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Recommended reading list: counterfeit medicines

Phil Taylor

08-Jul-2010

man holding books 1 SecuringPharma.com presents a round-up of papers published in the peer review literature, including a new analysis on the use of RFID in counterfeit prevention, a case study of a man made dangerously ill by counterfeit Cialis and a host of new analytical techniques.

Pharmaceutical counterfeiting and the RFID technology intervention

This review article analyses the scope and severity of pharmaceutical counterfeiting and examines whether the use of radiofrequency identification (RFID) devices can be used more efficiently within the pharmaceutical supply chain to reduce the problem counterfeit drugs. The authors conclude that implementing RFID for tracking drugs at the item level in the pharmaceutical supply chain has the potential to alleviate the counterfeit drug problem, and make recommendations to accelerate the take-up of RFID by the drug industry.

Journal of Hospital Marketing & Public Relations (Vol 20, No 2, July 2010)

Severe hypoglycaemia associated with ingesting counterfeit medication

The Medical Journal of Australia (2010 June 21;192(12):716-7)

In this article, clinicians from Townsville Hospital in Queensland, Australia, describe a 54-year-old man with the first Australian case of severe hypoglycaemia induced by a counterfeit copy of Eli Lilly's erectile dysfunction drug Cialis (tadalafil). The imported product has been confirmed as counterfeit by laboratory analysis. The case "serves to remind medical practitioners that counterfeit medication may be the cause of severe hypoglycaemia or other unexplained illness."

Stable isotope-labeled excipients for drug product identification and counterfeit detection

This study examines the use of stable isotope-labelled excipients in solid dosage forms as a method to identify drug products and to detect counterfeits. The researchers from the University of New Mexico in the USA used labelled glucose incorporated in wet granulated formulations at a variety of different isotopic ratios, and showed it was possible to differentiate between specific batches of granules. "This demonstrates the potential of this technique for in-product, batch-specific identification," they write.

Drug Development and Industrial Pharmacy (19 June 2010 - Epub ahead of print)

Application of laser ablation multicollector inductively coupled plasma mass spectrometry for the measurement of calcium and lead isotope ratios in packaging for discriminatory purposes

Researchers from GlaxoSmithKline and laboratory standards company LGC describe a technique to detect counterfeits by analysing calcium and lead isotope ratios in cardboard and/or ink in packaging materials using a technique known as laser ablation multicollector inductively coupled plasma mass spectrometry (LA-MC-ICP-MS) . This is the first time calcium isotope ratios have been used to detect counterfeits using a LA-MC-ICP-MS instrument, according to the authors.

Rapid Communications in Mass Spectrometry (15 Jun 2010 - Epub ahead of print)

Counterfeit drugs detection by measurement of tablets and secondary packaging colour

In this paper Italian researchers describe a simple, low-cost screening tool based on a colorimeter used in the graphic industry that can used by inspectors to decide in the field whether to send a sample for further laboratory analysis. The colorimeter was tested on genuine and counterfeit copies of Pfizer's Viagra (sildenafil), Eli Lilly's Cialis (tadalafil) and GlaxoSmithKline/Bayer's Levitra (vardenafil) by measuring the colour of tablets' surface and of a specific spot on the pack.

Journal of Pharmaceutical and Biomedical Analysis (27 April 2010 - Epub ahead of print)

Related articles:

Recommended reading list: counterfeit medicines (March 2010)

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