A Guide to State Opioid Prescribing Policies

Pain Policy and Regulation: Tennessee

53-10-101. "Legend Drugs" Defined

1. For the purpose of this part, "legend drugs" means any item that federal law prohibits dispensing without a prescription from a licensed doctor, dentist, optometrist, or veterinarian.
2. This definition of legend drugs shall not be construed to include blood and blood fractions.
3. Acts1939, chapter 164, §1; C. Supp. 1950, §6632.24 (Williams, §6632.6); Acts 1955, chapter 89, §1; 1959, chapter 52, §1; 1971, chapter 163, §43; 1980, chapter 710, §1; T.C.A. (original edition), §52-1201; Acts 1993, chapter 295, §7

53-10-304. Administrative Attachment: Controlled Substance Database -- Data Requirements

1. There is created within the department a controlled substance database to be attached administratively and for purposes of staffing to the Board of Pharmacy. The executive director of the Board shall be responsible for determining staffing.
2. The Board and the committee shall establish, administer, maintain, and direct the functioning of the database in accordance with this part. The Board, upon concurrence of the Committee may, under state procurement laws, contract with another state agency or private entity to establish, operate, or maintain the database. Additionally, the Board, upon concurrence of the Committee, shall determine whether to operate the database within the Board or contract with another entity to operate the database, based on an analysis of costs and benefits.
3. The purpose of the database is to assist in research, statistical analysis, and the education of healthcare practitioners concerning patients who, by virtue of their conduct in acquiring controlled substances, may require counseling or intervention for substance abuse. This is accomplished by collecting and maintaining data as described in this part regarding all controlled substances in schedules II, III, and IV dispensed in this state, and schedule V controlled substances identified by the controlled substance database advisory committee as demonstrating a potential for abuse.
4. The data required by this part shall be submitted in compliance with this part to the Committee by any practitioner or person under the supervision and control of the practitioner, pharmacist, or pharmacy who dispenses a controlled substance contained in schedules II, III,IV, and V controlled substances identified by the controlled substance database advisory committee as demonstrating a potential for abuse. The reporting requirement shall not apply for the following:
   1. A drug administered directly to a patient;
   2. Any drug dispensed by a licensed healthcare facility, provided the quantity dispensed is limited to an amount adequate to treat the patient for a maximum of forty-eight (48) hours;
   3. Any drug sample dispensed; or
   4. Any facility that is registered by the United States Drug Enforcement Administration as a narcotic treatment program and is subject to the recordkeeping provisions of 21 CFR 1304.24.

Acts 2002, chapter 840, §1; 2004, chapter 673, §s 24 and 25; 2007, chapter 518, §3

53-11-308. Prescription Requirements

1. No controlled substance in schedule II may be dispensed without the written prescription of a practitioner except when dispensed directly by a practitioner, other than a pharmacy, to an ultimate user.
2. In emergency situations, schedule II drugs may be dispensed after a verbal request for prescription by a practitioner, but a written prescription must be submitted promptly be and filed by the pharmacy. Prescriptions shall be retained in conformity with the requirements of §53-11-305. No prescription for a schedule II substance may be refilled.
3. A controlled substance included in schedule III or IV, that is a prescription drug, shall not be dispensed without the written or oral prescription of a practitioner except when dispensed directly by a practitioner, other than a pharmacy, to an ultimate user. The prescription shall not be filled or refilled more than six (6) months after the date of the written or oral prescription or be refilled more than five (5) times, unless renewed by the practitioner.
4. A controlled substance included in schedule V shall not be distributed or dispensed other than for a medical purpose.

Acts 1971, chapter 163, §24; TCA, §52-1431

39-17-401. Tennessee Drug Control Act

• Acts 1989, chapter 591, §1
• This part and title 53, chapter 11, parts 3 and 4, shall be known and may be cited as the "Tennessee Drug Control Act of 1989."

39-17-402. Definitions

As used in this part and title 53, chapter 11, parts 3 and 4, unless the context otherwise requires:

