Pharmacists boning up on osteoporosis care

Thirty years ago, when Kathy Karas, R.Ph., graduated from Ohio Northern University's Rudolph H. Raabe College of Pharmacy, osteoporosis was a little-known bone disease with few treatment options available to patients. Within the past few decades, as the medical community learned how to prevent and treat the bone-thinning disorder and new drug therapies arrived on pharmacy shelves, Karas became increasingly interested in helping patients improve their bone health.

"Some pharmacists specialize in diabetes and hypertension, but I was interested in women's health and no other pharmacy was focusing on osteoporosis care in my community," said Karas, of Sand Run Pharmacy in Akron, Ohio. She added, "Many women are not encouraged to take calcium, and they don't understand the risk factors and lifestyle behaviors that can affect their bone density."

About four years ago, Karas became one of the first pharmacists in the country to offer osteoporosis screening and counseling on how to maintain healthy bones. She completed 15 hours of specialized training and was awarded a certification in osteoporosis care through the National Institute for Pharmacist Care Outcomes (NIPCO), the disease management division of the National Community Pharmacists Association (NCPA) in Alexandria, Va.

As pharmacists play a greater role in drug therapy monitoring and disease state counseling in their community pharmacies, some like Karas have chosen to specialize in osteoporosis by offering vital health information to the community, expanding their business, and differentiating themselves from other pharmacies.

"Osteoporosis screening and monitoring are rapidly becoming one way in which pharmacists are fulfilling an unmet patient need and, at the same time, helping to capitalize on the public's growing demand for prevention services," said Lindsey Stephens, R.Ph., senior manager of professional services at Medicap Pharmacies of West Des Moines, Iowa.

Currently, there are approximately 1,200 pharmacists certified in osteoporosis care. The certificate program is one of 12 that are offered by NIPCO, which also provides training in other disease states, ranging from arthritis and diabetes to nutrition and respiratory care.

"The idea behind the certificate programs is to give pharmacists a comprehensive clinical overview of the disease state and provide the business strategies for implementing such a counseling program in their community pharmacies," noted Kathryn Kuhn, R.Ph., NCPA's senior VP of pharmacy programs.

A multidisciplinary team developed the osteoporosis certificate program, which helps pharmacists learn how to manage patients at risk for osteoporosis or help those with the disease. The program covers the pathophysiology and diagnosis, prevention strategies, and drug therapy as well as therapeutic considerations and patient care issues. In addition, pharmacy-based bone mineral density testing, marketing tips, legal issues, and pharmacist reimbursement are all covered.

Growing health threat

Despite increased public awareness about the risks of osteoporosis, millions of Americans with this condition go untreated—and undetected. Osteoporosis, a disease characterized by low bone mass and structural deterioration of bone tissue and an increased susceptibility to fractures, is the nation's most common bone disease. According to the National Osteoporosis Foundation, the disease afflicts more than 10 million people, eight million women and two million men in the United States. Another 34 million Americans, both men and women, are at increased risk for osteoporosis and fractures because of low bone mass. With 1.5 million osteoporotic fractures occurring in the United States every year, the direct medical costs are about $14 billion, a cost that is estimated to increase, as a result of the aging population, to $50 billion by 2040.

To address this serious health problem, the American Pharmacists Association Foundation launched an initiative called Project ImPACT: Osteoporosis. Based on a previously successful hyperlipidemia program, the APhA Foundation, with support from Merck & Co. partnered with Ukrop's Super Markets in Richmond, Va., to launch the demonstration project on a regional basis to identify patients at risk for osteoporosis through bone mineral density screening.

Through one program, pharmacists screened 532 patients; of these, 305 were contacted and monitored to determine outcomes and results. Of those patients, 70% were identified as moderate- to high-risk candidates for osteoporosis. Thirty-seven percent of patients scheduled and completed a physician visit, 19% had a diagnostic scan, and 24% started osteoporosis therapy, according to results published in the Journal of the American Pharmacists Association (2004; 44:152-167).

