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11 Articles in Volume 14, Issue #5
DEA and Doctors Working Together
Working With Law Enforcement and DEA
Demystifying CRPS: What Clinicians Need to Know
Glial Cell Activation and Neuroinflammation: How They Cause Centralized Pain
History of Pain: The Treatment of Pain
Spirituality Assessments and Interventions In Pain Medicine
The Stanford Opioid Management Model
We Need More “Tolerance” in Medical Pain Management
Treating Rebound or Chronic Daily Headaches
Buprenorphine With Naloxone for Chronic Pain
More on Nitrous Oxide and Meperidine in Pain Care

DEA and Doctors Working Together

Share the Risk model is an example of successful collaboration among interdisciplinary teams of clinicians and law enforcement to mitigate professional risks while improving patient care.

In 2002, we developed the Share the Risk model as an interdisciplinary approach to the most challenging patients in medicine—patients with chronic pain.1 The fundamental premise of the Share the Risk model is that no clinician, no matter how well educated, competent, compassionate, committed, or meticulous, can adequately meet all the needs of patients with chronic and intractable pain. Instead, the Share the Risk model calls for a multidisciplinary team approach for optimal pain management.

Started in San Diego, the Share the Risk model is a work in progress. The goal is to bring together the various resources in the community—clinicians, as well as representatives from biotech/pharmaceutical industry and the Drug Enforcement Agency (DEA)—to address the many groups affected by pain and pain management. On a national level, the model was the catalyst for the development of an educational program called Emerging Solutions in Pain (ESP).2 ESP’s mission is to “address some of today’s most critical issues in pain management.” According to the ESP Website, “These issues involve balancing fundamental rights of patients and clinicians with the challenge of risk containment for opioid misuse, abuse, and addiction associated with medical prescribing and use of controlled substances.” Like ESP, the Share the Risk model helps pain management healthcare professionals overcome these challenges by providing practical tools, resources, and courses to help navigate these issues.

Although these goals have not changed, the political atmosphere in which we practice has. This has led the authors to try and work together with the DEA in Southern California. In the past several years, the authors have held several meetings to educate health professionals about Share the Risk mission. These meetings, attended by between 50 and 65 healthcare professionals, have been the most passionate and emotional meetings that any of the coauthors have ever observed. We are not aware of other DEA field divisions with the same level of interaction with healthcare professionals. This article summarizes some of the problems clinicians who treat chronic pain patients face and offers strategies to help address these problems.

Shift in Perceptions About Opioids

There have been multiple newspaper articles and television programs questioning the use of opioids for pain management over the past several years. Perhaps the most noted among pain specialists was the front cover article in The Wall Street Journal in December, 2012, that featured an interview with Russell Portenoy, MD, one of the leading proponents of improving pain management (and access to opioids) in noncancer patients.3 Acknowledging in the interview that standards and recommendations regarding opioids have changed, Dr. Portenoy said: “Did I teach about pain management, specifically about opioid therapy, in a way that reflects misinformation? Well, against the standards of 2012, I guess I did.” He added, “We didn’t know then what we know now.”

Dr. Portenoy noted that long-term clinical studies about the effectiveness of opioids do not exist. “Do they work for 5 years, 10 years, 20 years? We’re at the level of anecdote,” he said.

Even with these doubts, Dr. Portenoy still credits opioids with providing pain relief and benefit in carefully selected patients, including his own mother who has taken hydrocodone to control arthritis for 17 years. “If you insist on regulation, then you’re consigning my mother and many millions of people like my mother to live in chronic pain,” he noted. But there is little research to show whether patients who embark on long-term opioid therapy will ever be able to stop.

Misuse and Abuse of Opioids

Abuse and misuse of prescription opioids has become a public health crisis. Prescription drug overdose as a cause of death has tripled since 1990, and has surpassed motor vehicle accidents. In 2010, overdose deaths from prescription opioids (16,651) far exceeded those from heroin and cocaine combined.4 Overdose and death risks increase significantly with higher doses of opioids.

There have been multiple articles over the past few years about physicians across the country who have been investigated because of opioid overdoses occurring among their patients. The Los Angeles Times reported that there are physicians in Southern California who have had 14 or more patients die due to opioid overdoses.5 But perhaps the most disturbing report has been the investigation of Lynn Webster, MD, the Immediate-Past President of the American Academy of Pain Medicine.6 Dr. Webster serves as a leading expert in the safe use of opioid pain medications. He created the Opioid Risk Tool (ORT), an assessment tool to identify patients who are most likely to abuse opioids.7 Presently, he is under investigation by the DEA, which raided his Utah Clinic in 2010. Dr. Webster and associates treated thousands of patients and approximately 20 patients died of polypharmacy overdoses. Dr. Webster remains a highly respected expert in pain management, and has received broad support from the pain management community.

