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Duract (bromfenac) provides fast relief of acute pain

| Filed under NSAIDs

Bromfenac (Duract, Wyeth-Ayerst Laboratories) was cleared for marketing by the FDA on July 15, 1997 and provides an alternative to opioids for the management of acute pain. It provides fast relief of acute pain without the bothersome side effects of opioid analgesics.

How It Works

Bromfenac is a peripherally acting analgesic that belongs to the nonsteroidal anti-inflammatory drug (NSAID) class. Although the exact mechanism of action of this class of drugs is not known, there are many theories. Duract (bromfenac) seems to have anti- inflammatory, antinociceptive, and antipyretic effects. These activities of the drug are thought to be the result of its inhibition of the arachidonic acid cascade at the cyclooxygenase level.

Following bromfenac administration, the onset of analgesia occurs within about 30 minutes. The peak effect is seen within 2 to 3 hours and lasts about 6 to 7 hours. Bromfenac is more than 99% protein bound and has an elimination half-life of about 1.3 hours. The half-life, however, does not correlate with the duration of action of this drug. Bromfenac is metabolized by the liver into a cyclic amide metabolite and four glucuronide conjugates of aglycone metabolites and is excreted via the urine.

Duract (Bromfenac): Clinical Tips

Currently, the recommended dose for bromfenac is 25 mg every 6 to 8 hours for short-term pain management. If bromfenac is to be taken with a high-fat meal, the dose should be increased to 50 mg every 6 to 8 hours. However, the total daily dose of bromfenac should not exceed 150 mg. If a physician wishes to prescribe this medication for longer than 4 weeks, it would be advisable to monitor the liver enzymes, which can become elevated. Other possible adverse events include abdominal pain, headache, nausea, and vomiting.

Although opioids have proved to be excellent agents in the management of moderate to severe pain, their adverse event profile leaves much to be desired. These agents are known to make people drowsy, tired, and “spaced out,” often leading to noncompliance with the drug regimen. The efficacy of Duract (bromfenac) in relieving pain has already been demonstrated, and, unlike opioids, it does not interfere with people’s lifestyles. As experience with this agent grows, people may elect to use it instead of the opioid analgesic because of its favorable adverse event profile.

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Osteoarthritis drug may help menstrual pain

| Filed under NSAIDs

A new study concludes that the osteoarthritis drug Vioxx(R) (rofecoxib) is both safe and effective in relieving the pain associated with menstrual cramps.

  • researchers at the Merck Research Laboratories compared the effects of rofecoxib to those of both the non-steroidal anti-inflammatory drug (NSAID) naproxen sodium and placebo in 127 women, aged 18 and older, who had histories of moderate to severe menstrual pain.
  • found that menstrual pain at eight and 12 hours after medication was relieved similarly in both rofecoxib and naproxen sodium recipients.
  • side-effects were similar among all three groups in the study.
  • authors note that menstrual pain is thought to be caused, at least in part, by substances called prostaglandins, and that rofecoxib works to reduce the production of prostaglandins by inhibiting the COX-2 enzyme.
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Managing Pain in the Older Patient Part 4

| Filed under Pain Management

Challenges in Medicating the Senior Patient

Choosing an appropriate dosage form of analgesic drug is essential to successfully manage pain in the older patient. Beyond the clinical recommendations, the pharmacist can be instrumental in providing information on products that will optimize pain relief in this patient population. Swallowing difficulties secondary to other medical conditions, such as Parkinson’s disease, dementia, or stroke, may preclude the use of large tablets or sustained-release medications that cannot be crushed. Liquid medications provide an acceptable alternative for administering analgesics. Unfortunately, few analgesic preparations are available in liquid form. Ibuprofen and naproxen suspensions are the few NSAIDs available as liquids for the relief of mild to moderate pain. For moderate to severe pain, fentanyl patches provide continuous pain relief and are suitable for patients who cannot swallow sustained-release preparations, are tube-fed, or who have difficulty remembering to take their medication. The 72-hour administration interval also reduces the burden of administering medication by nursing staff in long-term care facilities or caregivers at home. The initial dose of the patch may be increased after the first three days of therapy. Additional dose increases should only occur after two cycles of patches have been applied. Morphine sulfate controlled-release capsules may be opened and the pellets mixed in applesauce or administered via a gastrostomy tube without loss of continuous pain relief. Patient controlled analgesia (PCA) through the use of a pump has not been as widely used in elderly patients, particularly those with cognitive impairment, since successful use requires active involvement by the patient.

 

Analgesics that are considered unnecessary drugs with a high potential for significant adverse effects and should be avoided include pentazocine and oral meperidine.

