PostScript

A Newsletter from UniCare, Inc.

 

 

 

October 2004

 

 

 

IMPORTANT FLU VACCINATION UPDATE—

MAY NEED TO ACT NOW!!!

 

In order to develop an effective distribution plan for flu vaccines to the long term care priority group, the U.S. Centers for Disease Control and Prevention, with the assistance of Aventis Pasteur, the American College of Health Care Administrators, the American Health Care Association (AHCA)/the National Center for Assisted Living (NCAL) and the American Association of Homes and Services for the Aging (AAHSA) have developed a web-based survey to appropriately identify vaccine needs.  This survey instrument will be available to all long-term care facilities at the AHCA website.  Even if your facility has completed previous surveys, it is very critical that you complete the AHCA survey according to the most recent information we’ve received.  The deadline for completing this survey is today!  You can go to the AHCA website at:  www.ahca.org. 

 

You will need the following information when you go online: your facility’s Medicare/Medicaid provider number and/or state license number; the number of beds and direct care staff and contact support staff at the facility; the name and address of the supplier (if you’ve ordered from us, our address is 842 Peachtree Street; Prattville, AL  36066); the quantity of that order and the name and address of the distributor that was to provide the vaccine to your supplier (if you’ve ordered from us, that name and address is FFF Enterprises, Inc.; 41093 County Center Driver; Temecula, CA  92591).

 

 

ANNUAL SURVEY MONTHS

 

If you have not responded to our request for your last annual survey month, please do so at your earliest convenience.  Since this newsletter was e-mailed to you by Sallie Reynolds, you could just reply now.  If not, please e-mail her with this information at sallie.reynolds@omnicare.com. 

 

 

HAVE A SAFE AND HAPPY HALLOWEEN!!

 

Please review the attachment for information about new drugs, drug indications and warnings and other valuable information.

NEW DRUGS/FORMULARY INFO

Duloxetine (Cymbalta) Approved for Depression and Pain of Diabetic Peripheral Neuropathy

 

The Food and Drug Administration approved Eli Lilly and Co.'s antidepressant Cymbalta (duloxetine hydrochloride) for the management of diabetic peripheral neuropathic pain.  Duloxetine, a serotonin and norepinephrine reuptake inhibitor, is the first therapy approved by the FDA for this indication. The regulatory agency's approval was based on data from two 12-week, randomized trials of the drug in non-depressed adults who had experienced diabetic peripheral neuropathic pain for at least six months. Patients were administered duloxetine 60 mg, duloxetine 120 mg or placebo in the trials.

 

Results from the two trials showed that duloxetine significantly reduced 24-hour pain as compared with placebo. Symptom improvement was observed as early as week one, and positive results were maintained throughout the duration of the trials. The therapy was notably effective in relieving pain at night, which can interfere with sleep.

 

In August, duloxetine received approval from the FDA for treating major depression at doses of 60 – 120 mg/day, in adults.  Because of the dual action of duloxetine on both serotonin and norepinephrine reuptake, the drug may be particularly effective in people with common physical symptoms of depression such as vague aches and pains. The drug is also being evaluated for management of urinary incontinence. Duloxetine has been studied in more than 6,000 adults with major depression and demonstrated effectiveness in four placebo-controlled trials. The most commonly observed adverse events were nausea, dry mouth, constipation, fatigue, decreased appetite somnolence and increased sweating.

 

Doraiswamy PM. J Clin Psych 2001;62(Suppl12):30-5. Detke MJ et al. J Clin Psych 2002;63:308-15.

 

Trospium Chloride (Sanctura): Another Anticholinergic Drug for Overactive Bladder

Trospium is a quarternary ammonium compound that acts mainly as a muscarinic receptor antagonist. Trospium has been shown to decrease the average urinary frequency from 12.7 times to 10.3 times per day in controlled trials. Like other anticholinergic drugs used to treat overactive bladder, trospium causes dry mouth (20% of patients).  Trospium appears to offer no advantage over long-acting anticholinergics for treatment of overactive bladder.  Drugs such as trospium, tolterodine (Detrol LA), oxybutynin (Ditropan XL and Oxytrol) yield disappointing results in decreasing the number of incontinence episodes in patients with overactive bladder.

