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Published byEmily Marsh Modified over 9 years ago
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Commitment to Preventing Opioid Abuse & Misuse
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The New Actavis Actavis (NYSE:ACT) markets a broad portfolio of branded and generic pharmaceuticals and develops innovative medicines for patients suffering from diseases principally in the Central Nervous System, Gastroenterology, Women’s Health, Urology, Cardiovascular, Respiratory and Anti-infective therapeutic categories. The Company is an industry leader in R&D, with one of the broadest brand development pipelines in the pharmaceutical industry, and a leader in the submission of generic product applications. Actavis has commercial operations in 60+ countries and operates 30+ manufacturing and distribution facilities around the world.
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The Pharmaceutical Supply Chain API Suppliers ManufacturersDistributors Pharmacy Patient/ Consumer
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The Supply Chain… What Manufactuers Can Control API Suppliers ManufacturersDistributors Pharmacy Patient/ Consumer
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Addressing Diversion API Suppliers ManufacturersDistributors Pharmacy Patient/ Consumer Reality To Make an Impact, We Need to Educate Pharmacists/Patients/Consumers about Their Role in Preventing Diversion/Abuse
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The Challenge: Balance Mitigate the opportunity for diversion while ensuring that patients have access to appropriate treatment Chronic pain is a major health issue 100 million Americans suffer with chronic pain Need to provide effective treatment for patients Yet misuse and abuse of pain medications is a significant societal issue ‒ Especially among teens It is a Complicated Issue
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Addressing the Issue In 2011, the White House Office of National Drug Control Policy (ONDCP) outlined a Prescription Drug Abuse Prevention Pla n Four Pillars ‒ Education ‒ Monitoring ‒ Proper disposal, and ‒ Enforcement Combat the issues holistically, across all disciplines –Highlights the critical role healthcare providers, law enforcement, manufacturers, wholesalers, parents and patients play in preventing prescription drug abuse –Working together
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Preventing Abuse & Misuse throughout the Product Lifecycle: Industry Perspective
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Industry and Diversion Prevention Raise awareness through education ‒ Risk Evaluation and Mitigation Strategies (REMS) ‒ Social Awareness campaigns ‒ Support national medicine disposal & monitoring initiatives Enhance product safety through R&D ‒ Support development of abuse deterrent formulations (ADF) ‒ Expand the use of abuse deterrent technologies Support the integration of federal and state prescription monitoring programs
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Industry and Diversion Prevention (continued) Supporting drug take-back and addiction rehabilitation programs Participate in defining industry involvement in working to minimize the risk of diversion ‒ Anti-Diversion Industry Working Group
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Our Commitment to Diversion/Abuse Education and Prevention
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Our Commitment to Preventing Diversion As a responsible manufacturer and a good corporate citizen to the communities where we conduct business, Actavis takes its responsibility to prevent drug diversion very seriously. Our commitment to preventing drug diversion is critical. Throughout our manufacturing and supply chain processes, we employ safeguards that work to ensure legitimate patients receive our medicines, while minimizing the risk of diversion. By engaging all Actavis team members on dangers of prescription drug abuse and the many things we can do as a company to safeguard against diversion, we achieve our mission of providing high quality, critical medicines while preventing abuse.
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Best Practices Throughout the Product Lifecycle Holistic Approach Receipt of API Manufacturing & packaging Distribution Advanced security standards based upon: Type of activity Type and form of controlled substances Geographic location Building construction Type of storage (safe/vault, etc.) Associated diversion methods
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Key Elements Personnel Security First line of defense Extensive background check Toxicology screening Pre-employment & periodic Access Control through procedural & physical means Authorized access Limited Access Areas Controlled substance activity areas Documentation Transactions Storage area access Shipping/receiving
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Manufacturing Operations Security Secure handling, movement, storage & accountability of controlled substance materials. -Use of digital video recording, electronic access control, locks, intrusion detection, to limit access and monitor activities within production areas -Designated observer policy -Pocketless uniforms -Two-person escort of CS material in-transit -Security Inspections -Tamper evident seals
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Distribution Security Prior to shipping controlled substance product Customer Registration Verification Customer Vetting Process Questionnaire/Site visit ‒ Type of business ‒ Customer base ‒ Percentage of controlled substance v. non- controlled ‒ Geographic location ‒ Previous sanctions ‒ Ordering history Suspicious Order Monitoring Disclose orders of unusual size, pattern & frequency Evaluate & investigate “orders of interest” Report suspicious orders to DEA field office
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Transportation Security “Freight at rest is freight at risk” Vulnerable point in supply chain Carrier Selection ‒ Established standards Site procedures ‒ Shipping/receiving ‒ Inspections/verification Shipment monitoring ‒ Route coordination ‒ Real time GPS monitoring technology
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Employee Engagement is Key Responsibility Obligation to report drug diversion Illicit Activities Subject to State or Federal prosecution Awareness By engaging all Actavis team members on dangers of prescription drug abuse and the many things we can do as a company to safeguard against diversion, we achieve our mission of providing high quality, critical medicines while preventing abuse.
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Actavis’ Industry-leading Commitment to Employee Diversion Education and Prevention
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Education Beyond Our Company: Actavis Commitment to Community Outreach
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