Counterfeit Medicine Advice for Healthcare Professionals

Counterfeit medicines are rampant in countries where law enforcement and regulations are weakest. In most industrialized countries, there are rules that prevent counterfeiting but in developing nations, these rules are not based in anything because of the lack of knowledge of its manufacture and production even from professionals. Cities like Jakarta, Indonesia, Kuala Lumpur, Malaysia and Singapore are now integrating practices from America for security measures and importing.

The Peterson Group, a nonprofit organization with an aim to eliminate the illegal usage, importation, exportation and distribution has asked experts in this field to give some advices and warnings for better detection and evaluation of medicines prescribed to clients:

1. Establish the Integrity of the source prior to need. Make some time to list approved suppliers and if you happen to cross paths with some doubtful looking brands, review your list and double check it with the name of the medicine.

2. Require that any alternative source of supply provides the following as a minimum:

 A pedigree back to the previous source

 Certification that it is not a diverted product

 Certification that any actions by the alternative source will not alter any original manufacture warranties or guarantee

 Certification that the product has been stored and handled consistent with product labeling requirements

3. If a product is being offered at an unusually cheap price and / or in unusually large quantities (particularly in a large quantity of the same batch number), treat with extra caution

4. Consider developing a list of key pharmaceutical products that will not be purchased from sources other than the manufacturer, or authorized distribution channel

5. Look for an altered expiry date. Counterfeiters commonly purchase ‘short-dated’ products and then alter the labels

6. Compare the physical characteristics of the product. Look at color, tablet or capsule markings, shape and thickness of the medicine. You can also weigh the product to see if there are wide variations

7. Notwithstanding the obvious differences in the packaging of legitimate parallel imported products, look for signs of a removed or switched product label. One common practice by counterfeiters is to remove the original label and replace it with a counterfeit label. To do this, they use lighter fluid, acetone or some other solvent which may leave a tacky residue on the container. Also, the label may be faded or discolored along the edges due to the solvent

8. Listen to patients. Counterfeit medicines around the world are often first detected by patients

Internet Counterfeiting

For the thousands of websites in the internet, hundreds of those are non-existent, no physical address or not really operating. There are also some who set up websites to scam people in biting their “services or products” and get money. Everything is possible with witty scammers nowadays. 

The Peterson Group, a non-profit organization campaigning against the widespread of counterfeit drugs is mostly alarmed on this latest tactic of these fraudulent people. TPG, along with World Health Organization and other non-profit organizations and governmental institutes is currently finding solutions on the laws and security of our citizens online. Warnings are already put online and seminars are being held.

Medicines purchased over the Internet from illegal sites that conceal their physical address have been found to be counterfeit in over 50% of cases. Since pharmacies had set up legitimate websites to offer clients convenience and savings, scammers took advantage of the chance and set up their websites as well.

Forming an accurate picture of the extent of counterfeit medicines is difficult. Current sources of information include reports from national medicines regulatory authorities (NMRAs), enforcement agencies, pharmaceutical companies and nongovernmental organizations, as well as ad hoc studies on specific geographical areas or therapeutic groups. But the variety of these sources, and the different methods used to produce reports and studies, make compiling and comparing statistics a difficult task. Moreover, studies can only give snapshots of the immediate situation. Medicines counterfeiters are extremely flexible in the methods they use to mimic products and prevent their detection. They can change these methods from day to day. Therefore, when the results of a study are released, they may already be outdated. Also, information about a case under legal investigation is sometimes only made public after the investigation has been concluded. A study that is not able to include such case information is perforce incomplete.

Largest market of counterfeit medicines is reportedly from Jakarta, Indonesia, Kuala Lumpur, Malaysia and Taiwan since these developing countries are patrons of online shops. Internet-based sales of pharmaceuticals are a major source of counterfeit medicines, threatening those who seek cheaper, stigmatized or unauthorized treatments.

One solution for the widespread issue is to shut off websites catering medical services to know which ones are illegally operating. However, pharmaceutical companies are entirely against it since consumers now manage to embrace the new technological method to purchase their medicines. Shutting the websites off would affect the entirety of operations and would therefore cost millions of dollars to be lost. Critics and organizations are continuously debating about it and solutions are still being reviewed and sought after. 