Zinner N et al. J Urol 2004;171:2311. The Medical Letter 2004;46:63-4.

 

DRUG INDICATIONS / WARNINGS

Hip Fracture Rate May Increase with Short- as well as Long-Acting Benzodiazepines

New evidence demonstrates a significant increase in the incidence of hip fracture among elderly adults enrolled in Medicaid who were exposed to any benzodiazepine. Researchers analyzed the New Jersey Medicaid health care claims data for all enrollees (n=125,203) between January1987 and June 1990. People were assigned to categories of benzodiazepine exposure and other predictors related to prior drug use. There were 2,312 first hip fractures during the 42 months.  Patients exposed to a benzodiazepine had a 54% higher risk of hip fracture compared to those with no exposure to benzodiazepines. During the first two weeks of therapy, the risk of hip fracture among new benzodiazepines users was more than twice that of nonusers.  New users also had a significantly higher hip fracture rate during the first 15 days of use compared with continuous benzodiazepine users.

 

 

 

 

Of note, was the finding that short-acting benzodiazepines (lorazepam, alprazolam, triazolam, oxazepam, and temazepam) were associated with the same risk of hip fracture as long-acting benzodiazepines (diazepam, chlordiazepoxide, flurazepam, clorazepate, quazepam, clonazepam, halazepam, and prazepam).  The incidence of hip fracture appears to be associated with benzodiazepine use.  Contrary to several previous studies, short-half-life benzodiazepines are not safer than long half-life benzodiazepines.

 

Safer alternatives exist for the treatment of anxiety (SSRIs such as Lexapro or Zoloft) and for insomnia (Ambien or Sonata).  Patients with epilepsy may need a few doses of lorazepam on hand in case they develop status epilepticus, where lorazepam is still the drug of first choice.  However, beyond emergent seizure treatment, benzodiazepines should be considered unsafe in elderly nursing home patients. The Beer’s list, of drugs to be avoided in elderly patients, includes benzodiazepines. 

 

Wagner AK et al. Benzodiazepine use and hip fractures in the elderly. Arch Intern Med 2004;164:1567-72.

Fick DM et al. Updating the Beers criteria for potentially inappropriate medication use in older adults. Arch Intern Med 2003;163:2716-24.

 

Stalevo for Parkinson’s Disease

Levodopa combined with carbidopa (e.g. Sinemet) is widely used to treat Parkinson’s disease but after 2 – 5 years most patients develop troublesome complications.  The newest treatment for Parkinson’s patients with end-of-dose “wearing off” is Stalevo, a combination of the catechol-O-methyltransferase (COMT) inhibitor entacapone (Comtan) with 3 different doses of levodopa/carbidopa (50/12.5, 100/25, and 150/37.5).  The rationale for Stalevo is that it permits some patients to take one pill instead of two.  Stalevo is bioequivalent to separate but equivalent doses of levodopa/carbidopa (100/25) plus entacapone. Stalevo ($182/month) costs the about the same as entacapone alone ($163/month), without the levodopa/carbidopa ($50/month).  Therefore, patients who are eligible for conversion to Stalevo will save money.

 

Patients needing more than 150 mg of levodopa per dose will have to take an additional carbidopa/levodopa pill to provide their required dosage. Patients who take controlled-release levodopa preparations plus entacapone cannot easily be switched to Stalevo due to bioavaibility differences between products.

 

Adverse effects that occur with entacapone or Stalevo include dyskinesias, nausea, diarrhea, and excessive daytime sleepiness.

