Stiff scrutiny of the qualification and conformity of dealers with the standards of practice of the pharmaceutical business is the next tool to be deployed in Nigeria’s latest attempt to curb unsafe practices in its multibillion open drug market.
After several years of clamouring, the Pharmacy Council of Nigeria Bill received presidential assent on Monday, empowering the council to oversee all players along the pharmaceutical chain and whip errant players into shape.
The new Act regulating the education and practice of pharmacy in Nigeria repeals the Pharmacists Council of Nigeria Act 2004 and removes the clause that only pharmacists are covered by the regulation. The National Assembly began the processing in 2016 and passed it in 2017.
Some top sector stakeholders who spoke to BusinessDay said the law will usher in a new dawn in the regulation of all the aspects of pharmaceutical practice in Nigeria, not just pharmacists.
They expect that the limitations of the previous PCN laws, which were exploited by interlopers in the profession and trade of pharmacy, will now be blotted out through sanitisation, particularly in the wholesale and retailing of drugs.
Samuel Ohuabunwa, former president of the Pharmaceutical Society of Nigeria (PSN), said the law implies that all in the business of drugs, from manufacturers to importers to distributors, wholesalers, retailers or dispensers will be managed and regulated by the PCN.
The law has strengthened the prosecutorial power of the PCN to quicker justice quicker. With enhanced responsibility, the PCN can cover a wider spectrum of the environment they should regulate, he said.
The law means that those engaged in open drug marketing will run out of business in no time if effectively implemented and enforced. To remain in the trade, business owners or investors in drug trading will have to do so under the supervision of a professional pharmacist who qualifies to oversee safety practices in the handling of the business.
Large unregulated markets fraught with fake medicines will be closed, with the government taking over through an initiative called ‘coordinated wholesale centres’.
“Drug distribution and drug availability have been so haphazard and indiscriminate that many Nigerians have suffered a lot of debilitation by exposing themselves to quacks feigning knowledge of the pharmaceutical practice. It is exciting because it will bring better control to the profession,” Ohuabunwa said.
“Not all pharmacists, for example, can even practice community pharmacy. Even though they are professionals, they can’t meet the requirements in terms of the size of premises, furnishing, provision of books and the level of assistance, employment, regulation and quality assurance that needs to be established in a pharmacy.”
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Putting an end to open drug marketing in Nigeria has been a tough task for the federal government, which is often trapped in a dilemma of flushing out unwholesome practices and blocking access to essential drugs in a large consumer market of over 200 million.
Four years after setting a deadline to end open drug sales, the practice has persisted, forming a key part of an expanding pharmaceutical market estimated could reach $4 billion in value by 2026, according to a 2017 analysis by Mckinsey & Company.
Riding on the heels of rising household consumption expenditure and growth in out-of-pocket healthcare expenditure, Nigeria could contribute between $1.9 billion and $2.2 billion to pharma sales growth, 55 percent of it from prescription drugs, the projection states.
Stakeholders fear that these ambitious growth forecasts could come at a grave cost to Nigerian consumers if different kinds of unethical and controlled medicines are indiscriminately sold by traders who lack knowledge on preservation of medicines, required temperature, and environmental order, for instance.
There is a place for patent medicine vendors in the system, Samuel Adekola, national chairman, Association of Community Pharmacists said in a live interview monitored by BusinessDay. But it has to be with the bandwidth of regulation. Patent medicine vendors, for instance, have a list of over-the-counter medications that are generally safe.
“Stakeholders including those in the open drug market have bought into the idea of coordinated wholesale centres. This is about bringing them to a place where they can be regulated and monitored,” he said.
“In the law, a session talks about satellite pharmacies, making smaller pharmacies to be supervised by bigger ones.”
