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Step 2: Select Agent

Step 2: Select Agent

Universal Precautions, Step 2: Select Agent

If your clinical and risk assessment of the patient with chronic pain indicates that prescription opioid therapy is appropriate, the next step is to select a specific opioid agent. Numerous treatment guidelines exist to help guide the selection of appropriate opioid therapy for patients with chronic pain.1-5

Factors to consider when selecting an opioid agent and dosage include, but are not limited to, the patient’s general condition, medical status, and prior experience with opioids, including whether he or she is opioid tolerant.1,6 Patients who are opioid tolerant are those receiving, for 1 week or longer, at least 60 mg/day oral morphine, 25 mcg/hour transdermal fentanyl, 30 mg/day oral oxycodone, 8 mg/day oral hydromorphone, 25 mg/day oral oxymorphone, or an equianalgesic dose of another opioid.6

Another emerging consideration is opioid pharmacogenetics.

Pharmacogenetics

The rapidly progressing field of pharmacogenetics promises to contribute to our understanding of the variation in patient response to mu-opioid analgesics. For example, patients who have low or high expression of enzymes that are essential to the metabolism of specific opioid agents may experience poor efficacy or exaggerated medication effects, respectively.1,2 Pharmacogenetics soon may be applied in clinical practice to better predict which opioid agent may be best for an individual patient. For now, careful titration of treatment to patient response is key.1

References

  1. Argoff CE. Clinical implications of opioid pharmacogenetics [review]. Clin J Pain. 2010;26(suppl 10):S16-S20. PMID: 20026961
  2. Vuilleumier PH, Stamer UM, Landau R. Pharmacogenomic considerations in opioid analgesia [review]. Pharmgenomics Pers Med. 2012;5:73-87. PMID: 23226064

After deciding on an opioid agent, you may wish to consider prescribing an abuse-deterrent opioid, if one is available.7,8 Abuse-deterrent opioids are opioids that have been given FDA approval for demonstrating an ability to reduce abuse: (a) by making manipulation of the opioid—by crushing, chewing, dissolving, or extracting—more difficult, and/or (b) by making the effect of the manipulated opioid less attractive or rewarding. These products do not address the problem of oral overconsumption.9 Select a tab below for more information about methods and routes of prescription opioid abuse and the types of abuse-deterrent opioids.

Note that careful consideration should be given to the initial quantity of opioid medication prescribed. Patients receiving opioid therapy for the first time or being switched to a different opioid agent might require dose titration within the first 2 to 4 weeks. The follow-up interval should be considered when deciding on the initial quantity of medication. Be sure you are familiar with any state regulations concerning maximum quantities for opioid prescriptions; numerous states restrict these prescriptions to a 30-day supply.10

Abuse-deterrent formulations do not address oral overconsumption of prescription opioids, which is the most common form of prescription opioid abuse.9 There are limited data available to assess the impact of abuse-deterrent formulations on drug abuse, misuse, and diversion, and further studies are needed.7,11

As you do with any medication, consult the product labeling for the prescription opioid agent you have selected.

Select a tab below for more information about agent selection.

References

  1. Chou R, Fanciullo GJ, Fine PG, et al; American Pain Society–American Academy of Pain Medicine Opioids Guidelines Panel. Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain. J Pain. 2009;10(2):113-130. PMID: 19187889
  2. US Department of Veterans Affairs, US Department of Defense. VA/DoD Clinical Practice Guideline for Management of Opioid Therapy for Chronic Pain. Version 2.0. Washington, DC: US Dept of Veterans Affairs, US Dept of Defense; 2010. http://www.va.gov/PAINMANAGEMENT/docs/CPG_opioidtherapy_summary.pdf. Accessed May 20, 2014.
  3. Washington State Agency Medical Directors’ Group (AMDG). Interagency Guideline on Opioid Dosing for Chronic Non-cancer Pain: An Educational Aid to Improve Care and Safety With Opioid Therapy. 2010 Update. Olympia, WA: Washington State Agency Medical Directors Group; 2010. http://www.agencymeddirectors.wa.gov/Files/OpioidGdline.pdf. Accessed May 20, 2014.
  4. Manchikanti L, Abdi S, Atluri S, et al; American Society of Interventional Pain Physicians. American Society of Interventional Pain Physicians (ASIPP) guidelines for responsible opioid prescribing in chronic non-cancer pain: part 2—guidance. Pain Physician. 2012;15(3 suppl):S67-S116. PMID: 22786449
  5. Utah Department of Health. Utah Clinical Guidelines on Prescribing Opioids for Treatment of Pain. Salt Lake City, UT: Utah Dept of Health; 2009. http://www.dopl.utah.gov/licensing/forms/OpioidGuidlines.pdf. Accessed May 20, 2014.
  6. US Food and Drug Administration. ER/LA Opioid Analgesic Class Labeling Changes and Postmarket Requirements. Letter to ER/LA opioid application holders. http://www.fda.gov/downloads/Drugs/DrugSafety/InformationbyDrugClass/UCM367697.pdf. Accessed May 20, 2014.
  7. Passik SD. Issues in long-term opioid therapy: unmet needs, risks, and solutions. Mayo Clin Proc. 2009;84(7):593-601. PMID: 19567713
  8. Webster LR, Fine PG. Approaches to improve pain relief while minimizing opioid abuse liability. J Pain. 2010;11(7):602-611. PMID: 20444651
  9. US Food and Drug Administration. Guidance for Industry: Abuse-Deterrent Opioids—Evaluation and Labeling [draft guidance]. Silver Spring, MD: FDA; 2013.
  10. Medscape Web site. State-by-State Opioid Prescribing Policies. http://www.medscape.com/resource/opioid/opioid-policies. Accessed May 20, 2014.
  11. Stanos S. Continuing evolution of opioid use in primary care practice: implications of emerging technologies. Curr Med Res Opin. 2012;28(9):1505-1516. PMID: 22937723

