Evaluating REMS CE: A Standards Based Approach

MedBiquitous Annual Conference April 9, 2013

Evaluating REMS CE: A Standards Based ApproachGenesis of the ER/LA Opioid Analgesic REMS

Linda Kitlinski, Senior Director Clinical Development & Medical Science Department, EndoCo- Chair, CE Sub-team of the REMS Program Companies (RPC)

What is a Risk Evaluation and Mitigation Strategy (REMS)?

• A risk management plan that the FDA has determined is necessary to ensure that the benefits of a drug outweigh the risks of the drug.

A REMS is…

http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/FDCAct ChapterVDrugsandDevices/default.htm. Accessed March 15, 2013.

REMS Program Company (RPC) Members* Apotex, Inc. Endo Pharmaceuticals, Inc. Impax Janssen Pharmaceuticals,

Inc. Mallinckrodt, Inc.

(Covidien) Mylan Technologies, Inc. Noven Pharmaceuticals,

Inc. Par Pharmaceuticals Pfizer, Inc.

Purdue Pharma, L.P. Ranbaxy Pharmaceuticals,

Inc. Rhodes Pharmaceuticals, L.P. Roxane Laboratories, Inc. Sandoz, Inc. The PharmaNetwork, LLC VistaPharm, Inc. Watson Laboratories

* Updated March, 2013

Intersection of two major public health crises Opioid misuse & abuse, resulting in injury & death, has emerged

as major public health problem1

Morbidity, mortality, disability & costs of pain for >116 million Americans2

Broad impact of ER/LA Opioid Analgesic REMS 1.4 million prescribers/potential prescribers in DEA registration

database

320,000 active prescribers (wrote 1 ER/LA opioid Rx in 12 mo.)

>4 million unique patients

First use of accredited CE for delivering REMS education Collaboration among all stakeholders critical for success

ER/LA Opioid Analgesic REMS: Truly Unprecedented & Groundbreaking

1 http://www.fda.gov/downloads/drugs/drugsafety/informationbydrugclass/ ucm277916.pdf.2 IOM (Institute of Medicine). 2011. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education & Research. Washington, DC:The National Academies Press.

Genesis of ER/LA Opioid Analgesic REMS

' 09 Q12009

Q2-Q32009

Q42009

Q12010

Q2 2010

Q3-42010

Q12011

Q2-32011

Q42011

Q1-32012 ' 13

ER/LA Opioid REMS approval

(w/final Blueprint) (July

2012)

CE Blueprint in Fed Reg

(Nov 2011)

Sponsors submit proposed REMS

(Aug 2011)

FDA Opioid REMS meeting with

Industry (May 2011)

Advisory Committee meeting

(Oct 2010)

Advisory Committee meeting (Jul 2010)

Public meeting with IWG

(Dec 2009)

Public meeting of "Interested

Parties"

Sponsor meeting (May 2009)

Letters to Sponsors that

REMS is required (Feb 2009)

RPC CE RFAs (Aug-Nov 2013)

MedBiq Working Group Formed (July

2012)

Q4 2012- Q1 2013

RPC Grants Approved (Jan 2012)

First REMSCE (2/28/2013)

MEMS Specs & Implementation

Guide (Feb 2013)

REMS letter to Sponsors (Apr 2011)

Stakeholder meetings (Apr 2009)

First time accredited CE utilized for REMS “training”

Central component of the ER/LA Opioid REMS is voluntary education for DEA-registered prescribers delivered through accredited CE RPC provides educational grants to accredited providers who

develop/provide the CE

ACCME & other Accreditors’ standards already provide effective framework for assuring independence of REMS CE

The education must be provided at no cost, or nominal cost, to participants

Unprecedented opportunity for CE to positively impact patient safety and public health

Unparalleled engagement among REMS stakeholders CE Community, FDA, RPC, HCPs, Professional Organizations, Patient &

Consumer Advocacy Groups, Pain & Addiction Treatment Communities, Government Agencies, etc.

Leadership & insights of Accreditors/Conjoint Committee on CME have provided invaluable guidance to FDA & RPC on operationalizing the REMS

Genesis of the REMS: Importance of Collaboration and Transparent Communication

Utilizing CE for REMS “training” is a new paradigm Must adhere to FDA statutory/regulatory requirements, as well as the

standards for commercially-supported accredited CE

Potential for confusion/misinterpretation because of differences in Regulatory vs CE nomenclature

REMS Education Conundrum:

Uniform data set & collection system needed to aggregate data from numerous Providers/Accreditors for FDA reporting

Genesis of the REMS: Accompanying Challenges

Continuing Education REMS SuccessReflected in Outcomes

(Misuse, abuse)

CE Providers RPC

ACCME FDA

=

US healthcare is at a crossroads

Accredited CE is being asked to provide solutions.

