Pharmaceutical Drug Packaging and Traceability: A Comprehensive Review

Kumar, Gaurav

doi:10.31586/ujpp.2023.769

Cited by 13 publications

(3 citation statements)

References 21 publications

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“…The DSCSA has established a 10-year timeline during which it plans to integrate blockchain technology into the traceability of pharmaceutical drugs [15,16]. Section 582(a)(9) of the FD&C Act, part of the Drug Supply Chain Security Act (DSCSA), mandates that each sales unit and its grouped similar packaging unit must feature a 2D matrix barcode that includes human-readable data [17].…”

Section: United States Food and Drug Administration Regulations For C...mentioning

confidence: 99%

Global drug serialization in pharma sector: Complete review

Madalsa Kumar

2023

World J. Adv. Res. Rev.

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The primary aim of this paper is to acquire an understanding of drug serialization within the pharmaceutical sector and explore its various dimensions. Presently, pharmaceutical counterfeiting poses a significant challenge in the industry. Various countries have established regulatory measures to combat counterfeit drugs, with drug serialization being one such regulatory compliance mechanism to address this issue. Over an extended period, counterfeit drugs have severely impacted the healthcare industry. Regulatory bodies across different nations are actively deliberating ways to alleviate the problem of counterfeit drugs and their adverse effects on consumers who unknowingly ingest fraudulent medications. Research indicates that in underdeveloped countries, as many as 4 out of 10 drugs are fake or have been adulterated through illicit means, contributing to a substantial problem. This situation has dire consequences for the healthcare industry, resulting in substantial financial losses due to the infiltration of counterfeit drugs into the supply chain. Additionally, consumers are put at risk when they unwittingly consume fake medicines, instead of the life-saving drugs they require. Regulatory authorities are responding by enacting new regulations to tackle this issue and prevent counterfeit or adulterated drugs from entering the supply chain. To ensure the safe and genuine delivery of drugs to patients, the pharmaceutical industry must implement robust traceability measures and adhere to stringent regulations. The tracking and tracing process of pharmaceutical drug serialization ensures the ability to trace individual drug packaging throughout the entire supply chain, encompassing manufacturers, distributors, wholesalers, pharmacies, and end consumers. Importantly, these serialization measures enhance the security of drugs within the supply chain without compromising drug quality, effectively reducing the infiltration of counterfeit drugs into the distribution network.

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Section: United States Food and Drug Administration Regulations For C...mentioning

confidence: 99%

Global drug serialization in pharma sector: Complete review

Madalsa Kumar

2023

World J. Adv. Res. Rev.

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“…Nevertheless, the healthcare sector is still in the early stages of building the necessary infrastructure, software solutions, and strategic approaches to effectively integrate diverse data types in a reliable, secure, and consistent manner [6]. Risk is especially common among people of Hispanic ethnicity with limited educational opportunities, living in impoverished conditions, lacking citizenship status, lacking health insurance, and facing significant out-of-pocket healthcare costs [7]. Concerns regarding the traceability of the pharmaceutical supply chain within healthcare are mounting due to issues related to effectiveness.…”

Section: Introductionmentioning

confidence: 99%

Serialized Drug Traceability in the Supply Chain Using Distributed Ledger Technology

Patra

2023

UJPP

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Currently, Drug Counterfeiting is the biggest challenge facing the pharmaceutical industry. They are encountering this threat due to high market demand for the drugs and their profit margin. The lack of data transparency and traceability also lured criminals into the counterfeiting of drugs which, is impacting people's health and put their life in danger. Through the drug supply chain, a substantial portion of counterfeit drugs are injected and distributed through the healthcare supply chain network, so the supply chain plays a vital role in drug distribution and impacts patient lives. Through digitalization in the healthcare sector, Distributed Ledger Technology (DLT) provides a platform with ground-breaking results by providing a system for drug traceability with consideration of the critical requirements of transparency, privacy, and authenticity without involving any third party. In DLT, each distribution partner is registered to maintain transparency with the drug information. Real-time transfer of information about the change of ownership with date and time in the form of blocks gives visibility to all the partners in real time about the authenticity of drugs. This article will give information about the benefits of Distributed Ledger Technology to the pharmaceutical industry and the traceability of drugs from end-to-end of the pharmaceutical supply chain.

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“…The Blockchain system will provide information regarding the source of the medication, ensuring its high quality and verifying that it originates from an authorized pharmaceutical manufacturer. Track and trace and/or authentication smart technology integration into databases will also prevent counterfeiting [32].…”

mentioning

confidence: 99%

Role of Enterprise Applications for Pharmaceutical Drug Traceability

Juturi

2023

UJPP

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The role of enterprise applications in pharmaceutical industries is driving the digital transformation of various critical processes, and one process benefiting from this innovation is pharmaceutical drug traceability. This industry grapples with challenges like a lack of transparency, difficulties in tracking products, a deficit of trust, and issues related to shipping expired products. To address these concerns, blockchain technology as an enterprise application has been harnessed as a solution. Notably, counterfeit drug prevention emerged as the most prevalent category, aligning with the pharmaceutical industry's primary objective. Blockchain technology is an emerging innovation that is finding enterprise applications in various industries, including healthcare. In the healthcare sector, Blockchain networks are being utilized to securely store and exchange patient data across hospitals, diagnostic laboratories, pharmacies, and medical practitioners. These enterprise applications can effectively identify and mitigate critical errors, including potentially hazardous ones within the realm of healthcare. Consequently, this enterprise technology holds the promise of enhancing the efficiency, security, and transparency of medical data sharing within the healthcare system. Moreover, it offers valuable tools for medical institutions to gain insights and improve the analysis of medical records. It visually represents the diverse capabilities, enablers, and the unified workflow process of Blockchain technology in supporting healthcare on a global scale. Additionally, the paper presents a thorough discussion of fourteen significant applications of Blockchain in healthcare, underscoring its pivotal role in addressing issues like deception in clinical trials.

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Pharmaceutical Drug Packaging and Traceability: A Comprehensive Review

Cited by 13 publications

References 21 publications

Global drug serialization in pharma sector: Complete review

Global drug serialization in pharma sector: Complete review

Serialized Drug Traceability in the Supply Chain Using Distributed Ledger Technology

Role of Enterprise Applications for Pharmaceutical Drug Traceability

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