Are there any laws governing the reporting of adverse drug reactions?

In West Virginia, adverse drug reactions (ADRs) to prescription medications must be reported to the West Virginia Board of Pharmacy from licensed pharmacies, manufacturers, and practitioners. The board has authority to receive reports of ADRs and investigate them to protect the public health and welfare. The West Virginia Code of State Regulations states that all licensed pharmacies, manufacturers, or practitioners must report any ADRs that they become aware of. This could include any reactions that occur in the patient as a result of taking the medication, effects during pregnancy or lactation, or any drug-related injuries. Furthermore, any adverse event caused by a medication or drug that has not yet been approved by the FDA must be reported. The reports must be in writing and sent to the Pharmacy Board via the online ADR reporting portal. In the report, the license holder should include the name of the drug, the lot number, the name and address of the patient, and any other information that may be relevant to the investigation. In order to protect public safety, the West Virginia Board of Pharmacy takes these reports very seriously. The board may issue a warning if it is found that any ADRs are not being reported, and a failure to report ADRs could result in disciplinary action against a licensee.

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Are there any laws governing the reporting of adverse drug reactions?

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