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					    LEGAL AND PRACTICAL ASPECTS OF
   PRESCRIBING OPIATE NARCOTICS FOR
      TREATMENT OF CHRONIC PAIN
                       (with Frequently Asked Questions)
                      IPS MLWhitworth, MD July 2008


FUNDAMENTAL PRINCIPLES OF OPIATE PRESCRIBING FOR
CHRONIC PAIN:
  1. Patients must be sufficiently responsible to use opiate narcotics as
     prescribed
  2. Physicians must monitor patients appropriately that are receiving
     prescription opiates and be willing to take action to eliminate
     substance abuse and diversion
  3. Physicians must be willing to work with the patient in achieving pain
     control by using a variety of methods outside of opiate prescribing
     and simultaneously adjusting the opiate narcotic dosing to achieve
     significant (but not complete) pain relief if side effects are minimal
  4. Physicians cannot violate state or federal laws in their quest to provide
     sufficient pain relief
  5. Opiates should only be prescribed for a legitimate medical purpose
     and in the usual course of business of a medical practice


Chronic pain affects 70 million Americans and some will require long term
treatment with opiate narcotic analgesics. In the context of a comprehensive
pain treatment continuum, opiates may be a viable option for pain control in
many patients. Opiates have the potential to reduce pain, improve function,
and decrease psychological sequelae of focusing continually on pain.
However, there are many pitfalls in prescribing these drugs, not in the least
due to overlapping populations:
    A. Legitimate pain patients that utilize the medications appropriately
    B. Legitimate pain patients that engage in substance abuse
    C. Legitimate pain patients that divert part of the medications for sale to
       help pay expenses
   D. Legitimate pain patients with family members that steal or divert the
      elderly or handicapped patient medications
   E. Legitimate pain patients that lack the capability of protecting their
      medications from theft or diversion by others
   F. Chronic substance abusers that pose as pain patients in order to obtain
      opiate narcotics, benzodiazepines, and stimulants to misuse or abuse
   G. Drug diverters that pose as pain patients in order to obtain prescription
      medications to sell or trade, often for illicit drugs
   H. Agents of law enforcement or state medical boards that pose as pain
      patients in order to entrap physicians by using hidden cameras and
      wireless microphones
   I. Opiate induced hyperalgesia effects that actually spread and worsen
      the pain

       It is often very difficult initially to determine the group that best fits a
patient or person posing as a patient. The motif is not static, and some may
gravitate between groups in a short period of time.
       Prevention of substance abuse and diversion are of paramount
importance for the physician due to the complex problems of drug addiction,
drug overdose, and illicit use of drugs. The illegal street drug culture and
the patient receiving opiate narcotics from physicians are not incisively
separate groups, and the failure of physicians to recognize this fact leads to
the physician becoming part of the drug trade pipeline since opiate
medications are frequently used to trade or sell for illicit narcotics. The laws
in Indiana and in the US regarding opiate prescribing are designed to prevent
drug diversion, but not substance abuse. Physicians prescribing drugs to
substance abusers may not run afoul of federal or state law, but may be
culpable for substandard medical care and action taken by state boards of
medicine for failure to recognize and act to eliminate substance abuse,
especially if it results in injury or death of patients. The guidelines below
will address federal and state laws in addition to good prescribing practices
for the chronic pain population. Acute pain is a separate issue and is not
addressed here.

DEA REGISTRATION TO PRESCRIBE OR
DISPENSING/ADMINISTERING CONTROLLED
SUBSTANCES
The granting of the DEA registration to prescribe controlled substances comes with legal
and ethical attachments. The practitioner must attempt to assure drug diversion is not
taking place and that the patient is using the medication in a manner consistent with that
prescribed and good medical practice. FAQ:
    A. Are separate DEA licenses required for each location of practice?
        It depends on whether the drugs are being prescribed or dispensed/administered.
        If one is prescribing drugs only, then one DEA registration per state is used.
        However if there are multiple locations of administration/dispensing within the
        state, multiple DEA registrations are required. For multiple states, separate DEA
        numbers are required.
    B. Does the state of Indiana have a separate controlled substance registration?
        Yes. This is required in addition to the DEA. It may only be obtained after the
        DEA registration is granted.




CONTROLLED SUBSTANCE SCHEDULES:
The schedules of controlled substances by the federal government under USC 21-13-1-
814 categorizes the abuse potential/addiction potential of drugs based on expert opinion,
not on evidence based medicine. Some classifications are anachronistic while others are
inconsistent. For instance, the most abused prescription drug in the US during the recent
past was hydrocodone, a Schedule III drug. Prescription drug abuse is more directly
related to availability of the drug rather than the abuse potential as defined by the DEA
Controlled Substance Schedules. Easy access to hydrocodone due to it being one of the
most prescribed prescription drugs in the US along with its refillable status, creates part
of the abuse issue with this drug. Hydrocodone, in a single tablet containing 15 mg is
classified as Schedule II while 2 tablets of 10mg hydrocodone are classified as Schedule
III. The most abused illicit drug in the US is the Schedule I marijuana, while THC, the
active ingredient, is a Schedule III drug. Cocaine, methamphetamine, and PCP (angel
dust) all have a very high potential for abuse (arguably much more than marijuana) yet
are all Schedule II drugs. Hydrocodone 10mg tablets are Schedule III yet are
approximately twice as potent as oxycodone 5mg, a Schedule II drug. Both Oxycontin
80mg and oxycodone 5mg are Schedule II even though the former contains 1600% the
quantity of active ingredient as the latter.
Notwithstanding the glaring inconsistencies in this system, it forms the basis for specific
legal requirements for writing prescriptions.
Schedule I: Marijuana, LSD, Ecstacy, GHB, many precursors and derivatives of other
legal and illegal drugs. Schedule I drugs may be prescribed only with permission from
the DEA for research purposes only. Schedule I drugs have no useful medical purpose.
Schedule II: Cocaine, methamphetamine, PCP, poppy straw, opium, morphine,
oxymorphone, oxycodone, hydromorphone, meperidine, methadone, fentanyl, sufentanil,
alfentanil, remifentanyl, levodromoran
Schedule III : buprenorphine, butalbital, codeine (up to 90mg/dose unit combination
product), hydrocodone (less than 15mg/dose unit), morphine combinations up to
50mg/ml, ketamine, androgenic steroids, marinol
Schedule IV:Darvocet, talwin, ambien, lunesta
Schedule V: Lyrica, dilute dihydrocodeine, dilute opium
The State of Indiana includes Soma (carisoprodol) in the Schedule IV classification under
IC 35-48-2-10(c).


WRITING PRESCRIPTIONS
A. Legal Requirements for the prescription documents are?:

A prescription for a controlled substance must include the following information:

              Date of issue (must be the date signed…cannot be post dated)
              Patient’s name and address,
              Practitioner’s name, address and DEA registration number,
              Drug name,
              Drug strength,
              Dosage form,
              Quantity prescribed,
              Directions for use,
              Number of refills (if any) authorized, and
              Manual signature of prescriber.

The provider does not have to personally write out the information on the schedule III-V
script: this may be done by one or more individuals. Prescriptions for Schedule II
controlled substances must be written and be signed by the practitioner. (Note: It is
permissible for an electronic medical record to print out the Schedule II-V script at the
time of the patient visit, then be signed by the physician). In emergency situations, a
prescription for a 48 hour supply (IC 35-48-3-9) of a Schedule II controlled substance
may be telephoned to the pharmacy and the prescriber must follow up with a written
prescription being sent to the pharmacy within seven days. Prescriptions for Schedule III
through V controlled substances may by written, oral or transmitted by fax. When
written prescriptions are given to patients, often the pharmacist will verify address
information and will usually input this data onto the script. FAQ:

B. How many refills on scheduled drugs are permissible?
   1. Schedule III/IV may be refilled up to 5 times and the scripts are valid up to 6
      months, however good medical practice would dictate follow-up monitoring visits
      more frequently than 6 months. This is especially true if the most frequently
      diverted drug hydrocodone is prescribed.
   2. Schedule II medications may not be refilled. However the DEA rules as of this
      writing do permit multiple (2 or 3) scripts for one month supplies each, with all
      scripts dated the same. Written on the script should be “To be filled on or
      after…<insert date>.
   3. Schedule II drugs may be written as 3 month supply scripts for insurance plans
      that permit such, however it is suggested follow-up visits occur every 4-6 weeks
      for monitoring. It is also suggested these scripts not be mailed to patients by the
      physician’s office and that the patient mail the script to the pharmacy certified for
      tracking purposes. 3 month scripts should never be written on the first patient visit
      since the patient needs to establish a record of being able to take the drugs as
      prescribed and be on a stable dose for several months prior to instituting 3 month
      mail-in scripts.
   4. It IS legal to write instructions to the pharmacist “To be filled on or after…..” on a
      script. It IS legal to write “no-partial refills” on a script although the pharmacist
      is not bound to follow this directive. It IS legal to write a refill interval (eg. May
      be filled no sooner than every 28 days). It IS legal to write a maximum number
      of tablets per day, week, or month.


C. Are duplicate scripts or copies of the controlled substance prescription required?
       In Indiana, duplicate scripts are not required, however the use of such greatly
    enhances the ability to determine whether patients have altered scripts at the time they
    present them for refill. Also, duplicates or copies assist the provider’s office in
    determining exactly what was prescribed in the case of pharmacies or patients
    questioning the amounts or dosages. Electronic medical records with the ability to
    print narcotic scripts may serve as an alternative to paper duplicate copies or scanned
    copies of narcotic scripts.

D. Is a special prescription form required for controlled substance scripts?
        Special non-alterable prescription paper must be used for prescriptions for
    controlled substances in some states including Indiana. Regular computer paper may
    not be used for controlled substance scripts. The DEA is strongly opposed to the use
    of scheduled drug prescription pads being used for non-scheduled drugs, although at
    this time, the practice is not illegal.

E. Are there any special precautions needed when writing prn scheduled drugs?
       It is important to be crystal clear with patients on how frequent narcotics may be
    taken with imposed limits on the numbers of tablets per day. A script written 1-2
    tablets PO Q4-6H prn would permit up to 12 tablets per day, therefore also write
    “Maximum __ tablets per day” with any prn narcotic script.

F. Are there any special licenses required to write prescriptions for methadone,
    suboxone, or subutex?
        When used solely for the treatment of pain, there are no special licenses required
    outside of the DEA Controlled Substance License. However, when treating addiction
    or addiction in combination with pain when dispensing these medications, special
    registration is required for methadone treatment of addiction. Methadone addiction
    treatment requires the special DEA registration under 21 U.S.C. Section 823(g)(1).
    Subutex or Suboxone addiction treatment requires a DATA2000 waiver from the
    DEA. DATA2000 waivers permit the prescription or dispensing of suboxone and
    subutex in any setting, including hospitals, to treat addiction. . As the DEA notes the
    only drugs approved for narcotic addiction are the above three plus LAAM, the use of
    any other narcotic to treat addiction requires a new drug use application. Other forms
    of buprenorphine such as Buprenex are not approved by the US government for
   treatment of addiction and may not be used under the DATA2000 waiver program.
   Suboxone, subutex, and methadone may all be used to treat chronic pain without any
   special licensure. The treatment of a chronic pain patient with methadone followed
   by designation of the patient as an “addict” then continued treatment with methadone
   by physicians without the special DEA methadone treatment registration is illegal.
   Non-physicians may not treat patients with methadone, suboxone, or subutex for
   addiction.

