Ethical issues in opioid prescribing for chronic pain.

Medical ethics traditionally focused on ensuring that physiciansused their powers benevolently. Since cure was unusual, palliation,symptom control and relief of suffering were central to the physi-cian’sart. Notsurprisingly,given theiruniqueability to controlsuf-fering, opioids were indispensable, and a constituent of manyremedies. They were freely dispensed by pharmacists and physi-cians, their use being limited largely by the conscience of the indi-vidual, or by limited supplies.At the beginning of the 20th century, drug regulations wereintroduced into the United States and other industrialized nations.These regulations attempted to control the import, distributionand trade of narcotics, and placed the onus on physicians to controlmedical use of opioids. There was thus an immediate switch of themoral imperative from patient to physician, and in fact a chillingeffect on the provision of opioids for pain. The stigmatization andcriminalization of opioids produced by regulations continues tointerfere with the rational use of opioids for pain to this day.Paradoxically, other changes in medicine have shifted medicaldecision making away from physicians, into the hands of patients.Modern medicine has the capability not only to cure, but to create,extend or terminate life, with such profound implications contem-porary medical ethics have had to adapt. It is a philosophy of liber-alism that now guides medical ethics in free countries. Thephysician is no longer seen as all powerful, or the chief decisionmaker in an active–passive relationship, but instead enters a guid-ance–cooperation relationship whereby the patient is the chiefdecision maker, guided by the physician [28]. This has been for-malized in the concept of shared decision making in which all ofthe alternative treatments and outcomes are explained and patientpreferences for each are assessed [9]. The evidence supporting thecapability of a treatment to achieve patient chosen outcomes be-comes an important basis for the process of shared decisionmaking.Outcomes considered desirable to patients are often encapsu-lated in measures of health related quality of life (HRQoL). In addi-tion, direct measures of patient satisfaction can be used to assesspatient preferences. Patient satisfaction could, in fact, be consid-ered the only ‘‘true” outcome, and other outcomes merely ‘‘surro-gates” [17]. But what does patient satisfaction actually mean whenthe treatment is an addictive drug and how valid and reliable areour measures of patient satisfaction [25]? In pain studies, patientsatisfaction may be the only positive ﬁnding while measures suchas HRQoL, function, health care utilization and pain itself show noimprovement [6,12,13,31]. It seems that simply addressing pain,even if the treatment itself has only marginal beneﬁt, may improvepatient satisfaction [21,32].Patient satisfaction is a complex concept incorporating manydimensions including sociodemographic, cognitive (evaluative)and affective (emotional), in their turn inﬂuencing the expectationthat underpins satisfaction – satisfaction being the congruence be-tween expectation and accomplishment [17,27,29]. Patient satis-faction instruments have many limitations, including lack ofpsychometric standards, the poor reliability and validity of sur-veys, and discriminatory assessment [5]. Many patient satisfactionsurveys also lack discriminatory value. Thus pain treatment maycontribute to global satisfaction with medical care, while closeranalysismayrevealsatisfactionwith pain treatmentis actuallylessthan with other aspects of care such as interpersonal interaction[23,33]. Health care organizations frequently utilize patient satis-faction ratings as an integral part of marketing and benchmarkingof services [1]. This can be problematic when it comes to opioidpain treatment: clinicians may feel threatened into prescribing inorder to meet the satisfaction metrics by which they and theirpractices are judged. Here the moral issue is whether prescribingopioids to drive up patient satisfaction metrics is justiﬁed.In the United States, unlike Europe, 20th century regulationsmade it illegal to prescribe opioids for addiction. Clinicians riskedcensure (or loss of medical license) if they prescribed opioids (forpain, but unwittingly for addiction), and patient fears of addictionwere exacerbated because addiction had been criminalized. Painwas then undertreated, and it took years of lobbying and politicalactivism, culminating in the enactment of ‘‘intractable pain” stat-utes, to restore opioid treatment for intractable pain (includingintractable chronic pain) [3,14,18]. Pain advocacy in the UnitedStates extended its reach even further when advocates succeededin persuading The Joint Commission (TJC, formerly known as JCA-HO) to include pain management as a quality metric for healthcarefacilities [11]. Although it was never the intention of the mandateto force opioid treatment of pain, the fact that opioids are some-times the only option for treating severe pain meant that in prac-tice, the mandate did increase opioid prescribing, sometimeswith unintended consequences [30].Given this history, and the hard fought campaign to establishthe right of patients to receive opioids for the treatment of pain