Kentucky Statutes 218A.172 – Administrative regulations on prescribing or dispensing of Schedule II controlled substance or Schedule III controlled substance containing hydrocodone — Continuing course of treatment — Recordkeeping — Exemptions
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(1) Administrative regulations promulgated under KRS § 218A.205(3) shall require that, prior to the initial prescribing or dispensing of any Schedule II controlled substance or a Schedule III controlled substance containing hydrocodone to a human patient, a practitioner shall:
(a) Obtain a medical history and conduct a physical or mental health examination of the patient, as appropriate to the patient’s medical complaint, and document the information in the patient’s medical record;
(b) Query the electronic monitoring system established in KRS § 218A.202 for all available data on the patient for the twelve (12) month period immediately preceding the patient encounter and appropriately utilize that data in the evaluation and treatment of the patient;
(c) Make a written plan stating the objectives of the treatment and further diagnostic examinations required;
(d) Discuss the risks and benefits of the use of controlled substances with the patient, the patient’s parent if the patient is an unemancipated minor child, or the patient’s legal guardian or health care surrogate, including the risk of tolerance and drug dependence; and
(e) Obtain written consent for the treatment.
(2) (a) Administrative regulations promulgated under KRS § 218A.205(3) shall require that a practitioner prescribing or dispensing additional amounts of Schedule II controlled substances or Schedule III controlled substances containing hydrocodone for the same medical complaint and related symptoms shall:
1. Review, at reasonable intervals based on the patient’s individual circumstances and course of treatment, the plan of care;
2. Provide to the patient any new information about the treatment; and
3. Modify or terminate the treatment as appropriate.
(b) If the course of treatment extends beyond three (3) months, the administrative regulations shall also require that the practitioner:
1. Query the electronic monitoring system established in KRS § 218A.202 no less than once every three (3) months for all available data on the patient for the twelve (12) month period immediately preceding the query; and
2. Review that data before issuing any new prescription or refills for the patient for any Schedule II controlled substance or a Schedule III controlled substance containing hydrocodone.
(3) Administrative regulations promulgated under KRS § 218A.205(3) shall require that, for each patient for whom a practitioner prescribes any Schedule II controlled substance or a Schedule III controlled substance containing hydrocodone, the
practitioner shall keep accurate, readily accessible, and complete medical records which include, as appropriate:
(a) Medical history and physical or mental health examination; (b) Diagnostic, therapeutic, and laboratory results;
(c) Evaluations and consultations; (d) Treatment objectives;
(e) Discussion of risk, benefits, and limitations of treatments; (f) Treatments;
(g) Medications, including date, type, dosage, and quantity prescribed or dispensed;
(h) Instructions and agreements; and
(i) Periodic reviews of the patient’s file.
(4) Administrative regulations promulgated under KRS § 218A.205(3) may exempt, in whole or in part, compliance with the mandatory diagnostic, treatment, review, and other protocols and standards established in this section for:
(a) A licensee prescribing or administering a controlled substance immediately prior to, during, or within the fourteen (14) days following an operative or invasive procedure or a delivery if the prescribing or administering is medically related to the operative or invasive procedure or the delivery and the medication usage does not extend beyond the fourteen (14) days;
(b) A licensee prescribing or administering a controlled substance necessary to treat a patient in an emergency situation;
(c) A licensed pharmacist or other person licensed by the Kentucky Board of
Pharmacy to dispense drugs or a licensed pharmacy;
(d) A licensee prescribing or dispensing a controlled substance:
1. For administration in a hospital or long-term-care facility if the hospital or long-term-care facility with an institutional account, or a practitioner in those hospitals or facilities where no institutional account exists, queries the electronic monitoring system established in KRS § 218A.202 for all available data on the patient or resident for the twelve (12) month period immediately preceding the query within twelve (12) hours of the patient’s or resident’s admission and places a copy of the query in the patient’s or resident’s medical records during the duration of the patient’s stay at the facility;
