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.
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
“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
“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
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
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 firstname.lastname@example.org.
Find more information about PAINWeek at painweek.org.
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
Rhonda Sciarra, 314-654-8618
Senior Vice President, Communications
Vice President, Investor Relations