the script - issue 5a · the script summer 2014, issue 5 the serious nature of controlled dangerous...
TRANSCRIPT
The Script A Publication of the Department of Pharmacy, Norman Regional Health System
The Script Summer 201 4, Issue 5
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 [email protected]
Kcentra® -‐ A Human Prothrombin Complex Concentrate for Urgent Reversal of Warfarin . . . . . . 1
Pharmacy and Therapeutics Committee Update. . . . . . . . . . . . . . 2
Prevention of Carbapenem-‐Resistant Enterobacteriaceae (CRE) . . . . . . . . . 2
The Serious Nature of Controlled Dangerous Substances: Wasting Edition . . . . . . 3
RX2GO App Available for Employee Prescription Refills . . . . . .3
Critical Medication Shortages . . . . . 3
Importance of Accurate Patient Height and Weight . . . . . . . 4
The Big Bang: Why Go-‐Live with CPOE . . . . . . . . . . 4
In This Issue: Kcentra® - A Human Prothrombin Complex Concentrate
for Urgent Reversal of Warfarin By Lisa Mayer, Pharm.D., BCPS and Minh Troung, Pharm.D.
Kcentra® was approved by the FDA in April 2013 for urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA) therapy (e.g., warfarin) in adult patients with acute major bleeding or a need for an urgent surgery/invasive procedure. Kcentra® is a four-‐factor prothrombin complex concentrate (PCC) rapidly increases plasma levels of the vitamin K-‐dependent coagulation Factors II, VII, IX, and X as well as Proteins C and S.
Kcentra® has a boxed warning stating that arterial and venous thromboembolic complications may occur with use. Potential benefits of reversing VKA should be weighed against the potential risks of thromboembolic events, especially in patients with the history of a thromboembolic event. Resumption of anticoagulation should be carefully considered as soon as the risk of thromboembolic events outweighs the risk of acute bleeding.
Fatal and non-‐fatal arterial and venous thromboembolic complications have been reported with Kcentra® in clinical trials and post marketing surveillance so monitoring patients receiving Kcentra® for signs and symptoms of thromboembolic events is needed. Kcentra® is made from human blood and may carry a risk of transmitting infectious agents, including viruses and possibly the Creutzfeldt-‐Jakob disease agent. The most common adverse reactions observed in subjects receiving Kcentra® were headache (1-‐8%), hypotension (5-‐7%), nausea and vomiting (4-‐6%), and anemia (3-‐6%). The most serious adverse reactions were thromboembolic events including stroke (1-‐2%), pulmonary embolism (≤ 2%), and deep vein thrombosis (1%). Kcentra® contains heparin to blunt the bioaccumulation of factors with long half-‐lives (II and X) in order to reduce the risk of thrombosis, so it is contraindicated in patients with a known history of heparin-‐induced thrombocytopenia. It is also contraindicated in patients with disseminated intravascular coagulation (DIC).
Kcentra® was not studied in subjects who had a thromboembolic event, myocardial infarction, DIC, cerebral vascular accident, transient ischemic attack, unstable angina pectoris, or severe peripheral vascular disease within the prior 3 months. It may not be suitable for use in patients with thromboembolic events in the prior 3 months.
There are currently no studies involving the use of Kcentra® to reverse the newer oral anticoagulants apixaban, dabigatran, or rivaroxaban. Eerenberg 2011, showed that Cofact, a four-‐factor PCC available in Europe, was equivalent to placebo when administered to patients receiving dabigatran 150 mg by mouth twice daily. They also showed in patients taking rivaroxaban 20 mg oral twice daily, that Cofact reduced the prothrombin time to near base line values within 15 minutes. There are currently no studies of PCC to reverse the anticoagulant effects of apixaban, but given the similar structure-‐activity relationship and mechanism of action of PCCs compared with those of rivaroxaban, PCCs may produce comparable effects as seen in patients who are receiving apixaban.
