March 2010

Staffordshire woman sentenced for the supply of counterfeit drugs

The Medicines and Healthcare products Regulatory Agency (MHRA) and Staffordshire Police have investigated, since January 2008, a website called pharma2u.com advertising the sale of branded prescription only medicines such as Viagra, and found the products to be counterfeit. Norma Ene Ruutel-Glykys, a Canadian/Cypriot 51 year old woman from Staffordshire was found guilty for the possession of controlled drugs with the intent to supply, and for the possession of medicines with the intent to place them on the market without a licence. The operation visited Ms Ruutel-Glykys home address; Forest Court, Hanley, Stoke-on-Trent, which proved to be the UK distribution centre for the website and led to the seizure of 65,000 drugs and prescription only medicines. Ms Ruutel-Glykys was sentenced to 8 months in prison.
Read the full story: http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON076468

FDA arrests two for production and distribution of counterfeit weight loss pills

On March 23 2010 in Hawaii, Sengyang Zhou, a 30-year old Chinese national was charged by Criminal Complaint for illegally importing counterfeit weight loss medication. An extensive joint federal law enforcement operation by Food and Drug Administration Office of Criminal Investigations (FDA OCI), U.S. Immigration and Customs Enforcement (ICE), and the U.S. Postal Inspection Service (USPIS) led to Zhou's arrest. A second defendant, 60 year old Qingming Hu was also arrested for participating in and aiding this illegal scheme.

During the course of 2008-10, the FDA issued a series of alerts on its website concerning tainted weight loss pills and counterfeit drugs. The FDA expressed that these items pose a very serious health risk to the public as they were found to contain undeclared active pharmaceutical ingredients, including Sibutramine (a controlled substance that can cause high blood pressure, seizures, tachycardia, palpitations, heart attack or stroke), antidepressants, prescription-only potent diuretics, and drugs not approved in the United States. The counterfeit versions of Alli were being sold in the United States, among other ways, through internet auction websites such as 2daydietshopping.com

A man who had been taking an authentic version of Alli found a cheaper version of the product being sold over the internet, which were counterfeit produced by Zhou. As a result of taking the pills, the victim fell ill, exhibiting a significant adverse reaction including symptoms associated with heart attack such as heart palpitations, numbness within his left arm, severe anxiety, enormous eye pressure/headaches, profuse sweating and chills. Following testing at FDA’s Forensic Chemistry Centre, the pills were found to contain Sibutramine - fake, and dangerous, versions of the branded weight loss pill, Alli.

“The Food and Drug Administration will work together with other government entities to aggressively target those individuals who put the public’s health at risk by selling counterfeit drugs,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D.  “International borders and the perceived anonymity of the Internet will not deter FDA from investigating violations of the law.”

Zhou is charged with introduction and delivery for introduction into interstate commerce of unapproved new drugs, which carries a penalty of not more than 3 years imprisonment and up to a $250,000 fine; the importation of pharmaceutical drugs contrary to law, which carries a penalty of not more than 20 years in federal prison, and up to a $250,000 fine; the importation and distribution of schedule IV, non-narcotic controlled substances, which carries a penalty of not more than 5 years imprisonment and up to a $250,000 fine; and trafficking in counterfeit goods, which carries a penalty of not more than 10 years in federal prison and up to a $250,000 fine.
Read the full story http://www.fda.gov/ICECI/CriminalInvestigations/ucm206314.htm

Department of Health summit agrees tougher actions are required to support medicines supply

Ministers met in early March with a number of pharmaceutical supply chain stakeholders from across the UK to discuss the nature and scale of current difficulties with the supply of medicines and how the issues can be tackled collaboratively. A package of tough new actions to ensure that NHS patients can get the medicines they need was agreed and included the following:
• Manufacturers and wholesalers are to have a more explicit duty to ensure that sufficient stocks of medicines are available to NHS patients
The Medicines and Healthcare Products Regulatory Authority will undertake a series of proactive, targeted inspections.
• Medical wholesalers will face tougher standards on the issue of licences
• Best practice guidelines will be developed on how doctors, pharmacists, manufacturers and wholesalers will deal with supply difficulties
• The Supply Chain Group, we will together develop and maintain a list of products in short supply, so that no-one has the excuse that they were not aware of supply difficulties and prioritise the products on that list for further examination, with a view to finding possible means of mitigation and resolution.

