Fake drugs are not a recent
development. Like anything counterfeit, they are almost as old as real
medicine. All over the world, drug counterfeiting is a potentially deadly
phenomenon, but the situation may be actually worse in Nigeria as we have a
tendency to be reactive to problems instead of proactive.
In Nigeria, fake drugs undermine
every aspect of medical treatment and health care delivery and are a major
cause of suffering and death. The problem of fake, counterfeit, spurious,
unwholesome and adulterated drugs has rocked the Nigerian health care
system for years on end. Drug counterfeiting contributed negatively to the
well being of the average Nigerian that former Director General of the National
Agency for Food and Drug Administration and Control, NAFDAC, the late Prof.
Dora Akunyili described it as an act equivalent to mass murder.
From a health provider’s point of view,
counterfeit drugs are bad news. They erode confidence of the patient
in the health provider. They waste scarce and hard-earned resources, cause
treatment to be ineffective, potentially harm the health of the
patient. A doctor who declined giving his name shared that “I once had a
patient during my horsemanship that needed to treat what is commonly
known as toilet infection. She didn’t want the insertion drug, so I prescribed
a dose of fluconazole. Unfortunately the drugs she procured from
a mobile chemist around Yaba did not work. So she went about telling her
friends that I was a quack. She came back to me and said it was
because I was not a woman that I cannot treat her issue. She showed me the rest
of the drugs and we discovered they were fake and helped
her get a new prescription and she took it and it worked. That was how I was
vindicated.”
Counterfeited drugs are dangerous
not because of their counterfeit nature, but because of how they are created. A
counterfeit drug, by definition, is one that has been made by someone other
than the genuine manufacturer. It is done by either copying the formulation of
the drug or imitating it without permission to do so.
Many counterfeits don’t have the active
ingredients that the packets claim they have. Some even have the wrong
ingredients, while others have incorrect quantities of the correct ingredients.
According to the World Health Organisation, WHO, counterfeit drugs are
those “that have been deliberately or fraudulently mislabeled with respect to identity
and/or source”. The products can include incorrect ingredients, wrongly stated
amount of active ingredients, or can be manufactured under circumstances that
lack quality control. It is known that more than 30 per cent of the counterfeit drugs that
are available today don’t contain any active ingredients whatsoever.
The problem, however, did not simply appear in
Nigeria suddenly. On 12, April 2001, Prof. (Mrs.) Dora Nkem Akunyili was
appointed the Director General of National Agency for Food and Drug
Administration and Control (NAFDAC) of Nigeria. She was a pharmacist and
governmental administrator who gained international recognition and won several
awards for her work in pharmacology, public health and human rights. Following
her appointment, Akunyili established as a top priority the eradication of
counterfeit drugs and unsafe foods in Nigeria, something that was
almost anathema in Nigeria.
Before she took office, fake and
substandard foods and drugs were sold in Nigeria without any form of
regulation. She was recorded to have been disheartened by the
inability of Nigerians to successfully fight killer diseases like
malaria and tuberculosis due to the sale of drugs that were
little more than sugar syrup and chalk tablets, cynically packaged to look
like the real drugs.
Though a difficult process, Akunyili led
Nigerians down the road of freedom from fake drugs, and she almost
won the fight. Under her administration, little went unnoticed and producers of
food products and drugs began to work with prescribed
standards.
Well over a decade since she left office,
Nigeria seems to be back at the point we started from. Fake antimalarial
medication has been threatening efforts to control malaria in Africa.
According to the World Health Organisation (WHO), Nigeria is Africa’s
largest drug market, and over 70% of its drugs are imported from
India and China, considered a big source of fakes.”
In 2010, NAFDAC in Nigeria launched an
SMS-based anticounterfeiting platform using technology from Sproxil. That
system was also adopted by GlaxoSmithKline (GSK) in February 2011. In 2011, it
was discovered that 64% of Nigeria’s imported antimalarial drugs were fake.
