General guidance regarding the handling of GTMPs and patient specimens
| Precaution | Details |
| Protective clothing* | Disposable apron, gown or lab coat† Safety glasses or goggles Gloves Mucous membrane splash protector (face mask) |
| Clean air device (biological safety cabinet (minimum class 2, type B) or pharmaceutical grade isolator (compliant with European standard EN12469:2000)) | See figure 2 |
| Care with use and disposal of needles and sharps | See figure 5 |
| Decontamination of work surface areas | See figure 2 |
| Decontaminate patient bedding according to procedures for blood- or body fluid-soiled laundry† | See figure 5 |
| No special precautions for patient elimination of stools or urine, unless specified in the SmPC or clinical trial documents | Provide patients/caregivers with guidance on appropriate precautions to take at home, as viral shedding could result in antibody development in family members with the same condition Patients may use normal bathroom facilities unless advised otherwise |
| All transport and storage of patient specimens, GTMPs and associated waste must be in a double-enclosed, biohazard-labelled, leak-proof container20 | See Figure 3 |
| Disposal of GTMPs, contaminated waste and patient specimens must follow institutional decontamination procedures | See figure 5 |
| A spill kit must always be on hand6 20 |
Suggested spill kit contents:
2×disposable gowns or arm covers 4×gloves 2×masks 2×aprons 2×goggles 4×disposable shoe covers 2×disinfectant sachets (or other, pre-prepared, decontaminant) Absorbent paper towels 2×disposable forceps 2×biohazard incineration bags Emergency contact number Copy of spillage procedure |
| Institutional procedures and policies should be put in place for all steps along the GTMP handling pipeline21 | Steps include storage, transportation, reconstitution, dispensing, administration, disposal and decontamination, accidental exposure and spills and personnel training21 |
| Hazardous signage must be used20 21 | On all containers, storage cabinets/fridges/freezers and the door to the reconstitution room20 |
| All GTMPs should be added to the institutional hazardous drugs list22 | As required by local legislation |
This table is intended as a framework to aid the development of institutional standard operating procedures and should be amended as required to comply with local regulations.
*Protective clothing is required to minimise the risk of microbiological contamination of the therapeutic agent during reconstitution, as well as to protect the person preparing the agent.
†Unless there is solid evidence that the vector is not being shed, disposable clothing/laundry is advised.
GTMP, gene therapy medicinal product.