Years of deadlock between government and pharmaceutical manufacturers over drug prices has transpired into a severe shortage of anti-tuberculosis (TB) drugs in Pakistan. The stocks of anti-TB drugs, particularly pyrazinamide and ethambutol, have been running low in the country, says a report by Kazi AN published in BMJ on May 3rd, 2016.

With over 420,000 cases emerging each year, tuberculosis is a major health problem in Pakistan. In fact, the prevalence and incidence of TB is so high in Pakistan that the World Health Organization (WHO) has ranked it among the “high-burden” countries.

Given the prevalence of the “killer disease” in the country, the shortage of essential drugs has created a crisis. Javaid A Khan, professor of medicine and consultant physician at Aga Khan University, Karachi, is concerned about the shortage of anti-TB drugs, particularly ethambutol and pyrazinamide, in the market. “Most patients with TB are treated with a fixed dose combination available free under the Directly Observed Treatment, Short Course (DOTS) program, but more complex cases need TB treatment with ethambutol and pyrazinamide,” he said.

He further went on to say that most pharmacies have run out of the stock of anti-TB drugs over the last six months. “Ethambutol and pyrazinamide,” says Khan, “have completely disappeared from the market.”

TB cases, complicated by the presence of a concomitant disease, such as hepatitis or renal failure, do not respond to the conventional fixed dose combination, and require ethambutol and pyrazinamide. The bacterium, Mycobacterium tuberculosis, is an extremely resistant microorganism. If not treated properly, the bacteria mutate and multiply in the body. Tuberculosis treatment lasts from six months to two years. In Pakistan, most of the TB cases that are uncomplicated are treated under DOTS program but complicated cases are usually treated in private sectors. The shortage of ethambutol and pyrazinamide is therefore affecting this sector the most.

In the absence of ethambutol and pyrazinamide, moxifloxacin (a fluorquinone antibiotic), is being prescribed for the time being in the country. But as per Khan, this replacement is temporary and will not benefit TB patients in the long run.

“We used moxifloxacin only in selected cases. But if we keep on using it as a first line drug for drug sensitive TB, we will lose an important medicine reserved for treating complex cases of multidrug resistant TB.”

The shortage of life-saving medicines in the country is due mainly to the deadlock between the government and the pharmaceutical companies manufacturing TB drugs over the upcoming drug policy. The Drug Regulatory Authority of Pakistan has proposed a reduction of 45% in the prices of scheduled drugs.

The issue of drug shortage has recently been underscored by the human rights cell of the Supreme Court of Pakistan.

In a bid to counter the claim, the Drug Regulatory Authority of Pakistan and a few other pharmaceutical firms have negated any shortage of drugs exists in the country. TB is a serious infection; the continuity of the present condition can soon lead to multi-drug resistant endemic in the country.

The federal government is yet to respond to the alarm raised by health quarters. The crisis, though going on for the last six months, has worsened over the last couple of months.

The shortage of anti-TB drugs and the potential endemic in the country have been addressed in the Executive Board meeting of the WHO officials held in the last week of January this year. Discussions are going on about the possible solution of the global shortages of medicines. The issue will be brought to the floor in May this year.

DOTS is an internationally recommended strategy of the World Health Organization for TB control. It has been recognized as highly efficient and cost-effective, and is currently employed successfully in many countries of the world.

Currently, the government of Pakistan is successfully running a “National Tuberculosis Prevention (NTP) Control Program”, funded by the Global Fund and USAID. The national TB program reports directly to the World Health Organization.

Pakistan Bearing The Brunt Of Tuberculosis Endemic

Pakistan is among the countries with the highest incidence and prevalence of the infection. According to a careful estimation by WHO, 420,000 new cases of TB emerge each year. Along with China, India, Bangladesh and Indonesia, Pakistan shares more than half of the disease burden in the world i.e., 61% in the WHO Eastern Mediterranean Region.

Globally, Pakistan has the fourth highest prevalence of multidrug-resistant TB (MDR-TB). However, steady progress has been made in terms of TB detection and treatment in the country over the last decade.

The National TB Control Program has successfully treated more than 1.5 million cases of TB. Currently, more than 5,800 diagnostic and treatment centers across the country are providing free TB testing and treatment services.