Title: Prescribing Opiates for Chronic Pain: A Practical Guide
1Prescribing Opiates for Chronic Pain A
Practical Guide
Algos
2The Setup Checklist
- Infrastructure Opiate clinic rules established
before prescribing Chart available 24 hours a
day to provider, patients given informed consent
including risks and understanding of clinic rules
(Chapter I Slide 3) - Compliance Program UDS, pill counts, pharmacy
queries, duplicate scripts or scripts scanned or
copied (Chapter 2 Slide 58)
- Familiarity with State and Federal Laws (Ch 3
Slide 104) - FSMB Prescribing Guidelines (Ch 4 Slide 125 )
- Patient selection (Ch 5 Slide 131)
- Optimizing Narcotics (Ch6 Slide 154)
- Treatment of Side Effects (Chapter 7 Slide 256 )
- Documentation, Withdrawal Techniques, Exit
Strategies (Chapter 8 Slide 262)
Algos
3Chapter I- Setting Up Infrastructure for Opiate
Prescribing
- Risk and Consequences of Substance Abuse/Drug
Diversion in the Practices of Pain Physicians - Clinic Rules for Opiate Prescribing
- Narcotic Agreements/Informed Consent
Algos
4Why Prescribe Narcotics?
- Narcotics provide a central treatment for a
central issue chronic pain. Chronic pain is not
simply nociceptive in nature. - Long track record of efficacy
- Expands the treatments from block jock
mentality of a technician to that of a physician - Pain physicians should be the experts in narcotic
prescribing and serve as a resource to other
physicians when chronic pain requires treatment
in doses and with regimens out of the realm of
the PCP
Algos
5Issues of Concern to Pain Physicians Punitive
Actions, Abuse, and Diversion
- Risk to the Physicians Practice by Prescribing
Opiate Narcotics for Chronic Pain - Risks to Patients from Substance Abuse from
Prescription Narcotics, Substance Abuse of
Alcohol in Combination with Prescription
Narcotics, or Substance Abuse of Illicit Drugs in
Combination with Prescription Narcotics - Drug Diversion
Algos
6Risks to the Physicians Practice
7Risks of Disciplinary Action for Prescribing
Opiates
- J Pain Symptom Manage. 2005 Feb29(2)206-12. The
risk of disciplinary action by state medical
boards against physicians prescribing opioids.
Richard J, Reidenberg New York State Board for
Professional Medical Misconduct for 3 years and
of all medical boards in the United States for 9
months was done to determine this risk. New York
State, with 7.8 of U.S. physicians, had 10
physicians disciplined annually related to
overprescribing opioids. The total physicians
disciplined for overprescribing for the entire
U.S. was 120 physicians annually. - Not a single physician, for whom information
was available, was disciplined solely for
overprescribing opioids. - The actual risk of an American physician being
disciplined by a state medical board for treating
a real patient with opioids for a painful medical
condition is virtually nonexistent.
8Disciplinary Actions Against US Physicians
Regarding Opiate Prescribing 2005
Feb29(2)206-12.
Algos
9However, there have been many physicians who have
been jailed or lost their licenses for multiple
infractions over the past several years
- Kickback schemes from patients bilking insurance
for meds not needed, then selling the meds and
giving part of the proceeds to the prescribing
physician - Kickbacks by requiring use of a single pharmacy
which was part owned by the physician or had
kickback from pharmacist - Drug mills without standard medical history or
physical exams/no other therapies offered - Massive over-prescribing well beyond extremes of
a pain practice
Algos
10Punitive Actions Against Physicians
- Most punitive actions are taken by state medical
boards against physicians, not by the DEA - The DEA often refers cases to the State Medical
Boards for action if there is no diversion
involved. - DEA concentrates on diversion cases using tips
from law enforcement and undercover agents - The absolute amounts of drugs prescribed are
usually not a significant factor in and of
themselves - There are nearly 1,000,000 DEA controlled
substance licenses in the US and only a few
hundred DEA agents. These agents handle all
aspects of drug diversion including the illegal
drug trade.
Algos
11Key Features in Recent DEA Cases Against
Physicians
- Drug mills with very short visit times
(inadequate follow up), failure to monitor or
address addiction, inadequate records, reputation
as a drug mill, undercover cameras during
physician encounter - Large prescription or frequent large
prescriptions for the same patient in conjunction
with one of the above
Algos
12Famous Cases of Punitive Action Against
Physicians Prescribing Narcotics
- 2003 Levertz Indianapolis convicted of drug
kickbacks from Medicaid - 2001-2003 7 doctors in Eastern Kentucky pleaded
guilty or were convicted of felonies for
prescribing without a legitimate medical reason
David Proctor pleaded guilty April 29,2003 - Joseph Tally, MD North Carolina was charged with
24 counts of prescribing without adequate exams
or records in 2002 - Dr. Franklin J. Sutherland, 46, was convicted
of 430 counts of prescribing narcotics without
legitimate medical purpose and faced life
imprisonment in Virginia 2001 - Hurowitz MD in Virgina gave up his practice after
years of legal battles of federal and state
authorities because of his narcotic prescribing
(2002) - Frank Fisher, MD California was convicted of
manslaughter in 1999 for prescribing narcotics to
5 people who overdosed and died - Dudley Hall, MD Bridgeport, CT charged with 36
counts of overprescribing - James Graves, MD of Florida was convicted of 4
counts of manslaughter for overprescribing
Oxycontin in 2001
Algos
13Physicians Can Now Be Disciplined for
Underprescribing Opiates
- New Federation of State Medical Boards Model
Policy for the Use of Controlled Substances for
the Treatment of Pain (2004) considers
undertreatment of pain or continued use of
ineffective treatmentsto be a departure from
the standards of practice and will investigate
allegations of such.
This absurdly myopic policy was adopted in spite
of vehement physician protest
Algos
14Litigation by Patients or Their Families Poses A
Small, But Real Risk
- In order to assuage grief over loss of a patient
through self administered drug overdose, some
patients families resort to litigation in order
to deflect blame onto physicians, pharmacists,
and manufacturers of narcotics. - Involving families in patient care can serve to
mollify such risks, but is much less likely to be
accepted by chronic non-malignant pain patients
than those with malignancy or who are terminally
ill. There are HIPAA considerations that must be
addressed before engaging family members in
assistance with patient care issues.
