CHILD’S TEETHING PROBLEMS, MY PIKIN TEETHING MIXTURE AND WHERE MOTHERS GOT IT WRONG

Dateline 1990, locations, University of Jos Teaching Hospital and the University College Hospital, Ibadan; 109 Children died after administration of Paracetamol Syrup. This was 57 years after the infamous 1937 Elixir Sulphanilamide disaster in the United States of America in which 107 people died after taking sulphanilamide dissolved in diethylene glycol.

Eighteen years after, My Pikin Teething Mixture, a product registered by NAFDAC may have been fingered as the ‘killer‘ drug that has claimed the lives of not less than 25 children. The drug is manufactured by Barewa Pharmaceuticals Limited, a certified manufacturer by NAFDAC. The national drug law enforcer has, however, shut down the company in the wake of the death allegedly in consequence of the administration of the drug.

Barewa, has, since then, spiritedly defended the contents of My Pikin Teething Mixture as a Paracetamol based drug containing Paracetamol B.P. 120 mg and Diphenhydramine HCL B.P. 6.25 mg per 5mls. But a preliminary test carried out by the National Agency for Food and Drug Administration and Control, has revealed that besides Paracetamol, the drug contains Diethylene glycol as against propylene glycol which is the commonly used excipient. Incidentally, Diethelyne glycol was also implicated in the 1990 deaths in Jos and Ibadan

What is more worrisome with this type of poisoning is the fact that the original chemical entity, Paracetamol is naturally poisonous to the kidneys and liver in high doses. Marry this with the toxicity of Diethylene glycol, what do you have? Bomb!! Instant death.

These, however, are 25 deaths too many. While we await the report of more detailed investigations from the appropriate authorities, so many questions are begging for answers;

Is the drug registered by NAFDAC?

Is the factory currently certified by NAFDAC?

When was the last audit of the factory carried out by NAFDAC?

When was the last time NAFDAC independently surveyed this particular drug in the market?

Has NAFDAC a structured process/procedure to routinely carry on surveillance on ALL products in the market or does the agency randomly pick products?

What do all the agencies, LUTH, UCH, NAFDAC want to achieve by ‘issuing alert’? What in specific terms have they done? What have they put in place to ensure positive outcome? What has been the distribution route of all products from this factory in the last Three months?

Does this ‘alert’ consider the chaotic nature of our drug distribution channels which the Pharmaceutical Society of Nigeria has been talking about over the last several years?

Over the years, regulatory bodies have scaled up their regulatory oversight on pharmaceutical excipients. Pharmaceutical excipients – are inactive ingredients used to formulate active ingredients into finished dosage forms

“…For example, excipients can:

• aid in the processing of the drug delivery system during its

manufacture,

• protect, support or enhance stability, bioavailability or patient

acceptability,

• assist in product identification, or

• enhance any other attribute of the overall safety, effectiveness

or delivery of the drug during storage or use…”

It may interest the Nigerian public to know that since 2007, European regulatory agencies have initiated steps to improve the quality and regulatory aspects of all excipients used in pharmaceutical products all over Europe because of the risks associated with pharmaceutical excipients. Some of the documented evidence of risk includes:

• Fraudulent product obtained from broken supply chain and distribution routes leading to contamination cases and tragedies as outlined below:

1990 Nigeria: Cough syrup contaminated with solvents (47 reported deaths)

1986-1998 India and Bangladesh: Paracetamol syrup contaminated with diethylene glycol from propylene glycol origins (236 reported deaths)

1996 Haiti: Glycerine contaminated with diethylene glycol (88 reported deaths)

Potential exposure:

• Use of inappropriate grade of materials for critical route of administration (e.g. pyrogene-free requirements)

• Excipient variability between suppliers

It is a known general requirement of Good Pharmaceutical Manufacturing Practise to analyse ALL inputs to the production process. We need to know what is contained in the production process submitted by the company while registering My Pikin Mixture as submitted by the company and approved by NAFDAC. Is this process complied with by the manufacturer?

Some pharmacists have long questioned the rational for our regulatory body to continue to register teething formulations. Teething is a well known non specific condition that is common with children and the usual practise is to symptomatically manage the child.

‘We are confronted with cases of mothers using various teething formulations at once usually resulting in a child taking about 4X the dose of paracetamol’ says a colleague during our brain storming section on Teething mixtures some Six months ago. Cases abound where mothers administer these teething formulations (which usually contain Paracetamol 120mg/5ml) with standard Paracetamol syrup. This health risk is further compounded as they are both Over The Counter (OTC) medicines without regulatory restriction/control of use. While this school of thought has spoken against the outright ban of Paracetamol, some have advocated more stringent packaging alert and warning to parents

This should not be the time for agencies and institutions to trade blames or to start defending themselves. The Federal government should consider these deaths a national tragedy. The loss of defenceless innocent children is not taken lightly in countries where citizens are considered supreme

One thing is clear, the way NAFDAC is currently constituted underscores the fact the agency is a reactionary agency. The agency should be reformed to anticipate problems and prevent them from happening. Life is too precious to be treated the way we currently do, particularly that of Innocent Children

It is the responsibility of the Federal Government to protect the health of the Nigerian Population and I believe that this is one of the reasons NAFDAC was set up. Parents should not just take this as another case of an ‘act of God.’ They should consider this as another case of the carelessness of the state through her agencies against the citizen. This may just be an opportunity for the victims to challenge this callous act through our judicial process. This may just be the wake up call we need to usher in a new healthcare system that really cares for the Nigerian citizens

The dry weather is back again. This is usually the period for high prescription of chloramphenicol eye drop. Has this been prescribed for you. Below is the prescribed way to administer it for maximum benefit.

ADVICE TO PATIENTS

(1) Chloramphenicol Eye Drop;

1. Chlopramphenicol is an antibiotic used to treat eye infection.

2. It is important to use this eye drop as frequently and for as long as the doctor has prescribed and advised by your pharmacist.

3. Do not wear contact lenses while using this drug.

4. If using two drops, for each dose wait for a minute or two between applying the first and second drop. Using more than two drops will not help because the excess will run out of your eye.

5. Pressing your finger against the inner corner of the eye (by the nose) for about a minute after using the drops can help to stop the drops draining into your nose and throat.

6. Discard any unused and left over content three (3) weeks after opening.

7. You may feel a brief stinging after using this eye drop. If this is prolonged for more than three days or your eyes do not get better please see your doctor or pharmacist.