In this subtitle the following words have the meanings indicated. “Board” means the Advisory Board on Prescription Drug Monitoring. “Dispense” has the meaning stated in § 12–101 of the Health Occupations Article. “Dispense” does not include: Directly administering a monitored prescription drug to a patient; or Giving out prescription drug samples. “Dispenser” means a person authorized by law to dispense a monitored prescription drug to a patient or the patient’s agent in the State. “Dispenser” includes a nonresident pharmacy. “Dispenser” does not include: A licensed hospital pharmacy that only dispenses a monitored prescription drug for direct administration to an inpatient of the hospital; An opioid treatment services program; A veterinarian licensed under Title 2, Subtitle 3 of the Agriculture Article when prescribing controlled substances for animals in the usual course of providing professional services; A pharmacy issued a waiver permit under COMAR 10.34.17.03 that provides pharmaceutical specialty services exclusively to persons living in assisted living facilities, comprehensive care facilities, and developmental disabilities facilities; and A pharmacy that: Dispenses medications to an inpatient hospice; and Has been granted a waiver under § 21–2A–03(f) of this subtitle. “Licensing entity” means an entity authorized under the Health Occupations Article to license, regulate, or discipline a prescriber or dispenser. “Monitored prescription drug” means a prescription drug that contains a Schedule II, Schedule III, Schedule IV, or Schedule V controlled dangerous substance designated under Title 5, Subtitle 4 of the Criminal Law Article. “Monitored prescription drug” does not include naloxone medication. “Naloxone medication” means an opioid antagonist approved by the federal Food and Drug Administration for the reversal of an opioid overdose. “Naloxone medication data” means the information submitted to the Program for naloxone medication. “Office” means the Office of Controlled Substances Administration in the Department. “Opioid treatment services program” means a program that: Is certified in accordance with § 8–401 of this article or licensed by the State under § 7.5–401 of this article; Is authorized to treat patients with opioid dependence with a medication approved by the federal Food and Drug Administration for opioid dependence; Complies with: The Code of Federal Regulations 42, Part 8; COMAR 10.47.02.11; and Requirements for the secure storage and accounting of opioid medication imposed by the federal Drug Enforcement Administration and the Office; and Has been granted a certification for operation by the Department, the federal Substance Abuse and Mental Health Services Administration, and the federal Center for Substance Abuse Treatment. “Pharmacist” means an individual who is licensed under Title 12 of the Health Occupations Article, or by another state, to dispense a monitored prescription drug. “Pharmacist delegate” means an individual who is: Authorized by a registered pharmacist to request or access prescription monitoring data; and Employed by or under contract with the same professional practice as the registered pharmacist. “Prescriber” means a licensed health care professional authorized by law to prescribe a monitored prescription drug. “Prescriber delegate” means an individual who is: Authorized by a registered prescriber to request or access prescription monitoring data; and Employed by or under contract with the same professional practice as the prescriber. “Prescription drug” has the meaning stated in § 21–201 of this title. “Prescription monitoring data” means the information submitted to the Program for a monitored prescription drug. “Program” means the Prescription Drug Monitoring Program established under this subtitle. “Registered” means registered with the Program to request or access prescription monitoring data for clinical use. “Terminal illness” means a medical condition that, within reasonable medical judgment, involves a prognosis for a patient that likely will result in the patient’s death within 6 months.

There is a Prescription Drug Monitoring Program in the Department. The mission of the Program is to: Assist prescribers, pharmacists, and public health professionals in: The identification and prevention of prescription drug abuse; and The identification and investigation of unlawful prescription drug diversion; and Promote a balanced use of prescription monitoring data to assist appropriate law enforcement activities while preserving the professional practice of health care providers and the access of patients to optimal pharmaceutical care. To carry out its mission, the Program shall monitor the prescribing and dispensing of all Schedule II, Schedule III, Schedule IV, and Schedule V controlled dangerous substances and the dispensing of naloxone medication by all prescribers and dispensers in the State.

