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 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
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 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 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 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 An estimated 32,128 babies were born with NOWS in 2016. 83 Babies born to women who are taking opioids are at risk for birth defects (including neural tube defects, congenital heart defects, and gastroschisis), preterm delivery, poor fetal growth, and stillbirth. 64 Given the risks during pregnancy and postpartum, HCPs are encouraged to include obstetricians and gynecologists as part of the pain care management team. 3 When caring for pregnant women who are prescribed opioids, HCPs should arrange for delivery at a facility prepared to evaluate and treat NOWS. 64
Women with SUD should be offered evidence-based treatment. In pregnant women with OUD, the risk of opioid exposure from opioids used to treat OUD should be discussed and balanced against the risk of untreated OUD, which might lead to illicit opioid use associated with outcomes such as low birth weight, preterm birth, or fetal death. 84 Pain management guidelines in Tennessee recommend the following measures when treating women of child-bearing age: 85 Initiating Therapy 1. The provider should discuss a method to prevent unintended pregnancy with every woman of child-bearing age who has reproductive capacity before opioids are initiated. 2. The practitioner should obtain a signature indicating that any woman who wishes to become or is at risk to become pregnant has been educated about the risks and benefits of opioid treatment during her pregnancy. 3. Women of child-bearing age who have reproductive capacity shall undergo a pregnancy test prior to the initiation of opioids. 4. Women of child-bearing age who have reproductive capacity should be asked about the possibility of pregnancy at each visit. For women who wish to avoid unintended pregnancy, use of long-acting reversible contraceptives should be discussed, or referral to appropriate high-risk obstetrician made. Ongoing Therapy 1. The provider should discuss a method to prevent unintended pregnancy with every woman of childbearing age who has reproductive capacity when opioids are initiated. 2. The provider shall advise every woman of child-bearing potential on opioids that she be on a method to prevent unintended pregnancy specifically considering long acting contraceptive methods. 3. The treatment agreement shall include an expectation that a female patient will tell the provider if she becomes pregnant or plans to become pregnant. 4. If she plans to become or becomes pregnant she shall be referred to an obstetrician. 5. When a UDT is performed, results must be documented in the medical record. Older Adults People who are ≥65 years require cautious opioid dosing and management as they may have numerous co-occurring medical problems with treatments that increase the risk for polypharmacy and harmful drug interactions. 78 Their risk for falls and cognitive effects with sedating medications and their sensitivity to analgesic effects are increased. In addition, prescription drug or other substance use may be difficult to spot, mimicking symptoms of common conditions such as dementia, diabetes, and depression.
c. Oxycodone d. Pentazocine e. Tramadol
The correct answer is c. Rationale : Oxycodone is an opioid analgesic that is an example of a pure agonist.
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