Chapter 30 PRESCRIBING AND DISPENSING DRUGS

Chapter 30 PRESCRIBING AND DISPENSING DRUGS

INTRODUCTION...... 30:1

DEFINITIONS........... 30:2

PRESCRIBING AND DISPENSING DANGEROUS DRUGS.............. 30:3

Dangerous Drugs.............. 30:3

Who May Possess, Administer, and Dispense Dangerous Drugs... 30:3

Requirements for Prescriptions.............. 30:4

Recording and Inspection Requirements.............. 30:5

Hypodermic Devices.............. 30:5

PRESCRIBING AND DISPENSING CONTROLLED SUBSTANCES........... 30:5

Registration Requirements.............. 30:6

Prescription Requirements.............. 30:6

Recording and Storage Requirements.............. 30:8

Appetite Suppressants.............. 30:9

PAIN MANAGEMENT.... 30:10

Adopted Regulation of the Board of Medical Examiners R007-99 30:11

Sample Mailing List request letter............ 30:17

PENALTIES FOR PRESCRIPTION AND DISPENSING VIOLATIONS......... 30:18

MISCELLANEOUS. 30:18

Record Keeping............ 30:18

Silicone.......... 30:18

Supervising Physician’s Responsibilities........ 30:18

INTRODUCTION

Prescribing, administering and, to a more limited extent, dispensing drugs are some of the` most common activities of a physician. The bulk of statutes and regulations controlling the dispensation of drugs are directed at pharmacists; nonetheless physicians who prescribe, dispense, or administer drugs are held responsible under many of these statutes and regulations, both in terms of their own actions and for the actions of others who dispense or administer drugs under a physician’s supervision. The prescription and dispensing of controlled substances is one of the areas of medical practice in which the federal government has numerous regulations with which the practitioner must be familiar. Physicians who prescribe drugs or dispense medications from their offices must meet certain legal requirements. Failure to do so may result in disciplinary action as well as possible criminal penalties under federal or state law. In addition, civil malpractice suits are an all-too-real possibility for even minor errors in prescriptions or in dispensing drugs.

In general, administering, dispensing, or prescribing any controlled substance or dangerous drug (prescription drugs), except as authorized by law, is grounds for the medical board to initiate disciplinary action or deny a physician licensure. Further, any conduct by a physician that violates a regulation adopted by the state board of pharmacy is also grounds for discipline or denial of licensure. NRS 630.306.

DEFINITIONS

The legal definitions of words related to prescriptions of drugs are not always precisely the same as their accepted medical usage. Because this chapter repeatedly uses these terms in their legal sense, their definitions follow:

Administer means the direct application of a drug or medicine whether by injection, inhalation, ingestion, or any other means, to the body of a patient or research subject. NRS 454.191. Drugs may be administered by the practitioner, in the practitioner’s presence, or by the practitioner’s agent, or by the patient at the direction and in the presence of the practitioner. NRS 453.021.

Dangerous Drug means any drug, other than a controlled substance, that is unsafe for self-medication or unsupervised use. Dangerous drugs include any drug which bears the federal warning and any drug that the board of pharmacy finds dangerous to the public health or safety. NRS 454.201.

Dispense means the furnishing of a dangerous drug in any amount greater than necessary for the present and immediate needs of the ultimate user. The furnishing of a dangerous drug by a hospital pharmacy for inpatients is excluded from the definition. NRS 454.211. In the limited context of controlled substances, dispense means both the delivery and any action directed toward the delivery of a controlled substance to an ultimate user, including prescribing. NRS 453.056.

Furnish means to supply by any means, by sale or otherwise. NRS 454.006.

Prescription means an order given individually for the person for whom prescribed by means of an order signed by the practitioner, or an electronic transmission from the practitioner to a pharmacist, or a chart order written for an inpatient specifying drugs which he is to take home upon his discharge. Prescription does not include a chart order written for an inpatient to use while he is an inpatient.

