The Group held its most recent meeting at Aston University, Birmingham. Items of general interest are summarised below.
Education and Certification of Radiopharmaceutical Scientists A set of National Occupational Standards for Health Care Scientists is being prepared and radiopharmaceutical science will be recognised as a separate specialty (one of about 60). This will involve definition of the role of a radiopharmaceutical scientist, a syllabus for training, and will result in a career structure. Update: Representatives of UKRG met with the NOSHCS consultants on 22 May to begin the process of "function mapping". Despite the jargon, those in attendance emerged with a more optimistic view than had been anticipated.
Various options for a continuing professional development (CPD) framework are being explored, including the Pharmaceutical Society, the College of Pharmacy Practice, and IPEM. In addition, IPEM could offer accreditation of programmes if UKRG were to become an affiliated subgroup.
Radiopharmacy Software Packages Many radiopharmacies have software written in-house, while some are still using pen and paper systems (though no quills and papyrus to my knowledge). There is not a satisfactory commercial system on the market yet. Dr Peter Jarritt, consultant physicist in Belfast, is spearheading an effort to design and develop a package specifically for the UK regulatory environment. The proposal would be to commission a commercial software package with the design specified by a user group from within the UK. Another advantage of a common system would be compliance with Good Automated Manufacturing Procedures (GAMP). In order for this to fly, there will need to be a financial commitment from a number of institutions. Dr Jarritt would like to convene a workshop to establish a user group which would develop a specification for a commercial firm to work to, and to discuss tendering, commissioning, costs of setting up, ownership, maintenance contract, and further development. For further information please contact Paul Maltby ( paul.maltby@rlbuh-tr.nwest.nhs.uk; full address and phone/fax via UKRG web site).
News from the Medicines Control Agency
The MCA is re-organising its inspection system. This will no longer be done on a regional basis but will be arranged centrally by specialty (manufacturing, clinical trials, etc.) This means that most of us will see a different inspector come renewal time.
Clarification was received on the issue of pharmacist supervision and technologist checking. For units operating under a Section 10 exemption, supervision by a registered pharmacist is required. It is possible to delegate the task but not the responsibility. In the case of out-of-hours emergencies, it is possible for a lone worker to prepare and release the radiopharm-aceutical as long as records are checked at the beginning of the next working day. However, this only applies to true emergencies and is not a substitute for adequate staffing levels.
VIRAD The establishment of VIRAD (Virtual Radiopharmacy), a learning community funded by the European Commission for a three-year period, is progressing under the direction of Professor Mather. The EANM radiopharmacy syllabus will be supported by virtual radiopharmacy training packages. The RADPHARM discussion group may be subsumed by VIRAD.
Adverse Reactions / Defective Products The latest report should be included with this Newsletter. Previous reports have mentioned Mo/Tc generator elution problems which do not fit the pattern of the wet column phenomenon, in that the yield did not recover on subsequent days. It appears that some may be related to excessive use of alcohol-based disinfectant sprays. There was discussion of this during the BNMS meeting in Manchester and subsequently on RADPHARMUK. Those who use alcohol-impregnated wipes tend to have fewer problems than those who operate in an isopropanol fog. It has been suggested that a generic disinfection procedure for generators be established nationally.
Several physical problems with generators have been reported in the last quarter. The current report also reflects changes in radiopharmaceutical usage, in that adverse reactions are now appearing for I-123-beta-CIT (analogue of ioflupane) and I-131 iodocholesterol (as selenocholesterol is no longer available). For further discussion of iodocholesterol, see the letter-to-the-editor by Mr Maltby in the May issue of Nuclear Medicine Communications (23: 505-6)
Manufactured "Specials" for Radiopharmacy There is a move toward rationalisation of "specials" manufacturing within the NHS. The UKRG has identified Hespan as the most important item for radiopharmacy use, along with ACD, potassium iodate, potassium perchlorate, and tropolone.
Cambridge Laboratories are reviewing their documentation for potassium iodate tablets 85 mg and would welcome comments from the radiopharmacy community (the major customer is the Ministry of Defence for use in radiation emergencies). They are also willing to consider packaging the most appropriate number of tablets per pack to suit nuclear medicine requirements. Given the varying recommendations for thyroid blockade, can we reach a consensus on one or two pack sizes that would be appropriate for our use? Paul Maltby is co-ordinating our response (paul.maltby@rlbuh-tr.nwest.nhs.uk; full address and phone/fax via UKRG web site).
Radiopharmacy Handbook The 2002 edition of the Handbook is available on the UKRG web site (www.ukrg.org.uk) and will be updated on an ongoing basis. However, some users may prefer to download a complete copy. To this end, Dr Ellis has prepared a zipped e-book version which will be available on the web site soon. This version will be current only to the download date.
Note from the Editor The editor, Jim Ballinger, Nuclear Medicine, Addenbrooke's Hospital, Hills Road, Cambridge CB2 2QQ, phone 01223 217351, fax 01223 274596, e-mail jim.ballinger@addenbrookes.nhs.uk, welcomes feedback, positive or negative, though the former is preferable to the latter.
HOT OFF THE PRESS The abstract book for the SNM meeting in Los Angeles arrived as I was preparing this Newsletter. At a quick glance, two new(ish) radiopharmaceuticals seem to be coming into their own: Tc-99m-Annexin V for imaging apoptosis in a variety of conditions, and Tc-99m-Trodat-1, which is an analogue of ioflupane (Datscan). When I last spoke with Hank Kung, he was on the verge of an agreement with one of the major radiopharmaceutical suppliers for commercialisation of Trodat.