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OPIOID USE IN CHRONIC NON-CANCER PAINThe Past, Present and Future

Shameik Brooks, Pharm.D.

Ambulatory Care Clinical Pharmacist

UF Health Jacksonville

I have no actual or potential conflicts of interest to disclose concerning possible financial or personal relationships with commercial entities that may have direct or indirect interest in the subject matter of this presentation.

At the end of this presentation the participants should be able to:

Identify causes of widespread use of opioids for CNCP

Discuss present implications of opioid misuse

Utilize strategies to ensure appropriate use of opioids for CNCP

CNCP = Chronic Non-Cancer Pain

Opium Available in US before 1800s Recommended for numerous conditions

Morphine Opium derivative, discovered in 1804 Manufactured legally from domestic/imported poppy seeds Invention of the hypodermic needle in 1870s increased use

Heroin Discovered in 1874 Bayer Pharmaceuticals marketed heroin as cough suppressant in 1898 Used as treatment for tuberculosis, pneumonia Commonly prescribed into 1920s

Frakt. New York Times 2014.King County Bar Association 2005.http://www.merriam-webster.com/top-ten-lists/top-10-words-from-trademarks-vol-1/heroin.html

Porter et al Evaluated records of 39,946 patients to

determine addiction rates

Results 11,882 patients received at least one

opioid 4 cases of addiction in patients with no

history of drug abuse 2 Meperidine, 1 Percodan®, 1 hydromorphone

Conclusion Addiction rare in patients with no history

of drug abuse

Perry et al Evaluated management of pain during

burn debridement 4 questionnaires sent to 151 burn units 181 completed questionnaires

Results 67% used morphine or meperidine ~50% used psychotropic drugs with opioids No cases of iatrogenic addiction in ≥10,000

patients treated 22 patients reported drug abuse after

discharge, all had prior history of drug abuse

Conclusion Unable to determine most effective method

of analgesia

Perry et al. Pain 1982;13:267–280. Zee AV. Am J Public Health 2009; 99(2): 221–227.Porter et al. N Engl J Med 1980;10;302(2):123. Portenoy et al. Pain1986;25(2):171-86.

Portenoy et al Evaluated indication, course, safety, efficacy Retrospective review of 38 patients Regimens included oxycodone, methadone, codeine

Results 50% treated for > 4 years, 15% treated for > 7 years 67% prescribed < 20 mg morphine equivalents per day 10% prescribed > 40 mg morphine equivalents per day 63% experienced adequate pain relief No toxicity reported Management difficult in 2 patients, both with history of drug abuse

Conclusion Therapy is safe, beneficial, more humane

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Rosenthal. New York Times 1993.

American Pain Society (APS) first introduced idea in 1995 Elevated level of importance for better management

Adopted by the Veterans Health Administration and The Joint Commission

Pain assessments routine in hospitals and clinics HCAHPS Scores

Contributed to increased opioid prescribing Some prescribers lack training to treat pain Writing a Rx is efficient

Frakt. New York Times 2014.Morone et al. Clin Ther 2013; 35(11): 728–1732. HCAHPS = Hospital Consumer Assessment of Healthcare Providers and Systems

Mularski et al. Evaluated impact of “Pain as the 5th Vital Sign” initiative Retrospective medical records review at a single Veteran Affairs medical center Compared 300 pre-initiative and 300 post-initiative visits

Results and conclusion

Mularski et al. J Gen Intern Med 2006;21:607-612.

Effective pain management a part of quality medical practice

Cause of inadequate pain control Deficient pain management knowledge Insufficient understanding of addiction Fear if sanctions, investigations

First adopted 1998 Created to clarify the Board’s stance on

pain control Ease physician hesitation Improve management of pain

Overview Opioids may be essential for chronic pain Management based on knowledge and research Utilize both pharmacologic and non-

pharmacologic treatments Promptly assess and treat pain Increase quantity and dosing frequency based

on pain duration and intensity Tolerance and physical dependence normal, not

same as addiction Prevent drug diversion Do not fear disciplinary action if prescribing

controlled substances for legitimate medical purpose in usual course of practice

Federation of State Medical Boards (FSMB). Model Guidelines for the Use of Controlled Substances for the Treatment of Pain,1998.