PRESCRIBING AND DISPENSING DANGEROUS DRUGS

Dangerous Drugs

Under Nevada law, any drug, other than a controlled substance, that is unsafe for self-medication or unsupervised use is classified as a dangerous drug. The designation includes all drugs approved by the Food and Drug Administration that bear the federal warning prohibiting dispensing without prescription, certain substances that have been licensed for manufacture in Nevada but have not been approved as drugs by the Food and Drug Administration, and those drugs may be sold only by prescription because the state board of pharmacy has found them to be dangerous. NRS 454.201. As long as the medication in question bears the federal caution, it is deemed a dangerous drug, and must be dispensed by a licensed physician (practitioner). Under these regulations the unauthorized dispensing of diet pills violates Nevada law. Smithart v. State, 86 Nev. 925, 478 P.2d 576 (1970).

It is noteworthy that a conviction for the violation of any of the provisions concerning dangerous drugs constitutes grounds for the revocation of a professional license. The provisions include inadequate record-keeping and dispensing drugs without a prescription. NRS 454.361.

Who May Possess, Administer, and Dispense Dangerous Drugs

Dangerous drugs may be possessed or administered by practitioners, and under certain conditions, by physician’s assistants, licensed dental hygienists, registered nurses, emergency medical technicians, and other caregivers, including medical or nursing students in the presence of a physician or registered nurse or authorized to administer the drug or medicine outside the presence of a physician or nurse. NRS 454.213. Dangerous drugs, that is, prescription drugs, may be dispensed by physicians, and under certain restrictions, physician’s assistants, registered pharmacists, registered nurses, and physicians in post-graduate training. NRS 454.215.

According to the Nevada Attorney General, homoeopathic physicians who are also licensed as allopathic or osteopathic physicians, in addition to the limited abilities to prescribe and administer certain drugs according to homeopathic practice, may also possess, prescribe, or administer controlled substances or dangerous drugs as appropriate or necessary to their allopathic or osteopathic practices. AGO 93-21 (9-17-1993).

Requirements for Prescriptions

Each prescription for a dangerous drug must be written on a prescription blank or as an order on the chart of a patient. Written prescriptions must contain the name of the practitioner, his signature (if the prescription was not transmitted orally), the classification of his license, and his address, if not immediately available to the pharmacist. The name of the patient, and his address if not immediately available to the pharmacist, must be included as must the date on which the prescription is issued. The prescription must contain the name, strength, and quantity of the drug(s) prescribed and directions for use. The directions must indicate the portion of the body to which the medication is to be applied, or, if the drug is not taken orally, the directions must specifically indicate what orifice or part of the body the medication is to be inserted or injected. NRS 454.223.

Since 1994, regulations require that each written prescription for a dangerous drug contain the handwritten signature of the prescribing practitioner in non-erasable ink and be submitted to the pharmacist in its original form. NAC 454.060.

A practitioner cannot furnish drugs without a written prescription unless he meets specific requirements. First, he cannot charge for the drugs, either separately or together with charges for other professional services. He must also keep accurate records of all drugs furnished without a written prescription. The drugs must be clearly labeled with the date, the name and address of the furnisher, the name of the patient, the name, strength, expiration date, and the directions for use. Finally, the drugs cannot be dispensed or furnished by a nurse or attendant. NRS 454.301. A person who dispenses drugs in violation of these explicit standards is guilty of a gross misdemeanor. NRS 454.321.

Recording and Inspection Requirements

Any practitioner who dispenses or furnishes drugs to patients must maintain a complete and accurate record of all dangerous drugs purchased and prescribed, dispensed, furnished, or disposed of in any manner. The records must be kept for two years and must be open to inspection by inspectors of the Food and Drug Administration and members, inspectors, or investigators of the board of pharmacy. It is a misdemeanor for any person to violate any provision of the section governing the keeping of records of dangerous drugs. NRS 454.286.

Prudent medical practice suggests that a physician retain a patient’s records, including records of prescriptions, for at least as long as he retains the patient. In any case, NRS 629.051 requires that records be kept for five years, a rule that should be the minimum length of time records are retained.

Hypodermic Devices

Hypodermic devices that are not restricted by federal law may be sold with or without a prescription for defined uses, including for use in the treatment of persons with asthma and diabetes.

PRESCRIBING AND DISPENSING CONTROLLED SUBSTANCES

The prescribing and dispensing of controlled substances receives extensive treatment in Chapter 453 of the Nevada Revised Statutes. Nonetheless, this subject is largely governed by federal regulations, and the practitioner must be aware of both federal and state law when prescribing or dispensing controlled substances.

