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Diagnostic errorsby Laura Hale Brockway, ELS

Presentation

A 67-year-old man was admitted to the hospital at 2:40 p.m. under the care of an internal medicine physician. The patient had a history of abdominal pain, nausea, and vomiting for several days. The internal medicine physician wrote admission orders with a diagnosis of acute pyelonephritis. He ordered a gastroenterology consult and a CT scan of the abdomen to rule out kidney stones. He also ordered a full liquid diet for the patient. The physician had not seen or evaluated the patient when these admission orders were written.

Physician action

At 5:08 p.m., the internal medicine physician assessed the patient. He revised the admission orders, changing the diagnosis to “acute gastro-enteritis.” The internal medicine physician also changed the order for the CT scan to include contrast and changed the status to “stat.”

A gastroenterologist saw the patient at 7:20 p.m. He ordered an EGD to be performed the next morning. His progress notes indicated that

he was aware the CT scan was pending. The gastroenterologist contacted the internal medicine physi-cian to discuss his plan to perform the EGD.

At 7:44 p.m., the CT scan report became available in the hospital’s electronic medical record system. The results indicated a partial small bowel obstruction. A copy of the CT report was also printed on the surgical floor so the report could be placed in the patient’s chart.

At 11:10 p.m., a nurse on the surgical floor logged in to the hospital computer system and printed a copy of the CT report. However, neither this paper copy nor the one that printed when the CT report was generated, made it to the patient’s paper chart. The internal medicine physician logged on to the hospital’s EMR system at 11:15 p.m. and ordered a surgical consult. The plaintiffs later alleged that the internal medicine physician knew about the results of the CT scan, which explained why he ordered a surgical consult.

Nursing notes throughout the evening indicate the patient’s abdomen was distended with no bowel sounds. The patient vomited once and complained of indigestion.

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At 5:30 a.m., the patient signed a consent form for the EGD. A nurse examined him 30 minutes before the EGD and documented that his abdomen was distended with no bowel sounds. The gastroenterologist accessed the radiology records in the computer system at 8:22 a.m. for approximately 22 minutes. He claims he did not see the CT report. The patient was already in the endoscopy suite and anesthesia commenced at 8:30 a.m. The procedure began and the patient began vomiting violently after the endoscope tube was inserted. The gastroenterologist suctioned 700-800 cc of stomach contents with an NG tube. The patient was taken to the PACU. He was later intubated and transferred to the ICU on ventilator support due to aspiration of stomach contents.

The patient had a long hospital course. He experienced multi-ple complications including aspiration pneumonia, ventilator requirements, and deconditioning. The partial bowel obstruction resolved without surgical intervention.

Allegations

Lawsuits were filed against the gastroenterologist, the internal medicine physician, the radiologist, the anesthesiologist, and the hospital. The plaintiffs alleged that the EGD was contraindicated because the CT scan showed a dilated bowel and possible bowel obstruction.

Legal implications

The CT scan of the abdomen showed a small bowel obstruction. This report was available on the hospital’s computer system the night before the scheduled EGD. The access log shows that the gastroenterologist logged in to the system on two occasions after the CT report was in the system, but he apparently failed to see the CT report.

A nurse’s note — written approximately 30 minutes before the procedure — documented that the patient’s abdomen was distended with no bowel sounds. This note was available on the hospital’s system and the patient’s chart. The gastroenterologist testified that, when he examined the patient just before the proce-dure, his abdomen was not distended. This was not documented in the medical record.

Additionally, the gastroenterologist had to acknowledge that he was aware that a CT scan of the abdomen had been ordered, but he went forward with the EGD without knowing the results. He also testified that, had he known the CT report showed a partial bowel obstruction, he would have cancelled the procedure.

The internal medicine physician re-wrote the admission orders to change the diagnosis from pyelonephritis to gastroenteritis. He also changed the CT order to “stat.” The gastroenterologist did not follow up on these results, and he claimed that he never saw the results of the CT scan. The plaintiffs argued that he must have known about the CT findings since he ordered a surgical consult.

Disposition

The cases against the radiologist and the hospital were dropped. The cases against the gastroenterologist and the internal medicine

physician were settled prior to trial. The case against the anesthesiologist went to trial and the jury found in favor of the anesthesiologist.

Diagnostic errors

Efforts to improve patient safety often address issues such as medication errors, nosocomial infection, wrong-site surgery, postsurgical complications, and hand-offs. Diagnostic error — which is the leading cause of malpractice claims against primary care physicians — has received comparatively less attention. 1

This article will review the current research on the prevalence of diagnostic errors, identify common causes of diagnostic errors, and discuss ways to prevent these types of errors.

Prevalence

Determining the prevalence of diagnostic errors is challenging, particularly outside the fields of pathology and radiology. With the progressive decline in autopsy rates, physicians do not gener-ally receive feedback on their diagnoses. As a result, “diagnostic errors often are unrecognized or underreported, and the science of measuring these errors (and their effects) is underdeveloped.” 2

A few studies have attempted to measure the frequency of misdiagnosis, but these studies are limited by patient selection, inadequate standards for diagnosis, and issues of hindsight bias. The Harvard Medical Practice Study found that diagnostic error accounted for 14% of preventable errors in hospitalized patients. 3

Researchers analyzing the results of 53 autopsy studies over a 40-year period found that approximately 9% of patients experi-enced a major diagnostic error that went undetected until after the patient’s death. 4

“In aggregate, studies consistently demonstrate a rate of diagnos-tic error that ranges from <5% in the perceptual specialties (pathology, radiology, dermatology) and up to 10% to 15% in most other fields.” 5

Physician decision making

Other studies have examined the causes of diagnostic error at the individual physician level. This research has been influenced by findings from cognitive psychology, which studies how individu-als process information and make plans. 6

In cognitive psychology, most tasks are classified as involving schematic behavior or attentional behavior. Schematic behav-ior tasks are performed reflexively or on auto-pilot. Attentional behavior tasks require active planning and problem solving.

Errors associated with schematic behavior are known as “slips” and occur due to distractions, fatigue, or lapses in concentration. Errors related to attentional behavior are “mistakes” and are often caused by a lack of experience or training.

In health care, the majority of errors are caused by slips. Interven-tions such as checklists have been shown to greatly reduce the

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likelihood of errors due to slips. 7 Conversely, errors that involve attentional behavior — such as diagnostic errors — “require solutions focused on training, supervision, and decision support rather than standardizing behavior.” 8

When it comes to making diagnostic decisions, physicians frequently use heuristics or shortcuts to make a preliminary diagnosis, especially when treating a patient with common symptoms. “While heuristics are ubiquitous and useful, research-ers have used categories developed in cognitive psychology to classify several types of errors that clinicians commonly make due to incorrect application of heuristics.” Table 1 lists some examples. 6

Other causes of cognitive diagnostic errors include:

• Confirmation and related bias — “the tendency to seek out data that confirm one’s original idea rather than to seek out disconfirming data.”

• Context errors — characterizing a “problem in terms of the organ system involved, or the type of abnormality that might be responsible. In these situations, clinicians are biased by the history, a previously established diagnosis, or other factors, and the case is formulated in the wrong context.” (5)

In the closed claim study featured with this article, the physician diagnosed the patient with acute pyelonephritis, but later changed this diagnosis after examining the patient. The new diagnosis was “acute gastroenteritis,” but it was eventually discovered that the patient had a partial bowel obstruction. The internal medicine physician diagnosed the patient based on the available informa-tion, but then did not follow up on test results that would have altered the diagnostic and treatment plan. The gastroenterologist did not seek out additional information to confirm the need for the EGD.

Other causes

Diagnostic errors are not simply a consequence of cognitive biases on the part of caregivers. They result from multiple causes, such as poor teamwork and communication between physicians; poor communication between patients and physicians or patients

and staff members; lack of reliable systems for following up on test results; and patient noncompliance. Underlying health system issues — such as health insurance refusal to pay for diagnostic testing — also contribute to errors in diagnosis.

A study of diagnostic errors in the ambulatory setting published in the Annals of Internal Medicine found that few diagnostic errors were linked to single contributing factors. The study identi-fied the following as main breakdowns in the diagnostic process:

• failure to order appropriate diagnostic tests;• inappropriate or inadequate follow up;• failure to obtain an adequate medical history;

• failure to perform an adequate physical exam; and• incorrect interpretation of diagnostic test results. 8

In the closed claim study, the appropriate tests were ordered, but neither the internal medicine physician nor the gastroenterologist followed up on the results.

Preventing diagnostic errors

Efforts to reduce the occurrence of diagnostic errors focus on both physician cognitive process and health system factors. System-related suggestions to reduce diagnostic error include:

• “Ensure that diagnostic tests are done on a timely basis and that results are communicated to providers and patients.”

• “Optimize coordination of care and communication. Develop formal and universal ways to communicate information verbally and electronically across all sites of care.”

• “Continuously improve the culture of safety. Include diagnostic errors as a routine part of quality assurance surveillance and review; identify any adverse events that appear repeatedly . . .”

Suggestions to reduce diagnostic errors related to cognitive process include:

• “Take advantage of suggestions from the human-factors liter-ature on how to improve the detection of abnormal results.”

Cognitive Bias Definitions Example

Availability heuristic Diagnosis of current patient biased by experience with past cases.

A patient with crushing chest pain was incorrectly treated for a myocardial infarction, despite indications that an aortic dissection was present.

Anchoring heuristic (premature closure)

Relying on initial diagnostic impression, despite subsequent infor-mation to the contrary.

Repeated positive blood cultures and Corynebacterium were dismissed as contaminants; the patient was eventually diagnosed with Corynebacterium endocarditis.

Framing effectsDiagnostic decision-making unduly biased by subtle cues and collateral information.

A heroin-addicted patient with abdominal pain was treated for opiate withdrawal, but proved to have a bowel perforation.

Blind obedience Placing undue reliance on test results or “expert” opinion.

A false-negative rapid test for Streptococcus pharyngitis resulted in a delay in diagnosis.

Table 1. Types of errors

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• “Provide physicians with access at the point of care to the Internet, electronic medical reference texts and journals, and electronic decision-support tools.”

• “Have appropriate clinical expertise available when it’s needed. Facilitate referrals to appropriate subspecialists. Encourage second readings of key diagnostic studies . . . . and encourage second opinions in general.”

