CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`APPLICATION NUMBER:
`
`022272Orig1s027
`
`RISK ASSESSMENT and RISK MITIGATION
`REVIEW(S)
`
`
`
`
`

`

`Department of Health and Human Services
`Public Health Service
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Surveillance and Epidemiology
`Office of Medication Error Prevention and Risk Management
`
`FINAL RISK EVALUATION AND MITIGATION STRATEGY (REMS)
`MODIFICATION REVIEW
`
`Date:
`Reviewers:
`
`Team Leader:
`
`August 13, 2015
`Danny S. Gonzalez, Pharm.D., M.S.
`Division of Risk Management
`
`Joan Blair, R.N., M.P.H.
`Health Communications Analyst, DRISK
`Kim Lehrfeld, Pharm.D., BCPS
`DRISK
`
`Acting Deputy
`Division Director
`Drug Name(s):
`Therapeutic Class:
`Dosage and Route:
`
`Reema Mehta, Pharm.D., M.P.H.
`DRISK
`OxyContin (oxycodone hydrochloride)
`Opioid Agonist
`10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, and 80 mg
`extended-release oral tablet
`Application Type/Number: NDA 022272
`Applicant/sponsor:
`Purdue Pharmaceuticals, LP
`
`*** This document contains proprietary and confidential information that should not be
`released to the public. ***
`
`Reference ID: 3805720
`
`

`

`INTRODUCTION
`1
`The purpose of this review is to document the Division of Risk Management’s (DRISK)
`evaluation of a proposed modification to the risk evaluation and mitigation strategy
`(REMS) for the extended release and long-acting (ER/LA) opioid analgesic REMS for
`OxyContin (oxycodone hydrochloride) (NDA 022272). On December 10, 2014, Purdue
`Pharmaceuticals, LP (Purdue) submitted prior approval supplement-0027 (PAS-0027)
`proposing to extend the current indication to pediatric patients 11 years of age and older.
`Initially, the Sponsor proposed changes only to the labeling and did not propose changes
`to the ER/LA Opioid Analgesic REMS. On July 30, 2015, the Sponsor was informed of
`the need to modify the ER/LA REMS and amended PAS-0027 on July 31, 2015 to
`include a proposed REMS modification. The Sponsor is currently a member of the REMS
`Program Companies (RPC) and will continue to market their product under the single,
`shared system ER/LA Opioid Analgesic REMS.
`
`1.1 BACKGROUND
`Oxycodone hydrochloride (HCl) is an opioid agonist indicated for the management of
`pain severe enough to require daily, around-the-clock, long-term opioid treatment and for
`which alternative treatment options are inadequate. The brand name for this product is
`OxyContin, which is part of the ER LA opioid analgesic drug class. OxyContin
`(oxycodone HCl) (NDA 22272) 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, and 80 mg
`extended-release oral tablet strengths were approved on April 5, 2010.
`
`In February 2009, FDA notified Sponsors of ER/LA opioid analgesics that their products
`would require a REMS to ensure that the benefits of those products continued to
`outweigh their risks.
`
`On July 9, 2012, FDA approved a single, shared system REMS for ER/LA opioid
`analgesic drug products.1 The ER/LA Opioid Analgesics REMS was approved with the
`following elements:
` Medication Guide
` Elements to Assure Safe Use
`o Prescriber Training
` Timetable for Submission of Assessments
`
`The REMS includes ER and LA opioid analgesic brand name and generic products
`indicated for the management of pain severe enough to require daily, around-the-clock,
`long-term opioid treatment and for which alternative treatment options are inadequate
`formulated with the following active ingredients: buprenorphine, fentanyl, hydrocodone,
`hydromorphone, methadone, morphine, oxycodone, oxymorphone, and tapentadol.
`
`
`1Details of the regulatory history, development, and rationale for the design of the REMS and REMS
`materials of the ER/LA Opioid Analgesic REMS are discussed in the Executive Memorandum, dated July
`6, 2012.
`
`Reference ID: 3805720
`
`