Opportunity for CE to address the professional practice gaps of learners.

It is a Critical Time…

Opportunity

2002

2003

2007

2009

Continuing education is effective in assisting professionals to modify

and improve their practice

CE is Effective…

stakeholders…

Conjoint Committee on CMENovember 2007 Summit

Flashback….

ER/LA Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS) – Food and Drug Administration (08/2012)

“ The goal of this REMS is to reduce serious adverse outcomes resulting from inappropriate prescribing, misuse, and abuse of extended-release or long-acting opioid analgesics while maintaining patient access to pain medications.”

A new stakeholder…

…Education for prescribers of these medications, which will be provided through accredited continuing education (CE) activities supported by independent educational grants from er/la opioid analgesic companies…

• FDA developed core messages to be communicated to prescribers in the Blueprint for Prescriber Education

• FDA Blueprint will focus on the safe prescribing of ER/LA opioid analgesics

• Accrediting bodies and CE providers will ensure that the CE activities developed under this REMS will be in compliance with the standards for CE of the Accreditation Council for Continuing Medical Education (ACCME) or another CE accrediting body as appropriate to the profession.

FDA REMS Blueprint for Prescriber Continuing Education – August 2012

Role of the CE System

Facilitating Conditions…

Criteria 2. Incorporates into CME activities the educational needs (knowledge, competence, or performance) that underlie the professional practice gaps of their own learners.

Criteria 3. Generates activities/educational interventions that are designed to change competence, performance, or patient outcomes as described in its mission statement.

Criteria 5. The provider chooses educational formats for activities/interventions that are appropriate for the setting, objectives and desired results of the activity.

Criteria 11. The provider analyzes changes in learners (competence, performance, or patient outcomes) achieved as a result of the overall program’s activities/educational interventions.

FDA Blueprint for Prescriber Education for ER/LA Opioid Analgesics (08/2012)

“The expected results of the prescriber education in this REMS are that the prescribers will:

a. Understand how to assess patients…

b. Be familiar with how to initiate therapy, modify dose, and discontinue use…

c. Be knowledgeable about how to manage ongoing therapy…

d. Know how to counsel patients and caregivers…

e. Be familiar with general and product-specific drug information…”

Validity of Requirements

C7: The provider develops activities/educational interventions independent of commercial interests (SCS 1, 2 and 6).

C8: The provider appropriately manages commercial support (SCS3)

C9: The provider maintains a separation of promotion from education (SCS 4).

C10: The provider actively promotes improvements in health care and NOT proprietary interests of a commercial interest (SCS 5).

Independence

“…REMS CE is a process not a product. Accredited CE will

develop as a range of activity formats intended for a diverse

target audience. We expect some (CE) will be present on the

web, or in print, and some will occur where prescribers live,

work and learn. As I wrote in June 2011, Accredited CE is a

diverse array of activities done by a range of providers in a

multitude of formats on many topics, to address many needs, and

with a range of intended outcomes. The decisions on each of

these variables are made by the CE providers. This diversity

ensures that the right CE is available to all the professionals. We

expect that we will see this same diversity in REMS CE and that

the locus of control for these decisions will remain with the

providers.” Letter from Murray Kopelow, MD, CEO of ACCME to

Industry Working Group – October 2011

Independence

Evaluating REMS CE: A Standards Based ApproachFDA-mandated Requirements of the ER/LA Opioid Analgesic REMS

ER/LA Opioid Analgesic REMS Goal & RequirementsGoal:

Reduce serious adverse outcomes resulting from inappropriate prescribing, misuse, abuse, etc. while maintaining patient access to medications

REMS Requirements: Medication Guide to be dispensed with each Rx RPC REMS website: www.ER-LA-opioidREMS.com

No promotional content: REMS-related info only

Educational activities will be made available to all HCPs who prescribe ER/LA opioid analgesics

“REMS-compliant CE” must: Include all elements of FDA Blueprint in the educational

activity/materials Include post-activity assessment covering all sections of FDA

Blueprint Be subject to independent audit (CE Accreditors = auditors)

