Drug counterfeit

The pre-ICDRA meeting on counterfeit drugs was mentioned and a followup meeting to the pre-ICDRA meeting was planned in order to discuss closer global cooperation in this area. 

A report was given on the activities being undertaken to combat counterfeit drugs. Strong efforts were being made to promote the concept of improved international collaboration (e.g. a framework convention) in national and international forums, and negotiations to obtain funding and support for an international conference. The conference is planned to be held in Rome in February 2006. 

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Csillag C. Epidemic of counterfeit drugs eauses eoneem in Brazil. Lancet, 15 August 1998, 352 55. 

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. ... 

Services (HHS) and spells out research, enforcement, and education requirements. The Prescription Drug Marketing Act prevents the resale of diverted drugs, requires drug wholesalers be licensed, restricts reimportation, and bans the sale, trade, or purchase of drug samples or counterfeit drug coupons. 

One of the many challenges facing regulatory authorities worldwide is that of counterfeit drugs. The World Health Organization (WHO) defined... 

The current counterfeit drugs market is estimated to be about US 40 billion and is expected to increase to almost US 80 billion by 2010. Most of the counterfeit drugs are found in developing countries, where the enforcement of the regulatory authorities is weak or ineffective. In general, the distribution of counterfeit drugs as a proportion of the total market is as follows ... 

The WHO has set up the International Medicinal Products Anti-Counterfeiting Taskforce (IMPACT) with all 193 member states to combat counterfeit drugs. Five key areas were identified ... 

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... 

How do the WHO and member countries tackle the problem of counterfeit drugs ... 

Refer to Section 8.9. The five strategic areas identified to combat counterfeit drugs are ... 

A case study of the identification of a counterfeit drug molecule is discussed in Section IX. C. This is a step-by-step discussion of the experimental procedure using FTMS to address this important issue. After the exact mass of the unknown componnd has been determined, the next step is to derive its elemental composition. The minimnm and maximum number of expected atoms present in the componnd mnst be specified in the search criteria to allow the compnter program to calculate possible elemental compositions. A nniqne fit of only one elemental composition is rarely obtained. The nnmber of possible compositions increases with the increasing nnmber of elements present and with increasing mass. However, other information, snch as the number of double bond eqnivalency and the isotopic distribution of the parent ion mass spectrnm, can be used to reduce the possible elemental compositions to a reasonable nnmber. Fnrther discussion can be fonnd in Section IX. C. 

Counterfeit drugs pose a serious threat to public health. According the World Health Organization, a counterfeit medicine is one... 

Lipitor recall in Spring 2003—millions of fake pills were smuggled into the United States from abroad. The Lipitor case highlights the problem of increasing and increasingly sophisticated counterfeit drugs. 

Amgen, in May 2001, was forced to recall its Epogen when counterfeit vials of the product were discovered in the market. Investigation revealed that the counterfeit drug contained only one-twentieth of the labeled strength. 

The participants of the WHO international Conference Combating Counterfeit Drugs Building Effective International Collaboration, gathered in Rome on 18 February 2006... 

Cockburn R, Newton PN, Agyarko EK, Akunyili D, White NJ. The gobal threat of counterfeit drugs why industry and governments must communicate the dangers. PLoS Med 2005 2(4) 1-18. 

WHO. Counterfeit drugs guidelines for the development of measures to combat counterfeit drugs. Geneva World Health Organization 1999. (WHO/EDM/QSM/99.1). 

Given that drugs are very high-value products relative to their bulk, and in very high demand, the profitability and proliferation of counterfeit drugs is not surprising. 

Scafi, S.H. and Pasquini, C. (2001) Identification of counterfeit drugs using near-infrared spectroscopy Analyst 126, 2218-2224. 

January 10, 2002 In a series of ecstasy-related arrests in Washington County in northwest Arkansas, Timothy Paul Moldenhauer, age 23, was convicted of delivery of a counterfeit substance. Police said that he claimed he had ecstasy pills, when he actually had ben-zylpiperazine pills, a legal drug. Moldenhauer was sentenced to five years for the counterfeit drug in Washington County Circuit Court, according to a story by Julie Allison in The Morning News, Fort Smith, Arkansas, on January 22, 2002. 

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