SAFE HANDLING OF GENE MEDICINES
Marion Watson1, Nicola Stoner2
Oxford Radcliffe Hospitals NHS Trust, Oxford & Cancer Research U.K.
1. Biological Safety Officer, Oxford Radcliffe Hospitals NHS Trust, Oxford
2. Consultant Pharmacist, Cancer Research UK, Oxford Cancer Centre, Oxford Radcliffe
Hospitals NHS Trust, Oxford
Dr Nicola Stoner
Consultant Pharmacist
Oxford Cancer Centre
Churchill Hospital
Oxford Radcliffe Hospitals NHS Trust
Headington
Oxford OX3 7LJ
Tel: 01865 226187
Fax: 01865 226174
Email: nicola.stoner@orh.nhs.uk
SAFE HANDLING OF GENE MEDICINES
Marion Watson1, Nicola Stoner2
Oxford Radcliffe Hospitals NHS Trust, Oxford & Cancer Research U.K.
3. Biological Safety Officer, Oxford Radcliffe Hospitals NHS Trust, Oxford
4. Consultant Pharmacist, Cancer Research UK, Oxford Cancer Centre, Oxford Radcliffe
Hospitals NHS Trust, Oxford
Introduction
As gene medicine begins its long awaited move from research into the clinic [1-3] it brings
new challenges in safety for pharmacists and clinicians.
Aims
Pharmacists are well placed to lead on the dissemination of good practice for safe
handling of gene medicines, particularly for hospitals that have no experience with GMOs
through research or laboratory work.
Method
In 2007 the UK the Health and Safety Executive have issued specific guidance for the use
of GMOs in clinical settings [4] that will be invaluable to hospitals working with gene
medicines for the first time. Some gene medicines require class II containment as they are
replication competent, they may reproduce in human cells until eliminated by the immune
system. These require additional precautions to protect staff so will always need to be
drawn up in a biological safety cabinet or isolator. Standard operating procedures (SOPs)
are essential to safe handling and manipulation of gene medicines [9]. Gene medicines will
ideally be drawn up in an aseptic pharmacy facility. Risk assessments need to be carried
out for each gene medicine.
Results
Gene medicines can be handled safely if staff are trained about gene therapy, risk
assessments have been undertaken, SOPs are adhered to and procedures put in place to
ensure cross-contamination with other medicines is prevented. The European Association
of Hospital Pharmacy guidance on handling gene medicines [10] is an essential tool for
hospital pharmacists who will be involved with gene medicine products in the future
Standard Operating Procedures for Safe Handling of Gene
Medicines
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Delivery and storage
On site transport
Staff training, including record keeping
Use of biological safety cabinet or isolator
Use of personal protective equipment
Gene medicine preparation (medicine specific)
Preparation of disinfectants or chemical deactivators
Decontamination of surfaces
Decontamination of equipment
Decontamination of bedding and linen
Accidental spillages (including spill kits)
Waste disposal including unused medication
Procedures for accidental exposure of staff/visitors, including
Occupational Health procedures
Incident reporting and investigation
Discussion
Staff confidence in handling gene medicines is fundamental to safety. Training is essential.
Procedures must be in place and staff trained on dealing with spills. The future may well
bring licensed GMOs that will require higher containment, those which survive for longer in
the human body, replicating and infecting new cells (UK Class III).
References
1. Pearson S, Jia H, Kandachi K. China approves first gene therapy. Nature
Biotechnology 2004: 22:3-4.
2. Arktherapeutics. Cerepro™ (sitimagene ceradenovec) – treatment for brain cancer
(malignant glioma). http://www.arktherapeutics.com
3. Immonen A, Vapalahti M, Tyynelä K, Hurskainen H, Sandmair A, Vanninen R, et al.
AdvHSV-tk Gene Therapy with Intravenous Ganciclovir Improves Survival in Human
Malignant Glioma: A Randomised, Controlled Study. Mol Ther 2004;10:967-972.
4. HSE. The SACGM Compendium of guidance. Part 6: Guidance on the use of
genetically modified microorganisms in a clinical setting.
http://www.hse.gov.uk/biosafety/gmo/acgm/acgmcomp/part6.pdf
5. Simpson J, Stoner NS. Implications of Gene Therapy to Pharmacists. Pharm J 2003;
271:127-130.
6. Bamford KB, Wood S, Shaw RJ. Standards for gene therapy clinical trials based on
pro-active risk assessment in a London NHS Teaching Hospital Trust. Q J Med
2005;98:75-86.
7. European Parliament. Directive 2001/18/EC on the deliberate release into the
environment of GMOs. Official Journal of the EC 2001; L301:13-31
8. European Parliament. Directive 98/81/EC on the contained use of GMOs. Official
Journal of the EC 1998; L106:1-38
9. Stoner NS. Appendix 6: Gene therapy. In: Beaney AM, ed. Quality Assurance of
Aseptic Preparation Services, 4th edn. London: Pharmaceutical Press. 2006;123-33.
10. Vulto, A.G., Stoner, N., Balasova, H., Cercos, A.C., Hoppe-Tichy, T., Vinent Genestar,
J.L., Kontra, K., Nydert, P., Vermes, A., Wolfsberger, A. (2007) European Association
of Hospital Pharmacists (EAHP) Guidance on the Pharmacy Handling of Gene
Medicines. European Journal of Hospital Pharmacy Practice. 13(5):29-39.