Farmacovigilancia

Pharm World Sci (2007) 29:43–46 DOI 10.1007/s11096-005-5975-4

SHORT RESEARCH ARTICLE

Pharmacovigilance and pharmacoepidemiology of drugs in a Mexican pediatric hospital. A proposed guide
´ ´ ´ Hugo Juarez-Olguı´ n Æ Gabriela Perez-Guille Æ Janett ´ Flores-Perez

Received: 23 February 2005 / Accepted: 16 December 2005 / Published online: 1 February 2007 ª Springer Science+Business MediaB.V. 2007

Abstract We describe the procedures of pharmacovigilance (PV) and pharmacoepidemiology (PE) of drugs in a pediatric hospital. These activities contribute to the detection and registration of adverse drug reactions and to determine the patterns of drug prescription among children attended at the hospital. The PV activities show that there is a relation between an increase in incidenceof adverse drug reactions and the prescription of a larger number of drugs. The PE activities reveal that antibiotics are the most frequently prescribed drugs and next are drugs used for gastrointestinal diseases. Since PV and PE activities were initiated at our hospital, they have contributed to a more adequate use of drugs in children. As a conclusion of these activities, it could be that if thePE of a hospital is known, drug consumption can be optimally planned. PV and PE demonstrate that, if polytherapy is not necessary, it must be avoided. Finally, the present guide can be adopted to initiate PV and PE at a hospital. Keywords Drugs Æ Hospital pharmacy Æ Pediatrics Æ Pharmacoepidemiology Æ Pharmacovigilance

Introduction The National Institute of Pediatrics in Mexico is atertiary-care hospital that attends patients with diverse health problems. A significant percentage of the patients present chronic and complex diseases, and fewer arrive with recently acquired ailments. Both groups require multiple studies and treatments, hospitalization and subsequent consultation, some of them with long-term follow-up. The Institute provides approximately 200,000 annual consultations;about 8,000 patients are hospitalized; more than 6,000 surgical interventions and 500,000 laboratory tests are performed per year. The Institute attends children from newborns to teenagers. The pharmacology service was founded recently, arising from the need of having a center to support the activities of pharmacovigilance and pharmacoepidemiology regarding the most frequently used pediatric drugs inthe hospital, which is the main objective of this work. We describe a procedure for pharmacovigilance (PV) and pharmacoepidemiology (PE) for drugs used in a pediatric hospital. These activities contribute to the detection and registration of adverse drug action and to determine the patterns of drug prescription among children attended at the hospital.

´ ´ ´ H. Juarez-Olguı´ n Æ G. Perez-GuilleLaboratory of Pharmacology, National Institute of Pediatrics, Mexico city, Mexico ´ H. Juarez-Olguı´ n (&) Laboratory of Pharmacology, Instituto Nacional de Pediatrı´ a, ´ Avenida Iman No 1, 3er piso, Colonia Cuicuilco, CP 04530, Mexico city, Mexico E-mail: juarezol@yahoo.com ´ ´ H. Juarez-Olguı´ n Æ J. Flores-Perez Department of Pharmacology, Medicine Faculty, Universidad ´ ´ Nacional Autonoma deMexico, Mexico city, Mexico

Pharmacovigilance The term adverse drug reaction (ADR) describes any harmful and unintentional response to the usual doses of a drug in humans administered for prophylaxis, diagnosis, treatment or modification of physiological activities. An ADR can be caused by hypersensitivity, idiosyncrasy, accumulation or pharmacological interactions between two or more drugs.Most drugs that produce ADR can threaten or worsen the patient’s condition. For this reason, PV programs, also called

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Pharm World Sci (2007) 29:43–46

phase IV studies, have been developed, which identify ADR of drugs to guarantee the safety of drugs used. The pharmacology service participates in the detection, notification and registry of ADR caused by medicaments used in...