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Duragesic

Duragesic (or Durogesic in europe) is the trade name of a fentanyl transdermal therapeutic system manufactured by ALZA Corporation and marketed by Janssen Pharmaceutica Products, L.P. A generic version was under development by Sandoz Laboratories, Inc, formerly Mylan Laboratories Inc. for launch in January 2005. The generic bioequivalent of Duragesic is available in 25, 50, 75, and 100 mcg dosages, while the trade name Duragesic is available in 12.5, 23, 50, 75, and 100 mcg dosages. more...

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The system employs a form-fill-seal technology in which a drug-laden gel is sealed between an impermeable backing and a drug-permeable release liner.

Durogesic D-Trans, available in some European countries, consists of a thinner, solid single-layer plastic patch with the fentanyl matrix-bonded in an adhesive layer.

During the period of June 2002 - June 2003, Duragesic sales totalled over one billion dollars.

Janssen Pharmaceutica Products, L.P., initiated a series of Class II Recalls in March 2004 due to a potentially life-threatening manufacturing defect. At least one fatality, possibly due to the defect, has been reported to the FDA.

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Pain management
From Townsend Letter for Doctors and Patients, 1/1/05 by Jule Klotter

In its 2000-2001 standards manual for accredited healthcare facilities and agencies, the Joint Commission on Accreditation of Healthcare Organization (JCAHO) included pain control requirements. In order to receive accreditation, facilities must have policies and procedures that encourage "the appropriate use of analgesics and other pain control therapies." As part of an accredited pain care management program, health care providers must employ regular pain assessment and reassessment and patient education about the importance of effective pain management.

Fears about possible addiction to pain-relieving drugs and the difficulty of assessing pain severity has resulted in under-treatment. Professor Harald Breivik, president of the European Federation of IASP whose organization co-sponsored the 1st Global Day Against Pain, says that chronic pain is a highly underestimated healthcare problem, "causing major consequences for the quality of life of the sufferer and a major burden on the healthcare system in the Western world." Pain causes more than discomfort. "Acute pain may contribute to wound dehiscence [a splitting open]," Sonia Strevy, RN, MS explains in her article "Myths & facts about pain," or cause guarding and decreased mobility. "The latter may contribute to pneumonia and embolism. Chronic pain diminishes quality of life and may also bring on anxiety, depression, and a sense of helplessness."

The World Health Organization has outlined a three-step approach for controlling pain. For the least severe pain, WHO recommends oral analgesics such as acetaminophen and ibuprofen. The next step includes mild opioids like codeine that can be used in combination with the oral analgesics if necessary. When pain refuses to subside, WHO advises moving to the third category: strong opioids like morphine or fentanyl (Duragesic, Sublimaze). The goal of pain management is to keep the patients as comfortable as possible and improve the quality of their lives.

Many clinicians use too low a dose of these strong opioids or avoid prescribing them because they fear that patients will become addicted to the drugs. Strevy's article marks the difference between physical dependence and psychological dependence (aka addiction). Patients using opioids can become physically dependent on the drugs after two or three weeks of use, depending on the dose. Physical dependence means that patients will experience withdrawal symptoms, if the drug is abruptly discontinued.

Patients who are physically dependent on drugs with a short half-life (e.g. codeine, morphine) experience anxiety, chills, irritability, hot flashes, joint pain, sweating, and/or vomiting six to twelve hours after the last dose. Discontinuing opioid drugs with a longer half-life (e.g. levorphanol and transdermal fentanyl) usually results in less severe effects. Psychological dependence is a different phenomenon. An article by R. C. Rinaldi, E.M. Steindler et al [JAMA, 259(4), 555] defines psychological dependence as the "compulsive use of a substance resulting in physical, psychological, or social harm to the user and continued use despite that harm." Studies with cancer patients who have taken strong opioids for long periods show that very few become psychologically dependent on the drugs.

Effective doses of pain medication given at regular intervals (which avoids a see-saw effect) is just one part of pain management. Strevy's article mentions several non-drug approaches that can reduce the need for medication: massage, transcutaneous electrical nerve stimulation (TENS), exercise, heat/cold applications, progressive muscle relaxation, guided imagery, and therapeutic touch. By including these therapies in a pain management treatment program, drug reactions and medical costs decrease.

Patient education is essential for good pain management. "Many patients in pain don't ask for medication," Sonia Strevy explains, "and many of those who do don't ask early enough to obtain adequate pain control." Patients have diverse reasons for not requesting pain medication. They may not want to 'bother' the nurse. They may fear side effects from the drugs. The use of pain medication may conflict with a cultural or religious belief, or they may believe that their pain is "inevitable and untreatable." Explaining the risks and benefits of pain medication will help. Patients need to understand that forestalling pain before it takes hold and becomes unmanageable (i.e., taking medication before a painful procedure or increased activity) is more effective than waiting until they are in agony before asking for help. Pain management begins by letting patients know that "most pain can be controlled."

Acello, Barbara, RN, MS. Meeting JCAHO Standards for Pain Control. Nursing 2000, Vol 30, No. 1.

Australian Broadcasting Corporation. Pain relief a human right: WHO. 11 October 2004. www.abc.net.au/news/newsitems/200410/s1217682.htm

Strevy, Sonia R., RN, MS. Myths & facts about pain. RN February 1998.

COPYRIGHT 2005 The Townsend Letter Group
COPYRIGHT 2005 Gale Group

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