Pdf title 30 professions and occupations part 2640 prescribing

Pdf File 338.03 KByte, 40 Pages

Title 30: Professions and Occupations

Part 2640: Prescribing, Administering and Dispensing

Part 2640 Chapter 1: Rules Pertaining to Prescribing, Administering and Dispensing of Medication

Rule 1.1 Scope. These rules apply to all individuals licensed to practice medicine, osteopathic medicine or podiatric medicine in the state of Mississippi.

Source: Miss. Code Ann. ?73-43-11 (1972, as amended).

Rule 1.2 Definitions. For the purpose of Part 2640, Chapter 1 only, the following terms have the meanings indicated:

A. "Administer", "Controlled Substances", and "Ultimate User" shall have the same meaning as set forth in Mississippi Code, Section 41-29-105, unless the context otherwise requires.

B. "Physician" means any person licensed to practice medicine, osteopathic medicine or podiatric medicine in the state of Mississippi.

C. "Prescribe" means to designate or order by means of either a written or oral prescription the delivery of a controlled substance or legend drug to an ultimate user.

D. "Dispense" means to deliver a controlled substance or legend drug other than by administering or prescribing to an ultimate user or research subject including the packaging, labeling, or compounding necessary to prepare the substance for that delivery.

E. For the purpose of enforcement of the labeling requirements set forth in this chapter, Part 2640, Rule 1.6.B, "Dispensing Physician" means any physician who shall dispense to a patient for the patient's use any controlled substance, legend drug or other medication where such medication is purchased by the physician for resale to a patient whether or not a separate charge is made.

F. "Prescription Drug" or "Legend Drug" means a drug required under federal law to be labeled with the following statement prior to being dispensed or delivered; "Caution: Federal law prohibits dispensing without prescription," or a drug which is required by any applicable federal or state law or regulation to be dispensed on prescription only or is restricted to use by physicians only.

G. "Pain Management Clinic" means a public or privately owned facility for which the majority (50% or more) of the patients are issued, on a monthly basis, a prescription for opioids, barbiturates, benzodiazepines, carisoprodol, butalbital compounds, or tramadol.

H. "Bariatric Medicine/Medical Weight Loss Clinic" means a public or privately owned facility for which 30% or more of the patients are provided a comprehensive weight management treatment program. Advertised medical weight loss must include behavior modification, comprehensive nutritional education, exercise or physical therapy intervention, long-term maintenance programs, dispensing and/or prescribing FDA-approved medications as indicated for weight loss on a monthly basis as part of the patient's treatment plan.

1

Source: Miss. Code Ann. ?73-43-11 (1972, as amended).

Rule 1.3 Registration for Controlled Substances Certificate. Every physician licensed to practice in Mississippi who prescribes, administers or dispenses any controlled substance within Mississippi or who proposes to engage in the prescribing, administering or dispensing of any controlled substance within Mississippi must be registered with the U.S. Drug Enforcement Administration in compliance with Title 21 CFR Part 1301 Food and Drugs.

Pursuant to authority granted in Mississippi Code, Section 41-29-125, the Mississippi State Board of Medical Licensure hereby adopts, in lieu of a separate registration with the Board, the registration with the U.S. Drug Enforcement Administration as required in the above paragraph. In the event, however, a physician has had limitations or other restrictions placed upon his or her license wherein he or she is prohibited from handling controlled substances in any or all schedules, said physician shall be prohibited from registering with the U.S. Drug Enforcement Administration for a Uniform Controlled Substances Registration Certificate without first being expressly authorized to do so by order of the Mississippi State Board of Medical Licensure.

Persons registered to prescribe, administer, dispense or conduct research with controlled substances may order, possess, prescribe, administer, dispense or conduct research with those substances to the extent authorized by their registration and in conformity with the other provisions of these rules and in conformity with provisions of the Mississippi Uniform Controlled Substances Law, Mississippi Code, Sections 41-29-101 et seq.

