Proper prescribing module1_revised v2

CPH© - All Rights Reserved 2011
Proper Prescribing of
Controlled Prescription Drugs©
Center for Professional Health©
Module 1:
Overview: The Controlled Prescription Drug
Epidemic, Physician Misprescribing and the Roles of
the DEA and Medical Board

Target Audience
This learning module is designed for all physicians and
healthcare providers who prescribe controlled prescription
drugs.

Objectives
Participants completing this module will be able to:
1. Discuss the controlled prescription drugs (CPD)
epidemic.
2. Define misprescribing of CPD.
3. Compare and contrast the role of the medical
board and the Drug Enforcement Administration
(DEA).
4. Determine one’s risk for misprescribing.

References and Resources
All data, references and resources provided in these
modules are linked to main source or reference. You can
learn more about any report by clicking the link. Links
are displayed by hyperlink, picture/logo, or web-page
link.
Examples:
• Picture link: (click on picture)
• Web-page link:
– www.mc.vanderbilt.edu/cph
• Hyperlink:
– Center for Professional Health

Rights & Responsibilities
Our job is to provide you with important and valuable
information to improve your understanding of prescribing
controlled drugs and prepare you for challenges you may
face in your practice.
We are committed to providing educational programs for
all students, trainees and all healthcare providers.
Please do not copy or reproduce this information without
written approval from the Center for Professional Health
(CPH). To request permission to reproduce or use any
part of The Proper Prescribing of Controlled Prescription
Drugs© or any other CPH program or materials, please
contact us at cph@vanderbilt.edu. Thank you.

Introduction
“No one ever told me the
rules. This was never
taught in medical school.”
~ CPH participant

Introduction
Welcome! This course could save
your career! Many of us don’t think
about the consequences of
misprescribing, but we should.
Over >900 physicians and other
healthcare providers from 40 states,
Canada and Europe have attended
our proper prescribing course at the
Center for Professional Health at
Vanderbilt between 1998 and 2014
and many others have gone to similar
programs around the country.

Introduction
Many of these physicians face years of career
challenges due to probation, suspension or revocation of
their medical license or DEA registration. All of these can
result in significant fines (into the six figure range), loss
of patients, community respect, faculty appointments,
and sometimes, in the case of revocation, loss of career.
The information contained within these modules will help
arm you with valuable information to prevent
misprescribing and guide you in ways that may protect
you if you are investigated by the state medical board or
the DEA.

Introduction
Can you answer these questions:
1. What are the criteria for misprescribing?
2. What are the potential consequences for a physician who
is sanctioned for misprescribing?
3. Would you know what to do if you are sanctioned for
misprescribing?
4. Have you kept abreast of the latest information on the use
of opioids for chronic pain?
5. What are the latest guidelines regarding screening for
substance use in patients requesting controlled
prescription drugs?
6. Can you identify and manage a patient who misuses
controlled substances?

Introduction
If you answered NO for any of these
three questions, then this module is
for you!
We feel it is far better to gain new
knowledge than to experience being
sanctioned by the medical board.
This is the first module within the
series. Complete as many modules
as you wish or only those most
applicable at this time.
Revocation
Sanction
Intervention
Prevention

Instructions
Complete the module in order. If you need to return to a
section, use the icon to return to the table of
contents. This icon is located in the top right hand corner
of each page.
Click on the title in the table of contents to go directly to
that section in the module.

Table of Contents
Table of Contents
Importance
The CPD Epidemic
Misprescribing CPDs
Role of the State Medical Board
Role of the DEA
Summary

Part 1:

Importance
Did you know that writing one
prescription for a controlled
substance can cost you a lot of time
and money, result in restrictions being
placed on your prescribing license,
your license to practice medicine, and
possibly cost you your career?
The sad truth is that it can happen. Many physicians
have already lost prescribing privileges, medical
licenses, jobs, respect, and careers over misprescribing
practices.

Importance
The media will play up the cases of popular individuals
who lose their lives due to abuse of controlled
prescription drugs (CPD), but what is not always
publicized is the story of the everyday physician who lost
his/her license to practice because they misprescribed
and weren’t even aware of it.