2. As part of the patient’s hospice or end-of-life treatment;
3. For the treatment of pain associated with cancer or with the treatment of cancer;
4. In a single dose to relieve the anxiety, pain, or discomfort experienced by a patient submitting to a diagnostic test or procedure;
5. Within seven (7) days of an initial prescribing or dispensing under subsection (1) of this section if the prescribing or dispensing:
a. Is done as a substitute for the initial prescribing or dispensing;
b. Cancels any refills for the initial prescription; and
c. Requires the patient to dispose of any remaining unconsumed medication;
6. Within ninety (90) days of an initial prescribing or dispensing under subsection (1) of this section if the prescribing or dispensing is done by another practitioner in the same practice or in an existing coverage arrangement, if done for the same patient for the same medical condition; or
7. To a research subject enrolled in a research protocol approved by an institutional review board that has an active federalwide assurance number from the United States Department of Health and Human Services, Office for Human Research Protections, where the research involves single, double, or triple blind drug administration or is additionally covered by a certificate of confidentiality from the National Institutes of Health;
(e) The prescribing of a Schedule III, IV, or V controlled substance by a licensed optometrist to a patient in accordance with the provisions of KRS § 320.240; or
(f) The prescribing of a three (3) day supply of a Schedule III controlled substance following the performance of oral surgery by a dentist licensed pursuant to KRS Chapter 313.
(5) (a) A state licensing board promulgating administrative regulations under KRS
218A.205(3) may promulgate an administrative regulation authorizing exemptions supplemental or in addition to those specified in subsection (4) of this section. Prior to exercising this authority, the board shall:
1. Notify the Kentucky Office of Drug Control Policy that it is considering a proposal to promulgate an administrative regulation authorizing exemptions supplemental or in addition to those specified in subsection (4) of this section and invite the office to participate in the board meeting at which the proposal will be considered;
2. Make a factual finding based on expert testimony as well as evidence or research submitted to the board that the exemption demonstrates a low risk of diversion or abuse and is supported by the dictates of good medical practice; and
3. Submit a report to the Governor and the Legislative Research Commission of its actions, including a detailed explanation of the factual and policy basis underlying the board’s action. A copy of this report shall be provided to the regulations compiler.
(b) Within one (1) working day of promulgating an administrative regulation authorizing an exemption under this section, the promulgating board shall e- mail to the Kentucky Office of Drug Control Policy:
1. A copy of the administrative regulation as filed, and all attachments required by KRS § 13A.230(1); and
2. A request from the board that the office review the administrative regulation in the same manner as would the Commission on Small Business Innovation and Advocacy under KRS § 11.202(1)(e), and submit its report or comments in accordance with the deadline established in KRS § 13A.270(1)(c). A copy of the report or comments shall be filed with the regulations compiler.
Effective: June 29, 2021
History: Amended 2021 Ky. Acts ch. 185, sec. 139, effective June 29, 2021. — Amended 2013 Ky. Acts ch. 2, sec. 1, effective March 4, 2013. — Created 2012 (1st Extra. Sess.) Ky. Acts ch. 1, sec. 3, effective July 20, 2012.
(a) Obtain a medical history and conduct a physical or mental health examination of the patient, as appropriate to the patient’s medical complaint, and document the information in the patient’s medical record;
Terms Used In Kentucky Statutes 218A.172
- Action: includes all proceedings in any court of this state. See Kentucky Statutes 446.010
- Child: means any person under the age of majority as specified in KRS §. See Kentucky Statutes 218A.010
- Complaint: A written statement by the plaintiff stating the wrongs allegedly committed by the defendant.
- Dispense: means to deliver a controlled substance to an ultimate user or research subject by or pursuant to the lawful order of a practitioner, including the packaging, labeling, or compounding necessary to prepare the substance for that delivery. See Kentucky Statutes 218A.010
- Drug: means :
(a) Substances recognized as drugs in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them. See Kentucky Statutes 218A.010 - Evidence: Information presented in testimony or in documents that is used to persuade the fact finder (judge or jury) to decide the case for one side or the other.
