Meaning:
A counterfeit medication or drug is defined as a pharmaceutical product that is produced and sold with the intention to deceive the consumer about the origin, authenticity or efficacy of the product.
WHO Definition of a counterfeit medicine (1992)
“A product that is:
deliberately and fraudulently mislabelled with respect
to source and/or identity.”
Counterfeiting can apply to both
generic and branded products.
✒️Counterfeit products may include:
– products with the correct ingredients or
– with the wrong ingredients,
– without active ingredients,
– with incorrect quantities of active ingredients or
– with fake packaging.
Then,
✒️Substandard medicines are pharmaceutical products that do not meet their quality standards and specifications.
‘ The WHO defines ‘counterfeit’ drugs as ‘medicines that are deliberately and fraudulently mislabelled with respect to identity and/or source’
Reference.1:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4137817/
✒️Examples of Drugs that can be counterfeited or substandardized:
Drug counterfeiting has become a $200-billion business annually, according to the World Customs Organization. By some calculations, the counterfeiting trade has become more lucrative than the narcotics business. It’s a global problem. And experts say that solving it–or at least stemming the tide–requires the participation of both government and industry.
Top counterfeit drug types:
-Alimentary
-Anti-infectives
-Cardiovascular
-Central nervous system
-Cytostatic
The Pharmaceutical Security Institute is one example of a stakeholder collaboration that’s fighting fake drugs. PSI chief executive Thomas Kubic says in a phone interview that he counts 2,003 incidents involving 808 different drug products that were counterfeited, illegally diverted or stolen last year. That’s a worldwide total, and it includes branded, generic and over-the-counter drugs.
#Counterfeiters will manufacture a product to resemble any type of drug. Medications for chronic conditions are most popular, from hypertensive drugs to diabetes medicines. Antibiotics, corticosteroids, drugs for erectile dysfunction, cancer drugs and antiretrovirals for HIV/AIDS are also among those most counterfeited. According to PSI, however, criminal organizations now target drugs in every therapeutic category.
Top therapeutic areas for counterfeits, in terms of number of incidents, are cardiovascular, central nervous system, cytostatic, anti-infective, musculoskeletal and alimentary, Kubic says. He notes that last year marked the fifth straight in which medicines for genitourinary (including a counterfeiter-favorite category, erectile dysfunction), anti-inflammatory and central nervous system conditions topped the counterfeit list. Alimentary drugs, he says, experienced a staggering 57 percent increase in counterfeits between 2008 and 2009, with “a big bump from Latin America.”
✒️#The World Health Organization estimates that counterfeit drugs make up ten percent of the drug market worldwide. That breaks down to 30 to 40 percent (sometimes higher) in developing countries versus perhaps one percent in developed countries.
But counterfeits are on the rise in developed countries, thanks largely to the prevalence of online pharmacies. The FDA periodically buys drugs online and routinely finds that more than half are fakes.
✒️Causes & consequences of Drug counterfeiting:-
Drug products have often been counterfeited, and the consequences are well understood to have affected the credibility of public health systems around the globe, as they often are ineffective, promoting drug resistance, causing severe illness and even death. Drug manufacturing takes substantial working capital and trained staff to assure quality medicine. Cutting corners lowers expenses but increases risks for consumers
Counterfeiting affects not only finished drug products (branded and generic products) but also medical diagnostics and pharmaceutical ingredients (Active Pharmaceutical Ingredients (API), excipients or ancillary substances) used in pharmaceutical formulation. In this post, we will identify the key players in fake drug business and also talk about the consequences of drug product faking.
#The Key ️ Player’s:-
Key Players in the Fake Drug Business
1. Drug manufacturers:
This comprises local or foreign manufacturers who produce fake drugs or drugs that are prohibited, unauthorized and are not allowed by law to be manufactured or sold within the country of production or exported to another country.
2. Drug importers, wholesalers, and retailers
A greater percentage of drugs used in most developing countries are usually imported from China and India. Some importers connive with manufacturers to produce and import fake or substandard drug products at a cheaper rate. These drug products are then sold to the wholesalers and retailers who may or may not know if the drugs are faked or not.
3. Criminals and terrorist organizations:
Terrorist organizations engage in the manufacture, distribution and/or sale of fake drug products in a bid to fund their illegal and unrelated activities worldwide. They are known to seek out the weakest link among local jurisdictions. As capacity increases in one region, illicit syndicates and terrorists move on to expose the loopholes in the next. Often, when one illicit facility is shut down, criminal producers are able to quickly reconstitute operations in other jurisdictions within days. With porous borders, lacking or minimal oversight, and opportunities to expand through internet-based sales, the network of this criminal operations continues to spread.
4. Informal drug sellers:
These are individuals with limited drug information who sell drug products in an unregulated manner and without professional consultation. Most times, their aim is to make double profit even when they are aware of the consequences of selling these fake drug products. They also store and handle drugs in inappropriate conditions that can endanger the drug potency.
5. Consumers/ Patients:
Geographical accessibility, cheaper price and flexible pricing policies, close proximity, flexible payment method, perception of confidentiality, high stock out rate at the health facilities, shorter waiting times, longer opening hours, greater confidentiality, more personable social interaction, ease of seeking advice, no separate fee charged for advice etc., have been identified as some of the reasons why consumers tend to patronize informal drug sellers. These increase their chances of purchasing fake drugs thus, exposing them to dangers of using fake drug products.
✒️#Let’s talk about the CONSEQUENCES Properly:-
Consequences of Fake Drugs
Counterfeit/ fake medicines whether sold in streets, markets or on unregulated websites have significant consequences which include:
1. Therapeutic failure
The use of counterfeit drugs in the management and treatment of disease conditions pose a danger to individual patients and to public health as they are rarely efficacious and lead to increased resistance to existing antimicrobial agents, spread of drug resistance, and treatment failures in disease conditions like HIV, tuberculosis etc. The use of fake drugs can eventually lead to the death of a patient when it contains entirely incorrect active ingredients that are harmful to the patient.
2. Economic consequences
The proliferation of fake drugs has greatly affected the consumers, legitimate importers, manufacturers and the government.
a. Economic consequences of fake drugs on a consumer/ patient
In addition to the untoward effects of fake drugs, a patient would surely spend more if treated with fake drugs. The patient’s poor therapeutic response may lead to repeating the course of treatment or ordering more laboratory tests by the physician.
b. Economic consequences of fake drugs on legitimate importers and manufacturers
Apart from patent and copyright infringement, legitimate importers and drug manufacturers especially the local pharmaceutical industries find it difficult to compete favourably and break even because of unfair competition with counterfeiters, who are only paying for packaging and probably freighting without spending a dime on active ingredients, which are most of the time the most expensive components of any drug.
c. Economic consequences of fake drugs on the government
The Government is not left out when it comes to the economic loss resulting from the activities of fakers. They are affected through loss of revenue generated from taxation and also the undermining of the national healthcare system.
3. Security Threat
Illegal drug activities, including manufacture, importation, and trade has grown to the ugly dimension of affecting national and international security due to the availability of sophisticated technology, growing size of counterfeiting ring and the widening involvement of organized crime groups looking for means to fund their nefarious activities worldwide.
✒️Tips on How to Identify Fake Drugs:
A Fake drug is a drug product which is not what it purports to be. It is any drug product which is formulated or made to appear to be better than it really is. The term can also refer to a drug which is deliberately and fraudulently mislabeled with respect to identity and/or source or with fake packaging.
The deadly consequences of using counterfeit medicine are well understood to be a challenge to the integrity of public health systems round the globe, and also a threat to our individual health and welfare. The issue of fake drug has persisted despite all efforts by regulatory bodies towards compliance with standards.
As a consumer, you may not have access to most of the test equipment used by regulatory bodies to verify the identity of a drug product as discussed in our previous article “Drug Product Faking: Methods for Testing Counterfeit Drugs”. The following tips will serve as a guide to purchasing genuine drug products.
1. Visual inspection:
-Examine the package and check if it appears suspicious or different from what you previously know.
