EAHP Guidance on the Pharmacy Handling of Gene Medicines
European Association of Hospital Pharmacists
European Association of Hospital Pharmacists
Guidance on the Pharmacy Handling
of Licensed Gene Medicines
Dr. Nicola Stoner Consultant Pharmacist, Cancer Services & Cancer Research UK
Oxford Radcliffe Hospitals NHS Trust.Principal Visiting Fellow, The University of Reading.
BOPA October 14th, 2007
EAHP Guidance on the Pharmacy Handling of Gene Medicines
European Association of Hospital Pharmacists
The History
• May 2006: Ark Therapeutics approached the EAHP President– Suggestion to collaborate with the EAHP to develop guidance
on the handling of gene medicines– EAHP President recommended consultation with EAHP board
member Professor Arnold Vulto
• August 2006: First meeting between Professor Arnold Vulto and Ark Therapeutics; approval of the plan by the EAHP board
• Ark Therapeutics provided unrestricted funding for the establishment of a working group and the development of the guidance
EAHP Guidance on the Pharmacy Handling of Gene Medicines
European Association of Hospital Pharmacists
The History (continued)
• September 2006: National delegations at the EAHP General Assembly were approached to nominate gene medicines-experienced hospital pharmacists to take part in the working group to develop the guidance
• Ten expert gene medicines hospital pharmacists across 8 EU countries were selected and invited to participate in the development of the EAHP guidance– All were locally recognised as gene medicine specialist
pharmacists
EAHP Guidance on the Pharmacy Handling of Gene Medicines
European Association of Hospital Pharmacists
• Austria: Andrea Wolfsberger• Czech Republic: Hana Balásová• Finland: Kirsi Kontra• Germany: Torsten Hoppe Tichy• The Netherlands: Arnold G Vulto, András Vermes• Spain: Juan L Vinent Genestar, Ana-Cristina
Cercos• Sweden: Per Nydert• United Kingdom: Nicola Stoner
The Experts
EAHP Guidance on the Pharmacy Handling of Gene Medicines
European Association of Hospital Pharmacists
The Philosophy
• Guidance for licensed gene medicine, not research setting
• Limit to class I or II biosafety level– As such, similar procedures to cytotoxic preparations and
handling
• Recommendations should be practical, and feasible to implement in hospital pharmacies providing standard of oncology pharmacy support– Risk level and procedures not exceeding an existing
routine comparator product like BCG bladder instillation
EAHP Guidance on the Pharmacy Handling of Gene Medicines
European Association of Hospital Pharmacists
The Process
1. Review of existing literature, guidance and local practices
– Existing guidelines were collated and sent to all members prior to first meeting to gain insight into current standards
– All members completed a pre-meeting survey on handling of gene medicines in their country/facility
2. First working group meeting (November 2006)– 8 members attended the 1-day workshop in Schiphol
Airport, Amsterdam, for in depth discussions– Professor Vulto chaired the workshop– Consensus on major points of the guidance reached
EAHP Guidance on the Pharmacy Handling of Gene Medicines
European Association of Hospital Pharmacists
The Process (continued)
3. Standard operating procedure (SOP) charts and tables drafted and reviewed by the working group – Based on input prior to and during November meeting– Editorial support was provided by Michelle O’Donovan,
PhD, Ogilvy Healthworld Medical Education
4. Text to accompany SoPs drafted and reviewed by the working group– Extensive review and consultation by all members in
advance of second meeting in April 2007
EAHP Guidance on the Pharmacy Handling of Gene Medicines
European Association of Hospital Pharmacists
5. Second working group meeting (April 2007)– Outstanding issues discussed in great detail and
consensus reached– Full text, including discussion section, drafted and
reviewed by the working group
6. External validation of the guidelines by three external experts
The Process (continued)
EAHP Guidance on the Pharmacy Handling of Gene Medicines
European Association of Hospital Pharmacists
External Validation
• Prof Gavin Brooks, School of Pharmacy, University of Reading, UK
• Dr Marion Watson, Biological Safety Officer, Oxford Radcliffe Hospitals NHS Trust, UK
• V'lain Fenton-May, Hospital Pharmacist and QA Officer, Pharmacy Department, University Hospital of Wales, Cardiff, UK
EAHP Guidance on the Pharmacy Handling of Gene Medicines
European Association of Hospital Pharmacists
7. Draft sent to EAHP board
8. June 2007 presentation of the results of the EAHP Working Group to the EAHP General Assembly
The Process (continued)
EAHP Guidance on the Pharmacy Handling of Gene Medicines
European Association of Hospital Pharmacists
Final Outputs of this Working Group
• Submission as publication in European Journal of Hospital Pharmacy-Practice edition
• Available on EAHP website: downloadable versions of SOPs and charts; easy to update
EAHP Guidance on the Pharmacy Handling of Gene Medicines
European Association of Hospital Pharmacists
Gene Therapy - Definition
The introduction of genetic material into an individual, or the modification of the individual’s genetic material, to achieve a therapeutic objective.