G. Are there any accepted maximum limits on the daily or monthly amount of
   narcotics that can be written for a patient?
            There are no legal limits on the amounts of narcotics that may be written in
   mg or number of tablets, however prudent prescribing would dictate reasonable limits
   be employed. When prescribing significant amounts of schedule II narcotics (>60mg
   a day oxycodone equivalent), referral to pain medicine for evaluation of the
   appropriateness of dose prescribed is useful. Significant hydrocodone amounts have
   the same effect clinically as the schedule II drugs, therefore the amounts of
   hydrocodone prescribed should be limited. There is a recent movement by health
   insurers to limit the amount or type of medication that is covered due to solely
   financial considerations of the insurers expenditures. The most extreme case is a
   group of Washington State medical directors (of insurers) that have artificially
   contrived 120mg a day morphine or its equivalent as being the maximum dose needed
   for chronic pain. There is no scientific evidence to support this position.

H. Is it legal to mail the prescriptions to the patient instead of having them come in to
        pick them up?
               Whereas this may be done in emergency situations such as when a patient
   becomes temporarily homebound to due severe weather or illness, routine mailing of
   opiate narcotic prescriptions is a very bad idea. There is no way for you to verify the
   intended person only would receive the prescriptions thereby creating a situation
   enabling drug diversion. Also, mailing of prescriptions fails to provide for routine
   and timely face to face patient assessment to insure lack of significant side effects and
   to explore substance abuse issues.


INSPECT PROGRAM FAQ
A. What is the INSPECT program?
       An Indiana program of the board of pharmacy that permits nearly instantaneous
   access on-line for all controlled substance prescriptions filled in the state for a given
   patient over the past 1-2 years. The data is returned includes the date the prescription
   was filled, the quantity and dose, pharmacy name and telephone number,
   physician/practitioner name and telephone number, and the number of days the script
   was estimated to last. ALL PHYSICIANS PRESCRIBING OPIATE NARCOTICS
   SHOULD UTILIZE THE INSPECT QUERY FOR ALL NEW PATIENTS AND
   RANDOMLY FOR CURRENT PATIENTS.

B. How do I register for the INSPECT program?
      www.in.gov/pla then click on “Inspect” on the left hand side of the screen.
   Under FAQ is information on how to sign up.

C. May my staff run INSPECT reports?
   Yes. The clinic staff may be designated as an agent of the practitioner and run the
   reports for the practitioner. There are penalties for misuse of this information. The
   information obtained from INSPECT is to be used only by the practitioner, however it
   may be shared with other physicians treating the patient.

D. What patient information is required to run an INSPECT report?
   First name, last name, date of birth, street address, zip code. The INSPECT program
   has software to search for other addresses for the patient.




RESPONSIBILITY OF THE PHARMACIST FAQ
A. Is the pharmacist obligated to fill a presented script?
        No. Pharmacists have an obligation to assure controlled substance prescriptions
    are legally valid and whether they are therapeutically appropriate. This means the
    pharmacist is the last check on the patient’s prescription before the patient receives
    the controlled substance. If the pharmacist suspects diversion, overdose, or other
    irregularities (such as multiple prescriptions for narcotics being presented by several
    practitioners in a short period of time) , he has an obligation to with-hold the
    prescription and seek clarification. If there is obvious alteration of the script, the
    pharmacist will usually call the prescribing physician and in some cases may contact
    the police since script alteration is a felony offense.

B. May a pharmacist legally change the script?

       The pharmacist may add the patient’s address or change the patient’s address
   upon verification. The pharmacist may change or add the dosage form, drug strength,
   drug quantity, directions for use, or issue date only after consultation with and
   agreement of the prescribing practitioner. Such consultations and corresponding
   changes should be noted on the prescription as well as the patient’s medical record.
   The pharmacist is permitted to make information additions that are provided by the
   patient or bearer, such as the patient’s address, and such additions should be verified.
   The pharmacist is never permitted to make changes to the patient’s name, controlled
   substance prescribed (except for generic substitution permitted by state law) or the
   prescriber’s signature.

C. May a pharmacist partially fill a narcotic script?

      Yes, but with restrictions. A schedule III script may be split into smaller fills as
   long as the total amount given to the patient does not exceed the amount prescribed.
   Schedule II scripts may be filled for less than the amount written with the option for
   the balance to be filled by the pharmacist within 72 hours. Partial refills of Schedule
   II scripts by law must be reported to the practitioner by the pharmacist. In order to
   avoid multiple patient visits to the practitioner in a given month, the physician may
   write or have typed on the script “NO PARTIAL FILLS” and instruct the patient to
   not accept partial fills of scripts.

D. What is the responsibility of a mail in pharmacy to assure the patient receives their
scripts in a timely manner?
         None. Mail in pharmacies may hold scripts for days or weeks before the patient
    receives their medication. Frequently mail in pharmacies tout to patients a 5-10 day
    turnaround time. However when the initial scripts are mailed, the timeframes are
    often much longer, therefore it is prudent to prescribe medications for one month,
    then have the patient come back the next week to pick up a 3-month mail in script to
    be mailed immediately.

E. My patient tells me they have been receiving their medications through an off-shore
internet pharmacy without a prescription. Is this legal?
        No, it is illegal because it involves unauthorized importation of narcotics into the
    US, and is a felony. If the patient seems not to understand the gravity of this situation
    or appears to be equivocal about cessation of this practice, it would be prudent for the
    physician to not prescribe any narcotics to such patients.

F. A company has approached me about dispensing narcotics from my office in order
to save the patient money and for their convenience. Is this a good idea?
        Although the practice is legal if record-keeping and storage requirements are met,
    there are several reasons not to do this. The practitioner’s office may become a target
    for break-in and theft of drugs along with destruction of property. The patient will
    receive less scrutiny from the practitioner that may have no idea the patient is
    receiving medications from multiple prescribers (pharmacists may have alternative
    avenues in determining subterfuge and diversion). The increased documentation
    requirements of having to input the patient’s entire list of drugs into a separate
    computer may not be efficient use of practitioner’s or staff time. Having a
    pharmacist serve as a final check on the patients in this population that necessarily
    includes drug abusers and diverters is an excellent idea to protect the patients and
    potentially protect the practitioner’s license to prescribe these potent substances.




FEDERAL AND STATE BOARD ACTIONS AGAINST
PHYSICIANS WRITING SCRIPTS FOR OPIATES IN
CHRONIC PAIN TREATMENT

Am I incurring risk to my medical or DEA license when prescribing opiates for
chronic pain?
      In spite of all the press received by physicians having their medical license revoked
or their DEA license surrendered as a consequence of prescribing opiates in their
practice, the actual numbers are quite small, and most instances were due to physicians
engaging self prescribing, prescribing for non-patients, inadequate documentation, etc.
There are 120 physicians a year disciplined in the US for opiate related causes. There
have also been several high profile cases in which physicians were involved in kickback
schemes for money or drugs, or were averting their eyes from obvious drug diversion.
Some physicians have warranted jail time, but for most of those disciplined, temporary or
permanent licensure revocation was the order. The DEA primarily comes into contact
with physicians when there is evidence of drug diversion by the physician, kickback
schemes, etc whereas competency issues, self prescribing, and other issues are referred
to state medical licensure boards. When the rare action is taken by medical licensing
boards against physicians, most of the time the actions are justified. However, given the
dichotomy in opinion within the medical community regarding the suitability of opiate
prescribing for chronic pain, occasionally actions are taken by state medical licensure
boards that are excessively harsh, frequently due to testimony by contrarian physicians
opposing the use of opiates for the treatment of chronic pain. However, adhering to the
Federation of State Medical Board Model Policy for the Use of Controlled Substances for
the Treatment of Pain published 2004 will usually avert the physician from being directly
targeted by state medical licensing boards and the DEA. The abridged version of these
guidelines is listed in the section below “MINIMUM PROVIDER REQUIREMENTS…”
Does Indiana have any regulatory protection for physicians prescribing opiates for
chronic pain?
No. As of May 2008, neither the legislature nor the state board of medical licensure has
adopted any document that protects physicians as is specified by the Model Guidelines of
the Federation of State Medical Boards (FSMB) 1999, revised 2004: “physicians will not
be sanctioned solely for prescribing opioid analgesics for legitimate medical purposes”.
Indiana is a member of the FSMB but remains one of the few jurisdictions in the US that
has not adopted at the legislative or medical board level any policy on opiate prescribing.
However, it appears through the very cryptic medical licensure board meeting minutes
throughout the years that there has been a balanced and non-extremist view on opiate
prescribing.


