title: Pharmacovigilance of psychoactive medications in a Mexican psychiatric hospital.
abstract: Pharmacovigilance is the permanent collection and assessment of the safety data of drugs in the interest of precise knowledge of the safety profile. We monitored notifications of suspected adverse reactions (AR) produced by psychoactive medications (ARPM) in a Psychiatry Hospital, during a 4-month period. Yellow cards for adverse reaction reporting were distributed to the medical personal at the Hospital Psiquiátrico Villa Ocaranza, Pachuca Hidalgo, Mexico. For each notification, the ARPM was analyzed in order to verify causality. One hundred twelve hospitalized patients entered the study (44 male and 68 female). The mean +/- SD age of the patients was 46 +/- 4.5 years. The major diagnoses found were: schizophrenia (35.7%), severe mental retardation (17 %), moderate mental retardation (MMR)/epilepsy (12.5%), MMR (8.03%), and others (26.7%). During the study there were 721 therapeutic regimens prescribed to patients on psychiatric service. Patients were receiving an average of 5.3 +/- 1.1 (range 4 to 8) psychiatric medications. The psychiatrists reported only 5 ARPMs in five patients (prevalence: 4.46%). Among the drugs involved were neuroleptics (47.8%), antiepileptic (39.1%), and others (13.04%). The organs and systems affected by the ARs were the central nervous system, skin, endocrinological and gastrointestinal. A causal association between the medication and the AR were classified as probable in three cases, as possible in one case, as doubtful in one case and as definite in no case.
authors: Area Académica de Medicina del Instituto de Ciencias de la Salud, Universidad Autónoma del Estado de Hidalgo, Pachuca, Hidalgo, Mexico. mario_i_ortiz@hotmail.com
authors: Mario I
authors: MI
authors: Ortiz
authors: Héctor A
authors: HA
authors: Ponce-Monter
authors: Eduardo
authors: E
authors: Fernández-Martínez
authors: Arturo
authors: A
authors: Macías
authors: Jeannett A
authors: JA
authors: Izquierdo-Vega
authors: Manuel
authors: M
authors: Sánchez-Gutiérrez
authors: Lourdes Cristina
authors: LC
authors: Carrillo-Alarcón
authors: Eduardo
authors: E
authors: Rangel-Flores
authors: José F
authors: JF
authors: Saavedra-Ramírez
mesh_terms: D000328:Adult; D005260:Female; D006778:Hospitals, Psychiatric; D006801:Humans; D008297:Male; D008800:Mexico; D008875:Middle Aged; D060735:Pharmacovigilance; D011619:Psychotropic Drugs / Q000627:therapeutic use*
chemical_list: D011619:Psychotropic Drugs