Catch 22

These high profile articles raise questions in the minds of patients, clinicians, regulators, and law enforcement about the safety of opioid pain medications. Conversely, the media explosion has had a powerful, negative effect on the pain management community. Clinicians wonder, ‘If I prescribe opioids, will I become a target of the DEA?’ Out of fear of being targeted, many pain management physicians, family practice doctors, and other clinicians are refusing to take care of people in pain or are simply refusing to prescribe opioids. The unwillingness to treat these patients is simultaneously occurring at a time when the Affordable Care Act is attempting to provide greater coverage and access to healthcare to all Americans. In the end, more and more patients suffer—and that number is only expected to grow. With the aging population, 1 out of 2 people over 50 years of age are expected to suffer with chronic pain.

There are several views of this difficult situation. Healthcare professionals who treat pain patients and prescribe medications fear the DEA will make them a target. On the other side, the DEA enforcement strategists are trying to strike the proper balance between access to opioids for legitimate patients and preventing drug abuse and diversion.

Federal health agencies have taken on this cause as well. In June 2011, The Institute of Medicine (IOM) issued a “Blueprint for Relieving Pain” in America.8 The IOM rightfully pointed out that chronic pain was underdiagnosed and undertreated and cost the nation up to $635 billion each year in medical treatment and lost productivity. They encouraged “federal and state agencies and private organizations to accelerate the collection of data on pain incidence, prevalence, and treatments.”8 Following this call to action, in January 2012 the Centers for Disease Control and Prevention (CDC) proclaimed “Prescription Drug Overdoses—A US Epidemic.”9 In step with the CDC, the Food and Drug Administration (FDA) has developed a Risk Evaluation and Mitigation Strategy (REMS) for Transmucosal Immediate-Release Fentanyl products, and for Extended-Release and Long-Acting Opioids.10 Congress passed the Controlled Substance Act in 1970. The act states that opioids “have a useful and legitimate medical purpose and are necessary to maintain the health and general welfare of the American people; good public policy calls for balancing the benefits to the patients of the legitimate use of these drugs and the positive economic benefits of drug therapy, which allows patients to be productive members of society against the harms of prescription drug abuse.”11

Unfortunately, we are still lacking long-term studies (over 6 months) that demonstrate improvement of function, quality of life, and pain relief in patients with nonmalignant pain taking opioids. Many of these issues were raised by Physicians for Responsible Opioid Prescribing (PROP), who submitted a petition to the FDA asking the agency to update labeling of opioid analgesics.12 After over a year of debate, petitions, and hearings, in September 2012 the FDA announced class-wide safety labeling changes and new post-market study requirements for all extended-release and long-acting (ER/LA) opioid analgesics intended to treat pain.13 The agency is now requiring drug companies to “conduct further studies and clinical trials [to provide needed data]. The goals of these postmarket requirements are to further assess the known serious risks of misuse, abuse, increased sensitivity to pain [hyperalgesia], addiction, overdose, and death.”

Collaboration With the DEA

As noted, the Southern California pain management community, led by Dr. Shurman, has been working with the local DEA to improve communication and cooperation with the agency and local law enforcement. (See Working With Law Enforcement,) This coordination with the various groups working together has facilitated the optimal resolution of many situations related to opioid prescribing. The following is several examples showing the benefits of this coordinated process.

