Transcript The Proper Prescribing of Controlled Prescription Drugs.

Charlene M. Dewey, M.D., M.Ed., FACP
Associate Professor of Medical Education and Administration
Associate Professor of Medicine
Co-Director, Center for Professional Health
Vanderbilt University Medical Center
September 2011
Proper Prescribing of CPD
 Which
doctor is at risk of mis-prescribing?
Proper Prescribing of CPD
 The
purpose of the session is to provide
learners with an overview of the CPD
epidemic and review guidelines on proper
prescribing and office practices based on the
CSA and the practitioner’s manual.
Proper Prescribing of CPD
Be the end of the session participants will be
able to:
1.
2.
3.
Discuss the CPD use/misuse epidemic in the US
and TN
Apply proper prescribing rules from the
practitioner’s manual in their individual and office
practices
Identify behaviors associated with drug seekers
Proper Prescribing of CPD
1.
2.
3.
Introduction: the CPD problem
CSA
Proper prescribing practices – using the PM
 Individual
 Office
4.
5.
Q&A
Summary
Proper Prescribing of CPD
 Substance
abuse, including controlled
prescription medication, is the nation's
number one health problem affecting millions
of individuals
 Rate of controlled prescription drug (CPD)
abuse - almost doubled from 7.8 million to
15.1 million in the past decade (1992 to 2003)
 Adults >18 is up by 81%
Manchikanti L, et al. 2005; Substance Abuse 2001; Bollinger LC 2005. 2006 National Survey on Drug Abuse
and Health, SAMHSA
Proper Prescribing of CPD
Rate has nearly tripled in the teenage population
 Children aged 12 -17:




New drug users of prescription opioids = 2.4
million


abusing CPD more than adults
rate estimated at 212%
Marijuana (2.1 million); Cocaine (1.0 million)
Total abusing > those abusing cocaine,
hallucinogens, heroin, and inhalants combined!
Manchikanti L, et al. 2005; Substance Abuse 2001; Bollinger LC 2005. 2006 National Survey on Drug Abuse
and Health, SAMHSA
Proper Prescribing of CPD
More “new users” tried opioids for non-medical
reasons in the past year than any other illicit drug
 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
Proper Prescribing of CPD
 Americans



= 4.6% of world’s population
Use 66% of world’s illicit drugs
Use 80% of global opioid supply
Use 99% of global hydrocodone supply
2006 National Survey on Drug Abuse and Health, SAMHSA
Proper Prescribing of CPD
 TN
#2 in nation in rate of prescription drug
use


Hydrocodone is #1 drug
2.8% of all prescriptions (More than Lipitor,
Nexium)
 Death
rate from accidental drug poisoning in
TN is 26% above national average
 Rx for top 5 narcotics rose 90% nationwide
from 1997-2005 (The largest increase in any state)
 Increase was 206% in TN
Proper Prescribing of CPD
 Prescription
drug diversion is simply the
deflection of prescription drugs from medical
sources into the illegal market.
 Physicians remain the #1 provider of CPD
 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).
Proper Prescribing of CPD
4%
<1%
Given free from a friend
or relative
Given by a single
doctor
9%
19%
56%
Bought from a friend or
relative
Bought from
stranger/dealer
Internet
SAMHSA 2006
Proper Prescribing of CPD
 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 on identifying
prescription drug abuse and addiction
Bollinger et al, 2005
Proper Prescribing of CPD
 Many
are not trained to effectively handle
drug-seeking patients
 “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, 2005
Proper Prescribing of CPD
“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
Proper Prescribing of CPD
Proper Prescribing of CPD
 The
mission of the DEA is to:
 Enforce
the controlled substances laws
and regulations of the United States and
to recommend and support nonenforcement programs aimed at reducing
the availability of illicit controlled
substances.
Proper Prescribing of CPD
 Controlled

Substances Act of 1970 (CSA)
Assigned legal authority for the regulation of
controlled substances (illicit and licit)
 Responsibility
1.
2.
is two-fold:
Ensuring that adequate supplies are available
to meet legitimate domestic medical, scientific,
and industrial needs
The prevention, detection, and investigation of
the diversion of controlled substances from
legitimate channels
Proper Prescribing of CPD
Providers must be registered
 Registration can be suspended/revoked by the
Attorney General if a registrant:






Materially falsified any application filed
Been convicted of a felony
Had his/her state license or registration suspended,
revoked, or denied by competent state authority
Committed such acts as would render his registration
inconsistent with the public interest
Been excluded (or directed to be excluded) from
participation in a program pursuant to section 1320a-7(a)
of title 42 = Medicare Fraud!
Proper Prescribing of CPD
 Monitors:
1.
Diversion to Illicit Use
-
2.
3.
Maintenance of addictions
Latrogenic addictions
 Five



