Lessons from those who are succeeding at stamping out the toxic but persistent problem of substandard medicines
But even before the pandemic, substandard medicines – those that do not contain the right ingredients to be effective – were a problem in every region of the world.
“Patients taking medication should be able to count on two things. First, the medication will contain the active ingredient in the dosage claimed on the label. Second, that the medication is free of contamination or adulteration and was stored properly before it was given to you,” says C. Michael White, distinguished professor and chair, pharmacy practice, at the University of Connecticut School of Pharmacy.
“Unfortunately, consumers in both developed and developing countries can unknowingly access counterfeit products and have no confidence that either of these things have been done by the manufacturer or the seller.”
Poor manufacturing and quality-control practices as well as inadequate storage conditions lead to substandard medicines, whereas falsified medicines are produced and labelled with the intent to defraud. Both claim to be something they are not, and both can be deadly.
Some countries have succeeded in reducing the number of substandard medicines, but poor-quality manufacturing, contamination and storage issues remain, leading to a loss of confidence in medicines, healthcare providers and health systems.
Earlier this year Pfizer recalled its blood-pressure medicine Accuretic because substandard batches were found containing a higher-than-acceptable amount of nitrosamine, a harmful impurity that can cause cancer if taken in high enough quantities.
In 2021 the US Food & Drug Administration condemned 10 million COVID-19 vaccine doses from Emergent BioSolutions over a failure to “adequately train personnel involved in manufacturing operations, quality control sampling, weigh and dispense, and engineering operations to prevent cross-contamination of bulk drug substances”.
There are solutions: from regulatory vigilance and innovation, to novel ways to stamp a medication as authentic, researchers offer ways to stamp out this toxic but persistent problem.
The World Health Organization (WHO) estimates 1 in 10 medical products in low- and middle-income countries are substandard or falsified.
Antibiotics and antimalarial medications are among the most counterfeited medications in the developing world. Their lack of active ingredients results in 144,000 global deaths annually.
Substandard medicines with too little of the stated active pharmaceutical ingredient encourage the rise of antimicrobial-drug-resistant infectious diseases such as malaria, HIV and tuberculosis.
In 2018 the WHO said fewer than 30 percent of the world’s medicine regulatory authorities had the capacity to perform the functions required to ensure medicines, vaccines and other health products actually worked and did not harm patients.
Quote attributable to Yasuhide Nakamura, National College of Nursing, Japan:
“Tackling the proliferation of low-quality medicines is not merely a matter of enhancing pharmaceutical regulation, defining counterfeit medicines, and making technical improvements. It is also a question of international politics.”
Quote attributable to C. Michael White, distinguished professor and chair, pharmacy practice, at the University of Connecticut School of Pharmacy:
“More funding to find and remove counterfeit medications globally is needed, as are efforts from major social media and internet companies to deny illegal sellers access to consumers.”
Editors Note: In the story “Bad medicine” sent at: 25/07/2022 14:59.
This is a corrected repeat.