Evidence map›Paper›PMID 36779022›Full record

ArticleBlockchain in healthcare today2022

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

Kathleen Hayes, Natalie Meyers, Christopher Sweet, Ayenew Ashenef, Tim Johann, Marya Lieberman, David Kochalko

Abstract read
In one paragraph

Article in Blockchain in healthcare today, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Kathleen HayesDepartment of Chemistry and Biochemistry, University of Notre Dame, Indiana, USA.ORCID https://orcid.org/0000-0003-1217-0050
Natalie MeyersLucy Family Institute for Data & Society, University of Notre Dame, Indiana, USA.ORCID https://orcid.org/0000-0001-6441-6716
Christopher SweetCenter for Research Computing, University of Notre Dame, Indiana, USA.ORCID https://orcid.org/0000-0001-8214-7177
Ayenew AshenefDepartment of Pharmaceutical Chemistry, School of Pharmacy, College of Health Sciences, Addis Ababa University, Ethiopia.ORCID https://orcid.org/0000-0003-2505-899X
Tim JohannDepartment of Chemistry, Roanoke College, Salem, Virginia, USA.ORCID https://orcid.org/0000-0003-2212-9684
Marya LiebermanDepartment of Chemistry and Biochemistry, University of Notre Dame, Indiana, USA.ORCID https://orcid.org/0000-0003-3968-8044
David KochalkoARTiFACTS, Cambridge, Massachusetts, USA.ORCID https://orcid.org/0000-0002-3331-2751

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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 1,000 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 the 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 these 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 the blockchain technology 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.

Indexed as

analytical chemistryblockchainledgerpharmaceuticalquality of medicinesupply chain

Identifiers

PMID36779022
PMCPMC9907419

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.