Counterfeit Medications: Impurities in the American Drug Supply

Abstract

The World Health Organization defines counterfeit medication as "one which has been deliberately and fraudulently mislabeled with respect to the identity and/or the source. Counterfeiting can apply to both branded and generic products and may include products with the correct ingredients or the wrong ingredients, without active ingredients, with insufficient active ingredients, or fake packaging." 1 Counterfeit medications have become more common in the last decade and, with this, so has the need for health care workers to stay informed about this threat.It is impossible to know exactly how many medications are counterfeit. The Centers for Disease Control and Prevention has estimated that the percentage varies from approximately 1% to 10% in developed countries and could be as high as 30% in countries in Africa, Asia, and Latin America. 2 Commonly counterfeited drugs include antibiotics, antimalarials, hormones, and steroids. 3 Counterfeit medications can lead to resistant bacteria, treatment failure, or death. They may contain insufficient amounts of active ingredients or may contain the proper ingredients but may not have been properly stored and/or shipped. Some medications are delicate and can easily degrade when exposed to varying temperatures or light or when shaken. This can result in a product that may be below needed potency or altogether ineffective. Some counterfeit medications have even been shown to contain toxic ingredients such as lead-based paint. For example, 3 pregnant Argentinean women were treated for anemia with a counterfeit injectable iron product. Two of the women died after being exposed to the toxic ingredients contained in the counterfeit iron. The third woman survived but gave birth prematurely at 26 weeks' gestation. 4 Because of the risks posed by counterfeit medications, it is imperative that midwives and other health care providers stay informed about counterfeit medications so they can help protect women from an increasingly tainted drug supply.

Оцінка Ефективності Боротьби З Фальсифікацією Лікарських Засобів В Україні: Погляд Фахівців Аптечних Закладів

“…Each of these Chapter 1: Introduction to the Research Project scenarios could lead to treatment failure, illness and even death. A significant amount of evidence is available to confirm the risk to the public of counterfeit medicines (10)(11)(12)(13)(14)(15)(16)(17).…”

“…of the medicines circulated in the EU, and may be as high as 15% (23). Furthermore, the Centres for Disease Control and Prevention (USA) has estimated the percentage of counterfeit medicines in the developed world is between 1% and 10%, and could be 30% in countries in Africa, Asia and Latin America (14). In Southeast Asia, 53% of anti-malarial medicines are estimated to be counterfeited.…”

“…For instance, when a cancer patient needs a precise concentration of medicine to counter the side-effects of chemotherapy, if that patient is not administered the correct dose, he or she could die (10). The third effect of counterfeit medicines is when counterfeiters add materials (that might be toxic) to a counterfeit medicine, merely to make it look like the genuine article; they may use polluted water, toxic yellow road paint, floor wax and boric acid (which is used to kill cockroaches) (14,17).…”

“…(1.95%) actually sold prescription drug products, and that of those 1,009 websites, only 214 were registered to a Canadian entity (11). A study conducted by the US FDA in 2005 found that 85% of online pharmacies claiming to be Canadian in origin actually were from other countries (14).…”

Running in Place: The Challenge of Prescribing Medications Today

“…Direct‐to‐consumer advertising has women asking for specific brand name drugs that may or may not be appropriate. Counterfeit drugs are slowly infiltrating even the largest pharmacies 14 . Agents previously considered relatively innocuous (eg, pseudoephedrine) are manipulated in home laboratories to become agents of abuse, necessitating a new behind‐the‐counter category for a previously over‐the‐counter drug.…”