Importance
All healthcare providers who prescribe controlled
substances should be well aware that they will be held
accountable for their prescribing practices; thus every
prescribing physician should follow the published
guidelines.

Importance
How familiar are you with the following prescribing
guidelines?
 The Medical Practice Act
 The Controlled Substances Act
 Drug Enforcement Administration Practitioner’s Manual
 The Federation’s prescribing guidelines
 Your state medical board’s prescribing requirements

Importance
Our experience with training hundreds of physicians
teaches us that most have had less than 1-2 hours of
training on prescribing practices and/or drug diversion
during medical school or residency training.
How much training did you receive on proper prescribing
guidelines? Select only one answer.
a) None
b) 1-2 hrs
c) 3-4 hrs
d) >5 hrs

Part 2:

The CPD Epidemic
Substance abuse, including controlled prescription drugs
(CPD), is the nation's number one health problem
affecting millions of individuals according to The Robert
Wood Johnson Foundation.
Illicit drug use, including controlled prescription drugs
(pain relievers, stimulants, sedatives, and tranquilizers),
marijuana, cocaine, heroin, hallucinogens, and inhalants
cost the U.S. economy over $193 billion dollars in 2007;
more than either diabetes or smoking alone. (One DCP
update vol2;iss5, June 2011)

The CPD Epidemic
"There are more deaths,
illnesses and disabilities from
substance abuse than from
any other preventable health
condition. Of the more than 2
million deaths each year in the
United States, approximately
one in four is attributed to
alcohol, tobacco and illicit drug
use."

The CPD Epidemic
“According to the 2012 National Survey on Drug Use and
Health, almost twice as many Americans (6.8 million)
currently abuse pharmaceutical controlled substances
than those using cocaine, hallucinogens, heroin and
inhalants combined.”
“Nearly 110 Americans die every day from drug-related
overdoses, and about half of those overdoses are
related to opioids, a class of drug that includes
prescription painkillers and heroin.”

The CPD Epidemic
“More than two-thirds of people who misuse prescription
painkillers for the first time report obtaining the drugs
from friends or relatives, including from a home medicine
cabinet.”
“In July, the Office of National Drug Control Policy
(ONDCP) released the 2014 National Drug Control
Strategy, which is a “shift away from a law enforcement
emphasis and towards a public health and prevention
approach to drug-related harm,” according to Davis.”

The CPD Epidemic
“He added that the Strategy emphasizes evidence-based
efforts such as increased access to treatment, criminal
justice reform and access to naloxone for opioid
overdose reversal.”
To read more on this report click the RWJ link.

The CPD Epidemic
“Under the Affordable Care Act, most health insurance
plans must cover mental health and substance use
disorder (SUD) services. The ACA has also created
improved access for SUD services by extending a
federal law that requires SUD benefits be provided at the
same reimbursement rate as medical and surgical
benefits.” – RWJ Foundation web page
To read more on this report click the RWJ link.

The CPD Epidemic
An estimated 22.6 million Americans (>12 years of age)
admitted to using illicit drugs within the past month and
this equates to 8.9% for this population and up to 22%
for those 18-22 years of age. (SAMSHA)
The rate of controlled prescription drug abuse has
increased 94% in the past decade (1992 to 2003). Rates
have nearly tripled in the teenage population (12 -17
years old) - an increase of 212% compared to 81%
increase in the adult population. (Bollinger)

The CPD Epidemic
Rate of controlled prescription drug (CPD) abuse –
nearly doubled from 7.8 million to 15.1 million in the past
decade (1992 to 2003)
• Adults: Use in adults (>18 years) is up by 81%
• Teens: Rate has nearly tripled for teen population (age
12 -17):
– abusing CPD more than adults
– rate estimated at 212%

The CPD Epidemic
In 2010, of the three million new users of illicit drugs for
youth aged 12 and older, 62% used marijuana and 26%
use CPD. (SAMSHA)
Controlled prescription drugs (opioids, stimulants and
benzodiazepines) rank number four on the list of most
abused substances falling just under marijuana, alcohol
and tobacco. (Bollinger)

The CPD Epidemic
Americans make up 4.6% of world’s population but
use…
– 66% of world’s illicit drugs
– 80% of global opioid supply
– 99% of global hydrocodone supply
2006 National Survey on Drug Abuse and Health, SAMHSA

