American Society of Health-System Pharmacists Midyear Clinical Meeting

Orlando, FL; December 7-11, 2008
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Pharmacologic Treatment for the Elderly Requires Special Considerations

Orlando, Florida—Healthcare professionals face unique issues when dealing with geriatric pharmaceutical care, including the critical area of polypharmacy. These special considerations and the changing dynamic of the geriatric population were the subjects of a presentation at the ASHP meeting, “Polypharmacy and the Elderly: Case-Based Topics in Geriatric Care.”

The first presenter was Judith L. Beizer, PharmD, CGP, FASCP, Clinical Professor, St. John’s College of Pharmacy and Allied Health Professions, Jamaica, NY. Dr. Beizer began with an overview of pharmaceutical care in the elderly. She noted that by 2010, there would be an estimated 6.12 million Americans over the age of 85. By the year 2050, the U.S. Census Bureau estimates that the number of citizens over the age of 85 will be 20.86 million, creating what Dr. Beizer called a “silver tsunami.” She continued by saying that people over the age of 80 fill, on average, 22 prescriptions each year, as compared with those age 50 to 64 who fill, on average, 13 prescriptions per year.

Dr. Beizer outlined several considerations when prescribing for the elderly, including the physiologic changes that may have an impact on pharmacokinetics and pharmacodynamics, as well as changes in functionality that may affect the ability of patients to administer medications or to be adherent. She mentioned the need to consider the risks and benefits of treating with medications versus watchful waiting or nonpharmacologic treatment, the need for communication between healthcare providers, the possible socioeconomic barriers to access, and the ability of the elderly to afford their medications.

She continued her presentation with a discussion of the Beers Criteria 2003 update. The Beers Criteria provide a list of medications that are generally considered inappropriate when prescribed for the elderly because they tend to cause side effects related to the physiologic changes of aging. Dr. Beizer said the top three medications on the Beers list still being prescribed are propoxyphene, diphenhydramine, and promethazine. She continued by noting that high doses of short-acting benzodiazepines may be problematic in the elderly, and that high doses of iron are often prescribed for the elderly, creating problems with constipation.

Dr. Beizer then turned to polypharmacy, stating that use of multiple medications created potential for nonadherence and adverse effects, especially due to drug interactions, duplications of therapy, and increased costs. The causes of polypharmacy include multiple diseases, multiple prescribers, multiple sites of care, multiple pharmacies, self-medicating, using borrowed or leftover medications, not following directions carefully, and the use of medications to counteract side effects of other medications.

She also noted that clinical practice guidelines do not as a rule address treatment for older adults with multiple comorbid conditions. She cited the case of a hypothetical woman, 79 years of age, with chronic obstructive pulmonary disease, diabetes mellitus, osteoporosis, hypertension, and osteoarthritis. That patient would likely be taking 12 medications costing approximately $406 per month. To avoid polypharmacy, Dr. Beizer suggested regular review of every medication a patient is taking, including the indication for the medication and continued need, the dose being taken, adverse effects, and the use of other monitoring parameters. A good time to review medication use is when a patient is undergoing a transition in care, from hospital to nursing home, or rehabilitation center to home, for example.

Nonadherence is also a concern in treating the elderly. Dr. Beizer said that nonadherence accounts for > 10% of hospital admissions for older adults, 25% of nursing home admissions, 20% of preventable adverse drug events in older adults, and 125,000 deaths each year. Nonadherence costs the healthcare system in the United States $100 billion a year, according to a 2007 report from the Institute of Medicine. She suggested ways to improve medication adherence, including developing office systems or teams to ensure that all pertinent information is given when a new medication is prescribed, developing better systems of communication during transitions in care, and the use of more combination tablets and polypills.

Dr. Beizer concluded her remarks with a report on FAME (Federal Study of Adherence to Medications in the Elderly). In that study, 200 patients at Walter Reed Army Medical Center, 78 years of age, taking a minimum of four chronic medications, following a 2-month run-in period were given 6 months of pharmacy care intervention consisting of standardized medication education, regular follow-up with a pharmacist, and medications dispensed in blister packs. At the end of 6 months, patients were randomized to receive 6 months of usual care or 6 months of continued pharmacy care. Results showed that in the 6 months of pharmacy care, adherence rates went from 60% to nearly 100%. However, in the following 6 months, adherence rates for those in the usual care group declined to 60%, while rates for those in the pharmacy care group stayed at the increased level.