• “Encourage discussion of diagnostic errors. Encourage and reward autopsies and ‘morbidity and mortality’ conferences. Establish pathways for physicians who saw the patient earlier to learn that the diagnosis has changed.” 9

Risk management considerations

Physicians can consider the following guidelines to help reduce liability related to errors in diagnosis.

• Stay current with clinical practice standards that are applica-ble to your practice. Consider using computer-based decision support tools or other electronic resources at the point of care. If you use these resources, do not ignore the guidelines, alerts, and reminders these systems employ.

• Making an accurate diagnosis requires asking the right questions, conducting a thorough physical exam, and gather-ing clinical data.

• When possible, follow up with patients to ensure diagnostic accuracy. Repeat calls or visits from patients with ongoing complaints provide physicians opportunities to reassess the patient and identify an issue that may have been previously overlooked.

• Have a well-defined and consistently followed process to verify that test results have been received and acted upon. Processes should be developed for both diagnostic studies and specialist referrals.

• Even if the patient is advised to contact the practice in a set time frame, it is recommended that the physician have a follow-up system in place.

• When test results or consultant reports are received in the office, do not file the reports in a medical record until the ordering physician has reviewed, dated, and initialed

them. When caring for hospitalized patients, maintain open communication with all members of the health care team, including consulting physicians and hospital staff. Thorough patient evaluation and assessment — including reviewing nursing notes and directly communicating with consulting physicians — promotes optimal patient care.

Sources1. Physician insurers association of america. semi-annual data

sharing report. 2011 edition. January 1, 1985 to december 31, 2010. rockville, Md

2. Newman-Toker de, Pronovost PJ. diagnostic errors — the next frontier for patient safety. JAMA. March 11, 2009. 301;(10):1060-1062.

3. leape ll, brennan Ta, laird N, et al. The nature of adverse events in hospitalized patients. results of the Harvard Medical Practice study ii. N Engl J Med. 1991;324:377-384.)

4. shojania KG, burton ec, Mcdonald KM, Goldman l. changes in rates of autopsy-detected diagnostic errors over time: a systematic review. JAMA. June 4, 2003. 289;(21):2849-2856.

5. berner es, Graber Ml. overconfidence as a cause of diagnostic error in medicine. American Journal of Medicine. 2008. 121;(5a): s2-s23.)

6. agency for Healthcare research and Quality. Patient safety primers: diagnostic errors. available at http://www.psnet.ahrq.gov/primer.aspx?primerid=12. accessed october 6, 2011.

7. Haynes ab, Weiser TG, berry Wr, et al for the safe surgery saves lives study Group. a surgical safety checklist to reduce morbidity and mortality in a global population. N Engl J Med. 2009;360:491-499.

8. Gandi TK, Kachalia a, Thomas eJ, et al. Missed and delayed diagno-ses in the ambulatory setting: a study of closed malpractice claims. Ann Intern Med. 2006; 145:488-496.

9. Graber Ml. Taking steps towards a safer future: measures to promote timely and accurate medical diagnosis. American Journal of Medicine (2008) Vol 121 (5a),s43-s46.)

Laura Brockway can be reached at [email protected].

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Course authors

James F. Arens, MD is a graduate of Creighton University Medical School. He trained at Tripler Army Hospital in Hawaii and Charity Hospital in Louisiana. He is former professor and chairman of the Department of Anesthesiology at the University of Texas Health Science Center at Houston.

Dr. Arens served as the medical director for Memorial-Hermann Operating Rooms and president of the Texas Society of Anesthe-siologists. He is past president of the ASA, ABA, RRC, and ABMS, and has been chairman of anesthesia at four institutions. Dr. Arens speaks to physician groups on risk management issues specific to anesthesia.

Jay Henderson, JD is a partner in the law firm of Henderson, Block, and Elmore in Houston and Kerrville. He received his undergraduate degree from Texas A&M and his law degree from Baylor Law School. He has represented physicians in numer-ous drug and device lawsuits across Texas. Mr. Henderson is a member of the American Board of Trial Advocates and has been consistently voted a Texas Superlawyer. He speaks and writes regularly on liability issues related to drugs and devices.

Disclosure

The authors of this CME article have no commercial affiliations/interests to disclose related to this activity.

Target audience

This 2.5-hour activity is intended for physicians of all specialties who are interested in practical ways to reduce the potential for malpractice liability.

CME credit statement

Under newly revised AMA guidelines, physicians are now required to complete and pass a test following a CME activity in

order to earn CME credit. A passing score of 70% or better earns the physician 2.5 CME credits. Physicians will be allowed two attempts to pass the test.

Texas Medical Liability Trust is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. TMLT designates this enduring material for a maximum of 2.5 AMA PRA Category 1 Credits ™. Physicians should claim only the credit commensu-rate with the extent of their participation in the activity.

Ethics statement

This course has been designated by TMLT for 1 credit in medical ethics and/or professional responsibility.

Discount

TMLT policyholders who complete this course will earn a 3% discount (maximum $1,000) that will be applied to their next eligible policy period. Instructions

You have two options to obtain CME credit from this activity.

Option 1 – online

Complete Reporter CME test and evaluation forms online. After reading the article, go to www.tmlt.org/reporterCME. Click on “Earn CME” under “Pain management — clinical and legal perspectives” (2011 Volume 6). Follow the instructions to complete the test and evaluation forms. Your CME certificate

Pain management — clinical and legal perspectivesObjectives

1. discuss statistics about chronic pain and its associated costs;

2. recognize common patient conditions that cause chronic pain;

3. access resources and tools available to physicians for guidance in pain management;

4. discuss statistics relevant to prescription drug abuse;

5. identify state and federal requirements for controlled substance prescriptions; and

6. list steps that can be taken to help prevent drug diversion.

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will be emailed to you. Please allow up to 4 weeks for delivery of your certificate

Option 2 – on paper

Please read the entire article and answer the CME test questions on the paper test forms on pages 20-23. To receive credit, submit the completed test and evaluation forms to TMLT. All test questions must be completed. Please print your name and address clearly. Please allow 4 to 6 weeks from receipt of test and evaluation form for delivery of the certificate. Questions? Please call the TMLT Risk Management Department at 800-580-8658, ext. 5919.

Estimated time to complete activity

It should take approximately 2.5 hours to read this article and complete the questions.

Release/review date

This activity is released on December 1, 2011 and expires on December 1, 2014.

by James F. Arens, MD

Types of pain

Pain is “an unpleasant sensory and emotional experience associ-ated with actual or potential tissue damage or described in terms of such damage.”

One distinction between acute and chronic pain is that chronic pain persists for an interval of three to six months. Another definition is that chronic pain extends beyond the expected period of healing. In the American Society of Anesthesiologists (ASA) 2010 Practice Guideline for Chronic Pain Management, “chronic pain is defined as pain of any etiology not directly related to neoplastic involvement, associated with a chronic medical condition or extending in duration beyond the expected tempo-ral boundary of tissue injury and normal healing, and adversely affecting the function or well-being of the individual.” Neoplastic involvement is excluded because there is another Practice Guide-line for Cancer Pain Management.

Pain is usually subdivided into nociceptive and neuropathic pain. Nociceptive pain is further subdivided into somatic and visceral pain.

Somatic pain often follows the distribution of a somatic nerve and is sharp in nature. It may be constant or periodic. Visceral pain is diffuse and described as dull or aching. The pain referred to as gallbladder pain may be felt in the scapular area. Patients frequently are nauseated.

Neuropathic pain results from damage or dysfunction of nerves in either the peripheral or central nervous system. The pain is often described as burning or electric. A small stimulus may elicit severe pain. Occasionally the pain may present as a dysesthesia—e.g., hand going to sleep. Neuropathic pain is often more difficult to treat than nociceptive pain. For example, post thoracotomy pain may be nearly disabling and yet resistant to almost all forms of therapy. Sciatica is another form of neuropathic pain.

Statistics

Discussing statistics for pain is very difficult because of the ill-defined nature of pain. In prostate cancer, outcomes are discussed in terms of well-defined Gleason scores. Coronary artery surgery outcomes can be linked to the ejection fraction or the quality of the anastomoses.

Survival from breast cancer surgery is determined by staging criteria. However, pain is subjective and measured in terms of very imprecise criteria such as the scale of one to ten or happy to sad faces.

Pain perception may vary from nationality to nationality, socio-economic environments, emotional variations, possible financial implications secondary to pain, etc. Thus, a physician faces many dilemmas when attempting to diagnose pain, such as determining the severity and prescribing the appropriate therapeutic regimen.

Some estimate that in the United States 50-60 million people suffer from chronic pain, or one in six patients. Dr. Richard Rosenquist, the chair of the ASA Committee on Pain Medicine, says that the American Pain Foundation states that up to 75 million patients in the U.S. are affected by pain. The incidence seems to be higher in women. The CDC states that chronic pain is the leading cause of disability in the U.S. and may occur in as many as 90% of cancer patients. Sixty-five percent of primary care patients report having pain. A European study revealed that 19 percent of those surveyed over 18 years of age had pain for more than six months with pain being 5 or more on a scale of 10.

Of these 4839 patients with pain:

• 34% had severe pain 8-10;• 46% had constant pain;• 21% had depression due to pain; and• 19% had lost a job.

These patients also noted sleep disturbances, insomnia, decreased physical activity, weakened immune systems, change in mood (especially hopelessness), irritability, and anxiety. 1

According to the American Academy of Pain, one in every two Americans has pain and one of every four has chronic pain. About four in ten say that pain interferes with their life activities. Thirteen percent of the total work force experienced a loss of productive time during a two-week period due to a chronic pain condition.

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The percentages for each pain condition were stated as follows:

• 5.4% for headaches;• 3.2% for back pain;• 2% for arthritic pain; and• 2% for musculoskeletal pain.