The World Health Organization (WHO)
EAHP Guidance on the Pharmacy Handling of Gene Medicines
European Association of Hospital Pharmacists
Genetically Modified Organism (GMO)
An organism in which ‘the genetic material has been altered in a way that does not occur naturally using recombinant nucleic acid techniques involving the formation of new combinations of genetic material by the insertion of nucleic acid molecules, into any virus, bacterial plasmid or other vector system and their incorporation into a host organism in which they do not naturally occur but in which they are capable of continued propagation.
The Health and Safety Executive (HSE), UK
EAHP Guidance on the Pharmacy Handling of Gene Medicines
European Association of Hospital Pharmacists
Need for Guidance on Handling Gene Medicines
• Viral vectors used in gene medicines include adeno-, retro-, adeno-associated, & pox viral vectors
• Handling as biological agents
• Procedures similar to handling cytotoxics or Bacillus Calmette-Guérin (BCG)
• Hazards of gene medicines less than other infectious organisms in hospitals.
EAHP Guidance on the Pharmacy Handling of Gene Medicines
European Association of Hospital Pharmacists
Existing Guidance
• Gene Therapy Advisory Committee (GTAC) UK
• Medicines for Human Use (Clinical Trials) Regulations 2004
• EU Council Directive 98/81/EC
• Health and Safety Executive (HSE) UK
EAHP Guidance on the Pharmacy Handling of Gene Medicines
European Association of Hospital Pharmacists
Aims, scope and target of the guidance
• Centers that already have a dedicated gene medicine suite are in the best position to safely prepare and administer gene medicines.
• The guidance aims to provide broad, practical recommendations for the handling of licensed gene medicines in clinical practice within Europe.
• It encompasses recommendations for storage, transportation, preparation, dispensing, administration, waste disposal, decontamination and accidental exposure.
