Risk Management for the 21st Century: Current Status and Future Needs

Mouchantaf, Rania; Auth, Doris; Moride, Yola; Raine, June; Han, Soon Young; Smith, Meredith Y.

doi:10.1007/s40264-020-01033-z

Cited by 13 publications

(13 citation statements)

References 40 publications

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“…A lack of explicit procedures for handling DHPCs in hospitals may lead to individual HCPs missing important issues or recommendations. Our findings re-emphasise the need to adapt to local (hospital) practices and have local medication committees to support optimal drug use in organisations [27], as well as to provide actionable recommendations when regulatory authorities and industry design risk minimisation measures or communication strategies [28,29]. Previous studies showed that, for example, having an antibiotic policy committee within a hospital was associated with appropriate antibiotic use [30] or having a medication safety officer was associated with better medication error detection and prevention [31].…”

Section: Discussionsupporting

confidence: 52%

Handling of New Drug Safety Information in the Dutch Hospital Setting: A Mixed Methods Approach

et al. 2022

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IntroductionThe implementation of new drug safety information and Direct Healthcare Professional Communications (DHPCs) in hospitals is important for patient safety. Objectives The aim of this study was to gain insight into which procedures and practices are in place to handle new drug safety information and particularly DHPCs in the Dutch hospital setting. Methods We first conducted focus groups including medical specialists and hospital pharmacists, focusing on handling of drug safety information at the individual and organisational level. A survey was then developed and distributed among hospital pharmacists in all Dutch hospitals to quantify the existence of specific procedures and committees to handle drug safety information and DHPCs. Results Eleven specialists and 14 pharmacists from six hospitals participated in focus groups. Drug safety information was usually considered before drugs were included in formularies or treatment protocols. Furthermore, drug safety information was consulted in response to patients experiencing adverse events. DHPCs were mostly dealt with by individual professionals. DHPCs could lead to actions but this was very uncommon. Completed surveys were received from 40 (53%) of the hospitals. In 32 (80%), the hospital pharmacy had procedures to deal with new drug safety information, whereas in 11 (28%) a hospital-wide procedure was in place. Drug safety was considered in committees concerning drug formulary decisions (69%) and antibiotic policies (63%). DHPCs were assessed by a hospital pharmacist in 50% of the hospitals. Conclusions Drug safety information was used for evaluation of new treatments and in response to adverse events. Assessment of whether a DHPC requires action was primarily an individual task. Key PointsDrug safety information is consulted when evaluating new drugs and updating hospital formularies or when confronted with adverse events in individual patients.

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Section: Discussionsupporting

confidence: 52%

Handling of New Drug Safety Information in the Dutch Hospital Setting: A Mixed Methods Approach

et al. 2022

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“…Mouchantaf and colleagues, in a review of the state of risk minimization measures, noted that in addition to evaluating the intended effects of a risk minimization measure, attention should also be paid to the potential unintended consequences of these measures, such as burden on the healthcare system and barriers to medication access for patients and healthcare professionals 46 . They noted that the feasibility of measuring an outcome should be considered when developing an evaluation plan.…”

Section: Overview Of Assessments Of Risk Evaluation and Mitigation Strategiesmentioning

confidence: 99%

The Use of Real‐World Data to Assess the Impact of Safety‐Related Regulatory Interventions

Pan

2021

Clin Pharma and Therapeutics

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The regulation of medicines seeks to ensure the efficacy, safety, and quality of prescription and non‐prescription medicines. Given that the conditions under which a medicine’s benefits outweigh its risks are complex, it is essential that communications about the safe and effective use of medicines be clear and actionable. Assessing the impact of interventions to improve the safe and effective use of medicines is a developing area, and one in which real‐world data are playing an increasingly important role. Although real‐world data are commonly used to assess the impact of regulatory interventions, there are several areas where their use could be improved. Specific areas for improvement include assessing regulatory interventions across a wider range of medicines, rather than concentrating on a relatively few therapeutic areas; assessing more clinically relevant outcomes rather than relying on measures such as changes in the number of prescriptions, which may not always correlate with the desired impact; assessing the potential unintended or negative consequences of regulatory interventions; applying methods to address potential confounders; assessing long‐term, rather than just short‐term, impacts of an intervention; increasing the use of comparator groups, when feasible; and evaluating the impact of regulatory interventions from multiple dimensions, rather than from a single dimension. Expanded use of real‐world data could inform some of these efforts, although data sources beyond administrative claims data will likely be necessary to achieve all these goals.

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“…While there is stark need for clear guidance for sponsors, MAHs, HCPs and patients, there is also an immediate requirement for harmonization, decreased unnecessary complexity and simplification of processes. According to Mouchantaf et al ., there are several areas of our current legislative environment that may benefit from harmonization: standardization of terms and definitions, use of consistent methodologies, standardization of risk minimization planning, implementation and communication 15 …”

Section: Discussionmentioning

confidence: 99%

“…14 Global adoption of risk management principles outlined in the International Conference on Harmonization (ICH) E2E guideline and the Council for International Organizations of Medical Sciences (CIOMS) Working Group VI guidance introduced greater proactivity and consistency into the practice of PV and benefit-risk management throughout the life cycle of a drug. 15 The main objectives of the PV system are to promote and protect public health by supporting the availability of medicines including those that fulfil previously unmet medical needs and to reduce the burden of ADRs. This is achieved via…”

Section: Regulatory Environmentmentioning

confidence: 99%

The evolution of pharmacovigilance ecosystems: Does Moore's law invite the use of Occam's razor?

Mueller

Lewis

Alexe

2022

Brit J Clinical Pharma

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Aims Moore's law predicts the doubling of complexity of integrated circuits every 2 years; Kryder's corollary assumes a doubling of data storage every 13 months. With the increasing volume of legislation, pharmacovigilance systems today are inherently complex, and the emphasis has shifted from reactive (responding to emerging risks) to planned, active, risk‐proportionate approaches operating throughout the life cycle of medicines. Methods Exploration of the drivers for increasing complexity of pharmacovigilance systems, focusing on regulatory environment, data management and evaluation. Results Evaluation of postmarketing data plays an increasingly important role in pharmacovigilance. There is great interest on the part of all stakeholders in optimizing the use of these data. Innovative approaches, including pharmacogenetics and passive measures (sensors), will lead to increased complexity and volumes of data and inevitably to an increase in the volume of case reports. There is a multiplicity of regulations and guidelines on how to manage these data, with an inherent lack of harmonization. Conclusion We summarize the current characterization of safety data types, sources and the classification of these data. Using this benchmark, we discuss the future requirements of an effective pharmacovigilance ecosystem, keeping the principle of parsimony in mind. In this complex, continuously and rapidly changing environment, there is a need for a return to simplicity and pragmatism. The application of Occam's razor could help to support the rapid provision of new, affordable medicines with a positive benefit to risk profile.

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Risk Management for the 21st Century: Current Status and Future Needs

Cited by 13 publications

References 40 publications

Handling of New Drug Safety Information in the Dutch Hospital Setting: A Mixed Methods Approach

Handling of New Drug Safety Information in the Dutch Hospital Setting: A Mixed Methods Approach

The Use of Real‐World Data to Assess the Impact of Safety‐Related Regulatory Interventions

The evolution of pharmacovigilance ecosystems: Does Moore's law invite the use of Occam's razor?

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