Prospective Assessment of Inpatient Boxed Warning Prescriber Adherence

Kloet, Megan A.; Lohr, Brian; Smithburger, Pamela L.; Seybert, Amy L.; Kane‐Gill, Sandra L.

doi:10.1097/pts.0000000000000101

Cited by 5 publications

(1 citation statement)

References 29 publications

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“…This indirect mechanism appears to have wildly varying effects. Studies of BBW adherence have found that different patient populations faced BBW violation rates ranging from 0.7% to 56.6% (Lasser et al, 2006;Ricci et al, 2009;Kloet, Lohr, Smithburger, Seybert, & Kane-Gill, 2017). Thus, it appears that FDA can only affect off-label use with great ambiguity.…”

Section: Can Fda Warnings Affect Off-label Use?mentioning

confidence: 99%

When ignorance is bliss: Intentional agnosticism in drug approval

Litvin

2019

Health Economics

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In developed nations, public health agencies typically use data from randomized controlled trials to evaluate new drugs. However, these trials routinely exclude populations to which clinicians prescribe approved drugs, meaning some patients are treated with drugs, which were approved on the basis of another group's treatment response. Despite having opportunities to change, some health agencies have not mandated greater inclusion in drug trials and appear to prefer remaining ignorant of some populations' treatment effects when approving a drug. To explore this decision, I introduce a novel mechanism by which a health agency would choose to be intentionally agnostic regarding a population's treatment response. The main contribution of this paper is in showing how ambiguity about on-label and off-label prescription rates could possibly encourage population exclusion in drug approval trials even in the absence of concerns about trial necessity or cost.

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Section: Can Fda Warnings Affect Off-label Use?mentioning

confidence: 99%

When ignorance is bliss: Intentional agnosticism in drug approval

Litvin

2019

Health Economics

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Recognition and Knowledge of Medications with Black Box Warnings Among Pediatricians and Emergency Physicians

Smollin

Levin

2015

J. Med. Toxicol.

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"Boxed warnings" (BW), sometimes referred to as "black box warnings," are the most serious level of warning provided by the Food and Drug Administration (FDA). We aimed to assess physician awareness and knowledge of BW, and to gain a better understanding of where physicians obtain information about serious adverse drug reactions for commonly prescribed medications. A cross-sectional survey instrument was administered to emergency medicine (EM) and pediatrician (Peds) attending and resident physicians. The main outcome measures were physician performance in identifying medications with and without black box warnings and the content of the warnings. The survey response rate was 81/ 198 (41 %). Respondents correctly identified medications with BW only 36.3 % of the time, but were able to correctly identify medications without such warnings 83.8 % of the time. Attending physicians were better able to identify medications with or without BW when compared with residents (p<0.05). Among residents, there was a statistically significant increase in the ability to identify medications with or without BW with increasing year of training (p<0.01). Correct identification of the content of BW was low in both groups (13.3 %). Only 19/50 (37 %) EM physicians and 16/ 31 (52 %) Peds reported that they consider BW when prescribing medications. 23/81 (29 %) respondents indicated that they did not stay current or had no method of staying current with black box information. EM and Peds attending and resident physicians at a single institution had limited ability to identify medications containing BW or the content of such warnings. A significant number reported that they did not stay current or had no consistent method for staying current with BW.

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Black-Box Warnings of Antiseizure Medications: What is Inside the Box?

Wahab

Iqbal

2023

Pharm Med

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Prospective Assessment of Inpatient Boxed Warning Prescriber Adherence

Cited by 5 publications

References 29 publications

When ignorance is bliss: Intentional agnosticism in drug approval

When ignorance is bliss: Intentional agnosticism in drug approval

Recognition and Knowledge of Medications with Black Box Warnings Among Pediatricians and Emergency Physicians

Black-Box Warnings of Antiseizure Medications: What is Inside the Box?

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