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2011, Number 3

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Med Sur 2011; 18 (3)

Farmacovigilancia en instituciones de salud

Rosete RA

Language: Spanish
References: 27
Page: 102-110
PDF size: 96.11 Kb.


ABSTRACT

Introduction. Pharmacovigilance development is still limited in Mexico. It is mandatory for hospital setting since 2005 and its relevancy has been exhibited. Objective. Describe pharmacovigilance methods for application of its results in continuous improvement of healthcare and for patient safety. Material and methods. Pharmacovigilance basic tool is spontaneous reporting of adverse drug reactions (ADRs), although diverse descriptive, analytical and special models are available. It will be shown the potential usefulness of a case series collected from January to December 2010. Results. We received 171 reports including 229 ADRs, 61.13% of female gender, mean age 46.9 ± 19.6 years. Notifications were informed by physicians in 15.7% of our cases, and by pharmacists in 80%. Common source medical specialties were: Oncology, Internal Medicine and Gastroenterology. Pharmacological related groups, according ATC were: anti-infective agents 19.6%, antineoplastics 13.3%, corticosteroids 11.17%, opioids 7.4%, contrast media 6.9%. Affected organs and systems were: skin 29.7%, gastrointestinal 15.28%, central nervous system 13.1%, cardiovascular 7.9%, endocrine 7.4%. Causality assessments were probable 75.1%, defined 4% and possible 20.9%. There were 47.16% moderate ADRs, 33.18% severe and 19.21% mild reactions. All moderate and severe ADRs needed some intervention for relieving. We detected 16/229 (7%) ADRs related to medication errors, 10 were generated outside the hospital. All were solved without harm. Conclusions. Pharmacovigilance in hospital setting has a valuable and immediate application through simple case series with high impact in patient safety and prevention of medication risks.


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