- Guardian: A person legally empowered and charged with the duty of taking care of and managing the property of another person who because of age, intellect, or health, is incapable of managing his (her) own affairs.
- Month: means calendar month. See Kentucky Statutes 446.010
- Person: means individual, corporation, government or governmental subdivision or agency, business trust, estate, trust, partnership or association, or any other legal entity. See Kentucky Statutes 218A.010
- Pharmacist: means a natural person licensed by this state to engage in the practice
of the profession of pharmacy. See Kentucky Statutes 218A.010 - Practitioner: means a physician, dentist, podiatrist, veterinarian, scientific investigator, optometrist as authorized in KRS §. See Kentucky Statutes 218A.010
- Prescription: means a written, electronic, or oral order for a drug or medicine, or combination or mixture of drugs or medicines, or proprietary preparation, signed or given or authorized by a medical, dental, chiropody, veterinarian, optometric practitioner, or advanced practice registered nurse, and intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals. See Kentucky Statutes 218A.010
- State: when applied to a part of the United States, includes territories, outlying possessions, and the District of Columbia. See Kentucky Statutes 446.010
- Testimony: Evidence presented orally by witnesses during trials or before grand juries.
- Treatment: when used in a criminal justice context, means targeted interventions
that focus on criminal risk factors in order to reduce the likelihood of criminal behavior. See Kentucky Statutes 446.010
(b) Query the electronic monitoring system established in KRS § 218A.202 for all available data on the patient for the twelve (12) month period immediately preceding the patient encounter and appropriately utilize that data in the evaluation and treatment of the patient;
(c) Make a written plan stating the objectives of the treatment and further diagnostic examinations required;
(d) Discuss the risks and benefits of the use of controlled substances with the patient, the patient’s parent if the patient is an unemancipated minor child, or the patient’s legal guardian or health care surrogate, including the risk of tolerance and drug dependence; and
(e) Obtain written consent for the treatment.
(2) (a) Administrative regulations promulgated under KRS § 218A.205(3) shall require that a practitioner prescribing or dispensing additional amounts of Schedule II controlled substances or Schedule III controlled substances containing hydrocodone for the same medical complaint and related symptoms shall:
1. Review, at reasonable intervals based on the patient’s individual circumstances and course of treatment, the plan of care;
2. Provide to the patient any new information about the treatment; and
3. Modify or terminate the treatment as appropriate.
(b) If the course of treatment extends beyond three (3) months, the administrative regulations shall also require that the practitioner:
1. Query the electronic monitoring system established in KRS § 218A.202 no less than once every three (3) months for all available data on the patient for the twelve (12) month period immediately preceding the query; and
2. Review that data before issuing any new prescription or refills for the patient for any Schedule II controlled substance or a Schedule III controlled substance containing hydrocodone.
(3) Administrative regulations promulgated under KRS § 218A.205(3) shall require that, for each patient for whom a practitioner prescribes any Schedule II controlled substance or a Schedule III controlled substance containing hydrocodone, the
practitioner shall keep accurate, readily accessible, and complete medical records which include, as appropriate:
(a) Medical history and physical or mental health examination; (b) Diagnostic, therapeutic, and laboratory results;
(c) Evaluations and consultations; (d) Treatment objectives;
(e) Discussion of risk, benefits, and limitations of treatments; (f) Treatments;
(g) Medications, including date, type, dosage, and quantity prescribed or dispensed;
(h) Instructions and agreements; and
(i) Periodic reviews of the patient’s file.
