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New REMS Education Program Helps Increase Safe, Responsible Use of Opioid Analgesics for Pain Relief

Intensive Measurement Tools Verify Positive Outcomes on Prescribing Behavior and Patient Care

ST. LOUIS--(BUSINESS WIRE)--Sep. 8, 2014-- Assessments of a novel Continuing Medical Education (CME) initiative showed meaningful changes in opioid prescribing behavior and improvements in pain-patient outcomes. These assessments of REMEDIES (Risk Evaluation and Mitigation Strategies – An Employer-Driven CME Initiative for Efficacy and Safety) – were presented this past week at PAINWeek, the nation’s largest conference for clinicians with an interest in pain management.

Mallinckrodt Pharmaceuticals (NYSE: MNK) provided the regulatory framework for and served as the sole funder of this continuing medical education (CME) initiative, which trains prescribers on evidence-based approaches to optimize the evaluation, treatment and management of chronic pain. Opioid analgesics are a class of prescription medications intended to treat chronic pain, but they have a significant potential for abuse.

The REMEDIES program was developed to meet the goals of the class-wide Risk Evaluation and Mitigation Strategy (REMS) for extended-release and long-acting opioid analgesics, as required by the U.S. Food and Drug Administration.

“REMEDIES is a novel educational platform for prescribers and is intended to improve the quality of care for opioid-tolerant pain patients,” said Van Velle, President of Applied Clinical Education, a medical education company with 20 years of programming experience in the area of pain management. “The key factor that differentiates REMEDIES from other CME programs is an intensive assessment that measures changes in prescribing behavior and improvements in patient outcomes.”

The REMEDIES initiative was jointly provided by Global Education Group, an Accreditation Council for Continuing Medical Education (ACCME)-accredited provider, with commendation, and Applied Clinical Education.

“As a leader in prescription pain medicine, Mallinckrodt is committed to supporting programs that educate and encourage behavioral changes for health providers and patients to ensure that analgesic opioid use is beneficial, not harmful, to people in need of pain relief,” said Mario Saltarelli, MD, Chief Science Officer, Mallinckrodt Pharmaceuticals. “This report confirms that practical and engaging content, conveyed through a blend of learning methods, has a measurable impact as gauged by positive participant feedback and observed behavioral changes in opioid analgesic prescribing practices and use.”

The REMEDIES curriculum incorporates a variety of tools that include live symposia, interactive web-based activities, a three-stage performance improvement program, and a series of three patient screening and education activities that help healthcare providers navigate the clinical challenge of opioid prescribing.

REMEDIES Results Show Positive Impact on Prescribers, Patients

REMEDIES program goals include reaching more than 10,000 primary care physicians, pain specialists, nurse practitioners, physician assistants and other professionals involved in pain management; delivering educational content in three hours or less; and achieving continuing educational outcomes of Levels 1 through 7 as defined by the Moore Scale. The Moore Scale is a framework for continuing education programs that measures participation, satisfaction, learning, performance, patient health and community health, and it incorporates noncertified online educational resources for healthcare professionals and patients.

Outcome-assessment tools were developed to accurately measure the effects of knowledge, competence, performance and patient outcomes throughout all activities. The tools also measure reliability of self-reported clinician changes in confidence and practice behaviors with actual patient outcomes. Results through July 31, 2014, indicate a strong impact on program outcomes levels:

• Participation (Level 1) Outcomes: More than 21,000 participants (more than twice the goal), nearly 4,500 content completions, 4,231 evaluations and certificates, and more than 24,000 resource center visits.
• Satisfaction (Level 2) Outcomes: Evaluations found 98% of participants Agree or Strongly Agree that learning objectives were met, 97% Agree or Strongly Agree that faculty members were effective, and 97% Agree or Strongly Agree that activities were free from bias.
• Learning/Competence (Levels 3 and 4) Outcomes: Participants experienced a 39% increase in knowledge of curriculum topics and a 43% increase in confidence/competence.
• Performance (Level 5) Outcomes: Participants demonstrated an average 67% increase in applying the practice strategies learned.
• Patient Health (Level 6) Outcomes: 100 of 200 physicians enrolled met the criteria for opioid prescribing, and physician behavior increased 96% from stages A to C, with more than 300 patients documented in the ongoing program.
• Community Health (Level 7) Outcomes: Employees seeking medical care for 1 of 20 identified pain conditions increased 12.8%, with an 8.3% decrease in payments across 20 ICD-9 (insurance) codes and a collective saving of more than $58,000 among patient participants.

Partners collaborating in the development of REMEDIES included Global Education Group (CME provider and statistical analysis partner); Applied Clinical Education (joint provider and distribution partner); American Society of Pain Educators and National Association of Managed Care Physicians (education and distribution partners); Intelligent Medical Decisions (performance improvement partner); MedMatRX (education and employer liaison); and RealCME (technology and outcomes partner). REMEDIES will complete its certification in October 2014, at which time a final outcomes assessment will be performed and results published in a peer-reviewed scientific journal.

For more information about Mallinckrodt’s presence at PAINWeek, contact Mallinckrodt Medical Information at 1.800.788.7898 or at medinfo@mallinckrodt.com. Find more information about PAINWeek at painweek.org.

About Mallinckrodt

Mallinckrodt is a global specialty pharmaceutical and medical imaging business that develops, manufactures, markets and distributes specialty pharmaceutical products and medical imaging agents. Areas of focus include analgesics and central nervous system drugs for prescribing by office- and hospital-based physicians, and autoimmune and rare disease specialty areas like neurology, rheumatology, nephrology and pulmonology. The company's core strengths include the acquisition and management of highly regulated raw materials; deep regulatory expertise; and specialized chemistry, formulation and manufacturing capabilities. The company's Specialty Pharmaceuticals segment includes branded and specialty generic drugs and active pharmaceutical ingredients, and the Global Medical Imaging segment includes contrast media and nuclear imaging agents. Mallinckrodt has more than 5,500 employees worldwide and a commercial presence in roughly 65 countries. The company's fiscal 2013 revenue totaled $2.2 billion. To learn more about Mallinckrodt, visit www.mallinckrodt.com.

Source: Mallinckrodt Pharmaceuticals

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