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7 Articles in Volume 8, Issue #3
CES in the Treatment of Pain-Related Disorders
Commonsense Opioid-Risk Management in Chronic Non-cancer Pain
Injection Needle Injury of Oral Sensory Nerves
Maximizing Safety with Methadone and Other Opioids
Personality Disorders and the Bipolar Spectrum
Protecting Pain Physicians from Legal Challenges: Part 2
Technology in Pain Medicine

Protecting Pain Physicians from Legal Challenges: Part 2

Practice recommendations to avoid malpractice resulting in deaths, complications, or undertreatment together with illustrative case examples.

Dr. Tennant has practiced ambulatory pain management with opioids since 1975 and has reviewed over 50 cases of malpractice suits brought against physicians and hospitals—sometimes in the role of expert witness. This article presents his perspective on how pain physicians can learn from others’ mistakes and protect against legal challenges to their practice.

The landscape for risk in pain treatment is rapidly changing. Heretofore, physicians have been reluctant to prescribe opioids for chronic pain treatment due to fear of prosecution by State Medical Boards and the Federal Drug Enforcement Agency (DEA). Due to pressure from a public that demands opioid drugs for pain treatment, most states, however, have now adopted laws, regulations, and guidelines that allow a physician to treat chronic pain without fear of retribution. Risk of malpractice is, however, replacing the risk of government prosecution as the physician’s cross-to-bear. In this decade, a variety of mal-practice suits have befallen physicians who have attempted to treat chronic pain with opioid drugs. In the last issue of Practical Pain Management, we focused on the problem of sudden, unexpected deaths in pain patients and the misinterpretation of their opioid blood levels. In this second article we wish to highlight other legal challenges that have come to our attention. In addition to unexpected deaths we are aware of legal challenges involving undertreatment, withdrawal from opioids while pain is still present, and complications of severe chronic pain (see Table 1). Not discussed here are legal challenges that may result from billing practices or invasive interventions.

A ten-point malpractice-prevention program is presented to avoid risk and protect against legal challenges. Selected cases are then presented to emphasize that all could have been prevented in a medical practice.

Ten-point Malpractice Prevention Plan

This plan is designed for the busy practitioner who may have limited time to spend with each patient (see Table 2). Futhermore, it doesn’t depend upon expensive laboratory tests, consultations, or large office staff. Due to the high pre-valence of chronic pain in the general population, it is well recognized that chronic pain treatment with opioid drugs must be done. Treatment must necessarily take place in busy practice settings throughout rural and urban areas of America. Put another way, this ten-point plan can be done in a two-person office, and the author believes that the implementation of these points either prevented or would have prevented all the malpractice suits personally reviewed.

Table 1. Malpractice
Challenges for Physicians
  1. Sudden, unexpected death in a pain patient.
  2. Undertreatment or opioid withdrawal and failure to prevent pain flares.
  3. Complications of severe, chronic pain such as dementia, infection, or cardiovascular events.
  • Point 1. Follow The National Federation of State Medical Board Guidelines. Chronic pain treatment is about the only condition that has published national guidelines. To avoid legal challenges, the pain practitioner must righteously follow them simply because they have become the universal standard. Although widely published and endorsed by essentially all professional pain organizations, they are shown here in brief, tabular form (see Table 3). Every MD should be able to articulate the essence of these guidelines and practice them faithfully.

  • Point 2. Put a Written Diagnosis in the Chart. Many physicians who treat pain and prescribe opioids maintain voluminous records and eloquently dictate observations and treatments. The physicians chart may not, however, list a formal diagnosis. Without a formal, written diagnosis an outside observer or reviewer may get the idea that the doctor is simply following the patient for a lucrative fee or the doctor didn’t care enough to do a real evaluation. Worse, an outside reviewer may conclude that the patient doesn’t truly have pain.

