The UK Radiopharmacy Group met at St Bartholomew's Hospital, London, prior to Professor Stephen Mather's innaugural lecture at Queen Mary University. Items of general interest are summarised below.
Shaping Careers/NOS/AfC
Adrian Hall represented the UKRG at a Career Pathway workshop in late March. Good progress has been made but there is still work to be done. Discrepancies between the Radiopharmacy and Nuclear Medicine NOS documents have been ironed out but differences in assignment of grading remain. The final workshop is at the end of May with one representative of each discipline.
Once again there was discussion of the need to develop a specialist radiopharmacy training programme, analogous to the grade A training scheme currently in place for physicists. Two difficulties are incorporation of both pharmacists and non-pharmacists, and the lack of recognition of radiopharmacy as a modality. The latter could be addressed by attempting to gain recognition from the Association of Clinical Scientists or Health Professions Council. An approved educational institution would be required to promote the training programme, which would have to be accredited by an independent body. A working group will report to the next meeting.
Agenda for Change (AfC) is rolling out very rapidly across the country but still no outcomes for radiopharmacy have been reported from the early implementer sites. While some staff have been asked to fill out the 40-page assessment questionnaire, in other instances the criteria for matching have been relaxed.
Radiopharmacy Computer Software Veenstra intends to launch a prototype in December 2004, although Bright Technologies will only offer it if there is sufficient interest from UK radiopharmacies. A demonstration version may be available at the EANM congress in Helsinki.
Error Reporting The question as to what constitutes an error was discussed, and the definition used by the National Patient Safety Agency was thought to be best. In this, if you self-correct, it is not an error, but if it gets on to the next stage or if the checker picks up the mistake, it is an error. In addition, anything which is out of specification should be included, as problems with a kit cannot always be distinguished from operator error. The point was made that as well as recording and tracking errors, corrective action must be taken and recorded. Paul Maltby will be revising the document in light of discussion.
Cr-51 EDTA Issues The UKRG is continuing its correspondence with MHRA over acceptable methods of diluting and dispensing Cr-51 EDTA for GFR determination.
QA Audit of Section 10 Exemption Units Section 10 units must be inspected by regional quality controllers under EL(97)52. However, this could be carried out in conjunction with a radiopharmacy peer audit.
Handbook/Website Several people have provided information on drug interactions which will be added to the Handbook in due course.
Paul Maltby brought the MAG3 package insert to the group's attention, in particular, explicit information on how it should be prepared, cooled, and verified.
Manufactured Specials While the UKRG has input at several levels to ensure continuity of supply of the specials we require (e.g. ACD, tropolone, hetastarch), a problem has emerged in that there appears to be no national co-ordination of closures for refurbishment, with the result that certain products may not be available for a period.
Education/Training There are three people registered for the radiopharmacy module of the Leeds PTQA course and work-based tutors have been assigned.
The isolator conference is being held at the University of Warwick in Coventry on 5-8 December 2004 with the radiopharmacy sessions on the morning of 7 December.
The Bournville workshop will be held during the first week of January 2005.
VirRAD The VirRAD programme is in its final year of start-up funding. An updated platform will be introduced over the summer to resolve some of the teething problems, such as notification of new postings. If you haven't registered yet, please do so at community.virrad.eu.org.
Clinical Trials Directive The directive takes effect 01 May 2004. An IMP licence is required for manufacture of clinical trial material, but not for assembly only. A licence is not required for use of radiopharmaceuticals given for standard indications as part of a trial (e.g. bone scan to monitor effects of novel chemotherapy). However, considerable confusion remains.
Sterilisation Media The use of hydrogen peroxide as a sterilisation agent was discussed. There is the potential for oxidation of kit contents if residue remains or enters permeable containers.
Membership Changes The committee welcomed Keith Jones as the new representative of the MHRA. With the impending retirement of Stuart Hesslewood, his post as treasurer will be assumed by Adrian Hall and collation of drug defects will be performed by Neil Hartman. In other social news, the committee congratulated Maggie Cooper on the recent birth of her son Dominic.
Note from the Editor The Editor, Jim Ballinger, apologies for the late running of this newsletter service, which he blames on "the wrong kind of stress". He can be reached in care of Nuclear Medicine, Guy's and St Thomas' Hospital, St Thomas Street, London SE1 9RT, phone 020 7188 5521 or 020 7188 4116, fax 020 7188 4094, e-mail james.ballinger@gstt.nhs.uk