NAFDAC, PSN differ over study’s result
MANY a resident had dutifully used them as prescribed by their trusted physicians and wondered why the drugs failed to deliver on promise, as they did not get any better.
This may well be the reason: No fewer than 84.6 per cent of anti-malarial drugs sold in Lagos State are sub-standard, a research carried out by the Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Lagos (UNILAG), on 13 brands of Artesunate-amodiaquine combinations, also known as Artemisin Combination Therapy (ACT), bought from pharmacies in the state has shown.
The researchers found that 84.6 per cent of the drugs failed to meet the United States Pharmacopeia (USP) specifications for one of the Active Pharmaceutical Ingredients (APIs).
All the 13 brands of ACT tested have the National Agency for Food, Drug Administration and Control (NAFDAC) registration numbers.
The situation, experts say, raises the risk of treatment failures and resistant strains of the malaria parasite.
The USP Reference Standards are highly characterised physical specimens used in testing by pharmaceutical and related industries to help ensure the identity, strength, quality, and purity of medicines (drugs, biologics, and excipients), dietary supplements, and food ingredients.
The researchers, in the study published recently in African Journal of Pharmacy and Pharmacology, concluded: “Even though there is no case of outright counterfeiting from the results obtained in the study, the potency of the drugs vary considerably. Only 15.4 per cent of the samples studied had required amount of active ingredients for the two drugs.
“It is clear that the quality of most brands of artesunate amodiaquine combined therapy in circulation in Lagos metropolis is less than adequate. This result can be extrapolated for other cities in the sub-Saharan Africa. This poses a great threat to the global effort to combat the scourge of malaria.”
The study is titled: “Quality survey of some brands of artesunate-amodiaquine in Lagos drug market.”
However, the Pharmaceutical Society of Nigeria (PSN) and the NAFDAC are divided over the result of the study.
While NAFDAC says anti-malarial drugs registered by the agency are not sub-standard, the PSN says the study’s finding could have been caused by improper drug storage and weak strategy in the fight against sub-standard and counterfeit drugs.
An earlier study published in the January 2012 edition of Malaria Journal warned that hopes of controlling malaria in Africa could be dashed due to production and circulation of sub-standard cum fake anti-malarial drugs. Except urgent actions are taken both within Africa and on the global stage, they argue, millions of lives could be put at risk.
In a study published in the journal, an international team of researchers reported that some batches of drugs on sale in Africa have been deliberately counterfeited by criminals or are of poor quality because of factory errors.
Both types are not only potentially harmful to the patient but also risk promoting the emergence of drug resistance among the parasites that cause malaria.
According to the World Malaria Report 2010, malaria killed an estimated 781, 000 people in 2009, mainly young children and pregnant women. It is caused by parasites injected into the bloodstream by infected mosquitoes.
The most effective anti-malarial drugs are the artemisinin derivatives, which have the advantages over other anti-malarial drugs (such as chloroquine and mefloquine) of having few side effects but the fastest action.
Although the drugs have been used on their own as monotherapy, fears over the development of resistance mean that they are recommended for use in conjunction with one or more other drugs as ACTs, now recommended by the WHO as the first-line treatment for uncomplicated falciparum malaria globally.
Artesunate-amodiaquine, like other ACTs, has been widely implicated in this menace due to the market value and affordability.
The UNILAG researchers wrote: “13 representative brands of Artesunate-amodiaquine were procured from different outlets in urban and peri-urban parts of Lagos, Nigeria. Quantitative and qualitative analysis were carried out on the different brands using High Performance Liquid Chromatography (HPLC).”
Sometimes referred to as High Pressure Liquid Chromatography (HPLC), it is a chromatographic technique used to separate a mixture of compounds in analytical chemistry and biochemistry with the purpose of identifying, quantifying and purifying the individual components of the mixture.
The researchers continued: “The results show all brands to contain the test APIs but in proportions varied about the USP specified limits. 30.8 per cent of the test brands had artesunate within the USP specification. 30.8 per cent of amodiaquine also had met the quality specification of USP. But only 15.4 per cent of the sample had both amodiaquine and artesunate within the USP specification. 53.8 per cent failed the active content test for both amodiaquine and artesunate.”
But in a reaction, Director-General of NAFDAC, Dr. Paul Orhii, said the anti-malarial drugs approved by NAFDAC were not sub-standard.
However, Orhii stated that a similar study by WHO last year showed that over 50 per cent of anti-malarial drugs marketed in Nigeria were counterfeits.
Orhii explained: “The anti-malarial drugs approved here are not substandard. For anti-malarial you cannot allow substandard because it is even more dangerous than counterfeit. We make sure that the drugs contain the right quantities of the active ingredients before we approve.”
On what the agency is doing to check the situation, the NAFDAC boss said: “We do constant sampling with Truscan (hand-held device used for on-the-spot determination of the authenticity of drugs). It cost N2 million to N3 million to send a team out for sampling. Doing constant sampling is very important.”
President of PSN, Azubuike Okwor, said: “The study is a strong confirmation of our Society’s long-held position that we need a new strategy in our fight against substandard and counterfeit medicines. One is not able to comment on certain specific findings of the study until one is availed the detailed study, though.”
Okwor said the results of the study flow naturally from the national attitude of Nigerians to medicines and other health-related commodities.
The PSN President said to be able to guarantee and sustain the quality of medicines especially anti-malaria drugs “certain imperatives are necessary and unfortunately these imperatives are the exceptions rather than the rule in Nigeria.
“As pharmacists and custodians of the nation’s drug armamentarium, we are aware that drugs are generally not stored in the conditions prescribed by the pharmacopeia.
“In Nigeria, we have a situation where drugs are handled by every Okonkwo, Musa and Muftau, with grave implication for our wellbeing as a nation.
“A corrupt system as is evident in several revelations at probe panels lately can only breed a system where substandard and counterfeit drugs permeate the entire fabric of healthcare delivery.”
Okwor disclosed that the PSN has just published National Good Pharmacy Practice Guidelines, which incorporates a good storage policy that every pharmacy and pharmacist must subscribe to.
He also charged the regulatory agencies to embark without delay on a post marketing surveillance as a measure to ensure sustained quality for registered drugs.