When the Best of Intentions Leads to Bad Outcomes.

There is no question that the opioid use problem in America has reached unacceptable proportions. What is in question, however, is the best way to address this problem. Unfortunately, this is a multidimensional problem that will not be solved with a simple unidimensional solution. This commentary examines the multidimensional nature of this problem and the resultant guidelines that have been proposed to address it. There is a cautionary tale of the historical dangers of applying an "obvious" solution to a problem, only to find that more investigation and an iterative approach can actually lead to the correct solution. In particular, the authors question the wisdom of implementing guidelines that have no provisions for re-examination, to assess both intended as well as unintended consequences that might occur. This is the standard for good evidence-based guideline development and implementation. To do less, even under such dire circumstances as these, is to provide less than optimum medical care.

Reality and responsibility revisited: Stakeholder accountability in the effort to develop safer opioids.

This supplement is dedicated to an exploration of the science, potential utility, and the current state of abuse-deterrent formulations (ADF) of opioid analgesics. There are many stakeholders in the search for safer pain treatments in general, and safer opioid therapy in particular. Healthcare providers, patients, third-party payors, law enforcement and government regulators, the pharmaceutical industry, and the media all have a stake in seeing pain treated and addiction and overdose avoided. As it applies to ADFs, obviously not everyone has a stake in seeing that ADFs succeed commercially; but all stakeholders certainly have a responsibility to see that any potential advance, including ADFs, in protecting the public health is fairly and thoroughly evaluated. Particularly at a time of crisis. In this article, we revisit the framework used by Passik, Heit, and Kirsh (2006) to evaluate stakeholders' responsibilities with regard to both the opioid abuse and chronic pain epidemics. After evaluating the present status of aspirations delineated over a decade ago, we discuss the updated roles and responsibilities of each stakeholder, with emphasis on the role of ADFs as this technology was unavailable when the original manuscript was written.

Using urine drug testing to support healthy boundaries in clinical care.

Risk management is first and foremost about protecting patients. This article will examine risk management in general, and urine drug testing (UDT) in particular, as core constituents in an effective, comprehensive risk management strategy. The article will explore UDT as a tool to help practitioners and patients make better choices in the clinical management of chronic pain. How one makes these difficult clinical decisions based on UDT results as well common barriers encountered in conducting patient-centered UDT will also be examined.

Trends in drug use from urine drug testing of addiction treatment clients.

OBJECTIVE: Urine drug testing (UDT) can play an important role in the care of patients in recovery from addiction, and it has become necessary for providers and programs to utilize specific, accurate testing beyond what immunoassay (IA) provides. DESIGN: A database of addiction treatment and recovery programs was sampled to demonstrate national trends in drug abuse and to explore potential clinical implications of differing results due to the type of testing utilized. SETTING: Deidentified data was selected from a national laboratory testing company that had undergone liquid chromatography tandem mass spectrometry (LC-MS/MS). PATIENTS/PARTICIPANTS: A total of 4,299 samples were selected for study. INTERVENTIONS: Descriptive statistics of the trends are presented. RESULTS: In total, 48.5 percent (n = 2,082) of the samples were deemed in full agreement between the practice reports and the results of LC-MS/MS testing. The remaining 51.5 percent of samples fell into one of seven categories of unexpected results, with the most frequent being detection of an unreported prescription medication (n = 1,097). CONCLUSIONS: Results of UDT demonstrate that more than half of samples yield unexpected results from specimens collected in addiction treatment. When comparing results of IA and LC-MS/MS, it is important to consider the limits of IA in the detection of drug use by these patients.

Universal precautions revisited: managing the inherited pain patient.

"Universal Precautions in Pain Medicine: A Rational Approach to the Treatment of Chronic Pain" was published in 2005. In it, a unified 10-step approach to the assessment and management of patients suffering from chronic pain was proposed. As well, a triage scheme of risk stratification was offered. By placing patients into risk categories of low, medium, or high (Groups I, II, and III), it became possible to recommend to primary care practitioners those patients whom they might confidently manage on their own, comanage with specialty support, or refer to specialty clinics with more experience and resources to tackle these often challenging cases. It is important to note that Universal Precautions is not simply about opioid prescribing, although the use of opioids does highlight the value inherent in managing risk in all patients. Moreover, it should serve to remind health care professionals that the presence of significant psychiatric comorbidities, including substance-use disorders, may represent treatable conditions that must be addressed in order to optimize outcomes. Universal Precautions as a concept should be based upon mutual trust and respect between patient and practitioner, both of whom should be committed to setting and achieving realistic goals in both cancer and noncancer pain patients. The goal of this article is to explore the application of a Universal Precautions approach to manage the care of patients with chronic pain who no longer have an appropriate source of the medications upon which they have become physically dependent-so-called inherited pain patients.

