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Top 10 new drugs and medication errors Mark Malesker, pharm.d., FCCP, FASHP, BCPS Professor of Pharmacy Practice and Med

Objectives. Recognize newly approved pharmaceutical products and significant new dosage formsDiscuss the indications, contraindications, dosage, drug interaction potential, and side effect potential of each agentDistinguish the appropriate place in therapy for each agent reviewedEvaluate common medication errors in the acute care setting.

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Top 10 new drugs and medication errors Mark Malesker, pharm.d., FCCP, FASHP, BCPS Professor of Pharmacy Practice and Med

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    1. Top 10 new drugs and medication errors Mark Malesker, pharm.d., FCCP, FASHP, BCPS Professor of Pharmacy Practice and Medicine Creighton University 16th Annual Pharmacological Conference for Advanced Practice Nurses, Omaha, Nebraska, July 21, 2011

    2. Objectives Recognize newly approved pharmaceutical products and significant new dosage forms Discuss the indications, contraindications, dosage, drug interaction potential, and side effect potential of each agent Distinguish the appropriate place in therapy for each agent reviewed Evaluate common medication errors in the acute care setting 2

    3. Disclosures Consultant Otsuka Speaker Otsuka, ZymoGenetics Grant Support Otsuka 3

    4. Outline Newly approved FDA medications Focused review of select medications Medication safety Review of common medication errors 4

    5. Audience Question #1 What is the appropriate dose of IV acetaminophen in adults ? A. 650 mg IV every 3 hours B. 15 mg/kg IV every 6 hours C. 1000 mg IV every 4 hours D. 1000 mg IV every 6 hours 5

    6. Audience Question #2 Which medications are most likely to be associated with adverse event that requires treatment in a hospital ? A. Insulin B. Warfarin C. Hydrocodone/acetaminophen D. Penicillin 6

    7. Audience Question #3 Which of the following has a significant drug interaction with mometasone/formoterol (Dulera) ? A. Acetaminophen (Tylenol) B. Fluconazole (Diflucan) C. Theophylline (Theo-Dur) D. Amlodipine (Norvasc) 7

    8. 2010 Year in Review 8 Medication shortages

    9. New Drugs Approvals 9

    10. New Drug Approvals 10

    11. New Drug Approvals 11

    12. New Drug Approvals 12

    13. Selected New Dosage Forms 13

    14. Selected New Dosage Forms 14

    15. Acetaminophen Injection (Ofirmev) Indications Management of mild to moderate pain Management of moderate to severe pain with adjunctive opioid analgesics Reduction of fever Dose (Adults and adolescents > 50 kg) 1000 mg IV every 6 hours or 650 mg IV every 4 hours to a maximum of 4000 mg per day Minimal dosing interval of 4 hours May be given as single or repeated dose 15

    16. IV Acetaminophen Patient Selection 16 NPO Suspected ileus Avoid CNS depression Thrombocytopenia Renal dysfunction Opioid sparing effect Avoid NSAIDs

    17. Clinical Studies with IV Acetaminophen 17 Pain – placebo-controlled studies Ear, nose and throat surgery, spinal surgery, orthopedic surgery, GI surgery, gynecologic surgery, urologic surgery Pain – comparison with rectal acetaminophen Adenotonsillectomy Pain – comparison with other agents Cardiac surgery, hernia repair, orthopedic surgery, gynecologic and obstetric surgery, ear, nose and throat surgery, dental surgery Pain – impact on opioid consumption (mixed results) Fever

    18. Adverse Reactions = 3% 18

    19. IV Acetaminophen Drug Interactions 19 Agents that induce or regulate CYP2E1 Ethanol, ethotoin, fosphenytoin, phenytoin, barbiturates, primidone Chronic oral acetaminophen at 4 g/day has been shown to cause an increase in INR in some patients stabilized on warfarin

    20. IV Acetaminophen (Ofirmev) Instructions 20 Give 100 ml glass vial (10mg/ml) without dilution Clear, odorless solution Give dose over 15 minutes – onset ? 15 minutes Do not add other medications to the vial For doses < 1000 mg, the appropriate dose must be withdrawn from the vial and placed into a separate container prior to administration Once the vacuum seal of the vial has been penetrated, or the contents transferred to another container, administer the dose within 6 hours Diazepam and chlorpromazine are incompatible

    21. Ceftaroline Fosamil (Teflaro) IV fifth generation cephalosporin (MRSA) Activity similar to ceftriaxone, but better MRSA coverage Indications Acute bacterial skin and skin structure infections, including those caused by MRSA Treatment of community-acquired pneumonia Binds to penicillin-binding proteins, inhibiting cell wall synthesis High affinity in vitro for PBP2a As effective as vancomycin + aztreonam for skin infections and ceftriaxone for community acquired pneumonia 21

