The twin 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 • Laudanum ( in base) • 1811: – Serturner, Morpheus: Civil War veterans. • 1874: – Wright (Bayer, 1898); cough • 1916: (Germany) • 1920: • 1932: (Demerol) – Germany: Anti-spasmodic and • 1938: (Germany) – Dolorphine: End • 1960: New Opioids • Laudanum (opium in alcohol base) • 1804: Morphine (Germany) – Serturner, Morpheus: Civil War veterans. • 1832: (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

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 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