ASHP InterSections ASHP InterSections

March 29, 2012

ASHP eLearning Offers Rich, Interactive CE

Filed under: ASHP News,InfoCentral — Kathy Biesecker @ 2:15 pm

With ASHP eLearning, you can prepare for certification or recertification, earn continuing education credits, and enhance your understanding of specific topic areas, anytime, anywhere. ASHP’s Core Therapeutic Module (CTM) series helps you prepare for a Board of Pharmacy Specialties (BPS) exam with a base knowledge of a variety of topics including cardiac arrhythmias and advanced cardiac life support, diabetes, congestive heart failure, management of shock, psychiatric disorders, statistics, women’s health, HIV/AIDS, and more.

With a total of 14 modules offering 16 hours of CE credit, there is something for everyone regarding various topics and disease states. Available as individual modules or as a package.

March 28, 2012

The Next Frontier: Pharmacy and the Emerging Sciences

Filed under: Current Issue,Feature Stories — Tags: , , , , , — jmilford @ 5:20 pm

 

A pharmacist discovered the mistake, and it was a big one. Gone unnoticed, the error would have corrupted an entire clinical trial.

The detection occurred at the outset of a phase I gene therapy trial at The Cancer Institute of New Jersey (CINJ) in New Brunswick. Patients with carcinoma of the bladder were to receive a vaccine composed of a recombinant fowlpox virus expressing two proteins (TRI-COM and GM-CSF). The virus would be injected directly into the bladder. When the research team’s pharmacist reviewed the National Cancer Institute (NCI)-approved protocol, she realized that the normal saline solution used to dilute the vaccine was too acidic to support virus stability. Had the vaccine been administered, the results would have been meaningless.

The pharmacist alerted Susan Goodin, Pharm.D., BCOP, associate director of clinical trials and therapeutics at CINJ and professor of medicine at the University of Medicine & Dentistry of New Jersey-Robert Wood Johnson Medical School in New Brunswick. Dr. Goodin agreed with the evaluation and notified the research team and the NCI. Both were stunned. Eventually, a more suitable diluting agent was used.

“She caught the error before any of the 33 patients received the vaccine,” said Dr. Goodin. “We would have gotten to the end and said, ‘It doesn’t work,’ without ever knowing why.”

From Fatal Disease to a Cure

It is hard to imagine a more conspicuous example that establishes the value of pharmacists in research.

Pharmacists who are involved in emerging medical sciences research say the field requires patience and persistence.

Dr. Goodin and her vigilant colleague are part of a growing trend: pharmacists who are deeply involved in emerging medical sciences research, which include pharmacogenomics, gene therapy, biosimilar drug therapy and nanomedicine, among others. This is not a calling for individuals who thrive on instant gratification, because the payoff—if there is a payoff—usually doesn’t arrive for years, maybe decades, after the work commences, noted Dr. Goodin, who has been a researcher and clinical pharmacist for 20 years. But those rewards can be enormous.

“I truly believe that these kinds of trials will make some cancers chronic illnesses or possibly cure them,” said Dr. Goodin, who oversees all of the clinical trials at CINJ. “Gene therapy may be among the best opportunities for managing diseases like bladder cancer, pancreatic cancer and melanoma.” The team at CINJ is currently conducting a clinical trial of PANVAC, a vaccine for pancreatic cancer patients.

Individualizing Drug Therapy

Orly Vardeny, M.S., Pharm.D., conducts research on the pharmacogenomics of cardiovascular medications, insulin resistance and heart failure, and immune function and influenza vaccine response in patients with cardiovascular disease. Considered broadly, pharmacogenomics is the study of how variations in genetic composition affect a patient’s response to medication. The presence of specific genetic markers may allow a heretofore unreachable level of individualization and accuracy in drug therapy.

“Pharmacists who possess information about a patient’s genetic profile could provide prescribers with highly specific therapeutic recommendations,” said Dr. Vardeny, an associate professor of pharmacy at the University of Wisconsin in Madison.

Dr. Vardeny’s recent work includes a study of nondipping nocturnal blood pressure, which is characterized by disruptions in the normal circadian rhythm that leads to a lack of normal declines in blood pressure during sleep. The absence of a normal drop in blood pressure at night has been associated with heart failure, myocardial infarction and stroke, as well as sudden cardiac death.