Definitions Specific to Controlled Substances

Narcotic Drug includes, but is not limited to, any opium derivative, synthetic opiate, cocaine, ecgonine, poppy straw, and any compound, mixture, or preparation containing any quantity of the above and other listed substances. NRS 453.101.

Opiate means any substance having, or capable of conversion into a substance having, an addiction-forming or addiction-sustaining liability, similar to morphine. NRS 453.106.

Steroid means any of the compounds that contain a hydrogenated cyclopentophenanthrene-ring system, including the sterols.

Controlled substances are listed in five schedules, depending on their potential for abuse, degree of physical or psychological abuse caused, and whether the substances have been accepted for medical use in the United States. NRS 453.166 to 453.206. The exact substances that make up Schedule I through V are listed in the Nevada Administrative Code sections 453.510 to 453.550 (reproduced in the appendix, below).

Registration Requirements

Nevada law grants the Board of Pharmacy broad powers to regulate and enforce laws and regulations related to the prescription and dispensing of controlled substances. The board may grant or deny registration to a practitioner, set regulations for the storage, inspection, and dispensing of controlled substances and records of controlled substances, and control the classification of the substances.

Every practitioner who dispenses any controlled substance in Nevada must obtain a registration from the Board of Pharmacy. A separate registration is required at each principal place of business or professional practice where the applicant dispenses controlled substances. NRS 453.226. Dispensing controlled substances without being registered with the board is a category D felony in Nevada. NRS 453.232. Any person who is exempt from federal registration by federal laws and regulations for activities involving controlled substances is also exempted from registration in Nevada. NAC 453.100. The Board of Pharmacy charges a $50.00 fee for each registration and biennial re-registration. NAC 453.180.

Prescription Requirements

A practitioner who is registered with the board to possess and dispense controlled substances may dispense dangerous drugs or controlled substances only after he has issued a written prescription that authorizes the patient to have the prescription filled by the dispensing practitioner or at another location of the patient’s choosing. NRS 453.410. A practitioner may prescribe or administer controlled substances only for a legitimate medical purpose and in the usual course of his professional practice. NRS 453.381.

Each Schedule II prescription must be written on a separate prescription blank or as an order on a patient’s chart. The prescription must contain the name of the practitioner, his signature if the prescription was not transmitted orally, his address if not immediately available to the pharmacist, the classification of his license, and his registration number from the Drug Enforcement Administration if it is not immediately available to the pharmacist. The name, strength, and quantity of the drugs must be included, as well as directions for use and the date of issue. Schedule II prescriptions must generally be written and signed entirely by hand, except that standard practitioner information, such as address and registration number may be preprinted, and the address of the patient and the practitioner may be added by the pharmacist. NRS 453.385.

No Schedule II substance may be prescribed without a practitioner’s written prescription, unless stringent rules are followed. In an emergency a Schedule II substance may be dispensed without a written prescription, if it is reduced to writing promptly, and in all cases within 72 hours, signed by the practitioner, and filed by the pharmacy. In cases of direct administration to a patient or use in certain facilities, a facsimile machine transmission is authorized, if the transmission is printed on paper that is capable of being retained for two years. Refills are not authorized for Schedule II drugs. NRS 453.256.

Generally, Schedule III, IV, or V substances cannot be dispensed unless a practitioner signs a prescription for the substance. NRS 453.385. Schedule III and IV substances that are dangerous drugs must not be dispensed without a written or oral prescription by a practitioner, unless administered directly by the practitioner to a patient. Prescriptions may not be refilled more than five times or more than six months after the original prescription, unless renewed by the physician. NRS 453.256.

No practitioner may dispense a Schedule II, III, or IV substance for his own personal use except in a medical emergency. A violation of any of the above laws related to the prescription of dispensing of controlled substances constitutes a category E felony. NRS 453.256. Further, a physician may not prescribe, administer, or dispense a Schedule II controlled substance for himself, his spouse, or his children except in an emergency. NRS 453.381.

All prescriptions for controlled substances must specifically indicate the portion of the body to which the medication is to be applied, or, if the medication is to be taken by means other than orally, the orifice or canal of the body into which the medication is to be inserted or injected must be specified. NRS 453.385.

