Adverse Drug Reaction
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"The HIPAA Privacy Rule recognizes the legitimate need for public health authorities and others responsible for ensuring public health and safety to have access to protected health information to carry out their public health mission. The Rule also recognizes that public health reports made by covered entities are an important means of identifying threats to the health and safety of the public at large, as well as individuals. Accordingly, the Rule permits covered entities to disclose protected health information without authorization for specified public health purposes."1

In order to keep effective drugs and devices available on the market for use by you and your patients, the FDA relies on the voluntary reporting of serious adverse events or product problems that you suspect are associated with a drug or medical device you have used. The FDA uses this data to maintain safety surveillance of all FDA-regulated products. Your report may be the critical action that prompts a modification in use or design of the product, improves the understanding of the safety profile of the drug or device, and leads to increased patient safety. To make a report with the FDA, you may download:

Form FDA 3500 - Voluntary Reporting. For use by healthcare professionals, consumers, and patients. FDA Form 3500 Adverse Drug Reaction Download
Form FDA 3500A - Mandatory Reporting. For use by individual reporters, manufacturers, distributors, importers, user facilities personnel. FDA Form 3500A Adverse Drug Reaction Download
You may also make an online report directly to the FDA. FDA Form 3500 Adverse Drug Reaction Online Reporting

 

 

     

1(From OCR Guidance Explaining Significant Aspects of the Privacy Rule - DISCLOSURES FOR PUBLIC HEALTH ACTIVITIES, page 28. See also 45 CFR 164.512(b)(1)(i) and (iii))

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