 

Hauser RA. Neurol 2004;62(Suppl 1):S64. The Medical Letter 2004;46:39-40.

 

Gabapentin (Neurontin) for Chronic Non-Malignant Pain

Until recently, only the brand drug version of gabapentin, called Neurontin has been available.  In August a comparably bioavailable generic version of gabapentin became available.   Gabapentin is FDA-approved for the treatment of partial epilepsy and postherpetic neuralgia but is used off-label for a number of other indications, especially neuropathic pain syndromes. The generic product represents a lower cost alternative to brand name Neurontin for patients who may benefit from treatment with the drug.

 

Neuropathic pain (chronic non-malignant pain) usually responds poorly to analgesics such as acetaminophen or non-steroidal anti-inflammatory drugs (NSAIDS). Clinicians prescribe anticonvulsants, such as carbamazepine or gabapentin and tricyclic antidepressant medications such as amitriptyline and desipramine. The anticholinergic side effects, such as orthostatic hypotension, urinary retention and constipation) of tricyclic antidepressant medications are dose limiting in elderly nursing home residents. For these reasons, gabapentin is an attractive alternative.

 

In a randomized, double blind, 8-week trial in 165 patients with diabetic peripheral neuropathy, mean pain scores were significantly lower with gabapentin (1800-3600 mg/day) compared to placebo. Gabapentin compared favorably to amitriptyline in a double blind crossover trial in 21 patients with diabetic peripheral neuropathy. Gabapentin has been studied with some success in the treatment of trigeminal neuralgia, multiple sclerosis pain, neuropathic head and neck pain, HIV-related sensory neuropathy, phantom lib pain, Guillain-Barré syndrome and other pain syndromes.

 

Common adverse effects of gabapentin are dizziness and somnolence, which usually occur during the upward titration of doses and resolve over time.  Ataxia, fatigue, peripheral edema, confusion, depression and asthenia can occur. Starting with 100 mg/day administered at bedtime and titrating doses up to between 1800 and 3600 mg/day can minimize sedation over 3 – 8 weeks.

 

Backonja M et al. JAMA 1998;280:1831. Morello CM et al. Arch Intern Med 1999;159:1931.  The Medical Letter 2004;46:29-30.

PATIENT CARE INFORMATION

Pain Management in the Elderly

 

Pain is defined as an unpleasant sensory and emotional experience associated with actual or potential tissue damage.  This definition acknowledges the influence of social history, cultural expectations, and individual differences on the perception of pain.  The human pain experience is now recognized to involve a complex interaction of sensory, cognitive, and behavioral processes, which age may selectively influence.

 

Pain is common among the elderly population.  It has been estimated that 45% to 80% of nursing home residents have substantial pain that is undertreated. Many factors may contribute to suboptimal management of pain, including clinicians’ inadequate knowledge of effective pain assessment and management; negative societal attitudes about the use of narcotics by patients, family members, and clinicians; and an array of federal and state regulations surrounding the use of narcotic analgesics.

 

Pain is reported to be twice as prevalent in the elderly as in younger individuals.   The degenerative processes that occur in aging and the prevalence of diseases such as cancer, arthritis, and diabetic neuropathy in this age group help to explain why pain is so common. The comorbidity of illnesses increases the likelihood that pain management will be a serious problem for some elders.

 

Many perceptions exist regarding pain in the elderly.  While some have speculated that elderly persons perceive pain differently from younger persons, studies have failed to support any difference. Elderly individuals generally report pain less often than their younger counterparts, despite the greater frequency of illnesses associated with pain and no decrease in pain perception. Elderly patients may not bring pain to the attention of clinicians because they fear being labeled as bothersome, hypochondriacal, or addicted.  Many elderly are stoic, are slow to respond to pain assessment, and may have subtle cognitive defects, further disguising their condition.  Therefore, careful assessment of pain is necessary. Assessment is further complicated in demented individuals because compromised cognitive and verbal skills confound interpretation and reporting of subjective experiences.