According to the board of medical examiners, a physician engages in prohibited professional conduct if he writes a prescription for a controlled substance for any person without making an appropriate examination that confirms the medical necessity for the controlled substance, or engages in the practice of writing prescriptions for controlled substances in amounts excessive enough to constitute a departure from the prevailing medical standards.

A physician also engages in unprofessional conduct if he prescribes anabolic steroids to increase muscle mass for competitive or athletic purposes, or prescribes certain controlled substances for weight control (specifically, schedule II or III controlled substances, controlled substance analogs, chorionic gonadotrophic hormones, thyroid preparations, or thyroid synthetics). NAC 630.230.

Recording and Storage Requirements

There are numerous requirements related to recording the dispensing of controlled substances and ensuring that controlled substances dispensed are done so in an accurate manner. In general, practitioners must keep complete, accurate, and readily retrievable records. Prescriptions must be serially numbered and kept in numerical order.

Each record of a controlled substance dispensed must contain the patient’s name, and the patient’s address if it is not readily available from the practitioner’s records, as well as the name of the prescribing practitioner, his license classification, the practitioner’s DEA registration number. The signature of the prescribing practitioner, and the initials of the dispensing practitioner, if the dispensing practitioner did not prescribe the controlled substance, must be included. The name, strength, and quantity of the controlled substance must be recorded as must the date of the prescription. The record must also include directions for use of the controlled substance. NAC 453.410

A practitioner who is registered to possess controlled substances is required to establish and maintain effective controls and procedures to guard against theft and misuse of controlled substances.

A dispensing practitioner must maintain a separate file for his schedule II controlled substances purchases as well as a separate file for the dispensing of each controlled substance. Prescriptions for controlled substances must be kept in a separate file according to the requirements set out by NAC 453.80. All controlled substances and dangerous drugs must be kept in a locked storage area, with access restricted to authorized persons. NAC 453.375.

Practitioners dispensing dangerous drugs are responsible for ensuring that each package or container in which a controlled substance or dangerous drug is dispensed complies with all state and federal packaging requirements. Further, each package in which a controlled substance is dispensed must be clearly labeled according to the requirements of NRS 639.2801. NAC 453.410.

As a condition of registration to dispense controlled substances, the Board of Pharmacy may inspect the establishment of a practitioner who dispenses controlled substances. NRS 453.226. With an administrative warrant, officers or employees of the Board of Pharmacy may enter the premises of a practitioner, inspect and copy records, and inventory the stock of any controlled substance and related equipment. No warrant is required to inspect books and records. NRS 453.261.

Appetite Suppressants

A physician who is authorized to prescribe controlled substances may prescribe appetite suppressants under certain specific conditions. Appetite suppressants are defined as drugs or other substances listed in schedule IV which are used to suppress the appetite of a natural person. Before prescribing an appetite suppressant, a physician must obtain a medical history and conduct a physical exam and appropriate studies to determine if the use of appetite stimulants is contraindicated in a patient.

Appetite suppressants may be prescribed if used in the treatment of exogenous obesity as part of a program which includes dietary restrictions, modification of behavior, and exercise. The physician must determine that the patient’s obesity represents a threat to the patient’s health or the patient’s weight exceeds by twenty percent the upper limits of the patient’s healthy weight set forth by the U.S. Department of Health and Human Services. Appetite suppressants may not be prescribed for more than three months, unless the patient is losing at least two pounds a month or is maintaining a weight established by the physician, and the patient is weighed at the beginning and end of each month during the time the patient is taking the appetite suppressant. NAC 630.205.

PAIN MANAGEMENT

Nevada law protects physicians using controlled substances to treat pain when the physician’s treatment complies with the prevailing standards of acceptable medical practice. A physician is not subject to disciplinary action solely for prescribing or administering a controlled substance listed in schedule II, III, IV, or V by the state board of pharmacy, or for prescribing or administering amygdalin (laetrile) or procaine hydrochloride (Gerovital H3) if the patient has consented in writing to its use. Physicians may only prescribe or administer pain-relieving controlled substances to patients actually under their care. If the controlled substance is administered in accordance with the prevailing standards of accepted medical practice, the physician is not subject to disciplinary action per Nevada law. NRS 630.3066.

