'I am stopping TB today'

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What is TB

Tuberculosis is caused by bacteria called 'Mycobacterium tuberculosis', which was discovered in 1882 by Robert Koch. The bacillus enters the body through inhalation and as such anybody who breathes can be infected with the bacillus. Tuberculosis can affect any organ in the body.

The commonly affected are the lungs. But, TB bacteria can attack any part of the body such as the kidney, spine, and brain. If not treated properly, TB disease can be fatal. Once the lungs are affected the person develops the common symptom, cough and bring out sputum. Many of these patients when cough, excretes bacilli in sputum and they are responsible for the transmission of the disease in the community.

The group of patients having the disease affecting lungs and do not excrete the bacilli in their sputum and those who have the organs other than lungs affected are not a danger to the community as the chance of infecting another person is minimal.

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by Shanika Sriyananda

The future safety of many lies in their hands. If each and every individual who are suffering from globally threatened diseases could take extra care to control it at their own doorsteps, they, in fact, would be helping to avert yet another health disaster.

The scourge of one of the widely known diseases - the Tuberculosis - is not yet done away with despite modern detection and treatment facilities, it still remains as one of the major communicable diseases in Sri Lanka as well as the world.

The world taking a new turn, by starting its 'warfare' against 'TB' marked yet another 'World TB Day', last week. The health experts want the TB patients to keep to their promise "I am stopping TB", not only today but through out the whole year.

The seriousness of the disease is evident with its rate of infection. The micobacterium, Tuberculosis bacillus infects one person and, one out of every three are at risk of contracting the disease at any given second. They warned that if TB, is left unchecked in the next 20 years, almost one billion people will become infected, 200 million will develop the disease, and 35 million people will die of the disease.

Over 8,497 new cases of TB have been recorded in Sri Lanka last year and the estimated number of new cases around the world is over 445,000. Each year estimated 8 to 10 million new TB patients added to the existing number and over 34 percent of them are living in South East Asian countries.

The health authorities want TB patients to take action by themselves to curb the spreading as each individual patient can spread the bacteria to over 15 persons, if not detected and treated timely.

According to the Director, National Programme for Tuberculosis Control and Chest Diseases, Dr. (Ms.) Chandra Sarukkali, still the local health authorities could not keep the disease at bay, in Colombo, Gampaha, Kandy and Kalutara districts due to over-crowding in and due to poor ventilation.

Amidst the success achievements like high detection rate of 86.6 percent and treatment success rate of 87 percent, the highest number of TB patients have been reported from the Colombo district.

Most of the patients are in the age group of 15 to 55 years and four percent out of the total number of TB patients are children.

"They are in the most economically productive age group and the average loss of income is around 20-30 percent per patient a year. These estimates indicate us about the devastating financial losses but what about the impact of TB on the family and community? There have been instances where the children had to leave school because one of the parents had TB. Their jobs were at risk.

People had to face the problem of family break-ups and the opportunities of marriage. TB has been stigmatized as a disease of hereditary in origin and affects only those in the low socio-economic group", she said.

She said that the most effective method of curbing the disease is the detection of the disease. " These are the patients who have tuberculosis in their lungs and excreting tubercle bacilli.

In addition tuberculosis control aims at curing all forms of the disease in order to reduce mortality and morbidity. Examination of a sputum smear under a microscope (sputum microscopy) to identify bacilli is the most efficient way of identifying sources of infection in the community", she added.

Sri Lanka adopted the DOTS strategy in 1996 and according to Dr. Sarukkali the DOTS coverage is over 97.54 percent today. " Treatment observer must be accessible and acceptable to the patient and accountable to the health system. Currently in Sri Lanka the direct observation is done by a health staff personnel and the services have been extended up to the lowest health institution.", she said.

According to Dr. Sarukkali, the standard treatment for a diagnosed new patient is the four drugs for two months (Intensive phase) and two drugs for the next four months (Continuation phase).

The full course of treatment for 6 months should be continued to ensure cure. Though ideally the treatment should be directly observed for the full course, in most instances in Sri Lanka it is being done in the first two months of treatment because of the difficulties that the patient has to face when visiting a health institution (DOTS centre) daily to swallow the drugs.

