First Report ® American Medical Directors Association Annual Symposium Charlotte, NC; March 5-8, 2009

Pain Medication Protocol for Chronic Pain in a LTC Setting

Charlotte, NC—Chronic pain is common among the long-term care population. It is estimated that 45-80% of nursing home patients have chronic pain. Despite its prevalence, pain in this population is often underdetected and undertreated.

At the AMDA meeting, Serge Gingras, MD, and colleagues described a pain management program that was implemented at Sainte-Anne Hospital in Montreal, a veterans’ hospital, in the year 2000. The indicator used in their program, percentage of residents with 50% or more reduction of intensity of pain at 72 hours, revealed poor results: there was only a 5-27% reduction of pain at 72 hours. These poor results brought the researchers to analyze the validity of the indicator used and the reasons that explained these results.

One of the reasons identified by a file audit was the high use of as-needed pain medication. On review of the literature, no studies specific to the use and control of as-needed pain medication was found. An interdisciplinary committee was thus created to review the use of as-needed pain medication, and an interdisciplinary protocol was presented. The authors concluded that more clinical work and research should be conducted in this field.
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Study Shows Reduced Exacerbations in COPD with Combination Corticosteroid and Long-Acting Beta2-Adrenergic Agonist Use

Charlotte, NC—24 million people have chronic obstructive pulmonary disease (COPD), but only about 12 million will be diagnosed. The numbers are increasing, with women catching up.

At a learning lab at the AMDA meeting, Albert Riddle, MD, CMD, Northeast Center for Special Care, Lake Katrine, NY, discussed the prevalence, impact, multicomponent nature, and clinical considerations of COPD, and referred to the American Thoracic Society/European Respiratory Society evidence-based guidelines for treatment of the disease, as well as the GOLD Criteria 5 stages of COPD. He talked about the complex physiology of COPD and exacerbations such as airway inflammation, mucociliary dysfunction, chronic cough with sputum, as well as structural and vascular changes. Systemic components include cardiovascular impairment, impaired skeletal muscle, poor nutrition and weight loss, and reduced body mass index. He presented case studies that showed that patients treated with the combination fluticasone propionate 250 mcg/salmeterol 50 mcg inhalation powder showed better lung function as compared to salmeterol 50 mcg. The combination treatment is the only FDA-approved product for reducing exacerbations of COPD.

Dr. Riddle pointed out that it is not a rescue therapy and does not replace a long-acting inhaler. Patients in long-term care must be monitored for bone loss and increase in blood pressure.

A recent study conducted by Ferguson et al and published in Respiratory Medicine compared fluticasone propionate 250 mcg/salmeterol 50 mcg inhalation powder versus salmeterol 50 mcg in reducing COPD exacerbations. The randomized, double-blind, parallel-group, multicenter study was conducted at 94 research sites in the United States and Canada. As-needed albuterol was provided for use throughout the study. Use of concurrent inhaled long-acting bronchodilators, ipratropium/albuterol combination products, inhaled corticosteroids, oral beta-agonists, and theophylline preparations were not allowed during the treatment period. Oral corticosteroids and antibiotics were allowed for acute treatment of COPD exacerbations.

The study looked at patients age 40 years and over with a diagnosis of COPD, a 10-pack or more history of cigarette smoking, pre-albuterol FEV1/FVC of 0.7 or less, FEV1 of 50% or lower of predicted normal, and a history of at least one COPD exacerbation in the past year that required treatment with antibiotics, oral corticosteroids, or hospitalization. The primary endpoint was annual rate of moderate/severe exacerbations, and secondary endpoints were time to first moderate/severe exacerbation, annual rate of exacerbations requiring oral corticosteroids, and pre-dose FEV1.

Results showed that fluticasone propionate 250 mcg/salmeterol 50 mcg inhalation powder significantly reduced the annual rate of moderate/severe exacerbations by 30% versus salmeterol (P = 0.001), and provided statistically greater lung function (AM pre-dose FEV1) versus salmeterol 50 mcg at endpoint.
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Administration Errors for Medications in Long-Term Care

Charlotte, NC—Philip D. Sloane, MD, MPH, University of North Carolina at Chapel Hill, discussed the medications most likely to result in serious errors in the long-term care (LTC) setting. He reported on the McCormick and Reinhard study conducted in Oregon and Washington that focused on errors that included giving twice the amount of warfarin as required, giving furosemide twice a day instead of once daily, giving insulin when not prescribed, giving diazepam when not prescribed, and giving twice the amount of glipizide as prescribed.