Purdue Pharma introduced OxyContin® in1996

Marketing strategy Hosted all expense paid conferences Targeted top opioid prescribers Bonuses for sales reps Coupon program Branded promotional items Minimized addiction risk

↑ Sales from $48 million in 1996 to $1.1 billion in 2000

↑ Rxs from ~ 670,000 in 1997 to 6.2 million in 2002

CNCP = Chronic Non-Cancer PainZee AV. Am J Public Health 2009; 99(2): 221–227.http://addicthelp.org/wp-content/uploads/oxycontin-addiction-300x299.jpg

OxyContin® most abused drug by 2004 First reported in 1999 68% of oxycodone extracted from

crushed tablets Swallowed, inhaled, injected

Criminal charges for misbranding “Less addictive and less subject to abuse

and diversion than other opioids” Purdue Pharma and 3 executives plead

guilty in 2007 Paid $634 million in fines

CNCP = Chronic Non-Cancer PainZee AV. Am J Public Health 2009; 99(2): 221–227.http://www.davegranlund.com/cartoons/wp-content/uploads/arc18.jpg

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Committee on Finance sends letters requesting documentation in 2012“Recent investigative reporting from the Milwaukee Journal Sentinel/MedPage Today andProPublica revealed extensive ties between companies that manufacture and market opioids andnon-profit organizations such as the American Pain Foundation, the American Academy of PainMedicine, the Federation of State Medical Boards, the University of Wisconsin Pain and PolicyStudy Group, and the Joint Commission.”

The Joint Commission“In 2003, the GAO report pointed to Purdue’s partnership with the Joint Commission onAccreditation of Healthcare Organization (JCAHO) as possible means for Purdue to havefacilitated its access to hospitals to promote OxyContin. The report revealed that Purdue fundedover 20,000 pain-related educational programs through direct sponsorship or financial grants inaddition to funding the JCAHO pain management programs.”

FSMB“Specifically, the Sentinel reported that the Federation of State Medical Boards, with financialsupport from opioid manufacturers, distributed more than 160,000 copies of a model policy bookthat drew criticism from doctors because “it failed to point out the lack of science supporting theuse of opioids for chronic, non cancer pain.”

FSMB = Federation of State Medical BoardsGrassley et al. Letter to The Joint Commission 2012. Grassley et al. Letter to the Federation of State Medical Boards 2012.

Dr. Portenoy, New York pain specialist Advocated use of opioids to treat CNCP Past president of American Pain Society

Comments from Wall Street Journal interview "Did I teach about pain management, specifically about opioid therapy, in a way that

reflects misinformation? Well, against the standards of 2012, I guess I did" "I gave innumerable lectures in the late 1980s and '90s about addiction that weren't true” "Clearly, if I had an inkling of what I know now then, I wouldn't have spoken in the way that

I spoke. It was clearly the wrong thing to do” "Data about the effectiveness of opioids does not exist" "Do they work for five years, 10 years, 20 years?" "We're at the level of anecdote."

Catan et al. The Wall Street Journal 2012.https://u.osu.edu/kinney.64/files/2014/05/whendidichangemymind-1065sm4.jpg

Became most prescribed drug in 2009 Reclassified as Schedule II in 2014

No longer most prescribed Superseded by levothyroxine in 2014

IMS Institute for Healthcare Informatics, 2014.Volkow. National Institute on Drug Abuse 2014.http://www.cdc.gov/drugoverdose/epidemic/providers.html

National 3-fold increase from 2001 to 2013

Florida 61% increase from 2003 to 2009

National Institute on Drug Abuse 2015.Johnson et al. MMWR 2014; 63(26);569-574. Volkow. National Institute on Drug Abuse 2014.

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Centers for Disease Control and Prevention 2015.National Institute on Drug Abuse 2015.

Heroin in FL Cause of death in 89.7% of cases

involving drugs Deaths increased by 102.9 % compared

to 2013 May have been taken with

other drugs 90 % of deaths classified

as accidental Occurrences increased by 119.7%

compared to 2013

Florida Department of Law Enforcement 2015.Centers for Disease Control and Prevention 2015.

Florida Department of Law Enforcement 2015.

