Certains médicaments agissant sur le système nerveux central ont comme particularité d'entraîner parfois des troubles de l'abus et de la dépendance. Ces effets indésirables sont étudiés avant la mise sur le marché du médicament, lors des essais cliniques et non cliniques. Cependant, l'abus est un phénomène plurifactoriel, influencé par des facteurs liés à la substance, individuels et environnementaux. Ces déterminants ne peuvent pas être pris en compte avant la mise sur le marché du médicament et rendent essentielle la surveillance de l'abus de médicaments après la mise sur le marché, par l'intermédiaire notamment d'études pharmacoépidémiologiques. Une surveillance efficace de l'abus de médicament implique de comprendre les déterminants de l'abus et ses mécanismes sous-jacents. L'objectif de ce travail de thèse est donc d'analyser des déterminants de l'abus en utilisant des approches pharmacoépidémiologiques. Le premier travail a été d'établir un état des lieux des systèmes de surveillance de l'abus de médicaments en France et à l'étranger (publication n°1). Nous avons par la suite utilisé une enquête en population auprès des patients fréquentant des centres de soins spécialisés pour les usagers de drogues, afin d'étudier l'impact de la mise sur le marché de génériques de la Buprénorphine Haut Dosage (BHD) sur l'abus de BHD (publication n°2). Cette étude nous a permis d'analyser l'influence de la formulation sur l'abus de médicaments. L'exploration de la localisation géographique comme déterminant de l'abus n'a jamais été réalisée en France. / Some central nervous system medications sometimes lead to abuse or dependence. These adverse effects are assessed using premarketing studies such as clinical trials and non clinical studies. However, abuse is influenced by many factors, substance-related, individual and environmental. These factors could not be taken into account in premarketing studies. Thus, postmarketing surveillance of prescription drug abuse, using in particular pharmacoepidemiologic studies is essential. An efficient postmarketing surveillance requires the comprehension of abuse-related factors and underlying mechanisms. The purpose of this work was to analyse prescription drug abuse factors using pharmacoepidemiological approaches. The first part of this work was an overview of postmarketing surveillance systems dedicated to prescription drug abuse in France and in foreign countries (publication n°1). Then, we used a survey in population of patients seen in care centres dedicated to drug users in order to assess the impact of buprenorphine maintenance generic introduction on buprenorphine maintenance abuse (publication n°2). This study allows to observe the influence of the formulation on prescription drug abuse. The factors related to geographic area have never been explored in France, at our knowledge. Therefore, we studied geographic variations of prescription opioid abuse in three regions of southern France, Provence-Alpes-Côte d'Azur-Corse, Rhône-Alpes and Midi-Pyrénées using a pharmacoepidemiologic approach based on prescription drug reimbursement database, the doctor shopping method (publication n°3).

Background: Drug interactions resulting in adverse drug reactions (ADRs) represent a major health problem both for individuals and society in general. Post-marketing pharmacovigilance reporting databases with compiled individual case safety reports (ICSRs) have been shown to be particularly useful in the detection of novel drug - ADR combinations, though these reports have not been fully used to detect adverse drug interactions. Aim: To explore the potential to identify drug interactions using ICSRs and to develop a method to facilitate the detection of adverse drug interaction signals in the WHO Global ICSR Database, VigiBase. Methods: All six studies included in this thesis are based on ICSRs available in VigiBase. Two studies aimed to characterise drug interactions reported in VigiBase. In the first study we examined if contraindicated drug combinations (given in a reference source of drug interactions) were reported on the individual reports in the database, and in the second study we examined the scientific literature for interaction mechanisms for drug combinations most frequently co-reported as interacting in VigiBase. Two studies were case series analyses where the individual reports were manually reviewed. The two remaining studies aimed to develop a method to facilitate detection of novel adverse drug interactions in VigiBase. One examined what information (referred to as indicators) was reported on ICSRs in VigiBase before the interactions became listed in the literature. In the second methodological study, logistic regression was used to set the relative weights of the indicators to form triage algorithms. Three algorithms (one completely data driven, one semi-automated and one based on clinical knowledge) based on pharmacological and reported clinical information and the relative reporting rate of an ADR with a drug combination were developed. The algorithms were then evaluated against a set of 100 randomly selected case series with potential adverse drug interactions. The algorithm’s performances were then evaluated among DDAs with high coefficients. Results: Drug interactions classified as contraindicated are reported on the individual reports in VigiBase, although they are not necessarily recognised as interactions when reported. The majority (113/123) of drug combinations suspected for being responsible for an ADR were established drug interactions in the literature. Of the 113 drug interactions 46 (41%) were identified as purely pharmacodynamic; 28 (25%) as pharmacokinetic; 18 (16%) were a mix of both types and for 21 (19%) the mechanism have not yet been identified. Suspicions of a drug interaction explicitly noted by the reporter are much more common for known adverse drug interactions than for drugs not known to interact. The clinical evaluation of the triage algorithms showed that 20 were already known in the literature, 30 were classified as signals and 50 as not signals. The performance of the semi-automated and the clinical algorithm were comparable. In the end the clinical algorithm was chosen. At a relevant level, 38% were of the adverse drug interactions were already known in the literature and of the remaining 80% were classified as signals for this algorithm. Conclusions: This thesis demonstrated that drug interactions can be identified in large post-marketing pharmacovigilance reporting databases. As both pharmacokinetic and pharmacodynamic interactions were reported on ICSRs the surveillance system should aim to detect both. The proposed triage algorithm had a high performance in comparison to the disproportionality measure alone.