The registration requirement set forth in these rules does not apply to the distribution and manufacture of controlled substances. Any physician who engages in the manufacture or distribution of controlled substances or legend drugs shall register with the Mississippi State Board of Pharmacy pursuant to Mississippi Code, Section 73-21-105. For the purposes herein, "distribute" shall mean the delivery of a drug other than by administering, prescribing or dispensing. The word "manufacture" shall have the same meaning as set forth in Mississippi Code, Section 41-29-105(q).

Source: Miss. Code Ann. ?73-43-11 (1972, as amended).

Rule 1.4 Maintenance of Records and Inventories. Every physician licensed to practice medicine, osteopathic medicine or podiatric medicine in the state of Mississippi shall maintain inventories, logs, and records prescribed in this rule.

Controlled substances inventory record. All controlled substances classified under Schedules II, IIN, III, IIIN, IV and V which are purchased by the physician must be inventoried at least every two (2) years. All inventory records for controlled substances in Schedules II and IIN must be maintained separately from the inventory records for Schedules III, IIIN, IV and V controlled substances. To insure the reliability of an inventory, the physician shall maintain a readily retrievable record of controlled substances purchased, including a copy of all purchase invoices identifying the name, quantity and strength/dose of the controlled substance purchased, the supplier and the date purchased.

2

Controlled substances dispensation/administration record. Every physician who shall dispense or administer Schedules II, IIN, III, IIIN, IV and V controlled substances shall maintain a separate readily retrievable record of all such substances dispensed or administered. This requirement shall not apply to Schedules III, IIIN, IV and V prepackaged samples and starter packs. All dispensation/administration records for controlled substances in Schedules II and IIN must be maintained separately from the dispensation/administration records for Schedules III, IIIN, IV and V controlled substances. The record shall contain the following information:

A. The date the controlled substance was dispensed or administered. B. The name, quantity and strength/dose of the controlled substance dispensed or

administered. C. The method of administration of the controlled substance, i.e. oral, IV or

subcutaneous. D. The name and address of the patient to whom the controlled substance was dispensed

or administered. E. For all Schedules II and III amphetamines, amphetamine-like anorectic drugs, or

sympathomimetic amine drugs dispensed in the treatment of narcolepsy, hyperkinesis, brain dysfunction, epilepsy, or depression, the dispensing or administration records shall include the diagnosis and the reason for use of the Schedules II and III controlled substances.

Within thirty (30) days after the effective date of this rule the Mississippi State Board of Medical Licensure shall cause a notice to be mailed to every physician whose practice location is in the state of Mississippi notifying them of the Controlled Substance Inventory and separate Dispensation/Administration Record. Every physician shall within ninety (90) days of the effective date of this rule, prepare an initial inventory of controlled substances. An example combination Controlled Substances Inventory Record and Controlled Substances Dispensation/Administration Record are hereby incorporated as Appendixes "C" and "D" to these rules.

Patient Record. A physician who prescribes, dispenses or administers a controlled substance shall maintain a complete record of his or her examination, evaluation and treatment of the patient which must include documentation of the diagnosis and reason for prescribing, dispensing or administering any controlled substance; the name, dose, strength, quantity of the controlled substance and the date that the controlled substance was prescribed, dispensed or administered. The record required by this rule shall be maintained in the patient's medical records, provided that such medical records are maintained at the office of the physician and are available for inspection by the representatives of the Mississippi State Board of Medical Licensure pursuant to authority granted in Mississippi Code, Section 41-29-125.

No physician shall prescribe, administer or dispense any controlled substance or other drug having addiction-forming or addiction-sustaining liability without a good faith prior examination and medical indication therefore.

