Pain Medication Management: Are you prepared?
In a Nutshell:
- Implement your state medical board’s Guidelines for Prescribing Controlled Substances for Pain.
(See discussion below.)
- State licensing boards can, and will, impose discipline on a physician for negligent prescribing practices, even in cases in which the physician feels that he or she is appropriately providing chronic pain management. A medical board can take licensure action against a physician for either an act of gross negligence, or repeated acts of simple negligence.
- Be familiar with “black box” warnings for all controlled substances that you prescribe.
Register at PDR.net to receive current FDA-approved drug alerts and recall drug information electronically. (See the Case Study below.)
- Develop and adhere to risk reduction strategies, including: urine drug screens, regular face-to-face office visits to evaluate patients’ response to opioids and risk of misuse, follow a pre-defined refill schedule (i.e., restricting refills of opioids prior to expiration of the previous prescription), and clearly document your treatment plan and management thereof.
- Have patients sign a Medication Management Agreement. (Figure 1.)
- Consider seeking a pain management consultation for patients whose medication management becomes complex, or those who present with few clinical symptoms. Carefully document physical findings (or lack thereof) and refer such patients to a pain management specialist or a psychiatrist.
As reported by an Institute of Medicine panel in July 2011, more than 116 million Americans struggle with chronic pain nationwide. Medical expenses and lost productivity linked to chronic pain cost the United States as much as $635 billion annually. According to the Centers for Disease Control and Prevention (CDC), fatal poisonings from opioid overdoses tripled to nearly 14,000 nationwide between 1999 and 2006 and opioid-related emergency department visits doubled to more than 300,000 between 2004 and 2008.
Perhaps even more disturbing for physicians than these enormous statistics are the number of doctors who have been convicted in criminal matters for the over-prescription of painkillers. Reuters replicated research conducted by James Filkins, a doctor and lawyer who has written about the criminal prosecution of physicians and tallied over 37 reported criminal cases between 2001 and 2011. Most recent cases against physicians for over-prescribing painkillers and other controlled substances, such as the case of Michael Jackson’s physician Dr. Conrad Murray. US Drug Enforcement Administration (DEA) information also suggests a similar trend. For 2003, the DEA reported 15 physician arrests that resulted in convictions and by 2008, the most recent year of comprehensive data, the number had grown to 43.
Failure to adhere to risk reduction strategies
Experts recommend the close oversight of patients who receive opioid analgesics for chronic non-cancer pain (CNCP), especially those with increased risk of misuse (e.g., patients with risks factors such as age <45, drug or alcohol use disorder, tobacco use, and mental health disorder). In a study published in the Journal of General Internal Medicine online February 24, 2011, researcher Joanna Starrels, MD, MS, et al. hypothesized that physicians employ opioid risk reduction strategies more frequently in higher risk patients; however, this was not borne out by the study results. Strategies include: urine drug testing, regular face-to-face office visits to evaluate patients’ response to opioids and risk of misuse, and adhering to a pre-defined refill schedule (i.e., restricting refills of opioids prior to expiration of the previous prescription).
The study, time framed from January 1, 2004 to April 30, 2008, was a retrospective cohort using administrative data from eight urban or suburban primary care practices within the University of Pennsylvania Health System. All practices shared an electronic medical record. Participants were age 18 and older who completed three or more visits to a primary care practice, were on long-term opioids (defined by three or more opioid prescriptions written at least 21 days apart for six months), and were treated for CNCP. The study aimed to: (1) evaluate the frequency of urine drug testing, regular office visits, and restricted early refills; and (2) to examine the association of patient risk factors for opioid misuse with receipt of each of the three strategies.
- While being treated with long-term opioids, fewer than 10% of the cohort (approximately 1600 primary care patients) received any urine drug testing, only half had regular office-based visits, and 23% received more than one early opioid refill.
