Dental team resources Early planning
Under the direction of the Food and Drug Administration Amendments Act of 2007, the FDA has the authority to mandate drug manufacturers to provide these educational documents for patients’ and providers’ use whenever the benefits of a drug outweigh the risks (FDA, 2018a). The FDA website contains a list of REMS, including those for the use of extended-release (ER) and long-acting (LA) opioid medications. This list aims to reduce the risk and improve safe use of this group of drugs by providing the information needed, including patient counseling documents containing helpful “dos” and “don’ts” and doctor-prescribing directives. (See the Resources section of this course for a link to the full list.) ● Access to the Database: In states with a PDMP, access is available to prescribers, dispensers, law enforcement (pursuant to active investigations), and licensing boards. Pennsylvania was until recently the only state to make data available only to law enforcement officials; however, following the passage of Pennsylvania Act 191 in 2014, the Commonwealth began the process of expanding the PDMP to provide information to physicians and dispensers (Pennsylvania Department of Health, n.d.). ● Housing: States house their PDMPs within the state board of pharmacy, department of health, or other single state authority. Some states house the program at law enforcement sites such as the Office of the Attorney General. ● Frequency of Reporting: Clearly, the more recent the data available to practitioners, the more valuable it is to the clinical decision-making process. Depending on the state, data can be reported from daily to monthly. Oklahoma currently operates in real time with information going to the database at the time a prescription is filled. Such reporting is the goal of several systems, but is often limited by the expense of a real-time system. ● Interstate Data Exchange: As of 2018, 45 states had agreed to share data through the National Association of Boards of Pharmacy’s PMP InterConnect program (Lockwood, 2018). The establishment of new programs or the updating of existing programs invariably includes provisions for interstate data sharing. The importance of such sharing is obvious when providers practice near borders with other states and have patients from both states. ● Required PDMP Use: The number of states requiring practitioners to access the PDMP started out small but continues to grow. Usually this requirement involves Schedule II and III drugs, under designated circumstances, such as prescribing for a new patient or prescribing more than a designated amount. ● Generation of Unsolicited Reports: The majority of states generate some form of unsolicited reports to practitioners or law enforcement indicating opioid use or prescribing out of the norm (as defined by each state). Such reports have been shown to be one of the most effective strategies to combat drug abuse and diversion. ● Funding: There are a number of funding options used by states to initiate and maintain their PDMPs. They include federal grants, pharmaceutical companies, general revenue, program user fees, third-party payer fees, court costs from prescription drug prosecutions, health professional licensing fees, and state agency grants (Clark et al., 2012; Sacco et al., 2018; National Conference of State Legislatures, 2016). After the state of Florida instituted a PDMP and began regulating pain clinics, 80% of counties saw a decline in opioid prescriptions between the years 2010 and 2015. The number of opioid-related deaths by overdose declined as well (Bulloch & Shuman, 2018).
In order to best serve the needs of their patients, the dental team must have quick access to resources during a time of need. Because no one can predict when a patient may present and require assistance for prescription drug addiction, prior planning by the dental team is needed to ensure success. Computers at the dental office should have bookmarks to sites such as SAMHSA’s Behavioral Health Treatment Services Locator, so the dental team can expeditiously refer patients in need to local treatment centers. Risk evaluation and mitigation strategies Risk evaluation and mitigation strategies (REMS) are an example of a resource that can be readily accessible to the dental team. Prescription drug monitoring programs The diversion of prescription drugs (such as opioids) often involves fraudulent procurement for self-use or the selling of drugs for personal gain. Access is often accomplished by the patient: ● Seeing several doctors with complaints of pain symptoms in order to get multiple prescriptions (doctor shopping). ● Filling prescriptions at several pharmacies to avoid detection (pharmacy shopping). ● Presenting to emergency rooms, outpatient clinics, and dental offices with unsubstantiated pain symptoms. ● Altering valid prescriptions (e.g., either quantities or refill authorizations). ● Producing written or electronic forgeries for presentation to pharmacies. (Centers for Medicare and Medicaid Services, 2015; Kraman, 2004) Some of the current methods to combat prescription drug abuse and diversion include the use of triplicate numbered prescription forms, electronic prescribing for controlled substances (in certain states), the use of tamper-resistant prescription pads (required by Medicare since October 2008), collaborative practice agreements between pharmacists and prescribers, and utilization of state-operated prescription drug monitoring programs (PDMPs; Sacco et al., 2018). Prescription drug monitoring programs are state-driven databases that collect information on controlled (scheduled) prescription drugs and allow reports to be available to certain key individuals in the prescription drug process (CDC, 2017). The goal of such programs is to provide practitioners with the most current data on a patient’s controlled drug use to identify shoppers who may be abusers or diverters. Currently, 49 states have operational PDMPs or legislated programs that are under construction (Thielking, 2017). As of late May 2019, Missouri still lacked a statewide PDMP, in spite of years of attempted legislation. However, county PDMPs do cover almost 90% of Missourians (Hauswirth, 2019; Weber, 2019). In 2017, Missouri’s governor: Issued an executive order to create a statewide PDMP that allows Missouri Department of Health and Senior Services to analyze and identify inappropriate prescribing, dispensing, and obtaining of controlled substances, and to address these actions by making referrals to appropriate government officials, including law enforcement and professional licensing boards. (Federation of State Medical Boards, 2018). Prescription drug monitoring programs vary widely across the country because each program is an independent, state-driven entity. Variability in each program centers on issues that include the following: ● Drugs Monitored: Most states, at a minimum, report Schedule II, III, and IV controlled substances to the database. Approximately 60% of states additionally monitor Schedule V drugs.
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