Harmonization of individual case safety reports transmission requirements among PAHO reference authorities: a review of their current regulation.

To perform optimal monitoring of the safety profile in the postmarketing phase, Marketing Authorization Holders and National Regulatory Authorities (NRAs) must evaluate the adverse drug reactions (ADRs) that occurred and characterize their nature, frequency, and severity. Management is possible through Individual Case Safety Reports (ICSRs), which are the reports of organized and processed data. Globally, the International Council for Harmonisation (ICH) E2B guideline suggests harmonized activities for the ICSR electronic content and transmission. In America, the Pan American Health Organization (PAHO) is the agency responsible to implement cooperation among its members, which are recognized as National Regulatory Authorities of Reference (NRARs) such as Argentina, Brazil, Canada, Chile, Colombia, Cuba, Mexico, and the United States. PAHO published the 'Good Pharmacovigilance Practices for the Americas' suggesting improvement and harmonization in the region. After reviewing the regulatory framework, it is assumed that all NRARs have a regulated ICSR transmission system (i.e. a systematic vigilance system for collecting, analyzing, and disseminating information from ADRs). However, significant differences exist, such as the requirement for social media vigilance, expedited and non-expedited ICSRs, coding, severity, and transmission. The volume of ICSRs has significantly increased, due to using electronic standards managed by the NRAs, which facilitates early identification of new ADRs, allowing the implementation of novel minimization activities, contributing to the continuous assessment of the benefit-risk balance of medicines. Nevertheless, there is still area for improvement, especially in Latin America.

Transmission of spontaneous adverse drug reactions by industry in countries designated as a reference by the Pan American Health Organization (PAHO): comparison on regulatory requirements This review aims to describe regulatory criteria and compare harmonization across regions that marketing authorization holders must fulfill when transmitting spontaneous adverse drug reactions to the authorities for postmarketing surveillance. It centers on the regulatory requirements of authorities designated as a reference by the PAHO. Consequently, it is important to review the regulatory framework, to evaluate the requirements for transmission and have the context of the current harmonization among these agencies in America. This review contains the minimum criteria for transmission and harmonized guidelines according to the International Council for Harmonisation (ICH) and PAHO. However, identifying the differences is only the first step, future research in harmonization must continue to advance the understanding and establish guidelines that allow a better evaluation of the safety profile of medical products.

Effect of co-cultivation of white and brown rot species on basidiome production, lignocelluloytic enzyme activity and dye decolourisation.

The aim of this work was studying the impact of co-cultivating two mushroom species: a white (Pleurotus albidus CLA 45) and a brown rot one (Laetiporus sulphureus BAFC 205) in substrates based on poplar or pine sawdust, on their lignocellulolytic enzyme production, yield values and basidiomes properties. Laetiporus sulphureus only developed basidiome primordia, but P. albidus monoculture and co-culture in pine sawdust achieved biological efficiencies of up to 50-55 %. Co-cultivation on diverse substrates rendered varied enzyme titers. Laccase and Manganese peroxidase titers were highest in pine co-culture and P. albidus poplar monoculture, respectively. Enzymatic extracts obtained from spent poplar substrate of dual cultures displayed potential for treating non-sterile textile-coloured effluents, achieving 35 % decolourisation after 120 h. The knowledge available on the effects of co-culture of white and brown rot fungi is still limited. This study represents an initial exploration of the interaction between them within intensive cultivation conditions.

Ocular Cyclopentolate: A Mini Review Concerning Its Benefits and Risks.