Self
Others
(5) schedules
I-V
Addictive potential
Rules on schedule IIs
http://www.justice.gov/dea/concern/narcotics.html
Proper Prescribing of CPD
Schedule 1
Substance
DEA Number
Non
Narcotic
Other Names
1-Methyl-4-phenyl-4propionoxypiperidine
9661
MPPP, synthetic heroin
Gama Hydroxybutyric Acid
(GHB)
2010
Heroin
9200
Lysergic acid diethylamide
7315
N
LSD, lysergide
Marijuana
7360
N
Cannabis, marijuana
Myrophine
9308
Psilocybin
7437
N
Constituent of "Magic
mushrooms"
N
GHB, gama hydroxybutyrate,
sodium oxybate
Diacetylmorphine, diamorphine
Proper Prescribing of CPD
Schedule II
Amobarbital
Amphetamine
Cocaine
Codeine
Fentanyl
Hydrocodone
Hydromorphone
Meperidine
Methadone
Methadone intermediate
Methamphetamine
2125 N
1100 N
9041
9050
9801
9193
9150
9230
9250
9254
1105 N
Methylphenidate
Morphine
Opium, raw
Oxycodone
1724 N
9300
9600
9143
Oxymorphone
Pentobarbital
Phencyclidine
9652
2270 N
7471 N
Amytal, Tuinal
Dexedrine, Biphetamine
Methyl benzoylecgonine, Crack
Morphine methyl ester, methyl morphine
Innovar, Sublimaze, Duragesic
dihydrocodeinone
Dilaudid, dihydromorphinone
Demerol, Mepergan, pethidine
Dolophine, Methadose, Amidone
Methadone precursor
Desoxyn, D-desoxyephedrine, ICE, Crank,
Speed
Ritalin
MS Contin, Roxanol, Duramorph, RMS, MSIR
Raw opium, gum opium
OxyContin, Percocet, Tylox, Roxicodone,
Roxicet,
Numorphan
Nembutal
PCP, Sernylan
Proper Prescribing of CPD
Schedule III
Anabolic steroids
4000
Barbituric acid derivative
2100
Butalbital
2100
Codeine combination product 90 mg/du 9804
N
N
N
Hydrocodone combination product 15
mg/du
Lysergic acid
Chlordiazepoxide
Clonazepam
Clorazepate
Dexfenfluramine
Dextropropoxyphene dosage forms
9806
7300
2744
2737
2768
1670
9278
N
N
N
N
N
Diazepam
Dichloralphenazone
Diethylpropion
Lorazepam
Lormetazepam
Modafinil
Pentazocine
Temazepam
Triazolam
Zaleplon
Zolpidem
2765
2467
1610
2885
2774
1680
9709
2925
2887
2781
2783
N
N
N
N
N
N
N
N
N
N
N
"Body Building" drugs
Barbiturates not specifically listed
Fiorinal, Butalbital with aspirin
Empirin, Fiorinal, Tylenol, ASA or APAP w/codeine
Tussionex, Tussend, Lortab, Vicodin, Hycodan,
Anexsia ++
LSD precursor
Librium, Libritabs, Limbitrol, SK-Lygen
Klonopin, Clonopin
Tranxene
Redux
Darvon, propoxyphene, Darvocet, Dolene,
Propacet
Valium, Valrelease
Midrin, dichloralantipyrine
Tenuate, Tepanil
Ativan
Noctamid
Provigil
Talwin, Talwin NX, Talacen, Talwin Compound
Restoril
Halcion
Sonata
Ambien, Stilnoct,Ivadal
Proper Prescribing of CPD
Practitioner’s Manual
An Informational Outline of the
Controlled Substances Act
2006 Edition
DEA remains committed to the 2001 Balanced Policy of promoting
pain relief & preventing abuse of pain medications.
http://www.deadiversion.usdoj.gov/pubs/manuals/pract/index.html
Proper Prescribing of CPD
1.
2.
What constitutes schedule I or other
schedules assignments for drugs?
Identify the schedule for each of the
following:

