Sell Yourself

By DWIGHT NYBERG | President | MPA

In the early 1970’s, my Dad’s prescription volume was one-third of today’s volume, and he made twice the profit! That’s the new math I never understood.

The President’s call for zero copay on prescriptions for our Tricare patients is a prime example of not understanding healthcare. The lower copay for prescriptions should be available at the pharmacies that provide one-on-one or face-to-face consultation, patient education, drug therapy modification and/or product selection. The remaining pharmacies are mandated to charge copays.

It’s a proven fact that medication therapy management and patient education are both proactive methods of: Improving healthcare outcomes and quality of life. What an example of managing healthcare expenses! The same pharmacists who are hurt by this are already dispensing a larger percent of generic drugs. This helps the health care system save more money.

Could you do 20 or 30 MTM’s or patient education sessions each day, at $100 to $150 per session?

Remember, you’re the expert, you’re the best, you’re selling yourself.

Take a moment, estimate the dollar savings you could create each day, week, month, and year.

An easy $200 to $300 a day, $1,000 to $1,500 a week, $20,000 to $30,000 a month … you continue and use your estimate. Are you worth more than $150 per session?

Now, think about the diabetic, the asthma patient, the potential fall patient who’s lifestyle and quality of life you helped improve.

You’re the drug expert, you’re selling yourself !!!

Afraid the future will leave you behind? Then help create the future!

Participate with the Missouri Pharmacy Association as we challenge, change, and develop the future of Pharmacy.

An opportunity for all pharmacists!

Sell yourself, SELL YOURSELF!!!

UMKC Students Active all Semester Long

By KK VOUTHY | UMKC 2013 Pharm.D. Candidate

UMKC Student pharmacists jumped into action before the fall semester started in mid-August. The year began with a collaborative effort between the medical, dental , and nursing school for an event called “Lunch on the Lawn.” Students on the Health Sciences campus came together for an opportunity to learn about respective disciplines located on the Hospital Hill. Various organizations from the three schools had an opportunity to show case and recruit new members.

In October, student pharmacists from both campuses participated in the Script Your Future Campaign to spread awareness regarding the dangers of not taking medications properly. The APhA-ASP chapter published a public service announcement in the Kansas City Star newspaper about American Pharmacist month and promoting medication adherence.

Numerous activities helped launch the event in conjunction with the American Pharmacist Month Celebration on October 3. A reception was held for pharmacy faculty, staff, and students. UMKC and Columbia campuses both held multiple health fairs at the local farmer’s market to offer patient care screenings such as blood glucose testing and blood pressure measurements. Patients were also educated on medication compliance and proper drug disposal methods for unused, unwanted medications.

In the same month, students volunteered at the Kansas City CROP walk to distributed water for walkers. UMKC students educated over 300 walkers about medication compliance.

In November, fourth year student pharmacists assisted at the annual UMKC Healthy for Life Employee Health Fair. Student gave flu shots, took blood pressures, and performed blood glucose testing for faculty and staff. The experience gave students the opportunity to apply their class room knowledge to the real world.

Most recently, the national pharmacy leadership society, Phi Lambda Sigma teamed up with UMKC APhA-ASP to offer student pharmacists the opportunity to improve upon their interviewing skills and sharpen their curriculum vitae.

As the semester comes toward an end, students get a week break for Thanksgiving to catch up on family, work, and rest. When they return, it will be time for finals and preparation for the coming new year. Until the next time, on behalf of all student pharmacists at UMKC, we appreciate all the support from the Missouri Pharmacy community.

Working for Better Medication Adherence

By CAMERON LINDSEY, Pharm.D., BC-ADM, CDE | UMKC Professor of Pharmacy Practice & Administration

Taking medication as directed may seem simple, but non-adherence among people with chronic conditions is a complex and widespread public health problem. Nearly three out of four Americans report that they do not always take their medications as directed, leading to serious health consequences and avoidable costs. That is why this October student pharmacists from the University of Missouri-Kansas City worked to raise awareness among patients across the state about the importance of taking medication as prescribed – a vital first step toward a longer, healthier life.

There are many reasons why people do not take their medication as directed, but the result is the same – they don’t receive the therapy their health care professionals have prescribed for them, leading to more serious health complications, reduced quality of life, and even early death.

