Ignorance of counterfeit pharmaceutical products among consumers and its consequences

Introduction

Counterfeit productions could be imitation of names, products. Packaging, repacking, labelling or making of any good whereby those produced goods are imitated in such a manner that those goods are identical or substantially similar produced. It is an infringement upon intellectual property rights or imitation so that other goods are calculated to be confused with the original (Otieno-Odek, 2010). Counterfeit of almost anything can be found in pharmaceuticals, electrical goods, bleach and dyes, books and food items. Counterfeiting can apply to both branded and generic products. Counterfeit products may also include products with the correct ingredients or with the wrong ingredients or with fake packaging.

According to the World Health Organization (WHO, 2006) definition, what makes a medicine counterfeit is the deliberate or intentional (criminal) nature of mislabelling the machine. Also, counterfeit medication have been defined as products deliberately or fraudulently produced or mislabel led with respect to identify and or source to make if appear to be a genuine product (Ziance, 2008). Examples include medication that contain an active ingredient or incorrect amount of active ingredient or inferior quality active ingredient a wrong contaminant are repackaged products (Walter, Chambliss and Caroll, 2012). They are products made in imitation of the original with the intent to deceive consumers, it could also mean something likely to be mistaken for something of higher value.

The impact of counterfeit medication on the legitimate global pharmaceutical market has been estimated to reach 75 billion dollars and the profit margin is reportedly greater than illicit drugs trafficking (Everts, 2010). Counterfeit medication has been distributed via complex network that have been traced to terrorist and organized crime (Pellek, 2011). Estimates indicate that less than 1% of prescribe medications in the United States and Europe and 30% in developing nations are counterfeit (Howard, 2010) and the problem is growing rather than receding. Although, 1% may seem low, if a pharmacy dispenses 200 to 300 prescriptions per day, two or three of them could be counterfeit.

Drug counterfeiting poses a great danger to every society and the less the awareness the more it gains root into the system. The first step towards combating counterfeiting is getting people to know that it exists with all its consequent delirious effect counterfeiting is the greatest evil of our time and the highest weapon of terrorism against public health as well as economic sabotage. It is an ill wind that blows no body any good.

The evil of fake drugs is worse than combined scourge of malaria, HIV/AIDS and armed robbery put together. This is because malaria can be prevented, HIV/AIDS can be avoided and armed robbery may kill a few at a time but counterfeit drugs kills in masses (Akinyili, 2005).

Fake drugs have embarrassed our health care providers and eroded the confidence of the public on our health care delivery system. This development has led to the treatment failures, organ dysfunction or damage, worsening of chronic disease condition and the death of many Nigerians. The situation has become so bad that even when patients are treated with genuine antibiotics, they no longer respond due to resistance induced by previous in-take of fake antibiotics.

Local drugs manufacturing became unattractive due to unfair competition. Many multinational companies diverted and left Nigeria out of frustration, Boerhrinya, ICI, Sandoz, Merek, Boots etc. made in Nigeria drugs were officially unaccepted in other West African countries like Ghana, Sierra Leone, etc. Consumer’s awareness and protection is a general concept that involves protecting people from buying drugs that are unsafe or fraudulent. Consumer protection is a major social policy promoted by most modern states governments because of the importance it represents for the contemporary economy if it is an independent policy with own objective priorities and tools.

The concept of counterfeiting and counterfeit products

The term counterfeit drugs or sub standard drugs are often confused for public health purposes the health organization. World Health Organisation (WHO,2006) defines counterfeits drugs as one that is deliberately and fraudulently mislabelled with respect to identify and a quality specification sect for them.

World Health Organization (2006) opined that if sub standard drugs are knowingly produced to make unlawful products, counterfeit. Furthermore, an additional “gray pharmaceutical” spaces is emerging which illicit profiteers are ostensibly marketing competition brands without regulatory approval. These products are seldom “counterfeit” parse, but are very often substandard.

Counterfeiting is defined as the manufacture, production, packaging, repackaging, labelling or marketing whether in Nigeria or elsewhere of any products whereby those protected goods are imitated in such manner and to such a degree that those goods that are identically or substantially or substantially similar copies of the protected goods.

