Opioids, differentiation: dependence & addiction Recommend screening to differentiate between dependence and addiction with opioids. The screening instruments below have been developed or are in the development stages to aid in differentiation between drug dependence and addiction. See also Opioids, red flags for addiction; Opioids, screening for risk of addiction; Opioids, patients at high-risk for misuse; & Substance abuse (tolerance, dependence, addiction).
1) The Prescription Drug Use Questionnaire: (Compton, 1998) This is a tool still in development, and it has not been validated. Variables found to be positive for individuals with a substance disorder were the following: (a) Belief by the individual that he/she was addicted; (b) Drug seeking behaviors (having more than one provider, increasing analgesic dose or frequency, calling in for early refills, and obtaining analgesics from the ER); (c) Using analgesics to relieve symptoms other than pain (insomnia, anxiety, depression); (d) supplementing analgesics with alcohol or other psychoactive drugs; & (e) Having been terminated from care by a physician or dentist. The three variables that correctly classified > 90% of addicts were: (1) A tendency to consider oneself addicted; (2) A preference for the route of administration; & (3) A tendency to increase opioid dose.
2) Prescription opiate abuse in chronic pain patients (A NIH workshop summary): (Chabel, 1997) These criteria were developed to define prescription opiate abuse in patients using long-term opiates to treat chronic pain. Opiate abusers had at least three of the five of the following positive variables: (a) An overwhelming focus on opiate issues (persisting beyond the 3rd treatment session); (b) a pattern of early refills (3 or more) or escalating drug use in the absence of acute changes; (c) Multiple phone calls are made to the office for more opiates, early refills, or problems filling a previous prescription; (d) There is a pattern of prescription problems (lost medications, spilled medications, stolen medications); & (e) There is evidence of supplemental sources of opiates (multiple providers, emergency rooms, or illegal sources).
3) Chelminski multi-disciplinary pain management program criteria: (Chelminski, 2005) Criteria used to define serious substance misuse in a multi-disciplinary pain management program: (a) cocaine or amphetamines on urine toxicology screen (positive cannabinoid was not considered serious substance abuse); (b) procurement of opioids from more than one provider on a regular basis; (c) diversion of opioids; (d) urine toxicology screen negative for prescribed drugs on at least two occasions (an indicator of possible diversion); & (e) urine toxicology screen positive on at least two occasions for opioids not routinely prescribed.
4) The Pain Medication Questionnaire (PMQ): (Adams, 2004) This is a screening instrument that is in development.
5) Portenoy criteria: (Portenoy, 1997) A compiled list of “aberrant drug-related behaviors.” Those behaviors that were identified as “probably more predictive” included: (a) forging prescriptions; (b) Stealing or borrowing drugs from others; (c) Frequent loss of prescriptions; & (d) Revisiting change to pain treatment (especially in light of adverse side effects).
6) Michna - Predicting aberrant drug behavior based on abuse history: (Michna, 2004) Six aberrant behaviors identified: (a) multiple unsanctioned escalations in dose; (b) lost or stolen medication; (c) frequent visits to the pain center or emergency room; (d) family members expressed concern about the patient’s use of opioids; & (e) excessive numbers of calls to the clinic. Other predictive variables included: (a) family history of substance abuse; (b) past problems with drugs and alcohol; (c) history of legal problems; (d) higher required dose of opioids for pain; (e) dependence on cigarettes; (f) psychiatric treatment history; (g) multiple car accidents; & (h) reporting fewer adverse symptoms from opioids.
