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The Healthcare Professionals' Perspective on Impact and Actions Taken Following Severe Infusion Reaction Events in Oncology Centers in Europe.
Kafatos, George; Dube, Sabada; Burdon, Peter; Lowe, Kimberly; Leclerc, Marjorie; Flinois, Alain; Demonty, Gaston.
Affiliation
  • Kafatos G; Center for Observational Research, Amgen Ltd, Uxbridge Business Park, Sanderson Road, Uxbridge, UB8 1DH, England, UK. gkafatos@amgen.com.
  • Dube S; Center for Observational Research, Amgen Ltd, Uxbridge Business Park, Sanderson Road, Uxbridge, UB8 1DH, England, UK.
  • Burdon P; EU Medical Affairs, Amgen (Europe) GmbH, Rotkreuz, Switzerland.
  • Lowe K; Center for Observational Research, Amgen Inc, Thousand Oaks, CA, USA.
  • Leclerc M; RWE/Epi Studies, Kantar Health, Paris, France.
  • Flinois A; RWE/Epi Studies, Kantar Health, Paris, France.
  • Demonty G; Medical Development, Amgen, Avenue Ariane/Arianelaan 5, 1200, Brussels, Belgium.
Drugs Real World Outcomes ; 7(2): 119-130, 2020 Jun.
Article in En | MEDLINE | ID: mdl-32170663
ABSTRACT

PURPOSE:

The study aim was to describe the management strategies used for severe infusion-related reactions (SIRs) and understand the impact of such events in oncology day hospitals in France, Germany, Spain, and the UK.

METHODS:

The study was based on qualitative telephone interviews and quantitative self-completion questionnaires and asked healthcare professionals about the impact of SIRs and consequent actions taken.

RESULTS:

The procedures to prevent and manage SIRs were similar across countries and settings. In all countries, they were part of a larger risk-assessment and adverse events-prevention process. Preventive measures included patient history, risk assessment, pre-medication, and close monitoring of high-risk patients. The management procedures comprised stopping the infusion, triggering of the emergency chain, administering corticosteroids ± antihistamines, and hospitalization if necessary. The recalled SIRs had important consequences to affected patients, healthcare providers, and hospital organizational plans. All affected patients needed to be monitored closely for a prolonged time, thus blocking hospital beds. 44% of patients needed to be hospitalized, 17% needed resuscitation, and one patient died of cardiac arrest immediately after the start of the infusion. Importantly, 82% of patients were not re-challenged with the presumedly SIR-causing regimen or re-challenged in a later line.

CONCLUSION:

SIRs are unpredictable in nature, may have an extremely rapid onset, and are potentially fatal. Such events have a profound impact on the affected and surrounding patients, the care team and the organizational plan of the day-hospitals. Specific tools to reliably identify high-risk patients and predict the occurrence of events are needed.

Full text: 1 Collection: 01-internacional Database: MEDLINE Type of study: Prognostic_studies / Qualitative_research / Risk_factors_studies Language: En Journal: Drugs Real World Outcomes Year: 2020 Document type: Article Affiliation country: United kingdom

Full text: 1 Collection: 01-internacional Database: MEDLINE Type of study: Prognostic_studies / Qualitative_research / Risk_factors_studies Language: En Journal: Drugs Real World Outcomes Year: 2020 Document type: Article Affiliation country: United kingdom