Paul Wynn is a Brooklyn, N.Y.-based pharmacy journalist.

Paul Wynn

"Most elderly patients have multiple diseases, some of which are asymptomatic, such as high blood pressure," said principal investigator Lee, in a statement. "They also often have complex medication regimens. They might stop taking medications because they don't feel any different or cannot remember what the medications are for or when to take them. Resulting health problems can lead to emergency department visits, hospitalizations, and increased healthcare costs." 

The research, funded by the American Society of Health-System Pharmacists Research & Education Foundation, followed 200 elderly patients aged 65 or older who were seen at either Walter Reed Army Medical Center or the geriatric pharmacy clinic in the Armed Forces Retirement Home in Washington, D.C. Patients took a mean of nine different chronic daily medications. 

During the first six months of the study, patients saw a pharmacist every two months for disease education and medication counseling. Patients were also provided with customized medication blisterpacks that organized their drugs according to their individual needs.  

What researchers discovered surprised them and their patients: The medication adherence rate soared to 96.9% during the first six months of the study. Before participation in the program, patients' rate of medication adherence was 61.2%.  

"We were surprised by the greatly increased adherence rate," said Lee. "We customized blisterpacks according to each patient's medication regimen-some patients had as many as 19 medications. They just had no idea what to take or when. We made medication charts for them and updated them each time their medications changed." 

The researchers also reported encouraging results in patients' cardiovascular health outcomes. They found a reduction in hypertension as well as in LDL cholesterol. Systolic blood pressure went from 133.2 to 129.9 mmHg (diastolic pressure was not significantly affected). Among patients with drug-treated cholesterol, LDL cholesterol declined from 91.7 to 86.8 mg/dL. 

During the second six months of the study, patients were randomized to continue the program or  return to their usual medication routine. Rates improved dramatically for patients randomized to continue in the program-a 95.5% rate of medication adherence. The drug compliance rate dropped to 69.1% for patients who returned to their usual care. 

"We learned that elderly patients have to stay in a pharmacy care program long-term in order to reach a successful medication persistence," explained Lee.  

Lee hopes to use the program results in developing a clinic for patients at high risk for nonadherence, especially elderly patients. "It's important to be able to provide medications to patients, but we also need a system that helps them actually take those medications and take them correctly. There is such a lack of education, and pharmacists can play a key role in this problem. We are the ones who can help with this." 

THE AUTHOR is a pharmacy writer based in Brooklyn, N.Y. 

Articles

Pharmacists at one of the nation's largest military medical centers found that elderly patients are likelier to comply with drug regimens following a program of patient education, pharmacy counseling, and specially packaged drug blisterpacks. Jeannie Lee, Pharm.D., and Karen Grace, Pharm.D., clinical pharmacists at the Walter Reed Army Medical Center, led the research. "The Federal Study of Adherence to Medications in the Elderly" (FAME) was published in the Dec. 6 issue of the Journal of the American Medical Association.

Adherence program improves health of elderly

"When you look at the new House leadership, community pharmacy could be better positioned to address some important healthcare issues. We have had real problems with the current leadership over the past couple of years," said Charles Sewell, senior VP of government affairs for the National Community Pharmacists Association. 

New House Speaker Nancy Pelosi (D, Calif.) has vowed to introduce two pieces of legislation that would have an immediate impact on pharmacy: raising the minimum wage and enabling Medicare to negotiate lower drug prices with pharmaceutical manufacturers. 

John Coster, R.Ph., Ph.D., VP, Policy and Programs, the National Association of Chain Drug Stores, agreed that bipartisanship is critical to moving the Democrats' agenda forward. They really have just next year to pass meaningful legislation. "Nothing substantive will happen in 2008 during an election year," Coster said. 

With the Democrats returning to power for the first time since 1994, the pharmacy community is hoping for renewed support to advance several critical issues. Topping the list of legislative priorities is prompt pay for Medicare Part D reimbursement and rolling back the proposed cuts to Medicaid reimbursements outlined in the Deficit Reduction Act.  

