Outdated Prescription Drug Labeling: How FDA-Approved Prescribing Information Lags Behind Real-World Clinical Practice.
Michael B SheaMark D StewartHugo Van DykeLinda OstermannJeff AllenEllen SigalPublished in: Therapeutic innovation & regulatory science (2018)
The labeling for many cancer drugs, particularly for older drugs, is outdated. Although FDA-approved labeling can never be fully aligned with real-world clinical practice, steps should be taken to better align the two when high-quality data exist. Such steps, if taken, will assist patients and prescribers in discerning which uses of drugs are supported by the highest quality evidence.
Keyphrases
- clinical practice
- end stage renal disease
- ejection fraction
- primary care
- newly diagnosed
- prognostic factors
- drug administration
- drug induced
- peritoneal dialysis
- physical activity
- adverse drug
- middle aged
- patient reported outcomes
- big data
- young adults
- patient reported
- machine learning
- health information
- data analysis