Occupational Health and Safety Statistics as an Indicator of Worker Physical Health in South African Industry.

Operations in general industry, including manufacturing, expose employees to a myriad of occupational health hazards. To prevent exposure, occupational health and safety regulations were enacted, with both employers and workers instituting various risk reduction measures. The analysis of available occupational disease and injury statistics (indicators of worker physical health) can be used to infer the effectiveness of risk reduction measures and regulations in preventing exposure. Thus, using the READ approach, analyses of occupational disease and injury statistics from South African industry, derived from annual reports of the Compensation Fund, were conducted. The publicly available database of occupational disease and injury statistics from the South African general industry is unstructured, and the data are inconsistently reported. This data scarcity, symptomatic of an absence of a functional occupational disease surveillance system, complicates judgement making regarding the effectiveness of implemented risk reduction measures, enacted occupational health and safety regulations and the status of worker physical health from exposure to workplace hazards. The statistics, where available, indicate that workers continue to be exposed to occupational health impacts within general industry, notwithstanding risk reduction measures and enacted regulations. In particular, worker physical health continues to be impacted by occupational injuries and noise-induced hearing loss. This is suggestive of shortcomings and inefficiencies in industry-implemented preventive measures and the regulatory state. A robust national occupational disease surveillance system is a regulatory tool that should detect and direct policy responses to identified occupational health hazards.

Cross sectional study on food safety knowledge, attitudes, and practices of food handlers in Lahore district, Pakistan.

Annually, millions of the people suffer from foodborne diseases which are mainly associated with poor food handling practices. The poor food safety knowledge and practices increase the risk of food contamination and foodborne diseases. The aim of this study was to evaluate the relationship between demographic attributes and food safety knowledge, attitudes, and practices (KAP) of food handlers (chefs and servers) working in small-scale restaurants, hotels and eateries in Lahore, Pakistan. A structured questionnaire including questions related to demographic characteristics and food safety KAP attributes of food handlers (n = 202) was used to collect the responses. The responses of food handlers were statistically analyzed using Spearman Correlation and Chi-Square tests. The results showed that a large proportion of food handlers had good attitudes towards food safety and followed good food safety practices (FSP) but had poor food safety knowledge (FSK). Demographic characteristics of food handlers i.e. level of education, professional category, current job tenure, and total food service industry experience were significantly (p < 0.05) associated with FSK, FSA, and FSP. FSK was found to be moderate to strongly correlated with FSP of food handlers (rs = 0.675), whereas FSA was found to be strongly correlated with FSP (rs = 0.733). The study highlighted the importance and impact of food safety knowledge on food safety practices and overall perspective of food handlers working in restaurants.

Analysis of Medical Device Alerts Issued by the Portuguese Medicines Agency: Scoping the Purpose of New Regulatory Recommendations.

INTRODUCTION: Medical devices are healthcare technologies with a significantly growing market worldwide. This study aims to analyze medical device alerts issued by the Portuguese Medicines Agency, INFARMED, I.P. during 2017, as well as to identify the respective regulatory actions and to suggest additional recommendations. MATERIAL AND METHODS: All alerts on medical device alerts publicly available in the website of INFARMED, I.P. were identified and analyzed, including actions taken. Additionally, reports on medical devices from the Portuguese national competent authorities were compared with reports from other European Union member states such as Germany. RESULTS: A total of 32 safety alerts were identified: 18 (56%) related with devices without identified records of commercialization in Portugal, six (19%) related with devices voluntarily withdrawn from the market, such as counterfeit products, and eight (25%) categorized as 'other'. In both Portugal and Germany, 0.28 and 4.53 reports of national competent authorities per million inhabitants were identified, respectively. Diverse regulatory actions were taken, such as six compulsory indications to not acquire or use devices. DISCUSSION: Considering that the European Union is an open market where citizens should have equal access to medical devices, the Portuguese system of medical device safety alerts seems to be functioning normally. The identified safety alerts seemed relevant, with Portugal registering a proportionally slightly lower number of alerts when compared with higher sales volume markets, which may be explained by an underreporting of this type of problems. Further studies are needed to confirm these preliminary results, although the development of databases comprising data on patients using medical devices is recommended in order to generate automatic email and text message alerts. CONCLUSION: A limited number of safety alerts on medical devices was identified in Portugal, with few reported cases of counterfeit or falsified devices. The Portuguese Medicines Agency contributes to the citizens' access to quality medical devices, by issuing safety alerts, recommendations and mandatory market withdrawals for unsuitable or unsafe medical devices.

