There should be much harsher penalties, including homicide charges, for those who intentionally tamper with medicines and include harmful ingredients, according to Kawaldip Sehmi, CEO of the International Alliance of Patient Organizations (IAPO).
Sehmi was speaking at an event organized by Fight the counterfeit alliance in Geneva on Wednesday to highlight the global proliferation of fake medicines and the threat they pose to patients.
In October, 99 children died in Indonesia cough syrup contaminated with antifreeze chemicals.
The previous month, 66 children died in Gambia – also contaminated cough syrup. These tragedies echo the deaths of 12 Indian children in 2020 – from cough syrup that had been made toxic after one of the ingredients was replaced with a toxic one.
Yet, Sehmi said, most countries treated falsified medicines as a commercial crime such as “product liability or negligence” when they should be treated “in the same way as narcotics”.
“Trust is at the heart of everything. Patients need to be confident that the product they receive is of appropriate quality and safety,” said Pernette Esteve, who leads the World Health Organization (WHO) team on substandard medical products and falsified.
“Gaining public trust once you’ve lost it is very difficult. Think back to the COVID pandemic. Making sure people trusted the vaccines, the acceptability of the vaccines, was a key point.
For 10 years, WHO has built a database of substandard (inadvertently defective) and falsified (deliberately altered) medicines to understand the scope, scale and harm.
From this database, the WHO identified the three driving forces: lack of access to medicines, poor governance, including corruption, and weak technical capacity, Esteve said.
WHO’s response was based on “prevention, detection and response”, she added.
The extent of the problem
Stanislav Barro, global head of anti-falsified medicines at Novartis, says his company has faced fake medicines in all regions of the world.
Rapidly authenticating medicines was both the biggest challenge and the biggest opportunity to stamp out counterfeits, he said – but warned it was a “very complicated process”.
All suspect samples must be brought to a location where they can be properly authenticated using forensic means,” Barro said.
However, almost 50 pharmaceutical companies were now sharing data through the Pharmaceutical Security Institute, and there had been a 38% increase in the incidence of falsified medicines between 2016 and 2020 in 142 countries, and the incidence jumped in 2021. at the start of the covid pandemic.
“Basically, it’s anything criminal organizations can make money from. It does not matter if it is falsified, tampered with, stolen, illegally diverted. It’s a bit of everything, quite frankly,” Barro added, noting that it usually means “terrible news for patients.”
“We need to find solutions to leverage digital technologies to locate authentication, identify falsified medicines and make it timely. Reduce these delays from weeks to days, hours if possible, and expedite notification to local authorities and WHO.
raw materials font
Sireesha Yadlapalli, Vice President of International Government and Regulatory Affairs for United States Pharmacopoeia (USP)called for more commodity policing.
Drugs are made up of two components, the active pharmaceutical ingredients (APIs) and the inactive ingredients or excipients, including reagents, solvents, and items related to the taste or appearance of the product.
Excipient monitoring was less stringent, and that’s often where problems arose, Yadlapalli said.
“There may be a problem with an ingredient, but the manufacturer may not be aware of that particular problem because they just took the supplier’s word and the certificate of analysis at face value, and that’s because that raw materials are not tested when accepted by suppliers,” she added.
“Manufacturers need to test raw materials. Regulations should be put in place to require testing of these raw materials.
Improve regulatory systems
Members of the International Generic and Biosimilar Medicines Association represent up to 80% of quality-assured medicines worldwide, according to its secretary general, Suzette Kox.
“We think the biggest challenge is the weak health systems, which of course includes the underfunded regulatory system and quality control. Most countries in the world do not have appropriate regulatory systems in place, nor appropriate competition policies.
Oksana Pyzik, who teaches at UCL’s Faculty of Pharmacy, said one of the biggest challenges is the lack of public awareness.
Highlighting the proliferation of online medical supply outlets during COVID-19, Pyzik said many patients don’t know how to check out legal online pharmacies.
“Pharmacists are the last line of defense before patients receive these drugs and take them home. And there is a real opportunity there for patient education as part of broader public awareness,” she said, adding that this was why educating pharmacists about falsified medicines was essential.
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