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  • December 01, 2011 1:59 PM | Brad Miller (Administrator)

    Congratulations to our new and returning board members for 2012!

    President-Elect: Dana Staat

    Treasurer: Kim Melgarejo

    Technician: Ciji Marckini

    Board Members: Kasey Bucher, Kristina Rowley, Abby Sturm, & Kari Vavra

  • October 30, 2011 2:00 PM | Brad Miller (Administrator)

    Listed below are the nominees for next year's new WMSHP officers.  Each active WMSHP member will receive an official ballot in the mail within the next few days.  This ballot should be completed and either mailed back to us, or given directly to a current WMSHP board member.  All votes must be received before the November General Meeting on November 10, 2011.  Results will be announced at the meeting.

    Proposed Addition to the WMSHP By-Laws:

    It is proposed that the following definition be added to Chapter II, Article I, Section 1 of the WMSHP By-Laws:

    D. "STUDENT" MEMBER: A person enrolled at a college or university in a pharmacy or pharmacy technician curriculum who supports the objectives of the Society may apply for a Student membership. A Student member shall be eligible for the services of the Society, but is not eligible to vote or hold an elected office. Student members shall be exempt from payment of annual dues.

    President:

    Dana Staat, Pharm.D. is a Clinical Pharmacist in Internal Medicine at Spectrum Health in Grand Rapids, MI. Dana attended Ferris State University for her Pharm.D. degree and completed a PGY1 residency at Spectrum Health. Dana's interest areas include infectious disease, cystic fibrosis, and pugs.

    Treasurer:

    Kim Melgarejo (INCUMBENT) is currently a Pharmacy Manager at Borgess Medical Center and Borgess Pipp Hospital. She been a member of WMSHP since 2005 and treasurer since 2007.

    Technician:

    Ciji Marckini (INCUMBENT) has been a certified pharmacy technician for 6 years and is currently working at Spectrum Health as lead medication reconciliation technician. She have a biomedical science degree from Grand Valley State University. While going to school at GVSU she started working at Walgreens pharmacy and became certified. After becoming certified, she started teaching technician certification classes for the Grand Rapids Walgreens district. She started working at Spectrum health 4 years ago as an inpatient technician and then a medication reconciliation technician. In October of 2010 she became lead medication reconciliation technician.

    Patty Vander Hoff is currently Program Chair at Sanford Brown College Grand Rapids campus for the Medical Billing/Coding, Medical Billing and Administrative Specialist, and Health Information Technology with possible Pharmacy Technician certification program. She has been a Certified Pharmacy Technician since 2000, and has 23 years experience in retail pharmacy and 13 years in a hospital pharmacy. She was a Pharmacy Technician Educator at West Michigan Center for Arts & Technology (WMCAT 2/09 -11/09). She has been a member of the Pharmacy Technician Certification Board since 2000, and a previous member of Pharmacy Technician Educator Council (PTEC 2009-2010) and National Pharmacy Technician Association (NPTA 2009-2010).

    Board:

    Kristina Rowley (INCUMBENT) completed her Pharm.D. training at Ferris State University. She completed her PGY1 residency at Borgess Medical Center in Kalamazoo, MI. Then, she completed her PGY2 residency with a specialty in Ambulatory Care at William Beaumont Hospital in Royal Oak, MI. She currently practices at the Kalamazoo Center for Medical Studies Clinic as an Assistant Professor of Pharmacy Practice with Ferris State University.

    Kasey Bucher graduated from the Ferris State University College of Pharmacy in 2008 and then went on to complete a PGY-1 Pharmacy Residency and a PGY-2 Specialty Residency in Critical Care. Kasey recently joined the clinical pharmacy team at St. Mary's Health Care in Grand Rapids, Michigan as an Emergency Medicine Clinical Specialist.

    Louis Kynard MBA, Pharm D. has practiced in the profession of pharmacy since 1984. He has served in various roles throughout his career in pharmacy as Informatics Pharmacist, Purchasing Supervisor, Pharmacy Site Manager, Regional Director of Pharmaceutical Care and Respiratory Care and currently serves as the Director of Pharmacy Services at Bronson Methodist Hospital. Dr. Kynard's primary focus as a leader has been Patient Safety, and was involved in the implementation of Automation and Progressive Pharmacist Clinical models at several hospitals prior to joining the Pharmacy Team at Bronson.