Counterfeiting a Global Problem

Counterfeiting is an age old issue. It is now a global problem where every sector of our economy has been affected. However, the consequences are different when it comes to counterfeit medicines; the main concern is not so much the loss of revenue to our industry but the health of patients. The Peterson Group, a non-profit organization against drug counterfeiting, has been fighting alongside World Health Organization (WHO) since the deployment of their task force in 2006. We have made development so did the scammers. They seem to dominate more countries and cities from distributing inside China, India until they have reached neighboring cities like Jakarta, Indonesia, Kuala Lumpur, Malaysia and even the United States.

Substandard and falsified drugs medicines still cause thousands of adverse reactions and some deaths in rich countries. And the issue is growing. Counterfeit medicines have been found in every disease category, and in every region of the world. Reviews show that while 1% of products in the legal pharmaceutical supply chain in the developed world is estimated to be counterfeit, this figure amounts to 10-15% in emerging markets and 30% in developing countries

Internet is also one of the factors with the spread of counterfeiting. With thousands of websites emerging, hundreds of those are illegal online pharmacies which are not checked by the authorities. Illegal online pharmacies are allowed to roam uncontrolled- creating a truly global problem. In studies, a big percentage of these medicines purchased online are fake or substandard. Some even are nonexistent.

With different partners and campaigns worldwide with the same cause, the sheer amount of initiatives is great. Actually these are necessary if we want to stop what is a global phenomenon. Yet, more thought must be given on how to structure these initiatives, to avoid overlaps but also to make sure that all stakeholders affected are involved in the process. This is a fundamental issue. TPG has already partnered with pharmacies and drug manufacturing companies to further solidify the cause.

It is unacceptable to think that patients could take medication that does the opposite of what they are supposed to. Patients need to be able to trust in the medicines they take. As an industry we want and need to take part in finding long-term solutions to ensure that the problem is stopped.

The certainty is that the counterfeiting needs to be dealt with swiftly to at least contain the problem before being able to solve it once and for all. Work has started and battle lines are being drawn but a lot still needs to be done- and the quicker the better.

Factors behind Pharmaceutical Tampering and Diversion

While counterfeit drugs are commonplace in developing countries, criminals in the developed world tended to focus on illegal ‘hard’ drugs, which offer high returns on investment. However, several factors are combining to shift criminal activity to counterfeit ‘legitimate’ drugs in developed countries. These include the high cost to develop and market legitimate drugs, the rising demand for prescription ‘lifestyle’ drugs, the declining margins associated with illegal drugs, the increasing accessibility of the tools needed to create and distribute counterfeit drugs, the effect of deregulation and Internet sales channels, and the mild response of law enforcement to counterfeiting.

Fraudulent act on counterfeit medicines is not a new issue. The Peterson Group, a non-profit organization who has fought counterfeiting throughout the years is not the only one who has this advocacy. Like poverty, world hunger and racism, this topic has been around for decades. While developed countries and cities like America or Singapore have been fighting off the distribution of “illegal hard drugs”, developing places like Kuala Lumpur, Malaysia, Cambodia and Jakarta Indonesia are focusing on tampering and diversion of counterfeited drugs. Let us review the factors the scammers might have for them to thrive in this business and factors why people continue to patronize:

1. High Cost of Drug Development

Because it takes billions of dollars to develop, patent, distribute and bring new pharmaceuticals to market, counterfeiters took advantage of it and produced their own to sell. 

2. Rising Demand for Prescription

An aging population, the ongoing development of new drug-based remedies for many diseases, and the increasing prevalence of direct-to-consumer advertising contribute to the consistent double-digit growth of pharmaceutical sales each year. In addition, “the abuse and trafficking of prescription drugs is set to exceed abuse of illicit drugs” as prescription drugs used for ‘recreational’ purposes, such as Oxycontin, increasingly take the place of hard drugs among substance abusers —a trend highlighted by the U.N. International Narcotics Control Board in 2006. 