Opioids, indicators for addiction Recommend screening for indicators below. It is estimated that the prevalence of addictive disorders and/or serious substance misuse in patients with chronic pain may be as high as 30%. (Chelminski, 2005) The prevalence of current substance abuse disorders in patients with chronic back pain ranges from 3% to 43%, with a lifetime prevalence of 54% (but the author warns that these statistics are limited by poor study design and publication bias). (Martell-Annals, 2007) In studies of patients in methadone maintenance treatment as many as 44% of patients with chronic pain felt that the use of prescription opioids led to their problems with addiction. (Jamison, 2000) One particular problem is that in patients with substance abuse disorders and chronic pain the detrimental effects of drug use on lifestyle and psychosocial function may be ascribed to chronic pain instead of drug use, making the addiction disorder difficult to diagnose and treat. In addition, intermittent substance abuse withdrawal presents as and/or may cause hyperalgesia and facilitate pain. Another problem is that physicians are not well trained in diagnosing addiction or treating this condition. (Compton, 1998). (Savage, 2002) Clinical judgment by a physician trained in recognition of addiction is needed to determine if the patient actually has an addiction disorder. A history of an addiction disorder does not preclude a patient from being treated with opioids. (Savage, 1999) (Portenoy, 1996) See also Criteria for use of opioids; Opioids, screening for risk of addiction; Opioids, screening for dependence vs. addiction; Opioids, patients at high-risk for misuse; & Substance abuse (tolerance, dependence, addiction)
Indicators and predictors of possible misuse of controlled substances and/or addiction:
1) Adverse consequences: (a) Decreased functioning, (b) Observed intoxication, (c) Negative affective state
2) Impaired control over medication use: (a) Failure to bring in unused medications, (b) Dose escalation without approval of the prescribing doctor, (c) Requests for early prescription refills, (d) Reports of lost or stolen prescriptions, (e) Unscheduled clinic appointments in “distress”, (f) Frequent visits to the ED, (g) Family reports of overuse of intoxication
3) Craving and preoccupation: (a) Non-compliance with other treatment modalities, (b) Failure to keep appointments, (c) No interest in rehabilitation, only in symptom control, (d) No relief of pain or improved function with opioid therapy, (e) Overwhelming focus on opiate issues.
4) Adverse behavior: (a) Selling prescription drugs, (b) Forging prescriptions, (c) Stealing drugs, (d) Using prescription drugs is ways other than prescribed (such as injecting oral formulations), (e) Concurrent use of alcohol or other illicit drugs (as detected on urine screens), (f) Obtaining prescription drugs from non-medical sources
(Wisconsin, 2004) (Michna, 2004) (Chabal, 1997) (Portenoy, 1997)
Opioids, long-term assessment CRITERIA FOR USE OF OPIOIDS
Long-term Users of Opioids (6-months or more)
(a) Has the diagnosis changed?
(b) What other medications is the patient taking? Are they effective, producing side effects?
(c) What treatments have been attempted since the use of opioids? Have they been effective?
For how long?
(d) Document pain and functional improvement and compare to baseline. Satisfactory response to treatment may be indicated by the patient's decreased pain, increased level of function, or improved quality of life. Information from family members or other caregivers should be considered in determining the patient's response to treatment. Pain should be assessed at each visit, and functioning should be measured at 6-month intervals using a numerical scale or validated instrument.
(e) Document adverse effects: constipation, nausea, vomiting, headache, dyspepsia, pruritis, dizziness, fatigue, dry mouth, sweating, hyperalgesia, sexual dysfunction, and sedation.
(f) Does the patient appear to need a psychological consultation? Issues to examine would include motivation, attitude about pain/work, return-to-work, social life including interpersonal and work-related relationships.
(g) Is there indication for a screening instrument for abuse/addiction. See Substance Abuse Screening.
2) Strategy for maintenance
(a) Do not attempt to lower the dose if it is working
(b) Supplemental doses of break-through medication may be required for incidental pain, end-of dose pain, and pain that occurs with predictable situations. This can be determined by information that the patient provides from a pain diary or evaluation of additional need for supplemental medication.
(c) The standard increase in dose is 25 to 50% for mild pain and 50 to 100% for severe pain (Wisconsin)
3) Visit Frequency
(a) There is no set visit frequency. This should be adjusted to the patient’s need for evaluation of adverse effects, pain status, and appropriate use of medication, with recommended duration between visits from 1 to 6 months.
