European Association of Hospital Pharmacists EAHP Guidance on the Pharmacy Handling of Gene Medicines European Association of Hospital Pharmacists Guidance

EAHP Guidance on the Pharmacy Handling of Gene Medicines

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



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



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



• 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



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



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



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



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




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



7. Draft sent to EAHP board

8. June 2007 presentation of the results of the EAHP Working Group to the EAHP General Assembly




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



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)



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



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.



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



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.



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



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



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



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.



*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



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



*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


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



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)



Preparation (2)

• Co-ordination of preparation with administration

• Aseptic procedures

• Disinfectant in biosafety device

• Records of decontamination

• Eradication of aerosols



Transportation

• Seal in plastic bag/secondary container

• Leak-proof, labelled, biohazard container

• Temperature control

• Spill kit to be available

• Use immediately



*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


Administrative step

Key:

Chart 3. Dispensing procedure for gene medicine



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



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


Administrative step

Key:

Chart 4. Administration procedure for gene medicine: Guidance for clinical staff to develop SoPs



Administration

• Co-ordination between pharmacy and administration

• Administer within recommended timelines

• Appropriate protective clothing

• Inpatient/outpatient/containment depends on risk assessment for each product



*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


Administrative step

Key:

Chart 5. Gene medicine waste disposal



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



*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


Administrative step

Key:

Chart 6. Decontamination of gene medicine product spills



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



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



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


Administrative step

Key:

Chart 7. Accidental exposure to a gene medicine



Accidental Exposure

• Manufacturers guidance

• Normal hospital procedure

• Occupational health

• Biological Safety Officer

• Incident reporting



Roles and Responsibilities

• Physician• Chief Pharmacist• Pharmacists• Pharmacy Technicians• Nursing staff• Biological Safety Officer• Infection Control• Occupational Health• Waste disposal services• Hospital Management



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)



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



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



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)



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8. The Medicines for Human Use (Clinical Trials) Regulations 2004. 1031; 2004.



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.

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References (3)

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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]

Documents

European Association of Hospital Pharmacists EAHP Guidance on the Pharmacy Handling of Gene Medicines European Association of Hospital Pharmacists Guidance