Counterfeit drugs are “false copies of famous brands of medicines pharmaceutical preparations which may have similar ingredient to the original. After the investigations, some of the sold products contained just chalk powder, starch or flour but they found drugs or pills designed to mislead patient into thinking that “pills” would have a beneficial effort. Product counterfeiting is a form of consumer fraud; a product is sold purporting to be something that is not. This is different from the crime of copy right violation which involves the unauthorized transfer of licensed material such as sharing of music of videos-files electronically (Andreascen, 1977). Products counterfeiting is typically an organized group activity because the manufacturing of goods takes people and time and the goal is profit. Many justifications take the offence quite seriously for reasons described below.

As a result most product counterfeiting would be considered organized crime under the convention. In general commercial counterfeiting can be described as the fraudulent practice of affixing a false trade mark to a product. The false trademarks then appear indistinguishable from its legitimate counterpart. The purpose of this fraudulent activity is to dupe the consumer into purchasing the counterfeit under the mistaken that the product is the genuine article for the consumer who unknowingly purchase a counterfeit, the result is typically dissatisfaction for the firm whose goods are counterfeited, loss of revenue and good will are possible for the counterfeiters profits are reaped with little financial or legal risk and with minimal marketing effort very essentially the issue of counterfeiting has become a common place in Nigeria as at today.

Although, this problem has been with us long age but it is like the problem is getting more grounded every day. In Nigeria, as at today the scale of this problem is not well documented, but it is common knowledge that there are erroneous counterfeit products either in from of currency, pharmaceutical or consumer goods. Counterfeit medicine are falsified in connection with a genuine medicine with the intent to deceive consumers, consequently counterfeit medicines have not undergone regulatory review and thus, must be considered substandard. The sale of counterfeit pharmaceutical products represent a serious threat to both the manufacture of legitimate products and the consumers who purchase them perhaps, of all crimes none is as potentially dangerous yet neglected as drug counterfeiting. It causes so much suffering and death that some experts rightfully regard it as an attempted murder (Atolphus, 2005; Akunyili 2007), no agreement for countries on what constitutes a counterfeiting drug (WHO, 2006). The most widely accepted definition is the working definition developed by World Health Organization (WHO, 2006) which defines a fake or counterfeit drug as a medicine deliberately and fraudulently mislabelled with respect to identify and or source. Counterfeit can apply to both branded and generic products and counterfeit product may include products with the correct ingredients without active ingredient, with Insufficient active ingredient or with fake packaging (WHO, 2006) generally, all counterfeit drugs are substandard as counterfeit drug may not be considered as counterfeit if there is no intent to deceive (Reggi, 2007).

Causes of influx of counterfeit pharmaceutical products in Nigeria

Some of the factor responsible that encourage drug counterfeiting in Nigeria according to Akinyuli, 2005) is as follows:

  • Corruption and conflict of interests: Corruption is a driving force for poor regulation which encourages drugs counterfeiting. The efficiency of personal is adversely affected by corruption and conflict of interest resulting in laws not being enforced and criminals not being arrested, prosecuted, and evicted for crime. Criminal in many part of the world have discovered that these counterfeiting of medicines financially lucrative and of relatively low risk. As a result, organized crime has shifted from the smuggling of narcotics and using of weapons to the counterfeit of medicines. This problem of counterfeiting is partly as a result of inadequate supervision on the part of NAFDAC due to negative attitudes to work and corruption on the importers, dumping was business as usual as long as they could pay their way through the regulatory authorities. Distributors are not spared of these corruptive practice because some of them are involve in re-labelling of drugs with the intention of extending their shelf life (Cochbum, 2002)
  • Insecurity and unfriendly environment: Insecure and unfriendly environment hamper the efforts of regulatory authorizes. The threat to the security of life of staff and properties continue to pose great challenges to food and drugs regulation in Nigeria, for example in July 2014 NAFDAC officers who confronted drug hawkers in Gombe State were severally beaten and their vehicles were destroyed (Akinyili, 2005)
  • Discriminatory regulation by exporting countries: Discriminating regulation and control of drugs met for export as against those used in many countries have promise the quality of drugs moving in international commerce.