    Michael Michutka is a clinical pharmacy specialist in Internal Medicine at Borgess Medical Center. He graduated with his Doctor of Pharmacy in 2009 from Ferris State University and completed an ASHP accredited PGY-1 at Borgess in 2010. Michael's professional interests include heart failure, acute coronary syndrome and public health.

    Abby Sturm graduated with a Pharm.D. from Butler University in 2004, and then completed 2 years of residency experience at Clarian/IU Health Partners in Indianapolis,Indiana with a focus in IM/Family Medicine. Following residency, she worked in as a clinical pharmacist and adjunct faculty for the University of Cincinnati. In 2008, she began working as a staff pharmacist at St. Mary's Hospital after she and her husband moved to Grand Rapids. Currently, she is a part-time clinical pharmacist at St. Mary's and full-time mother of 2 kids.

    Kari Vavra, Pharm.D. is an Assistant Professor of Pharmacy Practice at Ferris State University College of Pharmacy. Her General Medicine clinical practice site is at Spectrum Health-Butterworth Hospital in Grand Rapids, Michigan. She received her Doctor of Pharmacy degree in May 2009 from Ferris State University College of Pharmacy. After obtaining her Pharm.D., she completed a Pharmacy Practice Residency at Sparrow Health System in Lansing, Michigan. Kari is a current member of several professional organizations, including MPA and MSHP, and hopes to become more actively involved as a member of WMSHP!

    Cherie Woodhams is a graduate of Ferris State University and currently practices as a Pharmacy Educator at Bronson Methodist Hospital in Kalamazoo, MI. Cherie currently holds the position of WMSHP's Past President and is also a MSHP Board Member. She looks forward to continue to serve the members of WMSHP.

  • October 28, 2011 2:04 PM | Brad Miller (Administrator)

    In the October WMSHP Newsletter, Julie Pardy, a PGY-1 Pharmacy Resident at Spectrum Health, reviews the use of lacosamise for partial onset seizures.

    _____

    Lacosamide (Vimpat®) for Partial Onset Seizures

    Julie Pardy, PharmD, PGY-1 Pharmacy Resident

    Despite extensive research and multiple treatment options, the ideal anti-epileptic is yet to be found. Patients that suffer from epilepsy often find themselves taking multiple medications, experiencing adverse reactions, requiring serum drug monitoring, and still experiencing seizures.

    In October of 2008, Lacosamide (Vimpat®) was approved as an adjunctive treatment for partial onset seizures in patients 17 years of age and older. Lacosamide is available as an oral tablet (50 mg, 100 mg, 150 mg, and 200 mg), oral solution (10 mg/mL), and solution for injection (10 mg/mL). Lacosamide has a novel mechanism of action. Lacosamide selectively enhances slow inactivation of sodium channels, this causes decreased neuronal hyperactivity while preserving physiological activity. Additionally, lacosamide has shown evidence of activity at the collapsing response mediator protein 2 (CRMP-2). CRMP-2 has multiple actions including neuronal differentiation and regulation of gene expression. However, the clinical significance of CRMP-2 in seizure control is unknown. There is some evidence in animal models that CRMP-2 inhibition may prevent neuronal development and this is why in Helen DeVos Children’s Hospital (HDVCH) we are not recommending lacosamide for infants less than 1 year old.

    Many aspects of lacosamide’s pharmacokinetic profile are favorable. It has 100% oral bioavailability, it has rapid absorption that is not affected by food, and it has a long half life allowing for twice daily dosing. Its 100% bioavailability allows for equivalent daily doses when switching from IV to oral formulations. Additionally, it has low protein binding and has predominately renal elimination as unchanged drug (>40%). Lacosamide has minimal CYP 450 interactions.

    Lacosamide is generally well tolerated by patients. The most common adverse effects with the oral formulations include dizziness, headache, nausea and diplopia. All of these adverse effects were dose related except for headache, which was more predominant during dosage titration. Adverse effects associated with the IV formulation include those of the oral formulation as well as injection site pain. The most predominant adverse effect and most likely cause for discontinuation is dizziness. Of note, lacosamide may prolong the PR interval, so patients at risk for arrhythmias should have cardiac monitoring performed prior to therapy.