Script Your Future focuses on patients affected by three serious chronic conditions – diabetes, respiratory disease and cardiovascular disease.

“Poor medication adherence is costing Americans their good health and our nation billions,” says Russell B. Melchert, Dean, UMKC School of Pharmacy. “Improved adherence is in all our best interests, contributing to lower overall health care costs and increased quality of life. By focusing national attention on this issue, Script Your Future helps us all take the first step towards a healthier future. UMKC has made it a priority to educate the next generation of pharmacists about the importance of communicating openly with patients about medication adherence, learning about the challenges they face and helping them find a solution.”

UMKC joins other schools of pharmacy across the country in participating in the Script Your Future Adherence Challenge. Script Your Future is a national coalition of more than 100 public and private stakeholder organizations, led by the National Consumers League. The campaign provides tools – available online at www.ScriptYourFuture.org – to help patients and health care professionals better communicate about ways to improve medication adherence.

To get involved in the Script Your Future Adherence Challenge, please contact Cameron Lindsey, PharmD, BC-ADM, CDE at lindseyca@umkc.edu. For more information about the campaign, please visit www.ScriptYourFuture.org or follow the campaign via Twitter (@IWillTakeMyMeds) and on Facebook.

UMKC School of Pharmacy Update

By RUSSELL B. MELCHERT, Ph.D | Dean | UMKC School of Pharmacy

Thank you for the opportunity to update you on the UMKC School of Pharmacy! We are undergoing many changes right now, and this is a very exciting time for us!

Our curriculum has undergone some major changes recently. We have modified our curriculum from a “1-5” to a “2-4.5” meaning that approximately two years of pharmacy prerequisite courses are required for admission to our program, and the professional doctor of pharmacy program is approximately four and one-half years in duration. Functionally, this amounts to moving the “old” first year of our curriculum to prerequisite courses, but most of the courses taken will be the same as before (e.g. general chemistry through organic chemistry). The change required us to go through one year where we do not admit any students. Not having an incoming class this year is somewhat traumatic for most of us on faculty and staff at UMKC, but we will get through it. The worst part for us was telling some great students that they could not apply for admission in 2011. We really look forward to our incoming class next year, and we are already accepting applications for entry in the fall of 2012. All applicants will need to apply through the national PharmCAS system—information on the process is available on our website.

A second major change is that back in June of this year Governor Nixon signed legislation that will provide the funding necessary for us to expand our pharmacy program to the Missouri State University (MSU) campus in Springfield. Even though the economy has exerted a significant negative impact, demand for pharmacists continues to outstrip supply throughout the country, particularly in rural states. Missouri is no exception to this phenomenon, and according to the latest Pharmacy Manpower Project data, Missouri’s demand for pharmacists continues to exceed supply and continues to be higher than the national average. Further, our school of pharmacy continues to receive requests for pharmacists from pharmacies in rural parts of the state. Our expansion of the program to the MU campus in Columbia has helped with this issue to some degree with the vast majority of our first two graduating classes (2010, 2011) filling positions throughout central and southern Missouri. Our graduate placement data trend seems to support the conclusion that regional programs can help meet regional demand for pharmacists. If all goes as planned and we receive approval to expand the program from our accrediting body, then we plan to enroll the first group of students on the MSU campus in the fall of 2014. We are very excited about this opportunity, and we are most grateful for the commitment of our partners at MSU and in the hospitals, clinics, and pharmacies throughout Springfield and the surrounding communities!

Yet another major change is that our enrollment for the fall of 2012 will return to our “pre-Caring for Missourians” level. That is, with the CFM funds, we were able to increase our enrollment by 15 students per year for three years. Beginning next fall, our entering class will go down by 15 and consist of 95 students in Kansas City and 28 students in Columbia. For the fall of 2014, we are planning on admitting 30 students per year at the MSU site. If approved, all students applying to the UMKC School of Pharmacy in 2014 will be able to indicate their preference for Columbia, Kansas City, or Springfield.

