Source: http://regulations.delaware.gov/register/july2015/proposed/19%20DE%20Reg%2027a%2007-01-15.htm
Timestamp: 2018-03-22 13:41:35
Document Index: 111382865

Matched Legal Cases: ['§4731', '§10118', '§4711', '§4718', '§4720', '§4718', '§4720']

Pursuant to 16 Del.C. §4731, the Delaware Controlled Substance Advisory Committee (“Committee”) has proposed revisions to its rules and regulations. New Section 9.0 is added to provide requirements for the prescribing of opiates in order to address potential prescription drug overdose, abuse and diversion. The Section puts safeguards in place with respect to prescribing practices and patient monitoring. These safeguards will serve to protect patients and the public. Former Sections 9.0 and 10.0 have been renumbered.
A public hearing will be held on July 29, 2015 at 9:00 a.m., Buena Vista Conference Center, 661 South DuPont Highway, New Castle, DE 19720. Anyone wishing to receive a copy of the proposed rules and regulations may obtain a copy from the Delaware Controlled Substance Advisory Committee, 861 Silver Lake Boulevard, Dover, Delaware 19904. Persons wishing to submit written comments may forward these to the Committee at the above address. In accordance with 29 Del.C. §10118(a), the final date to receive written comments will be August 13, 2015 which is 15 days following the public hearing. The Committee will deliberate on any public comment at its next regularly scheduled meeting, at which time it will determine whether to adopt the rules and regulations as proposed or make additional changes due to public comment.
3.1.4	The Secretary shall periodically review the requirements of paragraphs 3.1.1, 3.1.2, and 3.1.3 to determine adequacy.
8.1	No prescriber who is not the owner of a pharmacy or who is not in the employ of such owner, may dispense more than a 72-hour supply of schedule II through V controlled substances except for the following, who still must comply with other sections of this Regulation including but not limited to Regulation 4.7:
9.0	Safe Opiate Prescribing
9.1	This Regulation provides requirements for the prescribing of opiates in order to address potential prescription drug overdose, abuse, and diversion. To prescribe opiates in Delaware, the practitioner must be licensed in this state and registered with the U.S. Drug Enforcement Administration and must comply with all applicable federal and state regulations. Out-of-state practitioners, who are prescribing controlled substances to patients in Delaware, must hold active licensure and registration in the home state. Practitioners are referred to the Practitioner's Manual of the U.S. Drug Enforcement Administration and specific rules governing controlled substances.
9.2	The following definitions apply to Section 9.0:
“Acute Care” means pain less than three months in duration.
“Acute Pain” means the normal, predicted physiological response to a noxious chemical, thermal or mechanical stimulus and typically is associated with invasive procedures, trauma and disease. It is generally time-limited.
“Addiction” means a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include the following: impaired control over drug use, craving, compulsive use, and continued use despite harm. Physical dependence and tolerance are normal physiological consequences of extended opioid therapy for pain and are not the same as addiction.
“Chronic Care” means pain more than three months in duration.
“Chronic Pain” means a state in which pain persists beyond the usual course of an acute disease or healing of an injury, or that may or may not be associated with an acute or chronic pathologic process that causes continuous or intermittent pain over months or years.
“Opiate'' means any substance having an addiction-forming or addiction-sustaining liability similar to morphine or being capable of conversion into a drug having addiction-forming or addiction-sustaining liability. It does not include, unless specifically designated as controlled under §4711 of this title, the dextrorotatory isomer of 3-methoxy-n-methylmorphinan and its salts (dextromethorphan). It does include its racemic and levorotatory forms.
“Physical dependence” means a state of adaptation that is manifested by drug class-specific signs and symptoms that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug, and/or administration of an antagonist. Physical dependence, by itself, does not equate with addiction.
“Practitioner” means physician, dentist, podiatrist, nurse practitioner, physician assistant or other individual, licensed, registered, or otherwise permitted, by the United States or the State of Delaware to prescribe, dispense, or store a controlled substance in the course of professional practice but does not include a veterinarian, a pharmacist, a pharmacy, or an institutional practitioner.
"Risk Assessment" means utilizing a tool, such as the Screener and Opioid Assessment for Patients with Pain (“SOAPP”), which is designed for predicting the likelihood that a patient will abuse or misuse a prescribed controlled substance based on past behavior, genetic predispositions, social or environmental factors, or other risks.
"Substance Abuse" means using a controlled substance in a way that is not prescribed.
“Tolerance” means a physiologic state resulting from regular use of a drug in which an increased dosage is needed to produce a specific effect, or a reduced effect is observed with a constant dose over time. Tolerance may or may not be evident during opioid treatment and does not equate with addiction.
“Treatment Agreement” means a written agreement between the practitioner and patient outlining patient responsibilities, including;
The rights, responsibilities, and risks of being on a controlled substance and the treatment being received;
Urine/serum/saliva medication levels screening when requested;
Number and frequency of all prescription refills;
Reasons for which drug therapy may be discontinued (e.g., violation of agreement); and
Where possible, the patient should receive prescriptions from one licensed practitioner and one pharmacy.
9.3	A practitioner may not prescribe opiates unless a practitioner-patient relationship has been established.
9.4	Prior to prescribing an opiate for acute care the practitioner must perform an appropriate evaluation of the patient’s medical history and condition.
