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Review article

Pharmacovigilance – Keeping our Patients Safe

Vanesa Ivetić Tkalčević ; PLIVA Hrvatska d. o. o., Zagreb
Gabriella Letinić Klier ; PLIVA Hrvatska d. o. o., Zagreb
Petra Lazarić Bošnjak ; PLIVA Hrvatska d. o. o., Zagreb
Klaudija Marijanović Barać ; PLIVA Hrvatska d. o. o., Zagreb

Full text: croatian pdf 188 Kb

page 53-58

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Full text: english pdf 188 Kb

page 53-53

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Pharmacovigilance is the science which implicates activities related to the detection, assessment, understanding, prevention and treatment of side effects, and new information on the hazards of medicines. It relies on the cooperation between marketing authorization holders, clinical trial sponsors, medicines agencies, health care providers (HCP) and patients. The mission of pharmacovigilance is to enable the reporting of adverse events (AE) by patients and HCP and to collect AE in clinical trials and in everyday practice in order to identify previously unrecognized AE and new aspects of the previously recognized AE. Individual AE case reports are forwarded to medicines agencies in legally defined timelines. Received AE are periodically qualitatively and quantitatively assessed. The gathered information is forwarded to HCP through direct letters or Summaries of product characteristics, and to patients through Patient information leaflets. The aim is to make sure that the appropriate medication is prescribed in the appropriate dose and in an appropriate manner. According to the collected data, the risks and benefits of the drug are assessed, package leaflets updated, and additional measures introduced. Further monitoring of the impact of all undertaken measures and procedures is set to ensure safe and effective administration of drugs. The drug is on the market as long as the measures are effective and as long as the benefits outweigh the risks. If the measures and procedures have not led to a secure drug use, and it is anticipated that no measures can ensure safe use of the drug, then the drug is withdrawn from the market.


pharmacovigilance, adverse event, adverse drug reaction, therapeutic agent, patient safety, summary of product characteristics, patient information leaflet, healthcare providers, pharmaceutical industry, medicines agency, risk minimization

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Article data in other languages: croatian

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