`

`1.2
`
`REGULATORY HISTORY
`
`The following is a summary of the regulatory history relevant to the proposed
`modification to the ER/LA Opioid REMS submitted under PAS —0027:
`
`December 10, 2014: The Sponsor submitted the Pediatric Study Report as part of PAS-
`0027; eCTD Seq. No. 0224 and requested 6 months of pediatric exclusivity. This
`submission supported their Pediatric Exclusivity Request and included proposed, revised
`prescribing information related to the proposed pediatric indication. The submission did
`not include a proposed ER/LA Opioid Analgesic REMS modification.
`
`May 18, 2015: The Sponsor submitted a revised version of section 12.3
`(Pharmacokinetics) of the Full Prescribing Information including additional pediatric
`data. The Sponsor did not submit include a proposed ER/LA Opioid Analgesic REMS
`modification.
`
`June 8, 2015: The Agency‘s
`
`or PAS-0027.
`
`June 10, 2015: The Agency
`0027.
`
`(”N0
`
`M“) for PAS-
`
`June 18, 2015: The Agency issued, via email, an updated version of the OxyContin
`prescribing information (PI) which included the proposed pediatric indication.
`
`June 25, 2015: The Sponsor submitted an amendment to the previous Agency IRs which
`summarized their commitment to conduct post-marketing requirements (PMR) including
`a drug utilization study (PMR #2923-1) and a post-market adverse event and medication
`error report (PMR # 2923-2) (PAS-0027; eCTD Seq. No. 254).
`
`July 30, 2015: The Agency issued, via email, comments to the Sponsor regarding
`modifications to the ER/LA REMS document and materials. The recommended
`
`modifications were reviewed by DRISK, DAAAP, and OPDP.
`
`July 31, 2015: The Sponsor submitted final REMS materials (PAS-0027; eCTD Seq. N0.
`0262), via the Gateway, for the Agency’s review. The Sponsor accepted all the FDA
`changes and added one proposed revision to Patient Counseling Document to
`accommodate average patient understanding. These materials are the focus of this review.
`
`2 MATERIALS REVIEWED
`
`2.1
`
`SUBMISSIONS
`
`0 Purdue Pharma, LP. Proposed ER/LA Opioid REMS Materials. Submitted via
`Gateway July 31, 2015 (PAS-0027; eCTD Seq. No. 0262).
`
`2.2 MATERIALS INFORMING THIS REVIEW
`
`The following is a list of materials that informed our review:
`
`0 Purdue Pharma, LP. Prescribing Information for OxyContin. Submitted via email
`June 15, 2015 (PAS-0027)
`
`0 Purdue Pharma, LP. Extended Release and Long Acting Opioid Analgesics
`REMS. Approved June 26, 2015.
`
`Reference ID: 3805720
`
`

`

` Lee K. OPDP REMS Review for OxyContin, July 24, 2015.
` Walker M. and Lee K. Patient Labeling Review, May 27, 2015.
` Gonzalez D. DRISK REMS Modification Review for OxyContin,
`August 13, 2015.
` Purdue Pharma, LP. Pediatric Exclusivity Determination Request for OxyContin.
`Submitted December 10, 2014 (PAS-0027; eCTD Seq. No. 0224)
`
`3 RESULTS OF REVIEW OF THE PROPOSED REMS
`
`3.1 REMS DOCUMENT
`The Sponsor did not propose changes to the REMS document.
`
`3.2 REMS APPENDED MATERIALS
`
`3.2.1 ER/LA Opioid REMS Blueprint
`The Sponsor incorporated the changes to the ER/LA REMS Blueprint provided by the
`Agency on July 30, 2015. The Sponsor did not propose additional changes; therefore,
`DRISK finds the Blueprint acceptable.
`
`3.2.2 Patient Counseling Document (PCD)
`The Sponsor proposed changing the phrase, "A child has unintentionally taken this
`medicine" to "A child has taken this medicine by accident." DRISK and DAAAP have
`agreed that this language will help patients and caregivers better understand the intended
`message. Therefore, the proposed change is acceptable.
`
`3.2.3 ER/LA REMS Website
`The Sponsor incorporated the changes to the ER/LA REMS Website provided by the
`Agency on July 30, 2015. The Sponsor did not propose additional changes; therefore,
`DRISK finds the Blueprint acceptable.
`
`3.2.4 Timetable for Submission of Assessments
`The Sponsor did not propose changes to the timetable for submission of assessments.
`
`3.2.5 Assessment Plan
`The Sponsor did not propose changes to the REMS assessment plan.
`
`4 DISCUSSION
`The Sponsor submitted a proposed REMS modification on July 31, 2015 based on the
`Agency's comments received during the review of PAS-0027. DRISK finds the proposed
`ER/LA Opioid REMS materials (attached) acceptable; therefore, DRISK recommends
`approval of the REMS appended to this review.
`
`Reference ID: 3805720
`
`3
`
`