1. "Administer" means the direct application of a controlled substance, whether by injection, inhalation, ingestion, or any other means, to the body of a patient or research subject by:
   1. A practitioner or by the practitioner's authorized agent in the practitioner's presence; or
   2. The patient or research subject at the direction and in the presence of the practitioner;
2. "Agent" means an authorized person who acts on behalf of or at the direction of a manufacturer, distributor, or dispenser. Agent does not include a common or contract carrier, public warehouseman, or employee of the carrier or warehouseman;
3. "Bureau" means the United States Drug Enforcement Administration, United States Department of Justice, or its successor agency, except when used as the Tennessee Bureau of Investigation;
4. "Controlled substance" means a drug, substance, or immediate precursor in schedules I through VI of §§39-17-403-39-17-415;
5. "Counterfeit substance" means a controlled substance which, or the container or labeling of which, without authorization, bears the trademark, trade name, or other identifying mark, imprint, number or device, or any likeness thereof, of a manufacturer, distributor, or dispenser other than the person who in fact manufactured, distributed, or dispensed the substance;
6. "Deliver" or "delivery" means the actual, constructive, or attempted transfer from one person to another of a controlled substance, whether or not there is an agency relationship;
7. "Dispense" means to deliver a controlled substance to an ultimate user or research subject by or pursuant to the lawful order of a practitioner, including the prescribing, administering, packaging, labeling, or compounding necessary to prepare the substance for that delivery;
8. "Dispenser" means a practitioner who dispenses;
9. "Distribute" means to deliver other than by administering or dispensing a controlled substance;
10. "Distributor" means a person who distributes;
11. "Drug" means:
    1. Substances recognized as drugs in the United States Pharmacopoeia, official Homeopaths Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them;
    2. Substances intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animal;
    3. Substances, other than food, intended to affect the structure or any function of the body of man or animal; and
    4. Substances intended for use as a component of any article specified in subdivision (11)(A), (B), or (C). Drug does not include devices or their components, parts, or accessories;
12. "Drug paraphernalia" means all equipment, products, and materials of any kind which are used, intended for use, or designed for use in planting, propagating, cultivating, growing, harvesting, manufacturing, compounding, converting, producing, processing, preparing, testing, analyzing, packaging, repackaging, storing, containing, concealing, injecting, ingesting, inhaling, or otherwise introducing into the human body, a controlled substance as defined in subdivision (4). Drug paraphernalia includes, but is not limited to:
    1. Isomerization devices used, intended for use, or designed for use in increasing the potency of any species of plant that is a controlled substance;
    2. Testing equipment used, intended for use, or designed for use in identifying, or in analyzing the strength, effectiveness, or purity of controlled substances; and
    3. Objects used, intended for use, or designed for use in ingesting, inhaling, or otherwise introducing marijuana, cocaine, hashish, or hashish oil into the human body, such as:
       1. metal, acrylic, glass, stone, or plastic pipes with or without screens, permanent screens, hashish heads, or punctured metal bowls;
       2. water pipes;
       3. carburation tubes and devices;
       4. smoking and carburation masks;
       5. chamber pipes;
       6. carburetor pipes;
       7. electric pipes;
       8. chillums;
       9. bongs; and
       10. ice pipes or chillers;
13. "Immediate methamphetamine precursor" means ephedrine, pseudoephedrine, or phenylpropanolamine, or their salts, isomers, or salts of isomers, or any drug or other product that contains a detectable quantity of ephedrine, pseudoephedrine, or phenylpropanolamine, or their salts, isomers, or salts of isomers;
14. "Immediate precursor" means a substance that the Commissioner of Mental Health and Developmental Disabilities, on the agreement of the Commissioner of Health, has found to be and by rule designates as being the principal compound commonly used or produced primarily for use, and that is an immediate chemical intermediary used or likely to be used in the manufacture of a controlled substance, the control of which is necessary to prevent, curtail, or limit manufacture;
15. "Manufacture" means the production, preparation, propagation, compounding, conversion or processing of a controlled substance, either directly or indirectly by extraction from substances of natural origin, or independently by means of chemical synthesis, and includes any packaging or repackaging of the substance or labeling or relabeling of its container. Manufacture does not include the preparation or compounding of a controlled substance by an individual for the individual's own use or the preparation, compounding, packaging, or labeling of a controlled substance by:
    1. A practitioner as an incident to administering or dispensing a controlled substance in the course of professional practice; or
    2. A practitioner, or an authorized agent under the practitioner's supervision, for the purpose of, or as an incident to, research, teaching, or chemical analysis and not for sale;
16. "Marijuana" means all parts of the plant cannabis, whether growing or not; the seeds of the plant; the resin extracted from any part of the plant; and every compound, manufacture, salt, derivative, mixture, or preparation of the plant, its seeds, or resin. Marijuana does not include the mature stalks of the plant, fiber produced from the stalks, oil or cake made from the seeds of the plant, any other compound, manufacture, salt, derivative, mixture, or preparation of the mature stalks, except the resin extracted from the mature stalks, fiber, oil, or cake, or the sterilized seeds of the plant, which are incapable of germination;
17. "Narcotic drug" means any of the following, whether produced directly or indirectly by extraction from substances of vegetable origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis:
    1. Opium and opiate, and any salt, compound, derivative, or preparation of opium or opiate;
    2. Any salt, compound, isomer, derivative, or preparation thereof that is chemically equivalent or identical with any of the substances referred to in subdivision (16)(A), but not including the isoquinoline alkaloids of opium;
    3. Opium poppy and poppy straw; and
    4. Coca leaves and any salt, compound, derivative, or preparation of coca leaves, and any salt, compound, isomer, derivative, or preparation thereof that is chemically equivalent or identical with any of these substances, but not including decocainized coca leaves or extractions of coca leaves that do not contain cocaine or ecgonine;
18. "Opiate" means any substance having an addiction-forming or addiction-sustaining liability similar to morphine or being capable of conversion into a drug having addiction-forming or addiction-sustaining liability. Opiate does not include, unless specifically designated as controlled under §39-17-403, the dextrorotatory isomer of 3-methozy-methyl-morphinan and its salts (dextromethorphan). Opiate does not include its racemic and levorotatory forms;
19. "Opium poppy" means the plant of the species Papaver somniferum 1 , except its seeds;
20. "Person" means individual, corporation, governmental subdivision or agency, business trust, estate, trust, partnership, or association or any other legal entity;
21. "Pharmacist" means a licensed pharmacist as defined by the laws of this state, and where the context so requires, the owner of a store or other place of business where controlled substances are compounded or dispensed by a licensed pharmacist; but nothing in this part or title 53, chapter 11, parts 3 and 4 shall be construed as conferring on a person who is not registered or licensed as a pharmacist any authority, right, or privilege that is not granted to that person by the pharmacy laws of this state;
22. "Poppy straw" means all parts, except the seeds, of the opium poppy after mowing;
23. "Practitioner" means:
    1. A physician, dentist, optometrist, veterinarian, scientific investigator, or other person who is licensed, registered, or otherwise permitted to distribute, dispense, conduct research with respect to, or to administer a controlled substance in the course of professional practice or research in this state; or
    2. A pharmacy, hospital, or other institution licensed, registered, or otherwise permitted to distribute, dispense, conduct research with respect to, or to administer a controlled substance in the course of professional practice or research in this state;
24. "Production" includes the manufacturing, planting, cultivating, growing, or harvesting of a controlled substance;
25. "State," when applied to a part of the United States, includes any state, district, commonwealth, territory, insular possession thereof, and any area subject to the legal authority of the United States;
26. "Ultimate user" means a person who lawfully possesses a controlled substance for the person's own use or for the use of a member of the person's household or for the administering to an animal owned by the person or by a member of the person's household; and
27. "Wholesaler" means a person who supplies a controlled substance that the person has not produced or prepared, on official written orders, but not on prescriptions.
28. Acts 1989, chapter 591, §1; 1993, chapter 295, §8; 2005, chapter 18, §9

63-6-233. Continuing Medical Education

1. Any person licensed to practice medicine in this state shall complete continuing medical education as required by the Board of Medical Examiners. The Board of Medical Examiners may establish waivers from such continuing medical education requirements and exemptions for certain licensees through rules and regulations.
2. The Board of Medical Examiners shall establish the continuing medical educational requirements, waivers, and exemptions through rules and regulations promulgated in accordance with the provisions of the Uniform Administrative Procedures Act, compiled in title 4, chapter 5.

Acts 2001, chapter 320, §1

63-6-236. Drug Prescriptions

1. Any handwritten prescription order for a drug prepared by a physician or surgeon who is authorized by law to prescribe a drug must be legible so that it is comprehensible by the pharmacist who fills the prescription. The handwritten prescription order must contain the name of the prescribing physician or surgeon; the name and strength of the drug prescribed; the quantity of the drug prescribed, handwritten in both letters and numerals; instructions for the proper use of the drug; and the month and day that the prescription order was issued, recorded in letters or in numerals or a combination thereof. The prescribing physician or surgeon must sign the handwritten prescription order on the day it is issued, unless the prescription order is:
   1. Issued as a standing order in a hospital, a nursing home or an assisted care living facility as defined in §68-11-201; or
   2. Prescribed by a physician or surgeon in the Department of Health or local health departments, or dispensed by the Department of Health or a local health department as stipulated in §63-10-205.
2. Any typed or computer-generated prescription order for a drug issued by a physician or surgeon who is authorized by law to prescribe a drug must be legible so that it is comprehensible by the pharmacist who fills the typed or computer-generated prescription order. The prescription order must contain the name of the prescribing physician or surgeon; the name and strength of the drug prescribed; the quantity of the drug prescribed, recorded in letters or in numerals; instructions for the proper use of the drug; and the month and day that the typed or computer-generated prescription order was issued, recorded in letters or in numerals or a combination thereof. The prescribing physician or surgeon must sign the typed or computer-generated prescription order on the day it is issued, unless the prescription order is:
   1. Issued as a standing order in a hospital, nursing home or an assisted care living facility as defined in §68-11-201; or
   2. Prescribed by a physician or surgeon in the Department of Health or local health departments, or dispensed by the Department of Health or a local health department as stipulated in §63-10-205.
3. Nothing in this section shall be construed to prevent a physician or surgeon from issuing a verbal prescription order.

Acts 2004, chapter 678, §5; 2005, chapter 12, §3.

63-6-1102. Part Definitions

• For the purposes of this part:
  1. "Board" means the Board of Medical Examiners.
  2. "Chemical dependency" means
     1. The abuse of alcohol or a controlled substance;
     2. A pathologic use of alcohol or a controlled substance that chronically impairs the applicant's ability to competently provide legal advice or services; or
     3. A physiologic or physical dependence on alcohol or a controlled substance.
  3. "Intractable pain" means a pain state in which the cause of the pain cannot be removed or otherwise treated and, in 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.
  4. "Physician" means a physician licensee of the Board of Medical Examiners or an osteopathic physician.