 

The American Geriatric Society Panel on Persistent Pain in Older Persons recently updated their guidelines; The Management of Persistent Pain in Older Persons (http://www.americangeriatrics.org/products/positionpapers/index.shtml#1).  These guidelines stress the importance of ongoing pain assessment and include recommendations for pain assessment in cognitively impaired persons, the long-term use of nonsteroidal anti-inflammatory medications, the unethical use of placebos, and many other issues in persistent pain management. 

Summary of Key Recommendations:

SOURCE: AGS Panel on Persistent Pain in Older Persons. The Management of Persistent Pain in Older Persons. American Geriatrics Society. J Am Geriatr Soc 2002; 50;6:1-20.

 

Pharmacologic Options:

Despite the prevalence of painful conditions in the elderly, the prescribing and use of analgesics decline with age, possibly because of underreporting of pain, decreased drug requirements to alleviate pain, or decreased pain perception by the caregiver.  Effective pain management requires appropriate selections of drug, dose, route of administration, and frequency of administration.  These considerations are particularly important in the elderly because of the high prevalence of altered renal and hepatic functions and of coexisting chronic conditions that require polypharmacy.  Adverse effects associated with analgesic drugs such as nausea, constipation, urinary retention, sedation, and confusion are more difficult to prevent and manage in the elderly. Ongoing reassessment and reinterpretation are essential.  Pain management options are also complicated by significant pharmacokinetic and pharmacodynamic variations among analgesics, the potential for clinically significant drug interactions, intrapatient and interpatient variability, age-related physiologic changes, and preferences specified in an individual’s advance medical directives.  The following table lists some of the agents, which should be avoided in the geriatric resident. 

 

 

 

 

 

 

 

 

Analgesics to Avoid in the Elderly

Drug

Rationale

Meperidine (Demerol)

Risk for toxicity; safer alternative available

Pentazocine (Talwin)

Risk for toxicity; safer alternative available

Propoxyphene (Darvon, Darvocet)

Risk for toxicity; safer alternative available

Indomethacin (Indocin)

Risk for toxicity; safer alternative available

Cyclobenzaprine (Flexeril)

Toxic and minimally effective

Amitriptyline (Elavil)

Anticholinergic side effects; sedation

Doxepin (Sineqan, Zonalon)

Anticholinergic side effects; sedation

 

The effective pharmacologic management of chronic pain in the elderly requires routine (scheduled), versus PRN, dosing.  In addition, because of age-related changes, the elderly may metabolize analgesics differently from younger patients. Thus, starting with a low dose and gradually titrating upward, slowing until significant pain relief achieved, without intolerable side effects or toxic serum levels, is a generally accepted approach when initiating analgesic therapy in the elderly. The Geriatric Pharmaceutical Care Guidelines provided to client nursing facilities by Omnicare, is a rich resource for medication management of chronic pain in the elderly. 

A systematic approach to assessment, detection, and early intervention is essential for optimal pain management in the nursing home patient. The Omnicare Pain Management Initiative is designed to be integrated with the nursing facilities’ initiatives to identify and manage pain and to adequately document the resident’s response to pain management strategies. The Pain Management Initiative includes comprehensive educational materials, therapeutic recommendations, interdisciplinary communication strategies, and program implementation tools to facilitate the systematic identification and appropriate management of residents with pain.

 

 

EDITORIAL BOARD

Karen Burton, Pharm.D., CGP, FASCP

Mark Coggins, Pharm.D., CGP, FASCP

Kelly Hollenack, Pharm.D., CGP

Philip King, Pharm.D., CGP

Susan J. Klem, B.S. Pharm., CGP, FASCP

Terry O’Shea, Pharm.D., CGP, FASCP

Elmer Schmidt, Pharm.D., CGP, FASCP

Barbara J. Zarowitz, Pharm.D., CGP, BCPS, FCCP