APPROPRIATE CANDIDATES FOR PRESCRIPTION
NARCOTICS
        Patients complaining of moderate to severe daily pain with legitimate appropriate
   medical diagnoses, lack of recent alcohol/substance abuse/illicit drug use, that have
   failed other more conservative therapies may be a candidate for opiate therapy. It is
   quite difficult to decide what constitutes a legitimate medical condition since in some
   diseases and syndromes commonly associated with the use of opiate analgesics, there
   are no objective findings to substantiate an anatomical/pathological reason for pain.
   The use of narcotics must be for a legitimate medical reason, therefore a correlative
   appropriate diagnosis is needed prior to institute chronic opiate prescribing. This may
   entail an appropriate medical workup including laboratory studies, neurological
   physical examination, thorough history, and radiological tests as indicated.
   Prescription opiates, as a means of pain control on a long term basis, should not
   be used in a vacuum without continuing evaluation and treatment of the
   psychological and functional deficits, and socioeconomic effects of chronic pain.
   Other means of pain control in addition to opiates should be simultaneously
   employed. In Indiana, an INSPECT report should be created prior to acceptance
   of any patient for narcotic therapy. The INSPECT report may be obtained far in
   advance of the initial patient visit, and if it is obvious the patient will not be a
   candidate for opiate narcotic therapy, the physician should give the patient this
   information in advance so as to avoid unrealized expectations of the patient.
        The appropriate candidate for short acting narcotics (excludes continuous release
   products, levorphanol, and methadone) include pain that has not responded to more
   conservative treatments or reasons more conservative treatments cannot be
   implemented. Acute pain, chronic pain, cancer pain may all respond to opiate
   prescribing and short acting opiates may be appropriate. Patients with substance
   abuse histories (other than recent prescription drug abuse) are ideally referred to
   comprehensive pain centers with psychological assessment capabilities for evaluation
   and dose stabilization. If opiates are to be prescribed in the community for those with
   a past substance abuse history (any illicit drug, alcohol, or prescription drugs), then
   extraordinary monitoring should be employed including a prescription history from
   all pharmacies the patient has visited in the past 6 months, short follow up intervals
with limited narcotics being prescribed, use of maximum number of tablets per day
being written on each script, compliance testing with urine drug screens (random),
random pill counts, etc. Patients with current co-morbidities of substance abuse and
chronic pain require intensive monitoring and scrutiny in addition to psychological
and addiction counseling that is usually far beyond the typical family physician office
capabilities and often exceeds the capabilities of most pain clinics. If such intensive
treatments for these co-morbidities are not available in the community, then referral
to a university based program (regardless of how far the patient must travel for this
treatment) may be appropriate. It is inappropriate and foolish to prescribe opiates to
patients with these co-morbidities in the absence of addiction treatment and
psychological support. It is inappropriate for community primary care, specialists, or
pain specialists to prescribe chronic opiates to patients receiving methadone in a
methadone addiction program. Primary care referral of a patient with
current substance abuse issues to one pain clinic after another when
the patient is discharged from each for substance abuse (or the pain
clinic stops prescribing opiates to the patient due to substance abuse)
is not only inappropriate and substandard medicine but is also
perpetuating the patient’s addictive behaviors, sometimes for many
years.
   Long acting narcotics (all continuous or sustained release drugs, methadone,
levorphanol) should not be prescribed for acute post operative in patients that are not
already taking significant amounts of narcotics. Long acting narcotics are
inappropriate for those that have recently engaged in substance abuse with short
acting narcotics. Other preclusions regarding co-morbidities of addiction/substance
abuse and chronic pain as delineated above also apply to long acting opiate
prescribing in the presence of chronic pain.
   Opiate narcotics should not be prescribed for those with a history
of drug diversion at any time in the past (selling or trading narcotics,
use of oral narcotics ground up and injected or snorted, alteration of
prescription, prescription theft). These people, despite their claims
of pain, are committing felony acts, and the continued prescribing of
opiates given the knowledge about their behavior, is not only
perpetuating a crime, but also makes the physician culpable as an
accessory to a felony. A 2007 poll of Indiana county prosecutors
found that nearly all prosecutors believe the physician may be
charged with a felony if they know drug diversion is or has occurred
and do not take immediate steps to stop this from occurring.
    You may not write narcotic prescriptions for yourself, your family members, or
friends. The prescriptions must be written for selected patients during the usual
course of business and only for legitimate medical purposes (see below). You cannot
write prescription narcotics for patients you have not seen for recent evaluation or
consultation, and must have performed a history and physical exam prior to writing
prescription narcotics. FAQ:
Are there any methods to predetermine who is an appropriate candidate for
prescription narcotics on initial evaluation?

   RED FLAGS: DO NOT PRESCRIBE NARCOTICS
       1. No available prior medical records even though patient is receiving narcotics
       2. Will not divulge name or sign information release for prior physician’s records
       3. Refuses all psychological, physical therapy evaluations, home exercise, and
          interventional techniques…wants drugs only
       4. Needle track marks, skin pop marks
       5. History of selling narcotics, forging prescriptions, manufacture of
          methamphetamine or other illegal drugs, or stolen prescriptions
       6. Patient travels hundreds of miles to see you when there are many other pain
          physicians closer to the patient's home
       7. Previously discharged from your practice for substance abuse or diversion
       8. Refuses urine drug screen testing
       9. Medical records have been altered to remove incriminating evidence

   YELLOW FLAGS: TREAT BUT WITH CAUTION
      Patients with substance abuse history (alcohol or any drug, legal or illegal) need
   continuous multidisciplinary care including psychology or addictionology in addition to
   frequent visits early on and random drug screens. Do NOT prescribe narcotics to these
   patients without first obtaining psychological consultation regarding the appropriateness
   of narcotic therapy and unless the patient is willing to continuously be engaged in a
   formal addiction counseling program while controlled substances are being used for
   chronic pain. Consider urine drug screen on first visit prior to prescribing any narcotics in
   patients who are self-referred or in those without a primary care physician.
       Patients who are "allergic" to nearly every narcotic you name except the one they
   want should be treated with great suspicion, especially if you mention new narcotics they
   could not have possibly tried yet. Patients who request name brand should be told that is
   contrary to your medical practice. (Name brands have a much greater street recognition
   and therefore increased street value). There are exceptions to this however in that not all
   sustained release drugs have the same absorption profile.
       Young patients ages 20-30. (Have a statistically significant increase in illicit drug use,
   binge drinking both of which may result in overdose when combined with narcotics.) This
   age group has 300% the substance abuse of the 40-50 age group. The illicit substance
   abuse rate is as high as 25% of the 19-26 age group. The prescription narcotic substance
   abuse rate in this population is 5% within the past month and is 4 times higher than older
   populations.
       Smokers have 500% the overall non-nicotine substance abuse rate of non-smokers.
       The unemployed have 300% the substance abuse vs. full time employed.
       Those with serious mental illness have 300% the substance abuse rate vs. those
   without serious mental illness.
       American Indians and Alaska Natives have the highest race linked substance abuse
   rate of 13%, Afro-Americans have a 10% rate, while Caucasians have an 8% rate.
   Asians have a 3% substance abuse rate. (2005 NHDUS data)
       Personal or social maladjustment, depression, personality disorder, or a family history
   of addictive problems may predispose to prescription medication abuse.
       The Medicaid population is much more at risk for substance abuse or diversion (Pain
   Med. 2007 Mar;8(2):171-83) with 60% of this population exhibiting prescription narcotic
   misuse or illicit drug use (J Ky Med Assoc. 2005 Feb;103(2):55-62).

There are also several patient questionnaires that correlate to risk of substance abuse
(eg. Pain Pract. 2006 Jun;6(2):74-88, J Pain Symptom Manage. 2006 Oct;32(4):342-
51), but these all depend on the veracity of the patient. Astute drug abusers or
professional drug diverters will know not to give truthful answers and will therefore
erroneously be gauged to be of less risk.


PRESCRIPTION DRUG DIVERSION
The license to prescribe narcotics comes with the responsibility to assure the drugs
are not being diverted for sale or trade (federal and state obligation), the patient is not
engaging in substance abuse (state obligation), and that the drugs are being used for
the intended purpose. Providers writing prescriptions for narcotics are not policemen,
but have an ethical and medical duty to insure both the safety of the patient and of the
community. Drug diversion is the sale or trade of controlled substance prescription
drugs (USC 21-1-841-D) for other legal or illicit drugs, possessing controlled
substances without a valid prescription (USC 21-1-844), the use of controlled
substance prescription drugs for recreational purposes, or illegally obtaining
controlled substance prescription drugs through illegal manufacture or importation of
the drugs (IC 35-48-4, USC 21-1-941-D) or via prescription forgery, obtaining
controlled substances by subterfuge or false identity (IC 35-48-4-14c), or prescription
theft. In 2007, the Drug Enforcement Agency reported hydrocodone continued its
long history as being the top prescription drug diverted in the state of Indiana,
primarily via illegal sale and distribution by health care professionals and workers,
“doctor shopping” (going to a number of doctors to obtain prescriptions for a
controlled pharmaceutical), and forged prescriptions. Xanax®, Valium®, and
methadone were also identified as being among the most commonly abused and
diverted pharmaceuticals in Indiana.
    Drug diversion is not limited to the patients receiving prescription drugs but may
extend to family members using a patient to obtain opiate narcotics. The elderly are
particularly at risk for this type of diversion as the family members may not have the
elderly patient’s best interest in mind (Clin Geriatr Med. 2008 May;24(2):263-74).
    Prescription drug diversion is not at all uncommon and is facilitated primarily by
physician controllable activities as below:
As can be appreciated above, a significant amount of prescription drug diversion
could be eliminated in Indiana if appropriate physician actions were employed.
Doctor shopping is easily detected by an INSPECT report, requiring about 20 seconds
of the physician’s time. Script theft is curtailed by never leaving scripts unattended,
controlling access to prescription pads by keeping them in a safe, and using numbered
prescriptions. Instituting clinic policies of no call-in scripts for controlled substances
and making regional pharmacists aware of your policy serves to thwart patients from
calling in their own scripts or your staff from profiting through the illegal sale of
called in Schedule III scripts. Forgery and script alteration is detected by either
employing duplicate scripts or by using an electronic medical record to print out all
controlled scripts and electronically store the information. Physician pill mills,
responsible for 5% of all drug diversion, may be eliminated by incorporating good
medical practice in prescribing opiates as defined by the Federation of State Medical
Board Guidelines on prescribing prescription opiates for chronic pain, incorporation
of urine drug testing, pill counts, and employing inflexible clinic policies regarding
prescribing. Virtually 80% of prescription drug diversion as defined by the study
above, is due to inadequate physician monitoring of patients and physician
prescribing practices (lack of control over prescription pads and
duplication/electronic storage of prescriptions) as is indicated by the starred columns
above. Requiring patients (as a condition of treatment of pain with prescription
narcotics) to take simple precautions to avoid residential theft such as use of a safe to
store prescription narcotics will eliminate an additional 5% of drug diversion.
     Because the tools to eliminate a significant amount of prescription drug diversion
are readily available to physicians in Indiana, it would be difficult to justify not
utilizing these tools if a medical practice comes under regulatory scrutiny for serving
as a conduit for drug diversion. Physicians are legally culpable and may be charged
as felons under relevant state (IC 35-48-4-13,14) and federal laws as a DEA registrant
if they have knowledge of drug diversion and do not take action to stop this from
occurring. A poll of Indiana county prosecutors conducted in 2007 by the Indiana
Pain Society found a vast majority concur with this viewpoint.
     If drug diversion is known by the physician to have occurred or been attempted
(identical under federal law), the first steps should be immediate cessation of
prescribing of all prescription narcotics, entering the information into the medical
record as a warning to future physicians regarding the patient’s behavior, notifying
the dispensing pharmacy, and notification of all other physicians the patient lists as
current physicians. It may also be appropriate to notify law enforcement (local police
in the patient’s place of residence, police drug investigation units, and in some cases
the DEA) since a felony has occurred. A poll of county prosecutors in Indiana in
2007 concurs with this position. Withdrawal medications such as tizanidine may be
appropriate if the patient was ostensibly on high doses of opiates, but it is
inappropriate to prescribe any more narcotics to a person that has committed a felony
act based on obtaining, diverting, selling, or trading prescription narcotics.
     If drug diversion is suspected, investigative efforts should be employed by the
physician to assure appropriate patient compliance with clinic policies and relevant
laws. In cases where there are anonymous reports of diversion, the physician should
require a mandatory pill count at their office or at the prescribing pharmacy within 24
hours of the call to the patient. Urine drug screens may also be useful, however those
using a physician to obtain prescription narcotics for purposes of diversion may take
the appropriate steps to assure an appropriate drug screen. Failure to comply is taken
as prima fascia evidence of drug diversion and this pill count policy should be noted
in the opiate agreement with the patient. The presence of hard drugs in a urine drug
screen such as cocaine, methamphetamine, ecstacy, or heroin may indicate the
patients are selling or trading their prescription drugs for these illicit drugs.
Several law enforcement agencies have confirmed this assertion, especially with
respect to methamphetamine. Therefore, the presence of the above illicit drugs in
urine drug screens in patients receiving prescription opiates should be considered
to be putative evidence of prescription drug diversion and action must be taken to
stop prescription opiate prescribing.
SUBSTANCE ABUSE OF PRESCRIPTION
CONTROLLED DRUGS
    Substance abuse is defined as aberrant behavior in which the patient has lost
control of their use of prescription opiates. Strongly suggestive behaviors include:
negative drug screens for prescription opiates being prescribed, lost or stolen scripts
or medications, positive drug screens for drugs not being prescribed by physicians,
aberrant behaviors such as calls after-hours about opiate medications (not related to
side effects of the medication), doctor shopping (on multiple occasions obtaining
prescription opiates from multiple providers without a medical reason to do so),
prevarication about opiate issues, inconsistent pill counts, and illicit drug use (see
below). Other indicators include overdosing on drugs (taking more than prescribed or
mixing with non-prescribed drugs/illicit drugs/alcohol) with resulting hospitalization.
Unlike drug diversion, substance abuse of prescription drugs is not illegal in Indiana
but a physician with knowledge of substance abuse is obligated to take action to
curtail or eliminate it as consistent with the medical practice act. Failure to
intervene in situations where there is substance abuse may lead to serious patient
injury or death. It may be difficult at times to discriminate between substance
abuse and drug diversion since both have may of the same common patient behaviors.
For instance, regarding prescription drugs used for non-medical purposes according
to the 2006 National Survey on Drug Use and Health (NSDUH), 55.7 percent
reported that the source of the drug the most recent time they used was from a friend
or relative for free. Another 19.1 percent reported they got the drug from just one
doctor. Only 3.9 percent got the pain relievers from a drug dealer or other stranger,
and only 0.1 percent reported buying the drug on the Internet. Technically, receiving
a controlled prescription opiate from a friend is drug diversion although most patients
are unaware of this. One study of substance abuse found the following indicators:
    In the US population over age 12, the number of prescription drug abusers now
tops 11 million with a lifetime prevalence rate of 20% of the US population. Most of
these prescription drug abuses are opiates. The number of new abusers of
prescription opiates began to climb precipitously in the late 1990s when several
potent drugs were introduced (eg. Oxycontin) and after some pain societies began to
extol the virtues and benefits of opiates through policy statements. Several states
began adopting intractable pain laws, then the Federation of State Medical Boards
promulgated their guidelines for the prescription of opiates for chronic pain treatment,
further legitimizing the wholesale prescribing of opiates.
Manufacturers of narcotics in the 1990s began promulgating the idea that the
“addiction rate” to prescription opiates was so insignificant that there should be
virtually no concerns about this issue. While this assertion defied logic based on the
available statistics of the time, the source was largely traced not to a study, but to a
single 10one letter to the editor (not even a formal study) in a journal stated the
addiction rate was less than 0.05% based on follow-up of acute surgical and medical
pain treatment in a hospital setting. Even though this information was not relevant to
the chronic pain population, the connection was nonetheless made by drug
manufacturers. This type of nonsensical study was widely touted by the drug
manufacturers in their advertising to physicians and in “seminars” at posh resorts
designed to convince doctors to prescribe more narcotics and to prescribe liberally.
The 0.05% statistic became the mantra of aggressive narcotic company manufacturers
and also that of chronic pain patients attempting to justify to their physicians why
virtually unlimited opiate prescribing should be acceptable. Other studies
demonstrating very low addiction rates were in tightly controlled populations or with
exclusion criteria of prior alcohol or substance abuse. The following graph indicates
the degree to which some of the opiates have increased in sales in the US, with the
highest increases predictably seen in the more potent drugs with active marketing
campaigns.




