‘Poor regulation, open markets spike risks of banned drugs’

Although drugs are critical for the health and well-being of all, they can sometimes be poisons, which constantly remind us of the imperative of testing and control of medicines – as well as the importance of adequate drug regulations to protect lives from harmful and substandard drugs.
Drugs in open market

Although drugs are critical for the health and well-being of all, they can sometimes be poisons, which constantly remind us of the imperative of testing and control of medicines – as well as the importance of adequate drug regulations to protect lives from harmful and substandard drugs.

While substandard drugs are known as drugs manufactured in the absence of good manufacturing practices, experts define banned drugs as products that have been discovered during use to have more damaging effects on health and life than were known before or realised.

In Africa and Nigeria in particular, pharmaceutical regulation is severely constrained by limited national capacities to undertake core regulatory roles and this situation has been exacerbated due to factors tied to unregulated open drug markets, poor local pharmaceutical manufacturing capacity, and porous cross-border monitoring and surveillance systems.

Despite efforts by the National Agency on Food, Drugs Administration and Control (NAFDAC) towards a better drug-regulated society, shortcomings in drug regulation can be seen in the continuous reports on fake or substandard drug availability in open drug markets around the country and the ease of accessibility to drugs without a proper prescription from the doctor.

The most recent data gathered to establish the factors that have contributed to the prevalence of counterfeit drugs in Nigeria despite the laws suggests that drug laws were adequate; however, it fell short in its implementation with task forces rated as ineffective as seen in the case of Metamizol popularly called Analgin injection.

Analgin is banned in most parts of the world including in the U.S., Australia, Japan, Canada, Sweden and France. It was also barred in a few developing countries such as Nigeria and Nepal due to its effects on the white blood cells, but this drug continues to be distributed around the country, endangering the lives of many.

The Managing Director, Engraced Pharmacy, Jonah Okotie, confirmed that some banned drugs are still in distribution and use among the populace in the country.

He referenced a recent death due to the Analgin administration, which has been banned in the country and urged experts, as well as everyone to desist from shielding perpetrators of banned drug distribution in the society.

“It takes observation of people in the communities to see and report those who we know are distributing such. Shielding them because they are our kith and kin is not in our best interest. You never know who will be a victim of such. The other day, it was reported a former governor died from the administration of some injections in his house by a supposed nurse, one of which was the banned Analgin.

“I’m sure, a trained nurse knows better. Besides, our security agencies and politicians must realise that opening pharmacy premises or patent medicine stores is not a reward for political or whatever loyalty.”

Okotie compared drug security issues to that of owning a gun, which requires the owner to be licensed, trained, identifiable, traceable, and knowledgeable. He continued that an unqualified person has no business neither holding it nor distributing it.

“Shielding peddlers of such substances is aiding and abetting the daily murder and debilitation of the lives and health of citizens and by extension the economy of the nation. We don’t know the huge amount we are spending daily whether out of our own pockets or by the government to mitigate the challenges that stem from the use of these products,” he added.

Speaking of the regulation of drug channels, Okotie pointed out that there are too many uncontrolled channels for drug distribution, including hospitals, making drug regulation and medicine control difficult.

He noted that drug regulators have the statutory responsibility of ensuring that citizens are adequately informed and restricted from access to unnecessary medicines. According to him, most drug dispensaries frown at or resist inspection by the drug agencies, “because they believe there is always a hidden agenda but we are a team and ought to be working together”.

The pharmacist referred to banned products as inimical to the health and lives of many and its circulation exposes people to the harmful effects of the products that the regulatory body, government, and experts are trying to protect people from.

Okotie continued that although communication and transparency between regulators and pharmacists have improved over the years to address issues related to banning drugs.

He, however, noted that like every human endeavour or engagement, there would always be areas of improvement, especially in creating an enabling environment and equal opportunity for all when it comes to product distribution.

The former Chairman, Association of Industrial Pharmacists of Nigeria, Dr Lolu Ojo told The Guardian that it is not unusual to find these banned products in the market due to several reasons including the fact that Nigeria is a place where illegal dealings in pharmaceutical products are common.

He continued that a substantial percentage of drugs distributed do not go through the proper regulatory control. “Our borders are porous and the system is easily corrupted to bypass the controls and barriers set by the relevant agencies. People will still patronise the banned drugs since they lack information about their current status and in most cases, these drugs are popular,” he added.

Ojo noted that although pharmacists are bound by the ethics of the pharmacy profession to resolve all doubts in the favour of the patients, a bigger part of the drug trade is not within the ambit and control of pharmacists and their associations. He advocated government ensure that all persons and corporate bodies dealing with drugs come under regulatory control.

A community pharmacist, Chukwu Unique, pointed out that although certain medications are not supposed to be out in the public, it does not rule out the fact that they are also indispensable and useful to some people with certain medical conditions. Using Tramadol as an example, she explained that the implication of banning a drug completely or restricting its manufacturing will lead the real patient who needs the drug to be denied its use.

She also noted that drugs can be recurred after some level of negative effects have been detected and this could be from a particular batch during production, after approval and commercial release but oftentimes, people mistake drug recall as drug banning. “Death is also another risk associated with the circulation of banned drugs because depending on the level of harm, the incidence of death can increase due to the use of banned drugs,” she added.

Unique stressed the need for awareness as a tool to aid regulatory agencies in achieving their goals in an adequately regulated drug society. She advised pharmacist to desist from restocking and dispensing prohibited drugs on their shelves as soon as they get banned.

The community pharmacist advised NAFDAC to discover unsafe drugs ban them, and pass the information to the public.

“Such drugs will continue being in circulation and increasing the chances of why it was banned in the first place. NAFDAC alone cannot do it but pharmacists operating in communities, academic areas, administrations and more people can be reached through such means. So, getting involved in more awareness programmes, conducting more research, being committed to our ethical standard of practice would help inform more people on drug ban,” she said.

Unique recommended intense regulation in open drug markets because they are the major hindrance to completely removing banned drugs from society, as well as ensuring that patent drug stores stick to dispensing only the drugs they are supposed to dispense to the communities.

“NAFDAC and pharmacy regulators should implement regulations to guide open drug markets in ban drugs circulation because that is where anyone that get access to such medications. So, NAFDAC and pharmacy regulative bodies can work together to effectively implement these regulations. It is one thing to make these rules; it is another to ensure compliance. Also, patent drug stores are restricted to selling non-prescription medicines but these days, you see them having access to prescription medicines. The pharmacy regulators should step up and ensure they stick to the drugs they are supposed to dispense to the community,” she said.

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