July 19, 2024

Management of adverse drug reactions: Pharmacovigilance Notes

Management of adverse drug reactions: Pharmacovigilance Notes

Risk Minimization

  • 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).

Recognition, Detection

  • 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.

Suggested readings:


Further readings:

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


Final Year B Pharm Notes, Syllabus, Books, PDF Subjectwise/Topicwise

Final Year B Pharm Sem VIIBP701T Instrumental Methods of Analysis Theory
BP702T Industrial Pharmacy TheoryBP703T Pharmacy Practice Theory
BP704T Novel Drug Delivery System TheoryBP705 P Instrumental Methods of Analysis Practical
Final Year B Pharm Sem VIIBP801T Biostatistics and Research Methodology Theory
BP802T Social and Preventive Pharmacy TheoryBP803ET Pharmaceutical Marketing Theory
BP804ET Pharmaceutical Regulatory Science TheoryBP805ET Pharmacovigilance Theory
BP806ET Quality Control and Standardization of Herbals TheoryBP807ET Computer-Aided Drug Design Theory
BP808ET Cell and Molecular Biology TheoryBP809ET Cosmetic Science Theory
BP810ET Experimental Pharmacology TheoryBP811ET Advanced Instrumentation Techniques Theory
BP812ET Dietary supplements and NutraceuticalsPharmaceutical Product Development

Recommended readings: