In August 2011, the Department of Health announced a new policy for the decentralised management of drug-resistant tuberculosis. If this plan is put into action as intended, it could be a major step forward in South Africa’s fight against the disease. But almost two years on, implementation remains patchy.

What is the policy of decentralising treatment?

‘Multi-Drug Resistant Tuberculosis: A Policy Framework on Decentralised and Deinstitutionalised Management for South Africa’ is a Department of Health (DoH) document that begins by recognising the high burden of TB in South Africa. Our nation now has the third highest prevalence of TB in the world, and while our exact burden of MDR-TB is unknown, one estimate – which may even be conservative – suggests that there are 13,000 new cases in the country each year. The prevalence of extensively-drug resistant TB (XDR-TB) is also on the rise.

The policy document discusses the weaknesses of the TB treatment programme that lead to the development of the policy changes. These include delays in the initiation of treatment after diagnosis, limited beds for hospitalisation, poor infection control in health settings, and poor treatment adherence. Poor adherence, the document indicates, is also the result of the many side-effects experienced by patients during their lengthy treatment, and the refusal of patients to be hospitalised because of competing personal responsibilities.

Before the development of this decentralisation policy, all drug-resistant TB (DR-TB) patients had to be hospitalised for a period of at least six months. The new policy stipulates that “all MDR-TB smear-negative, TB culture-positive patients need to be started on [out-patient] treatment. Other MDR-TB patients without extensive disease, [who are] stable [and] smear-positive should be admitted until two negative smear microscopy results are received. Only very sick MDR-TB [patients] with extensive disease and XDR-TB patients will be admitted until they have two consecutive TB culture[-]negative results.” (An analysis of sputum is used to diagnose TB, and patients who are smear-negative are less infectious that those who are smear-positive.)

Long hospital waiting lists have often led to delays in treatment initiation of up to four months. Fewer than 55% of MDR-TB patients diagnosed in 2009 started treatment the same year, and this percentage rose to 71% in 2010.

New evidence suggests that a large proportion of DR-TB infection is caused by direct transmission, rather than from patients who default on treatment and develop resistance. Patients who begin treatment and remain adherent rapidly become non-infectious. By contrast, undiagnosed and untreated TB accounts for the highest percentage of transmission.

Treatment outcomes under South Africa’s previous TB policy were alarmingly poor. The Department of Health (DoH) conducted a review of their 2007 cohort of MDR-TB patients. The data revealed a treatment success rate of just 42% and a treatment default rate of 9.6%. 20.4 % of the MDR-TB patients died.

The DoH’s new policy framework therefore aims to make treatment more accessible and socially acceptable. It seeks both to improve individual patient outcomes and to reduce overall transmission.

According to the policy document, each province will still maintain one centralised TB treatment unit. These units will be responsible for initiating and monitoring all XDR-TB patients, including children, and MDR-TB patients with complications.

Decentralised DR-TB units, which could be as large as an entire hospital or as small as just one ward within a hospital, will be responsible for initiating and monitoring MDR-TB patients and could also be used to manage XDR-TB patients.

Satellite units will assume responsibility for providing medication and monitoring once patients have started their treatment at the centralised or decentralised units. Such units will be transitional and located in hospitals, community health centres or other health facilities. Eventually, many will be equipped to function as decentralised units themselves.

Once patients become asymptomatic and are able to tolerate treatment, they can be discharged to continue it at their nearest primary health care (PHC) facility or at home.

The policy allows for the creation of mobile teams, based at the satellite units of PHC facilities. These teams will be responsible for providing patients with home-based treatment and ensuring good infection control.

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Ms ZD presented to the obstetric clinic at Rahima Moosa Mother and Child Hospital in the third trimester of her pregnancy with coughing and night sweats. It had taken her two weeks to reach the hospital because she lived far away and had another young child to care for. She was diagnosed with multidrug-resistant TB (MDR-TB) and referred to Helen Joseph Hospital, which houses a decentralised TB unit.

Because Ms ZD was unable to secure transport money for her journey to the Helen Joseph Hospital to begin treatment, her local clinic arranged transportation for her. Two weeks later, further testing revealed that Ms ZD had smear-positive MDR-TB. According to the new treatment guidelines, this meant that she would have to be hospitalised.

