Will 40-45% spurious drugs in Pakistan increase anti-TB drug resistance and treatment failure rates?

[bobby ramakant]

Dear friends,
please read the news 40-45 per cent news in Pakistan are spurious.

What does this news mean to drug
resistance, anti-TB treatment, Anti-Retroviral Therapy, and other
essential medicines? Please be welcome to share your perspectives,
experiences and comments.

A Stop-TB eForum member Ayyaz Kiani from Pakistan has commented on this news as below:

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"...THERE REMAINS A SIGNIFICANT PROBABILITY THAT SOME PATIENTS WOULD GET SPURIOUS ANTI-TB MEDICINES CAUSING TREATMENT FAILURES AND DRUG RESISTANCE"

Dear Stop-TB members,

Availability of spurious medicines in Pakistan market is indeed a problem and we have been campaigning against it for a number of years.

It is quite likely that such malpractices by the industry might also prevail in the anti-TB medicines market as well. However empirical research on the subject has been conspicuously missing.

It is also well known that the government machinery for surveillance and quality assurance is deficient in qualitative as well as quantitative terms.

However the issue of quality of medicines is a complicated one and depends on a number of additional factors like the process of licensing and registration of the manufacturing companies and their products, overall number of products in the market, cross border smuggling and the overall legal and policy framework in the country.

Stories of corruption and negligence in pharmaceutical sector are rampant and lead to low confidence in patients and healthcare providers alike. As a result there has been a trend of prescribing brands of multinational companies (as they are generally believed to be less likely to be spurious) which practice come at a high premium and become a heavy burden to the public exchequer and the shallow pockets of the consumers.

The anti-TB program in the country has been cognizant of these issues and is taking extra care for quality assurance in the medicines procured directly by them. Nevertheless there remains a significant probability that some patients would get spurious anti-TB medicines causing treatment failures and drug resistance.

It is high time that research is carried out to quantify the problem and corrective measures are taken to rule out malpractices and bad patient outcomes.

Ayyaz Kiani
Consultant, Access to Medicines
Islamabad, Pakistan
Email: [e-mail]

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[bobby ramakant]

another comment on Stop-TB eForum to this post from Dr Shaloo Puri:

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It seems the percentage [of spurious drugs] matches that in India!

Distinguishing a spurious drug from a genuine one is a challenge for most of us. Consumer awareness needs to be complemented with access to good quality drugs and a vigilant regulatory mechanism.

Thanks

Dr Shaloo Puri

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[bobby ramakant]

dear friends,
below is another comment from Stop-TB eForum. Look forward to learning more from you all on your experiences with spurious or counterfeit drugs and the way communities are ensuring high quality drugs in TB and HIV programmes locally?
warm wishes, bobby
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Comment: 40-45 percent drugs sold in Pakistan are spurious (3)
Jitendra Dwivedi
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[Mods note: Below is a comment to a news about spurious drugs in Pakistan, online at: http://tapedik.blogspot.com/2010/01/40-45-percent-drugs-sold-in-pak... . Member comments are welcome. What does this news mean to drug resistance, anti-TB treatment, Anti-Retroviral Therapy, and other essential medicines? Please be welcome to share your perspectives, experiences and comments. Thanks]
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I am sharing an article on this issue below - hope this will add value to this discussion on spurious drugs in Pakistan and elsewhere, and what it may imply for TB/HIV programmes.
Thanks
Jitendra Dwivedi
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Online at: http://www.citizen-news.org/2010/01/counterfeit-medicines-can-resul...

"COUNTERFEIT MEDICINES CAN RESULT IN TREATMENT FAILURE"

Counterfeit medicines are medicines that are deliberately and fraudulently mislabelled with respect to identity and/or source. According to the World Health Organization (WHO), use of counterfeit medicines can result in treatment failure or even death. Public confidence in health-delivery systems may be eroded following use and/or detection of counterfeit medicines. Both branded and generic products are subject to counterfeiting, says the WHO.

All kinds of medicines have been counterfeited, from medicines for the treatment of life-threatening conditions to inexpensive generic versions of painkillers and antihistamines. Counterfeit medicines may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient or too much active ingredient, or with fake packaging, adds WHO.

Walk down the old signature-market of Lucknow, Ameenabad, shows us an open and very busy market for pharmaceutical products. These are possibly not counterfeit, but surely, easy and open availability of medicines and other pharmaceutical products, is a big cause of worry - particularly because of rising drug resistance in India. So this market may not qualify at all as an example of counterfeit medicines, but may be closer to factors that are propelling irrational use of drugs.

According to the WHO, counterfeit medicines are found everywhere in the world. They range from random mixtures of harmful toxic substances to inactive, ineffective preparations. Some contain a declared, active ingredient and look so similar to the genuine product that they deceive health professionals as well as patients. But in every case, the source of a counterfeit medicine is unknown and its content unreliable. Counterfeit medicines are always illegal. They can result in treatment failure or even death. Eliminating them is a considerable public health challenge.

WHO states that studies can only give snapshots of the immediate situation. Counterfeiters are extremely flexible in the methods they use to mimic products and prevent their detection. They can change these methods from day to day, so when the results of a study are released, they may already be outdated. Finally, information about a case under legal investigation is sometimes only made public after the investigation has been concluded.

