Part X. Pharmacy Services to Long-Term Care Facilities
18VAC110-20-520. Drugs in long-term care facilities.
Prescription drugs, as defined in the Drug Control Act, shall not be floor stocked by a long-term care facility, except those in the stat-drug box or emergency drug box or as provided for in 18VAC110-20-560 within this chapter.
Statutory Authority
§§ 54.1-2400 and 54.1-3307 of the Code of Virginia.
Historical Notes
Derived from VR530-01-1 § 11.1, eff. October 25, 1989; amended, Virginia Register Volume 9, Issue 4, eff. December 16, 1992; Volume 10, Issue 1, eff. November 4, 1993; Volume 11, Issue 21, eff. August 9, 1995; Volume 25, Issue 24, eff. September 2, 2009.
18VAC110-20-530. Pharmacy's responsibilities to long-term care facilities.
A. The pharmacy serving a long-term care facility shall:
1. Receive a valid order prior to the dispensing of any drug.
2. Ensure that personnel administering the drugs are trained in using the dispensing system provided by the pharmacy.
3. Ensure that the drugs for each patient are kept and stored in the originally received containers and that the medication of one patient shall not be transferred to another patient.
4. Ensure that each cabinet, cart, or other area utilized for the storage of drugs is locked and accessible only to authorized personnel.
5. Ensure that the storage area for patients' drugs is well lighted, of sufficient size to permit storage without crowding, and is maintained at appropriate temperature.
6. Ensure that poison and drugs for "external use only" are kept in a cabinet and separate from other medications.
7. Provide for the disposition of discontinued drugs under the following conditions:
a. Discontinued drugs may be returned to the pharmacy for resale or transferred to another pharmacy for redispensing to the indigent if authorized by § 54.1-3411.1 of the Code of Virginia and 18VAC110-20-400, or disposed of by appropriate means in compliance with 18VAC110-20-210 and with any applicable local, state, and federal laws and regulations.
b. Drug destruction at the pharmacy shall be witnessed by the PIC and by another pharmacy employee. The pharmacy may transfer the drugs for destruction to an entity appropriately licensed to accept returns for destruction. Drug destruction at the facility shall be witnessed by the director of nursing or if there is no director, then by the facility administrator and by a pharmacist providing pharmacy services to the facility or by another employee authorized to administer medication.
c. A complete and accurate record of the drugs returned or destroyed or both shall be made. The original of the record of destruction shall be signed and dated by the persons witnessing the destruction and maintained at the long-term care facility for a period of two years. A copy of the destruction record shall be maintained at the provider pharmacy for a period of two years.
d. Long-term care facilities shall destroy discontinued or unused drugs or return them to the pharmacy within 30 days of the date the drug was discontinued.
8. Ensure that appropriate drug reference materials are available in the facility units.
9. Ensure that a monthly review of drug therapy by a pharmacist is conducted for each patient in long-term care facilities except those licensed under Title 63.2 of the Code of Virginia. Such review shall be used to determine any irregularities, which may include drug therapy, drug interactions, drug administration, or transcription errors. The pharmacist shall sign and date the notation of the review. All significant irregularities shall be brought to the attention of the attending practitioner or other party having authority to correct the potential problem.
B. A pharmacist employed by or contracted with a pharmacy providing services to a long-term care facility may share a copy of a Schedule VI prescription or order with a pharmacist at another pharmacy for the purpose of dispensing an immediate supply of drugs, not to exceed a seven-day supply, without transferring the prescription pursuant to 18VAC110-20-360
.
Statutory Authority
§§ 54.1-2400 54.1-3307 of the Code of Virginia.
Historical Notes
Derived from VR530-01-1 § 11.2, eff. October 25, 1989; amended, Virginia Register Volume 9, Issue 4, eff. December 16, 1992; Volume 10, Issue 1, eff. November 4, 1993; Volume 11, Issue 21, eff. August 9, 1995; Volume 12, Issue 21, eff. August 7, 1996; Volume 19, Issue 20, eff. July 16, 2003; Volume 20, Issue 23, eff. August 25, 2004; Volume 25, Issue 24, eff. September 2, 2009.
