The Script Winter 2014, Issue 4 A Publication of the Department of Pharmacy, Norman Regional Health System Meet the Pharmacy Residents By Lisa Mayer, Pharm.D., BCPS NRHS offers a yearlong accredited PGY1 Pharmacy Residency that begins each year in July and ends in June of the following year. It allows pharmacists to accelerate their growth beyond entry-‐level competencies, to refine their clinical skills in a broad range of disease states and to provide evidence-‐based, patient centered medication therapy. Residents are also cross-‐trained in distribution activities and can be found staffing at the Healthplex on Monday through Thursday evenings. The Pharmacy Department is proud to announce our pharmacy residents for the 2013-‐ 2014 year: Justin Booth, Kim Whitley, and Minh Truong. Justin Booth is a 2013 graduate of Southwestern Oklahoma State University College of Pharmacy. He was born and raised in Guymon, OK. His pharmacy interests include critical care and infectious disease. He is considering pursuing a PGY2 pharmacy residency in critical care or infectious disease. Kim Whitley is a 2013 graduate of the University of Oklahoma College of Pharmacy. She was born in Ridgewood, NJ and raised in Vernon, NJ. Kim moved to Edmond, OK when she was 15 Left to right: Minh Truong, Kim Whitley, and Justin Booth years old, in the summer of 2002. Her current pharmacy interests include oncology and infectious disease, but she is excited to experience new areas of pharmacy. She would like to either pursue a PGY2 pharmacy residency in oncology or start a career as a decentralized clinical pharmacist. Kim also aspires to attain Board Certified Pharmacotherapy Specialist (BCPS) certification as well as to spend time both precepting and teaching students. Minh Truong is a 2013 graduate of the University of Oklahoma College of Pharmacy. He was born in Vietnam and immigrated to Oklahoma when he was 6 years old. His pharmacy interests include diabetes, anticoagulation, infectious disease and pharmacy operations. He plans to pursue a clinical pharmacy position in a health system setting upon completion of his PGY1 pharmacy residency. Each resident undertakes a project during their residency, which they present at local and national pharmacy meetings. Justin’s project will focus on reducing inappropriate utilization of parenteral nutrition. Kim’s project is focused on The National Institute for Occupational Safety and Health (NIOSH) and the safe handling of hazardous drugs. Her project aims to create safe and effective policies and procedures to handle, administer and dispose of dangerous medications and chemicals at NRHS. Minh’s residency project deals with managing pharmaceutical waste in order to be more in line with the Environmental Protection Agency (EPA) mandates. In This Issue: Meet the Pharmacy Residents. . . . . 1 Pharmacy and Therapeutics Committee Update. . . . . . . . . . . . . . 2 Eliquis® A Novel Oral Factor Xa Inhibitor for Atrial Fibrillation . . . . . 2 Why So Serious? The Serious Nature of Controlled Dangerous Substances .. . . . . . . . . . 3 Critical Medication Shortages . . . . . 3 Multidose Medication Dispensing at Discharge . . . . . . . . . 4 Entering Patient Allergies and Adverse Reactions in MEDITECH™ . . . . . . . . . . . . . . . . . 4 We welcome your thoughts, comments and/or suggestions. Do you have an idea for a story? Is there information we can provide you? All correspondence concerning The Script should be sent to: Lisa Mayer, Pharm.D., BCPS 901 N Porter Ave., Box 1308 Norman, OK 73070 Please welcome our new residents! Did your patient experience an adverse drug reaction during their admission? After notifying the prescribing practitioner and properly entering the ADR in MEDITECH™, call the ADR Hotline to report it. Call 307-3333 with the following information: patient’s name, reaction, medication, and action taken to relieve the ADR. Winter 2014, Issue 4 The Script Pharmacy and Therapeutics Committee Update Drug Apixaban (Eliquis®) Fondaparinux (Arixtra®) Prothrombin complex concentrate (Kcentra®) Indication Reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation Treatment of acute deep vein thrombosis (DVT) and pulmonary embolism (PE); prophylaxis of DVT in patients undergoing surgery for hip replacement, knee replacement, hip fracture or abdominal surgery. Vitamin K antagonist reversal in patients with acute major bleeding Usual Dose 5 mg oral twice daily unless patient has any 2 of the following: age ≥ 80 years, body weight ≤60 k g, or serum creatinine ≥ 1.5 mg/dL, then reduce dose to 2.5 mg twice daily DVT prophylaxis (for patients ≥ 50 k g): 2.5 mg SubQ once daily Dosage and Strength P&T Action 2.5 and 5 mg tablets Added to formulary 2.5, 5, 7.5, and 10 mg syringes Added to formulary with restrictions 500 units injection, powder for reconstitution Added to formulary Acute DVT/PE treatment: <50 kg: 5 mg SubQ once