Maryland Department of Health and Mental Hygiene
Controlled Dangerous Substance Integration Unit
Project Charter
This Charter establishes the Controlled Dangerous Substance Integration Unit (CDSIU or Unit) within the Department of Health and Mental Hygiene (the Department or DHMH); describes the background, vision, and purpose of the Unit; defines the principles and authority under which the Unit will operate; assigns membership and responsibilities, and; establishes procedures for the operation of the Unit.
1.1 Background
The non-medical use, abuse and diversion of prescription Controlled Dangerous Substances (CDS) is a growing public health and safety problem in Maryland and across the country. The Department has tracked an alarming increase in overdose deaths, admissions to substance abuse treatment programs and presentations at hospital emergency departments related to prescription CDS, and law enforcement agencies have reported increases in criminal activity related to CDS diversion. Numerous administrative units within the Department have regulatory authority over the manufacture, distribution, prescribing or dispensing of CDS, yet coordination and information sharing among these units has been limited. Likewise, coordination with external public health authorities, healthcare providers and law enforcement agencies has been conducted by individual units ad hoc and without strategic oversight. The scale of the problem requires that the Department adopt a comprehensive strategy to reduce CDS abuse and diversion.
1.2  Vision
DHMH will conduct a comprehensive public health initiative to reduce the non-medical use, abuse and diversion of prescription CDS throughout the state. This initiative will employ evidenced-based prevention, intervention and enforcement strategies based on intra-departmental data sharing and analysis and seamless coordination with external stakeholders.
1.3  Purpose
The purpose of forming a CDS Integration Unit (CDSIU) is to:
·         Identify the prescription CDS-related data sets and indicators of potentially problematic prescribing, dispensing and use currently available to each relevant administrative unit of the Department;
·         Identify the policies and procedures in place within each unit that govern the analysis of these data sets and indicators and the responses taken;
·         Establish policies and procedures for data sharing between units that take into account current restrictions on disclosure and properly balance the need to protect confidential information with the Department’s responsibility to protect public health; 
·         Conduct strategic planning and implement comprehensive responses to identified CDS-related public health threats, and;
·         Establish policies and procedures for data disclosure to and operational coordination with external public health authorities, healthcare providers and federal, state and local law enforcement agencies that have concordant CDS-related responsibilities.
1.4  Authority
The CDSIU is established as a “medical review committee” within the Department pursuant to Health Occupations Article, § 1-401(b)(3) and (c), Annotated Code of Maryland. The directive for forming the CDSIU comes from the DHMH Secretary and Deputy Secretary for Public Health Services (the Deputy Secretary), who will support and oversee the CDSIU’s development and operations. 
1.5  Principles
·         The CDSIU will pursue strategic approaches to reducing prescription CDS abuse and diversion that preserve legitimate professional practice and patient access to optimal pharmaceutical-assisted care.
·         The CDSIU and its members will adhere in all instances to the “Controlled Dangerous Substance Integration Unit Privacy Policy” to ensure that protected information, including confidential, privileged and personally identifiable information, is protected and not disclosed in violation of federal or state law or regulation.
·         The effort will be sustained, not short term.
·         Personnel from administrative units of the Department will be assigned to participate in and provide support for CDSIU operations.
·         The CDSIU will be staffed with a Manager and organizationally linked to the Alcohol and Drug Abuse Administration.   
2.1  CDSIU Membership
The CDSIU will be composed of the following:
·         The Deputy Secretary for Public Health Services, or his/her designee;
·         The DHMH Chief Medical Officer;
·         The executive officer, or his/her designee, from these DHMH administrative units:
Alcohol and Drug Abuse Administration;
Office of the Attorney General;
Office of the Inspector General;
Office of Health Care Quality;
Office of the Chief Medical Examiner;
Laboratories Administration/Division of Drug Control;
Maryland Medicaid;
Maryland Board of Physicians;
Maryland Board of Nursing, and;
Maryland Board of Pharmacy.
·         A CDSIU Manager assigned by the DHMH Secretary;
·         Any other employee or contractor of the Department upon approval by the DHMH Secretary.
2.2  Roles and Responsibilities of CDSIU Members