    Lacosamide is initially dosed in adults at 50 mg twice daily with dose titrations at weekly intervals by 100 mg/day. The maintenance dose is usually between 200 to 400 mg/day for most patients. In a human abuse study, lacosamide produced euphoria in 15% of patients when dosed at 800 mg leading to its schedule V status. The incidence of euphoria was minimal (<1%) in clinical trials at therapeutic doses.

    As stated previously, lacosamide is only indicated as adjunctive therapy of partial onset seizures in patients 17 years of age and older. However, ongoing research suggests that lacosamide may have a role in other types of seizures as well as treatment refractory status epilepticus. Currently there is a lack of data and dosing recommendations for pediatric patients, although there are two ongoing multicenter dose-ranging pharmacokinetic trials for this population. The dosing recommended and approved for use in HDVCH is provided in the table below and is based on the on-going studies.

    Lacosamide is being investigated as a treatment option for diabetic neuropathic pain, fibromyalgia, and migraine prophylaxis. With its novel mechanism of action and favorable pharmacokinetic and safety profile, there is no doubt that we will be seeing more of this drug in the future.

     

    Pediatric Lacosamide (Vimpat®) Dosing
    Loading Dosing (oral or IV): 2-4 mg/kg/dose (max dose of 200 mg)
    Maintenance Dosing (oral or IV): 4-6 mg/kg BID (max 400 mg/day)
    Note: Pharmacokinetic and efficacy studies are not available in children. Dosing is provided per clinicaltrials.gov on-going investigational studies.

     

    References

    1. Halford et al. Clinical Perspectives on Lacosamide. Epilepsy Currents. 2009; 9(1): 1-9.
    2. Kelemen and Halasz. Lacosamide for the Prevention of Partial Onset Seizures in Epileptic Adults. Neuropsychiatric Disease and Treatment. 2010; 6: 465-471.
    3. Vimpat [package insert]. Smyrna, GA: UCB, Inc; 2011.
    4. Chung. New Treatment Option for Partial-Onset Seizures: Efficacy and Safety of Lacosamide. Ther Adv Neurol Disord. 2010: 3(2): 77-83.
    5. Kellinghaus. Lacosamide as Treatment for Partial Epilepsy: Mechanisms of Action, Pharmacology, Effects and Safety. Therapeutics and Clinical Risk Management. 2009; 5: 757-766.
    6. Abou-Kalil. Lacosamide: What can be expeted from the next new antiepileptic drug? Epilepsy Currents. 2009; 9(5): 133-134.
    7. A Multicenter, Open-Label Study to Investigate the Safety and Pharmacokinetics of Lacosamide in Children with Partial Seizures. NCT00938431. Last updated on July 25, 2011.
    8. The Safety of Intravenous Lacosamide. NCT00832884. Last updated on Mar 5, 2010.
    9. An Open-label Extension Study to Determine Long-Term Safety, NCT00938912. Last updated 25, 2011.
  • October 28, 2011 2:01 PM | Brad Miller (Administrator)

    WMSHP elections are coming this month.  Please take time to review the candidate biographies and vote!  I am pleased that we have more candidates than positions, and want to thank everyone for showing interest.  I especially want to acknowledge Dana Staat for stepping forward to accept the position of president-elect. 

    The next meeting is scheduled for November 10th at the Wege Institute on the campus of St. Mary’s in Grand Rapids.  The topic this month is on Parkinson’s Disease.  Please RSVP as soon as possible and join us for an exciting presentation.

  • September 22, 2011 2:05 PM | Brad Miller (Administrator)

    We had a great meeting in September to kick off WMSHP’s return to monthly meetings after the summer break.  The attendance at the meeting was quite impressive.  Hopefully everyone enjoyed the great pain talk and good dinner!

    I want to share a few things with you regarding our monthly meetings.  As most of you are aware, WMSHP pays for the majority of our monthly meetings.  It is very difficult to find grants or industry sponsorship for these meetings.  The board meets after Spring Seminar and sets a budget for each meeting in the upcoming year.  The budget includes the cost of food, speaker honorarium, and the charge for ACPE continuing education credits.  The board has attempted to hold down the cost of food by not holding meetings at restaurants.  This year it was decided to hold one WMSHP funded meeting at a restaurant in Grand Rapids and another in Kalamazoo.  We are working diligently as a board to come up with ways to expand the space available at these meetings.  If you aren’t able to get a RSVP in before the deadline or if the meeting is full, please email the meeting planner.  This information is always found on the website or in the newsletter.  Typically we can add your name to a waiting list, or add you directly.  In addition, please be considerate of your fellow members and email if you are unable to attend the meeting.  This will allow us to invite those on the waiting list.  To assist in this, we will begin sending reminders to each person that has registered on the Monday prior to the meeting.  Please let us know if you can no longer attend the meeting!

