Availability in Spain of 'one-pill killers' and other highly toxic drugs in infants

Objective: To prepare a list of highly toxic drugs in infants (HTDs) marketed in Spain, comparing those that reach the lethal dose in a child of 10 kg with the ingestion of one to three units. Method: HTDs are defined as those capable of causing severe or lethal poisoning in children less than 8-year-old. Severe poisoning is considered as that corresponding to Grade 3 in the Poisoning Severity Score classification and to the “major effects” category in publications in the American Association of Poison Control Centers (AAPCC). A literature review was carried out on the annual reports of the AAPCC, as well as in PubMed, between January 2000 and February 2019 (key words: “severe”, “fatal”, “life-threatening”, “poisoning”, “child”, “paediatric”, “toxicological emergency”). An observational, retrospective study was also conducted on infants less than 8-year-old that were seen in a Paediatric Emergency Department due to suspected drug poisoning between July 2012 and June 2018.The active ingredients responsible marketed in Spain were selected, and the lethal or highly toxic doses were determined. The number of units (pills) necessary to reach this dose in children of 10 kg was calculated. Results: A total of 7 HTD groups were identified: analgesics; psychotropics and other medication used in neurological disorders; catarrh decongestants – cough –antihistamine – asthma drugs; cardiovascular drugs; antibiotics, topical preparations, and other drugs. In 29 active ingredients, the ingestion of a single pill could cause death in 10 kg infant, in another 13, the ingestion of 2 pills could cause death, as well as the ingestion of 3 pills in 10 cases. Conclusion: There are numerous HTDs marketed in Spain, some of which are available in potentially fatal presentations with few pills. Resumen: Objetivo: Elaborar un listado de medicamentos altamente tóxicos en la infancia (MAT), comercializados en España, diferenciando aquellos que alcanzan la dosis letal para un niño de 10 kg con la ingesta de una a tres unidades. Método: Se definió MAT como aquellos capaces de producir intoxicaciones graves o letales en niños menores de 8 años. Se consideró toxicidad grave la correspondiente al grado 3 en la clasificación Poisoning Severity Score y a la categoría “major effects” en las publicaciones de la American Association of Poison Control Centers (AAPCC). Se realizó una revisión bibliográfica de los informes anuales de la AAPCC y de PubMed entre enero 2000 y febrero 2019 (palabras clave: “severe”, “fatal”, “life-threatening”, “poisoning”, “child”, “pediatric”, “toxicological emergency”). Además, se realizó un estudio observacional retrospectivo de menores de 8 años que consultaron en un servicio de urgencias pediátrico por sospecha de intoxicación farmacológica entre julio 2012 y junio 2018.Se seleccionaron los principios activos responsables comercializados en España y se determinó la dosis letal o la dosis altamente tóxica. Se calculó el número de unidades necesarias para alcanzarla en niños de 10 kg. Resultados: Se identificaron 7 grupos de MAT: analgésicos; psicofármacos y medicamentos neuromusculares; anticatarrales descongestivos-antitusígenos-antihistamínicos-antiasmáticos; medicamentos cardiovasculares; antimicrobianos; preparados tópicos y otros medicamentos. En 29 principios activos, la ingesta de una única unidad podría causar la muerte en un lactante de 10 kg de peso, en 13 podría causarla la ingesta de dos unidades y en 10 la ingesta de tres unidades. Conclusión: Existen numerosos MAT comercializados en España, algunos de ellos disponibles en presentaciones potencialmente letales con pocas unidades.