The Department shall implement the Program, subject to the availability of funds. The Secretary may: Assign responsibility for the operation of the Program to any unit in the Department; Contract with any qualified person for the efficient and economical operation of the Program; and Identify and publish a list of monitored prescription drugs that have a low potential for abuse by individuals. Except as provided in subsection (d) of this section, each dispenser shall submit prescription monitoring data and naloxone medication data to the Program by electronic means, in accordance with regulations adopted by the Secretary. The Secretary, for good cause shown, may authorize a dispenser to submit prescription monitoring data or naloxone medication data by an alternative form of submission. The Secretary, in consultation with the Maryland Health Care Commission and the Board, shall: Determine the appropriate technology to support the operation of the Program; and Educate dispensers, prescribers, pharmacists, prescriber delegates, pharmacist delegates, and consumers about the purpose and operation of the Program. The Secretary shall grant a waiver to a pharmacy that dispenses medications to an inpatient hospice from reporting to the Program prescription monitoring data for hospice inpatients if: The pharmacy demonstrates how it will distinguish hospice inpatients from other consumers receiving medications from the pharmacy; and The pharmacy agrees that it will be subject to onsite, unannounced inspections by the Department to verify its reporting of the prescription data of consumers who are not hospice inpatients. A waiver granted under this subsection may remain in effect for up to 2 years. The Secretary may establish an application process for a pharmacy to apply for a waiver under this subsection.

The Secretary, in consultation with the Board, shall adopt regulations to carry out this subtitle. The regulations adopted by the Secretary shall: Specify the prescription monitoring data and naloxone medication data required to be submitted under § 21–2A–03 of this subtitle; Specify the electronic or other means by which information is to be submitted: Without unduly increasing the workload and expense on dispensers; and In a manner as compatible as possible with existing data submission practices of dispensers; Specify that the information be submitted by dispensers once every 24 hours; Specify that the Program: Shall provide the information technology software to dispensers necessary to upload prescription drug monitoring data and naloxone medication data to the Program; and May not impose any fees or other assessments on prescribers or dispensers to support the operation of the Program; Identify the mechanism by which: Prescription monitoring data are disclosed to a person, in accordance with § 21–2A–06 of this subtitle; and Naloxone medication data are disclosed to a person, in accordance with § 21–2A–06.1 of this subtitle; Identify the circumstances under which a person may disclose prescription monitoring data or naloxone medication data received under the Program; Specify the process for the Program’s review of prescription monitoring data and naloxone medication data and reporting of: Possible misuse or abuse of a monitored prescription drug under § 21–2A–06(c) of this subtitle; or A possible violation of law or possible breach of professional standards under § 21–2A–06(d) of this subtitle; Establish requirements for Program retention of prescription monitoring data and naloxone medication data; and Require that: Confidential or privileged patient information be kept confidential; and Records or information protected by a privilege between a health care provider and a patient, or otherwise required by law to be held confidential, be filed in a manner that, except as otherwise provided in §§ 21–2A–06 and 21–2A–06.1 of this subtitle, does not disclose the identity of the person protected.

A prescriber shall be registered with the Program before obtaining a new or renewal registration with the Department under § 5–304(a) of the Criminal Law Article or by July 1, 2017, whichever is sooner. A pharmacist shall be registered with the Program by July 1, 2017. Before registering with the Program, a prescriber and a pharmacist shall complete a course of instruction and training developed by the Department, including the effective use of the Program.

