title: Developing an adverse drug reaction reporting system at a teaching hospital.
abstract: Adverse drug reactions (ADRs) are a frequent cause for hospitalization and occur often in hospitalized patients. The objective of this study was to establish an ADR reporting and monitoring system at a teaching hospital. The pharmacovigilance unit of Masih Daneshvari hospital was established by a clinical pharmacist and a clinical pharmacologist. Healthcare professionals were encouraged to report any suspected ADRs encountered in in-patients. The incidence, pattern, seriousness, severity and preventability of the reported ADRs were analysed. During the period of 12 months, for 6840 patients, 112 spontaneous reports were received. The most frequently reported reactions were due to anti-infective agents (58.2%). Ceftriaxone accounted for the highest number of the reported ADRs among anti-infective agents. The skin and appendages system was the most frequently affected system (32.5% of all reactions). Seventeen per cent of the ADRs were reported as serious reactions. Although the incidence of ADRs reported by physicians and nurses was found to be low, this programme was useful as a preliminary programme in initiating a culture of ADR reporting among healthcare professionals. Improved communication between the physicians and nurses with the pharmacovigilance centre in the hospital is suggested.
authors.affiliation: Pharmaceutical Care Unit, TB and Lung Disease Research Center, NRITLD, Masih Daneshvari Hospital, Shahid Beheshti University, Tehran, Iran.
authors.forename: Shadi
authors.initials: S
authors.lastname: Baniasadi
authors.forename: Fanak
authors.initials: F
authors.lastname: Fahimi
authors.forename: Gloria
authors.initials: G
authors.lastname: Shalviri
mesh_terms: D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems / Q000458:organization & administration* / Q000706:statistics & numerical data; D000890:Anti-Infective Agents / Q000009:adverse effects; D000970:Antineoplastic Agents / Q000009:adverse effects; D001291:Attitude of Health Personnel; D002648:Child; D002675:Child, Preschool; D003142:Communication; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced / Q000453:epidemiology; D006784:Hospitals, Teaching / Q000458:organization & administration* / Q000706:statistics & numerical data; D006801:Humans; D015994:Incidence; D007223:Infant; D007231:Infant, Newborn; D007492:Iran / Q000453:epidemiology; D008297:Male; D008508:Medication Errors / Q000517:prevention & control* / Q000706:statistics & numerical data; D008875:Middle Aged; D019555:Physician-Nurse Relations; D010865:Pilot Projects; D016730:Program Development; D012720:Severity of Illness Index; D012871:Skin Diseases / Q000139:chemically induced / Q000453:epidemiology; D013997:Time Factors
chemical_list: D000890:Anti-Infective Agents; D000970:Antineoplastic Agents