The only support system available to Ms ZD was a neighbour who had offered to care for her five-year-old daughter if Ms ZD were admitted to the centralised TB facility, Sizwe Hospital. Newborns are separated from their mothers shortly after delivery at Sizwe, and it was unclear where the baby could go because the neighbour was unable to care for the new child as well.

Those in charge of the care of Ms ZD felt that both the mother and baby would do best if they remained together. Her treatment was therefore continued at the Rahima Moosa Hospital. Her newborn is also receiving specialised care and monitoring at the same health facility.

Decentralised TB care allowed Ms ZD rapid access to appropriate treatment and also enabled her and her infant to remain together, while still receiving the specialised care they need.

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How does the policy link with the NSP?

The current NSP, which was released shortly after the decentralisation policy, provides the foundation for South Africa’s response to the HIV, STI, and TB epidemics. While the NSP does not specifically refer to the decentralisation policy, it draws on a similar organisational framework.

Filling the gap in treatment provision to achieve the NSP goals for reducing TB illness and death will only be possible through decentralisation.

One of the broad goals of the NSP is a 50% reduction in the number of new TB infections and related deaths.

The NSP goals will be achieved through interventions grouped according to clear strategic objectives. The third strategic objective of the NSP focuses on health and wellness and aims to reduce death and disability by means of universal access to care. This care ensures that patients remain within the health system and that the services they receive adapt to their needs.

Specific TB interventions include annual screening, tracing close contacts of TB patients, providing access to affordable and good quality drugs – particularly new DR-TB drugs – and ensuring the earliest possible enrolment of patients into care. There is a recognition that referral systems between levels of care will need to be strengthened and the integration of HIV and TB services will need to be improved.

The NSP recognises that further decentralisation of care is possible through community models for household contact. The primary health care re-engineering plan allows for this, and the services offered by the mobile units described in the decentralisation policy document can be integrated within the broader PHC plan.

The NSP talks specifically about the need to prevent DR-TB. This goal can be achieved through increased diagnosis and better treatment of drug-susceptible TB, such as DS-TB, to ensure that further resistance does not develop.

Improved MDR-TB care will also help to prevent the spread of resistant strains. Specific commitments in the NSP include reducing the time between the diagnosis of MDR-TB and treatment to only five working days, ensuring that 100% of patients are treated according to the guidelines, and that there is a 60% cure success rate.

Slow progress

In 2007, Médecins Sans Frontières (MSF), in collaboration with the City of Cape Town and the provincial government of the Western Cape launched a pilot project in Khayelitsha to provide decentralised care for patients with DR-TB.

Case detection of DR-TB has doubled over the past five years, and the average number of days between diagnosis and treatment initiation has fallen from 71 days in 2007 to 33 days in 2010. The number of cases treated successfully has almost tripled.

In 2010, 72% of patients were able to start treatment at their local clinic, 15% began treatment at the community-based sub-acute facility in Khayelitsha, and only 14% were admitted to the centralised DR-TB hospital. This approach avoided too much reliance on over-burdened hospitals.

While Khayelitsha has shown notable achievements with its programme of decentralisation, at other sites, such as at the Helen Joseph Hospital in the Johannesburg metro area, overall progress has been slow and variable.

Provincial operational plans, for example, for the decentralisation of MDR-TB have yet to be drafted. Many proposed units for decentralised treatment have not yet been assessed, and the training of health workers has been limited.

Activists can use their presence on Provincial and District AIDS Councils to question the lack of operational plans for decentralised TB care.

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Five keys in the fight against DR-TB

1. Improved diagnosis

The rollout of GeneXpert, a new instrument capable of diagnosing drug-resistant TB in under two hours, has allowed for the rapid diagnosis and referral of patients with drug resistance. With over 190 machines in South Africa, and plans to purchase an additional 134, the country stands to make sizeable progress in DR-TB management. However the success of this new diagnostic technique rests on the constant availability of testing cartridges.