Introdução: Os dispositivos médicos são tecnologias de saúde com um significativo crescimento a nível mundial. Foi objetivo deste trabalho analisar os alertas sobre dispositivos médicos emitidos pela Agência Portuguesa do Medicamento: INFARMED, I.P. durante 2017, identificar as respetivas ações regulatórias e sugerir recomendações. Material e Métodos: Todos os alertas e ações sobre dispositivos médicos publicamente disponíveis no website do INFARMED, I.P. foram identificados e analisados. Adicionalmente, os relatórios da autoridade competente nacional sobre dispositivos médicos foram comparados com relatórios de outros países da União Europeia como a Alemanha. Resultados: Identificou-se um total de 32 alertas de segurança de dispositivos médicos: 18 (56%) sem registos de comercialização em Portugal, seis (19%) voluntariamente retirados do mercado, como produtos contrafeitos, e oito (25%) categorizados como 'outros'. Em Portugal e na Alemanha foram identificados 0,28 e 4,53 relatórios de autoridades competentes por milhão de habitantes, respetivamente. Diversas ações regulamentares foram tomadas, como seis indicações obrigatórias para não adquirir ou utilizar dispositivos médicos. Discussão: Considerando que a União Europeia é um mercado aberto no qual os cidadãos detêm igual acesso à utilização de dispositivos médicos, o sistema Português de alertas de segurança sobre estes dispositivos parece ter uma atividade normal. Os alertas de segurança identificados aparentam ser relevantes, com Portugal a registar um número ligeiramente inferior de alertas quando proporcionalmente comparado com outros mercados de maior volume de vendas, o que eventualmente pode ser explicado por uma subnotificação deste tipo de problemas. São necessários estudos adicionais para confirmar estes resultados preliminares, sendo o desenvolvimento de bases de dados sobre o uso de dispositivos médicos pelos doentes recomendado de forma a gerar emails e alertas telefónicos automáticos. Conclusão: Foi identificado um número limitado de alertas de segurança em dispositivos médicos em Portugal, com escassas notificações de contrafação ou falsificação. A Agência Portuguesa de Medicamentos contribui para o acesso dos cidadãos a dispositivos médicos de qualidade, através da emissão de alertas de segurança, recomendações e retirada obrigatória de dispositivos médicos inadequados ou inseguros do mercado.

Factors associated with physical injury or police involvement during incidents of workplace violence in hospitals: Findings from the first year of California's new standard.

BACKGROUND: Workplace violence in healthcare settings is known to be a costly and often underreported problem. In California, hospitals are required to report incidents of violence towards workers to the California Occupational Safety and Health Administration (CalOSHA) using an online reporting system that went into effect in 2017. METHODS: Reports submitted to CalOSHA from July 2017 to September 2018 pursuant to this new requirement were analyzed using descriptive methods and logistic regression. RESULTS: Four hundred eight hospitals submitted reports using the new incident reporting system. Behavioral health units had 1.82 times the odds of the reported incident resulting in physical injury compared to inpatient medical units, and investor-owned facilities had 2.43 times the odds of the reported incident resulting in physical injury compared to city or county-owned facilities. Inpatient and behavioral health units had significantly reduced odds of a reported incident resulting in police involvement when compared to other locations within the hospital. CONCLUSIONS: These findings indicate that protections for healthcare workers deserve ongoing attention from stakeholders and legislators and provide insight into how healthcare facilities report incidents of violence towards workers.

Costs and Effectiveness of Interventions to Reduce Motor Vehicle-Related Injuries and Deaths: Supplement to Tool Documentation.

Motor vehicle crashes account for a large number of deaths and injuries. In the United States, in 2015, more than 35,000 people were killed and approximately 2.44 million were injured in motor vehicle crashes. In 2010, the economic costs associated with motor vehicle crashes in the United States were substantial, estimated to be $242 billion. Fortunately, a wide range of evidence-based interventions, including both policies and programs, can help prevent motor vehicle-related injuries and deaths. In 2014, RAND researchers developed an online tool, the Motor Vehicle Prioritizing Interventions and Cost Calculator for States (MV PICCS), to help determine the costs and effectiveness of various interventions to reduce injuries and deaths from motor vehicle crashes and what interventions together generate the largest reductions in injuries and deaths for a given implementation budget. A 2015 update added two new interventions and produced a series of reports about allocating traffic safety funds. The 2017 update, MV PICCS 3.0, determined whether to add new interventions, updated information on the interventions' effectiveness and costs, and redesigned the tool's user interface to be more user-friendly.

The Science of Gun Policy: A Critical Synthesis of Research Evidence on the Effects of Gun Policies in the United States.

