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No one has an exact road map of the future of pharmacy. Even an educated guess is just that — a guess. Nevertheless, being aware of some of the more likely possibilities can help pharmacists prepare for whatever eventuality finally crops up, simultaneously build an expanded professional role, and provide better care for patients.
Seeking to explore pharmacy’s prospects, Drug Utilization Review turned to highly credentialed, talented pharmacists working across the spectrum of practice settings. These professionals shared their varied views regarding pharmacy administration, technology, drug information, the Food and Drug Administration (FDA), patient privacy, managed care, ethics, herbal alternatives, DUR, and drug delivery systems. Here’s what they’re thinking:
"I see the pharmacy director being a clinical business person," says Ray Wilkins, RPh, MS, director of pharmacy at Truman Medical Center, Hospital Hill in Kansas City, MO. "PharmDs are now getting MBAs and MPHs. They will be tomorrow’s clinical directors. They’ll need the clinical acumen and the business savvy to make decisions that are sound both clinically and financially.
"There’s already a big transition underfoot to a clinical and business background for pharmacy directors. They have to know all the ins and outs of technology, drug therapy enhancements, and the significantly increased costs of new drugs — and all of this has to be measured through outcomes and the potential reduction of cost to the facility. Pharmacists have to be heavily involved. They’re helping dismiss patients from the hospital earlier and, hopefully, helping keep patients out of the hospital.
"The best thing that could happen in the future for pharmacy administration is for the pharmacy director and the pharmacy department to be viewed throughout the facility as very valuable clinical resources," Wilkins tells DUR.
Along with this departmentwide recognition, the pharmacy director would be at a level commensurate with the chief of nursing and medical director. "Once the pharmacy director is at that level, people will see significant enhancements in delivery of pharmacy services and in quality of patient care," he suggests. "The worst thing that could happen to pharmacy administration in the future is for pharmacy directors not to try to fully utilize technology and its capabilities."
"We’re already seeing the effects of technology on pharmacy practice through Pyxis machines and other medication delivery systems," notes Wilkins. "We’re doing away with unit dose systems and moving forward to cartless systems with drugs stored in equipment at the nursing unit."
With these new systems, the pharmacist gets a copy of the drug order, inputs that order into the clinical informatics system, and reviews the order based on the specific patient diagnosis and concomitant drugs, he explains. After the pharmacist has authorized the order, the nurse can then pick up the patient profile on consult and access the drugs for the patient — avoiding the need to send first doses from the pharmacy. The nurse can access a few emergency drugs with overrides, but the typical order must go through pharmacy before nursing accesses a drug.
"I see us going to barcoding on the drug package itself, on the patient’s armband, and on the medication administration record. Then, before the nurse administers a drug, all three barcodes must match up. This will have a positive effect on the role of the pharmacist," says Wilkins. "This system will help take the pharmacist from the distributive function to a more cognitive service. The role of the pharmacist is becoming more that of reviewing orders and determining whether or not the order is for the right drug and the right dose for the patient at that point in time. Pharmacists will have more time to use their clinical skills for things like reviewing the patient’s disease state, reviewing renal status, and adjusting doses appropriately."
This sentiment is confirmed by Larry Liberti, RPh, MSc, president of Pharmaceutical Information Associates (PIA) of Fairless Hills, PA. "Computerization will improve the ability to get more information about the patient to the pharmacy so that better drug-selection decisions can be made by the physician and verified by the pharmacist," says Liberti. "As we learn more about individual patient variances, we’ll be able to tailor drug therapy more specifically. There will always be the need for the physician to prescribe. But with technology, pharmacists can be better gatekeepers and verify that appropriate therapy is being used."
Pharmacists’ increasing reliance on technicians means technology can help pharmacists support the hospital staff more efficiently. "We’ll be able to use technology for better quality control," says Liberti. "It will also serve as cost-efficient methodology for dispensing drugs."
That technology can appear as robotics or, because many technicians are working under a pharmacist, through the use of technological links. "I’d like to see an electronic link between nurses, physicians, and pharmacists so they can all have input into a single, handheld device that would let everyone know what’s going on with patient lab results and other pertinent information at the same time," says Liberti.
