FDA Discusses Accidental Overdoses

This story, from Sept 19, 2002, can be found on HealthWorld Online. It is written by LAURAN NEERGAARD, AP Medical Writer.
“SILVER SPRING, Md. (AP) – Thousands of Americans may unwittingly take toxic doses of acetaminophen, putting themselves at risk for serious liver damage, say federal scientists who are debating whether consumers need stiffer warnings about how to safely take the popular over-the-counter painkiller.”

Pain Assessment

Pain Assessment & Management in the New Millennium
Understanding Pain

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)

Emotional and Physiological Effects

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)

Assessing Pain

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.

Coping & Management

“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. Alternative techniques commonly used include relaxation, imagery, medical massage like shiatsu and reflexology, hydrotherapy, homeopathy, music therapy, touch healing, hypnotherapy, magnet therapy, herbalism, reiki, aromatherapy, diet/nutrition, supplements, ayurvedic medicine, acupuncture/acupressure, yoga, exercise regimens, TENS units and biofeedback. Psychological counseling is often incorporated into a patient’s pain management program to relieve anxiety, anger, fear and other emotional aspects of pain. Over-the-counter medications and non-narcotic prescriptions like NSAIDs (Non-Steroidal Anti-Inflammatory drugs) are also used for pain management and relief. Finally, narcotic prescriptions are used alone or in conjunction with other therapies to treat a patient’s pain.

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.

Continued Lack of Relief

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.

Tolerance, Dependency & Addiction

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)

Risks & Side Effects of Opioid Maintenance Therapy

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. If you anticipate the discontinuation of any opioid, the dose should be gradually tapered to avoid or lessen this withdrawal syndrome.(17)

The Oxycontin Controversy

Originally met with international support the year of it’s launch,(18) Oxycontin is making the news again; this time with a reputation as the latest “street” drug.

Oxycontin is a unique form of oxycodone. It is extremely effective for time-released opioid pain control in both cancer and non-cancer pain patients. Oxycontin is the only oral oxycodone that acts for a full 12 hours to relieve pain, making it the longest-lasting form of oxycodone to date. It also contains no aspirin or acetaminophen like its competitor products, which may be potentially toxic in maximal daily doses. Analgesic onset occurs within 1 hour in most patients.(19)

Oxycontin has been hailed as a “miracle drug” by chronic and acute pain patients everywhere, in a society where pain has generally gone undertreated. Unfortunately, the drug has now been nicknamed “the poor man’s heroin” because of it’s cheap price on the streets. Some have even called the illegal distribution of Oxycontin an “epidemic.”

When Oxycontin is broken, crushed and inhaled or injected, as is the method of ingestion by abusers, it is potentially lethal. In two states alone, at least 90 people have died as a result of Oxycontin abuse.(20)

Despite success stories associated with the drug, the bad publicity is taking its toll. Some pharmacies are so afraid of being robbed that they won’t even carry the drug and an Alabama lawmaker is drafting legislation that would ban it altogether, except in cases of terminal cancer.(21)

To make matters worse, some physicians are even being accused of cashing in on this and other pain relievers. In one instance, investigators cracked a pain management clinic that was a front for one of the largest narcotic-selling operations in the Midwest. Oxycontin was prescribed in half the cases for which the physician who ran the clinic was charged. The physician pleaded guilty to engaging in a pattern of corrupt activity, forfeited his medical license and was sentenced to 3 years in prison. In exchange, prosecutors dropped 46 counts of drug trafficking against him.(22)

These unfortunate developments have resulted in patients with true, intractable pain being unable to receive Oxycontin. One State Department of Professional and Financial Regulations has even urged “extreme caution” and issued voluntary guidelines for physicians and pharmacists when prescribing or filling prescriptions for Oxycontin. Physicians have been recommended to use special prescription forms that cannot be copied; use numbers followed by words to describe the quantity and strength of medication; specify on the prescription the name of the pharmacy selected by the patient for controlled substance prescriptions, as well as the patient’s insurance plan; and to fax a copy of the prescription to the selected pharmacy, when feasible, for authentication.”(23)

Joining the War Against Pain

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.

If you or someone you love suffers from pain, chronic or acute, it is important that you become an educated patient. Understanding why you have pain is your first step to treating it. Finding a physician who allows you to be a partner in your healthcare is equally as important. Communicate what you are feeling: if your doctor doesn’t ask, volunteer the information. To assist you in your communication with your health professionals, keep a pain journal…when pain occurred, what you were doing at the time, how severe it was, what alleviated it and when it abated. Take your medications as prescribed. Finally, in appropriate instances, learn what definitive measures may be taken to alleviate your pain, i.e. surgery.

If you are a caregiver, educate yourself about your loved one’s condition and offer help in various ways, like helping them maintain their pain journal, running errands, picking up prescriptions, etc.

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.

For more information:

To report a complaint about a Health Care Organization to the Joint Commission on Accreditation of Healthcare Organizations:

The National Foundation for the Treatment of Pain:

American Pain Foundation:

American Chronic Pain Association:

American Society for Action on Pain:
Copyright (c) by Heather C. Guidone. All Rights Reserved. Do not Reproduce Without Express Permission From Author.

Proudly powered by WordPress | Theme: Baskerville 2 by Anders Noren.

Up ↑