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  • February 01, 2007 2:27 PM | Brad Miller (Administrator)

    Wow! We saw record attendance at last month's meeting. Approximately 75 WMSHP members attended the 2006 ICAAC review in Grand Rapids. I want to thank Dana Staat for doing a great job facilitating the unusually large crowd and arranging for Michael Klepser to do the presentation for Michael Tiberg, who encountered a family emergency at the last minute. As a thank you for giving the presentation at such short notice, WMSHP's Board of Directors is extending an honorary lifetime membership to Michael Klepser. Thanks again, Mike!

    One of my responsibilities as your president is to serve as the Regional Delegate to the Michigan Society of Health-System Pharmacists (MSHP). I attended my first MSHP board meeting and committee day on January 18th. It was a great experience meeting pharmacy leaders from around the state and providing them with a summary of our recent activities. I would like to recognize several WMSHP members, who also currently serve on MSHP's Board of Directors: Fred Schmidt, President; Jesse Hogue, Director, and Jean Lee, Director.

    February is going to be a short, but busy month. On February 8th the WMSHP meeting will take place in Kalamazoo. Sandra Chase will be giving a presentation on using low molecular weight heparin in medically ill patients. Also, the MPA's Annual Convention and Exposition (ACE) meeting will take place February 23 -25th in Dearborn. More information regarding the ACE meeting can be found at MPA's website, www.michiganpharmacists.org. I hope to see you at one of the events.

  • January 01, 2007 2:28 PM | Brad Miller (Administrator)

    Happy New Year! Hopefully, you were able to enjoy the holidays with your family and friends.

    I would like to start off the year by introducing this year�s board of directors to you. Your officers include: Ryan Bickel, President; Jesse Hogue, Past President; Dana Staat, President-Elect; Ted Riley, Treasurer; and Brad Miller, Secretary. Your board members include: Jodie Bakus, Bill Kriel, Jean Lee, Kim Melgarejo, Natalie Paul, Shaun Phillips, Cindy Pollock, Jeff Van Houten, and Cheri Woodhams.

    On behalf of the board, I would like to thank Jesse Hogue for all of his hard work and guidance as President. I would also like to recognize Jean Lee for her service as Past-President last year. Fortunately, she will be remaining with us as a board member. Finally, I would like to welcome our newest board member, Cindy Pollock.

    I am honored to serve as your president and look forward to working with you to promote the profession of pharmacy. To assist me in serving you, please feel free to share your ideas regarding educational opportunities, topics of interest, or anything else that pertains to advancing health-system pharmacy.

    Many of you are currently making New Year resolutions. I have a couple ideas that I would like to offer. If you are not currently a member of the Michigan Society of Health-System Pharmacy (MSHP) and Michigan Pharmacists Association (MPA), consider joining. If you are already a member, consider becoming involved with a committee, serving as a delegate, and/or attending the MPA's Annual Convention & Exhibition in February. More information regarding these opportunities can be found at MPA's website, http://www.michiganpharmacists.org.

  • November 01, 2006 2:29 PM | Brad Miller (Administrator)

    In the November WMSHP Newsletter, Sakar Wahby, a pharmacy practice resident at Spectrum Health, writes about recent studies of vitamin E's potential neuroprotective effect in patients receiving chemotherapy drugs.

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    Neuroprotection in Patients Receiving Chemotherapy

    Sakar Wahby, Pharm.D.
    Pharmacy Practice Resident
    Spectrum Health, Grand Rapids, MI


    Cancer has been the leading cause of death in the United States for the population younger than 85 years of age since 1999.1 Chemotherapeutic agents have played a big role in curative therapy for various types of cancers since their discovery in the nineteen fifties and sixties. However, these agents have the potential for causing adverse events such as nausea, vomiting, alopecia, and myelosuppression. Other side effects could be specific to some agents and cause damage to certain organs of the body such as toxicity to the gastrointestinal tract, the immune system, the kidneys, heart, and nerve tissues.2