daily 50-‐100 k g: 7.5 mg SubQ once daily >100 kg: 10 mg SubQ once daily Pretreatment INR: 2 to < 4: 25 units/kg (maximum dose: 2500 units) Pretreatment INR: 4-‐6: 35 units/kg (maximum dose: 3500 units) Pretreatment INR: >6: 50 units/kg (maximum dose: 5000 units) Repeat dosing is n ot recommended Eliquis® A Novel Oral Factor Xa Inhibitor for Atrial Fibrillation By Lisa Mayer, Pharm.D., BCPS Apixaban (Eliquis®) was approved by the FDA in December 2012 for reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Apixaban exerts its effect by directly inhibiting factor Xa (FXa) in the coagulation cascade, which ultimately decreases thrombin generation and thrombus development. It is an oral alternative to warfarin that doesn’t require monitoring of INR or coagulation parameters. Apixaban is the second FDA-‐approved oral FXa inhibitor. The other oral agent in its class is rivaroxaban (Xarelto®), which was found to be non-‐inferior to warfarin for prevention of stroke in patients with atrial fibrillation, without a significant increase in rates of bleeding events. Fondaparinux (Arixtra®) is also a FXa inhibitor, given subcutaneously for deep vein thrombosis (DVT) prophylaxis as well as the treatment of DVT and pulmonary embolism. Another oral agent, dabigatran (Pradaxa®), is a direct thrombin inhibitor dosed twice daily and was found to be superior to warfarin in prevention of stroke with no difference in major bleeding. All of these anticoagulants are on the NRHS formulary. Two major studies have been published evaluating the use of apixaban in patients with atrial fibrillation, AVERROES and ARISTOTLE. AVERROES Apixaban was superior to aspirin (81 mg to 324 mg) in risk reduction of stroke and systemic embolism, occurring at a rate of 1.62% per year in patients receiving apixaban, compared to 3.63% per year in patients receiving aspirin (hazard ratio (HR) = 0.45; 95% confidence interval (CI), 0.32 to 0.62; p<0.0001). Major bleeding was shown to be similar between apixaban and aspirin, occurring in 1.4% per year in patients receiving apixaban, compared to 1.2% per year in patients receiving aspirin (HR = 1.13; 95% CI, 0.74 to 1.75; P=0.57). ARISTOTLE Apixaban was superior to warfarin for the primary endpoint of risk reduction of stroke or systemic embolism, occurring in 1.27% per year in patients receiving apixaban, compared to 1.60% per year in patients receiving warfarin (HR = 0.79; 95% CI, 0.66 to 0.95; p<0.001 for non-‐ inferiority, p=0.01 for superiority). Major bleeding was shown to be significantly less with apixaban compared to warfarin, occurring in 2.13% per year in patients receiving apixaban, compared to 3.09% per year in patients receiving warfarin (HR = 0.69; 95% CI, 0.60 to 0.80; P<0.001). Abixaban has a boxed warning for an increased risk of stroke following discontinuation in patients with nonvalvular atrial fibrillation. If anticoagulation must be discontinued, coverage with another anticoagulant should be strongly considered. It is contraindicated in patients with active pathological bleeding or a severe hypersensitivity reaction to apixaban. Use is not recommended in patients with severe hepatic impairment. Apixaban has not been studied in patients with creatinine clearance less than 15 mL/min or on dialysis, so its use is not recommended. The most common adverse reactions were bleeding complications, which were similar to aspirin, but significantly less than with warfarin. Strong dual inhibitors of CYP3A4 and P-‐glycoprotein (i.e. ketoconazole, itraconazole, ritonavir, clarithromycin) increase blood levels of apixaban, so it’s recommended to reduce the dose of apixaban to 2.5 mg twice daily or avoid concomitant use. Simultaneous use of strong inducers and C YP3A4 and P-‐ glycoprotein (i.e. rifampin, carbamazepine, phenytoin, St. John’s wort) reduce blood levels of apixaban, so it’s recommended to avoid concomitant use. Unlike warfarin, apixaban does not have any food interactions. The onset and time to peak of apixaban is 3-‐4 hours, so it does not require bridging with a parenteral anticoagulant like warfarin does. If converting from warfarin to apixaban, warfarin should be discontinued and apixaban started when INR is below 2. There are also specific recommendations when converting from apixaban to other anticoagulants and vice versa. Apixaban should be discontinued at least 48 hours prior to elective surgery or invasive procedures with a moderate or high risk of unacceptable or clinically significant bleeding. It should be discontinued at least 24 hours prior to elective surgery or invasive procedures with a low risk of bleeding or where the bleeding would be noncritical in location and easily controlled. See the Pharmacy and Therapeutics Committee Update for dosing. 