Report on methods of safety signal generation in paediatrics from pharmacovigilance databases

This deliverable is based on the need to develop and test methods for safety signal detection in children. Signal detection is the mainstay of detecting safety issues, but so far very few groups have specifically looked at children. We developed reference sets for positive and negative drugevent combinations and vaccine-event combinations by a systematic literature review on all combinations. We retrieved the FDA AERS database, the CDC VAERS database and EUDRAVIGILANCE database. In order to analyse the datasets we had a stepwise approach from extraction of data, cleaning (e.g. mapping MedDRA and ATC codes) and transformation into a a common data model that we defined for the spontaneous reporting databases. A statistical analysis plan was created for the testing of methods and we provided some descriptive analyses of the FAERS data. Next steps will be to complete the analyses

Pharmacovigilance and the safety of veterinary medicinal products

Dissertação de Mestrado Integrado em Medicina VeterináriaPharmacovigilance in veterinary medicine has developed considerably in the recent years. The increase in legislation in the area of veterinary medicinal products, as well as the increased awareness of the veterinarian regarding the need to report the adverse events observed during the use of the medicines in the animals in his care, has led to an increase in the number of cases reported at European level. For the preparation of this master's dissertation, a review was made of the existing published references on the subject of pharmacovigilance, namely the legal framework, the requirements for the marketing authorization holder of the veterinary medicinal product as well as for the veterinarian prescribing the medicines to the animals which are under her/his responsibility and treatment. Signal management is currently considered the best way to carry out drug surveillance and it follows a specific methodology. Signal management is the pillar of the future legislation on veterinary medicinal products as well as human medicines. In this study the European pharmacovigilance systems, France, Portugal, Spain, UK, are analysed and compared because although having the same legislative frame, each one has different particularities. There is also a reflection about the underreporting of adverse events by veterinarians and some measures that can improve notification, such as use of new technologies and improvement in the feedback to reporter, among others. Whether as a clinician, as veterinarian working in the pharmaceutical industry as well as in the competent authorities, the veterinary professional is essential in the veterinary pharmacovigilance system, the continuous monitoring of veterinary medicinal products, maintaining the positive benefit-risk balance and in the protection of animal health and food safety.RESUMO - Farmacovigilância e a segurança dos medicamentos veterinários - A farmacovigilância em medicina veterinária tem-se desenvolvido bastante nos últimos anos. O aumento de legislação na área do medicamento veterinário, bem como a maior sensibilização do médico veterinário para a necessidade de reportar os eventos adversos observados aquando da utilização do medicamento veterinário nos animais que estão a seu cuidado, têm resultado num aumento no número de casos reportados a nível europeu. Para a elaboração desta dissertação de mestrado foi feita uma revisão das publicações existentes sobre o assunto da farmacovigilância nomeadamente o enquadramento legal, os requisitos para o titular de autorização de introdução no mercado do medicamento veterinário, bem como para o médico veterinário que prescreve os medicamentos aos animais que tem sob sua responsabilidade e tratamento. Atualmente considera-se que a gestão de sinais é a melhor forma para realizar a vigilância dos medicamentos e esta segue uma metodologia específica. A gestão de sinais dos eventos adversos é o pilar da futura legislação quer do medicamento veterinário, quer do medicamento de uso humano. Neste estudo os sistemas de farmacovigilância europeus, como de Espanha, França, Portugal e Reino Unido, são analisados e comparados, pois tendo como base a mesma moldura legislativa europeia, cada um deles tem as suas particularidades. Também se faz uma reflexão sobre a subnotificação de eventos adversos por parte dos veterinários e algumas medidas que podem melhorar a notificação, como a utilização das novas tecnologias e uma melhoria nas respostas que se dão aos notificantes, entre outras. Seja como médico veterinário clínico, como médico veterinário profissional do sector farmacêutico, bem como membro nas autoridades competentes, a figura do médico veterinário é fundamental no sistema de farmacovigilância veterinária, na monitorização contínua dos medicamentos veterinários, na manutenção do benefício-risco positivo e na proteção da saúde animal e segurança alimentar.N/

Normalizing Spontaneous Reports into MedDRA: some Experiments with MagiCoder

Text normalization into medical dictionaries is useful to support clinical task. A typical setting is Pharmacovigilance (PV). The manual detection of suspected adverse drug reactions (ADRs) in narrative reports is time consuming and Natural Language Processing (NLP) provides a concrete help to PV experts. In this paper we carry on experiments for testing performances of MagiCoder, an NLP application designed to extract MedDRA terms from narrative clinical text. Given a narrative description, MagiCoder proposes an automatic encoding. The pharmacologist reviews, (possibly) corrects, and then validates the solution. This drastically reduces the time needed for the validation of reports with respect to a completely manual encoding. In previous work we mainly tested MagiCoder performances on Italian written spontaneous reports. In this paper, we include some new features, change the experiment design, and carry on more tests about MagiCoder. Moreover, we do a change of language, moving to English documents. In particular, we tested MagiCoder on the CADEC dataset, a corpus of manually annotated posts about ADRs collected from social media

Useful Interplay Between Spontaneous ADR Reports and Electronic Healthcare Records in Signal Detection

Background and Objective: Spontaneous reporting systems (SRSs) remain the cornerstone of post-marketing drug safety surveillance despite their well-known limitations. Judicious use of other available data source

BIG DATA ANALYTICS IN PHARMACOVIGILANCE - A GLOBAL TREND

Big data analysis has enhanced its demand nowadays in various sectors of health-care including pharmacovigilance. The exact definition of big data is not known to many people though it is routinely used by them. Big data refer to immense and voluminous computerized medical information which are obtained from electronic health records, administrative data, registries related to disease, drug monitoring, etc. This data are usually collected from doctors and pharmacists in a health-care facility. Analysis of big data in pharmacovigilance is useful for early raising of safety alerts, line listing them for signal detection of drugs and vaccines, and also for their validation. The present paper is intended to discuss big data analytics in pharmacovigilance focusing on global prospect and domestic country-India

Conceptual graph-based knowledge representation for supporting reasoning in African traditional medicine

Although African patients use both conventional or modern and traditional healthcare simultaneously, it has been proven that 80% of people rely on African traditional medicine (ATM). ATM includes medical activities stemming from practices, customs and traditions which were integral to the distinctive African cultures. It is based mainly on the oral transfer of knowledge, with the risk of losing critical knowledge. Moreover, practices differ according to the regions and the availability of medicinal plants. Therefore, it is necessary to compile tacit, disseminated and complex knowledge from various Tradi-Practitioners (TP) in order to determine interesting patterns for treating a given disease. Knowledge engineering methods for traditional medicine are useful to model suitably complex information needs, formalize knowledge of domain experts and highlight the effective practices for their integration to conventional medicine. The work described in this paper presents an approach which addresses two issues. First it aims at proposing a formal representation model of ATM knowledge and practices to facilitate their sharing and reusing. Then, it aims at providing a visual reasoning mechanism for selecting best available procedures and medicinal plants to treat diseases. The approach is based on the use of the Delphi method for capturing knowledge from various experts which necessitate reaching a consensus. Conceptual graph formalism is used to model ATM knowledge with visual reasoning capabilities and processes. The nested conceptual graphs are used to visually express the semantic meaning of Computational Tree Logic (CTL) constructs that are useful for formal specification of temporal properties of ATM domain knowledge. Our approach presents the advantage of mitigating knowledge loss with conceptual development assistance to improve the quality of ATM care (medical diagnosis and therapeutics), but also patient safety (drug monitoring)