-Check if the security seal has been tampered with by looking for breaks or tears in the sealing tape and seals.
Look for unusual fonts, font sizes, print colour, and spelling errors.
-Check the legibility of the information on both the primary and secondary packages.
-Check if the batch number, expiry date and manufacturer’s address on the secondary package are the same with that on the primary package.
-Check if the manufacturer’s address is traceable, that is, if it contains the exact location of the company and not just the country address.
-Check if the registration number (NAFDAC number as the case is for products marketed or sold in Nigeria) is properly printed or if it appears to be tampered with.
2. Mobile Authentication Service using Short Message Service (SMS):
Mobile Authentication Service (MAS) is one of the cutting edge technologies used to curb the menace of fake drugs. It is a technology that has put the power of identifying fake drug products in the hands of many cell phone users.
3. Source:
The source of the drug also determines if you are buying a fake drug or not. Filling your prescription in a reputable pharmacy greatly reduces your chances of buying fake drugs while buying from illiterate and unqualified vendors who hawk drugs in buses, motor parks and in the streets increases your chances of buying fake drugs
4. Price:
This is another way of identifying fake product. If the price is far cheaper than what is expected, then you have to think twice. However, this may not always be true especially for some products (fake innovator/generic brands) which may be sold at the same price as the genuine one.
5. Unexpected side effect:
Counterfeit drugs most of the time contains inert substances other than the appropriate Active Pharmaceutical Ingredient (API). They may also contain incorrect substances, improper dosage or hazardous substances which do no elicit therapeutic effect.
Unusual side effects, allergic reactions, or a worsening of medical condition after taking a medication may be a pointer to identifying a fake drug. The medication should be stopped once any of the above is noticed.
Conclusion:
There are a thousand and one counterfeit, gray and substandard drugs in the market today; and the negative impacts of these drugs know no boundaries. Drugs are poisons and care must be taken to avoid fake ones. The tips discussed in this article will not only help reduce your chances of purchasing, using, and suffering the untoward effects of fake drug products but will also save you some money.
You can contribute your quota in fighting the war against counterfeit drugs by sharing this information. Let me know your thoughts in the comment section.
✒️5 Strategies To Combat Counterfeit Drugs And Other Pharma Supply Chain Threats:
It’s hard enough to detect errors in the entire process of manufacturing and distributing one’s own pharmaceutical products, but pharma companies must also address the challenge of counterfeit medications that at best are ineffective and at worst are deadly.1 Legitimate drugs can be diverted, or fake drugs can be created completely parallel with and invisible to your own supply chain, with their own distribution networks deliberately made complex to disguise them.
✒️Counterfeiters will replace effective active ingredients with inert ingredients like chalk or cornstarch and manufacture their fake products in humid, unsanitary buildings, blending them in washing machines or cement mixers. Vendors often offer their fake meds in open-air markets in the tropics, likely without storing them under the temperature conditions required for a drug to be stable. The most sophisticated counterfeiters may add an insignificant layer of active ingredient to avoid detection. The results can be deadly, particularly to children. Counterfeiters count on the fact that these patients are already ill to quell suspicions about the integrity of their fake drugs. To escape detection, more care is given to the appearance of the packaging of these fakes than to the quality of the products themselves. For products that were once in the legitimate supply chain but that have been diverted, it is possible that the products have been degraded either by being past their expiration date or stored in inappropriate conditions.
Here are five of the most noteworthy ones:
1. Assign a dedicated individual or group in your organization to monitor the security of your supply chain.
2. Work with regulatory agencies, industry organizations, international agencies such as the WHO, and law enforcement (e.g., Interpol) to identify and combat fakes.
3. Incorporate design elements into your packaging to make counterfeiting more difficult.
4. Use verification methods at different points in the supply chain to ensure the integrity of your product.
5. Take advantage of new technologies.
For Reference/Future sake:.https://www.pharmaceuticalonline.com/doc/strategies-to-combat-counterfeit-drugs-and-other-pharma-supply-chain-threats-0001
