Transcript Introduction

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
The History
European Association of
Hospital Pharmacists
• 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
The History (continued)
European Association of
Hospital Pharmacists
• 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
The Experts
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
EAHP Guidance on the Pharmacy Handling of Gene Medicines
The Philosophy
European Association of
Hospital Pharmacists
• 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
The Process
European Association of
Hospital Pharmacists
1.
Review of existing literature, guidance and local
practices
–
–
2.
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
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
The Process (continued)
European Association of
Hospital Pharmacists
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
The Process (continued)
European Association of
Hospital Pharmacists
5.
Second working group meeting (April 2007)
–
–
6.
Outstanding issues discussed in great detail and
consensus reached
Full text, including discussion section, drafted and
reviewed by the working group
External validation of the guidelines by three
external experts
EAHP Guidance on the Pharmacy Handling of Gene Medicines
External Validation
European Association of
Hospital Pharmacists
• 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
The Process (continued)
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
EAHP Guidance on the Pharmacy Handling of Gene Medicines
Final Outputs of this
Working Group
European Association of
Hospital Pharmacists
• 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
Gene Therapy Definition
European Association of
Hospital Pharmacists
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
Genetically Modified
Organism (GMO)
European Association of
Hospital Pharmacists
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
Need for Guidance on
Handling Gene Medicines
European Association of
Hospital Pharmacists
• 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
Existing Guidance
European Association of
Hospital Pharmacists
• 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
Aims, scope and target
of the guidance
European Association of
Hospital Pharmacists
• 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
The Guidance…
•
•
•
•
•
European Association of
Hospital Pharmacists
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
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
European Association of
Hospital Pharmacists
•
•
•
•
•
EAHP Guidance on the Pharmacy Handling of Gene Medicines
Table 1. General guidance regarding the handling of gene medicine and
associated patient specimens
Un iversal pre cau tion smu st be observe d in the h an dli ng of ge ne me dicin e,s
clin ical spe cime n s (patie nt blood, tissu e ,body flu ids)and materi als or e qu ipme n t
con tami nated by th e sesu bstan ce fol
s lowing treatme nt. Th is in clu de s:
Wear suitable protective clothing to minimise
Ideally disposable apron or gown
the risk of microbiological contamination of the
(or lab coat)*
therapeutic agent during preparation. The
Safety glasses (or goggles)
clothing (see right-hand box) and its quality
Gloves
should be appropriate to protect the therapeutic
Mucous membrane splash
agent from contamination
protect or
Use of a biological safety cabinet or
See Chart 2
pharmaceutical grade isolat or (compliant with
European standard EN 12469:2000
) for
dispensation and preparation of gene medicines
(minimum class II, type B)
Needles and sharps: take adequate precaution
See Chart 5
with use and disposal
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
See Chart 5
according t o procedures used for blood- or body
Specific isolation wards are not
fluid-soiled laundry*
required
No special precautions for patient elimination of
P atients may use normal bathroom
st ools or urines, unless specified in the SP C for
facilities unless advised otherwise
product-specific information
T ransport and st orage of patient specimens must
See T able 2
be in a closed, labelled leak-proof container
Disposal of products, contaminated waste (eg
Materials t o be decontaminated
gloves, gowns etc) and patient specimens must
outside the immediate area should
follow the local procedures of the institution for
be placed in a robust, leak-proof
decontamination
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
Pharmacist should wear protective
clothing as per recommendations
(see Table 1)
Chart 1. Storage of gene
medicine
Discard shipment
packing with normal
waste*
Remove shipment packing
Is the vial
damaged?†
Yes
European Association of
Discard to biohazard
container for
Hospital Pharmacists
decontamination. See
Chart 6 for
decontamination
procedure if required
No
Is freezer
storage
required?
No
Store‡ at room temperature in
suitable cabinet or in fridge,
after consulting productspecific requirements
Yes
Has the
medicine
defrosted?
Yes
Discard to
biohazard
container for
incineration/
autoclaving
No
Store‡ in –20ºC or –70ºC freezer, per
product label. Dedicated, secure
freezer within the pharmacy with one
compartment for each product is ideal
Monitor freezer temperature regularly
to ensure accurate temperature for
storage
*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
Key:
Question/
Administrative
step
choice of
step
EAHP Guidance on Action
the Pharmacy
Handling
of Gene Medicines
action
Disposal/waste
removal step
Gene Medicine Storage
European Association of
Hospital Pharmacists
•
•
•
•
•
•
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
Display biohazard sign* at entrance to production area. All
biohazards used in the room and the biosafety device
should be listed in dispensing log
Chart 2. Preparation of
gene medicine and
decontamination of
biological safety device
used for gene medicine
procedures
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
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
European Association of
Hospital Pharmacists
Switch on device approximately 15 minutes before use and
ensure correct air flow†
If using an
isolator, follow
validated
decontamination
procedure
Repeat
procedure for
decontamination.
