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Electronic Transmission of Orders ..................................................................................... 1 Treatment of Narcotic Addiction ........................................................................................ 3 Can Buprenorphine Be Used in Pain Management?........................................................... 4 What is Methadone Maintenance? ...................................................................................... 7 Uniform Controlled Substance Act of 1992: Federal Code of Regulations ....................... 7 Considerations Concerning Confidentiality........................................................................ 8 Prescription Drug Monitoring Program .............................................................................. 9 Colorado Revised Statutes ................................................................................................ 11

ELECTRONIC TRANSMISSION OF ORDERS The Standards Committee of the Drug Abuse Task Force has had several requests to add a chapter on electronic transmission of orders. This rapidly evolving area of practice is sometimes not clearly addressed by present laws and regulations. We are grateful to the Chief Inspector of the Colorado Board of Pharmacy for his help with this chapter. In it, we have attempted to address some common questions concerning electronic transmission of orders. A. What is the electronic transmission of orders? The statute says that a prescription order may be transmitted electronically or by facsimile, or by other means of communication but does not elaborate or further define the term(s) [CRS 12-22-102(22.5)(a)]. Electronic might mean via computer, for example, email or other methods of digital transfer. B. Are electronic signatures on prescription orders authorized by current laws and regulations? The Colorado Board of Pharmacy has determined that electronic signatures are authorized for Schedule III, IV, and V prescriptions. The Drug Enforcement Administration (DEA) has taken a similar position regarding electronic signatures. C. If a Schedule III, IV, or V prescription with several remaining refills is transferred, can all refills also be transferred or must the receiving pharmacy get a new order from practitioner after filling the transferred prescription one time? Schedule III, IV or V prescriptions, plus all remaining refills must be transferred. The receiving pharmacy may not transfer this prescription again. The intent of regulations is that when a prescription is transferred, all refills will also be transferred. The original prescription must then be invalidated and the patient must be advised of that fact (see Board of Pharmacy Rules and Regulations 2.01.50(c)(3), 2.01.52(a) and 2.01.56). The receiving pharmacy will assign a new number to the transferred prescription and the refills left on that prescription may not be transferred again. The only exception is when two or more pharmacies share the same real-time on-line data base, the prescription is filled and refilled under the same prescription number assigned at its original filling and the shared data base is accessed and information reordered in that shared data base each time the prescription is filled or refilled. (In this case, the prescription is not truly transferred.) When a receiving pharmacy assigns a new number to a transferred prescription (even though it may share or access the same database as the transferring pharmacy), the criterion of a real-time on-line data base

is not met and the transfer is therefore limited to one time, at which time all refills must be transferred. D. Can a pharmacist fill a Schedule III, IV, or V prescription faxed to the pharmacy by the patient? The DEA specifies that if the order is faxed, it must be transmitted by the practitioner or the practitioners agent to the pharmacy [21 CFR 1306.21(a)]; therefore it would be illegal for the pharmacist to fill a Schedule III, IV, or V prescription faxed by the patient. E. What are the rules for faxed and dispensing Schedule II prescriptions in an emergency? As stated in C.R.S. 18-18-414 (2): 2.(a) A pharmacist in an emergency situation, in lieu of a written prescription order, in good faith, may dispense up to a seventy-two hour supply of any controlled substance listed in Schedule II of Part 2 of this article without a written prescription order. An emergency situation, as used in this paragraph (a), means a situation in which the prescribing practitioner determines: I. That immediate dispensing of the controlled substance is necessary for proper treatment of the intended ultimate user. II. That no alternative prescription drug is available, including drugs that are not controlled substances under Schedule II of Part 2 of this article. III. That it is not reasonably possible for the prescribing practitioner to provide a written prescription order to be presented to the person dispensing the controlled substance prior to such dispensing. (b) Upon receiving such an emergency oral prescription order from the practitioner, the pharmacist shall immediately reduce the prescription order to writing and shall write on its face authorization for emergency dispensing and the date and time of dispensing of the oral prescription. The prescribing practitioner shall reduce the prescription order to writing and deliver the prescription order in person, by facsimile transmission as provided in paragraph (c) of this subsection (2), or by mail to the pharmacist within seventy-two hours. If delivered by mail, the envelope must be postmarked within seventy-two hours of prescribing. The pharmacist, upon receipt of the prescription order, shall attach the prescription order to the oral prescription order that has been reduced to writing. The pharmacist shall notify the board if the prescribing practitioner fails to deliver the written prescription order to the pharmacist. (c) I. A prescription for a controlled substance listed in Schedule II of Part 2 of this article may be transmitted via facsimile equipment, so long as the original written, signed prescription is presented to the pharmacist for 2