Surgery is often associated with postoperative chronic pain. The incidence of chronic pain following certain types of surgery is as follows:

• limb amputation: 30-80%;• thoracotomy: 22-70%;• cholecystectomy: 3-56%; and • inguinal herniorrhapy: 0-37%

The above accounted for a $61.2 billion loss in productive time. Seventy-five percent of these workers showed health-related reduced performance. 2

On June 29, 2011, the Institute of Medicine (IOM) released a report: Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. The report states that chronic pain affects an estimated 116 million American adults at a cost of up to $635 billion each year for medical treatment and lost productivity. This is more than what is spent for heart disease, cancer, and diabetes combined. Because pain varies from patient to patient, a treatment plan needs to be tailored for each patient. Self management of pain should be promoted once a tailored plan is designed. The report also states that the risk of suicide is high in chronic pain patients. Five percent of patients with chronic musculoskeletal pain have attempted suicide, as did 14% of patients with chronic abdominal pain. 3

Back pain

According to the American Academy of Family Physicians, back pain is the fifth most common reason for a physician visit. Nine out of ten adults will have back pain some time in their lives. Five out of ten have had back pain in the past year.

In the U.S., back pain is the fifth most common diagnosis for hospitalization and the third leading cause of surgery. Therapies frequently include medications, acupuncture, local electrical stimulation (TENS), surgery, psychotherapy, use of placebos, relaxation methodologies including massage, biofeedback, and behavior modification including weight loss. Weight loss and exercise are certainly not stressed enough for patients suffering from back pain. These patients also seek chiropractic care or alternative forms of treatment. 4

In 2005, $85.9 million was spent for relief of back pain through surgery, physician visits, x-rays, MRIs, and medications. In this same time frame, 15% of Americans had back pain, up from 12% in 1997. The annual cost of therapy for back pain per patient treated in the same time period increased from $4695 to $6096. In high surgery areas, five per 1000 patients had back surgery versus

0.6 patients per 1000 patients in low surgery areas with no differ-ences in the incidence of back pain. This is no different from studies that have shown similar differences in the rate of coronary artery bypass procedures in our own state. 5

It has been estimated the direct costs of back pain in the United States are $15 billion annually. These data were obtained from more than 23 million patients. The $15 billion are broken down as follows:

• inpatient visits: $4.5 billion• outpatient visits: $2 billion• office-based: $5.75 billion• prescriptions: $94 million• home health visits: $725 million• ED visits: $557 million 6

The direct cost of work-related back pain is $2.7 billion. The direct cost of missed work days is $5.4 billion. Interestingly, most back pain injuries occur outside the work place. Back pain accounted for 23% of all worker compensation claims and repre-sented 33% of the total cost. 7

Headaches

It is estimated that 4% of the U.S. population suffer from daily headaches. Many of these are rebound headaches caused by the overuse of medications. The economic impact of headaches is thought to be $5 to $13 billion per year. This includes time off from work, inability to work at full capacity, and costs of medical care. Up to 9% of patients report having the occasional tension headache.

The three major categories of headache are: 1) primary headaches — migraine, tension, cluster;

2) secondary headaches — underlying causes such as intracranial bleeds, tumor, meningitis; and

3) cranial neuralgias, facial pain.The treatment of primary headaches is primarily by the use of standard medications. The major concerns are unexpected complications from the prescribed medication, such as Reyes syndrome or masking serious underlying causes such as meningi-tis, tumor, or even carbon monoxide poisoning.

Trigeminal neuralgia — tic douloureax — is a very painful type of neuralgia in the facial area. Pain is often unilateral, described as electric shocks, and precipitated by ordinary activities such as brushing one’s teeth or chewing. Anti-seizure drugs such as gabapentin or carbamazine; muscle relaxants such as clonazepam; or tricyclic antidepressants can be used. If necessary the nerve may be destroyed by the injection of alcohol or phenol, surgical excision, or stereotactic radiosurgery.

The World Health Organization estimates the cost of migraine headaches in lost work productivity to be $5.6 to $17 billion per year. Migraines may affect up to 28 million U.S. patients per year.

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Migraines occur more commonly in women than in men. About half of migraines are preceded by a warning sign (aura) such as irritability, yawning, and 20% are preceded by an aura such as scotomata.

Migraine treatment includes over-the-counter medications such as acetaminophen and non-steroidals; tryptans such as Imitrex; ergotamines; Midrin-a drug combining a vasoconstrictor, a pain reliever, and a sedative; or Valproate injectable if oral medica-tions cannot be tolerated because of nausea. Prophylactic medications include beta blockers, calcium channel blockers, and tricyclic antidepressants.

Triggering agents for migraines should be avoided. These can include excess stress, flashing lights, red wine, aged cheeses, nitrites, caffeine, etc. Menstruation may also serve as a trigger. Fortunately, these headaches tend to become less severe with age.

Fibromyalgia

Fibromyalgia is defined by the Mayo Clinic as a “disorder characterized by widespread musculoskeletal pain accompanied by fatigue, sleep, memory and mood issues.” It may be related to allodynia, a heightened and painful response to pressure especially dealing with muscle and fibrous tissues. Some refer to fibromyalgia as a synonym for chronic fatigue syndrome. Fibro-myalgia remains a controversial diagnosis. 8

The cause of fibromyalgia is unknown, but many theories are being reported to explain the etiology. Peter White of the London Barts and White School of Medicine states the incidence is 35 cases per 100,000 people with the incidence being 4:1 greater in females with an average age of 48. 9

Newer diagnostic criteria include:

1) widespread pain lasting at least 3 months; and

2) no underlying condition causing the pain.

With such poorly understood mechanisms and definitions, there are a wide variety of treatments for fibromyalgia, such as analge-sics, antidepressants, and anti-seizure medications like pregabalin, the first drug approved for the treatment of fibromyalgia. Alterna-tive therapies include yoga, acupuncture, and massage.

TV advertising is a clue to the economic impact of this ill-defined disease. In 2007 Pfizer data listed the worldwide sales for pregab-alin at $1.8 billion, a 50% increase over a one-year period. Pfizer spent $46 million advertising for medications to treat a disease that is a diagnosis of exclusion.

Arthritis

Arthritis is an inflammation of one or more joints resulting in pain, swelling, stiffness, and limited motion. The symptoms may range from mild to debilitating pain. There are many forms of arthritis. Osteoarthritis is the most common and likely occurs as a person ages. Risk factors include obesity, previous injury, and repetitive motion in certain joints such as workers doing heavy lifting or in athletes.

Rheumatoid arthritis (RA) is another common form of arthritis and thought to be an autoimmune disease and is more prevalent in women. Diagnostic blood tests include anti-CCP; C-reactive protein; sedimentation rate; and rheumatoid factor. A variety of medications are used to treat RA, such as non-steroidals, celecox-ib (Celebrex), methotrexate, and corticosteroids.

Surgical treatments such as synovectomy may be used to improve finger motion. In severe cases, joint replacement may be neces-sary. These cases are especially challenging for anesthesiologists since this systemic disease may affect areas such as the larynx, cervical spine, temporomandibular joint, lung, and heart. Region-al anesthesia is often difficult due to the patient’s inability to be comfortable for long periods of time on an OR table.

The National Institute of Arthritis and Musculoskeletal and Skin Diseases estimates the incidence of arthritis to be 1 in 7 (13.6%) on a group of 37 million U.S. patients. The disease affects patients as follows:

• osteoarthritis: 20 million• rheumatoid arthritis: 2.5 million• gout: 275 per 100,000 patients.

Complex regional pain syndrome

Complex regional pain syndrome — causalgia-reflex sympathetic dystrophy — occurs in 1-2% of patients following fractures and in 2-5% of patients with peripheral extremity injuries. It was first noticed in soldiers who had sustained gunshot wounds to their extremities in World War I.

The pain begins as a continuous burning or throbbing pain with extreme sensitivity and swelling in the affected areas. The skin is red at first but changes to a blue discoloration with time. An early clue is that the patient will abruptly withdraw his or her hand when one attempts to shake hands. As the condition progresses, disuse atrophy occurs along with hair loss, joint stiffness, and loss of use of the involved extremity, such as frozen shoulder.

Early treatment can prevent many side effects. Repeated sympa-thetic blocks are often effective, and occasionally a surgical sympathectomy may be indicated. Infusion of vasodilator drugs into an extremity with a tourniquet applied can also produce a sympathectomy. Early physical therapy is a key to preventing future disability. Analgesics, non-steroidals, and steroids have been used with some success. However, because this condition is frequently misdiagnosed, treatment is often delayed.

Cancer pain

I had the experience of a lifetime to work at a cancer research center for several years. As a physician I witnessed the ravages persistent pain causes cancer patients in various stages of the disease. Patients would occasionally come to surgery on what were called “industrial doses” of narcotics. For post-operative pain control, I found it necessary to consult our “pain service” to

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write the orders for the narcotics since I had little experience in managing patients on such high doses of narcotics.

Cancer occurs in 3% of the U.S. population or 10 million patients. An estimated 20-50% of these patients have pain at the time of diagnosis. Seventy-five percent of patients with advanced cancer have pain. While 80% of all cancer patients describe their pain as moderate to severe. 10

With the identification of pain as the fifth vital sign, “pain control has become an essential part of comprehensive cancer care.” A patient’s length of survival and responsiveness to oncologic treatment may be related to adequate pain control. Better pain control allows for increased mobility and better physical condi-tioning, and thus less likelihood of pulmonary embolism and pressure sores. 11

The pain may be related to the cancer itself, tumor impingement, metastases, or treatment including radiation therapy, surgery, or chemotherapy. Confounding factors include anxiety, intractable depression, nausea and vomiting, anorexia, decreased exercise tolerance, sleep deprivation, loss of self-esteem, feelings of hopelessness, and family-related issues such as impending divorce, fear of death, and financial worries.

Pancreatic cancer frequently causes intense upper abdominal pain. Unexpected continued weight loss or severe pain penetrat-ing to the back is often the presenting symptom. Pancreatic cancer is often associated with a life span of only about six months; thus, aggressive therapy is warranted for severe pain.

Many conventional adjuvant medications are used in the early stages of cancer pain management. Weak opioids such as hydro-codone and codeine may be effective for varied periods of time. Stronger opioids such as morphine, fentanyl, and hydromorphone may be employed next. It may be necessary to gradually increase the dosage of these medications to what some might think are excessive doses. A physician at the cancer research center provided two such examples.

• A 55-year-old man with lung cancer eroding into the chest wall was on methadone 80 mg qid and hydromorphone 8-16 mg q 4 hours around the clock in addition to gabapentin, amitriptyline, and numerous nerve blocks.

