Barriers and Facilitators of Availability of Hydroxyurea for Sickle Cell Disease in Tanzania; A Qualitative Study of Pharmaceutical Manufacturers, Importers, and Regulators
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Published:2022-11-07
Issue:11
Volume:10
Page:2223
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ISSN:2227-9032
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Container-title:Healthcare
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language:en
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Short-container-title:Healthcare
Author:
Mlyuka Hamu J., Kilonzi ManaseORCID, Mutagonda Ritah F.ORCID, Chirande Lulu, Mikomangwa Wigilya P., Myemba David T.ORCID, Sambayi GodfreyORCID, Mwakawanga Dorkasi L.ORCID, Ndunguru Joyce, Jonathan AgnesORCID, Makani Julie, Ruggajo Paschal, Minja Irene K.ORCID, Balandya EmmanuelORCID, Kamuhabwa Appolinary A. R.
Abstract
Despite three decades of proven safety and effectiveness of hydroxyurea in modifying sickle cell disease (SCD), its accessibility is limited in Sub-Saharan Africa, which shares 75% of the world’s SCD burden. Therefore, it is time to explore the barriers and facilitators for manufacturing and importation of hydroxyurea for SCD in Tanzania. This was qualitative research that employed a case study approach. Purposive sampling followed by an in-depth interview (IDI) using a semi-structured questionnaire aspired by data saturation enabled us to gather data from 10 participants. The study participants were people with more than three years of experience in pharmaceuticals importation, manufacturing, and regulation. The audio-recorded data were verbatim transcribed and analyzed using thematic analysis. Two themes were generated. The first comprised barriers for importation and manufacturing of hydroxyurea with sub-themes such as inadequate awareness of SCD and hydroxyurea, limited market, and investment viability. The second comprised opportunities for importation and manufacturing of hydroxyurea with sub-themes such as awareness of activities performed by medicines regulatory authority and basic knowledge on SCD and hydroxyurea. Inadequate understanding of SCD, hydroxyurea, and orphan drug regulation are major issues that aggravate the concern for limited market and investment viability. Existing opportunities are a starting point towards increasing the availability of hydroxyurea.
Funder
National Heart, Lung and Blood Institute of the National Institutes of Health
Subject
Health Information Management,Health Informatics,Health Policy,Leadership and Management
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