ADRs
As such, pharmacovigilance heavily focuses on adverse drug reactions, or ADRs
Adverse Drug Reaction : ADR
A response to a medicinal product which is noxious and unintended. i.e. resulting not only from the authorised use of a medicinal product at normal doses, but also from medication errors and uses outside the terms of the marketing authorisation, including the misuse and abuse of the medicinal product.
Special Reporting Requirements
- Pregnancy/breastfeeding
- Paediatric use
- Overdose and abuse/misuse
- Compassionate use
- Lack of efficacy
- Suspected transmission of infectious agents
- Medication errors
- Occupational exposure
Information received from patients and healthcare providers, as well as other sources such as the medical literature, plays a critical role in providing the data necessary for pharmacovigilance to take place. In fact, in order to market or to test a pharmaceutical product in most countries, adverse event data received by the license holder -a pharmaceutical company- must be submitted to the local drug regulatory authority.
Ultimately, pharmacovigilance is concerned with identifying the hazards associated with pharmaceutical products and with minimizing the risk of any harm that may come to patients.
Contact Details
Phone: +30 210 281 5353 (ext. 9)
Mobile: +30 697 373 2426 | 24 hours every day
Fax: +30 210 281 1850
Email: [email protected]
