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Abstracts (PDF file, 1.8MB) - Society for Risk Analysis

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SRA 2013 Annual Meeting <strong>Abstracts</strong><br />

T4-A.3 Kazemi, RK*; Rahaman, FR; Urban, JU; William Carter,<br />

WC; USFDA; rezakazemi@gmail.com<br />

A Probabilistic <strong>Risk</strong> <strong>Analysis</strong> (PRA) Framework <strong>for</strong><br />

Modeling <strong>Risk</strong> in Global Drug Supply Chain<br />

To make drug supply chain safer and more secure, we need<br />

models that can realistically and comprehensively characterize<br />

the risks associated with global drug supply chain. Most<br />

prescription (Rx) and over-the-counter (OTC) drugs consumed<br />

in the U.S. are manufactured in <strong>for</strong>eign facilities. The industry<br />

imports drugs as bulk active pharmaceutical ingredients (APIs),<br />

bulk finished dose <strong>for</strong>m (FDF) drug products <strong>for</strong> final packaging<br />

in the US, or FDF products in the final packaging <strong>for</strong> wholesale<br />

or retail marketing. It is estimated that 40 percent of finished<br />

drugs used by U.S. patients, and 80 percent of active<br />

ingredients and chemicals used in U.S. drugs are produced<br />

abroad. Globalization and underlying complexities in<br />

pharmaceutical supply chain have created opportunities <strong>for</strong><br />

criminal actors to take advantage of the weaknesses of the<br />

supply chain and to introduce substandard drugs that would<br />

reach and harm patients. A well publicized instance of such<br />

substandard drug that entered the drug supply chain, and<br />

claimed many lives, is the case of adulterated heparin. To<br />

ensure quality and safety of drugs consumed by patients, it is<br />

crucial to ensure drug component manufacturers and finished<br />

drug product manufacturers adhere to quality standards. It’s<br />

also critical to ensure the security of the supply chain which<br />

starts from raw material manufacturers to patients. Additionally<br />

a meaningful, efficient and effective oversight on the supply<br />

chain from the regulatory agencies is required to strengthen<br />

drug supply chain safety and security. In this study a<br />

probabilistic risk analysis (PRA) framework has been adapted to<br />

<strong>for</strong>mally identify and assess the vulnerabilities in the global<br />

drug supply chain and model the risk of counterfeit or<br />

substandard drugs reaching to patients.<br />

P.18 Kazemi, R*; Rahaman, F; Urban, J; USFDA;<br />

rezakazemi@gmail.com<br />

A Bayesian Belief Network (BBN) <strong>for</strong> Modeling <strong>Risk</strong> of<br />

Adverse Events Due to the Particulate Matter in<br />

Injectables<br />

Particles in injectable medications chiefly come from two main<br />

sources, intrinsic contaminants that result from manufacturing<br />

and packaging processes and extrinsic particles that are<br />

introduced at the time of administration to patients. These<br />

particles are generally considered to be harmful and can have<br />

many shapes or types (e.g. glass, metal, rubber, lamellae, etc.)<br />

and many sizes. Many factors play a role in determining<br />

whether these particles will have imminent effect of patient’s<br />

health, whether the particulates could cause serious health<br />

problems or death, temporary health problems or no serious<br />

adverse health reaction is expected at all. Among these factors<br />

are particulate pro<strong>file</strong> (e.g. type, size, etc.), amount of<br />

particulates administered to the patient, Route of<br />

administration, whether or not barriers will be effective to<br />

screen out the particulates (i.e. use of filters) as well as<br />

patient’s resistance factors. Due to the uncertainties involved in<br />

how these particles may influence risk of adverse events in<br />

patients, Bayesian Belief Network (BBN) <strong>for</strong>malism has been<br />

