Protecting the Public - Pharmaceutical Technology

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Protecting the Public
Overt and covert packaging technologies evolve to authenticate drugs and fight counterfeits.


Pharmaceutical Technology
Volume 36, Issue 11

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 has increased its outreach efforts as well. A proposed USP sub-Saharan Africa Center for Pharmaceutical Advancement and Training (CePAT) in Accra, Ghana, will provide training in quality control and good manufacturing practices as well as laboratory testing and consulting services for the region. The USP Board of Trustees is requesting donations to cover construction costs beyond the $1.5 million it has committed to the project. Donations also are needed to purchase instrumentation for the training laboratories, hire staff, and subsidize the Center’s first three years of operation. Expected to be self-sustaining by year four, the CePAT in Ghana will serve as a model for future operations in Asia and South America. The effort is the first initiative of USP’s Global Health Impact Program and is a successor to Promoting the Quality of Medicines (PQM) and predecessor programs that targeted specific African countries and diseases.

“The work that USP has been able to do through the PQM program has opened our eyes to new opportunities to provide assistance in sub-Saharan Africa,” explained Patrick Lukulay, vice-president of global health impact programs at USP, in a press release (7). “Our ability to do long-term work in Africa through this center in Ghana will improve health of patients in the region who are desperate for medicines they can trust.”

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 (8).

Evolving technologies

For brand owners and makers of generic- drug products and dietary supplements, a constantly evolving array of anticounterfeiting technologies help discourage counterfeiting and authenticate product.

Taggant- and ink-based approaches are particularly popular, but other technologies like holograms and security materials also are available.


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FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
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