Based on the current shortage of pharmacists and the tremendous time demands made upon physicians and residents, "We need to have physician order entry potential via voice recognition," asserts Wilkins. "I would hope that the physician, pharmacist, and nurse — the team — would be in one room, and the physician would say what the diagnosis is; the pharmacist would make a recommendation for the drugs to be used; the physician would OK the pharmacist’s recommendation; the nurse, respiratory therapist, or whoever else is on the team would chime in with recommendations and all of this would be recorded through voice recognition," he forecasts.
"Nothing would have to be written by hand. Everything would then be translated to one written document that’s easy to read. It’ll be a long time before that caliber of voice recognition is available, but we’re already seeing physician order entry available at computers and through Palm Pilot devices. This process would also reduce both the time required to get orders entered and the potential for medication errors.
"I envision having the clinical pharmacist on the floor, available for consultation with the physician prior to the writing of patient orders," Wilkins continues. "In a teaching hospital such as ours, I’d like to see pharmacists [be] able to impact the order at the time it is written. That means having pharmacists round with the medical teams. This is a change that is met with reluctance by some and enthusiasm by others. Those pharmacists who have been in a distributive function for years are reluctant to make the transition to a more clinically oriented practice.
"Recent pharmacy grads and those with residency experience or who have been through clinically oriented programs recognize that this type of practice is more professionally rewarding. In fact, this group of pharmacists is very reluctant to perform distributive functions. You end up with a split staff. It works out OK for now, but as we make the transition to a cartless system, while the need for distribution will still be there, it won’t exist to the extent it does today."
Initially, it will be very difficult economically for hospitals to make large jumps in technology, according to Wilkins. "Historically though, as technology improves, either prices come down or the technology is enhanced for the same price. With this type of technology, those hospitals that are not on the cutting edge as alpha or beta sites will wait until the price is right for their use, and then they’ll jump in. Hospitals will try to justify the costs of equipment and software through enhanced patient safety or cost-effective care," he notes. "Once we show that implementation of new technology helps free up pharmacists so that we have the right people available to impact therapeutic decisions, we can show that hospitals are getting an appropriate return on investment by having the most cost-effective care available."
As an analyst, Don Fearon, Immediate Response Center analyst at Cerner Corp. in North Kansas City, MO, figures out the location and details of technical problems when they occur and fixes those problems within two hours’ time. So he is well-equipped to share another side of technology — that of technical support.
"Everything’s moving toward automation, and hospitals are one of last true frontiers for becoming fully automated and paperless," he says. "Handheld devices are widely used today. Physicians are taking laptops and putting them in docking stations, dialing in from home, and then synchronizing with patient data from work to stay on top of the status of their patients. Any time machines are used, though, there’s the possibility that they will break or be broken."
Technical support, then, will continue to play an important role in the future of technology as it becomes a fact of life in pharmaceutical practice.
"Technology has already and will continue to greatly improve the availability of drug information," notes Wilkins. "Where it doesn’t already exist, we will one day have a computer system in every patient room. Already, there are terminals near rooms. In addition, there is the proliferation of handheld devices that readily provide drug information. For example, ASHP [the American Society of Health-System Pharmacists; find it at www.ashp.com] has a handheld device that provides drug information from their AHFS book."
"In the future, there could be a central repository of drug information," says PIA’s Liberti. "Pharmacists could call up side-by-side comparisons of drugs being considered for formulary inclusion. Those evaluations then could be presented to the P&T committee with some local interpretation. This would provide a really good starting point. There would be a national overview. Manufacturers could feed information into all the centers. That could include New Drug Application (NDA) data, the manufacturer’s assessment of the data, published resources, and expert opinions."
Liberti would like to see more totally independent drug analyses conducted — "not clinical studies, but evaluation of the data," he says. "This could be performed by independent drug information committees. Some countries have independent committees at the regulatory level assess NDA equivalents and regulatory submissions.
"I see having academic teams of specialists perform unbiased assessments of new drugs using standardized formats — such as the AHFS system of categories. The bulk of assessments can be done by an oversight committee, then disseminated to P&T committees," he adds. "That way, preparatory work for P&T committee meetings can be more centralized, saving the duplicative work routinely performed by numerous P&T committees. We could have centralized centers of excellence — perhaps the NIH [National Institutes of Health; find it at www.nih.gov] would be one. This would be a boon to hospital pharmacists. It would also help remove any potential manufacturer bias and provide better interpretation of manufacturer information across many kinds of drugs."
