Risk minimization measures (RMMs) are interventions intended to mitigate or prevent the occurrence of adverse reactions associated with medications. Having consistent measures across regulatory ...bodies (i.e., the Saudi Food and Drug Authority (SFDA), the United States Food and Drug Administration (US FDA), and the European Medicines Agency (EMA)) benefits medication use and safety and ultimately the patient.
This study aimed to investigate whether there is variability in these published RMMs between the three regulatory bodies.
A specific data collection form was created to extract information from the SFDA’s RMM list, US FDA’s Risk Evaluation and Mitigation Strategy (REMS) list, and EMA’s Risk Management Plan (RMP) list, as of February 2022 all RMMs that were available on the websites were reviewed. Medications with the same trade name were matched across regulators, and unmatched medications were checked for approval status. For medication groups such as NSAIDs in the SFDA’s RMM list, they were matched by searching for the groups individually in the regulatory websites. All risks and types of minimizing measures were compared.
A total of 317 medications were retrieved from the SFDA’s RMM list. The majority of medication classes were immunosuppressants (n = 60), antihypertensive (n = 33), and oncology medication (n = 29). There were only 62 medications with REMS from the US FDA website, a total of 14 medications were approved by the SFDA, and only nine medications were matched with the SFDA’s RMM list. Also, there were 828 medications with RMP from the EMA website, a total of 334 has RMM, 128 are approved by the SFDA, and 71 matched with the SFDA’s RMM list. Furthermore, seven medications were matched between SFDA, US FDA and EMA. After content review, four medications had similar risks and measures across the regulators and three medications had different risks and measures across the regulators. For the medication groups, a total of 36 groups were in the SFDA’s list, 18 groups were matched with the US FDA, and 14 were matched with the EMA.
Our study showed substantial differences among the regulatory authorities regarding RMMs. Harmony in published risk measures can have a significant impact on medication safety.
Using hedonic methods, we examine how chemical accidents at industrial facilities impact home values. The study focuses on facilities regulated by the U.S. Environmental Protection Agency’s Risk ...Management Plan (RMP) program, which is in place to reduce the risk of harm to offsite populations from accidental chemical fires, explosions, and releases of toxic vapors. RMP facility and accident data were linked to residential transactions in Michigan, Ohio, and Pennsylvania. To facilitate causal inference, alternative difference-in-differences and triple differences models are estimated, where we compare homes near and far, and before and after, an accident; as well as homes near facilities where an accident did and did not occur. We find that the typical accident does not generally affect home values, but accidents resulting in offsite injuries, property damage, evacuations, or shelter-in-place orders lead to a 5% to 8% decrease in the value of homes within five kilometers; suggesting an average loss of $12,000 to $20,000. The benefits of policies that help avoid these impacts are particularly relevant from an environmental justice standpoint. Proximity to an RMP facility, irrespective of any incidents, is associated with significantly lower home values. Existing inequities are exacerbated by chemical accidents that impact offsite populations.
•Hedonic study of home price impacts from chemical accidents at industrial sites.•Focus on MI, OH, and PA sites regulated by US EPA's Risk Management Plan program.•Implement alternative difference-in-differences and triple difference comparisons.•Find home values decline by 5–8% from accidents that impact nearby communities.•Existing inequities are exacerbated by these accidents.
Introduction: Risk Management Plans (RMPs) aim to optimize a medicinal product's benefit/risk balance for the individual patient and the target population. Despite differences in regulatory RMP ...requirements between jurisdictions worldwide, their ultimate aim is to protect public health.
Areas covered: The review presents findings of different RMP requirements by different regulatory authorities and additional risk minimization measures (issued between January 2010 and December 2018) indicate how RMPs and additional risk minimization measures translate into actions to protect public health within the European Union (EU) member states and worldwide. Areas covered also include the different International Council for Harmonization (ICH) regional requirements of RMPs by the different regulatory authorities as well as data regarding the number of RMP assessments carried out by the EMA, FDA and Japan, and number of safety communications issued in Malta (taken as an example of a typical small EU member state) and in the United States of America (USA).
Expert opinion: The EU legislation adopted in 2010 required RMPs to be included in all new applications for medicinal products in the EU, both for EU centrally authorized and nationally authorized medicinal products. Lessons learnt by EU regulators during this process are discussed in this review.
The flood risk management plan challenges both water engineers and spatial planners. It calls for a new mode of governance for flood risk management. This contribution analyses how this mode of ...governance distinguishes from prevalent approaches. Spatial planning and water management in Europe are explored in terms of their actor relation, their institutional context, and their approach to the object. These three characteristics of the modes of governance are compared with the governance requirements that flood risk management demands. It is concluded that the governance of flood risk management in Europe should strike a balance between comprehensive and hierarchical planning on the one hand, and interactive planning on the other hand, leading to a spatial water governance.
The pharmacovigilance system plays one of the key roles in ensuring safety and efficacy of medicine use. The risk management process helps to ensure the most favourable benefit/risk ratio of a ...medicine or combination of medicines both for the target populations and the general public. Unavailability of a risk management process for medicines may adversely affect the health of the general population. One of the major documents in medicine risk management is the risk management plan (RMP).
The aim of the study
was to analyse compliance of RMPs submitted as part of registration dossiers with the requirements of the Eurasian Economic Union (EAEU), and to analyse problems arising during their preparation.
Materials and methods
: the authors analysed 200 RMPs submitted from January 1 until August 31, 2021.
Results
: it was determined that the most frequent mistakes made by pharmacovigilance officers are related to medicine summaries in RMPs covering several medicines, medicine safety specification parts of RMPs, description of risks in the pharmacovigilance plan and description of risk minimisation measures, and insufficient representation of the key elements of the medicine efficacy and safety overview in the RMP summary. For instance, RMPs often lack information on the epidemiology of indications for target populations in the EAEU, or RMPs may lack some of the major risks reflected in the patient information leaflets, or lack assessment of safety risk minimisation actions, etc.
Conclusions
: proper preparation of RMPs that would comply with the EAEU Good Pharmacovigilance Practice is inconceivable without further professional training of pharmacovigilance officers.
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