| Adverse Event Reporting is a very important part of | | | | These are predictable but are often unavoidable. |
| the entire pharmacovigilance exercise. Adverse | | | | - Type B: Allergic or idiosyncratic reactions, usually |
| events are unwanted effects caused by drugs. Each | | | | occurs in a minority of patients and usually unrelated |
| drug may have many adverse effects and these | | | | to dosage. These effects are serious, unexpected |
| may be heterogeneous. Adverse reactions may vary | | | | and unpredictable. |
| from a simple headache to even death, in some | | | | - Type C: Chronic effects related to an increased |
| extreme cases. | | | | frequency of 'spontaneous' disease |
| Clinical trials management system and other | | | | - Type D: Adverse reactions that are a delayed |
| observational procedures work to track adverse | | | | response to the drug |
| reactions during drug development. But that's just not | | | | - Type E: The adverse effects at the end of the |
| enough. Often adverse reactions can be identified | | | | treatment using the particular drug |
| even after successful marketing of drugs. In some | | | | - Type F: Failed therapy Classification based on |
| cases, adverse event patterns may be identified | | | | severity: |
| years after the drug was launched, and products | | | | - Permanent, persistent or significant disability |
| have been withdrawn from market. | | | | - Life-threatening condition |
| Monitoring and assessing adverse reactions goes a | | | | - Need for hospitalization |
| long way in improving drug safety. Adverse Event | | | | - Congenital Anomaly |
| Reporting System helps monitor adverse drug | | | | - Intervention needed to prevent permanent damage |
| reactions and bring it to the notice of regulatory | | | | - Death Classification of adverse reactions helps |
| authorities and pharmaceutical companies. These are | | | | identify the cause, assess the severity and evaluate |
| classified under different categories to make | | | | the safety of a drug. It helps drug companies and |
| assessment of effects easier. Adverse effects are | | | | regulatory bodies analyze the relative benefits of the |
| classified based on causal factors and severity. | | | | drug as against the adverse effects. An efficient |
| Classification based on causal factors: | | | | adverse event reporting system helps identify and |
| - Type A: Overdose reactions that are related to the | | | | classify these adverse effects, thereby improving |
| exaggeration of the therapeutic effects of the drug. | | | | strategies for pharmacovigilance. |