At least 10% of activities will be audited for compliance with Blueprint, compliance with assessment requirements & compliance with Accreditors’ standards for commercially-supported CE

ER/LA Opioid Analgesic REMS Website

ER/LA Opioid Analgesic REMS Requirements (cont’d)

First REMS CE must be available by March 1, 2013 Boston University launched first CE activity February 28, 2013 Searchable listing of RPC-supported REMS-compliant CE are posted

at www.ER-LA-opioidREMS.com

FDA-mandated “goals” for # of HCPs completing CE on full Blueprint

80,000 by March 2015 (25% of 320,000 active prescribers)

160,000 by March 2016 (50% of 320,000 active prescribers)

192,000 by March 2017 (60% of 320,000 active prescribers)

REMS & REMS CE notification letters with copy of Patient Counseling Document sent to: All DEA-registered prescribers for Schedule II & III drugs Professional Organizations & Licensing Boards

Assessments to FDA at 6 mo. post-REMS approval & annually thereafter http//www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformation

for PatientsandProviders/UCM311290.pdf Accessed March 12, 2013

Central component of the ER/LA Opioid Analgesics REMS is education for: Patients

Medication Guide to be dispensed to each patient along with Rx

Patient Counseling Document on risks/safe use to be utilized by Providers

Prescribers: Physicians, NPs, PAs, other “Prescribers” of ER/LA opioids

Prescriber education (see FDA Blueprint) must include information on: Assessing patients for treatment Initiating therapy, modifying dosing & discontinuing therapy Managing therapy & monitoring patients

How to recognize evidence of/potential for opioid misuse, abuse & addiction

Counseling patients & caregivers on safe use General drug information (class-wide characteristics) Specific drug information (table listing key safety info for each ER/LA

opioid)

Training/education will be developed & conducted by accredited CE providers under educational grants awarded by RPC

Requirements for Patient & Prescriber Education

Easiest path to site: Google “FDA ER LA Opioid REMS”

distribution mechanism

ActivitiesHours of

Instruction

132,768 952,736

Physician Participants

Non-Physician

Participants13,741,621 9,558,789

2011 Reporting Year

ACCMEAccredited

N = 687

StateMedicalSociety

AccreditedN = 1,392

Activities Hours of InstructionCourses 66,509 384,881Regularly scheduled series 22,766 451,040Internet (live) 2,078 6,144Test-item writing 132 997Committee learning 598 1,731Performance improvement 502 7,137Internet searching and learning 587 3,879Internet (enduring materials) 27,624 47,829Enduring materials (other) 7,097 39,549Learning from teaching 665 2,442Journal CME 4,136 6,870Manuscript review 74 238

~133,000 ~953,000

Where they live, work, learn

Role of MEMS

2009 MEMS: Data standard for organizations to bring together data from multiple systems about CE activities.

2013 MEMS 2.0: Revised to include standards for compiling data about REMS CE activities.

Role of MEMS

CE Providers record data about CE activities according to

MEMS 2.0 standard transmit to accreditors in XML format

ACCME and other AccreditorsAccept data about CE activities into their

databases which have been designed to conform to the MEMS 2.0 standard

Transmit data about REMS-compliant CME activities to third-party aggregator

PARS currently…

• Data descriptive of CME activities provided by ACCME and some SMS-accredited providers

• Used by providers each year to enable ACCME to:– select activities

for demonstration of Practice in Performance

– create ACCME’s Annual Report.

Optional Data that may be provided for each CME activity:• Provider activity identifier• Description of the activity

content, • Subcategories for courses, • AMA PRA Category 1 Credits

Designated,• Names of joint sponsors and

commercial supporters, • Nature of in-kind support, and • Some activity-specific income and

expense information

Required Data that must be provided for each CME activity:• Activity Type , Title, Date, and, if

applicable, Location• Sponsorship (Direct or Joint)• Hours of Instruction• Designed to change (Competence,

Performance or Patient Outcomes)?• Changes in (Competence, Performance

or Patient Outcomes) evaluated?• Number of physicians and non-

physicians who participated in the activity

• Commercial Support Received? (Y/N)- If Yes, # of Commercial Supporters, and nature of support (Monetary and/or in-kind)