High unemployment, low income, lack of education

Majority of cases linked to oxymorphone abuse

Feb 2015 26 confirmed cases 4 preliminary positive > 80% Hepatitis C coinfection

September 2015 181 confirmed cases 0 preliminary positive

Interventions Job training HIV testing HIV care coordination Enrollment in state’s insurance plan Substance abuse referrals Needle exchange program Vaccines

Reel. Indiana State Department of Health 2015.Adams. Indiana State Department of Health 2015.O’Malley. Indiana State Department of Health 2015.

Manufactures Opana® (oxymorphone)

Introduced new abuse deterrent formulation

Requested FDA to rule old formulation unsafe

FDA denied request New formulation harder to crush and snort but easier to inject

Endo denies Opana® at fault for outbreak Blames generic formulations

Calabresi. Time 2015.http://www.opana.com/prescriber/Woodcock. Department of Health and Human Services 2013.

29 patients of Mountain Medical Center, West Virginia 8 law suits against 3 pharmacies Alleged pharmacists aware of the “pill mill”, filled controls too early and for excessive

time periods, filled contraindicated and “synergistic” combinations

One of three pharmacists sentenced 6 months federal prison, 1 year supervised release, > $500,000 in fines

Lowery. Drug Topics 2015.Gilchrist. Pharmacy Times 2015.Bonner. American Pharmacists Association 2015.http://www.sanfranciscosentinel.com/wp-content/uploads/2009/06/lawsuit-cartoon-2.jpg

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Florida’s PDMP Created in 2009, operational in 2011 Provide safer prescribing, decrease abuse and diversion Collects prescribing and dispensing data on Schedules II to IV Information reported within 7 days Cannot accept funds from pharmaceutical companies

Florida Health 2015. PDMP = Prescriptions Drug Monitoring ProgramE-FORCSE = Electronic-Florida Online Reporting of Controlled Substance Evaluation Program

Florida Health 2014. E-FORCSE = Electronic-Florida Online Reporting of Controlled Substance Evaluation Programhttp://www.floridahealth.gov/statistics-and-data/e-forcse/news-reports/2014-pdmp-annual-report-final.pdf

Florida Health 2014. E-FORCSE = Electronic-Florida Online Reporting of Controlled Substance Evaluation Programhttp://www.floridahealth.gov/statistics-and-data/e-forcse/news-reports/2014-pdmp-annual-report-final.pdf

90 of top 100 oxycodone prescribers were in FL

New laws passed in 2010 Inspection, prescribing, dispensing

requirements created

Pain clinic requirements State registration, physician-owner

> 50% decrease in oxycodone overdose deaths in 2012 First documented decline in overdose

deaths nationwide in past 10 years

Health Day. Medline Plus 2015. Rutkow et al. JAMA Intern Med 2015.Rapaport. The Huffington Post 2015.http://www.cdc.gov/drugoverdose/policy/successes.html

Overview Evaluated effect of new legislation on opioid prescribing and use Study period, July 2010 to September 2012 Florida as intervention state, Georgia as control state

Results 480 million prescriptions associated with 2.6 million patient, 431,890 prescribers,

2829 pharmacies 7.7% of prescriptions were opioids ↓ 1.4% in opioid prescriptions ↓ 2.5% in opioid volume ↓ 5.6% in morphine milligram equivalents per transaction

Conclusion PDMP and pill mill laws yielded modest reductions in prescribing and use ↓ greatest in providers and patients with highest baseline prescribing and use

Rutkow et al. JAMA Intern Med 2015. PDMP = Prescriptions Drug Monitoring Program

Walgreens-US alleged record-keeping and dispensing violations under the CSA

Jupiter Distribution Center Failed to report suspicious prescription drug

orders Allowed retail pharmacies receive at least

three times the FL average for controlled substances

6 retail pharmacies Received suspicious drug shipments from

distribution center Filled prescriptions they knew were not for

legitimate medical use Failed to properly mark hardcopy controlled

substance prescriptions outsourced to “central fill” pharmacy

$80 million to settle civil penalty claims

CVS- US alleged violations of the CSA and record-keeping regulations Created invalid “dummy” DEA numbers Filled prescriptions for prescribers with

invalid DEA numbers Maintained dispensing records with falsified

DEA numbers

$11 million to settle civil penalty claims

DEA = Drug Enforcement AgencyCSA = The Controlled Substance ActUnited States Drug Enforcement Administration 2013.

