Understanding Adverse Drug Events, Reactions, and Medication Errors Killing people FAQs Unveiled
Reporting Adverse Drug Reactions India : Council of International Organizations of Medical Science
Frequently Asked Questions About Documenting and Reporting Adverse Drug Reactions in India
DEFINITIONS
What constitutes an adverse drug event (ADE)?
An adverse drug event encompasses injuries resulting from drug use, including harm caused directly by the drug or harm from the use of the drug, such as dose reductions or discontinuations of drug therapy. While some ADEs result from medication errors, the majority do not.
How is an adverse drug reaction (ADR) defined?
An adverse drug reaction is a noxious and unintended response to a drug occurring at doses typically used for treatment or diagnosis. Unlike side effects, there is a direct causal link between the drug and the adverse reaction.
How does an ADR differ from a side effect or allergy?
An allergy involves an adverse drug reaction mediated by the immune system, while a side effect is an expected outcome of drug use that is not the intended therapeutic effect. The term “side effect” is recommended to be avoided in favor of adverse drug reaction to emphasize the potential for harm.
What constitutes a medication error?
Medication errors are mishaps that occur during any stage of drug management, including prescribing, dispensing, administration, and monitoring. Not all prescribing errors lead to adverse outcomes, but they can pose risks to patient safety.
People Are Dying Because of Medicinal Reactions
DOCUMENTING AND REPORTING Medicinal Reactions Adverse Drug Reactions :
Why is it important to document adverse drug reactions?
Documenting adverse drug reactions is crucial for preventing future harm to patients. It helps in identifying new adverse reactions as drugs are used in larger or different populations than during initial clinical trials.
Which types of adverse drug reactions should be documented?
Suspected adverse drug reactions for new drugs within three years of market entry and suspected severe adverse reactions for any drug should be documented. Additionally, adverse reactions that cause harm, alter therapeutic care, or pose future dangers to patients should be documented.
Where should adverse drug reactions be documented?
Adverse drug reactions should be documented in clinic notes and in the allergies/adverse reactions data field in CPRS (Computerized Patient Record System).
How are adverse drug reactions entered into CPRS?
Adverse drug reactions can be entered into CPRS using the Order menu, selecting Allergies, entering the drug name, and completing the form, which takes approximately 30 seconds.
What is the distinction between “Observed” and “Historical” Adverse Drug Reactions?
When entering adverse reactions into CPRS, providers can specify whether the event was observed or historical.
Should additional information be provided?
Providers should document the severity of adverse reactions, listing them as mild, moderate, or severe in the CPRS template.
What happens with the information provided?
Information on observed reactions is reviewed by pharmacists and reported to the Pharmacy & Therapeutics (P&T) Committee. Serious reactions are reported to the FDA’s MedWatch program.
May individual providers report problems to the FDA?
Clinicians can report serious events to the FDA, typically through their facility’s pharmacy service.
What does the FDA do with MedWatch reports?
Reports received through MedWatch are investigated to determine their clinical significance and potential public health impact.
How should significant medication errors be reported?
Significant medication errors should be reported through the patient incident reporting system at healthcare facilities via the Patient Safety Manager.
Is there anything else to be done for VA patients experiencing serious adverse drug reactions?
Patients should be informed about the adverse reaction and advised on drugs to avoid in the future.
Is there a scenario where previously documented Allergies/Adverse Reactions may be removed from CPRS?
Removal of documented adverse reactions should follow institutional policy and protocols developed by the Pharmacy & Therapeutics Committee.
Reference: Nebeker JR, Barach P, Samore MH. Clarifying Adverse Drug Events: A Clinician’s Guide to Terminology, Documentation, and Reporting. Ann Intern Med. 2004; 140:795-801.
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