The value of quality control

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 14^th, 2012.