Current through Register Vol. XLI, No. 38, September 20, 2024
12.1.
Pharmacological interventions used shall be those recognized as appropriate to
treat neonatal abstinence syndrome in an inpatient community-based
setting.
12.2. Medication,
including over-the-counter medicine will be prescribed and monitored by a
licensed physician, physician's assistant or advanced practice registered
professional nurse.
12.3. Patients
admitted to the facility with properly labeled and bottled medications may
continue those medications with appropriate consents until the center obtains a
current physician's order. At no time shall this period exceed 24
hours.
12.4. Only the person with
prescriptive authority may order medications and dosages; only the program
physician may approve changes in dosage.
12.5. The parent and/or legal representative
shall be advised of any change in medication dosage or
administration.
12.6. Each neonatal
abstinence center shall have policies and procedures to comply with all
relevant federal and state laws, rules and regulations regarding the storage,
management and administration of medications kept at the facility. The policies
and procedures shall include measures to:
12.6.a. Ensure responsible handling and
secure storage of all medications kept at the facility;
12.6.b. Ensure responsible documentation of
all medications received, stored, administered and dispensed at the
facility;
12.6.c. Ensure only
authorized personnel may access the storage areas where any medications are
kept;
12.6.d. Ensure the security
of medications to prevent diversion;
12.6.e. Ensure the proper recording keeping
of all medications, including but not limited to, the:
12.6.e.1. Receipt of medication
records;
12.6.e.2. Initial
inventory;
12.6.e.3. Monthly
inventory;
12.6.e.4. Counting of
all controlled substances;
12.6.e.5. Perpetual logs;
12.6.e.6. Administration;
12.6.e.7. Documenting wastage;
12.6.e.8. Documentation of patient
charts;
12.6.e.9. Disposal of
controlled substances; and
12.6.e.10. Transferring of controlled
substances among registrants.
12.6.f. Ensure all personnel administering
medications to adhere to federal and state laws, rules, regulations, and
protocols or guidelines from approved authorities;
12.6.g. Ensure medications are administered
only by a practitioner who is qualified to do so by his or her scope of
practice, is licensed under the appropriate state law, and is registered under
the appropriate state and federal laws to administer opioid drugs;
and
12.6.h. Ensure all medication
is administered in accordance with its approved product labeling.
12.7. Medication Errors.
12.7.a. In the event of a medication error, a
registered professional nurse shall:
12.7.a.1. Complete a physical assessment of
the patient's condition;
12.7.a.2.
Provide any and all first aid, and contact emergency medical
services;
12.7.a.3. Place patient
on cardio-respiratory monitor, if opiate error;
12.7.a.4. Notify the attending physician
immediately;
12.7.a.5. Document and
read back physician orders; and
12.7.a.6. Once patient is stable notify the
Administrator, Director of Nursing, state protective services agency, and the
state oversight agency.
12.7.b. Medication errors are considered a
critical incident and must be reported to the state oversight agency.
12.8. Medication Storage and
Handling.
12.8.a. Each and every time
controlled substances change hands or are used, documentation must be generated
and maintained at the center.
12.8.b. Controlled substance records shall be
maintained according to chapter 60A, of the West Virginia Code.
12.8.c. Controlled substance records must be
maintained at the center and must be readily retrievable and open to inspection
and copying by the appropriate federal and state authorities.
12.8.d. The neonatal abstinence center shall
conduct and submit a regular narcotics inventory and log review to the
governing board on a quarterly basis.
12.8.e. On a regular monthly basis, and no
longer than a 30 day interval, a narcotics log review shall be conducted by the
Director of Nursing and one other professional staff member selected by the
facility or the Governing Body.
12.8.f. The center shall provide training to
all employees handling controlled substances in the proper procedures for
storage and handling. This training shall be in accordance with the provisions
of this rule.
12.8.g. All centers
are required to have adequate controls in place to detect and prevent diversion
of controlled substances.
12.8.h.
All centers must follow proper storage requirements for ensuring security of
medications, according to chapter 60A of the West Virginia Code, including but
not limited to:
12.8.h.1. All controlled
substances in a building must be stored in a permanently affixed, securely
double locked and substantially built safe or cabinet;
12.8.h.2. The process or system for security
of controlled substances must be commensurate with the quantity and types of
controlled substances stocked; and
12.8.h.3. Controlled substances must not be
left out or unattended at any time.
12.9. Handling Diversion, Loss and Theft.
12.9.a. A loss or theft must be immediately
reported to the Drug Enforcement Administration, Board of Pharmacy, the West
Virginia State Police, and the state oversight agency.
12.9.b. All reports of loss or theft must be
completed on the required forms or methods as indicated by state and federal
law, regulation or protocol.
12.9.c. All centers shall have a diversion
control plan to address the prevention, intervention, investigation and quality
control measures for the safeguarding of medications.
12.10. Administration of Narcotic
Medications. When administering narcotic medication:
12.10.a. Two licensed nurses, one of which
shall be a registered professional nurse, shall count the number of vials
belonging to the patient;
12.10.b.
The registered nurses shall remove the prescribed amount of the medication and
record the remaining number of vials;
12.10.c. The unused (excess) amount shall be
wasted and disposed of in accordance with state and federal law and within the
provisions of this rule; and
12.10.d. Both licensed nurses shall sign the
individual narcotic record book.
12.11. Medication Disposal.
12.11.a. Any medication that is unused,
outdated, discontinued, expired or contaminated as wastage must be disposed of
or destroyed according to local, state and federal laws and
regulations.
12.11.b. When
controlled substances are disposed of or destroyed, the following documentation
must occur:
12.11.b.1. Log must have the
center's name and address indicated;
12.11.b.2. Date of disposal or destruction;
12.11.b.3. Time of disposal or
destruction;
12.11.b.4. Patient's
name;
12.11.b.5. Drug name, drug
dosage, and quantity disposed of or destroyed;
12.11.b.6. Reason for disposal or
destruction;
12.11.b.7. Signature of
the person, who shall be a licensed professional, preparing the report and
performing the disposal or destruction; and
12.11.b.8. Signature of the witness, who
shall be a licensed professional, as to the report and disposal or
destruction.
12.11.c.
Controlled substances must be disposed of or destroyed beyond reclamation.
12.11.d. All other medications
shall be disposed of according to federal and state laws, regulations and
protocols.