The older patient may be taking numerous medications, some of which may induce similar side effects as pain management therapy. Constipation is frequently a side effect of narcotic analgesic administration, particularly as the dose increases, placing the patient at risk for fecal impaction. Patients may also be taking calcium supplements and psychoactive agents, which can contribute to constipation. A review of bowel management therapy is advised at the time of prescribing narcotics.

According to the World Health Organization guidelines, the basis for current pain management practices, senna is the laxative of choice for managing opiate-induced constipation. Normal peristaltic movement is inhibited by opiates, preventing movement of fecal material through the colon. Irritant laxatives, such as senna, can help stimulate bowel evacuation. Docusate or psyllium-containing products may be of additional benefit to prevent straining or to add bulk. Adequate fluid intake is essential to prevent possible bowel obstruction associated with the use of bulk-forming laxatives.

Health Care Financing Administration (HCFA) Interpretive Guidelines also influence the process of selecting drug therapy for pain management. The use of tricyclic antidepressants, especially amitriptyline and doxepin, is discouraged in elderly patients due to their increased sensitivity to adverse effects, particularly anticholinergic effects and heart rhythm abnormalities. If a tricyclic agent is to be used, particularly for neuropathic pain, nortriptyline is preferred at low doses with careful titration and monitoring. Patients currently receiving amitriptyline should be considered for conversion to nortriptyline in equipotent doses. Documentation of efficacy and absence of adverse effects should be readily available. During medication pass and meal observation, surveyors are instructed to determine whether NSAIDs are administered with a meal. If they are administered on an empty stomach, it is calculated into the facility’s medication error rate.

Analgesics that are considered unnecessary drugs with a high potential for significant adverse effects and should be avoided include pentazocine and oral meperidine. Both drugs have an increased risk of respiratory depression or central nervous system adverse effects, including seizures with meperidine, in patients over 65 years of age. Alternative agents with less serious adverse effects are readily available.

Conclusion

Successful chronic pain management in the senior patient requires the active involvement of the pharmacist in the community as well as the institution. Regulatory requirements have established a framework for a comprehensive approach to pain management and a fundamental right of patients to adequate relief of pain. Overcoming the barriers to adequate pain relief is only one of the challenges facing the patient and the clinician. Multiple opportunities exist for enhancing patient quality of life. The pharmacist can help educate patients, families and staff about pain management, provide the clinical expertise necessary to manage pain, recommend dosage forms and adjunct medications that will enhance therapy, and measure outcomes of pain management programs.

Managing Pain in the Older Patient Part 3

| Filed under Pain Management

Drugs Used in Pain Management

Pharmacologic options for pain management range from simple analgesics, such as acetaminophen or low-dose nonsteroidal anti-inflammatory agents (NSAIDs) for the relief of mild to moderate chronic pain, to opioids for more severe pain (Table 1).

Simple Analgesics: Acetaminophen is useful for the relief of mild to moderate osteoarthritic pain in scheduled, divided doses not exceeding 4 g/day.NSAIDs may also be used in appropriate doses, for short periods of time. COX-2 inhibitors may be less likely to be associated with gastrointestinal bleeding and may be administered once daily, reducing nursing time for medication administration or the likelihood of missed doses. All NSAIDs should be given with a meal to avoid gastrointestinal upset. Periodic monitoring of renal function and blood count should be performed.

Topical Analgesics: Topical analgesics may also be used in the management of chronic pain. Capsaicin cream, derived from red peppers, desensitizes nerve fibers associated with pain by depleting substance P. Regular applications of the cream, beginning with the 0.025% concentration and progressing to the 0.075% formulation, may be helpful in relieving pain. Patients generally report a warming sensation at the site of application. The cream should not be used on broken or irritated skin. Several weeks of therapy may be necessary to determine efficacy. Menthol or methylsalicylate-containing products in the form of liniments, creams, sprays and other formulations may also be effective in relieving joint pain. Topical anesthetics, such as lidocaine ointment or gel, and combination anesthetic ointments or creams may also be of benefit in relieving joint pain or pain in other localized sites.