Under Medicare Part D, drug claims are often paid past 30 days. Earlier this year, a bipartisan bill was introduced requiring payment for electronic claims within 14 days and paper claims within 30 days. It is hoped that the measure will be reintroduced and passed in the next Congress. The Deficit Reduction Act will reduce payments to pharmacies for generic medications by about $6.3 billion over the next four years, analysts estimate. Starting January 2007, federal payments for generic drugs will be based on average manufacturers price (AMP) rather than average wholesale prices (AWP), but there are no federal guidelines on how manufacturers should calculate AMP. 

NCPA supported 138 candidates in the election and 131 won their races, building a "community pharmacy majority" in Congress. Through the Coalition for Community Pharmacy Action, a newly formed alliance between NCPA and NACDS that lobbies Congress, many R.Ph.s became involved in local campaigns. 

Several long-time supporters of pharmacy issues are returning to Congress, including Arkansas Democrats Marion Berry, R.Ph., and Mike Ross, a pharmacy owner. But political newcomer Mike Barrett, R.Ph., representing northwestern Minnesota, lost his first run for Congress. An anti-Republican tide and an underfunded campaign spoiled his chances of unseating eight-term Democratic incumbent Collin Peterson. 

Community R.Ph.s could face a friendlier climate in Congress with Democrats having won the majority of both houses during the mid-term elections. Democrats will now take control of Congressional committees responsible for key pieces of healthcare legislation and financing.

Pharmacy agenda renewed under Democratic Congress

Barrett is one of many R.Ph.s running for office in this year's midterm elections. There are more than 40 pharmacists serving as legislators in local and national offices. Many of them are seeking reelection this year.  

"We've always encouraged community pharmacists to be active in politics, and there is no more direct way to participate in the political process than by holding public office," said Bruce Roberts, R.Ph., executive VP/CEO of the National Community Pharmacists Association. "Over the years, many pharmacists have been elected to local, state, and national office, and it is always valuable to pharmacy to have someone who understands pharmacy and health care in those positions." 

Barrett seeks to join Berry and Ross in Congress, but 2006 will probably not be the year. Not only is there a negative tide against Republican candidates, Barrett does not have the name recognition or the funds to muster a significant challenge to unseat Petersen. Additionally, Barrett has limited time to campaign because he works full-time and is the only pharmacist at the hospital.  

 that it is always difficult for a newcomer to run for the first time. "I'm in this for the long haul and will run again if necessary. It took my opponent three tries to get elected." 

Predictions of a revolt against Republicans at the ballot box did not deter Mike Barrett, R.Ph., from running for the House of Representatives. Barrett, a pharmacist at a 34-bed hospital, challenged eight-term Democrat Collin Petersen to represent northwestern Minnesota. "Many people have told me that it is probably not a good year to be a Republican, but my district is almost evenly split between both parties with about 10% undecided," said Barrett, pharmacy manager at Long Prairie Memorial Hospital and Home.

2006 election: Mixing pharmacy and politics

The Food & Drug Administration approved the dry powdered insulin in January for the treatment of adult patients with Type 1 and Type 2 diabetes. The launch was purposely delayed to train healthcare professionals on the inhaler's administration and maintenance, as the company built up inventory. A number of training sessions were held this past summer with endocrinologists, pharmacists, diabetes educators, and other healthcare providers.  

One of the trainers was Stephen M. Setter, Pharm.D., CDE, associate professor of pharmacotherapy at Washington State University College of Pharmacy. He was concerned about using the device, but once he began practicing with it, he felt more at ease. "I've trained a lot of skeptical physicians, pharmacists, and nurses who approached this with a lot of hesitation," he said. "But once they got it in their hands and went through the process, their fears and biases tended to fade away." 

The insulin is delivered through a 6-in. inhaler-about a foot long when it's fully extended. The complete kit includes one inhaler, one replacement chamber, 1 mg/180 blister pack or 3 mg/90 blister pack, and two release units. The retail price for the 1 mg/180 blister pack is about $150. 