`

`5 CONCLUSION
`In conclusion, the proposed REMS modification to incorporate the pediatric indication
`for OxyContin, received July 31, 2015, contains the appropriate and agreed upon
`revisions to the REMS as stipulated by the Agency. Therefore, the modified ER/LA
`Opioid REMS for OxyContin is acceptable and the Office of Surveillance and
`Epidemiology, DRISK recommends approval.
`
`6 RECOMMENDATIONS FOR THE REVIEW DIVISION
`DRISK recommends approval of the ER/LA Opioid REMS for OxyContin (oxycodone
`hydrochloride) (NDA 022272), received July 31, 2015 and as appended to this review.
`A REMS Modification Notification Letter should be sent to the other members of the
`ER/LA Opioid REMS to request the inclusion of these changes in their respective REMS.
`
`APPENDIX
`
`1. ER/LA Opioid Analgesic REMS Document and REMS Appended Materials
`
`Reference ID: 3805720
`
`4
`
`

`

`Initial REMS Approval: 07/2012
`
`
`
`
`Most Recent Modification: 08/2015
`
`
`
`
`
`EXTENDED—RELEASE (ER) AND LONG—ACTING (LA) OPIOID
`
`
`
`
`
`ANALGESICS RISK EVALUATION AND MITIGATION
`
`
`
`
`
`STRATEGY (REMS)
`
`
`
`
`
`
`Reference ID: 3805720
`Reference ID: 3805720
`
`5
`
`

`

`GOAL
`
`
`The goal of this REMS is to reduce serious adverse outcomes resulting from
`
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`inappropriate prescribing. misuse. and abuse of extended-release or long-acting (ER/LA)
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`opioid analgesics while maintaining patient access to pain medications. Adverse
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`outcomes of conceni include addictioni lulintentional overdose. and death.
`
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`I. REMS ELEMENTS
`
`
`
`A. Medication Guide
`
`
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`
`
`A Medication Guide will be dispensed with each ER/LA opioid analgesic
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`
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`
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`prescription in accordance with 21 CFR § 208.24.
`
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`The Medication Guides for ER/LA opioids are part of the ER/LA Opioid
`
`
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`Analgesic REMS program and will be available through the ER/LA Opioid
`
`
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`
`
`Analgesic REMS website www.ER-LA-opioidREMS.com.
`
`
`
`
`B. Elements to Assure Safe Use
`
`
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`
`
`
`. Training will be made available to healthcare providers who prescribe ER/LA
`
`
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`opioid analgesics.
`
`
`a. Training will be considered “REMS-compliant training“ tuider this
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`REMS if: 1) it. for training provided by CE providers. is offered by an
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`accredited provider to licensed prescribers. 2) it includes all elements
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`
`of the FDA Blueprint for Prescriber Education for Extended-Release
`
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`
`
`and Long—Acting Opioid Analgesics (“FDA Blueprint”): 3) it includes
`
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`a knowledge assessment of all of the sections of the FDA Blueprint.
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`and 4) it is subject to independent audit to confmn that conditions of
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`the REMS training have been met.
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`. The NDA/ANDA holders of ER/LA opioid analgesic products
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`(“NDA/ANDA holders") will ensure that REMS-compliant training is
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`made available to prescribers of ER/LA opioid analgesics and will
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`achieve the following perfonnance goals:
`
`
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`
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`i. Not later than March 1. 2013. the first REMS-compliant
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`training will be made available
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`ii. Within two years from the time the first REMS-compliant
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`training becomes available. 80.000 prescribers (based on 25%
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`
`of the 320.000 active prescribers in 2011) will have been
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`trained:
`
`iii. Within three years from the time the first REMS-compliant
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`training becomes available. 160.000 prescribers (based on 50%
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`of the 320.000 active prescribers in 2011) will have been
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`trained:
`
`iv. Within four years from the time the first REMS-compliant
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`training becomes available. 192.000 prescribers (based 011 60%
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`2
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`
`
`Reference ID: 3805720
`Reference ID: 3805720
`
`6
`
`

