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The role and responsibility of a pharmacist in the provision of ATMPs

Vaseline 2 months ago

Advanced therapy medicinal products (ATMPs) are an exciting new therapeutic approach based on genes, cells or tissues. It is a rapidly growing field of medicine that offers groundbreaking new options for treating disease and injury, with the potential to provide striking and lasting answers to a wide range of serious diseases and conditions.

As with medicines, the use of ATMPs is regulated and controlled by the Medicines Act 1968 and the Human Medicines Regulations (2012). These regulations set requirements for the legal sale, supply and administration of all medicines. Other legislation, such as the Health and Safety Executive (HSE), should also be considered as these products may also be genetically modified.

Due to the specificity and personalization of these products, these new medicines pose several challenges for pharmacists, who are the gatekeepers for the safe, effective and quality use of medicines.

The challenges we face are:

  1. The high cost of medicines – This requires adjustment from an insurance provider for coverage. For these drugs, treatment costs can reach £2.5 million. Many organizations have had to ensure that their insurance schemes cover the full cost of ATMPs.
  2. The responsibilities and high pressure on the pharmacist – This includes the pharmacist responsible for the aseptic preparation of, for example, gene therapy medicinal products (GTMP), independent prescribers, training multidisciplinary teams and supervision of preparation steps, including thawing of human cells at department level. Processes classified as preparation include thawing, washing, reconstitution, and loading into a delivery device.

Most sites will conduct clinical, technical and regulatory risk assessments, which define and outline how the gene therapy medicinal products (GTMP) will be used at the site, including considerations for their handling.

Regarding the role and responsibility of pharmacists in the provision of ATMPs, the ‘one-off’ dosing nature of these products must be taken into account. Patients can only be treated with these products once because the body becomes sensitive after administration of the product. Therefore, we must take into account the impact of dosing and preparation errors on:

  1. The cost of the medicine in the event that the product needs to be re-delivered.
  2. Lost/last chance for patient to be treated again with the same product.
  3. Secondary effects (e.g. secondary cancers) are borne by the Multidisciplinary Team.
  4. ‘Batch of one’ production, what is the impact of non-conforming products, ethical considerations for using products that do not meet specifications.
  5. Personalized and patient-specific medicines.
  6. Time and cells/tissues required to produce the dose.

In light of the severity and implications of any pharmacy errors in the supply of these products, it may be worthwhile to involve pharmacists in this work and consider whether their current personal indemnity arrangements would be sufficient in this new context. The PDA can advise on this and PDA members are encouraged to contact the PDA Member Support Point.

By means of Shingi M Mutamba, Chief pharmacist AT(I)MP And Responsible pharmacist at the Advanced Therapy Pharmacy Unit of University Hospital Southampton NHSFT

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