Beginning July 1, 2018, a prescriber: Shall request at least the prior 4 months of prescription monitoring data for a patient before initiating a course of treatment for the patient that includes prescribing or dispensing an opioid or a benzodiazepine; Shall, if a patient’s course of treatment continues to include prescribing or dispensing an opioid or a benzodiazepine for more than 90 days after the initial request for prescription monitoring data, request prescription monitoring data for the patient at least every 90 days until the course of treatment has ended; and Shall assess prescription monitoring data requested from the Program before deciding whether to prescribe or dispense or continue prescribing or dispensing an opioid or a benzodiazepine. If a prescriber decides to prescribe or continue to prescribe an opioid or a benzodiazepine after requesting prescription monitoring data from the Program and assessing the prescription monitoring data, the prescriber shall document in the patient’s medical record that the prescription monitoring data was requested and assessed. A prescriber is not required to request prescription monitoring data from the Program if the opioid or benzodiazepine is prescribed or dispensed to an individual: In an amount indicated for a period not to exceed 3 days; For the treatment of cancer or cancer–related pain; Who is: A patient receiving treatment in an inpatient unit of a hospital; A patient in a general hospice care program as defined in § 19–901 of this article; or Any other patient diagnosed with a terminal illness; A patient who resides in: An assisted living facility; A long–term care facility; A comprehensive care facility; or A developmental disabilities facility; or To treat or prevent acute pain for a period of not more than 14 days following: A surgical procedure; A fracture; Significant trauma; or Childbirth. A prescriber may not be required to comply with the provisions of this section when: Prescribing or dispensing an opioid or a benzodiazepine drug that has been listed by the Secretary under § 21–2A–03(b)(3) of this subtitle as having a low potential for abuse; Accessing prescription monitoring data would result in a delay in the treatment of a patient that would negatively impact the medical condition of the patient; Electronic access to prescription monitoring data is not operational as determined by the Department; or Prescription monitoring data cannot be accessed by the prescriber due to a temporary technological or electrical failure. If a prescriber does not access prescription monitoring data for any of the reasons provided under subsection (c)(2), (3), or (4) of this section: The prescriber shall use reasonable medical judgment in determining whether to prescribe or dispense an opioid or a benzodiazepine; and The prescriber shall enter an appropriate record in the patient’s medical chart, including the reason why prescription monitoring data was not accessed. If a pharmacist or pharmacist delegate has a reasonable belief that a patient may be seeking a monitored prescription drug for any purpose other than the treatment of an existing medical condition: Before dispensing a monitored prescription drug to the patient, the pharmacist or pharmacist delegate shall request prescription monitoring data to determine if the patient has received other prescriptions that indicate misuse, abuse, or diversion of a monitored prescription drug; and The pharmacist shall have the responsibility described in 21 C.F.R. § 1306.04. The Secretary may adopt regulations to provide additional clinical, technical, or administrative exemptions based on new standards of practice.

A prescriber or pharmacist may authorize a prescriber delegate or pharmacist delegate to request prescription monitoring data on behalf of the prescriber or pharmacist if: The prescriber or pharmacist takes reasonable steps to ensure that the prescriber delegate or pharmacist delegate is competent in the use of the Program; The prescriber or pharmacist remains responsible for: Ensuring that access to the Program by the prescriber delegate or pharmacist delegate is limited to purposes authorized by law; Protecting the confidentiality of the prescription monitoring data; and Any breach of confidentiality by the prescriber delegate or pharmacist delegate; and The decision whether to prescribe or dispense a monitored prescription drug for a patient: Remains with the prescriber or pharmacist; and Is reasonably informed by the prescription monitoring data obtained from the Program.

