Drug and Device Safety

Free FDA Email Alert Notifications for AAN Members

The American Academy of Neurology and the PDR Network have teamed up to offer AAN members PDR Drug Alerts, a FREE online service that delivers timely neurology–specific FDA–mandated patient safety drug alerts electronically. This important patient safety benefit is FREE to AAN members, but sign–up is necessary.

Benefits

  • The PDR Drug Alerts is the only service that delivers FDA–required drug alerts for recalls and warnings to physicians and prescribers online
  • Excellent opportunity for practicing neurologists to quickly and conveniently stay current on specialty–specific FDA alerts in order to provide the safest and best possible care for their patients
  • Alerts are targeted by specialty—not all doctors get all alerts, so participants can expect to receive less than one alert per week, on average
  • Alerts are emailed immediately from the FDA—no delays in receiving urgent news
  • All the largest pharmaceutical firms are engaged with PDR Drug Alerts
  • Convenient vehicle for forwarding appropriate warnings to patients
  • Improves patient safety and reduces physician liability
  • Endorsed by major liability carriers and medical societies
  • No paper or mailbox clutter
  • Physicians can have a copy of the alerts sent to up to three additional office staff, such as a nurse or receptionist
  • Delivery is guaranteed—if you don't open the email within 72 hours, this will trigger a postal delivery of the information.

How to Get Started Receiving Your FREE FDA Alerts


In order to begin taking advantage of this FREE AAN member benefit, interested members must sign–up by filling out the online PDR Drug Alerts Physician Registration Form.

It only takes a couple of minutes to register and once registered, participants will begin to receive applicable alerts as they are published by the FDA.

Note: Participants may opt out at any time.

Vaccine Adverse Event Reporting System

The Vaccine Adverse Event Reporting System (VAERS) is a national passive surveillance system that is co–managed by the U.S. Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA). VAERS monitors the safety of all vaccines licensed for use in the United States. VAERS accepts reports from healthcare providers, manufacturers, and the public of adverse events following immunization. VAERS serves as an early warning system that can detect patterns in adverse event reports and determine whether further investigation is necessary. Serious and other selected reports are reviewed by medical staff and epidemiologists at both CDC and FDA. However, VAERS data alone are usually not sufficient to determine if a vaccine caused an adverse event. An adverse event is considered serious if it is life threatening, or results in death, a persistent or significant disability or incapacity, congenital anomaly or birth defect, hospitalization, or prolongation of existing hospitalization.

Reporting to VAERS

Healthcare providers are encouraged to submit adverse events they think are clinically important and are required by federal law to report certain adverse events after vaccination; a report may be filed even if the provider is not sure if the vaccine caused an adverse event. VAERS does not actively solicit reports in any systematic way from all people who have been vaccinated. Reports can be submitted by anyone, including healthcare providers, patients, or family members.

Accessing VAERS Data

VAERS reports are available through the public CDC's website, WONDER. All personal identifying information is removed prior to posting the public data. VAERS data in WONDER should be used with caution because it only contains the original VAERS report information and does not reflect data collected during follow–up. Events reported to VAERS and viewed in WONDER should not be considered as evidence that the vaccine caused the event.

Limitations of VAERS

Some adverse events reported to VAERS may have occurred by chance following vaccination, while others may actually be caused by vaccination. However, VAERS data alone cannot usually determine causality. Underreporting and biased reporting are main limitations, inherent to passive surveillance systems, and therefore VAERS only receives reports for only a small percentage of actual events in the general population. VAERS reports can also vary in quality and completeness. A report to VAERS generally does not conclude that a vaccine caused an adverse event. It only confirms that the adverse event happened sometime after a vaccine was received. If a patient believes they have a serious adverse event following a vaccination, they should seek help from their healthcare provider.