Risperdal^® CONSTA^® Needle Detachment. Incidence Rates Before and After Kit Redesign: A Retrospective Study using...

Area of Science:

• Pharmacovigilance
• Medical device safety
• Retrospective cohort studies

Background:

• Janssen received reports of needle detachments associated with Risperdal® CONSTA®.
• A redesigned kit was introduced to address these safety concerns.

Purpose of the Study:

• To estimate the incidence of needle detachments for Risperdal® CONSTA® before and after the introduction of a redesigned kit.
• To assess the effectiveness of the redesigned kit in reducing needle detachment events.

Main Methods:

• Retrospective study utilizing record abstraction from the US Department of Veterans Affairs (VA).
• Included a pilot study, a baseline study (original device), and a follow-up study (redesigned device).
• Employed administrative codes and natural language processing with clinical review to identify needle detachment events.

Main Results:

• The baseline incidence of needle detachments with the original device was 0.0459% (22 events per 47,934 administrations).
• The follow-up incidence with the redesigned device was 0.0335% (14 events per 41,819 injections).
• This represents a 27% reduction in the incidence of needle detachment events.

Conclusions:

• The study methodology allowed for the identification of both spontaneously reported and previously unreported needle detachment events.
• While the method may have led to some undercounting, it did not bias the comparison between the original and redesigned kits.
• The redesigned Risperdal® CONSTA® kit demonstrated a significant reduction in the incidence of needle detachment events within the VA population.