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Commitment to Preventing Opioid Abuse & Misuse The New Actavis Actavis (NYSE:ACT) markets a broad...

Date post: 28-Dec-2015
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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

API Suppliers Manufacturers Distributors Pharmacy

Patient/Consumer

Reality

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 SecurityPrior to shipping controlled substance productCustomer 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

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


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