46 I AnesthesiologyNews.com
SEPTEMBER 2014
COMMENTARY
When Prosecution Replaces Prescription BBy Lynn Webster, MD
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hances are that most of us know someone with disabling chronic pain. Spottting these people is not very easy. If sshe is in pain, for instance, you can bbet she won’t share it with anyone. The stigma associated with chronic T pain i often f produces d a sense of shame and, therefore, desire for concealment. Imagine this same scenario but on a national scale, with the only difference being that instead of some people withholding problems, society is withholding the solutions. Such is the plight of Americans who suffer from some type of chronic, persistent pain—a group of people that the Institute of Medicine estimates to number more than 100 million. Many of these people find relief with nonopioid treatment, but there are countless others whose pain is so severe that opioid therapy is the only option that provides enough relief for them to live functional lives. Because of this, it is critical for opioids to remain an available option to those who suffer agonizing pain. It also means that we must take the necessary steps to ensure that these medications are not abused or inappropriately prescribed. Today, in the U.S., prescription drug abuse and opioid-relatedd deaths are a full-fledgedd epidemic. Drug overdoses have tripled since 1990, and prescription drugs are a driving factor. More than 12 million people reported using prescription painkillers (i.e., opioids) without consent of a prescribing physician in 2010, and opioid-relatedd ER visits have skyrocketed. To combat these tragic realities, the federal government has moved aggressively to regulate, restrict and
OFF-PUMP...
monitor the use of painkillers. Even so, the prescription drug abuse and overdose epidemic persists. Now, in the face of increasing pressure to do more, we’ve turned to a new tactic: the prosecution of doctors who treat patients using painkillers. Quite recently, a pain physician in Des Moines, Iowa, was accused of involuntary manslaughter and nine counts of criminal wrongdoing. The physician, Daniel Baldi, DO, thankfully, was cleared of any wrongdoing by the judge and jury. Far from proving the prosecution’s assertion that reckless prescribing led inevitably to the deaths, testimony revealed that the decedents died from a variety of causes, including deteriorating medical conditions, the use of medications not prescribed by Dr. Baldi and the abuse of illicit substances. Tragically, Dr. Baldi is professionally scarred and financially ruined, and the legal system offers no recourse for this gross prosecutorial overreach. When a physician stands trial for criminal charges for essentially practicing medicine, patients pay the ultimate price, through inevitable abandonment by the medical establishment. Fearing reprisals, practitioners reduce their willingness to prescribe strong medications, even when they are critical to recovery and administered in a safe manner. In short, patients are denied the care that they need. Oftentimes, these patients resort to a hopeless and dehumanizing search for medical professionals who are willing to help them. They find themselves set adrift in a health care system that does not reimburse appropriately for safer alternatives and evidence-based therapies. In desperation, patients turn to clinicians whose medical training lacks even the most basic instruction on managing pain. Former colleagues and I also have dealt personally with the tragedy of patients who died, not as a
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show the advantage of offf pump cardiac surgery on mortality and morbidity,” he said. “But according to our research, reducing mild persistent pain could be an advantage of offf pump surgery.” Daniel T. Bainbridge, MD, lauded the researchers for tackling an important topic, but refrained from drawing firm conclusions with so few participants. “I’m actually surprised the investigators found much difference at all, since they had only 21 patients. You also have to be careful of potential confounding factors because of the small numbers as well as selection bias for patients who underwent offf or on-pump surgery. So the decreased pain may be due to reduced inflammation, but it also might be due to the surgical approach or even the patients. And with 21 people in the study, it’s fairly difficult to tease out.” Compounding the issue is the fact that few studies on CABG patients have used pain as a primary end point. “This makes it difficult to corroborate the current findings with other studies,” said Dr. Bainbridge, associate professor of anesthesia at The University of Western Ontario in London, Ontario, Canada. “Most of these studies have been done by surgeons who are interested in issues like stroke, [myocardial infarction], transfusion. And one of the problems we run into as anesthesiologists is that if the only difference between offf pump and on-pump surgery is pain at one month, they’d never switch for that reason. When a surgeon thinks of outcomes after CABG, pain is at the bottom of the outcome list.” Dr. Minami reported his findings at the 2013 annual meeting of the American Society of Anesthesiologists (abstract A2152). —Michael Vlessides
result of treatment but in spite of it, at a pain clinic in Salt Lake City. We all felt great torment throughout our practice when forced to choose between treating patients in excruciating pain and becoming a target for prosecution, especially in treatment plans involving opioids. That dilemma is only worsened when one realizes how close the link is between chronic pain and suicide. The scientific literature tells us that patients with chronic pain are two to three times more likely to take their own lives. Opioid medications are not the only therapy, nor are they always the best therapy for patients in varying degrees of pain. They clearly bring risk and should be reserved for a subset of the patient population who truly need them. Then—and only then—should opioids be prescribed by clinicians with the training and competence to assess and monitor patients in accordance with accepted medical guidelines. Moreover, each and every patient with chronic pain should have access to a minimum level of insurance benefits, and for some patients with certain pain conditions, that may include opioids. Over the long term, while we work toward finding better, nonopioid therapies, we need to change our attitudes about chronic pain in America. More people than we realize live with chronic pain every day. When I practiced medicine, I heard the cry for help from patients too often, many of whom just wanted someone to believe that their pain was real. Hopefully, society soon will start to believe that we need a better way before the chronic pain and drug overdose epidemic claims one more life. Dr. Webster is the immediate past president of the American Academy of Pain Medicine.
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way for us to go,” Mr. Churchilll said. The hospital also hired a microbiologist to work in the pharmacy department to coordinate all IV compounding quality assessment, including end-product testing, staff testing and facility testing. “Only after they pass muster with my microbiologist do they move into circulation for patients,” Mr. Churchill explained. BWH also invested in upgrading onsite cleanroom facilities. Once a new negative-pressure cleanroom is completed, the existing main cleanroom will be upgraded and renovated to further increase capacity. BWH also has purchased four IV compounding robots, with a fifth one dedicated to oncology.
Centralized Compounding? The pharmacy now produces about 70% of the CSPs used at the hospital—up from about 40% two years ago. Going forward, Partners HealthCare, the umbrella system for both BWH and MGH, is contemplating the feasibility of a centralized compounding facility to supply all 13 of its hospitals. In the interim, the steps taken have been challenging and progress gradual. “It’s an ongoing process where you take things in bite sizes that you feel comfortable with,” Mr. Churchill said. “To make the change, operationalize that change, go back and re-evaluate it, then continue to evolve your process with the next change until you finally get it where you want it, takes time and patience. The process simply cannot be rushed.” —Steve Frandzel