review prior to the actual dispensing of the controlled substance, except as provided in subparagraph (II) of this paragraph (c). II. A prescription written for a Schedule II controlled substance for a hospice patient or for a resident of a long-term care facility or for the direct home administration to a patient by parenteral, intravenous, intramuscular, subcutaneous, or intraspinal infusion drug therapy may be transmitted by the practitioner or the practitioners agent to the dispensing pharmacy or pharmacist by facsimile transmission. The practitioner or the practitioners agent shall note on the prescription that the patient is a hospice patient or a resident in a long-term care facility or a patient receiving infusion drug therapy. The facsimile serves as the original written prescription for purposes of this section and shall be maintained as specified by the board. III. For the purposes of this paragraph (c): A. Hospice patient means an individual who is receiving hospice care from an entity licensed and regulated by the department of public health and environment pursuant to sections 25-1.5-103 (1)(a)(I) and 25-3-101, C.R.S. B. Long-term care facility means a facility that is licensed and regulated as a skilled nursing facility or nursing care facility by the Department of Public Health and Environment pursuant to sections 251.5-103 (1)(a)(I) and 25-3-101, C.R.S. TREATMENT OF NARCOTIC ADDICTION Three medications are currently approved for use in the treatment of opioid addiction: methadone hydrochloride, buprenorphine/nalaxone (Suboxone), and buprenorphine (Subutex). All of these drugs require special state and federal licenses and registrations in order to be used in the treatment of opioid dependence. Methadone must be dispensed by the licensed Narcotic Treatment Program, which also must provide psychosocial rehabilitation services. Methadone may be prescribed for analgesic purposes; see Colorado Guidelines of Professional Practice for Controlled Substances for Health Care Professionals Who Prescribe, Dispense, and Administer.1

John T. Brewster, LCSW, Director-ARTS, Associate Professor, UCHSC

CAN BUPRENORPHINE BE USED IN PAIN MANAGEMENT? The Buprenorphine products Suboxone and Subutex are the two Schedule III narcotic medications currently approved for the treatment of opioid dependence under the federal Drug Addiction Treatment Act of 2000 (DATA). The off-label use of the sublingual formulations of buprenorphine (Suboxone/Subutex) for the treatment of pain is not prohibited under DEA requirements. However, off-label use does pose a dilemma for pharmacists. Currently, there is no requirement under the DATA for a qualified practitioner to put the Unique Identification Number (UIN) on a prescription for Suboxone or Subutex for maintenance or detoxification treatment. On June 24, 2003, the DEA published a Notice of Proposed Rulemaking (NPRM) that will require qualified practitioners to include the UIN on all prescriptions written for either Suboxone or Subutex for narcotic addiction treatment. This requirement will be the only way to determine whether a prescription for Suboxone or Subutex was written for maintenance or detoxification treatment or some other condition. Buprenex, a Schedule III, injectable formation of buprenorphine, is approved and marketed in the United States as an analgesic and is widely used in the treatment of pain. If a physician prescribes, dispenses, or administers buprenorphine (Suboxone/Subutex) for the treatment of pain or for any other reason, a DEA registration is required because both products are Schedule III controlled substances. The DATA waiver specifically authorizes qualified practitioners to treat narcotic dependent patients, using FDA approved Schedule III-V narcotic controlled substances for maintenance and detoxification. The DATA waives the requirement for obtaining a separate DEA registration as a narcotic treatment program for physicians using the approved drugs for maintenance and detoxification; however, it does not apply to physicians using Suboxone or Subutex for the treatment of pain. A physician using Suboxone or Subutex for the treatment of pain would be required to register with DEA as a practitioner with Schedule III privileges. The Narcotic Addict Treatment Act of 1974 and the DATA amend the Controlled Substances Act (CSA) to allow the use of opioid drugs to treat addiction either through maintenance or detoxification under specific criteria. Schedule II opioids approved for addiction treatment are limited to methadone, and may only be administered and dispensed (not prescribed) by DEA registered Narcotic Treatment Programs. Schedules III-V opioids specifically approved by the Food and Drug Administration (FDA) for use in addiction treatment may be prescribed administered and dispensed by certified practitioners who have obtained the appropriate waivers from the Center for Substance Abuse Treatment. The above legal allowances were established to allow for the treatment of addiction with opioid controlled substances. These limitations and requirements in no way affect the ability of a practitioner to utilize opioids for the treatment of pain when acting in the usual course of medical practice. Consequently, when it is necessary to discontinue a pain 4

