Consider a stepwise approach with the least invasive and least powerful pain management therapies appropriate for the patient (see Table 7 ). Counsel patients regarding common adverse effects of opioids used for acute pain. Upon initiation of opioid therapy, it is common for patients to experience sedation, nausea or vomiting, and pruritus. In most cases, these effects resolve within a few days. It is important to note that opioid- induced itching is not always indicative of an allergic reaction, as opioids induce the release of histamine. Treatment with antihistamines usually resolves the itching but may increase sedation. Ensure patients are aware of the risk of oversedation, respiratory depression, and overdose, and recommend that they not take more medication than prescribed without discussing it with their prescriber. The FDA approved the Opioid Analgesic Risk Evaluation and Mitigation Strategies (REMS), which apply to all opioid analgesics for outpatient use. The REMS program requires that training be made available to all healthcare providers involved in managing patients with pain, including nurses and pharmacists. 98 Prescribers are strongly encouraged, but not required, to do all of the following: • Complete a REMS-compliant education program offered by an accredited continuing education (CE) provider or another education program that includes all the elements of the FDA Education Blueprint for Health Care Providers Involved in the Management or Support of Patients with Pain. • Use the Patient Counseling Guide (PCG) to discuss the safe use, serious risks, and proper storage and disposal of opioid analgesics with patients and their caregivers. • Emphasize to patients and their caregivers the importance of reading the medication guide provided by their pharmacist every time an opioid analgesic is dispensed to them. • Consider using other tools to improve patient, household, and community safety, such as patient–prescriber agreements that reinforce patient–prescriber responsibilities. Give special safety instructions to patients with young children, especially toddlers, and those who live with a child or adult who is cognitively impaired. For example, prescribing a controlled substance to a patient with Alzheimer’s disease or other cognitive impairments must involve instructions to a responsible adult in the home. Family members should also have a plan for accidental overdoses, including poison control (1-800-222-1222) for unintentional ingestion of a known or unknown substance. Family members should call 911 and initiate emergency services if the individual is in respiratory distress. Prescription Drug Monitoring Program (PDMP) All states maintain a prescription drug monitoring program (PDMP) for controlled substances to address overprescribing opioids and other controlled substances.
In 2023, Missouri was the last state to create a statewide prescription drug monitoring program with State Bill 63. 107 Prescription drug monitoring programs are a statewide electronic database that tracks all controlled substance prescriptions. State requirements for using PDMPs while prescribing controlled substances vary substantially; however, the White House Office of National Drug Control Policy and the CDC recommend creating and utilizing these programs when prescribing controlled substances, especially opioids. In addition, the CDC’s National Center for Injury Prevention and Control is updating the 2016 CDC Guideline for Prescribing Opioids for Chronic Pain . PDMPs collect controlled substance prescription data from retail pharmacies (in-state, mail order, Internet), hospitals dispensing to emergency department patients (dispensing >48-hour supply), clinicians dispensing controlled substances from an office, and Department of Veterans Affairs pharmacies. Prescription data collected include patient information (e.g., name, date of birth, gender, Social Security number, driver’s license number), prescriber’s name and DEA registration number, and prescription information (dates prescriptions were written and filled, quantity, days supplied, National Drug Code [NDC; provides drug name and strength], and source of payment). PDMPs do not track methadone dispensed at federally regulated clinics; controlled substances dispensed for administration to patients in hospitals, long-term care facilities, jails, or correctional facilities; pseudoephedrine (often tracked separately); military pharmacy dispensing; or Schedule I substances. Most states share PDMP information with prescribers in other states through a nationwide network. As a result, authorized users can access prescription data such as medications dispensed and doses. PDMPs are tools (1) to promote safe prescribing and dispensing practices for Schedules II–V controlled substances to reduce the number of opioids and other controlled substances available for abuse; (2) that assist law enforcement in reducing drug diversion and illegal prescribing and dispensing; (3) for the health profession’s licensure boards to support licensee reviews and investigations; and (4) for analysis of data that can help identify problematic trends with specific drugs, geographic regions, and patient demographics. The purpose of PDMPs is to (1) improve medication safety for opioids and other controlled substances by allowing clinicians to identify patients who are obtaining controlled substances from multiple prescribers (i.e., doctor shopping), (2) calculate the total amount of opioids prescribed per day, and (3) identify patients who are being prescribed other substances that may increase risk of opioids, such as benzodiazepines. However, the effect of PDMPs is uncertain, as studies have reported conflicting results. Suggested improvements to prescription drug monitoring programs include improved clinician training in using PDMPs, prescriber dashboards for higher-risk patients, proactive alerts, mandatory registration,
mandatory querying for specific prescriptions, improved interfaces, and integration into electronic medical records. 108 Electronic Prescribing of Controlled Substances (EPCS) In June 2010, the DEA published an interim final rule allowing for the electronic prescribing of controlled substances (EPCS) in all states. States had to meet specific requirements, including certification of the electronic prescribing and pharmacy applications to sign, transmit, or process the controlled substance prescriptions; audits and certification reports for these applications; and two-factor authentication for prescribers. However, implementation of EPCS has been slow; in 2015, only 2.2% of prescribers and less than 50% of pharmacies were enabled for EPCS, while over 70% of prescribers and 95% of pharmacies could e-prescribe or accept other prescriptions. 99 Delays included necessary updates to electronic health records and pharmacy systems and changes to state legislation to allow for EPCS. As the opioid crisis worsened, the implementation of ECPS as a tool for increased security against diverted controlled substance prescriptions has been recognized. 109 E-prescribing continued raising the bar for safe, precise prescriptions in 2021 with better data quality and more efficient communication between pharmacists and prescribers. A Centers for Medicare & Medicaid Services (CMS) rule requiring that Part D providers use EPCS took effect January 1, 2021 (according to the requirements of the SUPPORT for Patients and Communities Act), and state legislation continued moving forward throughout the year. With between 20% and 26% of U.S. adults using telemedicine every month in 2021, it is no surprise that e-prescribing use grew throughout the year. EPCS brings extra safety and security to controlled substance prescriptions, which is critical amid an opioid overdose crisis that spiked as the COVID-19 pandemic hit the United States. Already used by virtually all pharmacies, EPCS saw an 18% jump in the number of enabled prescribers in 2021. 110 Schedule II Controlled Substance Prescribing Considerations Schedule II controlled substances require a written, signed prescription, except where states have enacted laws allowing EPCS. There is no federal law limiting when a signed prescription expires. A verbal order is permitted only in an emergency for Schedule II controlled substances. Written prescriptions for a Schedule II controlled substance may not be refilled. While there is no federal quantity limit for Schedule II controlled substance prescriptions, many states have enacted legislation limiting quantities for opioid prescriptions. As of 2018, 33 states passed legislation limiting it, guidance, or other requirements related to prescribing opioids. 111
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