On-the-increasing-prevalence-of-counterfeit-drugs-in-our-society-and-its-implications-on-public-health
September 7, 2020 | News
ON THE INCREASING PREVALENCE OF COUNTERFEIT DRUGS IN OUR SOCIETY AND ITS IMPLICATIONS ON PUBLIC HEALTH
It is sad how the greed for money and insane acquisition, has made many to smear their conscience with hot iron to the point where, they practically do not mind getting their hands stained with blood just to make it big. And it is also sad that in a society like Nigeria, we are daily daunted by news and happenings that really do not paint a good picture about us as a people. Nobody cares about how their (criminal) actions would adversely affect thousands and millions of the citizenry, so long as they make money. This is why we find it appalling that some persons would go to the point of counterfeiting drugs just to make money, without any consideration whatsoever, of how their actions would negatively impact public health and wellbeing.
We were dazed recently, when we came across a well-researched write-up on the subject matter by Mr. Abayomi (Yomi) O. Akinmutola (Pharm. D), a Clinical Pharmacist in Benin-City, Nigeria. He opened our eyes and broadened our minds to this subject matter of counterfeit drugs, which has obviously become a serious plague in our Nigerian societies that urgently requires attention by the relevant authorities in addressing it.
According to Abayomi, “Drug counterfeiting is a significant public health threat and is rapidly increasing with dozens of new cases being reported throughout the world every day. A drug must obtain Market Authorization (MA) granted by a competent authority before being marketed. This MA guarantees the product’s safety, quality and efficacy. “Counterfeit drugs” do not meet these requirements and subsequently are dangerous to an individual’s health. AT BEST, DRUG COUNTERFEITING IS A FORM OF TERRORISM AGAINST PUBLIC HEALTH AS WELL AS AN ACT OF ECONOMIC SABOTAGE.
“In the etymological meaning, counterfeiting is “the fraudulent copy of another’s product without their consent”. The World Health Organization (WHO, 2011) defines COUNTERFEIT DRUG AS A MEDICINE WHICH IS DELIBERATELY AND FRAUDULENTLY MISLABELED WITH RESPECT TO IDENTITY AND/OR SOURCE. This applies to both branded and generic products and It may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging. In the Nigerian, Counterfeit and Fake Drugs and Unwholesome Processed Foods (Miscellaneous Provisions) Decree; а fake drug is defined as: Any drug product which is not what it purports to be; or Any drug or drug product which is so colored, coated, powdered or polished that the damage is concealed or which is made to appear to be better or of greater therapeutic value than it really is, which is not labeled in the prescribed manner or which label or container or anything accompanying the drug bears any statement, design, or device which makes а false claim for the drug or which is false or misleading; or Any drug or drug product whose container is so made, formed or filled as to be misleading; or Any drug product whose label does not bear adequate directions for use and such adequate warning against use in those pathological conditions or by children where its use may be dangerous to health or against unsafe dosage or methods or duration of use; or Any drug product which is not registered by the recognized drug control or regulatory agency in accordance with the provisions of the Food, Drugs and Related Products (Registration) Decree 1999 as amended.”
In other words, “A counterfeit drug therefore, is a medication or pharmaceutical product which is produced and sold with the intent to deceptively represent its origin, authenticity or effectiveness. And if, according to WHO, “Public health is the science and art of promoting health, preventing disease and prolonging life through the organized efforts of society,” then it is imperative for the Nigerian public to be very much aware of this scourge. More so, we can see that the issue of counterfeit drugs covers a whole lot of areas that are often times, not known to the Nigerian public. This makes the issue even more dangerous because without the holistic knowledge of what constitutes counterfeit drugs, the health and wellbeing of the Nigerian public is more at risk.
In describing the extent of the problem of counterfeit drugs, Abayomi (Yomi) Akinmutola further noted that: “This problem is a global phenomenon known to exist in both developed and developing countries and it can occur to any pharmacological class and any formulation type. Antibiotics and antimalarial are the two highest categories of suspected drugs reported to the WHO by far WHO/IMPACT estimates the level of prevalence of counterfeit drugs to be less than 1% (US, EU, Canada), 5 - 10% South East Asia), 10% (Russia), 10 to 20% (Latin America), 16% - 20% (India) and up to 50% (Africa). Drug counterfeiting represented approximately 40 billion US Dollars in sales. This approximates almost 10 % of the world pharmaceutical market (WHO, 2016).