patients opioid therapy by tapering or weaning doses, there are no restrictions with respect to the drugs that may be used. This is not considered detoxification as it is applied to addiction treatment. The pharmacist should confirm the diagnosis before dispensing.2 Buprenorphine/naloxone (Suboxone) and buprenorphine (Subutex) 2mg and 8mg tablets have been approved by the FDA for the treatment of opiate dependence. Buprenorphine and buprenorphine/naloxone will become useful additions to the available range of pharamacotherapies that can help opiate-dependent patients overcome their addiction. The major benefit of Subutex/Suboxone is that treatment of opioid dependence will now be available through qualified office-based physicians in addition to the limited number of licensed drug treatment programs. Suboxone and Subutex are the first therapies approved for in-office prescribing under the DATA of 2000. Suboxone is a combination of two proven medications, buprenorphine, and naloxone. Buprenorphine, a partial opioid agonist, reduces withdrawal symptoms and blocks the effects of subsequently administered opioids, which suggests that it may help reduce illicit opioid use. Because it contains naloxone, Suboxone is highly likely to produce intense withdrawal symptoms if misused intravenously by opioid-addicted individuals; however, when used as prescribed, Naloxone has no effect. DATA enables physicians who meet certain qualifying criteria to prescribe and pharmacists to dispense Suboxone and Subutex for treatment of opioid dependency. Under DATA, qualified physicians can manage a total of 30 patients at one time. For more information about Suboxone and Subutex, please see full product information, prescribers criteria, dependency, confidentiality, induction doses, safe guidelines against diversion, and other pertinent information on the use of these products in the treatment of opioid dependence. Visit or call 1-877-Suboxone. The following information on Treating Opioid Dependence, Pharmacists Frequently Asked Questions (FAQs) was adapted from, accessed October 9, 2002. What is the role of the pharmacist in ensuring safe use of Suboxone and Subutex? 1. Verify that the prescriptions you receive are from physicians who are in compliance with the provisions of DATA. 2. Remind patients who are picking up induction doses to return as directed to the doctors office so that they can be supervised while taking the medication. 3. Be vigilant in detecting fraudulent prescriptions or simultaneous prescriptions for the same patient from multiple suppliers.

From the letter to Dr. Howard Heit, from Patricia M. Good, Chief Liaison and Policy Section, Office of Diversion Control, DEA, USDOJ

How can I be sure a physician is qualified to prescribe Suboxone and Subutex? Once all relevant criteria are verified, the DEA will issue the physician a UIN indicating that he or she is a qualifying physician under DATA. Pharmacists who seek information to verify whether or not physicians have valid waivers may contact 1-866-BUP-CSAT or by email at What if I get a prescription from a doctor who does not have a special DEA identification number? Call that physician for clarification that the physician has made the appropriate notification to the Department of Health and Human Services (DHHS). DEA is developing regulations that will require this number along with the physicians existing DEA registration number to be included on all prescriptions issued for the treatment of opioid dependence; therefore, physicians are being strongly urged to include this number on prescriptions. Most physicians will make arrangements to obtain the identification number before prescribing Suboxone or Subutex, but in rare cases, a physician may need to write a prescription before the number has been issued. This is allowed under DATA provided the physician has notified the DHHS of his/her intention to begin treating a patient right away; the notification form includes a check box for this situation. Are there any special storage, record-keeping, or other requirements associated with Suboxone and SUBUTUEX? As Schedule III controlled substances, Suboxone and Subutex are subject to certain federal regulations covering areas such as record keeping, inventory, proper dispensing, and disposal. These are explained in the DEA Pharmacists Manual, which can be found at Many states have their own additional requirements for pharmacists dispensing controlled substances. Be sure to check with the authority in your state. For more information, visit the website of the National Association of Boards of Pharmacy at for links to individual state boards of pharmacy. Since drug addiction is a sensitive topic, you should make sure you have access to a private area in which to counsel patients about Suboxone and Subutex therapy. When speaking with these patients, it is important to keep in mind that addicts in withdrawal may be irritable and short on patience.

