SIG – EAHP guidance on the pharmacy handling of in vivo gene therapy medicinal products

Gene therapy is becoming increasingly prevalent, with new gene therapy medicinal products (GTMPs) being approved for use every year. Hospital pharmacists are expected to prepare and dispense these products. However, arecent survey by the Special Interest Group (SIG) on Handing Gene Therapy Medicines identified a wide range of experience across centres in Europe, with some centres having relatively extensive experience while other centres reported having very little experience. As such, there is a need for practical guidance to help hospital pharmacies create safe and effective workflows, and to support a degree of standardisation of procedures across Europe.

This guidance document was developed by expert members of this SIG convened by the EAHP to update the EAHP’s Guidance on the Pharmacy Handling of Gene Medicine published in 2007. Areas for update were identified by a literature review of existing guidance and through the expert opinions of the SIG members. An initial kick-off meeting was held after development of the outline to discuss updates and additional content. A series of draft documents were produced, with each incorporating comments and input from the members of the SIG.   The Appraisal of Guidelines for Research (AGREE) II document was followed while preparing these guidelines. AGREE II consists of two global rating items and 23 further items within six domains (scope and purpose, stakeholder involvement, rigour of development, clarity of presentation, applicability and editorial independence), which allow the quality of a guidance document to be assessed. The final draft was validated and approved by external experts.

Here, we present the EAHP’s updated guidance on the handling of GTMPs. This document takes into account the substantial advances in recent years in GTMP technology and marketing approval being granted for a number of GTMPs in Europe. Each aspect of the GTMP handling process is addressed, including receipt and storage, dispensing and reconstitution, transportation, administration, waste disposal, decontamination of spills and accidental exposure. A series of charts are provided to aid the development of practical workflows.

This guidance document is intended as a framework to help develop institutional SOPs and should always be used in conjunction with local regulations.

Learning objectives

After the session, the participants should be able to:

• Gain an overview of the work done by the SIG on the preparedness of hospital pharmacy departments for the delivery of in vivo
• Outline the practical recommendations for the handling of GTMPs across the entire workflow of receiving a shipped product from the manufacturer, through to medicine reconstitution, transport, administration to the patient, advising patients/caregivers, waste disposal and procedures for accidental spills or exposures.
• Apply these guidelines in developing institutional standard operating procedures for the handling of gene therapy medicinal products.

Educational need addressed

There is a need for updated practical guidance to aid hospital pharmacy teams in developing institutional standard operating procedures for the safe handling of GTMPs across the entire workflow.

Keywords

Genetic therapy; Pharmaceutical preparations; Pharmacy service, hospital; Safety; Practice guideline.