Charlotte LoBuono

Hospitals and other healthcare facilities of the future will look more like hotels or office buildings and less like the institutional and often inconveniently designed buildings that many think of today, said Greg Lasker, an assistant professor of building construction management at Purdue University in West Lafayette, Ind. According to Lasker, Clarion North Medical Center in Carmel, Ind., is a precursor of what hospitals of the future will look like. Clarion North features private rooms; dedicated pavilions for women, children, and specialty surgery; an attached medical office building; comfortable waiting room chairs similar to those found in a private residence or hotel lobby; and greenery and a glass-covered atrium.  "Hospitals are definitely becoming more patient-oriented," said Jane Barrett, R.Ph., pharmacy manager at Clarion North. "By that I mean the stereotypical uncomfortable chairs and the sterile atmosphere are being done away with. These are being replaced with a more business-type setting."  

Scheckelhoff went on to say, "We asked pharmacy  directors where they see things going, and clearly the trend is decentralization. The bulk of pharmacy inventory will continue to be moved out to the nursing units, closer to the patients-in automated dispensing units or some other type of technology. This is particularly true of medications available in standardized dosage forms." 

He said that in addition to high-tech, custom compounding areas, the main pharmacy will also house offices for those who specialize in pharmacy informatics. These staffers will manage the information systems being used throughout the facility to prescribe, dispense, and administer medications. 

Scheckelhoff went on to say that a third group of pharmacists that will be needed in the future are those with both a technology background and a high level of clinical expertise. These pharmacists would build and maintain decision support tools that are used in automated medication use systems, he explained. They would, for example, program minimum and maximum doses and drug interactions into computerized prescriber order entry systems.   

 Regardless of increasing automation, however, Barrett feels the human element will never be removed from pharmacy or health care in general. Nor would you want it to, said Barrett. "Patients still want to talk to the pharmacist and know that a pharmacist is looking over their medication profile," she concluded.  

 THE AUTHOR is a clinical writer based in New Jersey.

Articles

Hospitals and other healthcare facilities of the future will look more like hotels or office buildings and less like the institutional and often inconveniently designed buildings that many think of today, said Greg Lasker, an assistant professor of building construction management at Purdue University in West Lafayette, Ind. According to Lasker, Clarion North Medical Center in Carmel, Ind., is a precursor of what hospitals of the future will look like.

Hospital pharmacies to go high-tech and decentralized

The guides are the first ancillary products of AHRQ's Effective Health Care Program. The clinicians' guide summarizes the evidence on both Rx and OTC drugs, including information on the efficacy, cost, and potential adverse effects of non-steroidal anti-inflammatory drugs (NSAIDs), cyclooxygenase-2 (COX-2) inhibitors, acetaminophen, and others. The clinician guide also evaluates the scientific evidence applicable to the benefits and risks of these drugs. 

"I thought the guides were quite good," said Steven Chen, Pharm.D., an associate professor of clinical pharmacy at the University of Southern California, Los Angeles. "We have needed these for a long time." He went on to say, "There is only one omission I might mention, and that involves the concomitant use of aspirin to reduce myocardial infarction [MI] risk." Chen said aspirin has, or appears to have, an interaction particularly with high does of ibuprofen. "It is enough of a concern that the Food & Drug Administration put out a bulletin in September 

									http://www.fda.gov/cder/drug/infopage/ibuprofen/science_paper.htm

) warning clinicians that this could be a problem." Circumstantial evidence suggests that 400 mg of ibuprofen attenuates the antiplatelet effect of low-dose aspirin when the drugs are dosed concomitantly. However, he said, the medication algorithm that is recommended in the AHRQ guides is appropriate.  

Schuna is also concerned about the advice that patients should use medications such as naproxen or ibuprofen to reduce swelling or inflammation. Although most patients will understand what swelling is, he said, they may not understand what inflammation is. If they have swelling and inflammation, they should be referred to a physician, he advised. "In rheumatology, we are putting major emphasis on getting early treatment. Patients may delay treatment based on the advice given in this guide." The reason this may be an issue, he said, is that patients with OA can develop another type of arthritis on top of OA. 

