In an effort to address the challenges associated with misuse of controlled medications, the Bureau of Justice Assistance (BJA), the Centers for Disease Control and Prevention’s (CDC) Unintentional Injury Center, and the Food and Drug Administration’s (FDA) Safe Use Initiative have collaborated with the Prescription Drug Monitoring Program (PDMP) Training and Technical Assistance Center (TTAC) at Brandeis University to undertake the Prescription Behavior Surveillance System (PBSS) project. The main goal of PBSS is to create an early warning surveillance and evaluation tool based on de-identified, longitudinal data from state PDMPs. This tool is intended to measure trends in controlled substance prescribing and dispensing as well as indicators of medical use and possible non-medical prescription drug abuse and diversion. A second goal of the project is to inventory, assess the evidence base for, and evaluate prescriber educational initiatives that aim to enable safer prescribing of controlled substances, using the PBSS database when feasible to assess the effectiveness of selected prescriber initiatives.
To guide the operation of the PBSS, an Oversight Committee has been established, consisting of representatives from the participating PDMPs, CDC, FDA, BJA, the Substance Abuse and Mental Health Services Administration (SAMHSA), the IJIS Institute, and TTAC. As of October 2016, twelve states have submitted de-identified data to PBSS. Seven other states are in the process of obtaining review and approval to participate.
The Oversight Committee has developed 43 prescription behavior measures for a standardized, periodic report based on elements of the multi-state database. These measures include: overall usage within drug classes and for selected individual drugs; daily dosage; overlapping prescriptions within each drug class, across the opioid and benzodiazepine classes, and across dosage forms of opioid analgesics (i.e., immediate vs. extended release); questionable activity within a class or classes; payment sources; indicators of possible pill mills; inappropriate prescribing measures; and pharmacy-based measures of possible inappropriate dispensing. Each participating PDMP provides an initial set of legacy data, with subsequent quarterly updates, enabling an ongoing surveillance of prescription activity trends.
The PBSS database represents a unique resource, in that it captures all filled controlled substance prescriptions in Schedules II though IV that are collected by the participating states’ PDMPs, including those paid for by cash, and provides data that can be timelier than health outcome data. As part of the PBSS project, the FDA requested that a report be produced describing current medical provider initiatives and interventions to promote safe prescribing of controlled substances and, using PBSS data, conduct evaluations of selected initiatives.
The PBSS project is expected to have significant national impact in the following ways:
• Providing the ability to detect changes in prescribing patterns before they result in changes in health outcomes; and hence
• Allowing time to prepare for and possibly interdict anticipated changes in health outcomes;
• Providing data relevant to assessing the effectiveness of initiatives to reduce prescription drug abuse and diversion, including community prevention programs and interventions aimed at promoting safer prescribing;
• Generating a national inventory of initiatives aimed at influencing prescriber behavior and their evidence base;
• Providing an evaluation of selected prescriber initiatives using the PBSS database, leading to more targeted and effective prescriber interventions.
Expected benefits to states participating in PBSS include:
• Detailed periodic epidemiological reports on prescribing behavior within the state;
• Receipt of expert technical assistance regarding best practices to monitor and improve PDMP data quality and patient linking procedures, and other PDMP best practices;
• Additional state-specific epidemiological reports and analyses produced at the request of each participating state, formatted at the state’s request for different stakeholders and audiences.