The following clarification is from a letter to Dr. Howard Heit from the DEA: WHAT IS METHADONE MAINTENANCE? Methadone is an opiate agonist, which has a series of actions similar to those of morphine and other narcotic medications. Opiate addicts will experience withdrawal symptoms if the concentration of opiates in the body falls below a certain level. In maintenance, treatment patients are given enough methadone to ward off opiate withdrawal symptoms, but not enough to induce narcotic effects. In proper doses, methadone does not create euphoria, sedation, or analgesia. Methadone has no adverse effects on motor skills, mental capability, or employability. Methadone has a more gradual onset of action than heroin, and as a result, patients stabilized on methadone medications do not experience a rush. In addition, methadone wears off much more slowly than heroin so there is no sudden crash and the brain and body are not exposed to the marked fluctuations seen with heroin use. Maintenance treatment with methadone markedly reduces the desire for heroin or other opiates. If an individual maintained on adequate, regular doses of methadone (once a day or several times per week) tries to take heroin, the euphoric effects of heroin will be significantly blocked. According to research, patients undergoing methadone maintenance treatment do not suffer the medical abnormalities and behavioral destabilization that rapid fluctuations in drug levels cause in heroin addicts. Patients in maintenance therapy graduate through phases of treatment as they demonstrate compliance, abstinence from all illicit substances and progress in individual and group therapy. Federal and state regulations serve as a guide in maintenance therapy for when clients are able to receive and earn less restrictive attendance schedules. For example, during the first ninety days of treatment, a client must engage in treatment six days per week. With abstinence and compliance in treatment, a client may then graduate to a lesser attendance schedule as set for by state and federal guidelines.

UNIFORM CONTROLLED SUBSTANCE ACT OF 1992: FEDERAL CODE OF REGULATIONS 1306.04. Purposes of issue of prescription. (a) A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties 7

provided for violations of the provisions of law relating to controlled substances. (b) A prescription may not be issued in order for an individual practitioner to obtain controlled substances for supplying the individual practitioner for the purpose of general dispensing to patients. (c) A prescription may not be issued for the dispensing of narcotic drugs listed in any schedule for detoxification treatment or maintenance treatment as defined in Section 102 of the Act (21 U.S.C. 802) [United States Code, Section 802 of the Controlled Substances Act]. DATA 2000 changes 1306.04(c) only in the case of buprenorphine (Subutex) and buprenorphine/naloxone (Suboxone). CONSIDERATIONS CONCERNING CONFIDENTIALITY Pharmacists are often reluctant to provide or exchange information about patients and practitioners who they suspect are violating legal or ethical standards. This reluctance, in part, stems from a lack of clarity concerning confidentiality requirements. This discussion is an educational one and is not intended to be a legal interpretation. The individual pharmacist or the corporation by which he or she is employed should consult with their own attorney if they wish advice on how to proceed on this matter. Appendix D references applicable state and federal regulations and laws. Based on these requirements, the following conclusions may be drawn regarding confidentiality: It is illegal for a pharmacist to knowingly dispense a false prescription for controlled substances. The pharmacist should take prudent measures to determine the authenticity of the prescription order (also see the discussion of Responsibilities on page 1). A pharmacist may divulge information when it is in the best interest of the patient. Therefore, it would be appropriate to discuss a patient with all the physicians who may be prescribing for the patient when it appears that the patient is seeing more than one physician in order to obtain more drugs than therapeutically appropriate or drugs which may have undesirable interactions. Clearly, information given a practitioner in order to unlawfully obtain controlled substances is not a privileged communication. The practitioner may disclose information if there is reason to believe the patient is acting in an unlawful manner. Under Colorado Revised Statutes (C.R.S.) 12-22-319 and 12-22-320 a pharmacist may disclose information on prescription orders for controlled substances only to persons authorized to enforce the applicable state and federal laws. These persons include local police, district attorneys, pharmacy inspectors, Department of Regulatory Agency 8

