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TitleFarmacovigilancia Mexico
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Page 1

102 Rev Invest Med Sur Mex, 2011; 18 (3): 102-110

Farmacovigilancia en instituciones de salud

Farmacovigilancia en instituciones de salud

* Centro de Investigación Farmacológica y Biotecnológica, Médica Sur.

Correspondencia:
Dra. Alejandra Rosete ReyesDra. Alejandra Rosete ReyesDra. Alejandra Rosete ReyesDra. Alejandra Rosete ReyesDra. Alejandra Rosete Reyes

Centro de Investigación Farmacológica y Biotecnológica, Médica Sur Puente de Piedra, Núm. 150. Col. Toriello Guerra,
Del. Tlalpan, C.P. 14050, México, D.F. Tel.: 5424-7200. Ext. 2007. Correo electrónico: [email protected]

Alejandra Rosete Reyes*

!"#$%&#"'($)"*$+,-$)"./$Julio-Septiembre 2011; 18 (3): 102-110

ARTÍCULO ORIGINAL

ANTECEDENTES

La farmacovigilancia está dedicada a detectar, anali-
zar, entender y prevenir los efectos adversos y cualquier
problema relacionado con los medicamentos.1 En México,

RRRRResumenesumenesumenesumenesumen

Introducción. Introducción. Introducción. Introducción. Introducción. La farmacovigilancia tiene poco desarrollo en
México. Desde 2005 es obligatoria para clínicas y hospitales, don-
de tiene una amplia aplicación. Objetivo.Objetivo.Objetivo.Objetivo.Objetivo. Describir los métodos
que utiliza la farmacovigilancia para aplicar sus resultados en la
mejora de la calidad de la atención médica y la seguridad del
paciente. Material y métodos.Material y métodos.Material y métodos.Material y métodos.Material y métodos. La herramienta básica de la
farmacovigilancia es el reporte voluntario de reacciones adversas a
medicamentos (RAM) y, aunque existen diseños descriptivos, ana-
líticos y modelos especiales, se mostrará la utilidad de una serie de
casos, colectada de enero a diciembre 2010. Resultados.Resultados.Resultados.Resultados.Resultados.
Se recibieron 171 notificaciones, con un total de 229 RAM, 61.13%
de género femenino, edad promedio de 46.9 ± 19.6 años. Notifi-
caciones hechas por médicos en 15.7%; farmacéuticos, 80%. Las
especialidades médicas con más reportes: Oncología, Medicina
Interna, Gastroenterología. Los grupos terapéuticos asociados: an-
tibióticos 19.6%, antineoplásicos 13.3%, corticoesteroides 11.17%,
opioides 7.4%, medios de contraste 6.9%. Aparatos y sistemas afecta-
dos: dermatológico 29.7%, gastrointestinal 15.28%, sistema
nervioso central 13.1%, cardiovascular 7.9%, endocrino 7.4%.
La asociación causal fue probable en 75.1%, definida en 4% y
posible en 20.9%. Hubo 47.16% reacciones moderadas, 33.18%
graves, 19.21% leves. Todas las moderadas y graves ameritaron
intervención para su resolución. En la serie hubo 16/229 (7%) rela-
cionadas a errores de medicación, diez no se generaron a nivel
local, todas se resolvieron sin secuelas. Conclusiones.Conclusiones.Conclusiones.Conclusiones.Conclusiones. La farma-
covigilancia hospitalaria tiene utilidad inmediata, aplicando los
resultados obtenidos de series de casos, pueden alcanzarse accio-
nes con impacto en la seguridad del paciente y para prevención de
riesgos asociados a medicamentos.

Palabras clave.Palabras clave.Palabras clave.Palabras clave.Palabras clave. Servicios farmacéuticos. Sistema de reporte de
reacciones adversas a medicamentos.

AAAAAbstractbstractbstractbstractbstract

Introduction. Introduction. Introduction. Introduction. Introduction. Pharmacovigilance development is still limited in
Mexico. It is mandatory for hospital setting since 2005 and its rele-
vancy has been exhibited. Objective.Objective.Objective.Objective.Objective. Describe pharmacovigilan-
ce methods for application of its results in continuous improvement
of healthcare and for patient safety. Material and methods.Material and methods.Material and methods.Material and methods.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 useful-
ness of a case series collected from January to December 2010.
Results.Results.Results.Results.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%, endo-
crine 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.Conclusions.Conclusions.Conclusions.Conclusions. Pharmaco-
vigilance in hospital setting has a valuable and immediate applica-
tion through simple case series with high impact in patient safety
and prevention of medication risks.