Clinicians were also trained on how to maintain the device. The inhaler needs to be replaced once a year, and the release unit needs to be replaced every two weeks and cleaned once a week with warm water and mild soap. Unlike injectable insulin, which needs to be refrigerated, inhaled insulin is kept at normal room temperature.  

Inhaled insulin has been studied in several thousand patients. Studies showed that inhaled insulin is effective in diabetes patients and provides glycemic control comparable to traditional insulin regimens. However, researchers found that fewer than 30% of people with Type 1 diabetes were able to reduce their blood sugar to recommended levels after six months of treatment with inhaled insulin, and, as a result, inhaled insulin should be used in combination with longer-acting insulin in Type 1 patients. In Type 2 diabetes, inhaled insulin can be used alone or in combination with oral diabetes agents or longer-acting insulin.  

One study compared the glycemic control achieved with inhaled insulin versus the sulfonylurea agent glibenclamide (glyburide) in 456 patients with Type 2 diabetes uncontrolled by metformin monotherapy. Researchers reported similar reductions in hemoglobin A1c. In patients with A1c levels above 9.5%, inhaled insulin provided superior blood glucose control to glibenclamide. 

Many pharmacy experts foresee that patients who have been delaying the use of insulin due to fear of needles will certainly use inhaled insulin. Because inhaled insulin has a similar pharmacokinetic profile to rapid-acting insulin analogs, it will likely be prescribed to help control postprandial glucose. It is recommended that it be taken within 10 minutes of eating. 

Zierler-Brown sees inhaled insulin being used primarily as add-on therapy to oral agents in patients who are still outside recommended A1c levels. She also suggested that inhaled insulin may be used as monotherapy for patients who fail to control blood glucose with diet and exercise alone.  

However, Setter said that he doesn't expect inhaled insulin to be used as monotherapy in Type 2 patients because many patients do not go straight to insulin. "I see those patients starting on the oral agents and moving to a long-acting insulin and then adding a pre-meal insulin like an inhaled version," he said. 

Setter also predicted that inhaled insulin may be used interchangeably with injectable insulin.  

More than 85 years after the discovery of insulin, patients will have a new alternative to injectable insulin. After years of testing, and doubt from the medical community that it would ever work, inhaled insulin (Exubera, Pfizer/Nektar) began arriving on pharmacy shelves in late August.

Inhaled insulin ushers in needle-free era

Like high cholesterol and hypertension, diabetes can contribute to changes in erections because it affects the vascular system. Diabetes can cause a cascade of events that lead to the thickening of arteries and restriction of blood flow. Without enough blood flowing to the penis, erectile problems often occur.  

More than half of men with diabetes experience decreased erectile function within 10 years of being diagnosed with diabetes. Some researchers estimate that the prevalence may be as high as 75%, rising to 95% for men over age 70. The presence of heart disease and hypertension further increases the prevalence of erectile dysfunction in men with diabetes, according to researchers at Harvard University School of Medicine. 

"Many Type 2 diabetes patients have insulin resistance for 10 to 15 years before they are diagnosed," explained R. Keith Campbell, B.Pharm., MBA, CDE, professor at Washington State University's college of pharmacy in Spokane, Wash. "Because patients are unaware that their glucose levels have been elevated for a long period, they are not doing anything to stay in control or to reduce the risk of erectile dysfunction."  

Campbell added that once a man has erectile dysfunction, better management of diabetes is not going to improve the situation. "The damage has usually been done and it can't be undone," he said. "That's why I think it's important that we tell men in their 30s and 40s to take better care of their cholesterol, blood pressure, and diet so they can prevent the development of erectile dysfunction." 

Despite the obvious physiological signs of erectile dysfunction, it often goes undiagnosed and untreated because it can be a difficult topic to discuss not only with a spouse but also with healthcare professionals.  

"Many patients are reluctant to talk about it at all," said Stuart Haines, Pharm.D., professor and vice chair for education at University of Maryland's school of pharmacy in Baltimore. "They are not likely to bring it up to a pharmacist at a counter with other people standing around." With many pharmacists playing a greater role in educating patients about diabetes, there are opportunities to initiate a conversation about the signs, symptoms, and treatments of the disease, he added.  