“ACCORDING TO THE INTERNATIONAL CRIMINAL POLICING ASSOCIATION OTHERWISE KNOWN AS (INTERPOL), COUNTERFEIT DRUGS KILLS MORE THAN ONE MILLION PEOPLE EVERY YEAR. STATISTICS FROM NAFDAC (2012) REVEALED THAT NIGERIA IS THE WORLD’S LARGEST MARKET FOR COUNTERFEIT DRUGS AMONG DEVELOPING NATIONS OF THE WORLD.” If this does not scare and trouble your mind, I really do not what else would. These statistics alone suggests that this issue is a scourge that must be dealt with from all angles. According to Abayomi, some of the amplifying factors responsible for this problem, especially in Nigeria, include: “Large profit potential from the counterfeit market, High cost of drugs, Scarcity and/or erratic drug supply, Infiltration of the supply chain, Highly porous borders, Weakness in drug regulatory systems, Weak enforcement and penal sanctions, Corruption, Lack of awareness among health professionals and the public, Reporting culture is not well established, Inefficient cooperation between stakeholders, etc.”
In case you are still wondering what are the implications of Counterfeit Drugs in our society, in the words of Abayomi: “THE EVIL OF COUNTERFEIT DRUGS IS WORSE THAN THE COMBINED SCOURGE OF MALARIAL, HIV/AIDS AND ARMED ROBBERY PUT TOGETHER. The regular use of counterfeit medicines can lead to therapeutic failure or drug resistance; economic losses; disability and discomfort; loss of confidence in medicines, healthcare providers and health systems; toxicities; diseases; in some cases, it can lead to death. 1995: In Niger Republic, the use of counterfeit meningitis vaccine resulted in the death of about 2500 persons. 1998: In Brazil, 200 cases of unwanted pregnancies resulted from the use of counterfeit oral contraceptives tablets. 2003: IN NIGERIA, 3 CHILDREN DIED AT A UNIVERSITY TEACHING HOSPITAL DURING AN OPEN-HEART SURGERY AS A RESULT OF THE USE OF COUNTERFEIT ADRENALINE. 2004: In France, contact lenses containing Pseudomonas bacteria were detected by the regulatory authorities after receiving complaints from patients. 2009: IN NIGERIA, THE CONSUMPTION OF A PARACETAMOL-BASED SYRUP PREPARED WITH DIETHYLENE GLYCOL LED TO THE DEATH OF 84 INNOCENT CHILDREN.”
As part of the ways to checkmate and educate the public on practical steps to safeguard one from counterfeit drugs, Abayomi noted that: “some analytical methods used in Detecting Counterfeit Drugs include: Physical characterization like Weights, Measures and Hardness testing of drugs; Chromatographic techniques like TLC and Gas chromatography helps to assay the chemical composition of the product and in identifying chemical impurities or contaminants in products; NIR spectroscopic techniques to generate thousands of spectra which can be analyzed to first classify the counterfeit product then see if they are linked to a common source and finally identify the chemical components and quantify them.” While some of the Innovative Solutions/method involves the use of technology and can be broadly classified as: Overt or visible features: this includes the use of Holograms, Product marking, Light sensitive colour change, and, Tilt view for some product packaging. This is similar to those images we see when we tilt our Drivers licenses, Certificates, Naira notes or even our ATM cards to check for marks of originality; Covert or hidden markers: this includes the use of Hidden Ghost images on product packaging and need special knowledge and techniques in identifying them. Also is the use of micro-encapsulated distinctive odor to uniquely identify the drugs.