    The written diagnosis must have two components:

    1. Pain Type
    2. Underlying Cause of Pain

    The pain can be described by the following terms:

    1. Chronic Pain– Persistent, Constant, or Intermittent
    2. Intractable Pain
    3. Chronic Pain Syndrome

    Once the pain is labeled, simply write “secondary to” the underlying cause. Here are some common examples:

    1. Chronic Pain–Intermittent— Secondary to Osteoarthritis of Lower Extremities
    2. Intractable Pain— Secondary to Fibromyalgia
    3. Chronic Pain Syndrome— Secondary to Degenerative Spine Disease

    The term “chronic pain syndrome” appears to be a term that is catching on. Many physicians like this term because it encompasses not only the pain, per se, but the panorama of complications and manifestations that are part and parcel of chronic pain.

  • Point 3. State Reason for Opioids on Your Prescriptions. There is a key point that is poorly understood about the necessity to place a written, pain diagnosis on the chart and on prescriptions. Opioids are only approved by the United States Food and Drug Administration for treatment of pain. If a pain diagnosis is not in the patient’s chart and noted on prescriptions, outside observers, including pharmacists, may believe that you are prescribing for an addict or for abuse purposes.

    Examples for Prescriptions:

    1. Oxymorphone 40mg, extended release — one at 7:00am and one at 7:00pm for intractable pain
    2. Hydromorphone 4mg — one every 4 to 6 hours as needed for breakthrough pain
  • Point 4. Educate Patient and Family. Remember the first tenet of malpractice and is almost always the situation with legal challenges involving pain treatment: The patient doesn’t sue; the family does.

    Patients who require long-term opioid therapy and their closest family members need to be educated about the following:

    1. Severe chronic pain is a disease with its own life-shortening complications;
    2. No other option but opioids may be viable;
    3. Medication must be taken as prescribed;
    4. When medication is properly prescribed and used it does not produce sedation or impair driving, working, and activities of daily living.
    5. Many pain treatments and medications are “off-label.”

    Patients and families must be educated as to the complications of pain, per se, or they may blame the physician and/or the prescribed medication as the cause of the problem. Any means of education is acceptable: clinic attendance, written materials, e-mail, or telephone. In particular, patients and families need to know about the recent studies which show that chronic pan may produce cerebral atrophy and its attendant loss of intellect or dementia. Chronic pan causes excess sympathetic, autonomic discharge and hormone abnormalities that may result in elevated cardiac and stroke risk, as well as severe infections.

    Most malpractice suits, to date, have involved patients who died and who consumed prescription drugs other than as prescribed by their physician. Also, patients usually took drugs that were unknown and unauthorized by their treating physician. A handout for patients involving “Sudden Deaths” is provided here for physicians to clip and use in their practices (see Appendix).

  • Point 5. See Patient Frequently. Pain patients who require opioids invariably also require ancillary drugs such as anti-depressants, benzodiazepines, muscle relaxants, nighttime sedatives, and other medications. Patients must be physically seen by the attending physician on a regular basis to observe for drug interactions or impairments caused by prescribed drugs. Monthly clinic visits are rather standard and are partially necessary due to the policy of insurance companies to only pay for a month of medications at any one time. Stabilized patients don’t need to be observed monthly. In many of the malpractice cases which this author has personally reviewed, the physician kept irregular office hours (i.e. late nights or “call in” to determine clinic hours, etc.) Sadly, some malpractice suits have revealed that pain patients go for extended periods without a clinic visit (i.e. up to a year) and only see the physician’s nurse practitioner (NP) or physician’s assistant (PA). Although these allied persons can do a majority of the ongoing medical management in stabilized patients, the physician must physically observe the patients from time-to-time to insure that the patient is progressing and that the NP or PA is accurately and competently making and recording accurate observations and giving sound advice.

