The role of databases in drug postmarketing surveillance

Rodriguez, Evelyn M.; Staffa, Judy A.; Graham, David J.

doi:10.1002/pds.615

Cited by 128 publications

(91 citation statements)

References 2 publications

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“…Lincoln Technologies standardized the generic name for each reported drug in its data releases, thereby making it easy to count all ADRs associated with a particular drug. in the first 2 years after approval (Rodriguez, Staffa, and Graham 2001;Lasser et al 2002). 16 With respect to the causation issue, we considered only ADRs for drugs suspected to be the cause.…”

Section: Adverse Drug Reactionsmentioning

confidence: 99%

“…We identified the annual number of adverse events for 1992-2002 NMEs using the Spontaneous Reporting System (SRS) and Adverse Event Reporting System (AERS) databases maintained by the FDA (Rodriguez, Staffa, and Graham 2001;Wysowski and Swartz 2005). 15 The ADRs listed in these combined databases are voluntary, spontaneous reports filed primarily by health care professionals such as clinicians, physicians, and pharmacists.…”

Section: Adverse Drug Reactionsmentioning

confidence: 99%

See 1 more Smart Citation

Do Faster Food and Drug Administration Drug Reviews Adversely Affect Patient Safety? An Analysis of the 1992 Prescription Drug User Fee Act

Grabowski

Wang

2008

The Journal of Law and Economics

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Food and Drug Administration (FDA) review times have significantly declined under the user-fee regime. This situation has provoked concerns that drug safety has been adversely affected. Combining information from several comprehensive databases, we analyze how the FDA's review time, a drug's novelty, and a lag between the foreign and U.S. launches of a drug affect the number of serious adverse events associated with new-drug introductions in the United States in 1992-2002. We find that more novel drugs, those with shorter U.S. launch lags, and those with black-box warnings have a larger number of serious adverse events. After controlling for these and other factors, we find no association between the FDA's review time and adverse events. Because many serious adverse events involve rare occurrences that are not observable in premarket clinical trials, policy makers should direct increased agency attention and resources to postmarketing surveillance.

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Section: Adverse Drug Reactionsmentioning

confidence: 99%

Section: Adverse Drug Reactionsmentioning

confidence: 99%

Do Faster Food and Drug Administration Drug Reviews Adversely Affect Patient Safety? An Analysis of the 1992 Prescription Drug User Fee Act

Grabowski

Wang

2008

The Journal of Law and Economics

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“…15 One advantage of health-care utilization databases-their representativeness of routine clinical practice in large populations-comes at a price: the reliance on previously collected data generated primarily for administrative purposes. In studies that use primary data collection, the timing of data collection and the detail and accuracy of data are to a large extent under the control of the investigator.…”

Section: Recurrent Interest In Comparative Effectiveness Researchmentioning

confidence: 99%

“…14 Such longitudinal health-care utilization databases have three key advantages for performing post-marketing comparative effectiveness research: 8 (1) they are available at relatively low cost and can often be conducted with little delay, although even the fastest studies will usually take a year or longer, particularly if medical records will be accessed and reviewed to validate end points; (2) their representativeness of routine clinical care makes it possible to study realworld effectiveness; and (3) the large size of covered population will shorten the time necessary to identify a sufficient number of users of a newly marketed drug. 15 One advantage of health-care utilization databases-their representativeness of routine clinical practice in large populations-comes at a price: the reliance on previously collected data generated primarily for administrative purposes. In studies that use primary data collection, the timing of data collection and the detail and accuracy of data are to a large extent under the control of the investigator.…”