Positive Interactions With the DEA

  • A pain management physician was providing services in a local drug and alcohol treatment facility. Because of the physician’s relationship with Adrienne Groza (disabled former police officer), Mrs. Groza was able to come to the facility several times and lecture to the patients on opioid abuse, giving her perspective as a former police officer and as a chronic pain patient.
  • On another occasion, a patient came to the same facility with a large suitcase of cocaine and other illicit drugs. Alex Groza, Detective Sergent, San Diego Police Department (retired) and DEA agent advised the team how to dispose of the drugs.
  • There have been several meetings for healthcare professionals who practice or treat pain management patients in the San Diego area. Mr. and Mrs. Groza and Tom Lenox, Supervisory Special Agent with the DEA, have been there to better understand the issues facing clinicians and to serve as a reference. During these lengthy meetings the lines of communication are opened, and the healthcare professionals, Mr. and Mrs. Groza, and Mr. Lenox learn from each other.
  • A pain physician had a secretary who was getting her Valium from a Kaiser Hospital, but she had a problem getting in to see the physician, so she called in a Valium order using the pain physician’s name. When this was discovered, Mr. Groza was consulted and several options were discussed. The option chosen was to terminate the secretary, with no further action taken if she agreed to see an addictionologist and a counselor. The secretary consented to this.
  • The relationship with DEA can save lives. A local pain practice had objective information of a patient using heroin and doctor shopping on their Prescription Drug Monitoring Program (PDMP). The patient refused recommended addiction treatment from the pain clinician. A phone call to the local DEA enabled a more forceful entry of the patient into active treatment, which could never have been accomplished by the clinician alone, and likely will save the life of this patient.
  • Dr. Shurman was covering for a pain management physician who was on vacation. The practice’s physician assistant (PA) called Dr. Shurman after being notified by a pharmacy that one of the practice’s patients had stolen a prescription pad and gone to 5 different pharmacies to fill prescriptions for opioids. Dr. Shurman informed the PA that it should be reported to the DEA. The PA expressed fear that the DEA would be called, but Dr. Shurman told her not to worry and that it was a problem that needed to be addressed. They contacted Mr. Lenox, who sent an agent who was very supportive and able to cooperate with the PA in a positive way and subsequently address they issues with the patient.
  • Because unintentional prescription drug abuse/overdose as a cause of death has surpassed motor vehicle accidents, Dr. Shurman discussed with Mr. Groza the feasibility of using a home monitoring system involving oximetry, respiratory rate, pulse, and blood pressure. Many of Dr. Shurman’s patients have implemented such a system as a way to monitor their vital signs at home, not just in the office. Patients are trying to monitor their vital signs twice a day, in the morning and in the evening (an article discussing this technology is in progress).
  • A pain specialist was asked to manage a patient after surgery. He had not seen the patient for over a year. He subsequently discovered that the patient’s husband, a physician, was prescribing high doses of opioids to his spouse. The pain specialist called Dr. Shurman, who spoke with the DEA about how to resolve this issue. The outcome is in progress.
  • A pain patient was prescribed pain medication, but the insurance company would only cover a portion of the expense. The patient would fill the portion of the prescription that was covered by the insurance and then at a later date would fill the additional prescription that he would pay for with cash. The healthcare professional was concerned that a third-party pharmacist or another person reviewing the CURES report (California’s PDMP titled: Controlled Substance Utilization Review and Evaluation System) would mistakenly interpret this with suspicion. A call to a DEA agent was made, and the Agency found no issue with this, as long as the treating physician was aware of this matter and documented in his records the reason for the staggered prescriptions and payment methods.
  • Another issue that came up with CURES was a difficult high-risk patient with aberrant behavior that the doctor was seeing weekly or twice a week to try and control escalation of opioid dosage. He notified the DEA proactively. The doctor was concerned that these frequent visits would trigger an audit or a DEA visit. The DEA recommended documenting the rationale for each visit.
  • A pregnant patient was opioid-dependent for several years and had been using opioids during each pregnancy. There was a plan to detox this patient, but she became pregnant immediately after the delivery of her second child. Because she was vomiting frequently, she was not able to hold her pills down and she was allergic to fentanyl patches. Because it was necessary for her to be seen frequently by the pain management specialist, his associate, and the obstetrician, it would appear on CURES that the patient was doctor-shopping. In addition, she was also seen during several emergency room visits, where she would show up in pain and vomiting, with visible pills in the vomitous (she had severe endometriosis and had undergone 7 laparoscopies). This prompted a call to the pain physician, and opioids were prescribed with enough pills to last the patient until she saw the pain management physician. The DEA again recommended documenting all of these visits so that there was a clear rationale for the entries on the CURES report.

Summary

An ongoing conversation around the country is needed regarding the interaction between healthcare professionals and those in charge of monitoring (the DEA, the medical boards, the police, hospital peer groups). The Share the Risk model is an ongoing action plan in the spirit of cooperation between all professionals interested in appropriate medical care balanced with law enforcement needs. This article is an attempt to show that it is possible to develop a more constructive strategy between all professionals dealing with this complex and expanding pain population. The hope is that this model will serve as an example for other communities throughout the country. We are not aware of any other DEA field divisions with this same extent of ongoing law enforcement and clinician/pain management interactions as seen in San Diego. It is the authors’ opinion that this type of program would benefit the medical professionals, law enforcement, and especially the pain patients if a similar process of ongoing collaboration was put in place nationwide.

Last updated on: April 14, 2015

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