If in future we are successful in our attempt to overcome the stigma attached to TB, we may extend the DOT services to the community level making use of the community leaders.

"If so direct observation of treatment could be done for the complete 6 months and the number which default treatment could be reduced", she said.

With the gradual improvement, 22 districts have been covered under the DOTS strategy. Dr. Sarukkali said that due to poor reportage, the number of TB cases reported from Mullaithiv, Kilinochchi and Mannar were not exact figures. According to statistics 37 new TB patients have been detected from the Mannar district and seven and 35 from Mullaithiv and Kilinochchi.

The National Program for TB Control functions under the Ministry of Health recorded a high success rate in controlling TB in the country. " To improve the control activities further we need public support. That is the challenge for us in delivering high quality services under the DOTS strategy. Here the community participation is vital ", she said.

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The internationally accepted strategy for effective TB control is the 'DOTS' (Directly Observed Treatment - Short course) which consists of five components.

1. Political commitment

2. Access to quality assured sputum microscopy

3. Uninterrupted supply of quality assured drugs

4. Directly observed treatment

5. Accountability

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Symptoms of TB

It depend on where in the body the TB bacteria are growing. TB bacteria usually grow in the lungs. TB in the lungs may cause symptoms such as

* A bad cough that lasts 3 weeks or longer

* Pain in the chest

* Coughing up blood or sputum (phlegm from deep inside the lungs)

Other symptoms of active TB disease are

* Weakness or fatigue

* Weight loss

* No appetite

* Chills

* Fever

* Sweating at night

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DOTS means

" Direct Observation of Treatment means that the intake of the drugs by the patient is directly observed by another person. This ensures treatment for the entire course with the right drugs in the right doses at the right intervals.

DOTS is necessary at least in the initial phase of treatment to ensure adherence to treatment and achieve sputum smear conversion. Observation is a service to patients and providers.

Why is it necessary to directly observe treatment?

* At least one third of the patients receiving self-administered treatment do not adhere to treatment

* Many patients do not take medicines regularly, even if excellent health education is provided and it is impossible to predict which patients will take medicines

* A TB patient missing one attendance can be traced immediately and counselled.

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The priviliged still get best of healthcare

by Adrian Basnayake, President, Sri Lanka Chamber of Pharmaceuticals Industry

In view of the on going debate on pharmaceuticals in the media and the diverse arguments and viewpoints being thrown across at the general public, the Sri Lanka Chamber of Pharmaceuticals Industry (SLCPI) presents herewith an industry perspective...

This article takes into consideration and explains some vital issues that will have an effect on patients and doctors, the place western pharmaceuticals have in disease prevention and control, and the need for flexibility in rules governing its accessibility. Pharmaceuticals: An industry perspective

Sri Lanka has one of South Asia's best regulatory environments for the control of legal entry of Pharmaceuticals to the country. The Cosmetics Devises & Drugs Authority (CDDA) was set up by an act of parliament in 1981 to ensure that only medicinal drugs, devices and Cosmetics of good 'quality, safety and efficacy' are permitted entry to Sri Lanka.

A potential pharmaceutical, device or cosmetics manufacturer or a Marketer is given a registration and a license to import, only after a rigorous evaluation by competent persons specially trained to do such evaluations.

As pharmaceuticals constituted a major share of the imports, CDDA initially concentrated more on pharmaceuticals but have now gradually expanded its role to surgical/medical devices (such as catheters syringes) as well as cosmetics.

The Sri Lanka Chamber of Pharmaceuticals Industry (SLCPI) and its membership have always extended their fullest cooperation to the Ministry of Health and to the Cosmetics, Devices & Drugs Authority with their evaluation system.

We firmly believe these controls are needed to safeguard the welfare of the patients - the consumer and to establish a level playing field for the marketers.

Our members welcome a statutory body to ensure a streamlined & efficient mechanism for the control of entry of healthcare products and more importantly well executed implementation of policies to ensure that spurious, counterfeit, and unregistered products do not enter the country, endangering Sri Lankan lives.

