PostScript A Newsletter from UniCare, Inc.

February, 2005

Medicaid Preferred Drug List Talking Points

Medicaid now has 11 therapeutic categories covered under their Preferred Drug List (PDL). These include many categories prevalent in LTC, such as Cardiovascular Health, Behavior Health, Diabetic Agents, and Respiratory Agents. Antibiotics will be the newest category, effective March 1, 2005.

In addition to the PDL, Medicaid requires prior authorizations or overrides on hundreds of other drugs that exceed Medicaid’s established “Maximum Quantity.” Prior authorizations are also required for therapeutic duplication.

UniCare has a designated staff that obtains these prior authorizations for your nursing home and residents. For the most part, UniCare staff members complete the appropriate paperwork for the resident/facility and submits it without the home ever being bothered. When prior authorizations or overrides cannot be obtained, UniCare has systems in place authorizing interchanges to covered drugs in many cases. Again, this occurs with minimal facility involvement.

UniCare routinely communicates updates about Medicaid requirements so that facility staff can be aware of drug orders that might result in a delay. If a delay will occur, UniCare has an automated process to communicate this via the delivery manifest. When your delivery manifest indicates that a drug will be delayed due to prior authorization, your nurses should refer to this and write, “drug will be started pending prior authorization from Medicaid.” State surveyors know this and they should not give you any problems.

It is critical that nursing staff partner with UniCare by becoming familiar with the PDL classifications and related coverage of the most common drugs within each category so that they can help prevent potential problems before they occur.

You may visit the Medicaid website at www.medicaid.state.al.us to obtain a PDL by Therapeutic category.

Thanks for your cooperation and we hope you enjoy the rest of the newsletter.

NEW DRUGS/FORMULARY INFO

Pregabalin (Lyrica) for Neuropathic Pain

Pfizer Inc. received Food and Drug Administration approval for Lyrica (pregabalin capsules) for the management of neuropathic pain associated with diabetic peripheral neuropathy and postherpetic neuralgia (Shingles). Pregabalin is classified as a controlled substance. Pregabalin was developed by Pfizer as a follow-up compound to gabapentin (Neurontin). It is a neurological agent that is also under investigation for a variety of neurological and psychological disorders and is believed to decrease pain by interfering with a subunit of calcium channels called alph-2delta found on overexcited nerve cells.

The efficacy of pregabalin was established in six double-blind, placebo-controlled trials, three involving patients with diabetic peripheral neuropathy and three involving patients with shingles. Pregabalin provided rapid and clinically meaningful pain reduction in a significant portion of patients, with pain relief beginning as early as the first week of treatment in some patients. Pain relief was sustained in studies of up to 12-weeks duration at an average dose of 300 mg/day of pregabalin. The most frequent adverse effects are somnolence, dizziness, peripheral edema, headache and dry mouth. The product should become available in the next few months.

Sabatwoski R et al. Pregabalin reduces pain and improves sleep and mood disturbances in patients with post-herpetic neuralgia: results of a randomized, placebo-controlled clinical trial. Pain 2004;109:26-35.

Rosenstock J, et al. Pregabalin for the treatment of painful diabetic peripheral neuropathy: a double-blind, placebo-controlled trial. Pain 2004;110:628-38.

DRUG INDICATIONS / WARNINGS

The Latest on COX-2 and NSAID Safety

Since the withdrawal of rofecoxib (Vioxx) from the U.S. market, three additional safety alerts have been issued for cyclooxygenase selective (COX-2) and nonselective (NSAID) nonsteroidal anti-inflammatory drugs – valdecoxib (Bextra), celecoxib (Celebrex) and naproxen (various otcs Aleve™ and legend Anaprox, Naprosyn). The Food and Drug Administration (FDA) is evaluating data submitted by the respective drug companies to determine the appropriate regulatory action. Although these are important findings, at this point the FDA has seen only the preliminary results of the studies.

In overall clinical studies the most common side effects are dyspepsia, diarrhea and abdominal pain, which are generally mild to moderate. NSAIDs and COX-2 agents pose inherent safety concerns in older persons due to the potential for gastrointestinal ulceration and bleeding, renal failure, hypertension, and heart failure. NSAIDs and COX-2s should be used with caution in patients with fluid retention, hypertension, or heart failure.