Post-marketing surveillance refers to any non-experimental or observational study, method, or monitoring strategy that is applied to obtain information on drug experience (primarily adverse) after a drug has been approved for clinical use. One of the major problems in post-marketing surveillance studies is the lack or under-reporting of drug experiences by health care professionals. This study was developed to describe the impact of three different prescription event monitoring programmes on the reporting of adverse drug reactions (ADR's) in the hospital situation. The intensive ADR monitoring programme and two voluntary ADR monitoring programmes which followed were conducted in the medical wards of an urban teaching and referral hospital. All patients admitted to the designated wards were monitored by a dedicated pharmacist in the intensive programme, ward pharmacists in the first voluntary programme and by medical and nursing staff in the second voluntary programme. The pharmacist monitored a cohort of patients prospectively in two medical wards for a period of three months. The patient's record was linked with any suspected ADR. All details, i.e. patient drug orders, characteristics and ADR description, were recorded and then reported. From 228 patients monitored, 25 cases have been reported. The impact of the intensive ADR monitoring programme was a reporting rate of 11 percent. Reports were received on ADR's of a particularly mild, common and pharmacologically predictable (type A) nature. The first voluntary ADR monitoring programme comprised the reporting of suspected AD R's and the recording of drug orders for the patients and the patient characteristics. The ward pharmacists monitored for suspected AD R's in all patients during their regular ward rounds. Six cases were reported in a population of 1506 patients monitored during the three months. The reports were mainly on moderate to severe suspected AD R's of pharmacologically unpredictable (type B) nature. The rate of reports received by the surveillance unit in this study was 4 reports per ward pharmacist per annum. The second voluntary ADR monitoring programme comprised the prospective monitoring of 1555 patients by medical and nursing staff during their stay at the designated medical wards during the three month period. Patients were monitored for any ADR and when an ADR was suspected, the patient characteristics and drug orders were recorded and reported to the surveillance unit. Ten cases were reported represented by six reports from doctors and four by sisters. The reporting rate was 2 reports per doctor in four years and 3 reports for each member of the nursing team in 5 years. Reports were mainly received on moderate to severe suspected ADR's of a pharmacologically unpredictable (type B) nature.