The authors found that a genetic predisposition involving the sympathetic nervous system may play a role in abnormal blood pressure dipping patterns. “Determining who, from a genetic standpoint, is predisposed to nondipping, may enable us to target individuals who require more vigorous control of their blood pressure,” said Dr. Vardeny.

Asking the Important Questions

For Daniel Crona, Pharm.D., the attraction of research boils down to a simple idea: “I like asking important questions, formulating hypotheses and figuring out the answers. The end game for me is that my work may eventually save lives.”

Crona conducts clinical pharmacologic research, focusing on pharmacogenetics, in patients with genitourinary malignancies at the University of North Carolina (UNC) Eshelman School of Pharmacy, and is pursuing a Ph.D. in the UNC ESOP’s Division of Pharmacotherapy and Experimental Therapeutics.

He is part of a team seeking to discover genetic biomarkers that predict differences in survival and adverse event profiles among patients taking oral small molecule tyrosine kinase inhibitors (i.e. sorafenib) for metastatic kidney cancer. Their efforts may one day be used to identify patients who can benefit most from these agents by mitigating dangerous side effects, optimizing chemotherapy doses and improving overall survival.

“The thought that what I’m doing will potentially have a far-reaching impact on patient care is gratifying,” said Dr. Crona. “I wouldn’t give it up for the world.”

John M. Valgus, Pharm. D., BCOP, CPP

Among the prominent emerging sciences, pharmacogenomics is one of the only disciplines to have produced applications used in mainstream medicine, according to John M. Valgus, Pharm.D., BCOP, CPP, hematology/oncology clinical pharmacist practitioner at the University of North Carolina Hospitals and Clinics, and a clinical assistant professor at UNC Eshelman.

“Several specific pharmacogenomic tests are used beyond the context of a clinical trial and are generally covered by insurance,” said Dr. Valgus.

An example is genetic testing for the presence and activity of the enzyme thiopurine methyltransferase (TPMT) in patients scheduled to receive azathioprine or mercaptopurine. Patients with low TPMT activity are at increased risk of drug-induced bone marrow toxicity. The information has a direct impact on treatment decisions.

Closing the Knowledge Gap

Despite the emergence of pharmacogenomics as a practical diagnostic option, many practitioners know little about it, said Sandra Oh Clarke, R.Ph., senior director, certification development and CE liaison in the ASHP Office of Resources Development, and former director of ASHP’s Section of Clinical Specialists and Scientists.

“We have a big knowledge gap,” she said. “The information is out there. What we need is a way to communicate the value of pharmacogenomics to clinicians and bring the technology to the bedside.”

ASHP’s Section of Clinical Specialists and Scientists’ (SCSS) Advisory Group on Emerging Sciences evaluates and implements recommendations of the ASHP 2008 Task Force on Science and assesses potential policy issues related to the emerging sciences. The group is currently developing several major initiatives for members who are involved or interested in research, including a resource center on ASHP’s website and proposed CE programs at the 2012 Midyear Clinical Meeting.

“Emerging sciences will play a big part in the future of pharmacy practice,” said Dr. Valgus, who chairs ASHP’s advisory group. “Almost anyone who cares for patients, regardless of specialty, will eventually need to understand them, particularly pharmacogenomics.”

Deadline for 2012 ASHP Foundation Pharmacy Residency Excellence Awards Applications

Filed under: Calendar Event — Tags: , , — jmilford @ 5:15 pm

ASHP Summer Meeting & House of Delegates Meeting

Filed under: Calendar Event — Tags: , , , , , — jmilford @ 4:04 pm

Regional Delegate Conferences

Filed under: Calendar Event — Tags: , , — jmilford @ 4:03 pm

Children’s New Pharmacy Model a Resounding Success

Richard Sakai, Pharm.D., FASHP, FCSHP

In 1998, Richard Sakai, Pharm.D., FASHP, FCSHP, became the director of pharmacy service at the 358-bed Children’s Hospital Central California (CHCC) in Madera. For Dr. Sakai, it was a homecoming of sorts. Nearly 20 years earlier, he had left the same hospital to continue his career at several other health systems across California. On his return, Dr. Sakai observed a pretty solid pharmacy program, albeit one that was a bit too centralized in its approach to patient care.

