TY - JOUR
T1 - Do anti-malarials in Africa meet quality standards? the market penetration of non quality-assured artemisinin combination therapy in eight African countries
AU - ACTwatch Group
AU - Akulayi, Louis
AU - Alum, Angela
AU - Andrada, Andrew
AU - Archer, Julie
AU - Arogundade, Ekundayo D.
AU - Auko, Erick
AU - Badru, Abdul R.
AU - Bates, Katie
AU - Bouanchaud, Paul
AU - Bruce, Meghan
AU - Bruxvoort, Katia
AU - Buyungo, Peter
AU - Camilleri, Angela
AU - Carter, Emily D.
AU - Chapman, Steven
AU - Charman, Nikki
AU - Chavasse, Desmond
AU - Cyr, Robyn
AU - Duff, Kevin
AU - Esch, Keith
AU - Evance, Illah
AU - Fulton, Anna
AU - Gataaka, Hellen
AU - Guedegbe, Gylsain
AU - Haslam, Tarryn
AU - Harris, Emily
AU - Hong, Christine
AU - Hurley, Catharine
AU - Isenhower, Whitney
AU - Kaabunga, Enid
AU - Kaaya, Baraka D.
AU - Kabui, Esther
AU - Kangwana, Beth
AU - Kapata, Lason
AU - Kaula, Henry
AU - Kigo, Gloria
AU - Kyomuhangi, Irene
AU - Lailari, Aliza
AU - Lefevre, Sandra
AU - Littrell, Megan
AU - Martin, Greta
AU - Michael, Daniel
AU - Monroe, Erik
AU - Mpanya, Godefroid
AU - Mpasela, Felton
AU - Mulama, Felix
AU - Musuva, Anne
AU - Ngigi, Julius
AU - Ngoma, Edward
AU - Norman, Marjorie
N1 - Publisher Copyright:
© 2017 The Author(s).
PY - 2017/5/25
Y1 - 2017/5/25
N2 - Background: Quality of artemisinin-based combination therapy (ACT) is important for ensuring malaria parasite clearance and protecting the efficacy of artemisinin-based therapies. The extent to which non quality-assured ACT (non-QAACT), or those not granted global regulatory approval, are available and used to treat malaria in endemic countries is poorly documented. This paper uses national and sub-national medicine outlet surveys conducted in eight study countries (Benin, Kinshasa and Kantanga [Democratic Republic of the Congo, DRC], Kenya, Madagascar, Nigeria, Tanzania, Uganda and Zambia) between 2009 and 2015 to describe the non-QAACT market and to document trends in availability and distribution of non-QAACT in the public and private sector. Results: In 2014/15, non-QAACT were most commonly available in Kinshasa (83%), followed by Katanga (53%), Nigeria (48%), Kenya (42%), and Uganda (33%). Non-QAACT accounted for 20% of the market share in the private sector in Kenya, followed by Benin and Uganda (19%), Nigeria (12%) and Zambia (8%); this figure was 27% in Katanga and 40% in Kinshasa. Public sector non-QAACT availability and distribution was much lower, with the exception of Zambia (availability, 85%; market share, 32%). Diverse generics and formulations were available, but non-QAACT were most commonly artemether-lumefantrine (AL) or dihydroartemisinin-piperaquine (DHA PPQ), in tablet formulation, imported, and distributed in urban areas at either pharmacies or drug stores. The number of unique manufacturers supplying non-QAACT to each country ranged from 9 in Uganda to 92 in Nigeria. Conclusions: Addressing the availability and distribution of non-QAACT will require effective private sector engagement and evidence-based strategies to address provider and consumer demand for these products. Given the variation in non-QAACT markets observed across the eight study countries, active efforts to limit registration, importation and distribution of non-QAACT must be tailored to the country context, and will involve addressing complex and challenging aspects of medicine registration, private sector pharmaceutical regulation, local manufacturing and drug importation. These efforts may be critical not only to patient health and safety, but also to effective malaria control and protection of artemisinin drug efficacy in the face of spreading resistance.
AB - Background: Quality of artemisinin-based combination therapy (ACT) is important for ensuring malaria parasite clearance and protecting the efficacy of artemisinin-based therapies. The extent to which non quality-assured ACT (non-QAACT), or those not granted global regulatory approval, are available and used to treat malaria in endemic countries is poorly documented. This paper uses national and sub-national medicine outlet surveys conducted in eight study countries (Benin, Kinshasa and Kantanga [Democratic Republic of the Congo, DRC], Kenya, Madagascar, Nigeria, Tanzania, Uganda and Zambia) between 2009 and 2015 to describe the non-QAACT market and to document trends in availability and distribution of non-QAACT in the public and private sector. Results: In 2014/15, non-QAACT were most commonly available in Kinshasa (83%), followed by Katanga (53%), Nigeria (48%), Kenya (42%), and Uganda (33%). Non-QAACT accounted for 20% of the market share in the private sector in Kenya, followed by Benin and Uganda (19%), Nigeria (12%) and Zambia (8%); this figure was 27% in Katanga and 40% in Kinshasa. Public sector non-QAACT availability and distribution was much lower, with the exception of Zambia (availability, 85%; market share, 32%). Diverse generics and formulations were available, but non-QAACT were most commonly artemether-lumefantrine (AL) or dihydroartemisinin-piperaquine (DHA PPQ), in tablet formulation, imported, and distributed in urban areas at either pharmacies or drug stores. The number of unique manufacturers supplying non-QAACT to each country ranged from 9 in Uganda to 92 in Nigeria. Conclusions: Addressing the availability and distribution of non-QAACT will require effective private sector engagement and evidence-based strategies to address provider and consumer demand for these products. Given the variation in non-QAACT markets observed across the eight study countries, active efforts to limit registration, importation and distribution of non-QAACT must be tailored to the country context, and will involve addressing complex and challenging aspects of medicine registration, private sector pharmaceutical regulation, local manufacturing and drug importation. These efforts may be critical not only to patient health and safety, but also to effective malaria control and protection of artemisinin drug efficacy in the face of spreading resistance.
KW - ACT
KW - Anti-malarial
KW - Medicine quality
KW - Regulation
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U2 - 10.1186/s12936-017-1818-8
DO - 10.1186/s12936-017-1818-8
M3 - Article
C2 - 28539125
AN - SCOPUS:85019704434
SN - 1475-2875
VL - 16
JO - Malaria journal
JF - Malaria journal
IS - 1
M1 - 204
ER -