Drug information practice has already changed in a different manner, according to Gordon Vanscoy, PharmD, MBA, assistant dean for managed care at the University of Pittsburgh School of Pharmacy. "Historically, the method of providing drug information was to go to published literature and let the literature help determine practice," he says. "Over the last three years, this method has changed because of technology. Now, when results of a trial are presented at a national meeting, instead of waiting months for those results to be published in a peer-reviewed journal, we go to the Internet to read the results of unpublished data as they were presented to peers at the meeting."
Also, a plethora of journals is available on-line now, he points out. This technological resource reduces the time needed to access articles by omitting the trip to a library to pull articles or the wait for a library service to provide them by mail.
Change is afoot at the FDA. "We’ll have a new FDA commissioner soon. That change alone will likely bring about other changes," says Kristi Wyatt, RPh, MBA, director of regulatory affairs at Pharmion Corp. of Overland Park, KS. "The FDA is working under a recent risk-management initiative. This initiative monitors adverse events of drugs more closely and is the impetus behind recent changes required for product labeling. As a result, the FDA is quicker to act in removing products from the market when problems arise."
Some industry insiders believe the FDA has slowed its review time for new drugs and drug products. "There’s a limit to how much review time can be shortened," asserts Wyatt. "I think that some temporary increases are to be expected when you’re near that limit. New adverse event reporting guidelines were recently released, and they mention changing the regulations in the future."
Personal health information protection regulations are on the horizon. On April 12, President George Bush agreed to proceed with privacy regulations written by the U.S. Dept. of Health and Human Services, with the possibility of changing the regulations as written under the Clinton administration. "The regulations initially applied only to the electronic transfer of patient information," says Wyatt. "The final rule as currently written applies to any individually identifiable records communicated in any form — whether electronically, on paper, or orally. Further, patients are allowed access to their records and have the right to correct any misinformation contained in those records. Failure to comply with the regulations is punishable by both civil penalties and federal criminal penalties."
How will technology affect patient privacy? "That’s an issue that no one has an answer to right now," says Wilkins. "The challenge of the new privacy laws under discussion lies in determining how to best protect the patient’s privacy and sensitive information given the proliferation of computer systems used in patient care. I don’t have an answer for that. What if someone loses a Palm Pilot filled with information about the patients on their service? We need guidelines for what type of information can be entered and carried on Palm Pilot devices."
Patient privacy is an important issue for technological devices and software. Software can be considered a medical device. When it is, the FDA requires that complaints and incidents be documented and reported. "You have to have good security for systems using the Internet to send and receive patient data," notes Cerner’s Fearon.
According to Vanscoy, "Key institutions need to take a proactive stance on protection of patient health information. This type of data is extremely valuable. Some institutions, in order to remain solvent, will exploit the data in their possession and sometimes cross lines of privacy. Technology will help ensure the ability to protect patient data, but patient protection must be the first priority of the institution."
Steve McRae, RPh, staff pharmacist at Truman Medical Center, Hospital Hill, views pharmacists as being outside the managed care loop. "The best thing that could happen with managed care from the pharmacy standpoint is for pharmacists to get back in the loop and have an impact on cost and quality," he proposes. "That’s what managed care used to be. This would have to happen on a regional or specific-location basis, as with a staff model setting. National attempts with big chains produce savings that are all on paper. That’s what we’re doing right now. Changing one brand to another to reduce cost is not satisfying to pharmacists who want to make a clinical difference for patients. The $5 to $8 they get for their effort isn’t satisfying either."
The worst thing that could happen with managed care in the future is already happening, according to McRae. "We’re outside the loop. It will be really tough for pharmacy to try to get back into the loop. Costs are already as low as they can go and care is just mediocre to good," he says. "Pharmacists already sell a product for the cheapest price. Anything we want to do for clinical outcomes has to be done for free. Instead of trying to back our way into managed care, we need to get out of it with automation and technician dispensing to decrease costs."
Vanscoy shares a different angle. "I see managed care continuing to strive toward a balance of quality and cost," he says. "Part of what needs to happen, though, is for drug budgets to go beyond the pharmacy. Drug cost is part of the cost of total patient care and should be shared by the institution. Drugs should be viewed as any other technology or tool used in improving patient care."
