The group held its most recent meeting in Birmingham in conjunction with the workshop on New and Impending Regulations affecting Radiopharmacy Staff. A brief report of the workshop is given later in this newsletter and it is intended to publish a fuller report in the April edition of the Hospital Pharmacist.
Problems with MAA. You will have noticed in the last compilation of problems with radiopharmaceuticals that foreign bodies had been observed in reconstituted MAA kits. There are similar reports in the current compilation. The matter has been taken up with the company via the Defective Medicines Report Centre. The response was that the problem probably arose from coring of the rubber stopper and this was due to user technique. This response was thought to be unsatisfactory since some of the foreign bodies were black and the rubber is grey. In addition fibres had sometimes been observed. The matter is to be followed up, so please report any occurrences with MAA in your department.
Potential drug interactions with radiopharmaceuticals. You will also note that the compilation contains reports suggesting that patient’s medication may have affected cell labelling procedures and one report where therapy with a biphosphonate may have affected the quality of a bone image. These problems do not occur frequently but in order to develop a good cause/effect relationship, all information is helpful.
On line reporting of defects/adverse reactions. This is now possible via the BNMS web-site www.bnms.org.uk. Please have a look at the site. The annual report for 1998, including all European data has been published in the blue pages of the European Journal of Nuclear Medicine (December 1999).
Survey on use of nitrogen filled vials. Thank you to those of you that replied to the questionnaire. The price of vials from Nycomed Amersham has caused concern and the alternative supply from Adelphi appears to be satisfactory.
Radiopharmacy discussion group "RADPHARM". You may be aware that Steve Mather has set up an e-mail discussion which has already been well used. If you were not aware of it but wish to be involved, please e-mail Steve at Mather@europa.lif.icnet.uk.
BNMS Annual meeting Brighton April 10 – 12 2000. The group will be actively participating in this year’s meeting. In addition to the usual radiopharmacy session of proffered papers and the group’s AGM, there will be an interactive session related to artefacts on images that may or may not be due to problems with the radiopharmaceutical. Such sessions have proved popular and informative in previous years and Group members are working hard to try and ensure this trend continues. In addition, there will be a guest lecture on PET radiopharmaceuticals to be given by Professor Geerd Meyer from Hannover. Booking forms have been widely distributed, but if you can’t get hold of one, contact BNMS Conference Secretary 56 Silverdale London SE26 4SJ. Alternatively, book on-line at www.bnms.org.uk/annmeet.
Workshop on New and Impending regulations. A highly successful workshop was held at the Beeches Management Centre, Birmingham on Friday 21st January 2000. There was a total of 48 participants and from the evaluation forms, the vast majority had gained valuable information from the day. Robert Shields from Manchester Royal Infirmary gave an informative talk on 5 pieces of legislation that have or are about to affect Nuclear Medicine and Radiopharmacy. The Ionising Radiations Regulations 1999 came into force on January 1st 2000. Key features are the need for risk assessments of all procedures and a change in the whole body dose limit which is reduced from 50 to 20 mSv per annum. This may have implications in terms of classified workers, the point at which classification becomes necessary is now 6 mSv, i.e. approx. 0.5mSv per month. There is also a change in definition of the finger dose. Although the dose limit remains at 500mSv p.a., this is now to be averaged over 1cm2 instead of 100cm2. This makes the positioning of TLD’s critical. Within 5 years, RPA’s must satisfy requirements to be laid down by the HSE, which will become a legally recognised qualification.
The Radioactive Substances Act 1993 is currently under review and comes into force in June 2000. It is anticipated that there will not be additional implications for nuclear medicine departments.
The "REPPIR" regulations relate to emergency preparedness for incidents involving radiation and should be in force by February 2000, but there may be some delay. It is anticipated that Radiopharmacy will not be affected, since the levels of activity of specific radionuclides they hold should fall below the limits set in the regulations.
The Transport of Dangerous Goods (Safety Advisers) Regulations came into force on January 1st 2000 and seems to have caught many employers on the hop. The regulations relate to all dangerous goods (not just radioactive materials) and require the appointment of a safety adviser who has passed an examination. It is possible that many trusts are operating outside these regulations. Some have contracted with an outside body to be their safety adviser.
The major thrust of the syndicate session was the Ionising Radiations (Medical Exposure) regulations 1999 (IRMER). These come into force in May 2000 and require the employer to ensure that all operators that can affect medical exposure have received adequate training. This specifically includes radiopharmacy staff. A core syllabus is laid out and groups discussed the content of the syllabus, how training could be achieved and delivered and how the process could be accredited, including accreditation of prior learning and the necessity for continuing education. An action plan with recommendations is being drawn up and informal contact suggests that the Department of Health will look favourably upon this. Clearly, a lot needs to happen quickly!