The Deputy Secretary for Public Health Services shall:

·         Chair meetings of the CDSIU;
·         Provide ultimate oversight of and direction for CDSIU operations;
·         Assign operational responsibilities to CDSIU staff or membership, including assignment to workgroups, subcommittees or other tasks as needed;
·         Ensure the availability of sufficient financial, technical and administrative resources to support CDSIU operations, and;
·         Contract or establish other agreements with external partners in support of the CDSIU’s goals and objectives;

The Chief Medical Officer shall:

·         Provide clinical analysis and interpretation of information reviewed by the CDSIU to assist the CDSIU’s investigations and responses to potentially improper professional practice related to the prescribing and dispensing of CDS and the legitimacy of patient procurement and use of CDS;

·         Advise the CDSIU on the proper use of CDS in medical treatment to support the CDSIU’s strategic planning;

·         Perform other duties as assigned.


The executive officers from each administrative unit shall:

·         Represent the administrative unit at CDSIU meetings or designate a representative to attend in his/her place;

·         Identify prescription CDS-related data sets and indicators of potentially problematic CDS prescribing, dispensing and use currently available to their administrative unit;

·         Identify the policies and procedures in place within their unit that govern the analysis of these data sets and indicators and the responses taken;

·         Identify restrictions on the disclosure of prescription CDS-related data to other DHMH units and external stakeholders;

·         Revise unit-specific policies and procedures governing data analysis and response as appropriate to support CDSIU operations;

·         Provide CDS-related data to the CDSIU and external partners in a timely manner as required by CDSIU policies and procedures;

·         Receive and respond to data requests, as conveyed by the CDSIU Manager, from CDSIU members;

·         Communicate with the CDSIU Manager in a timely way regarding the availability of data to respond to a request, and provide an estimate of the length of time needed to prepare the data;

·         Provide advice and consultation to the Deputy Secretary to support the CDSIU’s strategic planning process;

·         Conduct investigations, administrative and regulatory actions or disciplinary procedures independently of and in tandem with those of other administrative units according to action plans developed by the CDSIU;

·         Keep in regular contact with the CDSIU Manager between CDSIU meetings via established communication processes, and;

·         Ensure that information is conveyed to and received from the CDSIU and its staff in a manner that protects privileged, confidential and/or personally identifiable information.


The CDSIU Manager shall provide administrative support for the CDSIU, including:

·         Receive data requests from and transmit requested data to CDSIU members;

·         Coordinate responses to data requests that involve other units of the Department;

·         Facilitate direct contact with the requestor for data requests requiring additional information and/or decision making by the requestor;

·         Compile and maintain records of information and analysis products received by, retained and disclosed from the CDSIU;

·         Draft and update documents and prepare meeting materials;

·         Maintain an up-to-date roster of CDSIU members with contact information;

·         Liaison with other DHMH administrative units and external partners as needed;

·         Coordinate the acquisition and maintenance of equipment and support services for the CDSIU;

·         Organize and staff CDSIU workgroups and subcommittees;

·         Be familiar with outside data sources and maintain a listing of data contacts at other governmental agencies and stakeholder organizations, and;

·         Other duties as assigned.

3.1  Meetings
The CDSIU will hold monthly meetings. The Deputy Secretary may convene special meetings when appropriate.
Any CDSIU member may propose agenda items for consideration by the Unit. All items for consideration will be submitted to the CDSIU Manager for review and approval by the Deputy Secretary
The CDSIU Manager will ensure that minutes are taken at each meeting that include, at a minimum:
·         Meeting attendance;
·         Documentation of information reviewed, Unit decisions, disagreements and unresolved issues;
·         Deliverables with due dates and assigned responsibilities
Minutes will be distributed to CDSIU members via email prior to each meeting and approved by a quorum of the Unit.