Case Presentations

The session continued with presentations of case studies. Todd P. Semla, PharmD, BCPS, FCCP, AGSF, Clinical Pharmacy Specialist at the Department of Veterans Affairs, presented a case study demonstrating appropriate treatment of sleep disorders in the elderly.

He offered both nonpharmacologic treatments, including stimulus control, sleep restriction, cognitive interventions, relaxation techniques, and bright light therapy, as well as options using pharmacotherapy, including short-acting and intermediate benzodiazepines, hormone and HR agonists, and antidepressants. He advised avoiding antihistamines, tricyclic antidepressants, benzodiazepines (flurazepam, diazepam, lorazepam, alprazolam, and triazolam), barbiturates, and chloral hydrate. He also touched on concerns about use of hypnotics in the elderly, including tolerance, dependence, and adverse effects.

Dr. Semla then presented a case study on treating depression in the elderly. He noted that suicide is a concern when treating older adults for depression, stating that 13% of the elderly population accounts for 25% of suicides. Furthermore, 25% of suicide attempts by older adults are successful. Risk factors for suicide include the presence of comorbid physical illness, living alone, being male, and alcoholism.

Nonpharmacologic treatment options for mild-to-moderate depression discussed included cognitive behavioral therapy, interpersonal therapy, and psychodynamic psychotherapies. Pharmacotherapy for mild, moderate, or severe depression includes mono-adjunctive and combination therapy. For severe and psychotic depression, Dr. Semla suggested electroconvulsive therapy.

First-line pharmacotherapy for the treatment of depression in older adults includes selective serotonin reuptake inhibitors for patients with mild-to-moderate depression, cardiac disease, benign prostatic hyperplasia, uncontrolled glaucoma, and nonmelancholic depression, Dr. Semla stated. Serotonin-norepinephrine reuptake inhibitors are used as second- and third-line pharmacotherapy in the elderly.

Dr. Beizer continued with a case-study presentation addressing the use of antipsychotics in elderly patients with dementia. She said that 5% to 15% of people over 65 years of age have dementia, and it is estimated that the projected number of people with dementia will double by the year 2020. Neuropsychiatric symptoms are seen in 60% of patients in community settings and in 80% of residents in nursing homes. Dr. Beizer cautioned that all discussion of treating dementia with antipsychotics is off-label.

She cited the CATIE-AD (Clinical Antipsychotic Trials of Intervention Effectiveness-Alzheimer’s Disease) study. Results of CATIE-AD showed that antipsychotics may be effective for specific symptoms such as aggression, paranoia, and anger, but by 12 weeks there was no significant difference in cognition, care needs, or quality of life in patients treated with antipsychotics. She also cited studies that addressed concerns about the safety of these agents in the elderly. She cautioned against using antipsychotics in this population and stressed that careful monitoring and assessment are needed when antipsychotic treatment is initiated, and the agents should be discontinued as soon as possible.

Finally, Sandra L. Chase, PharmD, FMPA, a cardiopulmonary clinical specialist at Spectrum Health, Grand Rapids, MI, discussed the treatment of cardiovascular disease (CVD) in the elderly. A death occurs from CVD every 33 seconds in the United States; it is the number one killer in this country, and as the population ages, the number of patients with a diagnosis of CVD will increase, according to Dr. Chase.

She presented evidence that statins reduced the risk of a fatal or nonfatal stroke by 10% in a group of patients age 65 years and older. Statins have also been shown to lower 5-year mortality in patients age 65 years and older by 20%.

Dr. Chase concluded her remarks with statistics on the problem of nonadherence in elderly patients. According to the National Coalition on Health Care, the total 2004 healthcare expenditures were $1.9 trillion. The costs attributable to nonadherence cited in 1993 have been estimated to be more than $100 billion.

