Protecting the Public: Anticounterfeiting

The fight against counterfeit and gray-market drugs is worldwide. Under the FDA Safety and Innovation Act, signed by President Obama in July 2012, the Attorney General shall give increased priority to efforts to investigate and prosecute counterfeiting. In addition, the US Sentencing Commission is to consider increased penalties for drug counterfeiting (1). In the European Union, the Falsified Medicines Directive 2011/62/EU takes effect on Jan. 2, 2013 (2). The Directive requires authentication features on individual prescription-drug packs to enable verification throughout the supply chain. It also strengthens requirements for control and inspection of manufacturers of active substances. Manufacturers also must report any suspicion of falsified medicines. Other provisions give penalties for the manufacturing, distribution, import, and export of falsified medicinal products and point out the dangers associated with sale of medicines via the Internet.

With a significant percentage of medicines purchased from Internet sites found to be counterfeit, FDA has embarked on a public education campaign, BeSafeRx: Know Your Online Pharmacy (3). Another tool used by FDA is its October 2011 Guidance for Industry: Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting (4). FDA is also training field agents in the use of a handheld device to check for counterfeit products and packaging arriving at ports of entry. The CD3 (Counterfeit Detection Device #3) emits light in 10 wavelengths to check API and drug samples against stored scans. It also detects package tampering.

The World Health Organization’s (WHO) Working Group of Member States on Substandard/Spurious/Falsely-Labelled/Falsified/Counterfeit Medical Products takes a three-pronged approach: education, norms and standards, and technical support to countries (5). WHO also supports the International Medical Products Anti-Counterfeiting Taskforce, a group it launched in 2006 with a wide range of partners including, international organizations, nongovernmental organizations, enforcement agencies, pharmaceutical manufacturers’ associations, and drug and regulatory authorities.

The US Agency for International Development (USAID) provides technical assistance worldwide to identify fake and substandard products and help legitimate manufacturers meet internationally recognized good manufacturing practices. In some cases, its efforts are implemented by the United States Pharmacopeial Convention (USP).

USP also is finalizing General Chapter <1083> "Good Distribution Practices—Supply Chain Integrity". It will outline best packaging practices to combat counterfeit drugs and medical devices. Likely topics include tamper-evident designs, authentication technologies, serialization, pedigrees, machine-readable data carriers, repackaging, and information retention and security.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) is collaborating in efforts to combat counterfeit drugs. One project, the European Stakeholder Model, advocates the use of two-dimensional barcoding technology to authenticate products and comply with the Falsified Medicines Directive. This serialization system will be run by stakeholder organizations on a nonprofit basis.

“Potential advantages include the possibility of allowing for the automated checking of expiry dates, better pharmacovigilance, a reduction in the number of fraudulent reimbursement claims, higher effectiveness in preventing recalled products from being supplied to the patient, more efficient handling of product returns, and improved stock management processes for pharmacies,” said Camilla Kent Hansen, market access manager for EFPIA, in a recent article (6).

For brand owners and makers of generic-drug products and dietary supplements, a constantly evolving array of anticounterfeiting technologies help discourage counterfeiting and authenticate products. Read the full article online at PharmTech.com for details on packaging technologies, such as taggant- and ink-based approaches, holograms, security materials, and labels containing both covert and overt features.

References

1. S. 3187, US Senate, 112th Congress, 2nd Session (Washington, DC), June 27, 2012.
2. EC Directive 2011/62/EU, Falsified Medicines Directive (Brussels, July 2011).
3. FDA, “Buying Medicines Online? Be Wary, FDA Says,” Consumer Updates, accessed Oct. 3, 2012.
4. FDA, Guidance for Industry: Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting (Silver Spring, MD, Oct. 2011).
5. WHO, “Medicines: Spurious/Falsely-Labelled/Falsified/Counterfeit (SFFC) Medicines, Fact Sheet N°275, May 2012,” accessed Oct. 3, 2012.
6. EFPIA, “Tackling the Rise of Counterfeit Medicines,” accessed Oct. 1, 2012.