    Neurotoxicity is one of the widely known side effects for a various number of chemotherapeutic agents. Among the classes of chemotherapy known to cause neurotoxicity are the platinum compounds (cisplatin, oxaliplatin, and carboplatin), the taxanes (paclitaxel and docetaxel), vinca-alkaloids (vincristine, vinblastine, and vinorelbine), methotrexate, thalidomide, and ifosfamide. Neurotoxicity caused by vincristine, cisplatin, paclitaxel, and oxaliplatin can limit the dose of these agents that potentially can be used for treatment, thus leading to discontinuation of therapy and thereby hindering the possible full use of very effective cancer treatments.2

    Currently no standard of therapy is approved for neuroprotection for cancer patients who are treated with chemotherapy. Two pilot, randomized, controlled trials (Pace et al. and Argyriou et al.) were conducted in Europe investigating the effectiveness of vitamin E as a neuroprotective agent in patients receiving cisplatin or paclitaxel.3,4

    Cisplatin is a widely used agent in the treatment of various solid tumors such as testicular, ovarian, cervical, head & neck, bladder, and lung cancer. The incidence of neuropathy is up to 100% with this agent, and the severity varies depending on cumulative doses, duration of treatment, and possible underlying diseases that can also cause neuropathy, in addition to having received previous treatments with other neurotoxic medications.2,5 With cisplatin treatment, neurotoxicity is cumulative and signs and symptoms of neuropathy usually appear with cumulative doses of 300-500 mg/m2. Patients treated with cisplatin present with sensory signs and symptoms of paresthesia and numbness. The former manifests itself as tingling, "pins-and-needles" sensation, pulling, pressure, and tightness in the limbs, most often seen in the toes and feet.2,5

    Paclitaxel is a taxane compound used in the treatment of ovarian, breast, and lung cancer.5 Besides myelosuppression, paclitaxel can cause neurotoxicity with severity depending on single-dose and cumulative doses administered. At doses of 135 mg/m2 mild neuropathies have been observed in 50% of patients, but neurotoxicity can be dose-limiting when 175 mg/m2 doses are administered. A dose greater than 200 mg/m2 can cause significant neurotoxicity. The pattern of neurotoxicity from paclitaxel is manifested as paresthesia and numbness in a glove and stocking distribution in the limbs, Lhermitte’s sign (sensation similar to electrical shock) and loss of deep tendon reflexes. 2,5

    Both pilot studies have shown vitamin E to be effective in reducing the incidence and severity of neurotoxicity in patients receiving chemotherapy and vitamin E.

    Pace et al. randomized 47 patients into two groups. Group one received a cisplatin regimen with vitamin E and group two received a cisplatin-only regimen serving as control. After six cycles of cisplatin administration, the incidence of neuropathy was significantly lower in the vitamin E + cisplatin group as compared to the control group (cisplatin alone). Four out of 13 patients in the vitamin E group (30.7%) and 12 out of 14 patients in the control group (85.7%) reported some sign or symptom of neuropathy (p<0.01). The relative risk of developing neurotoxicity was lower in the vitamin E group compared to the control group (RR= 0.36; 95% CI = 0.15-0.83, P<0.001).3

    Argyriou et al. evaluated the neuroprotective effect of vitamin E in patients receiving cisplatin, paclitaxel, or combination of both agents. A statistically significant higher incidence of neurotoxicity were reported in the chemotherapy regimen group (16/20, 80%), versus (8/20, 40%) in the vitamin E + chemotherapy group (Yates p value= 0.023). The relative risk of developing neurotoxicity was lower in the vitamin E group compared to control (RR=0.34, 95% CI =0.14-0.84).4

    The results of both studies have shown great potential for vitamin E in reducing the incidence of neuropathy, acting as a free radical scavenger and protecting non-tumor cells from free radical damage. However, this hypothesis raises a concern regarding the potential of vitamin E to protect cancer cells as well from free radical damage, therefore reducing the efficacy of chemotherapy.6

    Neither study was powered enough to evaluate overall response rate and overall survival rate of those patients given vitamin E compared to placebo. Therefore, using vitamin E as a standard therapy with chemotherapeutic agents causing neurotoxicity can not be recommended at this time. Larger randomized, placebo controlled studies are warranted to further establish efficacy and safety of vitamin E in combination with chemotherapy.