A regulation has the same force and effect as any enforceable law. The following regulations, pertaining to the treatment of pain by licensees of the Nevada Board of Medical Examiners, indicates it became effective September 27, 1999. The regulation was filed with the office of the Nevada Secretary of State on October 11, 1999 as required by NRS 233B.070 and therefore officially became Nevada law on that date. See NRS 233B.070 and NRS 233B, the Nevada Administrative Procedures Act, generally.

Pertinent portions of this regulation, now codified in the Nevada Administrative Code, are reproduced in an abbreviated format here:

NEVADA ADMINISTRATIVE CODE CHAPTER 630

(regulations relating to the treatment of pain)

GENERAL PROVISIONS

NAC 630.010 Definitions. (NRS 630.130) As used in this chapter, unless the context otherwise requires, the words and terms defined in NRS 630.010 to 630.025, inclusive, and NAC 630.015 to 630.030, inclusive, have the meanings ascribed to them in those sections.

[Bd. of Medical Exam'rs, § 630.010, eff. 12-20-79]--(NAC A 6-23-86; 9-12-91; R007-99, 9-27-99)

NAC 630.015 "Acute pain" defined. (NRS 630.130) "Acute pain" means the normal, predicted physiological response to an adverse chemical, thermal or mechanical stimulus and is associated with surgery, trauma or acute illness. Acute pain is generally limited in duration and is responsive to therapies such as the use of opioids.

(Added to NAC by Bd. of Medical Exam'rs by R007-99, elf. 9-27-99)

NAC 630.020 "Chronic pain" defined. (NRS 630.130) "Chronic pain" means pain which is persistent and the cause of which cannot be removed or otherwise treated. Chronic pain may be associated with a long-term incurable or intractable medical condition or disease.

(Added to NAC by Bd. of Medical Exam'rs by R007-99, eff. 9-27-99)

NAC 630.025 "Controlled substance" defined. (NRS 630.130) "Controlled substance" has the meaning ascribed to it in NRS 0.031.

(Added to NAC by Bd. of Medical Exam'rs by R007-99, elf. 9-27-99)

NAC 630.030 "Substance abuse" defined. (NRS 630.130) "Substance abuse" means the use of a controlled substance for a nontherapeutic purpose or the use of medication for a purpose other than that for which it was prescribed.

(Added to NAC by Bd. of Medical Exam'rs by R007-99, cfr. 9-27-99)

NAC 630.193 Controlled substances for acute or chronic pain: Procedure for prescribing. (NRS 630.130, 630.275)

1. A physician and a physician's assistant shall control any acute or chronic pain of a patient for the duration of the pain by prescribing controlled substances in accordance with the prevailing standards of acceptable practice of medicine as described in subsection 2.

2. To comply with the prevailing standards of acceptable practice of medicine, the physician or physician's assistant shall:

(a) Before prescribing the controlled substance:

(1) Conduct an assessment and evaluation of the patient that includes, without limitation:

` (I) A physical examination;

(II) Investigation and documentation of the medical history of the patient; and

(III) Investigation of whether the patient has a history of substance abuse;

(2) Establish a plan for treating the patient that includes, without limitation:

(I) Objectives that will be used to determine the success of the treatment, including, without limitation, the objectives of pain relief and improved physical and psychosocial function;

(II) A list and timetable for diagnostic evaluations and other treatments that are planned for the patient; and

(III) An agreement between the physician or physician's assistant and the patient that the patient will obtain his prescription for the controlled substance only from that physician or physician's assistant and fill or refill the prescription at only one specified pharmacy;

(3) Discuss the risks and benefits of using the controlled substance with the patient, with the legal guardian or surrogate of the patient or with any other person at the patient's request;

(4) After discussing the risks and benefits pursuant to subparagraph (3), receive written consent from the patient or the legal guardian or surrogate of the patient to use the controlled substance;

(5) If the patient is a high risk for substance abuse, enter into an agreement with the patient pursuant to NAC 630.195; and

(6) Document the requirements of subparagraphs (1) to (5), inclusive, in medical records of the patient that comply with the requirements of NAC 630.197.

