Читать книгу Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) - William Gregory - Страница 84

The FDA maintains several databases that contain safety information:

FDA Adverse Event Reporting System (FAERS): This is a computerized information system for FDA’ s post-marketing safety surveillance program for drugs and biologics. It is compliant with the data elements specified in the ICH E2B guideline. This database is one of the largest of its kind and contained over 15-million ICSRs as of mid-2018. More than half of these are classified as serious. Quarterly (non-cumulative) data files since January 2004 are available for downloading as zipped SGML or ASCII files. The data in these files are not cumulative and not searchable online. However, there is a “Public Dashboard” that supports searches of FAERS data. It is also possible to request FAERS cases (redacted) using Freedom of Information (FOI) requests.

Data freely available for querying via the “Public Dashboard” include patient demographics, the suspect drug(s) reported, the adverse reaction(s), patient outcome, and the source of the reports. It is possible to stratify and organize data by product, patient age, type of adverse event, the timeframe in which the event occurred, etc.

Post-marketing Requirements (PMRs) and Commitments (PMCs): This database contains information on studies and trials that applicants have committed to carrying out after drug approval.

Vaccine Adverse Event Reporting System (VAERS): VAERS is a cooperative database run by the CDC and the FDA. VAERS collects information about AEs that occur after the use of licensed vaccines, or adverse events following immunization (AEFI). See below under CBER.

Manufacturer and User Facility Device Experience Database (MAUDE): This database contains selected safety information for medical device reports since 1991 and is updated weekly. See below under CDRH.

Clinical Trials Database: This is not a safety database but has information about governmental and private clinical trials under way in the United States and globally. There are tens of thousands of trials in more than 170 countries on file. Some contain safety information. The PDUFA/FDAAA laws require safety information to be put online and this has been a gradual process. See: www.clinicaltrials.gov

Other databases include such topics as poisonous plants.