The CPD Epidemic
“Drug overdose death rates in the United States have
more than tripled since 1990 and have never been
higher. In 2008, more than 36,000 people died from drug
overdoses, and most of these deaths were caused by
prescription drugs.4”
• Drug OD from CPD has tripled in two decades (CDC)
• 100 people die from OD every day in US (CDC)
• Men are more likely to die of opioid overdoses (>10,000
deaths in 2010) (CDC)
• Rate of opioid OD for women is increasing (CDC)

The CPD Epidemic
More “new users” tried opioids for non-medical reasons
in the past year than any other illicit drug
According to the CDC:
– Opioid prescription painkillers cause more drug overdose
deaths than cocaine and heroin combined
– Increased ER visits
– Increased accidental deaths
– Health care costs = millions of dollars annually
DEA Practitioners Manual 2006 ed.; Manchikanti L, et al. 2005; Substance Abuse 2001; Bollinger LC 2005. 2006 National Survey on Drug
Abuse and Health, SAMHSA

The CPD Epidemic
The CPD epidemic is real and affects many individuals.
The problem with the misuse and illicit use of CPD is the
excess burden on the health care system, the individual,
family members and the community as a whole.
Physicians play two important roles in this problem:
1) Physicians are the main source of CPD.
2) Physicians do not always identify and intervene when
misuse and dependence develops.

The CPD Epidemic
Prescription drug diversion is simply the deflection of
prescription drugs from medical sources into the illegal
market.
• Physicians remain the #1 provider of CPD
• Other Sources:
– doctor shopping
– illegal internet pharmacies
– drug theft
– prescription forgery
– illicit prescribing by physicians
U.S. Department of Justice, Drug Enforcement Administration, Prescription Accountability Resource Guide, September
1998, <http://www.deadiversion.usdoj.gov/pubs/program/rx_account/index.html > (5 January 2004).

The CPD Epidemic
Source: The Monitoring the Future Study, the University of Michigan
Physician misprescribing accounts for most of the excess CPD available for diversion.

The CPD Epidemic
• Up to 43% of physicians DO NOT ask about controlled
prescription drug abuse when taking a patient's health
history.
• Only 19% received any medical school training in
identifying prescription drug diversion.
• Only 40% received training to identify prescription
drug abuse and addiction.
• Many are not trained to effectively handle drug-
seeking patients
Center on Addiction and Substance Abuse (CASA). 2005. Under the Counter: The Diversion and Abuse of Controlled
Prescription Drugs in the US. New York: The National Center on Addiction and Substance Abuse (CASA).

The CPD Epidemic
Many are not trained to effectively handle drug-seeking
patients due to…
“Confrontational Phobia” - a term used to describe
physicians’ reluctance to say “no” to a patient, thus
making physicians an “easy target for manipulation.”
~ Bollinger et al. Under the Counter: The Diversion and
Abuse of Controlled Prescription Drugs in the U.S. July 2005
Center on Addiction and Substance Abuse (CASA). 2005. Under the Counter: The Diversion and Abuse of Controlled
Prescription Drugs in the US. New York: The National Center on Addiction and Substance Abuse (CASA).

Misprescribing CPD
Once a physician becomes known as an easy target,
substance abusers will find ways to take advantage of
them. Here is a comment from a substance abuser:
CASA Substance Abuser:
“Obviously, doctors don’t like to give you controlled substances
easily but if you’re aggressive and persistent enough…and can talk
a good enough game, I don’t know how they could not give it to you.
I mean they’re in the health field and they’re caring people and
they’re trying to take care of their patients’ individual needs.”
~A 52-year-old drug abusing patient interviewed in the CASA study
Bollinger et al, 2005

Misprescribing CPD
If the substance abuser knows this much about
physicians, what do physicians know about substance
abusers?
The evidence supports that most physicians weren’t
trained to identify and manage substance abuse. Most
participants in our courses have never had the training
needed to adequately care for the substance abuser or
identify those who started using a CPD for legitimate
reasons but end up with iatrogenic addictions.
Bollinger et al, 2005

Reflection
How much training have you had on identifying and
managing substance abuse?
a) None
b) Some
c) A lot
d) I don’t know

Misprescribing CPD

Misprescribing CPD
What is the physician’s role in misprescribing?
Am I
prescribing for
a legitimate
medical
problem?
Am I
prescribing the
appropriate
amount for the
condition?
Am I giving
patients full
informed
consent?
Did I screen
appropriately
for use vs
misuse?