Health minister Mike O’Brien said commented: 'The lower value of Sterling has resulted in some medicines destined for NHS patients being sold abroad for extra profit by a small number of unscrupulous speculators. Some pharmacists have had trouble getting hold of certain drugs because of this. For months, I have been seriously concerned about the potential impact of this on patients. It is unacceptable that some people have already had to wait longer than they should have to get their medication. Patients must come before profits. This new package of measures will help to ensure that NHS patients do not suffer and get the care they need when they need it.'
Read the full story: http://www.dh.gov.uk/en/News/Recentstories/DH_113507

EFPIA progress towards an EU-harmonised product coding system

EFPIA's serialisation and point-of-dispensing verification pilot study in Sweden
unveiled positive results at IQPC's Pharmaceutical Anticounterfeiting Conference in the
Netherlands at end of February. The end-to-end system - which involved the addition of randomised, serialised 2D datamatrix codes to pharmaceutical packaging – allowed for the verification of more than 11,000 medicinal products prior to dispensing.

As the products were dispensed to the patient, the codes were read in the pharmacy allowing the pharmacist to check the serial number had not been dispensed before. If it is marked in the database as already dispensed, the pharmacist is made aware that the medicinal product may be counterfeit and an alert is triggered. EFPIA, following the results of the study will continue to push for a harmonised product coding system for Europe.
Read the full story: http://www.securingpharma.com/40/articles/392.php

Sophisticated technologies successful in tracing pharmaceuticals through the supply chain

SecureTrace, 10 companies in the UK that are using electronic drug tracking and authentication technology to discourage counterfeiting and diversion of pharmaceuticals, have successfully piloted an ISRI-initiated project that aims to identify counterfeit products by tracing each step of an item's journey through the supply chain.
The process involves four sophisticated technologies, including unique and secure 2-D bar codes which comprise authenticating markers in the ink, and Laser Surface Authentication. The information from these technologies is then saved in a master database; after the pharmaceuticals depart from the packaging facility, field readers provide authentication and verification of the product as it traverses throughout the supply chain to the terminus, where it is dispensed.
Read the full story: http://packaging.pharmaceutical-business-review.com/news/securetrace_completes_pilot_runs_of_drug_tracking_authentication_project_100308/

Illegal online pharmacies targets UK universities

A security firm revealed UK academic institutions unknowingly became the accomplices of criminals selling fake drugs online. The counterfeit scam exploited software that many organisations using the .ac.uk domain use to piggyback the computing resources of the colleges and universities and redirect their students to illegal online pharmacies. Ravensbourne College of Design and Communication in Kent was one school that fell victim.
Read the full story: http://news.bbc.co.uk/1/hi/technology/8550219.stm

MHRA raids seize £180,000 worth of fake medicines

Police and officials from the UK Medicine and Healthcare products Regulatory Agency (MHRA) executed search warrants in Bristol in early March, confiscating a number of suspected counterfeit medicinal products totalling £180,000 in value.
Products uncovered in the raids included drugs presented as the erectile dysfunction treatments Levitra (vardenafil) from Bayer, Pfizer’s Viagra (sildenafil) and Eli Lilly’s Cialis (tadalafil), as well as other medicines such as the sedative diazepam.
Two men in their 20’s have been arrested in connection with the case.
Read the full story: http://www.securingpharma.com/40/articles/394.php

Counterfeit drugs reach NHS supply chain

A BBC documentary co-produced by EAASMs Chair Jim Thomson has investigated the increasing problem of counterfeit medicines in the UK and even discovers fakes making their way into the NHS supply chain.

As part of the BBC's Fake Britain series, Fake Medicines investigates the ease of buying prescription-only medicines over the internet, without a prescription, and looked at the often devastating consequences of counterfeit medicines.
Read the full story: http://http://www.pmlive.com/find_an_article/allarticles/categories/nhs/2010/march/news/counterfeit_drugs_reach_nhs_supply_chain