FDA启动可搜索药品和生物制品不良反应数据库

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FDA Launches Searchable Adverse Event Database for Drugs and BiologicsPosted 29 September 2017By Michael Mezher

The US Food and Drug Administration (FDA) on Wednesday launched a new searchable public dashboard for its adverse event database for drugs and biologics.

Known as FAERS (FDA's Adverse Event Reporting System), the database contains some 14 million adverse event reports submitted to FDA by healthcare professionals, consumers and manufacturers for drugs and biologics. Its immediate release led to questions over certain deaths, whether they were linked to the drug's safety profile and statements qualifying what FAERS can and cannot do.

FAERS does not include reports about vaccines or medical devices, which are recorded in separate databases. While adverse event reporting is voluntary for healthcare providers and consumers, manufacturers are required to submit reports they receive about their products to FDA.

FDA says the dashboard is meant to improve transparency and accessibility to adverse event data by allowing users to more easily run custom searches within FAERS without having to submit a request under the Freedom of Information Act (FOIA).

"Prior to today, the FAERS data were made available on a quarterly basis to the public in a format that was not very easy to sort or search. The user needs to know how to use specific applications and analytic tools that required extensive data management and knowledge of relational databases," said Gerald Dal Pan, director of FDA's Office of Surveillance and Epidemiology.

Specifically, the dashboard allows users to run searches based on a specific drug or biologic, patient age, type of adverse event and the year the adverse event took place and narrow results to a specific timeframe spanning back to 1968. As in the past, FDA says the data available through the dashboard will be updated quarterly.

FDA also says it will provide a tutorial on how to use the dashboard sometime in the next two months.

However, the dashboard does not contain any previously unavailable information. The data accessible via the dashboard is the same as FDA has released to the public on a quarterly basis, just packaged in a more user-friendly interface.

But Dal Pan cautioned that the dashboard has some significant limitations, namely that individual case report narratives, which he says can provide important information about the adverse event, are not available through the dashboard and still must be accessed through a FOIA request.

Dal Pan also pointed out that while FAERS data can be useful for identifying safety signals, it cannot be used to establish causation or the incidence rate for specific adverse events.

"While FAERS contains reports on a particular drug, this does not mean that the drug caused the adverse event. Importantly, the FAERS data by themselves are not an indicator of the safety profile of the drug," he said.

Additionally, FDA notes that there are a number of data quality issues that must be considered when looking at FAERS data, including the potential for duplicate, incomplete or inaccurate reports.

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FDA, FAERS Dashboard

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FDA Adverse Events Reporting System (FAERS) Public Dashboard

The FAERS Public Dashboard is a highly interactive web-based tool that will allow for the querying of FAERS data in a user friendly fashion. The intention of this tool is to expand access of FAERS data to the general public to search for information related to human adverse events reported to the FDA by the pharmaceutical industry, healthcare providers and consumers.

While the FAERS dashboard offers stakeholders many more ways of searching for and organizing data on adverse events reported to the FDA for many drug and biologic products, there remain limitations to the data. For example, while FAERS contains reports on a particular drug or biologic, this does not mean that the drug or biologic caused the adverse event. Importantly, the FAERS data by themselves are not an indicator of the safety profile of the drug or biologic. Some additional limitations to note include:

• Duplicate and incomplete reports are in the system: There are many instances of duplicative reports and some reports do not contain all the necessary information.
  
• Existence of a report does not establish causation: For any given report, there is no certainty that a suspected drug caused the reaction.  While consumers and healthcare professionals are encouraged to report adverse events, the reaction may have been related to the underlying disease being treated, or caused by some other drug being taken concurrently, or occurred for other reasons. The information in these reports reflects only the reporter's observations and opinions.
  
• Information in reports has not been verified: Submission of a report does not mean that the information included in it has been medically confirmed nor it is an admission from the reporter that the drug caused or contributed the event.
  
• Rates of occurrence cannot be established with reports: The information in these reports cannot be used to estimate the incidence (occurrence rates) of the reactions reported.
  
• Patients should talk to their doctor before stopping or changing how they take their medications.
  
  

Improving data access and transparency are core concepts that drove the development of this FAERS Dashboard.  The FDA anticipates that this increased transparency will help to spur the submission of more detailed and complete reports from consumers, health care providers and other members of the public. Complete and detailed reports are immensely helpful to the agency when identifying safety signals and choosing particular products for further scrutiny.

Launch the FDA Adverse Events Reporting System (FAERS) Public Dashboard

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