`

`C.
`
`
`d.
`
`
`of the 320.000 active prescribers in 2011) will have been
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`trained.
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`The content of the REMS-compliant training will be based 011 the
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`learning objectives established by the FDA Blueprint. The FDA
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`Blueprint contains core messages to be conveyed to prescribers in the
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`training about the risks and appropriate prescribing practices for the
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`safe use of ER/LA opioid analgesics. The NDA/ANDA holders will
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`direct providers of REMS-compliant training to the FDA Blueprint.
`
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`via the REMS website gwwwER-LA-opioidREMS.com). and via its
`
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`Request for Grant Applications. No less than annually. NDA/ANDA
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`holders will direct providers of REMS-compliant training to consult
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`the FDA Blueprint for possible revisions (e. g.. changes to the drug
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`specific information).
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`NDA/ANDA holders will ensure that independent audits of the
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`educational materials used by the providers of REMS-compliant
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`training are conducted. The audits must:
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`i. Be conducted by an auditor independent of the NDA/ANDA
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`holders. (Accreditation bodies of CE providers would be
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`considered independent of the NDA/ANDA holders and would
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`be eligible to conduct the audits.)
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`ii. Evaluate:
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`
`3.
`
`
`Reference ID: 3805720
`Reference ID: 3805720
`
`7
`
`
`1. whether the content of the training covers all
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`components of the FDA Blueprint approved as part of
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`the REMS:
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`2. whether the knowledge assessment measures
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`knowledge of all sections of the FDA Blueprint:
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`and
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`for training conducted by CE providers. whether the
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`training was conducted in accordance with the
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`standards for CE of the Accreditation Council for
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`Continuing Medication Educations (ACCME‘S). or of
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`another CE accrediting body appropriate to the
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`prescribers‘ medical specialty or healthcare profession.
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`iii. Be conducted on a random sample of 1) at least 10% of the
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`training funded by the NDA/ANDA holders. and 2)
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`REMS-compliant training not funded by the NDA/ANDA
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`holders but that will be counted towards meeting the
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`perfonnance goals in section B._1.b.
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`e. To facilitate prescriber awareness of the availability of the REMS and
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`REMS-compliant training. within 30 calendar days of the approval of
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`the REMS. the NDA/ANDA holders will make available. and then
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`