The RAND Corporation's Gun Policy in America initiative is a unique attempt to systematically and transparently assess available scientific evidence on the real effects of firearm laws and policies. Good gun policies require consideration of many factors, including the law and constitutional rights, the interests of various stakeholder groups, and information about the likely effects of different laws or policies on a range of outcomes. This study seeks to provide the third-objective information about what the scientific literature examining gun policy can tell us about the likely effects of laws. The study synthesizes the available scientific data on the effects of various firearm policies on firearm deaths, violent crime, the gun industry, participation in hunting and sport shooting, and other outcomes. By highlighting where scientific evidence is accumulating, the authors hope to build consensus around a shared set of facts that have been established through a transparent, nonpartisan, and impartial review process. In so doing, they also illuminate areas where more and better information could make important contributions to establishing fair and effective gun policies.

Advances in Mexico in the middle of the decade of action for road safety 2011-2020 / Avances en México a la mitad del decenio de acción para la seguridad vial 2011-2020

ABSTRACT OBJECTIVE To analyze the progress towards the accomplishment of the expected goal in the middle of the Decade of Action for Road Safety 2011-2020 in Mexico and its states. METHODS This is a secondary analysis of road traffic deaths in Mexico between 1999 and 2015. We projected the trend for the period 2011-2020 using a time series analysis (autoregressive integrated moving average models). We used the value of the Aikaike Information Criterion to determine the best model for the national level and its 32 states. RESULTS Mexico is progressing, approaching the proposed goal, which translates into 10,856 potentially prevented deaths in the five-year period from 2011 to 2015. This was due to a decrease in the number of deaths of motor vehicle occupants, as the deaths of pedestrians and motorcyclists were higher than expected. At least one third of the states had values below their goal; although the mortality rate remains unacceptably high in five of them. We identified four states with more deaths than those originally projected and other states with an increasing trend; thus, both cases need to strengthen their prevention actions. CONCLUSIONS The analysis can allow us to see the progress of the country in the middle of the Decade of Action, as well as identify the challenges in the prevention of traffic injuries in vulnerable users. It contributes with elements that provide a basis for a need to rethink both the national goal and the goal of the different states.

RESUMEN OBJETIVO Analizar el avance de la meta esperada a mitad del Decenio de Acción para la Seguridad Vial 2011-2020 en México y sus entidades federativas. MÉTODOS Análisis secundario de las muertes por accidentes de tránsito en México para el 1999-2015. Se proyectó la tendencia para el periodo 2011-2020 utilizando análisis de series de tiempo (modelos autorregresivos integrados de medias móviles). Se utilizó el valor del Criterio de Información de Aikaike para determinar el mejor modelo para el nivel nacional y sus 32 entidades federativas. RESULTADOS México va avanzando cercano a la meta propuesta, lo que se ha traducido en 10,856 defunciones potencialmente prevenidas en el quinquenio 2011 a 2015. Esto ha sido a expensas de una disminución en el número de muertes de ocupantes de vehículos de motor; ya que las muertes en peatones y motociclistas han ido por arriba de lo que se esperaba. Al menos una tercera parte de las entidades federativas tuvo el número de defunciones por debajo de su meta; aunque en cinco de ellas la tasa de mortalidad continúa inaceptablemente alta. Se identificaron cuatro entidades con más muertes que las proyectadas originalmente y otras con tendencia al incremento donde se requiere, para ambos casos, fortalecer las acciones de prevención. CONCLUSIONES El análisis realizado permite observar los avances del país a mitad del Decenio de Acción, así como identificar los retos en materia de prevención de lesiones causadas por el tránsito en usuarios vulnerables. Aporta elementos para soportar la necesidad de replantear tanto la meta nacional como la de las distintas entidades federativas.

The impact of child safety restraint legislation on child injuries in police-reported motor vehicle collisions in British Columbia: An interrupted time series analysis.

