Improving the Safety of Medicines in the European Union: From Signals to Action.
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ABSTRACT:
SUBMITTER: Potts J
PROVIDER: S-EPMC7027976 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundMedications and their prices are key issues for healthcare. Although access to medicines at affordable prices had been specified as a key objective of the European Health Policy, it seems that these goals have not been achieved. Therefore, we attempted an evaluation of affordability of selected medicines at full prices.MethodsThe analysis concerned 2012 and was conducted between 2013 and 2015 in all the European Union (EU) countries divided into 3 groups depending on the date of their accession to the EU. Finally, we considered 9 originators used in the treatment of schizophrenia and multiple sclerosis. Information on drug prices were collected from pharmacies. Participation in the study was voluntary and anonymous in order to avoid accusations of advertising. To evaluate affordability, several factors were used (e.g. minimum earnings and Gini coefficient). Due to unavailability in some countries, the exact number of analyzed medicines varies.ResultsDrug prices vary significantly between EU Member States. Almost eleven fold difference was observed between Germany (EUR 1451.17) and Croatia (EUR 132.77) in relation to Interferone beta-1a 22 μg. Generally, prices were the highest in Germany. The cheapest drugs were found in various countries but never in the poorest ones like Bulgaria or Romania. Discrepancies in wages were observed too (the smallest minimum wage was EUR 138.00 in Bulgaria and the highest EUR 1801.00 in Luxembourg). Full price of olanzapine 5mg, however, was higher in Bulgaria (EUR 64.53) than, for instance, in Belgium (EUR 37.26).ConclusionsAnalyzed medications are still unaffordable for many citizens of the EU. Besides, access to medicines is also impaired e.g. due to parallel trade. Unaffordability of medications may lead to the patients' non-compliance and therefore to increased direct and indirect costs of treatment. Common European solutions are needed to achieve a real affordability and accessibility of medications.
| S-EPMC5328386 | biostudies-literature
Project description:The recent Regulation (EU) 2019/1381, published on the 6th September 2019, aims to improve the transparency and sustainability of the EU risk assessment in the food chain by amending the General Food Law Regulation (EC 178/2002) and a number of other regulations related to the food sector. This Regulation is introduced as a response to the Fitness Check of the General Food Law Regulation as well as a response to public concerns expressed by a European Citizens' Initiative on glyphosate and pesticides. This article evaluates the amendments introduced by Regulation 2019/1381with respect to the institutional and regulatory environment in the food chain and more specifically concerning the risk assessment procedure. For this purpose, we perform a comparison of the institutional and organizational characteristics of the European Food Safety Authority (EFSA) and European Medicines Agency (EMA) in relation to the processes of risk assessment and risk evaluation, especially the processes surrounding genetically modified foods and pesticides, and how these characteristics affect the politicization of these processes. We conclude that the risk assessment process followed by EFSA would have benefitted and become more effective and less politicized, if the recent Regulation 2019/1381 had introduced some of EMA's institutional structures and methods on risk evaluation.
| S-EPMC7155385 | biostudies-literature
Project description:ObjectivesTo assess the use, and evaluate the usefulness, of non-interventional studies and routinely collected healthcare data in postmarketing assessments conducted by the European Medicines Agency (EMA).DesignWe reviewed and systematically assessed all referrals to the EMA made due to safety or efficacy concerns that were evaluated between 1 January 2013 and 30 June 2017. We extracted information from the assessment report and the referral notification. Two reviewers independently assessed the contribution of non-interventional evidence to decision-making.ResultsThe preliminary evidence leading to the assessment in 52 eligible referrals was mostly from spontaneous reports (cited in 26 of 52 referrals) and randomised trials (22/52). In contrast, many evidence types were used for the full assessment. Non-interventional studies were frequently used in the full assessment for the evaluation of product safety (31/52) and product efficacy (18/52). In particular, non-interventional studies were relied on for the evaluation of safety and efficacy in subgroups, the evaluation of safety relating to a rare adverse event, understanding product usage and misuse and for evaluation of the effectiveness of risk minimisation measures. The most common recommendations were changes to product information (43/52) and marketing authorisation withdrawal or suspension (12/52). In the majority of referrals, non-interventional evidence was judged to contribute to the decision made (30/52) and in three referrals it was the primary source of evidence.ConclusionsEuropean regulatory decision-making relies on multiple evidence types, particularly randomised trials, spontaneous reports and non-interventional studies. Non-interventional studies had an important role particularly for the characterisation and quantification of adverse events, the evaluation of product usage and for evaluating the effectiveness of regulatory action to minimise risk.