EAHP Guidance on the Pharmacy Handling of Gene Medicines
European Association of Hospital Pharmacists
The Guidance…
• Gene Medicines at biosafety level 1 or 2 in Europe• Licensed medicine• All staff involved at any stage of handling• Presented as tables and flowcharts• To be used in conjunction with Summary of Product
Characteristics (SPC)• Practice must comply with national legislation
EAHP Guidance on the Pharmacy Handling of Gene Medicines
European Association of Hospital Pharmacists
Patient Care & Handling Gene Medicines and Patient Specimens
• Appropriate protective clothing for task
• Universal precautions
• Biological safety device for preparation
• No specific precautions for patient specimens
• Handling as for infectious diseases
EAHP Guidance on the Pharmacy Handling of Gene Medicines
European Association of Hospital Pharmacists
Table 1. General guidance regarding the handling of gene medicine and
associated patient specimens
Universal precautions must be observed in the handling of gene medicines,
clinical specimens (patient blood, tissue, body fluids) and materials or equipment
contaminated by these substances following treatment. This includes:
Wear suitable protective clothing to minimise
the risk of microbiological contamination of the
therapeutic agent during preparation. The
clothing (see right-hand box) and its quality
should be appropriate to protect the therapeutic
agent from contamination
Ideally disposable apron or gown
(or lab coat)*
Safety glasses (or goggles)
Gloves
Mucous membrane splash
protector
Use of a biological safety cabinet or
pharmaceutical grade isolator (compliant with
European standard EN 12469:2000) for
dispensation and preparation of gene medicines
(minimum class II, type B)
See Chart 2
Needles and sharps: take adequate precaution
with use and disposal
See Chart 5
EAHP Guidance on the Pharmacy Handling of Gene Medicines
European Association of Hospital Pharmacists
Ensure decontamination of work surface areas See Chart 2
Cleaning/decontamination of patient bedding
according to procedures used for blood- or body
fluid-soiled laundry*
See Chart 5
Specific isolation wards are not
required
No special precautions for patient elimination of
stools or urines, unless specified in the SPC for
product-specific information
Patients may use normal bathroom
facilities unless advised otherwise
Transport and storage of patient specimens must
be in a closed, labelled leak-proof container
See Table 2
Disposal of products, contaminated waste (eg
gloves, gowns etc) and patient specimens must
follow the local procedures of the institution for
decontamination
Materials to be decontaminated
outside the immediate area should
be placed in a robust, leak-proof
container and closed for transport
from the area (contaminated waste
disposal). See Chart 5
*Disposable laundry is preferred unless there is solid evidence that the vector is not
being shed.
EAHP Guidance on the Pharmacy Handling of Gene Medicines
European Association of Hospital Pharmacists
*When gene medicines are delivered, the secondary packaging is guaranteed as not contaminated †If vial is damaged, the primary packaging should follow the decontamination process
‡Location of storage must ensure that no unauthorised person can gain access and there is no undue exposure of hospital staff. A biohazard label may be required on the door to the storage room, depending on the biosafety level of the stored gene medicine
Monitor freezer temperature regularly to ensure accurate temperature for
storage
Pharmacist should wear protective clothing as per recommendations
(see Table 1)
Is the vial damaged?†
Has the medicine
defrosted?
Discard to biohazard
container for incineration/autoclaving
Discard to biohazard container for
decontamination. See Chart 6 for
decontamination procedure if required
Yes
Yes
No
Store‡ in –20ºC or –70ºC freezer, per product label. Dedicated, secure
freezer within the pharmacy with one compartment for each product is ideal
Remove shipment packingDiscard shipment
packing with normal waste*
No
No
Yes
Store‡ at room temperature in suitable cabinet or in fridge,
after consulting product-specific requirements
Is freezer storage
required?
