Review article

Risk Management – Maximum Effect of Minimization Measures

Klaudija Marijanović Barać ; PLIVA Hrvatska d. o. o., Zagreb
Vanesa Ivetić Tkalčević ; PLIVA Hrvatska d. o. o., Zagreb
Gabriella Letinić Klier ; PLIVA Hrvatska d. o. o., Zagreb
Sanja Perko ; PLIVA Hrvatska d. o. o., Zagreb
Jelena Žanetić ; PLIVA Hrvatska d. o. o., Zagreb
Azra Omerović ; PLIVA Hrvatska d. o. o., Zagreb

Abstract

Based on non-clinical and clinical findings pharmaceutical companies needs to agree on a Risk Management Plan (RMP) with the authority at the time of drug approval in the European Union. RMP defines measures that a company needs to implement to collect more information and mitigate risk related to drug use. Measures are defined as either routine pharmacovigilance (reporting of adverse events, periodic reports, safety signal detection) or as additional measures (post-authorization safety studies). Safe drug use by healthcare providers and patients is assured by routine risk minimization measures (communication of information through the summary of products characteristics and patient information leaflet) and additional measures (such as educational materials, letters to healthcare providers and pregnancy prevention programs). RMP is updated during product life-cycle based on new information to assure positive benefit/risk of the drug and safe drug use by healthcare providers and patients. Pharmaceutical companies and health authorities may also take other actions to educate healthcare professionals and patients in order to decrease risks related to drug use.

Keywords

risk management plan; pharmacovigilance; adverse event; patient safety; periodic safety update reports; risk minimization; post authorization safety study

Hrčak ID:

185274

URI

https://hrcak.srce.hr/185274

Publication date:

26.7.2017.

Article data in other languages: croatian

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