Medicines FAQs

FAQs

• 1. Radiotherapy, controlled drugs, independent and supplementary prescribing

  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)

  Explanation:

  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.

• 2. Independent sector, NHS referrals, medicines governance, PGDs

  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.

• 3. 2nd checking of medicines

  Q3: What are the rules for 2^nd checking of drugs before administration? Can nonregistered staff 2^nd check drugs?

  A: The MHRA previously advised there is no legal requirement for 2^nd 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.

• 4. Management of contrast agent reactions in radiographer led diagnostic imaging or radiotherapy departments remote from an onsite resuscitation team.

  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.

   

  To consider:

  1. Support of employer for a particular approach (other services in the facility, cost, risk, geography, patient cohort, workload, hours of operation, ambulance service support)
  2. Physical facilities allow appropriate equipment to be available and readily accessible. E.g. emergency drugs and O2, AED, room entry allows adequate access for ambulance trolley or another patient trolley including MR safe trolley, the facility allows ambulance trolley access especially where lifts/stairs are a consideration, access to an appropriate area/private area to support patients off the scanner (a requirement for MR and recommended for CT),
  3. Identification or development of skills and knowledge already in the facility e.g. nonmedical prescriber availability to support patients experiencing contrast agent reactions – requires education and training to extend the scope of practice and investment incapacity
  4. Risk assessment of people being scanned in the community to filter out higher risk
  5. Development of advanced practice/consultant radiographer roles that include management of contrast agent reactions (consider the use of supplementary prescribing for diagnostic radiographers, or independent prescribing for therapeutic radiographers or developing PGDs for contrast agent management for senior and experienced radiographers trained to manage the reaction)
  6. Development of other staff in facility to support the management of contrast agent reactions
  7. Development of all CT/MR radiographer skills to recognise and manage anaphylactic reactions in the absence of a resuscitation team (consider use of simulation or practice scenarios to maintain skills)
  8. All staff as a minimum to have BLS, AED and Intramuscular adrenaline anaphylaxis training
     Considerations
     1. Availability of ambulance or other emergency support
     2. The number of radiographers to be trained (some or all?)
     3. Opportunity to practice skills, recognise reactions and retain competence
     4. Skill mix: Experience and seniority of radiographers and support team
     5. the role of temporary and locum staff
     6. Risk assessment of people being scanned in the community
         
  9. Immediate Life Support (ILS) training for radiographers with access to 999 ambulance support.
     Considerations
     1. Willingness and ability of radiographers to develop these skills – appropriate consultation and support
     2. Experience and seniority of radiographers and support team
     3. the role of locum or temporary staff
     4. Ability of ambulance service to respond appropriately
     5. Opportunity to practice skills, recognise reactions and retain competence
     6. Risk assessment of people being scanned in the community
     7. The number of radiographers to be trained (some or all?)
  10. Immediate life support (ILS) provided by other staff in the facility
      Considerations
      1. Risk assessment of people being scanned in the community
      2. Ability of ambulance service to respond appropriately
      3. Support of employer for this approach (cost and risk)
      4. Willingness of employer to train radiographers and maintain skills
      5. Willingness and confidence of radiographic staff
      6. Other community-based services benefit from ILS skills
      7. A core group of appropriate site-based staff is available and willing to provide support
      8. ILS trained staff are already available and close enough to provide support

• 5. Legal mechanism for administering Carbon Dioxide during a CTC

  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.

  • Medical Nitrous Oxide - Essential safety information 
  • Medical Carbon Dioxide - Essential safety information

• 6. Vetting, protocolling or justifying examinations and 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.

  Specialist Pharmacy Services who oversee patient group directions clarified this position in 2016 with an update in 2018: Patient Group Directions (PGDs) for administration of contrast media in radiology services and exemplar PGD templates.

• 7. Posting bowel prep using a PGD

  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:

  • the radiographer acting under the PGD must conduct a remote consultation with the patient,
  • the patient must give informed consent for supply and this be documented

  • the radiographer must undertake the whole episode of care including:
    • the handing over of the medicine to the individual or the representative if collecting immediately
    • personally undertaking the packaging and posting or dispatch of the medicine if posting
    • personally undertaking the packaging of the medicine if to be collected at a later time and handed over by another health care professional

  More details can be found on the Specialist Pharmacy Services website

• 8. Varying volume using a PGD

  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.

• 9. Off label/unlicensed medicines

  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. 

• 10. Bicarbonate of soda and lemon juice replacing Carbex for barium swallows and barium meals

  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.

• 11. Purchasing rules for products unavailable through NHS procurement systems

  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.

• 12. How is the administration or supply of thyroid-blocking agents (potassium iodide) for DAT and MIBG imaging managed? What legal mechanisms can services use to supply or administer this medicine?

  Potassium iodide is legally classified as a Pharmacy medicine 'P'.  

  Regulation 

  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.

  June 2023

• 13. Can Iodine- and Gadolinium-based contrast agents safely be given on the same day for routine examinations?

  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:

  1. Patients with normal renal function or moderately reduced (GFR > 30 ml/min/1.73 m2):
     75 % of both gadolinium- and iodine-based contrast agents are excreted by 4 hours after administration. There should be 4 hours between injections of iodine- and gadolinium-based contrast agents.
  2. Patients with severely reduced renal function (GFR < 30 ml/min/1.73 m2 or on dialysis):
     There should be 7 days between injections of iodine- and gadolinium-based contrast agents.

  Note: Gadolinium-based contrast agents attenuate X-rays well and may be misinterpreted on CT when they have been excreted into the urinary tract. For abdominal examinations, enhanced CT should be done before enhanced MR. For chest and brain examinations, either CT or MR may be done first.

  The radiology service should define the requirements within a written procedure/local policy and ensure that all relevant staff are aware.

  July 2023

• 14. Can a radiology assistant prepare IV imaging contrast before its administration to an individual by a Radiographer?

  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.

• 15. Peer-to-peer vaccinations

  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/