FDA drug prescribing warnings: Is the black box half empty or half full?

ArticleinPharmacoepidemiology and Drug Safety 15(6):369-86 · June 2006with20 Reads
DOI: 10.1002/pds.1193 · Source: PubMed
Black box warnings (BBWs) are the Food and Drug Administration's (FDA) strongest labeling requirements for high-risk medicines. It is unknown how frequently physicians prescribe BBW drugs and whether they do so in compliance with the warnings. The purpose of the present study was to assess the frequency of use of BBW medications in ambulatory care and prescribing compliance with BBW recommendations. This retrospective study used automated claims data of 929 958 enrollees in 10 geographically diverse health plans in the United States to estimate frequency of use in ambulatory care of 216 BBW drugs/drug groups between 1/1/99 and 31/6/01. We assessed dispensing compliance with the BBW requirements for selected drugs. During a 30-month period, more than 40% of enrollees received at least one medication that carried a BBW that could potentially apply to them. We found few instances of prescribing during pregnancy of BBW drugs absolutely contra-indicated in pregnancy. There was almost no co-prescribing of contra-indicated drugs with the two QT-interval-prolonging BBW drugs evaluated. Most non-compliance occurred with recommendations for baseline laboratory monitoring (49.6% of all therapy initiations that should have been accompanied by baseline laboratory monitoring were not). Many individuals receive drugs considered to carry the potential for serious risk. For some of these drugs, use is largely consistent with their BBW, while for others it is not. Since it will not be possible to avoid certain drug- associated risks, it will be important to develop effective methods to use BBWs and other methods to minimize risks.
    • "These studies find significant, although generally modest, declines in medication prescribing in response to FDA information. However, one study found that 40 % of patients received at least one medication with a black-box warning that could have applied to them, suggesting that FDA warnings may not result in targeted reductions in use of the labeled drugs (Wagner et al. 2006 information. Empirical findings are mixed and suggest that consumer responses are sensitive to the context of the warning and to the presentation of information in content, format and detail (Magat et al. 1988; Bettman et al. 1986). "
    [Show abstract] [Hide abstract] ABSTRACT: We examine how use of antidepressant medications is influenced by Food and Drug Administration (FDA) warnings about the increased risk of suicidality associated with pediatric antidepressant use. With individual-level data on antidepressant use from the Medical Expenditure Panel Survey, we consider whether consumer responses to FDA warnings differ among targeted (children) and nontargeted (adult) age-groups. Because the warning labels specifically mentioned new users, we examine separately the effects of the warnings on initiations of antidepressant therapy and on continued use of antidepressants. We find evidence consistent with reduced initiation of antidepressant use among the intended population of children, and that usage among children with more highly educated parents responded earlier to FDA information. However, we also find spillover effects of reduced initiation among the non-targeted population of adults. Overall, our results indicate that the FDA warning may have led consumers to perceive risks beyond those specifically mentioned.
    Full-text · Article · Dec 2014
    • "Each health plan maintains an electronic database of member demographics, enrollment, outpatient pharmacy dispensing, and inpatient and outpatient encounters. These data have been used in several drug safety studies21222324252627 and described in detail elsewhere [21,22,28]. Demographic information includes date of birth and sex. "
    [Show abstract] [Hide abstract] ABSTRACT: Background: Drug adverse event (AE) signal detection using the Gamma Poisson Shrinker (GPS) is commonly applied in spontaneous reporting. AE signal detection using large observational health plan databases can expand medication safety surveillance. Methods: Using data from nine health plans, we conducted a pilot study to evaluate the implementation and findings of the GPS approach for two antifungal drugs, terbinafine and itraconazole, and two diabetes drugs, pioglitazone and rosiglitazone. We evaluated 1676 diagnosis codes grouped into 183 different clinical concepts and four levels of granularity. Several signaling thresholds were assessed. GPS results were compared to findings from a companion study using the identical analytic dataset but an alternative statistical method-the tree-based scan statistic (TreeScan). Results: We identified 71 statistical signals across two signaling thresholds and two methods, including closely-related signals of overlapping diagnosis definitions. Initial review found that most signals represented known adverse drug reactions or confounding. About 31% of signals met the highest signaling threshold. Conclusions: The GPS method was successfully applied to observational health plan data in a distributed data environment as a drug safety data mining method. There was substantial concordance between the GPS and TreeScan approaches. Key method implementation decisions relate to defining exposures and outcomes and informed choice of signaling thresholds.
    Full-text · Article · Mar 2013
    • "Medications with BBWs are regularly prescribed, but BBW recommendations are not routinely followed. Of the 40% of patients who receive BBW medications, up to 40–50% do not get the recommended laboratory testing recommended in the BBW [3][4]. BBWs for possible medication interactions were not followed 36% of the time [5]. "
    [Show abstract] [Hide abstract] ABSTRACT: To develop a practical approach for implementing clinical decision support (CDS) for medication black box warnings (BBWs) into health information systems (HIS). We reviewed all existing medication BBWs and organized them into a taxonomy that identifies opportunities and challenges for implementing CDS for BBWs into HIS. Of the over 400 BBWs that currently exist, they can be organized into 4 categories with 9 sub-categories based on the types of information contained in the BBWs, who should be notified, and potential actions to that could be taken by the person receiving the BBW. Informatics oriented categories and sub-categories of BBWs include - interactions (13%) (drug-drug (4%) and drug-diagnosis (9%)), testing (21%) (baseline (9%) and on-going (12%)), notifications (29%) (drug prescribers (7%), drug dispensers (2%), drug administrators (9%), patients (10%), and third parties (1%)), and non-actionable (37%). This categorization helps identify BBWs for which CDS can be easily implemented into HIS today (such as drug-drug interaction BBWs), those that cannot be easily implemented into HIS today (such as non-actionable BBWs), and those where advanced and/or integrated HIS need to be in place to implement CDS for BBWs (such a drug dispensers BBWs). HIS have the potential to improve patient safety by implementing CDS for BBWs. A key to building CDS for BBWs into HIS is developing a taxonomy to serve as an organizing roadmap for implementation. The informatics oriented BBWs taxonomy presented here identified types of BBWs in which CDS can be implemented easily into HIS currently (a minority of the BBWs) and those types of BBWs where CDS cannot be easily implemented today (a majority of BBWs).
    Full-text · Article · Jan 2012
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