Looking into the issues of fake drugs,
the acting Director General of NAFDAC, Mr. Ademola Mogbojuri said, “The public
health implications of substandard and falsified medical products are dire.
This includes treatment failures, loss of confidence in the healthcare provider
and health system, high treatment cost, development of resistance and
ultimately results in fatality and death. He raised an alarm that the problem
has become a serious threat to the global public health and should be
looked into by both the governmental and the non-governmental bodies.”
A while back, the Pharmacists Council of
Nigeria, PCN, sealed off 287 premises of persons operating illegal pharmacies
in Kogi State. Stephen Esumobi, the PCN Deputy Director Enforcement said it
took the council a five-day raid for the operation, which covered 373
pharmacies and patent shops. He further said that the sealing, which cut across
the state, was made up of 27 illegal pharmacies and 260 patent medicine stores
who contravened various offences. “The premises were sealed for operating
without registration with PCN, failure to renew premises
licence, dispensing ethical products without the supervision of pharmacist,
poor storage and sanitary conditions among others. Findings of the PCN team
showed that in Kogi State, many pharmaceutical premises commenced operations
without fulfilling the minimum requirements for registration while others
failed to renew their licenses.”
Even though patients are advised to buy drugs only
from a registered pharmacies with the green cross RX sign, some
Nigerians due to ignorance, failing economy, scarcity or abject
distrust of a structured system still buy from roadside sellers, self-acclaimed
chemists and mobile chemists.
Speaking with a pharmacist with a
store in Omole area of Lagos, she said that some people see the store and
immediately revert to a preconceived notion that whatever they sell
there would be expensive. “A mechanic once came into my store having been
sent to buy drugs by his boss. He took off his shoes
outside before opening the sliding glass and coming in. When I asked him why,
he told me that the place is neat and fine and he does not know if we would
have let him in with his dirty shoes. When I asked how he buys
his drugs whenever he needs them from a pharmacy, he just told me
that he has never been into a pharmacy, that he buys his drugs at
Ojuirin at Agege on his way home from the women who display it on their tables
or make-shift stalls. He said he has a nurse that treats him in his compound
and she simply tells him what to buy. I was shocked.”
Counterfeiting is punishable by imprisonment
for between 3 months to 5 years or alternatively a fine of N100, 000
is imposed. Such a weak and incongruous penalty is incapable of making any
great impact in preventing this lucrative crime. NAFDAC has recommended life
imprisonment and forfeiture of assets of the offender to compensate
the victims, but the National Assembly is yet to pass this into law.
Recent studies show that the quality of
medicines on sale in Nigeria leaves much to be desired. Seizures of
counterfeit drugs running into billions and shutting the unlicensed
drug outlets have not solved the problem. Detection of counterfeits has become
more difficult as counterfeiters have got more sophisticated, cloning holograms
and other security features. Some of the counterfeiters are clever enough to add
active ingredients that pass quality test controls but don’t provide user
benefits.
For Nigerians, malaria drugs and
antibiotics are among the most popular drugs that have been
counterfeited.
The case of the ‘My Pikin’ drug readily
comes to mind. A toxic chemical mixed into a teething medicine for
babies killed at least 84 children in Nigeria as of February 16, 2009. The
children died after taking My Pikin Baby Teething Mixture, a syrup for teething
pain, according to Nigeria’s Health Ministry. Health officials said
that a batch of the medicine that went on in November contained diethylene
glycol, a chemical that can cause damage to the heart, kidneys and
nervous system when ingested; an industrial solvent and an ingredient in
antifreeze and brake fluid.
Abiodun Adeyemo and Ebele Austine Eromosele,
who were employees of the company that made the toxic syrup, were found guilty
by a court in Lagos, Nigeria. The company that produced the toxic syrup, Barewa
Pharmaceutical Company Limited, was ordered shut by the court and all of its
assets seized.
NAFDAC reported that the first affected child
was taken for treatment on November 19, 2008 and pulled more than 5,000 bottles
of My Pikin from the market soon thereafter. On November 26, 2008, NAFDAC shut
down Barewa Pharmaceuticals.