- Patients with increased risk of opioid misuse were more likely to have urine drug testing. However, it was still infrequent with less than 25% of the patients with three or more risk factors having any urine drug test. These patients were also more likely to receive more than one early refill, but their office-based monitoring was no greater than for patients without risk factors for opioid use. The study revealed lax monitoring.
- Only half of patients met the minimum recommendation frequency of office-based monitoring of patients on long-term opioid therapy. The lack of face-to-face encounters represents missed opportunities for physicians to examine responses to treatment, propose alternative treatments when response is inadequate, detect side effects, and assess for misuse.
- Researchers found that 23% of the cohort received more than one early opioid refill. Of greater concern, patients with a current or past drug use disorder were more likely to receive early refills.
- The study supported recommendations for a more standardized approach to opioid risk reduction including: using screening tools to identify patients at increased risk of misuse; a treatment agreement that stipulates the necessity for regular office visits, restricted early refills and urine drug testing; and team-based care to track patients’ visits, prescriptions, progress, and aberrant drug taking behaviors.
A Case Study: Be Familiar with the Black Box Warning
(The facts have been changed to protect the identities of the plaintiff and defendant.)
Allegation: Negligent prescription of Duragesic patches (fentanyl) resulting in death of a 45-year-old male from overdose.
The Board-certified internal medicine physician saw the patient, a 45-year-old disabled firefighter, one time only on September 2. The patient’s brother referred the patient to the internist’s office where he was to undergo a physical exam; chief complaint: severe pain, multiple sites. The patient had recently relocated to the area and did not have a copy of his medical records. As a result the internist did not have an opportunity to review them prior to the examination. The patient relayed that he sustained multiple fractures in a work-related accident as well as a subsequent motor vehicle accident in 2000. He reported fractures to his right arm, severe injuries to both shoulders with neck and low back pain. His medical history included long history of chronic pain, migraine headaches, degenerative joint disease, depression, and fibromyalgia. The patient had been treated with methadone and other pain medications for many years.
The patient expressed frustration with the number of different pain medications he had taken over the years with little relief. At the time of the visit, the patient claimed to have run out of his medications about a week prior to the visit and was in severe pain. His undocumented medication history included: Methadone 10 mg twice a day supplemented with high dosages of Demerol and Morphine Sulfate which the physician estimated to total 300-350 mg daily. In addition, the patient had taken Flexeril 10 mg three times a day, Cymbalta 30 mg twice a day, and Soma 350 mg as needed.
Based upon the conversation about the patient’s daily pain medication regimen, the physician prescribed Duragesic patches, 50 mg per hour to be used every 72 hours. The physician recommended a pain management consultant and tried to refer the patient to a specialist, but the patient refused. There was no documentation of an informed refusal discussion in the single chart note. According to the internist, the patient’s brother, who accompanied the gentleman to the visit agreed to help control the number of patches the patient used.
On September 7, the patient’s brother found him dead. He had one Duragesic patch in place and five patches were missing with three remaining in the box. The patient allegedly used seven patches within four (4) days. The autopsy revealed that the patient died from acute poisoning from a combination of fentanyl and duloxetine. The fentanyl drug level was 19.6 ng/mL (upper normal limits is 3 ng/mL) and the duloxetine concentration was 285 ng/mL.
This case had multiple issues impairing the physician’s defense:
- No documentation of a patient history (e.g., no medical records to review; no clear understanding of the patient’s pain management history or documentation thereof).
- The physician was not familiar with the black box warning for the patches, which read in part,
“DURAGESIC® should ONLY be used in patients who are already receiving opioid therapy, who have demonstrated opioid tolerance, and who require a total daily dose at least equivalent to DURAGESIC® 25 mcg/h. Patients who are considered opioid-tolerant are those who have been taking, for a week or longer, at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid.”
- No evidence of an informed refusal discussion.
As a result, the case was settled in the high six-figure range and defense costs totaled upwards of $150,000.