“Mobile Authentication Service (MAS): this addresses the problem of counterfeiting by enabling users to verify product authenticity using a security label. At the point of purchase, customers scratch the label to reveal a unique code on the product which they validate via SMS; voice calls or website. This technology is common with most antibiotics, antimalarial and creams in Nigeria; Serialization/Track and trace technology; Radio Frequency Identity (RFID) tagging”
On the way forward, some of the actions to address Counterfeit Drugs in Nigeria, especially in the area of Prevention, include: “Comprehensive legal frame work with stiffer sanctions for offenders; Multi-stakeholder engagement (Judiciary, medical professionals, pharmaceutical companies, regulatory agencies, the media etc); Continuous education and awareness of the general public by medical professionals (pharmacists, medical doctors, nurses, etc); Maintaining adequate Supply chain integrity; Purchase all drugs from registered Pharmacies. In the area Detection: Always use the MAS and carefully scratch the security label of all drugs purchased at the Pharmacy; Access to laboratories and screening technologies; High risk based inspection and surveillance by regulatory agencies; Reporting systems by professionals and the general public to the appropriate regulatory agencies; Adequate land, sea and air border control by the Government. Then when it comes to Response: Alerts and recalls of all detected counterfeit drugs; Strengthening the regulatory agencies in Nigeria with the needed support; Transparent legal process culminating in speedy dispensation of justice.
“The harmful implications of counterfeit drugs is a major challenge to the integrity of public health systems around the globe, and also a threat to our individual health and existence, especially in Nigeria. There is no single solution to every problem, and a secure strategy will involve a mixture of stakeholders and technologies, often in combination. But as long as counterfeiters target medicines for illegal profit, a product with no form of anti- counterfeit marker represents a significant potential risk to public health and safety. It is therefore important to make informed decisions when procuring any drug for consumption.”
As for us, the Nigerian Government across all levels have not done much in controlling the sales of counterfeit drugs in the country. The Federal Government especially, must strengthen its agencies in the control of the importation and even production of counterfeit/fake drugs in the country. There are importers whose specialty, is the importation of counterfeit and fake drugs into the country for their love/greed for money. Many Nigerians have lost their lives for taking fake and counterfeit drugs/medications, thinking that they were taking the right medications. Former NAFDAC boss, Dr. Dora Akunyili was known to battle the influx of fake and counterfeit drugs importers, to the point where her life was threatened by these importers. We are hereby joining words and efforts with Abayomi Akinmutola in his crusade against counterfeit drugs increase across the country. In my own view, both the layman and the pharmacists are involved in this booming counterfeit and fake drugs menace of a business in Nigeria. Hence, the apparent high cases of it in Nigeria. This needs to be addressed by all and sundry.
Zik Gbemre.
October 30, 2019
We Mobilize Others To Fight For Individual Causes As If Those Were Our Causes
It is sad how the greed for money and insane acquisition, has made many to smear their conscience with hot iron to the point where, they practically do not mind getting their hands stained with blood just to make it big. And it is also sad that in a society like Nigeria, we are daily daunted by news and happenings that really do not paint a good picture about us as a people. Nobody cares about how their (criminal) actions would adversely affect thousands and millions of the citizenry, so long as they make money. This is why we find it appalling that some persons would go to the point of counterfeiting drugs just to make money, without any consideration whatsoever, of how their actions would negatively impact public health and wellbeing.
We were dazed recently, when we came across a well-researched write-up on the subject matter by Mr. Abayomi (Yomi) O. Akinmutola (Pharm. D), a Clinical Pharmacist in Benin-City, Nigeria. He opened our eyes and broadened our minds to this subject matter of counterfeit drugs, which has obviously become a serious plague in our Nigerian societies that urgently requires attention by the relevant authorities in addressing it.
According to Abayomi, “Drug counterfeiting is a significant public health threat and is rapidly increasing with dozens of new cases being reported throughout the world every day. A drug must obtain Market Authorization (MA) granted by a competent authority before being marketed. This MA guarantees the product’s safety, quality and efficacy. “Counterfeit drugs” do not meet these requirements and subsequently are dangerous to an individual’s health. AT BEST, DRUG COUNTERFEITING IS A FORM OF TERRORISM AGAINST PUBLIC HEALTH AS WELL AS AN ACT OF ECONOMIC SABOTAGE.