    1. Jemal A, Murray T, Ward E, Samuels A, Tiwari RC, Ghafoor A, Feuer EJ, Thun MJ. Cancer Statistics, 2005. CA Cancer J Clin. 2005 Jan;55(1):10-30.
    2. DeVita VT Jr., Hellman S, Rosenberg SA. CANCER: Principles & Practice of Oncology. 6th ed. Vol. 2. Philadelphia: Lippincott Williams & Wilkins; 2001.
    3. Pace A, Savarese A, Picardo M, Maresca V, Pacetti U, Del Monte G et al. Neuroprotective Effect of Vitamin E Supplementation in Patients Treated With Cisplatin Chemotherapy. J Clin Oncol. 2003 Mar;21(5):927-31.
    4. Argyriou AA, Chroni E, Koutras A, Ellul J, Papapetropoulos S, Katsoulas G et al. Vitamin E for Prophylaxis Against Chemotherapy-Induced Neuropathy. Neurol. 2005;64:26-31.
    5. National Comprehensive cancer network [homepage on the internet]. NCCN Clinical Practice Guidelines in Oncology [updated 2005; cited 2006 Feb 26]. Available at: http://www.nccn.org/professionals/physician_gls/f_guidelines.asp?button=I+Agre
    6. Labriola D, Livingston R. Possible Interactions Between Dietary Antioxidants and Chemotherapy. Oncology. 1999 Jul;13(7):1003-8.
  • November 01, 2006 2:28 PM | Brad Miller (Administrator)

    Don’t forget! If you have not done so already, please send in your ballot for the WMSHP Board elections. We plan to announce the results at the November 9 meeting, so ballots need to be received before then.

    Hopefully every one participated in Michigan Pharmacy Week activities. Remember, if you are an MPA member please take a moment to fill out the reporting form with what you or your department did to celebrate.

  • October 05, 2006 2:30 PM | Brad Miller (Administrator)

    In the October WMSHP newsletter, Benjamin Mgboh, Pharm.D., a pharmacy practice resident at Spectrum Health, discusses a new medication to aid in smoking cessation.


    What Is New in the World of Smokers?

    Benjamin Mgboh, Pharm.D.
    Pharmacy Practice Resident
    Spectrum Health, Grand Rapids, MI


    In the United States, over 50 million people smoke annually with estimated deaths of 438,000 per year.1 Of current smokers, approximately 41% try to quit yearly with only 10% succeeding.2 The problem that arises most times is how to achieve the goal of quitting or what regimen is best for an individual. Smoking is an addictive act that could and has caused cardiovascular diseases. Smoking increases one’s risk of lung cancer, as well as causing drug toxicity by affecting metabolism in hepatic enzymes. According to the World Health Organization, every eight seconds a person dies of a smoking-related disease.3 Smoking is the leading cause of preventable death in the world. Smoking cessation is important because of the harmful role that smoking has on life. Smoking cessation tools such as the use of nicotine replacement therapy (nicotine gums, patches, lozenges), or a dopamine/norepinephrine reuptake inhibitor (Zyban®) are currently available. In spite of these tools, cessation is still a big issue.

    Varenicline (Chantix®) is a phase III smoking cessation drug which stimulates nicotine receptors in the brain without being addictive. It is an α-4, β-2 nicotinic acetylcholine receptor partial agonist.1,2,4 This unique mechanism of action helps to prevent withdrawal in people trying to quit smoking. Two studies were designed to compare the safety and efficacy of varenicline with bupropion SR and placebo. The studies’ (n= 10251 and n=10272) results showed varenicline was significantly better for quitting smoking than placebo throughout the 52 weeks of study. The investigators also reported that varenicline was notably better for smoking cessation than bupropion SR at the end of 12 weeks of study, and 24 weeks of follow-up. The methodology of the study includes a brief counseling to participants and varenicline titrated up to 1 mg orally twice a day. Furthermore, bupropion SR was titrated to 150 mg orally twice a day or placebo for 12 weeks, with 40 weeks of non-drug follow-up.