Table 1
Pharmacologic Management of Pain

Analgesics

Acetaminophen
Nonsteroidal anti-inflammatory agents
Nonselective
COX-2 inhibitors

Topical analgesics/anesthetics

Capsicum/Lidocaine

Tramadol

Antidepressants

Tricyclics SSRIs

Anticonvulsants

Gabapentin
Carbamazepine

Narcotic analgesics

Adjunct medications

Clonidine patches

Corticosteroids

Tramadol: Tramadol has been successful in managing pain in patients over the age of 75 years who are unable or unwilling to use opioids at doses of 300 mg or less per day. Doses in renally impaired patients (those with a creatinine clearance [CrCl] of 30 mL/min or less) should be further reduced by decreasing the dosing interval to every 12 hours and a maximum dosage of 200 mg/day. Dosage adjustment is also necessary in patients with hepatic impairment. Tramadol should not be used with opioids, tricyclic anti-depressants, or selective serotonin reuptake inhibitors. Patients taking other medications that lower the seizure threshold or who are at high risk for seizures may experience seizures with the addition of tramadol. Concomitant use of carbamazepine significantly lowers the bioavailability of tramadol, requiring a dose increase. In clinical studies with a majority of patients over the age of 65 years, dizziness, nausea, and vertigo were the most common side effects, reported in up to 46% of patients receiving tramadol for as long as three months.

Tricyclic Antidepressants: Tricyclic antidepressants have been successfully used in managing pain in combination with analgesic agents, particularly for neuropathic pain syndromes. Initiation of therapy at low doses (10­25 mg of nortriptyline) given at bedtime will avoid daytime drowsiness and improve sleep. Limited data exist for the efficacy of the selective serotonin reuptake inhibitors as adjunct pain management, precluding their routine substitution for tricyclic agents.

Anticonvulsants: With relatively few drug interactions in comparison to other anticonvulsants, gabapentin has been shown to be effective as adjunct pain therapy in patients with neuropathic pain. Gabapentin was shown to be as effective as amitriptyline in the management of diabetic peripheral neuropathy. In order to avoid the most common side effect, drowsiness, therapy is initiated at relatively small doses of 100 mg in the evening, with gradual upward titration every five to seven days. In patients with impaired renal function (CrCl>60 mL/min), doses should not exceed 1200 mg/day in divided doses.A maximum dose of 600 mg/day in divided doses is recommended in patients with CrCl 30­60 mL/min. Monitoring of drug serum levels is not indicated with gabapentin.

Narcotic Analgesics: Multiple narcotic analgesics are available as single agents or in combination with other analgesics for the relief of moderate to severe pain. Sustained-release preparations, such as morphine sulfate sustained-release tablets, offer the benefit of once or twice a day administration with continuous pain relief. Short-acting, immediate release formulations should be readily available to the patient for breakthrough episodes of pain. Use of the short-acting agents serves as a method of titration for the sustained-release preparations and as a measure of their efficacy. The timing of the use of immediate-release medications on a prn basis can help determine if pain control is diminished at the end of the dosing interval or if specific times of the day require an increased dose of analgesic. The inclusion of acetamin-ophen or ibuprofen with narcotic analgesics limits their usefulness. Acetaminophen-associated hepatotoxicity and ibuprofen-associated renal and gastrointestinal toxicities limit the total daily dose of the combination products. With gradual dose titration based on patient response, there is no dose limitation with single-agent narcotic analgesics. Oxycodone controlled-release tablets or other narcotic analgesics may be alternatives in patients unable to tolerate morphine sulfate, as intolerance of one agent does not prevent the trial of other narcotic analgesics.

Nonpharmacologic Interventions: Nonpharmacologic interventions have been used, often in conjunction with analgesic or adjunct medications, as part of a comprehensive pain management program (Table 2). Specific modalities may be used alone or in combination, depending on the patient’s condition.

As part of an interdisciplinary team, the pharmacist should ascertain whether all of the patient’s pain needs are being met during or after physical therapy sessions. Patients may refuse therapy sessions because they perceive the sessions as causing pain, or pain exists prior to the therapy visit. Premedication with a relatively rapid onset analgesic one-half to one hour prior to the therapy appointment can significantly reduce discomfort and allow the rehabilitation process to proceed smoothly. Medication after the therapy session can be useful in relieving discomfort or aching experienced by the patient.

Patients may also experience pain during wound care. Routine premedication for dressing changes in patients with a Stage III or IV pressure ulcer or other serious wound is recommended and can reduce the discomfort or pain associated with manipulation of the affected area.

Table 2
Nonpharmacologic Treatment of Pain
  • Acupuncture
  • Exercise
  • Guided imagery
  • Ice or heat packs
  • Occupational or physical therapy
  • Pastoral or psychological support
  • Transcutaneous electrical nerve stimulation (TENS)

Managing Pain in the Older Patient Part 2

| Filed under Pain Management

Managing Pain

 

Clinical assessment of elderly patients must attempt to ascertain the presence of pain through both verbalized and nonverbalized symptoms.