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NCPA Survey in 2014 Assessed controlled substance shipments over past 18 months ~1,100 pharmacies responded 75% experienced at least 3 delays 67.9% unable to order replacements from alternative suppliers

Legitimate patients unable to get opioids

Is the DEA responsible? Accused of targeting distributors to combat diversion and drug abuse Denies increased regulatory actions against distributors Maintains action only taken for violations

DEA = Drug Enforcement AgencyBuckley. American Pharmacist Association 2014.NCPA = National Community Pharmacists Association

Utilize non-pharmacologic therapies

Initiate non-opioids and adjuvants

Incorporate interventional treatments

Opioid prescribing Controlled substance agreement Screen for substance abuse/misuse Use E-FORCSE Track pain and function Track morphine milligram equivalent

used daily Avoid use of concomitant sedative-

hypnotics

Joint Commission Perspectives 2014; 34(1).Physicians for responsible opioid prescribing.

Substance Abuse and Mental Health Program Program within Department of

Children and Families Federal designation from SAMHSA

Treatment and referral services Available 24 hours a day, 7 days a week Online treatment facility locator Some programs with sliding fee scale

for uninsured

Florida Health 2015.National Institute on Drug Abuse 2012.SAMHSA = Substance Abuse and Mental Health Services Administrationhttp://www.drugabuse.gov/publications/principles-drug-addiction-treatment-research-based-guide-third-edition/frequently-asked-questions/how-effective-drug-addiction-treatment

Public health, safety concern with unused medications

National Prescription Drug Take-Back Days DEA collects expired, unwanted medications

780,000 lbs collected April 2014

> 4.1 million lbs collected since 2010

Secure and Responsible Drug Disposal Act of 2010 Enacted after 1st Take-Back Day

Certain DEA registrants may become authorized collectors

Provides safe and routine disposal

DEA = Drug Enforcement AgencyUnited States Drug Enforcement Administration 2014.http://www.davegranlund.com/cartoons/wp-content/uploads/Drug-take-back.jpg

Guidance published by FDA No legal requirements, only

recommendations Abuse-deterrent ≠ no abuse risk Abuse-deterrent ≠ tamper-resistant

Physical/chemical barriers Prevents chewing, crushing, cutting,

grating, grinding Resists opioid extraction OxyContin® (oxycodone) Hysingla®(hydrocodone)

Food and Drug Administration (FDA) 2015.http://www.quickmeme.com/meme/3tsgac

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Agonist/antagonist combinations Added to reduce euphoric effect Activated with manipulation of drug Tariniq® (oxycodone/naloxone) Embeda® (morphine sulfate/naltrexone)

Aversion Unpleasant effect if manipulated or

higher dose taken

Delivery system

New molecular entities/prodrugs

Combination

Novel approaches

Xtampza ®

Extended-release oxycodone Recently approved by FDA advisory panel DETERx technology Contains tiny beads of solution stored in

the capsule Contents may be directly placed in mouth,

feeding tube or sprinkled on soft food

Avridi ®

Immediate-release oxycodone Needs to be taken on an empty stomach Recently denied approval from FDA

advisory committee

Fiore. Medpage Today 2015.Food and Drug Administration 2015. http://www.scoop.it/t/naloxone/p/976391757/2012/01/12/keep-calm-and-carry-naloxone

Many factors contributed to the current opioid epidemic

Non-pharmacologic therapies should be incorporated in current practice

More safe, effective and abuse-deterrent options for pain management are needed

Pharmacists play an important role in educating prescribers and monitoring patients

Adams JM. HIV outbreak: why Austin? Why Indiana? Indiana State Department of Health. May 19, 2015. Available at:http://www.in.gov/isdh/files/May_19_HIV_Outbreak__Why_Austin__Why_Indiana_.pdf. Accessed August 28, 2015.

Bonner L. West Virginia ruling: People with addictions can sue pharmacists. American Pharmacists Association. May 26, 2015. Available at: https://www.pharmacist.com/west-virginia-ruling-people-addictions-can-sue-pharmacists. Accessed August 25, 2015.