We also received several pieces of other good news over the past year. Despite the difficult economy and tight federal funding, our basic science faculty received eight new federal and foundation research grants, supplements to grants, and patents. New grants and/or patents were awarded to Drs. Hari Bhat, Kun Cheng, Santosh Kumar, Simon Friedman, Ashim Mitra, Mridul Mukherji, and Celestin Youan. Together with the rest of our outstanding scholars and researchers, the UMKC School of Pharmacy will most likely move into the upper 25% of pharmacy schools in terms of extramural research next year!

Once again, we find ourselves in very exciting times for the UMKC School of Pharmacy! Students, staff, and faculty alike are all part of a pivotal point in the 125 year history of our great school, and we are grateful for the support the MPA has provided in our education and patient care missions. Wherever you are, you can always assist us and the profession by talking to children about your profession and recruiting them to pharmacy school—it’s never too early to start recruiting! Thank you everyone!

You are all more than welcome to come visit us any time. Just send me an e-mail and let me know when you are coming. We enjoy showing people around the school in Kansas City and in Columbia!

Have a great fall and holiday season!

New Oral Anticoagulants v. Warfin

By JASON R. PELLETIER | UMKC | Pharm.D. Candidate

Since it first appeared on the market in the early 1950s, warfarin has dominated the oral anticoagulation realm and kept many patients from premature thrombotic events. However, warfarin is also associated with a great number of drug and food interactions, trouble with genomic variations, and a narrow therapeutic window that make routine blood tests mandatory. These tests, along with faithful adherence to diet and drug dose (which may change each day) are not always achievable in some patients, and may result in a failure to maintain a therapeutic INR of 2-3. The blood tests and strict diet may also be considered a nuisance even in highly adherent patients. Fortunately for both groups, there are three new oral anticoagulants on the horizon: Eliquis™ (apixaban), Xarelto® (rivaroxaban), and Pradaxa® (dabigatran). These drugs are heralded as the new anticoagulants of the future that do not require monitoring and while this may be ideal in some patients it is not in others. A deeper comparative look between the new drugs and warfarin is necessary to decide which agent to use on a patient-by-patient basis.

Dabigatran is a direct thrombin inhibitor that inhibits factor IIa and is approved for prevention of stroke and systemic embolism in non-valvular atrial fibrillation. Unlike the other two new oral agents, dabigatran is predominately eliminated unchanged and does not interact with P450 enzymes. Dabigatran is, however, a substrate of the p-glycoprotein enzyme, so other drugs affected by this enzyme may cause increased or decreased plasma levels. Dabigatran is also very poorly protein bound, which means dialysis to remove the agent is reasonably possible in emergency situations. Unfortunately, short of a blood transfusion, there are no other agents currently available to reverse dabigatran.

In the RE-LY trial, two different doses of dabigatran (150mg and 110mg both given twice daily) were compared to warfarin; however the FDA has so far approved 75mg and 150mg. Both doses were shown to be non-inferior to warfarin, and the 150mg dose was superior. The 110mg dose of dabigatran showed significantly fewer rates of bleeding when compared to warfarin and higher dosed dabigatran. This would suggest that the 110mg dose of dabigatran may be associated with roughly the same level of anticoagulation as warfarin but has an even better safety profile. The 150mg dose of dabigatran demonstrated significantly lower rates of hemorrhagic stroke but higher rates of gastrointestinal bleeds when compared to warfarin.

Further analysis of the trial demonstrates that there was a trend for fewer strokes (non-hemorrhagic) in patients with warfarin when compared to 150mg of dabigatran as the quality of INR control improved. There were actually lower rates of major bleeding, major gastrointestinal bleeding, and mortality in the highest quartile (patients who spent the most time in a therapeutic INR of 2-3) of the warfarin population compared to 150mg of dabigatran. Dabigatran became statistically safer than warfarin as the time spent in an INR of 2-3 declined, however. Various lab tests such as activated partial thromboplastin time (aPTT), thrombin time (TT), and ecarin clotting time (ECT) may be elevated at therapeutic doses of dabigatran, however, there are no standards in the literature that define the appropriate therapeutic ranges of these lab tests yet. The current approximations for a reference range in those lab values are taken directly from the results seen in the RE-LY trial.

Rivaroxaban is an inhibitor of factor Xa and is approved for post-operative thromboprophylaxis in patients who have undergone hip or knee replacement surgery at an approved dose of 10mg daily (20mg if on concurrent CYP3A4 inducers). Rivaroxaban is also used off-label for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation. Rivaroxaban is a substrate of both p-glycoprotein and metabolized by CYP3A4 so while it may avoid some of the drug and food interactions with warfarin, it will also have additional interactions with substrates, inhibitors, or inducers of either enzyme.