This practice have resulted in drugs label for export not being subjected to the same strict regulation as those for eternal use in country of manufacture poor regulation of export for manufacturing countries exposes the countries within nonexistent or weak regulation to dumping of counterfeit drugs. Currently, there are 86 Pharmaceutical manufacturing companies producing less than 30% of Nigeria drug need while the rest are imported (Solomon and Adeyemi, 2012) if note worthy that most of the fake/counterfeit drugs in Nigeria are imported from Asia particularly from India and China discriminatory and poor regulation of export by exporting countries in formed prohibition of the NAFDAC management to prohibit the importation into Nigeria products marked “For Export only” any product that cannot be use in the country of manufacturing is officially unacceptable in Nigeria (Solomon and O’Brien, 1990).

  1. Chaotic drug distribution system: Drug distribution in Nigeria is very chaotic with drug marketed like any other commodity of trade. Due to poor regulation over fears, drug market involves and got deeply established all over the country despite the illegality of such activities. Almost all manufacturer and importers supply this drug market. Drugs sellers and even drug professionals are patronized the drug which also services the hawkers that sell in streets and commercial buses. Effort made by the National Agency for Food Drugs Administration and Control (NAFDAC) to create an orderly drug distribution system so as o enable the agency phase out the existing disorganized drugs. The drugs market suffers a setback legal risk and with minimal marketing effort. Very essentially, the issue of counterfeiting has become a common place in Nigeria as at today.

Although, this problem have been with us long age but it like the problem is getting more grounded every day. In Nigeria as at today, the scale of this problem is not well documented but is common knowledge that they enormous counterfeit products either in from of currency pharmaceutical or consumer goods.

Counterfeit medicine area falsified marked in conduction with a genuine with the intent to deceive consumers, consequently counterfeit medicine have not undergone regulatory review and thus must be considered substandard. The scale of counterfeit pharmaceutical products represent a serious threat to both the manufacturer of legitimate products and the consumers who purchase them perhaps of all crimes, none is as potentially dangerous yet neglected as drug counterfeit. It cause so much suffering and death hat some experts rightfully regarded it as an attempted murders (Atolphus, 2005; Akunyili, 2007) no agreement among countries on what constitutes a counterfeit drug (WHO, 2006) the most widely accepted definition is the working definition developed by World Health Organization (WHO) who defined a fake or counterfeit drugs as a medicine deliberately and fraudulently mislabelled with respect to identify and or source. Counterfeiting can apply to both branded and generic products and counterfeit product may include product with the correct ingredients without active ingredients or with fake packaging (WHO, 2006). Generally, all counterfeiting drug may not be considered as counterfeit in there is no intent to deceive (Reggi, 2007).

  1. This is a major constraint at the parts. Some drug importers in order to evade inspection and detection, make fake declaration about the nature/contents of the products in their containers. They employ unimaginable concealment methods for nefarious activities. In 2003, a large consignment of a controlled narcotic analgesic was concealed T-shirts and imported from India via Lagos airport last year, 32 container of various pharmaceutical were imported and manifested as motor spare parts. They were moved to various locations with in the ports to avoid detection, but were impounded by vigilante officials. It was also found drugs concealed in the inner part of containers containing textiles drugs, shoes etc. (Marrin, 2008).
  2. Sophistication in clandestine drugs manufacture

Drug counterfeiting is made easier by increasing sophistication in technology of drug production. This is why doing of fast moving drugs is so perfect that even the brand owners find it difficult to differentiation between fake and original (Akingali, 2005).

  1. Lack of or inadequate legislation

Nigeria has a multiplicity of drug control laws that are unwieldy overlapping and sometimes conflicting some of the laws were so old and needed to be amended or up dated to meet the demands of present day realities for effectives regulation. The explicit promulgation of the counterfeit and fake drugs (miscellaneous provisions) Decree No. 17 of 1989, was clear evidence that the penalties provided in the previously existing laws were not sufficiently severe and determinant against the deadly offence of faking or counterfeiting of drugs. By 1999, some of the provisions of decree if were still considered not to be severe enough and was consequently revised and replaced with a new decree, the counterfeit and fake drugs and unwholesome processed foods (Miscellaneous previsions) decree No 25 of 1999, which established the federal and state fake force as the enforcement aim of NAFDAC (Akinyili, 2005).

