Active drug safety surveillance: a tool to improve public health

Platt, Richard; Madre, Leanne K.; Reynolds, Robert F.; Tilson, Hugh H.

doi:10.1002/pds.1668

Cited by 34 publications

(17 citation statements)

References 3 publications

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“…The decision to develop, approve, and prescribe a drug requires that the therapeutic benefits of medications be continuously weighed against their potential toxicities 1, 4 . The liver represents an important target of drug toxicity because it metabolizes exogenous compounds into reactive intermediates, which can then cause progressive hepatocyte damage, fulminant hepatic failure, and death if liver transplantation is not performed 5 .…”

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confidence: 99%

Gap junction inhibition prevents drug-induced liver toxicity and fulminant hepatic failure

et al. 2012

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Drug-induced liver injury (DILI) limits the development and utilization of numerous therapeutic compounds, and consequently presents major challenges to the pharmaceutical industry and clinical medicine1, 2. Acetaminophen (APAP) containing compounds are among the most frequently prescribed drugs, and also the most common cause of DILI3. Here we describe a pharmacological strategy that targets gap junction communication to prevent amplification of fulminant hepatic failure and APAP-induced hepatotoxicity. We report that connexin 32 (Cx32), a key hepatic gap junction protein, is an essential mediator of DILI by showing that mice deficient in Cx32 are protected against liver damage, acute inflammation, and death. We identified a small molecule inhibitor of Cx32 as a novel hepatoprotectant that achieves the same result in wildtype mice when coadministered with known hepatotoxic drugs. These findings demonstrate that gap junction inhibition is an effective therapy for limiting DILI, and suggest a novel pharmaceutical strategy to improve drug safety.

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confidence: 99%

Gap junction inhibition prevents drug-induced liver toxicity and fulminant hepatic failure

et al. 2012

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“…Identifying barriers to the use of existing systems in the US, such as VAERS, may provide enhancement of surveillance and subsequently increased timely information. Vaccine post‐marketing surveillance is vital to ensure that acceptable safety profiles exist . The aim of this study was to identify strengths and weaknesses as they pertain to communications regarding potential vaccine‐associated AE associated with influenza vaccine administration.…”

Section: Introductionmentioning

confidence: 99%

Assessing vaccine safety communication with healthcare providers in a large urban county

Meranus¹,

Stergachis²,

Arnold

et al. 2011

Pharmacoepidemiology and Drug

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“…Their recommendations [17] encompassed several key points. Recognizing this, the US Centers for Education and Research on Therapeutics recently convened experts from US academia, government and industry to discuss active surveillance strategies for identifying and evaluating potential drug-safety signals.…”

Section: Recommendations From Us Drug-safety Expertsmentioning

confidence: 99%

Improving Drug Safety

McClure

2009

Pharm Med

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Spontaneous reporting systems (SRS) as a form of post-market drug-safety passive surveillance were created several decades ago. SRS do have several limitations. Somewhat common but serious events will not necessarily prompt the filing of a report. Reporting is voluntary, leading to under-reporting of adverse events, and submitted reports are often lacking in detail. Post-market active drug-safety surveillance is now emerging as a realistic and powerful complement to SRS. Recent examples of active surveillance systems are presented in this paper; these have some, but not all, the elements of an ideal active surveillance programme.An ideal programme should allow rigorous confirmation of suspected risks and have adequate scope for timely and validated signal detection of emerging adverse events. It should allow for both hypothesisgenerating and hypothesis-confirming investigations and be based on a well defined population including not only those with drug exposures but also those who are unexposed. In terms of analysis, epidemiological methods would be utilized that accurately control for confounding-by-indication, and statistical techniques would be used that account for multiple testing among several potential outcomes assessed at different points in time. All of the necessary information should be contained in readily accessible electronic medical record databases. There also must be patient data privacy protections that conform to law and ethical guidelines. However, there is much work to be done before active surveillance becomes the paramount tool in post-market pharmacovigilance.Among recent recommendations from US drug-safety experts were the establishment of the following: a distributed data network from the public and private sectors; working definitions of what constitutes a drug-safety signal; screening algorithms and criteria and strategies to confirm or refute signals; guidelines regarding communications to physicians and patients about safety signals; improved methods to identify and evaluate potential safety signals; and a sustainable and knowledgeable workforce to conduct the studies and to understand how to interpret the results. Some of these recommendations were incorporated in the recently announced US FDA Sentinel Initiative. However, stable and sufficient funding and demand from healthcare consumers must be strong to support long-term efforts in this regard. Public confidence must be high to support widespread drug-safety active surveillance. Patient data privacy protections must be maintained by government and private research staff. There should also be strong incentives for health insurance companies, hospitals, pharmacies and the pharmaceutical industry to fully support widespread and effective active drug-safety surveillance. CURRENT OPINION

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Active drug safety surveillance: a tool to improve public health

Cited by 34 publications

References 3 publications

Gap junction inhibition prevents drug-induced liver toxicity and fulminant hepatic failure

Gap junction inhibition prevents drug-induced liver toxicity and fulminant hepatic failure

Assessing vaccine safety communication with healthcare providers in a large urban county

Improving Drug Safety

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