Title of Regulation: 12VAC5-391. Regulations for the Licensure of Hospice (amending 12VAC5-391-460).

Statutory Authority: §§ 32.1-12 and 32.1-162.5 of the Code of Virginia.

Effective Date: April 7, 2016.

Agency Contact: Erik Bodin, Director, Office of Licensure and Certification, Department of Health, 9960 Mayland Drive, Suite 401, Richmond, VA 23233, telephone (804) 367-2109, or erik.bodin@vdh.virginia.gov.

Summary:

Pursuant to Chapter 668 of the 2015 Acts of Assembly, the amendment requires any hospice licensed by the Department of Health or exempt from licensure pursuant to § 32.1-162.2 of the Code of Virginia with a hospice patient residing at home at the time of death to notify every pharmacy that has dispensed partial quantities of a Schedule II controlled substance for a patient with a medical diagnosis documenting a terminal illness, as authorized by federal law, within 48 hours of the patient's death.

12VAC5-391-460. Pharmacy services.

A. Whether medications and biologicals are obtained from community or institutional pharmacies, the hospice facility is responsible for assuring availability for medications and biologicals, including 24-hour emergency services, for its patients and for ensuring that pharmaceutical services are provided according to accepted professional principles and appropriate federal and state laws.

B. The facility shall comply with the Virginia Board of Pharmacy regulations related to pharmacy services in long-term care facilities, (i.e., Part XII (18VAC110-20-530 18VAC110-20-520 et seq.) of the Virginia Board of Pharmacy Regulations Governing the Practice of Pharmacy).

C. Each hospice facility shall develop and implement policies and procedures for the handling of drugs and biologicals, including procurement, storage, administration, medication errors, self-administration, disposal and accounting of drugs and other pharmacy products.

D. Each facility shall have a written agreement with a qualified pharmacist to provide consultation on all aspects of the provision of pharmacy services in the facility.

The consultant pharmacist shall make regularly scheduled visits, at least quarterly, to the facility for a sufficient number of hours to carry out the function of the agreement.

E. Each prescription container shall be individually labeled by the pharmacist for each patient or provided in an individualized unit dose system.

F. No drug or medication shall be administered to any patient without a valid verbal order or a written, dated and signed order from a physician, dentist or, podiatrist, nurse practitioner, or physician assistant, licensed in Virginia.

G. Verbal orders for drugs or medications shall only be given to a licensed nurse, pharmacist or physician.

H. Each patient's medication regimen shall be reviewed by a pharmacist licensed in Virginia. Any irregularities identified by the pharmacist shall be reported to the physician and the director of nursing, and their response documented.

I. Medication orders shall be reviewed at least every 60 days by the attending physician, nurse practitioner, or physician's assistant.

J. Prescription and nonprescription drugs and medications may be brought into the facility by a patient's family, friend, or other person provided:

1. The individual delivering the drugs and medications assures timely delivery, in accordance with the facility's written policies, so that the patient's prescribed treatment plan is not disrupted;

2. Each drug or medication is in an individual container; and

3. Delivery is not allowed directly to an individual patient.

In addition, prescription medications shall be:

4. Obtained from a pharmacy licensed by the state or federal authority; and

5. Securely sealed and labeled by a licensed pharmacist according to 18VAC110-20-330 and 18VAC110-20-340.

K. Any hospice licensed by the Department of Health or exempt from licensure pursuant to § 32.1-162.2 of the Code of Virginia with a hospice patient residing at home at the time of death shall notify every pharmacy that has dispensed partial quantities of a Schedule II controlled substance for a patient with a medical diagnosis documenting a terminal illness, as authorized by federal law, within 48 hours of the patient's death.