Changes in Asthma Maintenance Therapy Prescribing Patterns Following the 2006 Long-acting β-Agonist FDA Drug Warning

Winter, Jonathan D.; Reetz, Matthew R; Kerns, J. William; Winter, Katherine; Sabo, Roy T.; Krugman, Saul

doi:10.1016/j.clinthera.2017.01.032

Cited by 4 publications

(8 citation statements)

References 10 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…In contrast, just 45% (17/38) of the studies in the “others” group were presented as ineffective or partially effective. But 53% (20/38) described an effective impact, and only 2% examined an unintended effect.…”

Section: Resultsmentioning

confidence: 95%

“…All of the 70 publications included are observational studies based on routinely collected health data, which included health insurance or hospital records. Thus, no RCTs were found for the defined search period.…”

Section: Resultsmentioning

confidence: 99%

“…Two publications examined safety warnings for two mutually independent substances each, that is, 70 publications reported 72 studies. If a study contained multiple characteristics, the characteristics of these studies were counted multiple times in the following analyses, for example, studies examining more than one safety warning on one substance or substance group (multiple counts for safety warnings per study) or where a safety warning included multiple recommendations, for example, indication limitations and new adverse reactions (multiple counts for the content of the safety warning) were also subject to multiple counting.…”

Section: Resultsmentioning

confidence: 99%

“…In 12 studies, the authors concluded that the content of the safety warnings investigated did not lead to a change in drug therapy . In 26 studies, a partial change in drug therapy was shown …”

Section: Resultsmentioning

confidence: 99%

“…-20,23,25,26,29,31,39-44,48,50-52,54,58,64,67,68,71,73,76,81 In 12 studies, the authors concluded that the content of the safety warnings investi-,22,24,25,33,34,56,61,65,78,79,82 In 26 studies, a partial change in drug therapy was shown 27,30,32,33,[35][36][37][38][45][46][47]49,53,55,57,59,62,63,66,69,70,74,77,[83][84][85]. …”

mentioning

confidence: 99%

See 4 more Smart Citations

Do drug‐related safety warnings have the expected impact on drug therapy? A systematic review

Georgi

Lämmel

Datzmann

et al. 2020

Pharmacoepidemiology and Drug

View full text Add to dashboard Cite

Purpose The need for drug‐related safety warnings is undisputed, and their impact should also be evaluated. This systematic review investigates and assesses the impact of safety warnings on drug therapy. Methods Studies published in English between January 1998 and December 2018 were searched in EMBASE and MEDLINE, complemented by manual search. Randomised controlled trials, cohort studies with a before/after component, and case‐control studies were included, selected to predefined criteria, and assessed for their reporting and methodological quality. Results Out of 7454 references identified, 72 studies were included. A total of 28/72 (39%) studies described the impact of safety warnings on drug therapy as being effective, whereas 12/72 (17%) studies did not. Further, 26/72 (36%) studies described a partial implementation of the warnings (one part of the warning had an impact on drug therapy and another did not). Unintended effects were investigated in 6/72 (8%) studies. While 34 (47%) studies examined safety warnings on psychotropic drugs using an interrupted time series (ITS) design (53%), a before/after (26%), and a time series design (21%), 38 (53%) studied other substances using an ITS design (34%), a before/after (40%), and a time series design (26%). The proportion of an effective impact on drug therapy was lower in the “psychotropic drugs” group (23%) than in the “others” group (53%). Conclusion Drug‐related safety warnings induce intended and unintended effects. The included studies are of broadly varying methodological quality. To better compare their effectiveness, studies should be conducted using standardised procedures.

show abstract

Section: Resultsmentioning

confidence: 95%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

mentioning

confidence: 99%

See 3 more Smart Citations

Do drug‐related safety warnings have the expected impact on drug therapy? A systematic review

Georgi

Lämmel

Datzmann

et al. 2020

Pharmacoepidemiology and Drug

View full text Add to dashboard Cite

show abstract

FDA postmarketing safety labeling changes: What have we learned since 2010 about impacts on prescribing rates, drug utilization, and treatment outcomes

Rosenberg

Sheehan

Zhou

et al. 2020

Pharmacoepidemiology and Drug

View full text Add to dashboard Cite

Purpose Prior literature reviews have identified gaps in understanding of how postmarketing safety labeling changes and related FDA communications impact key clinical and behavioral outcomes. We conducted a review of newly published studies on this topic to determine what new evidence exists and to identify which gaps may still remain. We believe that this information can support FDA as it develops and implements future risk communication approaches. Methods We searched PubMed and Embase for studies published between January 1, 2010, and August 7, 2017 that examined the impact of labeling changes or associated FDA safety‐related communications. For each study, we extracted information on research design and findings for key clinical outcomes and behaviors. We also conducted a ROBINS‐I review to identify potential for bias in the research design of each study. Results We found that the estimated impacts of FDA labeling changes on several key outcomes—including adverse events—varied. Labeling changes also yielded unintended consequences on drug prescribing in some cases, despite low provider adherence. Finally, some studies we reviewed exhibited potential for bias due to confounding, among other factors. Conclusions The new studies we reviewed contain many of the same limitations identified in previously published reviews. While there are several challenges to conducting this research there is substantial room for improvement in the quality of the evidence base. More information, particularly with respect to the types of populations and medications affected by labeling changes, is needed to support the development of more effective and targeted safety communications.

show abstract

Risk Evaluation and Mitigation Strategies (REMS), Pemoline, and What Is a Signal?

Shader¹

2017

Clinical Therapeutics

View full text Add to dashboard Cite

, MD, on the subject of pharmacovigilance and postmarketing surveillance. 1-5 In 2007 the Food and Drug Administration (FDA) was authorized to require sponsors to develop a Risk Evaluation and Mitigation Strategy (REMS) whenever there was a suspicion that more information might be needed to ensure the safety of a newly marketed product. 6 A REMS is an anticipatory risk management program intended to pick up unwanted drug effects once more patients are exposed to a drug than occurred during Phase II and III studies. This usually means that problems will be detected that require exposure of more than the typical 3000 to 5000 patients seen in the two pre-NDA (New Drug Application) phases. REMSs may also be important for agents for rare or orphan diseases. Such drugs have usually been marketed after an accelerated approval process, meaning that smaller numbers of patients were exposed before marketing approval. Also, real-world usage may reveal problems from other unstudied situations such as comorbidities or drug interactions. I created the mnemonic MICE to remember the main components of a REMS program. Table I lists the FDA's components in my rearranged order. For clinical safety purposes, the plans for implementation (eg, checking all databases, epidemiologic studies, creation of a registry) and communication (eg, a Dear Clinician letter) should occur early in the process of assuring safe use. The medication guide (an up-to-date version of a patient package insert) should flow from the planning efforts. Table II conveys an example of the types of information needed from patients included in a REMS. What the FDA cannot determine for the sponsor is what and how many unwanted events constitute a strong enough signal to initiate a full-blown REMS. This requires forthright discussions with the FDA, ideally initiated by the sponsor.

show abstract

Changes in Asthma Maintenance Therapy Prescribing Patterns Following the 2006 Long-acting β-Agonist FDA Drug Warning

Cited by 4 publications

References 10 publications

Do drug‐related safety warnings have the expected impact on drug therapy? A systematic review

Do drug‐related safety warnings have the expected impact on drug therapy? A systematic review

FDA postmarketing safety labeling changes: What have we learned since 2010 about impacts on prescribing rates, drug utilization, and treatment outcomes

Risk Evaluation and Mitigation Strategies (REMS), Pemoline, and What Is a Signal?

Contact Info

Product

Resources

About