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The Pill & the PENDULUM

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The Pill & the PENDULUM Jeffrey A Jacobs MD, MPH President, POEMS Associate Medical Director, WorkCare The Pill & The PENDULUM: An Evidence-based Approach to Avoid Opioid Overprescribing for Acute Pain Objectives At the conclusion of the presentation, the learner will be able to: • Name at least 3 factors, which led to the rise of opioid overprescribing in the United States since the 1990s. • Use recent evidence-based studies showing limited efficacy, poor risk/benefit ratio and delayed recovery when considering prescribing opioids for acute musculoskeletal pain • Compare and contrast the Prescription Drug Monitoring Programs found in each of the meeting component states (New York, New Jersey, Pennsylvania and Maryland Factors Which Led to the Rise of Opioid Prescribing 1. Pain Advocacy Groups- undertreatment of pain 2. Physicians- Medical literature; Pill mills 3. Federal & State Regulators 4. Big Pharma 5. Managed Care/Insurance Reimbursement Rates 6. Our Patients The Roots of Pain Advocacy 1970s- St. Christopher's Hospice- London Dame Cicely Saunders (RN) “dying in pain is inhumane- addiction doesn’t matter” 1980- WHO Ladder Stjernsward/Ventafridda “Freedom from pain is a universal human right” 1980s- Palliative Care Foley/Portnoy Sloan Kettering Institute (NYC) “Opiates should not be confined to just cancer patients but also to chronic non-cancer pain.” 1996- Pain as the 5th Vital Sign Dr. James Campbell “If pain were assessed with the same zeal as other vital signs are, it would have a much better chance of being treated properly. We need to train doctors and Quinones, Dreamland. nurses to treat pain as a vital sign”. Portnoy’s Complaint “These drugs [opioids] have certain characteristics, which, when interacting with a certain kind of brain, can lead to bad outcomes; but it’s not inherent in the pill such that everybody given that pill becomes an addict” Sam Quinones. Dreamland, p. 92. Portnoy’s Complaint “We conclude that opioid maintenance therapy can be a safe, salutary and more humane alternative to the options of surgery or no treatment in those patients with intractable non-malignant pain and no history of drug abuse.” Portnoy RK. Chronic Use of Opioid Analgesics in Non-malignant pain: Report of 38 cases. Pain 1986 May; 25(2): 171-86. The Letter that Launched a Billion Rxs 1995 FDA approves OxyContin- Time- released Oxycodone • Believed that it was less addictive- fewer surges of euphoria/depression • Allowed Purdue to claim that OxyContin had a lower potential for abuse than other oxycodone products due to time-release formula- cornerstone of company marketing strategy • Label warned patients not to crush tablets because that would release “a potentially toxic amount of the drug”- an invitation to a junkie • Didn’t realize OxyContin could be dissolved in water and injected • Supervisor of FDA’s team that reviewed application later left and joined Purdue Sam Quinones, Dreamland OxyContin Marketing • Emphasize small chance of addiction (<1%) • Personalize patient’s stories- “I got my life back” • Concentrate on heavy opiate physician prescribers • Visit RNs, pharmacists, hospices, hospitals and nursing homes • Incentivize sales force- bonuses • Oxy Swag • Pain Management/Speaker Training Seminars • CME- helped fund > 20K education programs • Funded Pain Societies and websites Sam Quinones, Dreamland Dollars Spent Marketing OxyContin (1996-2001) Source: United States General Accounting Office: Dec. 2003, “OxyContin Abuse and Diversion and Efforts to Address the Problem.” Pill Mills • Physician – DEA license to prescribe schedule II drugs – Rx’s written every month ($250 for visit) • Low Overhead- rent a building with a few offices/waiting rooms and hire staff – Dr. David Proctor- “The Godfather of the Pill Mill” – Dr. Frederick Cohn- saw up to 146 patients/day for 3 minutes each; 2.7 MM pills in 1 year – Dr. Fortune Williams- 2.3 MM pills in 9 months Sam Quinones, Dreamland The Oxy Economy • “Patient” gets #90 OxyContin 80 mg; #120 Oxycodone 30 mg and #90 Xanax bars – Split 50/50 with sponsor who drove them around to clinics and paid the $250 for clinic visit • Medicaid card pays for drugs ($800- $1200) • Cost- $250 for doctor visit and $3 co-pay for meds Sam Quinones, Dreamland “Tenderizing the Terrain” Sam Quinones- Dreamland • Factors which led to the “Opioid Epidemic” – Economic Factors • Loss of blue collar jobs – Unscrupulous Physicians • Pill Mills – Missionary zeal of pain treatment advocates • Pain is undertreated • You can’t become addicted – Criminal Pharma Marketing Mexican Black Tar Heroin Age-adjusted rate of drug overdose deaths, by state — 2010 and 2015 http://dx.doi.org/10.15585/mmwr.mm655051e1. (MMWR) Category Coverage (in BB $)/ (%) Cost (in BB $) Health