Introdução Sabe-se que a cadeia do produto farmacêutico é extensa, ampla, dinâmica e que é influenciada constantemente por diversos campos da sociedade. O estudo do risco envolvido em todo o ciclo de produtos farmacêuticos (da produção à pós-comercialização) é relevante diante das incertezas proporcionadas pela Ciência. A criação do SUS, os escândalos da falsificação de medicamentos, a consequente instauração da CPI dos medicamentos, o controle social, a implantação da Política de Medicamentos, o surgimento dos medicamentos genéricos, o advento da Anvisa e todo arcabouço legal advindo destas transformações deram força à democratização do País e a transparência da Gestão Pública. Objetivo Avaliar artigos científicos nacionais sobre aspectos da Vigilância Sanitária de Medicamentos a partir da criação do SUS (1990) até 2011. Métodos Pesquisa nas bases de dados: Lilacs, PubMed/Medline, Embase, Ipha, Web of Science e Scopus e seleção de artigos relacionados à Vigilância Sanitária de Medicamentos publicados entre 1990 e 2011. Resultados e Discussão - A esfera nacional das ações de Vigilância Sanitária foi a de maior foco de estudo (55,83 por cento ). O eixo Produção foi o mais pesquisado (50,92 por cento ) e a categoria mais estudada foi Prescrição e Dispensação (15,34 por cento ). É preocupante o reduzido número de artigos sobre Distribuição, Transporte e Armazenamento Os medicamentos de maior interesse para estudo foram os fitoterápicos (29,41 por cento ). Os autores da região Sudeste do Brasil foram os que mais publicaram (56,44 por cento ). Este fato pode estar relacionado à concentração econômica-industrial e a presença de pólos acadêmico-tecnológicos avançados nesta região geopolítica brasileira. Conclusão- A análise dos achados, opiniões e conclusões de diversos autores distribuídos pelo Brasil mostrou a ausência de qualidade, eficácia e segurança de alguns medicamentos disponíveis no mercado com inerente risco ao paciente / Introduction It is known that the pharmaceutical chain is long, wide, dynamic and constantly that is influenced by many fields of the society. The study of the risk involved in the whole cycle of pharmaceutical products (from production to post-marketing) is relevant in view of the uncertainties provided by Science. The creation of the unified health system (SUS), the scandals of counterfeit medicines, the consequent establishment of the the parliamentary inquiry (CPI) on medicines, social control, the implementation of the medicines policy, the emergence of generic medicines, the advent of ANVISA and the whole legal framework arising from these changes gave strength democratization of the country and the transparency of public management. Objective Assess national scientific articles on aspects of the Sanitary Surveillance of Medicines from the creation of the SUS (1990) until 2011. Method Search in databases: Lilacs, PubMed/Medline, Embase, IPHA, Web of Science and Scopus and selection of articles related to Sanitary Surveillance of Medicines published between 1990 and 2011. Results and Discussion - The national level of the tasks belonging to the Sanitary Surveillance was the major focus of the studies (55.83 per cent ). The axis \"Production\" (50.92 per cent ) and the category Prescription and Dispensing (15.34 per cent ) were the most searched. The small number of articles on \"Distribution, Transport and Storage\" is worrying. The authors have published more about herbal medicines (29.41 per cent ). The authors of southeastern Brazil were the most published (56.44 per cent ). This fact may be related to economic concentration and the presence of advanced industrial-academic-technological poles in this Brazilian geopolitics region. Conclusion - The analysis of the findings, opinions and conclusions of several authors throughout Brazil showed the absence of quality, safety and efficacy of some medicines available in the market with inherent risk to the patient

Introdução Sabe-se que a cadeia do produto farmacêutico é extensa, ampla, dinâmica e que é influenciada constantemente por diversos campos da sociedade. O estudo do risco envolvido em todo o ciclo de produtos farmacêuticos (da produção à pós-comercialização) é relevante diante das incertezas proporcionadas pela Ciência. A criação do SUS, os escândalos da falsificação de medicamentos, a consequente instauração da CPI dos medicamentos, o controle social, a implantação da Política de Medicamentos, o surgimento dos medicamentos genéricos, o advento da Anvisa e todo arcabouço legal advindo destas transformações deram força à democratização do País e a transparência da Gestão Pública. Objetivo Avaliar artigos científicos nacionais sobre aspectos da Vigilância Sanitária de Medicamentos a partir da criação do SUS (1990) até 2011. Métodos Pesquisa nas bases de dados: Lilacs, PubMed/Medline, Embase, Ipha, Web of Science e Scopus e seleção de artigos relacionados à Vigilância Sanitária de Medicamentos publicados entre 1990 e 2011. Resultados e Discussão - A esfera nacional das ações de Vigilância Sanitária foi a de maior foco de estudo (55,83 por cento ). O eixo Produção foi o mais pesquisado (50,92 por cento ) e a categoria mais estudada foi Prescrição e Dispensação (15,34 por cento ). É preocupante o reduzido número de artigos sobre Distribuição, Transporte e