Pain and addiction: managing risk through comprehensive care.

The use of controlled substances, including opioids, in people who may suffer from concurrent substance use disorders presents challenges to the healthcare professional. Pain and addiction can coexist either as a continuum or separate comorbid conditions. Success in the treatment of either condition requires an approach that encompasses the biopsychosocial needs of the patient. In pain management, controlled substances can be either the problem or the solution, depending on the healthcare professional's training and perspective. Not all patients on opioid pharmacotherapy do well. Some, with inadequate treatment responses, may actually improve on discontinuation of their opioids. Therefore, in any trial of pharmacotherapy, there must be a clear exit strategy as part of the treatment plan. The goal of this article is to explore the importance of making reasoned clinical decisions when faced with aberrant behavior, which is when the patient steps outside the boundaries of the agreed on treatment plan and is established as early as possible in the doctor-patient relationship. In this case, it is essential to separate the "motive" from the "problematic behavior" when trying to interpret the implications of aberrant behavior rather than simply applying a diagnostic label of addiction, which may or may not be correct.

Buprenorphine: new tricks with an old molecule for pain management.

Sublingual buphrenorphine is a unique opioid medication based on its pharmacokinetics and pharmacodynamic properties. It may be used "on label" as an alternative choice to methadone for the treatment of opioid addiction or "off-label" for the treatment of both acute and chronic pain. Because of high mu receptor affinity and resultant blockade, it has been suggested that this might interfere with the management of moderate to severe pain in patients on opioid agonist treatment. The following article will offer strategies and approaches to address some of these real and perceived challenges.

Evidence of morphine metabolism to hydromorphone in pain patients chronically treated with morphine.

Minor metabolic pathways in human subjects have been shown to exist for the conversion of codeine to hydrocodone but have not been reported for the metabolic conversion of morphine to hydromorphone. In this study, urine specimens were collected in an out-patient setting from 13 pain patients who were chronically treated with morphine and other opioids (methadone, oxycodone, and fentanyl). The chronic pain patients were chosen for study because they were treated with high-dose morphine and had no personal or family history of addiction. Results of the initial evaluation and follow up of these patients with random urine tests did not indicate opioid misuse. The specimens were analyzed by GC-MS for the presence of hydromorphone. The reporting limit for hydromorphone was 100 ng/mL. Ten of the 13 morphine-treated patients excreted hydromorphone in minor amounts ranging 120 to 1400 ng/mL. Concurrent morphine concentrations were exceedingly high in these 10 patients and frequently exceeded the upper limit of linearity (> 10,000 ng/mL) of the assay. The ratio of hydromorphone to morphine ranged from 0.015 to 0.024. Morphine concentrations in the three patients in which hydromorphone was not detected tended to be lower than those observed in other patients. For comparison, one additional patient was included in the study, who was prescribed both morphine and hydromorphone. Concentrations of hydromorphone in this patient were in the range of 3400-13,000 ng/mL, while concurrent morphine concentrations were in the range of 3200-6600 ng/mL. These data are highly suggestive that hydromorphone can be produced as a minor metabolite of morphine in humans. Although additional studies in more restricted settings are needed, it is recommended that interpretation of low urinary concentrations of hydromorphone in combination with high concentrations of morphine in morphine-treated pain patients should not be considered as conclusive evidence of hydromorphone misuse.

Universal precautions in pain medicine: a rational approach to the treatment of chronic pain.

The heightened interest in pain management is making the need for appropriate boundary setting within the clinician-patient relationship even more apparent. Unfortunately, it is impossible to determine before hand, with any degree of certainty, who will become problematic users of prescription medications. With this in mind, a parallel is drawn between the chronic pain management paradigm and our past experience with problems identifying the "at-risk" individuals from an infectious disease model. By recognizing the need to carefully assess all patients, in a biopsychosocial model, including past and present aberrant behaviors when they exist, and by applying careful and reasonably set limits in the clinician-patient relationship, it is possible to triage chronic pain patients into three categories according to risk. This article describes a "universal precautions" approach to the assessment and ongoing management of the chronic pain patient and offers a triage scheme for estimating risk that includes recommendations for management and referral. By taking a thorough and respectful approach to patient assessment and management within chronic pain treatment, stigma can be reduced, patient care improved, and overall risk contained.