Counterfeit Drugs: The Silent Epidemic | Do No Harm – May 27, 2012 – by Do No Harm Inc.
As much as 15% of medicines in the world are counterfeit thus causing 100,000 deaths worldwide according to the WHO. The increase of counterfeit drugs across the world in the last decade is both a consequence and a symptom of one phenomenon: the globalization of drugs production and distribution. The supply chain of medicines has become increasingly fragmented and scattered across the globe with raw material extraction taking place in one country and ingredients synthesis and formulation in another country. This globalized supply chain has two implications:
It makes the counterfeit drugs problem not an exclusivity of developing countries: developed countries are as much exposed to this risk as least developed countries.
If the problem is global, the solution has to be global too. As long as pharmaceutical companies source their active pharmaceuticals ingredients (APIs) in other countries any regulation which is purely domestic is bound to be ineffective.
The Real Impact of Counterfeit Medications – June 19, 2014 – US Pharm. 2014;39(6)(Generic Drug Review suppl):44-46.
Counterfeit drugs have been defined as products deliberately and fraudulently produced and/or mislabeled with respect to identity and/or source to make it appear to be a genuine product.1-4
Counterfeit medications include drugs that contain
- no active pharmaceutical ingredient (API),
- an incorrect amount of API,
- an inferior-quality API,
- a wrong API,
- contaminants, or
- repackaged expired products.
Some counterfeit medications may even be incorrectly formulated and produced in substandard conditions.
Counterfeiting can apply to both branded pharmaceuticals and their less expensive generic counterparts.
In fact, generic drugs are sometimes confused with counterfeit medications, which may pose an obstacle to the widespread use and acceptance of generic medications. This may create a particular challenge for pharmaceutical industries in places such as India, Europe, and Japan—countries in which generic drugs are manufactured.
Moreover, any impact on generic-drug use is potentially far-reaching. It is estimated that half of all prescriptions in the United States, for example, are now filled with approved generic drugs, with expenditures estimated in the billions.
Counterfeit Drugs: A Global Problem
For years, the number of counterfeit medications that have made their way into trusted pharmacies and subsequently to patients’ medicine cabinets has been on the rise.
Imagine the scenario in which a patient takes a medication for a life-threatening illness, only to become aware later that the doses contained no APIs. It is estimated that this misfortune has occurred with thousands of people worldwide and continues to happen.
Since the crimes of producing and selling counterfeit drugs generally become known only when the perpetrators are caught, any accurate determination of prevalence is difficult. The World Health Organization (WHO) has estimated that 10% of global pharmaceutical commerce, or $21 billion worth, involves counterfeit drugs.
Drug counterfeiting, although not a new phenomenon, has provoked greater concern because it has become so widespread in recent years
A WHO study revealed that nearly one-half (48.7%) of the documented cases of drug counterfeiting were reported in developing countries of the Western Pacific (China, the Philippines, and Vietnam), followed by developing countries grouped within WHO’s Regional Office for Africa, with 18.7%.
The industrialized areas of WHO’s Regional Office for Europe came in third, with 13.6% of reported cases. It is estimated that approximately 1% of counterfeit medications are sold in the U.S, but the numbers are increasing annually.
Most U.S. counterfeit medications are purchased online; however, others have infiltrated legitimate supply chains.
Drugs Most Often Counterfeited
High-demand, expensive medications such as various chemotherapeutic drugs, antibiotics, vaccines, erectile dysfunction drugs, weight loss aids, hormones, analgesics, steroids, antihistamines, antivirals, and antianxiety drugs are common counterfeiting targets.
Among those deceived into buying counterfeit drugs are consumers who use medicines inappropriately or who seek to purchase medications at discounted prices. In addition to being very cheap to make, counterfeit medicines often closely resemble actual medications, with nearly identical labels and tablets, thus duping unsuspecting pharmacists and patients
It has been reported that oftentimes drug counterfeiters use cheap and sometimes harmful materials such as brick dust, sheetrock, and flour to create their bogus tablets.
Pfizer reported discovering 14 of its counterfeited pharmaceutical products in at least 36 countries, including the U.S., in the first 9 months of 2009 and reportedly seized more than 11 million counterfeit tablets, capsules, and vials that year.
Also in 2009, a U.S. government crackdown uncovered some 800 packages of counterfeit medications, including Viagra (sildenafil citrate), Vicodin (hydrocodone bitartrate and acetaminophen), and Claritin (loratadine).
Mui and Ylan state that some of the drugs had as much as three times the amount of API than is typically prescribed, while others contained no API at all or harmful substances.
Internet Sites the Largest Suppliers
Thousands of websites openly sell unapproved and/or counterfeit drugs, as well as prescription drugs without requiring a valid prescription, all in violation of federal and state laws.
Many of these sites are hosted by U.S. registrars, accept payment by U.S. payment processors, and ship their products via U.S.-based express courier companies or the U.S. Postal Service (USPS)
Counterfeit Drugs: A Public Health Concern
Counterfeiting drugs is not only illegal, but it is also a major public health concern. Counterfeit drugs often contain the correct ingredients in incorrect quantities; however, they may also contain either a wrong API—which may even be toxic—or no active substance at all
Many anticounterfeiting technologies are being utilized by pharmaceutical companies to ensure distribution of the authentic product from the manufacturing site to the pharmacy.
Among these technologies used by pharmaceutical manufacturers are holograms, color-shifting inks, and embedded codes, images, and dyes. These anticounterfeiting features allow pharmacists to identify suspicious medications as possible counterfeits.
According to the Pharmaceutical Research and Manufacturers of America, consumers who purchase medications online should avoid the following:
- sites that are located outside of the U.S. that do not indicate any physical address;
- sites that do not have a license by the relevant State Boards of Pharmacy;
- sites without a licensed pharmacist to answer questions; and
- websites that do not require a prescription.
Consumers who wish to purchase drugs over the Internet should look for websites that have the Verified Internet Pharmacy Practice Sites seal.
These sites, which are created by the National Association of Boards of Pharmacy, are licensed pharmacies selling FDA-approved medications to discourage the sale of counterfeit drugs from illegitimate online sources