Acts 2001, chapter 327, §3

63-6-1103. Legislative Declarations

• The General Assembly finds and declares all of the following:
  1. The state has a right and duty to control the illegal use of opiate drugs;
  2. Inadequate treatment of acute and chronic pain originating from cancer or noncancerous conditions is a significant health problem;
  3. For some patients, pain management is the single most important treatment a physician can provide;
  4. A patient with severe chronic intractable pain should have access to proper treatment of such pain;
  5. Because of the complexity of their problems, many patients with severe chronic intractable pain may require referral to a physician with expertise in the treatment of severe chronic intractable pain. In some cases, severe chronic intractable pain is best treated by a team of clinicians to address the associated physical, psychological, social, and vocational issues;
  6. In the hands of knowledgeable, ethical, and experienced pain management practitioners, opiates administered for severe acute and severe chronic intractable pain can be safe;
  7. Opiates can be an accepted treatment for patients with severe chronic intractable pain who have not obtained relief from any other means of treatment;
  8. A patient with severe chronic intractable pain has the option to request or reject the use of any or all modalities to relieve such patient's severe chronic intractable pain;
  9. A physician treating a patient who has severe chronic intractable pain may prescribe a dosage deemed medically necessary to relieve severe chronic intractable pain as long as the prescribing physician is in conformance with the provisions of this part;
  10. A patient who has severe chronic intractable pain has the option to choose opiate medication for the treatment of the severe chronic intractable pain as long as a physician has first determined that such treatment is appropriate and medically necessary, and the prescribing is in conformance with the provisions of this part; and
  11. The patient's physician may refuse to prescribe opiate medication for a patient who requests the treatment for severe chronic intractable pain. However, that physician shall inform the patient that there are physicians whose primary practices are the treatment of severe chronic intractable pain with methods that include the use of opiates.

Acts 2001, chapter 327, §4

63-6-1105. Physician Authorized to Write Prescriptions

• Notwithstanding any other provision of law, a physician may prescribe or administer dangerous drugs or controlled substances to a person in the course of the physician's treatment of a person for intractable pain to provide adequate pain treatment.
• Acts 2001, chapter 327, §6
• The Tennessee Board of Medical Examiners is charged by the General Assembly to protect the citizens of the state from harmful physician management. A significant number of physicians who are asked to appear before the Board are required to do so because of their lack of information about the management and responsibilities involved in prescribing controlled substances. Frequently, the inadvertent offender is a physician with a warm heart and a desire to relieve pain and misery who is always pressed for time and finds himself or herself prescribing controlled drugs on demand over prolonged periods without adequate documentation. These are often for chronic ailments such as headache, arthritis, old injuries, chronic orthopedic problems, backache, and anxiety. (Terminal cancer pain management is not a consideration here.) The purpose of the Board of Medical Examiners in presenting the following information is to help licensed physicians in Tennessee consider and reevaluate their prescribing practice of controlled substances. Practicing physicians have often mentioned the abrupt education they received in their own prescribing patterns. Moreover, there have been many requests to the Board from physicians asking for detailed information about prescribing in certain specific situations.
• It is not what you prescribe, but how well you manage the patient's care and document that care in legible form that is important.
• The prescribing matters that come before the Board are almost always related to the prescription of controlled substances. We feel that a majority of instances where physicians have been disciplined by the Board for prescribing practices could have been avoided completely if the physician had followed the steps that are being outlined here.
• To prevent any misunderstanding, it is necessary to state what the Board does not have.
• It does not have a list of "bad" or "disallowed" drugs, except in certain circumstances, including amphetamines, amphetamine-like substances, and central nervous system stimulants. (See Board of Medical Examiner Rule 0880-2-.14, a copy of which is available to you by contacting the Board's administrative office at 615-367-6231.) All formulary drugs, except as previously noted, are good if prescribed and administered when properly indicated. Conversely, all drugs are ineffective, dangerous, or even lethal when used inappropriately.
• The Board does not have a magic formula for determining the dosage and duration of administration for any drug. These are aspects of prescribing that must be determined within the confines of the individual clinical case and continued under proper monitoring. What is good for one patient may be insufficient or fatal for another.
• What the Board does have is the expectation that physicians will create a record that shows:
  • Proper indication for the use of drug or other therapy;
  • Monitoring of the patient where necessary;
  • The patient's response to therapy based on follow-up visits; and
  • All rationale for continuing or modifying the therapy.
• STEP 1: First and foremost, before you prescribe anything, start with a diagnosis that is supported by history and physical findings and by the results of any appropriate tests. Too many times a doctor is asked why he or she prescribed a particular drug, and the response is "Because the patient has arthritis." Then the doctor is asked "How did you determine that?" and the answer is "Because that's what the patient complained of." Nothing in the record or in the doctor's recollection supports the diagnosis except the patient's assertion. Do a workup sufficient to support a diagnosis including all necessary tests.
• STEP 2: Create a treatment plan that includes the use of appropriate nonaddictive modalities, and make referrals to appropriate specialists, such as neurologists, orthopedists, and psychiatrists. The result of the referral should be included in the patient's chart.
• STEP 3: Before beginning a regimen of controlled drugs, make a determination through trial or through a documented history that nonaddictive modalities are not appropriate or they do not work. A finding of intolerance or allergy to nonsteroidal anti-inflammatory drugs (NSAIDs) is one thing, but the assertion of the patient that, "Gosh, Doc, nothing seems to work like that Percodan stuff!" is quite another. Too many doctors seen by the Board have started a treatment program with powerful controlled substances without ever considering other forms of treatment.
• STEP 4: Make sure you are not dealing with a drug-seeking patient. If you know the patient, review the prescription records in the patient's chart and discuss the patient's chemical history before prescribing a controlled drug. If the patient is new or otherwise unknown to you, at a minimum obtain an oral drug history, and discuss chemical use and family chemical history with the patient.
• STEP 5: It is a good idea to obtain the informed consent of the patient before using a drug that has the potential to cause dependency problems. Take the time to explain the relative risks and benefits of the drug and record in the chart that this was done. When embarking on what appears to be the long-term use of a potentially addictive substance, it may be wise to hold a family conference and explain the relative risks of dependency or addiction and what that may mean to the patient and to the patient's family. Refusal of the patient to permit a family conference may be significant information.
• STEP 6: Maintain regular monitoring of the patient, including frequent physical monitoring. If the regimen is for a prolonged drug use, it is very important to monitor the patient for the root condition that necessitates the drug and for the side effects of the drug itself. This is true no matter what type of controlled substance is used or what schedule it belongs to. Also, remember that with certain conditions, drug holidays are appropriate. This allows you to check to see whether the original symptoms recur when the drug is not given -- indicating a continuing legitimate need for the drug, or whether withdrawal symptoms occur -- indicating drug dependence.
• STEP 7: Make sure YOU the physician are in control of the supply of the drug. To do this, at a minimum, detailed records must be kept of the type, dose, and amount of the drug prescribed. All refills must be monitored, recorded, and personally controlled by the physician. Office personnel should not be authorized to refill prescriptions without consulting the treating physician. One good way to accomplish this is to require the patient to return to obtain refill authorization, at least part of the time. Records of the cumulative dosage and average daily dosage are especially valuable.
• A thumbnail sketch of 3 hypothetical cases will illustrate our point here. In the first case, a physician prescribes Tussionex (chlorphenirimine and hydrocodone) to a patient for approximately 5 years for a cumulative dosage of 19 and one half gallons. In the second case, a physician prescribes Tylenol 3 (acetaminophen with codeine) to a patient for slightly more than a year at the average daily rate of 30 per day! The third case is very similar, except that it was Tylenol 4 at the rate of 20 per day. Some quick observations:
• No physician who was aware of that kind of prescribing would have continued with it.
• Few, if any, patients could have been consuming that much Tylenol with codeine. In all likelihood, they were reselling it. Another important part of controlling the supply of drugs is to check whether the patient is obtaining drugs from other physicians.
• Checking with pharmacies and pharmacy chains and other healthcare providers may tell you whether a patient is obtaining extra drugs or the patient is doctor shopping. If you are aware it is occurring, contact other physicians and health professionals in your area.
• STEP 8: Maintaining regular contact with the patient's family is a valuable source of information on the patient's response to the therapy regimen and may be much more accurate and objective than feedback from the patient alone. The family is a much better source of information on behavioral changes, especially dysfunctional behavior, than is the patient. Dysfunctional changes may be observable when the patient is taking the drug, or when the drug is withdrawn. These changes, at either time, may be a symptom of dependency or addiction.
• The family is also a good source of information about whether the patient is obtaining drugs from other sources or is self-medicating with other drugs or alcohol.
• STEP 9: To reiterate, one of the most frequent problems faced by a physician when he or she comes before the Board or other outside review bodies is inadequate records. It is entirely possible that the doctor did everything correctly in managing a case, but without records that reflect all the steps that went into the process, the job of demonstrating it to any outside reviewer becomes many times more difficult. Luckily, this problem is solvable.