Algos
15One of the More Famous Cases of Physicians
Targeted by Patients Families Litigation
- Families file negligent death lawsuits against
Dr. Talley - Date August 19, 2002Families file negligent
death lawsuits against Dr. Talley Luann
Laubscher Star Staff Writer SHELBY Three new
negligence lawsuits for the deaths of former
patients were filed against Dr. Joseph Talley
this month in Cleveland, Rutherford and Gaston
counties. A fourth negligence lawsuit was filed
against Talley in Rutherford County in February
for the death of former patient David Barry
Bailey. Talley, a self-styled pain specialist who
had his medical license suspended in March by the
N.C. Medical Board, could also face federal
charges in connection with the deaths of 23
patients. The negligence lawsuits were filed in
the deaths of Roger Dean Huffstetler Sr. in
Gaston County, Jan Willis Coleman in Cleveland
County and Charles David Williams in Rutherford
County. Each plaintiff died from a narcotics
overdose, according to court documents.
Algos
16Risks to Patients Substance Abuse of
Prescription Narcotics, Alcohol, and Illicit Drugs
17SUBSTANCE ABUSE DEFINITION
- FIRST LINE INDICATORS of Substance Abuse
- 1. obtaining narcotics from a non-medical source
- 2. obtaining narcotics from overseas pharmacies
through the mail - 3. injecting oral formulations
- 4. repeated episodes of prescription loss/theft
- 5. concurrent abuse of illicit drugs or alcohol
- 6. multiple dose escalations despite warnings
against this behavior - 7. repeated episodes of gross impairment or
dishevelment - 8. obtaining narcotics chronically from multiple
medical providers - 9. non-iatrogenic overdose resulting in
intubation, obtundation, ICU admission, DUI, or
endangerment of another person through their
actions. - SECOND LINE INDICATORS include histrionic
behavior, drug hoarding, aggressive complaining,
requesting specific drugs, unsanctioned drug dose
escalation once, occasional mild impairment, or
unapproved use of a drug to treat other symptoms.
18Several Studies Demonstrate Very Low Substance
Abuse Rates in Patients Taking Prescription
Narcotics
- One out of 36 patients with non-malignant pain
demonstrated abuse with oxycodone treatment Spine
1998 Dec 123(23)2591-600 - Four out of 266 patients in a codeine/oxycodone
study for rheumatic disease demonstrated
substance abuse. Arthritis Rheum 1998
Sep41(9)1603-12 - Zero out of 10 patients demonstrated substance
abuse Pain Med. 2005 Mar-Apr6(2)113-21 - 3/152 Patients in an Orthopedic Spine Clinic
demonstrated substance abuse Arthritis Rheum.
2005 Jan52(1)312-21
Algos
19Many Studies Erroneously Purport Absurdly Low
Substance Abuse Rates From Prescription Opiates-
Less than the General Population NHDUS Rates
- Due to tight study controls (eg. those with
substance abuse histories are excluded from
participation) - Due to naïve assumptions regarding patient
veracity (instead of checking pharmacies and
other physicians for substance abuse, many
studies simply ask patients if they are abusing
drugs) - Due to restricted age groups with low substance
abuse propensities (eg. Osteoarthritis patients) - Due to improper extrapolation of results from one
study population (acute pain) to another
different population (chronic pain) - Study is too short to pick up developing
substance abuse
Algos
20Reality Check
- 4.9 of the US population age 12 and older will
have abused prescription narcotics in the past
year, half of these have abused prescription
narcotics in the past month. (2003 NHDUS Data) - The claims of 0.1 or less abuse of prescription
narcotics are ludicrous
Algos
21 of PopulationgtAge 12 Engaging in Substance
Abuse Past Year sans Marijuana (US 2003)
Algos
22Pain Patient Abuse Rate of Prescription Opiates
is Not Nearly So Low
- 34 abuse rate in chronic pain population
Clin J Pain 1997 Jun13(2)150-5 - Prescription opiate abuse is seen in 24-33 of
chronic non-cancer pain patients J Gen Intern
Med 2002 Mar17(3)173-9 Use of opioid
medications for chronic noncancer pain syndromes
in primary care. - Prescription narcotic abuse is seen in 25 of a
chronic pain clinic population Pain Physician
2001 July - 24 of spinal cord injury patients report abusing
prescription abusable drugs Int J Addict 1992
Mar27(3)301-16 - 50 of chronic headache patients had abuse of
narcotics over a 3 year period."Patients used
medications inappropriately, received them from
more than one physician, tried to fill
prescriptions early, or claimed to lose them and
requested more than prescribed. Neurology.
2004621687-1694
Algos
23Reasons for Higher Prescription Narcotic
Substance Abuse Rates in Pain Clinics
- Higher doses prescribed much easier to abuse
- Pain centers that prescribe opiates tend to
concentrate drug seeking patients in one location - Those who sell prescribed drugs often find high
dose narcotics readily available at pain centers - Internet sites instruct patients on what to say
in order to obtain narcotics. - Less rigidly controlled centers have higher rates
Algos
24Patient Consequences of Narcotic Substance Abuse
- Death by overdose single or multiple drugs
- Overdose requiring assisted ventilation
- Family and social withdrawal
- Loss of job increased incentive for diversion
- Injury to self or others via intoxication with
narcotics while driving - Encourages doctor shopping by patients
- May not be able to find anyone to prescribe
narcotics for pain afterwards
Algos
25Appropriate Monitoring Is Required
- Visits at regular intervals-usually monthly
- Higher doses of opiates generally should trigger
more vigilance in monitoring - Monitoring tools appearance, coordination,
speech pattern during office visits any ER
visits since last visit, UDS, early pill counts,
reports of illegal activity or hypersomnolence by
other patients or the patients family, any
arrests noted in the local newspapers, red or
yellow flags based on substance abuse criteria
(see Algos monitoring system later)
Algos
26New NASPER Law 2005-Prescription Monitoring Law
- Not a national program- it is a small federal
grant to states that plan on setting up their own
program with substantial federal rules of
operation - Not mandatory
- Not mandatory to share information with more than
one state - DEA may use info to track physician prescribing
- Ultimate impact is murky
- It does not absolve physicians of the
responsibility to appropriately monitor and to
prescribe rationally in order to avoid patient
substance abuse issues
27Alcohol, Illicit Drug Use During Narcotic
Prescribing for Pain
- Effects of depressant drugs such as alcohol,
barbituates, benzodiazepines, marijuana are
additive to the sedative/hypnotic/respiratory
depressant effects of the opiate narcotics and
are therefore not permitted due to much higher
risk of overdose and death. - Patients who fail to obey US drug laws regarding
illicit drugs have no incentive to comply with
the narcotic prescribing rules of your pain
clinic.