Ethical decisions made in the future, in one sense, won’t be much different from decisions pharmacists currently make, says Liberti. "We’ve always had opinions and made decisions based on our ethical standards. We’ve used them to determine whether or not drugs as prescribed were done so ethically. We will apply these same standards to newer drugs just as we have to the older drugs," he explains. "Dispensing can become complicated by genetic aspects and life-threatening issues. Pharmacists will always say whether or not they want to participate in dispensing. If need be, the task can typically be passed to another colleague with a different view. Pharmacists have been using their own ethics to support or validate physician decisions and they’ll continue to do so in the future.
"I believe there will be a heavy pharmacoeconomic influence on setting ethical standards of care. They’ll have to be balanced with legal standards of care expected in particular therapeutic areas. The patient’s well-being will remain the primary concern, but cost-effective care will be part of the challenge," he continues. "Ethical decisions in institutions will have to be multidisciplinary decisions. They can’t be monopolized by any one group. To do so would mean we’re going down the wrong path. I see more interdisciplinary standards of care developed."
If a Medicare component to pharmacy becomes law, there will be federal oversight of operations and payment/reimbursement processes, says Rhonda Beene, RPh, another staff pharmacist at Truman Medical Center, Hospital Hill. "There will be no Medicare fraudulent billing. People will be forced to be more ethical and toe the line," she projects. "Regulations will be enforced. I don’t see it happening as a result of something people do of their own accord but rather out of the need to survive financially.
"We’ve seen a huge shift in decision making from 10 years ago," says Beene. "In the past, providers had control. Then managed care and insurance companies took over. After that there was a shift in emphasis to information systems and integration. The recent change has resulted from fraudulent Medicare billing. With that came compliance officers who now determine how hospitals run. Those officers are typically attorneys, and a great deal of power lies in their office. It’s important now to step up proactive compliance.
"From the biology standpoint, if we map specific genes and associate different disease states with those genes, then develop gene-specific treatment, ethics will play an important role in how we practice medicine and pharmacy," she adds. "Moral and religious beliefs will have an impact on how comfortable physicians are in prescribing, how comfortable pharmacists are in dispensing, and how comfortable patients are in taking these new medications. We’ve already seen such issues with RU486. I foresee people becoming uncomfortable, to varying degrees, with anything that alters life or life function.
"Pharmacists who accept and embrace new practices of medicine and pharmacy will be more likely to provide the best patient care in the future," says Beene. "Genomic medicine will provide better care and change the whole focus of medicine and pharmacy practice. Current medicine has been pretty reactive and very much after the fact. Gene therapy could give us the opportunity to be more proactive and allow us to anticipate problems before they occur. We’ll have better management of diseases in the future."
To get to that point, though, pharmacists must be properly educated. "I don’t foresee our present pharmacy school curricula keeping up with information of this type. Gene therapy alone could bombard us with information. There will probably have to be some type of formalized educational program," she notes. "Continuing education will be very important for pharmacists already in practice. There might be certificate programs for pharmacists who specialize in genomic medicine.
"I hope to see pharmacists promoted as people who can help manage disease states. In order to gain that recognition, though, we need to be more proactive and be strong advocates of our own profession," asserts Beene. "We need to prove our worthiness so others can feel confident that we can bring something to the table. We need to be proactive in the management of disease states and have more interaction with physicians. In order to demonstrate valuable input, we’ll have to stay atop of changes in technology and medications.
"I believe the worst thing that could happen in the future regarding ethics would be complete control by the government over ethical issues," she says. "Expanding Medicare, in and of itself, will mean more oversight from the federal government. The government will definitely have a hand in making ethical decisions, in particular with issues surrounding human genomics."
"We’ll see stricter control on claims made for herbal remedies," Liberti tells DUR. "The situation has gotten out of hand now with claims that don’t require scientific support. I see an expansion of the Investigational Drug Application and NDA processes for a special category of neutraceuticals. There has to be greater control at some point in time. If we don’t do it proactively, there will be a safety problem in the future that will act as the catalyst to set controls into motion.
"Neutraceuticals should come under the scrutiny of the FDA because they are compounds that are ultimately designed to affect the structure and function of the body, just like any other medicinal," he suggests. "There will probably be interactions with the [Federal Trade Commission] and [the U.S. Dept. of Agriculture], but I see the FDA acting as the primary governing body."
FDA control of dietary supplements would simplify the pharmacist’s ability to recommend products, according to Liberti. "Right now we have a lack of standardized information about dosing and content. Compendial standards would help pharmacists give consumers a better sense of which products would best be used in specific situations, as well as provide information about interactions between herbals and drugs," he says. "The overall safety issues associated with these products are just now being defined. As they’re better codified, quantitated, and disseminated, we’ll see an improvement in the overall safety profile for patients.