BACKGROUND/OBJECTIVE: Motor vehicle collisions (MVCs) remain a leading cause of death and serious injury in Canadian children. In July 2008, British Columbia introduced child safety seat legislation that aimed to reduce the number of children killed or injured in MVCs. This legislation upgraded previous child seat legislation (introduced in 1985) and affected children zero to three and those four to eight years of age. The objective of the present study was to evaluate the effectiveness of this legislation. METHODS: Deidentified police reports for all MVCs involving zero- to 14-year-olds (2000 to 2012) were used to compare injury rates, booster seat use, and seating position among children before and after booster seat laws. An interrupted time series design was used to estimate the effect of the new law on injuries among children zero to three and four to eight years of age. Estimates were adjusted using children nine to 14 years of age as controls. RESULTS: The booster seat law was associated with a 10.8% (95% CI 2.7% to 18.9%) reduction in the monthly rate of injuries in four- to eight-year-old children (P=0.01). This was equivalent to a decrease of 14.3 injuries per 1,000,000 children. Similarly, the monthly injury rate among children zero to three years of age decreased by 13.0% (95% CI 1.5% to 24.6% [9.8 injuries per 1,000,000]; P=0.03). CONCLUSION: The results provide evidence that British Columbia's new child safety restraint law was associated with fewer injuries among children covered by the new laws.

HISTORIQUE ET OBJECTIF: Les accidents de voiture (AdV) demeurent une importante cause de décès et de graves blessures chez les enfants du Canada. En juillet 2008, la Colombie-Britannique a adopté une loi sur les dispositifs de retenue d'enfant afin de réduire le nombre d'enfants tués ou blessés dans des AdV. Cette loi, qui améliore la loi antérieure sur les sièges d'auto pour enfant (adoptée en 1985), touche les enfants de zéro à trois ans et de quatre à huit ans. La présente étude visait à en évaluer l'efficacité. MÉTHODOLOGIE: Les chercheurs ont utilisé les rapports de police dépersonnalisés de tous les AdV touchant des enfants de zéro à 14 ans (entre 2000 et 2012) pour comparer le taux de blessures, l'utilisation du siège rehausseur et la position assise chez les enfants avant et après l'adoption des lois sur les sièges rehausseurs. Ils ont utilisé une méthodologie chronologique interrompue pour évaluer l'effet de la nouvelle loi sur les blessures chez les enfants de zéro à trois ans et de quatre à huit ans. Ils ont rajusté ces évaluations à l'aide de sujets témoins de neuf à 14 ans. RÉSULTATS: La loi sur les sièges rehausseurs s'associait à une réduction de 10,8 % (95 % IC 2,7 % à 18,9 %) du taux mensuel de blessures chez les enfants de quatre à huit ans (P=0,01). Ce pourcentage correspondait à une diminution de 14,3 blessures sur 1 000 000 d'enfants. De même, le taux de blessures mensuelles chez les enfants de zéro à trois ans a diminué de 13,0 % (95 % IC 1,5 % à 24,6 % [9,8 blessures sur 1 000 000 d'enfants]; P=0,03). CONCLUSION: Les résultats démontrent que la nouvelle loi sur les dispositifs de retenue d'enfant adoptée en Colombie-Britannique s'associe à une diminution des blessures chez les enfants touchés par cette loi.

Pharmacovigilance in Europe: Place of the Pharmacovigilance Risk Assessment Committee (PRAC) in organisation and decisional processes.

The new European legislation that came into force in July 2012 reinforced the organisation of pharmacovigilance by setting up a committee in charge of risk assessment for medicines, the Pharmacovigilance Risk Assessment Committee (PRAC). The PRAC has a remit covering the assessment of all aspects of the safety and the risk management of medicinal products for human use in the European Union. It deals with issues regarding pharmacovigilance signals, the periodic evaluation of benefit/risk reports from marketing authorization holders (MAH), risk management plans, post-marketing studies, variations or renewals of marketing authorisations, management of under surveillance drugs lists, inspections for pharmacovigilance reasons and audits of pharmacovigilance systems. The PRAC works with the pharmacovigilance systems of the European Member States, which draw up evaluation reports. These evaluations are circulated and discussed by Member States so as to issue recommendations, which serve as a basis for other European medicines committees, the Committee for Medicinal Products for Human Use (CHMP) or the Coordination Group for Mutual Recognition and Decentralised Procedures-Human (CMDh) which then give their opinion. The final decision, which applies to all Member States and to the concerned MAH, lies with the European Commission (EC). This decisional procedure thus rests on coordination involving the PRAC, the CHMP, the CMDh, the EC, the Member States and the pharmaceutical companies. In the 3 years from July 2012, the PRAC has processed nearly 4500 procedures and is still facing an increasing workload.

The administration of probiotics and synbiotics in immune compromised adults: is it safe?

