The twin opioid crisis in the US and around the world. Towards balanced drug policies June 12, 2019 Jim Cleary, MD FAChPM
Professor of Medicine (Palliative Medicine) IU School of Medicine, Indianapolis Walther Senior Professor & Director of Supportive Oncology IU Simon Cancer Center
[email protected] @jfclearywisc
Blog: http://painpolicy.wordpress.com Data Website: https://painpolicy.iu.edu
The First Home for the Dying: Lyon 1842
Lyon Paris NY
1850 1900 1950 2000 1842: Jeanne Garnier, a widow Founder of the Women of Calvary
“I started my hospice with 50 Francs; …………..providence did the rest.”
A house for patients at the end of the lifetime An image, too often unhoped-for, which bring comfort, a start of happiness in the medium of the suffering. A house where one speaks again of the life, even if is also there to die. 1875: Paris 1899: Calvary Hospice, New York New Opioids • Laudanum (opium in alcohol base) • 1811: Morphine – Serturner, Morpheus: Civil War veterans. • 1874: Heroin – Wright (Bayer, 1898); cough • 1916: Oxycodone (Germany) • 1920: Hydrocodone • 1932: Pethidine (Demerol) – Germany: Anti-spasmodic and analgesic • 1938: Methadone (Germany) – Dolorphine: End Pain • 1960: Fentanyl New Opioids • Laudanum (opium in alcohol base) • 1804: Morphine (Germany) – Serturner, Morpheus: Civil War veterans. • 1832: Codeine (Germany) • 1874: Heroin – Wright (Bayer, 1898) • 1916: Oxycodone (Germany) • 1920: Hydrocodone • 1932: Pethidine (Demerol) – Germany: Anti-spasmodic and analgesic • 1938: Methadone (Germany) – Dolorphine: End Pain • 1960: Fentanyl Establishes a Framework to: 1.Prevent abuse and diversion, and 2.Ensure the availability of drugs for medical purposes
“the medical use of narcotic drugs continues to be indispensable for the relief of pain and suffering adequate provision must be made to ensure the availability of narcotic drugs for such purposes” (Preamble, p. 13) Essential Medicines 1St Edition 1977 WHO Model List 2.2 Opioid analgesics
Codeine Tablet: 15 mg (phosphate); 30 mg (phosphate).
Morphine Injection: 10 mg (morphine HCl or morphine sulfate) in 1‐ml ampoule. Oral liquid: 10 mg (morphine HCl or morphine sulfate)/5 ml. Tablet: 10 mg (morphine sulfate). Tablet (prolonged release): 10 mg; 30 mg; 60 mg (morphine sulfate)
“Balance” is the Fundamental Principle
National policy should establish a drug control system that prevents diversion and ensures adequate availability for medical use Drug control measures should not interfere with medical access to opioid Balance
Policy
MEDICINE Education Availability Consumption of Morphine 1980 - 2003 East vs. West Europe (mg/capita/yr)
25 mg/capita
20 Western Europe Eastern Europe
15
10
5
0
0 1 2 3 4 5 6 7 8 9 0 1 2 3 4 5 6 7 8 9 0 1 2 3 8 8 8 8 8 8 8 8 8 8 9 9 9 9 9 9 9 9 9 9 0 0 0 0 0 0 0 0 2 2 2 2 Opioid availability and cost: West Europe
Codeine Propox HC/DHC BuprPO BuprTD MoIR MoCR MoInj OcIR OcCR Methad. FentTD FentTM HmIR HmCR PethInj
Finland
France
Norway
Austria
Portugal
Italy
Denmark
Israel
Netherlands
Cyprus
Greece
Germany
Luxemburg
Spain
Switzerland
UK
Belgium
Iceland
Turkey
Free <25% 25-50% 50-75% 100% Cost Cost Cost cost
Opioid availability and cost: Eastern Europe
Codeine Propox HC/DHC BuprPO BuprTD MoIR MoCR MoInj OcIR OcCR Methad. FentTD FentTM HmIR HmCR PethInj
Czech R.
Croatia
Latvia
Rumania
Slovak R.
Hungary
Estonia
Serbia
Bulgaria
Moldova
Poland
Russia
Monten.
Maced.
Bosnia-H
Lithuania
Belarus
Albania
Georgia
Ukraine
Free <25% 25-50% 50-75% 100% Cost Cost cost cost
2001-3
2011-3
Formulary and Cost: Latin A+ Caribbean
Actual Availability: Latin A and Caribbean
Eligibility Restrictions : L Am + Caribbean Prescription Privileges: L Am. +Caribbean
Days allowed/prescription: L Am + Caribbean
Prescription forms: L Am + Caribbean
Pharmacist Restrictions: L Am + Caribbean
Dispensing: L Am + Caribbean Laws: Lat. Am +Caribbean
Restrictive regulations summary: Lat Am +Caribbean https://ppsg.medicine.wisc.edu/chart
James F Cleary, MD Asra Husain, JD Martha Maurer PhD
Pain & Policy Studies Group, UW Carbone Cancer Center, UWSMPH Madison, WI 53792, USA [email protected]
60% polypharmacy Benzodiazepines Alcohol
CDC 2016 Guideline
www.cdc.gov/drugoverdose/prescribing/guideline.html
• 32 deaths (1996-02) (definite or probable) • 15 oxycodone • 22 methadone
Misuse
• To address these shortcomings, the 2015 prescription drug questions were revised to ask survey respondents about the use of prescription drugs "in any way that a doctor did not direct you to use them," including • (1) use without a prescription of the respondent's own; • (2) use in greater amounts, more often, or longer than the respondent was told to take them; or • (3) use in any other way a doctor did not direct the respondent to use them.
Reasons for Misuse
From: Sources of Prescription Opioid Pain Relievers by Frequency of Past-Year Nonmedical Use: United States, 2008-2011
JAMA Intern Med. 2014;174(5):802-803. doi:10.1001/jamainternmed.2013.12809
Table Title: Source of Opioid Pain Reliever Most Recently Used by Frequency of Past-Year Nonmedical Usea
Copyright © 2015 American Medical Date of download: 10/24/2015 Association. All rights reserved.
Fig. 3. Annual age-specific rates of emergency department visits among patients with heroin and prescription opioid overdoses, Wisconsin, 2003–2012. Mass Data Key Findings • Individuals who died from opioid‐related overdoses are much more likely to have illegally‐obtained substances (i.e., not Schedule II‐III substances) present in post‐mortem toxicology. • Heroin was present in two‐thirds of deaths. Benzodiazepines in over half. Fentanyl and cocaine were each found in roughly one‐third. Among descendants, 22% had a positive toxicology report for a Schedule II‐III opioid, but only 9.1% had a prescription for that drug in PDMP. • Most toxicology reports had positive tests for more than one substance.
CDC 2016 Guideline
The Guideline is not intended for patients who are in active cancer treatment, palliative care, or end-of-life care.
www.cdc.gov/drugoverdose/prescribing/guideline.html
Policy
Balance Education MEDICINE Availability