ABSTRACT
Adverse drug reactions from medicinal products are one of the important public health issues. The Pharmacovigilance system is used to monitor the safety of authorized medicinal products and detect any change to their risk-benefit balance. It is characterized by its structures, processes and outcomes. To run an effective Pharmacovigilance system a protocol is required for reporting adverse reactions associated with drug use.
Subject(s)
Adverse Drug Reaction Reporting Systems/organization & administration , Adverse Drug Reaction Reporting Systems/standards , Adverse Drug Reaction Reporting Systems/trends , Adverse Drug Reaction Reporting Systems/statistics & numerical data , India , Pharmacovigilance , Public Health/organization & administrationABSTRACT
Background: During 2005, the surveillance system of the Chilean Immunization Program detected an increased number of adverse reaction notifications associated to diphtheria, pertussis and tetanus whole-cell vaccine (DPT), coincidentiy with a change in the vaccine manufacturer. Aim: To compare the reactogenicity of two DPT formulations (vaccines 1 and 2) in 18-month-old infants and 4-year-old children. Material and methods: Severe adverse reactions to DPT were studied at the emergency room of two hospitals of Santiago in a case-control study (110 cases and 171 controls, who consulted for other causes). Simultaneously the incidence of total adverse reactions (mild and severe) for vaccine 1 and 2 was estimated in a cohort of 1,017 children vaccinated in an ambulatory health center of the same área. The formulation of DPT received by all participants was verífied, as well as the temporal relation with consultation or symptoms referred by their caregivers. Results: There was a greater probability of consulting at the emergency rooms for severe adverse reactions among children who received vaccine 1 (odds ratio (OR) =7.1; p <0.001), being greater among 4-year-old children (OR =18.9; p <0.001). Coincidentiy, in the cohort of vaccinated children, those who received vaccine 1 had a higher risk of presenting adverse reactions (RR =2.9; p <0.001), being high fever the commonest. Conclusions: We confirmed that vaccine 1 was associated to a higher risk of adverse reactions, especially among 4-year-old children. These results allowed the sanitary authority to adopt an informed decisión. The usefulness of observational studies in vaccine adverse reactions is confirmed.
Subject(s)
Humans , Adverse Drug Reaction Reporting Systems/statistics & numerical data , Diphtheria-Tetanus-Pertussis Vaccine/adverse effects , Diphtheria/prevention & control , Immunization Programs/standards , Tetanus/prevention & control , Whooping Cough/prevention & control , Adverse Drug Reaction Reporting Systems/standards , Case-Control Studies , Chile , Incidence , Population SurveillanceABSTRACT
Drug safety monitoring is important in children. Young age, polypharmacy, prolonged hospitaliza-tion, being critically ill and use of unlicensed and off-label drugs have been identified as risk factors which predispose a child to experience an adverse drug reaction. In our country, the HIV/AIDS epidemic, setting up of intensive care units, increasing availability of imaging studies, and the introduction of several new drugs and vaccines have accentuated the need for improving drug safety monitoring in children. To achieve this aim, establishing in-hospital computerized event monitoring program in major hospitals and an effective national post- marketing drug surveillance network are the need of the hour.
Subject(s)
Adverse Drug Reaction Reporting Systems/standards , Child , Child, Preschool , Consumer Product Safety , Developing Countries , Drug Labeling/standards , Drug Prescriptions , Drug Utilization , Female , Forecasting , Humans , India , Infant , Male , Product Surveillance, Postmarketing , Total Quality ManagementABSTRACT
We evaluated the safety of a measles-mumps-rubella [MMR] immunization campaign for Saudi children [age range: 6-13 years] and gender differences in reporting post-MMR adverse events. After vaccinations were administered, we monitored 160 schools for 14 days and 19 hospitals in the 8 cities under study for 10 weeks. Incidence rates were: all MMR adverse events, 26.5/10,000 MMR vaccines [significantly higher in females than males]; Urabe strain aseptic meningitis, 1.0/295,000; fever, 40.2/10,000 [females] and 0.9/10,000 [males]; and parotitis, 5.4/10,000 [females] and 0.9/10,000 [males]. Combined MMR vaccine containing the Urabe mumps strain was safe for children aged 6-13 years. Gender differences regarding reactogenicity were evident and should be considered when designing future studies
Subject(s)
Adolescent , Child , Female , Humans , Male , Adverse Drug Reaction Reporting Systems/standards , Data Collection/standards , Drug Hypersensitivity/etiology , Fever/etiology , Immunization Programs/organization & administration , Sex Distribution , Metabolic Clearance RateABSTRACT
Las reacciones adversas a medicamentos (R.A.M.) se clasifican en de tipo A, relacionadas con la toxicidad del medicamento, y de tipo B, debido a un incremento de la susceptibilidad del paciente. El objetivo del presente trabajo consiste en detectar y evaluar las R.A.M. tipo B, y determinar sus factores de riesgo asociados. Se efectuó un estudio retrospectivo, utilizando estrategias