD. The pharmacy/medical gases department needs to confirm the legal status of the supply they receive. The attached CO2 datasheet from BOC has nothing regarding supply status which differs from the one for nitrous oxide which does (see page 9) as that is a P medicine so requires a prescription/PGD for supply.
Assuming CO2 is not a POM then it can be administered by anyone who is trained/competent under a local protocol or SOP.
The advice was provided on 4/4/22 by SPS specialist pharmacist for PGDs.
Q6: We as radiographers have been vetting for quite a while now. I was trained and signed off by a radiologist in approx 2007 to vet non-contrast scans. Since then a lot has changed. To improve vetting, anything that we routinely give contrast for, I can vet. Radiographers now administer contrast agents under Patient Group Directions (PGD) and I am unsure how the PGD relates to the vetting process. What responsibility am I taking for contrast agent administration? Who is prescribing the agent?
A: The process of vetting, protocolling, or justifying is completely separate from the process of using a PGD to administer a medicine.
When you are vetting, you are confirming that the imaging protocol for the clinical condition requires a contrast agent. You are not making any assessment about the suitability of the patient to receive the contrast agent or acting in any way as a prescriber.
The radiographer who is going to administer the contrast agent under the PGD takes the responsibility for the decision to administer the medicine. The PGD gives that responsibility to the radiographer alone, they cannot delegate any aspect of the administration process to another, nor can they rely on another to make the decision about the suitability of the patient for the medicine.
Should the patient not fit the PGD criteria, then there should be scope within the PGD for them to refer the patient to a prescriber who should assess the patient and make the decision, along with the patient, whether the patient will have the contrast agent. If the decision is made to administer the contrast agent, then the prescriber should create a Patient Specific Direction in whatever format is agreed for your organisation. The contrast agent is then administered in accordance with the Prescribers prescription, with the prescriber taking responsibility for the patient.
The radiographer who does not administer using the PGD may also consult a vetting radiographer for advice on whether an image without contrast media is appropriate, but the vetting radiographer cannot overrule the PGD radiographer’s decision on administering the medicine.
Q7: We need to supply bowel preparation for patients coming for CT colonography. It is not practical for the patient to attend the Department for a radiographer assessment and supply under a PGD. Can we post the bowel prep?
A: Specialist Pharmacy Services issued advice on February 22 on using PGDs for remote consultations.
The supply of bowel preparation for CTC fits the criteria in this advice note. In short:
More details can be found on the Specialist Pharmacy Services website
Q8: I am currently writing PGD's for the local anaesthetic I give during procedures. Due to the variation in volumes advised by the Consultants compared to the 'black and white' nature of the PGDs, it is quite difficult to get them through. For example, I wanted to put 10-20ml for liver biopsy as it varies with patient size and tolerance, but the pharmacy has advised I need to give an exact volume for each procedure.
A: It’s acceptable to have a range within a PGD, Specialist Pharmacy Service provide more information here. There needs to be consideration as to the risks of having ranges within a PGD, such as over/under dosing, and how these can be mitigated (e.g. use of weight-based guidance) and a maximum dose must be stated.
Also, if repeated doses are allowed under the PGD (i.e. and initial dose and then a subsequent one/s if initial dose not effective/sufficient) the PGD must state the maximum number of doses and maximum total dose permitted under the PGD.
Q9: Can I use a PGD to administer medicines off-label i.e. outside the manufacturers’ guidelines?
Can I use a PGD to administer 2 medicines I have mixed together? E.g. saline and contrast media, local anaesthesia and sodium bicarbonate, local anaesthesia and steroid.
A: If mixing medicines, unless stated within a product SPC or one is a diluent or vehicle for the other, produces an unlicensed medicine and these cannot be administered under a PGD. Off label medicines are different and these can be administered under a PGD if supported by guidance etc. More at Specialist Pharmacy Service and here. You may need advice from pharmacy teams as to whether off label or unlicensed as will make a difference to whether or not a PGD can be used.