Dr. Sakai had picked up a few ideas in his travels. One thing he noticed was how a decentralized pharmacy could increase patient safety and allow pharmacists to apply and hone their clinical skills. In California, where most health-system pharmacists have a Pharm.D. degree and don’t want to spend much time in a central pharmacy, that flexibility was important.

Integrating Pharmacists into Care Units 

Although he brought his vision to bear on CHCC, Dr. Sakai steered away from the prototypical decentralized pharmacy model (typified by satellite pharmacies located near patient care units). Instead, he persuaded the nursing and medical staff to provide pharmacists with space on the units themselves.

Jessie Kim, Pharm.D., checks a medication order.

“Over the years, I found that pharmacists tended to stay in the satellites because orders and questions continually came in. They just wait for ‘customers’ in their little office,” said Dr. Sakai. “Our pharmacists, though, have become integrated directly into the units, and they join team rounds. They can break away, if necessary, to process and validate orders, but they avoid getting bogged down in dispensing activities. To handle those functions, we have robust technology in our central pharmacy.”

Even pharmacists stationed in the central pharmacy provide clinical services—in fact, they are responsible for at least as many interventions as their colleagues out on the units because the central pharmacy operates around the clock. Decentralized pharmacists are on duty 10.5 hours a day. Because of the pharmacy staff’s frequent participation in clinical functions, added Dr. Sakai, they are considered essential components of the health care team. “The end result is that we enjoy a team approach to both dispensing and clinical services,” he said.

Shift in Attitude

That observation squares with the experience of Dave Hebert, Pharm.D., pediatric critical care pharmacist. Dr. Hebert has worked at CHCC for three decades, and he cannot recall a time when the medical staff was so openly reliant on his pharmacologic expertise. He attributes the shift in attitude to decentralization.

“The physicians walk by and want to enter an order into the computer. They also want my advice a lot of the time, and I am right there as a lead pharmacist to help them,” said Dr. Hebert. For instance, a physician might ask him what dose of Lasix he recommends for a child with low urine output. “They are pulling me in on the analytical side, and they usually follow my advice,” Dr. Hebert said.

Pharmacy technicians have also seen their roles expand. “In our facility, qualified technicians are crucial to provide high-tech distributive services and to support a complex pediatric unit-of-use philosophy for commercially available or extemporaneously compounded drugs,” said Dr. Sakai. “Our technicians have a career ladder, and each level requires greater skills and responsibilities.”

For Chris Dervin, CPht, a robot technician who has been at Children’s for more than nine years, work became decidedly more interesting as its scope expanded. “Everything has evolved; there are added safety measures because of technology, such as bar coding and scanning,” she said. “There is also a greater need to pay close attention to fine details and accuracy, which has made my position more challenging and rewarding.”

 A Reliance on Technology

Fundamental to the practice model’s calculus is technology. The pharmacy holds an impressive array: robotic dispensing, a TPN compounder, automated dispensing cabinets, computerized prescriber order entry, bedside scanning, a repackaging machine, and automated record keeping. A robotic IV admixture machine is on Dr. Sakai’s wish list.

CHCC’s medication-dispensing robot has allowed pharmacists to do more direct patient care.

“We use technology whenever feasible to minimize the time pharmacists spend on tasks like compounding, packaging, dispensing and record keeping,” he said. “That’s had a huge impact on efficiency and increased patient safety. When I see medication errors, they are human errors. The robot doesn’t make mistakes.”

The hospital’s administration has received the decentralized model enthusiastically because, according to Dr. Sakai, they embraced a culture of safety. Support from key physicians and medical staff committees were equally important to the program’s adoption and expansion.

The program’s financial impact certainly helped to foster support as well. For example, during the second quarter of 2011, there were 14,496 pharmacist interventions, 99 percent of which were accepted by prescribers. The resulting cost avoidance totaled nearly $350,000.

Dr. Hebert also credits Dr. Sakai for the success of the practice model.

“It took a director who had the vision to see the pharmacist as much more than someone cloistered in the basement,” he said. “Dr. Sakai finds people who have a passion for their work and he encourages them. When you do that, people feel empowered to do the best that they
possibly can.”

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