A preliminary report warns of potentially serious threats to the legitimate US
drug supply chain of counterfeit and substandard
drugs, say the FDA (Food and Drug Administration), NABP (National Association of Boards of Pharmacy) and some pharmaceutical companies. The FDA warns of serious risks and vulnerabilities in the drug supply chain in the USA.
The FDA wrote yesterday:
"Review revealed various schemes and examples of the types of players in the supply chain, how different products enter the supply chain, and how fraudulent or diverted products were discovered. Having a better understanding of these characteristics will help [FDA] to identify potential vulnerabilities."
The FDA report, titled
"Preliminary Review of Agency`s Diversion and Counterfeit Criminal Case Information", gives examples, including:Products being stopped at the borderSome diversion schemes specifically aimed at the system`s vulnerabilities to the supply chainInvolvement of unscrupulous wholesale distributorsOne example of a diversion scheme in which a pharmacists and a pharmacist sold diverted drug samplesThe FDA says that its report is a preliminary one, of..:
"..OCI case information and does not contain statistical inferences, future trend predictions or opinions. FDA expects to conduct further analysis and report as appropriate."
In its report, the FDA claims the USA, with its strict regulatory framework governing medication distribution and production, has one of the safest legitimate drug distribution systems worldwide. It adds, however, that the Agency is concerned about the country`s drug supply and its growing vulnerability to a range of illegal activities that could seriously undermine public
health if they are not addressed properly and promptly. Illegal activities range from making fake drugs to the stealing of legitimate medications.
If legitimate drugs are diverted, it is no longer possible to guarantee their safety and efficacy when they re-enter the legitimate supply chain. Counterfeit drugs, many with no proper active ingredients, inappropriate dosages, and sometimes potentially harmful ingredients, also have the potential to seriously impact on public health.
The following factors have forced the FDA to re-evaluate its approach to global supply-chain safety:Complex international supply chainsRegulated products being sourced and manufactured abroadThe increased volume of imported productsThe increased complexity of imported productsIn order to protect public health, the FDA urgently needs to find ways to tighten up security of the drug supply chain for its consuming citizens. The FDA stresses that intentional acts to illegally take advantage of the drug supply chain can occur anywhere in the drug life cycle, from its manufacture through to final distribution. The adulteration, diversion or counterfeiting of pharmaceutical ingredients to inactive "excipients" are real current threats.
Even though drug counterfeiting is rare in the US drug distribution system, it has been a progressively growing problem over the last decade. Drugs are being produced illegally - either with inactive or harmful ingredients, they are being stolen, and replaced with lower dosages or cheaper illegally-produced alternatives. The FDA adds that criminals involved in these activities are becoming more sophisticated in their movements. The Agency gives the examples of diethylene glycol for glycerin in elixirs, and the use of allergenic compounds in heparin.
Some experts and patients groups comment that the USA, with the most expensive prescription drugs in the world, is logically going to have groups trying to offer cheaper alternatives. In a country where millions of people cannot afford to fill their prescriptions, under the current system demand for such products will remain large.
Written by Christian Nordqvist
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Medical News Today
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