• A 42-year-old woman with retroperitoneal pain secondary to renal cell carcinoma was on MS Contin 400 mg tid and hydro-morphone 8-12 mg q 3 hours prn. She then had a pump inserted and received intrathecal morphine 15 mg per day and oral fentanyl 1200 micrograms up to 6 times a day for breakthrough pain.

Continued failure to provide adequate pain relief with such potent opioids will lead to the exploration of other alternatives such as neurolytic procedures, implanted intrathecal catheters, neuro-stimulators, etc. Neurolytic procedures are performed on a variety of nerve struc-tures. Severe pain involving the brachial plexus may be treated

with a continuous infusion of a local anesthetic or by neurolysis with phenol. However, permanent extremity paralysis will occur along with possible destruction of nearby nerves such as the phrenic or laryngeal.

Head, neck, and brachial plexus pain may subside after a stellate ganglion block. Once successful relief occurs following a block with a local anesthetic, a neurolytic or surgical sympathectomy may be performed. Major risks of the injection include inadver-tent subarachnoid injection, pneumothorax, or erosion of nearby vessels. A lesser but bothersome patient complaint may be persistent ptosis, which is treated by the insertion of neosyn-ephrin eye drops.

Postural hypotension is a frequent side effect of coeliac plexus blocks that may require use of an abdominal binder. GI hyper-motility with diarrhea may occur. Spinal or epidural injec-tion is another risk, along with hemorrhage from erosion of nearby vessels. Permanent coeliac plexus blocks should only be performed by very experienced physicians. Appropriate informed consent from the patient is warranted due to the inherent risks.

Subarachnoid neurolysis with alcohol may be performed in a patient with debilitating pain from rectal or pelvic cancer, but the residual paralysis is permanent. The ASA Task Force on Chronic Pain Management states that “chemical denervation should not be used in the routine care of patients with non-cancer pain” where-as “cryoablation may be used in the care of selected patients; e.g., post thoracotomy pain syndrome, low back pain and peripheral nerve pain.”

Radiofrequency (RF) procedures are used as a tool to treat a variety of chronic pain syndromes by interrupting or altering nociceptive pathways at various sites. Continuous radiofrequency is more commonly used than pulsed radiofrequency. Continuous radiofrequency produces a thermal lesion in a nerve, nerve root, spinal cord or ganglion. It is frequently used to treat trigeminal neuralgia. It can be used to ablate an occipital nerve for occipital headaches as well as other pain syndromes. At this time, pulsed radiofrequency has fewer uses but may be used in patients refrac-tory to other therapeutic modalities.

Intraspinal opiates and/or analgesics can be used to treat refrac-tory pain. Pump failure may occur along with catheter disruption or malfunction including catheter clogging. Infection is always a possibility especially in the lower back region. Complications may occur secondary to the opiates. Patients may fill their own pumps with a host of illicit or non-sterile substances.

Vertebroplasty and kyphoplasty may be used to treat compression fractures due to malignancies or osteoporosis. Very good pain relief is often seen in patients following this procedure.

A strong palliative care program should be in place in a compre-hensive cancer pain center. It is important that patients believe that their physicians have not given up on them, but care should be taken to empathetically avoid giving unrealistic expectations.

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Treatment options

As discussed earlier, there are a host of treatment options for chronic pain.

1) The initial plan will include such medications as acetamino-phen and non-steroidals (NSAIDS).

2) Anticonvulsant medications used include pregabalin, gabapentin and carbanazepine

3) Antidepressants employed include: tricyclics and serotonin and norepinephrin uptake inhibitors.

4) Topical medications such as: creams containing capsaicin, menthol, and skin patches containing local anesthetics.

5) Narcotics will be used to treat more severe pain and include oral, intra-muscular and intravenous forms of codeine, fentanyl, morphine, oxycodone, and fentanyl skin patches.

6) Various nerve blocks previously mentioned may be used.

7) Radiofrequency ablation techniques may likewise be employed.

8) Transcutaneous electrical nerve stimulators have been used with varying success.

9) Trigger point injections are frequently employed.

10) Spinal cord stimulators are considered for severe cases.

11) Intrathecal pumps injecting local anesthetics and/or narcotics may be employed.

12) Radiation therapy can be employed to shrink tumors and relieve pressure on the nerves.

13) Stress reduction including biofeedback mechanisms can be useful in some patients.

14) Appropriate counseling can be valuable.

15) Acupuncture can be a valuable adjunct.

16) Other therapies also may be helpful include chiropractic care, massage, yoga, and hypnosis.

17) Encouraging an active life style (if the patient’s condition allows it) is recommended.

18) Marijuana has been advocated by some for pain relief and to reduce nausea and vomiting, especially in cancer patients. However, on July 8, 2011, the Drug Enforcement Adminis-tration ruled that marijuana has “no accepted medical use” and remains illegal under federal law regardless of conflict-ing state legislation. This ruling was in response to a 2002 petition to reclassify cannabis as a Schedule 3, 4 or 5 drug. Following this ruling, cannabis remains a Schedule 1 drug and is illegal for any use. This is in conflict with a 1999 Institute of Medicine report that suggested there may be a potential therapeutic effect for cannaboid drugs.

Common side effects associated with narcotic use include consti-pation, ileus, urinary retention, nausea and vomiting, and pruritus. Respiratory depression, regardless of the route of administration, is of great concern. This issue is currently being reviewed by the

Anesthesia Patient Safety Foundation.

Newer techniques such as end tidal carbon dioxide monitoring play an important role, but have important limitations. However, even the most sophisticated technologies may not be sufficient without close monitoring by a well-trained health care professional.

Ethical issues

The ethical issues involved in pain management range from under-treatment of pain to excessive use of medications. Success-ful medical liability cases have been won based on these types of allegations. Undertreated pain has been reported in adult and pediatric ICUs, nursing homes, and outpatient cancer facilities.

It is understandable how the under-treatment of pain can occur, given the potential risks involved in pain management therapy. In addition, judging the severity of pain is very difficult. A patient may be reflecting allodynia or a stimulus causing excruciating pain. The ability of patients to tolerate pain is also variable and multifactorial. Patients may also use their pain complaints to support their addictive behaviors.

Guidelines

There have been multiple guidelines developed for the manage-ment of chronic pain. An ASA “Practice Guideline for Chronic Pain Management” was published in the April 2010 issue of Anesthesiology. (12) The ASA issued a practice guideline for cancer pain management published in Anesthesiology in May 1996. (13) The ASA has also issued a “Practice Guideline for Acute Pain Management in the Perioperative Setting” that was published in Anesthesiology April 1995 and amended by the ASA House of Delegates on Oct 15, 2003. 14

The Arizona Medical Board has issued Guidelines for the Treat-ment of Chronic Pain. The American Medical Directors’ Associa-tion issued a clinical practice guideline in 2009. The American Pain Society has issued guidelines for the following conditions:

1. Guidelines for Migraine Headache

2. Guidelines for Sickle Cell Pain

3. Guidelines for the Complex Regional Pain Syndrome

4. Guidelines for Chronic Pain in Older Patients

5. Guidelines for Chronic Pain Syndrome Patients

The APS also published “Nonsurgical Interventional Therapies for Low Back Pain” in 2009.

Conclusion

The incidence and overall cost of chronic pain to society remains poorly understood even in 2011. This may explain why special-ization in pain medicine was not seen until the late 1970s to early

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1980s. Of the various approved fellowships in anesthesiology, pain medicine is currently the most popular.

Because pain syndromes can be complex, there is a trend towards comprehensive pain programs rather than a practice featuring one physician. Although the advances seen in pain medicine are impressive, many patients still experience chronic pain. The possibilities for major advances in the diagnosis and treatment of pain are numerous and exciting.

Sources1. brevik, H. et al: survey of chronic Pain in europe. Eur J Pain 10:287,

May 2006.

2. Perkins, FM et al: chronic Pain Following surgery. Anesthesiology 93: 1123, 2000.

3. institute of Medicine: report from the committee on advanc-ing Pain research, care, and education: relieving Pain in america. a blueprint for Transforming Prevention, care, education, and research. The National academies Press, June 29, 2011.

4. american academy of Pain Website.

5. Marten, brock. us back Pain costs rise. JAMA Feb 2008.

6. Mychaskew, M. & Thomas, J. direct costs of back Pain in The united states-a National estimate--Jan 2003 in Google answers.

7. Martzel, a et al: The economic burden of low back Pain: a review of studies Published between 1996 and 2001.

8. best Practice and research clinical rheumatology 16:23 Jan 2002.

9. Professional Guide to diseases, Ninth edition. lippincott, Williams, and Wilkins, 2008.

10. Weir, PT et al: The incidence of Fibromyalgia and its associated co-morbidities. J Clin Rheumatology 12;124, June 2006.

11. cousins, M.J., bridenbaugh, P.o. et al: Neural blockade, lippincott, Williams, and Wilkins, 2009.

12. Practice Guidelines for chronic Pain Management. Anesthesiology 112: 1, april 2010.

13. Practice Guidelines for cancer Pain Management. Anesthesiology 84: 1243, May 1996.

14. Practice Guideline for acute Pain Management in the Perioperative setting. Anesthesiology april 1995. amended on oct 15, 2003.

James F. Arens, MD can be reached at [email protected].

by Jay Henderson, JD

Introduction

Pain has become one of the most common reasons patients seek medical treatment. Among the treatment options for pain are controlled substances — including opioids — that can be an effective therapy for select patients with chronic and acute pain. However, opioids are also associated with potentially serious side effects, including substance abuse, the risk of overdose, and the potential for diversion. 1

Recent reports and headlines have drawn attention to these problem areas by highlighting the unfortunate acts of a few physicians alleged to have abused their medical privileges. In Houston and Dallas media stories have included allegations of physicians running illegal pain management clinics and dispens-ing non-therapeutic prescription drugs to patients who later overdosed on the medications. 2,3 The Texas Medical Board (TMB) disciplinary actions related to non-therapeutic prescrip-tions, inadequate record keeping, and other dispensing viola-tions have also made their way into the news, causing additional scrutiny of physicians. 4

On the national level, the statistics on pain medication use are alarming. The Office of National Drug Control Policy (ONDCP) recently issued a formal report, acknowledging that prescrip-tion drug abuse is the nation’s fastest growing drug problem. Citing the National Survey on Drug Use and Health, the ONDCP reports a marked decrease in the use of illegal drugs; however, nearly one-third of those who used drugs for the first time in 2009 began by using a prescription drug non-medically. Pharma-cies dispensed more than 257 million prescriptions for opioids in 2009, an increase of 48% from 2000. 5

While the report states that there must be a balance between minimizing the abuse of these drugs and the need to ensure access for their legitimate use, emphasis is placed on educating patients and health care professionals. In fact, the ONDCP includes as one of its action items for Congress a requirement that practitioners be trained on opioid prescription practices as a pre-condition of their DEA registration. 6

As these statistics, reports, and media coverage become more prominent, there is mounting scrutiny of individual physician practices. Physicians fear being investigated, but at the same time are reluctant to leave a patient’s pain untreated or undertreated.

