System Maintenance Notice

Please note that maintenance work is scheduled between 4 AM and 5 AM - CET. During this time, you may experience reduced performance. Thanks for your patience.

Publications

Journal Article Epublish 6 citations

PubMed: 36360565 DOI: 10.3390/healthcare10112223

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

Healthcare (Basel) 10(11)

Authors: Hamu J Mlyuka, Manase Kilonzi, Ritah F Mutagonda, Lulu Chirande, Wigilya P Mikomangwa, David T Myemba, Godfrey Sambayi, Dorkasi L Mwakawanga, Joyce Ndunguru, Agnes Jonathan, Julie Makani, Paschal Ruggajo, Irene K Minja, Emmanuel Balandya, Appolinary A R Kamuhabwa

Affiliations

  • Department of Clinical Pharmacy and Pharmacology, School of Pharmacy, Muhimbili University of Health and Allied Sciences, Dar es Salaam P.O. Box 65013, Tanzania.
  • Sickle Pan African Research Consortium (SPARCO), Dar es Salaam P.O. Box 65001, Tanzania.
  • Department of Paediatrics and Child Health, Muhimbili University of Health and Allied Sciences, Dar es Salaam P.O. Box 65001, Tanzania.
  • Department of Pharmaceutics and Pharmacy Practice, School of Pharmacy, Muhimbili University of Health and Allied Sciences, Dar es Salaam P.O. Box 65013, Tanzania.
  • Department of Pharmacognosy, School of Pharmacy, Muhimbili University of Health and Allied Sciences, Dar es Salaam P.O. Box 65013, Tanzania.
  • Department of Community Health Nursing, School of Nursing, Muhimbili University of Health and Allied Sciences, Dar es Salaam P.O. Box 65001, Tanzania.
  • Sickle Cell Program, Department of Hematology and Blood Transfusion, School of Medicine, Muhimbili University of Health and Allied Sciences, Dar es Salaam P.O. Box 65001, Tanzania.
  • Nephrology Unit, Department of Internal Medicine, School of Medicine, Muhimbili University of Health and Allied Sciences, Dar es Salaam P.O. Box 65001, Tanzania.
  • Department of Restorative Dentistry, School of Dentistry, Muhimbili University of Health and Allied Sciences, Dar es Salaam P.O. Box 65001, Tanzania.
  • Department of Physiology, School of Medicine, Muhimbili University of Health and Allied Sciences, Dar es Salaam P.O. Box 65001, Tanzania.

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.

MeSH

Anemia, Sickle Cell, Pharmaceutical Preparations, Hydroxyurea, Cells, Investments

Cited by