Armazenamento Os medicamentos de maior interesse para estudo foram os fitoterápicos (29,41 por cento ). Os autores da região Sudeste do Brasil foram os que mais publicaram (56,44 por cento ). Este fato pode estar relacionado à concentração econômica-industrial e a presença de pólos acadêmico-tecnológicos avançados nesta região geopolítica brasileira. Conclusão- A análise dos achados, opiniões e conclusões de diversos autores distribuídos pelo Brasil mostrou a ausência de qualidade, eficácia e segurança de alguns medicamentos disponíveis no mercado com inerente risco ao paciente / Introduction It is known that the pharmaceutical chain is long, wide, dynamic and constantly that is influenced by many fields of the society. The study of the risk involved in the whole cycle of pharmaceutical products (from production to post-marketing) is relevant in view of the uncertainties provided by Science. The creation of the unified health system (SUS), the scandals of counterfeit medicines, the consequent establishment of the the parliamentary inquiry (CPI) on medicines, social control, the implementation of the medicines policy, the emergence of generic medicines, the advent of ANVISA and the whole legal framework arising from these changes gave strength democratization of the country and the transparency of public management. Objective Assess national scientific articles on aspects of the Sanitary Surveillance of Medicines from the creation of the SUS (1990) until 2011. Method Search in databases: Lilacs, PubMed/Medline, Embase, IPHA, Web of Science and Scopus and selection of articles related to Sanitary Surveillance of Medicines published between 1990 and 2011. Results and Discussion - The national level of the tasks belonging to the Sanitary Surveillance was the major focus of the studies (55.83 per cent ). The axis \"Production\" (50.92 per cent ) and the category Prescription and Dispensing (15.34 per cent ) were the most searched. The small number of articles on \"Distribution, Transport and Storage\" is worrying. The authors have published more about herbal medicines (29.41 per cent ). The authors of southeastern Brazil were the most published (56.44 per cent ). This fact may be related to economic concentration and the presence of advanced industrial-academic-technological poles in this Brazilian geopolitics region. Conclusion - The analysis of the findings, opinions and conclusions of several authors throughout Brazil showed the absence of quality, safety and efficacy of some medicines available in the market with inherent risk to the patient

Thesis (Ph. D.)--University of Oklahoma. / Bibliography: leaves 113-119.

Este estudo qualitativo e prospectivo baseou-se em entrevistas com os principais atores do sistema de controle de produtos para a saúde no país. No total 44 profissionais participaram da pesquisa de campo, sendo: 25 representantes do setor regulado, envolvidos predominantemente em áreas de assuntos regulatórios e qualidade, atuantes em empresas do segmento médico-hospitalar, nacionais e multinacionais; 19 profissionais representando o setor regulador, alocados em Brasília ou no Estado de São Paulo, envolvidos com o processo de registro e fiscalização de produtos médicos ou de entidades que produzam, façam uso ou comercializem estes itens. Os entrevistados responderam a quatro questões de referência sobre a função do registro, seu papel na garantia da segurança e eficácia dos produtos para a saúde e a fiscalização pós-comercialização. Os procedimentos éticos vigentes (relativos à pesquisa em seres humanos - RE CNS 196/96) foram observados na condução deste estudo. Todas as entrevistas foram gravadas, assim como o consentimento livre e esclarecido verbal do respectivo entrevistado, expresso através de declaração. Posteriormente, as falas foram transcritas para a análise de opiniões sobre o controle de produtos para a saúde. Os resultados (176 discursos individuais)foram avaliados de acordo com a metodologia do discurso do sujeito coletivo. A fiscalização de boas práticas de fabricação estabelecida pela RDC nº 59/00 é percebida como importante por ambos os setores para a garantia da segurança, qualidade e da eficácia dos produtos médicos. A boa-fé não é uma crença da maioria dos entrevistados, pois há grande desconfiança sobre as informações declaradas pelo setor regulado nos processos de registro de produtos para saúde. A falta de fiscalização no mercado foi enfatizada, bem como de infraestrutura e de conhecimento do setor regulador. A atuação das autoridades sanitárias é sustentada por denúncias do próprio setor regulado. O controle pré-comercialização é visto pelo setor regulado como necessário para liberar o produto médico no mercado e como uma responsabilidade da ANVISA (Agência Nacional de Vigilância Sanitária); entretanto, este não garante a qualidade do produto para a saúde, pois é documental e não há fiscalização eficiente. Os discursos expressam que o sistema atual não cumpre com as diretrizes de vigilância sanitária preconizadas por legislação – de eliminar, diminuir ou prevenir riscos à saúde pública. Os atores deste estudo entendem que a adoção da tecnovigilância é uma boa perspectiva para melhorar o controle de produtos para saúde na pós-comercialização, contando com o comprometimento de todos os envolvidos, inclusive