Key words.Key words.Key words.Key words.Key words. Pharmaceutical Service. Adverse drug reaction repor-
ting systems.

su desarrollo es limitado y su implementación fue obligato-
ria desde 2005 para clínicas y hospitales, entre otras áreas.2

La certificación de hospitales por parte del Consejo de Sa-
lubridad General ha incorporado a la farmacovigilancia en
el esquema vigente para tres tareas específicas:3

www.imbiomed.com.mx

Page 2

103Rev Invest Med Sur Mex, 2011; 18 (3): 102-110

Rosete Reyes A

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MATERIAL Y MÉTODOS

Métodos en farmacovigilancia

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OBJETIVO

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104 Rev Invest Med Sur Mex, 2011; 18 (3): 102-110

Farmacovigilancia en instituciones de salud

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105Rev Invest Med Sur Mex, 2011; 18 (3): 102-110

Rosete Reyes A

memente a los Comités de Farmacia y Terapéutica. Para
realizar estos estudios se utilizan las bases de datos ad-
ministrativas o de dispensación que permiten disponer
del número total de sujetos expuestos al medicamento
de interés y comparadores (denominador), así como los
sujetos que desarrollaron o no una reacción adversa es-
pecífica.18

Aunque en el medio hospitalario mexicano no es fre-
cuente utilizar estos datos, los movimientos de medica-
mentos de las farmacias de hospital permiten estimar el
número de usuarios y la dosis diaria definida, los patrones
de utilización y diversos datos útiles para la estimación de
riesgos en farmacovigilancia.

RESULTADOS

El Centro Institucional de Farmacovigilancia del Hos-
pital Médica Sur, hospital académico no gubernamental
de alta especialidad, fue creado en 2007 para promover
el uso racional y seguro de medicamentos. Sus activida-
des cubren la NOM-220-SSA1-2002, estándares y elemen-

tos de medición MMU.1, MMU.2, MMU.4, MMU.7, capa-
citación en MMU.5, MMU.6 (criterios del Consejo de Sa-
lubridad General para la certificación de hospitales) y la
meta internacional de seguridad en medicamentos de alto
riesgo; provee información para los Comités de Calidad/
Seguridad del Paciente, Farmacia y Terapéutica, Unidad
de Vigilancia Epidemiológica y para diferentes especiali-
dades, con el fin de establecer propuestas/estrategias de
mejora continua y los requerimientos para la acreditación
por la Joint Commission International.

Los resultados de 2010 en el campo de la farmacovigi-
lancia fueron 171 notificaciones de RAM con un total de
229 reacciones adversas, con la distribución descrita en el
cuadro 1.

Los datos demográficos mostraron:

• 61.13% fue población femenina (n = 140/229).
• Edad promedio 46.9 ± 19.6 años.
• Adultos 67.24% (n = 154).
• Pacientes geriátricos 29.2% (n = 67) y pediátricos 3.5%

(n = 8).

Figura 1. Diseño de cohorte. Para estimaciones de riesgo se requieren dos grupos de comparación en los que se determinará el número
de sujetos que presentan el evento de interés (con resultado = RAM) y que conforman los numeradores vs. el total de sujetos expuestos
al medicamento de interés y al comparador o control (denominadores).

Casos-Controles dentro de una cohorte

Expuestos o
casos

Cohorte
seleccionada

Tiempo

No expuestos o
controles

Con resultado

Sin resultado

Con resultado

Sin resultado
Otro medicamento
Sin medicamento

Medicamento
de interés

Page 5

106 Rev Invest Med Sur Mex, 2011; 18 (3): 102-110

Farmacovigilancia en instituciones de salud

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Cuadro 1. Reacciones adversas a medicamentos (2010).

Datos generales n (%)

Notificaciones recibidas 171
Reacciones adversas totales 229 (100)
Género femenino 140 (61.13)
Género masculino 89 (38.8)
Edad promedio (años) 46.9 ± 19.6
Rango de edad (años) 5-93
Adultos 154 (67.24)
Adultos mayores 67 (29.2)
Pacientes pediátricos 8 (3.5)

Datos generales de la serie de casos de reacciones adversas a
medicamentos colectadas de enero a diciembre 2010.

