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COLORADO GUIDELINES OF PROFESSIONAL PRACTICE FOR CONTROLLED SUBSTANCES

HEALTH CARE PROFESSIONALS WHO PRESCRIBE, DISPENSE, AND ADMINISTER

The Colorado Prescription Drug Abuse Task Force was organized in 1984 to prevent and eliminate prescription drug abuse in Colorado. This non-profit corporation is a consortium of private and public agencies including the Colorado Medical Society and other medical societies, the Colorado Department of Human Services, the Colorado Nurses Association, the Colorado Veterinary Medical Association, the Colorado Hospital Association, the U.S. Drug Enforcement Administration and many other law enforcement agencies, and the state regulatory boards for professional practice. Goals of the Task Force are to: 1) develop and distribution guidelines for health professionals who administer and prescribe controlled substances, 2) implement professional education programs, 3) improve coordination among private and public agencies concerned about prescription drug abuse, 4) monitor prescription drug abuse in the state, and 5) evaluate public policy related to controlled substances.

This project was made possible by a grant from The Alcohol and Drug Abuse Division of The Colorado Department of Human Services.

Appreciation is extended to the U.S. Drug Enforcement Administration.

The Colorado Prescription Drug Abuse Task Force sincerely acknowledges the efforts of the Professional Standards Committee for their dedication to the quality and usefulness of these guidelines.

The Colorado Prescription Drug Abuse Task Force appreciates the efforts of the Missouri Task Force on the Misuse, Abuse, and Diversion of Prescription Drugs. Their earlier manual served as a model for this publication.

COLORADO GUIDELINES OF PROFESSIONAL PRACTICE FOR CONTROLLED SUBSTANCES

HEALTH CARE PROFESSIONALS WHO PRESCRIBE, DISPENSE, AND ADMINISTER

Prepared by the Professional Standards Committee Colorado Prescription Drug Abuse Task Force

Committee Co-Chairpersons: Shirley J. Terry, M.S., R.N., CAC III, NCAC II James Woodard, R.N., C.F.N.C.

Committee Members: Scott Collier, DEA James Duke, M.D. Rita Morrill, R.Ph. Donna Heath, B.S.N., R.N. Charles D. Sintek, R.Ph., M.S., BCPS

Colorado Prescription Drug Abuser Task Force Director: Jody Gingery, M.Ed, R.N. (1984 2006)

With special acknowledgement to past Members: Valdis Kalnins, R.Ph. Jody Gingery, M.Ed., R.N.

Denver, Colorado i

December 1999
Third Edition

PREFACE
A major goal of the Colorado Prescription Drug Abuse Task Force is to develop guidelines which reflect consensus about what constitutes responsible prescribing and administration of controlled substances easily abused or misused by the patient or the professional. The Professional Standards Committee was given responsibility for determining guidelines for health care professionals who prescribe, dispense or administer controlled substances. Committee membership is comprised of representatives from health care professionals and various agencies which regulate health professionals. These guidelines were reviewed by the Colorado Board of Medical Examiners, the Colorado Board of Nursing, the Colorado Nurse Health Program of the Board of Nursing, the Colorado Board of Pharmacy, and the Colorado Board of Dentistry, but they are not binding as rules or regulations. These guidelines are meant to serve as an aid to the exercise of professional judgment and responsibility. They have been designed as a prevention tool. Individual patient circumstances may support modification or consultation with specialists in the field. Providers should also consult manufacturers prescribing information for drugs with which they are not familiar.
Special thanks for review and editing of the final draft goes to the following professionals: Section A: Section B: Ben Rich, J.D., Ph.D. Regina Fink, Ph.D., R.N. Michael P. Ernest, M.D. Ben Rich, J.D., Ph.D. Ernest E. Moore, M.D. Scott J. Hompland, D.O. Charles E. Lee, D.D.S. Richard Steig, M.D. Thomas Morgan, M.D. Nancy Hestor, Ph.D., R.N. Ben Rich, J.D., Ph.D. Scott J. Hompland, D.O. Ernest E. Moore, M.D. Stephen L. Dilts, Ph.D. Ben Rich, J.D., Ph.D. Scott J. Hompland, D.O. Ernest E. Moore, M.D. Donna Lindsey, R.N., C.A.R.N., CAC III, C.E.A.P. Jon Bell, M.D. Ben Rich, J.D., Ph.D. Scott J. Hompland, D.O. Ernest E. Moore, M.D. Ben Rich, J.D., Ph.D. The Ad Hoc Task Force on Intractable Pain in Nursing Home Residents of the Health Facilities Section of the Colorado Department of Public Health and Environment. This section was developed by the Ad Hoc Task Force on Intractable Pain in Nursing Home Residents of the Health Facilities Section of the Colorado Department of Public Health and Environment.

Section C:

Section D:

Section E:

Section F:

Section G:

A very special thanks goes to James Duke, M.D., Anesthesiologist, Denver Health Medical Center, for his valuable contribution to the scripting of Section B and to Ernest E. Moore, M.D., FACS, Chief Dept. of Surgery, Denver Health Medical Center, Prof. & Vice Chair of Surgery, UCHSC, for Tables B & C included in Section B.

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TABLE OF CONTENTS SECTION A ........................................................................................................................ 1 Responsibilities ............................................................................................................... 1 Controlled Substances and the Law ................................................................................ 2 Federal Schedules of Controlled Substances .................................................................. 2 Registration Information ................................................................................................. 3 How to Issue a Legal Prescription .................................................................................. 3 Emergency Prescribing of Schedule II Controlled Substances....................................... 4 Recommended Prescribing Procedures........................................................................... 5 Unacceptable Prescribing Procedures ............................................................................. 7 Office Procedures............................................................................................................ 9 The Four Ds ................................................................................................................. 10 Clues for Screening Drug Abusers ............................................................................... 10 Acceptable and Unacceptable Indications for Prescribing Controlled Substances ...... 12 For More Information ................................................................................................... 14 SECTION B ...................................................................................................................... 15 Management of Acute/Trauma Pain ............................................................................. 15 SECTION C ...................................................................................................................... 31 Management of Chronic Pain ....................................................................................... 31 SECTION D ...................................................................................................................... 35 Pain Management for the Recovering or Substance Abusing Patient .......................... 35 SECTION E ...................................................................................................................... 44 Prescribing for the Treatment of Anxiety and Insomnia .............................................. 44 SECTION F ...................................................................................................................... 46 Prescribing for the Elderly ............................................................................................ 46 SECTION G ...................................................................................................................... 50 Management of Pain in Nursing Home Residents ........................................................ 50 APPENDIX A ................................................................................................................... 56 Colorado Board of Medical Examiners Guidelines for Prescribing Controlled Substances for Intractable Pain ..................................................................................... 56 APPENDIX B ................................................................................................................... 60 Colorado Board of Medical Examiners Rule on the Prescribing of Schedule II Stimulant Drugs ............................................................................................................ 60

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SECTION A RESPONSIBILITIES The abuse of prescription drugs, especially controlled substances, is a serious social and health problem in Colorado and in the United States. As a healthcare professional, you share responsibility for solving the prescription drug abuse and diversion problem. Your social responsibility is to uphold the law and help protect society from drug abuse. Your professional responsibility, which is also stated in the 1996 Colorado Board of Medical Examiners Guidelines for Prescribing Controlled Substances for Intractable Pain (see Appendix A) is as follows: the Prescriber has a legal and ethical responsibility to prescribe controlled substances appropriately and to provide patients with state-of-the-art pain management or to promptly refer them to other professionals who can, while safeguarding against drug abuse (see Appendices A & B). Your personal responsibility is to protect your practice from becoming an easy target for drug diversions, which could result in legal actions against you and damage your professional esteem.

The purpose of this guide is to help you meet these responsibilities by providing a clear and concise reference for the appropriate prescribing of controlled substances which have a demonstrated potential for inappropriate use and dependence formation. It is recognized that occasional clinical situations may require therapeutic approaches that do not fit exactly into the guidelines. Use of controlled substances in exception to these guidelines may be considered after: Careful medical and/or psychiatric evaluation. Consultation for a second opinion. Consideration of the use of an informed consent with your patient. Thorough documentation of indications. Documented unsuccessful trials with alternative noncontrolled substances.

Keep in mind that this guide provides only a summary of key points. For answers to specific questions, consult the appropriate law or agency. Sources for additional information are listed on page 14.

CONTROLLED SUBSTANCES AND THE LAW A controlled substance is a drug or drug product that comes under the jurisdiction of the Federal Controlled Substances Act. This Act is administered by the Drug Enforcement Administration (DEA) and specifies five different groups of drugs called schedules. The five schedules are described below. Practitioners must be aware of what drugs the different schedules contain because prescribing guidelines and record keeping requirements vary by schedule. The Colorado Controlled Substances Act, administered by the Alcohol and Drug Abuse Division of the Colorado Department of Human Services and the Board of Pharmacy of the Colorado Department of Regulatory Agencies, closely parallels the federal law. In instances where there is a difference, the more stringent law prevails. Violations of the Federal Controlled Substances Act may result in civil sanctions (civil fine), criminal sanctions or action against a license. The diversion of controlled substances may result in criminal investigation by local, state, or federal law enforcement agencies. In Colorado, a memorandum of understanding for interagency coordination and collaboration exists among the Colorado Department of Human Services, Colorado Department of Public Safety, Division of Registration in the Department of Regulatory Agencies, U.S. Drug Enforcement Administration and District Attorneys in the State of Colorado. FEDERAL SCHEDULES OF CONTROLLED SUBSTANCES The drugs and drug products under the jurisdiction of the Controlled Substances Act are divided into five schedules. All the schedules are subject to change. Drugs may change schedules based on evolving data related to their abuse potential. For a complete listing of all the controlled drugs, obtain a copy of the Code of Federal Regulations. The following are examples of controlled substances.1 Schedule I: Drugs in this schedule have no accepted medical use in treatment in the United States and have a high abuse potential. Examples include: heroin, LSD and peyote. Schedule II: Drugs in this schedule have accepted medical uses and high abuse potential with severe psychological and physical dependence. Some examples of Schedule II narcotic controlled substances are: codeine, hydromorphone (Dilaudid), meperidine (Demerol), methadone (Dolophine), morphine and oxycodone (Percocet, Percodan, Tylox). Examples of stimulants in Schedule II are: dextroamphetamine (Dexedrine),

Examples of trademark products appear in parentheses. The same applies to similar drug products of all other pharmaceutical manufacturers within each generic drug classification.

methamphetamine (Desoxyn) and methylphenidate (Ritalin). Cocaine is also a Schedule II stimulant. An example of a schedule depressant is secobarbital (Seconal). Schedule III: Drugs in this Schedule have accepted medical uses and an abuse potential less than those in Schedules I and II. Combination products containing limited quantities of certain narcotic drugs, such as codeine (Tylenol with Codeine, Fiorinal with Codeine), hydrocodone (Tussionex) and opium (paregoric) are in Schedule III. Anabolic steroids are a new category in Schedule III and include: methyltestosterone (Android), oxandroline (Oxandrin), stanozlol (Winstrol), nandroline (Durabolin) and testosterone (Delatestryl). Schedule IV: Drugs in this Schedule have accepted medical uses and abuse potential less than those listed in Schedule III. Depressants in this Schedule include the benzodiazepines, such as alprazolam (Xanax), triazolam Z (Halcion), diazepam (Valium), lorezepam (Ativan) and clorazepate (Tranxene). Stimulants include diethylpropion (Tannate) and phentermine (Ionamin, Fastin). Analgesics include propoxyphene (Darvon) and pentazocine (Talwin Nx). Antitussives in Schedule IV include codeine (Robitussin AC, Phenergan with Codeine). Schedule V: Drugs in this Schedule have an accepted medical use and an abuse potential less than those listed in Schedule IV. This schedule consists primarily of preparations containing quantities of certain narcotic drugs generally for antidiarrheal or antitussive purposes.

REGISTRATION INFORMATION Practitioners who prescribe, administer, or dispense controlled substances must register with DEA. The registration is valid for three years, and the certificate of registration must be kept available for inspection at the registered location. If a practitioner prescribes, administers or dispenses controlled substances at more than one office, the practitioner must register each office with the DEA. Any change of practice location must be reported to the DEA.

