Anticounterfeiting, Track and Trace Systems

We decided to dedicate this month's issue of PTE to a topic that affects all of our readers; the threat of counterfeit medicines.

In order to combat the threat of counterfeits in Europe, the EU's current anti-counterfeiting directive is being amended.

Counterfeit pharmaceuticals are complex products that can vary from their legitimate counterparts both chemically and physically.

Wyatt Earp, the legendary sheriff of Tombstone used to solve troubles in a simple way: aiming, pulling the trigger and bang! ... problem eliminated! Some manufacturers check the readability of their barcodes in the same way.

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) published its "Ten Principles on Counterfeit Medicines" last week to draw public attention to the issue.

New Draft Guidance for Solid Oral Dosage Forms Focuses on Physical Chemical Identifiers. This article is part of PharmTech's supplement "Solid Dosage and Excipients 2010."

Governments, regulators and international agencies continue to defend against counterfeiters; in particular, the European Commission has outlined measures that may help to better regulate pharmaceutical distributors.

Five per cent of consumers across five European countries suspect they may have received a counterfeit prescription and 1% believe that they definitely have, according to research conducted by ICM on behalf of patient safety communications company Aegate (UK).

Five percent of consumers across five European countries suspect they may have received a counterfeit prescription, and 1% believe that they definitely have, according to research conducted by ICM on behalf of patient safety communications company Aegate (UK).

With counterfeit drugs on the rise, the Chairman and CEO of Ahura Scientific discusses the issue and explains how a handheld device is helping companies to tackle the problem.

New barcoding technologies are helping to aid product traceability and fight counterfeits. Mark Beauchamp of Citizen Systems Europe explains how.

The European Fine Chemicals Group (EFCG) gave an update of some of its activities at a press conference held at CPhI Worldwide (Spain) last week, and revealed some disturbing facts regarding counterfeit APIs, which the group is particularly concerned about.

The European Fine Chemicals Group (EFCG) gave an update of some of its activities at a press conference held at CPhI Worldwide (Spain) last week, and revealed some disturbing facts regarding counterfeit APIs, which the group is particularly concerned about.

Jeff Robertson talks about a unique form of micro-tag technology that can be applied to solid dose pharmaceuticals.

The US Food and Drug Administration issued a draft guidance for industry, Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting, on July 13.

As regulators work to curb counterfeiting, industry finds benefits to gaining granular data about the supply chain. This article contains bonus online-exclusive material.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) announced a pilot program, to launch in Sweden later this year, that will focus on coding and identification solutions.

The United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) seized nearly half a million pounds worth of counterfeit medicines on Mar. 26, 2009 in Middlesbrough, England, according to a MHRA press release.

Steps companies can take to help safeguard patients and the pharma supply chain.

GS1 UK, an independent organization that develops supply-chain standards, successfully completed the Pharma Traceability Pilot program and demonstrated the viability of a complete track-and-trace system for pharmaceutical products in a live, international supply-chain environment.

As counterfeiters become more cunning and technologically advanced, spotting their handiwork is increasingly difficult. Can surface analysis techniques be used to outwit them?

The European Federation of Pharmaceutical Industries and Associations (EFPIA), the trade association representing European pharmaceutical manufacturers, issued recommendations to the public consultation launched in March by the European Commission's proposed drug anticounterfeiting measures. EFPIA's proposal includes a ban on drug repackaging.

Researchers from the Georgia Institute of Technology described a fast method to detect counterfeit "Tamiflu," Roche's drug for preventing and treating bird flu.

Sophisticated replication techniques have made counterfeiting and fraud a serious threat to the pharmaceutical industry.

Brussels (May 30)-The European Federation of Pharmaceutical Industries and Associations (EFPIA) called for the pan-European and industry-wide adoption of 2-D barcode technology to combat the increase in counterfeit drugs in Europe.

Disappointed in progress thus far, the US Food and Drug Administration wants pharmaceutical manufacturers to make a greater effort to combat counterfeit products and recommends that they "move quickly" to implement radio-frequency identification technology.

The UK Medicines and Healthcare Products Regulatory Agency (MHRA, London) has reissued its recall of a specific batch of counterfeit ?Lipitor? 20-mg tablets. MHRA, in conjunction with Pfizer (New York City, NY), first issued the recall of batch number 004405K1 in July 2005. The new recall is in response to the discovery of more packages of the counterfeit drug in the United Kingdom.

The US Food and Drug Administration?s Counterfeit Drug Task Force (Rockville, MD, www.fda.gov) is recommending regulatory actions and the implementation of new technologies for reducing the risk of counterfeit drugs entering the United States. The group has followed up on its original 2004 report, in which it outlined the framework for protecting the public from counterfeit medicines, and an updated 2005 report with a third document encouraging electronic pedigrees, improved traceability in the drug supply chain, and the adoption of radio-frequency identification (RFID) tools.

Interphex provided an opportunity to examine the latest pharmaceutical packaging concepts and packaging machines.

Proposed Legislation to Help Fight Counterfeit Drugs