(Washington, 2002) (Colorado, 2002) (Ontario, 2000) (VA/DoD, 2003) (Maddox-AAPM/APS, 1997) (Wisconsin, 2004) (Warfield, 2004)
Opioids, pain treatment agreement Recommended. A written consent or pain agreement for chronic use is not required but may make it easier for the physician and surgeon to document patient education, the treatment plan, and the informed consent. Patient, guardian, and caregiver attitudes about medicines may influence the patient's use of medications for relief from pain. This type of written document should be obtained prior to initiating opioid therapy. It should be discussed with the patient and family. This plan should be signed and dated and placed in the patient’s chart, and include the following:(1) Goals of therapy, (2) Only one provider gives prescriptions, (3) Only one pharmacy dispenses prescriptions, (4) There will be a limit of number of medications, and dose of specific medications, (5) Medications are not to be altered without the prescribing doctor’s permission, (6) Heavy machinery and automobile driving is not to occur until drug-induced sedation/drowsiness has cleared, (7) Refills are limited, and will only occur at appointments, (8) Treatment compliance must occur for all other modalities enlisted, (9) Urine drug screens may be required, (10) The patient must acknowledge that they are aware of potential adverse effects of the use of opioids including addiction, (11) Information about opioid management can be shared with family members and other providers as necessary, (12) If opioid use is not effective, the option of discontinuing this therapy may occur, (13) The consequence of non-adherence to the treatment agreement is outlined. (VA/DoD, 2003) (Heit, 2007)
Opioids, patients at high-risk for misuse See Opioids, steps to avoid misuse/addiction.
Opioids, psychological intervention Recommended as an option to improve effectiveness of opioids for chronic pain. The following steps have been suggested to improve opioid treatment: (a) Provide ongoing education on both the benefits and limitations of opioid treatment. In particular, this should be based on the patient’s experience with medication treatment and behavior regarding controlled substances in general. (b) Emphasize non-opioid care including self-management techniques. These may include relaxation, mindfulness meditation, acceptance, and distraction. (c) Emphasize realistic goals. (d) Avoid increasing dosages of medications to “chase pain.” The result may ultimately be development of tolerance and/or hyperalgesia. (e) Encourage development of strategies for self-regulation of medication misuse. This may also include incorporation of a support group such as friends, family, an identified group (such as a 12-step group or group counseling), and/or individual counseling. (Naliboff, 2006)
Opioids, red flags for addiction See Opioids, indicators for addiction.
Opioids, screening for dependence vs. addiction See Opioids, differentiation: dependence & addiction.
Opioids, screening for risk of addiction (tests) Recommend screening for the risk of addiction prior to initiating opioid therapy. It is important to attempt to identify individuals who have the potential to develop aberrant drug use both prior to the prescribing of opioids and while actively undergoing this treatment. Most screening occurs after the claimant is already on opioids on a chronic basis, and consists of screens for aberrant behavior/misuse. Recommended screening instruments include the following:
1) The CAGE Questionnaire: (Brown, 1995) The most widely used screening tool prior to starting opioids is the CAGE questionnaire.
a) Have you ever felt the need to cut down on your drinking or drug use?
b) Have people annoyed you by criticizing your drinking or drug use?
c) Have you ever felt bad or guilty about your drinking or drug use?
d) Have you ever needed an eye opener the first thing in the morning to settle your nerves?
2) Cyr-Wartman Screen: (Cyr, 1988)
a) Have you ever had a problem with alcohol (or drugs)?
b) When was your last drink (or drugs)?
3) Skinner Trauma Screen (Skinner, 1984) Since your 18th birthday, have you
a) Had any fractures or dislocations to your bones or joints?
b) Been injured in a road traffic accident?
c) Injured your head?
d) Been injured in an assault or fight (excluding injuries from sports)?
e) Been injured after drinking?
4) The Screener and Opioid Assessment for Patients with Pain (SOAPP) (Akbik, 2006) A brief self-report measure to capture important information in order to identify which chronic pain patients may be at risk for problems with long-term opioid medications. The cutoff score has been found with a positive answer of 8 or higher. Five factors were identified on factor analysis labeled 1) history of substance abuse, 2) legal problems, 3) craving medication, 4) heavy smoking, and 5) mood swings.