profissionais de saúde e usuários. / This is a qualitative and prospective study based on interviews performed with the main stakeholders of the healthcare products’ regulatory control in Brazil. A total of 44 professionals were involved in the survey: 25 were predominantly employees responsible for regulatory affairs or quality assurance areas in medical device vendors, manufacturers or distributors, including national or multinational companies; 19 were government members responsible for pre-market review and postmarketing surveillance at the vendors or hospitals, located in Brasília or in the state of São Paulo. The participants have answered to four reference questions regarding to the register role, its purpose in assuring the safety and effectiveness of a medical device and the post-market vigilance. The ethical proceedings related to clinical trials in human subjects (Brazilian law RE-CNS 196/96) were followed in the execution of this study. All interviews were recorded, as well as the spoken agreement in participating of the study. Then, the speeches were written to perform the analyses and search for the collective opinions about the medical device controls. The results (176 speeches) were evaluated according to the qualitative methodology of the subject’s collective speech. Both vendors and government participants understand the good manufacturing practices issued by the Brazilian law RDC n. 59/00 as important to maintain the medical devices safety as well as their effectiveness and quality. The majority of the stakeholders surveyed do not trust in the good faith since most of them mistrust the information declared in the register submission by the vendors. During this survey, it was reinforced that there is a lack of infrastructure and expertise in the governing bodies and not enough on-market inspecting. The health authorities often acknowledge the medical devices problems when the vendors themselves denounce. The vendors perceive the model of register as mandatory to marketing clearance under the National Agency of Sanitary Surveillance (ANVISA) responsibility. However, this procedure does not assure the quality of the medical devices as a bureaucratic process not followed by an efficient postmarketing control. The speeches express that the system in place does not guarantee the health surveillance objectives described in the Brazilian laws in accomplishment - eliminate, decrease or prevent risks to public health. The participants of this study feel that the postmarketing surveillance is the main prospective to improve the medical device control, linked with the commitment of all stakeholders, including users and health care professionals.

Este estudo qualitativo e prospectivo baseou-se em entrevistas com os principais atores do sistema de controle de produtos para a saúde no país. No total 44 profissionais participaram da pesquisa de campo, sendo: 25 representantes do setor regulado, envolvidos predominantemente em áreas de assuntos regulatórios e qualidade, atuantes em empresas do segmento médico-hospitalar, nacionais e multinacionais; 19 profissionais representando o setor regulador, alocados em Brasília ou no Estado de São Paulo, envolvidos com o processo de registro e fiscalização de produtos médicos ou de entidades que produzam, façam uso ou comercializem estes itens. Os entrevistados responderam a quatro questões de referência sobre a função do registro, seu papel na garantia da segurança e eficácia dos produtos para a saúde e a fiscalização pós-comercialização. Os procedimentos éticos vigentes (relativos à pesquisa em seres humanos - RE CNS 196/96) foram observados na condução deste estudo. Todas as entrevistas foram gravadas, assim como o consentimento livre e esclarecido verbal do respectivo entrevistado, expresso através de declaração. Posteriormente, as falas foram transcritas para a análise de opiniões sobre o controle de produtos para a saúde. Os resultados (176 discursos individuais)foram avaliados de acordo com a metodologia do discurso do sujeito coletivo. A fiscalização de boas práticas de fabricação estabelecida pela RDC nº 59/00 é percebida como importante por ambos os setores para a garantia da segurança, qualidade e da eficácia dos produtos médicos. A boa-fé não é uma crença da maioria dos entrevistados, pois há grande desconfiança sobre as informações declaradas pelo setor regulado nos processos de registro de produtos para saúde. A falta de fiscalização no mercado foi enfatizada, bem como de infraestrutura e de conhecimento do setor regulador. A atuação das autoridades sanitárias é sustentada por denúncias do próprio setor regulado. O controle pré-comercialização é visto pelo setor regulado como necessário para liberar o produto médico no mercado e como uma responsabilidade da ANVISA (Agência Nacional de Vigilância Sanitária); entretanto, este não garante a qualidade do produto para a saúde, pois é documental e não há fiscalização eficiente. Os discursos expressam que o sistema atual não cumpre com as diretrizes de vigilância sanitária preconizadas por legislação – de eliminar, diminuir ou prevenir riscos à saúde pública. Os atores deste estudo entendem que a adoção da tecnovigilância é uma boa perspectiva para melhorar o controle de produtos para saúde na pós-comercialização, contando com o