Dr. Sloane discussed results of the CEAL-UNC data and asked the following questions: What makes a medication high-risk? What are clues to high risk? What medications are the highest risk? In determining error severity, clinicians should take into account the error itself (wrong dose, wrong timing), the toxicity of the drug, the therapeutic importance of the drug, the therapeutic index, and what might happen if errors occurred multiple times. Timing is also crucial: How often is a 2-hour, 4-hour, 6-hour, or 8-hour window okay? Timing of administration matters in parkinsonian agents, psychotropics, medications for chronic obstructive pulmonary disease/asthma, gastrointestinal problems, and medications for persons with diabetes.

Drugs associated with the highest level of harm were insulin, ipratropium, warfarin, risperidone, levodopa/carbidopa, galantamine, oxybutynin, glyburide/metformin, and albuterol. Common sources of administration errors are eye drops and inhalers, where the medication is not unit-dosed, administration requires specialized knowledge, and skill is required on the part of the patient (inhalers) and/or staff member (eye drops). He related the higher frequency of administration errors with eye drops and inhalers on observed medication passes, in addition to a higher frequency of the highest severity administration errors.

Dr. Sloane discussed the 2008 findings of Kuo et al on quality and safety in healthcare, which found that 70% of the medication errors in primary care are prescribing errors. The narrow therapeutic index drugs were covered, with concerns discussed regarding high toxicity risk, high potential for drug interactions, and the need to know how the drugs are eliminated: primarily liver-metabolized (eg, warfarin, phenytoin, theophylline), primarily renally excreted (eg, digoxin, propafenone, ethosuximide, insulin), or both metabolized and excreted (eg, levothyroxine).

Findings on the dangers of sedative administration errors from a 2009 study by Ray et al published in The New England Journal of Medicine and a 2005 study by Tamblyn et al published in The Journal of the American Geriatrics Society were presented, which included antipsychotics and the increased risk of sudden cardiac death, and benzodiazepines and fracture risk.

The cumulative anticholinergic burden is an emerging area of concern, according to Dr. Sloane. The worst offenders are not used much any more; however, many medications have mild or moderate anticholinergic effects, which can be cumulative in polypharmacy. This is an especially important issue in persons with cognitive impairment and Alzheimer’s disease.

Inappropriate prescribing can occur when continuing longstanding medications, honoring family requests, and treating symptoms such as sleep, agitation, or pain. Underprescribing can occur with treating cardiovascular disease (eg, beta blockers, aspirin), hyper-cholesterolemia, diabetes, osteoporosis, and hypertension.
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Assessment of Cholesterol Goal Attainment and Statin Dosing Considerations in Nursing Home Residents

Charlotte, NC—Cholesterol goal attainment rates, including in residents with coronary heart disease (CHD), were shown to be high in this study of 201 residents of a NJ nursing home by Breve and Gianarkis from the PharmaTech Consulting Group, Blackwood, NJ. The primary objective was to determine cholesterol goal attainment rates among nursing home residents receiving statins. Secondary objectives were to assess the frequency of switching, evaluate dosing, and compare goal attainment and prevalence of comorbidities in different statin cohorts.

Statin cohorts (atorvastatin and simvastatin) were compared using a two-sample t-test, and a z-test for proportions was selected for other comparisons (P = 0.05, considered statistically significant for both tests). Residents with incomplete data were excluded from the analysis. Although nearly 2 in 3 had CHD, diabetes, or a CHD risk equivalent, low-density lipoprotein cholesterol (LDL-C) goal attainment was high. Overall, 88.6% of residents were at their NCEP LDL-C goal.

For the high-, moderate-, and low-risk groups, goal attainment was 81.4%, 97.4%, and 100%, respectively. Notably, one-third of residents with CHD who were at goal achieved the optional LDL-C goal of less than 70 mg/dL. Fifteen residents (7.5%) had their statin switched during the study period. Atorvastatin to simvastatin accounted for nearly half of all switches, but changes in therapy did not appear to be related to LDL-C. In the simvastatin cohort, potential drug interactions were identified in 34.3% of residents, 71.4% of which were prescribed doses in excess of the recommended maximum daily dose. Additionally, it was noted that 15.4% had severe renal impairment without modification to their simvastatin dose. Residents who received atorvastatin compared to simvastatin had lower LDL-C values (76.5 mg/dL vs 81.7 mg/dL) and achieved greater LDL-C goal attainment (96.2% vs 86.1%), but these results were not statistically significant. However, fewer residents in the atorvastatin versus the simvastatin cohort had documentation of a stroke (11.1% vs 15.6%) or heart failure (11.1% vs 17.7%), respectively. These results were statistically significant (P < 0.001).