18VAC110-20-535. Repackaging of already dispensed prescriptions.
The primary provider pharmacy for a long-term care facility may, but shall not be required to, repackage a resident's prescription drugs dispensed by another pharmacy into the unit-dose or compliance packaging system used by the long-term care facility to assist in maintaining a uniform or more accurate system of administration.
1. Such repackaging shall only be done at the provider pharmacy.
2. Unit dose repackaging shall comply with requirements of 18VAC110-20-420 and compliance packaging shall comply with 18VAC110-20-340 B.
3. Records shall be maintained of all such repackaging of previously dispensed medications to include date; repackaging pharmacist's initials (or those of the checking pharmacist); and the pharmacy name, address, and prescription number of the original dispensing.
4. Any portion of a resident's medication not placed into unit dose or compliance packaging may be returned to the resident or kept for subsequent repackaging at the provider pharmacy in the original labeled container. If kept at the pharmacy, the medication shall be stored within the prescription department but separate from any working stock of drugs used for dispensing by the pharmacy, and shall only be used for the patient to whom the medication was originally dispensed.
Statutory Authority
§ 54.1-2400 and Chapters 33 (§ 54.1-3300 et seq.) and 34 (§ 54.1-3400 et seq.) of Title 54.1 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 25, Issue 24, eff. September 2, 2009.
18VAC110-20-536. Prescription drugs sent outside the facility.
A. The provider pharmacy shall assure that residents who leave a long-term care facility for short periods of time or are discharged and who are allowed to take dispensed prescription medications with them, do so only in appropriate packaging, properly labeled for outpatient use.
B. Pharmacies that provide medication to residents in compliance packaging that meets the requirements of 18VAC110-20-340 B, shall assure that if the facility separates and sends only the individual containers needed during the time the resident is away without the main package label, that the resident is also given a copy of the main package label or other appropriate documentation that contains the complete labeling information on the main package label.
Statutory Authority
§ 54.1-2400 and Chapters 33 (§ 54.1-3300 et seq.) and 34 (§ 54.1-3400 et seq.) of Title 54.1 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 25, Issue 24, eff. September 2, 2009.
18VAC110-20-540. Emergency drug kit.
A. The pharmacist providing services may prepare an emergency kit for a long-term care facility in which access to the kit is restricted to a licensed nurse, pharmacist, or prescriber and only these licensed individuals may administer a drug taken from the kit and only under the following conditions:
1. The contents of the emergency kit shall be of such a nature that the absence of the drugs would threaten the survival of the patients.
2. The contents of the kit or an automated drug dispensing system, as provided in subsection B of this section, shall be determined by the provider pharmacist in consultation with the medical and nursing staff of the institutions and shall be limited to drugs for administration by injection or inhalation only, except that Nitroglycerin SL, diazepam rectal gel, and the intranasal spray formulation of naloxone may be included.
3. The kit is sealed in such a manner that it will preclude any possible loss of the drug.
a. The dispensing pharmacy must have a method of sealing such kits so that once the seal is broken, it cannot be reasonably resealed without the breach being detected.
b. If a seal is used, it shall have a unique numeric or alphanumeric identifier to preclude replication, resealing, or both. The pharmacy shall maintain a record of the seal identifiers when placed on a box or kit and maintain the record until such time as the seal is replaced.
c. In lieu of seals, a kit with a built-in mechanism preventing resealing or relocking once opened except by the provider pharmacy is also acceptable.
4. The kit shall have a form to be filled out upon opening the kit and removing contents to write the name of the person opening the kit, the date, time, and name and quantity of items removed. The opened kit is maintained under secure conditions and returned to the pharmacy within 72 hours for replenishing.
5. Any drug used from the kit shall be covered by a prescription, signed by the prescriber, when legally required, within 72 hours.
B. Drugs that would be stocked in an emergency kit, pursuant to this section, may be stocked in an automated drug dispensing system in a nursing home in accordance with 18VAC110-20-555.
