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2016, Number 4

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Revista Cubana de Salud Pública 2016; 42 (4)

Adverse drug reactions reported in the Cuban elderly in the 2003-2013 period

Furones MJA, Cruz BMA, López AÁF, Broche VL, Jova BAP, Pérez PJ

Language: Spanish
References: 47
Page: 1-17
PDF size: 525.35 Kb.


ABSTRACT

Introduction: The characteristics of the adverse drug reactions in the elderly are not clearly identified in Cuba.
Objective: To determine adverse drug reactions in the elderly reported to the Cuban Pharmacovigilance System.
Methods: Descriptive cross-sectional research work. The universe of study was 26 489 adverse reaction reports to drugs from the Basic Drug Group in 60 years-old and over patients, registered in the national pharmacovigilance database from 2003 to 2013. The studied variables were age, sex, kind of adverse reactions, affected organ system, drug, pharmacological group, imputability, severity, frequency, notifying person and health care level. The summary measures were absolute frequencies, percentages and rates.
Results: The adverse drug reactions reporting rate was 1 479.4 x 105 elders. Women (1 885.1 x 105) and the 60-69 y old group (1 559.8 x 105) were the most affected ones. The predominating adverse drug reactions were skin rash (148.3 x 105), slight (741.1x 105), probable (1 097.5 x 105) and frequent (828.8 x 105) caused mainly by antibacterial drugs (341.5 x 105) and captopril (167.7 x 105). Adverse reactions were mostly reported physicians (68.8%) at the primary health care (85.8 %).
Conclusions: The adverse drug reactions reported in the elderly represent a small proportion of all undesirable effects notified to the Cuban pharmacovigilance System from 2003 to 2013; the main feature of adverse reactions were similar to that reported at international level, except for the affected age group, the kind of undesirable effect and the involved drugs.


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