61-07-01-07. Drug distribution and control.

1. General. The director of pharmacy services shall establish written procedures for the safe and efficient distribution of pharmaceutical products. An annual updated copy of such procedures must be on hand for inspections.

2. Responsibility. The director is responsible for the safe and efficient distribution of, control of, and accountability for drugs. The other professional staff of the hospital shall cooperate with the director in meeting this responsibility and in ordering, administering, and accounting for pharmaceutical materials so as to achieve this purpose. Accordingly, the director is responsible for, at a minimum, the following:

a. Preparation and sterilization of parenteral medications manufactured within the hospital. b. Admixture of parenteral products, including education and training of nursing personnel concerning incompatibility and provision of proper incompatibility information when the admixture of parenteral products is not accomplished within the hospital pharmacy. c. Manufacture of drugs, if applicable. d. Establishment of specifications for procurement of all materials, including drugs, chemicals, and biologicals, subject to approval of the appropriate committee of the hospital. e. Participation in development of a formulary for the hospital. f. Filling and labeling all containers from which drugs are to be administered. g. Maintaining and making available a sufficient inventory of antidotes and other emergency drugs, both in the pharmacy and inpatient care areas, as well as current antidote information, telephone numbers of regional poison control centers, and other emergency assistance organizations, and such other materials and information as may be deemed necessary by the appropriate committee of the hospital, if any. h. Records of all transactions of the hospital pharmacy as may be required by applicable law, state and federal, and as may be necessary to maintain accurate control over and accountability for all pharmaceutical materials. i. Participation in drug usage evaluation activities. j. Fullest cooperation with teaching or research programs, or both, in the hospital, if any. k. Implementation of the policies and decisions of the appropriate committees of the hospital. l. Effective and efficient messenger and delivery service to connect the pharmacy with appropriate parts of the hospital on a regular basis throughout the normal workday of the hospital. m. Meeting all compliance and other requirements of the North Dakota board of pharmacy rules and laws and this chapter.

3. Labeling.

a. For use inside the hospital. All drugs dispensed by a hospital pharmacy, not on an individual prescription, intended for use within the hospital, must be dispensed in appropriate containers and adequately labeled so as to identify, at a minimum, brand name or generic name, strength, quantity, source, and expiration date. b. For use outside the pharmacy. All drugs dispensed by a hospital pharmacy to patients about to be discharged or to whom it is certain will carry the item dispensed outside of the hospital, in compliance with pharmacy practice act and rules, must be labeled with the following information: (1) Name, address, and telephone number of the hospital pharmacy. (2) Date and identifying serial number. (3) Full name of patient.

1. (4) Name of drug strength, and number of units.
2. (5) Directions for use to the patients.
3. (6) Name of physician prescribing.
4. (7) Required precautionary information regarding controlled substances.
5. (8) Such other and further accessory cautionary information as may be required or desirable for proper use and safety to the patient.- c. Drugs added to parenteral admixtures. Whenever any drugs are added to parenteral admixtures, whether within or outside the direct and personal supervision of a pharmacist, such admixtures must be labeled with a distinctive supplementary label indicating the name and the amount of the drug added, date and time of addition and expiration, and name of person so adding.4. Discontinued drugs. The director shall develop and implement policies and procedures to ensure that discontinued and outdated drugs and containers with worn, illegible, or missing labels are returned to the pharmacy for proper disposition or that the director or the director's designee make proper disposition or dispose of such drugs at the storage site.5. Physician's orders. Drugs may be dispensed from the hospital pharmacy only upon written or verbal orders, direct copies or facsimiles thereof, of authorized physicians. Verbal orders for drugs are accepted only by personnel so designated in accordance with applicable law and regulations governing such acts and in accordance with the approved medical staff rules and regulations.- a. Authorization. The appropriate committee of the hospital shall designate, from time to time as appropriate, those physicians who are authorized to issue orders to the pharmacy.
6. b. Abbreviations. Orders employing abbreviations and chemical symbols may be utilized and filled only if such abbreviations and symbols appear on a published list of accepted abbreviations developed by the appropriate committee of the hospital.
7. c. Requirements - Orders for drugs for use by inpatients. Orders for drugs for use by inpatients shall contain, at a minimum: patient name and room number, drug name, strength, directions for use, date, and physician's signature or that of the physician's authorized representative.
8. d. Requirements - Orders for drugs for use by outpatients. Orders for drugs for use by outpatients become prescriptions and must meet all requirements of the law.
9. e. Pharmacist review. The pharmacist shall review the prescriber's order, or a direct copy thereof, before the initial dose of medication is dispensed (with the exception of emergency orders when time does not permit). In cases when the medication order is written when the pharmacy is 'closed' or the pharmacist is otherwise unavailable, the medication order should be reviewed by the pharmacist as soon thereafter as possible, preferably within twenty-four hours.
10. f. Signature. A means of identifying the signatures of all practitioners authorized to use the pharmaceutical services, as well as a listing of their drug enforcement administration numbers, must be maintained.6. Controlled drug accountability. The hospital shall establish effective procedures and maintain adequate records regarding use and accountability of controlled substances and

such other drugs as the appropriate hospital committee may designate which may specify at least the following:

a. Name of drug. b. Dose. c. Physician. d. Patient. e. Date and time of administration. f. Person administering the drug.

7. Recall. The director shall develop and implement a recall procedure that can be readily activated to assure the medical staff of the hospital that all drugs included on the recall, whether within or outside the hospital, are returned to the pharmacy for proper disposition.

8. Suspected adverse drug reactions. Any and all suspected adverse drug reactions must be reported orally immediately to the ordering physician and in writing to the pharmacy, and to the appropriate committee of the hospital. Appropriate entry on the patient's record must also be made. The director may, at the director's discretion, make further reports of such suspected reactions to the hospital reporting program of the United States food and drug administration, to the manufacturer, and to the United States pharmacopeia.

9. Records and reports. The director shall maintain and submit, as appropriate, such records and reports as are required to ensure patient health, safety, and welfare, and, at a minimum, the following: a. Physician's orders, direct copies, or facsimiles thereof. b. Controlled drug accountability report. c. Reports of suspected adverse drug reactions. d. Inventories of night cabinets and emergency kits. e. Inventories of the pharmacy. f. Biennial controlled substances inventories. g. Alcohol and flammables reports. h. Such other and further records and reports as may be required by law and this chapter.

10. Distribution systems. a. Floor or ward stock system. In this system, all but the most unusual drug items are stocked on the nursing stations. Drug products which require special control (e.g., antineoplastic agents) are often omitted from floor stock, and are sent to the nursing unit upon receipt of a prescription order for the individual patient. All containers used for floor stock must meet specific labeling requirements as addressed in these rules. b. Individual prescription order system. In this system, all medications are dispensed by the pharmacist on individual prescription orders.

c. Combination of floor stock and the individual prescription order system. In this system, most drugs are dispensed on an individual prescription basis. The remaining drugs are obtained via limited floor stock.

d. Unit dose. In this system, medications are contained in single unit packages; they are dispensed in as ready-to-administer form as possible, for most medications. All doses will be labeled properly to include name, strength, expiration date, or lot number or control number, or both.

History: Effective April 1, 1988.

General Authority: NDCC 28-32-02

Law Implemented: NDCC 43-15-10(9), 43-15-10(12), 43-15-10(14)