Pharmacogenetics

The rapidly progressing field of pharmacogenetics promises to contribute to our understanding of the variation in patient response to mu-opioid analgesics. For example, patients who have low or high expression of enzymes that are essential to the metabolism of specific opioid agents may experience poor efficacy or exaggerated medication effects, respectively.1,2 Pharmacogenetics soon may be applied in clinical practice to better predict which opioid agent may be best for an individual patient. For now, careful titration of treatment to patient response is key.1

References

  1. Argoff CE. Clinical implications of opioid pharmacogenetics [review]. Clin J Pain. 2010;26(suppl 10):S16-S20. PMID: 20026961
  2. Vuilleumier PH, Stamer UM, Landau R. Pharmacogenomic considerations in opioid analgesia [review]. Pharmgenomics Pers Med. 2012;5:73-87. PMID: 23226064

Methods and Routes of Prescription Opioid Abuse

Universal Precautions, Step 2: Select Agent

Adapted from Katz N, Dart RC, Bailey E, Trudeau J, Osgood E, Paillard F. Tampering with prescription opioids: nature and extent of the problem, health consequences, and solutions. Am J Drug Alcohol Abuse. 2011;37(4):205-217. PMID: 21517709

When selecting an opioid agent, consideration should be given to the potential methods and routes of prescription opioid abuse.1 Although a variety of methods and routes of abuse are well-documented, oral ingestion of the intact drug form is the most common method of abuse overall.2 In one large-scale survey of patients entering addiction treatment programs, 72% of users of a common prescription opioid stated that they took the medication orally (vs by inhalation or injection).3

The most common methods of abuse may vary among specific opioid medications, however.4 Extended-release (ER) formulations of prescription opioids, because of their relatively high opioid content compared with immediate-release (IR) formulations, are prone to tampering for abuse by nonoral routes.1,5 Most abuse-deterrent opioids have been designed to make product manipulation more difficult.2

References

  1. Katz N, Dart RC, Bailey E, Trudeau J, Osgood E, Paillard F. Tampering with prescription opioids: nature and extent of the problem, health consequences, and solutions. Am J Drug Alcohol Abuse. 2011;37:205-217. PMID: 21517709
  2. US Food and Drug Administration. Guidance for Industry: Abuse-Deterrent Opioids—Evaluation and Labeling [draft guidance]. Silver Spring, MD: FDA; 2013.
  3. Carise D, Dugosh KL, McLellan AT, Camilleri A, Woody GE, Lynch KG. Prescription OxyContin abuse among patients entering addiction treatment. Am J Psychiatry. 2007;164(11):1750-1756.
  4. Butler SF, Black RA, Cassidy TA, Dailey TM, Budman SH. Abuse risks and routes of administration of different prescription opioid compounds and formulations. Harm Reduct J. 2011;8:29. PMID: 22011626
  5. Butler SF, Cassidy TA, Chilcoat H, et al. Abuse rates and routes of administration of reformulated extended-release oxycodone: initial findings from a sentinel surveillance sample of individuals assessed for substance abuse treatment. J Pain. 2013;14(4):351-358.

Categories of Abuse-deterrent Opioids

Universal Precautions, Step 2: Select Agent

Abuse-Deterrent Opioid Categories1

Category
 
Description
Physical/chemical barrierPrevent/deter manipulation and tampering
Agonist/antagonist combinationAntagonist can interfere with, reduce, or defeat euphoria associated with abuse
AversionSubstances can be combined to produce unpleasant effect if dosage manipulated or higher-than-directed dose used
Delivery systemDrug-release design or method of drug delivery (eg, depot injection) offers resistance to abuse
ProdrugLacks opioid activity until converted to active drug in GI tract
CombinationTwo or more of the above methods
Adapted from US Food and Drug Administration. Guidance for Industry: Abuse-Deterrent Opioids—Evaluation and Labeling [draft guidance]. Silver Spring, MD: FDA; 2013.

Abuse-deterrent opioids may be grouped into several distinct categories, based on the potential mechanism(s) by which they are designed to help to deter abuse.1-3 The categories shown here represent potential types of abuse-deterrent opioids.

Abuse-deterrent formulations do not address oral overconsumption of prescription opioids, which is the most common form of prescription opioid abuse.1 There are limited data available to assess the impact of abuse-deterrent formulations on drug abuse, misuse, and diversion, and further studies are needed.4,5

References

  1. US Food and Drug Administration. Guidance for Industry: Abuse-Deterrent Opioids—Evaluation and Labeling [draft guidance]. Silver Spring, MD: FDA; 2013.
  2. Romach MK, Schoedel KA, Sellers EM. Update on tamper-resistant drug formulations. Drug Alcohol Depend. 2013;130(1-3):13-23. PMID: 23415386
  3. Stanos SP, Bruckenthal P, Barkin RL. Strategies to reduce the tampering and subsequent abuse of long-acting opioids: potential risks and benefits of formulations with physical or pharmacologic deterrents to tampering. Mayo Clin Proc. 2012;87(7):683-694. PMID: 22766088
  4. Passik SD. Issues in long-term opioid therapy: unmet needs, risks, and solutions. Mayo Clin Proc. 2009;84(7):593-601. PMID: 19567713
  5. Stanos S. Continuing evolution of opioid use in primary care practice: implications of emerging technologies. Curr Med Res Opin. 2012;28(9):1505-1516. PMID: 22937723