Misprescribing CPD
The majority of excess CPD available for illicit use or
sharing is due to physicians or other healthcare
providers prescribing more pills than a patient needed. A
total of 309 tons of pills were received in the DEA’s 9th
Prescription Drug Take-Back Day in November 2014.
Other Sources for excess CPD:
• doctor shopping
• illegal internet pharmacies
• drug theft
• prescription forgery
• illicit prescribing by physicians

Misprescribing CPD
Definition of Misprescribing: Prescribing CPD in
quantities and frequency inappropriate for the patient’s
complaint or illness … or any example below:
Examples:
– Prescribing large quantities, frequent intervals, or crescendo
pattern of CPD
– Progression to multiple drugs
– Prescribing CPD painkillers for trivial complaints
– Prescribing to a family member(s)
– Prescribing to a known alcoholic or drug addict
– Dispensing CPD without a license

Misprescribing CPD
Which doctor is at risk of misprescribing?
Answer
1 2 3 4

1.Brown ME, Swiggart WH, Dewey CM, Ghulyan MV. Searching for answers: proper prescribing of controlled prescription drugs. Journal of
Psychoactive Drugs. 2012; 44(22641969):79-85.
2.Wesson, D.R. & Smith, D.E. Prescription drug abuse: Patient, physician and cultural responsibilities. Western Journal of Medicine 1990; 152:
613-616.
Misprescribing CPD
Answer: All physicians who prescribe CPD are at risk of
misprescribing if unfamiliar with how to avoid it.
There are several reasons why physicians misprescribe.
Four identified by the AMA and two later identified by the
Center for Professional Health (CPH) (You can read both articles below by
clicking the hyper link.) The team at CPH also identified one for
advanced nurse practitioners (APRN) and may at times
be applicable for physicians as well. Thus physicians
misprescribe for the following reasons …

Misprescribing CPD
1.Brown ME, Swiggart WH, Dewey CM, Ghulyan MV. Searching for answers: proper prescribing of controlled prescription drugs. Journal of
Psychoactive Drugs. 2012; 44(22641969):79-85.
2.Wesson, D.R. & Smith, D.E. Prescription drug abuse: Patient, physician and cultural responsibilities. Western Journal of Medicine 1990; 152:
613-616.

Misprescribing CPD
Examples:
1. Dated: A physician is unaware of the latest prescribing
guidelines for managing chronic pain and prescribes CPD
over the recommended levels.
2. Duped: This is probably the most common reason for
misprescribing…the physician fails to detect the deceptive
practices of the patient even thought evidence is clearly
present.
3. Dismayed: The patient with several problems and
complications or side effects to other medications and the
physician fails to investigate due to time limitations and
the need to move on to the next patient.

Misprescribing CPD
Examples: (cont.)
4. Dysfunctional: This physician feels stressed and
unsure of how to handle the forceful patient and fails
to say no even when the physician may/may not
know the risk involved.
5. Dishonest: This physician, although rare, will
exchange CPD for sexual favors or money at street
prices for various reasons.
6. Disabled: This physician is also a substance user
and may prescribe higher quantities to share with
patients or self-prescribes or uses a family name to
prescribe CPD but will use it for himself.

Misprescribing CPD
Examples: (cont.)
7. Disempowered: This physician is disempowered by
a patient or an APRN is disempowered by a patient
or the supervising physician. Either may prescribe
because they failed to exhibit the appropriate level of
assertiveness within the situation.

Reflection
Reflect on your past prescribing practices. Have you
misprescribed? If so, how and for what reason?
Categories of Misprescribing
Dated: Fails to keep current
Disabled: Failed judgment due to impairment
Duped: Fails to detect
Dishonest: Personal or financial gain
Dismayed: Rx as a quick fix due to time
Dysfunctional: Fails to say no
Disempowered: Skewed perception of power

Consequences of Misprescribing
The consequences for misprescribing can be significant
and life/career changing. The consequences can vary
greatly from state to state. Both the physician’s medical
license and DEA may be restricted or revoked.
It is critical that you practice under the guidelines of your
state medical board and the federal guidelines of the
DEA. Find your state medical board by clicking on the
link below.

