As a result of a change in prescribing guidelines in the 1990s, the U.S. saw a dramatic increase in the long-term use of opioids for chronic non-cancer pain.  The prevailing view in the medical community at that time was that there was no clinically appropriate ceiling on maximum opioid dosing.  As a result, the long-term use of opioids increased significantly and today more Americans die from drug overdoses than from automobile accidents.
 

According to data from the Centers for Disease Control (CDC) and a report in the Journal of the American Medical Society in March 2017 “[o]ver the past 15 years, more than 165 000 people in the United States have died from overdoses related to prescription opioids, and millions more have suffered adverse consequences.”

Unlike prior drug mediated health problems, the opioid “epidemic” has liability risks at every stage of the distribution chain, from physicians, manufacturers, distributors, dispensers, payors, employers to the patients themselves.

Today, headlines report data detailing deaths, lawsuits filed, civil and criminal enforcement, and promises from the executive, legislative and administrative branches of government to address this “epidemic.”

Congress has allocated resources to this issue through legislation such as the 21st Century Cures Act and the Comprehensive Addiction and Research Act (CARA).  In addition, federal agencies, like the FDA and DEA have initiatives focused on reducing exposure.

The CDC recently released it guidelines for prescribing opioids, which provides recommendations addressing, among other things, initiation, dosage, and duration of opioid treatment for patients with chronic pain.  The federal government has also taken steps to promote and support prevention, education, treatment, and enforcement efforts related to reducing drug misuse, abuse, and addiction through federal legislation and funding initiatives. In late March 2017, the Trump administration announced the creation of a drug addiction task force led by New Jersey Governor Chris Christie that will work with state and local governments, law enforcement, medical professionals, and others to combat the drug addiction epidemic in America.

Recently, several states have implemented initiatives aimed at addressing opioid misuse and abuse within their respective borders, including imposing limits on the number of pills practitioners may prescribe to a patient, depending on the patient’s condition and treatment plan. In addition, some states allow a five- or seven- day prescription to treat acute pain, while patients with chronic pain may receive prescriptions for a longer period of time. Moreover, legislatures have re-examined laws relating to state prescription drug monitoring programs (PDMP), which track patients’ prescription history.

State laws and regulations impose various duties and responsibilities on practitioners to submit information to the PDMP when dispensing medication and/or verifying PDMP information prior to writing a prescription.  Some state laws now require insurers to cover treatment services for drug addiction or substance abuse.

States have taken the unprecedented step of permitting the dispensing of Naloxone, “a life-saving medication that can stop or reverse the effects of an opioid overdose” without a prescription.

State agencies have also adopted regulations relating to the prescription of opioids and other controlled substances.  For example, the Texas Medical Board’s pain management rules require a physician to:

• consider reviewing a patients’ PDMP data prior to writing a prescription,
• document a treatment plan in the patient medical records, and
• document certain expectations and patient responsibilities in a pain management agreement.

Texas also requires pain management clinics to register with the Texas Medical Board and comply with certain operational requirements. The Texas legislature is now considering a number of bills filed during this legislative session intended to curb the opioid epidemic in Texas.

Notwithstanding these efforts, civil and criminal enforcement and private litigation continue unabated. Physicians operating what the government terms “pill mills” are routinely sentenced, pharmacies filling alleged “fake prescriptions” are facing aggressive legal actions, distributors allegedly ignoring red flags are paying huge civil penalties, and manufacturers are facing an onslaught of tort claims and actions for alleged over-promotion and false claims.

Each step of the manufacturing and distribution chain needs a fresh look at policies and procedures to ensure that proper safeguards are in place and are being followed, and that warning signs are not being ignored.  Some of the most egregious cases have shown that sometimes the wrongdoer is the person responsible for overseeing compliance. For those companies that may risk liability when the fox is watching the hen house, an audit by a third party might be the best medicine.