Post-authorisation safety study of the incidence rate of medication errors before and after the discontinuation of the lower strength vials for Pharmalgen (NI-PH-X-01)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/30408
• EU PAS number:
  EUPAS25639
• Study ID:
  30408
• Official title and acronym:
  Post-authorisation safety study of the incidence rate of medication errors before and after the discontinuation of the lower strength vials for Pharmalgen (NI-PH-X-01)
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  United Kingdom
• Study description:
  ALK has discontinued production of the lower strengths ofPharmalgen (0.12 μg, 1.2 μg and 12 μg, lower strength vials).Removal of the lower strength vials from the market necessitates achange in the preparation of the up-dosing strengths. The purpose of this study is to characterize safety of Pharmalgenproducts after removal of the lower strength vials to evaluate if anincrease occurs in medication errors or systemic allergic reactionsrelated to medication errors during the up-dosing phase. The data collected for this study will be spontaneously reportedindividual case safety reports (ICSRs) of medication errors andserious systemic allergic reactions concerning patients in the up-dosing phase of treatment with Pharmalgen (801) Apis mellifera orPharmalgen (802) Vespula spp. from the UK.
• Study status:
  Finalised

Research institutions and networks

Institutions

ALK-Abelló

Study timelines

Date when funding contract was signed

Planned: 02/05/2017

Actual: 02/05/2017

Study start date

Planned: 01/01/2017

Actual: 01/01/2017

Data analysis start date

Planned: 01/01/2019

Actual: 01/01/2019

Date of final study report

Planned: 30/06/2019

Actual: 13/05/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

ALK-Abelló A/S

Study protocol

Initial protocol

PASS protocol Pharmalgen_final

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)