Buckley B. Pharmacists turning away legitimate pain patients as wholesalers limit shipments of controlled substances. American Pharmacist Association February 13, 2014. Available at:http://www.pharmacist.com/pharmacists-turning-away-legitimate-pain-patients-wholesalers-limit-shipments-controlled-substance-0. Accessed August 21, 2015.

Calabresi M. FDA warned drugmaker about pain pill injection. Time June 8, 2015. Available at: http://time.com/3912539/fda-opana/. Accessed August 25, 2015.

Catan T, Perez E. A pain-drug champion has second thoughts. The Wall Street Journal December 17, 2012. Available at: http://www.wsj.com/articles/SB10001424127887324478304578173342657044604. Accessed September 9,2015.

Centers for Disease Control and Prevention. Today’s Heroin Epidemic: more people at risk, multiple drugs abused. July 7, 2015. Available at: http://www.cdc.gov/vitalsigns/heroin/. Accessed September 1, 2015.

Federation of State Medical Boards (FSMB). Model Guidelines for the Use of Controlled Substances for the Treatment of Pain. Washington, DC: The Federation, 1998.

Fiore K. FDA panel like new abuse-deterrent opioid- benefits in chronic pain patients with dysphagia outweigh safety concerns from food effect. Medpage Today September 12, 2015. Available at: http://www.medpagetoday.com/Neurology/PainManagement/53528. Accessed September 12, 2015.

Fiore K. FDA panel nix Avridi reformulation- panelists say safety concerns outweigh benefits of abuse-deterrent, immediate release oxycodone. Medpage Today September 11, 2015. Available at: http://www.medpagetoday.com/Neurology/PainManagement/53498. Accessed September 12, 2015.

Florida Department of Law Enforcement. Drugs identified in deceased persons by Florida medical examiners: interim report 2014. April 2015. Available at:https://www.fdle.state.fl.us/Content/Medical-Examiners-Commission/MEC-Publications-and-Forms/Documents/2014-Interim-Drug-Report-FINAL.aspx. Accessed September 2, 2015.

Florida Health. 2013-2014 Prescription drug monitoring program annual report. December 1, 2014. Available at: http://www.floridahealth.gov/statistics-and-data/e-forcse/news-reports/2014-pdmp-annual-report-final.pdf. Accessed August 21, 2015.

Florida Health. E-FORCSE home page. Available at: http://www.floridahealth.gov/statistics-and-data/e-forcse/. Accessed August 21, 2015.

Florida Health. Substance Abuse. Available at:http://www.floridahealth.gov/programs-and-services/prevention/substance-abuse/index.html. Accessed August 21, 2015.

Food and Drug Administration. Abuse-deterrent opioids-evaluation and labeling, guidance for industry. April 2015. Available at: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm334743.pdf. Accessed September 5, 2015.

Frakt A. Painkiller abuse, a cyclical challenge. New York Times December 22, 2014. Available at:http://www.nytimes.com/2014/12/23/upshot/painkiller-abuse-a-cyclical-challenge.html?emc=eta1&_r=1. Accessed August 22, 2015.

Gilchrist A. Drug abusers can sue pharmacists, state court rules. Pharmacy Times May 27, 2015. Available at: http://www.pharmacytimes.com/news/drug-abusers-can-sue-pharmacists-state-court-rules. Accessed August 25, 2015.

Grassley CE, Baucus M. Letter to the Federation of State Medical Boards. United States Senate Committee on Finance May 8, 2012. Availableat:http://www.finance.senate.gov/newsroom/chairman/release/?id=021c94cd-b93e-4e4e-bcf4-7f4b9fae0047. Accessed August 28, 2015.

Grassley CE, Baucus M. Letter to The Joint Commission. United States Senate Committee on Finance May 8, 2012. Available at:http://www.finance.senate.gov/newsroom/chairman/release/?id=021c94cd-b93e-4e4e-bcf4-7f4b9fae0047. Accessed August 28, 2015.

Health Day. Florida law may help lower abuse of prescription painkillers. Medline Plus August 17, 2015. Available at:https://www.nlm.nih.gov/medlineplus/news/fullstory_154138.html. Accessed August 28, 2015.

IMS Institute for Healthcare Informatics. Medicine use and shifting costs of healthcare: a review of the use of medicines in the United States in 2013 April 2014.