HOW TO ISSUE A LEGAL PRESCRIPTION Prescription orders for controlled substances must be dated and signed on the day issued. A prescription must include the following information: Name and address of the patient (street and city) Name, address, and DEA registration number of the practitioner Signature of the practitioner Name and quantity of drug prescribed Directions for use 3

EMERGENCY PRESCRIBING OF SCHEDULE II CONTROLLED SUBSTANCES Adapted from DEA Regulations In the case of a bona fide emergency situation (see definition below), a prescribing practitioner may give verbal authorization to a pharmacist to dispense a Schedule II controlled substance provided that: 1. The quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period (24-72 hours). 2. Prescribing or dispensing beyond the emergency period must be pursuant to a written prescription order. 3. The prescription order shall be immediately reduced to writing by the pharmacist and shall contain all information, except for the prescribing practitioners signature. 4. If the prescribing practitioner is not known to the pharmacist, the pharmacist must make a reasonable effort to determine that the oral authorization came from a practitioner by verifying the practitioners telephone number with that listed in the directory and/or by making other good faith efforts to ensure proper identity. 5. Within 7 days after authorizing an emergency oral prescription order, the prescribing practitioner must cause a written, signed prescription order for emergency quantity prescribed to be delivered to the dispensing pharmacist. The prescription order shall have written on its face Authorization for Emergency Dispensing. The written prescription order may be delivered in person or by mail, but if delivered by mail it must be postmarked within the 7 day period. (Title 21, Code of Federal Regulations, Section 1306.11 (d)) However, Colorado Revised Statute 18-18-414(2)(b) currently allows only 72 hours for the written prescription order to be delivered. On receipt, the dispensing pharmacist shall attach this prescription order to the oral emergency prescription order which had earlier been reduced to writing. The pharmacist shall notify the nearest office of DEA and the Colorado Board of Pharmacy if the prescribing practitioner fails to deliver a written prescription order. Failure of the pharmacist to do so shall void the authority conferred by the subsection to dispense without a written prescription order of a prescribing practitioner. Definition: For the purpose of authorizing an oral prescription order of a controlled substance listed in Schedule II of the Controlled Substances Act, the term emergency situation means those situations in which the prescribing practitioner determines that: Immediate administration of the controlled substance is necessary for the proper medical treatment of the intended user No appropriate alternative treatment is available, including administration of a drug which is not a controlled substance under Schedule II of the Act

It is not reasonably possible for the prescribing practitioner to provide a written prescription order to be presented to the person dispensing the substance prior to dispensing.

When prescribing narcotic analgesics for pain, it is recommended that any deviation from Table A, B, or C in Section B (see pages 21-29) be thoroughly documented in the patient record. RECOMMENDED PRESCRIBING PROCEDURES Adherence to state and federal regulations goes a long way in protecting your practice from becoming a source of drug diversion and prescription drug abuse, but it should not impair or undermine your professional responsibility to provide your patients with prompt and effective pain relief. You can also protect your practice by safeguarding blank prescription pads, prescribing controlled substances judiciously and being on the lookout for patient scams. Forgery is a major cause of drug diversion. Prescriptions are forged on prescription blanks stolen from practitioners offices, hospitals and clinics. Whole pads or single sheets may be stolen. Forgers also alter legitimate prescriptions by changing the refill instructions or quantity to be disbursed or by erasing the name of the drug prescribed and replacing it with a controlled substance. Specific suggestions for preventing diversion and abuse of controlled substances: Perform and document a thorough diagnostic evaluation of the patient to include an assessment for alcohol or drug dependency. (See Section D, page 36 for sample screening checklist.) Prescription pads are extremely valuable and should be treated as a wallet, purse, or checkbook. Do not leave pads in unattended examining rooms, office areas or anywhere they can be easily picked up. Any pads used for controlled substances should be secured and used only as needed. Have prescription blanks numbered consecutively when printed so that you can tell if some sheets are missing. Stock only a minimum number of pads. Keep them in your personal possession when using them. When not in use, store surplus stock in a secured drawer or cabinet where they cannot be easily stolen. Report any prescription pad theft to the local police, the local pharmacy network and the State Board of Pharmacy.

Write complete prescriptions with signature and date of the day of issue. Include the full name and address of the patient, and your name, address, phone number and DEA registration number. Consider writing prescriptions only on your own personalized blanks. If you use hospital blanks, be certain to fill out completely and to include all appropriate information. Make sure your name is legible (print) and include your DEA number. Do not use plain paper for the purpose of writing a prescription. Do not preprint your DEA registration number on your personalized blanks. Have a line present on the blank onto which your DEA number can be written as needed. Indicate the number of units and strength to be dispensed by writing the Arabic or Roman numeral and also spell out the number of units, e.g., 10 ten. Indicate the number or refills for the prescription. If the acceptable number is zero, write zero (0) in the appropriate blank. If there are special considerations for the use of the prescription medication, be sure to indicate this under special instructions. Write prescriptions in ink or indelible pencil to prevent changes. Never sign prescription blanks in advance. Do not use blanks that are preprinted with the name of a proprietary controlled preparation. Write only one controlled substance on a single blank; pharmacist must file prescriptions for Schedule II drugs separately. Do not use your prescription blanks for writing notes or memos that can be erased and the blanks used again. In rare instances when it may be necessary to write a prescription for a patient and pick up the filled prescription for delivery, obtain a receipt from the patient or immediate family and keep it on the patients clinical file for documentation should the need arise. Do not use p.r.n. or as directed alone when writing prescriptions for controlled substances. Always specify directions for administration.

Patiently, personally and promptly respond to all calls from pharmacists to verify prescriptions for controlled substances. A corresponding responsibility rests with the pharmacist who dispenses the prescription order. UNACCEPTABLE PRESCRIBING PROCEDURES

Federal regulations (Title 21, Code of Federal Regulations (CFR) 1300 to end) clearly specify that: Practitioners may not issue a prescription to obtain controlled substances for dispensing to patients; instead, practitioners must use DEA form 222 to obtain Schedule II controlled substances for their office use. If common stocks are used, one practitioner must accept responsibility. Practitioners may not issue prescriptions to dispense narcotic drugs for detoxification or maintenance treatment of a person who is dependent on narcotic drugs unless separately registered with the DEA, FDA and the Colorado Department of Health as a narcotic treatment program. However, a practitioner can administer (but not prescribe) narcotic drugs to a patient daily for up to three days while arrangements are being made for referral to an existing narcotic treatment program. (Title 21, Code of Federal Regulations (CFR) 1306:07 [c]). Practitioners may not telephone a prescription for a Schedule II controlled substance. See Page 4 for Procedures for Emergency Prescribing of Schedule II Controlled Substances.

Colorado has additional laws that further delineate unacceptable prescribing procedures (Colorado Revised Statutes (C.R.S.) 12-36-117): Prescribing, distributing, or giving Schedule II controlled substances to a family member or to oneself except on an emergency basis. Prescribing stimulant drugs (amphetamine or sympathomimetic amine drugs, designated as Schedule II controlled substances), except for the following purposes: - Hyperkinesis/Attention Deficit Disorder in children and adults - Narcolepsy - Organic brain dysfunction - Organic affective disorder - Major depressive disorder and dysthymia - Reduction of side effects caused by opioid analgesics, especially sedation in terminally ill patients or other similarly severe conditions - Approved clinical investigation of the effect of such drugs within a research protocol (See Appendix B)

Prudent practice would discourage the following: Prescribing controlled substances for a patient simply because the patient tells you another practitioner has been prescribing it for him/her. Consult the practitioner or the hospital records, or examine the patient thoroughly and decide for yourself if a controlled drug product should be prescribed. Prescribing cocaine for any purpose. Prescribing any controlled substance for yourself or a family member. (See above for laws regulating Schedule II controlled substances.) Prescribing any controlled substance FOR ANYONE for whom you have no chart in your office.

The following table outlines state and federal limitations on prescriptions for controlled substances. Note that many limitations are more stringent for Schedule II prescriptions.

Prescription Characteristic Limitations Schedule II


Mode of issuing prescription: Written (except in a bona fide emergency)3 None allowed

Schedules III, IV, and V2


Verbal or Written

Refills:

Maximum of five within six months of issuing prescription

Schedule V is an over-the-counter provision of the Federal Act. All Schedule V medications require a prescription in Colorado. 3 The drug prescribed must be limited to the amount needed to treat the patient during the emergency period. Within 7 days, the practitioner must furnish the pharmacy with a written signed prescription for the drug (see page 4, Emergency Prescribing of Schedule II Controlled Substances).

OFFICE PROCEDURES Necessary Records Practitioners must maintain records of all controlled substances received in their offices. Federal regulations require dispensing practitioners to keep records of all narcotic drugs administered or dispensed and of other controlled substances administered or dispensed if the patient is charged for the dispensing service. It is recommended that all controlled substances dispensed from the office by a practitioner be recorded in a log book. Each instance of dispensing may be recorded chronologically in the log book, and each entry should include the following information: Name of drug Dosage form and strength of the substance Quantity dispensed Name and address of the patient (street and city) Date of dispensing Name or initials of the practitioner

Record-keeping requirements are summarized in the following table: Type of Record Schedule II records Schedule III, IV, and V records Federal Requirement Maintain separately from other records Maintain separately or readily retrievable from other records Conduct every two years Two years. Advisable to keep records on an ongoing basis and make available for inspection

Inventory of controlled substances on hand Record-retention requirement

Storage of Controlled Substances Under Federal Law, practitioners must store controlled substances in their offices or clinics in a securely locked, substantially constructed cabinet or safe. Access to the storage area should be kept to a minimum. Any loss or theft of controlled substances or DEA order forms must be reported to the DEA field office, using DEA form 106. Thefts also must be reported to the local police and the Colorado Board of Pharmacy.

THE FOUR DS The American Medical Association outlines four types of practitioners who are sources of drug diversion. If you or a colleague fit one of these categories, it is time to evaluate your practice or consult with one of the organizations on page 14. Dishonest or script doctors, who willfully and knowingly prescribe controlled drugs for purposes of abuse and usually for profit. Disabled or impaired practitioners, whose professional competence has been impaired by drug abuse, alcoholism or other physical or mental disorders. Deceived practitioners, who unwittingly acquiesce to some patients insistent demands for medication. Typically, these practitioners prescribe drugs in larger amounts for longer periods of time than are medically indicated. Dated practitioners, who have not kept pace with developments in pharmacology or drug therapy. These practitioners are poor prescribers, not because they intend to be, but because they lack information or understanding. They may be prescribing excessive amounts of drugs for exceptionally long periods of time, prescribing types of drugs that are not indicated for the condition or prescribing drugs when another type of therapy is indicated. Recently promulgated national guidelines such as the Agency for Health Care Policy and Research demonstrate that what is considered medically indicated is in a state of flux. Studies document that there has been a problem with many prescribers significantly under treating pain, particularly in the case of terminal cancer patients. The under treatment of pain could lead to doctor shopping. This under treatment has been attributed to a number of factors, including ignorance of currently recommended prescribing practices and concerns about regulatory scrutiny. CLUES FOR SCREENING DRUG ABUSERS Current Behavior Must be seen right away, very agitated, found you in the phone book. Makes a late afternoon (often Friday) appointment. Calls or comes in after regular hours. Must have a specific narcotic drug or other controlled substance right away. Gives evasive or vague answers to questions regarding medical history. Reluctant or unwilling to provide reference information. Traveling through town, visiting friends or relatives not a permanent resident. Does not give a primary or referring practitioner. Refuses laboratory tests or specialty evaluations. States that specific non-narcotic analgesics do not work or that they are allergic to them. 10

Presents characteristic types of pain: low back, root canal, migraine headache, abdominal, cysts and abscesses. Lost or stolen prescription needs replacing.

Medical History May admit excessive use of coffee, cigarettes, alcohol, other prescription drugs. May exaggerate medical problems and simulate symptoms. History of frequent trauma, burns or breaks. History of bizarre infections (malaria, tetanus, hepatitis). General debilitation. Social History Repeated automobile accidents and/or drunk driving arrests. Difficulty with employment. Child abuse or severe family problems. Psychological History Mood disturbance. Suicidal thoughts. Lack of impulse control. Sexual dysfunction. Physical Examination Overt debilitation not related to medical problems. Patients complaints out of proportion to physical findings. Unsteady gait. Slurred speech. Inappropriate pupil dilation or constriction. Nystagmus. Unexplained sweating or chills. Inappropriate lapses in conversations. Cutaneous signs of drug abuse: - Skin tracks and related scars on the neck, axilla, forearm, wrist, hand, foot, and ankle. Such marks usually are multiple, hyperpigmented and linear. New lesions may be inflamed. - Pop scars, small raised scars from numerous, subcutaneous injections in the same site. - Abscesses, infections, or ulcerations. These may be infective or chemical reactions to injections.