9.5	For instances of chronic care, the practitioner must adhere to the following additional requirements:
9.5.1	Evaluate and document relative risks and benefits for the individual patient of the use of an opiate. The evaluation must include, but not be limited to, a Risk Assessment as defined in subsection 9.2;
9.5.2	Document in the medical record that the prescription of an opiate required for the management of pain for which alternative treatment options, including non-pharmacological treatments, are ineffective, not tolerated, or would otherwise be inadequate to provide sufficient management of pain;
9.5.3	Develop written treatment plan regarding treatment goal, duration, risks and benefits, alternatives, patient’s responsibilities for safe medication use and compliance;
9.5.4	Query the Delaware Prescription Monitoring Program (“PMP”) for a prescriptive history;
9.5.5	Assure that all psychiatric and medical comorbidities are addressed concurrently rather than sequentially when concurrent treatment is clinically feasible;
9.5.6	Receive a signed Controlled Substance Treatment Agreement;
9.5.7	Receive a signed Informed Consent form and Agreement from the patient, or if the patient is not competent to provide informed consent, from the patient’s legal representative, that must include information regarding the drug’s potential for addiction, abuse, and misuse; and the risks associated with the drug of life-threatening respiratory depression; overdose as a result of accidental exposure potentially fatal, especially in children; neonatal opioid withdrawal symptoms; and potentially fatal overdose when interacting with alcohol; and other potentially fatal drug/drug interactions;
9.5.8	Prescribe controlled substance prescriptions that must be filled within seven (7) days and that do not exceed a 31 day or a maximum of 100 dosage unit supply, whichever is greater;
9.5.9	Schedule and undertake periodic follow-up visits and evaluations of the patient to monitor and assess progress toward goals in the treatment plan and modify the treatment plan, as necessary. The practitioner must determine whether to continue the treatment of pain with an opiate, whether there is an available alternative, whether to refer the patient for a pain management or substance abuse consultation. Periodic follow-up evaluations must include:
9.5.9.1	Querying the PMP at least annually; and
9.5.9.2	Administering drug tests at least once every six months.
9.5.10	Develop a plan for the discontinuance of prescribed opiates if the patient has failed to adhere to the Controlled Substance Treatment Agreement or upon completion of pain management therapy; and
9.5.11	Seek a case review and consult with, or otherwise refer the patient to, a state-licensed physician who holds a subspecialty board certification in addiction psychiatry from the American Board of Psychiatry and Neurology, an addiction certification from the American Board of Addiction Medicine, or a relevant subspecialty board certification by the American Board of Medical Specialties if any of the following occur:
9.5.11.1	Adulterated drug tests;
9.5.11.2	Diversion of prescribed medications;
9.5.11.3	Confirmatory drug tests; or
9.5.11.4	The patient has obtained controlled substances elsewhere without disclosure to the physician, as evidenced by PMP data.
9.6	Medical Records: The practitioner must keep accurate and complete records in compliance with state and federal law.
9.7	Records must remain current and be maintained in an accessible manner and readily available for review. Each practitioner must include documentation appropriate for each visit's level of care, in compliance with state and federal law.
9.8	Practitioners treating the following patients with chronic care are exempted from Section 9.0:
9.8.1	Practitioners treating the following chronic or long-term treatment groups:
9.8.1.1	Hospice care patients;
9.8.1.2	Active cancer treatment patients;
9.8.1.3	Patients experiencing cancer-related pain; and
9.8.1.4	Terminally ill/palliative care patients.
910.0	Procedures for Adoption of Regulations
910.1	Notice. Prior to the adoption, amendment or repeal of any of these controlled substances regulations, the Secretary of State/Committee will give at least twenty (20) days notice of the intended action.
910.1.1	The notice will include a statement of either the terms of substance of the intended action or a description of the subjects and issues involved, or the time when, and the place where to present their views thereon. The notice will be mailed to persons who have made timely request of the Office of Controlled Substances for advance notice of such rule-making proceedings and shall be published in two newspapers of general circulation in this State.
910.2	Hearing. The Secretary of State shall designate the Committee to preside over hearings. The Committee will afford all interested persons a reasonable opportunity to submit data, views or arguments, orally or in writing.
910.3	Emergency Regulations. If the Secretary of State, upon the recommendation of the Committee, finds that an imminent peril to the public health, safety or welfare requires adoption of a regulation upon fewer then twenty (20) days notice and states in writing his/her reasons for that finding, the Secretary of State may proceed without prior notice or hearing or upon any abbreviated notice and hearing he/she finds practicable, to adopt an emergency regulation. Such rules will be effective for a period not longer than 120 days, but the adoption of an identical rule under the procedures discussed above is not precluded.
910.4	Finding and Availability. The Secretary of State will maintain on file any adoption, amendment or repeal of these regulations. In addition, copies of these regulations will be available for public inspection at the Office of Controlled Substances.
1011.0	Severability
1011.1	If any provision of these regulations is held invalid the invalidity does not affect other provisions of the regulations which can be given effect without the invalid provisions or application, and to this end the provisions of the regulation are severable.
1011.2	Pursuant to 16 Del.C. §4718(f) and 16 Del.C. §4720(c) the Secretary of State finds that the compounds, mixtures or preparations listed in 21 CFR 1301.21, 21 CFR 1308.24 contain one or more active medical ingredients not having a stimulant or depressant effect on the central nervous system and that the admixtures included therein are in combinations, quantities, proportions, or concentrations that vitiate the potential for abuse of the substances which have a stimulant or depressant effect on the central nervous system, and therefore:
1011.2.1	The Secretary of State, as authorized by 16 Del.C. §4718(f) and 16 Del.C. §4720(c), does hereby except by rule the substances listed in 21 CFR 130.21, CFR 1308.24 and 21 CFR 1308.32 from Schedules III and IV of the Uniform Controlled Substances Act, 16 Del.C. Ch. 47.
19 DE Reg. 27 (07/01/15) (Prop.)