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