Effective pain management involves the challenges of provid-ing analgesia appropriate to the patient while reducing risks of aberrant drug-related behaviors and negative outcomes. The physician must strike a delicate balance to provide effective pain management while being compliant with state and federal

Pain management — legal perspectives

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regulations and being aware of patient drug diversion tactics. To navigate through these issues, this article will examine the current federal and Texas rules and regulations regarding pain manage-ment and prescribing controlled substances. In addition, we will discuss the many challenges physicians face with regard to diver-sion and how to best mitigate this risk in your practice.

Rules and regulations related to pain management

There are numerous federal and state laws that govern medical professionals and their use of controlled substances. The Texas Controlled Substances Act (TCSA) governs the handling of controlled substances in the state — who may dispense them, how prescriptions are written and filled, and what records must be kept. 7 The Texas Department of Public Safety (DPS) regulates controlled substances and enforces the provisions of the Texas CSA. Additionally, the Texas Occupations Code contains the Medical Practice Act, which addresses physician conduct and also includes the Intractable Pain Treatment Act. Further, there are guidelines, rules, and definitions issued by the TMB under Chapter 170 of the Texas Administrative Code concerning the physician’s assessment and treatment of pain.

The Controlled Substances Act (CSA) of 1970 sets forth the federal law regarding controlled substances in the United States and the Drug Enforcement Administration (DEA) is the federal agency responsible for its enforcement. 8 Federal law takes prece-dence over state law. However, the laws of the state in which a physician is licensed and practices may be more restrictive than federal law. 9 These laws are discussed below.

Texas Controlled Substances Act

The laws related to controlled substances are found in the Texas Controlled Substance Act (TCSA). 10 To clarify, controlled substances are heavily regulated due to their high risk of abuse. They are rated in the order of risk. Schedule I substances have the highest abuse potential and Schedule V substances have the lowest potential for abuse. The schedules are established by the DEA. 11 Pursuant to section 481.032(b) of the TCSA, the sched-ules are updated in the Texas Register, and a full list is available at the website of the Texas Department of Health Drugs and Medical Devices Group. 12

• Schedule I drugs carry an extremely high risk of abuse and addiction and have no safe medical use in the U.S. Examples include heroin, marijuana, LSD, PCP, and crack cocaine.

• Schedule II controlled substances (“C-II”) also carry a high abuse risk; however, they have safe and accepted medical uses in the U.S. These include certain narcotic, stimulant, and depressant drugs such as morphine, cocaine, oxyco-done, fentanyl, and other opioids. The requirements for C-II prescriptions as compared to those in other schedule risk levels are much more stringent and are further discussed below.

• Schedule III, IV or V drugs include medications that have an abuse risk less than Schedule II medications and have safe and accepted medical uses. However, these drugs contain

smaller amounts of certain narcotic and non-narcotic drugs. These include anti-anxiety drugs, tranquilizers, sedatives, stimulants and non-narcotic analgesics such as acetamino-phen with codeine, diazepam, and alprazolam. 13

Physician registration

Subchapter C of the TCSA outlines the regulation of manufac-turing, distribution, and dispensing of controlled substances. In order to prescribe a controlled substance in Texas, section 481.061(a) requires that a practitioner be registered with the state. The registration process is administered through the Texas Department of Public Safety (DPS) and is renewed on an annual basis. 14 A practitioner who prescribes or dispenses any controlled substance must also register with the DEA. Registration is through the DEA’s Office of Diversion Control and is applicable for three years. 15

Texas Prescription Program and the Texas Department of Public Safety

The prescription requirements for Schedule II controlled substances in Texas are set forth in the state’s prescription monitoring program known as the Texas Department of Public Safety Prescription Program. 16 Diversion is a significant abuse problem, and the program was created as an efficient tool for investigating and preventing drug diversion. The DPS manages this program and tracks prescriptions for Schedule II substances. Federal controls monitor substances from manufacture through distribution to retail facilities; however, most pharmaceuti-cal drug diversion occurs at the retail and consumer level. The Texas program follows and monitors the substance to the point of ultimate use. 17 The Texas program can also be used by health care professionals to verify their own records and inquire about patients. 18

The program includes the use of an official prescription form, and the physician must include the following information in order for a valid Schedule II prescription to be dispensed:

• the date of the prescription; • the controlled substance prescribed; • its quantity; • intended use and instructions for use; • the practitioner’s name, address; • DEA number; • the patient’s name, address and age or date of birth; and• signatures of the prescribing practitioner and dispensing

pharmacist. 19

If the prescription is to be filled at a later date, the prescriber must also note the earliest date in which the pharmacy may fill the prescription. Not more than one prescription may be recorded on an official prescription form. 20 In addition, a prescription written for any Schedule II controlled substance must be filled within 21 days from the date of issue. 21 Refills are not allowed for Schedule II substances; however, a physician may issue multiple prescrip-

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tions for a total of a 90-day supply if there are instructions for it to be filled at a later date. 22 In this instance, the physician needs to evaluate whether providing the patient with multiple prescrip-tions would create an undue risk of diversion or abuse.

In March 2010, the DEA removed its restriction on electronic prescribing of controlled substances. Writing prescriptions electronically is now permissible for those who receive an audit/certification report and meet additional DEA requirements. 23 Texas law has now been modified to also allow for electronic prescription of Schedule II drugs effective September 1, 2011. However, electronic prescribing of Schedule II controlled substances is subject to stringent requirements that must be complied with, as set forth by the DEA. A physician who is interested in electronic prescription of Schedule II drugs must carefully read, understand, and comply with the federal rules that govern electronic prescriptions. 24

Intractable Pain Treatment Act

“Intractable pain” is defined in the Texas Occupation Code as a state of pain for which the cause of pain cannot be removed or otherwise treated; and in the course of practice, relief or cure of the pain is not possible or has not been found after reason-able efforts. 25 The Texas Intractable Pain Treatment Act allows a physician to treat a patient with an acute or chronic painful medical condition with a dangerous drug or controlled substance without disciplinary action by the TMB under certain conditions. These include that the physician monitors the patient; ensures that measures are in place to prevent the diversion of the drug to another user; that the understanding between the physician and patient as to the course of treatment, drug, dose, and frequency is specifically documented; and that a consult with a psychologist or expert in the treatment of addictions is sought as appropriate. Texas Physicians should verify that their chronic pain patients who are prescribed opioids meet this definition of intractable pain and document the patient’s condition in their records. 26

Texas Medical Practice Act — disciplinary actions

Regulations concerning the treatment of pain fall to those who govern the practice of medicine and can be found in the Medical Practice Act (MPA). 27 These regulations — which set the standard for excellence in the general practice of medicine — apply equally to those in a pain management practice. The MPA embodies a variety of regulations to which the Texas Medical Board adheres when medical competency is at issue. 28 Disciplin-ary actions specific to controlled substances include unprofes-sional or dishonorable conduct in which a physician fails to keep accurate records of controlled substances. It is also a violation for a physician to write false or fictitious prescriptions for or dispense to a person who is known to be an abuser of narcotic drugs or controlled substances, or who the physician should have known was an abuser of narcotic drugs. 29 However, this section does not apply if the physician is prescribing to a patient with documented intractable pain 30 Additional dishonorable physician conduct is cited as the prescribing of a controlled substance that

is non-therapeutic or the prescribing or dispensing of the medica-tion in a manner inconsistent with public health and welfare. 31

Texas Medical Board — pain management

The TMB recognizes that the treatment of pain is a vital part of the practice of medicine and addresses this issue in Chapter 170 of the Texas Administrative Code. 32 Sections include practice guidelines for physicians when treating both acute and chronic pain, including the use of controlled substances and/or dangerous drugs. 33

In its purpose statement, section 170.1 makes reference to key points including “[p]hysicians should not fear board action if they provide proper pain treatment. The board will not look solely at the quantity or duration of drug therapy. Proper pain treatment is not a matter of how much drug therapy is used, as long as that therapy is based on sound clinical judgment. Sound clinical judgment results from evidence-based medicine and/or the use of generally accepted standards.” 34 Physicians can demonstrate sound clinical judgment by documenting the rationale for the treatment plan and maintaining medical records that are legible, current, and accurate for each patient.

With regard to chronic pain and the use of scheduled drugs, section 170.1 adds that a “reasonably detailed and documented plan” is needed to assure that treatment is monitored and that an “[e]xplanation of the physician’s rationale is especially required for cases in which treatment with scheduled drugs is difficult to relate to the patients’ objective, physical, radiographic, or labora-tory findings.” 35

In the event of a review, the TMB will use the following guide-lines to assess a physician’s treatment of pain:

1. Evaluation of the patient. The physician is responsible for obtaining a medical history that includes a medical history and physical exam. The medical record should document the nature and intensity of pain; current and past treatments for pain; under-lying or coexisting diseases; effect of the pain on physical and psychological function; history and potential for substance abuse; and the presence of one or more medical indications for the use of a dangerous or scheduled drug.

2. Treatment plan for chronic pain. A written treatment plan should include dosage and frequency of drugs prescribed; further testing and evaluations ordered; other treatments that are planned or considered; and objectives that will be used to determine treat-ment success such as pain relief and improved function.