| S-EPMC6830614 | biostudies-literature
Project description:The European Medicines Agency (EMA) and national regulators share the responsibility to communicate to healthcare providers postmarketing safety events but little is known about the consistency of this process. We aimed to compare public availability of safety-related communications and drug withdrawals from the EMA and European Union member countries for novel medicines.We performed a cross-sectional analysis using public Dear Healthcare Professional Communications (DHPCs) for all novel medicines authorized between 2001 and 2010 by the EMA and available for use in France, Netherlands, Spain, and the United Kingdom. Between 2001 and 2010, the EMA approved 185 novel medicines. DHPCs could not be ascertained for the EMA. Among the 4 national regulators, as of April 30, 2013, at least one safety DHPC or withdrawal occurred for 53 (28.6%) medicines, totaling 90 DHPCs and 5 withdrawals. Among these 53 medicines, all 4 national agencies issued at least one communication for 17 (32.1%), three of the four for 25 (47.2%), two of the four for 6 (11.3%), and one of the four for 5 (9.4%). Five drugs were reported to be withdrawn, three by all four countries, one by three and one by two. Among the 95 DHPCs and withdrawals, 20 (21.1%) were issued by all 4 national regulators, 37 (38.9%) by 3 of the 4, 22 (23.2%) by 2 of the 4, and 16 (16.8%) by one. Consistency of making publicly available all identified safety DHPC or withdrawal across regulator pairs varied from 33% to 73% agreement.Safety communications were not made publicly available by the EMA. Among the 4 European member countries with national regulators that make DHPCs publicly available since at least 2001, there were substantial inconsistencies in safety communications for novel medicines. The impact of those inconsistencies in terms of public health remains to be determined.
| S-EPMC4204813 | biostudies-other
Project description:This Scoping Review synthesises evidence of the impacts of European Union (EU) law, regulation, and policy on access to medicines in in non-EU low- and middle-income countries (LMICs), and the mechanisms and nature of those impacts. We searched eight scholarly databases and grey literature published between 1995-2021 in four languages. The EU exerts global influence on pharmaceuticals in LMICs in three ways: explicit agreements between EU-LMICs (ex. accession, trade, and economic agreements); LMICs' reliance on EU internal regulation, standards, or methods (ex. market authorisation); 'soft' forms of EU influence (ex. research funding, capacity building). This study illustrates that EU policy makers adopt measures with the potential to influence medicines in LMICs despite limited evidence of their positive and/or negative impact(s). The EU's fragmented internal and external actions in fields related to pharmaceuticals reveal the need for principles for global equitable access to medicines to guide EU policy.
| S-EPMC8513155 | biostudies-literature
Project description:West Nile virus (WNV) and Usutu virus (USUV) circulate in several European Union (EU) countries. The risk of transfusion-transmitted West Nile virus (TT-WNV) has been recognized, and preventive blood safety measures have been implemented. We summarized the applied interventions in the EU countries and assessed the safety of the blood supply by compiling data on WNV positivity among blood donors and on reported TT-WNV cases. The paucity of reported TT-WNV infections and the screening results suggest that blood safety interventions are effective. However, limited circulation of WNV in the EU and presumed underrecognition or underreporting of TT-WNV cases contribute to the present situation. Because of cross-reactivity between genetically related flaviviruses in the automated nucleic acid test systems, USUV-positive blood donations are found during routine WNV screening. The clinical relevance of USUV infection in humans and the risk of USUV to blood safety are unknown.
| S-EPMC6537739 | biostudies-literature
Project description:An audit of 143 surgical admissions showed that only 30% of general surgery and urology patients have complete medication charts on the day of surgery prior to going to theatre, compared to 94% of orthopaedic patients. This was despite having been seen previously in the pre-operative assessment clinic (POAC). These patients went to the wards post-operatively, where many then missed doses of their life-sustaining medications. Orthopaedic patients see a prescribing pharmacist in POAC who undertakes medicines reconciliation; this is performed by junior doctors for surgical patients. We designed three interventions to improve drug chart completion by junior doctors, and gathered prospective data for 22 weeks in the POAC. We also recorded attendance of junior doctors in the POAC and reasons for absence. Daily and weekly percentages of drug chart completion were plotted on a run chart. The baseline completion rate was 43%. This rose to 45% after the first and second interventions, and 51% after the third intervention. However, the completion rate remained markedly below our target of 94%. Junior doctors attended only 44% of POACs. They reported being "too busy to attend" 41% of the time, and could not be contacted on 11% of occasions. Junior doctors reported that they were unable to attend to both unwell inpatients and the POAC, the latter seeming less of a priority. This was despite a rota allocating doctors to attend POAC sessions free from clinical or teaching commitments. We were unable to increase the rate of drug chart completion with the resources available. We therefore recommend the employment of prescribing pharmacists in the POAC for general surgery and urology patients.