Cycloplegic and mydriatic agents are essential in ophthalmological clinical practice since they provide the means for diagnosing and treating certain eye conditions. In addition, cyclopentolate has proven to possess certain benefits compared to other available cycloplegics and mydriatics. Still, the incidence of some adverse drug reactions related to this drug, especially in susceptible patients, has created interest in reviewing the literature about the benefits and risks of using cyclopentolate. A literature search was conducted in Medline/PubMed and Google Scholar, focusing on identifying cyclopentolate's benefits and risks; the most important benefit was its usefulness for evaluating refractive errors, especially for hyperopic children, pseudomyopia, anterior uveitis, treatment of childhood myopia, idiopathic vision loss, and during examinations before refractive surgery, with particular advantages compared to other cycloplegics. While the risks were divided into local adverse drug reactions such as burning sensation, photophobia, hyperemia, punctate keratitis, synechiae, and blurred vision, which are relatively frequent but mild and temporary; and systemic adverse drug reactions such as language problems, visual or tactile hallucinations and ataxia, but unlike ocular, systemic adverse drug reactions are rare and occur mainly in patients with risk factors. In addition, six cases of abuse were found. The treatment with cyclopentolate is effective and safe in most cases; nevertheless, special care must be taken due to the potential severe ADRs that may occur, especially in susceptible patients like children, geriatrics, patients with neurological disorders or Down's syndrome, patients with a low blood level of pseudocholinesterase, users of substances with CNS effects, and patients with a history of drug addiction. The recommendations are avoiding the use of 2% cyclopentolate and instead employing solutions with lower concentrations, preferably with another mydriatic such as phenylephrine. Likewise, the occlusion of the nasolacrimal duct after instillation limits the drug's absorption, reducing the risk of systemic adverse events.

Prediction of leptospirosis outbreaks by hydroclimatic covariates: a comparative study of statistical models.

Leptospirosis, the infectious disease caused by a spirochete bacteria, is a major public health problem worldwide. In Argentina, some regions have climatic and geographical characteristics that favor the habitat of bacteria of the Leptospira genus, whose survival strongly depends on climatic factors, enhanced by climate change, which increase the problems associated with people's health. In order to have a method to predict leptospirosis cases, in this paper, five time series forecasting methods are compared: two parametric (autoregressive integrated moving average and an alternative one that allows covariates, ARIMA and ARIMAX, respectively), two nonparametric (Nadaraya-Watson Kernel estimator, one and two kernels versions, NW-1 K and NW-2 K), and one semiparametric (semi-functional partial linear regression, SFPLR) method. For this, the number of cases of leptospirosis registered from 2009 to 2020 in three important cities of northeastern Argentina is used, as well as hydroclimatic covariates related to the presence of cases. According to the obtained results, there is no method that improves considerably the rest and can be recommended as a unique tool for leptospirosis prediction. However, in general, the NW-2 K method gets a better performance. This work, in addition to using a long-term high-quality time series, enriches the area of applications of statistical models to epidemiological leptospirosis data by the incorporation of hydroclimatic variables, and it is recommended directing further efforts in this line of research, under the context of current climate change.

Modeling of leptospirosis outbreaks in relation to hydroclimatic variables in the northeast of Argentina.

The transmission of leptospirosis is conditioned by climatic variables. In northeastern Argentina leptospirosis outbreaks occur mainly in coincidence with periods of abundant precipitation and high hydrometric level. A Susceptible-Infectious-Recovered Epidemiological Model (SIR) is proposed, which incorporates hydroclimatic variables for the three most populated cities in the area (Santa Fe, Paraná and Rosario), during the 2009-2018 period. Results obtained by solving the proposed SIR model for the 2010 outbreak are in good agreement with the actual data, capturing the dynamics of the leptospirosis outbreak wave. However, the model does not perform very well in the last months of the year when isolated cases appear outside the outbreak periods, probably due to non- climatic factors not explicitly considered in the present version of the model. Nevertheless, the dynamic modeling of infectious diseases considering hydroclimatic variables constitutes a climatic service for the public health system, not yet available in Argentina.

Climate change communication by the local digital press in northeastern Argentina: An ethical analysis.

News articles about Climate Change (CC) represent the level of knowledge of the phenomenon by journalists and the public, as well as the value assigned to problems of ethical and transgenerational nature in a given society. Digital articles related to CC released by media from northeast Argentina were reviewed to study how the local digital press addresses the CC in this region as well as the social representation of the news. An analysis of the content of news articles released in the period January 2016-March 2018 was carried out to identify components that explain their social representation. This study shows that local digital media publish articles about regionally important topics. However, news about CC appear mainly when hydroclimatic events occur. Many of the digital media that release CC information are connected to important social sectors in the region, such as agriculture and economics. A difference between national and local media is that the first ones focus on international events while the latter show the regional reality. Our results also show that no exchange or reciprocity mechanism exists among CC stakeholders, such as journalists, academics and decision-makers. Consequently, building new ways to communicate CC remains a challenge. The media together with scientists, and policy-makers, have a fundamental role in showing the ethical value and importance of caring for Nature and our environment, so to leave the best possible world for future generations.

