Building research and development in hospital pharmacy · Building research and development in hospital pharmacy ... • One project per year, ... • Invisible to the naked eye

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Building research and development in hospital pharmacy

Prof. Pascal BONNABRY

Vienna March 2011

EAHP Congress

Vienna, March 2011

Conflict of interest

N thi t di lNothing to disclose

Pascal BONNABRY Research and development, March 2011

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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

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

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Dedicated human resources

• Specialisation research projects (MAS)(1 year)

• PhD(≈ 4 years)


( y )

• Master research projects (3 months)

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

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Financing


Financing

Institutional Public PrivateInstitutional Public Private

Existing positions- hospital- university

Internal grants

National research funding (FNRS)

European projects (FP7)

Professional associations

Pharmaceutical industries


- quality projects- R&D projects

Other institutions

Variable effort … … combine sources …

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Professional associations

• National research projects

• Started in 2009 to the initiative of the Swiss f bl h l h d


association of public health administration and hospital pharmacists (GSASA)

Objectives

• To promote research activities in swiss hospital h ipharmacies

• 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 j


projects

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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)

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 2011


• Submission deadline: March 31, 2011• Selection by May 31, 2011 (research working group, GSASA board)

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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

CIVAS: you have an idea !

• You would like to develop a Centralized IntraVenous Additive S i (CIVAS) t id d t i fService (CIVAS) to provide ready-to-use syringes 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 but they agree you to make an evaluation


being safe, but they agree you to make an evaluation.

• How do you organise the protocol ?

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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)


(500 syringes)

• Quantify the drug content

• Analyse results

CIVAS: results

> ± 10%: 29% > ± 50%: 8% > ± 100%: 4%

Pascal BONNABRY Research and development, March 2011Stucki C, EAHP congress, 2010

n=500mean = 114%

Atracurium Fentanyl Lidocaine Thiopental

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CIVAS: communication


Best poster award !

Publication submitted

CIVAS: next steps

• Discuss the results with the anaesthesiologistsd i i t i l i l t CIVASdecision to progressively implement CIVAS

• Decide priority of development

• Develop products• Stability indicating analytical methods

• Stability studies

New research ideas !


• Produce and distribute products

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Chemical contamination: you have an idea !

• You would like to investigate operator-related chemical t i ti d i t t i ticontamination during cytotoxic preparation.

• 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


• To work safely

• How do you organise the protocol ?

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


• Develop and validate a recovery procedure and a quantitative assay (fluorimetry)

• Measure the contaminations with a pool of operators

• Analyse results and make recommendations

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Chemical contamination: results

23.5

23.825.0

SPOTS

HIGH

7 0 .2 5.3

7.4

17.3

20.0

6.26.1

5.4

13.3

2

10.0

15.0

20.0

Contam

ination qu

antity [μL]

Mea

n co

ntam

natio

n

MEDIUM

LOW

Pascal BONNABRY Research and development, March 2011Sadeghipour F, EAHP congress, 2009

0.6

0.6

0.7 1.1

1.2 1.7

1.7

1.8

2.0 2.3 3.

3 4.2

4.3 4.5 4.7

4.7 5.0 5. 5

2.8

0.0

5.0

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

C

Operators

ZERO

SPOTS : Low : 1 ‐ 5 ; Medium : 6 ‐ 10 ; High : 11‐20

n=28

Chemical contamination: next steps

• Implement the quinine test in the routine training programme

• Develop a method to quantify traces of cytostatics in the environment

• Develop a global evaluation protocol• Quinine testing• Cytostatics measurement

New research ideas !


• Structural / organisational questionnaire

• Conduct a national evaluation Funding !

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Conclusion

• Structured research activities are essential to the development f h it l hof hospital pharmacy

• 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, international)

• Research is a key activity of medical staff … and we are…

Thank you for your attention

This presentation can be downloaded:

http://pharmacie.hug-ge.ch/ens/conferences.html


[email protected]

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Building research and development in hospital pharmacy · Building research and development in hospital pharmacy ... • One project per year, ... • Invisible to the naked eye