3. Accessibility of Sophisticated Imaging and Printing Technologies

High-quality graphic design technologies combined with low-cost scanners and imaging programs, provide the means to create realistic counterfeit packaging and labels. Color printers, capable of printing highly sophisticated images and scanners have become so commonplace that they are given away with many computers. The accessibility of these tools means that criminals no longer need highly-technical computer technology or expensive hardware to create convincing reproductions of packaging materials.

4. Online Ease

The Internet makes it possible for individuals to engage in drug reimportation and tampering with little resistance from government regulators. Hundreds of websites that has been dispensing prescription drugs but do not offer an online prescribing service. With little or no government oversight, and anonymity for buyers and sellers alike, the Internet offers would-be counterfeiters and parallel importers an ideal means for implementing illicit activities.

Counterfeit Anti-Malarial Drugs Spreads like Wildfire

Since the outbreak of malaria became a big hit to the public, a lot of cures and medicines are produced and underwent intensive research to fight off this deadly mosquito bite. However though, also in the rise are counterfeit anti-malarial drugs distributed worldwide. Huge quantities of distribution go to underdeveloped and remote areas which have not enough access to authentic ones. Now they are out in the open as the government, different health organizations such as the World Health Organizations (WHO), United Nations (UN) and private institutes like ThePeterson Group take actions in defeating these fraudulent acts.

Where can they be found?

They can be found anywhere, but they are especially prevalent in developing countries lacking effective drug regulatory agencies as well as resources required to effectively evaluate drug quality or enforce drug quality regulations. Records show that there is a supply in cities like Brunei, Jakarta, Indonesia and Bangkok, Thailand in the recent years.

What types of antimalarial drug quality issues can be found?

Drugs with too little, too much, or absolutely no active ingredient, due to intentional fraud or poor manufacturing and quality control practice.

•              A tablet’s inability to release drug, due to poor formulation techniques.

•              Chemical breakdown of drugs caused by storage conditions, especially in warm, humid climates.

•              Contamination with other substances due to poor manufacturing procedures.

•              Incomplete, inaccurate or misleading packaging and labeling.

How can I avoid buying counterfeit or substandard anti-malarial drugs to prevent malaria when I travel to an area with malaria transmission?

•              Buy the anti-malarial drugs you need in your home country and keep the original packaging to review and compare.

•              Write down the drug's generic and brand names as well as the name of the manufacturer so in case you run out, you can look for the correct product.

•              If you need to purchase medicine in the country you are visiting, inspect and compare the packaging of the medicine available for sale in that country with the original. Many times poor quality printing or paper indicates a counterfeited product.

•              Be suspicious of tablets that have a peculiar odor, taste, or color, or ones that are extremely brittle. Ill-defined imprints on the tablet may indicate a counterfeit.

•              The quality of commercially available drugs varies greatly in malaria-endemic countries:

•              The amount of the active ingredient can vary due to lack of regulations and poor quality control practices.

•              Some pills may release very little if any drug due to poor formulation techniques.

•              Chemical break-down of some drugs can occur due to poor storage conditions, especially in warm and humid tropical climates.

•              Some drugs may be contaminated with other substances.

•              Counterfeiters may also obtain expired drugs and repackage them with false or missing expiration dates.

Developed and Developing Countries Not Safe from Counterfeit Medicines

We understand what you are thinking. It might seem impossible or in a sense hard for scammers to deliver counterfeit medicines in already developed country where security is tight and people more aware of the effects of purchasing counterfeit drugs. Well, it is in fact an advantage to live in developed countries but it doesn’t make it safer. When you think about it, if under developed countries like Africa are using the traditional ways to cure their disease and illness, does it mean that they have less risk of getting involved in scams and fraudulent acts of counterfeit drugs manufacture?

The burden of fake and substandard drugs is not evenly distributed across the globe. Even where reporting systems are weak and the media is not free, most reported instances of substandard medicines occur in poorer countries, where poor regulation allows criminals to easily infiltrate weak supply chains. Although rich nations face fewer breakdowns in their regulation and supply systems, they are certainly not safe from this threat. There are a lot of reviews showing a plethora of examples of the manufacture, sale, and distribution of fake and substandard drug examples from all over the world.