Action stepQuestion/ choice of
action
Disposal/waste removal step
Administrative step
Key:
Chart 1. Storage of gene medicine
EAHP Guidance on the Pharmacy Handling of Gene Medicines
European Association of Hospital Pharmacists
Gene Medicine Storage
• Disposable protective clothing
• Package opening - biosafety cabinet
• Fridge, freezer (–20o or –70ºC)
• Separate shelves for each gene medicine
• Secure, restricted access
• Temperature monitoring
EAHP Guidance on the Pharmacy Handling of Gene Medicines
European Association of Hospital Pharmacists
*A biohazard sign may not always be necessary; for example, during preparation of a biosafety level 1 agent†The running of the safety device should be according to local procedures for aseptic preparation‡Disinfectant with proven virucidal activity, eg an oxidising/sterilising agent such as 1,000 ppm chlorine, 1–2% Virkonor 6% hydrogen peroxide§Any product spills should be decontaminated following Chart 6
Display biohazard sign* at entrance to production area. All biohazards used in the room and the biosafety device
should be listed in dispensing log
Action stepQuestion/ choice of
action
Disposal/waste removal step
Administrative step
Key:
Discard material to biohazard container for
decontamination (see Chart 5)
With the correct procedures in place and when using a validated biological safety device, simultaneous
preparations can take place in other biological safety devices within the same room; the key consideration is
always to prevent cross-contamination
Switch on device approximately 15 minutes before use and ensure correct air flow†
Prepare disinfectant‡: should be available for use during all gene medicine manipulation procedures
Disinfect all equipment by wiping with 70% alcohol as it is transferred into the biological safety device
When dry, wash device with sterile water or 70% alcohol to remove excess disinfectant, if required
Drug should be drawn-up using the ‘double-glove’technique§
Discard gloves to biohazard container for
decontamination (see Chart 5)
Transport directly to administration area (following recommendations in Table 2)
Prepared gene medicine should be placed in a
labelled sterile, plastic bag
Device should be left running for a sufficient time window post use to ensure eradication of any aerosols
Repeat procedure for decontamination.Secure room to prevent access and complete log book to confirm room is being decontaminated
Where necessary, reconstitute product in a validated (minimum class II, type B) biological safety device (either cabinet or isolator), with a background grading per local
guidance/regulations
If using an isolator, follow
validated decontamination
procedure
Wearing recommended protective clothing, the inside of the device and glass window should be washed with disinfectant‡ using disposable absorbent material
Chart 2. Preparation of gene medicine and decontamination of biological safety device used for gene medicine procedures
EAHP Guidance on the Pharmacy Handling of Gene Medicines
European Association of Hospital Pharmacists
Preparation (1)
• Biological safety device – Pharmaceutical grade isolator– Class II biological safety cabinet– Exhaust to the outside, no recirculation– Negative pressure (risk assessment)
• Prevention of cross contamination• Use of biohazard sign outside the room• Use of appropriate disinfectant (e.g. 1–2%
Virkon® or 6% hydrogen peroxide)
EAHP Guidance on the Pharmacy Handling of Gene Medicines
European Association of Hospital Pharmacists
Preparation (2)
• Co-ordination of preparation with administration
• Aseptic procedures
• Disinfectant in biosafety device
• Records of decontamination
• Eradication of aerosols
EAHP Guidance on the Pharmacy Handling of Gene Medicines
European Association of Hospital Pharmacists
Transportation
• Seal in plastic bag/secondary container
• Leak-proof, labelled, biohazard container
• Temperature control
• Spill kit to be available
• Use immediately
EAHP Guidance on the Pharmacy Handling of Gene Medicines
European Association of Hospital Pharmacists
*A biohazard sign may not always be necessary; for example, during preparation of a biosafety level 1 agent†The delivery device should be suitably disinfected after use‡Either dedicated spillage kit to be carried around with the product at all times or separate kits available at all locations during preparation, transport and administration