The ROCKET-AF trial demonstrated a once daily dose of 20mg of rivaroxaban was non-inferior to warfarin and caused fewer major bleeding episodes in the prevention of stroke and systemic embolism in non-valvular atrial fibrillation. However, in the same trial, rivaroxaban was also shown to have been associated with a greater number of clinically relevant non-major bleeding episodes that resulted in either transfusion requirements or hemoglobin drops of 2 g/dL or greater. It may be prudent to take some of the results of this trial with a grain of salt, as the time spent in a therapeutic INR (2-3) for the warfarin patients in this trial was only 57.8%.

Like dabigatran, there is no antidote or reversal agent for rivaroxaban. Major clinical trials have not really addressed laboratory monitoring for rivaroxaban. However, PT changes have been shown to correlate well with rivaroxaban concentrations so this may be used to approximate a patient’s level of anticoagulation even though there is no standard therapeutic level in the literature yet. Lastly, even though it’s dosed once daily, rivaroxaban’s half-life is only 5-13 hours which may create a sub-therapeutic problem much faster (when compared to warfarin) in patients who have trouble with adherence.

Apixaban is also an inhibitor of factor Xa, but does not yet have any FDA approved indication and is consequently not on the market. Like rivaroxaban, apixaban is also a substrate of p-glycoprotein and metabolized by CYP3A4. Lastly, like the rest of the new oral agents, there is no antidote or reversal agent available for apixaban and monitoring is not required. The lack of monitoring may also be considered a downfall in certain situations. Very few of the trials out so far address patients with renal or hepatic insufficiency in great detail for any of the new anticoagulants. Treating these patients without under or overdose may be difficult without standardized monitoring parameters.

A recent trial for the drug in atrial fibrillation, ARISTOTLE, was published in the New England Journal of Medicine on September 15th, 2011. In this trial, participants were given 5mg dosed twice daily of apixaban or warfarin with a target INR of 2-3. Patients in the trial had atrial fibrillation and at least one additional risk factor for stroke. The results of this trial demonstrated that apixaban was superior to warfarin in the prevention of stroke or systemic embolism in patients with atrial fibrillation. The trial also demonstrated a lower risk of major and minor bleeding when compared to warfarin.

Like all new drugs, information regarding interactions, safety and efficacy is constantly coming in for the new oral anticoagulants. To date, these agents do not appear to have any major food interactions like warfarin does. However, a fed state in general may increase maximum plasma concentrations as well as the time to reach those concentrations, but does not appear to affect the elimination half-life of rivaroxaban. The manufacturer further recommends taking only the 20mg dose of rivaroxaban with food.

Cost is also a major concern, especially when a new drug comes on the market. In a cost-effectiveness article published by the American Heart Association in 2010, dabigatran 150mg was estimated to be more cost-effective for stroke and systemic embolism prevention in atrial fibrillation patients as compared to warfarin when the time spent in a therapeutic INR (2-3 with warfarin) was < 57.1%. Warfarin, on the other hand, was more cost effective than dabigatran when the time spent at the therapeutic INR was > 72.6%. The current information from the manufacturer states that an opened bottle must be used within 30 days due to drug degradation from moisture, although the manufacturer is currently evaluating stability at 60 days and beyond. The FDA currently recommends using any opened bottle within 60 days. This impaired stability in the presence of moisture has the potential to increase direct drug costs if stored inappropriately and healthcare costs if unaware patients continue to use a product that has been compromised and are no longer therapeutically anticoagulated.

Information presented at the International Society on Thrombosis and Haemostasis in 2009 evaluated the cost-effectiveness of using rivaroxaban over enoxaparin for post-operative DVT prophylaxis in hip and knee replacement patients. The results of this comparison evaluated four different studies and found that rivaroxaban was more cost-effective than enoxaparin (indirect healthcare costs were included). The studies looked at prophylaxis for 10-35 days and within that time frame rivaroxaban was roughly $100-400 cheaper depending slightly on who administered the enoxaparin.

