As a global economic and healthcare force, the pharmaceutical industry operates in a highly regulated market – but one that is still vulnerable to fraud and counterfeiting. High-profile cases of counterfeit pharmaceuticals have cost well-known manufacturers and distributors many millions, and have put large populations of pharmaceutical consumers at risk. Efforts to integrate the global regulation of pharmaceutical production and trade have been weak. Drugs made abroad are often not controlled by the same standards as those produced for domestic use, allowing counterfeiters to vastly undercut the costs of legitimate production. This incentive to counterfeit is a growing threat to the entire pharmaceutical industry.
Areas of Concern
Drug Pedigrees & Packaging
Pedigrees are required by the Prescription Drug Marketing Act as one form of authenticating the chain of pharmaceutical custody. Vulnerabilities still exist where the pedigree is used in print form, such as at the point of retail sale or medical dispensing facilities. Another key vulnerability lies in the relative ease of creating counterfeit packaging. Solutions are needed to easily enable authentication of packaging down to the endpoints of the value chain.
Clinical Research Organization (CRO) & Clinical Investigator Documents
All pharmaceuticals go through extensive research, development and testing phases, in which numerous potential areas for fraud may exist. Clinical Research Organizations (CRO) and investigators must conduct clinical trials to exacting standards in order to ensure accurate results. Their documentation may be subject to fraud via illegal copying of study protocols and investigator booklets, falsification of critical forms like medical results and Case Report Forms (CRF), and improper reporting of results. This can lead to wasted research efforts and dollars, damaged corporate reputations, and most significantly, to potentially grave health risks to the public.
Drug Development & Production Documents
Research and development documentation, study protocols, project progress documentation and trial results are some of the internal documents that drug developers must protect from fraudulent use or alteration. Pharmaceutical companies’ intellectual property and future market share are put at risk. In the actual manufacturing of pharmaceuticals, documentation of processes and batch test results are a key part of quality control and compliance and must be protected from alteration or unauthorized duplication. The health of millions of consumers depends on the integrity of these processes, as does the financial health of the manufacturers themselves.
Outlook
The FDA and other governing bodies have imposed many regulations that pertain to the development, production and distribution of pharmaceuticals. Security processes in use include electronic encryption of some types of documents, physical security around sensitive documents, and use of special security papers. Pedigrees that document the chain of custody of pharmaceuticals are now mandated in the US, and large wholesalers are taking increasing measures to protect both themselves and the public from counterfeit drugs. However, the risks posed by pharmaceutical document falsification are not fully resolved. Pharmaceutical businesses can achieve higher levels of security by leveraging foundational technologies that enable easy authentication and protection, and provide additional layers of security in their printed materials.
AuthentiGuard On-Demand Can Help
AuthentiGuard-On-Demand is a sophisticated print security technology that combines the benefits of copy and tamper protection with the ability to conceal sensitive data within printed documents. Utilizing standard desktop and commercial printers, the solution provides for the dynamic delivery of comprehensive protection to documents like pedigrees, CRF’s and R&D documents that can cure the counterfeiting that is afflicting the pharmaceutical industry.