The sale of antibiotics without a prescription by licensed doctors continues in breach of a High Court directive to end the non-prescription sale of these drugs, which can lead to deaths from antimicrobial resistance or RAM.
Public health experts said antimicrobial resistance was on the rise in the country as the authority failed to end the misuse of antibiotics even after the HC passed the directive in 2019 to stop selling.
Anyone, they said, can still buy antibiotics without a prescription, while many quacks and drug store employees suggest antibiotics to patients without a diagnosis.
The government has listed only 39 drugs that can be sold without a prescription, but antibiotics are not on the list.
According to Md Sayedur Rahman, professor of pharmacology at Bangabandhu Sheikh Mujib Medical University, virtually all drugs in Bangladesh have become over-the-counter products, including antibiotics.
He said self-prescription, lack of knowledge and greed by traders, and lax oversight still prevent the misuse of antibiotics leading to antimicrobial resistance.
If someone develops antimicrobial resistance, drug interventions do not work against microorganisms such as bacteria, viruses and some parasites.
Director of the Directorate General of Drug Administration, Md Ayub Hossain, said they had decided to mark the packaging of the antibiotics with a red mark and a warning like “Do not use without a doctor’s prescription. accredited”.
“We have also proposed a fine of Tk 20,000 in addition to the current provision of revoking a pharmacy’s license in the new Medicines Control Act for selling antibiotics without a prescription,” he said. he declares.
Ayub, also a DGDA spokesperson, said the red marking and warning would help people realize the danger of using antibiotics without a diagnosis or prescription from a licensed doctor.
Selling prescription drugs without a doctor’s prescription is an offense because it violates the terms of a drug license, he added.
The DGDA can revoke the approval of a pharmacy that violates the condition. But the drug regulator takes virtually no action against an errant drug store.
DGDA legal adviser Md Nurul Alam said the Drugs Bill 2022 had been sent to cabinet to replace the Drugs Act 1940 and the Drugs Control Ordinance 1982.
The secretary general of the Bangladesh Pharmaceutical Industries Association, SM Shafiuzzaman, said they had asked pharmaceutical companies to follow government guidelines, adding that some companies had already started packaging antibiotics accordingly while other others were doing it.
“Once products currently on the market are sold out, products in new packaging will be available in pharmacies,” he said.
He hoped the antibiotics in new packaging would hit the market by October 2022.
Ayub Hossain said drug makers had six months to change the packaging.
The DGDA will take action against pharmaceutical companies that fail to meet the deadline, he said.
He said the DGDA could not monitor all pharmacies due to their shortage of manpower.
“We will recruit more staff for this task,” he said.
A study by the DGDA unveiled in May 2022 showed that 67.3% of drug retailers had no idea of the restrictions on the sale of antibiotics and that these stores were selling them without a prescription.
According to the DGDA, there are 1,53,000 licensed retail pharmacies across the country, but Bangladesh Chemist and Druggist Samity officials have estimated that this figure could be double the number of pharmacies operating without a license.
The association’s senior vice president, Abdul Hai, said the association educated pharmacy owners on the need to adhere to restrictions on the sale of antibiotics, adding that it could not take punitive action against anyone in case of violation.
“If the government takes action against unlicensed stores and illegal practices or takes action against fake drugs, we will help,” he said.
BSMMU Pharmacology Professor Sayedur said the new law was a good move but not enough to prevent the abuse and overuse of antibiotics.
“A mass awareness campaign is needed to inform people of the danger associated with the misuse of antibiotics,” he said.
He also suggested incorporating the subject into school textbooks.
He said self-medication of patients and the motivation of pharmacies to make money selling antibiotics without restriction as well as lack of government oversight were the reasons for the current situation.
He said that up to 60% of those who buy drugs buy antibiotics, which would not exceed 20% if the law and regulatory measures were indeed in place.
According to the DGDA study, people spend 15% of drug costs on antibiotics, which is huge, he said.
“Antibiotic resistance poses a significant risk in terms of mortality and economic burden worldwide,” he said, adding that collective global initiatives are also needed to address the problem.
Global Research on Antimicrobial Resistance in April 2019 said that antimicrobial resistant bacteria may have directly accounted for 1.27 million deaths in 2019.
Research has estimated that antimicrobial resistance could cause 10 million deaths per year by 2050.
There are no data on deaths caused by superbugs in Bangladesh, but doctors say a significant number of deaths in ICUs are caused by AMR.
Sayedur Rahman said that due to Covid-19 the situation got worse as people were taking more antibiotics during the pandemic through self-medication and sometimes doctors too were prescribing them more as a last resort as there was no effective drugs.
He said that so far, 13 to 15 basic antibiotics have been developed in the world, but many of them have lost their effectiveness while two to three new antibiotics, which would work in the current state, were in being developed but they were not available.
“If the antibiotics don’t work, people will die from very simple diseases,” he said.
The DGDA and the World Health Organization, in a joint study published in November 2019, showed that the consumption of antibiotics in Bangladesh had increased by 30.81% over the previous two years.
Meanwhile, a laboratory analysis, conducted by the BSMMU from 2010 to 2018, revealed a sharp increase in the number of superbugs in the country.
In 2010, superbugs and multidrug-resistant bacteria were detected in 6.5% of all patients seen. But the rate increased to 14% in 2018, according to the study.