  • Point 6. Routinely Observe Pulse Rate, Blood Pressure, Alertness, and Ambulation. At each clinic visit, note in the chart the pulse rate, blood pressure, and whether the patient is alert and has normal ambulation. Many malpractice suits claim that the pain patient was impaired by medications prescribed by the doctor. The only real defense in this situation is to show that, over time, the patient attended the doctor’s office and was alert and normally ambulated. The pulse rate and blood pressure are the simplest, cheapest, easy to assess measures of excess sympathetic discharge and catecholamine release that are present with poorly-controlled pain. If there is excess opioids or sedatives in the serum, blood pressure and pulse rate go down. A pulse rate above about 88 per minute should raise a question of poor pain control. The same for a blood pressure over about 130/90mmHg. Claims of undertreatment can be dispelled if the physician has an objective measure such as pulse rate and blood pressure in the patient’s chart.

  • Point 7. Justify the Use of Schedule II Opioids. Most of the malpractice suits concerning pain treatment involve the use of Schedule II opioids: oxycodone, fentanyl, morphine, and methadone. There appears great confusion as to when a Schedule II opioid should be pre-scribed. There are two indications. One is for the short-term pain of post-surgery or post-trauma. A reasonable length here would be 2 to 4 weeks. If used for chronic pain, however, the physician must justify the use of a Schedule II opioid due to their abuse and diversion potential.

    Justification for the use of Schedule II opioids is failure to control pain with a variety of non-opioid medications, and Schedule III and IV opioid drugs such as hydrocodone (Vicodin®, Lortab®, Norco®), codeine (Empirin®), and propoxyphene (Darvon®). The physician needs to draft a chart note, or use a check-off list to indicate that Schedule II opioids are being prescribed because the patient has failed trials with non-opioids and Schedule III and IV opioids.

  • Point 8. Heed Information From Third Parties. A patient who takes opioid drugs for pain will come in contact with numerous persons including pharmacists and family members. These third parties may witness an event or observe a prob-lem with the patient and contact the treating MD or his staff. Always be receptive to these messages because a failure to do so may result in a legal challenge. For example, the notorious malpractice cases of undertreatment which have made medical headlines all involved hospitalized or institutionalized patients whose family complained to the doctor that their loved one was not receiving enough pain relief. The physicians apparently ignored their plea and were subsequently prosecuted. Other high profile cases have occurred when the physician received third party reports that their patient was diverting drugs, yet the physician continued to prescribe them. Anytime a physician receives a third party report of undertreatment, diversion, abuse, or impairment, he/she should take necessary action to protect oneself—including a discharge of the patient.

  • Point 9. Don’t Withdraw Medication if Pain Still Persists. Various economic, religious, and anti-drug biases are still ubiquitous and exert great pressure on pain patients to withdraw or detoxify from opioid medication. Some of the bias is so unscientific and malignant that it suggests that the patient’s very pain is a result of their medication and pain will be miraculously cured if the patient with-draws from opioids.

    Physicians can simply deal with these pressures by informing all concerned parties that medication will always be necessary as long as pain is present. There is little question that opioids and some other medications may act as a sort of “splint” which allows healing, regeneration, and subsequent withdrawal. These cases are often used, however, by biased persons, as “proof” that opioids should not have been prescribed.

    Liability exerts itself if the physician abruptly stops opioids and a pain flare ensues. In these situations, a patient may also experience opioid withdrawal symp-toms.

    A pain flare combined with with-drawal symptoms produces a tremendous sympathetic, autonomic discharge state that may result in cardiac arrest or stroke. The cardinal rule is to make sure that no chronic pain patient who takes opioids abruptly runs out of medication and, if withdrawal is attempted, be pre-pared to re-start opioids should pain re-emerge. To prevent abrupt opioid with-drawal and prevent a severe pain flare, the author requires his patients to maintain a 10-day, emergency reserve of all medications.

  • Point 10. Don’t Just Prescribe Opioids. Although opioid drugs are the essential mainstay of chronic pain treatment, patients and families rightly regard them as representing a serious medical condition. While a patient may require them for life, all patients obviously hope their pain reduces to the point that they can stop or reduce opioids.

