2007, Number 4
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ABSTRACTObjective: To describe the type of presentation of adverse drug reactions (ADRs) notified in Medica Sur Hospital by healthcare personnel. Background data: Spontaneous reporting systems are truly helpful for decision makers, regarding safety of medicines utilization. Mexico is involved since 1999 and national regulation was established as mandatory in Norma Oficial Mexicana NOM-220-SSA1-2002 in 2004. Methods: Descriptive study with a prospective series of cases of ADRs, that were informed to the Pharmacovigilance Unit from October 2006 to August 2007. Results: There were 98 spontaneous reports, average 9.8 ± 1.7 reports/month. Sixty one were female patients, mean of age 41.4 ± 19.4 years old. Twenty five cases were associated with admission to hospitalization, additional 54% required pharmacotherapy. More common ADRs involved dermatologic reactions (n = 60, 61.2%) gastrointestinal symptoms (n = 15, 14.3%) and neurologic data (n = 14, 14.3%). 43 cases were attributable to antibiotics, 15 cases to NSAIDs. The 43.9% of reports were informed by Internal Medicine residents. The 95% of notifications were useful for the international database, which is the highest quality performance provided by healthcare institutions in Mexico. Conclusions: Our results show consistency with national data. We detected 5 cases associated with medication errors. It is necessary to apply improvement strategies directed to optimize prescription, dispensing and drug administration. Medica Sur could be the pioneer private hospital having acknowledgment as an Institutional Pharmacovigilance Center within the National Program supporting network.
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