“In the etymological meaning, counterfeiting is “the fraudulent copy of another’s product without their consent”. The World Health Organization (WHO, 2011) defines COUNTERFEIT DRUG AS A MEDICINE WHICH IS DELIBERATELY AND FRAUDULENTLY MISLABELED WITH RESPECT TO IDENTITY AND/OR SOURCE. This applies to both branded and generic products and It may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging. In the Nigerian, Counterfeit and Fake Drugs and Unwholesome Processed Foods (Miscellaneous Provisions) Decree; а fake drug is defined as: Any drug product which is not what it purports to be; or Any drug or drug product which is so colored, coated, powdered or polished that the damage is concealed or which is made to appear to be better or of greater therapeutic value than it really is, which is not labeled in the prescribed manner or which label or container or anything accompanying the drug bears any statement, design, or device which makes а false claim for the drug or which is false or misleading; or Any drug or drug product whose container is so made, formed or filled as to be misleading; or Any drug product whose label does not bear adequate directions for use and such adequate warning against use in those pathological conditions or by children where its use may be dangerous to health or against unsafe dosage or methods or duration of use; or Any drug product which is not registered by the recognized drug control or regulatory agency in accordance with the provisions of the Food, Drugs and Related Products (Registration) Decree 1999 as amended.”
In other words, “A counterfeit drug therefore, is a medication or pharmaceutical product which is produced and sold with the intent to deceptively represent its origin, authenticity or effectiveness. And if, according to WHO, “Public health is the science and art of promoting health, preventing disease and prolonging life through the organized efforts of society,” then it is imperative for the Nigerian public to be very much aware of this scourge. More so, we can see that the issue of counterfeit drugs covers a whole lot of areas that are often times, not known to the Nigerian public. This makes the issue even more dangerous because without the holistic knowledge of what constitutes counterfeit drugs, the health and wellbeing of the Nigerian public is more at risk.
In describing the extent of the problem of counterfeit drugs, Abayomi (Yomi) Akinmutola further noted that: “This problem is a global phenomenon known to exist in both developed and developing countries and it can occur to any pharmacological class and any formulation type. Antibiotics and antimalarial are the two highest categories of suspected drugs reported to the WHO by far WHO/IMPACT estimates the level of prevalence of counterfeit drugs to be less than 1% (US, EU, Canada), 5 - 10% South East Asia), 10% (Russia), 10 to 20% (Latin America), 16% - 20% (India) and up to 50% (Africa). Drug counterfeiting represented approximately 40 billion US Dollars in sales. This approximates almost 10 % of the world pharmaceutical market (WHO, 2016).
“ACCORDING TO THE INTERNATIONAL CRIMINAL POLICING ASSOCIATION OTHERWISE KNOWN AS (INTERPOL), COUNTERFEIT DRUGS KILLS MORE THAN ONE MILLION PEOPLE EVERY YEAR. STATISTICS FROM NAFDAC (2012) REVEALED THAT NIGERIA IS THE WORLD’S LARGEST MARKET FOR COUNTERFEIT DRUGS AMONG DEVELOPING NATIONS OF THE WORLD.” If this does not scare and trouble your mind, I really do not what else would. These statistics alone suggests that this issue is a scourge that must be dealt with from all angles. According to Abayomi, some of the amplifying factors responsible for this problem, especially in Nigeria, include: “Large profit potential from the counterfeit market, High cost of drugs, Scarcity and/or erratic drug supply, Infiltration of the supply chain, Highly porous borders, Weakness in drug regulatory systems, Weak enforcement and penal sanctions, Corruption, Lack of awareness among health professionals and the public, Reporting culture is not well established, Inefficient cooperation between stakeholders, etc.”
In case you are still wondering what are the implications of Counterfeit Drugs in our society, in the words of Abayomi: “THE EVIL OF COUNTERFEIT DRUGS IS WORSE THAN THE COMBINED SCOURGE OF MALARIAL, HIV/AIDS AND ARMED ROBBERY PUT TOGETHER. The regular use of counterfeit medicines can lead to therapeutic failure or drug resistance; economic losses; disability and discomfort; loss of confidence in medicines, healthcare providers and health systems; toxicities; diseases; in some cases, it can lead to death. 1995: In Niger Republic, the use of counterfeit meningitis vaccine resulted in the death of about 2500 persons. 1998: In Brazil, 200 cases of unwanted pregnancies resulted from the use of counterfeit oral contraceptives tablets. 2003: IN NIGERIA, 3 CHILDREN DIED AT A UNIVERSITY TEACHING HOSPITAL DURING AN OPEN-HEART SURGERY AS A RESULT OF THE USE OF COUNTERFEIT ADRENALINE. 2004: In France, contact lenses containing Pseudomonas bacteria were detected by the regulatory authorities after receiving complaints from patients. 2009: IN NIGERIA, THE CONSUMPTION OF A PARACETAMOL-BASED SYRUP PREPARED WITH DIETHYLENE GLYCOL LED TO THE DEATH OF 84 INNOCENT CHILDREN.”