2. Decentralisation of DR-TB care to the primary health care level

South Africa’s decentralisation policy still requires admission to a decentralised unit for at least eight weeks at the start of DR-TB treatment. Full decentralisation requires a commitment to invest in sufficient training and infrastructure support to permit the transfer of DR-TB care to the primary health care level.

A recent study on the cost of DR-TB care in South Africa found that while the disease made up 2.2% of the overall TB burden in the country, it consumed 32% of the total TB budget. 45% of DR-TB costs were for treatment and 25% for hospitalisation. Laboratory testing and treatment account for 71% of MDR-TB costs, while 92% of XDR-TB costs are for hospitalisation and treatment. The study concluded that a decentralised XDR-TB treatment programme could potentially reduce per patient costs by 26% and lower the total amount spent on DR-TB by 7%.

3. Improved treatment regimens for DR-TB and access to quality assured affordable drugs

The current treatment regimen, lasting between 18 and 24 months, is extremely long and is also expensive. The high pill burden and side-effects are immense challenges to patient adherence. The Medicines Control Council needs to ensure the rapid registration of new drugs and the DoH must negotiate affordable prices.

4. Access to a broader range of treatment options

Certain drugs, including capreomycin and PAS, are required for the treatment of XDR-TB patients or MDR-TB patients who experience side-effects or other difficulties, and are available only at specialised DR-TB sites. As a result, patients must be hospitalised to obtain the drugs. But not all hospital patients may be eligible for admission under the current guidelines. Decentralised sites need access to those drugs if South Africa is to avoid the unnecessary hospitalisation of patients.

5. Information systems

The current policy stipulates that PHC facilities, mobile teams and satellite units must send their data to the decentralised unit for collation. The information is then forwarded to the centralised site and the provincial TB directorate. Data should be captured on an electronic register of drug-resistant TB, known as the EDR-WEB.

It is unclear to what extent the new TB register is being used. Health care providers still point to the lack of centralised electronic medical records as a major barrier to monitoring patients across different levels of care and to ensuring continuity of treatment for highly mobile migrants.

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By Donela Besada

Donela Besada was previously an Advocacy Officer for Médecins Sans Frontières. She is currently working as a consultant.

 

Sources: South African Department of Health. ‘Multiple Drug Resistant Tuberculosis. A Policy Framework for the Decentralised and Deinstitutionalized Management for South Africa’ (August 2011) Available at http://www.doh.gov.za/docs/policy/2011/policy_TB.pdf ; World Health Organization, WHO-IUTALD Global Project on Anti-Tuberculosis Drug Resistance Surveillance. Anti-Tuberculosis Drug Resistance in the World (Report No. 4) [cited 2008 Apr 30] http://www.who.int/tb/publications/2008/drs_report4_26feb08.pdf ; Cox HS, McDermid C, Azevedo V, Muller O, Coetzee D, Simpson J, et al. ‘Epidemic Levels of Drug Resistant Tuberculosis (MDR and XDR-TB) in a High HIV Prevalence Setting in Khayelitsha, South Africa.’ PLoS One2010; 5(11): e13901 ; Nardell E, Dharmadhikari A. ‘Turning off the spigot: reducing drug-resistant tuberculosis transmission in resource-limited settings.’ Int J Tuberc Lung Dis 2010; 14(10): 1233- 1243 ; South African Department of Health. ‘Multiple Drug Resistant Tuberculosis: A Policy Framework for the Decentralised and Deinstitutionalized Management for South Africa.’ (August 2011)  http://www.doh.gov.za/docs/policy/2011/policy_TB.pdf ; Médecins Sans Frontières, ‘Scaling Up Diagnosis and Treatment of Drug-Resistant Tuberculosis in Khayelitsha, South Africa.’ (March 2011) http://www.msfaccess.org/our-work/tuberculosis/article/889 ;  http://www.thoughtleader.co.za/msf/2013/04/18/tb-the-good-bad-and-long-overdue/ ; Pooran, A, et al. ‘What is the Cost of Diagnosis and Management of Drug Resistant Tuberculosis in South Africa?’ PloS one 8.1 (2013): e54587.; The Per-patient cost of XDR-TB is four times greater than MDR-TB and 103 times greater than drug-sensitive TB