Statutory Authority
§§ 54.1-2400 and 54.1-3307 of the Code of Virginia.of the Code of Virginia.
Historical Notes
Derived from VR530-01-1 § 11.3, eff. October 25, 1989; amended, Virginia Register Volume 9, Issue 4, eff. December 16, 1992; Volume 10, Issue 1, eff. November 4, 1993; Volume 11, Issue 21, eff. August 9, 1995; Volume 15, Issue 8, eff. February 3, 1999; Volume 20, Issue 23, eff. August 25, 2004; Volume 25, Issue 24, eff. September 2, 2009; amended, Virginia Register Volume 32, Issue 22, eff. August 11, 2016; Volume 35, Issue 3, eff. October 31, 2018.
18VAC110-20-550. Stat-drug box.
A. An additional drug box called a stat-drug box may be prepared by a pharmacy to provide for initiating therapy prior to the receipt of ordered drugs from the pharmacy. Access to the stat-drug box is restricted to a licensed nurse, pharmacist, or prescriber and only these licensed individuals may administer a drug taken from the stat-drug box. Additionally, a valid prescription or lawful order of a prescriber must exist prior to the removal of any drug from the stat-drug box. A stat-drug box shall be subject to the following conditions:
1. The box is sealed in such a manner that will preclude the loss of drugs.
a. The dispensing pharmacy must have a method of sealing such boxes so that once the seal is broken, it cannot be reasonably resealed without the breach being detected.
b. If a seal is used, it shall have a unique numeric or alphanumeric identifier to preclude replication or resealing, or both. The pharmacy shall maintain a record of the seal identifiers when placed on a box and maintain the record until such time as the seal is replaced.
c. In lieu of seals, a box with a built-in mechanism preventing resealing or relocking once opened except by the provider pharmacy is also acceptable.
2. The box shall have a form to be filled out upon opening the box and removing contents to write the name of the person opening the box, the date, the time, and the name and quantity of items removed. When the stat-drug box has been opened, it is returned to the pharmacy.
3. There shall be a listing of the contents of the box maintained in the pharmacy and also attached to the box in the facility. This same listing shall become a part of the policy and procedure manual of the facility served by the pharmacy.
4. The drug listing on the box shall bear an expiration date for the box. The expiration date shall be the day on which the first drug in the box will expire.
5. The contents of the box shall be limited to those drugs in which a delay in initiating therapy may result in harm to the patient.
a. The listing of drugs contained in the stat-drug box shall be determined by the provider pharmacist in consultation with the medical and nursing staff of the long-term care facility.
b. The stat-drug box shall contain no more than 20 solid dosage units per schedule of Schedules II through V drugs except that one unit of liquid, not to exceed 30 ml, may be substituted for a solid dosage unit in each drug schedule. If the unit of a liquid that may contain more than one dose is removed from the stat-drug box pursuant to a patient order, the remainder shall be stored with that patient's other drugs, may be used for subsequent doses administered to that patient, and shall not be administered to any other patient.
B. Drugs that would be stocked in a stat-drug box, pursuant to this section, may be stocked in an automated drug dispensing system in a nursing home in accordance with 18VAC110-20-555, except that the quantity of drugs in Schedules II through V stocked in the system shall be determined by the provider pharmacist in consultation with the medical and nursing staff of the nursing home.
C. The pharmacy may provide more than one stat-drug box to a long-term care facility. Contents of the multiple boxes are not required to be uniform.
Statutory Authority
§§ 54.1-2400 and 54.1-3307 of the Code of Virginia.
Historical Notes
Derived from VR530‑01‑1 § 11.4, eff. October 25, 1989; amended, Virginia Register Volume 9, Issue 4, eff. December 16, 1992; Volume 10, Issue 1, eff. November 4, 1993; Volume 11, Issue 21, eff. August 9, 1995; Volume 15, Issue 8, eff. February 3, 1999; Volume 20, Issue 23, eff. August 25, 2004; Volume 25, Issue 24, eff. September 2, 2009; Volume 26, Issue 6, eff. January 7, 2010; Volume 35, Issue 3 eff. October 31, 2018; Volume 36, Issue 6, eff. December 11, 2019.