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ACCEPTABLE AND UNACCEPTABLE INDICATIONS FOR PRESCRIBING CONTROLLED SUBSTANCES Acceptable Clinical Indications Contact the Alcohol and Drug Abuse Division, Colorado Department of Human Services, regarding the state rules and regulations and their interpretations pertaining to the licensing and registration of researchers, analytical laboratories and addiction programs using controlled substances. In instances where the state rules and regulations are more stringent, they take precedence over the federal regulations. A. Federal law prohibits the dispensing or administering of narcotic drugs to narcotic dependent persons for detoxification or maintenance treatment unless the practitioner or clinic is separately registered with the Drug Enforcement Administration to conduct detoxification or maintenance treatment. A practitioner may, however, administer (but not prescribe) narcotic drugs to a person for the purpose of relieving withdrawal symptoms when necessary while arrangements are being made for referral for treatment. Such emergency treatment may be carried out for not more than three days and may not be renewed or extended. (Title 21, Code of Federal Regulations (CFR) 1306.07 [a][b].) B. Narcotic drugs may be administered or dispensed: 1) in a hospital to maintain or detoxify a person as an incidental adjunct to medical or surgical treatment or conditions other than addiction or, 2) to persons with intractable pain in which no relief or cure is possible or none has been found after reasonable efforts (21 CFR 1306.07[c]). C. When methadone is administered for treatment of (narcotic) dependence for more than three weeks, the procedure is no longer considered treatment of the acute withdrawal syndrome (detoxification) but is, rather considered maintenance treatment. Only licensed methadone programs may undertake maintenance or detoxification treatment. This does not preclude the treatment of the patient who is hospitalized for medical conditions other than addiction and who requires temporary maintenance or detoxification treatment during the critical period of his/her stay or whose enrollment in a licensed narcotic treatment program has been verified (see 21 CFR 1306.07[c]; 21 CFR 291.505[f][2]). Hospitals desiring to treat patients for narcotic addiction using methadone must obtain the proper state and federal licenses. If the hospital is not licensed, methadone must be supplied by a licensed program for each administration (it cannot be stored at the hospital). D. Methadone may be used for maintenance treatment only by practitioners who have the necessary training, experience and state/federal licenses, registrations and approvals. E. Schedule II narcotic analgesics (alone or in combination with non-narcotic analgesics) are to be used in cases of acute or chronic pain where non-narcotic analgesics (e.g., acetaminophen, aspirin, non-steroidal anti-inflammatory drugs (NSAIDs)) have a high probability of ineffectiveness. The term of use should not go beyond the period required for diagnosis and treatment of the cause of pain and for 12

recovery from the cause of pain. Treatment of patients with severe chronic pain may include therapeutic doses of Schedule II narcotics over long periods of time or regularly occurring short periods only when the patient does not take more medication than the prescribed amount and the practitioner has the necessary training and experience to properly diagnose and treat patients with chronic pain. (See Section C for a more in-depth discussion of the management of chronic pain.) F. The administration of Schedule II narcotic analgesics is warranted to relieve moderate to severe pain due to such conditions as terminal cancer; postoperative pain; severe pain associated with biliary, renal, or urethral colic; pain of acute myocardial infarction; and preoperative medication in anesthesia. G. Schedules III and IV narcotic combinations are appropriate for the majority of acute pain episodes that are not controlled by the use of acetaminophen, aspirin or NSAIDs. Unacceptable Clinical Indications A. Prescribing amphetamines for the purposes of diet control, increasing work capacity, maintaining wakefulness other than for narcolepsy, to combat the normal fatigue associated with any endeavor, or to chemically induce euphoria (C.R.S. 12-36117[1][p]). (See Appendix B.) B. Prescribing for the professional patient for abuse or resale of controlled substances. (See pages 10-13 for clues to identification of these persons.) C. Prescribing narcotic analgesics on the specific request of the patient who may be feigning a painful condition or unnecessarily maintaining a painful condition. D. Prescribing to comply with coercive tactics including eliciting sympathy or guilt, direct threats of physical or financial harm or the offer of bribes. Using the names of other practitioners, family members or friends are common tactics of drug abusers. E. Prescribing for detoxification or maintenance treatment of non-hospitalized opiate dependent persons. Federal and state law limits these treatments to practitioners with special licenses, registrations and approvals, and limit the narcotic drug to methadone.

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FOR MORE INFORMATION


U.S. Drug Enforcement Administration 115 Inverness Drive East Englewood, CO 80112 (303) 705-7300 DEA registration information (303) 705-7300 Division of Behavioral Health (FKA the Alcohol and Drug Abuse Division Colorado Department of Human Services 3824 West Princeton Circle Denver, CO 80236-3111 (303) 866-7400 Board of Medical Examiners Colorado Division of Registrations 1560 Broadway, Suite 1350 Denver, CO 80202 (303) 894-7690 Board of Nursing Colorado Division of Registrations 1560 Broadway, Suite 1350 Denver, CO 80202 (303) 894-2430 Board of Pharmacy Colorado Division of Registrations 1560 Broadway, Suite 1350 Denver, CO 80202 (303) 894-7800 Board of Dental Examiners Colorado Division of Registrations 1560 Broadway, Suite 1350 Denver, CO 80202 (303) 894-7800 Colorado Dental Association 3690 S. Yosemite St., #100 Denver, CO 80237 (303) 740-6900 www.cdaonline.org Colorado Medical Society 7351 Lowry Blvd. #110 Denver, CO 80230 (720) 859-1001;(800)654-5653 www.cms.org Colorado Society for Osteopathic Medicine 600 S. Cherry St. #510 Denver, CO 80246 (303) 322-1752 www.ColoradoDO.org Colorado Center for Personalized Education for Physicians 7351 Lowry Blvd. #100 Denver, CO 80230 (303) 577-3232 www.cpepdoc.org Colorado Pharmacists Recovery Network 2170 S. Parker Road, Suite 229 Denver, CO 80231 (303) 369-0039 Colorado Physicians Health Program 899 Logan Street, Suite 410 Denver, CO 80203 (303) 860-0122 800-927-0122 www.cphp.org Dentist Peer Assistance Program 2170 S. Parker Road, Suite 229 Denver, CO 80231 (303) 369-0039 866-369-0039 Nurse Peer Health Assistance Program 2170 S. Parker Rd #229 Denver, CO 80231 (303) 369-0039 866-369-0039 www.peerassist.org Peer Assistance Services 2170 S. Parker Road, Suite 229 Denver, CO 80231 (303) 369-0039 866-369-0039 www.peerassist.org Colorado Prescription Drug Abuse Task Force 2170 S. Parker Road, Suite 229 Denver, CO 80231 (303) 369-0039;(866)369-0039

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SECTION B MANAGEMENT OF ACUTE/TRAUMA PAIN Effective management of acute pain associated with traumatic injuries has many benefits for the patient, including earlier mobilization, hastened recovery, shortened hospital stay, reduced medical cost and prevention of chronic pain states. It has been estimated, however, that of the millions of patients experiencing pain secondary to traumatic injuries, over half will have inadequately treated pain due to unrealistic management strategies or under-medication. Though divisions are somewhat artificial, it is useful to divide pain states into acute, convalescing, and chronic periods. The acute phase normally lasts for a few days but depends upon the extent and severity of injuries. Tissues are injured and become inflamed and edematous, and peripheral pain receptors, known as nociceptors, are activated. Ordinarily, pain is at its worst in this phase and requires the most aggressive, frequent and invasive treatment to be effective. In convalescence, tissue healing is well under way as inflammation and edema resolves. Pain gradually lessens, as does the need for analgesics, and the patient resumes daily activities. Chronic pain may ensue if healing is impaired or if abnormal reflex pathways within nerve pathways develop. This discussion focuses principally on the acute phase but these principles apply to convalescence as well; the management of chronic pain is discussed in Section C. The number and complexity of management strategies available to assist in the treatment of acute pain are dependent upon the resources available at local health care facilities. A number of options are listed, roughly in order of their general availability: 1. Opioids and other analgesics (acetaminophen, non-steroidal anti-inflammatory drugs) and adjunctive medications such as antispasmodics, anticonvulsants, antidepressants, and benzodiazepines. These medications may be administered orally or parenterally depending upon the severity of pain, the pain phase and health care resources. Opioids will be discussed in greater depth subsequently. 2. Patient controlled analgesia (PCA): a route of delivery of opioid analgesics that has met with great success. The advantages include patient involvement in their treatment and avoidance of excessively high or low serum levels of medication (avoiding oversedation or under-medication of pain); the overall doses of analgesics tend to be lower with greater patient satisfaction. 3. Epidural administration of opioids and local anesthetics: highly invasive and extremely effective. This technique requires involvement of anesthesiologists or nurse anesthetists and an increased level of monitoring. The degree of pain relief is excellent, oversedation is avoided and the patient can be mobilized. Disadvantages include the level of nursing care required and side effects, including pruritus, nausea and vomiting, urinary retention, hypotension, respiratory depression, local anesthetic toxicity, etc. 15

4. Neural blockage-nerve blocks: extremely effective in relieving pain, but requires a good working knowledge of anatomy and relatively frequent redosing. Another disadvantage is the inability to monitor nerve function once the nerve is blocked. 5. Pain treatment:4 Morphine is best for bone pain. Morphine plus Versed is a good combination for pain control. Benzodiazepines & narcotics work well synergistically. (Benzodiazepines enhance pain relieving quality of the narcotics by relieving apprehension so that narcotics work more effectively.) 6. Physical therapy: Application of hot or cold Elevation Strengthening and range of motion exercises Outpatient exercise Therapeutic massage 7. Cognitive-behavioral interventions: Counseling Relaxation Distraction Imagery Biofeedback Therapeutic massage Opioid analgesics are the cornerstone of management of moderate to severe acute pain. Available in a great range of potency, a preparation is available to address pain of all severity. It is incumbent upon the practitioner to be familiar with a number of available preparations to address all contingencies. In particular, the duration of action of the medications must be understood to avoid over or under-medicating the patient. Used in the short-term, some tolerance develops but rarely does physical dependence or addiction occur. The estimated incidence of addiction is approximately 0.01%. 5 Quite to the contrary, under-medicating the patient out of unfounded concerns for physical dependence may actually lengthen recovery if the patient remains bedridden and inactive secondary to inadequately treated pain. Patients with previous or current substance abuse issues are more complicated to manage, but should never be denied adequate analgesia. (See Section D, page 34.)

4 5

Moore, Ernest E., M.D., FACS New England Journal of Medicine, 1980 Vol. 302, Pg. 123, Addictions Rare in Patients Treated with Narcotics.

16

When considering prescribing an opioid analgesic, it is important to choose: A strong enough agent At frequent enough intervals Titrated to the individuals requirements Because of the wide variation in patient response: Start with a small but reasonable dose If appropriate to the setting, begin with intravenous dosing Increase to an effective dose over a period of time Cues in assessing response: Verbal Physical Physiologic Patient admits or denies adequate pain relief Is the patient: - Relaxing or becoming drowsy - Tearing - Perspiring - Tachycardic - Tachypneic - Hypertensive Diagrams A, B, C, D and E are included to assist the practitioner in assessing the degree of pain and success of therapy. Time-contingent scheduling rather than a PRN regimen is more likely to provide effective pain relief as adequate serum analgesic levels are better maintained. Diagrams A and B compare the time a patient is in a comfort zone for these alternatives. With time-contingent dosing, smaller doses of medication are administered more frequently and on a regular schedule. PRN scheduling is often ineffective as the patient may be reluctant to request treatment until analgesia has worn off. Patients themselves may also harbor unfounded concerns about becoming dependent, denying themselves the advantages of adequate analgesia. Some time elapses before the patient is redosed and achieves pain relief. As prescribed doses of PRN medications are often larger, peak levels may be excessive, overly sedating the patient. In summary, both staff and patient education are key features in successful management of acute pain secondary to traumatic injuries. Establish treatment priorities taking into consideration the extent and severity of injury as well as coexisting illness. Choose appropriate medications administered by the most effective and appropriate route.

17

Dose adequately and at frequent enough intervals, in particular paying attention to initial and subsequent responsiveness. If treatment issues are complex, consider consultation with specialists in pain management. Always convey to the patient compassion, competency, and concern. DIAGRAMS A AND B

DIAGRAM C

0-10 numeric Pain Intensity Scale

0
No Pain

2
Mild Pain

4
Moderate Pain

6
Severe Pain

8
Very Severe

10
Worst Possible

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DIAGRAM D7 PAIN ASSESSMENT GUIDE TELL ME ABOUT YOUR PAIN Words to describe pain Aching Throbbing Stabbing Gnawing Tender Burning Tiring Penetrating Numb Miserable Dull Radiating Crampy Deep Pain in other languages Itami-Japanese Tong-Chinese Dau-Vietnamese Dolor-Spanish Douleur-French Bolno-Russian

Shooting Sharp Exhausting Nagging Unbearable Squeezing Pressure

Intensity (0-10) If 0 is no pain and 10 is the worst pain imaginable, what is your pain now? In the last 24 hours?

Location Where is your pain?

Duration Factors Is the pain always there? Does the pain come & go? (breakthrough pain) Do you have both types of pain?

Aggravating and Alleviating What makes the pain better? What makes the pain worse?

How does pain affect: Sleep Energy - Relationships Appetite Activity - Mood

Are you experiencing any other symptoms? Nausea/Vomiting Itching - Urinary retention Constipation - Sleepiness/Confusion - Weakness

Things to check: Vital signs-Past medical history-Knowledge of pain-Use of non-invasive techniques

Jacox A. Carr DB, Payne R, et al. Management of Cancer Pain. Clinical Practice Guidelines No.9 AHCPR, Publication No. 94-0592, Rockville, MD. Agency for Health Care Policy & Research, U.S. Dept. of Health & Human Svcs., Public Health Svc., March 1994- Wong, D & Whaley, L: Clinical Handbook of Pediatric Nursing, ed.2, The C.V. Mosby Co., St. Louis, 1986, p. 373. Copyright 1996, Regina Fink at Univ. of CO Health Sciences Ctr. Supported by an educational grant from Anesta Corp. Reprinted with permission.

