How medicine is falsified: defining counterfeit medicine
One of the biggest challenges facing the campaign against counterfeit medicine is defining what counts as counterfeiting. Some countries around the world still don’t have legislation to penalize the production, sale and distribution of counterfeit medicine — all because there is an ongoing debate on what to include and what not to include as a punishable offense.
For starters, let’s take a look what the World Health Organization specifically states as substandard and falsified medical products. This includes the following items:
Substandard medicines
Substandard medicines are medical products which are “out of specification” meaning these products do not meet quality standards or specifications, or both. This could be a regulatory body-approved medical product that may not be as effective because of formulation problems, poor manufacturing conditions, and/or may not have met QA standards.
An example of this would be the incident in Lahore, Pakistan which led to the deaths of over 200 people and over 1,000 people becoming seriously ill. The culprit was the cardiovascular medication Isotab, a drug used to lower high blood pressure, which was contaminated with 14 times the normal dosage of the antiparasitic pyrimethamine. The result was severe folate deficiency, which in turn destroyed platelets in the bone marrow and caused heavy internal bleeding.
Unregistered/unlicensed medicines
Unregistered and unlicensed medical products are products that have not been tested yet or have not received approval from a country’s regulatory body.
A paper published in 2015 cited a study of European cases involving unlicensed medication from 2004 revealing just how bad the cases of adverse drug reactions are involving unlicensed medicines, particularly in children. It is said that the failure to report or the omission of a report altogether is just as bad in child cases as they are in adult cases, and that the number of adverse drug reaction cases doubled when the study started using clinical methods of detection.
One good example of this is the topic of a study done in 2017 and published in The Journal of Tropical Medicine in February 2018 featuring the distribution of unlicensed antimalarial medication. The study reveals that in the rural district of Butaleja, Uganda, “only about one-quarter stocked an artemisinin-based combination therapy (ACT), one-quarter expressed a preference for ACTs, and less than one-tenth attested to firmly adhering to the national malaria treatment guidelines on dispensing ACTs as the first-line option. In contrast, nine out of 10 vendors stocked quinine and well over a third stocked antimalarials no longer recommended, such as chloroquine and sulphadoxine-pyrimethamine.” The result is an ineffective fight against childhood malaria.
Falsified medical products
Falsified medicine are products sold on the market with the intent of deception, whether in the true identity and ingredients of the products, its benefits, its source / place of origin — or it could be all of the above.
Out of the three items covered by the WHO’s definition of substandard and falsified medical products, this item is the most debated. This is because it includes a wide range of activities that can be debated as accidents or unintentional, such as mislabeling and the use of less or more ingredients in producing a given medical product.
There are many examples of this, but perhaps the most well-known problem worldwide is the falsification of antimalarial medication. Annually, 450,000 preventable deaths worldwide can be attributed to fake antimalarial medicine. The number of falsified antimalarials increased dramatically between 2005 and 2010 — a 90% increase. Some of these falsified antimalarials were found to contain ingredients such as starch, chalk and other toxic materials not meant to be consumed by humans.
What needs to be done?
A more unified, internationally-recognized definition of counterfeit medicine should be established in order to strengthen existing legislation in many countries and to finally create laws in those without substandard and falsified drug regulations. A better system to track the medical supply chain will also help track and verify the source of each product. But even more importantly, consumers need to be educated about counterfeiting in the pharmacological industry — signs they need to watch out for, how they can tell (and this can be difficult) the difference, and what to do in case of adverse drug reactions.
Discover how SparX can solve that problem by visiting our website. Plus, watch our video below to see how we’re taking the SparX blockchain platform to fight fraudulent food and medicines:
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