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.