utilized to assess the risk of adverse events due to the injection<br />

of particulates. BBNs are probabilistic in nature and the<br />

uncertainty in assessing risk of adverse events, given the<br />

different states of all influencing factors can be explicitly<br />

expressed and modeled. Given patient’s conditions and the<br />

characteristics of the particles, the model will be able to assess<br />

the likelihoods of adverse events with their respective<br />

uncertainties.<br />

M4-G.4 Keller, C*; Sütterlin, B; Siegrist, M; ETH Zurich;<br />

ckeller@ethz.ch<br />

A comparison of spontaneous associations with nuclear<br />

power underlying its acceptance be<strong>for</strong>e and after the<br />

Fukushima disaster, and of associations with nuclear and<br />

solar energy resources<br />

After the nuclear accident in Fukushima, energy policies<br />

changed in some European countries. In Switzerland, <strong>for</strong><br />

example, the government decided to phase out nuclear power<br />

in the near future and to promote and expand renewable<br />

energy resources. To better understand public acceptance of<br />

the changed energy policy, spontaneous associations with<br />

nuclear power as well as with solar power and the affective<br />

evaluations of these associations were examined. A study was<br />

conducted among Swiss residents in 2012 (N=1211), after the<br />

Fukushima disaster. Slightly fewer than half of the sample<br />

(n=561) had already participated in a study in which<br />

associations with nuclear power were assessed in 2009, be<strong>for</strong>e<br />

the Fukushima disaster. The present study compared the<br />

spontaneous associations with nuclear power plants between<br />

2009 and 2012, and examined the relationship with the<br />

acceptance of nuclear power. In addition, the spontaneous<br />

associations with nuclear power were compared with<br />

associations with solar power. The affective evaluation of<br />

nuclear power was more negative in 2012 compared to 2009.<br />

However, the general pattern of associations with nuclear<br />

power underlying the acceptance of nuclear power did not<br />

change. Almost all associations with solar power were rated<br />

positively. People did not associate risk with solar power.<br />

Practical implications will be discussed.<br />

M4-I.1 Kenney, L*; Arvai, J; University of Calgary;<br />

lmkenney@ucalgary.ca<br />

Confronting risks and benefits of energy system<br />

improvements in developing communities: The case of<br />

Canada’s Northwest Territories<br />

Decisions about energy development and delivery are<br />

inherently complex: they must address the technical challenges<br />

of energy production and transmission, and because they<br />

involve and affect people; as such, these decisions must address<br />

a range of often conflicting values. Decision making processes<br />

cannot proceed without input from multiple stakeholders.<br />

Ultimately, untangling this complexity means making tradeoffs<br />

across economic, social, and environmental concerns, while<br />

accounting <strong>for</strong> risk and uncertainty related to dynamic coupled<br />

natural-human systems. In developing communities these kinds<br />

of decisions are made more challenging as a result of the<br />

unique characteristics that typify these locations: e.g., poorly<br />

developed infrastructure; limited government budgets; political<br />

systems lacking transparency; economic vulnerability; and low<br />

education levels. Moreover, the social, economic, political, and<br />

environmental systems in these areas are tightly linked;<br />

changes in one system can easily affect the others. Decisions<br />

about energy have significant consequences in terms of quality<br />

of life and, there<strong>for</strong>e, are often part of larger development<br />

agendas. A case in point is Canada’s Northwest Territories<br />

(NWT), which is home to significant variations in geography,<br />

infrastructure development, economic activity, cultural<br />

traditions, and governance arrangements. Under these<br />

challenging conditions the NWT government is attempting to<br />

re<strong>for</strong>m the region’s energy systems. This presentation reports<br />

the results of case study research conducted in the NWT<br />

between 2012 and 2013. We discuss the risks, challenges and<br />

benefits related to improving energy systems in developing<br />

communities. We then provide recommendations about how to<br />

structure decisions related to the energy development and<br />

delivery in the NWT so as to effectively meet a range of<br />

stakeholders’ objectives in a transparent and inclusive manner.<br />

December 8-11, 2013 - Baltimore, MD

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