Antibiotics top the list of substandard, falsified drugs

You are sick and desperate to get treatment, but the medication you get might worsen the disease or lead you to an early grave.

This is Malawi’s case which has a high prevalence of substandard and falsified medicines, with antibiotics topping the list.

Kamuzu University of Health Sciences (Kuhes) studies reveal that an average of 14 percent medicines commonly used in Malawi, such as antibiotics, antimalarial, antihypertensive and antidiabetic, are either substandard or falsified.

Researchers are worried with these findings considering that antibiotics and antimalarial medicines are highly sought.

According to the study, more than 50 percent of prescriptions in low and medium income countries contain antibiotics.

What is even more concerning is the fact that malaria is a leading killer disease in Malawi with statistics showing that in 2023, the country registered 6.4 million malaria cases which is 32 percent of the population.

Reads the study: “Medicine classes analysed in the study are crucial as they are used for treatment of diseases with a high morbidity and mortality in Malawi and other Low and Middle Income Countries (LMICs).”

In December 2022, Kuhes medical experts; Felix Khuluza, Adamson Muula, Francis Chiumia, Happy Nyirongo and Elizabeth Kampira released a report showing the high prevalence of substandard and falsified medicines in the public health system.

The study sampled 23 public, faith-based and private health facilities, focusing on commonly used medicines based on Malawi Treatment Guidelines.

While establishing an average 14 percent across all sampled medicines, antibiotics and antihypertensive had a 25 percent prevalence rate while antimalarials had 7.8 percent with antidiabetics at 5.7 percent.

Other reports done in 2014 and 2017 all point to a high prevalence rate of substandard medicines. In 2014 and 2017, the prevalence rate for antibiotics was 45 percent and 13 percent respectively. This means Malawi has worsened on antibiotics.

For antimalarial medicines, , the study showed that the prevalence rate of nine percent in 2017 has now gone down to 7.9 percent.

Medical experts describe substandard medicines as those “approved or registered [not fake],” but for some reason fail to meet quality standards or specifications. This could be due to some random errors during manufacturing or post-production degradation.

On the other hand, falsified medicines are fake products “where manufacturers deliberately misrepresent the identity, contents, or source of the medicines”.

The latest research shows that local manufacturers are a major culprit as they contribute up to 30 percent of the substandard medicinal products.

In a written response Kuhes department of pharmacy associate professor Felix Khuluza said manufacturers take advantage of lack of capacity to assess the medicines.

He said: “Tests to assess medicine quality are not cheap and require well-trained personnel. Drug manufacturers know that Least Medium Income Countries may not have the capacity to test every medicine batch that enters the country and that is why they are target markets for SF (substandard/falsfied medicines”.

According to the findings, the low prevalence of substandard medicines among antimalarial medicines is attributed to a more controlled supply chain system for medicines and medical supplies due to donor driven special public health programmes such as malaria, HIV and tuberculosis.

Unlike the previous two, the latest study extends to non- communicable diseases medications (NCD) because of their increase.

While indicating that there is no study yet to explicitly state figures correlating sicknesses and deaths from substandard medicines, Khuluza is certain they are contributing to the high disease burden in Malawi.

Statistics from WHO (2017) show that about 169 000 children suffering from pneumonia die every year from taking substandard antibiotics.

Adds the report: “About four percent of malarial deaths among under-five patients who receive treatment in sub-Saharan Africa are also reported to occur due to use of substandard medicines. Furthermore, SF medicines are also associated with loss of public trust and increased individual, household or health system costs”.

In terms of country of origin, the study found that locally manufactured products had 30 percent only next to China at 33 percent, Kenya had 26 at percent while India had 6.7 percent. For China, the products were identified with one manufacturer.

On local manufacturers, who are supposed to benefit from the Buy Malawi Campaign and marginal of preference in public procurement, the findings attributed the development to inadequate regulatory supervision.

“This may be attributable to inadequate regulatory supervision on the part of the medicine regulator and lack of adequate resources to enable manufacturing and quality control processes that are fully compliant to current good manufacturing practices [cGMP] in local pharmaceutical companies” further reads the report.

The findings also show that there is post-production degradation of medicines due to poor storage facilities. Save for the Central Medical Stores Trust (CMST) said to have the required capacity on storage, other players who include private firms and public facilities lack in this area according to the report.

Collaborated information also shows that falsification is common on local products due to capacity deficiencies and the need to maximise profits.

In a written response Kuhes professor of epidemiology and public health Adamson Muula alleged that some local manufacturers import medicines and present them to CMST as their own at a higher price.

“Malawian drug manufacturing companies, noting that they have this wide window to supply medicines to CMST force the Trust to buy from them, even for those medicines and supplies it doesn’t need.

He noted political influence at play.

Asked if these findings have been shared with manufacturers themselves, Muula said efforts to meet them and other stakeholders have not materialised.

“I believe some may have reached out because they had anticipated a negative backlash that would have threatened their businesses. But as time went by and we have not met, they also realised that Malawians do not largely care whether the medicines they are taking are effective or not,” he said.

Pharmaceutical Society of Malawi preseidnt William Mpute said the problem of substandard medicines was not unique to Malawi, but prevalent in other countries.

The Pharmacy and Medicines Regulatory Authority (PMRA) is yet to respond to our questionnaire submitted over two weeks ago, despite promises that they would do so.