Not only is the total mass in grams of the prescribed drugs rising, but the overall
potency of the prescribed drugs is increasing to an even greater degree. The amount
of opiates sold retail in 2006 in the US increased to 250% of the 1997 levels, while
the overall potency of the drugs sold increased by 425% over the same time period
(IPS analysis and calculations).
This permissive attitude of prescribing predictably resulted in a vast increase in opiate
prescriptions and a 380% increase in substance abuse of prescription opiates by new
users compared to the stable period 1970-1989. The number of prescription narcotic
deaths soared across America and the pervasive degree of substance abuse of
prescription opiates continues to be a major societal problem. Doctors have
unwittingly created significant increases in a societal problem in their effort to
provide better pain control. The increased availability of opiates has predictably
resulted in an increase in the death rate from prescription opiates as shown above.
Note the numbers listed are per 10 million population.
The death rate associated with methadone per year is now nearly equal to that of all
other prescription opiates drugs as seen in the chart below. For methadone related
deaths, the majority, approximately 80% , are associated with polypharmacy and only
20% of the time is methadone the sole cause of death. Therefore, UDS screening for
polypharmacy opiates or benzodiazepines or illicit drugs may help reduce the rate of
death due to methadone. Similarly, polypharmacy is the rule, not the exception for
deaths associated with other opiate drugs.
    For chronic pain patients legally receiving prescription opiates, the incidence of
substance abuse varies by how the study is conducted (data acquisition from patient,
pharmacies, computerized central prescription databank, etc), the selection criteria
employed, exclusionary criteria (some studies exclude those from participating if they
have prior history of substance abuse), the definitions used for substance abuse, and
whether the study is a research study conducted or sponsored by drug manufacturers.
Poorly conducted studies that exclude prior history of substance abuse, are tightly
controlled drug trials, or have inadequate data acquisition (rely solely on patient self-
reporting instead of community pharmacy and physician data) demonstrate absurdly
low rates of substance abuse that are only a small fraction of the general population.
Well conducted relevant studies have shown the range of
substance abuse to be 24-50% in the chronic pain population
(Ann. Intern. Med. 2007 Jan 16;146(2):116-27, BMC Health Serv Res 2006:46, Clin
J Pain 1997 Jun;13(2):150-5, J Gen Intern Med 2002 Mar;17(3):173-9, Int J Addict
1992 Mar;27(3):301-16, Neurology. 2004;62:1687-1694). These relatively high
percentages are many fold higher than the opiate prescription abuse rate for the
general US population (2.1% NSDUH 2006 statistics). College aged individuals
have a much higher substance abuse rate of around 10% for non-prescribed opiate
pain relievers and frequently mix these opiates with other drugs or alcohol. Of
   college students that have taken prescription pain medications in the last year, 29.3%
   of the uses were at least partially for non-medical use of the drugs (Arch Pediatr
   Adolesc Med. 2008;162(3):225-231)

   Substance abuse is frequently equated to the disease of addiction, but this designation
   fails to recognize substance abuse, whether alcohol, illicit drug, or prescription drug
   abuse is frequently a lifestyle choice. Those that have made this choice do not want
   to modify their behavior and are perfectly satisfied in their mode of existence.




Those that have chosen substance abuse as a recreational use of narcotics may be
sophisticated enough to know the proper diagnoses (usually vague and unverifiable such
as chronic abdominal pain, chronic pancreatitis in the absence of enzyme changes,
chronic low back pain in the absence of any radiological or diagnostic findings, etc.
There are websites in which substance abusers go to learn about these diagnoses for the
purpose of fleecing the medical profession in order to obtain narcotics. These people will
say anything to obtain narcotics including overt lying to their physicians. Studies have
shown 21% patients will lie to their physicians regarding use of other prescription drugs
than are being prescribed by the physician (Berndt S, Maier C, Schutz HW.
Polymedication and medication compliance in patients with chronic non-malignant pain.
Pain 1993;52:331-9). Lying about prescription narcotics being taken that are not
disclosed by patients is not reserved to the young adult population. One study
demonstrated the sensitivity for self reporting is only 66% in the general medical
population with an average age of 72 (Clin Toxicol (Phila). 2008 Mar;46(3):239-42).
Another study demonstrated 50.5% of chronic pain patients had other non-prescribed
narcotics, illicit drugs, or alcohol in their random urine drug screens and 25% were
negative for the drugs prescribed. (J Pain Symptom Manage 2000 Jan;19(1):40-4).
Other studies demonstrate patients will lie about illicit drug use with 8.4% of the pain
patient population engaging in this form of prevarication (Clinical Journal of Pain
Volume 15(3), September 1999, pp 184-191). The same study found characteristics of
those that lie about illicit or non-prescribed narcotics include a higher rate in those that
are younger, are a workers' compensation CPP, and have been assigned a DSM-III-R
diagnosis of polysubstance abuse in remission.
        Physician’s prescribing practices, referral practices, and lack of defined or
absolute clinic policies are the main perpetuating factors in prescription narcotic
substance abuse. Hydrocodone is the most commonly diverted and abused prescription
narcotic and frequently physicians will call in prescriptions for this drug repeatedly for
patients without appropriate patient monitoring. Patients rarely seek treatment for
hydrocodone abuse (Pharmacoepidemiology and Drug Safety, 2007 (16): 827-840)
therefore it may not be perceived by prescribing physicians to be a drug of significant
abuse, therefore promoting lax prescribing and monitoring behavior by physicians.
PATIENTS WITH KNOWN SUBSTANCE ABUSE ISSUES THAT HAVE BEEN
DISCHARGED FROM A PAIN CLINIC FOR SUBSTANCE ABUSE SHOULD NOT
BE REFERRED TO YET ANOTHER PAIN CLINIC FOR FURTHER SUBSTANCE
ABUSE. Patients with a DSM-III-R diagnosis of polysubstance abuse in remission are at
extremely high risk of abusing prescribed prescription opiates. There are some patients
that cannot handle the responsible use of prescription opiate narcotics and the
failure to recognize such by physicians may lead to years or decades of continued
substance abuse. Physicians have a responsibility to not enable their patients to
continue with substance abuse. That being said, not all infractions for substance abuse
carry equal weight and physicians may have differing thresholds of tolerance of aberrant
patient behavior. Each situation should be examined within the context of the clinic
policies towards narcotic prescribing, patient explanation of what transpired causing their
designation as a substance abuser, INSPECT reports, other physician records, patterns of
lost/stolen drugs, etc.
        Prescription drugs being abused have traditionally thought to be those most
prescribed, ie. hydrocodone. Those seeking treatment for substance abuse in treatment
centers paint a different picture. Oxycodone ER appears to be one of the most abused
drug per 1000 prescriptions and per 100,000 population in the US
(Pharmacoepidemiology and Drug Safety, 2007 (16): 827-840 ). Buprenorphine also
appears to be a highly abused drug, although since its purpose is to treat substance abuse
in most cases, it is not surprising that it is strongly associated with continuing substance
abuse, and makes the point that opiate narcotic treatment for chronic pain patients that are
current substance abusers is extremely risky. The relative risk of substance abuse per
1000 prescriptions written are seen in the chart below:
The evidence presented above in the 2006 NSDUH survey showed that for every person
receiving treatment for prescription pain reliever abuse (547,000) there were 9 people
that were not in 2006 (4.5million in US). When recreational use of alcohol/illicit drugs
are evaluated in the same study, only 1 patient received treatment out of 65 that needed
treatment. Given the rate in which patients are abusing oxycodone ER that are in
treatment programs and noting the above ratios of untreatment/treatment, one may
calculate the overall substance abuse rate for oxycodone ER is 5.4-39% of the
prescriptions written. These numbers should give the physician pause when considering
every third to eighteenth prescription written for Oxycontin will result in substance
abuse.
       Another conclusion of the Pharmacoepidemiology and Drug Safety, 2007 (16):
827-840 study demonstrated the degree of substance abuse is directly correlated to the
number of prescriptions written. In areas where many opiate prescriptions are written,
the degree of prescription substance abuse is much higher. In fact, it has been suggested
that prescription opiate narcotics now are a “major societal problem with an incidence
that appears to exceed the use of street narcotics such as heroin in the US. “ (Curr Opin
Investig Drugs. 2004 Jan;5(1):61-6) Other authors concur with this conclusion (Drug
Alcohol Depend. 2003 Apr 1;69(3):215-32.).