Q: Can we use bicarbonate of soda and lemon juice to replace Carbex for barium swallows and barium meals? (Feb 23)
A: As neither bicarbonate of soda nor lemon juice is defined as a medicine, there is nothing to prevent their use. However, your employing organisation should be aware of the practice and be assured it is safe. The usual approach would be to undertake a risk assessment demonstrating that it is a viable replacement for Carbex, is equally as safe and gives the same imaging result. Your clinical director or governance committee should formally sign off as a legitimate change in clinical practice. Safe use, purchase, storage, preparation and dosage should be included in a written system of work.
Q: What are the purchasing rules for products unavailable through usual NHS procurement systems and using them in diagnostic imaging procedures? (Feb 23) e.g. sodium bicarbonate, lemon juice or cod liver oil capsules
A: Many and varied rules govern procurement. SoR recommends you approach your local pharmacy services for advice on purchasing a product for clinical use outside the usual systems. Pharmacy services may not be able to undertake the procurement but should be able to advise on what is considered a legitimate route for product safety.
Potassium iodide is legally classified as a Pharmacy medicine 'P'.
240 of the Human Medicines Regulations exemption allowing administration under protocol when linked to a nuclear medicine exposure can not apply as that is for Prescription Only Medicines.
Reg 220 relates to P medicines. As it is a P medicine, a prescription, PSD or PGD is needed for a supply to be made; if it needs to be supplied in advance due to its dosing schedule, this would require either a prescription for a supply to be dispensed or it may be supplied under a PGD.
For administration in the department, potassium iodide can be administered under protocol without a prescription, PSD or PGD. Whether or not an organisation allows it to be supplied/prescribed will be down to local formularies.
With thanks to colleagues at MHRA and Specialist Pharmacy Services for support in answering this query.
From: ESUR Guidelines on Contrast Agents European Society of Urogenital Radiology 2018 https://www.esur.org/wp-content/uploads/2022/03/ESUR-Guidelines-10_0-Final-Version.pdf
A: Efficient practice may involve giving iodine- and gadolinium-based contrast agents for enhanced CT and MR on the same day. To reduce any potential for nephrotoxicity the following are recommended:
The radiology service should define the requirements within a written procedure/local policy and ensure that all relevant staff are aware.
A. Where the radiographer administers under a Patient Group Direction PGD: IV contrast must be supplied and administered by the registered Radiographer approved to operate under the PGD; this includes all preparation and required manipulation of the contrast (e.g. dilution) and/or loading of pre-filled syringes into injectors. No part of the process can be delegated to another registered or unregistered HCP (e.g. health care assistant, radiographic assistant, nurse or another radiographer). A PGD cannot be used here. This is delegation.
B. Where the radiographer administers under a Patient Specific Direction PSD, a suitably competent healthcare assistant, radiographic assistant or other healthcare professional can prepare iv contrast media for injection. Safe systems of work should be in place to ensure there are no errors. The radiographer making the administration may not vary the dose, rate, volume or any other factor identified in the PSD.
There is further advice available on preparation of contrast and PGDs.
Q15: I am a registered radiographer. Can I become a peer vaccinator within my NHS Trust to help protect staff and patients against Flu this winter?
A: If an NHS organisation wishes to utilise radiographers as peer-to-peer vaccinators (offering vaccinations to that organisation’s staff only) a Patient Group Direction, PGD, is needed. This will be an organisational decision.
Radiographers are not covered by the change in 2020 to the Schedule 17 exemptions within the Human Medicines Regulations for those who can provide ‘flu (and COVID if/when they become part of an occupational health scheme (OHS) function) vaccinations as part of an occupational health scheme.
The legislation was extended from only nurses being able to work under an OHS written instruction to administer ‘flu/COVID vaccinations to include those terms ‘occupational health vaccinators’ who are Registered nurses, Registered midwives, Registered nursing associates, Operating department practitioners, paramedics or physiotherapists registered in Part 13, 8 or 9 of the Health and Care Professions Council register, Pharmacists.
Why these professions only were included, we cannot comment as we were not involved in the decision.
More information can be found at https://www.sps.nhs.uk/articles/using-written-instructions-for-seasonal-flu-vaccination/