Adopted by the Board of Medical Examiners on this the 19th day of September, 1995.

Policy: Prescribing for Oneself and One's Family

• The Tennessee Board of Medical Examiners adopts the following guidelines as policy for self-prescribing and prescribing for one's immediate family.
• Self-Prescribing
  1. A physician cannot have a bona fide doctor/patient relationship with himself or herself.
  2. Only in an emergency should a physician prescribe for himself or herself schedule IV drugs.
  3. Prescribing, providing, or administering of schedule II and III drugs to himself or herself is prohibited.
• Immediate Family
  1. Treatment of immediate family members should be reserved only for minor illnesses or emergency situations.
  2. Appropriate consultation should be obtained for the management of major or extended periods of illness.
  3. No schedule II, III, or IV controlled substances should be dispensed or prescribed except in emergency situations.
  4. Records should be maintained of all written prescriptions or administration of any drugs.

Adopted by the Board of Medical Examiners on this 21st day of January 1997.

Tennessee Code Annotated, Sections 63-6-214 (b) (1), (4), and (12)

• Tennessee Code Annotated, Sections 63-6-214 (b) (1), (4), and (12) enumerate grounds upon which the Tennessee Board of Medical Examiners may take licensure disciplinary action against a licensee and provide as follows:
  • (b) (1) Unprofessional, dishonorable or unethical conduct;
  • (4) Gross malpractice, or a pattern of continued or repeated malpractice, ignorance, negligence, or incompetence in the course of medical practice;
  • (12) Dispensing, prescribing, or otherwise distributing any controlled substance or any other drug not in the course of professional practice, or not in good faith to relieve pain and suffering, or not to cure an ailment, physical infirmity or disease, or in amounts and/or for durations not medically necessary, advisable, or justified for a diagnosed condition.
• The Board of Medical Examiners hereby states its position on the interpretation of those laws in regard to the issuance of prescriptions or dispensing of drugs to be as follows:
  1. Except as provided in paragraph (2), it shall be a prima facie violation of TCA 63-6-214 (b) (1), (4), and (12) for a physician to prescribe or dispense any drug to any individual, whether in person or by electronic means or over the Internet or over telephone lines, unless the physician has first done and appropriately documented, for the person to whom a prescription is to be issued or drugs dispensed, all of the following:
     1. Performed an appropriate history and physical examination; and
     2. Made a diagnosis based on the examinations and all diagnostic and laboratory tests consistent with good medical care; and
     3. Formulated a therapeutic plan, and discussed it, along with the basis for it and the risks and benefits of various treatments options, a part of which might be the prescription or dispensing drug, with the patient; and
     4. Ensured availability of the physician or coverage for the patient for appropriate follow-up care.
  2. (2) A physician may prescribe or dispense drugs for a person not in compliance with subparagraph (a) in circumstances including, but not limited to, the following:
     1. In admission orders for a newly hospitalized patient; and
     2. For a patient of another physician for whom the prescriber is taking calls; and
     3. For continuation medications on a short-term basis for a new patient prior to the patient's first appointment; and
     4. For established patients who, based on sound medical practices, the physician feels do not require a new physical examination before issuing new prescriptions.
  3. It shall be a prima facie violation of TCA 63-6-214 (b) (1), (4), and (12) for a physician to prescribe or dispense any drug to any individual the physician has never met based solely on answers to a set of questions regardless of whether the prescription is issued directly to the person or electronically over the Internet or telephone lines.

Adopted by the Board of Medical Examiners on this the 13th day of September 2000.

