Simulation: Prepare an Adverse Drug Reaction report

**Adverse Drug Reaction Report** **Report ID:** ADR-2023-001 **Patient Information:** - **Patient ID:** P-123456 - **Age:** 45 years - **Gender:** Female - **Weight:** 70 kg - **Height:** 165 cm - **Medical History:** Hypertension, Type 2 Diabetes Mellitus **Medication Information:** - **Medication Name:** Metformin - **Dosage:** 500 mg twice daily - **Route of Administration:** Oral - **Start Date:** September 1, 2023 - **End Date:** N/A (ongoing treatment) **Adverse Drug Reaction Details:** - **Date of Onset:** September 15, 2023 - **Date of Report:** October 1, 2023 - **Description of ADR:** The patient experienced severe gastrointestinal distress, including: - Nausea - Vomiting - Diarrhea - Abdominal pain - **Severity:** Moderate (patients experienced significant discomfort but no hospitalization required) - **Duration of ADR:** Approximately 3 days (September 15-17, 2023) - **Outcome:** The symptoms resolved completely after temporary discontinuation of Metformin. **Concomitant Medications:** - Lisinopril 10 mg once daily (for hypertension) - Atorvastatin 20 mg once daily (for hyperlipidemia) **Laboratory Tests:** - **Results:** No abnormalities reported; normal blood glucose levels were maintained throughout the episode. **Action Taken:** - Metformin was temporarily discontinued. The symptoms significantly improved within three days. After a consultation, the healthcare provider prescribed a lower dose of Metformin (250 mg twice daily) and advised dietary adjustments. Patient was monitored closely for any further ADRs. **Reporting Information:** - **Reporter Name:** Dr. Sarah Thompson - **Reporter Contact Information:** [Phone: (555) 123-4567; Email: This email address is being protected from spambots. You need JavaScript enabled to view it.] - **Institution:** General Hospital, Health City, State **Recommendations:** - Advise patients on the potential gastrointestinal side effects of Metformin. - Consider regular monitoring of patients starting Metformin, particularly those with a history of gastrointestinal issues. - Encourage proper hydration and dietary modifications when initiating this medication. --- **Note:** This report provides details of an adverse drug reaction for the purposes of simulation and training in pharmacovigilance practices.