What adverse drug reactions should be reported?

Reportable Adverse Drug Reactions

All serious adverse drug reactions should be reported to the FDA's MedWatch program, particularly those involving hospitalization, death, life-threatening illness, disability, or other medically important conditions. 1

Definition and Classification of Adverse Drug Reactions

An adverse drug reaction (ADR) is defined as a response to a medicinal product that is noxious and unintended, occurring at doses normally used for prophylaxis, diagnosis, or therapy of disease 2. These reactions differ from medication errors, overdoses, or access issues.

ADRs can be classified into several types:

• Type A (Augmented): Dose-related, predictable from known pharmacology
• Type B (Bizarre): Non-dose related, unpredictable
• Type C (Chronic): Dose-related and time-related
• Type D (Delayed): Time-related
• Type E (End of use): Withdrawal reactions
• Type F (Failure): Unexpected failure of therapy
• Type G (Genetic): Genetically determined reactions

Criteria for Reporting Adverse Drug Reactions

Healthcare professionals should report:

1. Serious adverse events defined as medical events that involve 1:

   • Hospitalization
   • Death
   • Life-threatening illness
   • Disability
   • Other medically important conditions

2. Events listed by manufacturers as contraindications to subsequent doses of the medication 1

3. Events listed in the Reportable Events Table that occur within the specified period after medication administration 1

4. Unusual or severe toxicities believed to be associated with medication use 1

5. Any clinically significant adverse events that occur after administration of medications, even if causal relation is uncertain 1

Reporting Mechanisms

1. For vaccines: Report to the Vaccine Adverse Events Reporting System (VAERS)

   • Web-based reporting available at http://secure.vaers.org/VaersDataEntryintro.htm
   • Phone reporting available 24 hours a day at 800-822-7967
   • Forms available at http://vaers.hhs.gov 1

2. For medications (including antiretrovirals) and biologics: Report to FDA's MedWatch program

   • Online at http://www.fda.gov/medwatch
   • By mail to MedWatch, HF-2, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857
   • By phone at 800-332-1088 1

Special Considerations for Specific Drug Classes

Chemotherapeutic Agents

Virtually all drugs used in oncology can cause adverse reactions, particularly:

• Platinum agents (carboplatin, cisplatin, oxaliplatin)
• Taxanes (paclitaxel, docetaxel)
• Liposomal doxorubicin

These reactions range from mild infusion reactions to severe life-threatening anaphylaxis 1.

Antiviral Medications

For antiviral medications like oseltamivir:

• Monitor for neuropsychiatric events, particularly in adolescents and children
• Report nausea, vomiting, and other side effects that may affect compliance
• Pay careful attention to dosing in young children and infants 1

Documentation Requirements

When documenting an adverse drug reaction, include:

1. Detailed description of the reaction
2. Timing in relation to drug administration
3. Management steps taken
4. Assessment of causality
5. Recommendations for future use of the medication 2

Common Pitfalls in ADR Reporting

1. Failure to recognize mild reactions that may predict more severe reactions with continued exposure 2
2. Inadequate documentation of reaction details, which impacts future medication decisions 2
3. Not reporting reactions that resolve after decreasing infusion rate or stopping medication 1
4. Missing drug interactions that contribute to adverse reactions 1
5. Overlooking the need to report even when causality is uncertain 1

Remember that proper reporting of adverse drug reactions is essential for patient safety and contributes to the ongoing evaluation of medication safety profiles.