`

`maintain a web site that will contain infomiation about the REMS
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`specified below gwwwER—LA-opioidREMScom):
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`ii.
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`iii.
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`A current list of the REMS-compliant training that is supported
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`by educational grants from the NDA/ANDA holders. when this
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`information becomes available.
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`A copy of the Patient Counseling Document (PCD) on
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`Extended-Release/Long-Acting Opioid Analgesics.
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`A copy of the Prescriber Letters 1. 2. and 3 (when mailed and
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`for at least one year thereafter) (see section B.1.f).
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`f. To make prescribers aware of the existence of the REMS and the
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`prescriber training that will be made available under the REMS. the
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`NDA/ANDA holders will electronically deliver (email or fax). or
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`directly mail letters to all DEA-registered prescribers who are
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`registered to prescribe Schedule II and III dings:
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`i.
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`ii.
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`Prescriber Letter 1 will be sent not later than 60 days afier the
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`initial approval of this REMS. notifying prescribers of the
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`existence of the REMS and the fact that prescriber training will
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`be offered. and providing a copy of the
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`Patient Counseling Document (PCD).
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`Prescriber Letter 2 will be sent not later than 30 days before the
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`first prescriber REMS-compliant training required by the
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`REMS is offered by providers and will notify prescribers of the
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`innninent upcoming availability of accredited REMS CE
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`courses.
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`iii.
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`The prescribers will be identified via the DEA Registration
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`Database.
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`At least annually from the date of initial approval of the REMS.
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`the DEA Registration Database will be reviewed and Prescriber
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`Letter 3 will be sent to all newly DEA-registered prescribers
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`who are registered to prescribe Schedule II and III drugs to
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`inform them of the existence of the REMS. provide them the
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`Patient Cotuiseling Document (PCD). and notify them of the
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`availability of the REMS-compliant training and how to find
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`REMS-compliant courses.
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`g. To further enstue that prescribers are aware of the existence of the
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`ER/LA Opioid Analgesic REMS and the prescriber training that will
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`be made available under the REMS. the NDA/ANDA holders will
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`electronically deliver (email or fax). or directly mail the following two
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`letters to the professional organizations and state licensing entities
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`listed in section B.1.g.iii with a request that the information be
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`disseminated to their members:
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`iv.
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`Reference ID: 3805720
`Reference ID: 3805720
`
`8
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`i. Professional Organization/Licensing Board Letter 1 will be sent
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`not later than 60 days after the approval of this REMS.
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`notifying prescribers of the existence of the REMS and the fact
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`that prescriber training will be offered. and providing a copy of
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`the Patient Counseling Document (PCD) on
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`Extended-Release/Lorig-Acting Opioids.
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`ii. Professional Organization/Licensing Board Letter 2 will be sent
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`not later than 30 days before the fn‘st prescriber REMS-
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`compliant training required by the REMS is offered by
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`providers and will notify prescribers of the imminent upcoming
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`availability of accredited REMS CE courses.
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`iii. The letter and enclosures referenced above. will be sent to the
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`following entities:
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`a) State Licensing Boards of:
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`1) Medicine (allopathic and osteopathic)
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`2) Niu‘sing
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`3) Dentistry
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`b) Associations of State Licensing Boards:
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`1) Federation of State Medical Boards
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`2) National Council of State Boards of Nursing
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`3) American Association of Dental Boards
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`c) Learned Societies and Professional Associations. including.
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`but not limited to:
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`1) American Academy of Addiction Psychiatry
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`2) American Academy of Family Physicians
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`3) American Academy of Hospice and Palliative Medicine
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`4) American Academy of Neurology
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`5) American Academy of Nurse Practitioners
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`6) American Academy of Nursing
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`7) American Academy of Orofacial Pain
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`8) American Academy of Pain Management
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`9) American Academy of Pain Medicine
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`10) American Academy of Physical Medicine and
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`Rehabilitation
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`1 1) American Academy of Physician Assistants
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`Reference ID: 3805720
`Reference ID: 3805720
`
`9
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`12)American Association of Colleges of Osteopathic
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`Medicine
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`13)American Association of Colleges of Nursing
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`14) American Association of Poison Control Centers
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`15) American Board of Medical Specialties
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`16) American Board of Orofacial Pain
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`17) American College of Nurse Practitioners
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`18) American College of Osteopathic Family Physicians
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`19) American College of Physicians
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`20) American College of Rheumatology
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`2 1) American Dental Association
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`22) American Dental Education Association
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`23) American Medical Association
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`24) American Medical Directors Association
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`25) American Nurses Association
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`26) American Nurses Credentialing Center
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`27) American Osteopathic Association
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`28) American Osteopathic Association of Addiction
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`Medicine
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`29) American Pain Society
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`30) American Society of Addiction Medicine
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`3 1 ) American Society for Pain Management Nursing
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`32) American Society of Anesthesiologists
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`33)A1nerican Society of Pain Educators
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`34)Association of American Medical Colleges
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`35) Council of Medical Specialty Societies
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`36) Hospice and Palliative Nurses Association
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`37)Nationa1 Association of Managed Care Physicians
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`38)National Association of State Controlled Substances
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`Authorities
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`39) National Commission 011 Ce1tification of Physician
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`Assistants
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`40)Nationa1 Hospice and Palliative Care Organization
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`4 1 ) American College of Emergency Physicians
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`Reference ID: 3805720
`Reference ID: 3805720
`
`10
`10
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`