Sidebar: Policyholders give advice
Dean J. Nickles, MD (Associated Internal Medicine Medical Group, Oakland, CA) recommends:
“Physicians who treat chronic non-cancer-related pain should get a number of medical disciplines involved such as neurology, psychiatry/psychology, and pain management. Also develop a pain contract that includes: only one physician will prescribe the patient’s narcotics; only one pharmacy will fill the patient’s prescriptions; and medications will not be refilled if lost.”
Steven Una, MD (Infectious Disease and MIEC Board of Governors member) advises:
“Maintaining an open bi-directional cooperative relationship is critical to managing pain. Many physicians do that through contracts, although one would hope that the contract is only a formality, and that trust would drive the physician-patient relationship.”
Gary Okamoto, MD (Physical Medicine and Rehabilitation and MIEC Board of Governors member) advises:
“In assessing a patient’s response to treatment, identify and monitor a set of specific activities of daily living (ADLs), work tasks, or physical capabilities. Data points on a patient’s self-reported disability and function can suggest pertinent questions about the effectiveness of one’s pain management.”
Guidelines for Prescribing Controlled Substances for Pain
A medical history and physical examination must be accomplished. This includes an assessment of the pain, physical and psychological function; a substance abuse history; history of prior pain treatment; an assessment of underlying or coexisting diseases or conditions; and documentation of the presence of a recognized medical indication for the use of a controlled substance.
Annotation One: The prescribing of controlled substances for pain may require referral to one or more consulting physicians.
Annotation Two: The complexity of the history and physical examination may vary based on the practice location. In the emergency department, the operating room, at night or on the weekends, the physician and surgeon may not always be able to verify the patient’s history and past medical treatment. In continuing care situations for chronic pain management, the physician and surgeon should have a more extensive evaluation of the history, past treatment, diagnostic tests and physical exam.
Treatment Plan, Objectives
The treatment plan should state objectives by which the treatment plan can be evaluated, such as pain relief and/or improved physical and psychosocial function, and indicate if any further diagnostic evaluations or other treatments are planned. The physician and surgeon should tailor pharmacological therapy to the individual medical needs of each patient. Multiple treatment modalities and/or a rehabilitation program may be necessary if the pain is complex or is associated with physical and psychosocial impairment.
Annotation One: Physicians and surgeons may use control of pain, increase in function, and improved quality of life as criteria to evaluate the treatment plan.
Annotation Two: When the patient is requesting opioid medications for his/her pain and inconsistencies are identified in the history, presentation, behaviors to physical findings, physicians and surgeons who make a clinical decision to withhold opioid medications should document the basis for their decision.
The physician and surgeon should discuss the risks and benefits of the use of controlled substances and other treatment modalities with the patient, caregiver or guardian.
Annotation: A written consent or pain agreement for chronic use is not required but may make it easier for the physician and surgeon to document patient education, the treatment plan, and the informed consent. Patient, guardian, and caregiver attitudes about medicines may influence the patient’s use of medications for relief from pain.
The physician and surgeon should periodically review the course of pain treatment of the patient and any new information about the etiology of the pain or the patient’s state of health. Continuation or modification of controlled substances for pain management therapy depends on the physician’s evaluation of progress toward treatment objectives. If the patient’s progress is unsatisfactory, the physician and surgeon should assess the appropriateness of continued use of the current treatment plan and consider the use of other therapeutic modalities.
Annotation One: Patients with pain who are managed with controlled substances should be seen monthly, quarterly, or semiannually as required by the standard of care.
Annotation Two: Satisfactory response to treatment may be indicated by the patient’s decreased pain, increased level of function, or improved quality of life. Information from family members or other caregivers should be considered in determining the patient’s response to treatment.
The physician and surgeon should consider referring the patient as necessary for additional evaluation and treatment in order to achieve treatment objectives. Complex pain problems may require consultation with a pain medicine specialist.
In addition, physicians should give special attention to those pain patients who are at risk for misusing their medications including those whose living arrangements pose a risk for medication misuse or diversion.
