**13. Pharmaceutical manufacturing and distribution: a clear health security concern**

In 1982, seven people died in the greater Chicago, Illinois metropolitan area after consuming acetaminophen that had been intentionally laced with potassium cyanide [257]. While the response by the drug manufacturers has since been widely recognized and praised as a textbook case in corporate crisis and public relations management, the greater concern was the recognition of how vulnerable pharmaceuticals are to potential tampering and bioterrorism [258, 259]. As a result, the United States Food and Drug Administration (US FDA) and Federal Government—working jointly with pharmaceutical manufacturers—established

harsh anti-tampering laws and guidelines to limit the risk of further contamination of the drug supply [260, 261].

However, it became clear that such "tampering" events—especially if intentional—can occur on a global scale [258, 259]. This is particularly true when one considers the extensive worldwide supply-chain manufacturing process that is involved in the production of consumer pharmaceuticals. Even slight changes in a drug's production—be it the initial recipes, mixing with drug stabilizers, buffers, or binders, all the way to packaging and distribution—can have catastrophic, if not fatal, consequences. The complexity of pharmaceutical development and distribution illustrates that there are numerous opportunities for sabotage, bioterrorism, neglect, or various forms of human error [262, 263]. Even local events can spark worldwide concerns and public fear. Any breakdown, intentional or otherwise, can compromise the safety of medications that millions depend on for their daily health. Potential observed effects may include avoidance of long-term maintenance medications, clinically significant manifestations of fear, and tremendous economic damage related to combined supply chain disruptions, in addition to increased downstream health-care costs.

While there are safeguards built into the entire process to assure pharmaceutical purity—including oversight by government agencies, such as the US FDA and European Union (EU) European Medicines Agency (EMA)—the system is not without potential risk. Many LMIR areas are challenged by the lack of appropriate regulatory oversight, government penalties, and even public (i.e., public company shareholders) accountability. In addition, pharmaceuticals that are no longer protected by intellectual property laws may be manufactured and distributed worldwide with lower regulatory or quality oversight [264, 265]. In fact, many wellestablished pharmaceuticals can vary significantly in their drug bio-availabilities and potencies depending on how and where they are manufactured [266, 267].

#### **14. Conclusions**

International health security is a complex and highly heterogeneous area of expertise. The American College of Academic International Medicine IHS Consensus Group (ACAIM-CG) developed a summative assessment highlighting the main issues that can impact IHS including emerging infectious diseases; chronic health conditions; bioterrorism; planetary changes (volcanic eruptions, earthquakes, wildfires, and climate change); nuclear incidents; information and cyber health; industrialization; globalization; pharmaceutical production; and communication platforms (social media). These concerns can directly and indirectly impact IHS both in the long and short term. When considering each IHS component, we aim to emphasize the utility of applying a predefined framework to effectively approach health security threats. This framework comprises of prevention, detection, assessment, reporting, response, addressing needs, and the ongoing repetition of this cycle (inclusive of appropriate mitigation measures). It is hoped that this collective work will provide a foundation for further research within the redefined, expanded scope of IHS.

#### **Acknowledgements**

The authors of this manuscript would like to thank all members of the ACAIM International Health Security Consensus Group, including non-author contributors, for their input and guidance throughout the process of drafting this important publication.

**29**

**Author details**

Tamara Worlton8

Thomas J. Papadimos<sup>5</sup>

and Stanislaw P. Stawicki17\*

, Manish Garg2

provided the original work is properly cited.

, Ricardo Izurieta<sup>3</sup>

2 Department of Emergency Medicine, New York Presbyterian Hospital, Cornell

© 2020 The Author(s). Licensee IntechOpen. This chapter is distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/ by/3.0), which permits unrestricted use, distribution, and reproduction in any medium,

Harry L. Anderson III12, Rebecca Jeanmonod13, Donald Jeanmonod13, Ijeoma Nnodim Opara14, Kristiana Kaufmann15, Juan A. Asensio16

, Bonnie Arquilla6

1 University of South Florida College of Medicine, Florida, USA

and Columbia University Schools of Medicine, New York, NY, USA

, Michael S. Firstenberg<sup>9</sup>

, Sona M. Garg4

, Andrew C. Miller7

,

, Sagar Galwankar10, Sunil Raina11,

, Abbas M. Khan7

,

Nicole K. Le1

*International Health Security: A Summative Assessment by ACAIM Consensus Group*

*DOI: http://dx.doi.org/10.5772/intechopen.93214*

CHC chronic health condition CHS cyber health security

HIR high-income regions

PC planetary changes PCC planetary climate change PHE public health emergency PHI protected health information

POC point-of-care

SM social media

EID emerging infectious diseases

IHS international health security LMIR low- and middle-income regions NGO nongovernmental organization

PTSD post-traumatic stress disorder SA summative assessment SDH social determinants of health

BT bioterrorism CG consensus Group

EOL end-of-life GH global health

**Glossary**

*International Health Security: A Summative Assessment by ACAIM Consensus Group DOI: http://dx.doi.org/10.5772/intechopen.93214*

## **Glossary**