Algos
28US Alcohol Use and Abuse 2002 NHDUS
- 71 of those gt21 years old have used alcohol
within the past 30 days - 51 of thosegt12 have used alcohol in the past 30
days - 22.9 have engaged in binge drinking at least
once in the past 30 days - 6.7 are heavy drinkers
- 14.2 admit to have been DUI in past 12 months
(not necessarily convicted)
29Is There a Link Between Illicit Drug Use And
Prescription Drug Abuse?
- The following study suggests this is the case.
- The study also illustrates the problems with pain
physicians who have too few penalties for
substance abuse or have complete lack of
enforcement of their rulesthey end up with an
out of control population that is freely abusing
the prescribed narcotics and illicit drugs. - In our practice, 70 of all illicit drug abuse
and substance abuse was from the Medicaid
population until these patients were eliminated
Algos
30Percent of Chronic Pain Population Engaging in
Abuse and Illicit Drug Use in Western Kentucky J
Ky Med Assoc. 2005 Feb103(2)55-62
31Why Are Medicaid Patients At Such High Risk for
SA and Diversion?
- Often the narcotic street value for one months
medications exceeds their entire yearly income-
therefore the incentive to sell these drugs for a
profit is very high - No social compass- they have little left to
loose, therefore their social values may be quite
aberrant compared to the rest of society.
Obeying the law is less important than survival. - Most are already addicted to one drug-cigarettes.
My Medicaid population had a 74 rate of daily
smoking.
Algos
32Strongest Predictor of Substance Abuse Past
History of Substance Abuse whether Drugs or
Alcohol
- Obtain your own records from a referring or prior
treating doctorask where the patient is
currently receiving their prescriptions. Your
office needs to obtain these records directly via
fax, mail, or email. If patient refuses to sign a
release or there are no records available (even
though patient is currently receiving
medications), then tell the patient to go
elsewhere.
Algos
33Clues to Substance Abuse First Visit
- Holes in the medical record with time periods
unaccounted for when patient was receiving
narcotics - Areas of the medical record marked out
- Cannot remember the name of the physician or
location of the clinic that was recently
prescribing potent narcotics - Extremely demanding they receive narcotics and
refuse all other therapies - Was treated at a methadone treatment center
- Patient lies to you about reasons for discharge
or leaving another pain center - Fulminant withdrawal symptoms when ostensibly
still taking opiate medications
Algos
34Patients Are Not Truthful About Illicit Drug Use
- Not all patients really have chronic pain and
even those who do will lie to their physicians
about substance abuse. 111 patients in a pain
practice random drug screens 50.5 had other
non-prescribed narcotics, illicit drugs, or
alcohol 25 had negative screen for drugs
prescribed. J Pain Symptom Manage 2000
Jan19(1)40-4
Algos
35 of Population Engaging in Illicit Substance
Abuse With The Past Year (US 2003)
36US Illicit Drug Abuse vs. Age2002 National
Survey on Drug Use and Health
37Employment and Illicit Drug Abuse 2002 (within
past 30 days)
- 17.4 of unemployed are illicit drug abusers
- 8.2 full time employees abuse illicit drugs
- 4.7 drive under the influence of illicit drugs
in past 12 months
38Drug Abuse vs. Race 2003
39Diversion
- Script alteration, forgery of signature, stealing
scripts, sale of narcotics for , sharing
narcotics with others, trading narcotics,
disabling the delivery system and alternate route
administration (crushing oxycontin and giving it
IV) - DIVERSION IS A FELONY AND MUST BE REPORTED TO THE
POLICE. This is a condition of DEA licensure.
Algos
40Patient Initiated Drug Diversion Can Cause a
Physician to Lose their License to Practice
- Take this VERY seriously! Do NOT prescribe
narcotics to a person who is diverting drugs for
sale or has altered/stolen scripts regardless of
the reason. - Duplicate or scanned scripts are very useful in
detection. Sequential numbered scripts are
useful but not foolproof. - Read the arrest record in the newspapers
Algos
41Setting Up the Clinic Rules
42Set Up Your Rules
- Determine abuse criteria in advance set up
through opiate agreement with patient - Strongly consider psychologist intervention in
potential problem patients - Consider a flag system or substance abuse point
system - BE SPECIFIC WITH YOUR PATIENTS AS TO WHAT
CONSTITUTES ABUSE
Algos
43Key Elements in Defining Your Clinic Rules
44 1. Patients must understand that pain may
not respond to opiates, and that in such cases,
you WILL withdraw the opiates if there are no
significant improvements in response rate with
escalating doses.2. Patient should be given a
target of 50-75 pain relief. Relief of 100 of
the pain is rarely possible and is not a goal
given the proclivity to develop escalation of
doses once the patient is used to 100 pain
relief.3. Patients must understand receiving
opiate therapy is not a right and has certain
risks attached of sedation, constipation,
respiratory depression, death, etc. These should
be included in the signed opiate agreement. The
rules under which opiates may be withdrawn
gradually or stopped suddenly should be spelled
out clearly in the opiate agreement.
Algos
454. All physicians, nurse practitioners, and
prescribing physicians assistants in the clinic
must agree to a uniform policy of interpretation
and enforcement of the opiate agreement. There
can be no deviation. If there is a question
regarding interpretation, ask one of the other
practitioners how the situation should be
handled. The staff is to reiterate the policy of
the practice to the patient, however if the
patient is insistent, then questions about the
policies should be addressed to the physicians in
the practice.
Algos
465. Enforcement mechanisms must be in place when
patients are receiving moderate to high dose
opiates (gt60mg/day oxycodone). These include
random drug screening, event triggered drug
screening, mandatory pill counts either at your
office or by the pharmacist at their local
pharmacy, surveys of the local pharmacies the
patient has visited (may require HIPPA
modification), insurance or Medicaid contact to
find out where , from whom, and how many
narcotics are being prescribed, close contact
with the PCP regarding any substance abuse
issues, employment of psychological counsel in
selected cases and always when past substance
abuse history is present.