    22. Antibacterial Spectrum 22

    23. Clinical Trial Data 23 Skin infection Two phase 3 studies comparing ceftaroline with vancomycin plus aztreonam (CANVAS 1 and CANVAS 2) Community-acquired pneumonia Two phase 3 studies comparing ceftaroline with ceftriaxone (FOCUS 1 and FOCUS 2) Patients with MRSA excluded from these trials

    24. Ceftaroline Fosamil (Teflaro) 24 Dose (dilute in 250 ml NS or D5W) 600 mg IV every 12 hours (over 1 hour) 400 mg IV q 12 hours when CrCl = 50 ml/min 300 mg IV q 12 hours when CrCl = 30 ml/min 200 mg IV q 12 hours for end stage renal disease or hemodialysis Adverse effects (similar to comparator groups) Diarrhea (5%), nausea (4%), constipation (2%), vomiting (2%), increased transaminases (2%), hyperkalemia (2%), rash (3%), phlebitis (2%)

    25. Ceftaroline Fosamil (Teflaro) 25 No significant drug interactions Precautions 1/10 patients may seroconvert from negative to positive Coombs test If anemia develops, consider drug-induced hemolytic anemia Pregnancy category B No activity against Actinetobacter, Pseudomonas, Enterococcus species (E. faecium), B. fragilis, ESBL producing organisms Cost is $82 per day of therapy

    26. 1st Generation Cephalosporins 26

    27. 2nd Generation Cephalosporins 27

    28. 3rd Generation Cephalosporins 28

    29. 4th Generation Cephalosporins 29

    30. Doxepin (Silenor) Low dose formulation of the TCA doxepin (Sinequan) indicated for treatment of insomnia associated with sleep maintenance Available in 3 and 6 mg tablets ($6 each dose) High fat meal delays absorption Side effects: somnolence, next-day residual Generic doxepin (10 mg capsule) and oral concentrate would be pennies a dose 30

    31. Rx for Insomnia 31

    32. Dabigatran Etexilate (Pradaxa) Direct thrombin inhibitor indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation Dose CrCl > 30 ml/min: 150 mg PO twice daily CrCl 15-30 ml/min: 75 mg PO twice daily Do not chew, break, or open capusles Converting from or to warfarin Converting from or to parenteral anticoagulants 32

    33. Clinical Studies 33 RE-LY trial (18,113 patients) with AF and at least 1 other risk factor for stroke (avg CHADS2 score 2.1), dabigatran 150 mg twice daily was superior to warfarin at preventing the combination of stroke and systemic embolic events with a similar rate of bleeding (NEJM 2009;361:1139-1151) Dabigatran is cost-effective alternative compared to standard-of-care adjusted-dose warfarin in AF (Ann Int Med 2011;154:1-11)

    34. Surgery and Interventions 34 Discontinue dabigatran 1 to 2 days (CrCl=50 ml/min) or 3 to 5 days (CrCl < 50 ml/min) before invasive or surgical procedures Consider longer times for major surgery, spinal puncture, or placement of a spinal or epidural catheter or port If surgery cannot be delayed, risk of bleeding must be weighed against urgency of intervention Bleeding risk can be assessed by the ecarin clotting time (ECT) aPTT provides an approximation of anticoagulant activity if ECT not available

    35. Interpretation of Coagulation Assays 35

    36. Management of Dabigatran Bleeding 36

    37. Other Dabigatran Considerations 37 Storage Once opened use within 60 days Keep bottle tightly closed Store in original package to protect from moisture Drug interactions Rifampin Side effect Dyspepsia

    38. Liraglutide (Victoza) GLP-1 receptor agonist for type II diabetes Incretin mimetics stimulate the pancreas to increase insulin secretion in response to high blood glucose Injected daily vs. twice daily for exenatide (Byetta) Any time of day, independent of meal times Expect A1C drop of 1.1% when added to metformin and/or sulfonylurea Side effects: N, V, weight loss, pancreatitis (rare) Available as pre-filled, multi-dose pen 38

    39. Denosumab (Prolia) Monoclonal antibody for osteoporosis Slows bone loss by inhibiting RANK-ligand Protein in TNF family that’s involved in bone breakdown Side effects: hypocalcemia, jaw osteonecrosis, serious infections 60 mg injected (SC) by healthcare professional once every 6 months (cost is $1600/yr) 1000 mg calcium, at least 400 IU of vitamin D daily For patients who have not responded to or are intolerant of bisphosphonates 39