(b) After prescribing the controlled substance:

(1) Review the progress of the patient towards the goals outlined in the plan for treatment and any new information about the etiology of the pain at periodic intervals based on the individual circumstances of the patient;

(2) Refer the patient, as necessary, for additional evaluation and treatment to achieve the objectives of the plan for treatment;

(3) Monitor the patient's compliance with instructions relating to use of the controlled substance and the plan for treatment;

(4) Adjust the medication therapy, as necessary, to meet the individual needs of the patient;

(5) Discontinue treatment if the physician or physician's assistant determines that the treatment is not effective; and

(6) Maintain medical records for the patient that comply with the requirements of NAC 630.197.

(Added to NAC by Bd. of Medical Exam'rs by R007-99, eff. 9-27-99)

NAC 630.195 Controlled substances for acute or chronic pain: Determination of patient as high risk for substance abuse; agreement outlining patient responsibilities if patient determined high risk. (NRS 630.130, 630.275)

1. Before prescribing a controlled substance to a patient for the treatment of acute or chronic pain, a physician or physician's assistant shall determine whether the patient is a high risk for substance abuse. In making such a determination, a physician or physician's assistant shall consider such factors as are medically reasonable. Regardless of the absence of other factors, a patient who has a history of substance abuse must be determined to be a high risk for substance abuse.

2. If a physician or physician's assistant determines that a patient is a high risk for substance abuse, he shall, before prescribing the controlled substance, enter into a written agreement with the patient which outlines the patient's responsibilities with respect to the controlled substance and which must include, without limitation:

(a) An agreement by the patient to submit, upon request of the physician or physician's assistant, to testing of the patient's blood or urine to determine the level of controlled substance being used by the patient;

(b) The number and frequency of refills of the prescription; and

(c) The reasons that the prescription for the controlled substance may be discontinued, including, without limitation, a violation of the terms of the agreement.

(Added to NAC by Bd. of Medical Exam'rs by R007-99, eff. 9-27-99)

NAC 630.197 Controlled substances for acute or chronic pain: Requirements for maintenance and contents of records of patients. (NRS 630.130)

1. A physician and physician's assistant shall maintain or cause to be maintained in an accurate, complete and current manner the medical records of each patient to whom he has prescribed a controlled substance to treat acute or chronic pain. Such records must be kept at the office in which the physician or physician's assistant practices and in a place that is easily accessible.

2. Medical records for a patient to whom a controlled substance has been prescribed to treat acute or chronic pain must include, without limitation:

(a) The medical history and physical examination of the patient, including, without limitation:

(1) The nature and intensity of the pain;

(2) Current and past treatments that the patient has received for the pain;

(3) Diseases and other medical conditions that the patient has that may cause or contribute to the pain;

(4) The effect of the pain upon the physical and psychological functioning of the patient; (5) Any history of substance abuse; and

(6) At least one recognized medical indication for the use ora controlled substance;

(b) Notable assessments of the patient, as applicable, including, without limitation:

(1) Whether the patient is a high risk for substance abuse;

(2) Tolerance;

(3) Analgesic tolerance;

(4) Physical dependence;

(5) Addiction; or

(6) Pseudo addiction;

(d) Notes from each assessment, evaluation and consultation with the patient;

(e) Treatment objectives;

(f) Discussion of risks and benefits;

(g) Suggested, prescribed and proposed treatments;

(h) Date, type, dosage and quantity of medications prescribed;

(i) Instructions and agreements; and

(j) Notes from periodic reviews.

3. As used in this section:

(a) "Addiction" means a neurobehavioral syndrome with genetic and environmental influences that result in psychological dependence on the use of medications for their psychic effects and is characterized by compulsive use despite harm. The term does not include physiological dependence, analgesic tolerance and tolerance.

(b) "Analgesic tolerance" means the need to increase the dose of an opioid to achieve the same level of analgesia.

(c) "Physical dependence" means a physiological state of neuroadaptation which is an expected result of the use of opioids and is characterized by the emergence of a withdrawal syndrome if medication use is stopped or decreased abruptly, or if an antagonist is administered.

(d) "Pseudo addiction" means a pattern of behavior, which can be mistaken for addiction, in which a patient who is receiving inadequate treatment for pain seeks additional medication to alleviate the pain.