Smoking cessation opportunities in severe mental illness (tobacco intensive motivational and estimate risk - TIMER-): study protocol for a randomized controlled trial.

BACKGROUND: There is an increased risk of premature death in people with severe mental illness (SMI). Respiratory disorders and cardiovascular disease are leading causes of increased mortality rates in these patients, and tobacco consumption remains the most preventable risk factor involved. Developing new tools to motivate patients towards cessation of smoking is a high priority. Information on the motivational value of giving the lung age and prevention opportunities is unknown in this high-risk population. METHODS/DESIGN: This article describes in detail a protocol developed to evaluate an intensive motivational tool, based on the individual risks of pulmonary damage and prevention opportunities. It is designed as a randomized, 12-month, follow-up, multicenter study. A minimum of 204 smokers will be included, aged 40 years and older, all of whom are patients diagnosed with either schizophrenia or bipolar disorder (BD). Chronic obstructive pulmonary disease (COPD) will be evaluated using spirometry, and the diagnosis will then be validated by a pneumologist and the lung age estimated. Based on this value, a motivational message about prevention will be issued for the intervention group, which will be reinforced by individualized text messages over a period of 3 months. The efficacy of the method and the pulmonary damage variables will be evaluated: smoking cessation at the end of follow-up will be confirmed by cooximetry, and the COPD diagnosis and the severity of the staging for disease will be assessed. DISCUSSION: In the context of community care, screening and early detection of lung damage could potentially be used, together with mobile technology, in order to produce a prevention message, which may provide patients with SMI with a better chance of quitting smoking. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT03583203 . Registered on 11 July 2018. Trial status: recruitment.

Presence of Stenoponia tripectinata (Tiraboschi, 1902) (Siphonaptera, Ctenophtalmidae) in murine (Rodentia) from the Canary Islands.

This article reports the geographical and host distribution of the flea Stenoponia tripectinata on the Canary Islands. S. tripectinata is widely distributed throughout the Mediterranean and North Africa as a parasite of Muridae rodents. To date, Gran Canaria is the only island of the archipelago where S. tripectinata had been found. In this report, S. tripectinata has appeared parasitizing 116 specimens of Mus musculus out of a total of 660, and only 2 Rattus rattus of 215 captured. All the trapped Muridae hosts found to be parasitized by S. tripectinata came from humid biotopes. The results showed that S. tripectinata is present on all the western Canary Islands and on one of the eastern islands, Gran Canaria, the only island already reported. The detection of S. tripectinata on El Hierro, La Palma, La Gomera and Tenerife represents the first records of this flea species on those Canary Islands.

New species in the Old World: Europe as a frontier in biodiversity exploration, a test bed for 21st century taxonomy.

The number of described species on the planet is about 1.9 million, with ca. 17,000 new species described annually, mostly from the tropics. However, taxonomy is usually described as a science in crisis, lacking manpower and funding, a politically acknowledged problem known as the Taxonomic Impediment. Using data from the Fauna Europaea database and the Zoological Record, we show that contrary to general belief, developed and heavily-studied parts of the world are important reservoirs of unknown species. In Europe, new species of multicellular terrestrial and freshwater animals are being discovered and named at an unprecedented rate: since the 1950s, more than 770 new species are on average described each year from Europe, which add to the 125,000 terrestrial and freshwater multicellular species already known in this region. There is no sign of having reached a plateau that would allow for the assessment of the magnitude of European biodiversity. More remarkably, over 60% of these new species are described by non-professional taxonomists. Amateurs are recognized as an essential part of the workforce in ecology and astronomy, but the magnitude of non-professional taxonomist contributions to alpha-taxonomy has not been fully realized until now. Our results stress the importance of developing a system that better supports and guides this formidable workforce, as we seek to overcome the Taxonomic Impediment and speed up the process of describing the planetary biodiversity before it is too late.