    The next meeting is scheduled for October 13th at the Lawrence Education Center on the campus of Borgess Medical Center.  The topic being presented is "Trauma Induced Coagulopathy: A Review" by  Shanna Cole, Pharm.D..  Shanna is a Clinical Pharmacy Specialist practicing in the intensive care units at Borgess.  Food is being catered by Chinn Chinn Asian Bistro, so plan on attending the great food and exciting presentation!

  • August 23, 2011 2:06 PM | Brad Miller (Administrator)

    I hope that everyone has had an enjoyable summer vacation!  I know that it has taken me by surprise that the monthly WMSHP meetings begin on September 8th.  WMSHP has had a very successful year thus far, and the board members are working hard to continue this momentum.  We are again seeking nominations for board member positions and for President-Elect.  Please contact me or any of the current board members if you are interested in running! 

    The next meeting is being scheduled for September 8th at Pietro’s Italian Restaurant in Grand Rapids.  We are excited to have Cheryl Genord coming over to West Michigan to discuss "Opioid Analgesics - What is the optimal drug and dose?".  Cheryl is a Clinical Pharmacy Specialist in Pain Management at St. Joseph Mercy Health in Ann Arbor.  Please plan on joining us for this meeting and complete your pain CE requirement!

  • March 22, 2011 2:06 PM | Brad Miller (Administrator)

    We are headed into the final WMSHP events before the summer break.  Coming up on Friday, April 8th we will be having our annual resident presentations in conjunction with the Grand Rapids Griffins at Van Andel Arena.  The presentations will begin at 5:30, with the hockey game to follow at 7:00.  The two local residents selected by the board members are Dr. Todd Super and Dr. Jennifer Lunger.  Todd will be presenting "Impact of Pharmacist Facilitated Discharge Medication Reconciliation" and Jennifer will be presenting "Comparison of Cumulative Drug Doses Administered for Sedation and Analgesia During Day and Night Shifts in Mechanically Ventilated Patients in a Medical Intensive Care Unit".  Please see the website for more information on this exciting event.

    The 42nd Annual Spring Seminar is being held on May 17th at the Prince Conference Center on the campus of Calvin College.  There are several interesting topics planned that should appeal to a variety of pharmacists and technicians.  Please plan on joining us again this year.  Watch your mailbox and email for more information! 

  • March 16, 2011 2:07 PM | Brad Miller (Administrator)

    In the April WMSHP Newsletter, Juan Miretti, a PGY-1 Pharmacy Resident at Spectrum Health reviews PRE-PEN's use for penicillin allergy testing.


    PRE-PEN: A skin test for the diagnosis of penicillin allergy

    By Juan Miretti, PharmD, PGY1 Resident

    BACKGROUND

    Approximately 10% of patients report a penicillin allergy. When these individuals become ill with a serious bacterial infection, healthcare providers will often avoid using inexpensive first-line therapies over fear of a potential reaction. These patients must not only avoid penicillin antibiotics, but also the numerous other beta-lactam antibiotics available (i.e. cephalosporins, carbapenems). This forces healthcare providers to resort to other antibiotics that may limit effective antimicrobial stewardship and leads to about 30% higher costs for antibiotic treatment.

    The most common hypersensitivity reaction to penicillin is an IgE-mediated reaction. IgE-mediated reactions, also known as type I hypersensitivity reactions, are life-threatening reactions characterized by systemic manifestations of anaphylaxis, which may include but not limited to erythema, urticaria, pruritis, angioedema, bronchospasm, and hypotension. Individuals having experienced such a reaction are diagnosed as having a penicillin allergy.