    Malpractice and other legal challenges tend to be brought against physicians who don’t prescribe or recommend non-opioid treatments. Ancillary, non-opioid prescriptions and treatments tend to make patients and families perceive that the doctor really cares and that there is hope in the future. For example, almost all chronic pain patients have troublesome symptoms such as insomnia, nausea, depression, muscle spasm, and symptomic treatment is available with a large number of non-opioid drugs. Recommendations for physical therapies, psychologic help, group involvement, and motivations for a better quality of life, all establish rapport and let patients and families know that their doctor is giving the patient his best effort. The summation of this point is not to be a physician that just refills opioids every so often.

Table 2. Ten-Point Protection Plan
  1. Follow national federation of state medical board guidelines.
  2. Put a written diagnosis in the chart.
  3. State reason for opioids on your prescriptions.
  4. Educate the patient and family.
  5. See patient frequently.
  6. Routinely observe pulse rate, blood pressure, alertness, and ambulation.
  7. Justify the use of schedule ii opioids.
  8. Heed the information of third parties.
  9. Don’t withdraw medication if pain persists.
  10. Don’t just prescribe opioids.
Table 3. Summary of Federation of State Medical Board Guidelines for Pain Treatment
  1. History and Physical Examination
  2. Treatment Plan With Objectives
  3. Informed Consent and Agreement for Treatment
  4. Periodic Review of Treatment
  5. Consultation’s When Necessary
  6. Compliance With Controlled Substance Laws and Regulations
  7. Written Medical Record

Case Examples

The following are illustrated cases reviewed by the author over the past several years. In each of these, a practicing physician was either sued or threatened to be sued and/or disciplined by his/her State Medical Board. In each instance a close adherence to the 10-point plan was preventive or could have been preventive.

Case 1.

Young adult male with docu-mented spine degeneration died sudden-ly and unexpectedly. He had intermittent episodes of tachycardia and hypertension. His daily medication was meth-adone, alprazolam, carisopriodol, and hydrocodone. Autopsy showed pulmo-nary edema. Toxicology showed the presence of his four prescribed drugs plus two other opioids, two benzodiazepines, and cannabinoids. The Coroner declared death due to intoxication.

Assessment. Gross non-compliance with physician prescribing. Only two of four opioids and one of two benzodiazepines were prescribed by the MD. Cannabinoids were not prescribed by the MD. The patient was clearly on a voluntary binge of abuse, however, his family sued the doctor and reported him to his State Medical Board. The patient didn’t want his family to be involved with his pain treatment, and the MD never talked with the family.

Case 2.

2. Young adult, obese male, who had spine and knee degeneration. He was stable on his medication regimen for over one year. He was found dead in bed. His medication consisted of methadone, a muscle relaxant, and an anti-depressant. Autopsy revealed pulmonary edema and dilated cardiomyopathy. Toxicology showed: methadone 3900ng/ml plus, hydrocodone, carisoprodol, and diaze-pam. Coroner declared multiple drug ingestion.

Assessment. Patient obviously ingested methadone in a dose far above that prescribed by the MD. He also had heart disease. The patient’s family sued the MD. They were unaware of his treatment. There was no monitoring of his blood pressure, or pulse rate on the chart.

Case 3.

Case 3. Middle age female with fibro-myalgia and migraine died unexpectedly. The medication regimen had been stable for over one year and consisted of metha-done 500mg/day and hydrocodone 80ng/ day. She was seen only two or three times a year. Blood toxicology findings were methadone 2700ng/ml, plus the presence of benzodiazepines. Coroner declared cause of death “over-ingestion of prescribed narcotics.”

Assessment. There was obvious non-compliance with physician prescribing. Despite this, the family sued the doctor on the basis that the doctor did not see her often enough.

Case 4.

A middle-aged woman developed a constant headache that did not respond to triptans but did respond to opioids. Her family, however, disapproved and talked her into stopping all her medications. Within 24 hours she apparently developed a severe pain flare while driving. She was followed by the Highway Patrol for 15 minutes of erratic driving before she ran into an embankment and died. An autopsy showed normal anatomic findings, and toxicology showed no opioids. The family sued the prescribing doctor but dropped the suit when they learned their loved one had succumbed to their wishes and stopped her medications only to die as a result.

