Neonatal infection is a major cause of babies dying within a month of birth. Then came the good news story that the application of Chlorhexidine gel to the umbilicus has a great impact on the reduction of these deaths.
When an incident occurs and no one stands up to speak to the public about it, it gives scope for speculations, real or fabricated. The dead silence from the various agencies and governmental ministries leaves much to be desired. A father abducts his son in the UK for proton treatment for cancer abroad and it becomes worldwide news. Volkswagen cheats on its emission testing and the news is all over the place. No one died! Six Nigerian babies have been blinded and scarred for life, yet no one seems to care.
SOURCE OF THE AGENT and THE BLAME GAME
The Chlorhexidine erroneously used as an eye drop in this case was manufactured by an Indian company, Galentic Pharma Ltd. It was packaged in bottles that are usually associated with eye drops. Wrong packaging or using similar packages is a strong basis for errors to occur as exemplified by the sodium chloride and potassium chloride package. The incident led to the wrongful injection of potassium chloride by educated people – doctors and nurses. Yet NAFDAC has chosen to lay the blame partly on illiterate mothers for not being able to read the writing on the bottles.
THE ROLE OF NAFDAC (NATIONAL AGENCY FOR FOOD & DRUG ADMINISTRATION & CONTROL)
NAFDAC’s Ports inspection directorate guidelines for clearance of imported drugs (human and veterinary) and related products into Nigeria (NAFDAC/PID/001/00) categorically states that
• No drugs and related products should be manufactured, imported, exported, advertised, sold or distributed in Nigeria unless it has been registered in accordance with the provisions of Act Cap F33 LFN (formerly decree 19 of 1993) and the accompanying guidelines.
• The importation of unregistered drug product(s) or registered drug products by persons or companies other than those that registered the products should be regarded as a violation.
NAFDAC is specific in the documentation of drugs required for importation of drugs from a number of countries including India. These are put in place to
1. Ensure that the quality, safety and efficacy of the drugs imported from India
2. To ensure compliance, NAFDAC appointed analysts, QCS CONSULTANTS, to inspect and analyse products from India before shipment into Nigeria.
All drugs and related products from the listed countries should be issued ‘Clean Report of Inspection and Analysis’ before shipment into Nigeria. Amongst the shipping documents that should be submitted for obtaining what is described as “First Stamp” include
• Evidence of valid product registration certificate with NAFDAC
• Original Certificate of Analysis issued by the manufacturer
THE NON-RESPONSE OR RESPONSE TO THE INCIDENT
THE FEDERAL MINISTRY OF HEALTH (FMOH)
In response to the news, the Federal Ministry of Health on 7 September released a press statement with an unhelpful title ‘WHY LITERACY MATTERS’. The ministry recommended that the State Ministries of Health and Primary Health Care Development Agencies and Boards should immediately withdraw and recall all inappropriately packaged Chlorhexidine solution for cord care from households, communities and health facilities.
An aid agency flaunted the Nigerian Drugs Process and reportedly imported this drug from an Indian firm, Galentic Pharma Ltd against advice not to do so. The press releases and news notes from UNICEF has made no mention of this incident. It has not refuted its authenticity. Releases from the UNICEF Press Centre on 15 August 2015 include the reported rape of a young girl in the Central African Republic by a UN police officer. On 18 September UNICEF reported that refugee and migrant children in Hungary “need to be treated with dignity”. They could not but report on the over 1.4 million children forced to flee conflict in Nigeria and region due to the Boko Haram insurgency. However, it has chosen to maintain a stony silence on its involvement or otherwise on its role culminating in the blindness of six Nigerian babies.
The recall and alert segment on NAFDAC’s website make no mention of the need to issue a nationwide alert. Its search button found nothing related to Chlorhexidine. However, alarmed by the wrong use of Chlorhexidine digluconate which caused blindness in some babies in Adamawa and Yobe States, National Agency for Food and Drug Administration and Control, NAFDAC, was reported to have commenced a mop-up and recovered 19, 000 pieces of the product from the various Primary Health Centres in the two states where the drug was distributed as part of delivery packs for mothers to avoid further harm.
NAFDAC Director General blamed the incident on ignorance on the part of mothers. Really? Only 15 percent of Yobe Indigenes are literate. The Director General (DG) stated that the drug was not registered by NAFDAC in Nigeria. Unbelievable! Who should have registered it? The DG was reported to have warned that henceforth, all agencies bringing in drugs either for public health intervention or otherwise must go through the appropriate channels before distribution. What is the statutory role of NAFDAC?
Social media tweets from NAFDAC were - This sad incident is as a result of ignorance on the part of the affected mothers. Chlorhexidine is not a bad drug in itself (@NafdacAgency) September 10, 2015; The drug Chlorhexidine was brought in by UNICEF as part of the kit given to mothers in an on-going UNICEF project in the two states - NAFDAC NIGERIA (@NafdacAgency) September 10, 2015.
The DG is reported to have said that appropriate sanction would be meted to persons, who distributed the drug without the right information to the innocent women. The Director-General assured that the product was not yet in the market but was brought in for a special programme. Appropriate sanction will be taken against who distributed these products to mothers without educating them. NAFDAC has blamed everyone apart from itself. NAFDAC cannot absolve itself of its actions or inactions in this tragedy?
The questions one raises include
• Were the mothers provided direct instructions on what each content in the pack they were given was for
• Could the instructions and labelling have been written in the local languages (drugs now have braille inscriptions and languages tailored to the locality of end use)
• Why was UNICEF allowed to brazenly break our regulations (reminds me of Shell Petroleum and its use of overland pipelines in Nigeria)
• Why were these goods cleared at the ports by the Customs/NAFDAC officers without a NAFDAC Registration number
• Did the Compliance Officers at the State Ministries of Health approve its use
A Nigerian Pharmaceutical Company was awarded the rights to manufacture Chlorhexidine in Nigeria. As an extension of our believe that anything from abroad is better than products manufactured in Nigeria, we allowed UNCEF without abiding by NAFDAC’s regulations to import Chlorhexidine from India, a country where NESTLE India, recently produced Maggi noodle unsafe and hazardous for human consumption due to its excess lead content. Lead exposure causes an estimated 143,000 deaths a year worldwide.
While one acknowledges the giant strides made towards health improvement by UNICEF, its silence over this issue demonstrates how much we have let people treat us with impunity. The Federal and State Ministries of health have not taken the necessary steps to reassure the public or announced what the underlying reasons for these incidents are. There are too many common cause failures (CCF), too many loopholes in this case reminiscence of the Swiss Cheese model (see picture).
On behalf of Nigerians, we request that a thorough root cause analysis of this incident is undertaken to prevent future occurrences. I maintain that each Nigerian life is priceless but Nigerians need to stand up and fight when our rights are impinged or national regulations violated by internal or external agencies. To the families of these babies I empathise with you. Lessons must be learnt from this incident.