While the world wide demand for brand name products is no doubt one of the leading causes of the counterfeiting explosion, there are a number of other factors that also help to explain why counterfeiting is such a thriving activity. East Asia and Africa is an important development which is potentially disastrous because alternative drugs are either accessible or unaffordable. Therapeutic failure may also be associated with the use of fake drugs containing insufficient or no actively radiant leading to loss of confidence by the patients on the conventional drugs and public health programme. An estimated 700,000 deaths annually are caused by fake anti-malaria and tuberculosis agents suggesting that the total annual mortality due to the menace will definitely be much higher (Harris et al 2007) various instances where fake drugs resulted in deaths due to failure life threatening conditions have been reported in the life — et al, 2009) about 192,000 people were reported to have died in China as a result of fake drugs. Also, about 2,500 people died in Niger following the administration of counterfeits of meaningoee calvacines (containing no active ingredients) so some 60,000 people during the 1995 meningitis epidermis (Corkburn et al 2005).

Toxicity

Toxicity is the degree to which a substance can damage an organism. It can also refer to the effect on a whole organism, such as animal or plant as well as the effect on a substructure of the organism such as a cell (cytotoxicity) or an organ such as the liver (hypatotoxicity). By extension the word may be metaphorically used to describes toxic effects on large and more complex of groups such as the family unit or the society at large.

The role of government agencies in creating awareness against counterfeit products

Combating drug countering is a dangerous phenomenon that requires collaboration from international community. This is why who recently alerted the international community on such need (WHO, 2006) cooperation as well as exchange of information between government and drugs companies in combating this menace is expected to provide better results. Experts believed that the big pharmaceutical industries have a lot of data that could help in combating the problem but are unwilling to reveal it (Gibson, 2004) there is a catch 22 situation in combating counterfeiting. The industry lose money as fake drug peddlers but negative that usually follows any cause of drug counterfeiting is a major fee for the industries whose products were counterfeited. This is also true for countries that are major exporters of drugs. It has been reported that some government are involved in considering information on the quantity of fake drugs circulating within their territories to avoid branding of their products as fake. These emergences of drug counterfeiting business on the internet that seriously affected profits coupled with litigation from affected patients targeted against them have forced major drug companies to start taking action on these issues in the developed nations. However, they remain uninterested in tackling the problem in developing countries.

Since the problem of drug counterfeiting is more common in less developed countries where civil laws are either vague or not enforced, one important short term strategy for combating fake drugs is that pharmaceutical.

Awareness strategies to combat counterfeit drugs in Nigeria

The following strategies have been evolved by NAFDAC to achieve the goals consumers’ protection and create a strong regulatory environment.

  1. Public enlightenment campaign: The organization deem it fit to embark on massive enlightenment campaign, dialogue, education and persuasion because this strategy addresses the fundamental issues at stake which is behavioural change NAFDAC did it through.
  2. Awareness through the mass media which includes Jingles, Alert notices, erection of billboards etc.
  3. Enlightenment and the resultant voluntary change of heart are result oriented and complimentary to confrontation and prosecution, which the agency had used over the years with little or no fruits. For example, it was the co-operation and support of the chairman and members of the Onitsha medicine dealers association (the largest drug market in Nigeria) brought about by our enlightenment campaign that enacted NAFDAC to locate one of the biggest and richest fake drug warehouses, seized the huge cache of fake drugs, got him to sign a letter of the future of these of these drugs for destruction and also made him to apologize publicly to Nigerians.

An assessment of world market factors suggests that the reasons are basically political and economic many developing countries simply do not have specific laws that address pharmaceutical counterfeiting. Those countries that do not anti-count exciting statutes typically have nominal penalties for violations and very lax attitudes regarding enforcement even in the United States, prosecution of counterfeiting is a relatively futile exercise. Counterfeiting in the united states is a civil offences (as opposed to a criminal offence) and a corporate plaintiff must structure its case to prove either mail fraud or violation of other federal statutes, otherwise if masterly on unsatisfactory state unfair competition laws (Mcclure, 1 979).