A determination as to whether a "good faith prior examination and medical indication therefore" exists depends upon the facts and circumstances in each case. One of the primary roles of a physician is to elicit detailed information about the signs and symptoms which a patient presents

3

in order that he or she may recommend a course of treatment to relieve the symptoms and cure the patient of his or her ailment or maintain him or her in an apparent state of good health. In order for a physician to achieve a proper diagnosis and treatment plan, a history and physical examination consistent with the nature and complaint are necessary. The importance of these aspects of proper medical practice cannot be over emphasized. The paramount importance of a complete medical history in establishing a correct diagnosis is well established. Standards of proper medical practice require that, upon any encounter with a patient, in order to establish proper diagnosis and regimen of treatment, a physician must take three steps: (a) take and record an appropriate medical history, (b) carry out an appropriate physical examination, and (c) record the results. The observance of these principles as a function of the "course of legitimate professional practice" is particularly of importance in cases in which controlled substances are to play a part in the course of treatment. It is the responsibility of the physician to dispense, prescribe or administer such drugs with proper regard for the actual and potential dangers. This fact has been established in a number of closely related administrative and criminal cases, United States v. Bartee, 479 F.2d 484 (10th Cir. 1973) (No physical examination prior to issuance of prescriptions for controlled substances); United States v. Greene, 511 F.2d 1062 (7th Cir. 1975); Arthurs v. Board of Registration of Medicine, 418 N.E. 2d 1236 (MA 1981) (failure to record in patient file prescriptions for controlled substances issued or failure to record patient visit); Brainard v. State Board of Medical Examiners, 157 P2d 7 (Ca. 1945); Dannerberg v. Board of Regents, 430 N.Y.2d 700 (1980) (issuance of three prescriptions for sleeping pills to an undercover agent without a physical examination; Widlitz v. Board of Regents of New York, 429 N.Y. 2d 794 (1980) (issuance of Desoxyn to patients whom physician knew were drug addicts without conducting physical examination); United States v. Rosenberg, 515 F.2d 190 (9th Cir. 1975) (no physical examination, evidences that prescriptions were not in course of professional practice); and United States v. Hooker, 541 F.2d 300 (1st Cir. 1976), (little more than cursory physical examination, frequent neglect to inquire as to past medical history, little or no exploration of the type of problem the patient allegedly had "indicates that the minimal professional procedures followed were designed only to give an appearance of propriety to appellant's unlawful distributions").

A determination of proper "medical indication": also requires a careful examination of the nature of the drug and all circumstances surrounding dispensation. Case law developed by the courts in connection with controlled substances criminal violations and administrative decisions further illustrates several indications of lack of good faith. See United States v. Greene, 511 F.2d 1062 (7th Cir. 1975) and United States v. Rosenburg, 515 F.2d 190 (9th Cir. 1975). One of primary importance is the failure to follow at least the minimal professional procedures. Some of the factors used in determining the existence of "good faith" may include, but are not limited to: (a) the physician's permitting the patient to name the drug desired; (b) a physician dispensing drugs to patients having no medical need, when the physician knew or should have known that the patients were addicts; (c) repeated refills over relatively short periods of time or the issuance of prescriptions at a time when the patient should not have been finished taking the same medication from a prior prescription had the prescription directions been properly followed or the correct dosage taken; (d) general remarks of the physician indicating his or her experience with non-therapeutic uses of the drug; (e) a physician prescribing contraindicated medication such as amphetamines and depressants in a manner which results in therapeutic conflicts

4

A physician shall not sell or trade any medication which he or she receives as prepackaged samples or starter packs, whether or not said samples are controlled substances, legend drugs or other medication.

The Controlled Substances Inventory, Controlled Substance Dispensation/Administration Record, and Patient Record required by these rules shall be maintained in the office of the physician for a period of seven (7) years from the date that the record is completed or the controlled substances, legend drugs or other medications are prescribed, administered or dispensed and shall be made available for inspection by representatives of the Mississippi State Board of Medical Licensure pursuant to authority granted in Mississippi Code, Section 41-29125.

A physician may use a data processing system or a manual record keeping system for the storage and retrieval of Controlled Substances Dispensation/Administration Records. If a physician utilizes a data processing system it must provide immediate retrieval of all dispensation/administration records of controlled substances.

