According to the CDC, counterfeit medicines are manufactured with incorrect or dangerous ingredients while still packaged and labeled to look like the real medicine. While counterfeit drugs have been widely understood for a while, there has been an increase in the production of counterfeit drugs that could cause harm. Over the years, counterfeit medicines have become a problem in the United States and more so internationally. While counterfeit medicines only make up about 1% in industrialized nations, the medicines make up 10-30% of medicines in the developing countries and are on the steady rise. For example, according to a WHO study, approximately half of counterfeit medicine cases came from the Western Pacific region which is a cause for concern due to the health and economic impacts.
While the harms of counterfeit medications impact people on a global scale regardless of wealth, age, gender, and race, the dangers of counterfeit medicine distribution continues to rise. For example, according to Mackey, et. al, Pharmaceutical Security Institute data showed that while pharmaceutical thefts only increased 66%, counterfeit incidents increased 122% from the years 2005 to 2010.
Common targets for counterfeit medication include chemotherapeutic drugs, antibiotics, weight loss supplements because legitimate medications are high-priced and in high demand. Due to this, consumers who unintentionally buy these medications expose themselves to potentially life-threatening conditions. Generally, counterfeit medications have two ways of harming consumers. The first being that the medication had no active ingredients which may leave the patient untreated of their condition. The second being that active ingredients in the drug were replaced by toxic ingredients. For example, according to the World Health Organization, in 2008, 150 people in Singapore were admitted to a hospital for having a sharp drop in blood-sugar level resulting in four deaths and seven severe brain damages. These people reportedly took counterfeit copies of drugs that contained large amounts of glyburide which is commonly used to treat diabetes.
Currently, counterfeit medications originate most frequently from India, Egypt, and China, with an estimated 75% of counterfeit drugs originating from India.
Counterfeit Cancer Medication in China Case Study:
The counterfeit cancer trade is steadily increasing due to the high profits that criminals can make from producing the fake drugs because drugs for cancer may cost upwards of $2,400. The Chinese pharmaceutical industry has been hit particularly hard by counterfeit cancer medications. The biggest case involved a counterfeit cancer drug similar to Avastin. However, the patients who took the drug, thinking it would help them, had an eye infection as a side effect from the counterfeit. The counterfeiters were able to do this so easily because they “collected empty vials of a cancer medication from the hospital’s trash and filled the vials with chemicals and water”. After creating the vials, the counterfeiters shipped them to the Middle East before reaching UK suppliers. After, online retailers bought the low cost fake cancer treatments and shipped them to the United States. The reason they were able to enter the US is because the UK supplier falsified customs declarations in order to allow the drugs to enter the United States. Because of its low cost, the fake medication was able to penetrate the US pharmaceutical market as US physicians started prescribing the fake cancer medication to patients. Unfortunately, the FDA’s ability to intervene was hindered because of the different chains the medicines went through before arriving in the United States.
In order to combat the importing of counterfeit medications, the solution should start at the root of the problem. In the case of the counterfeit cancer medications from China, vulnerabilities in hospital security led to the stolen vials. In order to stop this phenomenon, there should be a level of security in order to prevent counterfeiters from stealing the vials and making fake drugs. Through transports, there should be stricter customs laws that prevent distributors from faking the customs forms in order to import the drugs into the United States. While the World Health Organization set guidelines in order to combat counterfeit drugs, there are no strict regulations and rules to implement the guidelines. In addition, law enforcement should have harsher punishments for the criminals. As of right now, those who are convicted of making and distributing counterfeit drugs, they are sentenced to very little jail time with a chance of early release. If there were stricter sentences, counterfeiters would have to think twice before producing drugs that could harm the consumers. In addition, technology should be used to ensure that the drugs that are being distributed are legit and not counterfeited. Additionally, technologies such as holograms, color-shifting inks, and embedded codes, images, and dyes could prevent consumers from being harmed by unknowingly ingesting counterfeited drugs. Lastly, the main way that counterfeit medicines are getting into the hands of consumers are through online pharmacies. Especially during the rise of telehealth, there should be more regulation and monitoring to ensure that the drugs that are being imported are approved by the local administration and ensure the safety and quality of the drug.
Xeplion Recall in Denmark Case Study:
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In Europe, counterfeit medicine has become a growing threat, capable of causing both serious illness and even death while costing the pharmaceutical industry billions annually. Over the years, producers of such counterfeit medications have started to produce an increasingly diverse range of medicines, from drugs to treat serious illnesses such as cancer to anabolic steroids to over the counter products like birth control pills, according to an Europol report. These counterfeit medicines are often made in unhygienic laboratories and have the potential to contain the wrong active ingredient, inaccurate amounts of active ingredients, no active ingredient, or even traces of other toxic substances such as rat poison.
