The Group held its most recent meeting in the department of pharmacy at Aston University, Birmingham. Items of general interest are summarised below.
UKRG Executive
Dr Beverley Ellis of the Manchester Royal Infirmary has taken over as chair of the UKRG, following on from Professor Malcolm Frier. The new secretary of the Group is Jilly Croasdale of the Royal Free Hospital in Hampstead.
We congratulate them both on their (s)election and welcome them to their new posts.
Education and Certification of Radiopharmaceutical Scientists The National Occupational Standards for Healthcare Scientists (NOSHCS) process is continuing. Feedback from field testing has been incorporated into a revised version of the standards. Three members of the Group spent two and a half intensive and exhausting days at Padnell Grange working on assessment guidance. The seven Group members who formed the NOSHCS subcommittee (i.e. the exhausted three plus four who claimed to have been too busy to go to the Grange) then met and spent another day completing the assessment guidance. Input was sought from radiopharmaceutical scientists working in the area of PET. Assessment guidance attempts to map the unit processes in the standards to the grade or level of responsibility required to perform those processes and the method of assessment of competence. The next stage is pilot testing of the standards and assessment guidance in a variety of different radiopharmacy environments and sites are now being selected.
Transport Regulations and Containers
The orange plate is no longer required on vehicles of less than 3500 kg carrying a total transport index less than 3. It has been proposed that small vehicles also be exempt from the requirement for two fire extinguishers, but this is not definite yet.
The transport of urine collected for Schilling's tests does not fall under either radiation or biohazard regulations provided that the volume is less than 2.5 litres. Similarly, there is no legal requirement regarding packaging or seals, though one would hope that aesthetics would be taken into account.
Out-of-Hours Deliveries
The HSE is cracking down on out-of-hours deliveries of radioactive materials, particularly delivery and pick-up of generators. The driver must be accompanied by a Trust employee who will also sign for the delivery and ensure that the parcel is stored appropriately and securely. For more details, see:
http://www.hse.gov.uk/hthdir/noframes/rad_prad/rpa23.htm
Radiopharmacy Workshop 2004 The date of the Bournville workshop has been set as Friday 9 January 2004. The topic will be pharmaceutical care and radionuclide therapy. Mark your calendars!
BNMS Congress 2004 The BNMS meeting returns to the seaside at Brighton next year and is scheduled for 31 March to 2 April. It is the ideal meeting to spend down the surplus in your travel budget at the end of the financial year! The Radiopharmacy Group has been asked to prepare an interactive session as these always prove to be popular.
Problems Associated with Radiopharmaceuticals The latest compilation of reports should be included with this Newsletter. Most notable are a number of reports of problems with the new 99Mo/99mTc generator where the needle on the saline inlet bent or snapped off. Strangely, this happened only with the larger, depleted uranium shielded generators. Customers are being offered the option of returning to the former design. As we go to press, more problems with the generator are being reported.
Registration of Technologists With the upcoming requirement for state registration of all professionals within the NHS, the BNMS is encouraging all technologists, whether in imaging or radiopharmacy, to register with IPEM. The cost is minimal and the paperwork not excessive. Contact: www.ipem.org.uk.
Multiple Use of Injections The NHS Pharmaceutical Quality Assurance Committee issued a document in February entitled "Multiple Use of Injections". The UKRG discussed the document at our April meeting and expressed concern about possible misinterpretation by different health professionals within nuclear medicine which could lead to major operational problems within the UK. The document states that "injections for multiple use contain antibacterial preservatives," and suggests that multiple use of non-preserved injectibles leads to risk of contamination by micro-organisms and risk of cross-contamination between patients. However, most radiopharmaceuticals do not contain prevervatives yet are intended and indeed licenced for multiple use over a number of hours. At a recent meeting, the Pharmaceutical QA Committee has accepted that the multiple use of a radiopharmaceutical is within its marketing authorisation, that the QA document was not intended to stop this practice, and that the products involved are low risk.
Pyrogen Testing The small volume exemption from pyrogen testing for injectibles has been withdrawn by the British Pharmacopoeia, effective 1 January 2004
Clinical Trials Directive Discussion of the EU Clinical Trials Directive is continuing. A number of organisations, including the Medical Research Council and Cancer Research UK have made representations to the MHRA regarding the detrimental impact of the Directive on research in the UK. For nuclear medicine, under strictest interpretation the use of an approved drug as part of a clinical trail (e.g. bone scan to evaluate efficacy of chemotherapy) would require a separate application. This topic even caught the attention of "Boffin" in Private Eye! See issue number 1084, 11-24 July 2003.
Expansion of PET The availability of PET is slowly expanding in the UK. The PET Special Interest Group, mainly with a physics bent, has recently redesigned its web site and now has links to all the PET facilities in the UK, both public (clinical or academic) and private. It's well worth a look: www-pet.umds.ac.uk/UKPET/
Hot Off the Press The draft guidelines on radiopharmacy (including PET) prepared by the Committee on Radiopharmacy of the EANM, which were discussed at the Innsbruck meeting, are published in the blue pages of the latest issue of the EJNM.
Note from the Editor The Editor, Jim Ballinger, can be reached in care of Nuclear Medicine, Guy's and St Thomas' Hospital, St Thomas Street, London SE1 9RT, phone 020 7955 5000 ext 5644 or 020 7955 4595, fax 020 7955 2802, e-mail: james.ballinger@gstt.nhs.uk.