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`42) Society of Emergency Medicine Physician Assistants
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`11. NDA/ANDA holders will ensure that an interim single toll-free
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`number call center is implemented no later than July 23. 2012. and a
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`fully operational centralized call center is implemented no later than
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`90 calendar days after the approval of the REMS.
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`The following materials are part of the ER/LA Opioid Analgesic REMS and are
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`appended:
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`— Patient Counseling Document (PCD) on Extended-Release/Long—
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`Acting Opioid Analgesics
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`7 FDA Blueprint for Prescriber Education for Extended-Release and
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`Long-Acting Opioid Analgesics
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`— Prescriber Letter 1
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`— Prescriber Letter 2
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`— Prescriber Letter 3
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`— Professional Organization/Licensing Board Letter 1
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`— Professional Organization/Licensing Board Letter 2
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`— ER/LA Opioid Analgesic REMS website
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`gwww.ER-LA-opioidREMS.com)
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`II. Implementation System
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`The EFULA Opioid Analgesic REMS can be approved without the Elements to Assure
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`Safe Use specifically described under FDCA 505-1(f)(3) (B). (C). and (D) of the Act:
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`therefore an implementation system is not required.
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`III.Timetable for Submission of Assessments
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`REMS assessments will be submitted to the FDA at 6 months and 12 months afier the
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`initial approval date of the REMS (July 9. 2012). and annually thereafier. To facilitate
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`inclusion of as much infomiation as possible. while allowing reasonable time to prepare
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`the submission. the reporting interval covered by each assessment will conclude no
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`earlier than 60 days before the submission date for that assessment. The NDA holders
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`will submit each assessment so that it will be received by the FDA on or before
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`the due date based 011 the initial approval date of the REMS.
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`Reference ID: 3805720
`Reference ID: 3805720
`
`11
`ll
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`

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`Patient Counseling Document (PCD)
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`Patient Specific Information
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`Take this card with you every time you see your
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`healthcare provider and tell him/her:
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`- Your complete medical and family history,
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`including any history of substance abuse or
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`mental illness
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`If you are pregnant or are planning to become
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`pregnant
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`0 The cause, severity, and nature of your pain
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`- Your treatment goals
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`- All the medicines you take, including over-the-
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`counter (non-prescription) medicines, vitamins,
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`and dietary supplements
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`- Any side effects you may be having
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`0
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`Take your opioid pain medicine exactly as
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`prescribed by your healthcare provider.
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`Patient Counseling Document on Extended-
`Patient Counseling Document on Extended-
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`Release l Long-Acting Opioid Analgesics Release l Long-Acting Opioid Analgesics
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`Patient
`Patient
`Name:
`Name:
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`-
`.
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`-
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`The Q and DON’Ts of
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`Extended-Release / Long - Acting Opioid Analgesics
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`DO:
`. Read the Medication Guide
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`Take your medicine exactly as prescribed
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`Store your medicine away from children and in a safe
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`place
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`Flush unused medicine down the toilet
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`Call your healthcare provider for medical advice
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`about side effects. You may report side effects to
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`FDA at 1-800-FDA-1088.
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`Talk to your healthcare provider:
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`If the dose you are taking does not control your pain
`-
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`- About any side effects you may be having
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`. About all the medicines you take, including over-the-
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`counter medicines, vitamins, and dietary
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`supplements
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`DON’T:
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`Call 911 or your local emergency service right away if:
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`. You take too much medicine
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`- You have trouble breathing, or shortness of breath
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`- A child has taken this medicine by accident
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`a Do not give your medicine to others
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`. Do not take medicine unless it was prescribed for
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`you
`. Do not stop taking your medicine without talking
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`to your healthcare provider
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`. Do not cut, break, chew, crush. dissolve, snort, or
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`inject your medicine.
`If you cannot swallow your
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`medicine whole, talk to your healthcare provider.
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`. Do not drink alcohol while taking this medicine
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`For additional information on your medicine go to:
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`dailymed.n|m.nih.gov
`
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`
`Reference ID: 3805720
`Reference ID: 3805720
`
`12
`12
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`

