The dynamic interdependencies among the negativity and the positivity in news and user-generated content about safety in a firm's products and the firm's product recalls.

This article examines the dynamic interdependencies among the negativity and the positivity in news and user-generated content about safety in a firm's products (or the lack thereof) and the firm's product recalls. The authors use a panel vector autoregression (PVAR) to unearth theoretically novel and managerially relevant asymmetric associations. Specifically, they find that the negativity in the news negatively correlates with recalls, whereas the negativity in UGC positively correlates with recalls. Whereas the positivity in the news positively correlates with recalls, the positivity in UGC does not matter. Further, the negativity in the news and the negativity in UGC substitute for each other, whereas their positive counterparts complement each other's associations with recalls. Lastly, the negativity and positivity in the news have significant, though differently patterned, long-term associations with recalls. The findings contribute to research on the associations between earned media and managerial decisions in the product market.

Human Medicines Recall Announcements in Saudi Arabia Between 2017 and 2022: An Analysis of Saudi Food and Drug Authority (SFDA) Reports.

PURPOSE: This study aims to explore the characteristics of drug recall announcements issued over six years by the SFDA in Saudi Arabia. Additionally, to examine the patterns of voluntary drug recall requests by pharmaceutical companies (both innovator and generic) in response to product defects. METHODS: A retrospective data analysis was conducted on drug recall announcements issued by the SFDA between 2017 and December 2022. The study included recalls of registered and unregistered drugs posted on the SFDA Drugs Circulars and Withdrawal webpage. Descriptive analysis was performed on relevant variables: recall year, therapeutic class, recall type, pharmaceutical company type, recall reasons and voluntary or involuntary product defect reports. RESULTS: During the study period, a total of 371 products were recalled, with the majority being involuntary recalls (82.4%). About two-thirds of the recalls (66.0%) were related to registered products. The most common reasons for recalls were non-compliance with the manufacturer's specifications (33.2%), contamination (23.7%), and violations (20.5%). A total of 109 pharmaceutical companies were associated with the recalled products, with (85.3%) being generic pharmaceutical companies. The majority of innovator pharmaceutical companies (68.8%) requested voluntary drug recalls of defective products. Innovator pharmaceutical companies requested voluntary recalls more often than generic pharmaceutical companies. CONCLUSION: The study findings highlight the most frequent causes of drug recalls and the patterns of voluntary recall requests by pharmaceutical companies. Non-compliance with manufacturer's specifications was the most common reason for recalls. Significantly, more innovative pharmaceutical companies request voluntary recalls for product defects compared to generic pharmaceutical companies.

Recall de produtos alimentícios: um estudo baseado em grupo focal com gestores da cadeia produtiva de alimentos / Food products recall: a focus group-based study with food supply chain managers

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.

Five years of the CiPA project (2013–2018): what did we learn?

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.

Repercusión de la desfinanciación de la vacuna antineumocócica en una población con recursos bajos / Impact of the underfunding of the pneumococcal vaccine in a low income population

Introducción: en junio de 2010, la Comunidad de Madrid incluyó en el calendario vacunal infantil la vacuna neumocócica conjugada tridecavalente. Por razones presupuestarias, se retiró de la financiación en julio de 2012 y hasta enero de 2015. Nuestro objetivo fue evaluar cómo influyó este hecho en la cobertura vacunal y en la incidencia de enfermedad neumocócica invasiva, neumonía y otitis media aguda en una población de recursos económicos bajos y compararlo con los mismos datos publicados para el conjunto de la región. Material y métodos: estudio de cohortes retrospectivo de los casos de enfermedad neumocócica y cobertura vacunal en los niños nacidos entre mayo de 2012 y octubre de 2014 del centro de salud Entrevías (Madrid, España). Resultados: se encuentra una menor cobertura vacunal (66%; IC 95: 57,3 a 71,4) respecto a la media de la Comunidad de Madrid (77%). No hubo casos de enfermedad neumocócica invasiva y la incidencia de neumonías y otitis fue independiente del estado vacunal. El único factor asociado a la incidencia de otitis fue la asistencia a guardería. Conclusiones: la desfinanciación de la vacuna neumocócica conjugada condicionó la disminución de la cobertura vacunal por debajo de la media regional en una población de bajos recursos. No se encontró aumento de incidencia de enfermedad neumocócica, probablemente debido a la persistencia del efecto rebaño o a un tamaño muestral insuficiente (AU)

Introduction: since June 2010 the Community of Madrid included in the childhood vaccination schedule the conjugate vaccine against thirteen pneumococcal serotypes. By budgetary reasons, it was with-drawn from the financing public system in July 2012 to March 2015. Our goal was to evaluate how it influenced vaccination coverage and the incidence of acute otitis media, pneumonia and invasive pneumococcal disease in a low-income population, and compare them with published data for the whole region. Methods and materials: retrospective cohort study of pneumococcal disease and vaccination rate in children born between May 2012 and October 2014, who are patients in the Health Center of Entrevias. Results: there has been a reduction in the vaccination coverage (66%, 95% CI: 57.3 to 71.4%) compared to the average of the Community of Madrid (77%). There were no cases of invasive pneumococcal disease, and the incidence of pneumonia and acute otitis media was independent of immunization status. The only factor associated to the incidence of acute otitis was the attendance to daycare center. Conclusions: the defunding of the conjugate vaccine against thirteen pneumococcal serotypes caused a decrease of vaccination coverage in children a low-income population. In this study we found no increased incidence of pneumococcal disease, a fact that may be due to the persistence of the herd effect or to an insufficient sample size (AU)

Understanding the Drug-Drug Interaction

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.

Proyecto de Inocuidad de alimentos en mercados saludables y productos del municipio de Asunción-Paraguay / Project of Innocuity of foods in healthful markets and products of the municipality of Asuncio'n-Paraguay

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.