Desmond Tutu verily said “There comes a point where we need to stop just pulling people out of the river. We need to go upstream and find out why they’re falling in.”
Going blue for the World Antimicrobial Awareness campaign is a good initiative. But more importantly, we need to consult our honest serving men ‘What, Why, When, How, Where and Who’ to gain awareness regarding antimicrobial resistance (AMR) and its consequences. Since we must be on guard for loopholes in our strategy against AMR; this article specifically pinpoints “drug quality” as an impedance in lowering and curbing antimicrobial resistance AMR levels in ‘post-covid Pakistan’.
What is AMR?
Antimicrobial resistance (AMR) is the ability of microorganisms to grow in presence of antimicrobial drugs which should inhibit their growth or eradicate them. This is essentially a resistance, a withstanding capacity; microorganisms exhibit against drugs called antimicrobials. Thus antimicrobials are rendered ineffective in their purpose of benefiting mankind, as infections caused by the microorganisms continue to become untreatable.
Why is AMR a global issue?
Because it is warfare! Humans versus the pathogenic microorganisms. Microorganisms are equipping with a genetic arsenal to combat the antimicrobial formulations that humans are inventing as treatments for microbial infections. Also because AMR causes an estimated 700,000 deaths annually worldwide; which can increase to 10 million per year by 2050 [1].
When and How AMR develops?
It starts within us, and ends up where it begins! Microbial flora of the human body includes bacteria, fungi, protozoans, bacteriophages, and parasites inhabiting the skin and mucous membranes of healthy humans. These microbes outnumber human body cells by an approximate factor of 10.[2] Any shift or dislodgment of these microorganisms leads to infection/inflammation in the human body, which requires antimicrobials for treatment and cure. The antimicrobials (antibiotics, antivirals, antifungals, antiparasitics) should be cautiously administered in the prescribed doses over a recommended time period; for even a slight miscalculation can yield drastic long term consequences. Misuse of antimicrobials such as, by taking un-prescribed drugs or by disrupting a prescribed treatment regimen, results in antimicrobial resistance AMR. Since pathogenic microorganisms are capable of developing counter-strategies to withstand antimicrobials and evade their exterminating effect; a medicinal formulation that is effective against a certain microbial population; would cease to exert its lethal effect if administered poorly, hence microbial infection would persist and effective treatment would be lost.
The ‘Who’ behind AMR?
While discussing conventional factors causing antimicrobial resistance, it is important to highlight the link of current amplified AMR crises in lower and middle-income countries (LMIC) to the poor antimicrobials quality and a lack of stewardship in the medicine quality standards. The national action plan NAP themes recommended by WHO in 2018, confirmed ‘medicine quality’ as the most critical factor in tackling AMR. It demonstrated ‘drug quality as the core around which manufacturing practices, monitoring systems, surveillance data, and one health approach should be strengthened for “quality-assured, effective and safe antimicrobials”.
Poor-quality medicines can be: a) substandard therapeutics: with uncertified manufacturing or even degraded, b) falsified drugs: with no authentic source and composition grading. As reviewed by JAMA, about 12.4 % of antibiotics and 19.1% of antimalarials from LMICs were found either substandard or falsified [3]. Such compromised antimicrobial medicines retain and release the active ingredients in dosage, lesser than that prescribed, thus intensifying the threat of antimicrobial resistance AMR in hospitals and community settings. The prevalence and administration of poor quality medicines have become a huge concern recently, in the post-COVID era; where the menace of excessive antibiotics usage is already a hurdle in tackling increasing AMR. Such compromised antibiotics can wreak havoc when administered upon SARS-CoV-2 patients already facing the complexities of superinfection with bacteria. Following the climate crisis, AMR indeed is the catastrophic threat human population is facing globally.
Where are we headed?
The ‘Promoting the Quality of Medicines Plus’ (PMQ+) program is strengthening quality assurance for medicines in 14 LMICs, countries including Pakistan (Bangladesh, Burma, Ethopia, Kazakhstan, Kenya, Liberia, Mali, Mozambique, Nepal, Nigeria, Senegal, Serbia, Uzbekistan). It is assisting developing countries in uplifting their drug regulatory systems as per WHO’s World Health Organization’s global benchmarking tools (GBTs). In the PMQ+ program report (2020) Pakistan still has a long list of objectives to achieve, before it qualifies to fulfil international drug quality standards at a satisfactory level. It is a long journey ahead; once for Drug Regulatory Authority Pakistan DRAP is struggling to achieve the minimum acceptable level i.e WHO Maturity Level 3 for a stable regulatory system. DRAP is not yet enlisted in the WHO Authority status as per WHO’s global benchmarking tools, hence it is not meeting international standards for medicinal quality assurance [4].
Moreover, Pakistan’s licensing system for drug/ medicines regulation lacks transparency and uniformity and is not in line with the international standards. Pakistan’s licensing rule (1976) must be revised to ensure safe therapeutics regulation. For now, the ‘Promoting the Quality of Medicines Plus’ PQM+ program has provided expertise to DRAP and stakeholders in revising the licensing rules; and conducted training sessions for DRAP’s National Control Laboratory for Biologicals (NCLB) technical staff. Onwards, the major standardization tasks for Drug Regulatory authority Pakistan DRAP include: adopting data standards on substances (ISO 11238); pharmaceutical dose quantification, specification of dose units, routes of administration (ISO 11239); units of measurement (ISO 11240); regulating pharmaceutical (ISO 11616) and medicinal product information (ISO 11615) respectively 4. Given that the objectives and goals have been defined for regulatory authorities, this is now a test of our grit in maintaining standards, improving access to quality antimicrobials, and pooling investments for improving medicines quality to meet the international criteria of safety. Let’s see at which pace we choose to counter antimicrobial AMR at National level by investing efforts in policy and advocacy.