    Gonzales et al reported for weeks 9 through 12, the 4-week continuous abstinence rates was 26.3% higher for varenicline vs placebo (44% vs 17.7%). Continuous abstinence in varenicline was 14.5% higher than bupropion SR (44% vs 29.5%). For weeks 9-24 continuous abstinence rates was 8.8% higher for the Varenicline group than (29.5% vs. 20.7%) for bupropion SR. In both instances, the results were statistically and clinically significant. However, for weeks 9 through 52, the continuous abstinence rates was 13.5% higher for varenicline vs placebo but not statistically significant when compared with bupropion SR (21.9% vs 16.1%). Similarly, Jorenby et al reported that varenicline showed higher continuous abstinence than placebo at all times. For weeks 9 through 12, the 4-week continuous abstinence rate was 26.3% higher for varenicline vs placebo (43.9% vs 17.6%). Continuous abstinence in varenicline was 14.5% higher than bupropion SR (43.9% vs 29.8%). For weeks 9-24 continuous abstinence rates was 8.8% higher for the varenicline group than (29.7% vs. 20.2%) for bupropion SR. In both instances, the p value was statistically significant. However, for weeks 9 through 52, the continuous abstinence rates was 13.5% higher for varenicline vs placebo but not statistically significant when compared with bupropion SR (23% vs 14.6%).

    Both studies showed that varenicline was safe and generally well tolerated when compared with bupropion SR and placebo. There were no gender differences in efficacy for varenicline.1,2,5 Varenicline reduced craving, withdrawal symptoms, and smoking satisfaction for those who smoked during the studies.1,2,5 Nausea (28.1%) was the most common adverse events observed in participants receiving varenicline. It was mostly mild or moderate and rarely involved discontinuation of therapy.1,2,5 Minimal weight gain and insomnia were also associated with this treatment. However, these adverse effects were also present in the use of bupropion SR (insomnia 21.9%) or placebo.

    In conclusion, both studies stated that varenicline has a better efficacy than both placebo and bupropion SR in smoking cessation. However, it should be noted that the generalization of varenicline across all age groups (mean age studied = 42 years) or populations is limited based upon the inclusion criteria. Thus it is essential for anyone intending to use this drug for smoking cessation to be well evaluated to ensure they do not fall into the category of people that were excluded in the trial studies. The current FDA dosing recommendation for varenicline use in smoking cessation is 1 mg orally twice daily. However, this regimen starts after a one week titration with 0.5 mg orally once daily on days 1, 2 & 3, then 0.5 mg twice daily on days 4, 5, 6, & 7, then 1 mg twice daily for 12 weeks (including 1 week titration).4 Patients are advised to begin therapy one week prior to the date set to quit smoking. Renal adjustment is required in severe renal dysfunction.4


    1. Gonzales D, Bennard SI, Nides M, et al. Varenicline, an α4β2 Nicotinic Acetylcholine Receptor Partial Agonist, vs Sustained-Release Bupropion and Placebo for smoking cessation. A Randomized controlled Trial. JAMA. 2006;296(1):47-55
    2. Jorenby DE, Hays J, Taylor MD, et al. Efficacy of Varenicline, an [alpha]4[beta]2 Nicotinic Acetylcholine Receptor Partial Agonist, vs Placebo or Sustained-Release Bupropion for Smoking Cessation: A Randomized Controlled Trial. JAMA. 2006; 296(1):56-63
    3. Pfizer's Varenicline Receives U.S. FDA Priority Review. http://www.pfizer.com/pfizer/are/investors_releases/2005pr/mn_2005_1221.jsp (accessed 07/16/06)
    4. Klasco RK (ED): DRUGDEX® System. Thomson MICROMEDEX, Greenwood Village, Colorado (accessed 07/13/06).
    5. Varenicline May Be More Effective Than Bupropion for Smoking Cessation. http://www.medscape.com/viewarticle/540203. (accessed 07/17/06)
  • October 05, 2006 2:29 PM | Brad Miller (Administrator)

    It’s time for our annual elections again, and since we have so many nominations this year we decided to feature short bios on the candidates (see below). Hopefully they help you in your voting! We will be electing five candidates. Just a reminder, Michigan Pharmacy Week is fast approaching, October 22-28. If you are a member of MPA please take a moment after the week wraps up to report back on what you or your department did to celebrate. Individuals and departments that promote Pharmacy Week well and then submit a follow up report to MPA will be considered for MSHP or MPA Public Affairs awards. Also, don’t forget the MSHP Annual Meeting Nov. 3 in Lansing.