Pharmacist should draw up the required volume of gene medicine in the biological safety device
(see Chart 2)
Transfer vial to biological safety device or isolator, ensuring a disposable absorbent is
placed on the base of device and the spillage kit is available.‡ The primary package containing
the gene medicine should only be opened in the biological safety device
Remove gene medicine from locked storage, check correct dose and number of vials†
Protective clothing for dispensing should be worn as recommended (see Table 1)
Gene medicine prescription should be checked according to the normal pharmacy procedure
Discard empty vials and sharps (sharps bin within
the device) for decontamination
(see Chart 5)Transport directly to
administration area (following recommendations in Table 2)
Place the prepared gene medicine in a labelled,
sterile plastic bag
Complete and update administrative logs: • Accountability log (if used)• Staff exposure log if required based on drug and local regulations
Display biohazard sign* at entrance to dispensing area. All biohazards used in the room
and in the biosafety device should be listed
Action stepQuestion/ choice of
action
Disposal/waste removal step
Administrative step
Key:
Chart 3. Dispensing procedure for gene medicine
EAHP Guidance on the Pharmacy Handling of Gene Medicines
European Association of Hospital Pharmacists
Dispensing
• Prescriptions checked - normal procedure
• Appropriate protective clothing
• Disposable absorbent in safety cabinet
• Transfer gene medicine
• Defrost if required and dispense
• Place in plastic bag
• Staff exposure log
EAHP Guidance on the Pharmacy Handling of Gene Medicines
European Association of Hospital Pharmacists
Administering staff and other personnel dealing with the gene medicine should be dressed in a disposable gown and sterile gloves (minimum requirement), and disposable facemask and goggles (depending on risk assessment data available for product; for biosafety level I agents, some clothing may not apply). The
number of other personnel present should be kept to a minimum
Double-check before administration. Administration site should be prepared and patient should be ready for administration in a timely manner relative to drug
preparation
Gene medicine should be administered within the timelines stated in summary of product characteristics
If there is a spillage, refer to
Chart 6
The patient can have free access to walk around the ward or
outpatient department once the procedure is complete, dependent
on biosafety level, risk assessment and route of administration, providing
containment of the gene medicine is ensured
Complete and update administrative logs: • Accountability log (if used) • Staff exposure log if required based on drug and local regulations
Action stepQuestion/ choice of
action
Disposal/waste removal step
Administrative step
Key:
Chart 4. Administration procedure for gene medicine: Guidance for clinical staff to develop SoPs
EAHP Guidance on the Pharmacy Handling of Gene Medicines
European Association of Hospital Pharmacists
Administration
• Co-ordination between pharmacy and administration
• Administer within recommended timelines
• Appropriate protective clothing
• Inpatient/outpatient/containment depends on risk assessment for each product
EAHP Guidance on the Pharmacy Handling of Gene Medicines
European Association of Hospital Pharmacists
*Disinfectant with proven virucidal activity eg an oxidising/sterilising agent such as 1,000 ppm chlorine, 1–2% Virkon or 6% hydrogen peroxide†Inactivation should be conducted according to local regulations
Disposable materials used to
dispense and administer
gene medicine
Seal in biohazard container
Sharps used to dispense
and administer
gene medicine
Seal in yellow sharps box
Non-disposable items used to dispense
and administer
gene medicine
Clean with suitable
disinfectant*
Spillage on laundry
(should be treated as infectious)
Seal in laundry bags
Place in incineration waste bin, sealing it as quickly as possible; or
place in autoclave bags if appropriate
Disposable personal
protective equipment
Seal in biohazard container
Decontaminate waste† if necessary before incineration for certain biosafety levels of gene medicine, according
to local regulations
Dispatch for incineration as soon as possible, as per hospital policy
