Governmental and regulatory bodies are leveraging multiple initiatives to end the deadliest drug overdose epidemic in modern history. These entities, which have already implemented tighter regulations and more punitive legal actions on both the prescription and illicit sale of opioids, are poised to play an even larger role in America's evolving response to this crisis.
"No other American drug crisis has looked like what we've seen over the last two years," says Alex J. Keoskey, a partner with the New Jersey law firm DeCotiis, Fitzpatrick, Cole & Giblin. "For that reason, I think [regulatory entities] are dealing with it in a way that smacks of desperation, because they really don't know where the bottom is going to be."
Mr. Keoskey regularly handles litigation involving state licensing boards, federal agencies like the FDA and the Drug Enforcement Administration, as well as medical malpractice actions. He spoke with Becker's Hospital Review about how hospitals and health systems can ensure compliance with stricter opioid regulations and, ultimately, do what they can to address the crisis.
Here are three actions hospitals can take to protect against opioid-related legal ramifications.
1. Educate providers and patients
Provider education regarding safe opioid prescribing and current regulatory restrictions should be a top priority for hospitals to reduce opioid-related adverse events and the over-prescription of opioids. Compliance programs designed to increase the security of controlled substances in the facility and to bring prescribers in line with state and federal opioid rules is essential, according to Mr. Keoskey. Opioid regulations include prescribing limits, which have been implemented by a number of states, and rules regarding fiduciary relationships between physicians and drug companies.
Mr. Keoskey says compliance programs should not be limited to educating the provider. Hospitals should also prioritize patient education on safe opioid use and disposal to limit diversion and misuse outside of the healthcare setting.
"Diversion happens two ways," Mr. Keoskey says. "One is within the hospital when employees surreptitiously take the medications. The other way is when patients are legitimately prescribed the medication and its diverted by a family member or another individual due to the lack of security around the medication once it leaves the hospital."
2. Embrace alternative pain therapies
Solving the opioid crisis must involve significant reductions in the number of opioids prescribed. This task poses a challenge for hospitals as these organizations have become dependent on the medications to address patient pain. Reducing reliance on opioids for pain management means hospitals have the added responsibility of finding alternative therapies to treat patient pain.
"Once an individual gets a prescription for opioids, it tends to be all they want," Mr. Keoskey says. "The challenge is finding a way to deal with pain through either orthopedic means, or even alternative means such as acupuncture or chiropractic treatment. Providers need to find alternatives to alleviate pain other than just an opioid prescription. That's the mistake they've been making, and that's the mistake they need to turn around."
Relying on more alternative pain therapies can reduce the need for opioids and ultimately limit diversion opportunities and opioid-related adverse events.
3. Ensure compliance
Healthcare leaders should go the extra mile to ensure opioid compliance measures are not simply on the books, but thoroughly enacted and maintained. While many hospital leaders think their organizations are up-to-date on the latest opioid rules, it's easy to fall behind amid the rapid rate of new recommendations produced by medical societies and regulatory bodies, according to Mr. Keoskey.
"Having something in writing is not good enough," he says. "There has to be education, there has to be audits, there has to be discipline. That's the key."
Typical ongoing provider education efforts are almost exclusively geared toward improving care quality. Mr. Keoskey believes hospitals should consider tailoring some of these efforts to address legal and regulatory issues, especially those involving opioids.
"I think they need to get more lawyers in there, either private attorneys or state attorneys who can go in there and say, 'hey this is something they're looking at, these are some of the things that have come up, and the people that have gotten in trouble don't let it happen to you," Mr. Keoskey says, adding that hospital leaders should assess the current regulatory environment and institute policies and initiatives to protect providers from incurring penalties.
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