Strategies implemented for accurate dispensing of an investigational new drug in a multi-site HIV prevention clinical trial

Safe practices for dispensing investigational product (IP) during clinical trials are not standardized and information in this regard is often limited. ASPIRE was a Phase 3 safety and effectiveness trial of a vaginal matrix ring containing 25 mg of dapivirine for the prevention of HIV-1 in women. Th...

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Autores principales:	Cindy Jacobson, Jayajothi Moodley, Aruna Bhoola, Rebecca Sakwa, Jeeva Moodley, Jasmin Sukdao, Nivriti Hurbans, Bhavna Maharaj, Anushka Naidoo, Melanie Maclachlan, Gift Chareka, Kudzai Hlahla, Mary Chadza
Formato:	article
Lenguaje:	EN
Publicado:	Elsevier 2021
Materias:	Pharmacy Investigational product Dispensing errors Quality checks Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/f1a0194d2b9e41018ec43050784e0567
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spelling	oai:doaj.org-article:f1a0194d2b9e41018ec43050784e05672021-11-14T04:34:42ZStrategies implemented for accurate dispensing of an investigational new drug in a multi-site HIV prevention clinical trial2451-865410.1016/j.conctc.2021.100859https://doaj.org/article/f1a0194d2b9e41018ec43050784e05672021-12-01T00:00:00Zhttp://www.sciencedirect.com/science/article/pii/S2451865421001599https://doaj.org/toc/2451-8654Safe practices for dispensing investigational product (IP) during clinical trials are not standardized and information in this regard is often limited. ASPIRE was a Phase 3 safety and effectiveness trial of a vaginal matrix ring containing 25 mg of dapivirine for the prevention of HIV-1 in women. The study enrolled 2629 women at 15 clinical research sites in Malawi, Uganda, South Africa and Zimbabwe who were randomized in a 1:1 ratio to receive either a vaginal ring containing 25 mg of dapivirine or a matching placebo vaginal ring. The vaginal rings and packaging were identical in appearance in order to maintain the study blind. A real-time, documented second check of the dispensing process was conducted by a second pharmacy staff. Frequent inventory counts and real time accountability audits were also useful for rapidly identifying a dispensing error. A total of 52,625 vaginal rings were dispensed with only three documented pharmacy dispensing errors. There were zero dispensing errors at 13 of the 15 sites with an overall rate of <1.0 per 10,000 rings dispensed. Our study findings support the implementation of a double check dispensing process and real time accountability audits as standard practice in clinical trials.Cindy JacobsonJayajothi MoodleyAruna BhoolaRebecca SakwaJeeva MoodleyJasmin SukdaoNivriti HurbansBhavna MaharajAnushka NaidooMelanie MaclachlanGift CharekaKudzai HlahlaMary ChadzaElsevierarticlePharmacyInvestigational productDispensing errorsQuality checksMedicine (General)R5-920ENContemporary Clinical Trials Communications, Vol 24, Iss , Pp 100859- (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Pharmacy Investigational product Dispensing errors Quality checks Medicine (General) R5-920
spellingShingle	Pharmacy Investigational product Dispensing errors Quality checks Medicine (General) R5-920 Cindy Jacobson Jayajothi Moodley Aruna Bhoola Rebecca Sakwa Jeeva Moodley Jasmin Sukdao Nivriti Hurbans Bhavna Maharaj Anushka Naidoo Melanie Maclachlan Gift Chareka Kudzai Hlahla Mary Chadza Strategies implemented for accurate dispensing of an investigational new drug in a multi-site HIV prevention clinical trial
description	Safe practices for dispensing investigational product (IP) during clinical trials are not standardized and information in this regard is often limited. ASPIRE was a Phase 3 safety and effectiveness trial of a vaginal matrix ring containing 25 mg of dapivirine for the prevention of HIV-1 in women. The study enrolled 2629 women at 15 clinical research sites in Malawi, Uganda, South Africa and Zimbabwe who were randomized in a 1:1 ratio to receive either a vaginal ring containing 25 mg of dapivirine or a matching placebo vaginal ring. The vaginal rings and packaging were identical in appearance in order to maintain the study blind. A real-time, documented second check of the dispensing process was conducted by a second pharmacy staff. Frequent inventory counts and real time accountability audits were also useful for rapidly identifying a dispensing error. A total of 52,625 vaginal rings were dispensed with only three documented pharmacy dispensing errors. There were zero dispensing errors at 13 of the 15 sites with an overall rate of <1.0 per 10,000 rings dispensed. Our study findings support the implementation of a double check dispensing process and real time accountability audits as standard practice in clinical trials.
format	article
author	Cindy Jacobson Jayajothi Moodley Aruna Bhoola Rebecca Sakwa Jeeva Moodley Jasmin Sukdao Nivriti Hurbans Bhavna Maharaj Anushka Naidoo Melanie Maclachlan Gift Chareka Kudzai Hlahla Mary Chadza
author_facet	Cindy Jacobson Jayajothi Moodley Aruna Bhoola Rebecca Sakwa Jeeva Moodley Jasmin Sukdao Nivriti Hurbans Bhavna Maharaj Anushka Naidoo Melanie Maclachlan Gift Chareka Kudzai Hlahla Mary Chadza
author_sort	Cindy Jacobson
title	Strategies implemented for accurate dispensing of an investigational new drug in a multi-site HIV prevention clinical trial
title_short	Strategies implemented for accurate dispensing of an investigational new drug in a multi-site HIV prevention clinical trial
title_full	Strategies implemented for accurate dispensing of an investigational new drug in a multi-site HIV prevention clinical trial
title_fullStr	Strategies implemented for accurate dispensing of an investigational new drug in a multi-site HIV prevention clinical trial
title_full_unstemmed	Strategies implemented for accurate dispensing of an investigational new drug in a multi-site HIV prevention clinical trial
title_sort	strategies implemented for accurate dispensing of an investigational new drug in a multi-site hiv prevention clinical trial
publisher	Elsevier
publishDate	2021
url	https://doaj.org/article/f1a0194d2b9e41018ec43050784e0567
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Strategies implemented for accurate dispensing of an investigational new drug in a multi-site HIV prevention clinical trial

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