(a) It is the intent of the General Assembly that the Delaware Prescription Monitoring Act established pursuant to this section serves as a means to promote public health and welfare and to detect the illegal use of controlled substances. The Delaware Prescription Monitoring Act shall have the dual purpose of reducing misuse and diversion of controlled substances in the State while promoting improved professional practice and patient care.
(b) Definitions. — (1) “Administer” or “administration” means the direct application of a drug to the body of a patient by injection, inhalation, ingestion, or any other means.
(2) “Chemical dependency professional” means a person who uses addiction counseling methods to assist an individual or group to develop an understanding of alcohol and drug dependency problems, define goals, and plan action reflecting the individual's or group's interest, abilities and needs as affected by addiction problems.
(3) “Controlled substance” means any substance or drug defined, enumerated or included in this chapter and Title 21, Code of Federal Regulations.
(4) “Dispense” or “dispensing” means the interpretation, evaluation, and implementation of a prescription drug or, including the preparation and delivery of a drug to a patient or patient's agent in a suitable container appropriately labeled for subsequent administration to, or use by, a patient.
(5) “Dispenser” means a person authorized by this State to dispense or distribute to the ultimate user any controlled substance or drug monitored by the program, but shall not include any of the following:
a licensed health care facility pharmacy that dispenses, distributes or administers any controlled substance, or drug monitored by the program, for the purposes of inpatient care, or any emergency department dispensing a controlled substance for immediate use.(6) [Repealed.]
(7) “Drug” means any of the following:
a. Any substance recognized as a drug in the official compendium, or supplement thereto, designated by the Office of Controlled Substances for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans.
b. Any substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or pain in humans.
c. Any substance other than food intended to affect the structure or any function of the body of humans.
(8) “Drugs of concern” means drugs other than controlled substances as defined by rule which demonstrate a potential for abuse or diversion.
(9) “Licensed professional counselor of mental health” means an individual licensed as a professional counselor of mental health who publicly offers to render to individuals, groups, organizations or the general public a service involving the application of clinical counseling principles, methods or procedures and the diagnosis and treatment of mental and emotional disorders to assist individuals in achieving more effective personal and social adjustment.
(10) “Patient” means the person who is the ultimate user of a controlled substance or drug monitored by the program for whom a prescription is issued and for whom a controlled substance or drug is dispensed.
(11) “Prescriber” means a licensed health care professional with the authority to write and issue prescriptions, except it shall not include:
a. A prescriber or other authorized person who administers such controlled substance or drug upon the lawful order of a prescriber.
b. A prescriber or other authorized person who, in providing emergency patient care in a healthcare facility, causes the administration of a controlled substance for immediate relief of symptoms arising from an acute condition.
c. A prescriber or other authorized person who prescribes up to a 72-hour supply of a controlled substance for on call services or emergency care.
d. A veterinarian who prescribes for the purpose of providing veterinary services.
(12) “Prescription monitoring information” means data submitted to and maintained by the prescription monitoring program established under this section.
(13) “Prescription Monitoring Program” or “PMP” means the electronic program established by this section.
(14) “Public health surveillance” means the continuous, systematic collection, analysis, and interpretation of health-related data needed for the planning, implementation, and evaluation of public health practice. Public health surveillance may be used for all of the following purposes:
a. An early warning system for impending public health emergencies.
b. To document the impact of an intervention.
c. To track progress towards specified goals.
d. Monitor and clarify the epidemiology of health problems.
e. Establish public health priorities.
f. Inform public health policy and strategies.
(c) The Office of Controlled Substances shall establish and maintain a PMP program to monitor the prescribing and dispensing of all Schedule II, III, IV and V controlled substances by prescribers in this State, and to research the prescribing and dispensing of drugs of concern. The PMP must not interfere with the legal use of a controlled substance or drug of concern. The PMP may be used for the following purposes:
(1) Provide information to prescribers, dispensers, and patients to help avoid the illegal use of controlled substances.
