Risperdal ® CONSTA ® Needle Detachment. Incidence Rates Before and After Kit Redesign: A Retrospective Study using Electronic Health Records and Natural Language Processing in the Department of Veterans Affairs.

Autor: Wilcox MA; Epidemiology, Janssen Pharmaceutical Research and Development, LLC, 1125 Trenton-Harbourton Rd., Titusville, NJ, 08560, USA. MWilcox@its.jnj.com., Coppola D; Therapy Area Safety Head Immunology, Janssen Pharmaceutical Research and Development, LLC, 1125 Trenton-Harbourton Rd., Titusville, NJ, 08560, USA., Bailey N; Epidemiology, Anolinx, Inc., 428 E 2400 S, # 202, Salt Lake City, UT, 84107, USA., Wilson A; Anolinx, Inc., 428 E 2400 S, # 202, Salt Lake City, UT, 84107, USA., Kamauu AWC; Anolinx, Inc., 428 E 2400 S, # 202, Salt Lake City, UT, 84107, USA., Alba PR; Department of Veterans Affairs, Salt Lake City Health Care System, VA Informatics and Computing Infrastructure, Salt Lake City, 500 Foothill Blvd, Salt Lake City, UT, 84148, USA.; University of Utah School of Medicine, 30 N 1900 E, Salt Lake City, UT, 84132, USA., Patterson OV; Department of Veterans Affairs, Salt Lake City Health Care System, VA Informatics and Computing Infrastructure, Salt Lake City, 500 Foothill Blvd, Salt Lake City, UT, 84148, USA.; University of Utah School of Medicine, 30 N 1900 E, Salt Lake City, UT, 84132, USA., Viernes B; Department of Veterans Affairs, Salt Lake City Health Care System, VA Informatics and Computing Infrastructure, Salt Lake City, 500 Foothill Blvd, Salt Lake City, UT, 84148, USA.; University of Utah School of Medicine, 30 N 1900 E, Salt Lake City, UT, 84132, USA., Denhalter DW; Department of Veterans Affairs, Salt Lake City Health Care System, VA Informatics and Computing Infrastructure, Salt Lake City, 500 Foothill Blvd, Salt Lake City, UT, 84148, USA.; University of Utah School of Medicine, 30 N 1900 E, Salt Lake City, UT, 84132, USA., Solomon ID; Established Products, CNS Portfolio, Janssen Pharmaceutical Research and Development, LLC, 1125 Trenton-Harbourton Rd., Titusville, NJ, 08560, USA., DuVall SL; Department of Veterans Affairs, Salt Lake City Health Care System, VA Informatics and Computing Infrastructure, Salt Lake City, 500 Foothill Blvd, Salt Lake City, UT, 84148, USA.; University of Utah School of Medicine, 30 N 1900 E, Salt Lake City, UT, 84132, USA.
Jazyk: angličtina
Zdroj: Neurology and therapy [Neurol Ther] 2019 Jun; Vol. 8 (1), pp. 95-108. Date of Electronic Publication: 2019 Mar 07.
DOI: 10.1007/s40120-019-0130-7
Abstrakt: 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.
Databáze: MEDLINE
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