Care Costs & 26/(89.9%)- covered by health 28.9 Substance Abuse Treatment insurance Productivity (includes -------------- 20.4 decreased productive hours & lost productivity for incarcerated individuals) Fatal Overdoses --------------- 21.5 Criminal Justice Costs Costs borne by state and 7.7 local governments Total Economic Burden of Rx 78.5 Opioid OD, Abuse and Dependence Where Are We Today? • It is estimated that 1 out of 5 patients with a non-cancer pain diagnosis is prescribed opioids in office-based settings with primary care providers accounting for about half of all opioid pain relievers dispensed. Daubresse M, Medical Care 2013. Why Use Opioids for Acute Pain? • Opioids provide superior analgesia to other medications. • Opioid safety profile is no worse than other medications. • You can’t get addicted to opioids given for non-cancer pain. • Opioids reduce pain effectively, thereby getting the employee back to work faster. Opioids Provide Superior Analgesia to Other Medications. ACOEM Practice Guidelines: Opioids and Safety- Sensitive Work (Hegmann, JOEM 2014) There were four quality trials of acute pain patients treated with opioids compared with placebo, with a small overall magnitude of benefit, whereas the adverse effects profile was high. • Among trials for treatment of acute pain, Ibuprofen was reportedly superior to Codeine or acetaminophen for acute injuries including fractures. • Diflunisal was equivalent to Codeine for sprains, strains, and mild to moderate LBP. Diflunisal was also superior to Codeine/APAP for LBP. • Valdecoxib was better-tolerated and trended toward greater pain relief than Tramadol for ankle sprains. Valdecoxib was equivalent to Oxycodone as assessed by pain ratings, but trended toward less rescue medication use and had fewer adverse effects among patients with spine and extremity pain. • Ketorolac was equivalent for pain relief, but superior to Meperidine (Demerol) regarding adverse effects for treating severe LBP. Ketorolac was also superior to codeine/acetaminophen for acute LBP treated in emergency departments. Opioid Safety Profile Is No Worse Than Other Medications. Acetaminophen Liver warning: This product contains acetaminophen. Severe liver damage may occur if: • Adult takes more than 12 caplets in 24 hours, which is the maximum dose • Taken with other drugs which contain acetaminophen Ask a doctor before use if the user has liver disease Opioids- Adverse Reactions • GI- constipation, nausea/vomiting • Somnolence • Insomnia • Sexual Dysfunction • Hyperalgesia • Tolerance/Addiction • Respiratory Depression You Can’t get Addicted to Opioids Given for Non-cancer Pain Initiation Into Prescription Opioid Misuse Among Young Injection Drug Users (IDUs) • 50 IDUs (volunteers) in NYC and LA • Mean age- 21; 70% male; 72% white; 48% did not complete HS; 66% currently homeless; 90% w/ hx of jail time; 75% w/ hx of Psych Dx • Type of Opioid Misused First: Vicodin > Oxycontin> Percocet • Mode of Administration: – Swallowing: 82% – Snorting: 16% – Injecting: 2% Initiation Into Prescription Opioid Misuse Among Young Injection Drug Users (IDUs) Age of Initiation (in years): – Marijuana- 12.5 – Alcohol- 12.8 – Opioids- 14.5 – Heroin- 16.6 Initiation Into Prescription Opioid Misuse Among Young Injection Drug Users (IDUs) Misuse of own Opioid Prescription: –72% had been prescribed an opioid in their lifetime (often for sports injuries or dental procedures) –40% of the above respondents reported their own prescription as the source of first opioid misuse (15 years old) I was taking it as prescribed but I still got a high feeling. It wasn’t intentional- doing it to actually get high. Then I told all my friends that I was getting pain pills and they’re like “Get ‘em and we’ll buy ‘em”. So when we went back to the doctor, I lied and said “Yes, it still hurts”. They prescribed me a lower dose and I traded some off and got Oxy” In Their Own Words • Heroin is better “high” than Rx Opioids (98%) • Ease of Inhalation/Injection (32%) • Heroin is cheaper and easier to obtain than Rx Opioids “It [OxyContin] was getting harder and harder to get the pills that you could use in a needle, most of them would just gel-up. And it was cheaper and easier to get the heroin, which was much stronger and would get you higher than Oxycodone” From: The Changing Face of Heroin Use in the United StatesA Retrospective Analysis of the Past 50 Years JAMA Psychiatry. 2014;71(7):821-826. doi:10.1001/jamapsychiatry.2014.366 Figure Legend: Percentage of the Total Heroin-Dependent Sample That Used Heroin or a Prescription Opioid as Their First Opioid of AbuseData are plotted as a function of the decade in which respondents initiated their opioid abuse. Copyright © 2014 American Medical Date of download: 7/4/2017 Association. All rights reserved. Opioid-Prescribing Patterns
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