19

DIAGRAM E8 PAIN ASSESSMENT


PATIENT: DOCTOR: DATE: Pain Severity: Remarks: Where is the pain located? (Indicate on illustration I/Internal, E/External) 1 2 3 4 5 6 7 8 9 10

How long have you had the pain? Describe any patterns or changes:

C on st an t

Int er mit ten t

What relieves the pain?

What increases the pain?

How does the pain affect your: S le e p App etite Physical activity

Reprinted with permission from Janssen Pharmaceutical Research Fndt. Medical Doctors & Designers USA, Inc., 1994.JPI-DR-070-R.

20

Concentr ation Emoti ons Social relationships Current analgesic regimen:

21

TABLE A ORAL AND TRANSDERMAL NARCOTIC ANALGESICS FOR MANAGEMENT OF ACUTE AND CHRONIC PAIN IN ADULTS1 Prepared by Charles Sintek, R.Ph., M.S., BCPS
Drug Morphine Morphine controlledrelease (MS Contin, Oramorph SR, Kadian) Hydromorphone (Dilaudid) Levorphanol tartrate (Levo-Dromaran) Methadone (Dolophine) CII Available Strengths 15, 30 mg 15, 30, 60, 100, 200 mg Common Quantity for Prescribing Acute Pain 3-7 day supply NR3 Chronic Pain 15-30 day supply Common oral starting dose for moderate to severe pain2 Acute Pain Chronic Pain 15 mg q 3-4 hr 15 mg q 3-4 hr Comments For severe pain. For severe pain. Kadian is administered once or twice a day. Other controlled-release morphine products are usually dosed bid to tid. For severe pain. For severe pain. Average plasma half-life is 12-16 hr. Usual duration of analgesia is 6-8 hr. For severe pain. Average plasma half-life 24-36 hr, accumulates with repeated dosing. Duration of analgesia ranges 6-12 hr. For severe pain. Not recommended for chronic pain due to short duration of action. Toxic metabolite. For severe pain. Some patients may require q 48 hr changes in patch.

CII

15-30 day supply

NR

30-60 mg q 12 hr

CII CII

2,4,8 mg 2 mg

3-7 day supply NR

15-30 day supply 15-30 day supply

2 mg q 3-4 hr NR

2 mg q 3-4 hr 2 mg q 6-8 hr

CII

5,10 mg

NR

15-30 day supply

NR

5 mg q 6-8 hr

Meperdine (Demerol) Fentanyl Transdermal Patch (Duragesic)

CII

50, 100 mg

3-7 day supply

15-30 day supply

50 mg q 3 hr

NR

CII

25, 50, 75 100 mcg

NR

15-30 day supply

NR

25 mcg patch applied q 72 hr

1 2

Adults with weight 50 kg. Always consult manufacturers prescribing information for latest dosing recommendations before p rescribing opioids. Upper limit of dosing for chronic severe pain is determined by response. It is inappropriate to arbitrarily assign an upper limit on dosage when medication is carefully titrat5red to response or unacceptable side effects. 3 NR Not recommended. Short acting opioids are poor choices in management of chronic severe pain except for treatment of breakthrough pain not controlled by long acting opioids.

22

Oxycodone & Combinations (Tylox, CII Percodan, Percocet, Roxicodone) Oxycodone controlledCII release (OxyContin) Hydrocodone combinations (Vicodin, Lorcet, Lortab) CIII Tramadol (Ultram) CIII Codeine combinations (Tylenol with codeine, Empirin with codeine) CIII Propoxyphene & combinations (Darvon, Darvon Compound) CIV Propoxyphene napsylate combinations (Darvocet) CIV

5 mg

3-7 day supply

15-30 day supply

5 mg q 3-4 hr

5 mg q 3-4 hr

For moderate/severe pain.

10, 20, 40 mg 2.5, 5, 7.5, 10 mg

NR 3-7 day supply

15-30 day supply 15-30 day supply

NR 5 mg q 3-4 hr

10 mg q 12 hr 5 mg q 3-4 hr

For severe pain. For moderate/severe pain. For moderate/severe pain. 100 mg q 6 hr is maximum dose. Not classified as a controlled substance. For moderate pain. For moderate pain. Toxic metabolite with long half-life.

50 mg

3-7 day supply

15-30 day supply

50 mg q 6 hr

50 mg q 6 hr

15, 30, 60 mg 65 mg

3-7 day supply 3-7 day supply

15-30 day supply 15-30 day supply

30 mg q 3-4 hr 65 mg q 4-6 hr

30 mg q 3-4 hr 65 mg 4-6 hr

100 mg

3-7 day supply

15-30 day supply

100 mg q 4-6 hr

100 mg q 4-6 hr

For moderate pain. Toxic metabolite with long half-life.

When prescribing opioids, prescribers should individualize dose.

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TABLE A-1 COST OF ANALGESICS Prepared by Charles Sintek, R.Ph., M.S., BCPS
BRAND NAME MS Contin MS Contin MS Contin MS Contin MS Contin Oramorph SR Oramorph SR Oramorph SR Oramorph SR Kadian Kadian Kadian Morphine IR Morphine IR Dilaudid Dilaudid Dilaudid Dolophine Dolophine Demerol Demerol Duragesic transdermal Duragesic transdermal STRENGTH 15 mg 30 mg 60 mg 100 mg 200 mg 15 mg 30 mg 60 mg 100 mg 20 mg 50 mg 100 mg 15 mg 30 mg 2 mg 4 mg 8 mg 5 mg 10 mg 50 mg 100 mg 25 mcg 50 mcg COST $94.88 $180.33 $351.85 $520.94 $954.01 $87.44 $174.67 $298.24 $456.74 $501.51 $167.92 $298.34 NA NA $55.46 $84.32 $130.32 $9.86 $16.01 $78.38 $149.10 $56.04 $84.02 UNIT 100 100 100 100 100 100 100 100 100 500 60 60 NA NA 100 100 100 100 100 100 100 5 5 GENERIC NAME morphine CR morphine CR morphine CR morphine CR morphine CR morphine CR morphine CR morphine CR morphine CR morphine CR morphine CR morphine CR morphine IR morphine IR hydromorphone hydromorphone hydromorphone methadone methadone meperidine meperidine fentanyl fentanyl SOURCE NA NA NA NA NA NA NA NA NA NA NA NA Roxane Roxane Roxane Roxane NA Roxane Roxane Roxane Roxane NA NA COST NA NA NA NA NA NA NA NA NA NA NA NA $26.12 $44.34 $32.03 $49.07 NA $8.45 $14.04 $68.63 $130.55 NA NA UNIT NA NA NA NA NA NA NA NA NA NA NA NA 100 100 100 100 NA 100 100 100 100 NA NA

24

Duragesic transdermal Duragesic transdermal Tylox Percocet Percodan Roxicodone OxyContin OxyContin OxyContin OxyContin Vicodin Vicodin ES Lorcet HD Lorcet Plus Lorcet 10/650 Lortab 2.5/500 Lortab 5/500 Lortab 7.5/500 Lortab 10/500 Lortab ASA 5/500 Ultram Tylenol/codeine #2 Tylenol/codeine #3 Tylenol/codeine #4 Aspirin/codeine Aspirin/codeine

75 mcg 100 mcg 5/500 5/325 5/325 5 mg 10 mg 20 mg 40 mg 80 mg 5/500 7.5/750 5/500 7.5/650 10/650 2.5/500 5/500 7.5/500 10/500 5/500 50 mg 15 mg 30 mg 60 mg 30 mg 60 mg

$134.62 $167.72 $80.45 $69.90 $72.30 $42.49 $113.69 $217.59 $386.08 $726.01 $44.83 $49.43 $34.01 $63.47 $95.04 $53.99 $44.87 $47.41 $62.67 $67.86 $67.96 $31.20 $33.91 $59.92 NA NA

5 5 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 NA NA

fentanyl fentanyl oxycodone/APAP oxycodone/APAP oxycodone/ASA oxycodone oxycodone CR oxycodone CR oxycodone CR oxycodone CR hydrocodone/APAP hydrocodone/APAP hydrocodone/APAP hydrocodone/APAP hydrocodone/APAP hydrocodone/APAP hydrocodone/APAP hydrocodone/APAP hydrocodone/APAP hydrocodone/ASA tramadol codeine/APAP codeine/APAP codeine/APAP codeine/ASA codeine/ASA

NA NA Schein Schein Parmed NA NA NA NA NA Qualitest Qualitest Qualitest Qualitest Qualitest Qualitest Qualitest Qualitest Watson NA NA Qualitest Qualitest Qualitest Qualitest Qualitest

NA NA $54.38 $25.69 $18.95 NA NA NA NA NA $28.05 $34.40 $28.05 $34.25 $50.72 $30.30 $28.05 $33.80 $49.24 NA NA $7.56 $8.96 $17.70 $13.09 $18.40

NA NA 100 100 100 NA NA NA NA NA 100 100 100 100 100 100 100 100 100 NA NA 100 100 100 100 100

25

Darvon Darvon-N Darvon Compound- 65 Darvocet-N 50 Darvocet-N 100


Costs subject to change

65 mg 100 mg 65/389/32 50/325 100/650

$39.73 $57.79 $41.59 $33.78 $63.73

100 100 100 100 100

propoxyphene HCI propoxyphene N propoxyphene/CAF/ASA propoxyphene N/APAP propoxyphene N/APAP

Qualitest NA Schein NA Qualitest

$6.61 NA $25.00 NA $33.74

100 NA 100 NA 100

AWPavg. wholesale price APAPacetaminophen ASAaspirin

CAFcaffeine NAnot applicable Nnapsylate

CRcontrolled release IRimmediate release

26

TABLE B RECOMMENDATIONS FOR SEVERE ACUTE PAIN AND MINOR PROCEDURES1 LOCAL ANESTHETIC AGENTS 1% Lidocaine = 10 mg/ml 1% Lidocaine with epinephrine (1:100,000) = 10 mg/ml 2% Lidocaine = 20 mg/ml 2% Lidocaine with epinephrine (1:100,000) = 20 mg/ml Maximum dose: 4.5 mg/kg (without epi.) per package inserts 7 mg/kg (with epi.) .25% Bupivacaine (Marcaine) = 2.5 mg/ml Maximum dose: 2 mg/kg The relative effectiveness of combining Marcaine with Lidocaine remains controversial at this time. Toxicities of a combination of local anesthetics may be additive. Local anesthetic toxicity is caused by overdose or intravascular injection of the anesthetic. Toxicity involves the cardiovascular and central nervous systems. The CNS is usually affected first. CNS Reactions Lightheadedness, tinnitus, perioral numbness, confusion Muscle twitching, auditory and visual hallucinations Tonic-clonic seizure, unconsciousness, respiratory arrest Cardiac Reactions Hypertension, tachycardia Hypotension Sinus bradycardia, ventricular dysrhythmias, circulatory arrest Management of Local Anesthetic Emergencies Any change in the patients state of consciousness: administer oxygen For convulsions: maintain airway; evaluate and support circulation; IV Valium if circulatory status permits Circulatory depression: IV fluids; vasopressors if warranted TABLE C

Moore, Ernest E., M.D., FACS.