She specifically addressed treatment for early and significant reductions of low-density lipoprotein cholesterol (LDL-C), citing studies that suggest that reductions in LDL-C are associated with long-term adherence, so “the more successful we are at lowering out LDL levels, the more successful we are going to be with long-term adherence, so again, we do need to be aggressive in our patients. …If we can get aggressive with our goals and get our patients to goal, they may be more adherent to their therapy,” Dr. Chase concluded.
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Management of Hip Fracture Risks Needed for Elderly Patients

Orlando, Florida— Experiencing a hip fracture is a common concern among geriatric patients because of the increased risk of mortality, reduced quality of life, and loss of independence that can follow. At an educational session during the ASHP meeting, three presenters discussed treatment options for patients who have had hip fractures, osteoporosis, and osteoarthritis, but emphasized the importance of preventive measures to help seniors avoid these medical conditions in the first place. The presenters discussed complications associated with hip surgeries, chronic conditions associated with hip fracture, and treatments for osteoarthritis.

The first presenter was Sheila Wilhelm, PharmD, BCPS, Clinical Assistant Professor at Wayne State University, Detroit, MI. Dr. Wilhelm used a case study of a patient diagnosed with a low-trauma hip fracture requiring hip arthroplasty in her discussion, which was intended to describe normal hip anatomy, common types of hip fracture, and surgical options for hip fracture repair. She told the audience that in 2004 hip fractures were responsible for 320,000 hospital admissions, 75% of which occurred in women. Among seniors, more than 90% of hip fractures are due to falls. Risk factors include advancing age, low bone density and osteoporosis, prior or family history, inactivity, and tobacco use.

Patients who experience a hip fracture have a 40% likelihood of not regaining their pre-fracture walking ability, and half will not regain their full ability to perform the activities of daily living. They also have a 20-25% mortality risk within a year of the fracture, and about 25% will remain in a nursing facility for a year or more, even if they were previously independent. Surgical options include total hip arthroplasty (THA) or hip fracture surgery (HFS) such as hip resurfacing, hemiarthroplasty, and open reduction internal fixation (ORIF).

Although there are several complications that can arise after surgery, the presentation focused on preventing venous thromboembolism (VTE). Subtopics were VTE pathogenesis, preventive anticoagulants, patient-specific planning, and resolution of medication issues related to preventing coagulation after a hip fracture. Dr. Wilhelm said that vascular damage can arise as a direct result of trauma from hip surgery or due to the advancing age of the patient. She said that in clinical trials in which patients underwent hip or knee arthroplasty, HFS, major trauma, or spinal cord injury with no VTE prophylaxis and mandatory venography, VTE was found in 40-80% of patients.

Pharmacologic agents highly recommended for VTE prophylaxis are low-molecular-weight heparin, fondaparinux, and warfarin. Low-dose unfractionated heparin is not recommended for persons who have had THA, but is recommended after HFS; mechanical prophylaxis is recommended for both THA and HFS, but only in patients at high risk for bleeding. Aspirin is not recommended as a stand-alone pharmacologic measure to prevent VTE.

Dr. Wilhelm told the audience that although the average length of stay for THA is 5-6 days, coagulation activity can continue for at least 4 weeks, and the risk for VTE can last 3 months. The current recommendation is to provide extended prophylaxis after THA or HFS for at least 10 days and up to 35 days after surgery, and Dr. Wilhelm presented data showing that VTE prophylaxis is underutilized. Finally, she said that pharmacist involvement can increase VTE prevention utilization and patient and family education.

The second segment of the discussion was led by Mary Beth O’Connell, PharmD, BCPS, FASHP, FCCP, Associate Professor, Wayne State University, who discussed chronic conditions associated with hip fracture, beginning with osteoporosis. “Even though [osteoporosis] is a public health concern, most of our seniors are not getting adequate education or diagnosis,” she said before presenting data showing that the incidence of osteoporotic fractures among U.S. women is about four times greater than the risk of myocardial infarction, stroke, or breast cancer.

