This is a follow up story to the public service announcement concerning the misuse of Chlorhexidine digluconate 7.1% solution packaged as eye drops in Yobe State, Northern Nigeria.
A chilling weekend email
On Sunday we sent out an urgent public service announcement on the misuse of Chlorhexidine digluconate 7.1% solution (CHX). The solution, which is licensed for use in Nigeria as a gel, was packaged as a solution in a white plastic bottle normally used for eye drops and distributed in two states in Nigeria; Yobe and Adamawa, as far as we know, since March 2015. Chlorhexidine is normally used on the umbilical cords of newborn babies to prevent infection, but in the cases in Yobe, it was mistakenly used as eye drops for infants by three mothers who received it as part of a kit that they were given during delivery.
There are five known cases of irreversible blindness associated with the use of these drops already, three reported in Yobe State and two in Adamawa State. The three children in Yobe are 3 weeks, 4 weeks and two years old. Since we published this, there has been a flurry of comments on social media on several aspects of this story. We thought it important to provide context, so here is what you need to know about the Yobe eye drops cases.
Chlorhexidine is an approved medicine for umbilical cord care
Firstly, to be absolutely clear, there is no evidence of any problem with the active ingredient of the bottle. 7.1% chlorhexidine digluconate was added to World Health Organization (WHO) List of Essential Medicines for Children for umbilical cord care in 2013. In January 2014, the WHO approved its use in aqueous solution or 4% gel, delivered to the umbilical cord stump during the first week of life. The impact this has had in Nigeria is unequivocal, as we pointed out in our article on the impact of TSHIP’s intervention in Bauchi and Sokoto.
Dr. Nosa Orobaton, who has led the programme that introduced Chlorhexidine into Nigeria, recalls his interaction with the first patients in Sokoto to use the Chlorhexidine gel on an umbilical cord. “The thunderous sounds of rain that pelted the tin roof of my abode did occasionally drown out my phone chat with Sarkin Yakin Gagi, Alhaji Jabi Umar, district head of Gagi community in Sokoto, Nigeria,” Orobaton said. “He passionately recalled the progress witnessed in Gagi and Nigeria to make clean newborn cord care the norm. It began one momentous April morning in 2013, when Shamsuddeen’s, the first baby in Nigeria to use Chlorhexidine gel, cleanly cut cord was lavishly coated with Chlorhexidine gel. Fast forward to September 2015; Nana Asma’u was safely delivered. She too had a lavish coating of Chlorhexidine gel on her cord stump.”
Orobaton added that Chlorhexidine is now manufactured in Nigeria. “A recently published research paper about Sokoto State’s experience reported a much lower neonatal mortality rate associated its use,” he said, adding “Nigeria became the first country in Africa to manufacture its Chlorhexidine gel in March 2014. Since March 2014, Drugfield Pharmaceuticals Ltd has sold 1.2 million units of gel tubes; 300,000 units were shipped to seven countries in Africa, Asia and the Caribbean. In Gagi, every woman, well-informed, fully expects that her newborn will get Chlorhexidine gel, as a right. This is as it should be for every newborn in Nigeria.”
The solution as packaged did not have a NAFDAC Number
Another point to deal with early on is the fact that this particular product did not have a “NAFDAC Number”. This number is a unique number assigned by the Nigerian Agency for Food and Drug Administration and Control (NAFDAC) to a drug that has been approved for distribution and public consumption in Nigeria.
So, irrespective of WHO approval and inclusion on its essential drugs list, if a drug is not approved for distribution in Nigeria, it should not be distributed. We have it in good authority that NAFDAC and the Primary Health Care Development Agencies (NPHCDA) have stepped up their investigations to understand what actually happened and how this product got into public sector circulation.
The package is clearly labeled for “umbilical cord care”, but only 15% of Yobe indigens are literate
We received the tweet below, which has led us to wonder about other issues at play and how to respond to them.
