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The Endo risk minimization action plan was developed to reduce and control the potential risks of misuse,
abuse, and diversion associated with opioid analgesics. It focuses on appropriate drug labeling and promotion,
controls on distribution, proactive pharmacovigilance, extensive education of healthcare professionals, patients
and sales personnel, and support of clinically meaningful research. Key elements include:
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FDA-approved product labelling and responsible promotion:
All informational and promotional materials associated with our
product(s) undergo stringent reviews to ensure that they meet the
guidelines identified by the FDA.
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Diversion control in the supply chain:
Endo’s extensive opioid analgesic experience and
established procedures help ensure control of distribution.
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Surveillance:
To identify and track regional misuse and abuse trends, Endo utilizes proactive
pharmacovigilance and a variety of sources for data gathering, including the new National Addictions
Vigilance Intervention and Prevention Program (NAVIPPRO) monitoring system. This system, developed by Inflexxion, provides
real-time data to serve as an early warning system for misuse and abuse across the country.
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Education Intervention:
Educational intervention initiatives help healthcare professionals attempt to reach
the highest-risk age groups, including teens and young adults. Support from Endo will help myStudentBody.com provide key drug
education, helping to prevent abuse and misuse of prescription medications among college students.
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Employee and sales force training:
All relevant company employees, especially professional sales
personnel, are trained in the medical issues associated with opioid analgesics, the relevant regulations and
laws, the appropriate use of opioid medications, and risk management principles and responsibilities.
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