Figures from the Nigerian Health Ministry
estimated that three-quarters of children made sick by the medicine had died.
As of February 6, 2009, 111 children were affected.
The former Nigerian Health Minister, Professor
Babatunde Oshotimehin said in a statement at the time “The death of any
Nigerian child is a great loss to the nation. The Federal Ministry of
Health sincerely regrets this painful incidence and sympathises with the
nation and the families directly affected.”
Speaking with Dr. Ayoola of Lagos,
she told SATURDAY INDEPENDENT that “Fake drugs are bad
apart from having the problem of not actually being effective for the disease
that is actually treated. They can also have terrible side effects or they
could be toxic or poisonous just like the case of the ‘My Pikin’ drug. It was a
drug that was used for teething, but led to liver disease, liver
damage and death of children. Please ensure your drugs are NAFDAC
approved and registered before using them.
“NAFDAC generally, these days have a pin
identifier and the number which you send pin identifier is toll free, so it
doesn’t cost you anything. Everybody has a mobile phone these days, and it
doesn’t cost you anything to send that number to make sure
that the drug you are using is actually original. Also if you find out that the
drug is not original, you can also report that pharmacy or chemist store to the
appropriate authorities. Then the whole issue of fake drugsand
poisonous drugs can be traced back to the source and this
can be stopped.
“Some people complain about the price of these
original drugs. Well, you cannot put a price on safety and even some of
the brands that are less popular are available at affordable prices and they
also have pin number. NAFDAC is making it compulsory for any drug that passes
through its system to have a pin number. If you are alive, you can
enjoy your money but if you are dead from buying a cheap drug that comes
out to be toxic to you… I mean, that is being penny-wise
and pound-foolish.
“Even if you are buying drugs from
a chemist, make sure you read the pamphlet to know what the drug
contains, there are search engines that are available to see what the
drug contain. However, many of these drugs contain chemical that you
cannot even account for, some of the things that are done make the drug look
like the original drug.
“Unfortunately, you might not know what effect
the drug might have on your liver, your organs, your kidney; you don’t know the
effect the poisonous drugs can have on body systems. Every drug
has to pass through three stages of approval, the clinical trials,
the trials on people, case control files and things like that. They have to get
approval to make sure that the side effects are things that are
minimal, that will not cause too much harm to your body. That’s the
point of having a drug approved.
“Quite frankly, fake drugs are
unsafe. In Nigeria, we have a very bad drug control practice and generally
buying drugs on the road… I don’t know why someone will do
that. Drugs are dangerous chemical that needs to be
prescribed, though there are over the counter drugs that you can buy
without the prescriptions. Even the drugs that are approved for
specific conditions are not appropriate in every situation, some people are
allergic to some drugs, but we take those drugs without
knowing the effect they will have.”
INDEPENDENT also approached one such drug
seller who turned out to be quite taciturn though she eventually said
a few words.
“Not that my medicine is fake, it is just
that I have my customers. Some people, if they go supermarket, they go see
small mark for the medicine cover, thy no go wan use am. My own people no dey complain,
and e no dey expensive. My own medicine no be fake, e dey work. And I get
different types.” She explained.
When asked if some of the drugs could
be expired, she said no. “If you fit taste am you go see say na the same.
Medicine no dey expire like that. I no get expired medicine.”
It is imperative that we intensify efforts
in fake drug eradication. Although, drug counterfeiting is
adjudged to be more dangerous but just as lucrative as the narcotics
business, the penalty is less severe. In Nigeria, a counterfeiter is
allowed to pay a fine option of N100,000. Some people say that the
appropriate penalty for counterfeiting could be an effective deterrent; sadly,
the penalty for manufacturing or distributing counterfeit drugs is
rather lenient.
In all, the best defence against unhealing
medications is to know your medication. That knowledge in itself
doesn’t have to be inherent, it could be outsourced by any means
necessary, all to protect.
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