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Barriers and Facilitators of Availability of Hydroxyurea for Sickle Cell Disease in Tanzania; A Qualitative Study of Pharmaceutical Manufacturers, Importers, and Regulators

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 importa...

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Autores principales: Mlyuka, Hamu J., Kilonzi, Manase, Mutagonda, Ritah F., Chirande, Lulu, Mikomangwa, Wigilya P., Myemba, David T., Sambayi, Godfrey, Mwakawanga, Dorkasi L., Ndunguru, Joyce, Jonathan, Agnes, Makani, Julie, Ruggajo, Paschal, Minja, Irene K., Balandya, Emmanuel, Kamuhabwa, Appolinary A. R.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9690851/
https://www.ncbi.nlm.nih.gov/pubmed/36360565
http://dx.doi.org/10.3390/healthcare10112223
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author Mlyuka, Hamu J.
Kilonzi, Manase
Mutagonda, Ritah F.
Chirande, Lulu
Mikomangwa, Wigilya P.
Myemba, David T.
Sambayi, Godfrey
Mwakawanga, Dorkasi L.
Ndunguru, Joyce
Jonathan, Agnes
Makani, Julie
Ruggajo, Paschal
Minja, Irene K.
Balandya, Emmanuel
Kamuhabwa, Appolinary A. R.
author_facet Mlyuka, Hamu J.
Kilonzi, Manase
Mutagonda, Ritah F.
Chirande, Lulu
Mikomangwa, Wigilya P.
Myemba, David T.
Sambayi, Godfrey
Mwakawanga, Dorkasi L.
Ndunguru, Joyce
Jonathan, Agnes
Makani, Julie
Ruggajo, Paschal
Minja, Irene K.
Balandya, Emmanuel
Kamuhabwa, Appolinary A. R.
author_sort Mlyuka, Hamu J.
collection PubMed
description 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.
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spelling pubmed-96908512022-11-25 Barriers and Facilitators of Availability of Hydroxyurea for Sickle Cell Disease in Tanzania; A Qualitative Study of Pharmaceutical Manufacturers, Importers, and Regulators Mlyuka, Hamu J. Kilonzi, Manase Mutagonda, Ritah F. Chirande, Lulu Mikomangwa, Wigilya P. Myemba, David T. Sambayi, Godfrey Mwakawanga, Dorkasi L. Ndunguru, Joyce Jonathan, Agnes Makani, Julie Ruggajo, Paschal Minja, Irene K. Balandya, Emmanuel Kamuhabwa, Appolinary A. R. Healthcare (Basel) Article 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. MDPI 2022-11-07 /pmc/articles/PMC9690851/ /pubmed/36360565 http://dx.doi.org/10.3390/healthcare10112223 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Mlyuka, Hamu J.
Kilonzi, Manase
Mutagonda, Ritah F.
Chirande, Lulu
Mikomangwa, Wigilya P.
Myemba, David T.
Sambayi, Godfrey
Mwakawanga, Dorkasi L.
Ndunguru, Joyce
Jonathan, Agnes
Makani, Julie
Ruggajo, Paschal
Minja, Irene K.
Balandya, Emmanuel
Kamuhabwa, Appolinary A. R.
Barriers and Facilitators of Availability of Hydroxyurea for Sickle Cell Disease in Tanzania; A Qualitative Study of Pharmaceutical Manufacturers, Importers, and Regulators
title Barriers and Facilitators of Availability of Hydroxyurea for Sickle Cell Disease in Tanzania; A Qualitative Study of Pharmaceutical Manufacturers, Importers, and Regulators
title_full Barriers and Facilitators of Availability of Hydroxyurea for Sickle Cell Disease in Tanzania; A Qualitative Study of Pharmaceutical Manufacturers, Importers, and Regulators
title_fullStr Barriers and Facilitators of Availability of Hydroxyurea for Sickle Cell Disease in Tanzania; A Qualitative Study of Pharmaceutical Manufacturers, Importers, and Regulators
title_full_unstemmed Barriers and Facilitators of Availability of Hydroxyurea for Sickle Cell Disease in Tanzania; A Qualitative Study of Pharmaceutical Manufacturers, Importers, and Regulators
title_short Barriers and Facilitators of Availability of Hydroxyurea for Sickle Cell Disease in Tanzania; A Qualitative Study of Pharmaceutical Manufacturers, Importers, and Regulators
title_sort barriers and facilitators of availability of hydroxyurea for sickle cell disease in tanzania; a qualitative study of pharmaceutical manufacturers, importers, and regulators
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9690851/
https://www.ncbi.nlm.nih.gov/pubmed/36360565
http://dx.doi.org/10.3390/healthcare10112223
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