HHE Radiology and imaging supplement 2018 | Page 17

radiology and imaging Ensuring safety in nuclear medicine Hospital Healthcare Europe spoke with Jilly Croasdale of the UK Radiopharmacy Group about guidance on safe drawing up of radiopharmaceuticals in nuclear medicine departments Jilly Croasdale Head of Radiopharmacy; and Associate Director, Healthcare Science, Sandwell and West Birmingham Hospitals NHS Trust, UK EU good manufacturing practice (GMP) relates to the manufacture of medicines, and in radiopharmacy this can be a challenge in some ways. Because the products have to be used immediately, it is not possible to perform all the usual end product testing that you would with other types of products. For example, sterility testing is done retrospectively, and, because the batch size is often one, it is not possible to sterility test each batch produced (or there may be nothing left to administer to the patients). However, wherever possible, manufacture will conform to the regulatory requirements, and because of the need to often use radiopharmaceuticals immediately, there is particular emphasis on quality assurance of the process, in order to ensure the products made are fit for patient use. 17 HHE 2018 | hospitalhealthcare.com Once the radiopharmaceutical has been released for use, further manipulations of the product to enable administration do not come within the remit of GMP. However, it is important that their handling does not pose a risk to patients. How does the guideline relate to kits? The Safe Drawing Up Document 1 relates to how radiopharmaceuticals presented as multi-dose vials are handled in the nuclear medicine department. Although GMP does not directly apply, it should be remembered that the purpose of GMP is to make sure medicines are safe for use in patients. The manufacture of these is just one aspect – obviously how they are stored and used also has a considerable impact. The Safe Drawing Up document therefore