Drug counterfeiting

National Association of Boards of Pharmacy. 2007. Drug Counterfeiting Fact Sheet available at www.dan gerouspill.com/identifying reporting/fact sheet.html accessed on March 20, 2007. 

Drug counterfeiters have been known to substitute KNOj, a much cheaper and less reactive compound, for the organic nitrates. As a result, a fast analytical method was needed to determine if a substitution had been made and to simply check the drug to see if it contains the mixture reported on the label. You have been given a suspect sample, and you must determine if it contains an organic nitrate. 

One essential factor that differentiates this type of analyses from other analytical procedures is that the trace is the result of a past and uncertain action and its quantity cannot be modified. One can only assume that it is representative of the chemical makeup of the source and this assumption has to be taken into account when interpreting results. An essential limiting factor therefore comes from the sample that cannot be selected as in a true sampling procedure except when mass produced crime material is seized (illicit drugs, counterfeit). 

Holzgrahe U, Malet-Martino M. Analytical challenges in drug counterfeiting and falsification-the NMR approach. J. Pharm. Biomed. Anal. 2011 55 679-687. 

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. 

Lack of assurance of sterility in production or testing of sterile drug products. Discoloration. Counterfeit dosage form. 

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. 

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