Management of adverse drug reactions: Pharmacovigilance Notes
- Understand patient views about medication therapy.
- Educate about the benefits of treatment.
- Inform patients about potential ADRs and management strategies should any occur.
- Ensure an updated and accurate medication list.
- Utilize decision support software to help prevent ADRs.
- Start with low doses and frequencies and slowly titrate as tolerated.
- Initiate less-potent agents, agents with direct mechanisms of action, or alternatives with lower adverse event incidence.
- Avoid or reduce the use of interacting medications.
- Prescribe dosage forms with minimal systemic exposure (eg creams, patches).
- Be familiar with known ADRs of the medication as well as the patient’s pre-existing symptoms.
- Evaluate new symptoms as possible ADRs, looking into health conditions, labs, or other factors which may explain the symptoms.
- Consider the temporal relationship between medication initiation and symptom onset.
- Challenge concepts like stopping the medication to see if the symptom subsides in absence of the medication, and restarting to see if symptoms return.
- Utilize lab tests for more evidence to identify an ADR.
- Apply probability tools7-9 such as the Naranjo Adverse Drug Reaction Probability Scale or 4Ts for heparin-induced thrombocytopenia.10
- Express empathy and maintain a trusting relationship with the patient.
- Reduce dosing or discontinue the offending medication.
- Switch to another agent or dosage form less likely to cause ADRs.
- Treat side effects when necessary (beware of prescribing cascades).
- Document the ADR in the patient’s medical record.
- If working from a care setting separate from pharmacy, notify the patient’s pharmacy to document the ADR in the pharmacy records.
- Report ADRs through appropriate channels such as your organization’s reporting system, the drug manufacturer, FDA MedWatch11 or Vaccine Adverse Event Reporting System.12
- Track and trend ADRs for ongoing process improvement.
American Society of Health-Systems Pharmacists. Guidelines. ASHP Guidelines on adverse drug reaction monitoring and reporting. http://www.ashp.org/DocLibrary/BestPractices/MedMisGdlADR.aspx.
MedWatch: The FDA Safety Information and Adverse Event Reporting Program. http://www.fda.gov/Safety/MedWatch/.
CDC Vaccine Adverse Event Reporting System. https://vaers.hhs.gov/index
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