This study aimed to systematically evaluate safety of probiotics and synbiotics in immune compromised adults (≥18 years). Safety was analysed using the Common Terminology Clinical Adverse Events (CTCAE version 4.0) classification, thereby providing an update on previous reports using the most recent available clinical data (2008-2013). Safety aspects are represented and related to number of participants per probiotic strain/culture, study duration, dosage, clinical condition and selected afflictions. Analysis of 57 clinical studies indicates that probiotic and/or synbiotic administration in immune compromised adults is safe with regard to the current evaluated probiotic strains, dosages and duration. Individuals were considered immune compromised if HIV-infected, critically ill, underwent surgery or had an organ- or an autoimmune disease. There were no major safety concerns in the study, as none of the serious adverse events (AE)s were related, or suspected to be related, to the probiotic or synbiotic product and the study products were well tolerated. Overall, AEs occurred less frequent in immune compromised subjects receiving probiotics and/or synbiotics compared to the control group. In addition, the results demonstrated a flaw in precise reporting and classification of AE in most studies. Furthermore, generalisability of conclusions are greatly limited by the inconsistent, imprecise and potentially incomplete reporting as well as the variation in probiotic strains, dosages, administration regimes, study populations and reported outcomes. We argue that standardised reporting on adverse events (CTCAE) in 'food' studies should be obligatory, thereby improving reliability of data and re-enforcing the safety profile of probiotics.

Explaining Chile's traffic fatality and injury reduction for 2000-2012.

OBJECTIVES: The objective of the current study is to determine the contribution of Chile's 2005 traffic law reform, police enforcement, and road investment infrastructure to the reduction of traffic fatalities and severe injuries from 2000 to 2012. METHODS: Analyses based on structural equation models were carried out using a unique database merging aggregate administrative data from several Chilean public institutions. The sample was balanced (13 regions, over 13 years; N=169). Dependent variables were rates of traffic fatality (total, drivers, passengers, and pedestrians), severe injuries, and total number of crashes per vehicle fleet. Independent variables were (1) traffic law reform, (2) police enforcement, and (3) road infrastructure investment. Oil prices, alcohol consumption, proportion of male population 15-24 years old, unemployment, years' effects and regions' effects, and lagged dependent variables were entered as control variables. RESULTS: Empirical estimates from the structural equation models suggest that the enactment of the traffic law reform is significantly associated with a 7% reduction of pedestrian fatalities. This association is entirely mediated by the positive association the law had with increasing police enforcement and reducing alcohol consumption. In turn, police enforcement is significantly associated with a direct decrease in total fatalities, driver fatalities, passenger fatalities, and pedestrian fatalities by 17%, 18%, 8%, and 60%, respectively. Finally, road infrastructure investment is significantly associated with a direct reduction of 11% in pedestrian fatalities, and the number of total crashes significantly mediates the effect of road infrastructure investment on the reduction of severe injuries. Tests of sensitivity indicate these effects and their statistical significance did not vary substantively with alternative model specifications. CONCLUSIONS: Results suggest that traffic law reform, police enforcement, and road infrastructure investment have complex interwoven effects that can reduce both traffic fatalities and severe injuries. Though traffic reforms are ultimately designed to change road user behaviors at large, it is also important to acknowledge that legislative changes may require institutional changes--that is, intensification of police enforcement--and be supported by road infrastructure investment, in order to effectively decrease traffic fatalities and injuries. Furthermore, depending on how road safety measures are designed, coordinated, and implemented, their effects on different types of road users vary. The case of Chile illustrates how the diffusion of road safety practices globally promoted by the World Health Organization and World Bank, particularly in 2004, can be an important influence to enhance national road safety practices.

Probiotic and synbiotic safety in infants under two years of age.

In this study, we systematically evaluated safety aspects in clinical trials with probiotics and synbiotics in young infants (0-2 years of age). This study is an update of earlier reports and covers the recent literature from 2008-2013. The safety evaluation is performed along the Common Terminology Clinical Adverse Events (CTCAE) version 4.0 scale, hereby also providing guidance for future studies. Safety aspects are represented and related to number of participants per probiotic strain/culture, study duration, dosage, clinical condition and selected afflictions. The results show a deficiency in the precise reporting and classification of adverse events in most studies. Analysis of 57 clinical trials with probiotics and synbiotics in combination with eight follow-up studies indicate that probiotic administration to infants between 0 and 24 months is safe with regard to the evaluated strains in infants with a particular health status or susceptibility. Most adverse events and serious adverse events were considered unrelated to the study product, and there were no major safety concerns. Almost all studies concluded that none of the adverse effects were related to the study product; the study products are generally well tolerated. Finally, inconsistent, imprecise and potentially incomplete reporting as well as the variation in probiotic strains, dosages, administration regimes, study populations and reported outcomes, greatly limit the generalizability of conclusions and argue convincingly for obligatory and standardised behaviour on adverse events (CTCAE) reporting in 'food' studies.