Should We Blame Pharmacies or the Government for Opioid-Related Deaths?

Yesterday’s Cleveland federal jury found three pharmacy chains to have contributed to “public nuisance” caused by oversupply prescription opioids. This verdict is the first to hold retailers legally responsible for the opioid crisis. It follows two previous rulings that rejected similar claims by drug manufacturers in California and Oklahoma.

In these and thousands of other cases brought by local or state governments against legal drug providers for opioid-related death and addiction, the courts are asked to narrow down one chain in an extensive causal chain. The chain also includes actions of state and federal regulators.

In the Ohio case, Lake and Trumbull counties argued that the defendants—CVS, Walgreens, and Walmart—had ignored “red flags” indicating that some of the prescriptions they filled were medically inappropriate. They claimed that the defendants had only filled seemingly valid prescriptions for legal medication approved by licensed and regulated physicians. They also emphasized how important government agencies, such as FDA and Drug Enforcement Administration, played in overseeing distribution of prescription opioids. This made them complicit in what the plaintiffs claimed was a public nuisance.

The government also is responsible for the damage caused by its poor efforts. ReduitAs shown in a case involving Brent Slone (Kentucky), who died after seeing his pain medication suddenly cut, opioid prescriptions can be dangerous. CaSonya, his wife, filed a lawsuit against Commonwealth Pain and Spine. She claimed that the clinic denied her husband proper pain management. In August of last year, the Louisville jury awarded $7 million to her and their daughter. As STATAndrew Joseph, reporter on the case, gives an in-depth and insightful account. The government’s apparent counterproductive attempts to lower opioid-related death rates by restricting access to pain medications is clearly evident.

Joseph reports that Slone sustained injuries in 2011 from a car accident. He had a “broken pelvis”, a “compressed spinal cord” and was also left with chronic pain. In 2014, he was taking painkillers and had already sought help at Commonwealth Pain and Spine. After a series of operations, his daily dose of morphine was approximately 240 milligrams equivalents (MME). However, it eventually climbed to a maximum of 540 MME.

Joseph points out that Slone’s care “coincided” with efforts to correct opioid prescribing. In response to the rising number of opioid-related deaths regulators and legislators tried to stop all pain pill prescribing. Slone and other chronic pain sufferers were a target in the efforts to reduce opioid use.

The number of prescriptions for opioids per 100 Americans has fallen by 28% between 2010 and 2017. During the same period, the rate of high-dose opioid prescriptions—defined as 90 MME or more per day—fell by 56 percent. The Centers for Disease Control and Prevention, CDC published guidelines in 2016, which were widely misinterpreted by the CDC. They recommended doctors not exceed the 90-MME limit.

It would not be surprising that all of the opioid prescription reductions made by “campaigns for opioid prescribing reform” are medically justified, given the pressure doctors have put on them. Physicians were right to be concerned that their livelihoods and licenses would be at risk if they continued to prescribe opioids to patients despite the fact they have been using them for many years. Many complaints about the CDC guidelines revealed that doctors were not only ignoring patient welfare but also cutting back on medication.

While the benefits of long-term, high-dose opioid therapy are a contentious subject, Joseph notes, “experts and governmental guidelines agree that—with few exceptions—dose reductions need to go slowly, with patient buy-in.” Slone was not a case in point.

Slone began traveling to California as an advanced wound-care specialist in 2016, just one year after the CDC’s controversial warning. His wheelchair “caused pressure ulcers which led to bone infections” and he was unable “to stop himself from going back to work.” Slone was admitted to a La Jolla nursing home for several weeks in 2017. He had undergone a number of operations, including skin grafts. His daily opioid intake grew from 240 mg per day to over 400 mg, sometimes reaching as high as 540 mg. Slone was released with the prescription for the second level.

Slone’s August 2017 return to Kentucky saw a pain specialist who initially prescribed him a bridge prescription of 540MME/day. Slone was then suddenly given 240 mg of MME daily, a reduction of 56 percent at his next appointment. The reason for this is still unknown.

Joseph wrote that Slone was reduced because of the defense. Slone took 540 mg of MME to relieve acute pain after surgery. He was also closely monitored in hospital. This dose was not safe to be taken out into the wild. They simply moved him to his baseline for chronic pain and said he wouldn’t feel withdrawal as 240 mg of opioids was still providing enough.

By contrast, Hans Poppe, Richardson-Slone’s lawyer, “pointed to testimony indicating that a nurse inadvertently slashed Slone’s dose to his prior one—perhaps because she copied over information from his chart from months earlier—and that the doctors didn’t catch the error.” Poppe, Richardson-Slone’s lawyer, described the case as one of “patient abandonment” and the jury agreed.

It’s unclear whether Slone was deliberately or unintentionally reduced in dosage. This is contrary to recommendations that physicians who want to taper patients should start at a 10 percent reduction. Beth Darnall, who is a psychologist at Stanford Pain Relief Innovations Lab said, “This problem we see.” The rush is almost panic-like to lower doses as quickly as possible under the pretext of patient safety. However, the paradox is that patients are at greater risk from these fast changes.

Stefan Kertesz from the University of Alabama at Birmingham, an addiction and pain specialist, said that “it was a dose increase that people wouldn’t be expected to accept.” Slone was not able to tolerate the dose change and he committed suicide just weeks later.

Kertesz is currently researching suicides after abrupt tapering and helped to organize a 2019 correspondence from hundreds of experts concerned about the practice. In response, then–CDC Director Robert Redfield emphasized that the agency “does not endorse mandated or abrupt dose reduction or discontinuation, as these actions can result in patient harm.” Redfield stated that the CDC recommended clinicians work with patients to reduce or taper dosages. OnlyIf opioid therapy is deemed to be harmful for the patient, This report “recommends that patients be informed about their goals and concerns, and that withdrawal be managed slowly enough to prevent opioid withdrawal. For example, patients on high-dose opioids for over a decade, tapering should not exceed 10 percent per week.

FDA released a “safety alert” the following day. It stated that they had received “reports of serious harm to patients who are dependent on opioid pain medication suddenly having those medicines stopped or the dosage rapidly decreased.” The FDA warned of serious withdrawal symptoms and uncontrolled pain as well as psychological distress and suicide.

The CDC is currently revising their opioid prescribing guidelines. Deborah Dowell (co-author of the guidelines) stated that some policies and practices using the guideline were not consistent with the guidance. She spoke at the July meeting. Although the guideline doesn’t support abrupt tapering of sudden discontinuation, there are many stories of inappropriately citing it to justify a sudden stoppage of opioids.

Restrictions on pain medication do not just cause harm, but also pose a risk to the patients. The overall opioid prescribing rates had dropped by 48% since 2012, as of the end of 2013. The opioid-related death rate more than tripled during the same time. Illicit fentanyl was responsible for 83 percent.

“U.S. prescriptions for opioids The past decade has seen a decline in this number.,” Joseph notes, “even as the overdose crisis has reached record heights due to an explosion of illicit fentanyl.” This is not a coincidence. The crackdown on legal opioid production has led non-medical users to black market substitutes, which are much more dangerous due to their unpredictable potency.

This brings us to Walgreens and Walmart’s lawsuit. In order to make their case, they had to demonstrate that the public nuisance that they claimed was continuing. The county’s lawyers proved that patients became addicted to pills when supply stopped. The New York Times reports. According to lawyers, “That was an observable, direct result of the flooding of prescription opioid pills.”

The mistake of calling all opioid addicts “patients” is to assume that these people were given the drug and then became dependent on it. This happens less frequently than we think. However, the TimesYou are correct that the restriction of legal production of opioids has predictable fatal consequences.