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Regulatory Issues
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Radiation related:

Delivery and Collection of Radioactive Packages
Medical and Dental Guidance Notes
IRMER 2000
IRR 99

Pharmacy related:

Patient Group Directions - Revised November 2006
EU Clinical Trial Directive 2001/20/EC
Radiation-related

Delivery and Collection of Radioactive Packages
Guidance on acceptable procedures in the UK for the delivery and collection of radioactive packages has been published after consultation between stakeholders, professional bodies and the HSE. Click here to access the electronic version of the published article (published in Nuclear Medicine Communications, 2004, 25, 1161-1167)

Medical and Dental Guidance Notes
The 'Medical and Dental Guidance Notes : A Good Practice Guide to Implementing Ionising Radiation Legislation in the Clinical Environment' can be ordered from the IPEM Office (get an order form by phoning 01904 610821), or by visiting the IPEM Website. Note: these Guidance Notes cover both IRR99 and IRMER 2000. We have received information that suggests that some departments may be experiencing problems in treating young women with hyperthyroidism with radioiodine as a result of the behaviour restrictions listed in these Guidance Notes. If you are experiencing problems with this or indeed you would just like to make your own views known, please contact us.

IRMER 2000

Regular IRMER inspections are carried out by the Care Quality Commission who publish annual reports on IRMER incidents www.cqc.org.uk. BNMS guidance on clinical incidents in nuclear medicine can be found here

IRR 99
The Health and Safety Executive (HSE) conduct inspections with regard to the Ionising Radiation Regulations (IRR99), which has an approved code of practice (ACOP). This is not available on-line but a hard copy can be ordered through HSE Books, priced 20 GBP (ISBN 0717617467). For the benefit of understandably puzzled readers from outside the UK (and maybe some inside!), there are usually three key documents associated with UK ionising radiation legislation: Statutory Instrument, Approved COP, and Guidance Notes. The text of the statutory instruments themselves (not recommended for bed-time reading) can be found here.

Referral Guidelines
The EC document on referral guidelines, based on version 4 of the RCR guidelines can be accessed by clicking here.

Pharmacy-related

To access the MHRA website go the links page.

Patient Group Directions - advice updated November 2006

There has been considerable confusion about the impact on Nuclear Medicine practice following publication of HSC2000/026 Patient Group Directions [England Only] and the subsequent consultation document MLX 278 Sale, Supply and Administration of Medicines by Health Professionals under Patient Group Directions. Specifically, the role of clinical scientists and MTO’s as persons who administer drugs (radiopharmaceuticals and/or non-radioactive prescription only medicines) as part of a protocol has been brought into question.

The UK Radiopharmacy Group (UKRG) has been active in trying to clarify the position and has now received confirmation from the Medicines Control Agency that these Directions do not relate to the practice of Nuclear Medicine in the UK. For a detailed statement from the UKRG, click here.

EU Clinical Trial Directive 2001/20/EC

The EU Clinical Trial Directive 2001/20/EC has now been implemented in UK legislation. Under this legislation, radiopharmaceuticals come within the definition of Investigational Medicinal Products (IMP).

Any radiopharmacy which intends to be involved in the production of IMPs for use in clinical trials will need to have a manufacturers authorisation for IMPs and a Qualified Person must be available.

It is understood that the legislation does not apply when the radiopharmaceutical is being used merely to make a measurement of the effect of a trial drug (e.g. in the case of a bone scan used for monitoring in a chemotherapy trial).

However, the legislation does apply to new radiopharmaceuticals under development and to radiopharmaceuticals which have been modified in some way and which are being assessed.

Detailed information on the Directive can be obtained from the Medicines and Healthcare products Regulatory Agency (MHRA). Click here for further information .

 

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The BNMS is a registered as a company in England and Wales with number 08082786.  The BNMS is a charity governed by the rules of the Charity Commission for England and Wales - Registered Number 1150234.  Registered Office: The Royal College of Physicians, 11 St. Andrew's Place, Regent's Park, London NW1 4LE.
The British Nuclear Medicine Society is not able to give specific clinical advice to members of the public. If you are concerned about your scan or therapy please seek the opinion of a nuclear medicine clinician where you were seen or the clinician who referred you to the department or your GP.
Enquiries related to issues such as internships and work experience opportunities, should be directed to the relevant professional body e.g., for radiologists, this will be the Royal College of Radiologists.