Adverse Drug Reactions

Adverse drug reaction (ADR, or adverse drug effect) is a broad term referring to unwanted, uncomfortable, or dangerous effects that a drug may have. ADRs can be considered a form of toxicity; however, toxicity is most commonly applied to effects of overingestion  or to elevated blood levels or enhanced drug effects that occur during appropriate use (eg, when drug metabolism is temporarily inhibited by a disorder or another drug).Side effect is an imprecise term often used to refer to a drug’s unintended effects that occur within the therapeutic range. Because all drugs have the potential for ADRs, risk-benefit analysis (analyzing the likelihood of benefit vs risk of ADRs) is necessary whenever a drug is prescribed. Read More

Your Patient Has an Adverse Reaction to a Drug: How to Report to FDA's MedWatch

This article is the first in a series of activities in collaboration with the Food and Drug Administration (FDA) and Medscape Education on how to report safety issues to the FDA and how these reports are used to ensure safe use of drugs and medical products.

Healthcare professionals must remain knowledgeable and vigilant about the latest drug and device safety issues and other adverse events that may affect patient health outcomes. Physicians, physician assistants, advanced practice nurses, nurses, pharmacists, and other providers often are the first to identify and witness the negative effects of drug-drug interactions, drug use errors, malfunctions and flaws in medical devices, or other adverse events.

Documenting these types of problems is critical to the safety of patients and clinical practice. The healthcare professional must disseminate these findings to help inform the medical and public health communities and the general public of these potential serious adverse events or issues associated with a medication or medical product.

The US Food and Drug Administration (FDA) established MedWatch, the FDA Safety Information and Adverse Event Reporting Program, to assist healthcare providers and the general public in notifying the agency of adverse events or medical product errors.

To learn more about the MedWatch program and the types of safety information to report through the system,Medscape Education recently interviewed Anna M. Fine, PharmD, MS, director of the Health Professional Liaison Program, Office of Special Health Issues. Dr. Fine oversees the MedWatch educational outreach program. Read More

FDA Information on Vasostrict Storage

The FDA’s drug approval process provides a review of product-specific information that is critical to ensuring the safety and efficacy of a finished drug product. For instance, the applicant must demonstrate that its manufacturing processes can reliably produce drug products of expected strength, quality, and purity and identify appropriate storage conditions to maintain drug quality. Furthermore, FDA’s review of the applicant’s labeling ensures that health care professionals and patients have the information necessary to understand a drug product’s risks and its safe and effective use.

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