Dispatch for laundry, as
soon as possible, as per hospital
policy
Action stepQuestion/ choice of
action
Disposal/waste removal step
Administrative step
Key:
Chart 5. Gene medicine waste disposal
EAHP Guidance on the Pharmacy Handling of Gene Medicines
European Association of Hospital Pharmacists
Waste Disposal
• Limit contact with the environment and people
• Non-disposable items must be cleaned with appropriate disinfectant
• Autoclaving• Incineration• Label appropriately• Local regulations/legislation
EAHP Guidance on the Pharmacy Handling of Gene Medicines
European Association of Hospital Pharmacists
*Disinfectant with proven virucidal activity eg an oxidising/sterilising agent such as 1,000 ppm chlorine, 1–2% Virkon or 6% hydrogen peroxide
Note: Follow local legal and regulatory requirements regarding use of additional protective equipment eg respirator
Cleaning procedure kit minimum contents – must be available during all steps in gene medicine handling: storage, preparation, dispensing, transport, administration and disposal.Product information leaflet should be available at all times
2 x disposable gowns or arm covers4 ×gloves2 ×masks2 ×aprons2 ×goggles4 ×disposable shoe covers
2 ×disinfectant* sachets (or other prepared disinfectant)Absorbent paper towels2 ×Disposable forceps 2 ×Biohazard incineration bagsEmergency contact numberCopy of spillage procedure
Product spill inside biological safety device
Wearing appropriate protective equipment (eye protection, disposable apron and
gloves), saturate absorbent material with disinfectant*
Place saturated absorbent on spill*
Depending on type of biological safety device used, appropriate decontamination
must be carried out
Discard absorbent, liquid and all other materials used in spill clean-up,
including personal protective equipment, to biohazard container
for incineration (see Chart 5)
Allow 20–30 minutes contact time
Product spill outside biological safety device
Cordon off area for 20–30 minutes to allow aerosol to settle
Enter area in appropriate protective clothing and equipment – disposable
coveralls, shoe covers, mucous membrane protection (eye, nose, mouth),
arm covers and gloves. Saturate absorbent material with disinfectant*
Place absorbent material onto the liquid spill
Use mechanical means to pick up broken glassware or other sharps
Discard absorbent, liquid and all other materials used in spill clean-up,
including personal protective equipment, to biohazard container for incineration. Dispose of sharps in a
small sharps bin (see Chart 5)
Allow 20–30 minutes contact time
Allow device to operate to remove any aerosols
Action stepQuestion/ choice of
action
Disposal/waste removal step
Administrative step
Key:
Chart 6. Decontamination of gene medicine product spills
EAHP Guidance on the Pharmacy Handling of Gene Medicines
European Association of Hospital Pharmacists
Spillage Kit
• 2 disposable gowns or arm covers• 4 gloves• 2 aprons• 2 pairs of goggles• 4 disposable shoe covers• 2 disinfectant sachets• Absorbent paper towels• 2 disposable forceps• 2 biohazard disposal bags• Emergency contact number• Spillage procedure
EAHP Guidance on the Pharmacy Handling of Gene Medicines
European Association of Hospital Pharmacists
Spill Decontamination
• Spillage kit available at all times
• Procedures for within and outside a biological safety device
• Person spilling the agent responsible for initiating decontamination procedure
EAHP Guidance on the Pharmacy Handling of Gene Medicines
European Association of Hospital Pharmacists
Wipe area thoroughly with
gauze soaked in diluted bleach or
3% hydrogen peroxide rinse*,
followed by extensive water
washing
Wipe area thoroughly with
gauze soaked in 3% hydrogen
peroxide rinse*only, followed by extensive water
washing
Note: Any accidental exposure should also be recorded in the staff exposure log, where available
Needle stick
Encourage bleeding of the
wound
Splash to eyes,
mucous membranes
Rinse with water or 0.9% sterile
saline solution for at least 15
minutes while holding the
eyelids open
InhalationSkin
exposure
Wash immediately with soap and water
No Yes
Obtain medical attention
After any exposure, report to the occupational health department, biosafety/infection control officer and incident-report group (where
local protocol dictates)
Is the skin broken?