Annotation One: Coordination of care in prescribing chronic analgesics is of paramount importance.
Annotation Two: In situations where there is dual diagnosis of opioid dependence and intractable pain, both of which are being treated with controlled substances, protections apply to physicians and surgeons who prescribe controlled substances for intractable pain provided the physician complies with the requirements of the general standard of care and California Business and Professions Code sections 2241 and 2241.5.
The physician and surgeon should keep accurate and complete records according to items above, including the medical history and physical examination, other evaluations and consultations, treatment plan objectives, informed consent, treatments, medications, rationale for changes in the treatment plan or medications, agreements with the patient, and periodic reviews of the treatment plan.
Annotation One: Documentation of the periodic reviews should be done at least annually or more frequently as warranted.
Annotation Two: Pain levels, levels of function, and quality of life should be documented. Medical documentation should include both subjective complaints of patient and caregiver, and objective findings by the physician.
Compliance with Controlled Substances Laws and Regulations
To prescribe controlled substances, the physician and surgeon must be appropriately licensed in California, have a valid controlled substances registration and comply with federal and state regulations for issuing controlled substances prescriptions. Physicians and surgeons are referred to the Physicians Manual of the U.S. Drug Enforcement Administration and the Medical Board’s Guidebook to Laws Governing the Practice of Medicine by Physicians and Surgeons for specific rules governing issuance of controlled substances prescriptions.
Annotation One: There is not a minimum or maximum number of medications which can be prescribed to the patient under either federal or California law.
Annotation Two: Physicians and surgeons who supervise Physician Assistants (PAs) or Nurse Practitioners (NPs) should carefully review the respective supervision requirements.
Additional information on PA supervision requirements is available at www.pac.ca.gov.
PAs are able to obtain their own DEA number to use when writing prescriptions for drug orders for controlled substances. Current law permits physician assistants to write and sign prescription drug orders when authorized to do so by their supervising physician for Schedule II-IV. Further, a PA may only administer, provide or transmit a drug order for Schedule II through V controlled substances with the advanced approval by a supervising physician for a specific patient unless a physician assistant completes an approved education course in controlled substances and if delegated by the supervising physician. To ensure that a PA’s actions involving the prescribing, administration, or dispensing of drugs is in strict accordance with the directions of the physician, every time a PA administers or dispenses a drug or transmits a drug order, the physician supervisor must sign and date the patient’s medical record or drug chart within seven days. (Section 1399.545(f) of Title 16, California Code of Regulations)
NPs are allowed to furnish Schedule III-V controlled substances under written protocols.
While it is lawful under both federal and California law to prescribe controlled substances for the treatment of pain including intractable pain – there are limitations on the prescribing of controlled substances to or for patients for the treatment of chemical dependency (see Sections 11215-11222 of the California Health and Safety Code). In summary, a physician and surgeon must follow the same standard of care when prescribing and/or administering a narcotic controlled substance to a “known addict” patient as he or she would for any other patient. The physician and surgeon must:
- Perform an appropriate prior medical examination;
- Identify a medical indication;
- Keep accurate and complete medical records, including treatments, medications, periodic reviews of treatment plans, etc.; and,
- Provide ongoing and follow-up medical care as appropriate and necessary.
The Medical Board emphasizes the above issues, both to ensure physicians and surgeons know that a patient in pain who is also chemically dependent should not be deprived of appropriate pain relief, and to recognize the special issues and difficulties associated with patients who suffer both from drug addiction and pain. The Medical Board expects that the acute pain from trauma or surgery will be addressed regardless of the patient’s current or prior history of substance abuse. This postscript should not be interpreted as a deterrent for appropriate treatment of pain.
Alaska guidelines: Alaska’s medical board lacks a position statement on the use of controlled substances and the management of pain; however, the Alaska Board of Nursing adopted a guideline in 1996 patterned after the Federation of State Medical Board’s guideline. For a copy: Click Here.
