The spike in fake vaccines and treatments for COVID-19 was a reminder of the vulnerability of our medicine supply chains.
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.
REALITY CHECK
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.
BIG IDEAS
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.”
PERSPECTIVES
A spoonful of sugar can stop the (fake) medicine going down William H. Grover, University of California, Riverside The key ingredient in detecting a counterfeit medicine could be in your kitchen.
Australia's offshore pharma conundrum Bruce Baer Arnold, University of Canberra Australia is reliant on imports for the majority of its medicines – in this age of global epidemics regulatory vigilance has never been more important.
How the pandemic set back drug safety C. Michael White, University of Connecticut The best form of inspection is an unannounced one, but the pandemic changed the game for regulators. They’ll need to work together to protect consumers.
Poor-quality medicines are everyone’s problem Sangeeta Tanna and Rachel Armitage, De Montfort University COVID-19 has shown that regulatory processes can fail anywhere, allowing poor-quality medicines through. A new detection test could help shield consumers.
When the choice is between poor-quality medicine and no medicine at all Yasuhide Nakamura, National College of Nursing, Japan Poverty drives the market in inferior medicines just as it drives other examples of inequality. A socially integrated approach is needed to fight the problem.
Proactive regulators key to safe biopharmaceuticals Rashmi Shrivastava, National Institute of Biologicals India’s booming biopharma sector presents a new challenge for regulators.
Malaysia: Fake Viagra is no joke Gan Siew Hua, Monash University Malaysia The rampant trade in fake sexual stimulants is a reminder of how easy it is for substandard medicines to take hold and the need for greater public awareness.
India: Substandard medicines threaten the goal of zero malaria Amrita Chaudhary and Taruna Arora, Indian Council of Medical Research Fraudulent antimalarials have been called “manslaughter”. They and substandard antimalarials are the main obstacle as India pursues malaria eradication by 2030.
When shopping online is deadly Yusi Anggriani and Stanley Saputra, Pancasila University Buying medicines on the internet saves time and money, but it could be deadly. Indonesia is working to regulate online pharmacies and improve public safety.
Originally published under Creative Commons by 360info™.
