As part of the FDA’s action plan regarding the safety of opioid analgesics, it has released several safety-related product labeling updates. In addition, the FDA (2018) updated warnings across the entire class of opioids regarding drug interactions, adrenal issues, and alterations in sex hormone levels. Specifically, the FDA warns that opioids may interact with other medications that increase serotonin levels (e.g., certain antidepressants and migraine medications), which may lead to serotonin syndrome. In addition, opioids are rarely associated with adrenal insufficiency, and long-term use of opioids decreases sex hormone levels. Consider these potential drug interactions and adverse effects and discuss them with patients when determining the appropriateness of opioid therapy (FDA, 2022a). The FDA issues a black box warning (BBW) for all prescription opioid pain and cough medications and all prescription benzodiazepines regarding the risk for the CNS depression and serious adverse effects, including respiratory depression and death. The BBW was issued after several studies showed an increasing trend in concomitant dispensing of opioid analgesics and benzodiazepines and an increasing frequency of combined benzodiazepine and prescription opioid misuse, abuse, and overdose as measured by national emergency department visit and overdose death rates from prescribed or greater- than-prescribed doses (FDA, 2021). In addition, other CNS depressants (e.g., barbiturates, antipsychotics, and neuroleptic drugs; antiepileptic and antiparkinsonian drugs; anesthetics; autonomic nervous system drugs; and muscle relaxants) Tapering of chronic opioid therapy (CDC, 2022A) Sometimes, clinicians must decide whether to decrease or discontinue chronic opioid therapy. Many factors may contribute to this decision: patient request; lack of response; signs of substance abuse disorder, overdose, or other serious adverse events; or early signs of overdose risk. Therefore, any tapering schedule must be patient-specific to minimize withdrawal symptoms while maintaining adequate pain management. A general recommendation is to begin with a 10% decrease of the initial dose per week. Some patients who have taken opioids for a long time may require slower tapers (e.g., 10% per month). Adjust the rate and duration of the taper based on the patient’s response. It is advisable to slow or pause a taper to manage withdrawal symptoms rather than reversing the taper. It is essential to discuss the risk of overdose if a patient quickly returns to a prescribed higher dose. Consider prescribing naloxone to reverse possible overdose symptoms. After achieving the smallest available dose, the interval between opioid doses increases, and opioids stop when taken less than once a day. Naloxone for emergent opioid overdose On average, every eight minutes, an individual dies from an opioid overdose (Skolnick, 2018). Individuals at higher risk for acute overdose include those who use prescription opioids, benzodiazepines, and alcohol, as well as individuals with substance or mental health use disorders. These factors affect the entire family since these individuals may obtain opioids from family members. Children are at risk when ingesting opioids in the home. Individuals who have lower tolerance due to incarceration, detoxification, or other controlled settings are also at higher risk for acute opioid overdose. Physiological damage can occur after 4 minutes, and death occurs in 4 to 6 minutes. Signs and symptoms of acute opioid overdose include: ● Unusual sleepiness or unresponsiveness. ● Decreased or absent breathing. ● Slow heartbeat or low blood pressure. ● Skin feels cold and clammy. ● Pinpoint pupils. ● Dusky nails and lips.
contributed to deaths where opioids were also implicated (SureScripts, 2022b). Tori et al. (2020) found that alcohol and benzodiazepine coinvolvement in opioid-involved overdose deaths was common, varied by opioid subtype, and was associated with state-level binge drinking and benzodiazepine prescribing rates. The FDA states that clinicians should limit prescribing opioid pain medicines with benzodiazepines or other CNS depressants only to patients with inadequate alternative treatment options. Avoid prescribing opioid-containing cough medicines to patients taking benzodiazepines or other CNS depressants, including alcohol. When prescribing medications, limit dosages and the duration of each drug to the least possible while achieving the desired clinical effect. Counseling patients regarding possible adverse severe reactions is critical (FDA, 2021). The FDA clarified this warning for patients taking opioid- addiction medications. Specifically, the FDA advised that the opioid-addiction medications buprenorphine and methadone should not be withheld from patients taking benzodiazepines or other drugs that depress the CNS. Although the combined use of these drugs increases the risk of severe side effects, the harm caused by untreated opioid addiction can outweigh these risks. These medications are often used with counseling and behavioral therapies for patients undergoing MAT, and patients can be treated with them indefinitely. Careful patient monitoring is necessary when prescribing benzodiazepines or other CNS- depressant agents in combination with MAT and appropriate and continued patient counseling (FDA, 2022d). Patients at high risk of harm, such as pregnant women or those with substance abuse disorder, may require coordination with treatment experts. Withdrawal symptoms are especially concerning in pregnant patients due to the risks to the mother and fetus. It is crucial to ensure patients receive appropriate encouragement and psychosocial support, including consultations with mental health providers and treatment for opioid use disorder as needed. Reassure patients that most people have improved function, without worse pain, after tapering opioids. In addition, some patients experience less pain after a taper, even though the pain may worsen initially. Self-Assessment Quiz Question #5 Any tapering schedule must be patient-specific to minimize withdrawal symptoms. The CDC recommends what percentage while maintaining adequate pain management?
a. 10% decrease of the initial dose per week. b. 15% decrease of the initial dose per week. c. 25% decrease of the initial dose per week. d. 45% decrease of the initial dose per week.
Naloxone hydrochloride is an opioid antagonist which blocks opiate receptors in the brain and other parts of the body (drugs. com, 2023). By occupying the receptor and blocking the action of the opioid, effects of naloxone reverse opioid effects by competing for opioid sites in the central nervous system, with a great affinity for the µu receptor (drugs.com, 2023). Naloxone nasal inhalation kits are widely accepted for opioid reversal in emergent situations (Skolnick, 2018). The Substance Abuse and Mental Health Services Administration (SAMHSA) oversees the accreditation and standards for opioid treatment programs (OTPs). Many medication-assisted treatment (MAT) medications in opioid addiction are regulated under the CSA (SAMHSA, 2022a). The Drug Addiction Treatment Act of 2000 (DATA 2000 Act) permits physicians who meet set qualifications to manage opioid dependency with FDA-approved medications, such as buprenorphine, in treatment settings other than OTPs (see Table 9). The DATA 2000 Act allows physicians to obtain a waiver (i.e., DEA-X) to treat opioid use disorder with
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