The physician may be reported
to the National Practitioner Data
Bank, may lose privileges, be
dropped by insurance carriers,
and lose respect from patients
and colleagues.
When misprescribing crosses
the legal lines of justice, a
physician may be arrested.

The financial and personal toll of being sanctioned for
misprescribing is significant. Direct and indirect costs
include:
• Loss of income
• Loss of privileges
• Loss of respect
• Costs for educational programs
• Cost for lawyer fees
• Cost for board fees
• Cost for addiction assessments & treatment

Part 3:

State Medical Board
Under the Modern Medical Practice Act, the “state
medical board, acting as a governmental agency, to
regulate the practice of medicine, including the licensure
and discipline of physicians, in the jurisdiction.” Each
state’s Act varies in how they award or revoke licenses.
In TN, the state board’s mission is to “safeguard the
health, safety, and welfare” of the public and interpret
the laws, rules, and regulations to determine the
“appropriate standards of practice to ensure the
highest degree of professional conduct.” (TN SBME)

State Medical Board
Within each state’s regulations, the board will investigate
all complaints of alleged violations.
The board will hold physicians accountable for their
competency and behavior and will strike a balance
between enforcing accountability and being punitive –
meaning they will discipline licensees who are found
guilty of violations based on evidence from an
investigation.

State Medical Board
In most instances, the board will render a judgment
based on behavior, not only on patient outcomes, and
will try to distinguish between human error and
intentional reckless behavior.
The board may require education, coaching, non-
disciplinary counseling, training, and request evidence of
competency if appropriate.

State Medical Board
The medical board considers disciplinary/punitive action
for any event/medical error resulting from a practitioner
under the influence (ETOH or drugs), recklessly unsafe
practitioners, and any practitioner who has blatantly
disregarded the standards of practice or has committed
a criminal act.
The medical board will not randomly select physicians to
survey or investigate. All inquiries are complaint driven.
When the board receives a complaint, they will
investigate to determine if there is evidence of a possible
violation.

State Medical Board
The board’s course of action generally includes:
1) assign an investigator to make an inquiry
2) send a “notice of complaint” to the doctor where an
explanation may be requested
3) the investigator will either schedule a meeting with
the physician or randomly visit the physician

State Medical Board
Board investigators will request records to review. The
board will expect that the physician records the following
for each patient receiving CPD:
1. proper indication for the use of the CPD
2. plans for monitoring the patient while on the CPD
3. the response to using a CPD on follow-up visits
4. a rationale for continuing or modifying therapy.
If there is a clear concern for public safety, the board
may take an immediate action and suspend the doctor’s
license.

State Medical Board
Most complaints are resolved as follows:
1) Dismissal - lack of evidence to support the claim
2) Letter of Concern - a letter from the board is generated
expressing concern regarding an action
3) Consent Decree - an agreement is used for concerns such as
an expired license or incomplete CME requirements
4) Agreed Order – a formal disciplinary action in which both sides
agree that the complaint is valid and the doctor agrees to certain
terms and/or conditions.

State Medical Board
List of actions a board can take:
1. Revocation of the medical license
2. Suspension of the medical license
3. Probation
4. Stipulations, limitations, restrictions, probation, and
conditions relating to practice
5. Censure (including specific redress, if appropriate)
6. Reprimand
7. Chastisement, letters of concern and advisory letters

State Medical Board
8. Monetary redress to another party
9. A period of free public or charity
service, either medical or non-
medical
10.Satisfactory completion of an
educational, training and/or
treatment program(s), or
professional developmental plan
11.Levy fine
12.Payment of administrative and
disciplinary costs

State Medical Board
If appropriate, the board will proceed with a Hearing - a
formal trial-like procedure where the case is presented to
the medical board panel. In this process, the physician
will take part in a pre-hearing conference (a conference
between the doctor and the investigator including
attorneys to discuss the case) followed by the hearing.
The board will vote on any decisions in open session
and determine a proposed decision. The decision can
be appealed to the Circuit Court within 30 days.

