We will start this column with a few questions, answers, and interesting facts. In the United States, what would you guess is responsible for more unintentional deaths than cocaine and heroin combined? Opioid analgesics. In 2013, what caused more deaths than homicide? Prescription analgesics. While the United States accounts for approximately 5% of the world’s population, it accounts for 80% of the world’s opiate use and 99% of the world’s hydrocodone use. Forty Americans die each day due to prescription painkiller abuse. There is no doubt that appropriate care often involves pain management by prescription medications to help with both acute and chronic conditions. However, the data (there are many more facts that we are not presenting here) unequivocally demonstrates that prescription opioid abuse is at epidemic levels in the U.S.
As you know, prescription drug monitoring programs (PDMPs) are intended to address this problem. Interestingly, this is not a new problem, as the first PDMP was established in New York in 1918. The longest continually operating PDMP began in 1939 in California. Your PDMP is electronic, while the early programs were paper based. The Centers for Medicare & Medicaid Services (CMS) defined PDMPs as statewide electronic databases that store prescribing and dispensing records for controlled substances and other potential drugs of abuse. PDMPs are regulated at the state level, including who can access the data they contain.
Because PDMPs are operated at the state level, differences are found from state to state. For example, Missouri is currently the only state that does not have a PDMP, but this may be changing, as legislation to establish a PDMP passed the state senate in May. In those 49 states that do have a PDMP, the majority are operated by health departments, boards of pharmacy, or another single state agency. Currently, 16 states do not require practitioners to access their PDMP prior to writing the prescription. You may wonder how PDMPs are funded. That is also a state-level decision. In our state of Alabama, a portion of prescribers’ controlled substance certificate fees fund the PDMP; no fees paid by pharmacists or pharmacies to the board of pharmacy fund Alabama’s PDMP. Drugs of interest also vary by state. The majority of states collect data on schedules II to V. Seventeen states also collect data on noncontrolled substances with a high potential for abuse.
As legislation requiring reporting to PDMPs has become commonplace, reporting period requirements have undergone considerable change. The reporting period is the time from dispensing a prescription for a drug of interest to the point at which the dispensing information is submitted to the monitoring program. Reporting periods range from near real time to monthly, with daily and weekly being the most common reporting periods. The actual process of reporting is one area where standardization can be found. For the purpose of this discussion, we consider those pharmacies that report on paper to be outliers. In fact, in Alabama there are over 1,400 pharmacies that report to our state PDMP electronically. A single pharmacy reports via fax.
We mentioned above that the agency that operates a state’s PDMP varies by state. In general, state agencies are not building and maintaining their PDMP databases. Instead, they contract with vendors responsible for building and maintaining the database to the state’s specifications. Although there are a small number of vendors providing these services on a national level, their databases are exchanging information with thousands of pharmacies and prescribers’ offices. On the pharmacy end, pharmacy management systems (PMSs) house the data that ultimately ends up in the PDMP database. Similar to the use of the NCPDP standard for electronic prescribing, reporting to PDMP databases is enabled by the ASAP (American Society for Automation in Pharmacy) standard (version 4.2 is most commonly used).
At the individual pharmacy level, the actual process of reporting to the PDMP varies depending on a variety of factors. In general, pharmacists practicing in chain pharmacies likely take no overt action to report to their state’s PDMP. In these situations, reporting is initiated from a central hub that dials into the pharmacy’s PMS, extracts the appropriate dispensing records, and submits them to the PDMP database. Procedures for reporting to the PDMP database may require more hands-on attention in an independent pharmacy setting. Some PMS vendors do offer an extra service that functions similarly to the extraction/ submission process described above for chain settings. This usually involves using the PMS to create an ASAPformatted file that is uploaded to the PDMP database. We use the term “may” because processes and procedures are influenced by state law, the specific PDMP vendor a state uses, and PMS capabilities. Manual reporting of individual prescriptions can also be done and is most commonly seen in settings such as prescribers’ offices or veterinarians’ practices.
Using the Data
The value in reporting to a statewide PDMP database is that you can access the database when that voice in your head suggests that the patient in front of you may have a substance abuse problem. Access to PDMPs is currently not integrated into the PMS. Therefore, searching for a patient’s history usually requires checking a Web-based portal and querying using a core set of criteria (e.g., name, birth date, address). ASAP has developed a Web service standard that allows pharmacists to search their state’s PDMP database directly from the PMS. The Web service standard includes an option to receive morphine equivalency data for executed queries. This workflow integration should greatly ease the burden of searching. The standard was developed with input from all stakeholders, including 11 PDMPs. Here, we mention searching a single state’s PDMP database. Mechanisms are in place to allow states to share data and for prescribers and pharmacists to query on a person of interest not only for the state in which they are located but other states as well, for a more complete picture on that person’s history of prescriptions for controlled substances. However, states vary in terms of those who are authorized to have access to the patient’s data.
Pharmacy is certainly not regarded as a typical law enforcement agency, but pharmacy does have a responsibility to ensure appropriate medication therapy, including identifying and intervening in situations of addiction. As an aside, how to intervene is quite challenging. Some have suggested that pharmacists tell patients they are out of the desired medication. Others worry that this approach will just bring the patient back the next day or that it sends the patient to the next pharmacy. We are not advocating that readers place themselves in situations of potential harm. We encourage readers to talk with their colleagues, pharmacy associations, and state boards for effective ways to intervene in situations of apparent abuse. Pharmacists in virtually all states have the ability to access dispensing records for potential drugs of abuse. We welcome your comments. CT
Brent I. Fox, Pharm.D., Ph.D., is an associate professor, and Bill G. Felkey, M.S., is professor emeritus, in the Department of Health Outcomes Research and Policy, Harrison School of Pharmacy, Auburn University. They can be reached at foxbren@ auburn.edu and email@example.com.