`

`FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics
`
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`08/2015
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`Introduction for the FDA Blueprint for Prescriber Education for
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`Extended-Release and Long-Acting Opioid Analgesics
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`In April 2011, FDA announced the elements of a Risk Evaluation and Mitigation Strategy
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`(REMS) to ensure that the benefits of extended-release and long-acting (ER/LA) opioid
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`analgesics outweigh the risks. The REMS supports national efforts to address the prescription
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`drug abuse epidemic.
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`As part of the REMS. all ER/LA opioid analgesic companies must provide:
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`.
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`.
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`Education for prescribers of these medications, which will be provided through accredited
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`continuing education (CE) activities supported by independent educational grants from
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`ER/LA opioid analgesic companies.
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`Information that prescribers can use when counseling patients about the risks and benefits
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`of ER/LA opioid analgesic use.
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`FDA developed core messages to be communicated to prescribers in the Blueprint for
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`Prescriber Education (FDA Blueprint), published the draft FDA Blueprint for public comment.
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`and considered the public comments when finalizing the FDA Blueprint. This final FDA Blueprint
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`contains the core educational messages.
`It is approved as part of the ER/LA Opioid Analgesic
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`REMS and will remain posted on the FDA website for use by CE providers to develop the actual
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`CE activity. A list of all REMS-compliant CE activities that are supported by independent
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`educational grants from the ER/LA opioid analgesic companies to accredited CE providers will
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`be posted at www.ER-LA-ogicidREMS.com as that information becomes available.
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`The CE activities provided under the FDA Blueprint will focus on the safe prescribing of ER/LA
`
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`opioid analgesics and consist of a core content of about three hours. The content is directed to
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`prescribers of ER/LA opioid analgesics, but also may be relevant for other healthcare
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`professionals (e.g., pharmacists). The course work is not intended to be exhaustive nor a
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`substitute for a more comprehensive pain management course.
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`Accrediting bodies and CE providers will ensure that the CE activities developed under this
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`REMS will be in compliance with the standards for CE of the Accreditation Council for
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`Continuing Medical Education (ACCME)1‘2 or another CE accrediting body as appropriate to the
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`prescribers’ medical specialty or healthcare profession.
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`For additional information from FDA. including more detailed Questions and Answers about the
`
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`
`REMS for ER/LA Opioid Analgesics, see
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`http://www.fda.gov/Drugs/DrugSafety/lnformationbyDrugClass/ucm163647.htm.
`
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`
`
`‘Accreditation Council for Continuing Medical Education 2015 Accreditation Rfiuirements. Critena for CME Providers-Accreditation
`Criteria. Accessed on May 29, 2015.
`
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`‘Accreditation Council for Continuing Medical Education. 2015. Accreditation Requirements. Criteria for CME Providers—Standards
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`for Commercial Sumo. Accessed on May 29. 2015.
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`
`Reference ID: 3805720
`Reference ID: 3805720
`
`13
`13
`
`

`

`FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics
`
`
`
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`
`
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`
`
`08/2015
`
`
`
`FDA Blueprint for Prescriber Education for
`
`
`
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`
`
`Extended-Release and Long-Acting Opioid Analgesics
`
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`
`
`
`
`Why Prescriber Education is Important
`
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`
`Health care professionals who prescribe extended-release (ER) and long-acting (LA) opioid
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`analgesics (hereafter referred to as ER/LA opioid analgesics) are in a key position to balance
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`the benefits of prescribing ER/LA opioid analgesics to treat pain against the risks of serious
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`adverse outcomes including addiction, unintentional overdose. and death. Opioid misuse and
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`abuse, resulting in injury and death, has emerged as a major public health problem.
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`~
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`.
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`.
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`. Based on the 2010 National Survey on Drug Use and Health, public health experts estimate
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`more than 35 million Americans age 12 and older used an opioid analgesic for non-medical
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`use some time in their life—an increase from about 30 million in 2002.é
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`In 2009, there were nearly 343,000 emergency department visits involving nonmedical use
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`of opioid analgesics.é
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`In 2008, nearly 36,500 Americans died from drug poisonings, and of these, nearly 14,800
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`deaths involved opioid analgesics.5
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`Improper use of any opioid can result in serious side effects including overdose and death,
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`and this risk can be greater with ER/LA opioid analgesics.
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`Appropriate prescribing practices and patient education are important steps to help address this
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`public health problem. Health care professionals who prescribe ER/LA opioid analgesics have a
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`responsibility to help ensure the safe and effective use of these drug produ