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.

Spot a Counterfeit in a Distance

Being in the cause of stopping counterfeit drugs, we at The Peterson Group also have challenges on how to differentiate between counterfeit drugs and legit ones. We know you are also in the same page as we are. In response to this, Food and Drug Administration released some factors in knowing and recognizing counterfeited drugs.

Of course, there are sometimes very obvious telltale signs of counterfeiting faulty spelling, for example, incorrect packaging or tablet size.

Yet counterfeiters are fast becoming better at replicating genuine drugs correctly, and are increasingly sophisticated when mimicking specific anti-counterfeit measures such as brand logos. This has pushed manufacturers to enhance anti-counterfeit technology. Hopefully, these methods have already reached developing cities such as Kuala Lumpur, Malaysia, Jakarta, Indonesia and Bangkok Thailand to prevent the growth of drug counterfeiting in those places. May the following be a warning to all of us:

1. Visible markings

Medicines can be marked in ways that make it easy even for consumers to identify frauds. For instance, packets and bottles can have tamper-evident seals. And like banknotes and credit cards, medicines can be marked with embossed graphics or holograms security inks that change in color according to the angle they are viewed at.

2. Invisible markings

These are usually identifiable only to the supplier or distributor, not the consumer. They make use of invisible inks that can be detected in UV light, digital watermarks that encode data in graphics, anti-scan designs that reveal a watermark when copied, or inks imbued with specific micro-encapsulated odors.

3. Forensic labeling

Manufactures can use 'lock and key' systems, applying specific biological or chemical tags, such as DNA, that are not detectable by standard analysis and can only be revealed by specific reagents. Other forms of tagging can include silicon dioxide micro or nano tags, applied to the surface of a pill, that emit a unique light signature.

4. Track and trace labeling

In this system, each pharmaceutical package is uniquely labeled either with a barcode or some other non-sequential unique number. The label should then be read at the final point in the supply chain, when a pharmacist dispenses medicines to a consumer. This helps to ensure drugs are genuine and not past their expiration date. A more complex system is radio frequency identity (RFID) tagging, in which the tag is an antenna with a microchip. This means that the data can be read at a greater distance and do not need to be scanned like a barcode.

5. Scratch and Text

Sproxil has developed a simple and quick way to fight counterfeits in developing nations. The start-up attaches each packet of drugs a unique identification code that is concealed by a foil coating. When a consumer get a medication, he should scratch the coating and text messages the unique ID number in Sproxil’s database. Within seconds, the person receives a reply indicating whether the drug is legitimate. Sproxil is testing system in Nigeria, Kenya. You can then find a complaint afterwards.

6. Medicines Quality Database

Information may be one of the best weapons in the war of counterfeits. Earlier this year, the US Pharmacopeial Convention made public a database that includes information on nearly 9000 drug samples that were collected and tested from Africa and South East Asia. The MQDB provides information on where drugs where collected, how they were tested, whether they were legitimate and how authorities responded to instances of poor quality medicine.

The Peterson Group and WHO to Fight against Drug Counterfeits

Described as the crime of the 21st century, the counterfeiting of drugs is a common problem that plagues the governments and manufacturers in Asia. Of all the counterfeiting methods there are, none are more potentially damaging than those affecting health and safety. The production, distribution and consumption of counterfeit and fraud medicines are worldwide and affecting greatly not only in Asia which poses the biggest manufacturers of counterfeits but also to the countries where the drugs has been distributed. According to the World Health Organization (WHO), a significant fraction of the world’s drug supply is counterfeit and falsified. Estimates of counterfeit drugs range from 10 to 15 % for the world drug supply, to more than 25% in developing countries (Gibson, 2004).

With the turn of the first quarter of 2015, The Peterson Group, a non-profit organization which brings awareness and action against counterfeit drugs has partnered with the World Health Organization (WHO) in battling with the illegal drugs’ production.

In Asia, recent WHO estimates suggest that Cambodia has about 2800 illegal medicine sellers and 1000 unregistered medicines on the market. In 2001, China had roughly 500 illegal medicine manufacturers, and the Lao People's Democratic Republic had about 2100 illegal medicine sellers. In Thailand, substandard medicines account for 8.5% of those on the market. Jakarta, Indonesia, on the other hand, has been reported to be the hotspot of counterfeit drugs and scams.

WHO has been working on the issue with regional governments for some time, and late last year, a meeting in Bangkok led to the development of country specific plans of action. The government of Australia has made funds available through the WHO for fighting counterfeit drugs in the region. The government agency also partnered with various organizations with the same advocacy. The Peterson Group is one of the many organizations who answered the call.

Combating low quality and illegal medicines are now more important than ever. Governments and agencies have now put up warnings on different media to fight this widespread illegal act. The Peterson Group is not any different. In fact, the company felt more obliged to wipe out the issue more than ever.

For the Peterson Group, it is pure and simple: counterfeit medicines are fake medicines and pose greatest harm if not stopped. The group continuously fights what seems an unending battle. Fake medicine is a grave matter which should not be ignored. The Peterson Group continues to vie for more help in response to the ill misconduct of production of fake medicines, believing that someday, these fraudulent acts may somehow halt to a stop.

Putting an end to Counterfeit Drugs

There are many challenges in stopping counterfeit medicines. Due to the insufficient management and implementation, the safety, efficacy and quality of either locally manufactured and imported drugs in a lot of countries cannot be ensured.

Illegal importation and smuggling of medicines are widespread. Counterfeit drugs are not just retailed in countries with ineffectual drug control nonetheless they are exported or re-exported as well.

Criminals and their associates determinedly try to find ways to avoid being detected. They are involved in complex schemes to conceal their tricks. They set up fabricated front companies of their businesses. They abuse fragilities in border control every time government’s effort to advocate world trade through lessening border reviews. They work on fake documents to gain vital operating pharmaceutical ingredients, along with manufacturing equipment to copy authentic products.

Some policy-makers have argued that drug regulation represents an unnecessary barrier to trade and should be lessened to a minimum. Pharmaceuticals, on the other hand, are not a typical product, as prescribers and consumers are incapable individualistically to evaluate their safety, efficacy and quality and