(e) "Tolerance" means a physiological state resulting from regular use of a medication in which an increased dosage is needed to produce the same effect or a reduced effect is observed with a constant dosage.

(Added to NAC by Bd. of Medical Exam'rs by R007-99, elf. 9-27-99)

NAC 630.230 Prohibited professional conduct. (NRS 630.130, 630.275)

1. A person who is licensed as a physician or physician's assistant shall not:

(a) Falsify records of health care;

(b) Falsify the medical records of a hospital so as to indicate his presence at a time when he was not in attendance or falsify those records to indicate that procedures were performed by him which were in fact not performed by him;

(c) Render professional services to a patient while the physician or physician's assistant is under the influence of alcohol or any controlled substance or is in any ~mpaired mental or physical condition;

(d) Acquire any controlled substances from any pharmacy or other source by misrepresentation, fraud, deception or subterfuge;

(e) Prescribe anabolic steroids for any person to increase muscle mass for competitive or athletic purposes;

(f) Make an unreasonable additional charge for tests in a laboratory, radiological services or other services for testing which are ordered by the physician or physician's assistant and performed outside his own office;

(g) Treat any patient in a manner not recognized scientifically as being beneficial;

(h) Prescribe controlled substances listed in schedule II pursuant to NAC 453.520 or schedule III pursuant to NAC 453.530, controlled substance analogs, chorionic gonadotrophic hormones, thyroid preparations or thyroid synthetics for the control of weight;

(i) Allow any person to act as a medical assistant in the treatment of a patient of the physician or physician's assistant, unless the medical assistant has sufficient training to provide the assistance;

(j) Fail to provide adequate sup. ervision of a medical assistant who is employed or supervised by the physician or physician's assistant;

(k) If the person is a physician, fail to provide adequate supervision of a physician's assistant or an advanced practitioner of nursing;

(1) Fail to honor the advance directive of a patient without informing the patient or the surrogate or guardian of the patient, and without documenting in the patient's records the reasons for failing to honor the advance directive of the patient contained therein;

(m) Fail to adequately prescribe controlled substances for the control of pain in accordance with prevailing standards of acceptable practice of medicine as described in NAC 630.193; or

(n) Engage in the practice of writing prescriptions for controlled substances to treat acute or chronic pain in a manner that deviates from the prevailing standards of acceptable practice of medicine as described in NAC 630.193.

2. As used in this section:

(a) "Controlled substance analog" means:

(1) A substance whose chemical structure is substantially similar to the chemical structure of a controlled substance listed in schedule II pursuant to NAC 453.520 or schedule III pursuant to NAC 453.530; or

(2) A substance which has, is represented as having or is intended to have a stimulant, depressant or hallucinogenic effect on the central nervous system of a person that is substantially similar to, or greater than, the stimulant, depressant or hallucinogenic effect on the central nervous system of a person of a controlled substance listed in schedule II pursuant to NAC 453.520 or schedule III pursuant to NAC 453.530.

(b) "Medical assistant" means any person who:

(1) Is employed by a physician or physician's assistant;

(2) Is under the direction and supervision of the physician or physician's assistant;

(3) Assists in the care of a patient; and

(4) Is not required to be certified or licensed to provide such assistance by any administrative agency.

[Bd. of Medical Exam'rs, § 630.230, eff. 12-20-79]--(NAC A 6-23-86; 9-19-90; 1-13-94; 7-! 8-06; R007-O0, 0-27-00)

These regulations specify (mandate) the standard of care for the treatment of acute and chronic pain by Nevada physician licensees and physician assistant licensees of the Board of Medical Examiners practicing in Nevada . These regulations, however, have no effect upon non-licensees of the NBME such as osteopathic physicians, dentists, podiatrists, or other health professionals (who are not licensed by the NBME).

In a successful medical malpractice action, the patient-plaintiff must prove, by a preponderance of the evidence, four elements:

1. The physician had a duty to treat that patient according to the prevailing standard of medical care;

2. The physician breached that duty;

3. That breach of duty caused the patient’s injury or harm; and

4. Damages resulted entitling the patient-plaintiff to compensation for the harm or injury caused by the breach of duty.

The regulations specify the physician’s duty: a licensee physician shall not fail to adequately prescribe controlled substances for the control of pain in accordance with the prevailing standards of acceptable practice of medicine as described in NAC 630.193 and NAC 630.197.