       A patient has been discharged from 3 pain clinics for prescription narcotic
       substance abuse issues and comes to me for opiate narcotics. Should I refer
       them to another pain clinic or prescribe the narcotics for him?
       Neither. The sad fact is that some patients will never be able to control their use
       of opiate narcotics and therefore are simply not candidates for narcotic therapy.
       Referring the patient to yet another pain clinic or you as a practitioner prescribing
       narcotics is exacerbating the problem. This patient is not a candidate for further
       narcotic therapy period, and alternatives should be explored. There is an
       extremely high rate of recurring substance abuse in patients with substance abuse
       histories, especially if recent. Even those being actively treated in methadone
       treatment centers continue to abuse oxycodone and other drugs (J Subst Abuse
       Treat. 2008 Feb 21).




PSEUDOADDICTION
         Pseudoaddiction is a concept first published in 1989 that has no scientific merit. It
was based on observation of the behavior of a single leukemia patient. The term was
coined by a person that became the vice president of one of the largest narcotic
manufacturers in the US. The premise is that people without enough opiate narcotics can
justifiably lose control of their behavior regarding opiate narcotics and will subsequently
engage in behavior that appears to be substance abuse. The author’s contention was that
those that may engage in aberrant use of opiate narcotics are merely under-medicated.
The solution proposed by the author is to give more opiate narcotics to those exhibiting
substance abuse behaviors. Patients all over America have become familiar with this
pseudoscientific term and use it to try to convince their physician prescribing pain
medication that they need more and more narcotics. The embracement of the concept of
pseudoaddiction may lead to a chronic pain population that is out of control with their use
of opiate narcotics since the concept encourages excess permissiveness in the absence of
any definable or objective endpoint, and transfers legal and ethical responsibility for
misuse of opiates from the patient to the physician. Physicians may not ethically use the
erroneous concept of pseudoaddiction to absolve themselves of the responsibility of
adequate patient monitoring and taking action to prevent substance abuse.


ILLICIT DRUG USE
         There is a definite association between prescription drug abuse and the use of
illicit drugs. The use of urine drug screens (UDS) is therefore not merely an academic
exercise. Positive urine drug screens (UDS) for cocaine or marijuana were found in
38% of chronic pain patients and was the most common reason for discontinuation of
opiate prescribing in patients suffering from chronic pain (J Gen Intern Med. 2007
April; 22(4): 485–490) . There is a direct link between prescription substance abuse
and lifetime use of illicit drugs. Statistics show those that have used marijuana in their
lifetime has a 7 fold risk of prescription substance abuse, those that have used cocaine
have a 5 fold risk of prescription substance abuse and those having used heroin have a
4 fold risk of prescription substance abuse (Clin J Pain. 2006 Nov-Dec;22(9):776-83).
One logical regression analysis found the odds ratio for prescription drug abuse was
3.5 for positive marijuana UDS and nearly 6 for those with a positive cocaine UDS. (J
Pain. 2007 Jul;8(7):573-82). Still another study demonstrated a 40% positive UDS
rate for cocaine or methamphetamines (BMC Health Serv Res. 2006 Apr 4;6:46) in
patients receiving prescription opiates for chonic pain. Illicit substance abuse not only
serves as a marker for prescription opiate abuse but also may predispose the patient to
overdose, respiratory depression, and death. For instance, there is a 20x greater death
rate when cocaine is mixed with fentanyl than by fentanyl use alone (J Forensic Sci.
2007 Nov;52(6):1383-8. Epub 2007 Oct 17)
As seen in the graph below there is a direct correlation between illicit drug use and
abuse of prescription opiates.




When it becomes apparent that either the patient has lost control over their use of the
drugs, the patient is selling or diverting the drugs, or that the drugs are no longer
providing any relief when given in escalating doses, then the narcotics must be
withdrawn with alternative non-narcotic therapies being instituted, changing to another
narcotic, re-evaluated for other medical reasons for increased pain, or tight controls
imposed to assure compliance. Providers do not have a duty to provide complete pain
relief, and the use and availability of narcotics are not absolute rights of the patient:
prescription narcotics are a privilege afforded to those that can maintain control over
their use of the drugs, have legitimate medical needs for the drugs, and are not
diverting the drugs. Monitoring of patient use of the drugs (through patient history and
pharmacy query) and the effect the drugs are having on the patient by self assessment and
family reports are the minimum requirement for continuing to prescribe narcotics. When
higher potency/dose narcotics are used, urine drug screening and random pill counts are
of benefit and may ultimately save the patient from overdose or death.

  If there exists a acute pain problem, small doses of opiate narcotics with frequent
follow-up visits may be implemented but patients with recent illicit drug use should not
receive opiate narcotics for non-acute chronic pain (>2 months) without being referred to
a comprehensive pain clinic with addictionology available. The referral should be made
regardless of the distance the patient would have to travel or the inconvenience to the
patient. If the patient refuses, then the narcotics should be withdrawn and no further
narcotic prescribing rendered. FAQ:
        A new patient admits to recently taking cocaine and methamphetamine. Is it
        legal to prescribe narcotics for pain therapy?

       It is legal, but very unwise. A person that so flagrantly disregards US drug laws
       will have no respect for clinic rules regarding self control of narcotic use. The
       risk of untoward drug interactions between uncontrolled use of illicit drugs and
       prescription narcotics cannot be predicted, and may result in death or overdose.
       Also, a person taking illicit drugs has connections to divert the use of the
       prescribed narcotic for purposes of sale or trade for other drugs and is therefore at
       very high risk of drug diversion.




OPIATE INDUCED HYPERALGESIA
        A seriously downplayed or unrecognized effect of opiates is opiate induced
hyperalgesia (OIH) that may result in long term global body pain, reduced time
effectiveness of the narcotic, and potentially permanent changes in the neurological
system. Animal models in all tested species demonstrate this effect that is mediated by
opiate activation of the NMDA receptor (pain producing) along with activation of the mu
receptors. It is not necessary to take opiates for long periods of time for this effect to
occur. There is a dose dependent activation of OIH in animal models. NMDA blockers
that are non-competitive such as MK801 can eliminate OIH, however clinically available
blockers are competitive at the receptor site, and therefore cannot block OIH from
occurring. Methadone is a partial NMDA antagonist but OIH occurs with the use of that
drug, albeit slightly slower in onset than with other opiates. OIH does not occur in all
patients taking opiates, even those using high doses, although those taking high dosages
tend to develop the syndrome more frequently. All route of administration of opiates
produce OIH including intrathecal. There is some evidence in animal models that the
neural changes are mediated by the NMDA receptor but the ultimate pathology results
from new and permanent neural connections being made in the central nervous system.
We have no clinical method to prevent OIH nor do we have an effective treatment.
Additional opiate loads only amplify the problem and do not result in reduced pain. Drug
seeking behavior of patients may be an attempt to counteract the iatrogenic opiate
induced hyperalgesia in some cases.




URINE DRUG SCREEN MONITORING BY
PHYSICIANS
        Physicians who do not look for substance abuse or diversion in medical practices
prescribing potent opiates will not find substance abuse or diversion, and are lulled into a
false sense of security. Improper results on urine drug screens may be a red flag that the
patient is diverting drugs but also may indicate the patient is in trouble with substance
abuse issues. Polysubstance abuse is the rule rather than the exception in cases of drug
overdose or death and the physician performing the drug screen may be the last hope in
preventing such tragedies. In cases of oxycodone overdose leading to death, there are




only 3% of patients that do not have drugs with sedative or respiratory depressant
properties as a co-drug. In fact as can be seen in the following chart, there were 600
mentions of benzodiazepines as co-drugs in 1014 deaths, more than 450 mentions of
prescription opiate narcotics, at least 300 mentions of illicit drugs, 170 mentions of
carisoprodol or its metabolite, and 232 mentions of ethanol. Therefore, UDS should
include benzodiazepines, carisoprodol, illicit substance, in addition to opiates. In the
methadone death statistics shown previously in this paper, only about 1 in 5 have
methadone listed as the sole cause of death since there are frequently other drugs present.
Physicians are obligated to assure patients are not taking illicit drugs with their
prescription opiate narcotics, are not taking undocumented or undisclosed controlled
substances, and are taking potent prescription opiate medications as prescribed.
    The accuracy of UDS depends on the absence of interfering substances, the
technology employed in the measurement, submission of an unaltered true urine
specimen, and whether secondary confirmation tests such as GC/MS or HPLC/MS is
used. GC/MS confirmation testing is always recommended before any action is to be
taken against the patient since this test is virtually 100% accurate. The physician needs
to assure the non-prn medications show up in the UDS, that no illicit substances are
found, and that no unprescribed drugs of concern show up. One study demonstrated only
31% of patients with positive oxycodone on a specific oxycodone test strip showed up
positive on the opioid strip of a multidrug test strip, therefore confirmation of positive or
negative UDS for opiates via GC/MS or other sensitive method is imperative (J Subst
Abuse Treat. 2008 Feb 21). An accurate questionnaire regarding when last doses of
drugs were taken is imperative.
    The percentage of compliance of patients receiving chronic opiates is quite poor on a
national level. Ameritox has as of mid 2008 590,518 specimens tested and queries
patients prior to the drug screen about what drugs they are taking and when the last dose
taken. The following shows significant non-compliance with physician prescribing:
FAQ:

       A patient positive for opiates not prescribed, illicit substances, and is negative
       for the prescribed medication absolutely insists the test was wrong and demands
       to be retested. What should my response be?
       Retesting when the patient is expecting it when they are receiving prescription
       opiates is futile since substance abusing patients will have taken corrective action
       to ensure the retest would be negative. Discuss the specificity and sensitivity of
       the test with the lab for each class of drugs in question. Ask the lab about
       interferences in the specimen that may explain the positive values and non-
       positive values expected to be positive. Usually the list is small. If there are any
       potential interfering agents that the patient discloses that are not illicit substances
       and there is no other good reason the patient has for UDS to positive, then you
       may consider tagging the patient with presumptive substance abuse, then take the
       appropriate action in accord with clinic policies. If the patient is to continue
       receiving opiates, was a few months to recheck the UDS.
MINIMUM PROVIDER REQUIREMENTS FOR
PRESCRIBING CONTROLLED SUBSTANCES FOR
PAIN
Most state medical licensing boards incorporate the the Federation of State Medical
Boards Guidelines for Prescribing Narcotics. Below is an abridged version of these
guidelines. Following these guidelines will eliminate most problems regarding
scrutiny of the state medical boards with respect to prescribing opiate narcotics.