State Medical Board
National Practitioners Data Bank: Final actions are
reported to the Data Bank newsletter and web site.
All costs plus penalties are assessed to the physician
and can be excessive especially if the physician retains
a lawyer on his/her behalf.

State Medical Board
If a physician receives notice from their board of a
complaint, they should consider seeking guidance from
their state’s physician health program (PHP).
Most states have a PHP and can provide insight into the
process and make suggestions on compliance and
training options. Some will suggest proactive
assessments, training and education. Common PHP and
board suggestions/requirements include training courses
for improving documentation and proper prescribing
such as the CME courses at CPH.

Part 4:

Drug Enforcement Administration
The mission of the DEA is to enforce the controlled
substances laws and regulations of the United States
and to recommend and support non-enforcement
programs aimed at reducing the availability of illicit
controlled substances.
The DEA was created by President Richard Nixon
through an Executive Order in July 1973 in order to
establish a single unified command to combat "an all-out
global war on the drug menace." Through the Controlled
Substances Act (CSA) of 1970, he assigned legal
authority for the regulation of controlled substances (illicit
and licit).

Controlled Substances Act (CSA)
– Monitors:
1. Diversion to illicit use in:
– Self
– Others
2. Maintenance of addictions
3. Iatrogenic addictions
– Defined five (5) schedules
– All prescribers must be registered

DEA
The DEA has two major responsibilities:
1. Diversion: The prevention, detection, and investigation of
the diversion of controlled substances from legitimate
channels
2. Adequate Supplies: Ensuring that adequate supplies are
available to meet legitimate domestic medical, scientific, and
industrial needs (production to dispensing)

DEA
DEA registration can be suspended or revoked by the
Attorney General upon a finding that the registrant:
– Falsified an application
– Has been convicted of a felony
– Had state license/registration suspended, revoked, or denied
by competent State authority
– Has committed acts that would render registration
inconsistent with the public interest
– Has been excluded (or directed to be excluded) from
participation in a program pursuant to section 1320a-7(a) of
title 42. (improperly filed claims) – this is essentially Medicare
fraud.

DEA
The DEA developed and published the Practitioner’s
Manual: An Informational Outline of the Controlled
Substances Act 2006 Edition. It is available on their web
page. The manual provides an overview and practice
guidelines for physicians, physician assistants, advanced
nurse practitioners, and pharmacists.
The DEA remains committed to the 2001 Balanced
Policy of promoting pain relief & preventing abuse of
pain medications. If you have not read the manual, this is
a must read for those prescribing controlled substances.

DEA - Questions
1. What constitutes Schedule I or other schedule assignments for
drugs?
2. Identify the schedule for each of the following:
marijuana; morphine; heroin; codeine; LSD; opium; amphetamine;
cocaine
3. How often do you renew your DEA registration and what
happens if you move?
4. Which schedules can be refilled?
5. Can Schedule II prescriptions be faxed?
6. What do the numbers and letters in a DEA number stand for?
How is it different from the NPI number?
7. Can you “detox” a controlled substance user (using methadone)
under your current DEA registration?
DEA Practitioner’s Manual 2006; pg. 5-6 & 9-11 & 21-22 & 23

DEA
If you are unsure of any of the answers to the above
questions, please continue reading module 2: The
Proper Prescribing of Controlled Prescription Drugs.
Module 2 combines the guidelines from the Practitioner’s
Manual with a reasonable approach to prescribing
practices based on the standard office practices using
the SOAP format.

Summary
Having completed this module you should be able to:
1. Discuss the CPD epidemic.
2. Define misprescribing of CPD.
3. Compare and contrast the role of the medical board
and the DEA.
4. Identified your own risk for misprescribing.
So the question remains, “Are you at risk for
misprescribing?” Continue learning in Module 2 to
determine other risks for misprescribing and some tips to
avoid misprescribing.

The Center for Professional Health
Contact us at:
Center for Professional Health
1107 Oxford House
Vanderbilt University Medical Center
Nashville, TN. 37232-4300
(615) 936-0678 (phone)
(615) 936-0676 (fax)
cph@vanderbilt.edu

Proper prescribing module1_revised v2

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