Abstract
INTRODUCTION: Janssen received reports of needle detachments for Risperdal(®) CONSTA(®) and, in response, redesigned the kit. OBJECTIVE: The study objective was to estimate the rate of Risperdal(®) CONSTA(®) needle detachments prior to and after the introduction of a redesigned kit. METHODS: This retrospective study used record abstraction in the US Department of Veterans Affairs (VA). The 3 phases included: (1) a pilot study for methods evaluation in a sample of 6 hospitals with previously reported detachments; (2) a baseline study to ascertain the baseline detachment rate; and (3) a follow-up study to ascertain the rate for the redesigned kit. Administrative codes and natural language processing with clinical review were used to identify detachments. RESULTS: Pilot: we identified a subset of spontaneously reported detachments and several previously unreported events. In the baseline study (original device), from January through December 2013, 22 needle detachments were identified among 47,934 administrations of the drug in a census of administrations in the VA; an incidence of 0.0459%. In the follow-up study (redesigned device), from December 2015 through December 2016, there were 14 reported detachments in 41,819 injections, 0.0335%. This represents a reduction of 27% from the baseline. CONCLUSION: This approach enabled us to identify needle detachments we would not have otherwise found ("solicited"). However, it likely resulted in incomplete outcome ascertainment. While this may have resulted in lower overall rates, it did not bias the comparison of the baseline and follow-up studies. The results showed that the redesigned Risperdal(®) CONSTA(®) kit reduced the incidence of needle detachment events in the VA. FUNDING: Janssen Pharmaceuticals, Inc.