Prescribing Opiates for Chronic Pain: A Practical Guide

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Prescribing Opiates for Chronic Pain: A Practical Guide

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Title: Prescribing Opiates for Chronic Pain: A Practical Guide


1
Prescribing Opiates for Chronic Pain A
Practical Guide
  • algosresearch.com

Algos
2
The 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
3
Chapter 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
4
Why 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
5
Issues 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
6
Risks to the Physicians Practice
7
Risks 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.

8
Disciplinary Actions Against US Physicians
Regarding Opiate Prescribing 2005
Feb29(2)206-12.
Algos
9
However, 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
10
Punitive 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
11
Key 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
12
Famous 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
13
Physicians 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
14
Litigation 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
15
One 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
16
Risks to Patients Substance Abuse of
Prescription Narcotics, Alcohol, and Illicit Drugs
17
SUBSTANCE 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.

18
Several 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
19
Many 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
20
Reality 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
22
Pain 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
23
Reasons 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
24
Patient 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
25
Appropriate 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
26
New 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

27
Alcohol, 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
28
US 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)

29
Is 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
30
Percent of Chronic Pain Population Engaging in
Abuse and Illicit Drug Use in Western Kentucky J
Ky Med Assoc. 2005 Feb103(2)55-62

31
Why 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
32
Strongest 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
33
Clues 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
34
Patients 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)
36
US Illicit Drug Abuse vs. Age2002 National
Survey on Drug Use and Health
37
Employment 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

38
Drug Abuse vs. Race 2003
39
Diversion
  • 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
40
Patient 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
41
Setting Up the Clinic Rules
42
Set 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
43
Key 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
45
4.  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
46
5.  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
47
6. 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
48
7.  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
49
8.  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
50
10.  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
51
The 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

52
The 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.

53
Algos 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.  

54
Algos 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.

55
Algos 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.

56
Algos 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.

57
Algos 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________________  

58
Chapter 2- Compliance Program to Enforce the Rules
  • Compliance Methods
  • Urine Drug Screens
  • Serum Drug Screens
  • Be Aware of Subterfuge

59
Compliance Measurement and Enforcement
60
Algos 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)

61
Two 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
62
Three 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
63
Consequences 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

64
Narcotic Effectiveness and Abuse
Documentation Questionaire is Given Each Month
65
Drug Testing An Essential Part of a Narcotic
Prescribing Program
66
Goals 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
67
Having Your Patients Jump Through the Hoops In
Order to Assure Compliance
68
Types of Screening Tests
  • Urine
  • Blood
  • Saliva
  • Hair
  • Nails
  • EMIT
  • Monoclonal antibodies
  • HPLC/TLC
  • GC/MS

Algos
69
Serum 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
70
Urine 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
71
Drugs to be Screened in UDS
  • Opiate alkaloids (morphine, codeine)
  • Synthetic opiates
  • Semisynthetic opiates
  • Amphetamines esp. methamphetamine
  • Benzodiazepines
  • Cocaine
  • THC
  • MDMA (ecstacy)

Algos
72
Triggers 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
73
Detection 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
74
Cutoff 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
75
EMIT 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
76
Limitations 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
77
EMIT 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

78
Monoclonal 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
79
Distribution 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
80
MOR300 Test Strip Cutoffs
Opiate or Morphine Strips are Insensitive to
Semisynthetics
3100ng/ml
30,000ng/ml
50,000ng/ml
300ng/ml
Algos
81
Embedded Monoclonal Test Strips-No handling of
urine. 10 test panel kits cost around
11Includes methadone, darvocet,
oxycodonerapidxams.com
Algos
82
TLC Testing
83
TLC-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
84
GC/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
85
Hybrid 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
86
Limits 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
87
CPT 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
88
Medicare 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
89
Saliva 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

90
Hair 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
91
Subterfuge Attempting to Pass a Drug Test
Through Adulteration of the Specimen or
Surreptitious Submission of Clean Urine
Algos
92
Subterfuge 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
93
Most 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
94
Common 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
95
Common 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
96
Root cleaning system for patients whose labs
perform hair analysis
97
Effective 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
98
Directions 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.
99
Urine additive for detox. pH, specific gravity
balanced, comes with small heating pad to assure
correct temperature.
100
Advertising 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.
101
Whizzinator Complete Kit with Heat Packs and
Freeze Dried Urine
Contains Reservoir for Clean, Freeze Dried Urine
Algos
102
Whizzinator Comes in Different Colors To Match
the Skin of the Patient
Algos
103
Methods 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
104
Chapter 3 Federal and State Laws
  • DEA Act
  • Relevant State Laws
  • Reporting Requirements
  • The DEA Recent Changes in Position

Algos
105
DEA 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
106
Drug 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
107
Drug 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

108
PCP
  • 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

109
DEA 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

110
DEA 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
111
Prescription 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
112
Controlled 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.

113
DEAs 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.

114
SCHEDULE 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
115
SCHEDULE 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
116
SCHEDULE 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
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