La. Admin. Code tit. 48 § III-525

Current through Register Vol. 50, No. 9, September 20, 2024

Section III-525 - Pharmaceutical Services

A. Provision of Services

1. The center or clinic shall provide or make formal arrangements for pharmaceutical services in accordance with applicable federal, state, and local laws and regulations. Facilities with a pharmacy which dispenses drugs for inpatient and/or outpatient use shall employ a registered pharmacist on a full-time or part-time basis. Facilities which do not maintain a pharmacy and which obtain drugs from a community pharmacy shall have a formal agreement with a registered pharmacist to provide consultation on a regular basis concerning the ordering, storage, administration, disposal, and recordkeeping of drugs throughout the facility.

2. The facility shall have a written statement describing the provision of pharmaceutical services to inpatients and outpatients.

3. Pharmaceutical policies and procedures shall include:

a. provision of pharmacy services to inpatients and outpatients including storage, dispensing, administration, disposal, recordkeeping, and control of drugs in accordance with applicable federal, state, and local laws and regulations;

b. the use of investigational drugs in the facility;

c. the routine inspection of drug storage areas by the registered pharmacist;

d. an automatic stop order policy for all drugs not specifically limited as to time or number of doses when ordered by the physician;

e. the qualifications of persons authorized to administer drugs in the facility;

f. a procedure for reporting adverse drug reactions to the FDA;

g. the list of abbreviations and symbols approved for use in the facility;

h. recording of medication errors and adverse drug reactions and reporting them to the physician immediately;

i. provision for emergency pharmaceutical services;

j. functions and responsibilities of the pharmacist;

k. the use of controlled drugs in the facility; and

l. a list of physicians authorized to order medications for patients. The pharmacy manual shall be reviewed and revised at least annually.

B. Ordering, Dispensing, and Administration of Drugs

1. Medication shall be ordered only by the staff physicians and medical residents at the facility, dispensed only by a registered pharmacist, and administered only by appropriately licensed personnel.

2. Drugs shall be dispensed according to approved written policies and procedures and in accordance with federal, state, and local laws, and regulations. The pharmacist shall dispense from an original or a direct copy of the physician's order for medication.

3. Telephone and verbal orders for medications shall be given by an authorized physician only, and shall be accepted and written by another physician, a registered nurse, or a registered pharmacist; such action shall be limited to urgent circumstances. Telephone and verbal orders shall be signed by the responsible physician within 72 hours.

4. Orders involving abbreviations and chemical symbols shall be carried out only if the abbreviations and symbols appear on a standard list approved by the staff physicians at the facility.

5. The pharmacist shall maintain for each patient an individual patient medication profile which records all medications (prescription and nonprescription) dispensed including quantities and frequency of refills in addition to other pertinent information. The pharmacist shall review the drug regimen of each patient at least monthly or routinely when medication orders are received for possible drug interactions, allergies, administration errors, etc., and document the review. It is recommended that the pharmacist be actively involved in a program for providing information concerning the safe use of drugs to outpatients and to patients being discharged from the facility and in in-service education programs to facility personnel.

6. Labeling of drugs used throughout the facility shall be the responsibility of the pharmacist. Medication labels shall include the name of the patient; the name of the prescribing physician, the name and strength of the drug; the manufacturer or the trade name of the drug dispensed, the date of dispensing, the name or initials of the dispensing pharmacist, the name, address, and telephone number of the issuing pharmacy, the prescription number, and when applicable, the directions for use of the drug.

7. Drugs brought into the facility by patients shall not be administered unless they are identified and labeled by a staff physician or a registered pharmacist and written orders to administer these specific drugs are given by a staff physician at the facility. If the drugs brought into the facility by a patient are not to be used, they shall be packaged, sealed, stored, and returned to the patient, his parents, or the responsible party at the time of discharge, if such action is approved by a staff physician at the facility.

8. Self-administration of medications by patients in the inpatient element of service shall be permitted only when specifically ordered by a staff physician and supervised by a member of the clinic staff.

9. The facility shall have a policy on provision of medications for patients leaving the facility on a "pass" or being discharged from the facility.

10. Investigational drugs shall be used only in accordance with applicable federal, state, and local laws and regulations. When investigational drugs are used, a central unit shall be established where essential information is maintained, including dosage form, dosage range, storage requirements, toxicology, use and contraindications. Proper records of their use shall be maintained. Investigational drugs shall be properly labeled and shall be used only under the direct supervision of the principal investigator with the approval of the research review committee. Nurses may administer these drugs only after they have been given the basic pharmacological information about the drug.

C. Drug Storage and Preparations Areas

1. The facility shall have adequate and properly controlled drug preparation areas, as well as locked storage areas accessible only to authorized personnel. A registered pharmacist shall make inspections at least monthly of all drug storage areas including, where applicable, emergency boxes and emergency carts. A record of these inspections including suggestions for improvement shall be maintained in the facility in order to verify that:

a. poisons and drugs for external use are stored separately from internal and injectable medications;

b. all drugs and biologicals are properly stored;

c. outdated and discontinued drugs are removed from stock promptly;

d. distribution and administration of all drugs are adequately documented;

e. metric-apothecary weight and measure conversion charts are posted at each drug preparation area and wherever else necessary; and

f. there is an emergency drug kit which is:

i. readily available to staff yet not accessible to patients;

ii. properly controlled to assure completeness of content at all times;

iii. content determined by staff physicians and the registered pharmacist.

2. Drugs shall be stored under proper conditions of sanitation, temperature, light, moisture, ventilation, segregation, and security. Security requirements shall be maintained in accordance with federal and state laws and all drugs shall be kept under lock and key. Poisons and external use preparations shall be stored separately from internal preparations. Medications requiring refrigeration which are stored in a refrigerator containing items other than drugs shall be kept in a separate compartment with proper security. Storage and recordkeeping of drugs listed in the current Comprehensive Drug Abuse Prevention and Control Act of 1970 shall be maintained in accordance with federal and state laws and regulations. Antidote charts and the telephone number of the regional poison control center shall be kept at all drug storage and preparation areas.

La. Admin. Code tit. 48, § III-525

Promulgated by the Department of Health and Human Resources, Office of Mental Health, LR 13:246 (April 1987).

AUTHORITY NOTE: Promulgated in accordance with PL 94 :63, the Community Mental Health Centers' Act of 1975 and R. S.1950, Title 28, §203.