3.
4.
5.
Marijuana; morphine; heroin; codeine; LSD;
opium; amphetamine; cocaine
How often do you renew your DEA
registration and what happens if you move?
Which schedules can be refilled?
Can you fax CPD prescriptions?
DEA Practitioner’s Manual 2006; pg. 5-6 & 9-11 & 21-22
Proper Prescribing of CPD
 Schedule
I: no accepted medical use in the
US; therefore, cannot be prescribed,
administered or dispensed for medical use; no
evidence of safety; high potential for abuse
 Schedule II-V: some accepted medical use
and can be prescribed, administered, or
dispensed for medical use; High potential for
abuse; descending order (II > III > IV >V)
Proper Prescribing of CPD
 Schedule





<15mg of hydrocodone (Vicodin® & Lortab®)
<90mg of codeine
Benzodiazepines
Sleep aids
Marinol
 Schedule

IV:
narcotics (propoxyphene)
 Schedule

III:
V:
<200mg of codeine/100 ml or g (Robitussin AC® &
Phenergan with codeine®)
Proper Prescribing of CPD
Schedule I: marijuana; heroin; LSD
 Schedule II: morphine; codeine*; opium; cocaine;
amphetamine
 Renew DEA registration q3 years





Sent 45 days prior to expiration
Sent to address on file; will not be forwarded
If you don’t receive it w/in 30 days, call 800-882-9539
Relocating: modify application on-line @:
www.DEAdivision.usdoj.gov
Schedules II: cannot be refilled on the Rx
 Schedules III-V: can be refilled on the prescription


Up to 5 times w/in 6 mo
 Fax:
-
in urgent/emergent situations
printed version within 7 days or mandatory reporting
Proper Prescribing of CPD
 Example:




Drug name
Strength
Dosage form
Quantity
-






Patient: Wanna Findasucker
Address: 1 Skid Row Way
Hydrocodone/Acetamenophin 5/500 mg
1 tab po q4 hrs PRN pain
Disp: #20 tabs (Twenty Tabs) – NO
REFILLS
Suremakes M. Feelgood, M.D.
Dispense as written
Dr Suremakes Me Feelgood
Any Practice, USA
1-800-cal-ford
(# and written)
Indication
Directions
# of refills
Pt full name & address
Physician name, address & DEA #
Manually signed
DEA Practitioners Manual 2006; pg. 18
Today 2011
Substitution
Proper Prescribing of CPD
 Federal
courts expect a “legitimate medical
purpose in the usual course of professional
practice”
 Must Do’s:






DO prescribe for legitimate medical reasons
DO document history & physical examination
DO screen for substance abuse – SBIRT
DO use proper prescription writing techniques
DO keep prescription blanks in a safe place where
they cannot be stolen
DO use ONLY 1 tamper-resistant prescription pad
at a time
DEA Practitioners Manual 2006 ed.
Proper Prescribing of CPD



DO use electronic prescriptions when possible
DO give informed consent to EVERY patient
DO require for ALL chronic pain pts:
-



Signed “CPD agreement”
Random or routine urine drug screens
Check PDMP on every visit
DO keep meticulous records
DO require pt to use one pharmacy
DO know/communicate with the pharmacist(s)
DEA Practitioners Manual 2006 ed.
Proper Prescribing of CPD
 Must AVOID:





AVOID prescribing controlled drugs at intervals
inconsistent with legitimate medical treatment*
AVOID large quantities of CPD*
AVOID large numbers of prescriptions issued*
(*compared to other physicians)
AVOID warning patients to fill prescriptions at
different drug stores
AVOID prescribing drugs when there is NO
relationship between the drugs prescribed and
condition being treated.
DEA Practitioners Manual 2006 ed.
Proper Prescribing of CPD
 Never





Do’s:
NEVER issue prescriptions to patients known to
divert drugs
NEVER issue prescriptions in exchange for sexual
favors, money, or gifts
NEVER prescribe CPD for family members
NEVER use prescription blanks for writing notes
NEVER sign blank prescriptions and leave with
others
DEA Practitioners Manual 2006 ed.
Proper Prescribing of CPD
Follow the CSA – PM guidelines
 Train nurses/office managers to recognize the
drug-seeking pt
 Place copy of DEA regulations in office waiting
room
 Set new pt rules – E.g.: No CPD on first visits
 Scan photo ID for every pt with CPD use
 Use PDMP for all pts: http://prescriptionmonitoring.state.tn.us
https://prescriptionmonitoring.state.tn.us

Proper Prescribing of CPD






Use the 4 step approach for EVERY new patient
Implement full SBIRT for all (+) screens of SU
Assess the 4 A’s on EVERY f/u visit
Provide patient info on drug use, dependence,
and abuse
Set minimum documentation standards
System for reporting drug diversion – contact
DEA field office regarding suspicious prescription
activities
Proper Prescribing of CPD
Proper Prescribing of CPD
 Step