Effects of counterfeit pharmaceutical products on the consumers

In aggregate however, drugs counterfeiting poses a serious global challenges. The branding of products provide implicit quality assurance and a legal line of accountability that consumers have to take for granted without a brand to protect, counterfeiters have no incentive to produce any things but supervises quality. Where if become impossible to distinguish the real from the counterfeit, poor quality products destroy the reputation of the copies brand and the cheaper goods will inevitably dominate the ultimate threat of counterfeiting has been realized in some parts of the developing world, the original high quality products have been essentially priced out of the market.

The damage is not just felt in the receiving countries, the pricing countries also suffers, even as the major brands work to improve labour standards and work place safely it their out sourced manufacturing sites, counterfeiting goods take advantage of global sweat shops, as licensed manufacture try to improve their environmental impact standards counterfeiting enjoy the cost saving dirty production. In short, anywhere that the international community attempts to establish good practice standards for industry, counterfeits under ran them.

Thus, much of the impact of product counterfeiting is long-term, sub the and diffuse deaths, many of which occurs under-developing countries are often not tied hack to the counterfeit products or if they are there is little organized response as a result, the impact of counterfeiting can be frustratingly difficult to quality. The most accessible metric is loss of revenues and so, counterfeiting is often reduced to revenue issues, despite being much more than that.

Much of the global out sourcing is contracted to firms in Asia, both for manufacturing and increasingly for services. In pharmaceutical contract manufacturing for example, India and China are among the market leaders it is therefore not surprising that a large share of global counterfeit seizures originate in Asia. Because of counterfeiting consumers feel cheated. Due to counterfeiting not only consumers being cheated but also it destroys the promoted market share of own, moreover, there are many effects on other groups also, almost everyone in the value chain is affected when a brand is attached.

Brands many hamper the good will of famous companies. Because companies may he blamed and condemned by consumers’ discontentment due to lower satisfaction derived from the consumption of counterfeit products counterfeit of brand also increases the marketing case of original companies which hampers the competitive position of the genuine companies. Because they have to spend additional money for advertisement only to make alert the consumer about counterfeit. It may hamper the economy of the country in long time. This creates obstruction for the infant at their growing stages. As counterfeit products can be mechanized at a lower price, the manufacturer of original products confront a cute and intensive competition even at the flourishing time, as a result, they may be eliminated from the market.

When a person pays for the original goods and later found the poor quality of counterfeit goods, he hesitate to buy the goods in future and in this way, a good manufacturer is through reduction of his market. So, counterfeiting is a problem should immediately be remedied for the sake of greater interest of the consumers, markets and country.

Counterfeiting is the greatest evil of our time and the highest weapon of terrorism against public health as well as form of economic sabotage. If is an ill wind that blows nobody good. The evil of fake drugs is worse and the combined scourge of malaria, HIV/ AIDS and armed problem put together. This is because malaria can be prevented, HIV / AIDS can be avoided and armed robbers may kill a few at a time, but counterfeit / fake drugs kill in mass.

The social problem posed by hard drugs cocaine, heroin etc cannot be compared with the damage done by fake drugs because illicit drugs are fake out of choice and by those that can afford them but fake drugs are taken by all aid anybody can be a victim. Fake drugs have embarrassed out health care providers and eroded the confidence of the public on our health care delivery system. This development has led to treatment failures organ dysfunction or damage, worsening of chronic disease conditions and the death of many Nigerian. The situation becomes so bad that even when the patients were treated with genuine antibiotics, they no longer respond to resistance induced by previous intake of fake antibodies.

