by Jane Cotter Forbes

Published: Lifelines for Health Spring 2018

There are many medications for people with bleeding disorders in the marketplace today and our pipelines are bursting with new therapies and medications. Some medications have been available or many years while others are newly FDA approved. If you or your loved ones experience a serious adverse event (AE) while using a bleeding disorders medication, it is always a good idea to voluntarily report an AE to the Food and Drug Administration (FDA) MedWatch consumer voluntary reporting program. AE’s should be reported as soon as possible to MedWatch using Form FDA 3500B by those who are consumers and medical personnel for the following situations: death, life-threatening medical events (e.g., anaphylactic reactions), AEs that require hospitalization (short or long term), disability or permanent damage, congenital anomaly and/or birth defect, and any required medical intervention to prevent permanent impairment (e.g., hemorrhage). If you are not sure if the AE is related to the medications you are using, it still is a good idea to voluntarily submit a report to MedWatch just in case. Mandatory reporting is required by law by user- facilities, importers, distributors, and manufacturers. AE’s for these organizations need to be reported to MedWatch within 24-48 hours. In considering the filing of a voluntary report for an AE to the FDA, here are some points for guidance!

IT IS EASY. First you go directly to the FDA MedWatch website [https://www.accessdata.fda. gov/scripts/medwatch/index.cfm?action=reporting. home] and click on form 3500B. Then you start filling in the blanks. When you are done, you hit send. In particular, the website asks for a lot number, an NDC number, the strength, the units, and the quantity (how many doses or vials of the medication were used).

Most of this information can be found from the container of the medication and/or on the prescription label. The website asks for a detailed description of the AE or serious problem as well any and all medical reports (if available). You will need to include a list of all other medications in use. This website also suggests not throwing the medication away because the FDA may request what remains for further inspection.

In addition, medication that comes with faulty equipment or devices such as needle breaking or ineffective transfer device to be reported. If you are not able to use the website addressed herein, you are free to call the FDA at 1-800-FDA-1088 in order to file a report. “The FDA encourages patients to report AEs as soon as possible. If the AE team gets a cluster of reports about the same drug in a short period of time, it will be able to respond more quickly.” IT TAKES ONLY A FEW MINUTES. Depending on the details of what you submit and the explanation of the AE, it will mostly likely take only 10 to 15 minutes to complete.

IT IS IMPORTANT. It is the fundamental way by which American people can alert the FDA of any
and all AEs after having taken a pharmaceutical medication. This information is gathered, reviewed, analyzed, and a determination is readily made if further action is needed. All AE reports are kept in the FDA database.

IT IS APPRECIATED. The FDA truly welcomes this information, for it provides ready and immediate feedback on medications which they have approved. It is an essential feedback mechanism. The FDA MedWatch system also allows for consumers or patients to report voluntarily and independently from their doctors. The FDA “understands that for a variety of reasons, you may not wish to have the form filled out by your health care provider, or your health care provider may choose not to complete the form.

IT IS REWARDING. There is a genuine sense of personal fulfillment in having participated in this safety program for not only the American people, but for people worldwide, who might also have access to such medications. It is a tangible means by which we can protect ourselves from harmful medications.

IT IS FOR EVERYONE. All Americans using prescription drugs approved by the FDA are encouraged to report all adverse events or serious problems.

SO WHAT HAPPENS AFTER AN AE REPORT IS FILED?

The FDA reviews all of the submitted MedWatch reports for safety signals - similar adverse events

occurring with a particular drug. Some examples include:

• A new serious AE which is not listed in the drug’s package insert

• An increase in the reporting rate of an event already occurring with a drug

• A new report of how an FDA approved drug interacts with other medications.

• A product’s name, packaging, or labeling leading to an AE needs to be adjusted, relabeled, and added safety information needs to be included.

Depending on the information found during the FDA’s review of the safety signals and the severity of the AE, the FDA may decide to:

Update the drug’s package insert or labeling

• Place restrictions on the drug’s distribution

• Release a drug safety communication to inform the public

• Withdraw the drug from the market