Assessment. In this case the physician weathered the malpractice threat because he had never recommended the patient stop opioids since constant pain was still present. Furthermore, the physician had warned the patient and family that such a move could be disastrous.

Case 5.

A woman in her mid-30’s was in a motorcycle accident and developed reflex sympathetic dystrophy (RSD) of one leg as a result of trauma sustained in the accident. She belonged to a large pre-paid HMO which told her that her pain was psychological and refused to prescribe anything but muscle relaxants and anti-inflammatory agents. After she developed constant severe pain her RSD started to spread to her other extremities. Despite her pleas, her health plan only sent her to a pain class that preached the line that “pain is in the head and can be wished away.” She sought help from a pain physician outside her health plan who started opioid drugs that “gave her a new life.” She brought suit against her health plan and won an out-of-court settlement.

Assessment. It is clearly unacceptable today to tell patients that their pain is “psychological” and not in need of medication. Look for patient rights groups and plaintiff attorneys to take on physicians and health plans who make this type of claim and refuse to prescribe opioids when non-opioids don’t do the job.

Case 6.

A middle-aged man had a case of known hypertension requiring medication. His severe pain was due to spine degeneration and failed back surgeries. He required high dosages of oxycodone and hydrocodone to control his pain. His pain physician received a reliable third party report that he was selling some of his pain medication. Consequently, his physician discharged him. Before the patient could find an alternate source of care, he sustained a pain flare and died of a stroke. His wife sued and reported the physician to his State Medical Board. The physician had an accurate medical record that documented adherence to the National Federation of State Medical Board Guidelines. He saw the patient monthly and monitored his pulse and blood pressure. Consequently, all legal challenges were dropped.

Assessment. Patients who have bona-fide pain but who divert some of their medication put the prescribing MD in a precarious position. This is particularly true if the patient has concomitant cardiovascular disease and is at high risk of death during a pain flare.

Case 7.

Assessment. This case points out the protective effect of following the National Federation of State Medical Board guidelines, as well as regular clinic visits. Additionally, it shows that an immediate aggressive response by multiple physicians can force an end to legal challenges.

To a simple yes or no question, “Has prolotherapy changed your life for the better?” All of the patients treated answered “yes.” Seventy-seven percent of the patients reported that, overall, greater than 75% of their improvements resulting from prolotherapy remained positive after prolotherapy treatments ended. Of those whose pain/disability had increased since stopping the prolotherapy, 81% noted reasons for this occurrence. Fifty-five percent claimed the prolotherapy was stopped too soon (before 100% pain relief was achieved). Twenty-two percent reported a re-injury to the area. One hundred percent of patients knew someone who had received prolotherapy. Sixty-eight percent came to receive their first prolotherapy session on the recommendation of a friend. One hundred percent of patients have recommended prolotherapy to someone.

Case 8.

A female in her 20’s had fibromyalgia that didn’t respond to non-opioid drugs. She was started on long-acting morphine and short-acting opioids for breakthrough pain. She functioned very well on this regimen for about six years at which time she developed dementia and was unable to care for herself requiring her family to domicile her at considerable expense. The family, who had never been involved with her care or met her pain-treating physician sued the physician for prescribing opioids. The physician’s records were quite voluminous and the National Federation of State Medical Board Guidelines were clearly followed. Unfortunately, there was no record of family involvement and no monitoring of pulse rate or attempt to educate the patient and family about pain complications. Additionally, the physician had received third party reports that the patient abused cocaine and her medication, but he never had urine testing done or took any action to confront and possibly discharge her. In the lawsuit the family stated she never had pain. There was an out-of-court cash settlement against the MD.

