| Comment Record |
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Commentor |
Ms. Heather Guidone, Director of Operations |
Date/Time |
2001-11-14 10:03:02 |
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Organization |
Endometriosis Research Center |
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Category |
Association |
| Comments for FDA General |
| Questions |
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1. General Comments
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Pain, without question, is the most common reason individuals seek medical attention. It is estimated that nearly 50 million Americans are partially or totally disabled by pain, and 45% of all Americans seek assistance with pain at some point in their lives.(1) Some researchers are now even referring to chronic pain as a disease unto itself.(2)
Whether acute or chronic in nature, pain is defined by the International Association for the Study of Pain as an unpleasant sensory and emotional experience associated with actual or potential tissue damage. Acute refers to pain which has been caused by an injury, illness or surgery, responds well to pain management interventions and lasts less than 6 months. Acute pain generally disappears when the cause has been treated. Chronic pain, on the other hand, may last 6 months or more. It is a persistent state that is usually associated with a long term incurable or intractable medical condition or disease. Approximately 9% of the US adult population suffers from chronic, non-cancer related pain; the majority of which have been suffering an average of 6 days a week for over 5 years.(3)
Pain may include a range of distressing emotional and physical sensations, including aching, tightness, stabbing, burning and/or numbness. Signs and symptoms of pain vary from each individual, based on the patient's specific maladies.
Unrelieved pain has a wide spectrum of negative effects, including interference with mobility, sleep and daily routine; impairment of concentration and cognitive abilities; a loss of enjoyment of life; feelings of social isolation and inability to relate to others; conflicts in marriages or close relationships; and feelings of anger, fear, resentment, depression and anxiety. Physical effects include impaired mobility, GI and pulmonary functions; increased metabolic rate; decreased immune response; delayed wound healing; loss of appetite; nausea; and fatigue.
Pain can impair every aspect of an individual's life.
Women hurt worse: according to scientific reports, women are more sensitive to pain and require stronger doses of pain medication. Scientists believe that these differences are linked to genetic factors.(4) Additional study into this area has shown that women respond differently to pain due to the activation of different brain circuits than male counterparts. Some researchers believe that over time, men evolved with the ability to block pain of trauma, i.e. spear points and lion bites, while women, who were not traditionally exposed to hunting and fighting, have grown to become more attuned to visceral pain like childbirth.(5)
The Joint Commission on Accreditation of Healthcare Organizations (the Joint Commission) standards assert that individuals have the right to appropriate assessment and management of pain.(6) Pain assessment is most often measured through the use of scales. Examples include the 0-10 Numeric Pain Intensity Scale, as designed by the Agency for Healthcare Policy and Research in 1992. This scale rates pain from 0=no pain up to 10=worst possible pain. Another scale used by some practitioners is a simple descriptive scale, with captions reading, no pain, mild pain, moderate pain, severe pain, very severe pain, worst possible pain. Still another, the Wong-Baker FACES Pain Rating Scale, uses descriptive cartoon faces to allow patients to pick the one they most relate their pain with. Faces range from happy to very sad.
Management refers to a comprehensive approach to obtaining pain relief. The patient, in association with her physician and healthcare professionals, determines an effective management plan to keep her symptoms at a minimum and regain her quality of life.
Pain management can be achieved through varied methods, ranging from alternatives to opioids. According to the Joint Commission, the following levels of care should be adopted when treating pain patients:(7)
Level 1: Mild Pain
Initial choices for treating mild pain include NSAIDs, aspirin and acetaminophen.
Level 2: Mild to Moderate Pain
Choices range from non-opioid to combined non-opioid / opioid. Opioids may also be used alone as therapy for patients no longer responding to or tolerating non-opioids.
Level 3: Moderate to Severe Pain
Opioid analgesics are vital to the management of moderate to severe pain. Long-acting opioids are most advantageous for maintaining round-the-clock pain control while requiring fewer medication dosages.
Unfortunately, in spite of medical advancements and a growing list of pain treatment options, pain management has improved little over the last several decades.
Pain remains largely undertreated and seemingly ignored by the medical community, including at hospital level. One NY State study of pain control in surgical patients revealed that the majority of patients did not receive pain relief as recommended in federal standards issued in 1992 by the Department of Health and Human Services' Agency for Health Care Policy Research.(8)
Medical experts have even stated that the weakest and most severely ill patients, including children and the elderly, get inadequate relief for the intense pain of serious surgeries, injuries or prolonged/terminal illnesses.
Additional reports show that during an office visit, physicians will frequently fail to treat, or even discuss, a patient's pain.(9)
There are several reasons for the continued inadequate treatment of pain from both patient and practitioner standpoints, including:
Lack of Communication: patients who are not directly asked, and even some who are, often fail to speak up voluntarily about their pain for fear of appearing non-compliant or being viewed as a bad patient, having trepidation that they may be labeled a drug-seeker, and being concerned about having to take painkillers.
