A Mixed-Methods Framework Using Fragmentation to Establish Sampling Feasibility of Pharmaceuticals

25 Pages Posted: 9 Jul 2020

See all articles by Eugene Wickett

Eugene Wickett

Northwestern University - Department of Industrial Engineering and Management Sciences

Reut Noham

Northwestern University - Department of Industrial Engineering and Management Sciences

Theophilus Ndorbor

Ministry of Health, Liberia - Liberia Medical and Health Products Regulatory Authority

Karen Smilowitz

Northwestern University - Department of Industrial Engineering and Management Sciences

Date Written: May 15, 2020

Abstract

Substandard and falsified pharmaceuticals substantially increase levels of morbidity, mortality and drug resistance. These problems are most urgent in low- and middle-income countries. In the face of sophisticated counterfeiters, poor international coordination of global supply chains, and limited detection resources, pharmaceutical regulatory agencies in these countries require cost-efficient and systematic approaches to identify and act against substandard and falsified pharmaceuticals. Existing research has identified critical shortcomings in current surveillance. This paper proposes an iterative, mixed-methods framework that accounts for various factors of the regulatory environment and provides regulatory agencies with guidelines that can help focus limited sampling budgets more effectively. We demonstrate how knowledge of the patterns of substandard and falsified pharmaceuticals affects sampling budget requirements and enables tailoring of sampling plans. The suggested framework leverages risk differences by subdivisions of a pharmaceutical market (referred to here as fragments) to assess if feasible sampling policies exist and how policies can be efficiently tailored. Our work synthesizes existing models and guidelines with local stakeholder knowledge towards a more efficient deployment of valuable sampling resources. A case study applying this framework with the collaboration of the regulatory agency of Liberia is discussed.

Keywords: pharmaceutical supply chains, substandard and falsified medicines, mixed methods

Suggested Citation

Wickett, Eugene and Noham, Reut and Ndorbor, Theophilus and Smilowitz, Karen, A Mixed-Methods Framework Using Fragmentation to Establish Sampling Feasibility of Pharmaceuticals (May 15, 2020). Available at SSRN: https://ssrn.com/abstract=3628498 or http://dx.doi.org/10.2139/ssrn.3628498

Eugene Wickett (Contact Author)

Northwestern University - Department of Industrial Engineering and Management Sciences ( email )

2145 Sheridan Road
Room C210
Evanston, IL 60208
United States

Reut Noham

Northwestern University - Department of Industrial Engineering and Management Sciences ( email )

2145 Sheridan Road
Room C210
Evanston, IL 60208
United States

Theophilus Ndorbor

Ministry of Health, Liberia - Liberia Medical and Health Products Regulatory Authority ( email )

PO Box 1994 VP Road
Old Road
Monrovia, Montserrado County
Liberia

Karen Smilowitz

Northwestern University - Department of Industrial Engineering and Management Sciences ( email )

Evanston, IL 60208-3119
United States

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