investigators and Department of Health inspections authorized in accordance with C.R.S. 12-22-319(3)(c). It could be interpreted that the unfilled suspicious prescription order is not covered by 1222-320, because it represents information given in committing fraud and deceit and is not privileged. It would be appropriate to make a statement that describes the person who is suspected of presenting a false prescription order, the fact that the prescription order was for a controlled substance, the circumstances and related information given by the person and the general description of the prescriber (general location, type of practice). Confidentiality is a difficult area for the pharmacist since many situations are specifically addressed in the law, regulations, or case law. The pharmacist has a professional responsibility to act under laws and regulations in a manner that best meets the needs of the patient and the prescriber when faced with situations that may involve fraudulent attempts to obtain controlled substances.

PRESCRIPTION DRUG MONITORING PROGRAM (Amended 8/08) On June 3, 2005, Governor Bill Owens signed the HB05-1130 to create and implement a prescription drug-monitoring program (PDMP). The Colorado State Board of Pharmacy oversees the program and the statutory authority is located at C.R.S. 12-22-701. The PDMP became fully operational on February 4, 2008. For more specific information, please go to Electronic monitoring of prescriptions for controlled substances will provide a mechanism whereby prescribers can discover the extent of each patients requests for drugs, and whether other providers have prescribed similar substances during a similar period of time. There is an advisory committee titled The Prescription Controlled Substance Abuse Monitoring Advisory Committee. The Committee shall consist of the following seven members: 1. The Program Administrator of the Board of Pharmacy or his or her designee 2. A pharmacist appointed by the Board of Pharmacy 3. Three physicians appointed by the State Board of Medical Examiners, one of which is a pain specialist or addiction specialist 4. A dentist appointed by the State Board of Dental Examiners 5. A veterinarian appointed by the State Board of Veterinary Medicine 6. The Director of the Division of Alcohol and Drug Abuse in the Department of Human Services or his or her designee 9

7. Three persons appointed by the Committee, one of which is a representative of law enforcement The Committee shall advise and assist the Board of Pharmacy with the development, operation, and maintenance of the electronic Prescription Drug Monitoring Program; and with the development of access and security protocols for the program. The Committee shall advise the Board of Pharmacy regarding mandatory information to be reported for inclusion in the program. Committee members shall not receive compensation or reimbursement for expenses associated with service on the Committee. This section is repealed, effective July 1, 2011. Prior to such repeal, the Committee shall be reviewed as provided in Section 2-3-1203, C.R.S. The program will consist of the following: (1) The Board shall develop or procure a prescription controlled substance electronic program to track prescriptions written for controlled substances in Colorado. The program shall track information regarding controlled substance prescriptions that includes, but is not limited to, the following: (a) The date the prescription was dispensed (b) The name of the patient and the prescriber (c) The name and amount of the controlled substance (d) The method of payment (e) The name of the dispensing pharmacy (f) Any other data elements necessary to determine whether a patient is visiting multiple prescribers or pharmacies, or both, to receive the same or similar medication (2) The Board and Committee shall establish a method and format for prescription drug outlets to convey the necessary information to the Board or its designee. The method shall not require more than a one-time entry of data per patient per prescription by a prescription drug outlet. (3) The Division may contract with any individual, public, or private agency or organization in carrying out the data collection and processing duties required by this part. The program access will be the following: (1) The Board shall operate and maintain the program. The Committee shall advise and assist the Board. The Committee shall meet at least quarterly during the first two years of the program. (2) The Board shall adopt all rules necessary to implement the program. The Committee shall advise the Board regarding proposed rules.


