Unsafe drugs for patients

Study finds substandard medicines in pharmacies, hospitals

PHULUZA —Some were received in good quality

By Serah Chilora & Aubert Nkangama:

If you have ever accessed medication from public, faith-based and private health facilities and retail pharmacies in the country, you might have consumed substandard and falsified drugs.

This is if findings by a study conducted by the Department of Pharmacy at Kamuzu University of Health Sciences (Kuhes) are anything to go by.


The cross-sectional investigation was conducted in 23 health facilities and retail pharmacies in Zomba, Machinga and Nsanje districts. Results indicate a 14 percent prevalence rate of substandard and falsified medicines.

Head of the Pharmacy Department at Kuhes Felix Phuluza said the findings were derived from more than 300 samples.

“When we were following the medicines to see if they may be degrading in our storage conditions, we found that some were received in good quality but they were degrading.


“The biggest worry was that one or two products from one of the local manufacturers were alarmingly high in terms of degradation and it was consistently from the same manufacturer,” Phuluza said.

He was speaking in Mulanje Wednesday during a policy dissemination workshop on ‘Countering the Prevalence of Substandard and Falsified Medicines in Malawi (Copsmeds)’.

Phuluza said the researchers suspect that the drugs that degraded in quality might have gone through a manufacturing error as they were of good quality before they lost it after three or four months.

He said after that period, the medicines were degrading more quickly than internationally recommended.

Apart from the quality of the medicines, the scientists assessed storage conditions at targeted facilities.

“[Pharmacists] were able to maintain the storage conditions but, still, there were higher temperatures in a lot of facilities in the Southern Region.

“During the time of the study, they could not control the temperatures because of electricity problems after tropical storms [destroyed power infrastructure],” Phuluza said.

He has since called on the Pharmacy and Medicines Regulatory Authority (PMRA) to enhance post-marketing surveillance of medicines to deal with the problem of substandard and falsified drugs being offered to patients.

“We believe a multifaceted approach is necessary to minimise cases of substandard or falsified drugs. Local manufacturers need capacity building to improve on their product formulation so that whatever they produce meets basic minimum standards,” Phuluza said.

Commenting on the study’s findings, Director of Health Technical Support Services in the Ministry of Health, Godfrey Kadewere, said the researchers’ work will help the country on how to tackle gaps in systems and find solutions.

“It is the duty of the government to make sure that such kinds of challenges are addressed. But I should also state that the problem is there in Africa and the whole world.

“Of course, it is larger in Africa than anywhere else. We cannot pretend that we do not have the problem of counterfeit medicines in circulation. We have the [PMRA] whose role is to make sure the problem is lessened,” Kadewere said.

Phuluza, who spoke within the context of the European Union-funded Copsmeds project, has warned that some patients may not get cured of their illnesses if they consume substandard medicines.

The World Health Organisation (WHO) defines substandard medical products as those which are authorised but fail to meet their quality standards or specifications while falsified ones are those that deliberately misrepresent their identity, composition or source.

According to WHO, all countries are affected by such medical products although low-and middle-income ones and those hit by conflict, civil unrest or those with very weak health systems are disproportionately affected.

“Substandard and falsified medical products may cause harm to patients and fail to treat the diseases for which they were intended…

“Anti-malarials and antibiotics are amongst the most commonly reported substandard and falsified medical products,” the United Nations health agency says.

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