Breach of any of the mandates in the sections of NAC 630.193 or NAC 630.197 including performing and documenting in the patient’s medical records eight specified tasks before beginning pain treatment (one of which is to obtain the patient’s written informed consent before prescribing pain treatment medication) will likely serve to prove that the physician breached the prevailing pain treatment standard of care when a patient-plaintiff alleges medical malpractice for inadequate control or treatment of his or her acute or chronic pain. Once a breach of duty is established, a motion for a directed verdict in favor of the licensee physician cannot be granted because the plaintiff has met his or her burden of production of sufficient evidence. The case proceeds to the jury (trier of fact) for determination of causation and (money) damages.

Thus, non-compliance with the current regulations’ mandates creates physician licensee malpractice liability. This medical malpractice liability is independent of whether, and to what degree, the NBME exercises its discretion to enforce these regulations with licensure sanction actions.

Board licensees, and other members of the public, may keep abreast of all proposed regulations, elect to participate in workshop/hearings, and be informed of all public meetings of the NBME by requesting to be placed on the agency’s (NBME) mailing list. Mailing list requests lapse after six months and must be renewed in writing. An example letter requesting placement on the NBME mailing list and requesting publically available materials follows.

Intentionally left blank

Date ________________________________

Executive Director

Nevada State Board of Medical Examiners

1105 Terminal Way, Suite # 301

Reno, NV 89510

Dear Ms. Lyons:

As the Nevada legislature has provided in Nevada’s Administrative Procedures Act, Nevada Revised Statutes (NRS) 233B.0603, I request to be placed on the Board of Medical Examiners’ mailing list for all public notices including intent to adopt, amend or repeal regulation(s). Pursuant to NRS 233B.061, I request to be placed on the mailing list for proposed regulations including workshops and/or hearings.

As provided in Nevada’s Open Meeting Act, NRS 241.020.4, I request all meeting materials (agenda packet) provided to members of the Board except materials pertaining to the closed portion of the meeting, or materials confidential by law or agreement).

My mailing address is:

Name ____________________________________________

Street Address _____________________________________

City, State Zip ____________________________________

Sincerely,

__________________________________________________________

Signature

PENALTIES FOR PRESCRIPTION AND DISPENSING VIOLATIONS

In general, a physician who administers, dispenses, or prescribes any controlled substance or dangerous drug to or for himself or to others except as authorized by law is subject to disciplinary action and denial of licensure. NRS 630.306. Criminal penalties range from misdemeanor offenses to felonies, depending on the violation and the type of substance involved (refer to specific sections above or to the specific statutes and regulations below). Physicians may also be denied licensure or may have disciplinary action initiated against them for signing a blank prescription form. NRS 630.304. Finally, a mistaken prescription or faulty dispensing that results in harm to a patient is almost inevitably grounds for a civil suit.

MISCELLANEOUS

Record Keeping

Although different classifications of drugs call for various terms for which a physician must keep records, in general health care records must be kept for 5 years. NRS 629.051.

Silicone

A physician who performs, assists, or advises the injection of any substance containing liquid silicone into the human body, except silicone oil used to repair a retinal detachment, is subject to discipline or denial of licensure. NRS 630.306.

Supervising Physician's Responsibilities

A supervising physician is responsible for all the medical activities of his physician’s assistant. Specifically, he must ensure strict compliance with the provisions of the certificate issued by the board of medical examiners to his physician’s assistant regarding controlled substances, poisons, dangerous drugs or devices, and with the provisions of the certificate issued by the state board of pharmacy to his physician’s assistant. NAC 630.370. Further, a physician’s assistant cannot be authorized to prescribe controlled substances that his supervising physician cannot prescribe. NAC 630.271.

Physicians who collaborate with advanced practitioners of nursing are likewise responsible for ensuring that the advanced practitioner of nursing practices remains in strict compliance with the regulations of the state board of pharmacy regarding prescriptions, controlled substances, and dangerous drugs and devices, and that the advanced practitioner of nursing does not use pre-signed prescriptions. NAC 630.490.