3. Informed consent. The physician should discuss the risks and benefits of the use of controlled substances for the treatment of chronic pain with the patient or other persons designated. The discussion should be documented in writing and maintained in the records and include: diagnosis; treatment plan; anticipated results with realistic explanations; therapies in addition to or instead of drug therapies; potential side effects and how to manage them; adverse effects that include potential for dependence, addiction and withdrawal; and potential for impairment of judgment and motor skills.

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4. Agreement for treatment of chronic pain. The physician should inform the patient of the physician’s expectations that are necessary for compliance. If the plan includes extended drug therapy, there should be a written pain management agreement that includes the following provisions: laboratory tests for drug levels upon request; limitation on the number and frequency of prescription refills; only one physician is to prescribe and one pharmacy is to dispense dangerous and scheduled drugs, and reasons for which drug therapy may be discontinued.

5. Periodic review of the treatment of chronic pain. The physi-cian should see the patient for periodic reviews at reasonable intervals. The review should be documented in the record and is used to assess progress or lack thereof; note adjustments in the treatment plan; and in the event the patient’s progress is unsatis-factory, the physician should reassess the plan and consider other therapeutic options.

6. Consultation and referral. The physician should refer a patient with chronic pain for further evaluation and treatment as necessary, especially those who are at risk for abuse or addiction.

7. Medical records. Medical records shall document the physi-cian’s rationale for the treatment plan and drugs prescribed for the chief complaint. The record should illustrate that the physician has followed these guidelines and should include: medical history and examination; diagnostic, therapeutic and lab results; evalua-tions and consultations; treatment objectives; discussions of risks and benefits; informed consent; treatments; medications; instruc-tion agreements; and periodic reviews.

The guidelines conclude: “It is not the board’s policy to take disciplinary action against a physician solely for not adher-ing strictly to these guidelines if the physician’s rationale for treatment indicates sound clinical judgment documented in the medical records. Each case of prescribing for pain will be evaluated on an individual basis. The physician’s conduct will be evaluated by considering 1) the treatment objectives, including any improvement in functioning; 2) whether the drug used is pharmacologically recognized to be appropriate; 3) the patient’s individual needs; and 4) that some types of pain cannot be completely relieved.” 36

In 2004, the Federation of State Medical Boards adopted a “Model Policy for the Use of Controlled Substances for the Treat-ment of Pain” for states to use to evaluate physicians’ treatment of pain. Many of its recommendations mirror those under the TMB guidelines. 37

As there is no one national guide or standard for the use of opioids for pain management, a good source is the American Pain Society and the American Academy of Pain Management’s guidelines on the use of chronic opioid therapy. 37 The Opioid Treatment Guidelines provide physicians with recommendations for the assessment and treatment of chronic non-cancer pain and reviews several risk assessment and monitoring resources includ-ing the Screener and Opioid Assessment for Patients with Pain

(SOAPP) [Appendix 3]; Opioid Risk Tool [Appendix 4]; Diagno-sis, Intractability, Risk Efficacy (D.I.R.E.) Score [Appendix 5]; Pain Assessment and Documentation Tool [Appendix 8] and Current Opioid Misuse Measure (COMM) Monitoring Tool [Appendix 9.] 38 In addition, the guidelines emphasize the importance of an informed consent agreement and opioid management plan. 39 The Texas Pain Society also developed a combined “Informed Consent and Pain Management Agree-ment” that contains provisions that satisfy the TMB guidelines described above. 40

Controlled Substances Act and the Drug Enforcement Administration

The DEA serves as the primary federal agency responsible for the enforcement of the Controlled Substances Act (CSA). 41 With regard to pharmaceutical controlled substances, the DEA’s mission is to ensure an adequate supply is readily available to meet medical, scientific and research needs. At the same time it seeks to prevent diversion, abuse, and misuse of these drugs. 42

To prevent diversion, the CSA establishes a “closed system” of licensing, security, record keeping, and monitoring. All handlers of controlled substances need to be registered with the DEA and maintain strict accounting for all distributions. Through its tracking system, the agency monitors the movement of controlled drugs within the U.S., and the agency is alerted if an unusual amount of a controlled substance moves into any one area. The CSA does not regulate the practice of medicine as a whole. Therefore, the DEA does not act as the federal equivalent of a state medical board overseeing the general practice of medicine. While the DEA does not have the authority to educate physicians as to how to make “sound medical decisions in treating pain,” it does have the authority to investigate whether a prescription for a controlled substance was issued for a legitimate medical purpose. 43

The DEA can initiate investigations to stop the diversion or abuse of controlled substances. This includes inquiring about whether the physician is prescribing a controlled substance to a patient who requires the drug for a legitimate purpose and if the physician is doing so in the usual course of professional practice. 44 What exactly does this mean? There are no criteria to address every instance of prescribing; however, some recur-ring patterns indicate inappropriate prescribing practices. These include prescribing of an inordinately large quantity of controlled substances; prescribing in the absence of a physical exam; issuing a prescription knowing the patient was delivering the drugs to others; issuing a prescription in exchange for sexual favors or for money; prescribing controlled drugs at intervals inconsistent with medical treatment; or the absence of a logical relationship between the drugs prescribed and treatment of the alleged condition. 45

A review of the 2006 DEA investigations revealed that, out of the more than 700,000 registered physicians, only 250 physi-cians (0.033 percent) were the subject of a criminal investiga-tion. The number of actual physicians arrested that year was

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61, or 0.0081%. (46) While these numbers appear to be small, it is less than reassuring when arrests and prosecutions make headlines and the DEA’s own web site posts an 85-page book of “Cases Against Doctors” detailing names, offenses and penalties assessed. 47 These charges cover a wide variety of offenses from dispensing a controlled substance outside the scope of profes-sional practice, conspiracy to possess a controlled substance with intent to distribute, health care fraud, illegal dispensing, conspira-cy to commit fraud, involuntary manslaughter, money laundering, racketeering, and trafficking.

The DEA’s “Practitioner’s Manual” provides an understanding on how federal and state agencies work together:

“The federal controlled substances laws are designed to work in tandem with state controlled substance laws. Toward this same goal, DEA works in close cooperation with state professional licensing boards and state law enforcement officials to ensure that controlled substances are prescribed, administered and dispensed for authorized purposes. Within this cooperative framework, the majority of investigations are carried out by state authorities. However, DEA also conducts investigations into violations of federal law as circumstances warrant.

In the event a state board revokes the license of a practitioner, the DEA will take action and request a voluntary surrender of the practitioner’s DEA registration. The DEA may also pursue judicial action if there is sufficient evidence of illegal distribution or significant recordkeeping violations.” 48

As previously discussed, there are noted differences between federal and Texas law pertaining to registration and prescription requirements for controlled substances. A DEA registered practi-tioner must abide by the laws of the state in which the practice is located. (49) When federal law or regulations differ from state laws, the practitioner is required to follow the more stringent aspects of both the federal and state requirements. 50

For example, under both federal and state law, Schedule II drugs require a written prescription, that cannot be refilled, and multiple prescriptions can be filled sequentially for up to a 90-day supply. However, under federal law, there are no federal restrictions on the actual type of prescription form to be used, required diagno-sis and additional information to be included on the prescription forms, or date limits as to when it can be filled, as mandated under Texas law. Another historical difference existed in electron-ic prescription practices. Federal law has recently allowed for Schedule II drugs to be prescribed electronically; Texas just added this method of prescribing, but its practical implementation has yet to be fulfilled. The DPS forms will continue to be a valid method of prescribing Schedule II medications.

FDA and the opioid REMS

In addition to the DEA, another federal agency that contributes to the monitoring and risk management of controlled substances is the Food and Drug Administration (FDA). The FDA reviews clinical data to ensure that marketed drugs are safe for human

consumption. As part of its authority through the FDA Amend-ments Act of 2007, it may impose a Risk Evaluation and Mitiga-tion Strategy (REMS) on certain drugs to ensure that benefits of the drugs continue to outweigh the risks. 51

In February 2009, the FDA notified manufacturers of certain opioid drug products that they will be required to have a Risk Evaluation and Mitigation Strategy to ensure that the benefits of the drugs continue to outweigh the risks. As these drugs have serious risks when used improperly, this measure was imple-mented to prevent misuse, abuse, and accidental overdose of these drugs by providing additional warnings in the labeling and implementing a risk management plan. 52

In response to the Office of National Drug Control Policy’s Epidemic Report and Action Plan, the FDA met with members of the Industry Working Group on May 16, 2011 to discuss the next steps in implementing REMS for all long-acting and extended release (LA/ER) opioid products. As a result of this meeting, the FDA is requiring manufacturers to submit their respective REMS by August 17, 2011. 53 Applicant holders received a REMS notification letter outlining the Post-Approval REMS Notifica-tion requirements. 54 The letter states that the FDA has become aware of substantial numbers of post-marketing reports of abuse, misuse, addiction and overdose resulting in deaths associated with these drugs, which the FDA considers to be “new safety information.” The following are highlights of the notification requirements and meeting notes:

• Prescriber education. Manufacturers of long-acting and extended-release opioids are to ensure that training is provided to prescribers of these medications and to develop information that they can use when counseling patients of the risks and benefits of opioid use. Training must be developed by the applicant holders and should include information on safe opioid prescribing including patient selection and goal of therapy, assessment of risk of abuse, opioid tolerance, managing patients taking opioids, product specific informa-tion, and patient counseling. 55

• While the comprehensive action plan (ONDCP’s Epidemic Report) recommends legislation to require prescriber educa-tion as a condition of obtaining DEA registration, at this time the FDA’s opioid REMS education program will not have a mandatory requirement linked to the ability of health care professionals to prescribe these drugs. Prescriber education is voluntary. The FDA sees this as overly burdensome, poten-tially having a negative effect on access to medications. 56

• Medication Guides. Each application holder will have a medication guide that includes common content to the class of LA/ER opioids as well as product-specific information. Generic drug companies are required to have the same medication guide as the reference listed drug. The FDA is currently working on a common template for the LA/ER opioids. Medication Guides that are currently approved will need to be revised once the common content has been decided. 57

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• REMS assessment plan. The assessment plans must be in line with timetables for assessments submitted at select intervals and need to include: number of prescribers who have completed the training (FDA recommends utilizing an accredited CME provider); independent audit of training materials; evaluation of prescribers’ and patients’ awareness of serious risks; surveillance plan to monitor for misuse, abuse, overdose, addiction and death; drug utilization patterns; and evaluation of changes in prescribing behavior of prescribers, e.g. excessive prescriptions or early refills. 58

As there are many opioid drugs, the FDA provides a list of the long-acting and extended release opioid products that are required to have an opioid REMS at: http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm251735.htm.