    Patients may report an allergy to penicillin, but often the reaction experienced (i.e. nausea/vomiting) was an adverse drug reaction. There also exists the possibility that the reaction experienced (i.e. rash) was caused by the underlying infection and not by the penicillin. Of patients with a reported penicillin allergy, 80 to 90% do not have an IgE-mediated penicillin allergy when assessed by penicillin skin testing. Moreover, about 80% of patients that have had an IgE-mediated reaction to penicillin have negative skin tests after 10 years of avoidance. This indicates that many patients outgrow their allergy over time. It is also estimated that approximately 50% of penicillin allergic patients have outgrown their allergy after 5 years.

    PRE-PEN is the only FDA approved commercially available skin test for the diagnosis of penicillin allergy. With the recent return of PRE-PEN to the market, healthcare providers are now able to accurately determine the risk of IgE-mediated reactions to penicillin antibiotics and related beta-lactam antibiotics in patients with a reported penicillin allergy. PRE-PEN was widely used for over 30 years but in 2004 it was withdrawn from the market due to the lack of a dedicated manufacturing facility. This significantly limited a healthcare provider’s ability to evaluate for penicillin hypersensitivity. Healthcare providers turned to penicillin desensitization, which was the only way to assure safe retreatment of patients with a documented penicillin allergy. Now with the availability of PRE-PEN, many patients who have been incorrectly labeled as allergic to penicillin will be able to receive inexpensive first-line antibiotic therapies. Appropriate use of PRE-PEN can reduce hospital costs and improve antimicrobial stewardship.

    USAGE

    Candidates for PRE-PEN include any patient with a history of a reaction to a penicillin antibiotic that may have been IgE-mediated, or any patient who is currently denied access to beta-lactam antibiotics out of concern of such reactions. PRE-PEN is contraindicated in patients with clear histories of severe skin reactions (i.e. Stevens-Johnson syndrome, toxic epidermal necrolysis), patients known to be extremely hypersensitive to penicillin, and patients who have developed a systemic or marked local reaction to its previous administration.

    ADVERSE REACTIONS

    Occasionally, patients may develop an intense local inflammatory response at the skin test site. Rarely, patients will develop a systemic allergic reaction characterized by manifestations of anaphylaxis. Skin testing should be performed under direct medical supervision and treatment for an anaphylactic reaction should be available.

    THE SKIN TEST

    A proper skin test involves 4 prick/puncture skin tests, and if these tests are negative, then 5 intradermal skin tests. The 4 prick/puncture tests include tests with PRE-PEN (major determinant), Penicillin G (minor determinant), histamine (positive control), and a diluent (negative control). The 5 intradermal tests include tests with PRE-PEN in duplicate, Penicillin G in duplicate, and a diluent (negative control).

    Prick/puncture testing is performed first to decrease the risk of precipitating a systemic allergic reaction with intradermal testing. Most patients who have an IgE-mediated penicillin allergy will exhibit a negative prick/puncture skin test.

    The reasoning for performing the intradermal skin test in duplicate is to prevent healthcare providers from making the wrong diagnosis due to ambiguous results. A false positive or false negative may be observed since the changes at the test site are relatively small.

    To understand the rationale of using both major and minor determinants for the skin test, it is important to understand the immunochemistry of penicillin. When put into physiologic solution, penicillin spontaneously degrades into a number of intermediates, so called determinants. Penicillin mostly breaks down to penicilloyl, the major determinant, as well as other minor determinants that subsequently bind to host proteins. An allergic reaction occurs if the individual is sensitive to one or more of these determinants.

    PRE-PEN is benzylpenicilloyl poly-L-lysine and is the major determinant. Skin testing with PRE-PEN should be done in conjunction with Penicillin G, which is the only commercially available minor determinant. Studies have shown that skin testing with PRE-PEN along with Penicillin G identifies up to 97% of patients who have an IgE-mediated penicillin allergy.

    APPLICATION TO YOUR INSTITUTION

    An important and underappreciated aspect of penicillin allergy is the unnecessary withholding of appropriate antibiotic therapy. This can lead to less effective antimicrobial stewardship and increased medical costs in patients who are labeled as penicillin allergic. Implementing skin testing with PRE-PEN at your institution can facilitate appropriate antibiotic therapy in patients with a reported penicillin allergy. Moreover, it will demonstrate the absence of penicillin allergy in many patients, will provide cost-effective antibiotic treatment options for healthcare providers and patients, and may help avoid the development of resistance to more powerful antibiotics.

