Adverse drug reaction and ADR reporting.

The presentation deals about adverse durg reaction definition and types.Also how to report the adverse drug reaction in ADR form.

1. PH-1.7 Define, identify and describe the management of adverse drug reactions

2. ADR Reporting Form

3. Temporal relationship: The time relationship between administration of a medicine and appearance of new clinical features De-challenge : The suspected medicine is stopped and observed whether the new clinical feature disappears or not Rechallenge : Again exposing person to the suspected medicine and observe if the adverse event recurs If the adverse feature re-appears within plausible time period, it’s a strongest proof that medicine is associated

4. Confounding/alternative explanation for adverse event : It’s important to search for any alternative explanation to the adverse event Is it possible that the adverse event would have been caused by any other reason? Is it possible that other disease process is responsible for the event?

5. Naranjo ADR probability scale

6. Scoring for Naranjo algorithm: >9 = Definite ADR; 5-8= Probable; 1-4= Possible ADR; 0= Doubtful ADR

7. Question 1 Prajakta, a 45 year old female was suffering from burning micturition for 5 days. On examination, PR-78 bpm, BP-120/78 mmHg, Wt - 58 Kg She was diagnosed to have UTI for which TAB-NORFLOXACIN 400mg BD, TAB-DOXYCYCLINE 100mg BD, TAB-PANTOPRAZOLE 40 mg OD were prescribed for 5 days starting from 10/7/23. After 3 days of talking medication, burning micturition was resolved but she started feeling pain while climbing stairs. She was again taken to hospital and diagnosed to have TENDNITIS and the medications were discontinued. Adverse events improved when the drug was discontinued. Drug details: Name Manufacturer Batch no Expiry date Dose and Route Frequency Norfloxacin X 507001 8/7/24 400mg Oral BD Doxycycline Y 307821 15/6/24 100mg Oral BD Pantoprazole Z 207876 19/9/24 40mg Oral OD