This document discusses the prescription opioid epidemic in the United States. It argues that the epidemic is more about long-term non-medical opioid use and not about prescription opioids or pain patients. Restrictive policies aimed at prescription opioids have driven some users to street heroin and failed to address the root causes. The document calls for policies to be based on accurate analysis of the situation and ensures access to adequate pain treatment for all patients worldwide.

1. Prescription Opioids – An Epidemic of Poor Policies1
Willem Scholten Consultancy
Willem Scholten PharmD, M.P.A.
Consultant – Medicines and Controlled Substances
PRESCRIPTION OPIOIDS – AN
EPIDEMIC OF POOR POLICIES
A view on the facts

2. Prescription Opioids – An Epidemic of Poor Policies2
Willem Scholten Consultancy
Willem Scholten PharmD, M.P.A.
Consultant – Medicines and Controlled Substances
USA opioid OD epidemic
It is said that there is an ongoing prescription opioid
overdose (‘OD’) epidemic in the US
It is said that it is driven by pain patients
As a result, many pain patients no longer have access to
adequate pain management
Some want to impose restrictions on pain management
globally similar to the US

3. Prescription Opioids – An Epidemic of Poor Policies3
Willem Scholten Consultancy
Willem Scholten PharmD, M.P.A.
Consultant – Medicines and Controlled Substances
Is the OD epidemic about prescribed
opioids?
Sensationalizing press, politicians and some physicians
would suggest “Yes”
Prescription opioids is NOT the same thing as prescribed
opioids
There is a long history of non-medical opioid use in the
US since the Vietnam War and before
There does appear to have been a move from street
heroin to pills (which could be considered safer from a
public-health perspective)

4. Prescription Opioids – An Epidemic of Poor Policies4
Willem Scholten Consultancy
Willem Scholten PharmD, M.P.A.
Consultant – Medicines and Controlled Substances
This clearly suggests
a continuation of the decade-
long non-medical use of heroin
What this means?

5. Prescription Opioids – An Epidemic of Poor Policies5
Willem Scholten Consultancy
Willem Scholten PharmD, M.P.A.
Consultant – Medicines and Controlled Substances
Effective policies = accurate analysis
Non-medical use of opioid analgesics and heroin has
been a continuous problem since 1960’s
If this is to be addressed by one comprehensive policy -
it should be based on accurate evaluation of cause-
effect relations

6. Prescription Opioids – An Epidemic of Poor Policies6
Willem Scholten Consultancy
Willem Scholten PharmD, M.P.A.
Consultant – Medicines and Controlled Substances
Do the pain patients cause the OD
epidemic?
While a survey of West Virginia’s death registry showed
25% of OD deaths had opioid analgesics prescribed in
the last 3 months, this would suggest that at least 75%
were not pain patients.

7. Prescription Opioids – An Epidemic of Poor Policies7
Willem Scholten Consultancy
Willem Scholten PharmD, M.P.A.
Consultant – Medicines and Controlled Substances
Counter-productive policies
In 2010, new policies stabilized prescription
overdose deaths in the USA
However, the heroin overdose deaths started
rising again
The overall effect being a shift to the more
hazardeous use of street heroin

8. Prescription Opioids – An Epidemic of Poor Policies8
Willem Scholten Consultancy
Willem Scholten PharmD, M.P.A.
Consultant – Medicines and Controlled Substances
Age-adjusted rates for drug-poisoning
deaths, by type of substance
Year Opioid analgesics Heroin
Number Deaths Number Deaths
per 100,000 per 100,000
2000 4,400 1.5 1,842 0.7
2001 5,528 1.9 1,779 0.6
2002 7,456 2.6 2,089 0.7
2003 8,517 2.9 2,080 0.7
2004 9,857 3.4 1,878 0.6
2005 10,928 3.7 2,009 0.7
2006 13,723 4.6 2,088 0.7
2007 14,408 4.8 2,399 0.8
2008 14,800 4.8 3,041 1.0
2009 15,597 5.0 3,278 1.1
2010 16,651 5.4 3,036 1.0
2011 16,917 5.4 4,397 1.4
2012 16,007 5.1 5,925 1.9
2013 16,235 5.1 8,257 2.7
NOTES: Deaths are classified using the International Classification of Diseases, Tenth Revision. Drug-poisoning deaths are identified using underlying cause-of-death codes X40–X44, X60–X64, X85,
and Y10–Y14. Drug-poisoning deaths involving opioid analgesics are drug-poisoning deaths with a multiple cause code of T40.2, T40.3, or T40.4. Drug-poisoning deaths involving heroin are drug-
poisoning deaths with a multiple cause code of T40.1. Each year a small subset of drug-poisoning deaths involved both opioid analgesics and heroin. For example, in 2013, 1,342 deaths involved
both opioid analgesics and heroin. Deaths involving both opioid analgesics and heroin are included in both the rate of deaths involving opioid analgesics and the rate of deaths involving heroin.
Depending on the year, 22% to 25% of drug-poisoning deaths lack information on the specific drugs involved. Some of these deaths may involve opioid analgesics or heroin.
SOURCE: Data Brief 190: Drug-poisoning Deaths Involving Heroin: United States, 2000–2013
CDC/NCHS, National Vital Statistics System, Mortality.

