Pharmacovigilance aims to ensure that medicines are used safely and effectively by identifying, assessing, understanding, and preventing adverse drug reactions.

ADRs can be detected through various methods, including spontaneous reporting by healthcare professionals and patients, clinical trials, and data analysis from electronic health records.

A risk management plan aims to identify and assess risks associated with a medicine, develop strategies to minimize or eliminate risks, and monitor the safety of the medicine after it is marketed.

The Food and Drug Administration (FDA) is responsible for pharmacovigilance in the United States, including the monitoring of ADRs and the regulation of drug safety.

Healthcare professionals play a crucial role in pharmacovigilance by reporting suspected ADRs to regulatory authorities, educating patients about the safe use of medicines, and monitoring patients for ADRs.

A signal in pharmacovigilance refers to any information that suggests a possible causal relationship between a medicine and an ADR. It can include an increase in the number of ADR reports, a cluster of ADRs with a similar pattern, or a change in the safety profile of a medicine over time.

A pharmacovigilance risk assessment report (RARR) aims to evaluate the risk-benefit balance of a medicine, identify and assess risks associated with the medicine, and develop strategies to minimize or eliminate risks.

Type D ADRs are caused by an interaction between two or more medicines, resulting in an adverse reaction that is not predictable based on the individual properties of the medicines involved.

Regulatory authorities play a crucial role in pharmacovigilance by monitoring the safety of medicines after they are marketed, reviewing and approving new medicines before they are marketed, and conducting clinical trials to evaluate the safety and efficacy of medicines.

Developing risk management plans is an example of a proactive pharmacovigilance activity, as it aims to identify and assess risks associated with a medicine and develop strategies to minimize or eliminate those risks before the medicine is marketed.

A pharmacovigilance plan outlines the pharmacovigilance activities to be conducted for a medicine, including the methods for ADR detection, risk management, and regulatory reporting.

Monitoring ADR reports is an example of a reactive pharmacovigilance activity, as it involves responding to ADRs that have already occurred.

Patients play an important role in pharmacovigilance by reporting suspected ADRs to healthcare professionals, participating in clinical trials, and providing feedback on the safety of medicines.

Type A ADRs are caused by an overdose of a medicine or by an exaggerated pharmacological effect of the medicine.

A pharmacovigilance database is used to collect and store ADR reports, analyze ADR data to identify signals, and support risk management activities.