Ley de garantías y uso racional de los medicamentos y productos sanitarios. 1. Comentarios generales / Garanties Law and rational use of drugs and medical devices. 1. General comments

Se inicia una serie de comentarios sobre la Ley de garantías y uso racional de los medicamentos y productos sanitarios que empieza con una introducción que incluye el sumario o índice general comparativo con el de la anterior Ley del medicamento de 1990 y su estructura general

It is initiated a series of commentaries above the Guaranties Law and rational use of drugs and medical devices to begin by a introduction with the summary either general index comparative with the previous Drugs Law 1990, and the structure

Unit-dose packaging of iron supplements and reduction of iron poisoning in young children.

BACKGROUND: Iron poisoning is a major cause of unintentional poisoning death in young children. The US Food and Drug Administration proclaimed a regulation for unit-dose packaging of iron supplements in 1997. OBJECTIVE: To determine whether the requirement for unit-dose packaging of iron supplements decreases the incidence of iron ingestion and the incidence of deaths due to iron poisoning in children younger than 6 years. METHODS: This is a preintervention-postintervention study of the US federally mandated requirement for unit-dose packaging of iron supplements. The 10 years prior to the intervention were compared with the 5 years after its promulgation. The incidences of iron ingestion and of iron poisoning deaths for children younger than 6 years were obtained from the annual reports of the American Association of Poison Control Centers (Washington, DC). RESULTS: The average number of iron ingestion calls per 1000 of all calls to poison control centers regarding children younger than 6 years decreased from 2.99 per 1000 to 1.91 per 1000 (odds ratio, 1.29 [95% confidence interval, 1.27-1.32]; P<.001). The number of deaths decreased from 29 to 1 (odds ratio, 13.56 [95% confidence interval, 1.85-99.52]; P = .03). CONCLUSIONS: These are the first data that show a decrease in the incidence of nonintentional ingestion of a specific drug by young children and a decrease in mortality from poisoning by this drug after the introduction of unit-dose packaging. There was a decrease in the incidence of iron ingestion and a dramatic decrease in the number of deaths due to iron poisoning. This validates unit-dose packaging as an effective strategy for the prevention of iron poisoning and iron poisoning deaths in young children. This highly effective intervention should be considered for other medications with a high hazard for morbidity and mortality when taken as an overdose.

Iron-containing supplements and drugs; label warning statements and unit-dose packaging requirements; removal of regulations for unit-dose packaging requirements for dietary supplements and drugs. Final rule; removal of regulatory provisions in response to court order.

The Food and Drug Administration (FDA) is removing, in part, a final rule that required unit-dose packaging for iron-containing dietary supplement and drug products that contain 30 milligrams (mg) or more of iron per dosage unit. FDA is taking this action in response to the Court's ruling in Nutritional Health Alliance v. FDA, in which the Court concluded that the Federal Food, Drug, and Cosmetic Act (the act) does not provide FDA with authority to require manufacturers of iron-containing dietary supplement and drug products to use unit-dose packaging for poison prevention purposes. Today's action takes the ministerial step of removing the unit-dose packaging provisions from title 21 of the Code of Federal Regulations.