Algos
476. Physicians who prescribe high dose opiates
must have access what prescriptions were written
for that patient at all times, 24 hours a day.
This may require going to the clinic and pulling
the prescriptions in case an emergency department
calls you at night or having 24 hour
availability of the same information through
electronic medical records. It is highly
desirable to have exact copies of the
prescription scripts via duplicate scripts,
scanned scripts, or photocopied scripts in cases
where prescription alteration may have occurred.
Algos
487. Patients who are given a timeframe with which
to obtain the UDS must do so within that time
frame or they will not be prescribed any more
opiates into the future, period. It is
recommended this policy carry over for at least
one year before opiate prescribing is again
revisited.In-office immediate UDS or saliva
testing (illicit drugs only) is recommended over
having patients go to a lab or hospital for UDS
since patients may attempt to dilute their
systems with massive water intake or may use
commercial products to cleanse their systems of
illicit drugs.
Algos
498. If the staff is frequently beset by telephone
calls about lack of adequate pain control, set up
an urgent followup with the patient. If the
patient continues to call several times a day, an
administrative discharge of the patient may be
employed. If patients frequently push the
physician into uncomfortable territory, tell the
patient you are not willing to make such changes
as requested. If they persist or demonstrate a
lack of understanding when you tell them "no", it
may be time for the patient to find another pain
center. 9. Adopt a clinic policy on how
narcotic issues are to be handled (such as
preauth of drugs, early refill calls, etc) and
handle disputes with patients over narcotics,
calmly and with explanation. If the patient is
unreasonably persistent, demanding narcotics in
the clinic "or else...", it is time to call the
police in to the situation.
Algos
5010. Substance abusers are not only from poor
financial situations, but may be from the wealthy
or the socially connected. Occasionally
significant difficulty occurs from the "ritch
witch" who believes clinic rules simply do not
apply to them. 11. Set up the paperwork (opiate
agreement, drug screening handling, follow up
assessment form which should include both pain
assessment and functional assessment), be certain
everyone (staff, secretaries, physicians, NP,
PAs) in the clinic is on the same page with
respect to the rules, and DO NOT DEVIATE FROM THE
RULES. Deviation may lead to litigation due to
unfair treatment, discrimination, etc.
Algos
51The Algos Narcotics Agreement
- May be downloaded and modified for your practice
at the link below. The following slides
reproduce the text of the agreement. The
agreement serves also as a signed informed
consent for treatment. - http//algosresearch.org/PracticeTools/NarcoticsIs
sues/Narcotic_Policy.doc
52The Algos Narcotic Agreement (1)
- 1. The prescribing of narcotics for chronic pain
is a challenge under the best of circumstances
due to issues of substance abuse, addiction,
legal requirements, the historical high
percentage of drug abusers intermingled with the
chronic pain population, and other factors. The
goal of our medical practice is to provide
narcotics when deemed appropriate utilizing the
guidelines of the Federation of State Medical
Boards. In order to continue prescribing
narcotics to patients, it is necessary to have
tight controls and rigid rules established to
eliminate those who procure narcotics for illegal
purposes or for substance abuse, to protect the
privileges of our practice to prescribe, maintain
the health and welfare of the patients, and to
obey the laws under which we operate, both
federal and state. 2. Narcotics are but one
avenue of pain therapy and never represent the
sole method of pain control. Narcotics have
potential for addiction and substance abuse, are
diverted by some for sale or for improper routes
of administration or are shared with others.
Narcotics may produce dependence, tolerance, and
addiction. Side effects of narcotics include
sedation, respiratory depression, swelling in the
feet, dental decay acceleration, hives, itching,
slurred speech, impaired thinking and function to
the point a person may be dangerous when driving
or operating machinery when taking narcotics, ICU
admission, coma, and death. For these reasons,
we reserve the right to change to a non-narcotic
therapy at any time it is medically indicated.
We also reserve the right to insist on an in or
out patient treatment for narcotic dependence.
There is no implied or expressed patient right
to narcotic therapy in a physicians office or in
a hospital.
53Algos Narcotic Agreement (2)
- 3. EXPECTATIONS OF APPROPRIATE PATIENT BEHAVIOR
AND RESPONSIBILITY a. Our medical practice
will be the only entity prescribing narcotics for
chronic pain. If there is acute pain for a new
condition for which the patient seeks care
elsewhere, our practice must be called to let us
know of the other physicians prescribing, and at
that time we may adjust your chronic pain
medications. If it is discovered patients are
chronically receiving narcotics from multiple
physicians, we will immediately discontinue
medication prescribing and notify pharmacies and
other treating physicians of the patients
substance abuse. b. In certain states, there
may be laws prohibiting patients from obtaining
narcotics under false pretences (eg. seeing
multiple physicians for narcotics without
notifying the other physicians). In all states,
there are laws which prohibit sharing of
prescription narcotics with others, changing or
altering a narcotic prescription in order to
obtain early refills or an increased quantity of
narcotics, or the selling or trading of
narcotics. These events are felonies under
federal law and are not protected by the
patient-doctor professional relationship.
Therefore any information we receive regarding
the commission of a felony will be reported to
the police or US Drug Enforcement Agency. c..
One pharmacy must be used for scripts. If that
pharmacy does not have the prescription, then we
expect patients to go to another pharmacy rather
than receive a partial refill on the narcotic.
We will not write additional scripts to cover
the balance of a shortfall from a pharmacy with
insufficient supplies. Therefore in advance, ask
the pharmacist not to fill the script with a
partial refill if the pharmacy lacks sufficient
stocks to carry out the prescription filling.
If a second pharmacy must be used to fill a
script of narcotics, then notify our practice at
that time regarding the situation. d. Refills
of scripts for narcotics are only performed
during scheduled office visits. We will not call
in narcotic prescriptions nor write prescriptions
at the time of patient procedures or during
non-office hours.
54Algos Narcotic Agreement (3)
- 3e. There are no early refills period. The
patient is expected to make the prescription
quantity last until the next office visit. We do
not refill prescriptions that were lost, stolen,
spilled, eaten by the cat, etc. The
responsibility for safekeeping of these
medications lies solely with the patient.
Therefore, each patient is expected to keep a
lock box or location for safekeeping for the main
supply of the narcotic medication instead of
carrying around the entire months supply. f.