Diversion

Diversion is defined as the transfer of a controlled substance from a lawful to an unlawful channel of distribution or use. 59 Diversion comes in many forms and can occur at any point in the distribu-tion channel — from robberies of manufacturers and distributors; theft in the home; by staff in pharmacies, hospitals and office practices; purchases over the Internet; doctor shopping (moving from doctor to doctor in order to obtain multiple prescriptions), and forgery and/or alteration of prescriptions. The focus today is on medication diversion you may encounter by patients in your office.

The experience of pain is subjective, and there is no test to positively diagnose this condition; therefore, physicians must rely on the information provided to them by their patients. Abusers, however, can use this knowledge to deceive physicians and obtain prescription opioids for personal use and/or diversion. 60 While it is important to trust your patients and accept what they tell you, it is also crucial to maintain a bit of skepticism. Not every patient has the intent to divert, but the difference between a legitimate patient and a drug abuser or diverter is not always apparent. The physician must conduct an appropriately in-depth investigation by questioning and noting patient behavior during the exam. Physicians have a professional responsibility to prescribe controlled substances appropriately, but they also have the responsibility to protect their practice from becoming an easy target for drug diversion.

It is important to become aware of the potential situations in which drug diversion can occur and enact safeguards to prevent it 61 To have a better understanding of some of these behaviors and drug diverting tactics, the following are some signs to watch for:

• Strange stories. Be aware of new patients with interest-ing stories and excuses. These can include stories of lost or stolen prescriptions, such as they forgot to pack their medications and need something in the interim; or they were accidently thrown out or destroyed. Another common ploy is that patients may ask to be seen right away because they are

leaving town or they may deliberately request appointments at the end of the day or show up after hours. 62

• Evasive and reluctant to cooperate. Diverters may refuse a physical exam or be reluctant to provide reference informa-tion, authorization for medical records or in allowing contact with previous providers. They may be evasive or claim they do not know the name of the facility, hospital, or name of the physician who last treated them. 63

• Feigned symptoms. Diverters may feign physical problems such as abdominal or back pain, kidney stones, migraines, or toothaches in an effort to obtain pain medications. They may feign psychological problems such as anxiety, insomnia, fatigue, or depression to obtain stimulants or depressants. In addition, they may exaggerate medical problems and/or simulate symptoms. Diverters also generally have no interest in diagnosis and may fail to keep appointments for further tests. 64

• Unusually high (or low) knowledge of medications. Also be aware of those patients who seem very knowledgeable about specific medications or ask for certain brands and resist generic forms or substitutes. They may be very familiar with a particular disease or condition and give an almost textbook synopsis rather than one that is based on true experience. Some may even take an opposite approach and exhibit very little knowledge about their condition or deliberately mispro-nounce medication names. 65

Diversion can also occur by office staff, other physicians, friends, and family members. In Texas, a physician is required to report a discrepancy, loss or theft of a controlled or other regulated item or substance involving a potential for diversion. 66 Physicians are also required to notify the authorities of any discrepancy in the amount of an item ordered, a loss or theft from a shipment or from current inventory, or lost prescription forms. 67 This includes forged prescriptions. Under section 481.129 of the Texas CSA, if a person knowingly uses a prescription issued to another, obtains or attempts to possess a controlled substance, or increases the quantity by fraud, forgery or deception, this constitutes a fraudu-lent offense, which may be classified as a felony of the second degree if it involves a Schedule II controlled substance. 68

Risk management

To reduce the incidence of opioid abuse and to thwart abusers from improperly obtaining controlled substances, consider the following techniques.

• Patient assessment. Conduct a comprehensive evalua-tion of the patient. This should include a thorough medical history and physical examination, including an assessment of psychological factors and family history for risk stratifi-cation. Screening tools that assess potential risks based on patient characteristics can be helpful including the Screener and Opioid Assessment for Patient with Pain (SOAPP), the Opioid Risk Tool (ORT), and the Diagnosis, Intractability, Risk, Efficacy instrument (DIRE). 69

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• Obtain records. Request records from the patient’s previ-ous physician, and be skeptical of patients who are reluctant to disclose information or sign an authorization to release medical records. Request an official form of identifica-tion from patients who need treatment with psychoactive medications and include a copy of their ID in the chart. 70 In addition, physicians may inquire about a patient’s prescrip-tion history through the use of the Texas Prescription Program Information Request form. 71

• Must be clinically indicated. A practitioner may not prescribe a controlled substance except for a valid medical purpose. 72

• Informed consent and medication agreements. When starting therapy, informed consent should be obtained with a review of the risks and benefits of the treatment. Optimally, a treatment or medication agreement should outline patient responsibilities, including periodic screening of urine, serum medication levels for dose titration and/or frequency of refills, only one physician to prescribe, and the same pharmacy to be used. These agreements should also state reasons why therapy or treatment may be discontinued if violations occur. Violations include evidence of illicit street drug use, medication abuse, or diversion. It is essential to follow through if these violations occur. Not doing so could leave you open to allegations of enabling a drug addict and failing to prescribe for therapeutic purposes. 73

If abuse is suspected, refer the patient to an expert in pain management or addiction. If the patient continues to disregard the agreement, the next option is to terminate the physician/patient relationship. It is important to give an adequate warning and timeframe so that there is no abrupt discontinuation of potentially habit forming chemicals or basis for a claim of patient abandonment. 74

• Documentation. Good medical practice involves good documentation. The medical records reflect the physician’s rationale for the treatment plan and the prescriptions for the chief complaint of chronic pain. The records should include the medical history, physical examination, diagnostic, labora-tory results, evaluations/consultations, treatment objectives, discussion of risks and benefits, informed consents, medica-tion agreements, specific medications prescribed (with dosage, date, type and quantity), and periodic reviews. 75

• Periodic review. Once initiated on opioids, patients need to be regularly monitored for treatment efficacy, progress towards treatment goals, improvements in functionality, adverse events, aberrant behaviors and medication adherence. 76

• Controlled substances on site. If controlled substances are kept in the office, they need to be properly stored and disposed of. Schedule II through V controlled substances must be securely locked, and there are several statutory requirements regarding record keeping and inventory of these medications. Specifically, Texas law requires that all controlled substances must be accounted for in a log book,

including sample medications. 77 Physicians are required to report any theft of loss of a controlled substance to the DEA via Form 106, available at http://www.deadiversion.usdoj.gov/21cfr_reports/theft/. In addition, Texas physicians need to report a theft or loss to the Texas DPS utilizing the form available at http://www.txdps.state.tx.us/InternetForms/Forms/CES-10.pdf. This form or a copy of the DEA Form 106 may be submitted.

• Prescription pads must be secured. Prescription pads should not be out in the open in exam rooms or other accessible areas. Specifically, prescriptions for Schedule II substances must be written on required forms, which may be obtained through the Texas DPS. 78 If forms are stolen, the Texas Prescription Program Office should be contacted immediately at (512) 424-2189.

Conclusion

While there is no question that illegal diversion and abuse of prescription pain medications can cause public harm, the laws, regulations, and media attention may have hindered the good intentions of physicians trying to implement effective pain management programs. With federal and state registrations and rigid requirements as to prescription forms, there is a concern of being watched and a fear of being investigated. However, physi-cians are more vulnerable to investigation or disciplinary actions if they fail to comply with practice standards. 79 Therefore, maintaining sound medical practice and professional ethics are essential. 80 Careful assessment of the patient, prescribing only for a medical purpose, establishing goal directed treatment plans, monitoring patents’ adherence and progress, and documenting all decisions are critical to effectively treating patients and prevent-ing diversion and abuse.

Sources1. chou, r. et al. opioid Treatment Guidelines. clinical Guidelines

for the use of chronic opioid Therapy in Noncancer Pain. J. Pain. 2009; 10(2):113-130. available at http://www.jpain.org/article/s1526-5900(08)00831-6/fulltext; accessed July 7, 2011.

2. docs Tied to Multiple overdoses (March 28, 2011), Houston Chronicle. available at http://www.chron.com/cda/archives/archive.mpl?id=2011_4958044; accessed on april 20, 2011.

3. dr. Gerald ratinov and 18 others arrested in illegal Pain Manage-ment clinic operation. (March 29, 2011). dea News release. available at: http://www.justice.gov/dea/pubs/states/newsrel/2011/hou032911p.html; accessed april 20, 2011.

4. 15 Texas doctors citied in illegal drug sales (February 26, 2011), Houston chronicle. available at http://www.chron.com/disp/story.mpl/metropolitan/7446695.html. accessed on april 20, 2011.

5. epidemic: responding to america’s Prescription drug abuse crisis; office of National drug Policy, april 2010. available at http://www.whitehousedrugpolicy.gov/publications/pdf/rx_abuse_plan.pdf. accessed on april 21, 2011.

6. id. at 3.

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7. Texas Health & safety code §481.001 et seq. (Texas controlled substances act). available at http://www.statutes.legis.state.tx.us/docs/Hs/pdf/Hs.481.pdf. accessed July 13, 2011.

8. controlled substances act. 21 usc §801 et seq. available at http://www.deadiversion.usdoj.gov/21cfr/21usc/index.html. accessed July 14, 2011.

9. bloodworth, d. opioids in the Treatment of chronic Pain: legal Framework and Therapeutic indications and limitations. Phys Med Rehabil Clin N Am. 2006; 17; 355-379. available at http://www.med.nyu.edu/pmr/residency/resources/PMr%20clinics%20Na/PMr%20clinics%20Na_pain/opioids%20in%20the%20Treatment%20of%20chronic%20Pain-legal%20Framework%20and%20Therapeutic%20indications%20and%20limitations.pdf . accessed July 28, 2011.

10. Texas Health & safety code §481.001 et seq.

11. 21 usc §812 schedules of controlled substances. available at http://www.gpo.gov/fdsys/pkg/uscode-2009-title21/pdf/uscode-2009-title21-chap13-subchapi-partb-sec812.pdf. accessed July 14, 2011.