    Phil Early, Pharm.D., M.S., is the Administrative Director for Pharmacy Services at Borgess Medical Center, Kalamazoo. He received his B.S. and M.S. from The Ohio State University and Pharm.D. from Idaho State University. He completed a two year ASHP accredited general residency at Mount Carmel Medical Center, Columbus, Ohio in conjunction with completing his master’s degree. He is Adjunct Assistant Professor of Clinical Pharmacy for Ferris State University. Prior to coming to Borgess, Dr. Early was Director of Pharmacy Services at St. Rita’s Medical Center, Lima, Ohio.

    Andrea Goodrich is a clinical pharmacist at St. Mary's Health Care in Grand Rapids. Andrea received her B.S. in pharmacy in 2001 and will be completing her non-traditional Pharm.D. from Midwestern University this fall. Andrea's professional areas of interests include Internal Medicine and HIV.

    Jean C. Lee is a HIV/AIDS clinical pharmacist at the McAuley Health Center of Saint Mary’s Health Care in Grand Rapids. Lee completed her BSc. Pharm. from Memorial University, Newfoundland, Canada (1994), Hospital Practice Residency at The Hospital for Sick Children, Toronto, Ontario (1995) and a Diploma in Clinical Epidemiology (1999) before completing her Pharm D at Ferris State University (2001). In Canada, she has served on the National Canadian Society of Hospital Pharmacists (CSHP) Board of Directors as the Newfoundland CSHP Chapter Branch Delegate (1997-1999) and on the National CSHP Strategic Planning Committee (1997-1999). At the local level she served as co-chair for the Awards Committee (1999-2001). In Michigan, Lee is now completing her term as WMSHP Past-President and has been a member since 2001. She has also served on the MPA Employee Pharmacists Committee (2002), MSHP Organizational Affairs Committee from (2004-2005) the Society of Infectious Disease Pharmacists Internet Committee (2003-2004) and will serve on the MSHP Board of Directors (2007-2009). Lee’s professional affiliations also include ACCP, SIDP, NPhA, and MSHP.

    Sarah Paulson attended Ferris State University and graduated with her Doctor of Pharmacy in 2005. She then went on to complete a general pharmacy practice residency at Saint Mary's Health Care. After completion of the residency, she accepted a position as a clinical pharmacist at Saint Mary's Health Care assisting in coverage of the inpatient orthopedic unit, neurology unit, and inpatient pharmacy. Other interests include internal medicine, infectious disease/HIV, and psychiatry. Sarah has been a member of WMSHP since 2005 and also has membership with MPA, ASHP, ACCP, Phi Lambda Sigma (President 2003), and Lambda Kappa Sigma (Recording Secretary 2002). She has been married for 1 year and has 4 furry children (2 cats and 2 dogs). She would like to become more involved with WMSHP and is excited about this opportunity.

    Cindy Pollock received her PharmD at the University of Michigan in 2001. She completed a pharmacy practice residency from 2001-2002 at Spectrum Health/DeVos Children's Hospital in Grand Rapids, MI. She completed the examination to become a Board Certified Pharmacotherapy Specialist in 2002. Currently Cindy is the General Pediatrics Clinical Pharmacy Specialist at DeVos Children's Hospital, and has held this position for 4 years. She holds adjunct faculty appointments at the University of Michigan College of Pharmacy and Ferris State University College of Pharmacy. She is also a preceptor for pharmacy practice residents at DeVos Children's Hospital. She is married with one child and lives in Byron Center, MI.

    Jeff Van Houten received his B.S. from Ferris in 1990 and graduated from FSU's first Pharm.D. class in 1992. He completed a one year pharmacy residency in Pennsylvania and began working at Saint Mary's in Grand Rapids as a clinical pharmacist in 1993, where he has been since. Jeff' clinical interests are in Internal Medicine and Infectious Diseases. He worked along with Jean Lee to start the Pharmacy Residency program at Saint Mary's. Jeff has been on the Board of WMSHP in some capacity for the last 10 years, and held the president's position in 2000. Jeff is married (12 years) and has two daughters (6 and 8).

