Non available medicines for pediatric patients. Drug utilization study at the ?hospital infantil municipal (HIM)

FONTANA, D; VILLAGRA, B; MAZZIERI, M. R

Encuentro; 1st Annual RICiFA Meeting (International Meeting on Pharmaceutical Sciences; 2010

Introduction Once all R&D steps are overcome, pharmaceutical industry must apply for governmental authorization approval. The information included must specify the indication(s) with the age range and dosage form. In some situations, physicians are allowed to prescribe for any other indication or dosage form, if there is reasonable scientific evidence. The use of a drug in any age range different of that labeled is frequent in pediatrics and geriatrics, and this circumstance represents a matter of several investigations (1-3). The methods used in Pharmacoepidemiology offer tools to study the use of medicines in the population, among them Drugs Utilization Studies (DUE) are one of the most useful (4). In this context, we wanted to describe the use of medicines in hospitalized patients at the Hospital Infantil Municipal (HIM) and assess whether medications prescribed are marketed in Argentina in therapeutic indications and on appropriate dosage form. Materials and methods Between September and November 2009, a pilot observational, descriptive, cross-sectional study was carried out. Prescriptions made to hospitalized patients at HIM were registered Information was supplemented by reviewing the medical records and verbally checked with doctors and nurses. Drugs were classified according to the ATC Code (5). All prescriptions were compared with dosage forms approved by ANMAT (6) to determine the lack of availability. Also, they were analyzed with sources related to Evidence Based Medicine (7). A drug existing in more than one situation was selected for analysis. The information was processed using the statistical program SAS 9.2 Results A total of 5757 medical indications were sorted out (105 different drugs; 327 children). Among them, 312 received at least one prescription and patients received a mean of 5 medicines (1-21). The average period of hospitalization was 4 days (1-24). Six ATC groups included the 90% of the prescriptions drugs (A: 28%; N: 24%; J: 16%; R: 11%; H: 6% and B: 4%). In the 16% (n=165) of prescriptions, dosage form adaptation and off-label use were needed. They were necessary in 12% (n=39) of children. The 71% (n=117) of prescriptions was related to tablets and capsules for oral use. Scientific evidence related to safety and efficacy in pediatrics could not find for the 18% (n=19) of the drugs used, even more some of them were not recommended for use in this age group. The 65% (n=213) of patients received at least one prescription of these drugs. Sildenafil was selected as an example. It is marketed as oral tablets of 25, 50, 100mg. For a patient with pulmonary arterial hypertension was prescribed 6mg three times a day. It is considered orphan drug by EMA. Safety and effectiveness in pediatrics is not well-known. The pharmaceutical formulation should be manipulated to be administered. Conclusions A relevant proportion of prescribed medicines were not marketed in the suitable dosage form. For this situation was necessary its manipulation to administer them. A important group of patients were exposed to use of drugs without sufficient data about safety and efficacy or not recommended for use in children. Acknowledgments: -Secretaría de Ciencia y Tecnología. Universidad Nacional de Córdoba. (SeCyT-UNC) -Secretaría de Salud de la Municipalidad de Córdoba -Hospital Infantil Municipal de la ciudad de Córdoba (HIM) References: 1) Decreto de Medicamentos: normas de registros y elaboración. Decreto Nº 150/1992, Poder Ejecutivo Nacional, República Argentina (Enero 23, 1992). 2) Fontana D, Uema S, Mazzieri MR. Medicamentos huérfanos: una revisión necesaria para un problema sanitario no resuelto. Acta Farmacéutica Bonaerense 2005;24(1):123-9. 3) Fontana D, Uema S, Mazzieri MR. Medicamentos huérfanos: una definición. Acta Farmacéutica Bonaerense 2005;24(3):449-52. 4) Laporte JR, Tognoni G. Principios de epidemiología del medicamento. 2° Ed. Barcelona. Ed. Masson-Salvat. 1993. 5) WHO Collaborating Centre for Drug Statistics Methodology [database on the Internet]. Complete ATC/DDD index 2010. [updated 2010 March]. Available from: http://www.whocc.no/atcddd/indexdatabase 6) Administración Nacional de Medicamentos Alimentos y Tecnología Médica. [base de datos en Internet] Base de datos de medicamentos. [Acceso Marzo 2010]. Disponible en: http://www.anmat.gov.ar/Medicamentos/basedat.asp 7) DRUGDEX® System [database on the Internet]. Thomson Micromedex. [updated 2010 March] Available from: http://www.thomsonhc.com