Physicians often fail to inquire about a patient's pain level because of several deep-seated obstacles in the medical education process, including:
Lack of training: studies have shown that poor physician training, particularly in pain assessment as well as management, significantly impedes adequate treatment. Most medical schools typically offer their students little education in pain management. Indeed, in two studies, physicians delayed giving morphine to a dying patient until the prognosis narrowed to 6 months left. This pain management strategy was practiced despite the physicians' knowledge that morphine is required to treat severe cancer pain.(10)
Concern over adverse effects: fear that a patient will have a serious physical reaction to a substance has historically made physicians reluctant to administer and prescribe high doses of painkillers.(11)
Fear of scrutiny: in today's polemical society, some physicians worry about being placed under investigation by State or Federal agencies - or even by a patient's family - for writing alleged excessive prescriptions.
And then comes the Pandora's Box of fear regarding opioids.
Opioids all work to relieve pain in the same fashion; by attaching to opioid receptors on nerve cells, thereby causing a decrease in the transmission of pain impulses to the brain. Opioid medications all differ in strength, duration of action and side effects. In addition, no two patients are alike and therefore differ in reactions to the same drug.
One of the biggest impediments to pain relief is fear of addiction. While some believe that addiction and dependence are problems in pain patients treated with opioids, substantiated facts show that these fears are greatly exaggerated. For instance, in a review of the records of 11,882 hospitalized patients treated with opioids, there were only 4 cases of addiction in patients with no addiction history. It is further believed that opioids depress respiratory function and are too dangerous to be dosed safely. Research has shown that in reality, while respiratory depression is indeed the chief hazard of opioid use, clinically significant respiratory depression rarely occurs in patients in pain for whom doses of opioids are appropriately prescribed.(12)
Tolerance: refers to a decrease in the effect of a drug in response to repeat exposure. All opioid medications are capable of inducing tolerance.(13)
Dependence: a physiologic state in which abrupt cessation of the opioid results in a withdrawal syndrome. Dependency is an expected occurrence in all individuals using opioids for therapeutic and non-therapeutic purposes. It does not, in and of itself, imply addiction.(14)
Addiction: addiction in the context of pain treatment with opioids is characterized by a persistent pattern of dysfunctional opioid use that may involve any or all of the following: adverse consequences associated with the use of opioids; loss of control over the use of opioids; and preoccupation with obtaining opioids despite the presence of adequate analgesia.(15)
It is further noted, ...individuals who have severe, unrelieved pain may become intensely focused on finding relief for their pain. Sometimes such patients may appear to observers to be preoccupied with obtaining opioids, but the preoccupation is with finding relief of pain rather than using opioids per se. This phenomenon has been termed 'pseudo-addiction' in the medical literature.(16)
As with all medication, opioid therapy entails a number of risks including sedation, possible liver or kidney damage if taken chronically, constipation, insomnia, decreased libido, itching, depression, loss of menses, urinary frequency, urgency or retention, muscle spasms, fatigue, GI disturbances such as nausea or vomiting, edema, weight fluctuation, headaches and withdrawal syndrome.
The most common symptoms of withdrawal syndrome are an increase in pain, general aching, cold sweats, restlessness, tremors, dizziness, nausea, vomiting and diarrhea. The syndrome can be stopped by resuming opioid medications.(17)
In order to overcome problems faced by patients and physicians alike in pain management, specialists are calling for enhanced pain management education in medical school, as well as implementing new reimbursement categories for pain among insurance companies. California is breaking ground in this area, addressing the needs of it's residents by passing legislation to make pain the 5th vital sign to be assessed and recorded along with temperature, pulse, respiration and blood pressure.
California also makes medical license renewal contingent upon completion of education in pain management. It is hopeful that other states will soon follow suit.
Certainly, pain management is possible. However, more attention to this matter is needed by both patients and physicians alike in order to provide significant relief to those in need, to afford patients freedom from disabling pain, to allow patients to become more physically active and socially productive, and most importantly, to allow those in pain to lead a more fulfilling life.
REF:
1) American Pain Society, Chronic Pain in America: Roadblocks to relief. Study conducted by Roper Starch Worldwide, 1999.
2 & 4) Scientists Say Genes, Gender Influence Pain, Omaha World-Herald, 2/21/00.
3), 6) & 8) Pain Assessment & Management: an Organizational Approach, the Joint Commission on Accreditation of Healthcare Organizations, 1 Renaissance Boulevard, Oakbrook Terrace, IL 60181.
5) One Man's Pain May Be Another Woman's Agony, Hawkes N., London Times. 2/22/2000.
7) Hospitals Failing Post-op Pain Relief, Reuters.
9) and 10) Controlling Cancer Pain: Missed Opportunities, Cleeland CS, [Report]. MSJAMA, 1/5/00.
11) Biting the Bullet: Doctors Debate How Much Pain We Should Endure, Foster, D. Rocky Mountain News, 2/29/00.
12) Myths About Opioids and How you can Refute them to Help Patients get the Pain Relief they Need, The Purdue Frederick Company and Purdue Pharma L.P.
13) & 17) Opioid Maintenance Therapy, Dr. William Hurwitz. 1350 Beverly Road, Suite 104, McLean, Virginia 22101.
14), 15) & 16) The Rights & Responsibilities of Physicians in the Use of Opioids for the Treatment of Pain, American Society of Addiction Medicine. Public Policy Statement, 4/16/97.
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