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Assessment of the impact of scheduled postmarketing safety summary analyses on regulatory actions.

ABSTRACT: In addition to standard postmarketing drug safety monitoring, Section 915 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) requires the US Food and Drug Administration (FDA) to conduct a summary analysis of adverse event reports to identify risks of a drug or biologic product 18 months after product approval, or after 10,000 patients have used the product, whichever is later. We assessed the extent to which these analyses identified new safety signals and resultant safety-related label changes. Among 458 newly approved products, 300 were the subjects of a scheduled analysis; a new safety signal that resulted in a safety-related label change was found for 11 of these products. Less than 2% of 713 safety-related label changes were based on the scheduled analyses. Our study suggests that the safety summary analyses provide only marginal value over other pharmacovigilance activities.

SUBMITTER: Sekine S

PROVIDER: S-EPMC4943082 | biostudies-literature | 2016 Jul

REPOSITORIES: biostudies-literature

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Assessment of the impact of scheduled postmarketing safety summary analyses on regulatory actions.

Sekine S S Pinnow E E EE Wu E E Kurtzig R R Hall M M Dal Pan G J GJ

Clinical pharmacology and therapeutics 20160331 1

In addition to standard postmarketing drug safety monitoring, Section 915 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) requires the US Food and Drug Administration (FDA) to conduct a summary analysis of adverse event reports to identify risks of a drug or biologic product 18 months after product approval, or after 10,000 patients have used the product, whichever is later. We assessed the extent to which these analyses identified new safety signals and resultant safety-relat ...[more]

PMID: 26853718

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Project description:Elective surgical case cancelations negatively impact healthcare systems and patient dissatisfaction. Preanesthesia assessment clinics (PACs) have been established in many countries to facilitate preoperative medical optimization. However, their benefits for elective procedure cancelations in Thailand have not been formally assessed. This study evaluated the impact of a PAC on scheduled elective surgical case cancelations at a Thai university hospital. A retrospective cross-sectional study was conducted for the period covering from May 2016 to April 2017. We included all scheduled elective surgical cases at Siriraj Hospital, Thailand, canceled on the day of surgery. The cancelation incidences of patients attending and not attending the PAC were compared. Cancellation reasons were categorized as "patient issue," "hospital-facility issue," "surgeon issue," "anesthesiologist issue," "medical condition," and "miscellaneous." The PAC patients' reasons were rigorously explored to determine their preventability. There were 30,351 scheduled elective procedures during the study period. The case-cancelation incidences were 0.9% (95% confidence interval [CI], 0.7-1.2%) for patients visiting the PAC and 5.9% (95% CI, 5.6-6.3%) for those who did not. Medical conditions were the most common reason for cancelation for non-PAC patients (27.3%), whereas hospital-facility issues were the most frequent for PAC patients (43.8%). The cancelation rate for patient issues was significantly lower in the PAC group (4.2% vs 20.7%; P < .05). Thirty-one (64.6%) of the PAC patients' cancelations were potentially preventable. Of the 15 PAC patient cancelations related to medical conditions, 12 were for patients with a history of acute illness and were determined to be nonpreventable. Visiting the PAC was significantly associated with a decreased elective-case cancelation rate. Cancellations were most frequently related to hospital-facility issues for patients visiting the PAC and medical conditions for those who did not. Some PAC patient cancelations for medical conditions involved unpreventable acute patient illnesses. Clinical Trials.gov (NCT02816281).

Dataset Information

Assessment of the impact of scheduled postmarketing safety summary analyses on regulatory actions.

Publications

Assessment of the impact of scheduled postmarketing safety summary analyses on regulatory actions.

Similar Datasets

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