Section: Non-randomized Post-marketing Comparative Effectiveness Resementioning

confidence: 99%

Developments in Post-marketing Comparative Effectiveness Research

Schneeweiß

2007

Clin Pharmacol Ther

171

153

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Physicians and insurers need to weigh the effectiveness of new drugs against existing therapeutics in routine care to make decisions about treatment and formularies. Because Food and Drug Administration (FDA) approval of most new drugs requires demonstrating efficacy and safety against placebo, there is limited interest by manufacturers in conducting such head-to-head trials. Comparative effectiveness research seeks to provide head-to-head comparisons of treatment outcomes in routine care. Health-care utilization databases record drug use and selected health outcomes for large populations in a timely way and reflect routine care, and therefore may be the preferred data source for comparative effectiveness research. Confounding caused by selective prescribing based on indication, severity, and prognosis threatens the validity of non-randomized database studies that often have limited details on clinical information. Several recent developments may bring the field closer to acceptable validity, including approaches that exploit the concepts of proxy variables using high-dimensional propensity scores, within-patient variation of drug exposure using crossover designs, and between-provider variation in prescribing preference using instrumental variable (IV) analyses. POST-MARKETING COMPARATIVE EFFECTIVENESS RESEARCH Lack of evidence on the effectiveness of drugs in routine careClinicians balance benefits and risks of medicines every day. They are taught that randomized controlled trials (RCTs) provide the most robust evidence, and so they go to work happily extrapolating evidence from RCTs to their own patient population, believing that their patients will benefit from an equally large effect. Cochrane 1 pointed out some 35 years ago that RCTs on the efficacy of drugs for their regulatory approval study the extent to which an intervention does more good than harm under ideal circumstances ("Can it work?"). Effectiveness, however, assesses whether an intervention does more good than harm when provided under usual circumstances of health-care practice ("Does it work in practice?").Although there is no doubt about the scientific value of RCTs, their findings have often limited utility in daily practice: they may have sample sizes too small or drug doses too low to fully assess the safety of drugs; follow-up may be too short to show long-term benefits; they may under represent or exclude vulnerable patient groups, including elderly patients with multiple comorbidities, children, and young women, and operate in a highly controlled environment that is far from routine clinical practice. These issues are particularly relevant for preapproval trials. As drugs are on the market for a long time, more RCT evidence becomes available that NIH Public Access Author ManuscriptClin Pharmacol Ther. Author manuscript; available in PMC 2010 July 18. Published in final edited form as:Clin Pharmacol Ther. Few randomized effectiveness studies compare alternative treatment strategies in large heterogeneous populations, but they oft...

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“…Medicaid-Medicare in the United 5 States) (Rodriguez et al 2001) and medical practice databases (e.g. the General Practices 6 Research Database in the United Kingdom) (Garcia Rodriguez et al 1998).…”

Section: Risk Identification 14mentioning

confidence: 99%

Impact of drug warning system on prescriptions

Niyomnaitham¹

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The emergence of a serious adverse effect from a recently marketed drug is a great concern. The earlier we can detect and evaluate those unwanted effects, the better we can prevent them. Regulatory authorities play an important role in detecting, assessing and informing healthcare professionals and consumers on drug safety issues. Regulatory authorities use drug safety warnings as a communication tool for notifying prescribers about the risk and providing the recommendation for their practices. Expected outcomes of drug safety warnings are prescribers' awareness of these risks and a change in their prescribing according to the safety information. However, effectiveness of these safety warnings on clinical practice had been reviewed and led to recommendation for reform in These results suggest that changes in patterns of concerned drugs were associated with international warnings, which may get through to Australian prescribers via NPS MedicineWise or other medical associations. In summary, the impact on drug use depends on the intensity and clarity of warnings as well as the certainty, severity and prevalence of adverse effects. This thesis expands the current understanding of the impact of regulatory iii safety warnings on prescriptions and also provides the scope for possible improvement to the warning system in Australia.iv

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The role of databases in drug postmarketing surveillance

Cited by 128 publications

References 2 publications

Do Faster Food and Drug Administration Drug Reviews Adversely Affect Patient Safety? An Analysis of the 1992 Prescription Drug User Fee Act

Do Faster Food and Drug Administration Drug Reviews Adversely Affect Patient Safety? An Analysis of the 1992 Prescription Drug User Fee Act

Developments in Post-marketing Comparative Effectiveness Research

Impact of drug warning system on prescriptions

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