Secure room to
prevent access
and complete log
book to confirm
room is being
decontaminated
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
Discard material
to biohazard
container for
decontamination
(see Chart 5)
Wearing recommended protective clothing, the inside of the
device and glass window should be washed with
disinfectant‡ using disposable absorbent material
When dry, wash device with sterile water or 70% alcohol to
remove excess disinfectant, if required
Discard gloves
to biohazard
container for
decontamination
(see Chart 5)
Drug should be drawn-up using the ‘double-glove’
technique§
Device should be left running for a
sufficient time window post use to
ensure eradication of any aerosols
Prepared gene medicine
should be placed in a
labelled sterile, plastic bag
Transport directly to administration area
(following recommendations in Table 2)
*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% Virkon
or 6% hydrogen peroxide
§Any product spills should be decontaminated following Chart 6
Key:
Question/
Administrative
step
choice of
step
EAHP Guidance on Action
the Pharmacy
Handling
of Gene Medicines
action
Disposal/waste
removal step
Preparation (1)
European Association of
Hospital Pharmacists
• 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
Preparation (2)
European Association of
Hospital Pharmacists
• 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
Transportation
European Association of
Hospital Pharmacists
•
•
•
•
•
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
Display biohazard sign* at entrance to
dispensing area. All biohazards used in the room
and in the biosafety device should be listed
Chart 3. Dispensing
procedure for gene
medicine
Gene medicine prescription should be checked
according to the normal pharmacy procedure
Protective clothing for dispensing should be worn
as recommended (see Table 1)
European Association of
Hospital Pharmacists
Remove gene medicine from locked storage,
check correct dose and number of vials†
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
Pharmacist should draw up the required volume
of gene medicine in the biological safety device
(see Chart 2)
Place the prepared gene
medicine in a labelled,
sterile plastic bag
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)
Complete and update
administrative logs:
• Accountability log (if
used)
• Staff exposure log if
required based on drug
and local regulations
*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
Key:
Question/
Administrative
step
choice of
step
EAHP Guidance on Action
the Pharmacy
Handling
of Gene Medicines
action
Disposal/waste
removal step
Dispensing
European Association of
Hospital Pharmacists
•
•
•
•
•
•
•
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
Chart 4. Administration
procedure for gene
medicine: Guidance for
clinical staff to develop
SoPs
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
European
spillage,
refer to
Chart 6
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
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
Key:
Complete and update
administrative logs:
• Accountability log (if used)
• Staff exposure log if required
based on drug and local
regulations
Question/
Administrative
step
choice of
step
EAHP Guidance on Action
the Pharmacy
Handling
of Gene Medicines
action
Disposal/waste
removal step
Administration
European Association of
Hospital Pharmacists
• 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
Chart 5. Gene medicine
waste disposal
Disposable
materials
used to
dispense and
administer
gene
medicine
Disposable
personal
protective
equipment
Seal in
biohazard
container
Seal in
biohazard
container
Sharps used
to dispense
and
administer
gene
medicine
Spillage on
laundry
(should be
treated as
infectious)
Seal in yellow
sharps box
Seal in
laundry bags
Nondisposable
items used
to dispense
and
administer
gene
medicine
European Association of
Clean with
Hospital
Pharmacists
suitable
disinfectant*
Place in incineration
waste bin, sealing it as
quickly as possible; or
place in autoclave
bags if appropriate
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
*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
Key:
Question/
Administrative
step
choice of
step
EAHP Guidance on Action
the Pharmacy
Handling
of Gene Medicines
action
Disposal/waste
removal step
Waste Disposal
European Association of
Hospital Pharmacists
• 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
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
Chart 6.
