PMID- 11675163
OWN - NLM
STAT- MEDLINE
DCOM- 20011204
LR  - 20190901
IS  - 0895-4356 (Print)
IS  - 0895-4356 (Linking)
VI  - 54
IP  - 11
DP  - 2001 Nov
TI  - Global index of safety (GIS): a new instrument to assess drug safety.
PG  - 1120-5
AB  - There is an asymmetry between the extraordinary development of measures and tools 
      aimed at studying the beneficial effects of the drugs and the more limited 
      methods to assess their safety profile. The goal of our study was to develop a 
      global measuring tool to assess drugs' safety. We conducted a survey of Spanish 
      psychiatrists in mental health centers and outpatient treatment units to assess 
      the severity scores that they would assign to a list of the most common adverse 
      events (AEs) that usually occur with antipsychotic treatment. The severity scores 
      were then applied to the list of AEs that really occurred along a naturalistic 
      pharmacoepidemiological study on the use of different antipsychotics in the 
      treatment of schizophrenia. The Global Index of Safety (GIS) of the experimental 
      group treated with olanzapine (OLZ) was compared with the GIS of the control 
      group and with the GIS of specific antipsychotics for which the number of treated 
      patients was greater than 100. A total of 194 psychiatrists rated the severity of 
      each AE on a scale of 1 (insignificant) to 5 (extremely severe). The individual 
      severity was applied to the 2949 schizophrenic patients included in a 
      pharmacoepidemiological study. A GIS was calculated for every group of patients 
      receiving the same treatments. The GIS of the control group was higher (4.3) than 
      that calculated from the experimental group (2.5) (P < 0.001). The GIS of the 
      risperidone (3.6) and haloperidol (6.0) subgroups were higher than that 
      calculated from the OLZ group (P < 0.001). The development of a GIS may 
      facilitate the comparison of the safety of several drugs and may constitute a 
      very valuable aid for those involved in selecting drugs.
FAU - Sacristan, J A
AU  - Sacristan JA
AD  - Clinical Research Department, Lilly S.A., Madrid, Spain. Sacristan_jose@lilly.com
FAU - Gomez, J C
AU  - Gomez JC
FAU - Badia, X
AU  - Badia X
FAU - Kind, P
AU  - Kind P
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Clin Epidemiol
JT  - Journal of clinical epidemiology
JID - 8801383
RN  - 0 (Antipsychotic Agents)
RN  - 12794-10-4 (Benzodiazepines)
RN  - 3G0285N20N (Pirenzepine)
RN  - J6292F8L3D (Haloperidol)
RN  - L6UH7ZF8HC (Risperidone)
RN  - N7U69T4SZR (Olanzapine)
SB  - IM
MH  - *Adverse Drug Reaction Reporting Systems
MH  - Antipsychotic Agents/*adverse effects/therapeutic use
MH  - Benzodiazepines
MH  - Consumer Product Safety
MH  - *Drug Monitoring
MH  - Haloperidol/adverse effects/therapeutic use
MH  - Humans
MH  - Olanzapine
MH  - Pharmacoepidemiology
MH  - Pirenzepine/adverse effects/*analogs & derivatives/therapeutic use
MH  - Risperidone/adverse effects/therapeutic use
MH  - Schizophrenia/drug therapy
EDAT- 2001/10/25 10:00
MHDA- 2002/01/05 10:01
CRDT- 2001/10/25 10:00
PHST- 2001/10/25 10:00 [pubmed]
PHST- 2002/01/05 10:01 [medline]
PHST- 2001/10/25 10:00 [entrez]
AID - S0895-4356(01)00384-5 [pii]
AID - 10.1016/s0895-4356(01)00384-5 [doi]
PST - ppublish
SO  - J Clin Epidemiol. 2001 Nov;54(11):1120-5. doi: 10.1016/s0895-4356(01)00384-5.