"Because most neutraceuticals haven’t been subjected to good, quality scientific studies, there could be problems lurking unseen with lack of efficacy or problems of safety," he notes. "We don’t know about those problems until they’re out in the broader population. If we were to implement a simpler way of screening products through regulatory requirements, that would improve safety and consumer confidence."
"In the future we’ll see fewer retrospective drug utilization reviews and more prospective DURs performed," says Wilkins. "There will be an emphasis on outcomes. DURs will evaluate the cost to the system, pro or con, for use of specific agents. DURs will evaluate such issues as a drug’s costing more up-front, but then DURs will evaluate the overall cost and potential cost-saving to the system in the long run. DURs will evaluate how able drugs are to prevent return visits to the emergency department and readmissions to the hospital. Of course, patient compliance plays an important part in these matters. DURs will measure patient compliance and the impact of compliance on the effects of drugs."
Technology will play an important part in DURs of the future, according to Wilkins. "Different delivery systems will make the patient compliance issue more of a non-issue. New delivery systems — whether a completely new system altogether or a new drug reformulated into an already existing delivery system — will make it such that patients don’t have to remember when to take their medications," he suggests. "Implanted systems are an example of one such system. These new technologies in drug delivery will help increase outcomes and make drug utilization outcomes research more powerful."
Vanscoy agrees that technology will play a crucial role. "Technology is catching up to DUR," he says. "DUR criteria are held in computer systems to assure proper patient selection and management, and then the computers kick out the analyses."
"I see more concurrent DUR evaluation," he adds. "We’ll still have to create criteria and translate the parameters, but pharmacy computers can then use the variances to trigger target lists for pharmacists to follow up on. Additionally, we need to focus less on very expensive studies and more on opportunity costs from traditional programs," he says.
A lot of time will be spent by staff organizing drugs into storage systems and areas, according to Liberti. Sterile areas will be required for some of the new delivery systems. Special areas and equipment will be required for proper preparation of the drugs prior to delivery to the patient. "A lot more patient instruction will be required as these drugs are dispensed, resulting in more time spent by the pharmacist," he says. "There will be costs incurred to organize pharmacies and the physical plant to accommodate the storage, preparation, and administration of new drug delivery systems."
"Because we’re working on the development of long-acting depot forms, there is great promise for enhanced patient compliance," notes Liberti. "However, resistance remains on the part of the patient because many of these drug delivery systems are invasive. They require an injection or implant. Physicians are concerned because of limited options if an adverse event or drug interaction occurs. There’s no intuitive way to stop the effect of the drug. Does this put the patient at increased risk?
"That’s the balance we have to figure out — safety, compliance, and efficacy. The balance has been a problem for the past 20 years, but nothing’s changed the picture for today in any significant way."
• Rhonda Beene, RPh, Staff Pharmacist, Truman Medical Center, Hospital Hill, 2301 Holmes St., Kansas City, MO 64108. Telephone: (816) 556-3425.
• Don Fearon, Immediate Response Center Analyst, Cerner Corp., 2800 Rockcreek Parkway, North Kansas City, MO 64117. Telephone: (816) 201-0367.
• Larry Liberti, RPh, MSc, President, Pharmaceutical Information Associates Ltd., 333 N. Oxford Valley Road, Suite 404, Fairless Hills, PA 19030. Telephone: (215) 949-0490.
• Steve McRae, RPh, Staff Pharmacist, Truman Medical Center, Hospital Hill, 2301 Holmes St., Kansas City, MO 64108. Telephone: (816) 556-3425.
• Gordon Vanscoy, PharmD, MBA, Assistant Dean for Managed Care and Associate Professor of Pharmaceutical Sciences, University of Pittsburgh, School of Pharmacy, 512-3 Salk Hall, Pittsburgh, PA 15261. Telephone: (412) 624-2791. Also chairman and CEO of University Pharmacotherapy Associates.
• Ray Wilkins, RPh, MS, Director of Pharmacy, Truman Medical Center, Hospital Hill, 2301 Holmes St., Kansas City, MO 64108. Telephone: (816) 556-3057.
• Kristi Wyatt, RPh, MBA, Director of Regulatory Affairs, Pharmion Corp., 8717 W. 110th St., Overland Park, KS 66210. Telephone: (913) 266-0300.