New guidelines for the prevention and treatment of osteoporosis were published this year by the National Osteoporosis Foundation (NOF) and are available free of charge. The new guidelines focus on both women and men. These guidelines include new criteria for a central bone density test (DXA). World Health Organization (WHO) criteria are still the standard for determining a diagnosis, Dr. O’Connell said. A new tool available online is the FRAX WHO Fracture Risk Assessment Tool. This predicts the likelihood of a major hip fracture as well as the risk of hip fracture within the next 10 years.

FRAX evaluation requires information such as patient age, body mass index, fracture history, parental hip fracture in the patient’s mother or father, and current smoking status. Other factors included in the evaluation include use of glucocorticoids, rheumatoid arthritis, bone mineral density, and alcohol use. Dr O’Connell said that alcohol use is assessed primarily because it increases the risk of falls, but in patients who consume more than 3 units per day, alcohol use becomes an independent risk factor.

The new NOF guidelines for drug treatment have expanded the indications for treatment, she said, mainly to utilize information gleaned from use of the FRAX tool. Treatment guidelines still include lifestyle modification such as increasing physical activity and weight-bearing exercise, smoking cessation and avoidance, and proper nutrition. A major change, she said, is vitamin D intake. Previously, 400 units of vitamin D were recommended for adults and 600 units for seniors. This has been changed to a minimum of 800-1000 units. Prevention of falls is also an area of emphasis. Drug therapies for osteoporosis prevention include bisphosphonates to prevent resorption of calcium from the bones as well as raloxifene, calcitonin, and teriparatide.

Dr. O’Connell concluded that all seniors should adopt a bone-healthy lifestyle and undergo DXA tests and FRAX evaluation. Those with osteoporosis should be treated with bisphosphonates, and older persons should receive at least 1200 mg of calcium and 800-1000 units of vitamin D daily. She said that only zoledronic acid has been proven effective for secondary fracture prevention, and it also decreases mortality.

Next, Mary Beth Elliott, PharmD, PhD, Associate Professor, University of Wisconsin-Madison School of Pharmacy, discussed immediate and long-term considerations for the treatment of osteoarthritis in frail older patients. Dr. Elliott provided an overview of osteoarthritis and discussed the efficacy and safety of pharmacologic options, as well as the personalization of patient care plans. She said that osteoarthritis is the most common and costly form of joint disease and affects 16 million people in the United States. Risk factors include age, female gender, obesity, muscle weakness, and sports activities.

Nonpharmacologic therapies for osteoarthritis include patient education and self-management programs, weight loss, exercise, physical and occupational therapy, and range of motion exercises.

Acetaminophen is considered one of the top drugs of choice used to treat osteoarthritis, Dr. Elliott said. She noted the importance of a pharmacist in managing this medication because patients may be taking other drug therapies that contain acetaminophen, leading to the possibility that they may exceed the maximum 4-mg-per-day dosage. Some studies have found that acetaminophen can provide similar efficacy to nonsteroidal anti-inflammatory drugs (NSAIDs), even though patients sometimes prefer NSAIDs, which can be more effective at reducing pain. Patient response can vary.

Dr. Elliott said that there is no decisive evidence that any NSAID is superior for all patients. NSAID toxicities include dyspepsia, gastrointestinal bleeding and ulceration, cardiovascular risk, and renal insufficiency. She added that 16,000 deaths per year in the United States are attributed to NSAID use and that most are from gastrointestinal effects. Proton pump inhibitors are effective in reducing the risk of gastrointestinal bleeding and are recommended by the American College of Cardiology.

A newer option for treating osteoarthritis is diclofenac gel, which Dr. Elliott said is expensive and not appropriate for all patients, but provides significantly lower systemic exposure. Early studies of glucosamine and chondroitin were promising, but later studies have cast doubt on efficacy. Additional agents are capsaicin creams, tramadol, and local injections of corticosteroids and hyaluronic acid.

Dr. Elliott concluded her presentation by stating the importance of proper diagnosis and assessment of pain, function, and patient goals. Education and nondrug therapies should always be the first option, and drug therapy can be tailored for patient preference, effectiveness, and risk factors.