Due largely to the lack of necessary therapeutic monitoring and food interactions, these drugs may be better choices for certain patients that cannot otherwise maintain an INR of 2-3 on warfarin. The drugs may directly cost more than warfarin at this point in time, but when considering the increased indirect healthcare costs due to stroke or systemic embolism for a poor warfarin candidate the new anticoagulants may come out ahead. However, if the only reason a specific patient is unable to maintain a therapeutic INR is due to trouble with adherence to a daily dose of warfarin then dabigatran and abixaban may not immediately counter the problem as they are dosed twice daily. Rivaroxaban also has a half-life significantly shorter than warfarin so intermittent non-adherence will lead to a sub-therapeutic state of anticoagulation and potential thrombotic event much quicker.

While less monitoring may be significantly more convenient for some patients and practitioners alike, it also means the drugs may be more dangerous to use in patient populations that are not as well studied yet, such as those with more severe renal or hepatic insufficiency or patients that are extremely over or under weight. Drug-drug interactions may also become problematic, as some can increase or decrease plasma levels of the anticoagulants and leave a patient sub- or supra-therapeutic for longer periods of time that regular warfarin monitoring would have caught. The risks of exposure to sub- or supra-therapeutic doses carry serious consequences that can lead to death and irreversible bleeding. The inability to reverse any of the three new agents without blood transfusions may also pose additional complications and unforeseen increases in healthcare expenditures when compared to patients that may have been kept out of the hospital if monitored and kept at a therapeutic dose of warfarin or given vitamin K to help reverse a supra-therapeutic warfarin bleed risk.

In summary, while these new agents may be great anticoagulation tools for some patients, they also carry with them potential problems. In general, patients who are poor warfarin candidates and do not spend sufficient time at the therapeutic INR range of 2-3 due to food or drug interactions or possibly adherence (to regular monitoring or different dose adjustments) and have healthy renal and hepatic function are the ideal candidates for the new oral anticoagulants. On the other hand, patients who are able to maintain a therapeutic INR without major complications may find that the new oral anticoagulants are not quite as safe and cost-effective as simply remaining on warfarin at this point in time. As with any new drug, some of this information may change as more and more data from post-marketing studies continues to come in.

References

Shah, Shimoli, MD and Brian Gage, MD, MSc. “Cost-Effectiveness of Dabigatran for Stroke Prophylaxis in Atrial Fibrillation.” American Heart Association. 123. (2011): 2562-2570. Web. 29 Sep. 2011.

Kwong, Louis, Aurea Duran, Alexi Diamantopoulos, Nishan Sengupta and Michael Lees. “Cost-Effectiveness of Rivaroxaban for Prevention of Deep Vein Thrombosis and Pulmonary Embolism after Total Hip or Knee Replacement in US Patients.” International Society on Thrombosis and Haemostasis (ISTH) XXII Congress. Bayer Schering Pharma AG and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Boston, MA. 11-16 July 2009. Poster Presentation.

Granger, Christopher, et al. “Apixaban versus Warfarin in Patients with Atrial Fibrillation.” New England Journal of Medicine. 365.11 (2011): 981-992. Web. 29 Sep. 2011.

Connolly, Stuart, et al. “Dabigatran versus Warfarin in Patients with Atrial Fibrillation.” New England Journal of Medicine. 361.12 (2009): 1139-1151. Web. 29 Sep. 2011.

Patel, Manesh, et al. “Rivaroxaban versus Warfarin in Nonvalvular Atrial Fibrillation.” New England Journal of Medicine. 365.10 (2011): 883-891. Web. 29 Sep. 2011.

Dabigatran. Lexicomp Online. http://www.lexicomponline.com/. Updated 9/22/11. Accessed 9/29/11.

Rivaroxaban. Lexicomp Online. http://www.lexicomponline.com/. Updated 9/22/11. Accessed 9/29/11.

Dabigatran. Micromedex 2.0. http://www.thomsonhc.com/micromedex2/librarian/. Accessed 9/29/11.

Rivaroxaban. Micromedex 2.0. http://www.thomsonhc.com/micromedex2/librarian/. Accessed 9/29/11.

Apixaban. Micromedex 2.0. http://www.thomsonhc.com/micromedex2/librarian/. Accessed 9/29/11.