comprometimento de todos os envolvidos, inclusive profissionais de saúde e usuários. / This is a qualitative and prospective study based on interviews performed with the main stakeholders of the healthcare products’ regulatory control in Brazil. A total of 44 professionals were involved in the survey: 25 were predominantly employees responsible for regulatory affairs or quality assurance areas in medical device vendors, manufacturers or distributors, including national or multinational companies; 19 were government members responsible for pre-market review and postmarketing surveillance at the vendors or hospitals, located in Brasília or in the state of São Paulo. The participants have answered to four reference questions regarding to the register role, its purpose in assuring the safety and effectiveness of a medical device and the post-market vigilance. The ethical proceedings related to clinical trials in human subjects (Brazilian law RE-CNS 196/96) were followed in the execution of this study. All interviews were recorded, as well as the spoken agreement in participating of the study. Then, the speeches were written to perform the analyses and search for the collective opinions about the medical device controls. The results (176 speeches) were evaluated according to the qualitative methodology of the subject’s collective speech. Both vendors and government participants understand the good manufacturing practices issued by the Brazilian law RDC n. 59/00 as important to maintain the medical devices safety as well as their effectiveness and quality. The majority of the stakeholders surveyed do not trust in the good faith since most of them mistrust the information declared in the register submission by the vendors. During this survey, it was reinforced that there is a lack of infrastructure and expertise in the governing bodies and not enough on-market inspecting. The health authorities often acknowledge the medical devices problems when the vendors themselves denounce. The vendors perceive the model of register as mandatory to marketing clearance under the National Agency of Sanitary Surveillance (ANVISA) responsibility. However, this procedure does not assure the quality of the medical devices as a bureaucratic process not followed by an efficient postmarketing control. The speeches express that the system in place does not guarantee the health surveillance objectives described in the Brazilian laws in accomplishment - eliminate, decrease or prevent risks to public health. The participants of this study feel that the postmarketing surveillance is the main prospective to improve the medical device control, linked with the commitment of all stakeholders, including users and health care professionals.

Background: In paediatrics, the limited documentation to guide medication, the lack of suitable dosage forms, and the continuous development in childhood present a scenario where safety of medication is a particular challenge. Aim: To explore reported adverse drug reactions (ADRs) and the challenges in prescribing and administering medicines in paediatrics, in order to identify and suggest areas needing international surveillance within medication safety and improvement in the clinical setting. Methods: Four exploratory studies were conducted. Worldwide reporting of suspected ADRs (individual case safety reports, ICSR) with ages 0-17 years were examined overall. Twenty published case reports and ICSRs for adolescents, who developed a rare and incompletely documented ADR (rhabdomyolysis) during antipsychotic medicine use, were analysed in-depth. Prescribed doses of anti-inflammatory medicines were studied in a UK electronic health record database. Transcribed focus group interviews with 20 registered nurses from four paediatric wards in Sweden were analysed for factors that may promote or hinder safe medication practices. Descriptive statistics, multiple regression, and content analyses were used. Results: Although, skin reactions and anti-infective medicines were most frequently reported, and more reported in paediatric patients than in adults, medication errors and adverse reactions related to psychostimulant medicines were reported with increased frequency during 2005 to February 2010. The in-depth case analysis emphasised the need for increased vigilance following changes in patients’ medicine regimens, and indicated that ICSRs could contribute with clinically valuable information. Prescribed dose variations were associated with type of dosage form. Tablets and capsules were prescribed with a higher dose than liquid dosage forms. Six themes emerged from the interviews: preparation and administration was complex; medication errors caused considerable psychological burden; support from nurse colleagues was highly valued; unfamiliar medication was challenging; clear dose instructions were important; nurses handling medications needed to be accorded higher priority. Conclusions: Age-specific screening of ICSRs and the use of ICSRs to enhance knowledge of ADRs and medication errors need to be developed. Access to age-appropriate dosage forms is important when prescribing medicines to children. To improve medication safety practices in paediatric care, interdisciplinary collaborations across hospitals on national or even global levels are needed.