Decontamination of
gene medicine product
spills
2 x disposable gowns or arm
covers
4 ×gloves
2 ×masks
2 ×aprons
2 ×goggles
4 ×disposable shoe covers
2 ×disinfectant* sachets (or other
prepared disinfectant)
Absorbent paper towels
2 ×Disposable forceps
2 ×Biohazard incineration bags
Emergency contact number
European
Copy of spillage procedure
Association of
Hospital Pharmacists
Product spill inside biological
safety device
Product spill outside
biological safety device
Allow device to operate to remove any
aerosols
Cordon off area for 20–30 minutes to allow
aerosol to settle
Wearing appropriate protective equipment
(eye protection, disposable apron and
gloves), saturate absorbent material with
disinfectant*
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 saturated absorbent on spill*
Allow 20–30 minutes contact time
Place absorbent material onto the liquid
spill
Allow 20–30 minutes contact time
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)
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)
*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
Key:
Question/
Administrative
step
choice of
step
EAHP Guidance on Action
the Pharmacy
Handling
of Gene Medicines
action
Disposal/waste
removal step
Spillage Kit
European Association of
Hospital Pharmacists
•
•
•
•
•
•
•
•
•
•
•
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
Spill Decontamination
European Association of
Hospital Pharmacists
• 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
Chart 7. Accidental
exposure to a gene
medicine
Occupational health procedures must always be in place prior to
initiation of the use of gene medicine at the facility (see Table 3)
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
Skin
exposure
Inhalation
European Association of
Hospital Pharmacists
Wash
immediately with
soap and water
No
Is the skin
broken?
Yes
Wash with soap
and water
Dry area with
disposable
material, cover
with disposable
dressing
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
Obtain medical attention
After any exposure, report to the occupational health department,
biosafety/infection control officer and incident-report group (where
local protocol dictates)
Note: Any accidental exposure should also be recorded in the staff exposure log, where available
*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
Key:
Question/
Administrative
step
choice of
step
EAHP Guidance on Action
the Pharmacy
Handling
of Gene Medicines
action
Disposal/waste
removal step
Accidental Exposure
European Association of
Hospital Pharmacists
•
•
•
•
•
Manufacturers guidance
Normal hospital procedure
Occupational health
Biological Safety Officer
Incident reporting
EAHP Guidance on the Pharmacy Handling of Gene Medicines
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
European Association of
Hospital Pharmacists
• 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
Timeline Overview
European Association of
Hospital Pharmacists
2006
9
10 11 12 1
2007
2
3
4
5
6
7
2008
8
9
10 11 12 2
4
Advisory
board group
Mtg 1
Mtg 2
Publication of
guidance
Advisory group
reviews
External
validation
EAHP
website
EJHP-P
Print
Guidance drafting and submission
EAHP
endorsement
Other activities
BOPA
2007
ESOP
2007
ESGT
2007
ASHP
2007
EAHP
2008
EAHP Guidance on the Pharmacy Handling of Gene Medicines
BSGT
2008
6
8
10 12
The Result
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
EAHP Guidance on the Pharmacy Handling of Gene Medicines
The Result (continued)
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)
EAHP Guidance on the Pharmacy Handling of Gene Medicines
References (1)
European Association of
Hospital Pharmacists
1.
2.
3.
4.
5.
6.
7.
8.
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.
Research ACoH. Genomics and World Health: Report of the Advisory Committee on Health
Research. Geneva: World Health Organization; 2002.
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
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.
Roth RI, Fleischer NM. Gene therapy: applications to pharmacy practice. J Am Pharm Assoc
(Wash). 2002 Sep-Oct;42(5):692, 4-8.
Brosman SA, Lamm DL. The preparation, handling and use of intravesical bacillus CalmetteGuerin for the management of stage Ta, T1, carcinoma in situ and transitional cell cancer. J Urol.
1990 Aug;144(2 Pt 1):313-5.
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.
The Medicines for Human Use (Clinical Trials) Regulations 2004. 1031; 2004.
EAHP Guidance on the Pharmacy Handling of Gene Medicines
References (2)
European Association of
Hospital Pharmacists
9.
10.
11.
12.
13.
14.
15.
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.
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.
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.
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.
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.
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.
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
References (3)
European Association of
Hospital Pharmacists
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):22835.
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
Contact Details
European Association of
Hospital Pharmacists
Dr Nicola Stoner
Consultant Pharmacist, Cancer Services & Cancer Research UK
Oxford Radcliffe Hospitals NHS Trust.
Principal Visiting Fellow, The University of Reading
Cancer Research UK Medical Oncology Unit
The Churchill
Oxford Radcliffe Hospitals NHS Trust
Headington
Oxford OX3 7LJ
Tel. +44 (0)1865 226187
Fax. +44 (0)1865 226174
Email: [email protected]
EAHP Guidance on the Pharmacy Handling of Gene Medicines