(2) Assist law enforcement to investigate illegal activity related to the prescribing, dispensing, and consumption of controlled substances or drugs of concern.
(3) Effectuate the collection and storage of prescription monitoring information in a manner designed to minimize inconvenience to patients and prescribing medical practitioners.
(4) Assist the State Epidemiologist in public health surveillance for the purpose of reducing the burden of disease around substance use disorder.
(d) A dispenser including those dispensing an amount deemed medically necessary for a 72-hour supply, shall submit the required information regarding each prescription dispensed for a controlled substance, in accordance with the transmission methods and frequency established by regulation issued by the Office of Controlled Substances. When needed for bona fide research purposes and in accordance with applicable regulation, the Office of Controlled Substances may require a dispenser to submit the required information regarding each prescription dispensed for a drug of concern, but in no event should dispensers be required to submit such information any more frequently than that required for controlled substances. The following information shall be submitted for each prescription:
(1) Pharmacy name;
(2) Dispenser DEA registration number;
(3) Dispenser National Provider Identifier (NPI);
(4) Date drug was dispensed;
(5) Prescription number;
(6) Whether prescription is new or a refill;
(7) NDC code for drug dispensed;
(8) Quantity dispensed;
(9) Approximate number of days supplied;
(10) Patient name and date of birth;
(11) Patient address;
(12) Prescriber DEA registration number and name;
(13) Prescriber NPI;
(14) Date prescription issued by prescriber.
(e) When a dispenser has a reasonable belief that a patient may be seeking a controlled substance listed in Schedule II, III, IV or V for any reason other than the treatment of an existing medical condition, the dispenser shall obtain a patient utilization report regarding the patient for the preceding 12 months from the Prescription Monitoring Program before dispensing the prescription.
(f) A prescriber, or other person authorized by the prescriber, shall obtain, before writing a prescription for a controlled substance listed in Schedule II, III, IV or V for a patient, a patient utilization report regarding the patient for the preceding 12 months from the computerized program established by the Office of Controlled Substances when the prescriber has a reasonable belief that the patient may be seeking the controlled substance, in whole or in part, for any reason other than the treatment of an existing medical condition. The prescriber shall review the patient utilization report to assess whether the prescription for the controlled substance is necessary.
(g) A licensed chemical dependency professional or licensed professional counselor of mental health may obtain a patient utilization report from the Prescription Monitoring Program for patients enrolled in substance abuse treatment programs receiving treatment from, or under the direction of, the chemical dependency professional or professional counselor of mental health.
(h) The Chief Medical Examiner or licensed physician designee may obtain a patient utilization report from the Prescription Monitoring Program for the purpose of investigating the death of an individual.
(i) The Office of Controlled Substances may issue a waiver to a prescriber who is unable to access prescription information by electronic means. A prescriber who is unable to access prescription information by electronic means shall obtain a waiver from the OCS on annual basis until such time they can access the prescription information by electronic means.
(j) Unless a court of competent jurisdiction makes a finding of gross negligence, malice or criminal intent, the Office of Controlled Substances, any other state agency, any prescriber or dispenser, or any person or entity in proper possession of information pursuant to this statute is not subject to civil liability, administrative action or other legal or equitable relief for any of the following acts or omissions:
(1) Furnishing information pursuant to this section.
(2) Receiving, using or relying on, or not using or relying on, information received pursuant to this section.
(3) Information that was not furnished to the Office of Controlled Substances.
(4) Information that was factually incorrect or that was released by the Office of Controlled Substance to the wrong person or entity.
(k) Prescription information submitted to the PMP is protected health information, not subject to public or open records law, and not subject to disclosure, except as otherwise provided in this section.
(l) The Office of Controlled Substances shall maintain procedures to ensure that the privacy and confidentiality of patients and patient information collected, recorded, transmitted, and maintained is not disclosed, except as provided for in this section.
