Securing the Chain of Custody and Integrity of Data in a Global North-South Partnership to Monitor the Quality of Essential Medicines




supply chain, blockchain in healthcare, analytical chemistry, blockchain, ledger, pharmaceutical, quality of medicine


Substandard and falsified (SF) pharmaceuticals account for an estimated 10% of the pharmaceutical supply chain in low- and middle-income countries (LMICs), where a lack of regulatory and laboratory resources limits the ability to conduct effective post-market surveillance and allows SF products to penetrate the supply chain. The Distributed Pharmaceutical Analysis Laboratory (DPAL) was established in 2014 to expand testing of pharmaceutical dosage forms sourced from LMICs; DPAL is an alliance of academic institutions throughout the United States and abroad that provides high quality, validated chemical analysis of pharmaceutical dosage forms sourced from partners in LMICs. Results from analysis are reported to relevant regulatory agencies and are used to inform purchasing decisions made by in-country stakeholders. As the DPAL program has expanded to testing more than 1000 pharmaceutical dosage forms annually, challenges have surfaced regarding data management and sample tracking. Here, we describe a pilot project between DPAL and ARTiFACTs that applies blockchain to organize and manage key data generated during the DPAL workflow, including a sample’s progress through the workflow, its physical location, provenance of metadata, and lab reputability. Recording time and date stamps with this data will create a permanent and verifiable chain-of-custody for samples. This secure, distributed ledger will be linked to an easy-to-use dashboard, allowing stakeholders to view results and experimental details for each sample in real time and verify the integrity of DPAL analysis data. Introducing this blockchain-based system as a pilot will allow us to test the technology with real users analyzing real samples. Feedback from users will be recorded and necessary adjustments will be made to the system before the implementation of blockchain across all DPAL sites. Anticipated benefits of implementing blockchain for managing DPAL data include efficient management for routing work, increasing throughput, creating a chain of custody for samples and their data in alignment with the distributed nature of DPAL, and using the analysis results to detect patterns of quality within and across brands of products and develop enhanced sampling techniques and best practices. 


Download data is not yet available.


World Health Organization. WHO Global Surveillance and Monitoring System for substandard and falsified medical products. Available from: [cited 13 December 2021].

World Health Organization. A study on the public health and socioeconomic impact of substandard and falsified medical products. Available from: [cited 13 December 2021].

Roth L, Bempong D, Babigumira JB, et al. Expanding global access to essential medicines: investment priorities for sustainably strengthening medical product regulatory systems. Global Health. 2018 Dec;14(1):1–2.

Ndomondo-Sigonda M, Miot J, Naidoo S, Dodoo A, Kaale E. Medicines regulation in Africa: current state and opportunities. Pharmaceut Med. 2017 Dec;31(6):383–97.

Bliese SL, Berta M, Lieberman M. Involving students in the distributed pharmaceutical analysis laboratory: a citizen-science project to evaluate global medicine quality. J Chem Educ. 2020 Oct 26;97(11):3976–83.

Weaver AA, Reiser H, Barstis T, et al. Paper analytical devices for fast field screening of beta lactam antibiotics and antituberculosis pharmaceuticals. Anal Chem. 2013 Jul 2;85(13):6453–60.

Kochalko D, Morris C, Rollins J. Applying blockchain solutions to address research reproducibility and enable scientometric analysis. InSTI 2018 Conference Proceedings. Centre for Science and Technology Studies (CWTS); 2018 Sep 11, pp. 395–403. Available from: [cited 22 February 2022].

Heaven D. Bitcoin for the biological literature. Nature. 2019 Feb 1;566(7742):141–3. Available from: [cited 22 February 2022].

Kochalko D. Making the unconventional conventional: how blockchain contributes to reshaping scholarly communications. Inf Serv Use. 2019 Jan 1;39(3):199–204.

Benchoufi M, Ravaud P. Blockchain technology for improving clinical research quality. Trials. 2017 Dec;18(1):1–5.

