Shouldn’t there be a law against reckless opioid sales? Turns out, there is
The massive scale of prescription opioid shipments as the ongoing overdose epidemic unfolded has started to come into focus.
Drug companies shipped 76 billion opioid pain pills to U.S. health care professionals, hospitals and pharmacies between 2006 and 2012, according to data The Washington Post and the Charleston Gazette-Mail’s owner acquired by suing the government.
Hundreds of pills per person were delivered to rural areas like Wise County, Kentucky, and the town of Norton, Virginia. Meanwhile, the number of fatal overdoses involving all kinds of prescription opioids soared across all of Appalachia and other hotspots as the national death toll climbed from 3,442 in 1999 to 17,029 in 2017.
In addition, a federal court in Cleveland has released scores of previously sealed documents. The corporate memos and legal depositions suggest that drug company executives, pharmacists and others involved at every level of the prescription opioid trade failed to heed troubling signs that the industry was facilitating drug abuse.
As a health law professor who studies the relationship between the U.S. health care system and opioid overdoses, I have researched the epidemic’s causes. In particular, I have researched the likely liability of drugmakers and pharmaceutical distributors in the multiple pending and resolved federal and state lawsuits filed against all of the industry’s key players.
One thing that I’ve often wondered about is why no law on the books could slow what now appears to have been the reckless oversupply of opioids by companies in the health care business.
A duty to report
Well, there is, as it turns out.
The Controlled Substances Act creates what experts call a “closed system.” That is, the federal government has designed a way to track every controlled substance – medications with the potential for abuse or dependence, including opioids – from factory to pharmacy counter and hospital bed. Manufacturers, distribution companies, health care professionals, pharmacies, hospitals and others who buy, sell and dispense these drugs must be registered with the Drug Enforcement Agency.
The roughly 1.73 million people and companies registered with the DEA must maintain precise records and report their interactions with all controlled substances.
The Controlled Substances Act categorizes drugs into different “schedules” that determine the degree of regulatory oversight and the responsibilities required of anyone handling them. The government has designated opioids such as Oxycodone and hydrocodone as “Schedule II” drugs, the most dangerous category that can be prescribed.
Manufacturers and distributors of Schedule II drugs must file reports about the opioids that pass though their hands using the government’s Automated Reports and Consolidated Orders System, or ARCOS. These reports generate data that track the numbers of drugs shipped or sold and their destinations, at county and pharmacy levels.
A DEA rule issued back in 1971 also requires all registrants to design systems for reporting “suspicious orders” – meaning, among other things, purchases and deliveries that are unusually big or frequent.