Assessment. Education of the family is essential to prevent legal challenges. Dementia is now recognized as a possible complication of chronic pain. In this case, the patient apparently abused cocaine, and she may have also had tachycardia or other complications but these were not assessed during almost six years of opioid treatment. Failure to follow-up on a third party report of drug misuse was the MD’s downfall.

Case 9.

A middle-aged woman with fibromyalgia had her pain controlled with a modest dose of daily morphine that ranged from about 50 to 150mg. Her physician received a telephone call from a friend who informed him that she would sometimes over-medicate and become impaired. The patient was involved in a car accident in which a person was killed. Morphine was found in the patient’s blood and the doctor was held culpable.

Assessment. A third party report of over-medication can be a serious problem for the physician. In these cases, the family or caretaker must be enlisted for compliance or the physician should probably discharge the patient.

Case 10.

A middle-aged woman with degenerative spine disease had been treated with various opioids for several years. She had not responded to the usual corticoid interventions. She and her family wanted her to “detoxify” even though her pain persisted. She entered an in-patient hospital. Within 48 hours after stopping all opioids her pain began to flare and she asked the hospital to restart her opioids. They refused and the patient’s pain apparently flared to a point that she chose suicide by jumping out of a fourth story window. To avoid publicity, the hospital paid the family a large sum of money in an out-of-court settlement.

Assessment. If pain persists, with-drawal from opioids is hazardous. The physician should be prepared to re-start medication at any time during a withdrawal procedure if pain flares.

Summary

Malpractice suits and complaints to State Medical Boards now abound in pain practice, but they can usually be easily prevented with the ten-point plan presented here. It is essential to know that rarely does the patient sue. It is the patient’s family that will bring the legal challenge—by lawsuit and complaints—to a physician’s State Medical Board. Education of the family is essential. All parties need to understand that poorly-controlled pain has its own complications—such as dementia, hormone alterations, and over-stimulation of the cardiovascular systems—and that long-term opioid therapy may be essential. In the recent past, most legal challenges in pain practice simply involved the mere act of prescribing opioids. Today, the physician is being held accountable for undertreatment, unwarranted withdrawal attempts, and failure to heed warnings from third parties.

Appendix A
Patient Information Handout
Re: Sudden, Unexpected Death In Chronic Pain Patients

In recent years many chronic pain patients in treatment have suddenly and unexpectedly died without warning. “Sudden, without warning” is differentiated from the patient who knows they have a chronic medical condition such as diabetes, high cholesterol, or cancer. Sudden, unexpected deaths have multiple causes and every pain patient should know these causes and take specific precautions to prevent such an occurrence.
First, some patients have experienced a severe pain flare which caused heart stoppage and lack of oxygen to the brain. In some of these cases patients voluntarily stopped their pain medication in response to family members or others who didn’t approve of the patient’s pain medications. To prevent pain flares patients must never run out of medication and need to always maintain an emergency reserve of medications to control a severe pain flare.
A second major cause of sudden death in pain patients is patients who did not take their medication as prescribed on the label. In these cases pain patients sometimes died when they took medications in excess of what their pain doctor prescribed, and others took medication, particularly sedatives, tranquilizers, and muscle relaxants, not prescribed by their pain doctor. Some patients who suddenly died also drank alcohol or consumed other abusable substances on the same day that they took their pan medications. To prevent accidental overdoses and death, pain patients must take prescription medication only as prescribed and clear all prescription medication with their pain doctor. Alcohol and sedatives can only be consumed in very modest amounts on the same day the patient takes pain medication.
Patients who take methadone may develop heart stoppage due to a condition known as “electrical conduction defect”. This situation usually occurs when antidepressants or anti-seizure drugs are also taken. Patients who currently take methadone must be aware and accept this rare risk with methadone.
Another cause of sudden death in chronic pain patients is infection. Pain patients have an impaired immune system, so they are very susceptible to blood (“sepcis”) or pneumonia. All pain patients need to have a plan to acquire and use antibiotics at the first symptoms of an infection such as fever and chills.

Last updated on: December 27, 2011
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