Methodological Approaches to Evaluate the Impact of FDA Drug Safety Communications

Kesselheim, Aaron S.; Campbell, Eric G.; Schneeweiß, Sebastian; Rausch, Paula; Lappin, Brian M.; Zhou, Esther H.; Seeger, John D.; Brownstein, John S.; Woloshin, Steven; Schwartz, Lisa M.; Toomey, Timothy; Pan, Gerald J. Dal; Avorn, Jerry

doi:10.1007/s40264-015-0291-y

Cited by 33 publications

(41 citation statements)

References 37 publications

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“…However, the low ICS and ACM dispensing, as well as the low proportion of patients having poorly controlled asthma before LABA initiation, are not consistent with FDA’s LABA safe use recommendations. Additional analyses from the perspective of patients and prescribers may provide useful insight into the reasons for the low ACM use 22. For the assessment of step-down therapy, more granular clinical data are needed.…”

Section: Resultsmentioning

confidence: 99%

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The US Food and Drug Administration’s drug safety recommendations and long-acting beta2-agonist dispensing pattern changes in adult asthma patients: 2003–2012

Zhou¹,

Seymour²,

Goulding³

et al. 2017

JAA

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BackgroundEmerging safety issues associated with long-acting beta2-agonist (LABA) have led to multiple regulatory activities by the US Food and Drug Administration (FDA) since 2003, including Drug Safety Communications (DSCs) in 2010. These DSCs had three specific recommendations for the safe use of LABA products in adult asthma treatment.MethodsWe examined the initiation of LABA-containing products for adult asthma treatment using an intermittent time series approach in a claims database from 2003 to 2012. We assessed the alignment of dispensing patterns with the following 2010 FDA recommendations: 1) contraindicated use of single-ingredient (SI)-LABA without an asthma controller medication (ACM); 2) a LABA should only be used when asthma is not adequately controlled on inhaled corticosteroids (ICSs) or ACM; and 3) step-down asthma therapy (e.g., discontinue LABA) when asthma control is achieved.ResultsThere were 477,922 adults (18–64 years old) dispensed a new LABA during 2003–2012. Among LABA initiators, patients who initiated an SI-LABA and who did “not” have an ACM dispensed on the same date decreased from >9% in 2003 (the initial labeling change) to <2% post 2010 DSCs (p-value <0.0001 in the segmented regression model). The proportion of asthma patients dispensed an ICS in 6 months prior to initiating LABA treatment did not increase. The proportion of patients with longer than 4 months of continuous treatment did not decrease over the study period.ConclusionAlthough the decrease in SI-LABA initiation is consistent with FDA’s recommendations, low ICS dispensing before initiating a LABA and LABA continuation practices require further efforts to move toward the recommended safe practices.

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Section: Resultsmentioning

confidence: 99%

“…Overall, risk communications of medical products are important for patients using the products as well as for physicians prescribing them, yet such communications are rarely fully evaluated 22,23. There are many factors that could have had an impact on the LABA dispensing patterns in adult asthma patients over the 10-year study period.…”

Section: Discussionmentioning

confidence: 99%

The US Food and Drug Administration’s drug safety recommendations and long-acting beta2-agonist dispensing pattern changes in adult asthma patients: 2003–2012

Zhou¹,

Seymour²,

Goulding³

et al. 2017

JAA

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“…The true effectiveness of the label change, ie, causality, cannot be proven from this PRE/POST study design but only inferred. Using interrupted time series and a multidisciplinary approach that incorporated survey, qualitative, and social media analyses was beyond the scope of this pilot that was based solely on the use of existing Sentinel tools.…”

Section: Discussionmentioning

confidence: 99%

Do FDA label changes work? Assessment of the 2010 class label change for proton pump inhibitors using the Sentinel System's analytic tools

Sobel

Bate

Marshall

et al. 2018

Pharmacoepidemiology and Drug

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“…The U.S. Food and Drug Administration (FDA) issues Drug Safety Communications (DSCs) 1 to disseminate new safety information about approved drugs, alerting patients and health care professionals about new risks, or signals of new risks, so they can make informed decisions about use of the drugs. 2 Zolpidem, a commonly prescribed sedative/hypnotic insomnia drug, was the subject of DSCs in January and May 2013, as FDA recommended lowering the bedtime dose of zolpidem, due to concerns of incomplete elimination and nextmorning impairment; FDA also warned that patients who take zolpidem extended-release should not drive the next day. 3,4 Analysis of U.S. commercially insured persons has shown statistically significant, though clinically unremarkable, increase in low-dose and decrease in high-dose zolpidem dispensing after the DSCs.…”

