The value of quality control

Published: February 14, 2012

The writer is assistant professor of biomedical engineering at Boston University and tweets @mhzaman

Who would have thought that the cause of death of the patients at the Punjab Institute of Cardiology (PIC) would be large amounts of an anti-malarial? This is not only unfortunate, but also absurd. On a broader note, it also says a lot about the breakdown of the drug testing mechanisms that should be in place to safeguard society. It also says something about the health of our society’s general quality control mechanisms at large, but I will come to that a little bit later.

First, it is important to note that the PIC tragedy is the manifestation of a system-level problem. While one or more individuals may have triggered this catastrophe, the magnitude of the tragedy is amplified by the failure of the system as a whole. It is also important to note that as a society, we are developing a tendency of personalising the tragedies. Blaming one individual for the miscarriage of the system is not going to stop it from happening the next time. In our passionate moments, as we start searching for who to blame, we often ignore the need to strengthen the system itself.

The fact that one of the tainted drugs given to the patients was contaminated is incredibly perplexing. The realisation that no one responsible for quality control — within the various levels of manufacturing or the distribution — was unable to catch it, is even scarier. If this can happen once, in a manufacturing plant, what controls do we have in place to make checks for the next time around? If it can happen in one city, what makes us think that it won’t happen in another? If it can happen with cardiology patients, why are patients of another ailment safe? Going after the perpetrators of this tragedy is one of the many things that we need to do, but not the only thing. Strengthening quality control, at the systems-level, through human resources and technological tools is even more important.

Yet, I have not seen a clear change in policy or even an indication of the new safeguards that will be put in place to create multiple layers of safety nets. Like everyone else, I am still not sure if we have the means to test drugs or not. If we do, as some experts and bureaucrats claim, then why were the drugs sent abroad? And even if we had to wait for results from outside labs, did our own testing labs corroborate those results? If the problem of contamination of an anti-malarial was with Isotab, what about the three other drugs that were supposedly tainted as well? What were they contaminated with? And finally, what mechanism do we have in place not only to test the drugs, but also test the facilities that test the drugs? Are those facilities up to date and functioning? Are people in charge of the industry competent? These are just some of the many questions we should ask if we are to strengthen our system and have any faith in the drugs that come into the market.

Now let us come to the bigger issue, of quality control in the society itself. The issue of quality control and proper checks within the system goes beyond medicines or health. The culture of sifarshis that are able to go through various levels of the system is no different from a bad drug going through various levels of quality control. Whether it is complacency, criminal intent or a combination of both, this complacency leads to gaping holes in our system that benefit sifarshis and bad drugs. The sifarshi himself or herself is only part of the problem, like the bad drug, but the system that enables him or her to get through is the bigger problem. The PIC tragedy is a clear symptom of a bigger disease. Let’s hope we don’t treat it with a substandard drug.

Published in The Express Tribune, February 14th, 2012.

Reader Comments (11)

  • So So
    Feb 14, 2012 - 1:38AM

    Good points Dr. Zaman — the issue of quality control needs to be addressed in all matters of our public life, most importantly in education and public service. Extremely critical that we insist on quality from our leaders — but if they themselves have come from back door, little can be expected of them.

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  • Feb 14, 2012 - 3:46AM

    Nice post, very good

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  • Gul
    Feb 14, 2012 - 8:28AM

    Did CM punjab ever form an independent commission? I dont think so. Having police, that is part of the establishment, investigate is not the same thing as having an independent commission of expert doctors and other experts from other fields. I doubt if the CM will ever form a truly independent inquiry committee — you never know whose house the trail may lead to ….

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  • Kazmis
    Feb 14, 2012 - 8:34AM

    Wrong conception and wrong direction to control disasters. The quality control was there because the product was in use through many years. it was just contamination, perhaps made deliberately by someone. Why don’t think in this direction?

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  • Falcon
    Feb 14, 2012 - 9:34AM

    Well said. Risk management enacted through preventive and detective controls at various layers is the only way to mitigate these challenges and prevent recurrence of these tragedies. But as a whole, that only happens when institutions themselves are control and quality conscious. Unfortunately, people focused blame shifting prevents development of this system oriented thought process.

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  • Sikander
    Feb 14, 2012 - 11:09AM

    @Kazmis:
    Please.. lay off the conspiracy theories. It happens in mass production some batches may exceeds the control limits. Thus we have a procedure of random sampling and testing from every batch. The failure lies with drug testing authorities.

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  • Ishtiaq Ahmed
    Feb 14, 2012 - 2:52PM

    I hope someone at the helms of affairs is reading this article. The story of drugs storage and handling in whole-sale and retail markets is even more pathetic. Temperature, humidity or hygiene control are concepts alien to them. Couterfeit drugs is yet another story.

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  • Feb 14, 2012 - 3:08PM

    it is nt matter of quality control it is matter of corruption because they dont need to care what will be consequences they jst want to eran money any how that is going on every where in pakistan.

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  • ahsan
    Feb 14, 2012 - 8:31PM

    The valve of quality control is the dilemma in every department of our life in PAK accept in corruption.

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  • Rabia Umar Ali
    Feb 18, 2012 - 9:25PM

    One of the daily tragedies, the inhabitants of this poor, unfortunate country bear with almost on a regular basis. It sadly reduces big events to mere statistics. We sleep over it if it doesn’t concern us directly, and get up in the morning waiting for the callous and cruel rulers to design something new for the helpless millions. There is no accountability, none whatsoever. No heads roll, no resignations are tendered, no one stands accused. And soon the hype dies down from the TV screen.
    Its indeed a good effort on your part to have raised the issue, but only if things could change and old, rotten faces dominating the scene could be as brutally removed as the poor, hapless man of this society.

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  • Imran
    Feb 23, 2012 - 3:14PM

    It is unfortunate that quality-control mechanisms in Pakistan are not functional. I agree that tragedies like the PIC are just the tip of the ice burg. However it is embarrassing to see that the rotten system is left intact and no overhauling is conducted. It appears that people at the helm are indifferent to the plight of the masses. This piece is a good effort to create awareness about inadequacies in the working of our system.

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