NATIONAL AND INTERNATIONAL GUIDANCE ON HANDLING GENE
THERAPY IN THE CLINICAL SETTING
Nicola Stoner1, MarionWatson2
Cancer Research U.K. & Oxford Radcliffe Hospitals NHS Trust, Oxford.
1.
2.
Consultant Cancer Pharmacist, Cancer Research UK and Cancer Directorate, Oxford Radcliffe
Hospitals NHS Trust, Oxford
Biological Safety Officer, , Oxford Radcliffe Hospitals NHS Trust, Oxford
Dr Nicola Stoner B.Sc. (Hons), M.R.Pharm.S., Dip. Clin. Pharm., Ph.D.,
Certificate in Independent and Supplementary Prescribing
Consultant Cancer Pharmacist
Cancer Pharmacy Office CR-UK
Department of Oncology
The Churchill
Oxford Radcliffe Hospitals NHS Trust
Headington
Oxford OX3 7LJ
Tel. 01865 226187
Fax: 01865 226174
Email:Nicola.stoner@cancer.org.uk
Dr. Marion Watson
Biological Safety Officer
John Radcliffe Hospital
Oxford Radcliffe Hospitals NHS Trust
Headington
Oxford
NATIONAL AND INTERNATIONAL GUIDANCE ON HANDLING GENE
THERAPY IN THE CLINICAL SETTING
Nicola Stoner1, MarionWatson2
Cancer Research U.K. & Oxford Radcliffe Hospitals NHS Trust, Oxford.
1
Consultant Cancer Pharmacist, Cancer Research UK and Cancer Directorate, Oxford Radcliffe Hospitals
NHS Trust, Oxford
2
Biological Safety Officer, , Oxford Radcliffe Hospitals NHS Trust, Oxford
Introduction
The Oxford Radcliffe Hospitals NHS Trust has undertaken over twenty gene therapy and
genetically modified vaccine clinical trials since 1993, requiring containment level one
and two facilities. In 2007 the Health and Safety Executive (HSE) issued guidance that
includes gene therapy clinical trials. The European Association of Hospital Pharmacists
Gene Therapy Advisory Board has developed European guidance on handling licenced
gene therapy.
The aim of the poster is to highlight the national and international guidance which has
been developed on handling gene therapy in the clinical setting, to minimise the health
and safety risk to the staff, patients, visitors and the environment.
Method
Until 2007 there has been no national or international guidance available on the required
standards for handling containment levels one and two genetically modified organisms in
the clinical setting. The published literature, national and international guidance has been
reviewed to summarise the standards to which we should be working, now that national
and international guidance is available.
Results
This information was used to update standard operating procedures (SOPs) to maintain
correct standards within Oxford Radcliffe Hospitals NHS Trust, which were approved by
the Hospital’s Genetic Modification Safety Committee. A business case for central
facilities for the aseptic handling of gene therapy is currently being discussed within the
Trust. In the meantime, the Oxford Cancer Centre will have specific facilities for
handling gene therapy in the clinical setting following the national and international
guidance.
Conclusion
With the first gene therapy being licensed in China in 2004 and in Europe in 2007 for
cancer, it is essential that Hospitals prepare for the facilities they will require for
administering gene therapy in clinical practice. It is essential that the available national
and international guidance be adhered to, to ensure the safety of patients, staff and the
environment.
References
Vulto, A.G., Stoner, N., Balasova, H., Cercos, A., Hoppe Tichy, T., Vinent Genestar,
J.L., Kontra, K., Nydert, P., Vermes, A., Wolfsberger, A. (2007) European Association of
Hospital Pharmacists Guidance on the Pharmacy Handling of Gene Medicines.
SACGM. The SACGM Compendium of guidance. Part 6: Guidance on the use of
genetically modified microorganisms in a clinical setting. Available from:
http://www.hse.gov.uk/biosafety/gmo/acgm/acgmcomp/part6.pdf
Stoner, N.S., Logan, P, Bateman, R. “Appendix 6 - Gene Therapy” in Beaney, A.M.
(2006) Quality Assurance of Aseptic Preparation Services, 4th edition, Pharmaceutical
Press.
Simpson, J., Stoner, N.S. (2003) Implications of Gene Therapy to Pharmacists,
Pharmaceutical Journal 271(7259):127-130.
Stoner, N.S., Gibson, R.N., Edwards, J. (2003) Health and Safety Considerations for the
Administration of Gene Therapy Within the Clinical Setting. Journal of Oncology
Pharmacy Practice, 9: 29-35. (Best Practice Paper Award)
Brooks, G. Gene Therapy -The use of DNA as a Drug (2002), Pharmaceutical Press,
London.
Stoner, N.S. (Oct. 2002) Considerations for Cancer Pharmacists Undertaking Gene
Therapy Clinical Trials, BOPA Newsletter.