There is an Advisory Board on Prescription Drug Monitoring in the Department. The Board shall consist of the following members: The Secretary, or the Secretary’s designee; The President of the State Board of Pharmacy, or the President’s designee; The Chair of the State Board of Physicians, or the Chair’s designee; The President of the State Board of Nursing, or the President’s designee; The President of the State Board of Dental Examiners, or the President’s designee; The President of the State Board of Podiatric Medical Examiners, or the President’s designee; The Chairman of the Maryland Health Care Commission, or the Chairman’s designee; Four physicians and one nurse practitioner with expertise in clinical treatment using controlled dangerous substances, including pain management, substance abuse, and behavioral disorders, appointed by the Secretary after consultation with: For the physician appointments, MedChi, The Maryland State Medical Society, the Maryland Physical Medicine and Rehabilitation Society, the Maryland Society of Anesthesiologists, the Maryland–D.C. Society of Clinical Oncology, the Hospice and Palliative Care Network of Maryland, and the Maryland Chapter of the American Academy of Pediatrics; and For the nurse practitioner appointment, the Maryland Nurses Association; One pediatrician, appointed by the Secretary after consultation with the Maryland Chapter of the American Academy of Pediatrics; Three pharmacists who represent the perspective of independent and chain pharmacies, appointed by the Secretary after consultation with the Maryland Pharmacists Association, the Maryland Association of Chain Drug Stores, and any other appropriate organization; A local law enforcement official, appointed by the Secretary after consultation with the Maryland Chiefs of Police Association and the Maryland Sheriff’s Association; The Secretary of State Police, or the Secretary’s designee; The President of the Maryland Association of County Health Officers, or the President’s designee; An academic or research professional; and Two Maryland residents who represent the perspective of patients, appointed by the Secretary. The Secretary shall designate the chair of the Board. The term of a member appointed by the Secretary is 3 years. The terms of members appointed by the Secretary are staggered as required by the terms provided for members of the Board on October 1, 2011. If a vacancy occurs during the term of an appointed member, the Secretary shall appoint a successor who shall serve until the term expires. A member of the Board: May not receive compensation as a member of the Board; but Is entitled to reimbursement for expenses under the Standard State Travel Regulations, as provided in the State budget. The Board shall: Meet not fewer than three times annually; Make recommendations to the Secretary relating to the design and implementation of the Program, including recommendations relating to: Regulations; Legislation; and Sources of funding, including grant funds under the Harold Rogers Prescription Drug Monitoring Program and other sources of federal, private, or State funds; Provide annually to the Governor and, in accordance with § 2–1257 of the State Government Article, the General Assembly a report that includes: The number of prescribers and prescriber delegates registered with and using the Program; The number of pharmacists and pharmacist delegates registered with and using the Program; The number of disclosures made to federal law enforcement agencies or State or local law enforcement agencies; An analysis of the impact of the Program on patient access to pharmaceutical care and on curbing prescription drug diversion in the State; The number of providers, by provider type, who received outreach and education from the Program; and The number of cases for which the providers received outreach and education from the Program; The number of cases that were identified for technical advisory committee review before referral to the Office; and The number of providers, by provider type, involved in the cases; The number of cases that were referred to the Office for further evaluation and the outcomes of the Office evaluations; and The number of providers, by provider type, involved in the cases; and Any recommendations related to modification or continuation of the Program; and Provide ongoing advice and consultation on the implementation and operation of the Program, including recommendations relating to: Changes in the Program to reflect advances in technology and best practices in the field of electronic health records and electronic prescription monitoring; Changes to statutory requirements; and The design and implementation of an ongoing evaluation component of the Program. The Secretary and the Board shall consult with stakeholders and professionals knowledgeable about prescription drug monitoring programs as appropriate to obtain input and guidance about implementation of the Program.