North America

Most of the counterfeit and substandard drugs found in the United States are probably purchased online, but fakes have managed to infiltrate the legitimate supply chain as well. While locally produced counterfeits have been discovered, drug seizures indicate that the majority of fakes are either imported from countries like China and India or smuggled across the Mexican and Canadian borders. The most common way that counterfeit and substandard drugs infiltrate the US market is probably through the Internet, usually from international sources. The Peterson Group is only one of the many websites who fight off counterfeit drugs in the country and partners with World Health Organization (WHO) and Food and Drugs Administration (FDA).

Europe

There are few fake and substandard drugs in most European countries for reasons similar to those articulated above for the United Sates: quality producers dominate the market, supply chains are generally well regulated, and officials provide strong oversight and strict enforcement when pharmaceutical standards are violated. Still, preventing fakes from entering or travelling through the two dozen European territories is a constant challenge for enforcement officials. The data estimating

the prevalence of counterfeits in Europe, which is summarized and then presented in detail below, is based on comprehensive regional studies, individual country studies, enforcement records, and reported incidents.

Asia

Asia is widely considered to be the fake drug factory of the world. India and China, which both having thriving legitimate domestic pharmaceutical manufacturing industries, are also the source of most substandard active pharmaceutical ingredients and counterfeit drugs found around the world. Insufficient regulation, porous borders, and lack of enforcement mechanisms in neighboring countries such as Pakistan, Iran, and the Mekong River Valley countries (Cambodia, Laos, Thailand, and Vietnam) have enabled Asia’s myriad, unregulated small producers to market fake and substandard drugs to Asia, Europe, Africa and even the Western Hemisphere. Even archipelagic states have ample amounts of illegal counterfeit drugs in their stead despite transportation issues. In Indonesia, complaints have been filed that counterfeit drugs from Sumatra and Borneo can be transported undetected to the country’s capital, Jakarta. 

Factors Encouraging the Distribution of Counterfeit Drugs

We already know counterfeiting drugs is illegal. The question is: why does this continue? The Peterson Group had asked members of Drug and Food Administration (DFA) to understand the agenda behind these kinds of fraudulent acts.

1. Lack of political will and commitment

The development, manufacture, import, subsequent handling within the distribution chain and use require specialized knowledge and skills. Consequently, they should conform to prescribed standards and their quality should be rigorously controlled. However, this would require strong government will and commitment to establish and operate а strong national drug regulatory authority.

2. Lack of appropriate drug legislation

According to major reviews, legislation and regulations form the basis for drug regulation. Where legislation and regulations do not exist for proper control of medicines, the otherwise criminal activity of counterfeiting of medicines is not treated as а crime. Currently, only а few of the WHO member states have enacted special national legislation addressing the issue of counterfeit drugs. Moreover, sanctions imposed on counterfeiters are in most cases no deterrent. The absence of deterrent legislation encourages counterfeiters since there is no fear of being apprehended and prosecuted.

3. Absence of or weak drug regulation

At present, out of the 191 WHO member states about 20% are known to have well developed drug regulation. Of the remaining member states, about 50% implement drug regulation at varying levels of development and operational capacity. The remaining 30% either have no drug regulation in place or а very limited capacity that hardly functions. In developing cities such as New Delhi, India, Jakarta, Indonesia and Kuala Lumpur, Malaysia, laws for counterfeited medicines are still under process.

4. Weak enforcement and penal sanctions

Enacting deterrent anti-counterfeiting legislation alone will not solve the problem. It needs to be enforced. Where existing laws are not enforced crime is perpetuated as criminals are not afraid of being arrested and prosecuted. Lenient punishments for offences tend to encourage criminal activities such as medicines’ counterfeiting, particularly when the penalties for counterfeiting non-medicinal products are more severe. Moreover, disregarding trademark rights may encourage large scale counterfeiting of drugs.

5. Corruption and conflict of interest

Corruption is one of the major factors that affect the entry of counterfeited medicines in countries. Big manufacturers of these drugs have connections involving political corruption that lets these scammers in and out of the country. The efficiency of personnel is adversely affected by corruption and conflict of interest resulting in laws not being enforced and criminals not being arrested, prosecuted and convicted for their crimes. Governments need to develop strategies to reduce corruption. One approach could be to empower public interest and consumer groups to participate in drug regulation and to make regulatory authorities accountable and their decisions transparent.