Pharmaceutical Supply Chain Security: A View From the Pharmaceutical Research and Manufacturers of America

Abstract

The introduction of counterfeit drugs into the supply chain poses risks to patients. Supply chain security is of paramount concern to the pharmaceutical industry, and companies employ a variety of technologies that can be used to authenticate packaged pharmaceuticals. Serialization of individual package units coupled with the use of machine-readable codes should permit the electronic tracking and tracing of these units throughout the supply chain. Progress on establishing identification and information technology standards is moving forward, but many complexities must be resolved, such that full implementation is still some years away. Several states are implementing pedigree requirements. To prevent the proliferation of differing state requirements, the Food and Drug Administration should take a leadership role in establishing clear federal guidelines and implement the pedigree requirements under the Prescription Drug Marketing Act.

Pharmaceutical supply chain risks: a systematic review

“…Various works have been reported regarding different aspects of supply chain risks and risks management in the manufacturing sectors. In pharmaceutical sector, although there are some review studies in supply chain risk management with focus on counterfeit [ 26 - 29 ], supply chain logistics [ 30 ], quality assurance [ 31 ] and enterprise risk management [ 32 ] but there is not any systematic review on the pharmaceutical risk management with perspective of manufacturers risks; meanwhile, there are some systematic reviews on SCRM in other industries [ 33 - 35 ].…”

Dynamics of Pharmaceutical Drugs Serialization

“…Implementing and sustaining serialization system for drug traceability required skillful resources. Any human, mechanical and technical error can cause adversely to human life [17]. In India, DGFT' s requirement that manufacturers upload "dummy" or fake serial numbers for primary packages (i.e., individual vials, blister cards, or bottles) that are not serialized is possibly the most confusing requirement.…”

Anti-Counterfeit Technologies: A Pharmaceutical Industry Perspective

“…The implementation of anti-counterfeit technologies is the prominent preventive measure [9]. In addition to providing authentication, they make the production of a convincing copy of a drug more difficult and costly [7]. The government authorities, by employing these technologies, may ensure that drugs in the supply chain are legitimate.…”

“…Business personnel must be educated about the implementation of good anti-counterfeit technology and make consumers aware of such strategies used. Regulatory authorities must conduct checking plans and devise necessary measures to ensure the absence of counterfeits, increasing the penalty of the pharmaceutical counterfeiting based on the risk imposed on public health [7]. …”

“…The security of the pharmaceutical supply chain can be strengthened by innovative packaging technologies and better business practices [7]. Currently, Indian pharmaceutical companies produce about 20–22% of the world’s generic drugs (in value terms) and therefore counterfeiting is a subject that has great relevance for the Indian industry [8].…”