27

PARENTERAL PAIN RELIEF AND SEDATION IN ADULTS* Prepared by Charles Sintek, R.Ph., M.S., BCPS OPOIDS
Morphine DOSAGE, ADMINISTRATION & ACTION Usual IV dose: 2-5 mg IV over 5 min, may repeat with 2-5 mg q 5 min., then 2-5 mg IV q 2-4 hr. For geriatric patients: 1-2 mg IV over 5 minutes may repeat with 0.5-2 mg q 5 min., then 0.5-2 mg q 2-4 hr. 1-4 mg/hr IV continuous infusion. Average IM dose: 10-12 mg q 3-6 hr. IV onset: 1-3 min. peak effect: 20 min. Duration of action: 4-5 hr IM, 2-4 hr IV. Fentanyl 10-20 mcg IM/IV push is approximately equal to 1 mg of morphine. Initial dose: 25-50 mcg IV over 1-2 min, may repeat with 25 mcg q 5 min. For geriatric patients: 25 mcg IV over 1-2 minutes, may repeat with 12.5-25 mcg q 5 min. Usual dose range: 25-150 mcg IV over 1-2 min, up to 2 mcg/kg if used alone, 0.5-1 mcg/kg if used in combination with other agents. Maintenance dose usually 25% of initial dose, 25-100 mcg/hr IV continuous infusion. 25-100 mcg/hr intermittent IV push. High normal dose range: 3 mcg/kg/hr IV. Doses in the range of 100-500 mcg/hr may be required to maintain adequate sedation for patients who are tolerant to opioids and other sedating agents. IV onset of action: 1-3 min, analgesic peak action: 2-5 min, peak respiratory effect: 5-15 min. Average IM dose: 75-100 mcg q 3-4 hr. Duration of action: 1-2 hr IM, 30-60 min IV. Meperidine 75 mg SC/IM/IV is equivalent to 10 mg morphine. Usual dose range: 12.5-50 mg (0.5-1 mg/kg) IV over 1-2 min, may repeat with 10-15 mg q 5-10 min to q 1 hr. Maximum Single dose: 150 mg. Maximum daily dose: 600 mg. 10-50 mg/hr IV continuous infusion. High normal dose range: 2 mg/kg IV. IV onset of action: 1-5 min, peak effect: 5-15 min. Average IM dose: 75-100 mg q 3-6 hr. Duration of action: 3-5 hr IM, 2-4 hr IV. Hydromorphine 1.5 mg SC/IM/IV is equivalent to 10 mg morphine. Usual starting dose: 0.5-1 mg IM/IV push over 1-2 min for opioid nave patients. Higher doses may be necessary for opioid tolerant patients. IV onset of action: 10-15 min, peak effect: 15-30 min. Average IM dose: 1.5-2 mg q 3-6 hr. Duration of action: 4-5 hr IM, 2-3 hr IV. COMMENTS/PRECAUTIONS ANTAGONIST IS NALOXONE. All opioids potentiate the effects of benzodiazepines and other CNS depressants. Adverse effects include respiratory depression, apnea, myoclonus, bradycardia, and hypotension. Active metabolite, morphine 6-glucuronide, accumulates in renal impairment and can lead to prolonged sedation. May cause GI upset and vomiting, especially if given too fast IV push. ANTAGONIST IS NALOXONE. All opioids potentiate the effects of benzodiazepines and other CNS depressants. Causes less histamine release than morphine. Too rapid IV administration can cause skeletal muscle and chest wall rigidity and apnea. Respiratory depression may last longer than sedation. May cause nausea, vomiting, drowsiness, and dizziness. Avoid use in severe COPD or in patients who have used a MAO inhibitor within 14 days. Lower doses may be necessary in opioid-naive patients, the elderly, and patient receiving other CNS depressants.

Fentanyl (Sublimaze)

Meperidine (Demerol)

ANTAGONIST IS NALOXONE. All opioids potentiate the effects of benzodiazepines and other CNS depressants. Adverse effects include respiratory depression, apnea, bradycardia, hypotension, ataxia, nervousness, nausea, and vomiting. Do not use in patients taking monoamine oxidase inhibitors within 14 days. Normeperidine, a metabolite, accumulates in hepatic or renal impairment and can cause tremors, muscle twitches, hyperactive reflexes, and seizures. Avoid meperidine in patients with renal impairment. ANTAGONIST IS NALOXONE. All opioids potentiate the effects of benzodiazepines and other CNS depressants. Adverse effects include respiratory depression, apnea, bradycardia, and hypotension. High doses of hydromorphone may produce myoclonus (muscle twitching) but to a lesser extent than morphine.

Hydromorphone (Dilaudid)

28

BENZODIAZEPINES
Diazepam (Valium)

DOSAGE, ADMINISTRATION & ACTION Initially: 2-5 mg IM/IV push via a large vein over 1 min, may repeat with 2-5 mg IV q 5 min to desired sedation effect such as slurred speech. For geriatric patients: 2 mg IM/IV over 3 minutes, may repeat 1 mg IV q 5 min. Usual dose range: 2-10 mg IM/IV, not to exceed 5 mg/min. IV. Maximum of 0.1-0.2 mg/kg or 10 mg over 1 hr. High normal dose range: 30 mg. IV onset of action: 1-5 min, peak action: 5-30 min, duration of action: 2-6 hr. Elimination half-life: 20-40 hr. Hepatically metabolized.

Lorazepam (Ativan)

Initially: 0.5-2 mg (0.05 mg/kg) IM/IV over 2 min, may repeat one-half the initial IV dose q 10-15 min. IV doses of 0.05 mg/kg or 2 mg (whichever is smaller) will sedate most adults. Higher does of 2-6 mg may be necessary for patients who are tolerant to benzodiazepines or opioids, or highly anxious patients. Maximum dose: 2 mg IV, 4 mg IM. Up to 0.06 mg/kg/hr IV continuous infusion. IV onset of action: 20-40 min, peak action: unknown, duration of action: 8 hr. Elimination half-life: 10-20 hr. Hepatically metabolized. Initially: 0.5-2 mg IM/IV over 2-3 min, titrate to slurred speech, may repeat 0.5-1 mg IV q 2-5 min. Wait at least 2 minutes between doses. No more than 2.5 mg IV over 2 minutes. Usual total dose range: 2.5-5 mg. For geriatric patients: 0.5-1 mg IM/IV over 2-3 minutes, may repeat with half the initial dose IV q 2-5 min. No more than 1 mg IV over 2 min. Sedation usually maintained with 25% of total dose used to achieve sedation. Higher doses may be needed in patients who are tolerant to opioids or benzodiazepines. IV continuous infusion of 1-2 mcg/kg/min with range of 0.4-6 mcg/kg/min. IV onset of action: 1-5 min, peak action: within 5 min. duration of action: 30 min-6 hr. Elimination half-life: 1-4 hr. Hepatically metabolized.

COMMENTS/PRECAUTIONS ANTAGONIST IS FLUMAZENIL. Adverse effects include respiratory depression, drowsiness, confusion, and hypotension. Use lower doses in combination with opioids or other CNS depressants. Active metabolites can accumulate during prolonged use. Increased duration of action can cause prolonged sedation, especially in elderly or renal or hepatic failure. Not recommended for outpatients because extended observation may be required. May cause burning or phlebitis when administered through a small peripheral IV line. Do not administer in same line with other medication. ANTAGONIST IF FLUMAZENIL. Adverse effects include respiratory depression, drowsiness, confusion, and hypotension. Use lower doses in combination with opioids or other CNS depressants. Must be diluted prior to IV administration. May cause burning or phlebitis when administered through a peripheral IV line. Preferred over diazepam for patients with hepatic or renal impairment. Reduced doses may be indicated in elderly or debilitated patients because they may be more susceptible to adverse effects. ANTAGONIST IS FLUMAZENIL. Two to four times as potent as diazepam. Use lower doses in combination with opioids or other CNS depressants. Adverse effects include respiratory depression, respiratory muscle rigidity, decreased hypoxic and hypercapnic drive, bradycardia, hypotension, drowsiness, amnesia, dizziness, nausea, and vomiting. Reduce dosage if used in combination with opioids. Rapid injections may cause respiratory depression. Decreased clearance with cimetidine and erythromycin.

Midazolam (Versed)

29

MISCELLANEOUS
Naloxone (Narcan)

DOSAGE, ADMINISTRATION & ACTION Partial reversal: 0.1-0.2 mg IV push at 2-3 minute intervals until effect. Full reversal: 0.4 mg IV push. Opioid overdoses: 2 mg IV push initial dose. Usual dose range: 0.1-2 mg IV over 15 seconds. High normal dose range: 10 mg IV. Onset of effect: within 2 min. Duration of effect: 20-60 min. Elimination half-life: 1-1.5 hr.

Reversal of conscious sedation: initial dose of 0.2 mg IV over 15 sec. After 45 sec. Repeat 0.2 mg. Repeat 0.2 mg IV each minute up to 1 mg. Give no more than 3 mg/hr. Usual dose range: 0.2-0.5 mg IV. High normal dose range: 1 mg IV. Onset of effect: 1-3 min. Maximum effect: 6-10 min. Duration of effect: 30-60 min. Elimination half-life: 0.6-1.3 hr. *ALWAYS CONSULT MANUFACTURERS PRESCRIBING INFORMATION FOR LATEST DOSING RECOMMENDATIONS BEFORE PRESCRIBING OPIOIDS

Flumazenil (Romazicon) Slang name: Reversed

COMMENTS/PRECAUTIONS OPIOID ANTAGONIST. Observe patient for renarcotization for a minimum of 2 hours since duration of action of opioids may exceed that of naloxone. Higher doses may be needed with fentanyl. Use with caution in opioid dependent/addicted patients - may need to titrate dose to avoid excessive reduction in analgesia. Adverse effect include excitation, hypotension, hypertension, pulmonary edema, ventricular tachycardia, ventricular fibrillation. Naloxone should not be administered to patients receiving chronic administration of meperidine as it may precipitate seizures in such patients by eliminating the effects of meperidine and allowing the convulsant effects of its metabolite, normeperidine, to predominate. BENZODIAZEPINE ANTAGONIST. Primary adverse effects are hypoventilation, benzodiazepine withdrawal and seizures. Half-life is half that of midazolam or diazepam. Monitor at least 2 hours for resedation. Complete reversal of respiratory depressant effects may not occur even if sedative effect is reversed.

30

SECTION C MANAGEMENT OF CHRONIC PAIN Definition of Intractable Pain California, Florida, Missouri, North Dakota, Oregon and Texas have statutory definitions for intractable pain. The statutory definitions are fairly consistent among the states with the most comprehensive being Californias: Consistent non-cancer intractable pain is a pain state in which the cause of pain cannot be removed or otherwise treated and which in the generally accepted course of medical practice no relief or cure of the cause of the pain is possible or none has been found after reasonable efforts including, but not limited to, evaluation by the attending practitioner and surgeon and one or more practitioners specializing in the treatment of the area, or organ of the body perceived as the source of the pain.10 Long-held medical beliefs and regulatory traditions have rejected the use of opioids for chronic non-cancer pain. These are now undergoing reassessment in light of new knowledge, recent clinical experience and the public attention being given to better pain management. The ultimate goal of a balanced public policy should be to harmonize medical and drug regulation with clinical practice so that practitioners are free to use opioid treatment according to good medical judgment. Although all people have a right to be pain free, the appropriate use of a range of therapeutic options, including nonpharmacologic treatments, opioids and other drugs, depends on careful evaluation and monitoring of results by knowledgeable professionals supported by regulatory policy and practice. The Colorado Board of Medical Examiners Guidelines for Prescribing Controlled Substances for Intractable Pain states that the prescribing of opioid analgesics for patients with intractable non-cancer pain may also be beneficial, especially when efforts to remove the cause of pain or to treat it with other modalities have been unsuccessful. Practitioners who prescribe opioids for intractable pain should not fear disciplinary action from any enforcement of regulatory agency in Colorado if they use sound clinical judgment and care for their patients according to the following principles of responsible professional practice. CRS 12-36-117 states: (1.5)(a): A physician shall not be subject to disciplinary action by the Board solely for prescribing controlled substances for the relief of intractable pain.

10

Lorraine Dixon Jones, Research Associate, CO Legislative Council Staff Report: Legislation Concerning Intractable Pain in Colorado and Other States 1996, p.2.

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Drug Selection Morphine is the prototype of the opioid agonists, all of which have qualitatively similar actions on the central nervous system. The relative usefulness of the morphine-like opioid analgesic is determined by the type and severity of pain, the onset and duration of action by different routes of administration and the severity of adverse reactions. When analgesics are indicated for mild to moderate pain, adequate relief usually can be attained initially with a non-opioid (e.g., acetaminophen, aspirin, or a non-steroidal antiinflammatory drug [NSAID] such as ibuprofen). If pain is not controlled by one of these drugs, concurrent use of an opioid may be appropriate. Prolonged opioid use may be appropriate in patients with disabling, continuous pain for which non-opioid therapies, such as: Analgesic-antipyretics NSAIDs Antidepressants Nerve stimulation Physical therapy Steroid infiltration

have been documented to be inadequate. Various guidelines have been developed to minimize problems inherent in long-term opioid administration. Generally, these involve: Adequate documentation of opioid need Informed consent after explanation of the problems of long-term opioid use (including the risk of physical dependence in a neonate if a female patient is of childbearing age) Monthly evaluation of the patient

The availability of several analgesics in each category, including those with strong or potent or weak or mild activity, as well as those with agonist-antagonist properties, permits considerable latitude in the selection of an agent for a specific situation. Usually, therapy is initiated with a weaker opioid plus a salicylate or acetaminophen. Care should be taken to assure that the opioid preparation is not being used primarily to relieve anxiety or depression. Patients should be advised to avoid alcoholic beverages. Drugs with additive side effects (e.g., benzodiazepines or sedative-hypnotic drugs) should be used cautiously. Tricyclic antidepressants may be useful as an adjunct to opioids. Analgesic action is independent of their antidepressant activity. They must be taken regularly for full benefit. Administration at bedtime takes advantage of their sedative side effects; however, their anticholinergic activity may exacerbate the constipating effect of the opioids.

