When medications kill more than the diseases themselves

In the world, many counterfeit medications circulate, which certainly pose a significant problem for the treatment of various diseases. As will be analyzed below, the problems that exist and the ways these can be avoided will emerge. Publications of foreign literature have been analyzed, while publications on how widespread this problem is in the Albanian pharmaceutical market have not been found.

The spread of the problem worldwide makes you think that Albania should not be "immune" (more or less) from this occurrence. The authors have analyzed a group of medications, suggesting that this could happen with all medications.

• Antimalarials without an active ingredient, which have caused the death of more than 120,000 unaware children.
• Antibiotics with insufficient active substance to defeat bacteria but enough to cause resistance.
• Use of expired medications.
• Deadly for some, harmful for all.

The choice of this topic was not random: the authors considered it a "global pandemic" of counterfeit medications and published it in The American Journal of Tropical Medicine and Hygiene and insisted on the paradoxical, almost grotesque, aspect of the problem. A summary of 17 articles presented at Fogarty International Center of the National Institute of Health demonstrated that poor quality medications circulate worldwide, between 10 and 30% according to WHO, causing severe damage to public health.

Because not only do they not cure, but in a way "cause disease" by causing a real pandemic. These are deliberately falsified medications, or as a result of accidental changes caused by errors in the production or preservation process. Mostly, this concerns antimalarials, antivirals, and antituberculosis medications, antibiotics used in poor countries in Africa, Asia, and Latin America.

An example for all: In 2013, more than 122,000 children under five years of age in sub-Saharan Africa died because they were treated with expired antimalarials. This was verified by studies conducted by researchers at Center for Disease Dynamics, Economics and Policy in Washington.

Most counterfeit products originate from China and India, according to data from Pharmaceutical Security Institute Counterfeit system (PSI CIS). But it is not easy to identify poor quality medications, distinguish accidental modifications from deliberate ones, and determine the perpetrator of this intervention. To prevent it, based on one of the authors' publications in the Dossier, there are three factors:

• The lack of consensus on the definition of an expired medication.
• The inadequacy of technology to determine the weak points of a medication before starting therapy.
• There is no international market control organization to measure and monitor while respecting standards as done, for example, by Food and Drug Administration.

A risk for everyone

When medications do not work, to experience the consequences are not only the patients who suffer: the spread of resistant bacteria is, for example, a “collateral effect” that affects everyone. This happens when the percentage of the active principle of the medication content is very low, unable to fight pathogens but capable of causing the resistance process. The pandemic metaphor is that it continues to spread. An ineffective medication actually causes a reaction with a general effect, capable of overturning dozens of successes against diseases like Aids, Malaria, and Tuberculosis.

“The objective of this special issue – reads in the foreword – is to alarm scientists, public health institutes, and policymakers by showing them the problem of medications based on quality and to offer immediate actions to mitigate and solve this problem." The fear is justified by the results reported in the dossier: out of 17,000 samples of antivirals, antimalarials, antituberculosis medications, and anti-leishmania medications, the percentage of the product was below the standard in 41% of the cases.

The phenomenon, according to the authors of the dossier, might be underestimated. Often the spread of poor-quality medications is not signaled by competent institutions also because there is no international consensus on this problem. The problem for the authors of the dossier could be solved like this: "we need to classify poor-quality medications into three categories:

• Falsified (as a result of fraudulent production - deceitful),
• Below standard (for unintentional mistakes made during production),
• Deteriorated – expired (as a result of expiration due to poor storage or poor management).

The first category results from a criminal market of $75 billion a year, according to Interpol data that between 2010 and 2014 made 1400 arrests and seized 500 tons of counterfeit medications.

Some illustrative examples

The phenomenon mainly pertains to low-income countries. A recent study, cited by the dossier, reports that 1/3 of 4,000 antimalarial samples tested in Southeast Asian countries and 21 States of sub-Saharan Africa were devoid of the active principle of the medication. Other results carried out by several different authors who published in American Journal of Tropical Medicine and Hygiene are not much different from what we mentioned above.

In Cambodia, out of 291 samples of antimalarial medications, 30% of them had the active principle outside the set norm (85% - 115%), in most cases much lower than the acceptable threshold.

In Afghanistan, 26% of the packages analyzed did not pass the test set by Global Pharma Health Found, an organization that uses a portable mini-laboratory to verify the quality (quality) of medications in poor countries. In the Democratic Republic of Laos, 25% of the samples presented were outside the accepted limits.

In Ghana and Nigeria among 35 samples of antibiotics, 60% of them did not meet the acceptable quality standard.

Moreover, among the products seized by Interpol, 1/3 of the counterfeit antibiotics and antimalarials did not meet the acceptable quality limit.

New technologies

Remaining a metaphor, the authors of the dossier confirm that “diagnostic tools are at the heart of any effort to confront epidemics”. Even when, paradoxically, the harm is caused by medications. Thus, it is worth aiming for the perfection of four anticipated technologies that are capable of distinguishing an effective medication from a harmful, unnecessary one.

Without going into much detail, some of these, economically, are easily feasible, based on chemical tests with dyes and paper, others require more sophisticated techniques of fluorescence and luminescence that guarantee high precision but are more complicated to use in technologically less advanced countries.

An international response

In a special dedicated to pandemics from expired medications, some weaknesses in the international control system are revealed:

• there is no universally accepted definition of "poor-quality medications",
• there is no coordinated monitoring system by everyone,
• there is no regulation that imposes sanctions on individual states for those who market pills with false promises

Amir Attaran, the author of one of the 17 articles published in the dossier, is surprised, for example, that in Canada the penalty for counterfeiting medications is only three years in prison at maximum and a fine of $5,000. The same is true in France: three years in prison and 75,000 Euro fine. In Norway, the perpetrator of such an offense risks only 4 months in jail, in the Netherlands 6. In most cases, courts judge and punish only crimes against intellectual property and not those against public health.

"States must provide laws to hit and annihilate the harmful aspects of the global medication market, poor-quality medications, and counterfeit ones, without interfering in the right of free trade," says Attaran. It is enough to suggest a model of the law that he himself has established to fight the dark side of globalization: Model Law on Medicine Crime.

On the other hand, an international agreement is needed. In this case, the model to be copied to fight the pandemic of expired medications, as read in the dossier, could be Framework Convention on Tobacco Control, perhaps the most effective international treaty for health protection capable of controlling the safety of cigarettes sold worldwide. This is a valuable example from which we should be inspired, say the authors of the dossier.