As part of the ways to checkmate and educate the public on practical steps to safeguard one from counterfeit drugs, Abayomi noted that: “some analytical methods used in Detecting Counterfeit Drugs include: Physical characterization like Weights, Measures and Hardness testing of drugs; Chromatographic techniques like TLC and Gas chromatography helps to assay the chemical composition of the product and in identifying chemical impurities or contaminants in products; NIR spectroscopic techniques to generate thousands of spectra which can be analyzed to first classify the counterfeit product then see if they are linked to a common source and finally identify the chemical components and quantify them.” While some of the Innovative Solutions/method involves the use of technology and can be broadly classified as: Overt or visible features: this includes the use of Holograms, Product marking, Light sensitive colour change, and, Tilt view for some product packaging. This is similar to those images we see when we tilt our Drivers licenses, Certificates, Naira notes or even our ATM cards to check for marks of originality; Covert or hidden markers: this includes the use of Hidden Ghost images on product packaging and need special knowledge and techniques in identifying them. Also is the use of micro-encapsulated distinctive odor to uniquely identify the drugs.
“Mobile Authentication Service (MAS): this addresses the problem of counterfeiting by enabling users to verify product authenticity using a security label. At the point of purchase, customers scratch the label to reveal a unique code on the product which they validate via SMS; voice calls or website. This technology is common with most antibiotics, antimalarial and creams in Nigeria; Serialization/Track and trace technology; Radio Frequency Identity (RFID) tagging”
On the way forward, some of the actions to address Counterfeit Drugs in Nigeria, especially in the area of Prevention, include: “Comprehensive legal frame work with stiffer sanctions for offenders; Multi-stakeholder engagement (Judiciary, medical professionals, pharmaceutical companies, regulatory agencies, the media etc); Continuous education and awareness of the general public by medical professionals (pharmacists, medical doctors, nurses, etc); Maintaining adequate Supply chain integrity; Purchase all drugs from registered Pharmacies. In the area Detection: Always use the MAS and carefully scratch the security label of all drugs purchased at the Pharmacy; Access to laboratories and screening technologies; High risk based inspection and surveillance by regulatory agencies; Reporting systems by professionals and the general public to the appropriate regulatory agencies; Adequate land, sea and air border control by the Government. Then when it comes to Response: Alerts and recalls of all detected counterfeit drugs; Strengthening the regulatory agencies in Nigeria with the needed support; Transparent legal process culminating in speedy dispensation of justice.
“The harmful implications of counterfeit drugs is a major challenge to the integrity of public health systems around the globe, and also a threat to our individual health and existence, especially in Nigeria. There is no single solution to every problem, and a secure strategy will involve a mixture of stakeholders and technologies, often in combination. But as long as counterfeiters target medicines for illegal profit, a product with no form of anti- counterfeit marker represents a significant potential risk to public health and safety. It is therefore important to make informed decisions when procuring any drug for consumption.”
As for us, the Nigerian Government across all levels have not done much in controlling the sales of counterfeit drugs in the country. The Federal Government especially, must strengthen its agencies in the control of the importation and even production of counterfeit/fake drugs in the country. There are importers whose specialty, is the importation of counterfeit and fake drugs into the country for their love/greed for money. Many Nigerians have lost their lives for taking fake and counterfeit drugs/medications, thinking that they were taking the right medications. Former NAFDAC boss, Dr. Dora Akunyili was known to battle the influx of fake and counterfeit drugs importers, to the point where her life was threatened by these importers. We are hereby joining words and efforts with Abayomi Akinmutola in his crusade against counterfeit drugs increase across the country. In my own view, both the layman and the pharmacists are involved in this booming counterfeit and fake drugs menace of a business in Nigeria. Hence, the apparent high cases of it in Nigeria. This needs to be addressed by all and sundry.
Zik Gbemre.
October 30, 2019
We Mobilize Others To Fight For Individual Causes As If Those Were Our Causes