| S-EPMC4949617 | biostudies-literature
Project description:IntroductionSequence-based typing of hepatitis A virus (HAV) is important for outbreak detection, investigation and surveillance. In 2013, sequencing was central to resolving a large European Union (EU)-wide outbreak related to frozen berries. However, as the sequenced HAV genome regions were only partly comparable between countries, results were not always conclusive.AimThe objective was to gather information on HAV surveillance and sequencing in EU/European Economic Area (EEA) countries to find ways to harmonise their procedures, for improvement of cross-border outbreak responses.MethodsIn 2014, the European Centre for Disease Prevention and Control (ECDC) conducted a survey on HAV surveillance practices in EU/EEA countries. The survey enquired whether a referral system for confirming primary diagnostics of hepatitis A existed as well as a central collection/storage of hepatitis A cases' samples for typing. Questions on HAV sequencing procedures were also asked. Based on the results, an expert consultation proposed harmonised procedures for cross-border outbreak response, in particular regarding sequencing. In 2016, a follow-up survey assessed uptake of suggested methods.ResultsOf 31 EU/EEA countries, 23 (2014) and 27 (2016) participated. Numbers of countries with central collection and storage of HAV positive samples and of those performing sequencing increased from 12 to 15 and 12 to 14 respectively in 2016, with all countries typing an overlapping fragment of 218 nt. However, variation existed in the sequenced genomic regions and their lengths.ConclusionsWhile HAV sequences in EU/EEA countries are comparable for surveillance, collaboration in sharing and comparing these can be further strengthened.
| S-EPMC6636214 | biostudies-literature
Project description:Human enteroviruses have traditionally been typed according to neutralization serotype. This procedure is limited by the difficulty in culturing some enteroviruses, the availability of antisera for serotyping, and the cost and technical complexity of serotyping procedures. Furthermore, the impact of information derived from enterovirus serotyping is generally perceived to be low. Enteroviruses are now increasingly being detected by PCR rather than by culture. Classical typing methods will therefore no longer be possible in most instances. An alternative means of enterovirus typing, employing PCR in conjunction with molecular genetic techniques such as nucleotide sequencing or nucleic acid hybridization, would complement molecular diagnosis, may overcome some of the problems associated with serotyping, and would provide additional information regarding the epidemiology and biological properties of enteroviruses. We argue the case for developing a molecular typing system, discuss the genetic basis of such a system, review the literature describing attempts to identify or classify enteroviruses by molecular methods, and suggest ways in which the goal of molecular typing may be realized.
| S-EPMC121380 | biostudies-literature
Project description:BACKGROUND AND AIMS:The World Health Organization recommends increasing alcohol taxes as a 'best-buy' approach to reducing alcohol consumption and improving population health. Alcohol may be taxed based on sales value, product volume or alcohol content; however, duty structures and rates vary, both among countries and between beverage types. From a public health perspective, the best duty structure links taxation level to alcohol content, keeps pace with inflation and avoids substantial disparities between different beverage types. This data note compares current alcohol duty structures and levels throughout the 28 European Union (EU) Member States and how these vary by alcohol content, and also considers implications for public health. DESIGN AND SETTING:Descriptive analysis using administrative data, European Union, July 2018. MEASUREMENTS:Beverage-specific alcohol duty rates per UK alcohol unit (8 g ethanol) in pounds sterling at a range of different alcoholic strengths. FINDINGS:Only 50% of Member States levy any duty on wine and several levy duty on spirits and beer at or close to the EU minimum level. There is at least a 10-fold difference in the effective duty rate per unit between the highest- and lowest-duty countries for each beverage type. Duty rates for beer and spirits stay constant with strength in the majority of countries, while rates for wine and cider generally fall as strength increases. Duty rates are generally higher for spirits than other beverage types and are generally lowest in eastern Europe and highest in Finland, Sweden, Ireland and the United Kingdom. CONCLUSIONS:Different European Union countries enact very different alcohol taxation policies, despite a partially restrictive legal framework. There is only limited evidence that alcohol duties are designed to minimize public health harms by ensuring that drinks containing more alcohol are taxed at higher rates. Instead, tax rates appear to reflect national alcohol production and consumption patterns.
| S-EPMC6771486 | biostudies-literature