On request of our medical practice, the patient
will submit a urine sample to a designated
laboratory for testing to assure the medications
being prescribed are actually in the urine. The
patient has 24 hours in which to give the
specimen. On request, a pill count may be
necessary and the patient has 24 hours to bring
in the narcotics to be counted by our staff. For
patients out of town, it is acceptable to have a
local pharmacist perform a pill count and we will
call the pharmacist to verify. g. There
will be no alcohol or illicit drug use while
taking narcotic medications. Discovery of such
via internal or external sources may result in
discontinuation of narcotics immediately. h.
It is the policy of our practice that driving or
operating machinery while taking narcotics may
have untoward consequences, and if the patient
elects operate machinery or equipment, they do
so at their own risk of injury or death. - I. Sudden cessation of narcotics causes
injury to the patient only in very rare
circumstances however, sudden cessation of high
dose narcotics will result in severe abdominal
cramping, severe anxiety, rapid heart rate,
elevated blood pressure, nausea, etc. Therefore
it is prudent to use the narcotics as prescribed
rather than running out early or violation of our
policies which will result in sudden cessation of
narcotic prescribing.
55Algos Narcotic Agreement (4)
- 4. REASONS NARCOTICS MAY BE IMMEDIATELY
DISCONTINUED Reasons for which narcotics
will be stopped immediately and without any
withdrawal medications include but are not
limited to evidence of prescription alteration
or fraud or solid evidence presented to our
clinic that the patient has been selling the
narcotics, sharing narcotics with others,
injection of oral or trans dermal narcotics,
threats of legal action or violence made against
any of our staff in order to obtain narcotics,
etc.. In such cases the police will be called
immediately to report a felony drug diversion or
attempted extortion, and the patient will be
immediately discharged from our practice.
Committing a narcotics related crime is not
protected by doctor-patient privilege and will
not be tolerated by our practice.. Additionally,
refusal to take a urine drug screen within 24
hours of the request, refusal to bring in
medications for a pill count when requested, a
positive drug test for illicit drug use or
narcotics not prescribed by our clinic, or a
negative urine drug screen for narcotics we are
prescribing will be met with discontinuation of
narcotics. External source confirmation of
doctor shopping or obtaining narcotics
chronically from multiple physicians
simultaneously will require sudden narcotic
discontinuation. Impairment of the patient to
such a degree that in the opinion of our medical
practice that the patient poses a risk to
themselves or to others may require narcotic
discontinuation.
56Algos Narcotic Agreement (5)
- 5. REASONS NARCOTIC THERAPY MAY BE MODIFIED OR
REDUCED Reasons for which narcotic therapy will
be modified or discontinued with the possibility
of a drug taper or non-narcotic withdrawal
medication administration loss or stolen
scripts, overuse of medications, failure of
escalating doses of narcotics to provide relief
in the absence of any demonstrable worsening
findings on clinical examination including
xrays/MRI, arrest for driving while impaired,
arrest for any alcohol related offence,
excessively frequent calls to our clinic
regarding chronic pain issues, prevarication
regarding prior treatment and substance abuse,
canceling appointments for procedures but showing
up for office visits, failure to participate in
the integrated therapies of our practice, etc.
57Algos Narcotic Agreement (6)
- 6. Chronic pain is just thatit is a long
standing problem which has been present for
months or years. It is important that patients
keep a long term perspective on the treatment of
this condition. Frequent calls to our clinic for
non-urgent issues, frequent requests of narcotics
changes outside appointment times, or histrionic
behavior in the absence of new conditions may
make patients non-candidates for continued
therapy in our center. However, in the case of
potentially life threatening emergencies such as
severe respiratory depression and over sedation,
our physicians may be contacted 24 hours a day by
calling the designated number and asking for the
Pain Physician on call. Calls made for
non-emergent issues or issues which should be
handled during office hours may jeopardize
continued treatment in our practice.7. For
questions regarding our narcotic policy call our
office and ask to speak to the office manager.
TheModified Federation of State Medical Board
Narcotic Prescribing Guidelines 2004 used by our
practice are found below. - I, ____________________________ have read and
understand the narcotics prescribing policy
above.DATE________________
58Chapter 2- Compliance Program to Enforce the Rules
- Compliance Methods
- Urine Drug Screens
- Serum Drug Screens
- Be Aware of Subterfuge
59Compliance Measurement and Enforcement
60Algos Substance Abuse System
- One point calls in early for meds due to
running out early with up to 25 overuse lost or
stolen script non-emergent physician contact
regarding opiates on nights or weekends
telephone report (anonymous) that patient is
selling drugs (DRUG SCREEN AND PILL COUNT
IMMEDIATELY) - family report that patient is impaired (Pill
count)
61Two Points Algos Substance Abuse System
- Fails to show up for procedures or PT but shows
up for opiate prescribing - Telephone report (identified) that patient is
selling drug (must call police) - Marijuana in drug screen
- One time episode of multiple prescribers of
narcotics - Overuse of meds by 50 without physician
authorization
Algos
62Three Points Algos Substance Abuse System
- Police reports patient is selling drugs
- Overdose resulting in hospital admission (unless
due to incorrect dosing, hepatorenal function
change) - Prescription alteration
- Cocaine, methamphetamines, heroin, etc in drug
screen - Refusal to take drug screen in allotted timeframe
- Chronically (gt2 months) obtaining narcotics from
multiple prescribers - Hostile or threatening behavior in order to
obtain narcotics (call police extortion)
Algos
63Consequences Algos Substance Abuse System
- 3 points in a year no narcotics for at least a
year, then may re-institute with controlled
monitoring with frequent follow-up and mandatory
psychology visits. If overdose, then
addictionology consult is necessary. - 2 points Written warning to patient
- 1 point Verbal warning
64Narcotic Effectiveness and Abuse
Documentation Questionaire is Given Each Month
65Drug Testing An Essential Part of a Narcotic
Prescribing Program
66Goals of Random Drug Screens
- Truly random- patient does not know in advance of
their selection for such - Assures presence of prescribed drugs (this only
works if on prn narcotic medications you
specifically write maximum _ tablets per day
or max _/day - Assures patient is clear of illicit drugs or
non-prescribed drugs
Algos
67Having Your Patients Jump Through the Hoops In
Order to Assure Compliance
68Types of Screening Tests
- Urine
- Blood
- Saliva
- Hair
- Nails
- EMIT
- Monoclonal antibodies
- HPLC/TLC
- GC/MS
Algos
69Serum Testing
- Useful for screening for suicide drugs eg.