32

Other drug: Phenothiazines Anticonvulsants Antihistamines Amphetamine11 Corticosteroids

occasionally may be effective. Nitrous oxide 25% to 75% in oxygen, administered by a non-rebreathing face mask, may be useful for short periods to manage acute procedurerelated or movement-precipitated pain (incident pain). Palliative radiation therapy, chemotherapy or hormonal therapy, if appropriate, should be instituted before pain becomes difficult to control. Some patients may benefit from a referral to a pain clinic where multidisciplinary attention is available.12 Administration The oral route is preferred and is usually adequate if adjusted appropriately. Parenteral administration is required only if: Severe pain requires rapid relief There is persistent nausea and vomiting The patient cannot swallow medication Suppositories are impractical

Parenteral medication does not necessarily provide greater analgesia than the oral route, but it may if there are gastric absorption problems. The intramuscular and subcutaneous routes are preferred to the intravenous route because they reduce the bolus effect observed with intermittent intravenous administration. These routes may be unsatisfactory in: Patients with diminished muscle mass Children The terminally ill

Intermittent intravenous dosing by catheter also may be effective in some patients. Repeated parenteral administration may result in a prominent bolus effect (side effects at peak concentration and/or pain breakthrough at the trough). (See Diagrams A & B in Section B, page 18.) If administration is required at intervals of two hours or less, continuous intravenous administration with a flow-calibrated infusion pump can be considered.

11

Please review the CO Board of Medical Examiners Rules regarding the use of Amphetamines (see Appendix B). 12 Refer to the American Medical Assoc iations Drug Evaluations. Current Edition for references.

33

Schedule and Dose Analgesics should be administered on a fixed schedule rather than as needed when treating chronic pain. (See Diagrams A & B in Section B, page 18.) Dosage requirements should be reviewed frequently. Increasing the dose usually is preferable to increasing the frequency of administration. Results of trials using self administration indicate that many patients take less medication when self-administered. Pain Associated with Specific Conditions Neuropathic (deafferentation) pain may follow injury to sensory nerves caused by compression, surgery, viral infections (e.g., herpes zoster) or neoplastic disease. It is characterized by burning or shooting pain. Neuropathic pain usually responds poorly to opioid analgesics, but it may be relieved by selected antidepressants, anticonvulsants and other agents. Chronic pain associated with neoplastic disease requires special consideration. primary concern is maintenance of the patients comfort and non -medical aspects: Physical Social Mental Spiritual A

The drug regimen should be changed as required to obtain relief. Non-opioids for mild to moderate pain are particularly useful in metastatic bone disease. Non-opioids and opioids may be given concomitantly due to additive effects. Agonist-antagonists (e.g., Talwin Nx) with or without a non-opioid are of limited value in neoplastic disease because of their unacceptable psychotomimetic effects. In addition, the agonistantagonists may precipitate withdrawal symptoms in opioid-dependent patients. A wash-out period may be necessary before they can be used. These drugs probably also possess a ceiling effect for analgesic activity. Tolerance and Dependence Tolerance usually is expressed initially as a decrease in the duration of action. Dosage requirements also may increase because of progression of the disease. In any case, crosstolerance is not complete. When the need for larger doses becomes difficult to manage because of worsening adverse effects, cost, or excessive number of dose units required, it is reasonable to substitute another opioid. Iatrogenic psychological dependence should not be a concern when treating chronic pain and must never be a reason to withhold analgesics from any patient who may benefit from them.

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SECTION D PAIN MANAGEMENT FOR THE RECOVERING OR SUBSTANCE ABUSING PATIENT Concerns about addiction are common among both patients and practitioners when there exists a need for long-term pain relief with opioids. These fears take on a unique connotation when the involved patient actively abuses drugs, alcohol or is a recovering addict. When these patients require relief of chronic pain, appropriate management can be a challenge for medical and nursing personnel. Negative attitudes on the part of the health care professionals caring for the addicted patient may be prevalent.13 The staff may blame the patient for the condition (e.g., drug abuse related AIDS), they may have personal, negative experiences with drug abuse (e.g., an addicted family member) or they may perceive that the patient is not in pain and is instead using the health care system or its personnel to obtain drugs. (See pages 1 011.) While these attitudes cannot easily be dispelled, an understanding of the nature of addiction and the use of guidelines and objective measures of pain relief and medication use can help ensure patients are treated fairly and appropriately regardless of their drug status. The need for pain relief with opioids in the patient who is recovering from an addiction is best handled by a multidisciplinary team. Opioid craving and relapse can be triggered by pain, exposure to opioids or inadequate treatment of pain.14 The fear and stress that accompany a diagnosis of cancer or other significant disease process with accompanying pain and the existence of pain may be magnified by the fear of losing hard-won sobriety. Inclusion of addiction specialists in the treatment planning and increased use of recovery activities (e.g., 12-step program, counseling) can provide necessary support to these patients during episodes of pain.

13

McCaffery M. Vourakis C. Assessment and Relief of Pain in Chemically Dependent Patients. Orthopaedic Nursing. 1992, 11(2):13-26. 14 Wesson D. Ling W., Smith D. Prescription of Opioids for Treatment of Pain in Patients with Addictive Disease. J Pain Symptom Manage. 1993;8:289-296.

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Selected Pain Relief Strategies in the Active or Recovering Drug Addict 15,16 Establish a multidisciplinary treatment team as early as possible once addiction is suspected or acknowledged, including an addictionologist. (See page 39.) Work from a written treatment plan negotiated with the patient; follow the plan consistently. Assign one practitioner to prescribe all psychotropic medications; have written rules regarding prescription renewals and dealing with lost medications. Discuss expectations and define limits of acceptable and unacceptable behavior. Be aware that drug addicted or recovering patients may develop tolerance quickly and need larger doses at more frequent intervals to achieve pain relief. Keep the patient informed about what drugs are being used, the doses, the administration intervals and when changes are anticipated in drug, dose or route of administration. Avoid the use of placebos. Use meperidine cautiously. With repeated doses, toxic metabolites may accumulate, particularly in patients with renal or hepatic impairment.17 Avoid the use of opioid agonist-antagonists (e.g., pentazocine, butorphanol, nalbuphine) and antagonists (e.g. naloxone) as these drugs will produce withdrawal. Consider the use of non-opioid analgesics and non-pharmacologic pain relief strategies as adjuvants to opioid treatment. Consider the use of detox services at the completion of pain treatment if indicated.

15,16

Bennett GJ, Neuropathic Pain. In: Wall PD, Melzack R, eds. Textbook of Pain 3 rd ed. London: Churchill Livingstone, 1994:201-224. Jacox A. Carr DB, Payne R, et al. Management of Cancer Pain. Clinical Practice Guidelines No. 9, AHCPR Publication No. 94-0592, Rockville MD: Agency for Health Care Policy & Research, Public Health Svc., U.S. Dept. of Health & Human Services., March, 1994. 17 AHFS, 1997. Drug Information. Published by authority of the Board of Directors of the American Society of Health-System Pharmacists.

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The cornerstone of determining the team to care for the patient will be based upon the assessment. The following screening tool, the CAGE (Cut, Annoyed, Guilty, Eye) test was developed by John A. Ewing, M.D. It has proven to be particularly reliable in detecting alcoholism or substance abuse. 1. Have you ever felt you ought to cut down on your drinking or drug use? 2. Have people annoyed you by criticizing your drinking or drug use? 3. Have you ever felt bad or guilty about your drinking or drug use? 4. Have you ever had a drink first thing in the morning an eye opener to steady your nerves? Or, have you ever taken a different drug to counteract or enhance the effects of a drug previously taken? Answering yes to two questions is a strong indication of alcoholism or drug abuse. Answering yes to three questions compels complete evaluation. Be sensitive to gender and ethnic specific responses. A more in depth evaluation should include the following Risk of Addiction Screening Tool: 1. If you drink, how many drinks do you have on a typical day?
If less than 5 for men/ less than 4 for women, then ask If 5 or more for men/ 4 or more for women, then

Use caution when prescribing opioids

2. Have you used marijuana or hashish in the last year?


If NO, then ask If YES, then

Use caution when prescribing opioids

3. Do you currently smoke cigarettes?


If YES, then ask If NO, then Probably low opioid abuse risk

4. What is your age?


If under 40, then ask If 40 or over, then Probably low opioid abuse risk

5. Have you ever had a friend with a drug problem?


If NO, unless clinical judgments/intuition suggest false reporting, probably low opioid abuse risk If YES, then

Use caution when prescribing opioids

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Does patient have a history of or is he/she currently experiencing problems with: Alcohol Illicit drugs Prescription drugs and/or a combination of the above

Request information about frequency, last usage and history of care or treatment. Is patients health care provider available for consultation? Be aware that many individuals experiencing substance abuse problems understate both the frequency and amount of use. Questions about Prescription Drug Use The following list of questions may assist the practitioner and the patient to further evaluate problems with prescription drugs. The questions refer to mood-altering drugs (uppers and downers), sedatives (sleeping pills), tranquilizers (for nerves or anxiety), stimulants (diet pills) and any other medications that relax or stimulate you: Have you been taking sleeping pills every day for more than three months? Do you visit several doctors/clinics to get the same prescription? Do you sometimes feel the need to take pills in order to make life more bearable? Have you tried to stop taking pills and felt your body start to tremble and shake? Have you tried to stop taking pills and felt very vulnerable or frightened? Do you continue to take pills even though the medical reason for taking them is no longer present? Do you think your pills are more important than family and friends? Are you mixing pills, with wine, wine coolers, beer or liquor? When your doctor gives you a prescription, do you avoid telling him/her what other medications you are taking? Do you take prescriptions from your doctor without knowing what they are for? Are you taking one kind of pill to combat the effects of another pill? Do you take pills to get high and to have fun? Do you take pills that have been prescribed for family members or friends? 38

When you visit the doctor, do you feel happy if he/she writes you a prescription for pills that change your mood? Do you find it difficult to go to work or to fulfill work obligations when you are taking pills? Do you take more than the recommended amount of a prescribed drug? Do you take pills to combat loneliness? Do you take them to cope with the feeling that you cannot possibly do everything that is expected of you? Are you taking more pills to achieve the same effect you used to experience with a smaller dose? Do you take them before you experience emotional or physical discomfort? Do you take pills when you are upset? Do you ever promise yourself that you are going to stop taking pills, and then break the promise? Are you taking different types of pills to lose weight, relax or sleep?

If the patient answers YES or SOMETIMES to three or more of these questions, you should consider referral to an addictionologist. Reprinted with permission from the Womens Alcohol and Drug Education Project, Womens Action Alliance Inc.

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Guidelines for Management of Acute & Chronic Pain in the Recovering or Substance Abusing Patient 1. Define the pain syndrome and provide treatment for the underlying disorder. 2. Distinguish between patients in recovery, those receiving methadone maintenance and those who are actively abusing drugs. 3. Apply appropriate pharmacologic principles of opioid use. Use the appropriate opioid Use adequate doses and intervals Use appropriate route of administration 4. Provide concomitant non-opioid therapies when appropriate. Use non-opioid analgesics Use non-pharmacologic therapies 5. Recognize specific drug abuse behaviors. (See pages 10-11.) 6. Avoid excessive negotiations over specific drugs and doses. 7. Provide early referral to appropriate services: Psychiatry and substance abuse services Pain management service Detox services 8. Patients whose primary problem is opioid abuse should be considered to be referred to a methadone clinic. 9. Anticipate problems associated with opioid prescription renewals if outpatient treatment is required.18 Contracts (See following Sample Patient Contract)

18

Hoffman M. Provatas A. Lyver A, Kanner R. Pain Management in the Opioid Addicted Patient with Cancer, 1991; 681, 1121-1122.