Selecting an optimal therapy depends on patient-specific criteria, including medical history, previous medications utilized, drug allergies, swallowing ability, and response to therapy. A description of the pain is also useful in determining initial therapy. Nociceptive pain, often the result of chronic or other conditions arising from actual tissue damage as in osteoarthritis, can be described as aching or soreness, rather than sharp pain. Neuropathic pain, arising from damaged nerve tissue, is usually described as burning, stinging or stabbing pain. To adequately manage chronic pain, the clinician should employ a step-therapy approach that uses regularly scheduled doses of medication rather than dependence on a regimen of “prn” doses. This avoids underdosing and its resulting inadequate pain relief. Titrating the dose and managing occasional variations in pain patterns are achieved through the use of rescue analgesics. Adjunct medications and nonpharmacologic interventions enhance the efficacy of analgesics; both are useful in managing chronic neuropathic and nociceptive pain. Adjunct medications may also have a positive effect on accompanying symptoms, including insomnia and depression. Therapy should be initiated in low doses, with gradual upward titration until pain relief is achieved.

Adequate pain management is a cornerstone of both palliative care and hospice care. Palliative care, the active care of a patient whose disease is not responsive to curative treatment, may be long-term. In contrast, a patient who is receiving hospice care has a life expectancy of six months or less. Regardless of the category of care the patient is receiving, appropriate management of pain and other associated symptoms is essential to the patient’s well-being and quality of life.

Managing Pain in the Older Patient Part 1

| Filed under Pain Management

Older patients have a variety of chronic illnesses that may result in pain. However, the daily presence of pain often goes unrecognized and, therefore, untreated in both the community-dwelling and institutionalized elderly. Chronic pain may be the result of comorbidities, including osteoarthritis, osteoporosis, cancer, peripheral vascular disease, or neuropathies secondary to complications of diabetes. Procedures such as surgery, open wounds and pressure ulcers can also be a source of pain. Identifying and adequately managing pain in the elderly patient presents unique challenges for the pharmacist and the entire healthcare team.

The lack of recognition and consequent undertreatment of pain in all patient populations has resulted in new standards from the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) for all levels of care. Organizations seeking JCAHO accreditation or reaccreditation must have a comprehensive pain management program in place. Underlying the new standards is a commitment to every patient’s right to adequate treatment of pain. This is accomplished through the organization’s program of education for all staff, patients, residents, and families; development and use of appropriate tools for pain assessment; care of persons with pain; inclusion of pain management in discharge planning; and incorporating pain management into the institution’s performance improvement program. The pharmacist is considered an essential staff member for a successful pain management program, not only in the educational component, but also in the development of policies and procedures, drug therapy protocols, and outcomes assessment.

New JCAHO standards commit to every patient’s right to adequate treatment of pain.

To emphasize the importance of routine and ongoing pain assessment, the American Pain Society (APS) has labeled pain as “the fifth vital sign.” Consistent with the JCAHO standards, which the Society endorsed, the APS seeks to provide practical measures in order to make adequate pain management a reality for every patient.

Assessment and Identification of Pain

Clinical assessment of all elderly patients must attempt to ascertain the presence of pain through both verbalized and nonverbalized symptoms. An elderly patient may verbally respond to questions about the presence of pain by stating that he has no pain but may, in fact, be experiencing unrelieved or inadequately relieved pain. In addition to an inability to express the presence of pain due to progressing dementia, aphasia, or language barriers, there may be cultural or societal barriers to articulating pain symptoms. Cultural beliefs that pain is a sign of weakness and that suffering is preferable to accepting pain medication may precondition the patient to deny the presence of pain. The patient, his or her family, and health professionals may have the misconception that narcotic analgesics should not be used because of the potential for physical dependence. Healthcare staff may not be adequately trained in recognizing the signs of pain in the older patient or in assessing pain relief. Staff cultural beliefs about patient perception of pain and treatment may hinder adequate pain management as well.

Pain scales that can be used to assess the intensity of verbally expressed pain include numeric or descriptive scales. The Wong Baker Faces Scale may be especially useful when verbal description is not possible. The patient may be able to indicate which face best demonstrates how he or she feels; if not, staff can match the face to the patient in front of them. Nonverbal cues may indicate the presence of pain in the elderly patient who denies or is unable to indicate the presence of pain. In addition to facial expression, behaviors that can indicate actual unrelieved pain include agitated behavior, pulling away or refusing care, favoring or rubbing a limb or body part, gait disturbances, declining to participate in rehabilitation activities, withdrawing from social activities, loss of appetite with resulting weight loss, insomnia, or symptoms of depression.