In recent years, the opioid epidemic has been bifurcated into two categories: (i) recreational users of illicit drugs and the dealers who supply them; and (ii) individuals whose addictions started with a valid prescription from a professional licensee. The recent announcement by President Trump of stricter penalties for drug crimes (including a renewed endorsement of capital punishment for traffickers) may have ostensibly shifted the public rhetoric surrounding the opioid crisis toward the illicit drug trade, but in fact, enforcement efforts (including civil and criminal litigation and disciplinary Board actions) will continue to be focused in the health care space. In recent multidistrict litigation (MDL), municipalities, states and the federal government have identified multiple categories of culpability along the supply-chain continuum, including allegations that:
- Manufacturers were complicit in fueling opioid abuse and addiction by overstating the drugs’ benefits and downplaying their risks
- Wholesalers and distributors failed to fulfill their obligations under the Controlled Substances Act to report and stop suspicious orders (i.e., unusually large or frequent shipments of opioids)
- Prescribers engaged in negligent prescribing practices, such as failing to query their state’s prescription monitoring program database or abide by regulations concerning initial prescription dosage limits
- Pharmacists failed to identify inappropriate prescribing practices or offer the overdose antidote Naloxone to a vulnerable patient
The new plan announced by President Trump includes: (i) reducing demand and improper prescribing, with the objective of reducing opioid prescriptions by one-third within three years and ensuring that 95% of government-reimbursed opioid prescriptions comply with prescribing best practices within five years; (ii) an aggressive advertising campaign and website (www.crisisnextdoor.gov) aimed at educating the American public about the perils of opioid abuse; and (iii) assistance for people struggling with addiction (i.e., greater access to the overdose antidote naloxone and treatment program alternatives to incarceration). While opioid manufacturers, wholesalers and distributors will remain litigation and enforcement targets, physicians and pharmacists will continue to be viewed as the final gatekeepers between patients and potentially dangerous opioid prescriptions.
In an enforcement environment where liability is shared along the supply-chain continuum, the best way for participants to protect themselves is to adopt and implement a robust opioid compliance plan. For more information, contact Frier Levitt to speak to an attorney.