Wash with soap and water
Dry area with disposable
material, cover with disposable
dressing
*This refers broadly to agents that are biosafety level II; those that are level I may require less stringent decontamination agents: See product manufacturing details for specific decontamination
Occupational health procedures must always be in place prior to initiation of the use of gene medicine at the facility (see Table 3)
Action stepQuestion/ choice of
action
Disposal/waste removal step
Administrative step
Key:
Chart 7. Accidental exposure to a gene medicine
EAHP Guidance on the Pharmacy Handling of Gene Medicines
European Association of Hospital Pharmacists
Accidental Exposure
• Manufacturers guidance
• Normal hospital procedure
• Occupational health
• Biological Safety Officer
• Incident reporting
EAHP Guidance on the Pharmacy Handling of Gene Medicines
European Association of Hospital Pharmacists
Roles and Responsibilities
• Physician• Chief Pharmacist• Pharmacists• Pharmacy Technicians• Nursing staff• Biological Safety Officer• Infection Control• Occupational Health• Waste disposal services• Hospital Management
EAHP Guidance on the Pharmacy Handling of Gene Medicines
European Association of Hospital Pharmacists
Future Congress Activity
• Seminar at 13th EAHP Congress 2008 (27–29 February 2008, Maastricht, The Netherlands)
• Other presentations/posters at professional meetings:– ESGT 2007: 15th Annual Congress of the European Society of
Gene and Cell Therapy (27–30 Oct 2007, Rotterdam, The Netherlands)
– BSGT 2008: 5th British Society for Gene Therapy Annual Conference (7–9 April 2008, Edinburgh, UK)
– ESOP 2008: European Society of Oncology Pharmacy (Hamburg 2008 meeting)
– BOPA 2007: British Oncology Pharmacy Association (12–14 October, Glasgow, UK)
– ASHP 2007: American Society of Health-System Pharmacists (2–6 December, Las Vegas, USA)
EAHP Guidance on the Pharmacy Handling of Gene Medicines
European Association of Hospital Pharmacists
ASHP 2007
Timeline Overview
Mtg 1
Advisory board group
2006 2007 2008
9 10 11 12 1 2 3 4 5 6 7 8 9 10 11 12 2 4 6 8 10 12
Mtg 2
Publication of guidance
Guidance drafting and submission
External validation
EAHP endorsement
Advisory group reviews
Other activities
EJHP-P Print
EAHP website
ESGT 2007
EAHP 2008
BSGT 2008
ESOP 2007
BOPA 2007
EAHP Guidance on the Pharmacy Handling of Gene Medicines
European Association of Hospital Pharmacists
1. EAHP is taking the lead in providing guidance on a new form of therapy to be introduced in medical practice
2. The process guarantees broad acceptance of the guidance, compliant with current regulations
3. European hospital pharmacists can support medical practice with confidence when this new form of therapy is being introduced
The Result
EAHP Guidance on the Pharmacy Handling of Gene Medicines
European Association of Hospital Pharmacists
4. EAHP has been instrumental in providing this unique – first in the world – service to it membership
5. This project shows the synergistic power of EAHP, integrating scientific knowledge, professional standards and a unique way of communicating with all the members (ie the official journal EJHP and open-platform publication on the EAHP website, keeping the guidance up to date and available to all interested parties)
The Result (continued)
EAHP Guidance on the Pharmacy Handling of Gene Medicines
European Association of Hospital Pharmacists
References (1)
1. Collaboration TA. Development and validation of an international appraisal instrument for assessing the quality of clinical practice guidelines: the AGREE project. Qual Saf Health Care. 2003 Feb;12(1):18-23.
2. Research ACoH. Genomics and World Health: Report of the Advisory Committee on Health Research. Geneva: World Health Organization; 2002.
3. SACGM. The SACGM Compendium of guidance. Part 1: Introduction to the legislation and general health and safety issues. [cited 5 April 2007]; Available from: http://www.hse.gov.uk/biosafety/gmo/acgm/acgmcomp/part2.pdf
4. U.S. Department of Health and Human Services Public Health Service CfDCaP, National Institutes of Health. Biosafety in Microbiological and Biomedical Laboratories. 4e ed. Washington, DC: U.S. Government Printing Office; 1999.
5. Roth RI, Fleischer NM. Gene therapy: applications to pharmacy practice. J Am Pharm Assoc (Wash). 2002 Sep-Oct;42(5):692, 4-8.
6. Brosman SA, Lamm DL. The preparation, handling and use of intravesical bacillus Calmette-Guerin for the management of stage Ta, T1, carcinoma in situ and transitional cell cancer. J Urol. 1990 Aug;144(2 Pt 1):313-5.
7. Brosman SA, Lamm DL, van der Meijden AP, Debruyne FM. A practical guide to the use of intravesical BCG for the management of stage Ta, T1, CIS, transitional cell cancer. Prog Clin Biol Res. 1989;310:311-23.
