Mississippi Administrative Code › Title 30 - Professions and Occupations › Part 2640 - Rules Pertaining to Prescribing, Administering, and Dispensing Medication › Chapter 1 - Rules Pertaining to Prescribing, Administering and Dispensing of Medication › Rule 30-2640-1.4 - Maintenance of Records and Inventories

Current through June 25, 2024
Every licensee shall maintain inventories, logs, and records
				  prescribed in this rule.
A. Controlled
				substances inventory record. All controlled substances classified under
				Schedules II, IIN, III, IIIN, IV and V which are purchased by the licensee 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 must
				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. Controlled substances inventory must also meet all applicable
				federal statutes and regulations.
B. Controlled substances
				dispensation/administration record. Every licensee who dispenses or
				administers, Schedules II, IIN, III, IIIN, IV and V controlled substances must
				maintain a separate readily retrievable record of all such substances dispensed
				or administered. This requirement does 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 must contain the following
				information:
1. The date the controlled
				substance was dispensed or administered.
2. The name, quantity and strength/dose of
				the controlled substance dispensed or administered.
3. The method of administration of the
				controlled substance, i.e. oral, IV or subcutaneous.
4. The name and address of the patient to
				whom the controlled substance was dispensed or administered.
5. 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 must include the diagnosis
				and the reason for use of the Schedules II and III controlled substances.
Controlled substances dispensation/administration records
				  must also meet all applicable federal statutes and regulations.
Patient Record - A licensee who prescribes, dispenses or
				  administers a legend drug or controlled substance must 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 legend drug or controlled substance; the name,
				  dose, strength, quantity of the legend drug or controlled substance and the
				  date that the legend drug or controlled substance was prescribed, dispensed or
				  administered. The record required by this rule must be maintained in the
				  patient's medical records. If medical records are maintained at the office of
				  the licensee, the records must be available for inspection by the
				  representatives of the Mississippi State Board of Medical Licensure.
Licensees must not prescribe, administer or dispense any
				  legend drug; any controlled substance; or any drug having addiction-forming or
				  addiction-sustaining liability without a good faith prior examination and
				  medical indication. A determination as to whether a "good faith prior
				  examination and medical indication" 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 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 licensee to achieve a
				  reasonable diagnosis and treatment plan, a history and physical examination
				  consistent with the nature of the 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 licensee 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 is an integral component of the "course of legitimate
				professional practice."
Some of the factors used in determining the presence or
				  absence of "good faith" may include, but are not limited to:
1. the quality and extent of the
				documented history and physical exam, which may also be accomplished through
				appropriate telemedicine as defined in Part 2635 Rule 5.5;
2. the extent to which the prescribed therapy
				is supported by documented history and physical exam;
3. the licensee's permitting the patient to
				name the drug desired;
4. a
				licensee dispensing or prescribing drugs to patients having no medical need,
				when the licensee knew or should have known that the patients were addicts or
				abusing/misusing substances;
5.
				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;
6. general remarks of the licensee indicating
				his or her experience with non-therapeutic uses of the drug;
7. a licensee prescribing contraindicated
				medication such as amphetamines and depressants in a manner which results in
				therapeutic conflicts.
The aforementioned is of particular importance in cases in
				  which controlled substances are to play a part in the course of treatment. It
				  is the responsibility of the licensee to dispense, prescribe or administer all
				  therapies 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" requires
				  examination of the nature of the therapy and all circumstances surrounding its
				  implementation. Use of any therapy should be supported by standards of medical
				  practice, reasonable scientific evidence or consensus and documented in the
				  medical record. 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
A licensee must 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
				  must be maintained in the office of the licensee 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
				  must be made available for inspection by representatives of the Mississippi
				  State Board of Medical Licensure pursuant to authority granted in Mississippi
				  Code, Section
				  41-29-125.
				  Record retention for Controlled Substances Inventory, Controlled Substance
				  Dispensation/Administration Record, and Patient Record must also meet all
				  applicable federal statutes and regulations.
A licensee 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 licensee 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 must be made at regular
				  intervals, not to exceed seven (7) days. Such hard-copy printouts must be
				  maintained for a period of five (5) years and must be made available for
				  inspection and copying by investigators of the Mississippi State Board of
				  Medical Licensure.