Johnson H, Paulozzi L, Porucznik C et al. Decline in drug overdose deaths after state policy changes- Florida, 2010-2012. Morbidity and Mortality Weekly Report (MMWR) 2014; 63(26);569-574.

Joint Commission Perspectives. Clarification of the pain management standard. November 2014, 34(1).

King County Bar Association. Effective drug control: toward a new legal framework. 2005. Available at: http://www.csdp.org/research/effectivedrugcontrol.pdf. Accessed September 1, 2015.

Lowery M. WV. court rules drug addicts can sue pharmacists. Drug Topics May 26, 2015.Available at: http://drugtopics.modernmedicine.com/drug-topics/news/wv-court-rules-drug-addicts-can-sue-pharmacists?page=full. Acceded August 25, 2015.

Morone NE, Weiner DK. Pain as the 5th vital sign: exposing the vital need for pain education. Clin Ther 2013; 35(11): 728–1732.

Mularski RA, White-Chu F, Overbay D et al. Measuring pain as the 5th vital sign does not improve quality of pain management. J Gen Intern Med 2006;21:607-612.

National Institute on Drug Abuse. How effective is drug addiction treatment. December 2012. Available at: http://www.drugabuse.gov/publications/principles-drug-addiction-treatment-research-based-guide-third-edition/frequently-asked-questions/how-effective-drug-addiction-treatment. Accessed September 1, 2015.

National Institute on Drug Abuse. Over dose death rates. February 2015. Available at: http://www.drugabuse.gov/related-topics/trends-statistics/overdose-death-rates. Accessed September 1, 2015.

O’Malley J. Indiana State Department of Health Investigates additional HIV cases tied to southeastern Indiana outbreak. Indiana State Department of Health. Accessed August 28, 2015. Available at: http://www.in.gov/isdh/files/August_28_ISDH__Investigates_Additional_HIV_Cases_Tied_To_Southeastern_Indiana_Outbreak.pdf. Accessed August 28, 2015.

Perry S, Heidrich G. Management of pain during debridement: a survey of US burn units. Pain 1982;13(3):267-280.

Physicians for responsible opioid prescribing. Cautious, evidence-based opioid prescribing.

Portenoy RK, Foley KM. Chronic use of opioid analgesics in non-malignant pain: report of 38 cases. Pain1986;25(2):171-186.

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Porter J, Jick H. Addiction rare in patients treated with narcotics. N Engl J Med 1980;302(2):123.

Rapaport L. Florida legislation aimed at opioid abuse tied to dip in prescriptions. The Huffington Post August 17, 2015. Available at:http://www.huffingtonpost.com/entry/florida-legislation-opioid-prescriptions_55d244a3e4b055a6dab11c23. Accessed August 17, 2015.

Reel A. HIV outbreak in southeastern Indiana. Indiana State Department of Health. February 25, 2015. Available at:http://www.in.gov/isdh/files/February_25__Outbreak_in_Southeastern_Indiana.pdf. Accessed August 28, 2015.

Rosenthal E. Patients in pain find relief, not addiction, in narcotics. New York Times March 28, 1993. Available at:http://www.nytimes.com/1993/03/28/us/patients-in-pain-find-relief-not-addiction-in-narcotics.html. Accessed September 5, 2015.

Rutkow L, Chang HY, Daubresse M et al. Effect of Florida’s prescription drug monitoring program and pill mill laws on opioid prescribing and use. JAMA Intern Med 2015.

United States Drug Enforcement Administration. CVS to pay $11 million to settle civil penalty claims involving violations of Controlled Substances Act . April 3, 2013. Available at: http://www.dea.gov/divisions/hq/2013/hq040313.shtml. Accessed September 1, 2015.

United States Drug Enforcement Administration. DEA’s ninth and final prescription drug take back day being held Saturday September 27 . September 23, 2014. Available at: http://www.dea.gov/divisions/hq/2014/hq092314.shtml. Accessed September 1, 2015.

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Zee AV. The promotion and marketing of OxyContin: commercial triumph, public health tragedy. Am J Public Health 2009; 99(2): 221-227.

OPIOID USE IN CHRONIC NON-CANCER PAINThe Past, Present and Future

Shameik Brooks, Pharm.D.

Ambulatory Care Clinical Pharmacist

UF Health Jacksonville