Clofazimine (CFZ), previously used in the treatment of leprosy, has been repurposed for use in drug resistant tuberculosis treatment. In 2016 the World Health Organization published updated drug resistant tuberculosis guidelines that include CFZ as a core medicine in the treatment regimen. The new regimen adopted by South Africa (SA), has the potential to improve treatment success rates from 52% for multidrug resistant tuberculosis (2013 cohort) and 28% for extensively drug resistant tuberculosis (Global TB report 2016) to > 85% as reported under study conditions by Van Deun et al. As SA prepares to roll-out the new regimen it is important to assess factors impacting on access and availability of CFZ to ensure a sustainable supply of medicine to meet the needs of the population. Published literature was reviewed to identify barriers to CFZ access globally followed by a review of the South African policy guidelines and usage at a centralized drug resistant tuberculosis unit in KwaZulu Natal to assess if these barriers impact on access. A review of pharmacy issues between 2012 and July 2017 was conducted. A literature search of publications that cited barriers to CFZ access found that common provider barriers globally were lack of registration, regulatory restrictions, non-inclusion into National guidelines and essential medicines list and limitations in the number of pre-qualified products registered. A review of South African policy documents and usage indicated that although some global barriers did exist in SA, there is access to CFZ in KZN as shown by usage history although restricted to the centralized unit. During the study period 2012 – July 2017, 2209 patients with pre-extensively drug resistant tuberculosis (resistance to rifampicin, isoniazid, aminoglycoside or fluoroquinolone) and extensively drug resistant tuberculosis (resistance to rifampicin, isoniazid, aminoglycoside and fluoroquinolone) received CFZ as part of their treatment regimen. This was facilitated by the importation of CFZ into the country using a section 21 authorization. Compliance to the regulatory requirements of informed consents and progress reports was found to be a challenge and must be addressed if the authorization is to be renewed every 6 months. Expansion of the usage of CFZ to multidrug resistant tuberculosis (resistance to rifampicin and isoniazid only) will increase demand from approximately 300 to 3000 patients per year making it impossible to sustain the regulatory requirements associated with the use of an unregistered medicine. In conclusion there is political will in SA to enable access to CFZ as seen by inclusion into the South African multidrug resistant tuberculosis guidelines and usage. However, some barriers do exist that may impact negatively on sustainable access to medicine that may erode the perceived success of the new short course MDR TB treatment regimen. It is hereby recommended that CFZ registration in SA for a tuberculosis indication and inclusion into the National STG and EML must be fast-tracked and access to CFZ must also be decentralized to all initiating facilities in KZN.

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