Workup (Hx & PE)
-

1:
Pain scale
Labs, studies, etc.
Appropriate screening
-
 Step



Individual
Family
Develop plan of care
– WHO & Adjuvants
Informed consent
Reassessment
criteria
 Step
 Step

2:
Full SBIRT – if a
screen (+)


3:
4:
Document
PACT (Presenting complaint;
Additional information; Confirm
diagnosis; Therapeutic decision)

4 A’s – f/u visits
Proper Prescribing of CPD
Table 3: Definition and Components of SBIRT
S
Screening – Screening patients at risk for substance
abuse; inquiring about family history of addiction; using
screening tools such as the NIAA 1-question screening
tool for alcohol use, AUDIT, CAGE, CRAFT for
adolescents, etc.
BI
Brief Intervention - Establish rapport with pt; ask
permission; raise subject; explore pros/cons; explore
discrepancies in goals; assess readiness to change;
explore options for change; negotiate a plan for change(motivational interviewing)
RT
Referral to Treatment – For patients responding
positively to the screening tests, refer to AA, drug
addiction clinic, pain clinic, counseling, etc.
Proper Prescribing of CPD
 Screening




tools
NIAA
MAST
T-ACE
Pittsburg*
CAGE
 AUDIT
 CRAFT

 Have
you ever or do you currently use
___________ (tobacco, marijuana, ETOH, crack,
cocaine, speed/amphetamines, other street drugs, CPD)?
 Motivational
Interviewing
Proper Prescribing of CPD
Freedom from pain
MSO4 SR/ Fentanyl
patch, with MSO4 IR
(etc.) for breakthrough
Opiod for moderate-severe
pain +/- Nonopiod +/- Adjuvant
Pain persisting or increasing
Oxycodone
Hydrocodone
Codeine
Opiod for mild-moderate pain
+ Nonopiod +/- Adjuvant
Pain persisting or increasing
NSAIDs
Acetaminophen
Nonopiod +/- Adjuvant
Pain
MD Consult L.L.C. http://www.mdconsult.com Bookmark URL: /das/book/view/14899700/959/I366.fig/top
Proper Prescribing of CPD
 Exercise/PT
 TCAs
 Gabapentin
(Neurontin)
 Pregabalin (Lyrica)
 Valproate (Depakote)
 TENS unit
 Bisphosphonates
 Accupuncture
 Chiropractor
 Neutraceuticals
Proper Prescribing of CPD
 Analgesia
 Activities
 Adverse
Events
 Aberrancy
Created by the VUMC FPWC Prescribing Policy Team. Dewey, Jackson, Mullins, Garriss, Gregory and
Gregg, 2010.
Proper Prescribing of CPD
 Something




you didn’t expect…
Early refill
(+) or (-) UDS
Failed contract
Other
Proper Prescribing of CPD
 Physical
dependence and tolerance are
normal physiological consequences of
extended opioid therapy for pain and are
not the same as addiction
Use
Tolerance
Dependence
Pseudoaddiction
≠
Abuse
Addiction
Proper Prescribing of CPD
1. Four Step Approach
2. Proper Prescribing
1.
2.
3.
4.
5.
1 & 2 above
CPD Agreement
UDS
PDMP
Adjuvant Trx
1. 1 & 2 above
2. CPD Agreement,
UDS, PDMP, Adj Trx
3. Referrals
Proper Prescribing of CPD
Proper Prescribing of CPD
1.
2.
3.
4.
5.
Transient-passing through
Feigns physical or psychological
problems
Pressures the physician for a particular
drug or multiple refills of a prescription
Red flags in presentation and PE findings
Assertive
personality/demanding/overacting
Ref: Pocket card
Proper Prescribing of CPD
6.
7.
8.
9.
10.
Unwilling to provide references/medical
records
No PCP
Cutaneous signs of drug use
Has no interest in diagnosis
Rejects all forms of treatment that do not
involve narcotics
Ref: Pocket card
Proper Prescribing of CPD
“Its not what you prescribe, but how
well you manage the patient’s care,
and document that care in legible
form, that is important.”
First distributed by Minnesota BME in 1990, then taken by the
North Carolina BME and then adopted by the Tennessee BME
Proper Prescribing of CPD
Proper Prescribing of CPD




CPD epidemic is real and is costly to pts and
our community
Physicians are the #1 reason for excess
CPD on the streets
Apply proper prescribing rules from the
practitioner’s manual into individual and
office practices
Be on guard for drug seekers and know the
proper procedure to take if identified