9. Prescription Opioids – An Epidemic of Poor Policies9
Willem Scholten Consultancy
Willem Scholten PharmD, M.P.A.
Consultant – Medicines and Controlled Substances
A complex issue
This is clearly a highly complex and emotive
issue and knee jerk policy changes must never
be allowed to prevent patients receiving the
pain relief medicine they require

10. Prescription Opioids – An Epidemic of Poor Policies10
Willem Scholten Consultancy
Willem Scholten PharmD, M.P.A.
Consultant – Medicines and Controlled Substances
Myths about opioid consumption
 CDC and Physicians for
Responsable Opioid Prescribing
(PROP) claim that the 2010
annual opioid consumption in the
US was enough for a 30 days
supply for every adult.
 The US authorities reported a 7.3
day’s supply for opioid analgesics
(see next slide).
 PROP states that the US is consuming 99% of the world’s hydrocodone:
not surprising as hydrocodone is hardly available outside of the US.

11. Prescription Opioids – An Epidemic of Poor Policies11
Willem Scholten Consultancy
Willem Scholten PharmD, M.P.A.
Consultant – Medicines and Controlled Substances
US opioid consumption 2010
Total Defined Daily Doses for opioid analgesics 2290225370
Total Defined Daily Doses all reported opioids 5113874807
Total population USA 2010 314799000
Population 16 yrs and over USA 2010 284546314
Per capita monthly consumption in DDD Adults only
(>=16 yr )
All ages
Claimed by CDC and PROP 30 - 31
Opioid analgesics 8.0 7.3
All reported opioids (including cough suppressants,
anti-diarrhoeals and experimental substances)
18.0 16.2
Calculations based on data below; consumption as reported by US authorities to the INCB

12. Prescription Opioids – An Epidemic of Poor Policies12
Willem Scholten Consultancy
Willem Scholten PharmD, M.P.A.
Consultant – Medicines and Controlled Substances
Pain treatment is a human right
Access to pain treatment is part of the right to
health and recognized in multiple treaties
• CDC Guidelines withhold access to adequate
treatment for chronic non-cancer pain
patients
• CDC guidelines for chronic pain were
developed with involvement of only certain
elements of the pain specialist community

13. Prescription Opioids – An Epidemic of Poor Policies13
Willem Scholten Consultancy
Willem Scholten PharmD, M.P.A.
Consultant – Medicines and Controlled Substances
Proper access
Pain patients in the USA and the rest of the
world should have access to adequate and
effective pain mangement, including
pharmacological treatment

14. Prescription Opioids – An Epidemic of Poor Policies14
Willem Scholten Consultancy
Willem Scholten PharmD, M.P.A.
Consultant – Medicines and Controlled Substances
The USA is not the rest of the world
0
100
200
300
400
500
600
700
United States Netherlands Italy India Ghana
GHANAINDIA
IT
NL
584 mg 263 mg 132 mg 0.3 mg 0.1 mg
Expressed as equivalents of morphine
Scholten W, based on data International Narcotics Control Board
Per capita opioid analgesic
consumption (2013)
USA

15. Prescription Opioids – An Epidemic of Poor Policies15
Willem Scholten Consultancy
Willem Scholten PharmD, M.P.A.
Consultant – Medicines and Controlled Substances
A perspective
Damage expressed as Disability Adjusted Life
Years (DALYs)
• From opioid use disorders:
8 million DALYs
• Total from low back and neck pain +
neoplasms
305 million DALYs
Scholten W, based on WHO data

16. Prescription Opioids – An Epidemic of Poor Policies16
Willem Scholten Consultancy
Willem Scholten PharmD, M.P.A.
Consultant – Medicines and Controlled Substances
The real problem
The greatest problem is that
5.5 billion people live in countries where
there is no or very limited access to opioid
analgesics for the treatment of pain

17. Prescription Opioids – An Epidemic of Poor Policies17
Willem Scholten Consultancy
Willem Scholten PharmD, M.P.A.
Consultant – Medicines and Controlled Substances
Original article
Willem Scholten & Jack E. Henningfield
Negative outcomes of unbalanced opioid policy
supported by clinicians, politicians, and the
media.
Journal of Pain & Palliative Care Pharmacotherapy, (2016) 30:1,
4-12. DOI: 10.3109/15360288.2015.1136368
For more details and for references on the topics of this
presentation

18. Prescription Opioids – An Epidemic of Poor Policies18
Willem Scholten Consultancy
Willem Scholten PharmD, M.P.A.
Consultant – Medicines and Controlled Substances
Additional reading
Willem Scholten PharmD MPA:
Opioid overdose death epidemic sensationalised at
the cost of pain patients
Dr Carl Hart, professor of psychology at Columbia
University:
Mandatory Opioid Training for Doctors Isn’t Necessary
Maia Szalavitz, who has been addicted on cocaine and
heroin, and who is the author or co-author of seven
books:
Focus on Preventing Addiction Instead of
Prescribing Medication

19. Prescription Opioids – An Epidemic of Poor Policies19
Willem Scholten Consultancy
Willem Scholten PharmD, M.P.A.
Consultant – Medicines and Controlled Substances
Conclusion
All pain patients should have access to adequate
pain management, whichever part of the world
they live
and
Policies on the non-medical use of substances
are based on health and proper situational
analysis