Antidepressants, alcohol, benzodiazepines,
salicylates, acetaminophen, and barbituates. - Not useful for routine recreational drug testing
nor for opiate detection. - Performed by hospital labs stat
- Many cross reacting substances
- Quantitative values for opiates are useless since
there is a wide normal range (4 fold) for most
opiate concentrations given an identical dose
Algos
70Urine Drug Screens are Preferred
- AM urine specimens concentrate drugs and are more
likely to be positive than afternoon drug screens - Cannot detect alcohol
- Quantities detected have little relationship to
blood levels of the drug - EMIT method is insensitive for hydrocodone/oxycodo
ne, and may not pick up synthetics at all - Monoclonal antibody tests are more accurate and
have specific test strips available for oxycodone
and methadone - GC/MS (send out) is the most accurate and will
detect any interfering substances
Algos
71Drugs to be Screened in UDS
- Opiate alkaloids (morphine, codeine)
- Synthetic opiates
- Semisynthetic opiates
- Amphetamines esp. methamphetamine
- Benzodiazepines
- Cocaine
- THC
- MDMA (ecstacy)
Algos
72Triggers for Drug Screens
- Report patient is selling their drugs
- Report patient is taking other narcotic drugs or
illicit drugs from others - Reports from police patient is a dealer or
illicit drug user - Hyperactivity/paranoia (methamphetamine, PCP)
- Excessive somnolence (suspect concurrent drug
use) - Random
Algos
73Detection Time After Drug Use
- Methamphetamine up to 2-4 days
- Barbituates 2-4 days unless the barbituatate is
phenobaribital (detectable up to 30 days) - Benzodiazepines up to 30 days
- Cocaine up to 3 days
- Marijuana 30 days chronic, 7 days acute
- Opiates 2-4 days except darvocet that may be
detected up to 30 days later.
Algos
74Cutoff Values
- Set by the lab in cases of TLC, liquid
chromatography, or GC/MS - Set by the manufacturer for EMIT and specific
drug monoclonal antibody testing - Cutoff values are the 50 thresh-hold of
reactivity of the test. Some patients will react
at values 25 lower than cutoff, but nearly all
react at 25 above cutoff levels - Cutoff values for opiates needs to be 300ng/ml
Algos
75EMIT Technology-Dipsticks
- Least expensive testcosts 2-5 in the office or
15-30 for the same test in a hospital - Uses test strips
- Very sensitive for some drugs (eg. Marijuana) but
not specific - Many interferences and cross-reactants
- Unexpected positive or negative test should be
followed by GC/MS or liquid chromatography
Algos
76Limitations of EMIT screening
- Multiple interferences
- Overlap in detection
- 10-30 times higher concentration (vs. Morphine)
needed of semisynthetics to be detected under
opiate narcotic panel - Synthetics (methadone, propoxyphene, meperidine
are NOT detected on routine drug screening
Algos
77EMIT Urine Interferences
Algos
- Rifampin, poppy seeds, codeine cough syrup cause
positive urine opiate assays - Ibuprofen causes false positive for marijuana
- Ephedra, diet pills, cough and cold and allergy
OTC drugs cause false positive for
methamphetamine - Valerian causes false for benzodiazepines
78Monoclonal Antibody Immunoassay Testing
- Much more accurate than other dipstick methods-
costs 6-12 in the office - 95-98 agreement with GC/MS
- Cutoff values may be set lower than with
polyclonal antibody testing - Useful for semi and completely synthetic opiates
- Few interferences-bleach or alum invalidates test
Algos
79Distribution of Morphine Reactivity For the MOR
Test Strip
50
-50
At the cutoff value, slightly more than half the
samples will show up positiveat cutoff plus 25,
nearly all samples will be positive
Algos
80MOR300 Test Strip Cutoffs
Opiate or Morphine Strips are Insensitive to
Semisynthetics
3100ng/ml
30,000ng/ml
50,000ng/ml
300ng/ml
Algos
81Embedded Monoclonal Test Strips-No handling of
urine. 10 test panel kits cost around
11Includes methadone, darvocet,
oxycodonerapidxams.com
Algos
82TLC Testing
83TLC-Thin Layer Chromatography
- Laboratory test not available in offices
- More accurate than EMIT or monoclonal strips
- TLC is less sensitive but more specific than
dipstick methods - TLC is used as a confirmatory test when EMIT or
monoclonal technologies are positve - Used in hospital ER and labs
Algos
84GC/MS and HPLC/MS
- Far more accurate and discriminating than other
methods. - Uses a chromatographic separation then mass
spectrography detection of drugs - Interfering chemicals are not a problem
- Must be sent outturnaround is usually 1-2
daysnot available in physician offices - Expensive-physician cost is about 75 for opiate
panel alone
Algos
85Hybrid GC/MS, Enzyme Link Method
- Uses obligatory GC/MS for opiates
- Confirmatory GC/MS for all other substances
- Cost to the patient 100-200
- Expensive but most accurate methodvirtually 100
specific without false positives
Algos
86Limits of Detection Set by Lab or Agency
- SAMSHA THC 50 ng/dl
- SAMSHA Cocaine 150ng/dl
- SAMSHA Morphine 2000ng/dl
- SAMSHA Amphetamines 500ng/dl
- The limits of detection reported by the lab may
need to be changed to fit the profile and
sensitivity you require- the above are too high
to detect routine prescription narcotic use
Algos
87CPT Coding for UDS
- 80101 times the number of enzyme or antibody
linked tests. For instance a 10 panel test would
be coded 80101 x 10. - 80102 is used for confirmatory testing (TLC,
HPLC, etc) for each class of drug confirmed) - The code 80100 is to be used for hospitals and
labs for chromatographic testing
Algos
88Medicare Reimbursement
- Code 80101 pays 19.24 per unit as a clinical lab
fee. If multiple units are billed, the
reimbursement is obviously increased. - Check with your local Medicare carrier on
appropriate coding
Algos
89Saliva Testing
- The OratectTM Oral Fluids (Saliva) Drug Screen
Test is a one-step chromatographic immunoassay
device for the qualitative detection of
amphetamine, morphine, phencyclidine, THC
(marijuana), methamphetamine, cocaine, and their
metabolites in saliva. Cost 22 - Patient must give sample immediately, no excuses.