    40. Buprenorphine Patch (Butrans) Matrix patch containing active drug within the adhesive layer of the patch Buprenorphine is partial agonist/antagonist Available as 5, 10, 20 mcg/hr patches Applied once weekly for moderate to severe pain 20 mcg is max dose due to possible QT-prolongation Avoid with other agents that increase QT interval Initiate dosing based upon previous opioid burden Use NSAID, apap, hydrocodone or oxycodone for breakthrough pain 40

    41. Buprenorphine Patch (Butrans) Schedule III, adjust dose no sooner than 3 days Not strong enough if patient taking more than 80 mg/day of morphine If stopped, wait at least 24 hours before starting another opioid or start with a conservative dose Use only for chronic pain (osteoarthritis, back pain) May cause less respiratory depression, fewer withdrawal symptoms and have less potential for abuse than a pure opioid 41

    42. Risedronate (Atelvia) New delayed-release form of (Actonel) for postmenopausal osteoporosis Taken after breakfast as opposed to 30 to 60 minutes before breakfast Less interference with calcium, iron, etc Enteric coating keeps from dissolving in stomach Contains EDTA to bind any stray cations Tell patients to separate calcium, antacids, iron, magnesium from Altelvia & other bisphosphonates 42

    43. Risedronate (Atelvia) Patients should take plenty of water and remain upright for 30 minutes to reduce esophageal irritation Dose is 35 mg once weekly Cost is $135/month, similar to Actonel Alendronate is $4/month Utilized for those who have trouble taking an oral bisphosphonate on an empty stomach Avoid use of H2-blockers or PPIs 43

    44. Mometasone/Formoterol (Dulera) MDI for treatment of asthma in patients = 12 years Randomized, double-blind 26-week trial in 781 patients with persistent asthma (uncontrolled by inhaled steroid) compared mometasone/formoterol (200/10 mcg bid), individual ingredients or placebo Asthma deterioration occurred in 30% of patients taking combination compared to 34% on mometasone, 54% on formoterol, and 56% on placebo. Improvement in FEV1 was greater with the combination 44

    45. Mometasone/Formoterol (Dulera) 45 A 12-week study compared two strengths of the combination (100,200 mcg/5 mcg) with mometasone alone (400 mcg) twice daily in 728 patients uncontrolled on high doses of inhaled corticosteroid FEV1 improved more and fewer asthma deteriorations occurred with both combinations than with mometasone alone

    46. Mometasone/Formoterol (Dulera) 46 Same black box warning as other agents No head-to-head trials with other combination agents Adverse effects Similar to those of individual agents Drug interactions Formoterol ? hypokalemia MAOIs, TCAs potentiate cardiovascular effects CYP3A4 inhibitors (clarithromycin, fluconzole) can ? serum concentration of mometasone Dosage: delivered by hydrofluoroalkane propellant 100 or 200 mcg mometasone + formoterol 5 mg Two inhalations every 12 hours

    47. Inhaled Corticosteroid + Long Acting Beta-Agonists Products 47

    48. Lurasidone (Latuda) Tenth oral atypical antipsychotic Indicated for treatment of schizophrenia in adults Dose: 40 mg – 80 mg once daily Max 40 mg in renal, hepatic impairment, or with moderate CYP3A4 inhibitor (ketoconazole) Studied in four six-week, fixed-dose, placebo-controlled studies in more than 1200 patients Study data summarized in package label Side effects: akathesia, nausea, parkinsonism, agitation and somnolence 48

    49. Medication Safety 49 Propoxyphene [11-19-2010] The U.S. Food and Drug Administration (FDA) recommended against continued prescribing and use of propoxyphene because new data shows serious toxicity to the heart, even when used at therapeutic doses Prolonged PR interval, widened QRS complex and prolonged QT interval FDA has requested that companies voluntarily withdraw propoxyphene from the United States market Sold as a single-ingredient product (e.g., Darvon) and as part of a combination product with acetaminophen (e.g., Darvocet) Alternative treatments? Unapproved cough, cold, allergy products removed from market (MedWatch, March 2011)

    50. Medications That Are Involved with Adverse Events that Require Treatment in a Hospital 50

    51. Top 10 Medication Errors in Hospitalized Patients 51

    52. Audience Question #4 What is the mechanism of action for dabigatran? A. Vitamin K antagonist B. Factor Xa inhibitor C. Adenosine diphosphate (ADP) inhibitor D. Direct thrombin inhibitor 52

    53. Audience Question #5 Which of the following medications is most frequently cited with medication errors in hospitalized patients? A. Meperidine B. Vancomycin C. Insulin D. Cefazolin 53

    54. Audience Question #6 Which of the following medications is indicated for type II diabetes mellitus A. Lurasidone (Latuda) B. Liraglutide (Victoza) C. Ulipristal (Ella) D. Tocilizumab (Actemra) 54

    55. Questions ? 55

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