(1) If there is reasonable cause to believe a violation of law or breach of professional standards may have occurred, the Office of Controlled Substances shall notify the appropriate law-enforcement or professional licensure, certification, or regulatory agency or entity and shall provide prescription information required for an investigation. If there is reasonable cause to believe a breach of professional standards may have occurred, the PMP Advisory Committee shall notify the professional licensure, certification, or regulatory agency or entity and shall provide prescription information required for an investigation. In determining whether reasonable cause exists under this paragraph, the Office of Controlled Substances shall regularly examine data generated by the PMP, and promptly seek the direct input of the PMP Advisory Committee with respect to any cases that meet objective thresholds set by the PMP Advisory Committee. Agencies receiving referrals pursuant to this subsection shall promptly inform the Office of Controlled Substances of the disposition of any referral, and the reason for that disposition.
(2) The Office of Controlled Substances may provide data in the prescription monitoring program in the form of a report to the following persons:
a. A prescriber, or other person authorized by the prescriber, or a dispenser, or other person authorized by the dispenser, who requests information and certifies that the requested information is for the purpose of providing medical or pharmaceutical treatment to a bona fide patient;
b. An individual who requests the individual's own prescription monitoring information in accordance with procedures established pursuant to regulations;
c. A designated representative of any Board or Commission pursuant to § 8735(a) of Title 29 responsible for the licensure, regulation, or discipline of prescribers, dispensers or other persons authorized to prescribe, administer, or dispense controlled substances and who is involved in a bona fide specific investigation involving a designated person;
d. A local, state, or federal law-enforcement or prosecutorial official engaged in the administration, investigation, or enforcement of the laws governing controlled substances and who is involved in a bona fide specific drug-related investigation in which a report of suspected criminal activity involving controlled substances by an identified suspect has been made, and provided that such information be relevant and material to such investigation, limited in scope to the extent reasonably practicable in light of the purpose for which the information is sought, and include identifying information only upon a showing of need;
e. The Delaware Department of Health and Social Services regarding Medicaid program recipients;
f. A properly convened grand jury pursuant to a subpoena properly issued for the records;
g. Personnel of the Division of Professional Regulation for purposes of administration and enforcement of this section;
h. A licensed chemical dependency professional or licensed professional counselor of mental health who requests information and certifies that the requested information is for a patient enrolled in a substance abuse treatment program receiving treatment from, or under the direction of the chemical dependency professional or professional counselor of mental health.
i. The Chief Medical Examiner or licensed physician designee who requests information and certifies the request is for the purpose of investigating the death of an individual.
j. Qualified personnel for the purpose of bona fide research or education; however, data elements that would reasonably identify a specific recipient, prescriber or dispenser must be deleted or redacted from such information prior to disclosure; and further provided that, release of the information may be made only pursuant to a written agreement between qualified personnel and the Office of Controlled Substances in order to ensure compliance with this subsection.
k. A law-enforcement or regulatory agency in connection with any referral required by paragraph (l)(1) of this section.
l. The PMP Advisory Committee and the Addiction Action Committee, including identified prescriber and dispenser information. Information provided under this paragraph (l)(2)l. of this section is not a public record under § 10002 of Title 29.
m. The Drug Overdose Fatality Review Commission in furtherance of its duties and responsibilities set forth in § 4799C of this title.
n. The Secretary of the Department of Health and Social Services, the Secretary of State, and the Attorney General for purposes of administering and enforcing the Prescription Opioid Impact Fund under Chapter 48B of this title.
(m) The Division of Professional Regulation may contract with another agency of this State or with a private vendor, as necessary, to ensure the effective operation of the prescription monitoring program. A contractor shall comply with the provisions regarding confidentiality of prescription information under this section is subject to the penalties specified in this section for any unlawful acts.
(n) The Office of Controlled Substances may promulgate regulations setting forth the procedures and methods for implementing this section.
(o) The Office of Controlled Substances shall design and implement an evaluation component to identify cost-benefits of the Prescription Monitoring Program, including its effect on diversion and abuse of controlled substances and drugs of concern, and other information relevant to policy, research and education involving controlled substances and drugs of concern monitored by the Prescription Monitoring Program.