1140-3-.03 Medical and Prescription Orders

1. To the extent that a medical order contains an order for the compounding, dispensing or administration of a prescription drug or device or related material, the medical order shall be treated as a prescription order. Written medical and prescription orders must be signed by the prescriber. Verbal medical and prescription orders must be immediately reduced to writing (by hand or other means), dated, and initialed by the authorized individual accepting the medical and prescription orders.
2. Each medical and prescription order when dispensed shall be serially numbered, filed numerically, and maintained so as to be readily retrievable at the pharmacy practice site for at least two (2) years from the date the medical and prescription order was last dispensed. Institutional pharmacies shall not be required to serially number medical and prescription orders dispensed for administration to inpatients of that institution.
3. A pharmacist, upon initial dispensing of a medical or prescription order, shall record on that medical or prescription order: the date such medical or prescription order was dispensed, the pharmacist's initials, and the amount of any product dispensed. If the pharmacist merely initials and dates a medical or prescription order, the pharmacist shall be deemed to have dispensed the full face amount of the medical or prescription order.
4. A pharmacist, upon refilling a medical or prescription order, shall enter on the back of that medical or prescription order: the date such medical or prescription order was refilled, the pharmacist's initials, and the amount of any product dispensed on such refill. If the pharmacist merely initials and dates the back of the medical or prescription order, the pharmacist shall be deemed to have dispensed a refill for the full face amount of the medical or prescription order. As an alternative to recording refill information on the back of medical and prescription orders, an automated data processing system may be used for the storage and retrieval of refill information for medical and prescription orders, subject to the following conditions:
   1. Any such computerized system must provide online retrieval (via CRT display or hard copy printout) of the original medical or prescription order information and the complete refill history of all medical and prescription orders that are currently authorized for refilling. This shall include all the information contained in and required to be entered on each such medical or prescription order. These data must include at least the medical or prescription order serial number; date of issuance of the medical or prescription order; patient's name (and address on controlled substance medical and prescription orders); prescriber's name (and address and Drug Enforcement Agency registration number on controlled substance medical and prescription orders); product name, strength, dosage form, and quantity prescribed; directions for use and labeling instructions; refill instructions; and the date of dispensing, quantity dispensed, and identity (name, initials, or identification code) of the dispensing pharmacist for the original dispensing and each refill.
   2. Each individual pharmacist using a computerized system in the refilling of a medical or prescription order shall certify that the information entered into the computer for such a refill is correct by verifying, dating, and signing a hard-copy printout of each day's medical or prescription order refill data, or in lieu of such a printout, by signing a statement in a book or file each day attesting that the refill information entered that day has been reviewed by the pharmacist and is correct as shown. Such documentation shall be separately maintained at the pharmacy practice site for at least two (2) years from the date of the last dispensing.
   3. Any such computerized system shall have the capability of producing a hard-copy printout of any medical or prescription order refill data that the pharmacy practice site is responsible for maintaining under the laws and/or regulations of this state and/or the federal government. (This system would, for example, provide a medical or prescription order-by-medical or prescription order, refill-by-refill audit trail for any specified strength and dosage form of any prescription drug or device, by either brand or generic name or both.) Such a printout must include: the medical or prescription order serial number; patient's name (and address on controlled substance medical and prescription orders); name of prescriber; name, strength, and dosage form of the product; and the date of each refill, quantity dispensed on each refill, and the name or identification code of the dispensing pharmacist. Controlled substance data contained on such a printout must be separated, asterisked, or in some other manner visually identifiable apart from other items appearing on the printout. Any computerized system used by a pharmacy practice site must, upon the request of an authorized representative of the Board, send or provide such a printout to the pharmacy practice site within forty-eight (48) hours excluding weekends (Saturdays and Sundays) and legal holidays.
   4. In the event that a pharmacy practice site that uses such a computerized system experiences system down-time, the pharmacy practice site must have a written or readily retrievable auxiliary policy and procedure that will be used for documentation of refills of all medical and prescription orders. This auxiliary procedure must ensure that each refill is authorized and that all appropriate data are retained for on-line data entry as soon as the computer system is available for use again.
   5. Each pharmacy practice site and pharmacist using such a computerized system must comply with the provisions of paragraphs one (1) and two (2) of this rule. In addition, the requirements of paragraph three (3) of this rule shall apply, unless the initial dispensing data are included on the printout required by subparagraph four (4)(b) of this rule, and are identified as pertaining to the initial dispensing.
5. A pharmacist may dispense an appropriately authorized refill of a medical or prescription order by referral to a patient profile (medication record) instead of the original medical or prescription order on file at that pharmacy practice site, subject to the following conditions:
   1. The patient profile must contain all the information contained in and required to be entered on the original medical or prescription order, including the complete refill history of that medical or prescription order. This includes the medical or prescription order serial number; date of issuance of the medical or prescription order; name of patient; name of the prescriber; product name; strength; dosage form, and quantity prescribed; directions for use, and labeling instructions; refill instructions; and the date of dispensing, quantity dispensed, and initials of the dispensing pharmacist for the original dispensing and each refill. Dispensing data must be identified as pertaining to the original dispensing or to a refill.
   2. Controlled substance data contained in the patient profile must be asterisked, redlined, or in some other manner visually identifiable apart from other items appearing on the profile.
   3. The patient profile system must contain a complete and accurate record of the refill history of all medical and prescription orders dispensed at the pharmacy practice site. (This record will constitute compliance with the provisions of paragraph four (4) of this rule.)
   4. Each such profile must be maintained so as to be readily retrievable at the pharmacy practice site for at least two (2) years from the date of the last dispensing recorded on the profile.
   5. A pharmacist dispensing a medical or prescription order by referral to a patient profile in so doing certifies as to the accuracy and validity of the information contained on the patient profile.
   6. Each pharmacy practice site and pharmacist using such a patient profile system must comply with the provisions of paragraphs one (1) and two (2) of this rule. In addition, the requirements of paragraph three (3) of this rule shall pertain, unless the patient profile system contains a record of this initial dispensing information for all medical and prescription orders dispensed at the pharmacy practice site.
6. No pharmacist, or pharmacy intern or pharmacy technician under the supervision of a pharmacist, shall compound or dispense any medical or prescription order except upon the following conditions:
   1. All medical and prescription orders shall be compounded and dispensed in strict conformity with any directions of the prescriber. Nothing in this rule shall prohibit a pharmacist from substituting a therapeutically equivalent prescription drug or device or related material containing the same active ingredient or ingredients, dosage form, and strength;
   2. No medical or prescription order shall be refilled if it contains a statement over the signature of the prescriber that it is not to be refilled, and a medical or prescription order shall not be refilled unless so authorized by the prescriber;
   3. If any medical or prescription order contains a statement that it may be refilled a specified number of times within or during any particular period, such order shall be refilled in strict conformity with such statement; and
   4. If a prescription contains a statement that during any particular time it may be refilled at will, the order shall be refilled in strict conformity to dosage directions, with the exception that it may not be refilled after the expiration of the time specified or one (1) year from the date the order was originally issued or dispensed, whichever comes first.
   5. At a rate, based on the actual number of medical and prescription orders compounded and dispensed per hour or per day, that does not pose a danger to the public health, safety, or welfare.
7. Copies of medical and prescription orders.
   1. Copies of medical and prescription orders issued directly to the patient by the pharmacy practice site where the order was originally compounded and dispensed pursuant to the receipt of the order shall bear on the face thereof, in letters red in color and equal in size to those describing the prescription drug or device or related material, the statement: "Copy for Information Only." Presentation of an informational written copy or label of a dispensing container shall be for information purposes only and have no legal status as a valid medical or prescription order. The recipient pharmacist of such copy or label shall contact the prescriber or transferor pharmacy practice site and obtain all information required by this rule, which is the same as obtaining an original medical or prescription order;
   2. Medical and prescription orders shall be transferred between pharmacy practice sites for the purpose of compounding and dispensing provided that the transferee, upon receiving such order directly from the transferor, records the following:
      1. The name, address, and original medical or prescription order serial number at the pharmacy practice site from which the order was transferred;
      2. The name of the transferor; and
      3. All information constituting a medical or prescription order including the following:
         1. date of original dispensing;
         2. original number of refills authorized on the original order;
         3. date of last dispensing; and
         4. number of valid refills remaining.
   3. The transferee must inform the patient that the original medical or prescription order has been canceled at the pharmacy practice site from which it was obtained.
   4. Computerized systems must satisfy all information requirements.
   5. The transfer of schedule III, IV, V, controlled substances are subject to the conditions set forth in C.F.R. 1306.26.
8. It is unlawful for any pharmacy practice site, pharmacist, or pharmacy intern or pharmacy technician under the supervision of a pharmacist, or any other place of business engaged in compounding and dispensing prescription drugs and devices and related materials for human consumption to receive from any patient or other person the return of any portion of an order that has been taken from the premises of the pharmacy practice site or other place of business, except pursuant to 1140-4-.10.
9. Medical and prescription orders cannot be accepted, solicited, collected, or advertised at a location other than a pharmacy practice site for which a license has been issued by the Board, and such pharmacy practice site shall be actively engaged in compounding and dispensing medical and prescription orders.
10. Medical and prescription orders typed or printed must be signed by the prescriber. Oral medical and prescription orders shall be initialed by the authorized individual accepting the order.

