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  • 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.

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

    Heather Draper, Pharm.D.

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    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

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

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

    Oral
    • 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).

     


    References
    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.

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    Diabetes: No More Shots?

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

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    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.

  • February 01, 2006 2:32 PM | Brad Miller (Administrator)

    Mark your calendars! This year’s Michigan Pharmacist Association Annual Convention and Exposition (ACE) will be held at the Dearborn Hyatt Regency February 17-19. The ACE is a perfect opportunity to attend high quality continuing education programs as well as network with pharmacists from all over our state. Technicians, don’t forget that there is also targeted programming for you at the ACE. Students are encouraged to participate, too. I know from personal experience that the ACE is a perfect environment for students to begin building a network of peers that will be very beneficial when you start practicing. To register or obtain specific programming information please visit the MPA website at www.michiganpharmacists.org.

    The MPA House of Delegates is held annually during the ACE. Representatives of WMSHP this year include Jeff Van Houten, Shaun Phillips and Jesse Hogue. The delegates will be voting on issues and policies brought forward by MPA members. If you have any questions or would like an issue to be considered, please contact one of the representatives. Please keep in mind that the deadline for resolution submission is February 8.

    Don’t forget – the February WMSHP meeting will be Thursday, February 9 in Kalamazoo. Hope to see all of you there!

  • January 01, 2006 2:33 PM | Brad Miller (Administrator)

    Happy New Year! I hope everyone had a safe and merry Christmas Holiday.

    As you may be aware, we have several new faces on the WMSHP Board this year:

    Cherie Woodhams, who is the pharmacy educator at Bronson Methodist Hospital in Kalamazoo.

    Shaun Phillips, who is the clinical coordinator at Mercy General Health Partners in Muskegon.

    Kim Melgarejo, who is a clinical pharmacy specialist at Borgess Medical Center in Kalamazoo.

    Bill Kriel, who was elected to the pharmacy technician position on the board, from St. Mary’s in Grand Rapids.

    I look forward to working with all of them for the next two years. I would also like to welcome back Jodie Bakus for another two year term on the board, as well as Natalie Vazzana for a one year term.

    On behalf of the WMSHP board, I would like to extend a sincere thank you to Jean Lee for her hard work as President this past year, as well as to those leaving the board, including Jody Mehren who served as a board member, and Peggy deVoest who set the bar high as Past-President.

    I am very excited to serve as president for 2006 year, and hope to see all of you at our monthly meetings, starting this month at St. Mary’s.

  • November 02, 2005 2:34 PM | Brad Miller (Administrator)

    On October 17, WMSHP and FSU co-sponsored a residency showcase which was held at MERC in Grand Rapids. The format was slightly different this year, as it consisted of a panel of current residents, moderated by Dean VanLoo, discussing common questions when deciding on a residency program. Programs from all over the state were present, allowing our FSU students the opportunity to speak to these representatives about their specific programs.

    And don’t forget that it’s the time of year to give consideration to those pharmacists and technicians who would like to volunteer their time to serve on the WMSHP board. Please give your consideration to these candidates for the executive board positions. An election ballot is included in this month’s newsletter.

  • November 01, 2005 2:34 PM | Brad Miller (Administrator)

    The by-laws indicate the duration of terms for each executive board member. However, there is no term duration indicated for the Pharmacy Technician position. The executive board would like to add the following amendment to the by-laws:

    Article III – Nominations, Elections and Terms of Office
    Section 4. – Terms of Office
    Part F. – The Pharmacy Technician shall serve for two years.


    The vote for this amendment will take place at the January 2006 meeting in Grand Rapids. A simple majority vote of the active members present at this meeting shall carry the amendment to the by-laws.

  • October 02, 2005 2:35 PM | Brad Miller (Administrator)

    As you know, our President-elect position was vacated this summer. Jesse Hogue from Bronson Hospital has graciously accepted to fulfill the remaining time for this position. He will serve as President-elect for 2005, President in 2006 and Past-president in 2007. Jesse has served on WMSHP’s board for a number of years and has participated on MPA committees.

    Elections for four board positions, treasurer and President-elect will be conducted in November. Please consider the nominations carefully. We will announce the results at our November meeting.

    Again, as a reminder, the MSHP Annual meeting will be held in Lansing on November 4, 2005. Check out MPA’s website for more details.

  • October 01, 2005 2:35 PM | Brad Miller (Administrator)

    We are still looking for members who would like to serve on our board. The following positions are up for election this November:

    • Board Members (4 positions) - Each board member will organize the CE and meeting place for one general meeting per year. The term for this position is from January 2006 through December 2007.
    • President-Elect - This person will serve as President-Elect (Vice-President) in 2006, President in 2007, and Past-President in 2008. The President presides over monthly board meetings and serves as the regional delegate to the MSHP Executive Board (MSHP membership dues will be paid for by WMSHP). The Past-President organizes each year's Annual Spring Seminar.
    • Treasurer - This person is in charge of the finances for WMSHP. The term for this position is from January 2006 through December 2007.
    • Technician - This person may elect to organize a monthly CE meeting. The technician on our board often helps to arrange the Technician Track for the Annual Spring Seminar.

    Please contact any of our current board members if you or someone you know would be interested in running for any of these positions. Please make any nominations by Friday, October 21st.

  • August 29, 2005 2:36 PM | Brad Miller (Administrator)

    Another fun filled summer again has passed. I hope all of you had fun this summer enjoying the heat and sun. Welcome back to another term of CE programs that our Board members are currently organizing.

    For those of you who have not heard, our current President-Elect, Mitzi McGinnis is now working with University of Illinois in Chicago. I would like wish Mitzi and her husband all the best from WMSHP. In light of Mitzi’s departure, we will be looking for her replacement. This year we will be filling two president-elect positions. One to fulfill the remaining term and to serve as President in Jan 2006 and the other to serve as President-elect next year.

    We will again be conducting elections in the fall for the upcoming year. We will be looking for a number of board members. Please consider serving on our board. If you have any questions regarding these positions, please speak of any of our current board members.

    Also as a reminder, MSHP will be having their annual meeting on November 4, 2005 in Lansing. I will update you with details.

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