Prescribing Opiates for Chronic Pain: A Practical Guide

1
Prescribing Opiates for Chronic Pain A
Practical Guide

• algosresearch.com

Algos
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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
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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
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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
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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
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Risks to the Physicians Practice
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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
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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
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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
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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
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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
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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
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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
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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
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Risks to Patients Substance Abuse of
Prescription Narcotics, Alcohol, and Illicit Drugs
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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.

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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
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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

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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
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of PopulationgtAge 12 Engaging in Substance
Abuse Past Year sans Marijuana (US 2003)
Algos
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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

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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
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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

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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
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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

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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
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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)

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

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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
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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
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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
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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

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of Population Engaging in Illicit Substance
Abuse With The Past Year (US 2003)
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US Illicit Drug Abuse vs. Age2002 National
Survey on Drug Use and Health
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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

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Drug Abuse vs. Race 2003
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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.

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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
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Setting Up the Clinic Rules
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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
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Key Elements in Defining Your Clinic Rules
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  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
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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.  
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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.
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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.
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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.
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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.
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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
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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

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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.

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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.  

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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.

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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