Prescription monitoring data: Are confidential and privileged, and not subject to discovery, subpoena, or other means of legal compulsion in civil litigation; Are not public records; and Except as provided in subsections (b), (c), (d), and (f) of this section or as otherwise provided by law, may not be disclosed to any person. The Program shall disclose prescription monitoring data, in accordance with regulations adopted by the Secretary, to: A prescriber, or a licensed health care practitioner authorized by the prescriber, in connection with the medical care of a patient; A dispenser, or a licensed health care practitioner authorized by the dispenser, in connection with the dispensing of a monitored prescription drug; A federal law enforcement agency or a State or local law enforcement agency, on issuance of a subpoena, for the purpose of furthering an existing bona fide individual investigation; A licensing entity, on issuance of an administrative subpoena, for the purposes of furthering an existing bona fide individual investigation; A rehabilitation program under a health occupations board, on issuance of an administrative subpoena; A patient with respect to prescription monitoring data about the patient; The Office of the Attorney General, on issuance of a subpoena for the purpose of furthering a bona fide existing investigation; Subject to subsection (i) of this section, authorized users of another state’s prescription drug monitoring program or any other authorized local, state, territorial, or federal agency in connection with the provision of medical care; The following units of the Department, on approval of the Secretary, for the purpose of furthering an existing bona fide individual investigation: The Maryland Medical Assistance Program; The Office of the Inspector General; The Office of Health Care Quality; and The Office; The technical advisory committee established under § 21–2A–07 of this subtitle for the purposes set forth in subsections (c), (d), and (e) of this section; The medical director of a health care facility, as defined in § 19–114 of this article, or the medical director’s designee, for the purpose of providing health care practitioners employed or contractually employed at the health care facility access to the prescription monitoring data in connection with the provision of medical care or the dispensing of a monitored prescription drug to a patient of the health care facility; The Office of the Chief Medical Examiner in accordance with § 5–309 of this article; or The following entities, on approval of the Secretary and for the purpose of furthering an existing bona fide individual case review: The State Child Fatality Review Team or a local child fatality review team established under Title 5, Subtitle 7 of this article, on request from the chair of the State or local team; A local drug overdose fatality review team established under § 5–902 of this article, on request from the chair of the local team; The Maternal Mortality Review Program established under § 13–1203 of this article, on request from the Program; and A medical review committee described in § 1–401(b)(3) of the Health Occupations Article, on request from the committee. In accordance with regulations adopted by the Secretary: The Program shall review prescription monitoring data for indications of possible misuse or abuse of a monitored prescription drug; and If the Program’s review of prescription monitoring data indicates possible misuse or abuse of a monitored prescription drug, the Program shall: Report the possible misuse or abuse to the prescriber or dispenser of the monitored prescription drug; and Provide education to the prescriber or dispenser. Before the Program reports the possible misuse or abuse of a monitored prescription drug to a prescriber or dispenser under this subsection, the Program may obtain from the technical advisory committee: Clinical guidance regarding indications of possible misuse or abuse; and Interpretation of the prescription monitoring data that indicates possible misuse or abuse. In accordance with regulations adopted by the Secretary and subject to paragraph (3) of this subsection, the Program shall review prescription monitoring data for indications of a possible violation of law or a possible breach of professional standards by a prescriber or a dispenser. If the Program’s review indicates a possible violation of law or a possible breach of professional standards by a prescriber or a dispenser, the Program: Shall notify the prescriber or dispenser of the possible violation of law or possible breach of professional standards; and Shall provide education to the prescriber or dispenser; and Subject to paragraph (4) of this subsection, may provide prescription monitoring data to the Office for further investigation. Before the Program provides notification of a possible violation of law or a possible breach of professional standards to a prescriber or a dispenser, the Program shall obtain from the technical advisory committee: Clinical guidance regarding methods used to identify a possible violation of law or a possible breach of professional standards; and Interpretation of the prescription monitoring data advising whether the method identifies a possible violation of law or a possible breach of professional standards. In determining whether its review indicates a possible violation of law or a possible breach of professional standards by a prescriber or dispenser, the Program shall take into account to the extent practicable the particular specialty, circumstances, patient type, and location of the prescriber or dispenser. If methods developed under paragraph (3)(i) of this subsection indicate a possible violation of law or a possible breach of professional standards and the Program determines that outreach and education to the prescriber or dispenser is inadequate to address the possible breach or violation, the Program may refer the possible violation of law or a possible breach of professional standards along with prescription monitoring data to the Office for further investigation, provided that the Program: Provides notice and an opportunity to the technical advisory committee to make recommendations within 10 business days regarding interpretation of the data; Provides the recommendations of the technical advisory committee, if any, to the Office; and Notifies the prescriber or the dispenser that the prescription monitoring data will be provided to the Office for further investigation. On receipt of prescription monitoring data and relevant records under paragraph (2) of this subsection, the Office shall: Review the prescription monitoring data and records, along with any additional information the Office may obtain as part of its investigation; and If it determines that there has been a violation of law or a breach of professional standards, take any action authorized by law regarding the violation or breach, including providing the prescription monitoring data and records to the appropriate licensing entity for possible disciplinary action. Before the Program discloses information under subsection (b)(3), (5), (6), (8), or (9) of this section, the Program may request that the technical advisory committee: Review the requests for information; Provide clinical guidance and interpretation of the information requested to the Secretary to assist in the Secretary’s decision on how to respond to a judicial subpoena, administrative subpoena, or other request; and Provide clinical guidance and interpretation of the information requested to the authorized recipient of the information. The Program, in consultation with the Board, shall consider policies and procedures for determining the circumstances in which the review of requests for information and the provision of clinical guidance and interpretation of information by the technical advisory committee under paragraph (1) of this subsection is feasible and desirable. Except as provided by regulations adopted by the Secretary, a person who receives prescription monitoring data from the Program may not disclose the data. In addition to the disclosures required under subsection (b) of this section, the Program may disclose prescription monitoring data for research, analysis, public reporting, and education: After redaction of all information that could identify a patient, prescriber, dispenser, or any other individual; and In accordance with regulations adopted by the Secretary. The Secretary may require submission of an abstract explaining the scope and purpose of the research, analysis, public reporting, or education before disclosing prescription monitoring data under this subsection. The Office of the Attorney General may seek appropriate injunctive or other relief to maintain the confidentiality of prescription monitoring data as required under this section. The Program may provide prescription monitoring data to another state’s prescription drug monitoring program only if the other state’s prescription drug monitoring program agrees to use the prescription monitoring data in a manner consistent with the provisions of this subtitle. The Program may: Request and receive prescription monitoring data from another state’s prescription drug monitoring program and use the prescription monitoring data in a manner consistent with the provisions of this subtitle; and Develop the capability to transmit prescription monitoring data to and receive prescription monitoring data from other prescription drug monitoring programs employing the standards of interoperability. The Program may enter into written agreements with other states’ prescription drug monitoring programs for the purpose of establishing the terms and conditions for sharing prescription monitoring data under this section. Prescription monitoring data may not be used as the basis for imposing clinical practice standards.