Cuadro 2. Grupos terapéuticos asociados a las RAM colecta-
das en 2010.

Grupo terapéutico n (%)

Antibióticos 37 (19.6)
Otros diversos* 30 (15.9)
Antineoplásicos 25 (13.3)
Corticoesteroides 21 (11.17)
Opioides 14 (7.4)
Medios de contraste 13 (6.9)
Antiinflamatorio no esteroideo (AINEs) 13 (6.9)
Antipsicóticos 8 (4.2)
Anticoagulantes 4 (2.6)
Anticonvulsivantes 4 (2.6)
Antiespasmódicos 3 (2.1)
Inhibidor de la bomba de protones 2 (1)
Antibióticos analgésicos 2 (1)
Opioide/AINEs 2 (1)
Hipoglucemiantes 2 (1)
Antieméticos 2 (1)
Antivirales 2 (1)
Anestésicos 2 (1)
Agonistas adrenérgicos 2 (1)

*Grupos farmacológicos en los cuales sólo se reportó una reac-
ción adversa: Antagonistas D-adrenérgicos, antihipertensivos,
antihistamínicos, anticolinérgicos + agonista b2, antidepresivos,
antimicóticos, antimaláricos, antiparasitarios, antidiarreicos, anti-
tiroideos, antirretroviral, antineoplásicos/inmunomoduladores,
antivertiginosos, anorexigénicos, benzodiacepinas, bloqueador
adrenérgico D-1, diurético osmótico, electrolitos, inmunosupre-
sores, inmunoestimulantes, inhibidores ECA, producto herbola-
rio, mucolíticos, sulfunilureas, vasopresina y análogos, suple-
mento/multivitamínicos, D-E-agonistas + antihistamínicos. Fre-
cuencia de presentación de los diferentes grupos
farmacológicos, según la clasificación ATC (Anatomical Thera-
peutic Chemical Classification System).

Cuadro 3. Afección por órganos, aparatos y sistemas.

Órganos y sistemas n = 229 (100%)

Dermatológico 68 (29.7)
Gastrointestinal 35 (15.28)
Sistema nervioso central 30 (13.1)
Cardiovascular 18 (7.86)
Endocrino 17 (7.4)
Otros 16 (6.9)
Respiratorio 12 (5.24)
Hematológico 9 (3.9)
Urinario 9 (3.9)
Hepático 5 (2.1)
Metabólico 5 (2.1)
Músculo-esquelético 3 (1.3)
Psiquiátrico 2 (0.8)

Distribución de las manifestaciones clínicas presentadas por los
pacientes que tuvieron reacciones adversas a medicamentos.

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107Rev Invest Med Sur Mex, 2011; 18 (3): 102-110

Rosete Reyes A

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Cuadro 5. Descripción de los eventos temporalmente asociados a vacunación.

Notificación de ETAV 1 2 3

Vacuna involucrada Hepatitis B (Birmex) Tétanos y Difteria (Birmex) Hepatitis B
(laboratorio productor) (Sanofi Pasteur)

Influenza H1N1 (Sanofi Pasteur) Influenza H1N1 (Sanofi Pasteur)

Descripción del ETAV Fiebre, exantema, faringitis, Exantema, reacción local, Urticaria, reacción local,
astenia y adinamia congestión nasal y dolor y celulitis*

ardor de garganta

Severidad Leve Leve Moderado

¿Requirió tratamiento? No No Sí
(Sí/No)

Recuperación Recuperado sin secuela Recuperado sin secuela Recuperado sin secuela

*Probablemente debida a mala técnica de aplicación, no se encontraron disponibles reportes de celulitis por la vacuna. Los datos fue-
ron registrados posteriores a las campañas de vacunación realizadas para protección del personal de salud del hospital.

Cuadro 4. Clasificación de causalidad.

Tipo n (%)

Dudosa 0 (0)
Posible 48 (20.9)
Probable 172 (75.1)
Definida 9 (4)
Total 229 (100)

Las notificaciones probables y definidas incluyen la información
suficiente para establecer una relación causal con el medica-
mento sospechoso; las dudosas y posibles carecen de los datos
necesarios para ello.

Page 7

108 Rev Invest Med Sur Mex, 2011; 18 (3): 102-110

Farmacovigilancia en instituciones de salud

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Page 8

109Rev Invest Med Sur Mex, 2011; 18 (3): 102-110

Rosete Reyes A

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