● Evidence for or history of diversion of controlled substances (e.g., forged prescriptions, pharmacy robberies, selling own prescription drugs, theft of others’ drugs). Although the combination is sometimes used, the Department of Veterans Affairs/Department of Defense (VA/DoD) practice guideline lists concomitant use of benzodiazepines as a contraindication to initiating a trial of long-term opioid therapy. 23 The Centers for Disease Control and Prevention (CDC) recommends avoiding prescribing opioids and benzodiazepines concurrently whenever possible but allows for rare instances when the combination may be indicated (e.g., severe acute pain in the presence of long-term, stable, low-dose benzodiazepine therapy). 64 Medication errors may result from miscommunication, packaging design, confusion caused by similar drug names, and other sources. Patient counseling and education can help guard against medication errors. Methadone for pain presents special clinical challenges due to a long and variable half-life, risk for toxicity due to accumulation in plasma concentrations during the several days necessary to achieve steady-state, and risk for cardiac toxicities due to prolongation of the QTc interval. 77-79 Methadone-related deaths have occurred in disproportionate numbers relative to the frequency with which it is prescribed for pain.64 Methadone is only for patients whose severe pain is unrelieved by other opioids. Close monitoring is critical when initiating methadone and during dose changes, and caution is needed in patients with heart disease or taking medications with concurrent QTc interval effects. Patients should be assessed for cardiac health ahead of being prescribed methadone, and an initial Abuse-deterrent opioids The FDA defines abuse-deterrent properties as those that deter but do not prevent all abuse (i.e., misuse). 81 Common technologies incorporate physical barriers to deter crushing and chewing, chemical barriers to resist extraction in common solvents of the active ingredient for injection, or opioid antagonists to block euphoria when a pill is altered. These formulations have been suggested as a way to reduce harm from prescribed opioids. The FDA cautions that abuse may still occur by swallowing intact pills. Data on abuse-deterrent properties are included in the Drug Abuse and Dependence section of the Considerations with opioids in special populations 23 Women/pregnant women Several diseases with a high burden of pain are more common in women or are sex specific. These include endometriosis, musculoskeletal and orofacial pain, fibromyalgia, migraines, and abdominal and pelvic pain. 3 Sex differences extend to the pain response itself, and recent scientific literature suggests that, compared with men, women experience more pain, are more sensitive to painful stimuli, report more intense pain, and are more likely to misuse
ECG may be advisable, particularly if the patient has cardiac disease or risk factors. If methadone is initiated, it should be started at a very low dose (e.g., 2.5 mg tid) and slowly titrated (e.g., by no more than 25%-50%, no more frequently than weekly. 77,78 In adults on relatively low previous opioid doses (e.g., <40-60 mg per day of morphine or equivalent), experts suggest a starting dose of 2.5 mg tid with initial dose increases of no more than 5 mg daily every 5 to 7 days. 80 When switching to methadone from higher previous doses of another opioid, consider starting methadone at a dose that is 75% to 90% less than the calculated equianalgesic dose (no higher than 30 to 40 mg per day) with initial dose increases of no more than 10 mg per day every 5 to 7 days. 80 It is important to withhold methadone if there is evidence of sedation. 80 Bear in mind that pain relief from a methadone dose lasts only 4 to 8 hours, but methadone remains in the body much longer (8 to 59 hours). 79 Patients should be counseled never to exceed the prescribed dose, not to mix with alcohol or other unauthorized substances, and to take methadone doses only as scheduled, not as needed. HCPs without experience and knowledge of methadone should seek expert consultation before prescribing it. 77 Self-Assessment Question 5 Which opioid analgesic is an example of a pure agonist? a. Buprenorphine. b. Naloxone. drug’s prescribing information under 9.2 Abuse. If missing or located elsewhere, the FDA does not consider the product abuse deterrent. The label also contains information on the types of studies conducted and the routes of abuse the formulation is expected to deter (e.g., oral, intranasal, insufflation, intravenous). Thus far, 10 opioid formulations have received abuse-deterrent labeling from the FDA. Post- marketing studies for the approved formulations are in their infancy, and new deterrent formulations are continually in development. 82 prescription opioids, though there remain many research gaps related to women’s health and pain. 3 During pregnancy, HCPs and patients together should carefully weigh risks and benefits when making decisions about whether to initiate opioid therapy. 64 All women should be informed of the risks of long- term opioid therapy to the developing fetus during current or potential future pregnancies, including a drug withdrawal syndrome in newborns called neonatal opioid withdrawal syndrome (NOWS). 64 c. Oxycodone. d. Pentazocine. e. Tramadol.
Book Code: MDCO1025
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