Prescription Opioids: Risk Management and Strategies for Safe Use _ _________________________________ Patients with chronic pain who legitimately require ultra-high-dose opioids also require supplemental management considerations in addition to those applied to all patients with chronic pain prescribed opioids. Patients and their caregivers should receive education on recognizing overmedication and overdose and what to do if these occur, especially before tolerance has developed. Patients should be restricted from use of benzodiazepines, muscle relax- ants, sedatives, and any other potential respiratory depressant medication. While not used in most pain medicine settings, blood levels of opioids have value when a significant discrepancy is observed between prescribed dose and apparent drug effect; serum level results can suggest metabolic variation that impacts opioid dose-response. Serum opioid level testing in these patients can also establish baseline for compari- son against future tests. In the unfortunate event of patient death while receiving ultra-high-dose opioids, documenting high serum opioid level while the patient was ambulatory and functional can defend the prescriber against accusation of responsibility for the patient’s overdose death when coroner find- ings reveal high serum opioid levels in the absence of other explanatory findings [162]. the diversion of prescribed opioids, which the DEA initially achieved through the successful raiding and closure of many pill mills and rogue Internet pharmacies. The focus of the agency has now shifted to reducing opioid supply by targeting wholesalers and pharmacies within the legitimate supply chain. Many complaints have centered on DEA use of tac- tics identical to those use in combating illegal drug cartels, such as wiretaps, undercover operations, and informants. Retail and wholesale pharmacies raided by DEA tactical squads have complained of being treated as if they were armed criminal orga- nizations [164]. The DEA has accelerated the use of audits and inspections to identify and sanction drug wholesal- ers, levying millions of dollars in fines for what it has claimed were violations of the law. In 2012, the DEA suspended the license of drug wholesaler Car- dinal Health, Inc., prohibiting opioid analgesic sales from its central Florida center. The DEA rationale was failure to detect suspicious order volume from several of Cardinal Health’s pharmacy customers. Numerous Walgreens and CVS pharmacies and distribution centers were also raided [164].
The DEA has justified their tactics on the basis of Congressional pressure to contain opioid diversion, with agency success measured by disruption and destruction of organizations and networks feeding the problem. However, John Burke, president of the nonprofit National Association of Drug Diversion Investigators (NADDI), stated that DEA behavior reflects a mindset that retail and wholesale phar- macies comprise an enemy requiring containment. Concerns have been raised over the potential of DEA activity to adversely and negatively impact legitimate medical practice. This has led several congressional members to request that the Govern- ment Accountability Office investigate the effect of DEA conduct on medication shortages for patients with pain [164]. Actions of the DEA have produced widespread fear among prescribers and retail pharmacists regarding the prescribing or dispensing of opioids. In some localities, pharmacists greatly restrict dispensing opioids by refusing to fill prescriptions paid for in cash, from customers not well known to them,
Some complications are highly probable with ultra- high-dose opioid therapy that may not occur with lower doses. Endocrine suppression is likely to occur, with testosterone suppression possible in men and some women. Sudden suppression of adrenal corti- coids in an opioid-maintained patient manifests in nausea, weakness, and a drop in blood pressure. For these patients, hormone replacement is necessary if opioids remain essential for pain control. Movement and physical exercises are strongly recommended. Almost without exception, patients who require ultra-high opioid dosages have been too ill to engage in normal social or family functions and usually require resocialization counseling for guidance and motivation to resocialize and begin a new quality of life [162]. LAW ENFORCEMENT TACTICS Activities by the DEA to curb prescription opioid abuse and diversion have been identified in particu- lar as potentially excessive and inappropriate. The U.S. Congress has pressured the DEA to reduce
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