Noting the cost of laboratory pharmaceutical testing and the dearth of qualified laboratories in developing countries, the German Pharma Health Fund (now known as the Global Pharma Health Fund) developed the Minilab, a portable quality-analysis laboratory described in Box 6-4 (Jähnke et al., 2001; Kaale et al., 2011). During a November 2012 Minilab training session in Angola, trainees tested an illegal shipment of various pharmaceuticals seized by customs officials along the African coast (Minilab Saves Lives, 2012; World Customs Organization, 2012). Using the TLC and visual inspection techniques, they identified many drugs with no or little active ingredient (Minilab Saves Lives, 2012). Merck S.A. in Portugal provided 10 Minilabs to Angola, which has no drug testing labs (Minilab Saves Lives, 2012). Other similar field kits also exist, such as the Thermo Scientific FirstDefender and TruDefender field laboratory devices used by the Singaporean regulatory authority (Lim, 2012).

Detection in Every Setting

There is a wide range of technology available to detect falsified and substandard drugs; a good prevention strategy makes use of a wide variety of them. As Chapter 5 describes, some technologies, such as scratch-off codes, can be used by the consumer. There are also package technologies manufacturers may use to distinguish their products at the point of purchase. Holograms and reactive ink are examples of such package technologies. Holograms can be convincingly copied, as illustrated in Figure 6-10, but may give customers an extra level of assurance. Similarly, Brazil requires all drug companies to mark packages with a scratch-off label made from a reactive ink (Filho et al., 2010), though participants at the São Paulo site visit for this study expressed consistent doubt that consumers were adequately informed about how to use the label.

Informed patients can assist in identifying falsified and substandard drugs. Visual inspection of drug packages and color can identify gross differences between authentic and fake medicines. Similarly, patients might detect microbial contamination, seen as black specks on the surface of the product with the naked eye, or notice defects in a drug’s hardness when handling it. Table 6-2 describes the limits of visual inspection and other types of inspection.

Pharmacists are able to run a wider variety of tests to detect problems with medicine quality. If properly equipped, a pharmacist can run colorimetric tests and TLC on suspect samples in the pharmacy. The pharmacist, or a lower-level pharmacy worker, is also key in monitoring the chain of custody in track-and-trace systems. Field inspectors can take a similar role, especially in places where there are few trained pharmacists. As Boxes 6-3 and 6-4 explain, mobile testing is an important piece of drug quality monitoring in much of the world. Field inspectors can use handheld spectrometers and Minilabs to evaluate drug quality.

The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement