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2014, Number 5

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Med Int Mex 2014; 30 (5)

Pharmacovigilance: Main therapeutic groups causing adverse reactions in patients attending to Regional Hospital Lic. Adolfo Lopez Mateos, Mexico City

González-Jiménez B, Estrada-Hernández LO
Full text How to cite this article

Language: Spanish
References: 11
Page: 520-530
PDF size: 872.24 Kb.


Key words:

pharmacovigilance, adverse reactions, predisposing factors.

ABSTRACT

Background: In order to a drug be approved it must assure its secure and efficacy, by preclinic and clinic trials; the last ones involve human models with the aim to indentify, among others, adverse drug reactions. One important limitation of these trials is its population size, compared with population size that actually is going to take the drug.
Objectives: To detect, notify, register and assess adverse drug reactions in order to determine the frequency, some predisposing factors and most frequent therapeutic groups as causal of adverse reactions.
Material and method: A retrospective study was performed usin pharmacovigilance and collected relevant information in order to identify major therapeutic groups, as well as predisposing factors (gender and age) in patients attending to Hospital Regional Lic. Adolfo Lopez Mateos, Mexico City. Codification of adverse reactions was made according to suggested by National Center of Pharmacovigilance, consisting on five fields. Notifications were compiled to extract information of therapeutic groups, number of cases of adverse reactions and drugs causing them.
Results: Main therapeutics groups were antibiotics, antiretroviral and analgesic drugs. Male gender showed the highest number of adverse drug reactions; mean age of studied population was of 30-39 years.
Conclusions: By assessing notifications of adverse reactions to drugs the main therapeutic groups causing these reactions were detected: antibiotic, antirretroviral and analgesic; thus, this study contributes to health professionals and patients to control properly the administration of drugs.


REFERENCES

  1. NOM-220-SSA1-2012: Instalación y Operación de la Farmacovigilancia.

  2. 5o. Boletín Informativo de Farmacovigilancia. México: COFEPRIS, 2012.

  3. Farmacovigilancia. Comisión Federal para la Protección contra Riesgos Sanitarios, COFEPRIS.

  4. Estrada-Hernández LO, Morales-Enríquez ML, Ríos-Smith MD, Estrada-Hernández MR, Rivera-Zetina DJ. La farmacovigilancia en México. Una necesidad imperante. Med Inter Mex 2013;29:200-203.

  5. OMS. Perspectivas políticas de la OMS sobre medicamentos. La farmacovigilancia: garantía de seguridad en el uso de los medicamentos, 2004.

  6. OMS. Safety monitoring of medical products. The importance of pharmacovigilance. Ginebra: Organización Mundial de la Salud, 2002.

  7. Berga-Culleré C, et al. Detecting adverse drug events during the hospital stay. Farmacia Hospitalaria 2009;33:312-323.

  8. Gutiérrez-Rodríguez R, Soto-Arquiñigo L. Efectos adversos de la terapia antirretroviral. Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia. http://www.upch.edu.pe/tropicales/telemedicinatarga/ REVISION%20DE%20TEMAS/efectos%20adversos% 20version%20final.pdf

  9. Uso racional de los medicamentos por prescriptores y pacientes. Informe de la Secretaría. OMS. Ginebra, 2012.

  10. Valsecia M. Farmacovigilancia y mecanismos de reacciones adversas a medicamentos. En: Farmacología Médica 2000;5:135-148. En línea en: http://med.unne.edu.ar/ catedras/farmacologia/temas_farma/volumen5/13_farmacovigi. pdf (Consultado el 5 de diciembre de 2013).

  11. Directrices de la OMS sobre el tratamiento farmacológico del dolor persistente en niños con enfermedades médicas, Organización Mundial de la Salud, 2012.




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Med Int Mex. 2014;30