8. The Medicines for Human Use (Clinical Trials) Regulations 2004. 1031; 2004.
EAHP Guidance on the Pharmacy Handling of Gene Medicines
European Association of Hospital Pharmacists
References (2)
9. Armistead J, Zillich A, Williams K, Sitzlar S, Wermeling D. Hospital and Pharmacy Departmental Policies and Procedures for Gene Therapy at a Teaching Institute. Hospital Pharmacy. 2001;36:56-66.
10. 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. 2005;98:75-86.
11. COUNCIL DIRECTIVE 98/81/EC of 26 October 1998 amending Directive 90/219/EEC on the contained use of genetically modified micro-organisms. 98/81/EC; 1998.
12. Directive 2000/54/EC of the European Parliament and of the Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work (seventh individual directive within the meaning of Article 16(1) of Directive 89/391/EEC). 2000/54/EC; 2000.
13. Stoner NS. Appendix 6: Gene therapy. In: Beaney AM, editor. Quality Assurance of Aseptic Preparation Services, 4th edn. London: Pharmaceutical Press; 2006. p. 123-33.
14. Stoner NS, Gibson RN, Edwards J. Development of procedures to address health and safety issues in the administration of gene therapy within the clinical setting
J Oncol Pharm Practice. 2003;9:29-35.
15. SACGM. The SACGM Compendium of guidance. Part 6: Guidance on the use of genetically modified microorganisms in a clinical setting. [cited 5 April 2007]; Available from: http://www.hse.gov.uk/biosafety/gmo/acgm/acgmcomp/part6.pdf
EAHP Guidance on the Pharmacy Handling of Gene Medicines
European Association of Hospital Pharmacists
References (3)
16. DeCederfelt HJ, Grimes GJ, Green L, DeCederfelt RO, Daniels CE. Handling of gene-transfer products by the National Institutes of Health Clinical Center pharmacy department. Am J Health Syst Pharm. 1997 Jul 15;54(14):1604-10.
17. Power LA, Anderson RW, Cortopassi R, Gera JR, Lewis RM, Jr. Update on safe handling of hazardous drugs: the advice of experts. Am J Hosp Pharm. 1990 May;47(5):1050-60.
18. Kaijser GP, Underberg WJ, Beijnen JH. The risks of handling cytotoxic drugs. II. Recommendations for working with cytotoxic drugs. Pharm Weekbl Sci. 1990 Dec 14;12(6):228-35.
19. U.S. Department of Health and Human Services Public Health Service CfDCaP, National Institutes of Health. Primary Containment for Biohazards: Selection, Installation and Use of Biological Safety Cabinets. Washington, DC: U.S. Government Printing Office; 1995.
20. McCormick L, Maheshwari G. Inactivation of adenovirus types 5 and 6 by Virkon S. Antiviral Res. 2004 Oct;64(1):27-33.
21. Sauerbrei A, Sehr K, Eichhorn U, Reimer K, Wutzler P. Inactivation of human adenovirus genome by different groups of disinfectants. J Hosp Infect. 2004 May;57(1):67-72.
22. Wutzler P, Sauerbrei A. Virucidal efficacy of a combination of 0.2% peracetic acid and 80% (v/v) ethanol (PAA-ethanol) as a potential hand disinfectant. J Hosp Infect. 2000 Dec;46(4):304-8.
23. Identifying roles and responsibilities in change processes. Explanation of RACI, RASCI and RASIC. [cited 01/05/2007]; Available from: www.12manage.com/methods_raci.html
EAHP Guidance on the Pharmacy Handling of Gene Medicines
European Association of Hospital Pharmacists
Contact Details
Dr Nicola StonerConsultant Pharmacist, Cancer Services & Cancer Research UKOxford Radcliffe Hospitals NHS Trust.Principal Visiting Fellow, The University of Reading
Cancer Research UK Medical Oncology UnitThe ChurchillOxford Radcliffe Hospitals NHS TrustHeadingtonOxford OX3 7LJ
Tel. +44 (0)1865 226187Fax. +44 (0)1865 226174Email: [email protected]
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