18VAC110-20-555. Use of automated dispensing devices.
Nursing homes licensed pursuant to Chapter 5 (§ 32.1-123 et seq.) of Title 32.1 of the Code of Virginia may use automated drug dispensing systems, as defined in § 54.1-3401 of the Code of Virginia, upon meeting the following conditions:
1. Drugs placed in an automated drug dispensing system in a nursing home shall be under the control of the pharmacy providing services to the nursing home, the pharmacy shall have online communication with and control of the automated drug dispensing system, and access to any drug for a patient shall be controlled by the pharmacy.
2. A nursing home without an in-house pharmacy shall obtain a controlled substances registration prior to using an automated dispensing system, unless the system is exclusively stocked with drugs that would be kept in a stat-drug box pursuant to 18VAC110-20-550 or an emergency drug kit pursuant to 18VAC110-20-540 and are solely administered for stat or emergency administration.
3. For facilities not required to obtain a controlled substance registration, access to the automated dispensing device shall be restricted to a licensed nurse, pharmacist, or prescriber, or a registered pharmacy technician for the purpose of stocking or reloading.
4. Removal of drugs from any automated drug dispensing system for administration to patients can only be made pursuant to a valid prescription or lawful order of a prescriber under the following conditions:
a. A drug, including a drug that would be stocked in a stat-drug box pursuant to subsection B of 18VAC110-20-550, may not be administered to a patient from an automated dispensing device until a pharmacist has reviewed the prescription order and electronically authorized the access of that drug for that particular patient in accordance with the order.
b. The PIC of the provider pharmacy shall ensure that a pharmacist who has online access to the system is available at all times to review a prescription order as needed and authorize administering pursuant to the order reviewed.
c. Drugs that would be stocked in an emergency drug kit pursuant to 18VAC110-20-540 may be accessed prior to receiving electronic authorization from the pharmacist provided that the absence of the drugs would threaten the survival of the patients.
d. Automated dispensing devices shall be capable of producing a hard-copy record of distribution that shall show patient name, drug name and strength, dose withdrawn, dose to be administered, date and time of withdrawal from the device, and identity of person withdrawing the drug.
5. Drugs placed in automated dispensing devices shall be in the manufacturer's sealed original unit dose or unit-of-use packaging or in repackaged unit-dose containers in compliance with the requirements of 18VAC110-20-355 relating to repackaging, labeling, and records.
6. Prior to the removal of drugs from the pharmacy, a delivery record shall be generated for all drugs to be placed in an automated dispensing device, which shall include the date; drug name, dosage form, and strength; quantity; nursing home; a unique identifier for the specific device receiving drugs; and initials of the pharmacist checking the order of drugs to be removed from the pharmacy and the records of distribution for accuracy.
7. At the direction of the PIC, drugs may be loaded in the device by a pharmacist or a pharmacy technician adequately trained in the proper loading of the system.
8. At the time of loading, the delivery record for all Schedules II through VI drugs shall be signed by a nurse or other person authorized to administer drugs from that specific device, and the record returned to the pharmacy.
9. At the time of loading any Schedules II through V drug, the person loading will verify that the count of that drug in the automated dispensing device is correct. Any discrepancy noted shall be recorded on the delivery record and immediately reported to the PIC, who shall be responsible for reconciliation of the discrepancy or the proper reporting of a loss.
10. The PIC of the provider pharmacy or his designee shall conduct at least a monthly audit to review distribution and administration of Schedules II through V drugs from each automated dispensing device as follows:
a. The audit shall reconcile records of all quantities of Schedules II through V drugs dispensed from the pharmacy with records of all quantities loaded into each device to detect whether any drugs recorded as removed from the pharmacy were diverted rather than being placed in the proper device.
b. A discrepancy report shall be generated for each discrepancy in the count of a drug on hand in the device. Each such report shall be resolved by the PIC or his designee within 72 hours of the time the discrepancy was discovered or, if determined to be a theft or an unusual loss of drugs, shall be immediately reported to the board in accordance with § 54.1-3404 E of the Drug Control Act.
