In the words of Dr Nils Billo, Executive Director of the The Union: "This report is a wakeup call for the TB community. All TB patients should have the right to consistent supplies of simple, quality assured medicines when they need them. The world desperately needs to refocus on the most basic level of TB care or we risk returning to the times before antibiotics."
TB patients around the world are too often given poor quality medicines, or non-user friendly formulations consisting of up to 16 pills at a time. Sometimes they may be unable to take the prescribed medicines because of drug non availability. Without appropriate medicines at the right time, patients risk stopping treatment, spreading the disease to others, and raising the threat of drug resistance or even death.
Quality assured fixed dose combination drugs (FDCs), recommended by WHO, are considered the international “gold standard” for TB treatment and are extremely effective when administered correctly. FDCs are medicines that have two or more drugs combined in a single pill. FDCs can strengthen basic TB control by preventing mono therapy that can lead to drug resistance, thus helping to control the emergence of MDR-TB. They drastically reduce the number of pills a patient has to take, making treatment more acceptable to the patient and increasing the likelihood of treatment adherence. Using FDCs in TB control simplifies the doctor's prescription and patient's drug intake, as well as procurement and distribution of the drugs.
Government TB treatment programs of 20 out of 22 high burden countries are currently using some form of FDC formulation. But in China and India, which together carry the burden of 35% of the world’s TB cases, non FDCs continue to predominate the public sector. Brazil and China are slowly moving towards them. India, however, does not regard FDCs to be clinically or operationally superior to its current co-blistered single-drug pills. Opponents of FDCs in India refuse to accept the fact that co blistered single medicine pills substantially increase the risk of non adherence through selective consumption. They also say that FDCs cost more, although a full first line FDC drug regimen costs merely $26.
FDCs have many advantages over the single-pill regimen. A patient on WHO prequalified FDCs takes an average of 3 to 4 pills daily, which reduces the chance of missing a dose. Patients on the higher dosed Indian co-blistered single-medicine pills will take 7 to 12 pills thrice weekly (on alternate days). In actual practice, this makes adherence more non compliant. In the revised Indian DOTS program, the first dose of each week is administered under direct supervision at a DOTS centre, and the next 2 doses of the week are supplied to the patient (following his presentation of the empty blister pack of consumed drugs of the previous week).
FDCs are currently not available in the doses required for this thrice-weekly dosing schedule. But the current DOTS strategy of calling the patient to the centre has its own drawbacks. I personally know of many patients who are just too irregular and stay on and off the medicines, increasing the chances of drug resistance. There is very little follow up system to ensure that the patient goes to the DOTS centre every week. Also, patients may often forget to take the drugs on alternate days. It is much user friendly to take the pills every day.
FDC sales are strong in the Indian private sector, where 48 distinct first line dosage variants of FDCs available. This lack of standardization makes correct dosing more complicated, thus increasing the patients’ risk for treatment failure and drug resistance even when FDCs are used.
Apart from non availability of FDC drugs in the public sector, many TB patients seeking treatment are receiving medicines that do not meet the quality standards recommended by the WHO and required by the GDF. In India’s public sector, an estimated $14.8 million are spent on drugs that are not required to adhere to the international ‘gold standard’ level of QA, as against $12.2 million spent on quality assured drugs.
Very little is known about the quality of TB medicines in the private sector. Patients in this sector may be at risk from substandard medicines. It is appalling that many manufacturers in developing countries have separate production lines for domestic and international markets. Even some of those who produce WHO prequalified TB medicines simultaneously produce lower quality medicines for less regulated markets, as these are cheaper to make. The private market for FDCs is however more concentrated than the loose drug market, with just four manufacturers (Lupin, Macleods Pharma, Wyeth and Sandoz) capturing nearly 70% of the overall private market share across the 10 countries examined, including India. Three of them produce at least some TB medicines that are WHO prequalified.
Thus we see that substandard TB medicines are all too common in high burden countries. This can make TB treatment ineffective and even dangerous. Ensuring access to safe and effective medicines is a critical element of the global fight against TB and can limit transmission and prevent resistance.
Renewed political commitment to basic TB care is critical to addressing these challenges. Regulators will have to work with manufacturers, the WHO and others to ensure that patients get quality assured FDCs, even in the private sector. This becomes all the more critical in the light of new TB drugs in the pipeline, which are expected to drastically improve TB treatment. Once available, they may face the same challenges, defeating the very purpose of their invention.
Shobha Shukla - CNS
(The author is the Editor of Citizen News Service (CNS) and also serves as the Director of CNS Diabetes Media Initiative (CNS-DMI). She has worked earlier with State Planning Institute, UP. She was supported by the Stop TB Partnership to write from the 41st Union World Conference on Lung Health, Berlin, Germany (11-15 November 2010). Email: shobha@citizen-news.org, website: www.citizen-news.org)
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