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2 results on '"Aruna Bhoola"'

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

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, and Mary Chadza

Subjects
Pharmacy, Investigational product, Dispensing errors, Quality checks, Medicine (General), R5-920
Abstract

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

Published
2021
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2. Strategies implemented for accurate dispensing of an investigational new drug in a multi-site HIV prevention clinical trial

Author

Mary Chadza, Gift Chareka, Aruna Bhoola, Jasmin Sukdao, Melanie Maclachlan, Kudzai Hlahla, Jayajothi Moodley, Rebecca Sakwa, Nivriti Hurbans, Mtn, Jeeva Moodley, Cindy Jacobson, Aspire Study Team, Anushka Naidoo, and Bhavna Maharaj

Subjects
Medicine (General), PTID, Participant Identification, Dapivirine, GCP, Good Clinical Practice, Pharmacy, Audit, Article, Quality checks, SOPs, Standard Operating Procedures, R5-920, Dispensing errors, medicine, Double check, Investigational product, Pharmacology, business.industry, Investigational New Drug, General Medicine, ICH, International Council for Harmonisation, medicine.disease, Vaginal ring, Clinical trial, IP, Investigational Product, Clinical research, Medical emergency, business, NCR, No-carbon required
Abstract

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

Published
2021

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