- Does not detect semisynthetic opiates or
synthetic opiates
90Hair Analysis
- Within 5 days, drugs appear in the hair and
provide a history of the drug abused as the hair
grows out. - An accurate history of different drug use and
amounts are obtainable up to 90 days - Minimum amount hair needed 50 strands40 mg for
analysis plus GC/MS comfirmation
Algos
91Subterfuge Attempting to Pass a Drug Test
Through Adulteration of the Specimen or
Surreptitious Submission of Clean Urine
Algos
92Subterfuge Methods
- Washout
- Dilution
- Golden seal and other substances
- Donated or purchased urine
- Artificial Penis
- Denaturation or contamination of sample eg.
Bleach or alum - Time delay afternoon samples are much less
concentrated than AM samples
Algos
93Most Pain Patients are Not Sophisticated Enough
to Use These Technologies of Subterfuge,
Especially if UDS is Random and Infrequent
- Some of the dipstick technologies now include an
assay specifically to determine whether a patient
has attempted to adulterate or dilute the
sampledetect bleach, sodium (salt
contamination), creatinine-should be lt0.2mg/ml
(detects dilution), temperaturegt90.5F for more
than 10 minutes (detects additives or water at
room temperature)
Algos
94Common Subterfuge Methods and Detection
- Dilution Specific Gravitylt1.003 and
Creatininelt0.2mg/cc - Oxidants (invalidate the GC/MS confirmatory
marijuana testing even though dipstick method is
positive)-examples include nitrite (KLEAR),
chromate (URINE LUCK, pyridinium chlorochromate),
and peroxidase (STEALTH). These may be detected
through specific test strips for oxidants
Algos
95Common Subterfuge Methods and Detection
- Acid- When used in combination with chromates may
interfere with opiate assay- detect through pH
testing (normal 4.6-8) - Ammonia-largely ineffective- detected by high pH
and odor - Soap-affects all assays detected by presence of
foam, causes bizarre data - Gluteraldehyde (URINEAID)-affects all assays-
bizarre data
Algos
96Root cleaning system for patients whose labs
perform hair analysis
97Effective on urine or saliva testing. Urine 1-5
hrs effective, saliva 2-5 hours. Oral tablets.
28, effective from 1-5 hours after oral ingestion
98Directions for Urine Testing only (on the
internet) 1. Take Quick Fizz at least one hour
before your deadline. 2. Drop one Quick Fizz
tablet into 20 ounces of water . 3. Let
the tablet dissolve and drink it down.4. Wait 15
minutes. 5. Drop the second Quick Fizz
tablet into 20 ounces of water.6. Let the tablet
dissolve and drink it down 7. Quick Fizz will be
effective in one hour and lasts for up to 5
hours. FOR BEST RESULTS 1. The Quick Fizz is
recommended for light to moderate toxin
levels.2. Do not skip meals. 3. Avoid toxins
for at least 48 hours prior to deadline.4. Do
not drink more than 10 ounces of water per
hour.5. If possible, schedule deadline for the
afternoon and urinate 3 â 4 times prior to
deadline. Directions for Saliva Testing Only 1.
Abstain from toxins for at least 4 hours before
your saliva test. 2. Take Quick Fizz within 2
hours of your saliva test. 3. Drop one Quick
Fizz tablet into 10 ounces of water. 4. Let the
tablet dissolve, swish in mouth for about 10
seconds with each mouthful and swallow after the
10 seconds. 5. Drop the second Quick Fizz tablet
into 10 ounces of water. 6. Let the tablet
dissolve, swish in mouth for about 10 seconds
with each mouthful and swallow after the 10
seconds. 7. Quick Fizz will be effective on a
saliva test up to 2 hours. AVOID FOOD, BEVERAGES
AND TOXINS AFTER USING THE QUICK FIZZ. Avoid
toxins 48 hours before deadline. Do not drink
more than 10 oz. of water per hour. Eat
lightly, avoiding greasy foods, or those high in
fat. If possible, schedule deadline for the
afternoon and urinate 3 - 4 times prior.
99Urine additive for detox. pH, specific gravity
balanced, comes with small heating pad to assure
correct temperature.
100Advertising Text
The Zip-n-Flip is a revolutionary new product
invented by Spectrum Labs, which removes toxins
from a urine sample. The toxins remain in the bag
and are discarded when the users throw the bag
away. This product is revolutionary for two
reasons. First, no one has ever failed using this
product. Second, the labs can detect additives
that are several years old. The Zip-n-Flip will
never be detectable because the chemicals stay in
the bag. The chemicals do not stay in urine and
move on to the lab as with the use of an
additive. Two chemicals are in the bag. One
chemical destroys the toxins, while the second
chemical destroys the first chemical. The
compounds end up breaking down to air and water.
For this reason use of the Zip-n-Flip is
absolutely undetectable. The tester must not be
watched while using the Zip-n-Flip because the
sample needs to be shaken. This product is
perfect for the heavy smoker that needs to
detoxify at a moment's notice. No traces of the
product or toxins are left behind in the urine.
101Whizzinator Complete Kit with Heat Packs and
Freeze Dried Urine
Contains Reservoir for Clean, Freeze Dried Urine
Algos
102Whizzinator Comes in Different Colors To Match
the Skin of the Patient
Algos
103Methods to Assure Compliance with Testing
- Immediate drug test on demand
- Patient escorted to lab...no drinks, cannot leave
escort until entering testing area - Saliva testing. Patient gives saliva sample
immediately. - No running water in sample room...(some systems
require water to add to system for detox of
sample). Use blue dye in toilet tank.
Algos
104Chapter 3 Federal and State Laws
- DEA Act
- Relevant State Laws
- Reporting Requirements
- The DEA Recent Changes in Position
Algos
105DEA Act
- The CSA, which became effective May 1, 1971,
consolidated into one piece of legislation many
diverse laws passed by Congress since the
Harrison Narcotics Act of 1914, the first
comprehensive federal legislation to control
addicting drugs. Subsequent amendments to the CSA
include the 1984 Diversion Control Amendments,
the Controlled Substance Registrant Protection
Act of 1984, the Narcotic Addict Treatment Act of
1984, the Chemical Diversion and Trafficking Act
of 1988, the Domestic Chemical Diversion Control
Act of 1993, and the Comprehensive
Methamphetamine Control Act of 1996.