The investigators concluded that cholesterol goal attainment rates, including in residents with CHD, were high. Switching, while uncommon, did not appear to have a significant impact on LDL-C. However, both concomitant medications and renal function need to be considered in order to optimize dosing of certain statins. This information, along with knowledge of the LDL-C lowering activity of statins, can help clinicians achieve optimal outcomes with these agents.
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Significant Reduction of Urinary Tract Infections in the Elderly

Charlotte, NC—Urinary tract infections (UTIs) are the most frequent infection in long- term care (LTC) facilities. (The frequency of infection is 0.46 to 4.4 per 1000 resident days.) While most residents are asymptomatic, the prevalence rate of bacteriuria is 25% to 50%. The older people become, the more likely they are to develop a UTI. Common risk factors for UTI in the elderly include diabetic neuropathy, kidney stones, bowel incontinence, and dehydration. LTC residents also are highly functionally impaired. Many are incontinent, immobile, and have confusion and/or dementia.

The clinical manifestations of UTIs are often nonspecific in the elderly, in whom the absence of classic signs and symptoms does not rule out an infection. A resident often may not have the classic signs of a UTI, such as fever, painful urination, frequency, urgency, or visible hematuria. However, a change in mental status such as increased confusion, lethargy, or decrease in activity may be a significant sign in the elderly. Resident communication is often impaired because of dementia or debilitation, making accurate urine cultures a helpful tool in the diagnosis of a UTI.

The objectives of a study presented by Kenneth Brubaker, MD, CMD, at the AMDA meeting were to decrease numbers of UTls through better specimen collection and diagnosis and decrease treatment of possibly contaminated specimens. Multiple interventions were trialed while monitoring UTI number by MDS criteria. These interventions included new vacuum containers to collect the specimen for transport to the lab; new/clean toilet collection containers to collect each specimen from each resident; and a trial of three different methods for perineal cleansing such as soap and water, cleansing perineal disposable cloth, or an alcohol-based cleansing wipe prior to collecting a clean-catch urine.

None of these interventions decreased the number of UTIs. A protocol was then implemented to straight catheterize for all urine specimens/cultures unless contraindicated due to behavior. In addition, they engaged in extensive provider education relative to the appropriateness of collecting a urinalysis specimen in residents with behavior problems.

Results showed that the straight catheter protocol education was the only intervention to affect the percentage in UTI rates. The facility UTI percentage was stable in 2005-2007 at 11%. After implementation of the straight catheter protocol, the facility percentage in 2008 was 6.7%. The facility percentile on the CMS Quality Indicator report was 64th percentile in 2005, reduced to 37th percentile in 2008.

The authors concluded that continuous quality improvement provides the basis for building effective interventions resulting in better outcomes for elderly persons. Decreasing the number of UTls in the LTC elderly is difficult due to the lack of classic signs and symptoms. An accurate urinalysis and urine culture provides helpful information. This can be used in conjunction with physical findings to improve treatment of UTI and helps to avoid overtreatment in this age of resistant organisms.
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Study Shows Effective Combination Therapy for Alzheimer’s Disease

Charlotte, NC—This program focused on the diagnostic process and possible treatment outcomes in patients with Alzheimer’s disease. The latest clinical information was reviewed, including a recently published study demonstrating the potential long-term benefits of combination therapy for Alzheimer’s disease. Researchers conducted a large population study to see how cholinesterase inhibitors (ChoIs) and memantine work for a full range of patients in real-life situations by analyzing data on patients treated at the Massachusetts General Hospital Memory Disorders Unit since 1990. Patients in the study included 144 who did not receive any pharmaceutical treatment, 122 treated with ChoIs alone, and 116 who received both a ChoI and memantine. As part of their regular treatment, every 6 months patients received standardized assessments of both cognitive abilities and how well they carried out daily activities. The results showed significant differences in the rate of symptom progression among all three groups, with the smallest level of decline in those receiving combination therapy.

Researchers emphasized that providers need to help patients understand that the benefits of these drugs are long term and may not be apparent in the first months of treatment. Even if a patient's symptoms get worse, that doesn't mean the drug isn't working, since the decline probably would have been much greater without therapy.