c. The audit shall include a review of a sample of administration records from each device per month for possible diversion by fraudulent charting. A sample shall include all Schedules II through V drugs administered for a time period of not less than 24 consecutive hours during the audit period.
d. The audit shall include a check of medical records to ensure that a valid order exists for a random sample of doses recorded as administered.
e. The audit shall also check for compliance with written procedures for security and use of the automated dispensing devices, accuracy of distribution from the device, and proper recordkeeping.
f. The hard copy distribution and administration records printed out and reviewed in the audit shall be initialed and dated by the person conducting the audit. If nonpharmacist personnel conduct the audit, a pharmacist shall review the record and shall initial and date the record.
11. Automated dispensing devices shall be inspected monthly by pharmacy personnel to verify proper storage, proper location of drugs within the device, expiration dates, the security of drugs and validity of access codes.
12. Personnel allowed access to an automated dispensing device shall have a specific access code which records the identity of the person accessing the device.
13. The PIC of the pharmacy providing services to the nursing home shall establish, maintain, and assure compliance with written policy and procedure for the accurate stocking and proper storage of drugs in the automated drug dispensing system, accountability for and security of all drugs maintained in the automated drug dispensing system, preventing unauthorized access to the system, tracking access to the system, complying with federal and state regulations related to the storage and dispensing of controlled substances, maintaining patient confidentiality, maintaining required records, and assuring compliance with the requirements of this chapter. The manual shall be capable of being accessed at both the pharmacy and the nursing home.
14. All records required by this section shall be filed in chronological order from date of issue and maintained for a period of not less than two years. Records shall be maintained at the address of the pharmacy providing services to the nursing home except:
a. Manual Schedule VI distribution records may be maintained in offsite storage or electronically as an electronic image that provides an exact image of the document that is clearly legible provided such offsite or electronic storage is retrievable and made available for inspection or audit within 48 hours of a request by the board or an authorized agent.
b. Distribution and delivery records and required signatures may be generated or maintained electronically provided:
(1) The system being used has the capability of recording an electronic signature that is a unique identifier and restricted to the individual required to initial or sign the record.
(2) The records are maintained in a read-only format that cannot be altered after the information is recorded.
(3) The system used is capable of producing a hard-copy printout of the records upon request.
c. Schedules II through V distribution and delivery records may only be stored offsite or electronically as described in subdivisions 14 a and 14 b of this section if authorized by DEA or in federal law or regulation.
d. Hard-copy distribution and administration records that are printed and reviewed in conducting required audits may be maintained offsite or electronically provided they can be readily retrieved upon request; provided they are maintained in a read-only format that does not allow alteration of the records; and provided a separate log is maintained for a period of two years showing dates of audit and review, the identity of the automated dispensing device being audited, the time period covered by the audit and review, and the initials of all reviewers.
Statutory Authority
§§ 54.1-2400 and 54.1-3307 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 15, Issue 8, eff. February 3, 1999; amended, Virginia Register Volume 20, Issue 23, eff. August 25, 2004; Volume 25, Issue 24, eff. September 2, 2009; Volume 35, Issue 3, eff. October 31, 2018.
18VAC110-20-560. Floor stock.
In addition to an emergency box or stat-drug box, a long-term care facility in which only those persons licensed to administer are administering drugs may maintain a stock of intravenous fluids, irrigation fluids, heparin flush kits, medicinal gases, sterile water and saline, and prescription devices. Such stock shall be limited to a listing to be determined by the provider pharmacist in consultation with the medical and nursing staff of the institution.
Statutory Authority
§§ 54.1-2400, 54.1-3307, and 54.1-3312 of the Code of Virginia.
Historical Notes
Derived from VR530-01-1 § 11.3, eff. October 25, 1989; amended, Virginia Register Volume 9, Issue 4, eff. December 16, 1992; Volume 10, Issue 1, eff. November 4, 1993; Volume 11, Issue 21, eff. August 9, 1995.