Algos
106Drug Schedules
- Initially related to the purported addictive
nature and medical usefulness of a drug, but
since the DEA has no limits on how much may be
prescribed, the schedule III drug narcotic load
prescribed may be astonishingly highwell above
the amount of Schedule II drugs usually
prescribed by the same MD. - The relative schedules of drugs has become
somewhat farcical with significant
inconsistencies - PCPs may feel comfortable prescribing massive
doses of Schedule III drugs but not Schedule II
drugs that may actually be safer due to being
available without co-drugs
Algos
107Drug Schedule Inconsistencies
- Hydrocodone 10mg per tab is Schedule III while
hydrocodone 15mg per tab is Schedule II but up to
120mg per day of the schedule III drug may be
prescribed without hepatorenal toxicity. - Marijuana is Schedule I THC is schedule III
- Buprenorphine, from 1970-85 was Schedule II, then
from 1985-2002 was Schedule V, and since that
time is Schedule III - PCP and methamphetamine are Schedule II drugs
while marijuana is a Schedule I drug Algos
108PCP
- Used as an IV anesthetic in the 1950s and 1960s
- Withdrawn from the market in 1978 due to
increasing reports of abuse of the drug - Still is listed as a schedule II drug although it
has not been available for nearly 30 years for
legitimate medical use
109DEA Schedule Drug Classes
- I- No medically acceptable use. May be used in
research with a special DEA license. Includes
GHB, heroin, marijuana, fentanyl analogs, MDMA,
LSD - II- High addictive potential includes all
oxycodone, meperidine, morphine, methadone,
hydromorphone, oxymorphone, sufentanil, fentanyl
compounds,gt90mg codeine per dose, cocaine, PCP,
methamphetamine, amphetamine - III-Less addictive potential includes
hydrocodonelt15mg per tablet, codeine 90 or less
mg, buprenorphine - IV-Less addictive propoxyphene, butorphanol,
pentazocine
110DEA Registrants
- Physicians who prescribe or dispense controlled
substances EXCEPT - Public Health Service Physicians
- Dept. of Prisons Physicians
- Military Physicians
- (The former 2 use their SSN on the scripts and
the latter their military ID number) - House Officers or employees of hospitals may use
the institutional DEA number during medical
practice associated with the institution.
External moonlighting requires a separate DEA
registration - Physician DEA numbers begin with B and PA/NP
with M
Algos
111Prescription Requirements
- A prescription for a controlled substance must be
dated and signed on the date when issued.
(Cannot be post dated). - The prescription must include the patients full
name and address, and the practitioners name,
address, and registration number. (the
practitioner information may be preprinted) - The prescription must also include the drug name,
strength, dosage form, quantity prescribed,
directions for use, and number of refills. Where
an oral prescription is not permitted, a
prescription must be written in ink or indelible
pencil or typewritten and must be manually signed
by the practitioner. (computer generated
prescriptions are possible, but cannot be
generated with the drug name or quantity in
advance of the time of prescribing). - An individual (i.e., secretary or nurse) may be
designated by the practitioner to prepare
prescriptions for his/her signature. (the text of
the script does not have to be in the physicians
handwriting) The practitioner is responsible
for making sure that the prescription conforms in
all essential respects to the law and regulations.
DEA Pharmacist Manual April 2004
112Controlled Substance Requirements in General
- To be valid, a prescription for a controlled
substance must be issued for a legitimate medical
purpose by a practitioner acting in the usual
course of sound professional practice. The
practitioner is responsible for the proper
prescribing and dispensing of controlled
substances. However, a corresponding
responsibility rests with the pharmacist who
dispenses the prescription. An order for
controlled substances which purports to be a
valid prescription, but is not issued in the
usual course of professional treatment, or for
legitimate and authorized research, is not a
valid prescription within the meaning and intent
of the CSA. The individual who knowingly
dispenses such a purported prescription, as well
as the individual issuing it, will be subject to
criminal and/or civil penalties and
administrative sanctions.
113DEAs Warning to Pharmacists of A Prescription
Possibly Not Being for a Legitimate Medical
Purpose
- The following criteria may indicate that a
prescription was not issued for a legitimate
medical purpose. - The prescriber writes significantly more
prescriptions (or in larger quantities) compared
to other practitioners in your area. - The patient appears to be returning too
frequently. Prescription which should last for a
month in legitimate use, is being refilled on a
biweekly, weekly or even a daily basis. - The prescriber writes prescriptions for
antagonistic drugs, such as depressants and
stimulants, at the same time. Drug abusers often
request prescriptions for "uppers and downers" at
the same time. - Patient appears presenting prescriptions written
in the names of other people. - A number of people appear simultaneously, or
within a short time, all bearing similar
prescriptions from the same physician. - Numerous "strangers," people who are not regular
patrons or residents of your community, suddenly
show up with prescriptions from the same
physician.
114SCHEDULE II PRESCRIPTIONS
- Must be written. No refills are allowed
- No maximum quantity (physician may write one
script for 3 months) - No time limit on when the script may be filled
after being written (therefore have patients
return to you any narcotic prescriptions not
filled) - Physician may write to be filled on or
afterdate in the text of the prescription. - Physician may not write multiple scripts for the
same drug on the same daythis constitutes a de
facto refill which violates federal law.
Algos
115SCHEDULE II PRESCRIPTIONS
- EMERGENCY DISPENSING Emergency means that the
immediate administration of the drug is necessary
for proper treatment of the intended ultimate
user, that no alternative treatment is available
(including a drug which is not a Schedule II
controlled substance), and it is not possible for
the prescribing practitioner to provide a written
prescription for the drug at that time. - In a bona fide emergency, a practitioner may
telephone a Schedule II prescription to the
pharmacy or transmit the prescription by
facsimile to the pharmacy, and the pharmacist may
dispense the prescription provided that - The drug prescribed and dispensed must be limited
to the amount needed to treat the patient during
the emergency period. Prescribing or dispensing
beyond the emergency period must be pursuant to a
written prescription order - The pharmacist must receive a script for the
emergency drug within 7 days from the physician
or must report him to the Drug Diversion Division
of the DEA.
Algos
116SCHEDULE II PRESCRIPTIONS
- Facsimile Prescriptions for Schedule II
Substances the physician may fax the
prescription to the pharmacy but the patient must
present the original at the time of receiving the
script. In cases of hospice care and home IV
infusion therapy, the fax ma