    Natalie Vazzana is currently an Assistant Professor of Pharmacy Practice with Ferris State University College of Pharmacy. She obtained her Doctorate of Pharmacy at Purdue University and followed with a pharmacy practice residency with McKesson Medication Management at Mercy Hospital and Medical Center in Chicago, Illinois. She is currently practicing at Spectrum Health – Butterworth campus and is the clinical pharmacist on the progressive care unit. Natalie participates with the pharmacy residency program and is a member of the residency advisory committee. Also, she is completing her second year as a board member of the Western Michigan Society for Health-systems pharmacists.

  • August 25, 2006 2:30 PM | Brad Miller (Administrator)

    Welcome back! I hope everyone had a safe and fun-filled summer. The WMSHP Board has prepared yet another excellent year of CE programming for you to take part in, beginning September 14 with a talk on chronic kidney disease at Webster's Restaurant in Kalamazoo. I hope to see everyone there!

    The WMSHP Board will soon begin accepting nominations for 2007 Board positions. If interested, stay tuned for more information.

    Mark your calendars! Michigan Pharmacy Week takes place October 22-28 this year. This is a great opportunity to remind patients and other health care workers of the important role we play in patient care, or even to take your legislator to work with you. For more details or to download resources please check the MPA website (www.michiganpharmacists.org). Right on the heels of Pharmacy Week, the MSHP Annual Meeting is scheduled for November 3 in Lansing. This has traditionally been an excellent day of educational programming tailored to the needs of health system pharmacists. Stay tuned to the MPA website for details on programming and registration.

  • August 24, 2006 2:31 PM | Brad Miller (Administrator)

    In this month's WMSHP Newsletter, Heather Draper, Pharm.D. writes about strategies for managing elevated INR in patients on warfarin.


    Management of INR above the therapeutic range in patients treated with warfarin

    Heather Draper, Pharm.D.


    Anticoagulation with warfarin is effective for the primary and secondary prevention of thromboembolic events. However, this therapy exposes the patient to a higher risk of bleeding. Patient factors may precipitate the risk of bleeding—including advanced age, malignancy, decreased oral intake, or the use of new medications known to potentiate warfarin.

    Warfarin has a narrow therapeutic index, with the therapeutic INR typically targeted at 2-3. The risk of bleeding in patients on warfarin increases significantly when the INR exceeds 4-6, although the absolute risk of bleeding remains fairly low, at less than 5.5 per 1000 per day.1 Therefore, patients with an INR less than 9 and no significant bleeding can be managed by omitting subsequent doses of warfarin, more frequent monitoring of the INR, and resumption of therapy at a lower dose when the INR is therapeutic.2

    When rapid reversal of the INR is needed, fresh frozen plasma, prothrombin complex, or recombinant factor VIIa can be administered. Administration of coagulation factors provides only a temporary solution due to the short half-life of the provided clotting factors (3-4 hours for Factor VII), compared with a duration of action of 2 to 5 days for warfarin, as well as relative instability of clotting factors upon administration. Administration of either fresh frozen plasma or factor concentrates will decrease the PT/INR for 4 to 6 hours.3 Complete return to a therapeutic INR will require supplementation with vitamin K1.2

    Treatment of an INR above the therapeutic range requires a balance between reducing the risk for hemorrhage while minimizing the risk of thrombembolism. Treatment approaches are based on the current INR, presence of bleeding, and the time frame in which reversal is required.2 Vitamin K1 may be administered to reverse the anticoagulation effect of warfarin. The most appropriate dose of vitamin K1 will lower the INR to a safe level without resulting in a subtherapeutic INR. High doses of vitamin K1, although effective, may lead to warfarin resistance for a week or more, resulting in an increased risk for thromboembolism.1,2 In this situation, heparin can be given until the effects of the vitamin K1 are complete.