PARS currently…

MEMS 1.0 Compliant

PARS for REMS-compliantRequired Data that will be collected for each REMS-Compliant CME activity:• Activity Type, Title, Date, and, if applicable, Location• Provider activity identifier• Sponsorship (Direct or Joint)• Hours of Instruction• Designed to change (Competence, Performance or Patient

Outcomes)?• Changes in (Competence, Performance or Patient

Outcomes) evaluated?• Number of physicians and non-physicians who participated

in the activity• Commercial Support Received? (Y/N)

- RPC Funded vs. Non-RPC Funded

• # of Prescribers that Successfully Completed the Activity

• # of Prescribers by Profession (i.e. physician, nurse practitioner or pharmacist)

• # of Prescribers by Practice Type (i.e. primary care, pain specialist, non-pain specialist)

MEMS 2.0Compliant

Accredited Provider Perspective

Emma Trucks, MPH(c)Administrative Manager

Boston University School of Medicine

www.scopeofpain.com

www.scopeofpain.com

When the rubber meets the road!

• Implementing specifications while MEMS 2.0 was still in development

• Considering the Learners’ Perspective:– How will a learner interpret a question?– Do questions make sense for our target audience?– Are there too many questions that will become a

barrier to completion?• Considering the Provider’s Perspective– Will we collect the information that we need?

Registration:Not as simple as it

seems!

www.scopeofpain.com

Defining Prescribers

• Vital for RPC and FDA reporting requirements

www.scopeofpain.com

Are you currently licensed to prescribe schedule II and schedule III opioid analgesics?

87%

11%

2%

YESNONot Sure

n (completers) = 246

www.scopeofpain.com

Within the last 12 months, have you prescribed opioids for any patients for equal to/greater than 3 months?

47%53%

YESNO

n (completers) = 246

www.scopeofpain.com

Within the last 12 months, have you prescribed extended release long-acting (ER-LA) opioids?

46%54%

YESNO

n (completers) = 246

www.scopeofpain.com

Within the last 12 months, have you prescribed opioids for any patients

for equal to/greater than 3 months?

47%53%

YES NO

Of those saying yes, how many are prescribing ER/LA opioids?

n (completers) = 246

Profession• Certificates vs.

Reporting

• FDA Requirements vs. CME perspective

www.scopeofpain.com

Profession

n (completers) = 246

www.scopeofpain.com

Practice Type

• What is the background of our participants?

• Clearly Defined Categories41%

13%

34%

12%

PCPPain SpecialistNon-Pain SpecialistN/A

Specialty

• Helpful outcomes tool

• Not required by FDA

www.scopeofpain.comn (completers) = 246

Evaluating REMS CE: A Standards Based ApproachREMS Assessment Reports to FDA: Bringing Our Collective Efforts Together

Compliance in implementing REMS requirements Dear HCP Letter to ±1,400,000 registered prescribers plus

Professional Orgs & Licensing Boards Call center established & reports of call activity Website active & reports of website activity Training through accredited CE Providers made available to all

prescribers

Attainment of “training” performance goals Number of prescribers completing CE as per timelines set by FDA

First goal: 80,000 by Feb 28, 2015

Annual reports for 2013 & 2014 will detail progress toward goals

Results of independent audits Long-term evaluation of CE outcomes

Prescriber knowledge, practice changes 6‐12 mo. post-CE

REMS Assessment Reports: Evaluating “Success” of the ER/LA Opioid Analgesic REMS (cont’d)

Prescriber Survey Levels of knowledge Changes in practice Awareness of REMS

Patient Survey Knowledge and awareness Receipt of Med Guide & Patient Counseling Document

Changes in adverse outcomes Misuse, abuse, overdose, addiction, death Surveillance monitoring

Interventions to Address Surveillance Findings Evaluation of drug utilization patterns

Levels of knowledge Changes in practice Awareness of REMS

REMS Assessment Reports: Evaluating “Success” of the ER/LA Opioid Analgesic REMS (cont’d)

ER/LA Opioid REMS = unparalleled opportunity for real collaboration to address a public health imperative

Despite complexities, the “can do” attitude of all stakeholders has resulted in meeting all goals to date

Open, transparent communication is imperative Interpretations, nuances & terminology differences can lead

to misunderstandings – don’t hesitate to ask clarifying questions

RPC is 100% committed to effective implementation of this important patient safety/public health initiative

Your role is critical to the ultimate success of the REMS & we very much appreciate your assistance!

Summary: ER/LA Opioid Analgesic REMS

Discussion