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The World Health Organisation (WHO) and the United States Pharmacopoeia (USP) study on the content and dissolution of anti-malarial and anti-tuberculosis drugs in West Africa, revealed an alarming rate of failure.
“Anti-malarial and anti-tuberculosis products from Nigeria recorded the highest failure rate of over 70 per cent; Ghana over 60 per cent; Cameroon over 50 per cent; Kenya and Tanzania had relatively low failure rates whilst Ethiopia had all it products passing the tests.
“It confirms that the West African sub-region really has a big problem with regard to anti-malarial drugs,” Professor Ivan Addae-Mensah, Member of WHO Expert Committee on Quality Assurance of Medicines disclosed this at a public lecture in Accra on Wednesday.
The Public Lecture on the theme: “The Threat of Counterfeit and Substandard Drugs to Healthcare Delivery in Developing Countries,” was organised by the Ghana Academy of Arts and Sciences.
Prof Addae-Mensah a former Vice-Chancellor of the University of Ghana said the study revealed the lowest failure rate of Artemether lumefantrine while amodiaquine artesunate recorded the highest failure rate.
He said failure rate among products manufactured by companies pre-qualified by WHO were low while failure rate among non-prequalified products was very high.
“Overall amodiaquine artesunate failure rate was about 40 per cent. But all amodiaquine artesunate samples analysed failed (100 per cents), and Sulfadoxine/pyrimethamine recorded 33 per cent failure rate,” he said.
Quoting from the WHO/USP report presented to the WHO Expert Committee on Specifications for Pharmaceutical Products at its 45 meeting recently, Prof Addae-Mensah said the greatest cause of failure was with dissolution.
“If a drug is manufactured with the right amount of active ingredient but has poor dissolution, it is of no use because it means that when the drug is taken, it does not release the requisite therapeutic dose to the site of action.
“We say the drug has very low bioavailability. It therefore passes through the body without doing anything or may even cause harm and is excreted,” Prof Addae-Mensah who is also a Full Professor of Chemistry stated.
He noted that studies had confirmed a major problem in Ghana and the rest of West Africa.
“We need to tackle this as a team, not as individual professionals bodies jockeying for recognition.
“Chemists, pharmacists, clinicians, law enforcement agencies, customs officials, border security agencies, media practitioners, government and non-governmental organisations should all be involved in this fight.”
Prof Addae-Mensah said the Foods and Drugs Board (FDB) as constituted now is not strong enough to undertake the task of policing the country.
“Even anti-malarials alone present a major problem, how much more being in charge of all the medicines either manufactured or imported into the country as well as food and beverages?
He said the FDB faces acute shortage of qualified personnel and equipment, with few inspectors who cannot cope with the enormity of the drugs problem in the country.
He called on government to validate and accredit various laboratories in the universities, including faculties of pharmacy and departments of chemistry, biochemistry and microbiology to assist the FDB in its analysis and quality assurance duties.
Prof Addae-Mensah also called for frequent continuing education and training for all personnel involved in quality assurance and pharmacovigilance.
“Above all the players in the industry, manufacturers, importers, exporters and regulators, should all realise that each player’s success or failure depends on the output of the other.
“And the welfare of the consumer particularly the innocent child must be paramount in all we do as professionals in the health care delivery value chain, and not simply be blinded by the profit motive.
“It could indeed be your child, a close relative or yourself who will be treated with the counterfeit, fake, falsified or sub-standard medicine,” Prof Addae-Mensah stated.