Counterfeiting is greatest in regions where regulatory and enforcement systems for medicines are weakest, adds WHO. In most industrialized countries with effective regulatory systems and market control (i.e. Australia, Canada, Japan, New Zealand, most of the European Union and the United States of America), incidence of counterfeit medicines is extremely low – less than 1% of market value according to the estimates of the countries concerned. But in many African countries, and in parts of Asia, Latin America, and countries in transition, a much higher percentage of the medicines on sale may be counterfeit.

Not only is there a huge variation between geographic regions in terms of incidence of counterfeit medicines, variation can also be significant within countries: for example, between urban and rural areas, and between cities, says WHO.

All kinds of medicines have been counterfeited – branded and generic – ranging from medicines for the treatment of life-threatening conditions to inexpensive generic versions of painkillers and antihistamines, states WHO.

Counterfeit medicines pose a public health risk because their content can be dangerous or they can lack active ingredients, says WHO. Their use can result in treatment failure (and contribute to increased resistance in the case of antimalarials that contain insufficient active ingredient) or even death. Unlike substandard medicines where there are problems with the manufacturing process by a known manufacturer, counterfeit medicines are made by people with the intent to mislead.

The extreme difficulty in tracing the manufacturing and distribution channels of counterfeit medicines makes their circulation on markets difficult to stop. Even a single case of a counterfeit medicine is unacceptable since it indicates that the pharmaceutical supply system in which it was detected is vulnerable. Worse, it undermines the credibility of national health and enforcement authorities.

Online at: http://www.citizen-news.org/2010/01/counterfeit-medicines-can-resul...

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[bobby ramakant]

here there is another comment from our friend in Pakistan: who is a general practitioner and shares his experience on spurious/ counterfeit drugs:

Comment: 40-45 percent drugs sold in Pakistan are spurious (6)
Dr Muhammad Aslam Bajwa, Pakistan
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[Mods note: Below is a comment to a news about spurious drugs in Pakistan, online at: http://tapedik.blogspot.com/2010/01/40-45-percent-drugs-sold-in-pak... . Member comments are welcome. What does this news mean to drug resistance, anti-TB treatment, Anti-Retroviral Therapy, and other essential medicines? Please be welcome to share your perspectives, experiences and comments. Thanks]
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"IF THIS MARKET GOES UNCHECKED FOR SOME MORE TIME, THERE MAY BE A VERY DETERIORATING EFFECT ON ESTABLISHED AND GROWING EPIDEMICS IN THE COUNTRY, INCLUDING HEPATITIS, TB and HIV"

Dear SEA-AIDS members,

It seems to be a hard fact along with many other cruel realities belonging to the Pakistan. When we couple this fact of counterfeit and spurious medicine with almost unregulated market of supply and sale of medicine, unauthorized use of medicine and unchecked over the counter availability of anything including poisons.

Being a clinician it has been observed that at one hand the manufacturing of such a medicine is on the rise while on the other hand our worthy general practitioners are only concerned with the profit margins and promotions being offered from Pharmaceuticals.

There are number of instances where the people went for Hepatitis B vaccination in promotional camps under the supervision of clinicians, but they end up to be the HBsAg Positive.

Multi-drug resistant TB (MDR-TB), relapse and smear negative TB is increasing. It is shocking now that malaria and typhoid, which were easily treatable are now increasingly resistant to the potent drugs.

It is apprehended that if this market will go unchecked for sometime, there may be a very deteriorating effect on established and growing epidemics in the country, including Hepatitis, TB and HIV.

There should be an urgent call of action for all State and non-state actors to eliminate this flourishing evil.

Dr Muhammad Aslam Bajwa
Head: HEaP (Health Education and Program Development)
Organization for Participatory Development
Gujranwala, Pakistan
Website: www.opdpak.org
Email: [e-mail]

[bobby ramakant]

Dear friends,
there is another interesting comment from Pakistan in this thread on Stop-TB eForum:
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Going through the different contributions under this eForum discussion-thread it is now quite clear that poor quality (spurious, substandard and counterfeit versions) of medicines indicated to treat life-threatening diseases such as malaria, HIV/AIDS and tuberculosis is a real and arguably a growing threat throughout the developing world.

It is also evident that such quality failures potentially represent a wider threat to public health worldwide but pose a particular problem in developing countries, where lack of financial technical and other resources make it difficult to protect the drug supply chains. It has been rightly said that the availability and use of such medicines have the potential to undermine decades of investments in public health.

It is high time that the global aid initiatives aimed at treating and controlling these priority diseases took practical steps commensurate with the scale of the problem. Exporting countries like Pakistan and India should be of particular interest in any such quality assurance drive as they might be spreading the problem much wider in the importing countries.

I am distressed to see that currently in Pakistan little quality assurance measures are being taken on part of the national regulators as well as donor agencies. One can only hope that adequate measures would be taken without any further delay by all concerned to control the situation.

Ayyaz Kiani
Consultant, Access to Medicines
Islamabad, Pakistan
Email: [e-mail]