    Vitamin K1 is available for intravenous (IV), subcutaneous, and oral administration. Table 1 provides a brief summary of the advantages and disadvantages for each route of Vitamin K1. The subcutaneous route has a delayed onset and is less predictable.1 If rapid reversal is desired, the IV route should be utilized, as this route is associated with the fastest onset of action. Historically, intravenous vitamin K1 has been associated with an increased risk of anaphylaxis. A retrospective review of anaphylactic reactions associated with IV vitamin K1 from the Mayo Clinic revealed that the risk of anaphylaxis with vitamin K1 was 3 per 10,000 doses—a rate comparable to all forms of penicillin and less than that of IV iron dextran.4 If is administered by the IV route, lower doses and slower infusion rates are recommended. Unless rapid reversal of the INR is critical, oral vitamin K1 is the preferred route of administration. In the United States, oral vitamin K1 is only available as a 5 mg tablet (Mephyton®). Therefore, oral doses prescribed should reflect even divisions of 5 mg (e.g., 2.5 mg).

    Table 1. Summary of the Use of Vitamin K1

    Route Advantages Disadvantages

    • Fastest Onset of Action
    • Must be given by slow IV infusion
    • Warfarin resistance

    • Lower risk of anaphylaxis
    • Delayed onset
    • Unpredictable response
    • Least desired route

    • Safest route
    • Low risk of anaphylaxis
    • No IV site needed
    • Slower onset of action
    • Warfarin resistance

    The following table provides a summary of recommendations for managing elevated INRs and bleeding patients treated with vitamin K antagonists.

    Table 2. Management of Elevated INR in Patients Receiving Vitamin K Antagonists2

    INR Bleeding Present Rapid Reduction Required Management*
    < 5 No No Lower dose or omit dose; resume at lower dose when INR is therapeutic
    5-9 No No Omit one or two doses, resume at lower dose.
    No Yes — high risk May give vitamin K1 1-2.5 mg orally if at increased risk for bleeding.
    No Yes—surgery 2-4 mg oral vitamin K1 for reduction of INR in 24 hours; if INR still high, can repeat with 1-2 mg orally.
    ≥9 No No Hold dose and give vitamin K1 5—10 mg orally to reduce INR in 24 to 48 hours; may use additional vitamin Kas necessary. Resume at lower dose when therapeutic.
    Any Yes—Serious Bleeding


    Yes Hold dose, give vitamin K1 10 mg by slow IV infusion, supplemented with fresh frozen plasma, prothrombin complex, or recombinant factor VIIa; vitamin K1 may be repeated every 12 hours.
    Any Yes—Life Threatening Yes Hold dose, give prothrombin complex supplemented with vitamin K1 10 mg by slow IV infusion; repeat if necessary depending on INR.

    *Note: Oral vitamin K1 is only available in the United States as a 5 mg tablet (Mephyton®). Therefore, oral doses prescribed should reflect even divisions of 5 mg (e.g., 2.5 mg).


    1. Hanslik T, Prinseau J. The use of vitamin K in patients on anticoagulant therapy. Am J Cardiovasc Drugs 2004; 4: 43-55.

    2. Ansell J, Hirsh J, Poller L, et al. The pharmacology and management of the vitamin K antagonist: the seventh ACCP conference on antithrombotic and thrombolytic therapy [published correction appears in Chest 2005; 127: 415-416].Chest 2004; 126 (3 suppl): 204S-233S.

    3. Wittkowsky AK. Thrombosis. In: Young LY, Koda-Kimble MA, eds. Applied Therapeutics: the Clinical Use of Drugs. 6th ed. Vancouver, WA: Applied Therapeutics, Inc; 1995: 12-16.

    4. Reigert-Johnson DL, Volcheck GW. The incidence of anaphylaxis following intravenous phytonadione (vitamin K1): a 5-year retrospective review. Ann Allergy Asthma Immunol 2002; 89: 400-406.

  • March 24, 2006 2:32 PM | Brad Miller (Administrator)

    In the April WMSHP Newsletter, Andy Howells, a Pharm.D. Candidate at Ferris State University, writes about inhaled insulin therapy for diabetic patients.


    Diabetes: No More Shots?

    Andy Howell, Pharm.D. Candidate, Ferris State Univeristy


    Diabetes is a severe but controllable disease that affects many people. It is estimated that 20.8 million people in the U.S. had diabetes in 2005, while only 14.6 million of those were diagnosed. That makes up about 7% of the population. Approximately 1.5 million new cases of diabetes were found in 2005 in people over the age 20, most of whom were between the age of 40 and 59 years. In 2002, diabetes was the sixth leading cause of death with a total of 224,092 people dying due to the disease. The total estimated cost of having diabetes in the U.S. was about $92 billion in medical costs and another $40 billion due to indirect costs such as disability, work loss, and premature mortality.

