Post-approval adverse events of new and old anticoagulants

Hoffman, Keith B.; Demakas, Andrea; Erdman, Colin B.; Dimbil, Mo

doi:10.1136/bmj.g1859

Cited by 4 publications

(1 citation statement)

References 3 publications

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“…Critically ill adults are often at increased risk for serious cardiac events such as ventricular tachyarrhythmias and cardiac arrest, regardless of intravenous sedative choice, and therefore FAERS case reporters may have erroneously assigned causality to the intravenous sedative administered. These challenges have been noted by the Advera Health Analytics team in previous publications and are inherent in working with the FAERS database [31, 34–37, 72, 73].…”

Section: Discussionmentioning

confidence: 99%

Serious Cardiovascular Adverse Events Reported with Intravenous Sedatives: A Retrospective Analysis of the MedWatch Adverse Event Reporting System

Duprey

Al-Qadheeb

O'Donnell

et al. 2019

Drugs - Real World Outcomes

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Background Serious cardiovascular adverse events (SCAEs) associated with intravenous sedatives remain poorly characterized. Objective The objective of this study was to compare SCAE incidence, types, and mortality between intravenous benzodiazepines (i.e., diazepam, lorazepam, and midazolam), dexmedetomidine, and propofol in the USA over 8 years regardless of the clinical setting where it was administered. Methods The Food and Drug Administration’s MedWatch Adverse Event Reporting System was searched between 2004 and 2011 using the Evidex ® platform from Advera Health Analytics, Inc. to identify all reports that included one or more of ten different SCAEs (package insert incidence ≥ 1%) and where an intravenous benzodiazepine, dexmedetomidine, or propofol was the primary suspected drug. Results Among the 2326 Food and Drug Administration’s MedWatch Adverse Event Reporting System cases reported, 394 (16.9%) were related to a SCAE. The presence of a SCAE (vs. a non-SCAE) is associated with higher mortality (34 vs. 8%, p < 0.001). The percentage of cases with one or more SCAE, the case mortality rate (%), and the incidence of each SCAE (per 10 6 days of sedative exposure), respectively, were benzodiazepines (14, 26, 13) [diazepam (13, 23, 31); lorazepam (15, 43, 14); midazolam (14, 20, 11)]; dexmedetomidine (40, 15, 13); and propofol (17, 39, 7). Propofol (vs. either a benzodiazepine or dexmedetomidine) was associated with more total SCAEs (268 vs. 126, p < 0.001) but a lower incidence (per 10 6 days of sedative exposure) of SCAE (7 vs. 13, p = 0.0001) and cardiac arrest [6.3 (benzodiazepine) vs. 6.7 (dexmedetomidine) vs. 1.4 (propofol), p < 0.0001]. Conclusions Serious cardiac adverse events account for nearly one-fifth of intravenous sedative Food and Drug Administration’s MedWatch Adverse Event Reporting System reports. These SCAEs appear to be associated with greater mortality than non-cardiac serious adverse events. Serious cardiac events may be more prevalent with either benzodiazepines or dexmedetomidine than propofol. Electronic supplementary material The online version of this article (10.1007/s40801-019-00161-y) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 99%

Serious Cardiovascular Adverse Events Reported with Intravenous Sedatives: A Retrospective Analysis of the MedWatch Adverse Event Reporting System

Duprey

Al-Qadheeb

O'Donnell

et al. 2019

Drugs - Real World Outcomes

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Can Disproportionality Analysis of Post-marketing Case Reports be Used for Comparison of Drug Safety Profiles?

et al. 2017

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Clinical trials usually do not have the power to detect rare adverse drug reactions. Spontaneous adverse reaction reports as for example available in post-marketing safety databases such as the FDA Adverse Event Reporting System (FAERS) are therefore a valuable source of information to detect new safety signals early. To screen such large data-volumes for safety signals, data-mining algorithms based on the concept of disproportionality have been developed. Because disproportionality analysis is based on spontaneous reports submitted for a large number of drugs and adverse event types, one might consider using these data to compare safety profiles across drugs. In fact, recent publications have promoted this practice, claiming to provide guidance on treatment decisions to healthcare decision makers. In this article we investigate the validity of this approach. We argue that disproportionality cannot be used for comparative drug safety analysis beyond basic hypothesis generation because measures of disproportionality are: (1) missing the incidence denominators, (2) subject to severe reporting bias, and (3) not adjusted for confounding. Hypotheses generated by disproportionality analyses must be investigated by more robust methods before they can be allowed to influence clinical decisions.

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Tracking implementation strategies: a description of a practical approach and early findings

Bunger

Powell

Robertson

et al. 2017

Health Res Policy Sys

138

156

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BackgroundPublished descriptions of implementation strategies often lack precision and consistency, limiting replicability and slowing accumulation of knowledge. Recent publication guidelines for implementation strategies call for improved description of the activities, dose, rationale and expected outcome(s) of strategies. However, capturing implementation strategies with this level of detail can be challenging, as responsibility for implementation is often diffuse and strategies may be flexibly applied as barriers and challenges emerge. We describe and demonstrate the development and application of a practical approach to identifying implementation strategies used in research and practice that could be used to guide their description and specification.MethodsAn approach to tracking implementation strategies using activity logs completed by project personnel was developed to facilitate identification of discrete strategies. This approach was piloted in the context of a multi-component project to improve children’s access to behavioural health services in a county-based child welfare agency. Key project personnel completed monthly activity logs that gathered data on strategies used over 17 months. Logs collected information about implementation activities, intent, duration and individuals involved. Using a consensus approach, two sets of coders categorised each activity based upon Powell et al.’s (Med Care Res Rev 69:123–57, 2012) taxonomy of implementation strategies.ResultsParticipants reported on 473 activities, which represent 45 unique strategies. Initial implementation was characterised by planning strategies followed by educational strategies. After project launch, quality management strategies predominated, suggesting a progression of implementation over time. Together, these strategies accounted for 1594 person-hours, many of which were reported by the leadership team that was responsible for project design, implementation and oversight.ConclusionsThis approach allows for identifying discrete implementation strategies used over time, estimating dose, describing temporal ordering of implementation strategies, and pinpointing the major implementation actors. This detail could facilitate clear reporting of a full range of implementation strategies, including those that may be less observable. This approach could lead to a more nuanced understanding of what it takes to implement different innovations, the types of strategies that are most useful during specific phases of implementation, and how implementation strategies need to be adaptively applied throughout the course of a given initiative.Electronic supplementary materialThe online version of this article (doi:10.1186/s12961-017-0175-y) contains supplementary material, which is available to authorized users.

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Post-approval adverse events of new and old anticoagulants

Cited by 4 publications

References 3 publications

Serious Cardiovascular Adverse Events Reported with Intravenous Sedatives: A Retrospective Analysis of the MedWatch Adverse Event Reporting System

Serious Cardiovascular Adverse Events Reported with Intravenous Sedatives: A Retrospective Analysis of the MedWatch Adverse Event Reporting System

Can Disproportionality Analysis of Post-marketing Case Reports be Used for Comparison of Drug Safety Profiles?

Tracking implementation strategies: a description of a practical approach and early findings

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