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SAMPLE PATIENT CONTRACT For Use with Patients 1) At Higher Risk of Addiction; 2) Who have Had Compliance Problems With Medication in the Past Letter of Understanding This letter of understanding is being undertaken between _____________ (the patient), and __________________ (the practitioner), to define the responsibilities of the patient regarding treatment of a chronic pain problem, using opioid analgesics. 1. The patient hereby agrees that this trial of treatment has been explained to him/her in terms of the purpose, the side effects of the medication and the risks of this treatment. 2. In particular, the patient understands that using opioids to treat chronic pain will result in the development of a physical dependence on this medication, and that sudden decreases or discontinuation of the medication will lead to the symptoms of opioid withdrawal. The patient understands that opioid withdrawal is uncomfortable but not a physically life-threatening process. 3. The patient agrees not to change the dose or the frequency of taking medication without first consulting the practitioner, and to follow up with the doctor as an outpatient on a prescribed basis (____ times per week/month/year) for monitoring in the treatment. 4. The patient agrees to keep the prescribed medication in a safe and secure place and that lost, damaged or stolen medication will not be replaced until the next regularly scheduled visit. 5. The patient agrees not to give, sell, lend or in any way provide his/her medication to any other person, nor to obtain medication from anyone but a licensed pharmacist. 6. The patient agrees not to seek, obtain nor use ANY pain medication or moodmodifying medication from ANY other practitioner, without first discussing this with the undersigned practitioner. 7. In patients taking chronic opioid therapy, there is a small but definite risk that opioid addiction can occur. Almost always, this occurs in patients with a history of other substance abuse. Therefore, the patient agrees to refrain from the use of ALL other mood-altering drugs, including alcohol, with the exception of nicotine (although not recommended by the Colorado Prescription Drug Abuse Task Force, it is a legal substance) and caffeine, unless prescribed by a practitioner and agreed to by the undersigned practitioner. The patient agrees to random urine and/or blood testing at the practitioners request to verify this. 8. As part of this treatment program, the patient agrees to attend and participate fully in other chronic pain treatment modalities which may be recommended by the practitioner. 41

Goals (Desired Outcomes) for Opiate Treatment: 1. Decreased pain or increased ability to tolerate the pain. 2. Goals for increased functional ability (social, family, work-type activities):

The patient understands that ANY deviation from the above conditions can be grounds for ___________________ (the practitioner) to discontinue this form of treatment. Signed _____________________________ on _________________________, 2 _____. ___________________________________ ____________________________________ (Patient) (Practitioner)

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Guidelines for the Management of Chronic Pain in the Recovering or Substance Abusing Patient 1. Perform a comprehensive assessment. 2. Consider the use of primary therapy directed at the underlying organic cause of the pain (e.g., radiotherapy). 3. Distinguish between patients in recovery, those receiving methadone maintenance and patients who are actively abusing drugs. Until evaluated by the methadone clinic and the prescribing practitioner, patients receiving methadone should not discontinue maintenance. 4. Select an appropriate pharmacologic approach. (See Section C) 5. If an opioid is selected, apply appropriate pharmacologic principles: Select an appropriate opioid. Avoid the patients drug of choice Select the route of administration Apply appropriate dosing guidelines (See Section B, pages 21-22.) 6. Consider adjunctive approaches, including: Anesthetic Neurosurgical Psychiatric Psychological Neurostimulatory 7. Recognize drug abuse behaviors. 8. Provide early referral to appropriate service: Psychiatric and substance abuse services Pain management service Acupuncture Non-invasive methods of pain relief, which may include: - Exercise - Physical therapy19 - Biofeedback19 - Therapeutic massage - Methadone for addicted patients

19

McCaffery, M. Vourakis, C. Assessment and Relief of Pain in Chemically Dependent Patients. Orthopaedic Nursing: 1992 11(s): 13-26 AND Hoffman M. Provatas A. Lyver A. Kanner, R. Pain Management in the Opioid Addicted Patient with Cancer. 1991; 68:1121-1122.

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SECTION E PRESCRIBING FOR THE TREATMENT OF ANXIETY AND INSOMNIA Drugs used for the treatment of insomnia and anxiety can be very effective. These drugs are also capable of producing drug dependence and drug abuse. Guidelines Selected drugs are useful in 1) short term management of anxiety, sleep disorder, preanesthetic medications, intravenous anesthetic induction, alcohol withdrawal and barbiturate withdrawal and 2) long-term management of chronic anxiety disorders, panic disorders, social phobias and generalized anxiety disorders. Patient evaluation should exclude impulse control problems, disinhibition syndromes, agitated depression and suicidal ideation. These problems should be referred to a specialist for consultation. Anxiety. Patients should be instructed that the use of antianxiety drugs should be limited to thirty (30) days use at the appropriate dose (see Table D, page 48, for recommended doses/day for adults and elderly). It also is helpful to tell the patient that if the clinical problem persists, reevaluation by the primary or referral practitioner should take place. Reevaluation should address history, physical exam, interval psychiatric history and, if possible and indicated, a family interview. All findings should be thoroughly documented. If the problem persists beyond four (4) months, the condition falls into the category of chronic anxiety disorder and should be handled as noted in the exclusions set forth below. Insomnia. Discuss with the patient that the use of hypnotic drugs for insomnia should be limited to fourteen (14) days at the appropriate dose (see Table D, page 48 for recommended doses/day for adults and elderly). If the clinical problem persists, reevaluation by the primary or referral practitioner should take place. Reevaluation should address history, physical exam, interval psychiatric history and, if possible and indicated, a family interview. All findings should be thoroughly documented. If the problem persists beyond four (4) months, the condition falls into the category of chronic insomnia and should be handled as noted in the exclusions on the next page. Exclusion from the Guidelines Several chronic clinical conditions require therapeutic approaches that do not conform to the guidelines. These include: Seizure disorders (barbiturates and benzodiazepines) Nocturnal myoclonus (clonazepam) Skeletal muscle hyperactivity (diazepam) Chronic anxiety Chronic insomnia Chronic anxiety, including panic disorders and chronic insomnia, are relatively common clinical entities and represent a small part of the population of individuals with anxiety 44

and sleep disorders. The evaluation (with thorough documentation) should include history, appropriate physical exam, interval psychiatric history and, if possible and indicated, a family interview. Furthermore, every four months (at a minimum) the patient should be reevaluated. Regular reevaluation should address the ongoing problem, the outcome with drug use and investigation of drug tolerance, the use of other drugs, the use of alcohol, the ability to function in daily living, the occurrence of accidents and other items that are indicated by the patients general health status. If the primary care practitioner is not able or does not want to reevaluate the patient as recommended, a referral should be considered.

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SECTION F PRESCRIBING FOR THE ELDERLY As our population grows older, increasing numbers of persons over age 65 are at risk for misuse of prescription drugs. Because the elderly demonstrate higher levels of physical and mental problems than other age groups, they also have higher rates of overall drug use, especially psychotropic and psychoactive substances such as tranquilizers and sedative hypnotics. The vulnerability of the elderly for adverse effects from prescription drugs is probably related to several factors including: Number of drugs taken simultaneously for different ailments Interactions and cumulative effects of these drugs which may be absorbed, distributed, metabolized and excreted differently in the elderly Greater risk of the elderly for physical and psychological side effects from the drugs taken Adverse drug nutrient reactions, reduced appetite, impaired taste and smell Social isolation and emotional stress Poor communication with the practitioner

Elderly with multiple medical conditions may be even more sensitive to side effects and adverse reactions. Practitioners need to be aware of the consequences of drug choices for the elderly, including oversedation, orthostatic hypotension and anticholinergic effects. For some frail elderly these may result in falls, bowel and bladder dysfunction and mental deterioration. General Guidelines for Prescribing for the Elderly 1. Make a diagnosis and have a goal for the outcome. Avoid prescribing drugs just to see if they will help. Reevaluate periodically. 2. Treat the problem not the symptoms; do not allow drugs to become the problem. 3. Consider non-pharmaceutical solutions for treating the problem. These may include counseling, manipulating the environmental factors which contribute to anxiety or improving sleep hygiene. 4. Minimize the use of drugs through lower dosages for shorter periods of time. 5. Be aware of and vigilant for adverse effects. 6. Consider consulting with a psychiatrist before prescribing stimulants. 7. Recognize that side effects may be related not only to the drug or the dose, but also to patients underlying diseases or interactions with other drugs taken by the patient.

46

8. Over 85 percent of older adults suffer from chronic diseases that could benefit from nutritional intervention rather than prescription drugs. 20 Guidelines for Prescribing Narcotic Analgesics for the Elderly Consider non-drug approaches for the chronic pain patient, (e.g., physical therapy, exercise, relaxation). 1. Consider the possible benefits of using antidepressants in the treatment of chronic pain. 2. Seek non-narcotic medications for chronic pain. 3. Consider lower dosages because the elderly may have greater sensitivity to narcotics. 4. Be aware that under-medication also may be a problem. 5. Consider consultation for chronic pain management. Guidelines for Prescribing Sedative Hypnotics and Antianxiety Agents for the Elderly 1. Rather than routinely prescribing sedative hypnotics and antianxiety drugs for insomnia, complete a differential diagnosis and treat the following appropriately: Depression Pain Poor sleep hygiene (e.g., asleep during day) Alcoholism Nocturia Caffeine ingestion Congestive heart failure Esophageal reflux Drug side effects Pulmonary disease Interactions of over-the-counter medications Restless leg syndrome Primary sleep disorder (e.g., sleep apnea) Hyperthyroidism Anxiety disorder 2. Consider how readily the elderly patient may metabolize a given drug, given basic organ function. Try to use drugs with no active metabolites which are likely to build up. 3. Be aware that short-acting drugs are more likely to cause rebound effects while longacting medications are more likely to result in cumulative effects. 4. Use care in prescribing for confused or demented patients. 5. Look for a clear cut precipitating factor for anxiety and consider possible organic causes or medication interactions.

20

Administration on Aging, US Department of Health and Human Services

47

6. Consider the potential for interactions between benzodiazepines and CNS-depressant substances such as alcohol and over-the-counter hypnotics which may result in confusion, disinhibited behavior, agitation or increased sedation. 7. Hospitalized geriatric patients seldom require routine use of sedative hypnotics. 8. Barbiturates should not be used for insomnia until other possibilities have been exhausted.

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Drug Oxazepam (Serax) Lorazepam (Ativan) Diazepam (Valium) Chlordiazepoxide HCI (Librium) Prazepam (Centrax) Clorazepate Dipotassium (Tranxene) Alprazolam (Zanax) Halazepam (Paxipam) Triazolam (Halcion) Temazepam

TABLE D COMPARISON OF BENZODIAZEPINE DOSES FOR ADULTS AND THE ELDERLY Active Half-Life of Doses (mg/d) Doses (mg/d) Rate of Onset Half-Life (h) Metabolites Metabolites (h) Adult Elderly Intermediate to 5-15 None 10-60 10-30 slow Intermediate Fastest Intermediate Slow Fast Intermediate Intermediate to slow Fast Intermediate 10-20 26-53 8-28 30-200 30-200 6-15 14 2-5 12-24 None Yes Yes Yes Yes Yes Yes 36-200 36-200 36-200 36-200

Route of Administration Oral Oral, IM, IV Oral, IM, IV Oral, IM, IV Oral Oral Oral Oral Oral Oral

1-4 5-30 10-100 20-60 15-60 0.25-2.0 20-120 0.25-0.5 15-30

0.5-4.0 2-10 5-30 10-15 7.5-15 0.125-0.5 0.25-0.5 15-30

36-200 -

Reproduced with permission from Jenike MA; Handbook of Geriatric Psychopharmacology, Littleton, Mass. PSG Publishing. 1985.p.101; and Mosby Year Book, Inc., Chicago, IL. IM doses unreliably absorbed Unknown; probably about the same as the parent drug

49

SECTION G MANAGEMENT OF PAIN IN NURSING HOME RESIDENTS Developed by the Colorado Medical Directors Association, the Ad Hoc Task Force on Intractable Pain in Long Term Care Residents and the Colorado Department of Public Health and Environment. The feeling of pain and its residual feelings are defined in Sections B & C. These feelings may be experienced to a magnified degree by residents in nursing homes, for whom pain is but one of many exacerbating factors present in this population. OBRA Requirements: The Omnibus Budget Reconciliation Act (OBRA-87) required nursing homes to individualize care in ways that assist each resident attain or maintain his or her highest practicable physical, mental and psychosocial well-being. A corollary of this requirement is that long term care residents have the right to effective pain management since pain can be a major limiting factor to the quality of their lives. 1. Profile of the Nursing Home Resident Residents most often have multiple medical problems, many of which are accompanied by chronic and/or intractable pain. More often than not, the pain accompanying these conditions is neither diagnosed nor treated effectively. Some of the more common ailments nursing home residents suffer from are: Arthritis, osteoarthritis, rheumatoid arthritis Osteoporosis and associated fractures Pressure sores Neuropathic pain Cancers Pain associated with contractures Headache pain Ischemic pain Pain from other medical causes including ulcer disease, urinary tract infections, angina Dental pain (caries, fractured teeth, dental abscesses) Periodontal pain (gingivitis, periodontitis, periodontal abscesses) Residents may have difficulty verbalizing their pain due to secondary cognitive or neurological conditions and/or cultural factors. Residents may have learned to live with their pain. In many residents, untreated pain is exhibited as behaviors which may include: Depression Anxiety Withdrawal Decrease in appetite 50

Decrease in activities Insomnia Agitation such as yelling, pacing, striking out Refusal to participate in activities of daily living