1. Evaluation of the Patient: A complete medical history and physical examination must be
conducted and documented in the medical record. The medical record should document the
nature and intensity of the pain, current and past treatments for pain, underlying or coexisting
diseases or conditions, the effect of the pain on physical and psychological function, and
history of substance abuse. The medical record also should document the presence of one or
more recognized medical indications for the use of a controlled substance.
2. Treatment Plan: The written treatment plan should state objectives that will be used to
determine treatment success, such as pain relief and improved physical and psychosocial
function, and should indicate if any further diagnostic evaluations or other treatments are
planned. After treatment begins, the physician should adjust drug therapy to the individual
medical needs of eachpatient. Other treatment modalities or a rehabilitation program may be
necessary depending on the etiology of the pain and the extent to which the pain is
associated with physical and psychosocial impairment.
3. Informed Consent and Agreement for Treatment The physician should discuss the
risks and benefits of the use of controlled substances with the patient, persons designated by
the patient or with the patient’s surrogate or guardian if the patient is incompetent. The
patient should receive prescriptions from one physician and one pharmacy where possible. If
the patient is determined to be at high risk for medication abuse or have a history of
substance abuse, the physician may employ the use of a written agreement between
physician and patient outlining patient responsibilities, including urine/serum medication
levels screening when requested; number and frequency of all prescription refills; and
reasons for which drug therapy may be discontinued (i.e., violation of agreement).
4. Periodic Review: At reasonable intervals based on the individual circumstances of the
patient, the physician should review the course of treatment and any new information about
the etiology of the pain. Continuation or modification of therapy should depend on the
physician’s evaluation of progress toward stated treatment objectives, such as improvement
in patient’s pain intensity and improved physical and/or psychosocial function, i.e., ability to
work, need of health care resources, activities of daily living and quality of social life. If
treatment goals are not being achieved, despite medication adjustments, the physician
should reevaluate the appropriateness of continued treatment. The physician should monitor
patient compliance in medication usage and related treatment plans.
5. Consultation: The physician should be willing to refer the patient as necessary for
additional evaluation and treatment in order to achieve treatment objectives. Special attention
should be given to those pain patients who are at risk for misusing their medications and
those whose living arrangement pose a risk for medication misuse or diversion. The
management of pain in patients with a history of substance abuse or with a comorbid
psychiatric disorder may require extra care, monitoring, documentation and consultation with
or referral to an expert in the management of such patients.
6. Medical Records: The physician should keep accurate and complete records to include
the medical history and physical examination; diagnostic, therapeutic and laboratory results;
evaluations and consultations; treatment objectives; discussion of risks and benefits;
treatments; medications (including date, type, dosage and quantity prescribed); instructions
and agreements; and periodic reviews. Records should remain current and be maintained in
an accessible manner and readily available for review.
7. Compliance With Controlled Substances Laws and Regulations: To prescribe,
dispense or administer controlled substances, the physician must be licensed in the state and
comply with applicable federal and state regulations. Physicians are referred to the
Physicians Manual of the U.S. Drug Enforcement Administration and (any relevant
documents issued by the state medical board) for specific rules governing controlled
substances as well as applicable state regulations




A. How frequently should I have follow-up visits with patients receiving chronic
opiate narcotic therapy?

     There are no legal requirements to see patients at specific follow-up intervals or
frequencies, however in general for a compliant patient with no substance abuse
history and a stable dose of medications, every 4-6 weeks for schedule II drugs and
every 2-3 months for schedule III drugs. It is inappropriate and poor medical practice
to have patients show up at the office reception area to be routinely given scripts by a
nurse or receptionist without a practitioner follow-up visit. Acute pain issues or non-
stable dosing require more frequent follow-up visits.

B. What documentation is needed for follow-up patients receiving chronic opiate
narcotics?

    The following elements should be documented on each patient receiving narcotic
opiate prescriptions:
    1.       measure of the severity of the pain (eg. VAS scale or pain % reduction
    with medications)
    2.       some measure of the functionality of the patient (Activities of daily living,
    ability to work, etc)
    3.       any side effects that may be related to opiates
    4.       physical status including assessment of the patient’s level of
    consciousness, slurred speech, conversant level, any potentially opiate related
    physical exam effects
    5.       the reason for continuing opiate prescribing
    6.       plan including any changes in amounts of opiates with the reason for such
    7.       any substance abuse or diversion evidence including urine drug screening
    if performed

C. A new patient is seen at 5 PM and presents an apparently legitimate
   prescription bottle of MS Contin 100mg TID, telling me he ran out of
   medications today, and will go into withdrawal without the medication. He has
   no medical records from the prescribing physician and their office is now
   closed. What should I do?

    If there are no other red flag signs (admits to recently taking illicit drugs, no self
    reported prescription substance abuse history, no other inconsistencies in the
   history and physical exam), it would be reasonable to provide the patient with a
   prescription for a one day supply only, to return the following day when medical
   records are available. Caution should be used in treating late Friday afternoon
   new patients, especially when they were told they must have medical records,
   since this may be a ploy by a diverter or substance abuser to obtain drugs
   surreptitiously in larger quantities for the entire weekend. The other option is to
   give the patient tizanidine for a day until the full medical record can be faxed
   from the former provider.

D. A new patient arrives with their own medical records but it appears a page is
   missing. Should I prescribe narcotics if everything else is reasonably
   consistent?
   Substance abusers frequently will edit out parts of their medical record they do
   not wish to be seen by a physician. For that reason, it is a much more prudent
   policy to obtain the medical records directly from the prior physician’s office via
   fax. In this case it would be wise to avoid narcotics until the full and complete
   records are faxed.




SETTING UP A NARCOTIC PRESCRIBING
PROGRAM FOR CHRONIC PAIN TREATMENT.
     If the provider does not have formal training in pain medicine, then sending a
patient for consultation with a pain physician may be judicious and is consistent with
FSMB guidelines. The pain physician may recommend a treatment therapy, may
stabilize the patient on a specific regimen then return the patient to the provider for
chronic maintenance, or may assume the care of chronic narcotic prescribing.
Chronic pain is a neurological disease, not a solely a nociceptive symptom such as
acute pain. Accordingly, the philosophies and goals of treating chronic pain with
opiate narcotics are quite different than in acute pain. There are no long term studies
demonstrating positive outcomes from long acting opiate narcotic use for controlling
chronic pain. The longest prospective study is 16 weeks and demonstrated only
marginal improvement. In fact there are a few studies demonstrating patient’s pain
actually improved once they stopped taking narcotic pain medications (Am J Ther.
2006 Sep-Oct;13(5):436-44)- ostensibly due to the NMDA receptor effects.
     There are very high degrees of comorbidity with psychiatric disorders and
prescription drug abuse (J Clin Psychiatry. 2006 Jul;67(7):1062-73). Patients with
pre-existing psychiatric diseases are three times as likely to have opiate management
initiated and over twice as likely to opioid pain management continued long term (J
Clin Psychiatry. 2006 Jul;67(7):1062-73). Therefore the psychiatric assessment,
when available prior to initiation of opiate narcotics, may help to prevent substance
abuse.
     Unlike other types of medical therapy, the informed consent aspect must be very
specific and dictate that a patient may be withdrawn from narcotics or have the
narcotics discontinued abruptly if certain conditions exist. The patients should be
given a written copy of the policy in advance and you should keep a copy signed by
the patient that they understand the rules, obligations, and the actions that will be
taken against them if they abuse or divert drugs, engage in subterfuge to acquire
drugs, or become hostile to the staff in order to obtain drugs.
It should be stated there are limits on what the clinic will prescribe regardless of how
bad the pain is perceived to be, and those limits are solely the determination of the
practitioner. Before any self-escalations of dosing of drugs, the patient must contact
the physician first and discuss the situation. Consistent with drug monitoring
precepts, it is necessary the patient disclose all other controlled substances being
prescribed each month and whether the patient received any opiate narcotics from
another physician or from anyone else in the past month.

PRECEPTS OF AN OUTPATIENT OPIATE TREATMENT PROGRAM FOR
CHRONIC PAIN
-Communication to the patient of the rules of the clinic on the patient’s initial visit
   with the patient signing an opiate agreement that they understand and agree to
   abide by the clinic rules
-Uniform enforcement of rules of the clinic over time and between different staff
-Responsibility of patient for maintaining physical control over their scripts and
   narcotics (lock box, don’t leave them in a car, use of a small bottle for daily use
   and larger bottle to keep at home), no refills on lost scripts or medications
-Responsibility of patient for taking the meds as directed
-Monitoring (observation, calls from family or the police, urine drug screens and
   GC/MS or HPLC confirmation, pill counts, pharmacy printouts, etc) INSPECT
   program (see below)
-Consequences of drug diversion are known to the patient and staff, and are enforced
   with cooperation with law enforcement
-The patient understands up front that opiates have addictive potential and that they
   will be monitored for substance abuse using a variety of methods. They also must
   understand addiction to opiates may require outpatient or inpatient treatment

The INSPECT program in Indiana is a 20 second on-line query of patient
controlled substance prescriptions for the past year or more. All physicians
prescribing controlled substances should be employing this program as it is a
major advancement in the tools available to prevent substance abuse and
diversion. All new patients coming into a pain practice should have the
INSPECT program queried and also at random and targeted intervals when
substance abuse is suspected.

