Counterfeit pharmaceuticals

Counterfeit products, products of dubious quality and faulty information — especially exaggerated claims of efficacy — are often found to be widespread in the informal sector. Unlicensed manufacturers, importers, wholesalers, retailers and even persons engaged in the pharmaceutical business pose difficult challenges to dmg regulation. The DRA should not allow the informal sector to remain a loophole in regulation. Monitoring of pharmaceutical activities should cover the informal as well as the formal sector. 

Examining the inspectors workloads will also help to establish reasons for the success or failure of the inspection process. EHiring their inspection of pharmaceutical establishments, inspectors may learn of the presence of unregistered products, counterfeit products, etc. Quantitative information on these and other issues is valuable as an outcome measure. 

In pharmaceuticals, NIR is used for, of course, moisture, polymorphic (drug) forms, percent crystallinity, isomer purity, tablet/capsule assay, coating levels, evaluation of dissolution times, and numerous process tests. It is a rapid means for the Food and Drug Administration to check for counterfeit drugs, and for the Drug Enforcement Agency to ascertain what type of materials are impounded in drug raids. ... 

The most recent converts are in the health care industry. Pharmaceutical and biological applications have become myriad since the early 1980s. The first widespread application was for the identification/ qualification of incoming raw materials. Since then, applications have appeared for moisture (bound and free), blend uniformity of powders, tablet and capsule assays, counterfeiting, polymorphism, degree of crystallinity, hardness (of tablets), dissolution prediction, isomerism, as... 

Technology—involve pharmaceutical companies and distributors to develop innovative solutions, such as radiofrequency identification (RFID) to track movements of drugs, tamper-proof packaging to deter tampering, and printing technologies aimed at end user compliance Risk communication—IMPACT to develop and coordinate effective mechanisms to alert and respond to counterfeit drug activities inform and educate users and healthcare professionals to be alert and report suspicious cases... 

Since the monoisotopic signal is the protonated ion, the elemental composition for the API in the counterfeit tablets was therefore determined as C8lTj502N7S3. A computerized search of The Merck Index using the elemental formula suggested the unknown compound to be Famotidine, an active pharmaceutical ingredient widely used in over-the-counter antiulcerative medicine. 

Pharmaceuticals PCA and visual classification Drug authenticity assurance, counterfeiting control 65... 

Although even quality issues are still a problem (poor quality of starting materials including active pharmaceutical ingredients, quality problems with finished dosage forms, spreading of counterfeit medicines) it is likely that new technologies... 

It is relatively easy to hide and smuggle medicines. No country can count on customs controls specialized in combating counterfeit medicines. Customs control is not helped by liberalization of international commerce and the growing number of natural products , nutritional supplements and other products non-classified as pharmaceuticals that use packaging and forms more and more similar to those of medicines. 

Pharmaceutical distributors, wholesalers, importers, exporters, all those involved in the distribution chain are key players that, maybe more than others, should improve their capacity to combat counterfeit medicines. It is through the distribution chain that counterfeit medicines reach patients. It is therefore essential that distributors, wholesalers, importers, exporters develop and effectively implement business practices that make the distribution chain as impermeable as possible to counterfeits and open to appropriate verification by national authorities. It is known that in many countries unauthorized trade is widespread and that it is difficult to get unauthorized traders to respect rules and regulations. Yet, if unauthorized trade is the result of many factors, local distributors and retail pharmacists may find themselves part of the problem (for having left important areas of the country without effective supply mechanisms)... 

ICP-MS has been employed, as discussed in Section 9.5, for the determination of platinum originating from cisplatin, carboplatin and oxaliplatin in human plasma ultrafiltrate. The method developed was successfully used to support pharmacokinetic studies in cancer patients treated with cisplatin, carboplatin or oxaliplatin.5 Counterfeit products on the drug market, which have important implications for pharmaceutical companies and human health, can be clarified by mass spectrometric isotope ratio measurements. For example, precise and accurate sulfur isotope measurements (a 54S) by MC-ICP-MS, were employed to study the isotope variation of pharmaceuticals and to detect to the origin of counterfeits by Clough el al.6... 

Lybecker, K. M. 2000. Counterfeit Pharmaceuticals Product Piracy and the Transition to Stronger Intellectual Property Rights in Developing Countries. PhD dissertation. University of California, Berkeley. 

Lybecker, K. 2003. Product Piracy The Sale of Counterfeit Pharmaceuticals in Developing Countries. Mrmeo Drexel University (unpublished manuscript). Available at http //emertech.wharton. upenn.edu/WhartonMiniConfPapers/Lybecker%20-%20Product%20Piracy.pdf [Accessed December 7, 2005]. 

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