Whether maintained manually or in a data processing system, all records of dispensation/administration of controlled substances must be readily retrievable. If a data processing system is utilized, a hard-copy printout of the records of dispensation/administration shall be made at regular intervals, not to exceed seven (7) days. Such hard-copy printouts shall be maintained for a period of five (5) years and shall be made available for inspection and copying by investigators of the Mississippi State Board of Medical Licensure.

Source: Miss. Code Ann. ?73-43-11 (1972, as amended).

Rule 1.5 Use of Diet Medication. Pursuant to Mississippi Code, Section 41-29-139(e), it is unlawful for any physician in this state to prescribe, dispense or administer any amphetamine or amphetamine-like anorectic and/or central nervous system stimulant classified as Schedule II, pursuant to Section 41-29-115, for the exclusive treatment of obesity, weight control, or weight loss.

The Board of Medical Licensure is obligated under the laws of the state of Mississippi to protect the public health and safety. The Board recognizes that inappropriate prescribing of controlled substances, including those used for the purpose of weight reduction, may lead to drug diversion and abuse by individuals who seek drugs for other than legitimate medical use. Physicians should be diligent in preventing the diversion of drugs for illegitimate purposes.

Prescribing or dispensing a controlled substance for weight reduction or the treatment of obesity should be based on accepted scientific knowledge and sound clinical grounds. All such prescribing and dispending should be in compliance with applicable state and federal laws.

The physician and/or nurse practitioner/physician assistant being overseen/collaborating to provide comprehensive treatment of obesity shall be present at the facility when he or she prescribes or dispenses controlled substances for the purpose of weight reduction or the treatment of obesity.

5

As to the administration, dispensation or prescription of controlled substance anorectics in Schedules III, IV and V, use of said medications in the treatment of obesity or weight loss should be done with caution. A physician may administer, order, dispense or prescribe said medications for the purpose of weight loss in the treatment of obesity only as an adjunct to a regimen of weight reduction based on caloric restriction, provided the physician complies with the following and that all of the following conditions are met:

A. An initial comprehensive evaluation is to be conducted by and thoroughly recorded by the prescribing physician and/or mid-level provider prior to the prescribing, ordering, dispensing or administering of any drug. Such evaluation should include a thorough history and thorough physical exam of the patient to include at a minimum: 1. Past medical history, past surgical history, social history, family history, weight history, dietary history, gynecological (GYN) history if female, review of systems, allergies and medications. 2. Height, weight, Body Mass Index (BMI), blood pressure, pulse, % body fat or waist circumference/weight hip ratio, HEENT, chest, heart, abdomen, extremities. 3. Appropriate testing related to medical weight loss (CBC, comprehensive metabolic profile, lipid panel, thyroid panel, EKG, if prior or present history of cardiac disease, hypertension, diabetes, dyslipidemia, or strong family history of cardiac disease age >60 4. The patient should have a BMI of 30.0 in a normal otherwise healthy patient, or a BMI 27.0 in an individual with at least one associated co-morbidity, or current body weight 120 percent of a well documented, long standing healthy weight that the patient maintained after the age of 18, or body fat 30% in females, or body fat 25% in males, or waist -hip circumference such that the individual is known to be at increased cardiovascular and/or co-morbidity risk because of abdominal visceral fat, or presence of a co-morbidity condition or conditions aggravated by the patients excessive adiposity. 5. Absolute contraindications of Schedule III or IV anorectic drugs for purposes of weight loss management are pregnancy, breast feeding, or severe allergic reactions to these medications. Relative contraindications of Schedule III and IV anorectics for the purpose of weight loss management are uncontrolled bipolar, uncontrolled epilepsy, uncontrolled hypertension, episodic tachyarrhythmia, excessive stimulation, history of substance abuse, severe anticholinergic effects, such as, extreme dryness of mouth or unmanageable constipation should be addressed with physician prior to starting weight loss medications. Schedule III and IV anorectics can be used in conjunction with any other medications deemed safe by the physician.

B. The physician shall not utilize any Schedules III, IV or V controlled substance when he or she knows or has reason to believe an absolute contraindication exists or relative contraindication exists that would be harmful to the patient.

6

Download Pdf File