Building research and development in hospital pharmacy

Building research and development
in hospital pharmacy
Prof. Pascal BONNABRY
EAHP Congress
Vienna March 2011
Vienna,
Conflict of interest
N thi
Nothing
to
t disclose
di l
Pascal BONNABRY
Research and development, March 2011
1
Why ?
• To solve problems in a structured manner
• To develop new activities (make the proof of a concept)
• To collaborate with others (interdisciplinary)
• To communicate with others (congresses, publications)
• To educate young pharmacists
• To finance projects
Pascal BONNABRY
Research and development, March 2011
In which fields ?
• All fields of hospital pharmacy !!!
• Make choices, determine a research strategy
• Target relevant topics in your context
• They will represent the domains of recognition of your research group
Pascal BONNABRY
Research and development, March 2011
2
Dedicated human resources
• PhD
(≈ 4 years)
• Specialisation research
projects (MAS)
((1 year)
y )
• Master research projects
(3 months)
Pascal BONNABRY
Research and development, March 2011
Team work - network
• Build a team work
• Investigator(s)
• Supervisor(s)
• Interdisciplinary collaborations
(physicians, nurses, …)
• Other supporting persons
• Methodological conception
• Statistical analysis
y
• English editing
• Create a network, inside and outside of your hospital
Pascal BONNABRY
Research and development, March 2011
3
Financing
Pascal BONNABRY
Research and development, March 2011
Financing
Institutional
Public
Private
Existing positions
- hospital
- university
National research
funding (FNRS)
Professional
associations
European projects
(FP7)
Pharmaceutical
industries
Internal grants
- quality projects
- R&D projects
Variable effort …
Pascal BONNABRY
Other institutions
… combine sources …
Research and development, March 2011
4
Professional associations
• National research projects
• Started in 2009 to the initiative of the Swiss
association off public
bl health
h l h administration
d
and hospital pharmacists (GSASA)
Pascal BONNABRY
Research and development, March 2011
Objectives
• To promote research activities in swiss hospital
pharmacies
h
i
• To value the role of hospital pharmacists by scientific studies
• To develop benchmarking tools
• To improve the visibility of hospital pharmacy
• To promote collaborations in the context of multicentric research
projects
j
Pascal BONNABRY
Research and development, March 2011
5
Financing
• One project per year,
• Selection through a call for project process
• 4 x CHF 20’000.-, during 3 years
= CHF 80’000.-/year
(≈ Euros 60’000/year)
Pascal BONNABRY
Research and development, March 2011
First call for projects
• 2010: Quality and safety of drug use in hospital
• 3 submitted projects
• Selected project:
• Evaluation of the chemical contamination during the preparation of cytotoxics
(S. Nussbaumer, HUG, Geneva)
• 2011: Optimization of patient therapeutic management
• Submission deadline: March 31,
31 2011
• Selection by May 31, 2011 (research working group, GSASA board)
Pascal BONNABRY
Research and development, March 2011
6
From the question to the answer
• Have an idea !
• Build a research team
• Formulate an hypothesis
• Write a research protocol
(if needed, submit it to an institutional review board)
• Perform the research
• Analyse results and make conclusions
• Communicate (poster, oral, publication)
• Apply the new knowledge to the practice
Pascal BONNABRY
Research and development, March 2011
CIVAS: you have an idea !
• You would like to develop a Centralized IntraVenous Additive
S i (CIVAS) to
Service
t provide
id ready-to-use
d t
syringes
i
f
for
anaesthesiology.
• You are convinced this could improve the safety, by eliminating
selection and dilution errors.
• Physicians consider the preparation in the operating rooms as
being safe
safe, but they agree you to make an evaluation.
evaluation
• How do you organise the protocol ?
Pascal BONNABRY
Research and development, March 2011
7
CIVAS: research protocol
• Select 4 model drugs
• No dilution: lidocaine
• Dilution: fentanyl and atracurium
• Reconstitution and dilution: thiopental
• Develop and validate 4 analytical methods
• Collect unused syringes at the end of the day
(500 syringes)
• Quantify the drug content
• Analyse results
Pascal BONNABRY
Research and development, March 2011
CIVAS: results
> ± 10%: 29%
> ± 50%: 8%
> ± 100%: 4%
n=500
mean = 114%
Atracurium Fentanyl
Lidocaine Thiopental
Stucki C, EAHP congress, 2010
Pascal BONNABRY
Research and development, March 2011
8
CIVAS: communication
Best poster award !
Publication submitted
Pascal BONNABRY
Research and development, March 2011
CIVAS: next steps
• Discuss the results with the anaesthesiologists
¤ decision
d i i to
t progressively
i l implement
i l
t CIVAS
• Decide priority of development
• Develop products
• Stability indicating analytical methods
New research ideas !
• Stability studies
• Produce and distribute products
Pascal BONNABRY
Research and development, March 2011
9
Chemical contamination:
you have an idea !
• You would like to investigate operator-related chemical
contamination
t i ti during
d i cytotoxic
t t i preparation.
ti
• The objective is to implement a routine test during the initial and
continuing training programme.
• You need to use a non-cytotoxic tracer
• To differentiate from external vials contamination
• To work safely
• How do you organise the protocol ?
Pascal BONNABRY
Research and development, March 2011
Chemical contamination:
research protocol
• Select a non-cytotoxic tracer ¤ quinine diHCl
•
•
•
•
Soluble in water
Invisible to the naked eye
Visible under UV rays
Easy to quantify
• Develop an operators’ validation protocol
• Develop and validate a recovery procedure and a quantitative
assay (fluorimetry)
• Measure the contaminations with a pool of operators
• Analyse results and make recommendations
Pascal BONNABRY
Research and development, March 2011
10
Chemical contamination:
results
SPOTS
23.5
2
13.3
15.0
2.8
2.3
2.0
1.8
1.7
1.7
1.2
1.1
0.7
0.6
0.6
MEDIUM
6.2
7.4
6.1
5.3
5
5..2
5.0
0
4.7
7
4.7
4.5
4.3
5.0
4.2
5.4
10.0
Mean contamnation
20.0
17.3
20.0
3.3
Contamination quantity [μL]
C
23.8
HIGH
25.0
LOW
ZERO
0.0
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29
Operators
SPOTS : Low : 1 ‐ 5 ; Medium : 6 ‐ 10 ; High : 11‐20
n=28
Sadeghipour F, EAHP congress, 2009
Pascal BONNABRY
Research and development, March 2011
Chemical contamination:
next steps
• Implement the quinine test in the routine training programme
• Develop a method to quantify traces
of cytostatics in the environment
New research ideas !
• Develop a global evaluation protocol
• Quinine testing
• Cytostatics measurement
• Structural / organisational questionnaire
• Conduct a national evaluation
Pascal BONNABRY
Funding !
Research and development, March 2011
11
Conclusion
• Structured research activities are essential to the development
off h
hospital
it l pharmacy
h
• Topics can be selected in the daily practice of any field of activity
of any hospital (teaching, non-teaching)
• Professional associations have a role to play in the funding of
research activities, to help moving from the local to the global
(national international)
(national,
• Research is a key activity of medical staff … and we are…
Pascal BONNABRY
Research and development, March 2011
Thank you for your attention
This presentation can be downloaded:
http://pharmacie.hug-ge.ch/ens/conferences.html
[email protected]
Pascal BONNABRY
Research and development, March 2011
12