12. Texas register. controlled substances schedule available at: http://www.dshs.state.tx.us/dmd/control_subst_sched.shtm. accessed april 21, 2011.

13. Texas state board of Pharmacy. controlled drugs. available at http://www.tsbp.state.tx.us/consumer/broch2.htm accessed July 13, 2011.

14. Texas department of Public safety controlled substances regis-tration. available at http://www.txdps.state.tx.us/regulatoryser-vices/narcotics/narccsr.htm accessed July 13, 2011.

15. drug enforcement administration office of diversion control registration. available at http://www.deadiversion.usdoj.gov/drugreg/index.html. accessed July 14, 2011.

16. Texas Health & safety code. §481.075 (official Prescription Program).

17. Texas department of Public safety Prescription Program overview. available at http://www.txdps.state.tx.us/regulatoryser-vices/prescription_program/index.htm. accessed July 14, 2011

18. Texas Health & safety code. §481.076(3)(b) (official Prescription information).

19. Texas Health & safety code §481.075(e)(1) (official Prescription Program), revised by s.b. 1273, 82nd leg., r.s. (2011).

20. Texas Health & safety code §481.075(f).

21. Texas administrative code §13.73(d)(2) (Texas Prescription Program-Form). available at http://info.sos.state.tx.us/pls/pub/readtac$ext.TacPage?sl=r&app=9&p_dir=&p_rloc=&p_tloc=&p_ploc=&pg=1&p_tac=&ti=37&pt=1&ch=13&rl=73 accessed July 20, 2011.

22. Texas Health & safety code §481.074(d-1) (Prescriptions).

23. electronic Prescriptions for controlled substances. dea office of diversion control. available at http://www.deadiversion.usdoj.gov/ecomm/e_rx/faq/practitioners.htm. accessed July 22, 2011.

24. see drug enforcement administration, electronic Prescriptions for controlled substances, available at http://www.deadiversion.usdoj.gov/ecomm/e_rx/faq/faq.htm. accessed september 26, 2011; Texas department of Public safety. Texas Prescription Program, updates and Notices; available at http://www.txdps.state.tx.us/regulatory-services/prescription_program/updates.htm. accessed september 26, 2011.

25. Texas occ. code §107.001 et seq. (intractable Pain Treatment act). available at http://www.statutes.legis.state.tx.us/docs/oc/pdf/oc.107.pdf accessed July 26, 2011.

26. bloodworth, supra footnote 9 at 359.

27. Texas occ. code §151.001 et seq. (Medical Practice act). avail-able at http://www.statutes.legis.state.tx.us/docs/oc/pdf/oc.151.pdf. accessed July 14, 2011.

28. burton aW. Pain Management. a Handbook for Texas Physicians. Texas Medical association. 2006. available at http://texaspain.org/docs/Pain_Mgt_book.pdf. accessed July 20, 2011.

29. Texas occ. code §164.053 (unprofessional and dishonorable conduct). available at: http://www.statutes.legis.state.tx.us/docs/oc/htm/oc.164.htm#164.053 accessed July 14, 2011

30. id §164.053(c)(2) .

31. id. §164.053(6).

32. Texas Medical board. board rules. Texas admin. code, Title 22, Part 9, chapter 170.1 et seq. (Pain Management). available at http://www.tmb.state.tx.us/rules/docs/board_rules_effec-tive_06.28.2011.pdf. accessed July 27, 2011.

33. id.

34. id. §170.1(5).

35. id. §170.1(5), (6), and (8).

36. id. §170.3(a).

37. chou, supra footnote 1.

38. chou, supra footnote 1 at appendices 3, 4, 5, and 8.

39. chou, supra footnote 1 at 116-117.

40. sample informed consent and Pain Management agreement as required by the Texas Medical board-3rd edition developed by the Texas Pain society, april 2008 (www.texaspain.org). avail-able per search at http://www.texmed.org/searchcontent.aspx?searchtext=texas%20pain%20society,%20april2008&folderid=1336&searchfor=all&orderby=id&orderdirection=ascending. accessed July 27, 2011.

41. united states department of Justice-dea office of diversion control. Practitioner’s Manual: an informational outline of the controlled substances act; 2006 edition. available at: http://www.deadiversion.usdoj.gov/pubs/manuals/pract/pract_manual012508.pdf. accessed July 14, 2011

42. id. at 4.

43. 71 Fed. reg. 52716 (sept. 6, 2006). available at: http:// www.gpo.gov/fdsys/pkg/Fr-2006-09-06/pdf/e6-14517.pdf. accessed July 21, 2011.

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44. rannazzisi, J. Thawing the chill: The us drug enforcement admin-istration, Physicians and the controlled substances act. Journal of Global Drug Policy and Practice. available at: http://www.globaldrug-policy.org/2/1/2.php. accessed July 20, 2011.

45. dea-Practitioner’s Manual, supra footnote 42 at 30.

46. rannazzisi, supra footnote 45 at 4.

47. drug enforcement administration office of diversion. cases against doctors-updated May 20, 2011. available at: http://www.deadiversion.usdoj.gov/crim_admin_actions/index.html accessed July 27, 2011.

48. dea-Practitioner’s Manual, supra footnote 42 at 4.

49. id at 7.

50. 21 usc §903. available at http://www.gpo.gov/fdsys/pkg/uscode-2009-title21/pdf/uscode-2009-title21-chap13-subcha-pi-partF-sec903.pdf. accessed July 14, 2011.

51. Fda background on opioid reMs. February 6, 2009. available at: http://www.fda.gov/drugs/drugsafety/ informationbydrugclass/ucm187975.htm. accessed July 18, 2011.

52. id.

53. Fda opioid reMs Meeting with industry – May 16, 2011. avail-able at http://www.fda.gov/drugs/drugsafety/informationbydrug-class/ucm258184.htm. accessed July 15, 2011.

54. Fda Post-approval reMs Notification letter sent to opioid Manufacturers. available at http://www.fda.gov/downloads/drugs/drugsafety/informationbydrugclass/ucm251595.pdf. accessed July 25, 2011.

55. id. at appendix a, content of education Program.

56. Fda Q&a re Fda requires a reMs for long-acting and extend-ed release opioids. available at: http://www.fda.gov/drugs/drugsafety/informationbydrugclass/ucm251752.htm. accessed July 25, 2011.

57. Fda Preliminary responses to industry Questions about opioid reMs. available at: http://www.fda.gov/drugs/drugsafety/informa-tionbydrugclass/ucm258113.htm. accessed July 25, 2011.

58. Fda Post-approval reMs Notification letter, supra footnote 55 at 4.

59. uniform controlled substances act (1994). National confer-ence of commissioners on uniform state laws, §309 diversion Prevention and control. available at http://www.law.upenn.edu/bll/archives/ulc/fnact99/1990s/ucsa94.pdf accessed July 27, 2011.

60. Fishbain, d. et al. review of regulatory Programs and New opioid technologies in chronic pain management: balancing the risk of medication abuse with medical need. JMCP 2010; 16:276-287. available at http://www.amcp.org/data/jmcp/276-287.pdf. accessed July 20, 2011.

61. u.s. office of diversion control. don’t be scammed by a drug abuser. dec. 1999. available at: http:///www.deadiversion.usdoj.gov/pubs/brochures/drugabuser.htm#recognize. accessed July 21, 2011.

62. cole, be. recognizing and Preventing Medication diversion. Fam. Pract Management. October 2001; 8(9): 37-41. available at http://www.aafp.org/fpm/2001/1000/p37.pdf. accessed July 27, 2011.

63. id. at 2.

64. u.s. office of diversion control. don’t be scammed by a drug abuser, supra footnote 62 at 2.

65. cole, supra footnote 63 at 38.

66. Texas administrative code. Public safety & corrections, Title 37, Part 1, chapter 13, §13.251-254 (reporting discrepancy, loss, Theft or diversion). available at http://info.sos.state.tx.us/pls/pub/readtac$ext.ViewTac?tac_view=5&ti=37&pt=1&ch=13&sch=l&rl=y. accessed July 27, 2011.

67. id. at §13.253.

68. Texas Health & safety code §481.129. (offense: Fraud).

69. chou, supra footnote 1 at 115-116.


71. Texas Prescription Program information request Form. available at: http://www.txdps.state.tx.us/internetForms/Forms/TP-11.pdf. accessed July 27, 2011.

72. Texas Health & safety code §481.071(a).


74. Pain Management Treatment agreement. Texas Medical association. available at: http://www.texmed.org/templateprint.aspx?id=6437. accessed July 27, 2011.

75. Texas Medical board Pain Management Guidelines, supra footnote 32 at §170.3.

76. id.

77. Tex. occ. code §164.054. (additional requirements regarding drug records). available at http://www.statutes.legis.state.tx.us/docs/oc/htm/oc.164.htm#164.054. accessed July 28, 2011.

78. Texas Prescription Program. available at: http://www.txdps.state.tx.us/regulatoryservices/prescription_program/prescriptionforms.htm. accessed July 27, 2011.

79. chou, supra footnote 1 at 123.


Jay Henderson can be reached at [email protected]

http://www.tmlt.org/reportercme.html

Texas Medical Liability TrustP.o. box 160140 austin, Tx 78716-0140 800-580-8658 or 512-425-5800 e-mail: [email protected] www.tmlt.org

Editorial committeecharles r. ott, Jr., President and ceoJill Mclain, executive Vice President, claim operations & risk Managementdon chow, senior Vice President, sales & business developmentdana leidig, Vice President, communications & advertisingsue Mills, Vice President, claim operations

Editor laura Hale brockway, els

Associate Editor louise Walling

Staff William MalamonKatie stotts

Graphic DesignerKaren Hardwick

the Reporter is published by Texas Medical liability Trust as an information and educational service to TMlT policyholders. The information and opinions in this publication should not be used or referred to as primary legal sources or construed as establishing medical standards of care for the purposes of litigation, including expert testimony. The standard of care is dependent upon the particular facts and circumstances of each individual case and no generalizations can be made that would apply to all cases. The information presented should be used as a resource, selected and adapted with the advice of your attorney. it is distributed with the understanding that neither Texas Medical liability Trust or Texas Medical insurance company is engaged in rendering legal services.

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