Recently, studies have noted new cardiovascular risk. In brief, the situations leading to potential safety concerns include:

- higher rate of serious cardiovascular thromboembolic events (e.g. heart attack, stroke accident) in valdecoxib (Bextra) treated patients in two studies immediately following coronary artery bypass graft surgery (CABG) (valdecoxib is not FDA-approved for post surgical use following CABG);

- 3.4 times greater risk of cardiovascular events (e.g. heart attack and stroke) compared to placebo in a clinical trial of celecoxib (Celebrex®) to prevent colon polyps in patients taking 800 mg/day; 2.5 times greater risk in patients taking celecoxib 400 mg/day. Celecoxib in doses of less than or equal to 200 mg/day has not been associated with an increased risk of heart-related complications, and;

- 50% or 0.5 times greater risk of cardiovascular events compared to placebo in a clinical trial of naproxen being conducted to determine if naproxen or celecoxib would reduce the risk of developing Alzheimer’s disease. Naproxen is a Beers drug and is not recommended for use in the elderly because of its long half-life, associated edema and gastrointestinal adverse effects.

Based on this information, it appears that celecoxib can be continued safely at doses of 200 mg/day or lower. Persons receiving celecoxib doses of greater than 200 mg/day should be reevaluated for possible dosage reduction or selection of replacement therapy. As well, the risk to benefit ratio of continued treatment with naproxen should be reevaluated in light of this new information. As with all medications, the lowest possible dose of NSAIDs/COX-2s should be used for the shortest possible period of time needed. Non-acetylated salicylates (Disalcid and Trilisate) and acetaminophen are appropriate alternatives for the treatment of pain and inflammation in older persons.

PATIENT CARE INFORMATION

Cranberries and UTI Prevention

Ingestion of cranberry juice has been shown to be effective in decreasing bacteriuria with pyuria, but not bacteriuria alone or symptomatic urinary tract infection (UTI), in an elderly population. When combined with lingonberry, cranberry juice was demonstrated to reduce the rate of recurrent UTI in younger women. A randomized trial compared placebo, cranberry juice, and cranberry tablets (1:30 parts concentrated juice) for the prevention of UTIs in sexually active women aged 21 to 72 years. In this study, the women taking cranberry juice or tablets experienced significantly fewer symptomatic UTI over a period of 1 year.¹ Thus, although the efficacy of cranberry juice for the prevention of UTI needs further evaluation, there is mounting evidence that it may be effective in young, otherwise healthy women.² There was a 50% of the number of symptomatic UTIs per year and a 50% decrease in annual antibiotic consumption. A limitation of the cranberry juice concentrate is the taste. Most trials have used cranberry juice concentrate doses of 250 – 300 ml three times a day. If sweetened juice concentrate is used, blood sugars need to be monitored carefully in diabetic patients due to the high caloric load associated with adequately effective doses of cranberry.

1. Stothers L. A randomized trial to evaluate effectiveness and cost effectiveness of naturopathic cranberry products as prophylaxis against urinary tract infection in women. Can J Urol 9:1558, 2002.

2. Jepson RG, Mihaljevic L, Craig J. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev (1):CD0013213, 2004.]

Glaucoma

Loss of vision in the elderly can profoundly affect their quality of life, and, can result in an increased incidence of falls, as well as a decline in activities of daily living. Long-term care residents with vision impairments may require more nursing care, exhibit frustration-inducing agitation and withdraw from activities.

There are several common causes of visual loss but this article focuses on glaucoma. This is an area that depending on the transfer of medical information and the follow-up of eye care specialists to your nursing facility, can be underdiagnosed, undertreated or treated with less than optimal medication.

The Centers for Medicare and Medicaid also elevated the importance of identifying and treating glaucoma through The Benefits Improvement and Protection Act of 2000 (BIPA). This act provides coverage for annual glaucoma screening for eligible Medicare beneficiaries. These beneficiaries are eligible for this benefit if they 1) have family history of glaucoma, 2) are diabetic, 3) or are African-American over the age of 50.

Glaucoma is a slow progressive optic neuropathy. It is caused by poor drainage of aqueous humor from the eye, resulting in an increased intraocular pressure (IOP) outside the normal range of 10-20 mm/Hg, degeneration of the optic nerve head and a restricted visual field. The significance of consistent reduction of IOP was demonstrated in the Advanced Glaucoma Intervention Study (AGIS-7) study funded by the National Eye Institute in 2000. This study also concluded that IOPs should be consistently below 14 and that decreasing diurnal variations in IOP slow the progression of visual field loss.