Section: Introductionmentioning

confidence: 99%

Changes in emergency department visits for zolpidem‐attributed adverse drug reactions after FDA Drug Safety Communications

Geller

Zhou

Budnitz

et al. 2020

Pharmacoepidemiology and Drug

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Purpose To identify possible changes in the U.S. emergency department (ED) visits from zolpidem‐attributed adverse drug reactions (ADRs) after 2013 Food and Drug Administration (FDA) Drug Safety Communications (DSCs), which notified the public about FDA's new dosing recommendations for zolpidem. Methods We estimated the occurrence of ED visits from zolpidem‐attributed ADRs using nationally representative, public health surveillance of medication harms (National Electronic Injury Surveillance System‐Cooperative Adverse Drug Event Surveillance project, 2010‐2017). We estimated the number of zolpidem prescriptions using IQVIA National Prescription Audit, 2010‐2017. We calculated rates of ED visits for zolpidem‐attributed ADRs per 10 000 dispensed zolpidem prescriptions and identified time trends and potential inflection points using the joinpoint regression. For comparison, we repeated these analyses for sedating antidepressants commonly used to treat disordered sleep (trazodone, doxepin, and mirtazapine). Results The best‐fit regression model for rates of ED visits for zolpidem‐attributed ADRs by 6‐month intervals identified a single inflection point in the second half of 2014 (P = .024) with a 6.7% biannual decrease from 2010 to 2014 ([−13.1%, 0.3%], P = .059) and a 13.9% biannual increase from the second half of 2014 through 2017 ([−1.1%, 31.3%], P = .068). No change or inflection points were identified for rates of ED visits for sedating antidepressant‐attributed ADRs. Conclusions While there was a nominal decline in the rate of ED visits for ADRs in the time period before and for 18 months after FDA's 2013 zolpidem DSCs, the decrease was not sustained, and thus questions remain concerning the long‐term impact of the zolpidem DSCs on ADRs.

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Methodological Approaches to Evaluate the Impact of FDA Drug Safety Communications

Abstract: Using an integrated, multidisciplinary approach, we can obtain information that can be used to optimize regulatory communications by seeking to understand the impact of the information contained in FDA risk communications.

Cited by 33 publications

References 37 publications

The US Food and Drug Administration’s drug safety recommendations and long-acting beta2-agonist dispensing pattern changes in adult asthma patients: 2003–2012

The US Food and Drug Administration’s drug safety recommendations and long-acting beta2-agonist dispensing pattern changes in adult asthma patients: 2003–2012

Do FDA label changes work? Assessment of the 2010 class label change for proton pump inhibitors using the Sentinel System's analytic tools

Changes in emergency department visits for zolpidem‐attributed adverse drug reactions after FDA Drug Safety Communications

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Methodological Approaches to Evaluate the Impact of FDA Drug Safety Communications

Abstract: Using an integrated, multidisciplinary approach, we can obtain information that can be used to optimize regulatory communications by seeking to understand the impact of the information contained in FDA risk communications.

Cited by 33 publications

References 37 publications

The US Food and Drug Administration&rsquo;s drug safety recommendations and long-acting beta2-agonist dispensing pattern changes in adult asthma patients: 2003&ndash;2012

The US Food and Drug Administration&rsquo;s drug safety recommendations and long-acting beta2-agonist dispensing pattern changes in adult asthma patients: 2003&ndash;2012

Do FDA label changes work? Assessment of the 2010 class label change for proton pump inhibitors using the Sentinel System's analytic tools

Changes in emergency department visits for zolpidem‐attributed adverse drug reactions after FDA Drug Safety Communications

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Product

Resources

About

The US Food and Drug Administration’s drug safety recommendations and long-acting beta2-agonist dispensing pattern changes in adult asthma patients: 2003–2012

The US Food and Drug Administration’s drug safety recommendations and long-acting beta2-agonist dispensing pattern changes in adult asthma patients: 2003–2012