In many cases, illegal medicines are imported illegally by gangs from countries outside of the EU, such as China, before repackaging and distributing them for sale across Europe. They make their ways to the hands of consumers through unauthorised and unregulated online pharmacies and even social media pages. The continuous expansion of these unauthorised and unregulated online pharmacies are a growing threat. Counterfeiters market these medications by capitalizing on the increasing self-medication trend as well as consumer demand for access to cheaper medicines. In other cases, counterfeiters employ their own skilled workers and set up their own production lines as this illegal activity becomes more sophisticated. According to a report by the European Union Intellectual Property Office, counterfeit medicines cost the EU pharmaceutical sector EUR 10.2 billion each year and the loss of 37 700 jobs. One of the most notorious examples of counterfeit drugs in the EU is the Xeplion recall in Denmark.
Schizophrenia is a psychiatric disorder that is characterized by episodes or psychosis, often including hallucinations, delusions, and disorganized speech and thinking. It is less prevalent than other mental health disorders, affecting about 0.3% to 0.7% of people during their lifetime. However, this is not to say that the numbers are small. According to the World Health Organization, an estimated 20 million people were diagnosed with schizophrenia worldwide in 2019.
Antipsychotic medications are the primary form of treatment for schizophrenia and are often used in combination with psychosocial interventions and social support. While antipsychotics can reduce some symptoms, such as anxiety, within hours of their use, it can take days or weeks for the medication to reach its effect on other symptoms. One example of an antipsychotic in the category of atypical antipsychotics is Paliperidone. Xeplion is the prolonged-release injectable form of paliperidone that is marketed in Europe, while the same product is marketed as Invega Sustenna in the United States. According to the European Medicines Agency, xeplion is used for the maintenance treatment of schizophrenia in adults who are already stabilized by treatment with paliperidone or risperidone, another type of antipsychotic.
In 2017, a large recall of xeplion was announced by the Danish Medicines Agency. According to the report, the xeplion recall in Denmark started when Haemato Pharm, a parallel importer, found counterfeit packs in a batch of Xeplion 150 mg in Germany. At least three other batches of Xeplion 150 mg were found in Denmark and withdrawn from wholesale distributors, hospitals and pharmacies. Many Danish parallel importers including Abacus Medicine, Paranova Danmark, and Orifarm found counterfeit packs in their stocks.
Janssen Pharmaceutica, a pharmaceutical company headquartered in Belgium and owned by Johnson & Johnson, examined the counterfeit packs and found that they contained the correct active ingredient in appropriate quantities. This allowed the Danish Medicines Agency to suggest that there was likely a low risk for patients who may already have been injected with the medication before being recalled. However, since these packs came from outside of the legal chain, they were not able to rule out that the medications could have been improperly stored.
What makes it difficult for prescription drugs in the EU to be tightly regulated is that drug wholesalers operate across dozens of EU member states. Because the EU authorizes parallel trade, a cross-border trade made among member states, there is often very little oversight which introduces some security concerns. That is, any weakness in the regulatory structure of any EU member state could allow for a point-of-entry for counterfeit medications to enter the EU drug supply chain. A serious threat occurs when this illegal activity propagates into the global drug supply chain.
According to an article published by The Hill, Other examples of counterfeit medications found in the EU during this time include a counterfeit cancer drug (Votrient) discovered in Germany, a different cancer drug (Avastin) discovered in Cyprus, and human growth hormone (Omnitrope) discovered in France and Denmark. To disrupt the online sales of counterfeit medications, Operation Pangea was put into effect by INTERPOL. Operation Pangea also raises awareness of the serious risks and consequences of purchasing medicines from unregulated websites, citing warning signs such as suspiciously low prices, spelling mistakes, and demands for payments to be made in cryptocurrencies. According to the report, Operation Pangea has confiscated over 105 million units of counterfeit medications and made over 3000 arrests since its launch in 2008.
Operation Pangea XIII was conducted in March 2020 with over 90 participating countries. The global COVID-19 pandemic led to a rise in counterfeit medical products such as counterfeit facemasks, hand sanitizers, and unauthorized COVID-19 “vaccines” as criminals took advantage of the high market demand for personal protective equipment and sanitizing products. According to the INTERPOL’s report, they seized 4.4 million units valued at 14 million USD, made 121 arrests and took down more than 2500 websites selling these illegal goods.
“The illicit trade in such counterfeit medical items during a public health crisis shows their total disregard for people’s wellbeing, or their lives,” said Jürgen Stock, INTERPOL’s Secretary General.