1140-3-.04 Facsimile and Electronic Medical and Prescription Orders

1. Facsimile orders
   1. The transmission of a facsimile medical or prescription order shall be to a pharmacy practice site of the patient's choice and shall occur only at the option of the patient.
   2. Medical and prescription orders may be transmitted to a pharmacy practice site by a facsimile device. Medical and prescription orders for controlled substances may be transmitted by facsimile devices in compliance with 21 C.F.R. 21306.11, 1306.21, and 1306.31.
   3. A pharmacist may dispense medical and prescription orders transmitted by facsimile devices only when transmitted by an authorized prescriber or the prescriber's designated agent.
   4. A facsimile medical or prescription order that meets the requirements of this rule shall be deemed the original medical or prescription order for purposes of filing. The facsimile medical or prescription order must either be photocopied or the original medical or prescription order should be of such quality to not fade within the legal requirements of medical or prescription order record keeping.
   5. Wholesalers, manufacturers, pharmacists, and pharmacy practice sites are prohibited from supplying facsimile devices or supplies to any authorized prescriber under any conditions.
   6. An original medical or prescription order that indicates that it has been faxed to a pharmacy practice site, consistent with the provisions of this rule, may only be dispensed as an original medical or prescription order by the pharmacy practice site to which it was faxed, consistent with the notation on the medical or prescription order to be made in accordance with the requirements contained in this rule.
2. Electronic orders
   1. Prescription or medical orders transmitted electronically shall meet the following criteria:
   1. All prescription or medical orders shall be transmitted directly from an authorized prescriber or prescriber's agent to a licensed pharmacist or to an area in a licensed pharmacy of the patient's choice that is under the direct supervision of a licensed pharmacist, with no intervening person or entity having access to the order for purposes other than transmission of the order. Subject to the provisions of this rule, a prescriber or prescriber's agent may electronically transmit medical or prescription orders to a pharmacist within an institutional facility for inpatients and/or outpatients currently under treatment at that facility. Nothing in this subsection shall apply to distributors of medical gases.
   2. The transmission shall include:
      1. the telephone number of the authorized prescriber to allow verbal confirmation of the validity and accuracy of the order;
      2. the correct time and date of the transmission;
      3. the name of the pharmacy to which the order is being transmitted; and
      4. the prescribing practitioner's electronic signature or other secure method of validation. "Electronic signature" is defined as the process that secures the user authentication (proof of claimed identify, such as by biometrics, fingerprints, retinal scans, handwritten signature verification) at the time the signature is generated and creates the logical manifestation of a signature.
      5. If the transmission is delegated by the prescriber to an agent of the prescriber, the identity of the agent shall be included in the transmission.
   2. A hard copy or exact image of the transmitted order shall be maintained in the pharmacy and shall be deemed the original prescription or medical order meeting all requirements of rule 1140-3-.03 of the rules of the Board.
   3. The pharmacist receiving any transmitted order shall not knowingly participate in any system that restricts the patient's choice of pharmacy.
   4. The pharmacist may not provide financial or other remuneration to the prescriber for any prescription transmitted to the dispensing pharmacy. No person or entity, including but not limited to wholesalers, distributors, manufacturers, pharmacists, and pharmacies, shall supply electronic equipment, software, devices, or modems to any prescriber in exchange for transmitting orders.
   5. The pharmacist shall not use the electronic transmission of orders to circumvent or violate any provision of state or federal drug laws, or the Tennessee Pharmacy Practice Act, or the regulations of the Board.
   6. This rule shall not apply to medical or prescription orders electronically transmitted between pharmacies or medical or prescription orders transmitted by facsimile.

Authority: T.C.A. §§63-10-404(19),(26),(29),(30), and (34), 63-10-504, 63-10-504(b)(1) and (2), and 63-10-504(j).

Administrative History: Original rule filed February 7, 1983; effective March 9, 1983. Amendment filed March 30, 1994; effective June 13, 1994. Repeal and new rule filed May 11, 1998; effective July 25, 1998. Amendment filed August 19, 2002; effective November 2, 2002.

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Author Information

Jennifer Bolen, JD, Founder, The Legal Side of Pain, Lenoir City, Tennessee

Disclosure: Jennifer Bolen, JD, has disclosed no relevant financial relationships.