It is important to note that being at risk does not necessarily indicate that a patient will develop an addiction disorder, or is addicted. A history of an addiction disorder does not preclude a patient from being treated with opioids. (Savage 1999) (Portenoy, 1996)
Opioids, state medical boards guidelines The Federation of State Medical Boards Model Guidelines for the Use of Controlled Substances for the Treatment of Pain say State medical boards recognize undertreatment of pain as a public health priority. Underprescribing pain medications is considered as much a breach of the appropriate standard of care as overprescribing. (Federation, 2004) See also individual state guidelines, for example the California Medical Board Guidelines for Prescribing Controlled Substances for Pain. (California, 1994)
Opioids, steps to avoid misuse/addiction The following are steps to avoid misuse of opioids, and in particular, for those at high risk of abuse:
a) Opioid therapy contracts. See Guidelines for Pain Treatment Agreement.
b) Limitation of prescribing and filling of prescriptions to one pharmacy.
c) Frequent random urine toxicology screens.
d) Frequent evaluation of clinical history, including questions about cravings for the former drug of abuse (a potential early sign of relapse).
e) Frequent review of medications (including electronic medical record evaluation when available and pill counts at each visit, brought in the original bottle from the pharmacy).
f) Communication with pharmacists.
g) Communication with previous providers and other current providers, with evidence of obtaining medical records. (It has been recommended that opioids should not be prescribed on a first visit until this step has been undertaken.)
h) Evidence of participation in a recovery program (12-step or follow-up with a substance abuse counselor), such as speaking to his/her sponsor for the 12-step program.
i) Establishment of goals of treatment that can be realistically achieved.
j) Initiation of appropriate non-opioid adjunct medications and exercise programs.
k) Utilize careful documentation, and in particular, that which is recommended in the State in which opioids are prescribed.
l) Incorporate family and friends for support and education.
(Chabel,1997) (Michna,2004) (Weaver,2002)
Opioids, weaning of medications See Weaning of medications.
Opioid hyperalgesia Recommend screening and treatment as indicated below.
Definition: Patients who receive opiate therapy sometimes develop unexpected changes in their response to opioids. This may include the development of abnormal pain (hyperalgesia), a change in pain pattern, or persistence in pain at higher levels than expected. These types of changes occur in spite of continued incremental dose increases of medication. Opioids in this case actually increase rather than decrease sensitivity to noxious stimuli. It is important therefore to note that a decrease in opioid efficacy should not always be treated by increasing the dose, but may actually require weaning. (Chang, 2007)
Diagnosis: How to diagnose:
(1) Attempt to determine if pain has increased over that, which was pre-existing (in the absence of apparent disease progression).
(2) Attempt to determine if the patient has previously responded to opioids but now has worsening pain.
(3) Attempt to determine if the patient has never had improved pain with opioids.
(4) If disease progression is ruled out, is there evidence of possible opioid tolerance or is this opioid hyperalgesia.
(5) Evaluate pain: In cases of opioid hyperalgesia pain may spread and become more diffuse and less well-defined in quality, beyond what would be expected from the preexisting pain state. This is generally not an acute but is an insidious process.
(6) Psychological issues such as secondary gain, exacerbation of underlying depression or anxiety, and the development of addictive disease should also be ruled out.
Treatment: Suggested treatment for patients with increasing pain (assumes that the patient has had improvement with opioids at some point):
(1) It is not unreasonable to give a trial of opioid dose escalation to see if pain and function improves. If pain improves, the diagnosis is probable tolerance. If pain does not improve or worsens, this may be evidence of opioid hyperalgesia and the opioid dose should be reduced or actually weaned.
(2) Opioid rotation is another option.
(3) Use of adjuvant pain medications is recommended when there is evidence of either tolerance or hyperalgesia.
(4) Further evaluation by a specialist with additional expertise in psychiatry, pain medicine, or addiction medicine should be considered when there is evidence of no improvement of pain with increasing doses of opioids.
Opioid pumps See Implantable drug-delivery systems (IDDSs).
Oxcarbazepine (Trileptal®) See Anti-epilepsy drugs (AEDs) for general guidelines, as well as specific Oxcarbazepine listing.
Oxycontin® (oxycodone) See Opioids
Pain management programs See Chronic pain programs.
Percutaneous electrical nerve stimulation (PENS) [DWC] Not recommended.
