The Chair of the BNMS Radiopharmaceutical Sciences Group is Bev Ellis (Manchester)
Human Medicines Regulations 2012 (SI 2012:1916)
Prepared by Bob Ardley and Paul Maltby
These Regulations came into force on 14th August 2012. The regulations are the result of the initiative by the Medicines and Healthcare products Regulatory Agency (MHRA) to consolidate and review UK medicines legislation. They replace much of the Medicines Act 1968 and around 200 statutory instruments in the process repealing much obsolete law and contributing to the government’s drive for burden reduction.
Key Regulations relevant to Nuclear Medicine and Radiopharmacy are:
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 is now pleased to be able to report that new regulations have been introduced in the UK which explicity make it legal for an IR(ME)R operator to administer radiopharmaceuticals that have been authorised under protocol by the ARSAC certificate holder and also to administer associated non-active pharmaceuticals (such as frusemide) using IR(ME)R protocols, without the need to utilise Patient Group Directions.