All drugs for treating glaucoma either reduce the rate of aqueous humor production or increase the drainage from the eye. Agent selection is based on efficacy and compliance with safety obviously being considered. Because eye drops are absorbed through the mucous membrane, they may have considerable systemic effect and side effects can be profound. As an example, Betoptic-S® has 2.5% ocular absorption. Therefore, both oral therapies and eye drops must be considered in assuring against drug related problems. Ideally the best treatment is an effective agent administered once a day, with comfortable drop size and feel and lack of side effects.

Available medications include:

Class Medications Usual Dosing Side effects Contraindication

Miotics	Pilocarpine, epinephrine and in combination	Four times daily	Tearing, reduced night vision, headache	Acute iritis History of retinal detachment Highly myopic eye
Beta-Blockers	Betoptic-S® (Cardio-selective) Betagan®, timolol (Timoptic®)	Twice daily	Stinging, burning, blurred vision Decreased heart rate and BP Bronchospasm Insomnia	Coexisting cardiovascular or respiratory disease Allergy
Carbonic Anhydrase Inhibitors (CAI)	Trusopt® and Azopt®	Two or three times daily	Burning, tearing Dry mouth Lethargy GI upset	Allergy
Alpha2 Agonists	Iopidine® Brimonidine Alphagan-P®	Two or three times daily	Conjunctival hyperemia Lethargy in elderly	Allergy
CAI/timolol combination	Cosopt®	Twice daily	Burning and tearing Dry mouth Lethargy Decreased heart rate and BP Bronchospasm Insomnia	Allergy Coexisting cardiovascular or respiratory disease
Prostaglandin Analogues	Travatan® Xalatan® Lumigan®	Once daily	Hyperemia Iris color change Eyelash changes	Allergy

*Refer to the literature for complete product information

Timolol, a non-selective beta blocker had been the most frequently prescribed first-line therapy through the 1990’s. With concern for using timolol in residents with coexisting cardiovascular or respiratory disease, the introduction of prostaglandin analogues (e.g. Travatan) has allowed these agents to be used more frequently as first-line or adjunctive therapy.

Challenges in administration also include the residents’ tolerance, compliance with regulatory issues and efficacy surrounding the use of multiple eye drops. Monotherapy is cost effective, saves considerable administration time and improves medication adherence along with outcome.

As is the case with many disease, monotherapy is the most desirable treatment regimen however optimal IOP lowering may require appropriate combination therapy.

Areas that should receive scrutiny include:

- Residents that carry a diagnosis of glaucoma and have no treatment

- Residents that are receiving pilocarpine or other therapies that require administration two, three or four times a day

- Residents receiving oral and topical agents that increase the potential for drug related problems

- Residents receiving beta-blockers that have cardiopulmonary contraindications such as asthma or Sick Sinus Syndrome

- Residents receiving multiple eye drops that might be changed to monotherapy to reduce administration time and assure efficacy through proper absorption

Proper administration techniques should be reviewed periodically with the nursing staff. The bottles should be kept tightly closed and the expiration dates should be checked regularly. When dosed appropriately, the individual bottle should only last through the expected administration period. If more than one topical ophthalmic drug is administered, drops should be instilled 5-10 minutes apart to assure proper absorption.

Eye drop medications without proper documentation and follow-up can lead to an incomplete medical history that may occur unless residents or their caregivers are queried about all medications they are taking. As we are concerned about the implications of polypharmacy, we must be aware of all forms of medications as well as those taken over-the-counter.

Falls and fractures are a devastating occurrence and blindness is a frightening prospect. Given the level of attention to this disease, no person should become blind because of underdiagnosed, untreated or suboptimally treated glaucoma. Glaucoma is another condition that is predisposed to medication misuse, overuse and underuse.

The Omnicare Geriatric Pharmaceutical Care Guidelines 2004; 279-285

Novack, Gary. New Glaucoma Medications in the Geriatric Population: Efficacy and Safety. JAGS 2002 50:956-962

Lord, Stephen. Visual Risk Factors for Falls in Older People. JAGS 2001 49:508-515

Fiscella, Richard. Pharmacological Considerations in the Treatment of Glaucoma. Managed Care Supplement 16-20.

The AGIS Investigators. The Advanced Glaucoma Intervention Study (AGIS-7) The relationship between control of intraocular pressure and visual field deterioration. Am J Ophthal 2000;130:429-40.