N.J. Admin. Code § 8:39-29.4

Current through Register Vol. 56, No. 21, November 4, 2024

Section 8:39-29.4 - Mandatory pharmacy control policies and procedures

(a) The label of each resident's individual medication container or package shall be labeled in accordance with the New Jersey State Board of Pharmacy regulations at 13:39-5.9, permanently affixed, and contain the following information:

1. The resident's full name;

2. The prescriber's name;

3. The prescription number;

4. The name and strength of drug;

5. The quantity dispensed;

6. The lot number;

7. The date of issue;

8. The expiration date;

9. The manufacturer's name if generic;

10. Cautionary and/or accessory labels.

i. If a generic substitute is used, the drug shall be labeled according to the Drug Utilization Review Council Formulary, 24:6E-1 et seq. and N.J.A.C. 8:71.

ii. Required information appearing on individually packaged drugs or within an alternate medication delivery system need not be repeated on the label; and

11. The name, address, and telephone number of the pharmacy.

(b) If a unit dose distribution system is used ("unit dose drug distribution" means a system in which drugs are delivered to the resident areas in single unit packaging), the following requirements shall be met:

1. Each resident shall have his or her own medication tray labeled with the resident's name and location in the facility;

2. Each medication shall be individually wrapped and labeled with the generic or trade (brand) name and strength of the drug, lot number or reference code, expiration date, dose, and manufacturer's name, and shall be ready for administration to the resident;

3. Cautionary instructions shall appear on the resident's record of medication, and the system shall include provisions for noting additional information, including, but not limited to, special times or routes of administration and storage conditions; and

4. Delivery and exchange of resident medication trays shall occur promptly, and, if a 24-hour unit-dose system is used, then at least one exchange of resident medication trays shall occur every 24 hours, including weekends and holidays.

(c) Both over-the-counter and prescription medications may be kept as stock. A limited amount of prescription medications may be kept as stock for the administration of stat (emergency) doses, lost doses, or doses not sent by the provider pharmacy. These medications shall be approved by the pharmacy and therapeutics committee, monitored for accountability, and labeled to include drug name, drug strength, manufacturers' name, lot number, expiration date, recommended dosage for over-the-counter medications, and applicable cautionary and/or accessory labels.

(d) The consultant pharmacist shall:

1. Make monthly inspection of all areas in the facility where medications are dispensed, administered, or stored;

2. Periodically, as determined by the quality assurance program, observe a medication pass and review the crediting system; and

3. Document any problems and propose solutions to these problems.

(e) The contents of emergency kits shall have been approved by the pharmacy and therapeutics committee. Emergency kits shall be stored securely at each nursing unit, but not kept under lock and key, checked after each use, and checked at least monthly by the consultant pharmacist. Emergency kits shall not be accessible to residents but shall be accessible to staff in a timely manner.

(f) All medications repackaged by the pharmacy shall be labeled with an expiration date, name and strength of drug, lot number, date of issue, manufacturer's name if generic, and cautionary and/or accessory labels, in accordance with 13:39-5.9, United States Pharmacopoeia (U.S.P.) requirements and applicable FDA regulations.

(g) The pharmacy and therapeutics committee shall establish and enforce procedures for removal of discontinued, unused, expired, recalled, deteriorated, and unlabeled drugs and intravenous solutions and for removal of containers of medications with worn, illegible, damaged, incomplete, or missing labels.

(h) All medications shall be stored in accordance with manufacturers' and United States Pharmacopoeia (U.S.P.) requirements and all medications shall be kept in locked storage areas.

(i) All medication destruction in the facility shall be witnessed by at least two persons, each of whom shall be either the pharmacist consultant, a registered professional nurse or a licensed practical nurse. A record of each instance of drug destruction shall be maintained.

(j) Where allowable by law, the facility shall generate a crediting mechanism for medications dispensed in a unit-of-use drug distribution system, or other system that allows for the re-use of medications. The crediting system shall be monitored by the provider pharmacist and a facility representative.

(k) The pharmacy and therapeutics committee shall establish and enforce procedures for the inventory of controlled substances in accordance with law.

(l) Based on prescriber's orders for medications, drug tests, diet and treatments, the facility shall implement written methods and procedures for obtaining prescribed prescription medications and biologicals from a pharmacy that has a permit from the New Jersey State Board of Pharmacy, in accordance with N.J.A.C. 13:39-4. The telephone number of the pharmacy and procedures for obtaining drugs shall be posted at each nursing unit.

(m) If the facility utilizes drugs marked "sample", the pharmacy and therapeutics committee shall develop a mechanism for the control and limitation of these drugs, in accordance with 13:35-6.6.

(n) The facility shall develop and implement a system whereby instructions for use are provided whenever medications are released to residents. Instructions shall be written in a manner intended to promote proper storage, secure handling, and safe administration of medications released to residents. Documentation of released medications shall be entered into the resident's medical record.

N.J. Admin. Code § 8:39-29.4