Tactics to Bring Borderline Substance Abuse Patients Into Compliance
  a. Switch to fentanyl patches without breakthrough medications or with limited
      breakthrough medications
  b. Use more frequent follow-up visits of weekly intervals
  c. Do not write for refills on any narcotic script
  d. Reduction in the number of tablets prescribed
  e. Use of a pill box with daily sections
    Signs your patient may be in trouble:
1. Usage Increase- Previously, the erroneous             6. Change in Daily Habits and Appearance -
concept of pseudoaddiction was used to justify ever      Personal hygiene may diminish as a result of a drug
increasing doses of opiates. Increased pain may          addiction. Sleeping and eating habits change, and a
indeed justify the need for increasing opiates, but      person may have a constant cough, runny nose and
patients absolutely must be held accountable to          red, glazed eyes.
their controlling their use of the drugs. Increases in
opiates must be met with either a reduction in pain      7. Neglects Responsibilities - A dependent person
or improvement in function.                              may call in sick to work more often, although in the
                                                         case of chronic pain this may be common also.
2. Change in Personality –this can sometimes be
quite dramatic with patients lashing out at their        8. Increased Sensitivity - Normal sights, sounds
physician, alienating their home support system          and emotions might become overly stimulating to
members, or becoming excessively passive                 the person. Hallucinations, although perhaps
                                                         difficult to monitor, may occur as well.
3. Social Withdrawal – ask patients about their
activities, children, grandchildren and record these     9. Blackouts and Forgetfulness - Another clear
on the chart. If there is withdrawal from these later,   indication of dependence is when the person
substance abuse may be in play.                          regularly forgets events that have taken place and
                                                         appears to be suffering blackouts. This may also
4. Ongoing Use - Continued usage after a medical         indicate polypharmacy or relative overdoses of
condition has improved will result in the person         combinations of sedating drugs including opiates,
needing extensions on his/her prescription. The          but does require investigation.
person might talk of how they are "still feeling pain"
and need just a little longer on the medication in       10. Defensiveness - When attempting to hide a
order to get well. He or she might also complain         drug dependency, abusers can become very
frequently about the doctors who refused to write        defensive if they feel their secret is being
the prescription for one reason or another.              discovered. They might even react to simple
                                                         requests or questions by lashing out. Alarms
5. Time Spent in Obtaining Prescriptions- the            should go off if family members are insisting on
patient may drive great distances or out of state to     increasing the opiates prescribed when the patient
obtain prescriptions for opiates.                        is passive or when there are untoward side effects
                                                         being demonstrated with the use of the medications.




    HOW TO HANDLE DRUG DIVERSION
        Drug diversion includes alteration of the quantity, dosing frequency, or milligram
    amounts on the script. It also includes theft of a drug, attempting to obtain drugs by
    subterfuge. Drug diversion should be immediately reported to the police where the
    patient resides. Documented drug diversion requires immediate cessation of narcotic
    prescribing. To continue prescribing in this situation is to risk the license to prescribe
    these potent opiate narcotics in addition to risking the provider going to jail.
        Both drug diversion and substance abuse should be reported to the referring
    physician, primary care physician, any other specialists the patient told you they have
    been seeing. When patients engage in substance abuse and are receiving no more
    narcotics from a clinic, their first response is to call one of the other physicians with
    which they have a relationship, and ask them to prescribe the narcotics.
Communication by the provider discovering substance abuse to other providers may
save the patient from overdose or death.

In reporting to the local police that you received telephone calls from more than
one person that a patient is selling prescription opiates, you are notified the patient
has 3 arrest warrants outstanding for cocaine sale. The police wants to be notified
when the patient arrives at your office so they can arrest her. Should I comply?
No. Our role as physicians is not to actively invite law enforcement into our clinic to
arrest patients for felonies that have nothing to do with our practice of medicine,
unless the felony is committed on clinic grounds. For instance, if a patient is seen by
clinic staff selling prescription drugs in the parking lot, then having the police arrest
them is indicated. However, reporting a felony as a dutifully law abiding citizen and
actively participating in the arrest are different issues, with the latter being beyond the
scope of our profession.


DISCHARGE VS CHANGE IN THERAPY
The requirements for discharging a patient from the practice are much higher than
that of simply changing therapies to non-narcotic therapy. If a patient violates opiate
agreements or clinic policies, consider not discharging the patient (usually requires
yet another 30 day supply of drugs the patient can abuse, formal written notice of the
discharge that you have to prove the patient received, and in some states requires you
to find another physician for the patient), but simply tell them they are no longer a
candidate for narcotic therapy, and offer them non-narcotic therapy. Weaning or use
of non-narcotic withdrawal medications may be appropriate. In such cases, if the
patient on their own volition elects to seek care elsewhere, you are not responsible for
providing any other narcotic treatment nor are you responsible for finding another
physician for the patient. It should be noted in your chart that the patient stated they
plan on finding another physician. When a change of therapy approach is used, the
provider is required to provide continuing treatment of the patient in order to avoid
patient abandonment claims, but do not have to provide the patient with narcotics if
they are not a candidate for that therapy due to their abuse or diversion. Injections,
physical therapy, psychological therapy, referral for acupuncture, non-narcotic
medications are all other avenues to explore in the case when patients are no longer
candidates for narcotic therapy.


GOOD PRESCRIBING PRACTICES
    If all the criteria are met for opiate prescribing and opiates are to be prescribed on
the first visit, then appropriate dosage, drug, and followup interval with a plan for
monitoring must be employed. For patients already receiving opiate narcotics from
another physician that is transferring pain care to your practice, assessment of the
effectiveness of the opiate is necessary. The Oswestry, Beck Depression tests, and
Zung anxiety tests are easy to administer functional and psych screening tests in the
office setting. These tests also serve as a baseline assessment to gauge the effect of
further therapies. A VAS scale range of pain experienced on a daily basis is far more
useful than having the patient trying to pick an average VAS for an entire month.
Use of the Hochman pain scale may be useful to identify what each of the VAS
numbers mean.
     The initial prescription should not consist of more than a 100% increase in current
medication load regardless of how severe the pain may be. Methadone should not be
increased any more rapidly than 25% every week while other medications may be
safer for more rapid increases as necessary. The goal of pain therapy is to reduce the
pain by 50-70%. Further reduction in pain through the use of opiate narcotics may
lead to rapid development of tolerance. Strict controls must be implemented on the
initial patient visit. For patients that are found not to be able to control their narcotic
use in the first month will prove to be very poor candidates for future opiate therapy.
Excessive permissiveness with patient’s use of opiate narcotics in an early phase of
treatment may send the message that substance abuse is acceptable, and may result in
overdose or death during higher dose narcotic use.
     Followup visits initially should not further apart than monthly intervals for at least
3 months. During escalations of dosage by the physician, more frequent visits may
be necessary. For borderline substance abusers intervals as little as one week or
every 2 days may be appropriate.
     Side effects should be addressed in advance of their occurrence including
constipation, nausea, sedation, lowered testosterone levels.

   I have a patient that is to undergo some major abdominal surgery and will need
   pain medications post operatively. He takes 80mg Oxycontin TID for low back
   pain from another provider, but I am afraid prescribing that amount after
   surgery may cause respiratory distress. Should I wean the patient off oxycontin
   prior to the surgery coming up in a week?

   In this case, there are several options, but weaning the patient off this high dose of
   medication is impractical one week prior to surgery. There is little evidence mu
   receptors will reset to a lower level after one week of reduced opiate dosing. First,
   ask the anesthesiologist to place and manage an epidural infusion for several days
   after surgery. Secondly, patients on chronic stable high dose opiates typically will
   go through a very unpleasant and painful withdrawal when the dosage is adjusted
   downwards. Due to activation of the NMDA system, the pain during withdrawal
   is much worse than the original pain, and other pain sources are amplified in their
   intensity. Therefore it would be prudent to continue the same dose of oxycontin
   or equivalent dose during the post operative period unless post surgical GI
   hypomotility or respiratory issues arise. Additional pain medications may be
   needed on top of the usual daily dose of oral narcotics. Thirdly, it would be wise
   to consult the opiate prescribing physician and ask them to help manage the
   patient post operatively if they have hospital privileges at that location.


PROBLEM SITUATIONS
Most problems can be averted in advance by having a clinic policy that gives
direction to the patients regarding clinic requirements for narcotic use responsibility.
Since the substance abuse rate is present in approximately 25% of those receiving
opiate narcotic medications from physicians, compliance and monitoring must be
imposed to protect the integrity of the clinic and the continued prescribing ability of
the practitioner. Strict clinic policies are easier to enforce than those that are
nebulous, and also are easier to defend legally when necessary.

THEFT:
The entire month’s supply of Oxycontin was stolen from home-patient calls in to
obtain a refill
Patients must be required to assume personal responsibility for the safekeeping of
these medications. The clinic rules should specify there will be no replacement of lost
or stolen drugs. The clinic rules should specify the patient must have a lock box well
hidden or a safe at home. Theft of the lockbox or safe with a police report may be
grounds for refilling a medication once. Single incident theft in the absence of a lock
box or safe are usually not refilled. Repeated theft in light of patient refusing to buy a
lock box should cause the patients therapy to be changed to non-narcotic therapies
from that point on. High dose medications stolen may require withdrawal medicines
for several days, or in the case of methadone, for several weeks.

My patient is a 38 year old female with a 16 year old son that she says is a drug
addict. The patient reports for the third time in a year, he has stolen her
Oxycontin, that was not locked up. She refuses to report him to the police and will
not engage him in mandatory drug rehabilitation stating “he is just confused right
now”. How should this be handled?
The patient should be withdrawn from all narcotics and given non-narcotic therapy.
She is effectively enabling a drug addict and is aware that felony diversion is
occurring with her prescribed narcotics, but is unwilling to take any action nor hold
her son responsible for his actions. She has lost control over the prescription opiates
and is no longer a candidate for opiate therapy.

The entire month’s supply was stolen from their vehicle-patient wants a refill
Clinic policy: no refills for lost or stolen drugs. The patient should be informed the
pharmacist will create a smaller travel bottle for daily use and larger bottle to be kept
at home. The entire quantity of medications for a month should never be left
unattended in a car. Solution: withdrawal medications for high dose narcotic
prescriptions and have the patient follow-up for the regularly scheduled appointment.


LOST MEDICATIONS:
Patient lost their medication script for MS Contin 60mg TID at home prior to
filling it, calls you on the weekend for a refill.
Solution: clinic policy that does not replace lost or stolen scripts or medications.
Anyone can fill a prescription under the guise they are filling it for the patient that
cannot get out of the house. Prescriptions are like money: if you walk out of the
bank with a hundred dollar bill then lose it, the bank will not replace it. Neither
should we as physicians replace lost scripts since the drugs may end up on the street.
Also, the lost script excuse is commonly seen in substance abuse and in drug
diversion. It would be acceptable to call in a script (such as tizanidine) to mollify the
extent of the withdrawal response.

DESTROYED MEDICATIONS:
Patient spilled all the tablets into the commode when trying to take the medications-
young healthy 23 year old new patient Answer: withdrawal medicines until the next
scheduled script. Cancel all remaining refills on scripts and have the patient follow-
up one month from the original prescription date.

Spilled the tablets into the commode when trying to open the bottle-arthritic 75 year
old Answer: If there are no other violations of clinic policy, then refill the script and
have them ask the pharmacy for an easy open (non-child proof) lid.

