__________________________________ Prescription Opioids: Risk Management and Strategies for Safe Use of prescription filing and dispensing. Mandates cited as especially harmful were patient-prescriber opioid contracts required to specify a single phar- macy, a 30-day maximum supply of opioids and no refills, and prohibition of faxing or phoning opioid prescriptions to a pharmacy. Also mentioned was the increasing rate of pharmacy refusal to dispense opioids, the result of greater pressures imposed by the DEA on pharmacy networks to obtain additional patient information to verify legitimacy. These pharmacy networks, in turn, have transferred this burden to individual pharmacists, who, similar to prescribers, have become fearful of attracting DEA scrutiny over opioid prescription dispensing. The end result has been difficulty finding a pharmacy to fill opioid prescriptions [158]. PATIENTS WHO REQUIRE ULTRA-HIGH-DOSE OPIOIDS
An element of the backlash against escalating opi- oid prescribing and associated problems has been intense lobbying by some pain professionals to impose pre-established dose ceiling on opioid pre- scribing, such that a maximum daily dosage cannot be exceeded. Prominent among these groups has been Physicians for Responsible Opioid Prescrib- ing (PROP) and the advocacy group Public Citizen. The imposition of a 100-mg MED maximum daily ceiling and a maximum prescribing duration of 90 consecutive days was requested for noncancer pain. The groups cited observational study findings of a correlational relationship between prescribed opioid dose and overdose risk as evidence, but these recom- mendations were rejected by the FDA [160]. Despite FDA rejection of a mandate for daily dose ceilings, many practitioners believe that high-dose prescribing is irresponsible and without medical legitimacy. This view was disseminated and seem- ingly legitimized by the 2009 opioid prescribing guidelines published by the APS and the AAPM, which stated that no existing evidence supports daily opioid doses ≥200 mg MED [115]. The valid- ity of these assertions has been undermined by several findings of differences between patients in the opioid dose necessary to achieve sufficient pain control, which can vary 40-fold for the same clini- cal condition [161]. While ultra-high-dose opioid prescribing remains controversial, a small subset of patients do require massive doses of opioids for chronic pain. Authors and guidelines statements of the contrary are based on opinion without empirical support [162]. Patients with chronic pain who require ultra-high- dose opioids, in some cases more than 2,000 mg/ day MED, are likely to be labeled as addicts or abus- ers by healthcare professionals and family members alike. In general, these patients are profoundly ill, impaired, and/or bed- or house-bound due to severe unremitting pain refractory to analgesic efforts using lower-dose opioids. The reason some patients require ultra-high opioid doses remains unclear, but it is very likely that some, and perhaps the majority, possess a cytochrome P450 polymorphism or other genetic abnormality [163].
Similar concerns over negative unintended patient impact were communicated by Amy Abernethy, president of the American Academy of Hospice and Palliative Medicine (AAHPM) to the National Con- ference of Insurance Legislators (NCOIL). NCOIL is an organization of state legislators involved in insur- ance legislation and regulation, and her response concerned several recommendations in a proposed set of best practices guidelines to reduce opioid abuse that were released by NCOIL in 2013. Strate- gies included in the NCOIL draft were those already implemented at the state level that led to measurable reductions in abuse and overdose. Abernethy coun- tered by arguing that the narrow measure of success came at the expense of patients and providers [159]. With a shortage of pain medicine specialists in the United States, most chronic pain care is provided at the primary care level, and in some states (e.g., Wash- ington), many primary care practices display signs in offices stating they no longer prescribe opioids. Interestingly, a small number of primary care physi- cians have chosen to transform their practices into cash-only entities and charge very high fees for what amounts to the sole prescribing of opioid analgesics. Patients requiring opioids to maintain pain control and quality of life are forced to seek treatment from these physicians because many others have become intimidated by the new legislation [5].
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MDMS1526
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