    REFERENCES

    1. Park MA, Li JTC. Diagnosis and Management of Penicillin Allergy. Mayo Clin Proc. 2005; 80(3): 405-410. 
    2. PRE-PEN® [package insert]. Round Rock, Tex: ALK-Abelló, Inc. 2009.
    3. “PRE-PEN®, Penicillin Allergy Skin Test Antigen.” Fight the Cause Newsletter. Winter 2010. 1-5. Print. 
    4. PRE-PEN®, Penicillin Allergy Skin Testing Reference. Round Rock, Tex: ALK-Abelló, Inc. 2010. 
    5. PRE-PEN®. Round Rock, Tex: ALK-Abelló, Inc. 2010. DVD.
  • February 22, 2011 2:07 PM | Brad Miller (Administrator)

    In the March WMSHP Newsletter, Sara D. Schepcoff, a PGY-1 Pharmacy Resident at Spectrum Health, reviews the new oral anticoagulant dabigatran.


    Dabigatran overview

    For approximately half a century, warfarin has been the gold standard anticoagulant for patients living with atrial fibrillation (AF).  The new oral anticoagulant, dabigatran (Pradaxa – Boehringer Ingelheim), may be a simpler option for these patients.  On October 19th, dabigatran became the first FDA-approved oral direct thrombin inhibitor in the United States.  Its sole indication is to reduce the risk of stroke and systemic embolism in patients with nonvalvular AF.  Contrary to warfarin, dabigatran requires no monitoring of international normalized ratios (INRs), has minimal drug interactions, and comes with no known dietary restrictions. 

    Dabigatran etexilate is a prodrug which is rapidly absorbed and then converted in vivo to the active form, dabigatran, through esterase-catalyzed hydrolysis in the plasma and liver. It inhibits thrombin, thereby preventing the conversion of fibrinogen to fibrin in the coagulation cascade.  Free thrombin, clot-bound thrombin and thrombin-induced platelet aggregation are inhibited by dabigatran.

    Key studies

    The efficacy and safety of dabigatran have been evaluated in numerous clinical studies.  The pivotal trial for US approval was RE-LY (Randomized Evaluation of Long-Term Anticoagulation Therapy), in which dabigatran 110 mg or 150 mg twice daily was compared to dose-adjusted warfarin in more than 18,000 patients with AF. After a median duration of 2 years, dabigatran 150 mg twice daily was associated with lower rates of stroke and systemic embolism versus warfarin.  The two drugs had similar rates of major bleeding (3.11% per year with dabigatran 150mg and 3.36% per year with warfarin).

    In a more recent analysis of RE-LY, it was noted that for all vascular events, non-hemorrhagic events, and mortality, the advantages seen with dabigatran therapy were greater at sites with poor INR control than at those with good INR control. Therefore, many experts believe that dabigatran may be a good option for patients who have difficulty maintaining their INR within range, who are troubled by dietary or drug interactions, or who experience adherence issues. However, for patients who are currently stable on warfarin therapy, there may be no benefit to switching.

     

    Dosing and therapeutic considerations

    Dabigatran (Pradaxa)

    Drug class:  Direct thrombin inhibitor

    Indication:  Reduce the risk of stroke and systemic embolism in patients with nonvalvular      atrial fibrillation (AF)

    Dosage: 

    • 150 mg twice daily, by mouth, with or without food, for patients with a creatinine clearance (CrCl) above 30 mL/min.
      • For patients with renal impairment (CrCl between 15 and 30 mL/min), the recommended dose should be reduced to 75 mg twice daily as dabigatran is primarily renally excreted (80%). 
      • No dose recommendations are available for patients with CrCl less than 15 mL/min or for patients on dialysis. 
      • Patients can be converted from warfarin to dabigatran by starting dabigatran once their INR is less than 2.0.
      • Dabigatran should be discontinued 1 to 2 days (CrCl ≥ 50 mL/min) or 3 to 5 days (CrCl < 50 mL/min) before an invasive or surgical procedure.  

    Other considerations:

    Dabigatran is contraindicated for patients with active bleeding or those with a history of serious hypersensitivity to the drug.  As with all anticoagulants, dabigatran increases the risk of bleeding, especially when used in combination with other medications that increase this risk, such as antiplatelet agents, heparin, and NSAIDs.  While dabigatran is not a substrate, inhibitor, or inducer of cytochrome P450 enzymes, it is a P-glycoprotein (P-gp) substrate and should not be used with P-gp inducers such as rifampin, as exposure to the drug will be reduced.  No dosage adjustments are required if administered with P-gp inhibitors, such as ketoconazole, verapamil, amiodarone, quinidine, or clarithromycin.