(4) Administrative regulations promulgated under KRS § 218A.205(3) may exempt, in whole or in part, compliance with the mandatory diagnostic, treatment, review, and other protocols and standards established in this section for:
(a) A licensee prescribing or administering a controlled substance immediately prior to, during, or within the fourteen (14) days following an operative or invasive procedure or a delivery if the prescribing or administering is medically related to the operative or invasive procedure or the delivery and the medication usage does not extend beyond the fourteen (14) days;
(b) A licensee prescribing or administering a controlled substance necessary to treat a patient in an emergency situation;
(c) A licensed pharmacist or other person licensed by the Kentucky Board of
Pharmacy to dispense drugs or a licensed pharmacy;
(d) A licensee prescribing or dispensing a controlled substance:
1. For administration in a hospital or long-term-care facility if the hospital or long-term-care facility with an institutional account, or a practitioner in those hospitals or facilities where no institutional account exists, queries the electronic monitoring system established in KRS § 218A.202 for all available data on the patient or resident for the twelve (12) month period immediately preceding the query within twelve (12) hours of the patient’s or resident’s admission and places a copy of the query in the patient’s or resident’s medical records during the duration of the patient’s stay at the facility;
2. As part of the patient’s hospice or end-of-life treatment;
3. For the treatment of pain associated with cancer or with the treatment of cancer;
4. In a single dose to relieve the anxiety, pain, or discomfort experienced by a patient submitting to a diagnostic test or procedure;
5. Within seven (7) days of an initial prescribing or dispensing under subsection (1) of this section if the prescribing or dispensing:
a. Is done as a substitute for the initial prescribing or dispensing;
b. Cancels any refills for the initial prescription; and
c. Requires the patient to dispose of any remaining unconsumed medication;
6. Within ninety (90) days of an initial prescribing or dispensing under subsection (1) of this section if the prescribing or dispensing is done by another practitioner in the same practice or in an existing coverage arrangement, if done for the same patient for the same medical condition; or
7. To a research subject enrolled in a research protocol approved by an institutional review board that has an active federalwide assurance number from the United States Department of Health and Human Services, Office for Human Research Protections, where the research involves single, double, or triple blind drug administration or is additionally covered by a certificate of confidentiality from the National Institutes of Health;
(e) The prescribing of a Schedule III, IV, or V controlled substance by a licensed optometrist to a patient in accordance with the provisions of KRS § 320.240; or
(f) The prescribing of a three (3) day supply of a Schedule III controlled substance following the performance of oral surgery by a dentist licensed pursuant to KRS Chapter 313.
(5) (a) A state licensing board promulgating administrative regulations under KRS
218A.205(3) may promulgate an administrative regulation authorizing exemptions supplemental or in addition to those specified in subsection (4) of this section. Prior to exercising this authority, the board shall:
1. Notify the Kentucky Office of Drug Control Policy that it is considering a proposal to promulgate an administrative regulation authorizing exemptions supplemental or in addition to those specified in subsection (4) of this section and invite the office to participate in the board meeting at which the proposal will be considered;
2. Make a factual finding based on expert testimony as well as evidence or research submitted to the board that the exemption demonstrates a low risk of diversion or abuse and is supported by the dictates of good medical practice; and
3. Submit a report to the Governor and the Legislative Research Commission of its actions, including a detailed explanation of the factual and policy basis underlying the board’s action. A copy of this report shall be provided to the regulations compiler.
(b) Within one (1) working day of promulgating an administrative regulation authorizing an exemption under this section, the promulgating board shall e- mail to the Kentucky Office of Drug Control Policy:
1. A copy of the administrative regulation as filed, and all attachments required by KRS § 13A.230(1); and
2. A request from the board that the office review the administrative regulation in the same manner as would the Commission on Small Business Innovation and Advocacy under KRS § 11.202(1)(e), and submit its report or comments in accordance with the deadline established in KRS § 13A.270(1)(c). A copy of the report or comments shall be filed with the regulations compiler.
Effective: June 29, 2021
History: Amended 2021 Ky. Acts ch. 185, sec. 139, effective June 29, 2021. — Amended 2013 Ky. Acts ch. 2, sec. 1, effective March 4, 2013. — Created 2012 (1st Extra. Sess.) Ky. Acts ch. 1, sec. 3, effective July 20, 2012.