Detection and monitoring of ADRs
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This document discusses the detection and monitoring of adverse drug reactions (ADRs). It outlines that ADRs are detected through pre-marketing studies such as acute toxicity and specific animal tests as well as clinical trials. Post-marketing surveillance also plays an important role in ADR detection through spontaneous reporting systems and epidemiological methods. In hospitals, healthcare professionals can detect ADRs by closely monitoring high-risk patients and collecting detailed patient data to assess causality and severity of suspected ADRs.
Detection and monitoring of ADRs
- 1. DETECTION AND MONITORING OF ADRS Dr. Ramesh Bhandari Asst. Professor, Department of Pharmacy Practice KLE College of Pharmacy, Belagavi
- 4. Dr. Ramesh Bhandari Detection and monitoring of ADRs • Acute toxicity • Specific animal tests • Clinical trials Pre- marketing Studies • Spontaneous reporting system • Epidemiological methods Post- Marketing Surveillance
- 5. Dr. Ramesh Bhandari Acute Toxicity Study organs affected Study dose dependency of toxicity
- 6. Dr. Ramesh Bhandari Specific animal tests Carcinogenicity Teratogenicity Mutagenicity “However, animal can only serve as approximate models for humans”
- 7. Dr. Ramesh Bhandari Clinical Trials Approx. 4000-5000 individuals exposed In 3 phases Identify adverse reactions of a frequency greater than 0.5 – 1.0% “Children, elderly, multiple disease patients and pregnant women are normally excluded”
- 8. Dr. Ramesh Bhandari Post Marketing Surveillance Benefit for the identification of all drug related risks Include active and passive pharmacovigilance methodologies Spontaneous Reporting System Pharmaco-epidemiological methods
- 9. Dr. Ramesh Bhandari Spontaneous Reporting System Most sensitive, powerful and cost effective system for identification of ADR Every health care practitioner should report any suspicion of a drug unexpectedly causing a risk to patient situation. Outcome – signals generation of unknown problems. “Not possible to quantify the risk”
- 10. Dr. Ramesh Bhandari Pharmacoepidemiological Methods Verify the hypothesis of a causal link between drug exposure and an ADR. Also possible to quantify the risk Various pharmacoepidemiological methods includes Case reports Cohort studies Case-Control studies
- 11. Dr. Ramesh Bhandari Cohort Studies Population Drug Exposed ADR No ADR Drug Unexposed ADR No ADR Time
- 13. Dr. Ramesh Bhandari In Hospital Setup Healthcare professionals can detect ADRs during ward rounds with the medical team or during review of the patients treatment chart. To assist detection of ADRs, healthcare professionals should closely monitor patients who are at high risk. These include: ◦ Patients with renal or hepatic impairment ◦ Patients taking drugs which have a potential to cause ADRs example: Narrow therapeutic agents ◦ Patients who had previous allergic reactions ◦ Patients taking multiple drug therapy (poly pharmacy) ◦ Pregnant and breast feeding women.
- 14. Dr. Ramesh Bhandari In Hospital Setup First step in detection of ADR is data collection. Data to be collected includes patient’s demographic information, presenting complaints, past medical and medication history, drug therapy details including OTC, current and medication on admission, laboratory investigation details, Details of suspected ADR such as time of onset of reaction, nature and severity, details of the suspected drug including dose, frequency, time of administration, duration of treatment, plasma concentration of the drug, Previous reports on reactions, data on any other causes including risk factors and predisposing factors.
- 15. Dr. Ramesh Bhandari In Hospital Setup Suspected ADRs has to be then assessed for causality and/Or Severity.
- 16. Dr. Ramesh Bhandari REFERENCE 1) G. Parthasarathi, Karin Nyfort Hansen, Milap C Nahata. A textbook of clinical pharmacy practice Essential concepts and skills. 2nd edition, Universities Press.