     

    Advantages and limitations

    For patients treated with dabigatran, ecarin clotting time (ECT) is considered the best assessment of bleeding risk, but is not readily available.  The aPTT test provides an approximation of dabigatran’s anticoagulant activity, but is nonlinear at higher doses.  There is no readily available reversal agent for patients who develop bleeding complications with dabigatran.  Bleeding may be managed with diuresis and dialysis to remove the drug as well as replacement with fresh frozen plasma.                

    The high rate of dyspepsia (11.5% of patients treated with dabigatran in the RE-LY trial versus 5.8% treated with warfarin) may also be a concern for clinicians and patients.  At the beginning of the study, nearly 14 % of the patients in each treatment group were taking a PPI and roughly 4% were taking an H2-receptor antagonist.  Researchers reported a 20% dropout rate by the year-2 follow-up visit. 

    Dabigatran became available in US pharmacies at a wholesale acquisition cost of $6.75 per day.  An early-release article in the Annals of Internal Medicine found that dabigatran is cost effective compared with warfarin therapy because of the associated costs of warfarin monitoring and complications. However, for patients taking dabigatran as outpatient therapy, it may come at a high co-pay cost. For these patients, and for those requiring infrequent INR monitoring, cost savings may not occur.

    Summary

    Dabigatran (Pradaxa) is a promising new oral anticoagulant indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.  It may be a good alternative for patients who have difficulty maintaining a therapeutic INR on warfarin therapy as it requires no lab monitoring, has minimal drug interactions, and no dietary limitations. 

    References

    1. Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, et al, and the RE-LY Steering Committee and Investigators.  Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009;361:1139-51.
    2. Tanzi MG. Dabigatran: Anticoag simplifies therapy. Pharmacy Today 2010:34-35.
    3. Thompson CA. First oral thrombin inhibitor enters market. Am J Health-Syst Pharm 2010;67:1974-76.
    4. Pradaxa (dabigatran etaxilate mesylate) capsules for oral use (package insert).Ridgefield, CT; Boehringer Ingelheim Pharmaceuticals, Inc.;October 2010.
    5. Freeman JV, Zhu RP, Owens DK, Garber AM, et al.  Cost-effectiveness of dabigatran compared with warfarin for stroke prevention in atrial fibrillation. Ann Intern Med 2011;154(1):1-11. Epub 2010 Nov 1.
    6. Wallentin L, Yusuf S, Ezekowitz MD, Alings M, et al; RE-LY Investigators. Efficacy and safety of dabigatran compared with warfarin at different levels of international normalised ratio control for stroke prevention in atrial fibrillation: an analysis of the RE-LY trial. Lancet 2010;376:975-83.
  • February 15, 2011 2:08 PM | Brad Miller (Administrator)

    The snow is finally starting to melt, and spring is hopefully right around the corner.  We have a great meeting planned for March 24th at Mangia Mangia in Kalamazoo.  The presenter is Dr. John Devlin from Northeastern University and Tufts-New England Medical Center in Boston.  He will be presenting on sedation in the intensive care unit.  Please make note that this meeting is later in the month than typical meetings.  This change was made to accommodate the presenter’s schedule.

    The following meeting will be held on April 8th.  This is the second year that we are holding a special Friday meeting in conjunction with a Grand Rapids Griffins game.  Two local residents had their presentations selected by our board members.  Dr. Todd Super will be presenting "Impact of Pharmacist Facilitated Discharge Medication Reconciliation” and Dr. Jennifer Lunger will be presenting "Comparison of Cumulative Drug Doses Administered for Sedation and Analgesia During Day and Night Shifts in Mechanically Ventilated Patients in a Medical Intensive Care Unit".

    WMSHP is still accepting applications for the annual scholarship awarded at Spring Seminar.  The application deadline is March 31, 2011.  

    The WMSHP board has a vacancy for the pharmacy technician representative.  We are currently seeking nominations for any interested technician members.  Please send an email to adamdrzewicki@borgess.com by March 1st if you are interested in being considered for this board position.

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