UNAVAILABLE FOR INSPECTION:
Patient cannot tolerate the drug and threw it all away (nearly a full prescription),
wants another drug Solution: Clinic policy that requires non-tolerated drugs to be
brought to the clinic for disposal. The practitioner then witnesses the patient pouring
the drug into the commode. This prevents multiple drugs being available in a
household (available for theft, sharing, sale). If a clinic policy is in force, then
withdrawal medications (non-narcotic) until the next scheduled visit.

Clinic receives an anonymous call that the patient is selling the prescribed opiate
narcotic and is told to go to the pharmacy within 24 hours for a pill count. The
patient does not do so but shows up for a refill at the next visit
Solution: change to a non-narcotic therapy and consider relaying the report to the
police.

HOSTILE/THREATENING BEHAVIOR:
Patient is hostile and threatening physical harm against the physician if
medications are not given
Have the staff call the police immediately. This constitutes the crime of terroristic
threatening and/or attempted extortion. Discharge the patient from the practice
immediately with no further therapy. The clinic rules should specifically state such
discharge will occur under those conditions.

Patient is hostile and threatens to sue the physician unless prescriptions for opiate
narcotics or benzodiazepines are given
Document this behavior in the medical record, and if there are no medical reasons or
drug diversion reasons not to prescribe these medications, write the prescriptions for
one month and discharge the patient from your practice. Remember to follow this
with a letter to the patient stating you will be available for 30 days only for
emergency medical treatment issues and no more controlled substances will be
prescribed by your practice to the patient in the future.
OVERUSE OF PRESCRIPTION NARCOTICS:
Patient took the month’s supply of narcotics in 7 days because the patient claims he
cannot read. Answer: Patient is not a candidate for narcotics. He poses a risk to
himself and potentially to others through uncontrolled usage of narcotics. Change to a
non-narcotic therapy.

Patient took all the prn hydrocodone in 10 days rather than the 30 days due to his
increased pain, but the prescribing practitioner was not notified, and now the
patient wants more drugs. Answer: Patient has lost control over their use of the
drug. If this is the first offense, then tell the patient to take Tylenol or advil per the
recommendations on the bottle, then the drug will be available for refill one month
after it was originally filled. If this constitutes more than one offense, then the patient
should be changed to a non-narcotic therapy. Such escalations should also provoke
the instigation of further testing and examination of the patient to assure there are no
acute issues at play.

The patient overdoses on the prescribed opiate plus cocaine and is in the ICU
intubated for 2 days. You are not notified by the hospital at the time and are
unaware of the overdose (non-disclosed by the patient) until after the patient’s next
follow-up visit.
Response: call the pharmacy and cancel all refills on remaining controlled substances
and call and write the patient telling him you are converting the patient to a non-
narcotic therapy.


DRUG DIVERSION:
The script for narcotics presented to the pharmacy has the amount of medication
altered from #90 to #190 and the pharmacist notifies you by telephone. Answer:
Ask the pharmacist to call the police and have the person arrested at the pharmacy. If
the patient left the pharmacy and the pharmacist has the script, have the pharmacist
fax back to you a copy of the altered script, then call the police where the patient lives
and report a felony.

A husband and wife are both patients in the clinic taking different narcotics. The
UDS on each shows they are sharing drugs. Response: withdrawal from narcotic
therapy. The patients do not respect the US laws regarding drug diversion and have
little control over their use of the narcotics. If family members or two patients living
together are being seen in your clinic as patients, make sure they are taking different
opiate drug classes.

A patient states Fedex delivered the 3 month mail-in script for opiates to her front
door and they were stolen from the porch. What should my response be?
Response: This assertion requires some investigation by the physician’s office as this
allegation may be true. The mail in prescription pharmacies usually require Fedex or
other delivery service obtain a signature from the patient. Usually this is done,
however some delivery drivers will simply drop the package on the front porch
without signature. The possible scenerios include: a. theft by the delivery driver 2.
theft by a passerby or a person aware the patient is receiving opiates 3. The patient is
lying and actually had signed for the medication. In the latter case, the delivery
driver will have a signature on file. Compare this with the patient’s signature in your
clinic charts. If there is a match, then action must be taken against the patient
including confronting them directly about the matched signatures. If there was no
signature obtained, then the delivery service should be reported to local law
enforcement and the DEA for possible company diversion of the drug. In either
case, if the patient is to be retained in the practice, switch to monthly opiate
prescribing with monthly office visits regardless of the increase in cost to the patient
compared with 3 month mail-in prescriptions.

The patient states when they went to the pharmacy to pick up their hydrocodone
script, someone else had already signed for it and picked it up. Response: Call the
pharmacist that filled the prescription and ask if he recognized the person that picked
up the prescription as the patient. If this is affirmative, then the patient is attempting
to use subterfuge to obtain opiate narcotics which is drug diversion. Notify the local
police. If the pharmacist doesn’t remember the person picking up the prescription,
then fax over the patient’s photo from their driver’s license copy in your file or photo
from your electronic medical record. Ask the pharmacist to fax you the signature in
their logbook for the transaction. If the signature matches that which you have on
file, then notify the police of the attempted prescription drug diversion, and cancel all
remaining refills.



ILLICIT DRUGS ON UDS
A random UDS picks up methamphetamine in a patient that denies it is being used.
What should the response be?
Always offer GC/MS confirmation of the same sample to the patient at the patient’s
expense (usually urine specimens are retained by the lab for up to 3 days). UDS have
many interferences and should not be relied upon as an absolute test of patient
veracity. If the GC/MS is positive for methamphetamine, then consider changing to a
non-narcotic therapy. If it is negative for methamphetamine, continue therapy
uninterrupted.

A random UDS picks up marijuana. The patient claims they were with friends in a
closed car that were smoking pot.
Very low levels of marijuana can be absorbed in tight quarters but the levels should
be below 50mcg/dl. If the levels are higher, consider the patient to be actively
smoking marijuana as this is very common in our society. Some pain centers in the
US do not permit marijuana to be used at all while a patient there while others in
states with “medical marijuana” laws do permit its use. In Indiana, it is illegal to use
marijuana for any purpose, therefore a more conservative approach is warranted.
LACK OF PRESCRIBED DRUG IN UDS
One of my long term patients had an in-office urine drug screen dipstick method
today but none of the opiates being prescribed, oxycodone, showed up on the
screen. The patient swears they are taking the medicine and took the last dose this
morning 4 hours before the drug screen. What should be my response?
There are several reasons why a prescribed drug may not show up on a urine drug
screen. The sensitivity of the test may not be sufficiently high due to the test limits of
detection (eg. In polyclonal antibody systems, it may take 100 times as much
oxycodone as morphine to trigger the “Opiates” screening strip. The patient may
have substituted urine of another person or powdered reconstitute for their own urine
to avoid detection of illicit substances. The patient may have not taken any of the prn
narcotics in several days. The patient may have sold their medication or abused it
with escalation of dose resulting in none being available. There may be a lab error or
break in the chain of custody of the sample.
However, a negative drug screen does require some response, so it is prudent to offer
GC/MS confirmatory testing at the patient’s request. There are some drug screens
now available that have a much greater specificity for specific drugs (oxycodone,
hydrocodone) but in any case where the UDS is negative, confirmatory screening
should be offered prior to taking any specific action. In the case above, it may be
appropriate to continue with the usual prescriptions while obtaining GC/MS
confirmation. If the patient does not want to pay for this but insists on the
medications, you may elect to go forward with your own GC/MS confirmation that
typically costs about $20.

NON PRESCRIBED CONTROLLED SUBSTANCES IN UDS
Methadone showed up in a UDS in a patient in which we are not prescribing
methadone. What are the implications?
The patient may be simultaneously receiving treatment in a methadone treatment
center surreptitiously. These centers do not have to report either prescribing or
distribution of methadone to the INSPECT program and permit patients to continue
abusing methadone and other drugs since they operate outside physician monitoring
programs. They will not voluntarily call other physicians known to be treating the
patient and the only way to obtain patient information from them is via a signed
release of information by the patient. Therefore, if you are not prescribing
methadone, immediate cessation of all narcotics is warranted since this potent drug is
either being prescribed by methadone clinics or is being obtained via felony act.

The husband of a husband-wife patient pair in our practice had a UDS positive for
a drug being taken by the wife. What should my response be?
The husband is either stealing the medicine from the wife or is being given the
medicine by the wife. Immediately call both in for pill counts and drug test the wife
simultaneously. If there are discrepancies, you must take action against the husband
and possibly against the wife.

FREQUENT ER VISITS
A patient being treated for chronic low back pain and lumbar spondylosis with
oxymorphone PO has been in the emergency departments of 3 hospitals on 3
consecutive nights for calf spasticity and severe cramping requiring IV valium.
The last hospital refused the IV valium. The patient did not contact their pain
physician about the increased pain. What should my response be?
Have the patient come to your office with their medications for a pill count and
simultaneously evaluate for new sources of pain. If there is a drastic change in pain
pattern or character or intensity, emergency department or office practitioner
evaluation is always indicated. Do not tell patients they should not visit the
emergency department for pain, but it is acceptable to tell them they should not visit
the emergency department for the same chronic pain pattern and intensity that is
common for them on a daily basis.

MULTIPLE PRESCRIBERS
The potential patient demographic data was entered into the INSPECT program
and demonstrated frequent large prescriptions for opiate narcotics at 2 week
intervals. The amounts were unreasonable by any stretch of the imagination.
Should I accept this patient into my practice if I mandate a narcotic
contract/agreement?
This person has a serious substance abuse issue or is selling the drugs. It would be
prudent to both contact the police in the city where the patient lives reporting a
potential felony diversion and to contact each prescribing physician to make them
aware of the patient’s substance abuse. Under no circumstances should this patient be
accepted into the medical practice for narcotic prescribing, but may be accepted for
interventional invasive therapy or PT. If the patient is uninterested in pursuing pain
management sans opiates, then notify the referring physicians of this posturing.

A longstanding chronic pain patient is found through random INSPECT query to
have been receiving monthly opiate narcotics simultaneously for year from my
practice and that of the family physician. What should my response be?
Give the patient withdrawal medications and institute a no-more-narcotics treatment
regimen for this patient. Notify the family physician. (Note: withdrawal of narcotics
is only warranted if the patient has either falsified information about their narcotic use
or violated a written signed narcotic agreement…if you do not ask the patient about
receiving narcotics from other physicians, they may not tell you and if the narcotic
agreement does not spell out one doc for prescription narcotics, the culpability
becomes that of the physician)

A patient that has been legitimately receiving opiate narcotics from my practice was
discovered on INSPECT to have received narcotics from several dentists and
surgeons after surgical procedures. What should my response be?
If the surgical situations are bona fide, then additional opiate narcotic medications in
small limited time and numerical quantities are warranted and acceptable. This
should be reflected in your narcotic agreement with the patient.

				
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