Access to pain management hampered by addiction fears, government regulations

Much of the discussion about opioids to treat chronic pain separates cancer pain from noncancer pain. The two are more similar than people would think, according to David S. Craig, PharmD, BCPS, clinical pharmacist specialist and director of the Pain and Palliative Care Specialty Residency, H. Lee Moffitt Cancer Center, Tampa, Fla.

“The thought that cancer patients with cancer-related pain are somehow ‘protected’ from abuse/misuse [of opioids] just doesn’t make sense,” Craig said. “In fact, many of the pharmacological treatment strategies for noncancer and cancer pain management are similar if not the same.”

Anita Gupta, DO, PharmD, assistant professor of anesthesiology and critical care at the Hospital of the University of Pennsylvania, Philadelphia, said physicians receive little training in pain control. Photo courtesy of Anita Gupta, DO, PharmD

For Douglas C. Throckmorton, MD, deputy director for regulatory programs at the FDA’s Center for Drug Evaluation and Research, the distinction is more about end-of-life issues than cancer pain vs. noncancer pain.

“End of life needs to focus on appropriate management of pain. That’s not a question,” Throckmorton said. “For a patient without end-of-life concerns, pain management may be different.”

It is these differences in pain management that could raise concerns about abuse or misuse of pain medication. “Patients with cancer may receive higher-dose opiates,” said Anita Gupta, DO, PharmD, assistant professor of anesthesiology and critical care at the Hospital of the University of Pennsylvania, Philadelphia. “They often have severe pain, which can be difficult to manage.”

In addition, most physicians are not always comfortable treating pain, Gupta said, adding that most physicians receive very little training in pain control during medical school averaging approximately 90 hours of curriculum.

The real fears of opioid abuse or misuse on the part of oncologists and patients could be a barrier to effective pain management. Recent FDA regulations, although aimed at manufacturers, could inhibit some oncologists from using opioids if they are concerned about increases in paperwork or government oversight.

HemOnc Today spoke with oncologists, pain specialists and government officials about the prevalence of opioid abuse or misuse among cancer patients, screening and management tools to prevent abuse and whether oncologists have the necessary tools to treat pain adequately.

Abuse and misuse

The concepts of opioid abuse and opioid misuse are different. “Misuse” is generally defined as the use of any drug in a manner other than how it is indicated or prescribed. This can include selling or diverting prescription drugs or appropriation of a patient’s drugs by friends or family.

“Abuse” is the illegal or detrimental use of a substance, with addiction characterized by behaviors such as impaired control over drug use, compulsive use, continued use despite harm and craving.

Untreated pain may lead to opioid pseudo-addiction, in which patients focus on when their next dose is, the number of pills left and whether a doctor will provide additional prescriptions. Achieving pain relief may lead pseudo-addicted patients to illicit drug use and deception.

Although some patients and oncologists may view a tolerance to adverse effects as a sign of growing dependence on opioids, it is not the case. Tolerance is common and a favorable outcome. Physical dependence follows specific drug-receptor interactions.

Prevalence of abuse

The National Survey on Drug Use and Health (NSDUH) found that nearly one-third of those aged older than 12 years who used drugs for the first time in 2009 began by using a prescription drug outside of the prescription. More than 70% of those who used prescription pain relievers obtained them from family or friends, according to the NSDUH.

The use of opioids as pain relief is on the rise. The milligram per person use of prescription opioids increased from 74 mg in 1997 to 369 mg in 2007; the number of opioid prescriptions dispensed by retail pharmacies increased 48% from 2000 to 2009.

Approximately 7.1 million people in the United States were dependent on or had abused an illicit drug in 2009.

The figures point to two problems facing oncologists: understanding who is at risk for addiction and managing pain in patients with a history of substance abuse.

Previous history of abuse

“As individuals live longer, and as the prevalence of substance abuse increases in the general population in the United States, oncologists and oncology professionals are more likely to care for patients with concomitant cancer pain and addictive disease,” wrote Judith A. Paice, PhD, RN, director of the Cancer Pain Program, division of hematology-oncology at the Feinberg School of Medicine, Northwestern University, Chicago, and Betty Ferrell, PhD, RN, professor and research scientist, division of nursing research and education, City of Hope, Duarte, Calif.

Patients with a history of substance abuse may be active addicts or may have gone through recovery and continue to participate in 12-step or other support programs. Receiving pain treatment may ignite fears about jeopardizing their recovery.

“The challenge in the clinic is understanding who is at greatest risk for addictive disease and differentiating behaviors indicative of addiction from other factors, as well as knowing how to safely manage pain in patients with cancer who are at high risk for addiction,” Paice and Ferrell wrote in CA, A Cancer Journal for Clinicians.

