Transcript Drug Overdose Prevention

Commitment to Preventing Opioid Abuse & Misuse
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.
The Pharmaceutical Supply Chain
API
Suppliers
Manufacturers
Distributors
Pharmacy
Patient/
Consumer
The Supply Chain… What Manufactuers Can Control
API
Suppliers
Manufacturers
Distributors
Pharmacy
Patient/
Consumer
Addressing Diversion
Reality
API
Suppliers
Manufacturers
Distributors
Pharmacy
Patient/
Consumer
To Make an Impact, We Need to Educate Pharmacists/Patients/Consumers
about Their Role in Preventing Diversion/Abuse
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
Addressing the Issue
In 2011, the White House Office of National Drug Control Policy
(ONDCP) outlined a Prescription Drug Abuse Prevention Plan
• 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
Preventing Abuse & Misuse throughout the
Product Lifecycle: Industry Perspective
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
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
Our Commitment to Diversion/Abuse
Education and Prevention
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.
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
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
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
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. noncontrolled
‒ 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
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
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.
Actavis’ Industry-leading Commitment to Employee
Diversion Education and Prevention
Education Beyond Our Company:
Actavis Commitment to Community Outreach