2 Winter 2014, Issue 4 The Script Why So Serious? The Serious Nature of Controlled Dangerous Substances By Stefanie Stogsdill, Pharm.D., BCPS Welcome to our pharmacy newsletter series over controlled dangerous substances (CDS). In this article we will explore what makes a medication a CDS and why pharmacy is so picky about how prescriptions are written for them. In 1970 congress passed the Controlled Dangerous Substances Act. This is the federal drug policy under which the manufacture, importation, possession, use and distribution of certain substances is regulated. It created five schedules (classifications) of medications. The FDA and DEA are responsible for determining which substances are added or removed from the schedules. Classification decisions are made based on criteria including potential for abuse and currently accepted medical use in treatment in the US. This act creates a closed system of distribution for authorized personnel to handle CDS. The DEA requires authorized personnel to maintain complete and accurate inventories and records of transactions involving CDS, as well as maintaining security for the storage of them. Schedule Features Examples The most dangerous drugs of all the drug schedules with potentially severe psychological or physical dependence. High potential for abuse, have no currently accepted medical use in the US and have a lack of accepted safety for use. No prescriptions can be written for these. High potential for abuse and abuse of the substance may lead to severe psychological/physical dependence. Have a currently accepted medical use in the US (with severe restrictions). May be dispensed to patients provided there is an acceptable provider order for in-‐patient use or an acceptable prescription for outpatient use. Moderate to low potential for physical and psychological dependence. Schedule III drugs abuse potential is less than Schedule I and Schedule II drugs but more than Schedule IV. Have a currently accepted medical use in the US. They also have specific prescription criteria for outpatient use. Low potential for abuse and low risk of dependence. Have a currently accepted medical use in the US. They also have specific prescription criteria for outpatient use. Lower potential for abuse than Schedule IV and consist of preparations containing limited quantities of certain narcotics. Have specific prescription criteria for outpatient use. I II III IV V Ecstasy, heroin, LSD, methamphetamine and peyote marijuana, Dextroamphetamine with amphetamine, fentanyl, hydromorphone, methadone, methylphenidate, morphine, opium, oxycodone, oxymorphone, and pentobarbital Butalbital, codeine, dronabinol, hydrocodone with acetaminophen, and ketamine Benzodiazepines, pentazocine, phenobarbital, tramadol, zaleplon, and zolpidem Medications containing small amounts o f codeine, pregabalin, and pseudoephedrine With the schedule II-‐V CDS there are differing requirements for outpatient prescriptions. Schedule II CDS are not allowed to have refills, while schedules III-‐V may have refills but no more than 5 refills in a 6-‐month period. It should be noted that a recent change to Oklahoma law has been made regarding hydrocodone prescriptions (schedule III), which are no longer allowed to have refills as are schedule CII CDS. Schedule II prescriptions are only valid for 1 month after they are written and schedules III-‐V are valid for 6 months. Schedule III-‐V prescriptions may be transferred once, unless the filling pharmacy is using a real-‐time, online database. All prescriptions for CDS must contain the date of issue, full name and address of the patient, the name and quantity of substance prescribed, directions for use and the signature of the practitioner. Please note that using patient stickers is not consistent with prescription requirements. If a patient sticker is used, it could easily be taken off and any other name/address could be written on the prescription. According to O klahoma state law (OAC 4 75:30-‐1-‐4 Manner of Issuance of Prescriptions) “Each scheduled drug shall be written on a single prescription form, and no other prescriptions (controlled or non-‐controlled) shall be written on the same prescription form.” Stay tuned for more information about the serious nature of CDS in our next issue! Critical Medication Shortages By Sonal Yang, Pharm.D., BCPS and Donna Wilk, CPhT Medication Action Plan Papaverine IV Very limited supply that’s reserved for OR use. No imminent release date. Alternatives include ondansetron, metoclopramide, and scopolamine. Our current supply has been depleted due to a recent recall. Folic acid will not be added to rallypacks, but MVI (which contains some folic acid) has been added back to these. PO folic acid is available for use. Used in CABG and AV fistula surgeries. Pharmacy has obtained a small supply of papaverine. Potassium Phosphate Larger supply on hand than sodium phosphate, so use it instead when possible. Prochlorperazine IV Unavailable with no release date. Pharmacy has no reserve supply. Very limited supply on hand