The findings were confirmed in a separate regional program of Project ImPACT: Osteoporosis, which involved two independents and four chain pharmacies. Through this initiative, 140 women were invited for a free bone mineral density screening and 107 completed a survey after three months.

The majority of the patients reported that the screening was very useful to them, and 91% admitted that it encouraged them to talk to their physicians about osteoporosis. At the three-month mark, 11% of patients indicated that they improved their exercise regimen, and 30% increased their intake of calcium and vitamin D. Finally, 41% reported that they would be willing to pay $20 or more for the screening.

Getting started

Setting up a pharmacy-based osteoporosis screening program requires dedication, commitment, and investment, explained Stephens, who oversees screening services at Medicap Pharmacies' franchise stores. In pharmacies, the most popular method of bone density testing is through ultrasound bone mineral density analyzers. These machines cost around $15,000, about half the cost of older models. The analyzers, which are portable and approximately the size of a medium-size suitcase, use ultrasound to screen a person's heel, which correlates to the bone density of the hipbone.

The test results are expressed as T-scores, which compare a person's bone density to that of a younger adult of the same race and gender. For instance, a T-score of -2.5 or less indicates the person is at high risk for osteoporosis. A T-score of -1 to -2.4 indicates medium risk, and a score that is greater than -1 indicates a low risk for osteoporosis.

Despite the upfront costs, Karas has more than recovered the machine's expense. "The screenings have increased business," she stated. To supplement the investment, she also holds screenings at other pharmacies and physical therapy offices and charges about $35 to $40 for a consultation. Other pharmacists contract with large employers, health clubs, and nursing homes to offer screenings and counseling.

According to one report, osteoporosis screenings reach profitability when about three to four consultations are performed each week at about $35 a visit. Another study found that the expense of the machine could be recovered after 35 screening days, assuming that about 37 consultations are conducted each day at $30 a visit.

Like all disease management counseling, reimbursement for osteoporosis screening is difficult to obtain from health insurers and Medicare. Most managed care organizations reimburse physicians for in-office bone density testing at a rate of $40 to $150, but there are few drugstores that are currently being reimbursed by third-party payers. Under Medicare, pharmacies need to meet strict standards that include some physician involvement—such as ordering the test or overseeing a pharmacy-based Independent Diagnostic Testing Facility.

Pharmacotherapy options

Even with increased intake of calcium and vitamin D, many women, especially after menopause, continue to experience bone loss and require drug therapy. A number of medications are available today that pharmacists can recommend for the prevention and treatment of osteoporosis, including bisphosphonates, bone resorption inhibitors, and selective estrogen receptor modifiers. Scientists are investigating newer agents within these classes of drugs and examining the role of sodium fluoride and vitamin D metabolites for their bone-protective effects. One biologic agent, given every six months by injection, targets a key mediator of the resorptive phase of bone remodeling. Interim phase II results are promising, and the agent is expected to enter a phase III study this year.

The latest osteoporosis treatment, part of a new class of bone formation agents, is teriparatide (Forteo), manufactured by Eli Lilly & Co. Approved in December 2002, teriparatide is an injectable treatment that stimulates the formation of new bone by increasing the number and action of bone-forming cells, called osteoblasts.

Previously a well-established approach for osteoporosis prevention, hormone replacement therapy (HRT) has fallen out of favor since the results of the landmark Women's Health Initiative study raised questions about the use of estrogen and progestin combinations, and whether the increased cancer risk outweighs the benefits of reduced fractures.

Recently, the pharmacy community received good news on long-awaited safety information about Merck's bisphosphonate agent alendronate (Fosamax). A study in the New England Journal of Medicine (2004 350: 1,189-1,199) reported that postmenopausal women taking the medication maintained or continued to experience increases in bone mineral density at the hip and spine after 10 years of treatment. The study, which started in 1991 and was extended three times, found that alendronate increased mean bone mineral density by 13.7% at the lumbar spine and 10.3% at the hip.

Paul Wynn

THE AUTHOR  is a Brooklyn, N.Y.-based pharmacy journalist.

 

Paul Wynn. Pharmacists boning up on osteoporosis care. Drug Topics May 2, 2004;148:18s.