Maryland's Prescription Drug Monitoring Program (PDMP)
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Frequently Asked Questions
What is the PDMP?
Annotated Code of Maryland, Health General Article, Section 21-2A-02 requires the creation of a Prescription Drug Monitoring Program (PDMP) within the Department of Health and Mental Hygiene (DHMH). The program will be housed in the Alcohol and Drug Abuse Administration (ADAA), a unit of DHMH. The PDMP will require the electronic reporting of all Schedule II-V Controlled Dangerous Substances (CDS) dispensed pursuant to a prescription (see below for exemptions). Prescription data will be stored in a database and made available to controlled substance prescribers and dispensers, health professional licensing boards, law enforcement agencies, regulatory and investigative units within DHMH, patients and researchers.
When will the PDMP begin?
The PDMP is authorized by law to begin October 1, 2011, though actual dispenser reporting to the PDMP will not begin until the technical infrastructure to support electronic reporting is in place. Controlled substance prescription information will need to be reported to the Alcohol and Drug Abuse Administration (ADAA), or a third party designated by ADAA, by a date to be established in regulations promulgated by the Secretary of DHMH. Prescription data will be made available to authorized requestors only after reporting has begun and testing completed to ensure that system functionality and data security provisions are functioning properly.
Who is required to report prescription data to the PDMP?
Dispensers, including in-state pharmacies, non-resident pharmacies dispensing controlled substances in Maryland, and dispensing practitioners, are required to report. Prescribers are not required to report unless they are dispensing as well. The authorizing legislation includes only these exemptions to the reporting requirement:
- Licensed hospital pharmacies that only dispense controlled substances for direct administration to an inpatient of the hospital
- Opioid dependence treatment programs
- Veterinarian dispensing
- Pharmacies issued a waiver 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
- Dispensing to a hospice inpatient provided that the dispenser has received a waiver from DHMH. Waivers will be granted only if the dispenser demonstrates how it will distinguish dispensing to hospice inpatients from other controlled substance dispensing and the dispenser agrees that it will be subject to unannounced, on-site inspection by DHMH to verify that it is correctly reporting all dispensing to individuals other than hospice inpatients. Waivers shall be effective for 2 years. The waiver application process will be established after regulations are adopted.
What information is required to be reported to the PDMP?
The specific data that dispensers will be required to report to the PDMP will be detailed in regulations. At a minimum, this data must be sufficient to identify the patient for whom the prescription is dispensed, the prescriber, the dispenser and the drug type, dosage and quantity.
How often will prescription information need to be reported?
The specific timeframe for reporting prescription information after dispensing will be detailed in regulations. Dispensers should be advised that the authorizing legislation includes a civil penalty not to exceed $500 for knowingly failing to report.
How will prescription information be reported?
ADAA is currently working to identify the appropriate information technology to support electronic reporting. The PDMP will be assisted in this effort by the Advisory Board on Prescription Drug Monitoring, the Maryland Health Care Commission, national experts on prescription monitoring and other stakeholder organizations. Once the appropriate technology has been identified, ADAA will undertake training and technical assistance initiatives to ensure that all dispensers are aware of the reporting requirement and have the ability to report prescription data successfully.
Who will have access to prescription information?
The authorizing legislation lists the individuals and entities that can request prescription data and specifically prohibits any other disclosures from the program. Authorized requestors include:
- A prescriber, or a licensed healthcare practitioner authorized by the prescriber, in connection with the medical care of a patient
- A dispenser, or a licensed healthcare practitioner authorized by the dispenser, in connection with the dispensing of a monitored prescription drug
- A federal, 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 the issuance of an administrative subpoena voted on by a quorum of the board of a licensing entity, for the purpose 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 data about the patient
- The authorized administrator of another state’s PDMP, provided that the other state’s program agrees to use prescription data in a manner consistent with Maryland law
- Specific units of DHMH, including the Office of the Chief Medical Examiner, the Maryland Medical Assistance Program (Medicaid), the Office of the Inspector General, and the Office of Health Care Quality, on approval by the Secretary, for the purpose of furthering an existing, bona fide individual investigation
- The PDMP Technical Advisory Committee, for the purpose of providing clinical guidance and interpretation of the data to the Secretary and data recipients
- Researchers, after redaction of all information that could identify a patient, prescriber, dispenser or other individuals
What provisions will be made for the security and confidentiality of prescription information?
Prescription data are confidential, privileged, not subject to discovery, subpoena, or other means of legal compulsion in civil litigation, and are not public records. Any information technology utilized by the PDMP must meet or exceed industry data security standards for private health information. To deter misuse of prescription data, the legislation includes a criminal penalty for unlawful disclosure (misdemeanor offense punishable by up to 1 year imprisonment and a fine of $10,000).
Who is responsible for oversight of the PDMP?
ADAA will work closely with the Advisory Board on Prescription Drug Monitoring, a multi-disciplinary stakeholder board created by statute to advise on program design and implementation. The Advisory Board will also be responsible for evaluating the impact of the PDMP on prescription drug abuse and diversion and legitimate patient access to controlled substances. The Board will be composed of:
- DHMH Secretary, or designee
- The Chair or President of the Maryland Board of Physicians, Board of Pharmacy, Board of Nursing and the Maryland Health Care Commission, or designee
- Four physicians and one nurse practitioner with expertise in clinical treatment using controlled dangerous substances, including pain management, substance abuse, and behavioral disorders
- One pediatrician
- Three pharmacists who represent of the perspective of independent and chain pharmacies
- One local law enforcement official
- Two Maryland residents who represent the perspective of patients
Meetings of the Advisory Board are open to the public. If you would like to attend a meeting, please notify Michael Baier, PDMP Coordinator, at 410-402-8643 or mbaier@dhmh.state.md.us.
Who should I contact for more information?
Michael Baier
PDMP Coordinator
Maryland Alcohol and Drug Abuse Administration
55 Wade Avenue
Catonsville, Maryland 21228
410-402-8643
mbaier@dhmh.state.md.us
