title: Global index of safety (GIS): a new instrument to assess drug safety.
abstract: 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.
authors.affiliation: Clinical Research Department, Lilly S.A., Madrid, Spain. Sacristan_jose@lilly.com
authors.forename: J A
authors.initials: JA
authors.lastname: Sacristán
authors.forename: J C
authors.initials: JC
authors.lastname: Gómez
authors.forename: X
authors.initials: X
authors.lastname: Badía
authors.forename: P
authors.initials: P
authors.lastname: Kind
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D014150:Antipsychotic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D001569:Benzodiazepines; D003257:Consumer Product Safety; D016903:Drug Monitoring; D006220:Haloperidol / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D000077152:Olanzapine; D017891:Pharmacoepidemiology; D010890:Pirenzepine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018967:Risperidone / Q000009:adverse effects / Q000627:therapeutic use; D012559:Schizophrenia / Q000188:drug therapy
chemical_list: D014150:Antipsychotic Agents; D001569:Benzodiazepines; D010890:Pirenzepine; D006220:Haloperidol; D018967:Risperidone; D000077152:Olanzapine