Patients with previous addictions, however, are likely to make up a small proportion of patients in the oncologist’s office, said Rudy Keimowitz, MD, an assistant professor of hematology, oncology and transplantation at the University of Minnesota, Fairview, and a palliative medicine physician with a palliative consult service.

“Addicts can develop cancer like anyone else. They deserve to be treated. They deserve to be made comfortable and not have to suffer. Their pain can be more difficult to manage, but they deserve to have it under control,” Keimowitz said.

David S. Craig

Keimowitz, who is a HemOnc Today Editorial Board member, recommended oncologists work with substance abuse specialists or pain and palliative care specialists as a general rule, but particularly for patients with a history of abuse.

When considering opioid therapy, providers should ask patients about past history of substance abuse or addiction, Craig said, adding that “the presence of these past behaviors should not prohibit prescribers from conducting a proper pain management assessment and treating patients appropriately.

“Where oncologists get into trouble, in my experience, is when they assume because patients have cancer pain that they have lower risks of drug abuse/misuse than other patients and either forget to ask routine screening questions or are not aware these types of tools exist,” he said.

Before prescribing opioids for any reason, “a brief risk assessment of the patient is prudent to ensure he doesn’t have a history of addiction/chemical dependency, not forgetting the relevance of alcoholism, along with looking for other psychological traits (severe anxiety, bipolar, etc.) that may put the patient at risk for iatrogenic drug dependency/misuse issues,” said Allen W. Burton, MD, a pain specialist with Houston Pain Associates.

The questions should be part of a routine history. It is important for the oncologist and patient to realize that an addiction history does not preclude pain management. “It just makes pain management a bit more difficult and in need of more attentive and careful management,” Burton said.

Determining who is at risk

“Here at the University of Minnesota in palliative care, the issue of pain treatment leading to addiction rarely enters our conversation,” Keimowitz said.

Keimowitz approaches pain management with the goal to alleviate suffering. Patients are followed in outpatient clinics to determine whether they are receiving benefit from therapy. He said what the clinicians are looking for are more of a lack of adverse effects of pain medication than abuse issues.

He said as patients begin to see beneficial effects from cancer treatments, the need for opioids lessens. At this stage, opioid-sparing medications can be used to reduce adverse effects such as somnolence.

“A pain or palliative care specialist as part of the care team can determine when to use opioid-sparing medications in conjunction with opioids to prevent those adverse effects,” Keimowitz said.

A specialist can make opioid management easier and more successful, according to Gupta. “My training and expertise helps me assess patients’ pain and how it is being managed,” she said. “I also know my limits. I know when to be concerned that a patient is experiencing pain despite medications and can look for specific signs of abuse or misuse of medication.”

Screening for possible addiction is critical. Patients should be assessed for known risk factors for opioid abuse, or such as smoking, psychiatric disorders and personal or family history of substance abuse, wrote Steven D. Passik, PhD, an associate attending psychologist at Memorial Sloan-Kettering Cancer Center and an associate professor of psychology in psychiatry at Weill Cornell Medical College, New York. Assessing risk allows oncologists and other health care providers to be on alert for signs of abuse or misuse in a patient so “appropriate safeguards can be placed in his or her pain management plan.”

Screening tools

Various instruments can help oncologists assess opioid addiction risk. These include the Opioid Risk Tool (ORT), the Screener and Opioid Assessment for Patients with Pain – Revised (SOAPP-R) and the Screening Instrument for Substance Abuse Potential (SISAP).

Monitoring what Passik called the four A’s of pain treatment may also be helpful. Changes in analgesia, activities of daily life, adverse events and aberrant drug-taking behaviors should be tracked throughout opioid therapy.

Another tool to use is the Current Opioid Misuse Measure (COMM). A study from Brigham and Women’s Hospital, Boston, evaluated the COMM and found it could “offer clinicians a way to monitor misuse behaviors and to develop treatment strategies designed to minimize continued misuse.”

The most important set of behaviors associated with abuse/misuse in the COMM are signs of medication misuse and noncompliance. Patients may report stolen or lost prescriptions or complain of difficulties at the pharmacies. The patients may seek to avoid urine tests.

The net group of behaviors related to evidence of lying or drug use stems from positive urine tests or confessions of supplementing medication with alcohol or other pain medication.

The COMM also addresses emotional problems and psychiatric issues. Emotional stability, concerns over suicide, family or marital problems that are new or aggravating, along with anger and impulse control issues, may signal a need for closer management.

