N.J. Admin. Code § 8:39-29.3

Current through Register Vol. 56, No. 9, May 6, 2024

Section 8:39-29.3 - Mandatory pharmacy reporting policies and procedures

(a) The consultant pharmacist shall conduct a drug regimen review and enter appropriate comments into the medical record of every resident receiving medication, at least monthly, on a pharmacist consultation sheet or another portion of the medical record, in accordance with N.J.A.C. 13:39. The drug regimen review shall be performed in accordance with Federal and State statutes, rules and regulations, and currently accepted standards of practice for rational drug therapy.

1. The consultant pharmacist shall report any irregularities promptly to the attending physician or advanced practice nurse and to the director of nurses and these reports shall be acted upon. These reports shall include, but are not limited to, problems and recommendations about drug therapy which may be affected by biologicals, laboratory tests, special dietary requirements and foods used or administered concomitantly with other medication to the same recipient. Also, these reports are required to include monitoring for potential adverse effects, allergies, drug interactions, contraindications, rationale, and drug evaluation.

2. The consultant pharmacist shall report drug defects and adverse drug reactions, in accordance with the recommendations of the ASHSP-USP-FDA (American Society of Health System Pharmacists, United States Pharmacopeia, Food and Drug Administration) to the Adverse Event Reporting System.

i. Information on the Adverse Event Reporting System may be found at http://www.fda.gov/safety/medical-product-safety-information/forms-reporting-fda and reports may be filed electronically at http://www.fda.gov/drugs/fda-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-electronic-submissions.

3. All known drug allergies shall be documented in the resident's medical record including the medication administration records and physician or advanced practice nurse order sheets and on the outside front cover and communicated to the provider or dispensing pharmacy.

4. Drugs that are not specifically limited as to duration of use or number of doses shall be controlled by automatic stop orders. The resident's attending physician or advanced practice nurse shall be notified of the automatic stop order prior to the last dose so that he or she may decide whether to continue use of the drug.

5. If medication is withheld, the reason for withholding the medication shall be documented in the resident's medical record.

6. Medication errors and adverse drug reactions shall be reported immediately to the director of nursing or the alternate to the director of nursing, and a description of the error or adverse drug reaction shall be entered into the medical record before the end of the employee shift. If the resident has erroneously received medication, the resident's physician or advanced practice nurse shall be notified immediately. If a medication error originated in the pharmacy, the pharmacy shall be notified immediately. The Department shall be notified of an adverse drug reaction that results in death.

N.J. Admin. Code § 8:39-29.3

Amended by 53 N.J.R. 2199(a), effective 12/20/2021