At the Joslin Diabetes Center in Baltimore, where Haines works, sexual performance is one of many routine questions during the interview process. "We ask them in the questionnaire about their sexual health and whether they are having any problems during sexual intercourse."  

At Ukrop's Pharmacy in Glen Allen, Va., pharmacists hold classes with newly diagnosed diabetes patients and talk about erectile dysfunction as a complication of diabetes. "We especially try to talk to men over the age of 40 about it," said Tim Robertson, R.Ph., CDE. "There are some men who don't want to talk about it, but it's not a taboo subject given the whole Viagra phenomenon," he said. "It's not as big a deal to most men as it used to be."  

Haines recognizes that it's a difficult subject for pharmacists to bring up unless there is a private counseling room. For female pharmacists, he said, the topic can be particularly difficult to initiate with patients. "The cross-gender discussions of erectile dysfunction are fraught with subtle difficulties."  

Diabetes is associated with an increased risk for a number of serious complications, but the most dreaded among men-and least talked about-is erectile dysfunction.

Understanding the link between diabetes and erectile dysfunction

While electronic prescriptions offer many benefits over handwritten orders, some independent pharmacies still balk at adopting this new technology. Some say learning the new technology will pose an obstacle, while others are concerned about verification of who is sending the electronic Rx, as well as the additional costs associated with e-prescribing. 

Cost is the biggest deterrent for Jerry Whitman, R.Ph., owner of a self-named pharmacy in Buckingham, Pa. So far none of the physicians in Whitman's area are sending Rxs electronically, but he is concerned about the added cost of each electronic transaction. "E-prescribing is a good idea, but we can't afford to pay to receive prescriptions electronically."  

SureScripts spokesman Rob Cronin said the company is not in business to turn a profit. "We are here to serve the pharmacy community, and we hope to pass along a reduction in fees as volume increases." 

According to NCPA, independent pharmacy's involvement in e-Rxs has grown rapidly, from 2% last year to an estimated 20% by year's end, but physician involvement still lags behind. 

Donnie Calhoun, R.Ph., the owner of two pharmacies in Alabama, received his first e-Rx in August, after the doctor's office called to tell him to check his computer system. He is uncertain when other physicians will start using the technology, but he questioned why pharmacies should pay for the transaction. "We don't pay for the patient walking in the door with a script, we don't pay for it to be faxed, we don't pay for it to be called in. Why should we pay for it to be electronically sent to us?" he asked. 

Outside of Portland, Ore., Diana Courtney, R.Ph., owns Lake Shore Pharmacy. She is looking forward to wider use of e-Rxs to help lighten the administrative burden on her staff. In her experience, e-prescribing helped eliminate errors and a lot of extra time trying to figure out what was actually being prescribed. She admitted that it's not ideal that pharmacies have to pay the fees, but agreed that it's ultimately worth it. "It is worth the extra fee to ensure the safety and accuracy of getting the right prescription to patients." 

Calhoun said that he is concerned about who is sending the Rxs. He has been involved in some recent situations in which nurses were arrested for calling in unauthorized Rxs. "These are issues that we will probably always have, but electronic prescribing in the wrong hands could be a dangerous thing," he said.  

Calhoun acknowledged that it's only a matter of time until e-Rxs become standard practice. Managed care organizations and the Centers for Medicare & Medicaid Services are pushing for quicker adoption of e-prescribing. CMS expects to have standards in place by 2008 for Rxs paid under Part D. 

The bottom line for Calhoun is that whether or not R.Ph.s want to pay the fees or learn how to use the new technology, it will come down to market dynamics. "If the competitors are using the technology, pharmacy owners will not have a choice," he said. "The pharmacy has to use the technology or it won't be competitive anymore." 

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

While electronic prescriptions offer many benefits over handwritten orders, some independent pharmacies still balk at adopting this new technology. Some say learning the new technology will pose an obstacle, while others are concerned about verification of who is sending the electronic Rx, as well as the additional costs associated with e-prescribing.