‘Opioidphobia’

Long-term opioid therapy can provoke anxiety in patients and providers alike. Patients may not be comfortable with opioid pain management because they see opioid use as a personality flaw due to the societal stigma these medications have, Craig said.

Alaa Bashayreh, RN, MSN, Jordan University of Science and Technology, Irbid, Jordan, used the term “opioidphobia” in an article in the Journal of Pediatric Hematology/Oncology. She defined provider opioidphobia as the fear of both addiction and opioid-induced side effects. Provider fears can arise from not knowing enough about the management of cancer pain, not having adequate training in opioid therapy, not following prescribed guidelines and focusing more on treatment of cancer than on pain management. Concerns over nausea, vomiting, constipation and respiratory depression may cause some oncologists to hesitate before continuing opioid therapy.

“Opioid fear is a huge issue,” Keimowitz said. Fear of addiction can lead patients to reject opioid medication. Physicians are also fearful of the potential for abuse and the subsequent government oversight if it does occur.

Patients treated properly will rarely become addicts, he said.

Patients and physicians share similar fears. “Lack of patient and family education about myths of cancer pain management and management of the associated symptoms are the major factors that could lead to patient’s opioidphobia,” Bashayreh wrote.

Education is the best weapon against opioidphobia for patients, their families and for physicians and other health care providers. “Opioids by themselves do not cause the psychological dependence of addiction,” wrote Charles F. von Gunten, MD, PhD, provost of the Institute for Palliative Medicine at San Diego Hospice. “Addiction is a rare outcome of pain management when there is no history of [substance abuse].”

Provider training

A report from the Executive Office of the President of the United States determined that “prescribers and dispensers, including physicians, physicians’ assistants, nurse practitioners, pharmacists, nurses, prescribing psychologists, and dentists, all have a role to play in reducing prescription drug misuse and abuse.” Further, the report found most of the health care providers received little training on opioid treatment. The report spoke to an overall prescription drug abuse crisis, not specifically opioid treatment of cancer pain; however, its findings highlight an important disconnect between what physicians are taught and what they are expected to know once they begin practicing.

Allen W. Burton

Only 56% of medical residency programs required substance use disorder training in 2000. Opinions differ on whether that training is sufficient.

“We need improved education of the medical community regarding pain management,” Keimowitz said. “No certification is required for pain management or dispensing pain medication beyond acquiring a narcotics number. This leads to a general lack of experience with opioids among the medical community.”

Craig said oncologists can manage most cancer pain adequately. The trouble arises when patients have significant risk factors for abuse/misuse or have other comorbidities such as a psychiatric illness that can complicate pain management.

The ideal situation may be for oncologists to have 24/7 access to a palliative care team. Unfortunately, not all oncologists have access to a pain specialist, particularly in smaller communities or rural hospitals.

“In those cases, oncologists have to stay informed. They have to seek out continuing education on pain management and abuse. Educating themselves and their patients is key,” Gupta said.

She also advised oncologists to turn to other professionals in the area. Psychologists, for example, may have insight into pain management or abuse signs. If a patient is in physical therapy, the therapist may notice behavioral changes that signal the pain despite medication, or if the patient is experiencing more adverse effects than what would be expected from a therapeutic dose.

Formal plans

The Executive Office report encouraged Congress to require training for physicians who request DEA registration to prescribe controlled substances. The training would cover responsible opioid-prescribing practices as a condition of registration.

Already in action is the Executive Office’s mandate to require drug manufacturers to develop effective educational materials for physicians as part of a Risk Evaluation and Mitigation Strategy (REMS).

After 2007 legislation, the FDA could require REMS from drug manufacturers to ensure that the benefits of a drug or biological product outweigh its risks. The legislation did not focus on opioid medication separately, but recent FDA activity has placed more attention on opioids and REMS.

The new REMS plan focuses primarily on educating doctors about proper pain management; patient selection and other requirements; and improving patient awareness about how to use these drugs safely, according to the FDA.

“The FDA’s authority is over manufacturers, and REMS targets them, but we are aware more education and training is needed among health care providers,” Throckmorton said.

Manufacturers must develop effective educational materials. The FDA defines “effective” as nonpromotional and containing the best possible science.

Throckmorton said the agency is working with the pharmaceutical industry, educators, professional organizations such as ASCO and continuing education organizations “to design materials that present the most up-to-date, comprehensive science, so providers have a better understanding of how to best use pain medications and alleviate pain in their patients.”