Choudhury O, Sarker H, Rudolph N, et al. Enforcing human subject regulations using blockchain and smart contracts. Blockchain in Healthcare Today. 2018. Available from: [cited 15 December 2021].

Javed IT, Alharbi F, Bellaj B, Margaria T, Crespi N, Qureshi KN. Health-ID: a blockchain-based decentralized identity management for remote healthcare. Healthcare. 2021;9(6):712–32.

Kuo T-T, Kim H-E, Ohno-Machado L. Blockchain distributed ledger technologies for biomedical and health care applications. J Am Med Inform Assoc. 2017 Nov 1;24(6):1211–20.

Attili S, Ladwa SK, Sharma U, Trenkle AF. Blockchain: the chain of trust and its potential to transform healthcare—our point of view. ONC/NIST Use of Blockchain for Healthcare and Research Workshop. Gaithersburg, MD: ONC/NIST; 2016. Available from: [cited 22 February 2022].

Bliese SL, Maina M, Were P, Lieberman M. Detection of degraded, adulterated, and falsified ceftriaxone using paper analytical devices. Anal Methods. 2019;11(37):4727–32.

United States Pharmacopeia. <1225> Validation of compendial procedures. 2021. Available from: [cited 15 December 2021].

Nakamoto, S. Bitcoin: a peer-to-peer electronic cash system. 2008; p. 9. Available from: [cited 15 December 2021].

Lennart A. Non-fungible token (NFT) markets on the Ethereum blockchain: temporal tevelopment, cointegration and interrelations (August 13, 2021). Available at SSRN: or

Mettler M. Blockchain technology in healthcare: the revolution starts here. 2016 IEEE 18th International Conference on e-Health Networking, Applications and Services (Healthcom); 2016, pp. 1–3.

Massaro M. Digital transformation in the healthcare sector through blockchain technology. Insights from academic research and business developments. Technovation. 2021;102386.

Mistry C, Thakker U, Gupta R, et al. MedBlock: an AI-enabled and blockchain-driven medical healthcare system for COVID-19. ICC 2021—IEEE international conference on communications; 2021, pp. 1–6.

Taylor P. Applying blockchain technology to medicine traceability. Available from: -.WFnPQ7GZNzg [cited 22 February 2022].

Mackey TK, Kuo TT, Gummadi B, et al. ‘Fit-for-purpose?’—challenges and opportunities for applications of blockchain technology in the future of healthcare. BMC Med. 2019 Dec;17(1):1–7.

Sylim P, Liu F, Marcelo A, Fontelo P. Blockchain technology for detecting falsified and substandard drugs in distribution: pharmaceutical supply chain intervention. JMIR Res Protoc. 2018;7(9):e10163.

Clauson K, Breeden EA, Davidson C, Mackey TK. Leveraging blockchain technology to enhance supply chain management in healthcare: an exploration of challenges and opportunities in the health supply chain. Blockchain Healthcare Today. 2018;1.

Tseng JH, Liao YC, Chong B, Liao SW. Governance on the drug supply chain via gcoin blockchain. Int J Environ Res Public Health. 2018;15(6):1055.

Vruddhula S. Application of on-dose identification and blockchain to prevent drug counterfeiting. Pathog Glob Health. 2018;112(4):161.

Mackey TK, Nayyar G. A review of existing and emerging digital technologies to combat the global trade in fake medicines. Expert Opin Drug Saf. 2017;16(5):587–602.


2022-03-21 — Updated on 2022-03-22

How to Cite

Hayes, K., Meyers, N., Sweet, C. ., Ashenef, A. ., Johann, T., Lieberman, M., & Kochalko, D. . (2022). Securing the Chain of Custody and Integrity of Data in a Global North-South Partnership to Monitor the Quality of Essential Medicines. Blockchain in Healthcare Today, 5(S1).



Proof of Concept/Pilots/Methodologies