The original report, written by a team of experts at AHRQ's Evidence-based Practice Center at Oregon Health & Science University in Portland, is available on-line at 

effectivehealthcare.ahrq.gov/synthesize/reports/final.cfm

 The researchers compared the analgesics' effectiveness and health risks, including MI and gastrointestinal (GI) side effects. They also recommended topics for further research. The investigators concluded that:  

The Agency for Healthcare Research & Quality (AHRQ) recently released guides for clinicians and consumers on the use of analgesics for treating pain associated with osteoarthritis (OA). The guides draw on a report, called "Comparative Effectiveness and Safety of Analgesics for Osteoarthritis," based on a review of 351 published research studies. It represents the most comprehensive analysis to date of analgesics for osteoarthritis pain.

AHRQ issues two guides on osteoarthritis

The most significant proposals would update applicable regulations to clarify all circumstances under which access to developmental drugs is permitted-including single patients, small groups of patients, and larger clinical trial populations. For expanded access uses, the FDA must be satisfied that no satisfactory or alternative therapy is available, that the potential benefit to the patient(s) outweighs the risk, and that expanded access will not interfere with the standard drug approval process. 

He went on to note  that "other regulatory issues must also be addressed, including keeping track of adverse reactions among patients taking experimental drugs." 

Greg Simon, president of FasterCures, an advocacy group, agreed that overextension of compassionate use-or use of an investigational drug by patients not enrolled in clinical trials because they have run out of treatment options-may limit the number of patients willing to participate in clinical trials. He said patients may be unwilling to participate in a clinical trial if they think they may gain access to the drug without study participation. Simon also said pharmaceutical companies may be discouraged from conducting clinical trials for fear that adverse effects among a relatively small number of patients taking the drug for compassionate use may reduce the likelihood of its approval.  

Pharmacists can play a significant role in educating patients regarding compassionate use, Simon noted. They can help people understand why clinical trials are the best long-term solutions to curing diseases, and explain that compassionate use is an extraordinary measure that may help certain individuals. If overused, however, it might slow the development of cures for serious or life-threatening illnesses. 

The question of whether dying patients should gain easier access to unapproved drugs is at the center of a lawsuit, 

, now heading toward a possible showdown in the U.S. Supreme Court. FDA's new proposal to provide expanded access to experimental drugs was issued after the suit was filed.  

According to Albert Wertheimer, Ph.D., MBA, director of the Center for Pharmaceutical Health Services Research, Temple University School of Pharmacy, Philadelphia, greater access does not mean that patients will abuse experimental drugs. "People will not abuse these drugs or try to get high. They are not cheap, and they would be used primarily in cases of terminal illness when nothing available seems to work. In addition, many of these drugs have horrible side effects, so they would normally be used only when really needed."  

More information on expanded access is available through FasterCures (

) and the Abigail Alliance for Better Access to Investigational Drugs (

									http://www.abigail-alliance.org/

The Food & Drug Administration recently proposed regulatory changes to make investigational drugs more widely and easily available to seriously ill patients with no other treatment options. The proposal also clarifies the circumstances and the costs for which a pharmaceutical company can charge for developmental drugs. The proposed regulations were published in the Dec. 14 issue of the Federal Register. They are described in detail at http://www.fda.gov/cder/regulatory/applications/IND_PR.htm and are open for comment for 90 days.

FDA proposes new rules for investigational drugs

The 30-patient prescribing limit on individual physicians was part of the original Drug Addiction Treatment Act of 2000 (DATA 2000) that allowed office-based treatment with Schedule III-V drugs indicated for opioid dependence. To qualify for the 100-patient prescribing limit now allowed by law, doctors must be certified to treat opioid addiction with buprenorphine for at least a year, explained Edwin Salsitz, M.D., medical director of office-based opioid agonist therapy at Beth Israel Medical Center in New York City. 

The locator does not list every physician with a valid waiver, however-just those who have agreed to be listed. Pharmacists wishing to verify that a physician not listed on the site has a valid DATA 2000 waiver number can contact SAMHSA at (240) 276-2716 or by e-mail at 

Salsitz said that a waiver number is not required when buprenorphine is prescribed for off-label use. He did mention, though, that it would be nice if physicians wrote something on the prescription form about the indication-for example, "Take one tablet twice daily for chronic pain." He went on to say that it is very reasonable for a pharmacist to call the prescriber and verify whether the drug is being prescribed for on-or off-label use. 