(1) The Office of Controlled Substances shall report to the General Assembly the information obtained pursuant to this subsection on an annual basis.
(2) To the extent such information is made available to the Office of Controlled Substances, the report may include information and data, including surveys, polls, or other data from multi-disciplinary experts and stakeholders, relating to the negative or positive impact of the prescription monitoring program on appropriate prescribing practices of controlled substances and drugs of concern.
(3) The Office of Controlled Substances shall provide data in the PMP in the form of a report to the Office of the State Epidemiologist in the Division of Public Health, for the purpose of reviewing and analyzing public health surveillance data related to drug overdoses.
(p) The Office of Controlled Substances may exchange prescription information submitted to the PMP through an interstate commission with an authorized member state.
(q) A dispenser who fails to submit prescription monitoring information to the Office of Controlled Substances PMP as required by this section, or who knowingly submits incorrect prescription information, shall be subject to disciplinary sanction pursuant to Title 24.
(r) A person authorized to have prescription monitoring information pursuant to this section who knowingly discloses this information in violation of this section is guilty of a class G felony and, upon conviction, shall be fined not more than $5,000 nor imprisoned more than 2 years, or both.
(s) A person authorized to have prescription monitoring information pursuant to this section who intentionally uses this information in the furtherance of other crimes is guilty of a class E felony and, upon conviction, shall be fined not more than $10,000 nor imprisoned more than 5 years, or both.
(t) A person not authorized to have prescription monitoring information pursuant to this section who obtains such information fraudulently is guilty of a class E felony and, upon conviction, shall be fined not more than $10,000 nor imprisoned more than 5 years, or both.
(u) A prescriber who holds a controlled substance registration issued pursuant to § 4732 of this title must be registered with the Prescription Monitoring Program. A prescriber who is issued a controlled substance registration for the first time shall register with the Prescription Monitoring Program within 90 days of issuance. Failure to comply with this subsection may result in disciplinary action pursuant to § 4735 of this title.
(v) A PMP Advisory Committee is hereby established to provide input, advice, and guidance to the Office of Controlled Substances regarding the maintenance of the PMP. Its duties and powers shall include, but not be limited to, all of the following:
(1) Development of specific criteria for use by the Office of Controlled Substances in referring prescription monitoring information to the Advisory Committee for consideration of notification of law-enforcement or professional licensing agencies under paragraph (l)(1) of this section.
(2) Discussion of referrals made under paragraph (v)(1) of this section and recommendations to the Office of Controlled Substances regarding notification of law-enforcement or professional licensing agencies under paragraph (l)(1) of this section.
(3) Recommending improvements in the operation of the PMP, including interoperability with other state PMPs and electronic health information systems and improvements of prescriber and dispenser access to and use of the PMP.
(w) In carrying out its duties under subsection (v) of this section:
(1) Information provided to the PMP Advisory Committee shall be provided in a redacted manner that does not identify the patient, prescriber, dispenser, or other person who is the subject of the information. If the PMP Advisory Committee determines that a referral should be made pursuant to subsection (l) of this section, the Office of Controlled Substances shall make the appropriate referral using unredacted information.
(2) The PMP Advisory Committee's documents and meetings in connection with paragraphs (v)(1) and (v)(2) of this section shall not constitute public information, and shall not be subject to open record laws.
(3) The PMP Advisory Committee shall consist of the following members:
a. A member designated by the Medical Society of Delaware.
b. A member designated by the Delaware Pharmacists Society.
c. A member representing patients' rights designated by the Secretary of Health and Social Services.
d. A representative designated by the Delaware Department of Justice.
e. A representative designated by the Secretary of Homeland Security.
f. Two public members with relevant experience nominated by the Governor and confirmed by the Senate.
(4) The members of the PMP Advisory Committee shall serve at the pleasure of their respective designating agencies. The members shall elect a chairman from among their membership.