Naloxone medication data: Are confidential and privileged, and not subject to discovery, subpoena, or other means of legal compulsion in civil litigation; Are not public records; and Except as provided in subsection (b) of this section or as otherwise by law, may not be disclosed to any person. The Program shall disclose naloxone medication data, in accordance with regulations adopted by the Secretary, for public health surveillance, research, analysis, public reporting, and education after redaction of all information that could identify a patient, prescriber, dispenser, or any other individual. The Secretary may require submission of an abstract explaining the scope and purpose of the research, analysis, public reporting, or education before disclosing naloxone medication data under paragraph (1) of this subsection.

There is a technical advisory committee to the Program. The purpose of the technical advisory committee is to: Review requests for information from the Program under § 21–2A–06(b)(3), (4), (5), (8), or (9) of this subtitle; and Provide clinical guidance and interpretation to the Program regarding indications of possible misuse or abuse of a monitored prescription drug or a possible violation of law or a possible breach of professional standards by a prescriber or a dispenser under § 21–2A–06(c) and (d) of this subtitle. The technical advisory committee consists of members appointed by the Secretary, including: A board certified anesthesiologist licensed and practicing in the State, nominated by the Maryland Society of Anesthesiologists; A certified addiction medicine specialist licensed and practicing in the State, nominated by the Maryland Society for Addiction Medicine; A pharmacist licensed and practicing in the State; A medical professional, licensed and practicing in the State, who is treating cancer patients; A board certified physician specializing in the treatment of patients with pain, licensed and practicing in the State, nominated by the Maryland Society of Physical Medicine and Rehabilitation; Two medical professionals, licensed and practicing in the State with expertise or experience in providing care for patients with substance–related or mental health disorders; A dentist licensed and practicing in the State; and A medical professional licensed and practicing in the State in the field of internal medicine or family practice.

With respect to the administration and operation of the Program, the Department and its agents and employees are not subject to liability arising from: The inaccuracy of any information submitted to the Program in accordance with this subtitle; or The unauthorized use or disclosure of prescription monitoring data or naloxone medication data by a person to whom the Program was authorized to provide prescription monitoring data or naloxone medication data under this subtitle. Except as provided in § 21–2A–09(b)(3) of this subtitle, a prescriber, prescriber delegate, pharmacist, or pharmacist delegate, acting in good faith, is not subject to liability or disciplinary action arising solely from: Requesting or receiving, or failing to request or receive, prescription monitoring data from the Program; or Acting, or failing to act, on the basis of prescription monitoring data provided by the Program.

A dispenser who knowingly fails to submit prescription monitoring data or naloxone medication data to the Program as required under this subtitle shall be subject to a civil penalty not exceeding $500 for each failure to submit required information. A person who knowingly discloses, uses, obtains, or attempts to obtain by fraud or deceit, prescription monitoring data or naloxone medication data in violation of this subtitle shall be guilty of a misdemeanor and on conviction is subject to imprisonment not exceeding 1 year or a fine not exceeding $10,000 or both. In addition to the penalties under paragraph (1) of this subsection, a prescriber, prescriber delegate, pharmacist, or pharmacist delegate who knowingly discloses or uses prescription monitoring data or naloxone medication data in violation of this subtitle shall be subject to disciplinary action by the appropriate licensing entity. A prescriber or pharmacist who violates § 21–2A–04.1 or § 21–2A–04.2 of this subtitle shall be subject to disciplinary action by the appropriate licensing entity. The release of prescription monitoring data by a prescriber, prescriber delegate, pharmacist, or pharmacist delegate to a licensed health care professional solely for treatment purposes in a manner otherwise consistent with State and federal law is not a violation of this subtitle.