Sylvie Crauste-Manciet (FRANCE)
Sylvie Crauste-Manciet (FRANCE)
Sylvie Crauste-Manciet (FRANCE)
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Regulations in France<br />
• Centralization of the<br />
preparation of the<br />
cytotoxics under the<br />
responsibility of a<br />
pharmacist<br />
• Decree DGS/DH/AFS n°98n<br />
98-<br />
213 (24-03 1998)<br />
• Using dedicated facilities<br />
(isolator<br />
or LAF hoods)<br />
• Decree<br />
DHOS/SDO/2005/101 (22-<br />
02-2005)<br />
2005)<br />
• Encouraging home<br />
treatments<br />
• decree (20/12/2004)<br />
• “good use” contract<br />
• decree (24/08/2005)<br />
• Good Manufacturing<br />
Practices for preparation<br />
in hospital pharmacies<br />
(2002 project, unpublished)
Evolution<br />
of the<br />
Centralization<br />
in France<br />
Wards<br />
0%<br />
Objectives<br />
2008<br />
100%<br />
Pharmacy<br />
Pharmacy<br />
2002<br />
Wards<br />
65%<br />
35%<br />
Pharmacy<br />
1985<br />
Wards<br />
99%<br />
1%
Situation in France<br />
• Survey 2002 Health<br />
Services *“Caisse*<br />
nationale d’assurance<br />
maladie” CNAMTS<br />
• 642 Hospitals<br />
• Survey GERPAC 2005<br />
• 200 hospital<br />
pharmacies
Distribution of the Institutions<br />
3%<br />
Specialized<br />
Institution<br />
43%<br />
Private<br />
Public<br />
54%<br />
CNAMTS National Survey 2002
Centralization of the preparation of<br />
cytotoxic drugs in hospital pharmacies<br />
both<br />
4% 1%<br />
Outside Institution<br />
(contract)<br />
35%<br />
Centralized<br />
Uncentralized<br />
60%<br />
CNAMTS National Survey 2002
Prescription Analysis<br />
100,00<br />
90,00<br />
80,00<br />
70,00<br />
60,00<br />
50,00<br />
40,00<br />
30,00<br />
20,00<br />
10,00<br />
0,00<br />
95,00 53,00 39,10<br />
Centralized Uncentralized partially<br />
centralized<br />
CNAMTS National Survey 2002
Policies<br />
Preparation<br />
Clothing<br />
Spill<br />
managment<br />
Maintenance<br />
facilities<br />
Wastes<br />
management<br />
All policies<br />
100<br />
90<br />
80<br />
70<br />
60<br />
CNAMTS National Survey 2002<br />
URC<br />
All<br />
50<br />
40<br />
30<br />
20<br />
10<br />
0
Facilities distribution in France<br />
LAMINAR AIR<br />
FLOW<br />
57%<br />
43%<br />
ISOLATORS<br />
CNAMTS National Questionnaire 2002
Situation in France<br />
• GERPAC Survey<br />
2005<br />
• 200 hospital<br />
pharmacies<br />
Public<br />
Private<br />
Specialized<br />
Institution<br />
• Sample<br />
representativity<br />
GERPAC<br />
2005<br />
158<br />
34<br />
8<br />
CNAM<br />
2002<br />
344<br />
275<br />
20<br />
%<br />
45,9<br />
12,4<br />
40,0<br />
200<br />
639<br />
31,3
Distribution of Institutions<br />
17%<br />
4%<br />
Specialized<br />
Instituion<br />
Private<br />
Public<br />
79%<br />
GERPAC National Survey 2005
Centralization of the preparation of<br />
cytotoxic drugs in hospital pharmacies<br />
Uncentralized<br />
Centralized<br />
23%<br />
23 %<br />
77 %<br />
77%<br />
GERPAC National Survey 2005
Facilities distribution<br />
BSC/LAF<br />
ISOLATORS<br />
43%<br />
43 %<br />
57 %<br />
57%<br />
GERPAC National Survey 2005
LAF hood type<br />
19%<br />
?<br />
19%<br />
Cytotoxic<br />
Safety<br />
16%<br />
Cabinets<br />
16%<br />
65%<br />
BSC II<br />
65%<br />
GERPAC National Survey 2005
Isolator type<br />
8%<br />
8%<br />
?<br />
2%<br />
2%<br />
Négative<br />
air pressure<br />
90%<br />
Positive air pressure<br />
90%<br />
GERPAC National Survey 2005
Environment of the LAF<br />
6%<br />
• 32% in<br />
conformity<br />
14%<br />
C<br />
14%<br />
D<br />
6%<br />
18%<br />
B<br />
18%<br />
Non controlled area<br />
62%<br />
62%<br />
GERPAC National Survey 2005
Environment of the isolator<br />
Non controlled area<br />
47%<br />
D<br />
51%<br />
47%<br />
51%<br />
C<br />
2%<br />
2%<br />
2%<br />
GERPAC National Survey 2005
Room pressure differential<br />
?<br />
43%<br />
?<br />
Positive<br />
37%<br />
39%<br />
Positive<br />
42%<br />
Positive<br />
No<br />
16%<br />
Negative<br />
4%<br />
No<br />
18%<br />
Negative<br />
1%<br />
Negative<br />
BSC/LAF<br />
ISOLATORS<br />
GERPAC National Survey 2005
Air evacuation of the LAF<br />
23%<br />
?<br />
23%<br />
Outside<br />
building<br />
52%<br />
Inside<br />
working<br />
room<br />
room 25%<br />
25%<br />
52%<br />
GERPAC National Survey 2005
Air evacuation of the isolators<br />
8%<br />
8%<br />
?<br />
Outside<br />
building<br />
92%<br />
92%<br />
GERPAC National Survey 2005
Standards interest for French<br />
• Standards would improve<br />
chemical risk management<br />
with regards to:<br />
• facilities and ventilation tools<br />
• handling cytotoxic drugs<br />
• wastes handling<br />
• monitoring occupational<br />
exposure
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