Unfortunately, these behaviors are often seen as arising from mental disorders including generalized anxiety disorder, organic mental syndromes (delirium, dementia) and other cognitive disorders. In such cases, residents may receive psychoactive drugs for treatment rather than treatment for the underlying pain which causes or exacerbates certain of these behaviors. 2. Federal Guidelines on the Use of Psychoactive Medications Federal guidelines require that the use of psychoactive medications be carefully monitored and that practitioners provide a continuing rationale for their use as clinically appropriate. (See Guidance to Surveyors Long Term Care Facilities, Tag Number F329.) Failure to follow recommended steps may result in a facility being cited for non-compliance with the regulations. Regulations for use of psychoactive drugs prohibit excessive dose, excessive duration, inadequate monitoring, inadequate indications for use or use which creates adverse consequences. Treatment for pain may be a factor which can reduce or eliminate use of psychoactive medications. 3. Assessment and Care Planning The long term care setting offers an appropriate environment in which to manage pain more effectively. Assessment and care planning are linked with input from the resident, family members and his/her team of caregivers on a regular basis during care planning meetings. These meetings represent an opportunity to explore what the resident is experiencing in regard to pain, either through discussion with the resident and/or his/her family members. It is important for the long term care team to discuss issues, including pain management, with the resident and family. In patients who cannot communicate pain verbally, facial expressions and gestures are very important and family members can help interpret these to the health care provider. 4. A Comprehensive Approach to Pain Management for the Long Term Care Resident One should take into account the stage of the disease, concurrent medical conditions, characteristics of pain and psychological and cultural characteristics of the resident. Effective management of pain also requires ongoing reassessment of the pain and treatment effectiveness. (Adapted from the Clinical Practice Guideline, Number 9 Management of Cancer Pain: U.S. Dept. of Health and Human Practices, Public Health Service, Agency for Health Care Policy and Research.) 5. Opioid Analgesics May Be Added to Non-Opioids to Manage Acute and Chronic Pain For pain that does not respond to non-opioids alone, opioid analgesics may be added to non-opioids to manage acute and chronic pain. Many of these opioids are marketed with a non-opioid and it is the latter that limits the dose. Watch for aspirin and acetaminophen toxicity with these combinations. 51

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6. The World Health Organizations Three Step Analgesic Ladder (1990) is Recommended for Treating Pain: STEP ONE FOR MILD TO MODERATE PAIN Non-opioid Examples: Salicylate Acetaminophen NSAID Others Adjuvant medication Examples: Antispasmodics Anticonvulsants Muscle relaxants Anxiolytics Tricyclic antidepressants Steroids Others

STEP TWO PAIN PERSISTS OR INCREASES SECOND STEP FOR MILD TO MODERATE PAIN Opioid Examples: Codeine Hydrocodone Oxycodone Others Non-opioid (see examples in Adjuvant Step One above) STEP THREE PAIN PERSISTS OR INCREASES THIRD STEP FOR MODERATE TO SEVERE PAIN Opioid Examples: Oxycodone (controlled and instant release) Morphine (controlled and instant release) Hydromorphone Fentanyl Transdermal Others Non-opioid (see examples in Adjuvant Step One above) Note: An adjuvant is an agent (or another medication) added to a drug to increase or aid its effect. The symbols indicate that the use of an adjuvant may or may not be added depending on the type of pain being treated. When the step ladder approach is ineffective, alternative modalities include other routes of drug administration (besides oral) such as topical applications, nerve blocks and ablative neurosurgery. 53

7. Dosing When pain medications are not effective, it is recommended that individual doses be administered routinely rather than PRN to avoid chasing the pain. 8. Side Effects If the stepladder approach is used, side effects are generally minimal, self-limiting and easily treated. The most common side effect of opioid analgesics is constipation and this can be treated with appropriate laxative intervention. 9. Break-through Pain In addition to routine dosing, it is recommended that a PRN order for a supplementary opioid between regular doses be available for break-through pain. Continual assessment and reassessment should be the primary factor in effective pain management. 10. Overcoming Barriers to Pain Management. Techniques which may be tried include teaching pain assessment skills to staff, correlating knowledge with pain management strategies and using appropriate clinical scenarios including health care professionals at all levels in the facility. 11. Non-pharmacological, Natural Approaches to Pain Management. These are not substitutes for pharmacological treatmentthey are used to enhance pain medications. Here are some options: Relaxation eliminates or decreases stress, which is often an important component of severe pain. Pain produces stress which can lead to increased sensitivity of pain. Examples of relaxation techniques include: - Progressive muscle relaxation where one tenses/relaxes large muscle groups - Deep abdominal breathing - Jaw stretching and relaxing - Yawning Biofeedback relaxation used in conjunction with a machine that allows one to be more aware of ones physiological responses such as pulse, temperature and blood pressure. Biofeedback can also be learned without a machine by simply learning how to self-monitor and alter certain autonomic responses. Guided visual imagery helps to create and experience positive, peaceful mental pictures in ones own mind which produce relaxation and lessen pain. Hypnosis used a great deal with cancer pain. Distraction watching TV, taking walks, talking and visiting, journaling about such topics as health, pain, joy, family, gratitude. Music increases circulation to the brain; increases respirations and muscle strength. Studies find it allows for decreased medication usage. 54

Laughter deepens breathing, lowers blood pressure and releases endorphins. Changes mood, reduces anxiety, anger, fear, depression and resentment, all of which are components of chronic pain. Aromatherapy adds pleasant scents to the environment which positively affect mood and behavior. Derived from natural sources, aromatic substances may be used to calm, soothe, warm, comfort and relax individuals. Massage and similar techniques such as reflexology, therapeutic touch, acupuncture and acupressure are helpful to providing pain relief. Vibration, bathing, Cold/Heat treatments help relieve chronic pain. Use based on individual preference for heat or cold. Heat -- includes hot packs, moist air, radiant heat Cold -- reduces muscle spasm, skin sensitivity, inflammation and joint stiffness. Usually more effective than heat, but a little more uncomfortable to adjust to. Two types of cold therapies: cold pack, ice massage. Note: cold is not used where tissue is necrotic or there is poor circulation or malignancy. Other noninvasive adjuncts or alternatives to medications might be: - Hydrotherapy - Visualization - Nutrition - Elevation and support (ace wraps, splints, immobilization) - Exercise and physical therapy - Herbal preparations

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APPENDIX A COLORADO BOARD OF MEDICAL EXAMINERS GUIDELINES FOR PRESCRIBING CONTROLLED SUBSTANCES FOR INTRACTABLE PAIN Adopted 5/16/96 Introduction The Colorado Board of Medical Examiners (CBME) strongly urges physicians to view effective pain management as a high priority in all patients. Minorities, women, children, the elderly, and people with HIV/AIDS are at particular risk for under treatment of their pain. Pain should be assessed and treated promptly, effectively, and for as long as pain persists. The medical management of pain should be based on up-to-date knowledge about pain, pain assessment, and pain treatment. Pain treatment may involve the use of several drug and non-drug treatment modalities, often in combination. For some types, the use of drugs is better de-emphasized in favor of other therapeutic modalities. Physicians should have sufficient knowledge or consultation to make such judgments for their patients. The Board recognizes that inappropriate prescribing of controlled substances, including opiates, can lead to drug abuse and diversion. Inappropriate prescribing can also lead to ineffective management of pain, unnecessary suffering of patients, and increased health care costs. Concerns about regulatory scrutiny should not make physicians who follow appropriate guidelines reluctant to prescribe or administer substances for patients with a legitimate medical need for them. Drugs, particularly the opioid analgesics, are considered the cornerstone of treatment for pain associated with trauma, surgery, medical procedures, and cancer. Large doses may be necessary to control pain if it is severe, and extended therapy may be necessary if the pain is chronic. The CBME firmly believes that physicians have a duty to provide maximal comfort levels and alleviate suffering in their dying patients in a skillful and compassionate manner. The Board is concerned that fear on the part of physicians may result in ineffective pain control and unnecessary suffering in terminal patients. Physicians are referred to the U.S. Agency for Health Care Policy and Research Clinical Practice Guidelines, which reflect a sound yet flexible approach to the management of these types of pain. The prescribing of opioid analgesics for patients with intractable non-cancer pain may also be beneficial. Intractable pain is defined as pain in which the cause cannot be removed or otherwise treated and no relief or no cure has been found after reasonable efforts, including evaluation by one or more physicians specializing in the treatment of the area of the body perceived as the source of the pain. Physicians who prescribe opiates for intractable pain should not fear disciplinary action from any enforcement of 56

regulatory agency in Colorado if they use sound clinical judgment and care for their patients according to the following principles of responsible professional practice. Guideline for Prescribing Controlled Substances For Chronic Non-Malignant Pain Guidelines do not have the legal status of laws and regulations, but guidelines can explain what activities the Medical Board considers to be within the boundaries of professional practice. Guidelines alert licensees to unprofessional practices of concern to the Board and give physicians practical information about how to avoid these problems. 1. History/Physical Examination/Assessment A medical history and physical examination documenting the presence of a recognized medical indication for the use of a controlled substance must be performed. This includes an assessment of the pain, physical and psychological function, substance abuse history, and assessment of underlying or coexisting diseases or conditions. A statement of alternative strategies used for managing the pain and why these modalities are inappropriate or ineffective, as well as a summary of the evaluations performed by one or more specialists, should be included. 2. Treatment Plan/Objectives The treatment plan should state objectives by which treatment success can be evaluated. This may include: an ongoing assessment of the patients functional status, including the ability to engage in work or other gainful activities; patient consumption of health care resources; positive answers to specific questions about the pain intensity and its interference with activities of daily living; quality of family life and social activities; and physical activity of the patient as observed by the physician. The plan should indicate if any further diagnostic evaluations or other treatments are planned. The physician should tailor drug therapy to the individual medical needs of each patient. Several treatment modalities or a rehabilitation program may be necessary if the pain has differing etiologies or is associated with physical and psychosocial impairment. 3. Informed Consent The physician should discuss the risks and benefits of the use of controlled substances with the patient or guardian. A written consent is strongly advised when using drugs with a high dependence/tolerance potential. 4. Periodic Review The physician should periodically review the course of treatment of the patient and any new information about the etiology of progress toward treatment objectives. If the patient has not stabilized, the physician should assess the appropriateness of continued treatment with controlled substances. The physician is responsible for monitoring the dosage of controlled substances to ensure that it does not escalate over time without maintenance of the patients function. 57

Monitoring also includes ongoing assessment of patient compliance with the controlled prescribing practice of the physician. Utilization of a single prescribing physician and a single pharmacy is advised. 5. Consultation The physician should be willing to refer the patient as necessary for additional evaluation and treatment in order to achieve treatment objectives. In addition, physicians should give special attention to those pain patients who are at risk for misusing their medications, including those whose living arrangements pose a risk for medication misuse or diversion. The management of pain in patients with a history of substance abuse requires extra care, monitoring, documentation, and ongoing consultation with an addiction medicine specialist. 6. Records The physician should keep accurate and complete records according to items 1-5 above. The physician should keep detailed records of each drug dosage, amount, and number of refills. Again, the use of a single prescribing physician and a single pharmacy is advised. A written contract is recommended, which includes: contingencies for management of pain exacerbations, substance abuse, loss of prescriptions, misuse of medications, and noncompliance with treatment. 7. Compliance with Controlled Substances Laws and Regulations To prescribe controlled substances, the physician must be appropriately licensed in Colorado, have a valid controlled substances registration, and comply with federal and state regulations for issuing controlled substances prescription. Under federal and state law, it is unlawful for a physician to prescribe controlled substances to a patient for other than a legitimate medical purpose (i.e., prescribing opiates for the treatment of opioid addiction without a specialized license), or outside of professional practice (i.e., prescribing without a medical examination of the patient). The law does not allow the physician to prescribe or administer controlled substances to a person the physician knows to be using drugs or substances for non-therapeutic purposes. It is lawful to prescribe opioid analgesics in the course of professional practice for the treatment of intractable pain. 8. Addiction Versus Physical Dependence Addiction should be placed into proper perspective. Physical dependence and tolerance are normal physiologic consequences of extended opioid therapy and are not the same as addiction. Addiction is a behavioral syndrome characterized by psychological dependence and aberrant drug-related behaviors. Addicts compulsively use drugs for non-medical purposes despite harmful effects; a person who is addicted may also be physically dependent or tolerant. Patients with chronic pain should not be considered addicts merely because they are being treated with opiates. 58

Conclusion The Board hopes to replace practitioners perception of inappropriate regulatory scrutiny with recognition of the Boards commitment to enhance the quality of life of patients by improving pain management while, at the same time, preventing the diversion and abuse of controlled substances.

The Colorado Board of Medical Examiners wishes to acknowledge the work of the State Boards of California, Ohio, Oregon, Texas, and Washington, upon which these guidelines are based.

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APPENDIX B COLORADO BOARD OF MEDICAL EXAMINERS RULE ON THE PRESCRIBING OF SCHEDULE II STIMULANT DRUGS The following is the rule of the Colorado State Board of Medical Examiners, which declares the improper prescribing of Schedule II stimulant drugs to be unprofessional conduct. Prescription of stimulant drugs (amphetamine or sympathomimetic amine drugs designated as Schedule II controlled substances) is not acceptable for purposes of diet control, increasing work capacity, maintaining wakefulness other than Narcolepsy, to combat the normal fatigue associated with any endeavor, or to chemically induce euphoria. Prescription of these drugs is acceptable for: Hyperkinesis/Attention Deficit Disorder in children and adults Narcolepsy Organic Brain Dysfunction Organic Affective Disorder Major Depressive Disorder and Dysthymia The reduction of side effects caused by opioid analgesics, especially sedation in terminally ill patients or other similarly severe conditions Approved clinical investigation of the effect of such drugs within a research protocol

(Revised effective November 30, 1991)

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