Regulatory Governance

Pharmacovigilance is a process involving detection, assessment, understanding, and prevention of adverse events—ensures that medicines are used in the full knowledge of risks (opens in a new window); patients, health professionals, pharmaceutical companies and medicines regulators all contribute to pharmacovigilance activity. Knowledge acquired from the activity is used to continually reassess the balance between benefits and harms of medicines and for optimising drug (opens in a new window); therapy in the individual.

By maintaining vigilance for unwanted effects of medicines and by reporting them, clinicians play an important role in establishing a drug’s adverse-effect profile. Spontaneous reporting of suspected adverse effects (Yellow Card reports in the UK), together with post-authorisation (post-marketing) safety studies and literature reports, all contribute to the knowledge on adverse effects of medicines.

PharmaConsult will provide help in accessing up-to-date sources of information on adverse effects in order to select a medicine and to prescribe it in a way that minimises the risk of harm. Anticipating and minimising adverse reactions to medicines can have a very substantial effect on morbidity, hospitalisation, and on mortality.