(3) The program shall be available for query only to the following persons or groups of persons: (a) Board staff responsible for administering the programs (b) Any licensed practitioner with the statutory authority to prescribe controlled substances to the extent the query relates to a current patient of the practitioner to whom the practitioner is prescribing or considering prescribing any controlled substance (c) Practitioners engaged in a legitimate program to monitor a patients controlled substance abuse (d) Licensed pharmacists with statutory authority to dispense controlled substances to the extent the information requested relates specifically to a current patient to whom the pharmacist is dispensing or considering dispensing a controlled substance (e) Law enforcement officials so long as the information related is specific to an individual and is part of a bona fide investigation and the request for information is accompanied by an official court order or subpoena (f) The individual who is the recipient of a controlled substance prescription so long as the information released is specific to such individual (4) A licensed practitioner or licensed pharmacist who transmits data in compliance with the operation and maintenance of the program shall not be charged a fee for the transmission of such data. (5) The State Board of Pharmacy may, pursuant to a written agreement that ensures compliance with this Part 7, provide data to qualified personnel of a public or private entity for the purpose of bona fide research or education, so long as such information does not identify a recipient, prescriber, or dispenser of a prescription drug. (6) The Board shall provide a means of sharing information about individuals whose information is recorded in the program with out-of-state health care practitioners and law enforcement officials that meet the requirements of paragraph b), c), or e) of Subsection 3) of this section. 12-22-707. Violations-penalties. A person who knowingly releases, obtains, or attempts to obtain information from the program in violation of this Part 7 shall be punished by a civil fine of not less than one thousand dollars and not more than ten thousand dollars for each violation. Fines paid shall be deposited in the Prescription Drug Monitoring Fund.

COLORADO REVISED STATUTES 12-22-320. Records confidential. Prescriptions, orders, and records required by this Part 3 and stocks of controlled substances shall be open for inspection only to federal, state, county, and municipal officers whose duty it is to enforce the laws of this state or of the United States relating to controlled substances or the regulation of practitioners. No officer having knowledge by 11

virtue of his office of any such prescription, order, or record shall divulge such knowledge, except in connection with a prosecution or proceeding in court or before a licensing or registration board or officer to which prosecution or proceeding the person to whom such prescriptions, orders, or records relate is a party. 18-8-115. Duty to report a crime liability for disclosure. It is the duty of every corporation or person who has reasonable grounds to believe that a crime has been committed to report promptly the suspected crime to law enforcement authorities. Notwithstanding any other provision of the law to the contrary, a corporation or person may disclose information concerning a suspected crime to other persons or corporations for the purposes of giving notice of the possibility that other such criminal conduct may be attempted which may affect the persons or corporations notified. When acting in good faith, such corporations or person shall be immune from any civil liability for such reporting or disclosure. This duty shall exist notwithinstanding any other provision of the law to the contrary; except that this section shall not require disclosure of any communication privileged by law. 18-18-415. Fraud and deceit. (1) (a) No person shall obtain a controlled substance or procure the administration of a controlled substance by fraud, deceit, misrepresentation, or subterfuge; or by forgery or alteration of an order; or by the concealment of a material fact; or by the use of a false name or the giving of a false address. (b) Information communicated to a practitioner in an effort to procure a controlled substance other than for legitimate treatment purposes or unlawfully to procure the administration of any such controlled substance shall not be deemed a privileged communication. (c) No personal shall willfully make a false statement in any order, report, or record required by this article. (d) No person, for the purpose of obtaining a controlled substance, shall falsely assume the title of, or represent himself to be, a manufacturer, distributor, practitioner, or other person authorized by law to obtain a controlled substance. (e) No person shall make or utter any false or forged order. (f) No person shall affix any false or forged label to a package or receptacle containing a controlled substance. (2) Any person who violates any provision of this section commits: (a) A class 5 felony and shall be punished as provided in section 18-1-105 (b) A class 4 felony, if the violation is committed subsequent to a prior conviction for a violation to which this subsection (2) applies and shall be punished as provided in section 18-1-105. 12