Scientists have developed a chemical detection method to trace counterfeit medicines and stolen pharmaceuticals.

Stolen and counterfeit medications, sold on the black market

All the drugs that have been stolen from and discarded by manufacturers, but are being sold on the black market.

The counterfeit medicine, sold as and resembling something it is not.

All the opioids that are flooding the internet (http://www.dr.dk/nyheder/indland/lige-saa-nemt-som-bestille-pizza-det-vrimler-med-illegale-opioider-paa-nettet).

Researchers from the University of Copenhagen and Stanford University in California can now help answer this.

They have found out that all medications, whether they are fake or not, have their own unique characteristics, which reveal how they were made.

- We can chemically reveal the unique fingerprint of the medication, which can be used to both identify counterfeit medications and stolen medications, explains the main author of the study, Else Holmfred, who is a postdoc at Stanford University and the University of Copenhagen.

The method used is by using so-called isotopes, that is, a variant of an element that has more or fewer neutrons.

- It's a bit like if you, for example, buy a box of the same type of apples in the supermarket, and some are larger than others, explains Else Holmfred about isotopes with extra neutrons.

Because medications in one way or another always contain something organic - for example, potato starch - they always contain carbon, hydrogen, and oxygen.

And the specific isotope composition of these substances can reveal things that make it possible to trace counterfeit and stolen medicine.

There is a more technical explanation (https://pubs.acs.org/doi/full/10.1021/acs.molpharmaceut.5c00522), but you should just know this:

- With this technology it is possible to make a very precise assessment of where the medication originally comes from, says Else Holmfred.

- Isotopes never lie.

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Illegal medications are becoming an increasing problem

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The market for the sale and production of counterfeit medications is global and growing, warned EU's police cooperation, Europol, in January.

In an eight-month joint operation last year, authorities from 30 European countries confiscated 426,016 packages (https://www.europol.europa.eu/media-press/newsroom/news/europol-warns-consumers-to-be-mindful-about-fake-medicines-offered-online) with illegal medications.

Opioid pills are being smuggled into Denmark in the tens of thousands (https://www.dr.dk/nyheder/regionale/syd/tusindvis-af-piller-beslaglagt-ved-den-dansk-tyske-graense), and they are sold on social media and websites (https://www.dr.dk/nyheder/seneste/26-dansksprogede-hjemmesider-politianmeldt-ulovligt-medicinsalg), where it has become incredibly easy to buy prescription medication (http://www.dr.dk/nyheder/indland/lige-saa-nemt-som-bestille-pizza-det-vrimler-med-illegale-opioider-paa-nettet) without a visit to the doctor or the pharmacy.

Some of the products are made illegally, while others are stolen from pharmaceutical companies - for example, if they have discarded the medications because they in one way or another did not meet quality requirements.

As recently as in May, the Danish Health Authority warned about the discovery of some pills (https://www.dr.dk/nyheder/indland/professor-og-sundhedsstyrelsen-advarer-om-ekstremt-farligt-opioid-100-gange), which on the package looked like they were opioid oxycontin. In reality, the pills contained a substance that is 100 times stronger than morphine and therefore poses a great risk of overdose.

The blister pack, which was found in Copenhagen in May. The pack is marked 'OxyContin 80 mg Mundipharma A/S'. The tablets contained, however, the opioid Nitazener, which together with fentanyl and fentanyl derivatives are part of the so-called "high-potency opioids". (Photo:© Danish Health Authority)

The hope is that the researchers' new use of the isotope method can improve the health of many people, says Else Holmfred.

- If authorities have even better ways to identify counterfeit and poor-quality medications, the hope and desire is that it will reduce the amount of illegal substances on the market, she says.

- It's unfortunately very easy to make counterfeit medications, because they don't have to meet the strict requirements that pharmaceutical companies have.

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What are Isotopes?

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Isotopes are atoms that consist of the same number of protons and different numbers of neutrons.

In other words, it is a variant of the same element, where the only difference is that there are a few more or fewer neutrons in the nucleus. It can, for example, be carbon-13, hydrogen-2, or Oxygen-18. Isotopes can either be heavier or lighter.

Source: University of Copenhagen (https://fysikleksikon.nbi.ku.dk/i/isotop/).

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Harder to identify counterfeit medications

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The new method can, however, not do everything.

The isotope method can with certainty reveal whether a medication is counterfeit or stolen.

It can also trace a stolen medication back to a specific manufacturer, but it can at most give an indication of where in the world counterfeit medications were made.

Can't you already find out whether a medication is counterfeit or not without the method?

- It becomes harder and harder, because counterfeit medications that are bought illegally can resemble something from a legitimate company without being it. It can be incredibly difficult for consumers to see and document it if there are no chemical evidence, says Else Holmfred.

- This method can tell that something is counterfeit, with a much higher level of detail than the existing methods.

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