Percutaneous neuromodulation therapy (PNT) Not recommended. Percutaneous neuromodulation therapy (PNT) is considered investigational. Percutaneous neuromodulation therapy is a variant of PENS in which up to 10 fine filament electrodes are temporarily placed at specific anatomical landmarks in the back. Treatment regimens consist of 30-minute sessions, once or twice a week for eight to ten sessions. Percutaneous Neuromodulation Therapy™ (Vertis Neurosciences) received approval to market by the U.S. Food and Drug Administration (FDA) through the 510(k) process in 2002. The labeled indications reads as follows: "Percutaneous neuromodulation therapy (PNT) is indicated for the symptomatic relief and management of chronic or intractable pain and/or as an adjunct treatment in the management of post-surgical pain and post-trauma pain." (Condon, 2002) (BlueCross BlueShield, 2004)
Phentolamine infusion test Recommended as indicated below. An intravenous infusion of phentolamine, an alpha 2 blocker, results in generalized systemic sympatholysis. The infusion begins with intravenous saline for placebo control. For a positive response, pain relief should be 50 percent or greater and associated with functional improvement. This test aids in the diagnosis of SMP (Sympathetically maintained pain). (Colorado, 2002) See also Sympathetically maintained pain (SMP).
Phenytoin (Dilantin®) See Anti-epilepsy drugs (AEDs) for general guidelines, as well as specific Phenytoin listing.
Phototherapy See Low level laser therapy (LLLT).
Physical Medicine [ODG] Recommended as indicated below. Passive therapy (those treatment modalities that do not require energy expenditure on the part of the patient) can provide short term relief during the early phases of acute pain treatment and are directed at controlling symptoms such as pain, inflammation and swelling and to improve the rate of healing soft tissue injuries. They can be used sparingly with active therapies to help control swelling, pain and inflammation during the rehabilitation process. Active therapy is based on the philosophy that therapeutic exercise and/or activity are beneficial for restoring flexibility, strength, endurance, function, range of motion, and can alleviate discomfort. Active therapy requires an internal effort by the individual to complete a specific exercise or task. This form of therapy may require supervision from a therapist or medical provider such as verbal, visual and/or tactile instruction(s). Patients are instructed and expected to continue active therapies at home as an extension of the treatment process in order to maintain improvement levels. Home exercise can include exercise with or without mechanical assistance or resistance and functional activities with assistive devices. (Airaksinen, 2006) Patient-specific hand therapy is very important in reducing swelling, decreasing pain, and improving range of motion in CRPS. (Li, 2005)
Physical Medicine Guidelines –
Allow for fading of treatment frequency (from up to 3 visits per week to 1 or less), plus active self-directed home Physical Medicine.
Myalgia (muscle pain) or myositis (inflammation): 9-10 visits over 8 weeks
Reflex sympathetic dystrophy (CRPS-I): 26 visits over 16 weeks
Physical Therapy (PT) [DWC] See Physical Medicine [ODG]
Power mobility devices (PMDs) Not recommended if the functional mobility deficit can be sufficiently resolved by the prescription of a cane or walker, or the patient has sufficient upper extremity function to propel a manual wheelchair, or there is a caregiver who is available, willing, and able to provide assistance with a manual wheelchair. Early exercise, mobilization and independence should be encouraged at all steps of the injury recovery process, and if there is any mobility with canes or other assistive devices, a motorized scooter is not essential to care.
Pregabalin (Lyrica®) See Anti-epilepsy drugs (AEDs) for general guidelines, as well as specific Pregabalin listing.
See Ziconotide (Prialt®).
Prolotherapy Not recommended. Prolotherapy describes a procedure for strengthening lax ligaments by injecting proliferating agents/sclerosing solutions directly into torn or stretched ligaments or tendons or into a joint or adjacent structures to create scar tissue in an effort to stabilize a joint. Agents used with prolotherapy have included zinc sulfate, psyllium seed oil, combinations of dextrose, glycerine and phenol, or dextrose alone. "Proliferatives" act to promote tissue repair or growth by prompting release of growth factors, such as cytokines, or increasing the effectiveness of existing circulating growth factors. Prolotherapy has been investigated as a treatment of various etiologies of pain, including arthritis, degenerative disc disease, fibromyalgia, tendinitis, and plantar fasciitis. In all studies the effects of prolotherapy did not significantly exceed placebo effects. (BlueCross BlueShield, 2006)