Pharmacists are in an excellent position to educate the general public about buprenorphine therapy for opioid addiction. Timothy Lepak, president of the National Alliance of Advocates for Buprenorphine Treatment (

), reported that the organization recently launched a pharmacy outreach initiative that is currently piloting in New York City, Detroit, and Philadelphia. Pharmacists in those cities received a postcard directing them to the Web site at 

, where they can order free educational materials and counter displays for their pharmacy and opt to be listed in the pharmacy locator as a buprenorphine-stocking pharmacy. 

"Although most pharmacies can get buprenorphine rather quickly, very often timing is critical, because patients must be in the early stages of withdrawal when they take it," said Lepak. "If they have to wait, patients could be in severe withdrawal, and the risk of relapse increases tremendously." He said that the pharmacy locator would work like the NAABT physician locator (

									http://www.naabt.org/patient_dr_connection.cfm

), which uses patient ZIP codes to identify nearby physicians certified to treat opioid addiction with buprenorphine.  

President George W. Bush recently signed into law H.R. 6344, The Office of National Drug Control Policy Reauthorization Act of 2006. The law raises from 30 to 100 the number of patients a physician may treat for opioid addiction with buprenorphine (Subutex, Reckitt Benckiser Pharmaceuticals) C-III sublingual tablets or buprenorphine/naloxone (Suboxone, Reckitt Benckiser Pharmaceuticals) C-III sublingual tablets. Buprenorphine is the only controlled medication to receive Food & Drug Administration approval for this indication.

New law increases access to opioid treatment

"In addition," Thomas said, "there are long-standing safety concerns about whether patients receiving treatment for ESRD are actually being harmed by the perhaps unnecessarily high doses of anemia drugs they are prescribed." While the Food & Drug Administration has determined that epoetin alfa is necessary only when patients' hematocrit levels are at 30% to 33%, the Centers for Medicare & Medicaid Services allows for reimbursement at values of 39% or higher.  

"So the question is one not only of whether taxpayer money is being spent on a monopoly drug, but also what is reasonable and appropriate from a healthcare point of view," Thomas said. 

In its report to the committee, released the day before the hearing, the GAO asked Congress to consider establishing a bundled payment for all ESRD services as soon as possible. Walker said it "would encourage facilities to provide services efficiently." In particular, under a fixed, bundled rate for a defined episode of care, facilities would not have the incentive to provide more ESRD drugs than clinically necessary. Thus, with fewer incentives to prescribe a particular drug or treatment, bundled payments would afford clinicians more flexibility in decision-making. 

				Leslie Norwalk, acting administrator of CMS, given an opportunity to defend CMS' position on this issue, said, "To promote appropriate usage, CMS' monitoring policy considers both hematocrit levels and erythropoietin dosage levels." Current clinical guidelines call for maintaining the hematocrit level of patients on erythropoietin within a narrow target range of 33% to 36%. Factors such as nutritional status, infection, and bleeding may cause the hematocrit to fluctuate, so it is not easy to manage patients to this range."			

Norwalk said that if frequent, significant changes in doses of anemia-management drugs are imposed on these existing fluctuations, patient hematocrit fluctuations can become "even more variable and difficult to interpret and manage," especially within the narrow target range of 33% to 36%. "Under CMS' newly revised monitoring policy, Medicare expects a 25% reduction in the dosage of erythropoietin for patients whose hematocrit exceeds 39%," she said. If the dosage is not reduced, she noted, payment is made for the drugs as if the reduction occurred. 

"The monitoring policy clearly articulates that providers should adhere to the FDA label instructions on erythropoietin," Norwalk said. "The instruction to carriers to initiate monitoring when the hematocrit reaches 39% ... establishes a marker at which payment must be reduced because the reported hematocrit level was not maintained at levels consistent with FDA labeling." 

In terms of bundled payment reimbursement for ESRD care, "many Medicare providers have urged a shift from the current model of paying independently for dialysis treatments and separately billable drugs to a system of bundled payment," Norwalk explained. "CMS is generally supportive of such reforms." 

