infection. 4 – 6 It is now generally accepted that such activities are best performed centrally within the pharmacy or radiopharmacy department, where appropriate aseptic dispensing facilities are usually found. This was one of the principal recommendations of the Breckenridge report 7( and subsequently reinforced for all parenteral medicines by the National Patient Safety Agency in Patient Safety Alert 20). 8
Risk of miscalculation or misadministration of dose In a busy clinic, there could be an increased risk of error when carrying out complex calculations, drawing up part of a vial, measuring the correct volumes, etc. This could all add to the pressure on the operator to get the injection done one time, possibly increasing the risks of extravasation as a result.
How can misadministration be avoided? How should it be dealt with? It is recommended that the risk of misadministration be managed as follows:
• There should be an independent check of the dose by a second person at the time of drawing up
• The syringe( in its shielded container) should be transported to the patient and injected immediately. Therefore drawing up multiple doses in advance is not recommended. Not only does this increase the risk of maladministration, but it will also become a pharmaceutical activity rather than part of the administration process, and, as such, should be supervised by a pharmacist.
Any incident of misadministration involving the wrong patient should be reported both internally via the hospital incident reporting system and externally to the Care and Quality Commission( CQC), in accordance with the Ionising Radiation( Medical Exposure) Regulations( IRMER). 9
Should the right patient receive a dose much greater than that intended, then the need to report to the IRMER coordinator via the CQC website is determined by reference to Regulation 4( 5) of the IRMER, and will depend on the exposure level and whether it occurred as a result of procedural failure or equipment malfunction. In the case of the latter, the Health and Safety Executive( HSE) may need to be involved.
Further advice can be found at the Department of Health website 10 or on the BNMS website( www. bnms. org. uk).
How can written IRMER processes help to minimise errors in drawing up? It is the employer’ s responsibility to ensure that written IRMER procedures are in place, and their purpose is to control patients’ exposure to radiation and ensure their safety. 11 They include:
• Correct identification of the individual to be exposed to ionising radiation – this is obviously crucial in minimising risk of maladministration
• Entitlement to act as the IR( ME) R roles of referrer, practitioner and operator – so everyone’ s role and responsibility is defined. Anyone who has a potential impact on the radiation dose the patient receives is considered an operator.
• Processes around medico-legal exposures
• Establishing whether females of childbearing age may be pregnant or breastfeeding
• Quality assurance programmes for equipment and processes
• Assessment of patient dose – again, this is important if maladministration is suspected
• Diagnostic reference levels – these relate to the amount of radiation which may be administered for various tests. Obviously this will feed into the assessment of whether a patient has received an excessive radiation exposure.
• Medical research programmes
• Information and written instructions – this supports a consistently high quality service and helps assure patient safety
• Evaluation for each medical exposure
• What to do in the event of accidental or unintended doses.
What is the significance of the‘ non-touch’ aseptic technique and where does this apply? This is particularly important when drawing up doses in an area that is uncontrolled from a microbiological point of view. The product must remain sterile and therefore steps must be taken to reduce the risk of the operator introducing contamination. Because it is not being performed in a pharmaceutical aseptic area, full aseptic processing, whereby the operator is gowned up and the environment carefully controlled with filtered air, etc, is not possible. As a result, there is a greater chance that the operator will transfer micro-organisms from themselves into the product. It is therefore important that the operator does not touch the rubber septum of the vial, in addition to employing other precautions such as sanitising the area in which the radiopharmaceutical is being manipulated using sterile alcoholic sprays and wipes.
Why is it important to measure the syringe patient dose in a radionuclide calibrator prior to injection? Because of the radioactive nature of the products, they are constantly decaying. For this reason, the amount of radiation administered is not absolute – it is acceptable to inject an amount that falls within a range, as specified for the test in question.
Different tests will require different amounts of radioactivity to be injected. For example, a bone scan involves waiting for two to three hours while the radio-pharmaceutical is taken up into the skeleton and disperses from the bloodstream. During this time the radiation will be constantly decaying. The agent is also spread throughout the entire skeleton and, for both these reasons, the bone scan will require a larger amount of radiation than a lung scan, for example. In this case, the radioactive tracer is retained in a much smaller area and imaging can take place almost immediately, hence the smaller amount of radiation required.
In order to ensure the patient is to be injected with the correct amount of radioactive tracer for their examination, each dose must be measured before administration using a dose calibrator.
19 HHE 2018 | hospitalhealthcare. com
References 1 UK Radiopharmacy Group on behalf of the BNMS. Safe drawing up of radiopharmaceuticals in nuclear medicine departments. www. bnms. org. uk / images / stories / UKRG / UKRG _ Drawing _ up _ Feb-12. pdf( accessed March 2017). 2 RQA Multiple Use of Injections. 3 Ionising Radiation Exposure of the UK Population: 2010. Review by Public Health England. www. phe-protectionservices. org. uk / cms / assets / gfx / content / resource _ 3595csc0e8517b1f. pdf( accessed March 2017). 4 Daily MK, Dickey JB, Packo KH. Endogenous Candida endophthalmitis after intravenous anaesthesia with propofol. Arch Ophthalmol 1991; 109:1081 – 4 5 Bennett SN et al. Post operative infections traced to contamination of an intravenous anaesthetic, propofol. N Engl J Med 1995; 333:147 – 54. 6 Kuehnert MJ et al. Staphylococcus aureus bloodstream infections among patients undergoing electroconvulsive therapy traced to breaks in infection control and possible extrinsic contamination by propofol. Anesth Analg 1997; 85:420 – 5. 7 Breckenridge A. The Report of the Working Party on the Addition of Drugs to Intravenous Infusion Fluids( HC( 76) 9).( The Breckenridge Report) London. Department of Health and Social Security; 1976. 8 National Patient Safety Agency. Patient safety Alert 20. Promoting safer use of injectable medicines. Ref NPSA / 2007 / 20. March 2007. www. npsa. nhs. uk / health / alerts( accessed March 2017). 9 SI 2000 No. 1059 The Ionising Radiation( Medical Exposure) Regulations 2000. London. The Stationery Office; 2000. www. legislation. gov. uk / uksi / 2000 / 1059 / contents / made( accessed March 2017). 10 Department of Health. Reporting incidents of radiation. www. dh. gov. uk / en / Publicationsandstatistics / Publications / PublicationsPolicy AndGuidance / DH _ 4007957. 11 Society of Radiographers. Guidance on IRMER procedures. www. sor. org / learning / document-library / irmer- 2000-and-irme-amendment-regulations-2006 / 1-irmeremployer-s-proceduresschedule-1( accessed March 2017).