Counterfeit Antimalarial Drugs in Nigeria Case Study:
Malaria is a life-threatening disease that, despite being perfectly preventable and curable, continues to take numerous lives worldwide. According to the World Malaria Report released by the World Health Organization in December 2019, 228 million global malaria cases and 405,000 global malaria deaths occurred in 2018. According to the report, the African region contributed to 93% of malaria cases and 94% of malaria deaths. Alarmingly, six countries in particular (Nigeria, Democratic Republic of Congo, Uganda, Côte D’Ivoire, Mozambique, and Niger) accounted for more than half of all global malaria cases worldwide. Of the six countries burdened most heavily by malaria, Nigeria accounted for half of malaria incidence.
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Although known, the effects of the counterfeit drug trade on Nigeria have been largely ignored and underestimated. However, when analyzing factors leading to the persistence of malaria’s virulence in Nigeria, fake and substandard medications clearly emerged as one of the most significant public health issues regarding malaria treatment. Globally, around 200,000 preventable deaths occur as a result of faulty antimalarial medication. According to recent studies, 19.1% of antimalarial drugs tested in low and middle income countries, including Nigeria, were substandard or falsified. An estimated 12,300 deaths are caused by fake antimalarial drugs each year in Nigeria.
What makes antimalarial medication in Nigeria an especially easy target has to do with the usage of artemisinin derivatives. In 2001 the WHO recommended that malaria- endemic countries use artemisinin- derivatives, based of combination therapy (ACT) as first line treatment for malaria. Artemisinin-derivatives are especially vulnerable to counterfeiting because they are mainly produced in India and China which, unfortunately, are responsible for majority of counterfeit medication production. This, in combination with the fact that ACT courses are expensive and in shortage, yields for an attractive market for criminals in the counterfeit trade. Another major contributing factor to large counterfeit medication circulation in Nigeria is the continued presence of open drug markets that are widely unregulated. As a result of these unregulated open drug markets, counterfeits have an increased opportunity to enter legitimate supply chains, thereby making the problem even harder to combat for Nigeria.
Counterfeit medications can be extremely detrimental to patients’ physical and financial wellbeing. Counterfeit antimalarial drugs are often produced with quantities of artemisinin-derivatives that are too low for therapeutic purposes or contain dangerous substances such as metamizole, melamine, or safrole. Financially, counterfeits can cripple a patient’s life due to high expenditure. Patients who unwittingly purchase ineffective or fake antimalarial drugs will have to pay out of pocket for not only the substandard medication but also additional courses of treatment of antimalarial drugs or drugs to mitigate side effects from fake drugs. To a low income family that can barely afford one course of treatment, the cost of several courses of treatment can be potentially ruinous.
On a national level, Nigeria is forced to handle increased health expenditure due to the adverse effects of counterfeit medication on patients and also is forced to combat dangerous criminal organizations with extensive resources. Poor quality antimalarial drugs alone costed Nigeria an estimated $890 million. Unfortunately, this estimate is only expected to continue to grow as resistance to antimalarial drugs increases because of increased exposure to counterfeit drugs that inadvertently promote drug resistance as opposed to treatment. According to a recent study, an increase in resistance could increase the economic burden of malaria by 11%. Besides its perverse effects on Nigeria’s economy, the counterfeit trade has forced Nigeria to engage with criminal organizations. As an example of the negative consequences of directly combatting criminal organizations, Dr. Dora Akunyili, the former Director-General of the National Agency for Food and Drug Administration and Control for Nigeria was targeted by a drug gang producing and dispersing counterfeit medications because of her direct efforts to put them out of business.
Tackling the problem is difficult for a myriad of reasons but Nigeria is still committed to reducing and potentially eliminating the circulation of counterfeit medications. Nigeria is working to improve drug regulations and surveillance of ACT courses. Moving forward, many say that the dismantling of Nigeria’s open drug market will allow for the circulation of counterfeit drugs to drastically decrease. Elimination of the problem will be difficult but is certainly possible for Nigeria.
Significance and Next Steps
Of the one million lives lost annually to counterfeiting, three-fourths of the deaths are due to counterfeit vaccines. With the rollout of the COVID-19 vaccines against the novel coronavirus, the need for effective counterfeiting solutions is needed now more than ever.
As of now, anti-counterfeiting solutions fail either technically or conceptually. One of the most popular ways of combatting counterfeiting in the supply chain is through blockchain technology. Although technically advanced, blockchain technology fails conceptually as most retailers that are selling counterfeit medications are knowingly complicit in the counterfeit drug trade as profits are significantly higher and the risk of being caught is relatively low due to poor regulations. Another popular way of combatting counterfeiting is through end-user authentication. Currently, end-user authentication is done by hologram labels or hotlines. Both fail technically as they are too easy for counterfeiters to counterfeit.
Although the anti-counterfeiting landscape seems grim, more attention and concern is being given to the problem. The issue and its magnitude are better understood and as a result, more and more companies and governments are investing resources into finding effective solutions and regulations. Although not currently on the market, there are promising emerging solutions that are sure to leave a significant impact on the counterfeit drug trade and hopefully save millions of lives a year.