CMS believes a bundled payment system should promote efficiency and clinical flexibility for ESRD facilities, and the system should guard against incentives to undertreat or "cherry-pick" patients to maximize facility profits. Accomplishing these goals, Norwalk said, will require research to support the development of an adequate case mix adjustment for a fully bundled system and mechanisms to ensure beneficiary protections and promote quality care. 

Last month, the House Ways and Means Committee held a hearing on patient safety and quality issues regarding end-stage renal disease (ESRD) treatment. In his opening remarks, outgoing committee chairman Rep. Bill Thomas (R, Calif.) acknowledged that Medicare payments for the treatment of ESRD increased by almost 50% between 1998 and 2003. In fact, epoetin alfa (Epogen, Amgen) has been identified as the single largest drug expenditure in Medicare Part B each year.

Congress urges reform for Epogen reimbursement

Said Blumenthal, "We are concerned about the potential anticompetitive implications of guidelines that preclude certain forms of diagnosis and treatment, particularly if they interfere with insurance coverage." The national, nonprofit Lyme Disease Association (LDA) said in a statement that it applauded Blumenthal for beginning an investigation into IDSA's guidelines development process.  

The LDA and the International Lyme and Associated Diseases Society (ILADS) have also called for a retraction of the IDSA guidelines. As Pat Smith, president of the LDA, explained, "The IDSA guidelines are extremely restrictive. They say that certain alternative treatments such as intravenous immunoglobulin, certain antibiotics, and even entire classes of antibiotics should not be used to treat Lyme disease. The guidelines also do not recommend prolonged antibiotic therapy. Well, these are the therapies that Lyme docs are using. Patients often use alternative therapies in addition to their regular antibiotic therapy."  

"Pharmacists need to consider that patients may need alternative treatments that are very useful yet not recommended by IDSA," Stricker said. "We have heard from patients who have taken their prescriptions to the pharmacy, where they have been asked by the pharmacist, 'Why did your doc prescribe this? The IDSA guidelines do not recommend that drug,'" Stricker said.  

The guidelines also advocate the use of very narrow diagnostic criteria, Smith said. She stated that "IDSA has said physicians must diagnose Lyme disease based either on the presence of an 

 lesion, which occurs in approximately 50% of patients, or positive '2-step' serology-a positive ELISA followed by a positive Western blot." 

Smith estimated that 50% of patients with Lyme disease are not being diagnosed because they do not meet these criteria. She mentioned that the criteria are based on Centers for Disease Control & Prevention surveillance criteria, which the CDC has said are to be used for surveillance purposes only. 

"So many patients are not being expediently diagnosed and treated, which means that they will likely go on to develop chronic disease, or those who have been diagnosed with chronic disease may no longer be able to get any kind of treatment," said Smith. She went on to explain that, because clinical guidelines now drive the standard of care in this country, they are being adopted by insurance companies and state agencies, which cite them as the reason for denying treatment. Even the CDC is promulgating them, said Smith.      

Contacted for comment, an IDSA spokeswoman said that the organization is cooperating fully with the Connecticut attorney general's investigation. In addition, Gary Wormser, M.D., lead author of the IDSA guidelines, said that "ILADS had plenty of opportunity for input. As a matter of fact, Stricker was invited to address the IDSA annual meeting to discuss why he disagreed with the guidelines." 

As Wormser explained, "We certainly considered Dr. Stricker's viewpoint. We even mentioned in the guidelines that we considered long-term antibiotic therapy as an option. When the IDSA first published Lyme disease guidelines in 2000, we did not recommend prolonged antibiotic therapy. Then between 2000 and 2006, several studies came out to corroborate that long-term therapy was not beneficial in treating Lyme disease, so we did not change our recommendation at this time.  

Last fall, the Infectious Diseases Society of America (IDSA) released updated guidelines for the diagnosis and treatment of Lyme disease. (See Drug Topics, Nov. 20, 2006, "Updated Lyme disease guide clarifies confusion".) Approximately one month later, Connecticut attorney general Richard Blumenthal issued a Civil Investigative Demand (CID) to look into possible antitrust violations by IDSA in connection with exclusionary conduct and monopolization in the development of its Lyme disease guidelines.