Posts Tagged ‘drug safety’

Patient safety is the concern of every doctor, nurse, and pharmacist working in medicine today, reminded Founder of Partnership of Safe Medicines India, Bejon Misra. Counterfeit drugs impact patient safety, particularly in places where the drug supply chain is compromised.

In 2011, when asked what safe medicines meant to him, he responded simply, “Saving millions of lives.“

In the global fight to combat counterfeit drug crime, simple SMS technology is leading the charge for patient safety. 

A simple and low-cost solution to drug verification problems for patients, SMS text verification empowers consumers to protect themselves from counterfeit drugs by sending a numeric code from their drug packaging from their phone for free verification.  We’ll be discussing this and other technological innovations in the counterfeit drug fight at the 2012 Interchange on September 28, 2012.

The MHRA has announced that three men have been sentenced to 89 weeks imprisonment for laundering $400,000 generated by a fake online pharmacy selling counterfeit medicines.

The men were prosecuted as part of a wider investigation.  From 2004 to 2009 they were laundering profits from a criminal online pharmacy website based in Cyprus.  Says the MHRA, “The business was run by a UK criminal who set up a number of illegal online pharmacy businesses selling counterfeit and powerful prescription-only medicines from outside of the UK.”

The MHRA has been on a tear of prosecutions against illegal online pharmacies and counterfeit medicine and medical device sellers.  In early 2012, the MHRA let FDA agents know they suspected counterfeit cancer medications were being passed into the U.S.  They also prosecuted UK-based counterfeit drug distributor Peter Gillespie in 2011, who was working closely with Kevin Xu, convicted in the US for manufacturing and distributing counterfeit medications in 2010.

MHRA Director of Inspection, Enforcement and Standards, Gerald Heddell, will be speaking at the 2012 Interchange on September 28.  The Interchange, at the National Press Club, in Washington, DC, is a full day conference of policymakers, pharmaceutical manufacturers, patient advocates, law enforcement, healthcare professionals, and anti-counterfeiting companies discussing the safety, health, and legal issues of counterfeit medications. Learn about the most recent criminal cases involving the MHRA and others at the 2012 Interchange.

MHRA agents made test purchases of counterfeit medicines to establish a link to the criminal enterprise, and then financial investigators traced over $1.5 million in three years from the websites’ UK bank account to a bank account in Cyprus. 

The impact that online counterfeit drug sales have on patients’ health is real, remarked Nimo Ahmed, Acting Head of Enforcement at MHRA. 

“This case highlights the criminality of the people who continue to put profit before patient’s health. These illegal pharmacy websites selling medicines bought from illegitimate sources pose a real threat to people’s health because they simply don’t know what they are getting.”

However, not all internet pharmacies are specious.  Online pharmacies that have the Verified Internet Pharmacy Practice Seal (VIPPS) are safe sources for the convenience and cost savings of online shopping, without the risks of potential counterfeit medications.

On September 10th, 2012, the India Office of the Partnership for Safe Medicines is organizing a Patient Safety and Drug Detection Technology Workshop in New Delhi, India.  Working with the Government of India, the workshop builds upon a September 2011 APEC Drug Safety and Detection Technology seminar held in Beijing.   The workshop’s objectives are…

H.R. 3668, the Counterfeit Drug Penalty Enhancement Act, was approved by the House of Representatives on June 18, 2012.  Sponsored by Representatives Patrick Meehan (R-Pa.), Tom Marino (R-Pa.), and Linda T. Sánchez (D-Calif.), the House bill has stiffer penalties for drug counterfeiters than the Senate approved version. Reports Bloomberg BNA, the House version of the bill…

FDA Commissioner Dr. Margaret Hamburg seeks stronger penalties to fight counterfeit drug trafficking, saying, “We need legal authorities to give teeth to our action. We are increasingly concerned that this is becoming an attractive area for bad guys, including organized crime,” reported The Financial Times. Dr. Hamburg told the Financial Times that current penalties for…

World Health Organization (WHO) representative Michael O’Leary has announced that China now has five anti-malaria drugs that have met WHO standards for prequalification. China Daily reports that a study released in January 2012 by the Wellcome Trust cites Chinese manufacturers as a major source of counterfeit anti-malaria drugs in Asia and Africa.   Head researcher…

The Food and Drug Administration has sent warning letters to more than 50 U.S. doctors and medical clinics that may have purchased counterfeit cancer injectable medication. Originally the FDA sent 19 medical practices warnings in March. The FDA warns the physicians that purchasing from foreign or unlicensed medicine suppliers puts patients at risk of exposure to potentially fake, contaminated, ineffective and dangerous medication.

FDA official Dr. S. Leigh Verbois, Acting Deputy Director of the Division of Supply Chain Integrity asked physicians in 15 states to avoid using the fake medications in letters dated April 5, 2012.   

The doctors who received these letters reside in Alabama, Arizona, California, Florida, Illinois, Maryland, Michigan, Nevada, New Jersey, North Dakota, Oregon, South Carolina, Tennessee, Texas and Washington.  See map to find doctors warned in your state here.

“…your medical practice purchased multiple medications from a foreign distributor named Richards Pharma, also known as Richards Services, Warwick Healthcare Solutions, or Ban Dune Marketing Inc. (BDMI). Many of the products sold and distributed by this distributor have not been approved by the FDA,” said Dr. Verbois’ letters.   

“The Agency has learned that one of the products distributed by Richards Pharma is a counterfeit version of Roche’s Altuzan 400mg/16ml. Even if the version had not been counterfeit, Altuzan itself is not approved by FDA,” the letters continue.  

“Other drug products obtained from Richards Pharma, Richards Services, Warwick Healthcare Solutions, BDMI, or other foreign or unlicensed suppliers may be from unknown sources, may have unknown ingredients, may be counterfeit, or may not have been manufactured, transported or stored under proper conditions as required by U.S. law, regulations, and standards.  

“Purchasing prescription drug products, such as injectable cancer medications, from foreign or unlicensed suppliers puts patients at risk of exposure to drugs that may be fake, contaminated, improperly stored and transported, ineffective, and dangerous. In virtually all cases, purchasing unapproved prescription drugs from foreign sources violates the Federal Food, Drug, and Cosmetic Act and is illegal.”

LEARN MORE ABOUT COUNTERFEIT CANCER MEDICATIONS
IN THE US AT THE 2012 PARTNERSHIP FOR SAFE MEDICINES INTERCHANGE.

REGISTER TODAY.

The FDA letter goes on to point out that the medication counterfeited is not in short supply, and points back to an FDA Drug Integrity and Supply Chain Security memo released to physicians in January 2012.  The letter states that the FDA knows that some physicians are purchasing unapproved injectable cancer medications, and reminds them that importing medications from foreign sources is in violation of the Federal Food, Drug and Cosmetic Act (FDCA).  

Dr. Margaret Hamburg, Commissioner of the FDA, wrote in the FDA’s blog, “For patients with cancer, combating the disease is difficult enough. But to learn that the cancer drug you were taking to save or prolong your life might be nothing but a counterfeit is unthinkable.”

In honor of World Malaria Day, we are reprinting this blog post by PSM Board member Tom Kubic, President and CEO of the Pharmaceutical Security Institute originally posted on the Sproxil blog April 3, 2012.