Medicines must be manufactured according to high standards of quality and efficacy to reduce AMR risk
Antimicrobial resistance (AMR) is one of the most pressing global health challenges we are facing. Over 700,000 deaths are caused annually by AMR, according to estimates by World Health Organization (WHO).
AMR is predicted to kill two million people in India and 10 million deaths worldwide if nothing is changed to stop it.
Overuse of antimicrobials contributes to resistance. However, the quality of medicines and the way they are used also play a major role in this threat. Medicine quality can be compromised anywhere along the global supply chain, including quality assurance, manufacturing process, packaging integrity, storage and distribution conditions. When these factors are compromised, it contributes to the risk of AMR.
When patients are exposed to subtherapeutic levels of an antimicrobial, it increases their risk of developing resistant microbial strains that can cause deadlier infections. Nonadherence to prescribed medication has also been cited as a driver of AMR. Substandard and falsified medicines make patients who adhere to their treatment regimens vulnerable to antimicrobial resistance by exposing them to subtherapeutic levels of doses.
India has one of the largest burdens of drug-resistant pathogens in the world, particularly multi-drug resistant tuberculosis. Therefore, there is an urgent need to address this looming crisis.
Pandemics reinforce need to address AMR
The novel coronavirus disease (COVID-19) pandemic has seen an overuse of antibiotics, both for empirical treatments and due to misinformation on the benefits of consuming antibiotics to prevent the infection.
But there has also been a significant increase in the availability of substandard and falsified medicines, including vaccines, during this pandemic. At the same time, widespread disease caused worldwide supply chain disruptions, while unexpected demand for certain medical products spiked, leading to shortages of extremely important medicines and critical supplies like personal protective equipment.
Together, all these factors increased the risk for AMR occurring as a result of poor quality medicines.
Poor-quality antimicrobials and AMR
Ongoing research through USP’s Quality Institute — a research collaboration of leading academic partners around the world — is helping establish that when medicines break down due to poor storage and distribution practices, have insufficient quantity of active ingredients or have unwanted impurities, it increases the risk of antimicrobial resistance.
Such low-level resistance can carry over across antibiotic groups and is difficult to detect clinically. The findings also have implications for patients who are exposed to products that may have become contaminated or degraded along the way in the supply chain.
‘One Health’ approach
The principles and mechanisms of how quality issues in antimicrobials contribute to resistance are not sector-specific and may impact the use of microbials not just in humans, but also for the treatments of animals and use in agriculture. The 'One Health' approach requires coordination and collaboration across multiple sectors, including health care, environment, agriculture, and industry to ensure the appropriate use of quality antimicrobial medicines.
Potential solutions
In order to reduce the risk of AMR, medicines must be manufactured according to high standards of quality and efficacy. Medicine quality assurance measures should be included in national action plans and key guidance documents for containing antimicrobial resistance especially for low- and middle-income countries.
Investments have to be made in regulatory health systems and country-level quality management systems to monitor substandard medicines. This should be done along with promotion of current good manufacturing practices and current good distribution practices to ensure antimicrobial medicine quality.
Policymakers in low- and middle-income countries, should understand the economic impact of poor-quality medicines and their role in the emergence and spread of AMR.
One of the primary components of antimicrobial stewardship efforts is to have the right medicine for the treatment of infections. Quality standards ensure that medicines have the identity, purity and potency as required by the regulations, thus directly aiding in stewardship efforts.
Scenario in India
The Indian National Action Plan for AMR has robust language on medicine quality assurance and the stakeholder collaboration required for its implementation.
India has prioritised policies around tackling substandard medicines, given evidence that as much as 40 per cent of antibiotics like Gentamicin and Amikacin. Both these drugs are broad-spectrum aminoglycoside antibiotics and treat severe bacterial infections like meningitis.
As with many countries, progress on implementation has been slow. Although we see positive trends around collaboration among stakeholders, the emphasis on medicine quality as a contributing factor to AMR is low.
Investing in quality assurance of antimicrobials can result in a high rate of return and aim to mitigate AMR, reduce the burden of tuberculosis-resistant cases and achieve true universal health coverage.
Views expressed are the author’s own and don’t necessarily reflect those of Down To Earth.
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