Post‐market drug safety evidence sources: an analysis of FDA drug safety communications

Ishiguro, Chieko; Hall, Marni; Neyarapally, George A.; Pan, Gerald J. Dal

doi:10.1002/pds.3317

Cited by 33 publications

(23 citation statements)

References 11 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Administrative claims and electronic health record data are often used for epidemiological studies postlicensure . Analysis of safety data from spontaneous reporting systems (SRS), such as the FDA Adverse Event Reporting System (FAERS), remains a mainstay for monitoring the safety of these products and identification of safety signals . Individual case safety reports (ICSRs) contained in such systems provide first alerts for emerging drug and therapeutic biologic product safety concerns and help to generate hypotheses that can be evaluated using other data sources and methods.…”

Section: Introductionmentioning

confidence: 99%

An evaluation of statistical approaches to postmarketing surveillance

Ding

Markatou

Ball

2020

Statistics in Medicine

View full text Add to dashboard Cite

Safety of medical products presents a serious concern worldwide. Surveillance systems of postmarket medical products have been established for continual monitoring of adverse events (AEs) in many countries, and the proliferation of electronic health record systems further facilitates continual monitoring for AEs. We review existing statistical methods for signal detection that are mostly in use in postmarketing safety surveillance of spontaneously reported AEs and we study their performance characteristics by simulation. We compare those with the likelihood ratio test (LRT) method (appropriately modified for use in pharmacovigilance) and use three different methods to generate data (AE based, drug based, and a modification of the method of Ahmed et al). Performance metrics include type I error, power, sensitivity, and false discovery rate, among others. The results show superior performance of the LRT method in almost all simulation experiments. An application to the FDA Adverse Event Reporting System database is illustrated using rhabdomyolysis‐related preferred terms reported to FDA during the third‐quarter of 2014 to the first‐quarter of 2017 for statin drugs. We present a critical discussion and recommendations for use of these methods.

show abstract

Section: Introductionmentioning

confidence: 99%

An evaluation of statistical approaches to postmarketing surveillance

Ding

Markatou

Ball

2020

Statistics in Medicine

View full text Add to dashboard Cite

show abstract

“…Spontaneous reports of possible ADRs are a valuable source of information, e.g., in the USA, spontaneous reports were the primary evidence source of drug safety issues resulting in drug safety communication from 2007 to 2009 [3]. Traditionally, reporting of possible ADRs was reserved for healthcare professionals.…”

Section: Introductionmentioning

confidence: 99%

The Quality of Clinical Information in Adverse Drug Reaction Reports by Patients and Healthcare Professionals: A Retrospective Comparative Analysis

et al. 2017

View full text Add to dashboard Cite

IntroductionClinical information is needed to assess the causal relationship between a drug and an adverse drug reaction (ADR) in a reliable way. Little is known about the level of relevant clinical information about the ADRs reported by patients.ObjectiveThe aim was to determine to what extent patients report relevant clinical information about an ADR compared with their healthcare professional.MethodsA retrospective analysis of all ADR reports on the same case, i.e., cases with a report from both the patient and the patient’s healthcare professional, selected from the database of the Dutch Pharmacovigilance Center Lareb, was conducted. The extent to which relevant clinical information was reported was assessed by trained pharmacovigilance assessors, using a structured tool. The following four domains were assessed: ADR, chronology, suspected drug, and patient characteristics. For each domain, the proportion of reported information in relation to information deemed relevant was calculated. An average score of all relevant domains was determined and categorized as poorly (≤45%), moderately (from 46 to 74%) or well (≥75%) reported. Data were analyzed using a paired sample t test and Wilcoxon signed rank test.ResultsA total of 197 cases were included. In 107 cases (54.3%), patients and healthcare professionals reported a similar level of clinical information. Statistical analysis demonstrated no overall differences between the groups (p = 0.126).ConclusionsIn a unique study of cases of ADRs reported by patients and healthcare professionals, we found that patients report clinical information at a similar level as their healthcare professional. For an optimal pharmacovigilance, both healthcare professionals and patient should be encouraged to report.

show abstract

“…Although the Food and Drug Administration (FDA) would do drug safety surveillances by report collections on FDA drug safety communications and make consequent decisions on such approved drugs with unexpected safety problems including warnings and withdrawals [8], it should be more efficient for patients and pharmaceutical industry to minimize therapeutic risks if predictive approaches could be used to assess drug safety in the preclinical phase. In fact, there are already some drug safety predictive approaches developed to this end, which can be roughly divided into quantitative methods and qualitative methods.…”

Section: Introductionmentioning

confidence: 99%

Predicting the Drug Safety for Traditional Chinese Medicine through a Comparative Analysis of Withdrawn Drugs Using Pharmacological Network

Xue

Zhang

Cai

et al. 2013

Evidence-Based Complementary and Alternative Medicine

View full text Add to dashboard Cite

As the major issue to limit the use of drugs, drug safety leads to the attrition or failure in clinical trials of drugs. Therefore, it would be more efficient to minimize therapeutic risks if it could be predicted before large-scale clinical trials. Here, we integrated a network topology analysis with cheminformatics measurements on drug information from the DrugBank database to detect the discrepancies between approved drugs and withdrawn drugs and give drug safety indications. Thus, 47 approved drugs were unfolded with higher similarity measurements to withdrawn ones by the same target and confirmed to be already withdrawn or discontinued in certain countries or regions in subsequent investigations. Accordingly, with the 2D chemical fingerprint similarity calculation as a medium, the method was applied to predict pharmacovigilance for natural products from an in-house traditional Chinese medicine (TCM) database. Among them, Silibinin was highlighted for the high similarity to the withdrawn drug Plicamycin although it was regarded as a promising drug candidate with a lower toxicity in existing reports. In summary, the network approach integrated with cheminformatics could provide drug safety indications effectively, especially for compounds with unknown targets or mechanisms like natural products. It would be helpful for drug safety surveillance in all phases of drug development.

show abstract

Post‐market drug safety evidence sources: an analysis of FDA drug safety communications

Cited by 33 publications

References 11 publications

An evaluation of statistical approaches to postmarketing surveillance

An evaluation of statistical approaches to postmarketing surveillance

The Quality of Clinical Information in Adverse Drug Reaction Reports by Patients and Healthcare Professionals: A Retrospective Comparative Analysis

Predicting the Drug Safety for Traditional Chinese Medicine through a Comparative Analysis of Withdrawn Drugs Using Pharmacological Network

Contact Info

Product

Resources

About