    Glycemic control, assessed by blood glucose levels and hemoglobin A1C (A1C), is important in the treatment of all types of diabetes. With the finding that intensive glycemic control with the use of insulin decreases the complications associated with diabetes, other routes of insulin administration have been studied instead of the subcutaneous injections currently available. Pfizer set out to create an oral insulin human [rDNA] inhalation powder called Exubera®. In association with Nektar Therapeutics, they developed an inhaler to deliver insulin into the lungs. This device uses blister packs of 1 or 3 mg; each mg is equivalent to 2.5 to 3 units of insulin. A study measuring the time-action profile of Exubera® was completed. It was found that the onset of action was similar to rapid-acting insulin analogs and had a duration similar to regular insulin. Exubera®appears to be usable as a short-acting pre-meal insulin to help control blood glucose levels in the treatment of diabetes.

    Selected studies show that rapid-acting, dry-powder inhaled insulin, Exubera®, is safe and effective as pre-meal treatment in select type 1 and type 2 diabetes. These results coincide with the results of previous preliminary studies with Exubera®. Other studies have been conducted assessing satisfaction with the use of inhaled insulin as opposed to injecting insulin. All studies showed that patients were more satisfied with the use of inhaled insulin as compared to subcutaneous insulin. The results of one study showed that patients with type 2 diabetes were more willing to start insulin therapy with Exubera® than subcutaneous insulin.

    Exubera® has been approved by the FDA for the treatment of both type 1 and type 2 diabetes. An FDA approved Medication Guide will be required to accompany the inhaler when it is dispensed. Exubera® cannot be used in current smokers or those who have smoked within the previous 6 months due to changes in absorption of the insulin. It is also not recommended in patients with lung problems such as asthma, bronchitis, or emphysema. Lung function tests will be required at the beginning of treatment and every 6 to 12 months throughout treatment.

    The most common side effects of Exubera® were similar to normal insulin with increased chances of hypoglycemia and weight gain. Patients in clinical studies also experienced a cough but it was usually mild and decreased in severity over time. The long term effects of inhaled insulin are currently unknown, although studies are being conducted to determine these effects.

    The inhaler device is manually pumped to produce a cloud of insulin into a chamber which is then inhaled through the mouthpiece. The inhaler, when closed, is about the size of an eyeglass case that measures 6.5 inches in length and is opened to be used at a length of about 11 inches. The cost has not yet been determined, however it will probably be much more expensive than current insulin products.

    Exubera® appears to be an innovative inhaled insulin device that will prove itself to be very useful in a select population. It will not be appropriate for all patients with diabetes but may serve to be very helpful in patients with an overwhelming fear of needles. Future technology may improve upon the idea of inhaled insulin and possibly remove any need for injections ever again.

  • March 24, 2006 2:31 PM | Brad Miller (Administrator)

    Following the tradition established over the past few years, our April meeting will again highlight two research projects done by Western Michigan Pharmacy Practice Residents. We had many excellent submissions this year, and voting within the Board was very close. The projects chosen for presentation are “Vancomycin and Metronidazole in the Treatment of CDAD: A Retrospective Analysis,” presented by Joshua Petersen, and “Investigating the Role of a Clinical Pharmacist in the Emergency Department of a Community Teaching Hospital,” presented by Erin Lingenfelter. Although only two projects can be presented at our meeting, I would like to commend all the area residents for the hard work they put into their research projects.

    Mark you calendars! Just another reminder that the WMSHP Spring Seminar is fast approaching. It will again be held at the Grand Rapids Airport Hilton, on May 25. This is a great event to earn valuable CE as well as network with colleagues. Topics this year include addiction medicine, emergency preparedness, physician order entry, and pharmacy law. Clinical topics include a pharmacotherapy update, interactions between drugs and herbals, and HIV adherence and resistance.

    Stay tuned to the website (www.wmshp.net) for more details on cost and registration information.

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