ABSTRACT
A remoção de um produto não conforme em posse do consumidor, voluntariamente ou através de uma chamada pública, chama-se recall. Após breve pesquisa, nota-se que os tipos e procedimentos de recall de alimentos registrados nos órgãos reguladores no Brasil são subnotificados, quando comparados aos descritos em outros países como EUA, Canadá e pertencentes à União Europeia, especialmente se verificarmos o número de casos registrados por pequenas e médias empresas de alimentos. Sendo assim, o presente trabalho teve por objetivo verificar, através da técnica qualitativa de grupo focal, a percepção a respeito do recall de alimentos, e os entraves encontrados por gestores da cadeia produtiva de alimentos para a realização deste procedimento.
Subject(s)
Humans , Food Supply , Focus Groups , Product Recalls and Withdrawals , Quality ControlABSTRACT
Cases of drug-induced QT prolongation and sudden cardiac deaths resulted in market withdrawal of many drugs and world-wide regulatory changes through accepting the ICH guidelines E14 and S7B. However, because the guidelines were not comprehensive enough to cover the electrophysiological changes by drug-induced cardiac ion channel blocking, CiPA was initiated by experts in governments and academia in the USA, Europe, and Japan in 2013. Five years have passed since the launch of the CiPA initiative that aimed to improve the current ICH guidelines. This report reviews the current achievements of the CiPA initiative and explores unresolved issues.
Subject(s)
Computer Simulation , Death, Sudden, Cardiac , Europe , Ion Channels , Japan , Myocytes, Cardiac , Product Recalls and WithdrawalsABSTRACT
Drug-drug interaction (DDI) is defined as a change in effect or safety of a drug by another co-administered drug. The fact that more than half of the market withdrawal cases for the past ten years was caused by potentially fatal DDI's demonstrates its clinical importance. The mechanism of DDI can be categorized into pharmacokinetic and pharmacodynamic interactions. Most of the clinically important drug interactions are caused by inhibition or induction of oxidative metabolism by cytochrome P450 (CYP) isozymes. Recent researches are also focusing on drug transporter interactions as another significant factor underlying DDI's. It is hard to prevent unexpected or rare DDI's. However, most of the cases of DDI occur from an erroneous prescription of drugs that are already known to result in deleterious interactions. To avoid such well-established DDI's, physicians are first recommended to utilize hands-on summary tables for CYP substrates before prescribing. It should also be remembered that old age, polypharmacy and damaged hepatic or renal function are risk factors of DDI as well as adverse drug reactions. Moreover, patients treated with drugs with a narrow therapeutic index (immunosuppressants, antiarrhythmics, anticoagulants, digoxin, theophylline etc) deserve a special consideration when their prescriptions are changed. In Korea, the clinical significance of DDI has been underemphasized. The fundamental prescription to this old prescription habit is to teach medical students and physicians clinical pharmacology and therapeutics, which have long been neglected in Korea.
Subject(s)
Humans , Anticoagulants , Cytochrome P-450 Enzyme System , Digoxin , Drug Interactions , Drug-Related Side Effects and Adverse Reactions , Isoenzymes , Korea , Metabolism , Pharmacology, Clinical , Polypharmacy , Prescriptions , Product Recalls and Withdrawals , Risk Factors , Students, Medical , TheophyllineABSTRACT
Los problemas de salud se ven agravados en las ciudades por el crecimiento y el desarrollo que en gran parte no se planifica ni controlan y tienen asignados pocosrecursos económicos. La mayoría de los países latinoamericanos experimentan unproceso de urbanización intensivo y desordenado originando entre otros el aumento delcomercio informal y ambulatorio de todas clases de bienes y servicios, entre las que sedestaca la venta de comidas y una creciente industria informal de alimentos. En estecontexto, los procesos de descentralización se consideran estratégicos para el desarrollode las comunidades, y las Municipalidades están comenzando a fortalecer los serviciosadministrativos y económicos, para aumentar su eficiencia, eficacia y autonomía.