Preventable Adverse Drug Reactions reported to the Croatian Agency for Medicinal Products and Medical Devices (PREVENTABLE)

Study identification

• EU PAS number:
  EUPAS11644
• Study ID:
  26827
• Official title and acronym:
  Preventable Adverse Drug Reactions reported to the Croatian Agency for Medicinal Products and Medical Devices (PREVENTABLE)
• DARWIN EU® study:
  No
• Study countries:
  Croatia
• Study description:
  Non-interventional, observational study aimed at identifying, evaluating and describing preventable adverse drug reactions (ADRs) among the spontaneously reported ADRs to the Croatian Agency for Medicinal Products and Medical Devices (HALMED) will be conducted. Estimated total number of reports included in the study is 1000 cases and will capture individual case safety reports (ICSR) in the period between 2013 and 2015. The previously validated “P-method” will be employed to systematically detect preventable ADRs in ICSR sent to the Croatian pharmacovigilance centre at HALMED.
• Study status:
  Planned

Research institutions and networks

Institutions

Department for Pharmacovigilance and Rational Pharmacotherapy, Agency for Medicinal Products and Medical Devices (Phv Department -HALMED)

Croatia

Study timelines

Date when funding contract was signed

Planned:01/01/2015

Study start date

Planned:01/01/2005

Data analysis start date

Planned:01/01/2015

Date of final study report

Planned:31/12/2016

Sources of funding

Other

More details on funding

HALMED

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable