You often take medication. Some antibiotic for that relentless infection, or something mild to counter an incessant flu. An antiviral or antiretroviral. A prescription for malaria. If you have children, they will most likely have been vaccinated against some of the most dreaded diseases, and your kitchen cabinet has one or two syrups for the baby — just in case.
Now, imagine what all those efforts, what all those trips to the chemist shop round the corner, would mean if the pills and syrups did not contain an active ingredient — the vital component of a drug that cures, treats or prevents disease.
Even worse, imagine the danger you would be exposing yourself and your child to if those pills and syrups contained toxic substances that could harm your health and endanger your life.
For most of us, it is absurd to imagine that the trip to the pharmacy is often akin to playing Russian roulette: if you pick the wrong box, bam! This is because we often think that if a blister pack of pills looks the part — sealed in foil and accompanied by an insert detailing the ingredients and possible side effects — it will do the job, especially if it is from a ‘legit’ chemist.
But that could never be further from the truth. Countless women, for instance, have complained about how they bought emergency contraceptives only to discover months later they were pregnant.
It seems like rocket science, but it actually isn’t. What happened when these women popped the pills is that they had fallen victims to a devious scheme by unscrupulous individuals who concoct flour, starch and many other compounds to come up with tablets that, to the untrained eye, look like the real deal.
Mueni Mutuku, 23, understands this very well. The second-year student at a local university recently invited her boyfriend to her room. One thing led to another, and they had sex — protected sex, or so they thought, because the condom broke.
The panicky lovebirds dashed to the nearest pharmacy and, for Sh50, bought two tablets of the e-pill.
“I was glad that there was something to fall back to after that oops! moment,” Mueni told HealthyNation last week.
But she was wrong, because three weeks later she started feeling nauseous.
“I couldn’t stand my roommate’s cooking,” she said. “Whenever she chopped onions on the other side, I started throwing up on my end. Then my breasts became quite sensitive but I thought it was just the side effects of the e-pills.”
BILLION DOLLAR INDUSTRY
To calm her nerves, her boyfriend brought her a pregnancy kit. He was sure his girlfriend was not pregnant because he had personally supervised her as she swallowed the emergency contraceptive pills weeks earlier. He, too, was wrong, because his girlfriend’s urine test beamed two bold lines into his shocked face. She was pregnant.
“For a few seconds I couldn’t breathe,” Mueni says. “I was so confused. Hadn’t I taken e-pills to prevent this? And then all these fears about what could happen to my baby started floating ominously in my mind. Was the baby safe? Was I carrying an ectopic pregnancy? What was going on!”
E-pills could fail because of different factors, including if they were taken after conception, but a lot of them fail because they are simply fake.
Throughout Africa and south-east Asia, counterfeit medicine is leaving millions of sick and desperate patients in its wake. Whereas the problem is by no means confined to these two regions, they often bear the brunt of the vast majority of counterfeit medicines being circulated in the world.
These markets are flooded with fake and poor quality drugs, so much that the global counterfeit drug trade is regarded as a billion-dollar industry that thrives, mostly, in Africa.
The World Health Organisation (WHO) defines counterfeit medicine as “one which is deliberately and fraudulently mislabelled with respect to identity or source”. These include both branded and generic products, which can be faked. Medicines in this category have been found to either contain the wrong dose of active ingredients or none at all, or to have a completely different ingredient.
The global health entity estimates that about 100,000 deaths a year in Africa are linked to the counterfeit drug trade. And the International Policy Network (IPN), a British think-tank, estimates that, globally, 700,000 deaths a year are caused by fake malaria and tuberculosis drugs. To illustrate the silent epidemic, IPN compares the death toll to the equivalent of “four fully laden jumbo jets crashing every day”.
A 2013 assessment by the United Nations Office on Drugs and Crime (UNODC), focusing on Africa and South-east Asia, also posited that the counterfeit drug market in Africa is worth about US$4 billion (roughly Sh400 billion).
Locally, about five years ago counterfeit medicines accounted for approximately Sh9 billion in sales annually, according to the Kenya Association of Pharmaceuticals Industry (KAPI), who estimate this to be about 20 to 25 per cent of the total legal commercial pharmaceutical market.
Kenya’s extent and degree of unregulated pharmaceutical products in the retail market is unknown, but a proposed study could soon unravel this. KAPI, in collaboration with the University of Nairobi, is planning a nationwide market study to establish the prevalence of unregulated medicines in Kenya.
The association’s chaiperson, Dr Anastacia Nyalita, believes the illicit and counterfeit products are not sourced through the established channels, and generally get into the market as unregulated imports. The study, Dr Nyalita says, will provide a foundation for policy and enforcement interventions.
“This will help us have credible data that can be analysed further to aid in decision making among stakeholders, including the Commissioner of Customs at the Kenya Revenue Authority,” she says.
NOTORIOUS ENTRY POINT
KAPI’s study comes amidst plans by the World Customs Organisation (WCO) and the International Institute for Research against Counterfeit Medicines (IRACM) to intensify the fight against illicit and counterfeit drugs in Africa.
This follows the publication of the results of their fourth common initiative in the fight against fake medicines on the African continent, which established that the number of illicit and potentially dangerous pharmaceutical products seizures has now reached dramatic proportions, with almost 900 million counterfeits seized since 2012.
The value of the “potentially dangerous pharmaceutical products”, sourced mainly from China and India, is estimated at Sh6 billion.
A dragnet across 16 seaports on the eastern and western coasts of Africa in September last year nabbed huge hauls in, particularly, Nigeria, Benin, Kenya and Togo. Among the drugs seized were contraceptives, cough syrups, antibiotics, anti-parasitics, and anti-malarials.
“Data from the joint operations between the WCO and the IRACM show that the situation is worrying as regards to illicit goods in Africa,” says the report, titled Combating Counterfeiting and Piracy: Consumer Health and Safety.
The port of Mombasa, easily the gateway to eastern Africa, was fingered as a notorious entry point that oversees high levels of trafficking of fake essential pharmaceuticals and veterinary drugs. Over 12 million (12,509,823) units were netted here.
“Of the 243 maritime containers inspected, 150 contained illicit or counterfeit products,” says Kunio Mikuriya, the secretary-general of the WCO. “The need for greater scrutiny of this type of fraud is no longer to be demonstrated, and I hope that this operation and the mobilisation it has triggered on the side of customs administrations, other agencies involved in the control of these products, and among rights holders, will have a lasting effect.”,
Trafficking of counterfeit drugs is closely linked to money laundering and funding of terrorist groups.
HealthyNation has learnt that Chinese government representatives in Kenya are concerned over the report and are working with the Pharmacy and Poisons Board to get to the bottom of the matter as Beijing is worried that the criminals are spoiling the market for genuine traders.
In Kenya, there are two main bodies in charge of ensuring safety of drugs and medicines. These are the National Quality Control Laboratory (NQCL), which inspects drug samples and drug manufacturing premises before the Pharmacy and Poisons Board (PPB) — the other key agency — issues these premises with operating licences. The Anti-Counterfeit Agency also has a role to play in taming the crisis.
The PPB, as established under the Pharmacy and Poisons Act, is the national medicines regulatory authority mandated to oversee the quality, safety and efficacy of medicines in Kenya. The board regulates the practice of pharmacy and the manufacture and trade in drugs and poisons.
While trade in fake drugs can cause extreme impacts on public health and safety, action on this has generally been lukewarm at best. Counterfeit drugs, therefore, are stocked in Kenyan hospitals, pharmacies and homes.
In 2015 the Kenya Association of Manufacturers, the Judiciary and other players reported that Kenya was ranked among the largest markets for counterfeit goods, and that Nairobi served as the distribution point for the region. The recent report by the World Customs Organisation validates this observation.
The 2015 study found that “more than 30 per cent of the total medicines sold in Kenya are counterfeit”, and that “about 40 per cent of all malaria drugs in the Kenyan market are counterfeits that may be harmful to users”.
However, the PPB disputed these claims, arguing that they were not backed by evidence and could spark “unnecessary public alarm”.
But the debate and scrutiny just won’t die down, as a new study of malaria medicine quality in eight sub-Saharan African countries, including Kenya, has found a large and potentially growing market for non-quality-assured treatments.
Nearly 20 per cent of medicines in the private sector in the country are not pre-approved by global health organisations such as WHO, Global Fund or European Medicines Agency quality assurance programmes. This is despite the impact such drugs could have on patient health and safety, malaria control efforts, and Artemisinin drug efficacy.
The study, conducted between 2009 and 2015 in private and public sectors of Benin, DRC, Kenya, Madagascar, Nigeria, Tanzania, Uganda and Zambia, is published in the Malaria Journal.
“Although approval status alone does not guarantee the safety of a medicine,” the study notes in part, “it does provide a strong, evidence-based indication of quality.”
Poor quality antimalarials include falsified medicines — those produced fraudulently — and substandard medicines — which are improperly manufactured or have degraded over time.
The board, aware of the nature of the risks to the public, last year acquired portable machines for testing of medicines in the field. The specialised hand-held gadgets will enhance the surveillance of sub-standard and counterfeit medicines, including those sold in pharmacies as well as those imported into the country.
Further, there have been several raids to catch quacks dispensing drugs to unsuspecting Kenyans and running illegal joints. This is done through pharmacovigilance (the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems) and post-marketing surveillance activities. A crackdown on illegal pharmacy outlets was conducted on June 22, 2017.
The board also does post-marketing surveillance in a bid to promote and maintain the safety of pharmaceutical drugs and medical devices after release to the market. They also send alerts when they suspect that a fake drug is in the market and should be recalled, reported or not used.
- Moi Teaching and Referral Hospital has a gadget called the Paper Analytical Device (PAD) that is a mini lab on a piece of paper.
- It provides a quick and efficient way to check ingredients of medicines they prescribe to patients in Eldoret. It takes five minutes to complete the test. The sample of the drug is applied at a marked place in the device.
- It is then dipped in water vertically while holding it straight to allow water to rise into the strip. After five minutes a pink colour is spotted on one side of PAD meaning the colour reaction is over.
- Each of the cards contains 12 separate strips which react with a drug to create a colour bar code that gives information about the chemical content of a drug.
- These colours are read against a set standard of expected outcomes and thus interpret the results of whether a drug is genuine or not.
How do you know that you are being served by a professional or a legal pharmaceutical outlet?
- It’s simple, really! All registered chemists have a health safety code. Kenyans are advised to type the code and SMS it to 21031 to verify the registration status of the pharmaceutical outlet. A message will be sent about the registration status of the outlet.
How drugs work
A drug can be inhaled, absorbed through the skin, ingested, or injected.
When you take medicines by mouth, they go through the digestive tract and are taken up by internal organs such as the stomach and small intestine. They then go to the liver, where they might be chemically altered by protein molecules, called enzymes, before they are released into the bloodstream.
As the bloodstream carries medicines throughout the body, the drugs can interact with many organs. Once in the body, the drug will be chemically broken down just like food.
Often, when a drug is metabolised by the body, it is converted into products called metabolites. Usually, these metabolites are not as strong as the original drug, but in some cases they can have effects that are stronger than the original drug, such as the pain killer codeine. The drug metabolites often return to the liver and are chemically altered once again before they exit the body.
After a drug’s metabolites have circulated in the bloodstream, where they work as medicine, the body eliminates them the same way it eliminates liquids or solids. However, age-related changes in kidney function can have significant effects on how fast a drug is eliminated from the body.
Commonly used drugs most likely to be counterfeited
1. Analgesics and pain relievers such as Paracetamol
2. Antihistamines such as piriton and celastamine
3. Antimalarials such ACTS, Coartem, Cotexin and Metakelfin
4. Antibiotics such Augmentin and Amoxil
5. Emergency contraceptive pills, also called morning-after pills
6. Viagra, also know colloquially as the Blue Pill
7. Cough syrups, such ascoril and rhenatial
8. Eye drops