La. Admin. Code tit. 50 § II-10127

Current through Register Vol. 50, No. 11, November 20, 2024

Section II-10127 - Pharmacy Services

A. The facility must arrange for the provision of pharmaceutical services including procedures that assure the accurate acquiring, receiving, dispensing, and administering of all drugs and biologicals to meet the needs of each resident. Prescription drugs not covered by Medicaid or Medicare shall be at the expense of the resident. However, every attempt should be made to get the attending physician to order a covered medication before the resident incurs any expense.

1. The facility shall provide routine and emergency drugs and biologicals to its residents, or obtain them under an agreement with an outside resource.

2. The arrangement/agreement with an outside resource shall specify in writing that the facility assumes responsibility for:

a. obtaining services that meet professional standards and principles that apply to professionals providing services in such a facility; and

b. the timeliness of the service.

B. Pharmacist or Pharmaceutical Consultant. Facilities shall employ or obtain the services of a licensed pharmacist. The Pharmacist/Consultant shall be expected to:

1. provide consultation (at least 1 hour per quarter) on all aspects of the provision of pharmacy services in the facility to insure compliance with all state and federal regulations pertaining to Pharmacy Practice;

2. establish a system of recording the receipt and disposition of all controlled drugs in sufficient detail to enable an accurate reconciliation;

3. determine that drug records are in order and that an account of all controlled drugs is maintained and monthly reconciled;

4. perform drug monitoring;

5. identify drug errors;

6. alert the facility to drug recalls; and

7. be aware of adverse reactions/allergic reactions;

a. every 30 days the staff pharmacist or pharmaceutical consultant in nursing facilities shall conduct drug regimen reviews. Additionally, (s)he shall ensure compliance with drug record requirements and compliance with accounting requirements for controlled drugs;

b. the staff pharmacist or pharmaceutical consultant shall notify the attending physician if changes are appropriate;

c. the pharmacist shall report all irregularities to the attending physician or the Director of Nursing or both and these reports must be acted upon. The physician or director of nursing must verify that the irregularity has been noted, even if no changes are made, by initialing and dating;

d. the facility shall maintain a pharmaceutical committee which develops written policies and procedures for safe and effective drug therapy, distribution, control and use;

e. Pharmaceutical Committee:

i. the committee shall be composed of at least the pharmacist, director of nursing, the administrator and one physician;

ii. the committee oversees the pharmaceutical services in the facility, makes recommendations for improvement and monitors the services to ensure accuracy and adequacy;

iii. the committee meets at least quarterly and documents its activities, findings, and the adequacy of the drug program at the nursing facility;

iv. when medications are recorded or placed in unidose by pharmacist, expiration dates shall comply with pharmaceutically accepted practices;

v. the pharmaceutical committee and the facility assessment and assurance committee may be the same committee as long as all requirements are met.

C. Drug Therapy. The facility must ensure that:

1. for each drug ordered for residents there shall be a diagnosis or condition to validate the use of the drug;

2. residents shall not receive antipsychotic drugs unless the drug therapy is necessary to treat a specific condition;

3. residents who receive antipsychotic drugs should receive gradual dose reductions or behavioral programming unless clinically contraindicated in an effort to discontinue these drugs;

4. the facility shall be free of significant medication error rates; and

5. residents shall be free of any significant medication errors.

D. Approved Drugs and Biologicals. Only approved drugs and biologicals are used.

1. Such drugs and biologicals are:

a. included or approved for inclusion in the United States Pharmacopeia, National Formulary, or United States Homeopathic Pharmacopeia; or

b. included or approved for inclusion in AMA Drug Evaluations or Accepted Dental Therapeutics, except for any drugs and biologicals unfavorably evaluated therein; or

c. not included nor approved for inclusion in the compendia listed in the above paragraphs but may be considered approved if such drugs:

i. were furnished to the resident during his prior hospitalization, and

ii. Were approved for the use during a prior hospitalization by the hospital's pharmacy and drug therapeutics committee (or equivalent), and

iii. Are required for the continuing treatment of the resident in the facility.

E. Labeling of Drugs and Biologicals. The labeling of drugs and biologicals is based on currently accepted professional principles and includes the resident's full name, physician's name, full name of pharmacist dispensing, prescription number, name and strength of drug, date of issue, expiration date of all time-dated drugs, name, address, and telephone number of pharmacy issuing the drug, appropriate accessory and cautionary instructions. Non-legend or over-the-counter drugs may be labeled by the facility with resident's full name and room number not to obscure lot number and expiration date.

1. Medication containers which have soiled, damaged, incomplete, illegible, or makeshift labels are to be returned to the issuing pharmacist or pharmacy for relabeling or disposal. Containers which have no labels are to be destroyed in accordance with State and Federal laws.

2. An approved emergency medication kit shall be readily available and have a permit issued by the State Pharmacy Board. Facility must have definition of bonafide emergency in its policies and procedures.

3. The medications of each resident are to be kept and stored in their originally received containers. Transferring between containers is forbidden except by registered pharmacists.

4. A narcotic record shall be maintained which lists on separate sheets for each type and strength of narcotic the following information:

a. date;

b. time administered;

c. name of resident;

d. dose;

e. physician's name;

f. signature of person administering dose; and

g. balance (i.e. Barbiturates, non-narcotic analgesics and hypnotic).

5. Poisons and medications for "external use only" shall be kept in locked area separate from internal medications.

6. Medications no longer in use are to be disposed of or destroyed in accordance with Federal and State laws and regulations.

7. Expired medications shall be removed from usage and properly disposed of.

F. Storage of Drugs and Biologicals. Drugs and biologicals shall be stored in accordance with State and Federal laws. Drugs and biologicals must be stored in locked compartments and under proper temperature controls. Only authorized personnel shall be permitted access to the keys.

1. Separately locked, permanently affixed compartments for storage of controlled drugs listed in Schedule II of the Comprehensive Drug Abuse Prevention and Control Act of 1970 shall be provided.

2. Other drugs subject to abuse must be secure except when a single unit package drug distribution system is used in which the quantity stored is minimal and a missing dose can be readily detected.

H. Ordering of Medications. The facility shall neither expect, accept, nor require any provider to give a discount or rebate for prescription services rendered by pharmacists.

1. The facility may order at least a one-month supply of medications from a pharmacy of the resident's choice unless the attending physician specifies that a smaller quantity is necessary for a special medical reason. If a one-month supply is less than 100 unit doses, then 100 unit doses may be ordered.

2. The facility administrator or the authorized representative shall certify receipt of prescribed medications by signing and dating the pharmacy bill.

I. Unnecessary Drugs

1. Each resident's drug regimen is free of unnecessary drugs. For each drug ordered for residents there must be a diagnosis or condition to validate the use of the drug.

2. Residents shall not receive antipsychotic drugs unless the drug therapy is necessary to treat a specific condition. There shall be documentation in the chart that the resident is being monitored for side effects.

3. Residents who receive antipsychotic drugs should receive gradual dose reductions or behavioral programming unless clinically contraindicated in an effort to discontinue these drugs.

La. Admin. Code tit. 50, § II-10127

Promulgated by the Department of Health and Hospitals, Office of the Secretary, Bureau of Health Services Financing, LR 22:34 (January 1996).

AUTHORITY NOTE: Promulgated in accordance with R.S. 46:153.