On the surface, this is absolutely true. However, let’s consider the circumstances in Yobe State, North Eastern Nigeria. This is one of the poorest states in Nigeria. According to a Multi Dimensional Poverty Index , published in June 2015 by the United Nations, as at 2010, Yobe State’s poverty index was at 90.2%. It has a maternal mortality ratio of 1,500/100,000, which means that one in every 66 women dies during the process of giving birth. According to the 2013 NDHS, less than 20% of women give birth in a health care facility. The mothers of the three children in Yobe State did not have any formal education, their husbands are farmers. They belong to the less than 20% that do come to primary health care facilities. The Nigerian Bureau for Statistics estimated the literacy rate in Yobe to be about 15%. Of what use is a label if one cannot read. If kerosene is stored in a bottle of sprite, and the bottle is labeled “kerosene”, how many of us would look at the label, when we open the fridge and we find a bottle that we have always associated with sprite? How then, can anyone in good conscience distribute a product like this in Yobe State?
The Nigerian government has taken steps to address the issue
Yesterday, September 7, the Federal Ministry of Health (FMoH) released a statement about the Yobe eye drops cases, after holding an emergency meeting alongside the NPHCDA. In the release the FMoH made recommendations to be implemented immediately by the State Ministries of Health and Primary Health Care Development Agencies and Boards. Some of the recommendations include:
- Withdrawal and recall of all inappropriately packaged Chlorhexidine solution for cord care from households, communities and health facilities
- Replacement of Chlorhexidine solution in facilities with 4% Chlorhexidine gel
While we applaud the FMoH for the quick response to the situation, interestingly no comment was made in the release on how this could possibly have happened. No one has taken responsibility.
A deeper rooted problem
There is a bigger issue at stake here. A paradigm shift is required of the drug manufacturing industry. Right now, product information labeling and packaging is at best just to keep within the legal requirements, to protect the industry and fulfill all righteousness. It is neither patient focused nor user friendly, and there are no legal requirements to make labeling and packaging patient focused or user friendly. Info graphics are now quite advanced and should be used for the non-literate public, who are by no means stupid. In many cases, one needs magnifying lenses to see information, and sometimes even that does not help when the information is in Chinese. Tragic incidents like this one are critical proof that NAFDAC should work to significantly raise the bar on labeling and packaging of consumables and medicines in Nigeria.
The buck stops at patient-centered care
The other point to make is that incredibly high standards have to be assigned to medicines that are used for preventive purposes. It is one thing when a patient is ill and comes to the clinic, but a completely different scenario when we as healthcare workers offer healthy people products to keep them healthy. This is what makes this particular situation so tragic. In our duty of care, it is not enough to give out a product and not worry about the patient’s ability to understand the label. In this case, the staff of the primary health centres and hospitals involved are only the last part of a long chain of actors that failed these children. Their country failed them. Their government failed them. Their healthcare system failed them… We failed them.
Despite the Press Release by the FMoH – the five questions we asked on Sunday are yet unanswered. They will not go away.
These questions still remain:
- How can a drug, not registered by NAFDAC, not appropriately packaged, end up being distributed to mothers in government health care facilities? Who procured, imported, authorized, distributed this product? Where did the product governance processes fail?
- What assurance can be given to the Nigerian public that ALL of the bottles that were procured and distributed have been retrieved? The information on numbers procured, distributed and retrieved must be shared publicly to restore and assure public confidence.
- In 2014, the Nigerian Ministry of Health granted regulatory approval for the production Chlorhexidine Digluconate 7.1%, by a local company, Drugfield Pharmaceuticals Ltd. Why then should this commodity be imported at all?
- What are the medico legal consequences for healthcare providers through the entire chain from clinicians to government to the regulators through to the manufacturers, considering the implications of a life without vision for the babies involved?
- How do we safeguard the legitimate use of lifesaving Chlorhexidine gel in Nigeria?