Hawaii guidelines: In 2006, the Hawaii Board of Medicine adopted its pain management guidelines, which are patterned after the guidelines established by the Federation of State Medical Boards. For a copy: Click Here
Idaho guidelines: The Board has adopted criteria when evaluating the physician’s treatment of pain, including the use of controlled substances. The full document is available here.
Resource for state guidelines: http://www.medscape.com/resource/opioid/
In addition to the “In a Nutshell” guidelines, consider the following when treating chronic non-cancer pain patients. Fine-tune your index of suspicion and proceed cautiously with patients you suspect are drug-seeking:
- Know your state regulations as they pertain to the prescription of controlled substances and pain management. For example, California physicians licensed on or after January 1, 2002, must complete a CME course in pain management and end-of-life care within four years of initial licensure or by the second renewal date, whichever occurs first. All California physicians are required to complete twelve (12) hours of CME on this topic as part of the minimum of one hundred (100) hours of CME required every four years. The states of Alaska, Hawaii, and Idaho do not have such a requirement.
- Regularly access your state’s prescription monitoring program.
- California physician prescribers may request a Patient Activity Report (PAR), a printout that discloses the patient’s prescribing history found in the CURES data system. (See http://ag.ca.gov/bne/trips.htm for more information.)
- Alaska physicians can learn more about Alaska’s prescription monitoring program at http://pmp.relayhealth.com/AK/index.htm.
- Hawaii physicians can contact the state’s Department of Public Safety, Narcotics Enforcement Division, for more information about the prescription monitoring program.
- Idaho physicians can learn more about Idaho’s prescription tracking program through the Board of Pharmacy at http://bop.idaho.gov. Contact Program Information Coordinator Teresa Anderson.
- Seek continuing medical education resources for further training and education about pain management. For example, Responsible Opioid Prescribing: A Clinician’s Guide by Scott M. Fishman, MD, (Chief of the Division of Pain Medicine and Professor of Anesthesiology at UC Davis) is recommended by the Federation of State Medical Boards and physicians can earn 7.25 AMA PRA Category 1 Credits for reading the publication and completing the post-test.
- Consider designing progress note templates dedicated to pain management. If you use an electronic record, the software should allow you to develop such a template. (First Visit and Follow Up Templates.)
- Be wary of patients who vigorously request specific medications. Be kind but skeptical.
- Write prescriptions legibly and ensure that there is no room for alteration of your order (i.e., write out numbers; indicate “no refills;” be careful of placement of the zeros and decimal points, etc.).
- Ensure that patients do not have access to your prescription pads. Do not “pre-sign” prescription pads.
- Alert staff to inform you if patients’ behaviors are radically different in the reception area from what they are in the exam room.
- Alert patients, in advance and in writing, of the best time to call to request a refill of their medications (i.e., several days before they are due to run out; on weekdays rather than weekends, etc.). If they request an untimely refill (i.e., too early if it was taken properly), refill only enough medication to last them until they can come to the office for an appointment, a good faith exam, and a re-evaluation of their condition. Do not deviate from your written refill policy except for rare, unusual circumstances in which you feel confident of the patient and the clinical necessity to do so.
- If you believe that you have been duped by a patient and/or a patient is making unrealistic demands for medications with potential abuse consequences, you may call MIEC Claims Department for advice on how to proceed.
- If in doubt about your ability to identify and treat drug-seeking patients, consider a refresher course in pain management to strengthen your clinical and philosophical positions on the subject.
- Consider withdrawing from care from patients you believe are attempting to obtain prescriptions from you in the absence of clinically-determined necessity. (See “How to discharge a patient from your medical practice,” MIEC’s Managing Your Practice #2.)
Our thanks to MIEC Board members Drs. Gene Cleaver, Robert Margolin, Gary Okamoto, and Steven Una for their counsel on the contents of this article.