Industry Takes Steps to Prevent Counterfeit Drugs - Pharmaceutical Technology

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Industry Takes Steps to Prevent Counterfeit Drugs

Pharmaceutical Technology
Volume 37, Issue 8, pp. 45

The fight against counterfeit drugs is an international effort, as exemplified by the “Fight the Fakes” campaign, which was established in 2013 and has grown to include 25 healthcare groups, research institutes, foundations, non-profits and private-sector organizations, including the US Pharmacopeial Convention (USP).  “The challenges we face today, with raw materials and finished products circling the globe before they reach the hands of patients and consumers, require collaboration to stem the tide of fakes,” said USP CEO Ron Piervincenzi in a press release (1).


Implementing Supply-Chain Security

Industry Seeks Clearer Standards for Track and Trace

Securing the Supply Chain

More Standards and Regulations

Verifying authenticity
Packaging technologies can be used to thwart counterfeiters by providing tamper evidence and multiple ways to verify authenticity. “There has been growing interest in enhancing the use of tamper-evident security seals,” says Sarah Yacoub, senior marketing manager at SICPA Securink. “Such seals are being customized to client’s needs for additional security, incorporating authentication features, most notably covert marks and taggants. Enhanced authentication technology protects products and packaging against reuse or refilling, contamination, or adulteration, dilution, and substitution.” Security inks are used in both visible and invisible forms to combine multiple levels of authentication. A machine-readable taggant can be incorporated in the ink, and this hidden information can be retrieved and checked using a device or smart-phone application. The taggant can be matched to a visible serial number or other data for a multilayered authentication system, explains Yacoub.

Schreiner MediPharm’s SecuMed labeling system, for example, uses a combination of overt, covert, and machine-readable security features, such as holograms, color-shifting ink, and LaserSecure machine-readable security pigments. Another new product, the company’s Flexi-Cap label-and-cap combination, gives a clear indication when a cap has been opened to prevent the illegal reuse of medicine containers under the guise of being unopened, original products.
TruTag Technologies’ TruTags are inert, edible taggants that can be incorporated into an individual drug tablet or capsule as an on-dose authentication solution. Detailed information, such as site and date of manufacture or other critical data, can be embedded in an optical pattern that can be read in the field to authenticate the product. R&D services company WuXi PharmaTech is working with TruTag to develop solutions using this technology.

Implementing serialization
Drug suppliers are moving forward with serialization systems to meet regulatory deadlines. CDMO Vetter, for example, is making progress in a solution for state-of-the-art product packaging designed to support prevention of product counterfeiting, the company announced in a press release (2). Vetter’s current services include printing global trade item numbers on packages, and the company plans to have a range of serialization services as a basis for track-and-trace programs in place by the end of 2014.

CDMO Aesica Pharmaceuticals launched a serialization system at its site in Pianezza, Italy to comply with requirements of China’s Food and Drug Administration (CDMA). The serialization module developed in QAD Enterprise Applications allows the company to identify packaging down to the smallest sellable unit size and to aggregate individual unit serial numbers as packages are bundled, boxed, and placed on shipping pallets (3).

Verifying serialization codes using machine-vision inspection is a crucial piece of a serialization system, notes automation supplier Omron. In the past, human-readable code and data encoded in bar codes have been fixed for a batch, but unique serialization codes on each sellable unit add the challenge of synchronizing this data between the printer and verification system. Omron’s vision solutions can interface with high-level production-management software to request the data required to verify the unique serial number, whether through database integration or simple manipulation of data files, explains Dan Rossek, product marketing manager for Omron’s Sensing, Safety, and Vision.

As pharmaceutical companies invest in systems to comply with serialization regulations, they want to leverage their investment to collect value-added data for business-intelligence purposes, notes SICPA’s Yacoub. “Serialization beyond compliance can allow for increased supply-chain visibility, which can help reduce costs through better inventory control and reduced errors, while also protecting brand reputation and product safety through the ability to carry out more targeted, faster recalls. Supply-chain visibility facilitates asset management and operation efficiency, translating to financial benefits.”

1. USP, “USP Welcomes New Partners to ‘Fight the Fakes’ Campaign,” Press Release, June 6, 2014.
2. Vetter, “Vetter to implement serialization to support track-and-trace efforts,” Press Release, Mar. 27, 2014.
3. Aesica Pharmaceuticals, “Aesica Pharmaceuticals S.r.I. collaborates with QAD to meet China’s Food and Drug Administration’s shortened serialisation deadline,” Press Release, June 23, 2014.


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