so minimizing use. Use either potassium phosphate IV or K-‐Phos® Neutral PO (8 mmol phosphorous and 1.1 mEq potassium per 250 mg (elemental phosphorus) tablet. Conserving use of TPNs when possible. Lipids are restricted to 25 g daily in TPNs unless a patient has a significant need for more. Adult multivitamins (MVI) added to TPNs at half the usual dose daily; MVI has been added back to rallypacks and bariatric post-‐op IV fluids. Pediatric MVI use is not restricted at this time. Adult TPN patients are receiving Addamel N® in 50 mL IVPBs each night, while neonates are receiving Peditrace® in the TPN. Droperidol IV Folic Acid IV Sodium Phosphate TPN components (lipid emulsion, multivitamins, trace elements) Multidose Medication Dispensing at Discharge By Sarah Payne, Pharm.D., BCPS and Lisa Mayer, Pharm.D., BCPS Multidose medications include inhalers, insulin pens, and topical medications, including nasal and ophthalmic preparations. They are commonly dispensed to patients during their stay at the hospital and continued after discharge. There are a few things to know about these special medications that make them unique. First, multidose medications require an order from the prescribing physician to be continued after discharge. To meet the requirement of outpatient prescriptions, when continuing multidose medications at discharge, the prescribing physician can indicate that the medication is to be continued at discharge on the medication reconciliation form in addition to writing a prescription. Second, outpatient prescriptions require counseling. Some of the medications that are being dispensed at discharge have not been used by the patient before admission into the hospital or could have been taken the wrong way by the patient as an outpatient. Whenever dispensing medications, or giving the patient a new prescription, the patient should be counseled, which should include verbal instructions, a prescription handout, or even a demonstration in some instances. Last, as you may have noticed, inhaler labeling has changed slightly by the addition of a new label to the bag in which the inhaler is stored. This label allows the inhaler the patient has used during their admission to be dispensed to them at discharge. In the future, all multidose medications will be dispensed using this same process. When the patient is to be discharged: ! Verify if there is an order written to continue the inhaler at home ! Give the patient the inhaler stored in the bag AND provide education ! Inhalers used at NRHS include: o Albuterol (Ventolin HFA®) o Albuterol/Ipratropium bromide (Combivent®) o Budesonide/Formoterol (Symbicort®) o Fluticasone (Flovent HFA®) o Fluticasone/Salmeterol (Advair®) o Formoterol fumarate (Foradil®) o Ipratropium bromide (Atrovent HFA®) o Mometasone/Formoterol (Dulera®) o Salmeterol xinafoate (Serevent®) o Tiotropium (Spiriva®) Entering Patient Allergies and Adverse Reactions in MEDITECH™ By Sarah Payne, Pharm.D., BCPS and Lisa Mayer, Pharm.D., BCPS Did you know that when a medication allergy or adverse reaction is classified as “uncoded”, the interaction checker in MEDITECH™ is unable to check for potential interactions? For this reason, it is important to ensure all allergies and adverse reactions are The Script entered appropriately so that they are properly “coded” in MEDITECH™. It is easy! Just follow these steps: The Quarterly Newsletter of the Department of Pharmacy Editor in Chief: Lisa Mayer, Pharm.D., BCPS Clinical Pharmacy Specialist Contributors: Justin Booth, Pharm.D. PGY1 Pharmacy Resident Sarah Payne, Pharm.D., BCPS PGY2 Pharmacy Resident Stefanie Stogsdill, Pharm.D., BCPS Staff Pharmacist Minh Truong, Pharm.D. PGY1 Pharmacy Resident Kim Whitley, Pharm.D. PGY1 Pharmacy Resident Donna Wilk, CPhT Clinical Pharmacy Technician (A Sonal Yang, Pharm.D., BCPS Staff Pharmacist 1) When entering a new allergy or adverse reaction, start typing the first couple letters of the drug or allergen. Please do not enter MORE than one medication or allergen into one entry. 2) Then select the F9 button or the drop down arrow box on the right AND select the appropriate coded allergy 3) Select the severity AND whether it is an allergy or adverse reaction 4) Describe the reaction 5) Then save That’s it! If you don’t save the drug or allergen as a “coded” allergy or adverse reaction, it will display as “uncoded” in red. CORRECT INCORRECT INCORRECT If you see “uncoded”, then use fewer letters to search for the allergy. In this example, penicillin was incorrectly entered as an “uncoded” allergy using its abbreviation “PCN”. To correct this, just type PEN or PENI then search through the coded allergies by selecting F9 or the arrow box on the right. If you are having problems inputting an allergy or adverse reaction please contact another healthcare professional or pharmacist for assistance. 4
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