Another part of a REMS is restricted distribution. For some oncologists, this raises concerns over barriers to patient care. At a 2010 FDA committee meeting, Sydney Dy, MD, MSc, an associate professor and physician leader at the Duffey Pain and Palliative Care Program, Hopkins Kimmel Cancer Center, Baltimore, represented ASCO’s position on how REMS affects opioid access. “While ASCO understands the public health issue that FDA is addressing through REMS and supports the agency’s efforts, ASCO has expressed concerns that appropriate access to these drugs not be denied to cancer patients, and that the process for obtaining effective pain management drugs should not represent an undue burden to either the physician or the patient,” Dy said.

Throckmorton said “eliminating burdens on oncologists and providers is something we took very seriously. We don’t want to imperil access to care.”

The FDA set up a parallel program to assess REMS to detect any effect on access to proper pain management as soon as possible.

“The FDA has honestly listened [to oncologists’ concerns],” Dy said. “We want education that will help them manage pain effectively. We don’t want to create barriers to pain management.” – by Tammy Dotts

For more information:

• ASCO. Comments at advisory committee meeting on proposed FDA REMS for opioids - July 2010. Available at: www.asco.org.
• Bashayreh A. J Pediatr Hematol Oncol. 2011;33(suppl 1):S12-S18.
• Butler SF. Pain. 2007;130:144-156.
• Executive Office of the President of the United States. Epidemic: Responding to America’s prescription drug abuse crisis. Available at: www.whitehousedrugpolicy.gov/publications/pdf/rx_abuse_plan.pdf.
• Jamison R. Pain. 2007; 130: 144–156.
• Paice JA. CA Cancer J Clin. 2011;61:157-182.
• Passik SD. Mayo Clin Proc. 2009;84:593-601.
• von Gunten CF. J Pediatr Hematol Oncol. 2011;33(suppl1):S12-S18.

Disclosure: No sources for this story reported any relevant financial disclosures.

Are oncologists equipped in terms of training/experience with pain relief to manage pain and possible addiction effectively?

Rudy Keimowitz

There is a need for education in pain management beginning in medical school. Most medical school curriculum have a course in pharmacology that may touch on opioids. For medical residents and fellows at the University of Minnesota Medical Center-Fairview, we offer an elective in palliative medicine that includes pain management. Otherwise, house staff have little or no formal instruction to learn how to provide pain relief and alleviate suffering.

Cancer by itself is distressing and the associated anxiety often exacerbates pain. Opioids can improve the quality of life of patients by controlling their pain, and without access to appropriate opioids, there would be much suffering.

It doesn’t make sense for oncologists/hematologists to receive no formal training in pain management. Physicians can not perform surgery or other invasive procedures without structured training and certification, and yet they may prescribe medications for pain often without such training.

With proper instruction and consultation with pain and palliative medicine specialists, physician awareness could lead to better prescribing practices that would eliminate some of the fears of patients and physicians about opioids. Such efforts would probably counter the need for government oversight that threatens access to opioids and good pain relief.

Rudy Keimowitz, MD, is an assistant professor of hematology, oncology and transplantation at the University of Minnesota in Fairview, and a palliative medicine physician with a palliative consult service. He is also a member of the HemOnc Today Editorial Board. He reports no relevant financial disclosures.

Biren Saraiya

Issues of addiction are important for both patients and physicians. In my experience with patients with and without addiction history, both groups of patients are concerned for addiction.

Establishing a goal of treatment that includes living a pain-free life is the first step in caring for patients with cancer. This discussion allows patients to identify their concerns with addiction, should they have any. During history, assessment of comorbid conditions such as history of addiction (drugs, alcohol, tobacco, etc.) or psychiatric illnesses (depression, anxiety, etc.) that put patients at risk for future misuse are important. Comprehensive pain assessment to identify etiology of pain and prescribing appropriate pain medication are the next step. Frequent reassessments for effects of opioids and toxicity allow for long-term compliance and meeting the goal of living a pain-free life. If during this evaluation, patients at risk for addiction are identified, then closer communication with the health care team, including the patient’s pharmacist and other physicians, can assure physicians of patient compliance. Honest communication with patients about the concern for misuses addresses both patient and physicians’ concerns. Those with active addiction may need concurrent palliative care and psychiatric care.

Despite the increase in per capita use of morphine equivalent in the Western world, there is still a significant amount of pain-related suffering for patients with cancer. As a patient strives for “pain-free life” after cancer diagnosis, we must continue to strive for improved pain management.

Biren Saraiya, MD, is an assistant professor at the Cancer Institute of New Jersey at UMDNJ-Robert Wood Johnson Medical School and is a member of the HemOnc Today Editorial Board. He reports no relevant financial disclosures.