The WHO and the IFPMA (International Federation of Pharmaceuticals Manufactures Association) has voiced their concern at several recent seminars and forums with regard to counterfeit Pharmaceuticals.

However, one of the biggest problems developing countries face in the delivery of healthcare is the threat of counterfeit medicines, WHO presented the following statistics at a recent seminar.

Counterfeit medicines are on the rise in most countries but are particularly widespread and dangerous in developing regions. most recent figures estimate counterfeits at around 1% of sales in developed countries to more than 10% in developing countries.

However, in parts of Africa, Asia and Latin America, more that 30% of the medicines on sale can be counterfeit, while in some former Soviet Republics, counterfeits make up more than 20% of the market."

It is time the trade bodies, consumer groups and Legitimate Patients' Movements activate themselves to counter this dangerous situation. Going by the WHO statistics above, our systems still has loopholes for the counterfeit medicines to enter our markets and pose a threat to our people.

SLCPI and the Ministry of Health have made this issue public at various forums in order to caution the public. We need to work together with all stakeholders to ensure that our country is not used by errant traders as a dumping ground for their expired, relabelled or counterfeit products.

SLCPI is in support of strengthening the existing CDDA by giving adequate resources and powers to regulators to act against such perpetrators. A strengthened, well structured and well resourced Drug Authority will be an effective deterrent against such scrupulous elements without adding unnecessary non tariff barriers that can lead to shortages of drugs and delays in entry of new drug discoveries.

The healthcare industry, particularly the Pharmaceutical industry is very aware that it is subject to close scrutiny by consumers and patient groups as health is considered a basic human rights. The SLCPI has developed a self regulatory mechanism to guide and control its membership in Ethical Pharmaceutical marketing.

The SLCPI has implemented a Code of Pharmaceutical Marketing Practices and a Code of Conduct for member's representatives to self regulate behaviour that has led to criticism in the past. SLCPI has on going educational programs and joint workshops with healthcare professionals and the regulators to ensure transparency and adherence to these guidelines.

We are also pleased to note that in a spirit of reaching out to the needy who lack access to healthcare, many Pharmaceutical companies are engaged in various charities where millions of people benefit the world over.

Leprosy, TB eradication programmes & Glivec access programme (anti Leukaemia drug where over 70 patients have been given free treatment at a cost of over Rs.3 million each in Sri Lanka alone) by Novartis, Eradication of River Blindness campaign in Africa by Merck & Co. and the research grants by GSK both locally and Internationally, are just a few examples of the large scale projects undertaken by Pharmaceutical companies operating in developing countries.

The SLCPI too continues to provide drugs free to health camps organised by various organisations under our Corporate Social Responsibility projects.

In developed countries, quite a lot is achieved by dialogue and consultation of all stakeholders, therefore the drafting of the proposed National Medicinal Drugs Act through dialogue and consultation of all stakeholders is a definite way forward.

SLCPI has enthusiastically participated in this consultation process; however, we believe the arbitrary inclusion of certain clauses such as 'need', 'cost effectiveness' and 'other factors' to hitherto established WHO criteria of 'quality safety & efficacy' in the drug evaluation will result in rejection of new drugs on highly subjective grounds.

The People who want to restrict the number of drugs registered, the ones who want to prevent & delay registration of new drug discoveries because they are expensive want to degrade one of the most effective healthcare systems in the world where the best of both worlds ? State Provided free health and Private sector provided fee paying is available to all at costs acknowledged to be globally competitive.

We don't want to dilute the quality of our system or to trade it in for a second-rated system where only fifty year old drugs or drugs of questionable quality are available for the management of diseases, attempts to introduce radicalized out dated economic ideologies rejected over and over by the people of Sri Lanka to satisfy a small minority will result in wide spread shortages and denial of access to new drugs & therapeutics through legitimate means.

The only beneficiaries will be the smugglers and spurious drug suppliers at the cost of the unsuspecting public, while the economically privileged can take wings and have the best of healthcare the world has to offer..