Local drugs manufacturing becomes unattractive due to unfair competition. Many multinational companies divested and left Nigeria out of frustration e.g. Boebringer, ICI, Sandoz, Merck, Boots etc. made in Nigeria goods were officially unaccepted in other West African countries e.g Ghana, Sierra Leone etc (Akunyuli, 2005)

The problem of fake drugs is very important in medicine because of the associated health risk, the associated health risks include antibiotic resistance, therapeutic failure, toxic effects are even deaths. The relationship between counterfeit drugs and antibiotic resistance is twofold. Although, drug counterfeiting is one of the important causes of antibiotic resistance in developing countries, one also has to keep in mind the likelihood of fake reports of antimicrobial resistance man area where drug counterfeiting is widespread (Rozendaal, 2000; Basco et al 1997).

Counterfeit antibiotics with low loses of active ingredients are potentially more dangerous than that containing no active ingredient in terms of the negative effects of drug resistance that may affect the entire community. Antibiotic resistance causes by drug counterfeiting might have contributed significantly to the inability to eradicate or control important infections such as malaria and tuberculosis in developing countries. Resistance to chloroquine and sulfadoxine pyrinethamine is already common (Meremikwu et al, 2007).

The recent emergence of counterfeits of atemisinia derivatives (Dondripetal, 2004, Newton et al 2006) Atemkemp et al, 2007, Rozendaal, Newton, et al, 2003) and entire trovired drugs (Ahmad, 2004) in some countries. Companies should focus more on developing better technologies for protecting the identity of their genuine products development of complex label that are difficult to imitate as well as use of SMS text message to check the authenticity of a particular pharmaceutical products are examples of recent progress in this regard. The above mentioned SMS technology, developed in the USA and Ghana is increasing being adopted by other countries in Asia and Africa (Harris et al, 2009).

Long term strategies for batting drug counterfeiting include provision as well as enforcement of clear and adequate civil laws that will compensate and protect the rights of affected countries like US, punishment of drug counterfeiting needs to be revised to make the practice harder and less lucrative. Drug counterfeiting is a grievous crime tar amount to murder hence, use of lenient punishment is inadequate and it may even boost the morale of the counterfeiters. However, use of extremely harsh punishment (such as life sentence and death penalty) may be associated with an increase risk of drug counterfeiting being hijacked by organized criminal elements as well as likelihood of developing corrupt relationship with the law enforcement agents (Harris et a!. 2009). Also the judiciary will be more hesitant in giving a guilty verdict because of the grievous consequence of any possible wrong decision (Harris et al, 2009). Without adequate enforcement, state laws may not serve as an enough determinant to combat drug counterfeiting. In order to ensure such enforcement, stamping out corrupting among the staff of law enforcement agencies, government official as well as at each step of the pharmaceutical system, manufacturing registration and distribution may be helpful (Cohen et al, 2007).

Decreasing tariffs and taxes imposed on genuine drugs may also help in reducing the extent of the problem by decreasing the cost of the drugs to the final consumers. Giving incentives to individuals who provide useful information that leads to the conviction of the culprits may also help in tackling this menace China has adopted such a tragedy by honouring such informants with as much as 6,000 US dollars (WHO, 2006).

Health care providers such as physicians nurses and pharmacists are in well positioned placed to help governments in this difficult fight that requires enormous often lacking or inadequate in poor countries. They help by having high index of suspicious on the possibilities of drug counterfeiting in cases of treatment failure or uncommon adverse reactions. They can further contributes by educating themselves and their patients on how to identify fake drugs using visual security tools such as the size and shape of tablets or capsules and the quality of the print as well as other aids such as the examination of the holograms. After confirming any case of counterfeit drug, the health care providers should strictly convey the information to his colleagues, patients and appropriate authorities, unfortunately a recent survey of 69 pharmacists Lagos, Nigeria reveals that out of 42 respondents (61%) who have come across at least an incidence involving fake drug only 31% (13) both have to take the case to the appropriate authority i.e. the National Agency for Food, Drug Administration and Control (NAFDAC). This finding reveals the apathy of health care providers on this problem. The need for the contribution of health care personnel in fighting this menace is even more essential in the rural areas where control and monitoring of the sources of the drugs in circulation is difficult due to inadequate numbers of law enforcement personnel.

In developing countries, government tend to take actions only in response to a public outcry. Hence there is need for a well organized advocacy and public awareness from experts and health care professionals so as to generate enough pressure for the laws makers to change the current laws concerning drug counterfeiting.

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