Why didn't Poisons Board recall Benylin cough syrup batch sooner?
Benylin Paediatric cough syrup which has been recalled by the Pharmacy and Poisons Board.
In August 2021, 11,184 Benylin children's cough syrups arrived in the country and ended up in hundreds of homes, dispensed to treat coughs and allergies in children over the age of six.
Unbeknownst to thousands of parents, this batch '329304' contained high levels of diethylene glycol, a toxic substance linked to deadly cough syrups that have already claimed the lives of children in Gambia, Uzbekistan and Cameroon since 2022.
On April 10, Nigeria sounded the alarm and flagged the drug, manufactured by Johnson & Johnson, as a potential health hazard. Kenya quickly followed suit and initiated a recall of the specific batch.
Immediately, social media erupted with worried parents sharing their questions and concerns. Many wondered if they had unknowingly given the harmful syrup to their children, or if the syrup on their shelves was part of the recalled batch. Others questioned how this medicine had passed through regulatory checks.
Our reporter, Lilys Njeru, sat down with Dr Antony Toroitich, Deputy Director, Product Safety at the Pharmacy and Poisons Board (PPB), Kenya's drug regulatory authority, which is mandated to regulate the practice of pharmacy and the manufacture and trade of drugs and poisons.
Kenya issued a reactionary alert after Nigeria had raised the alarm. Have you let your guard down?
Whenever a product is recalled in another country, in this case, Nigeria, the first thing we do is that we check whether it was imported into the country because an alert is sent through the World Health Organisation (WHO) to all regulatory authorities.
The first important thing that we look at is whether the product was imported or manufactured locally. In this case, we checked and found that this specific batch recalled in Nigeria came to Kenya.
So, we don't even have to do any further investigation before recalling it from the market. If it’s recalled in another place, we just don’t even test it, we just recall it as a precautionary approach even before conducting independent testing.
As we speak, the samples have been taken to the lab, and we expect results before the week's end.
Does this mean that the batch hadn't been tested in Kenya since 2021 when it was allowed for distribution and use across the country?
What happens is that not all samples are tested when they come into the country. We do what we call risk-based sampling in that every year, we develop a protocol of products that are going to be tested or follow a passive system approach where individuals raise complaints.
Notably, it is also the responsibility of the manufacturer to test before release.
According to our plan, even without this Nigerian issue, we had already planned two weeks ago to sample all cough syrups.
What had necessitated that?
As a priority, we always target public health diseases. We have done samples targeting malaria, HIV, TB, hypertension and Diabetes. In the second phase, we were now targeting antibiotics, cough syrups and other products and that phase of this study, which is sampling was to start next week. Also, we work with other regulatory authorities because you can’t sample everything; we depend on what other countries with the same batch have done.
A recent spot check by Nation found Benylin Paediatric still for sale in city pharmacies, despite a previous batch containing harmful ingredients. Has this new batch been tested to ensure it's safe for children?
The recall was very batch-specific. And I would want to use an example that would be understood by the public. For example, if you cook today and the food gives you a stomach upset, it doesn’t mean that the food cooked the next day will do the same.
As we speak, the manufacturer, Johnson & Johnson, has confirmed to us that these other batches are okay, even as they investigate the affected one.
Since April 11 when the product was recalled, have you received any returns from the recalled batch?
The way the process works, we don't receive. What happens is that whenever we get such an alert, we ask for the distribution lists. So, the company which imported the product gives us the list of where they have sold. And then we instruct them to make a recall. Then they have weekly reconciliation. Because this one has not even exceeded a week.
What are the biggest challenges to implementing the WHO guidelines discouraging cough syrup use in children under five?
The problem that we have in our country currently in terms of health-seeking behaviour is that people do self-medication so it becomes difficult to be able to manage that. But as PPB, we are warning against that has not been prescribed by a healthcare practitioner. If anyone encounters a crook, we highly encourage them to file a report to us through the USSD Code *271#.
PPB has started registering online pharmacies. But the approach we have taken is global. Basically, what we are saying is that for an online chemist to advertise or sell medicines, they have to be linked to an existing physical chemist. You cannot have just a virtual marketplace for pharmacies. I have written many letters to a number of them to pull down some of those medicines that they are putting up there.
How has the doctor’s strike hurt the mandate of PPB?
I can say confidently we are still working.
How is PPB strengthening collaborations with international drug regulatory bodies to identify safety issues faster?
The WHO has a portal, global surveillance and monitoring system whereby all countries report any concerns over particular drugs with them. In Africa, we also have what we call the Africa Medicine Quality Forum, MQF. In that forum, there is also sharing of information on any poor quality product that has been found in other jurisdictions.
How would you describe Kenya's drug safety system?
The drug safety system in Kenya is two-pronged. We have active and passive approaches. The active approach focuses on medicine safety and the quality of medicine. And then there is passive which people complain about side effects and classify based on the seriousness of it to determine whether there is a causal relationship between the effect and the drug.