Pre-‐Treatment INR 2 – 3.9 4 -‐ 6 > 6
Dose of Kcentra (units of Factor IX) / kg 25 35 50
Maximum dose (units of Factor IX) 2,500 3,500 5,000
Kcentra® dosing should be individualized based on the patient’s INR and weight. Vitamin K should be given together with Kcentra® in order to maintain vitamin K-‐dependent coagulation factor levels once Kcentra® effects have diminished. Repeat dosing with Kcentra® is not supported by clinical data and is not recommended. Administer reconstituted Kcentra® only via the intravenous route at a rate of 0.12 mL/kg/min (~3 units/kg/min) up to a maximum rate of 8.4 mL/min (~210 units/min). Use the above table, which can be found in NRHS policy #40700-‐147, to dose Kcentra®.
The Script Summer 2014, Issue 5
Pharmacy and Therapeutics Committee Update Drug Indication Usual Dose Dosage and Strength P&T Action
Acetaminophen/ Caffeine/Aspirin (Excedrin®)
Pain management Mild-‐to-‐moderate pain: 325 to 650 mg every 4-‐6 hr PRN (do not exceed 4 g/day)
Mild-‐to-‐moderate pain associated with migraine: 500 mg every 6 hr PRN
Acetaminophen 250 mg, aspirin 250 mg, and caffeine 65 mg oral tablets
Added to formulary
Anidulafungin (Eraxis®)
Candidemia, Intra-‐abdominal or peritoneal candidiasis
Esophageal candidiasis
200 mg IV on day 1 followed by 100 mg IV daily (to continue until 14 days after last positive culture)
100 mg IV on day 1 followed by 50 mg IV daily (treat for a minimum of 14 days and for at least 7 days after symptom resolution)
50 and 100 mg IV solution for reconstitution
Added to formulary
Cyclosporine (Restasis®)
Keratoconjunctivitis sicca Instill 1 drop in each eye every 12 hours 0.05% ophthalmic emulsion
Added to formulary
Docosanol (Abreva®)
Herpes simplex (face/lips) Apply 5 times/day topically to affected area of face or lips
10% topical cream Added to formulary
Mesalamine (Lialda®)
Treatment of ulcerative colitis
Maintenance of remission of ulcerative colitis
2.4 to 4.8 g PO once daily for up to 8 weeks
2.4 g PO once daily
1.2 g delayed release oral tablet
Added to formulary
Mirabegron (Myrbetriq®)
Overactive bladder 25 to 50 mg PO once daily 25 and 50 mg extended release oral tablet
Added to formulary
Natalizumab (Tysabri®)
Multiple sclerosis and Crohn disease
300 mg IV every 4 weeks (infused over 1 hr) 300 mg/15 mL IV concentrate
Added to outpatient infusion center formulary
In a recent report on antibiotic resistance, the CDC classified carbapenem-‐resistant Enterobacteriaceae (CRE) as an urgent threat level in the United States. Here at NRHS, there have been 6 documented cases of CRE within the past year and the two available carbapenems are ertapenem (Invanz® – does not cover Pseudomonas) and meropenem (Merrem®). The CDC recommends four primary activities to reduce the incidence and impact of antibiotic resistant bacteria: “preventing infections and preventing the spread of resistance, tracking resistant bacteria, improving the use of today’s antibiotics and promoting the development of new antibiotics and developing new diagnostic tests for resistant bacteria. It is estimated that there are 9,000 infections due to CRE per year in the United States and that 600 deaths can be attributed to these infections—numbers that are trending upwards. There are only a few antibiotic therapy options for treatment of CRE infections, none of which have guaranteed coverage. The risk of increased incidence of CRE and the dearth of treatment choices for those infections certainly provides sufficient reason to limit carbapenem usage to approved criteria.
At NRHS, usage criteria have been approved through the Pharmacy & Therapeutics Committee to limit the use of carbapenems to prevent increased incidence of CRE infections. These criteria are included in the table below and are also available through policy manager under “Medication Restriction Policy Addendum”, but mostly consist of infections with documented resistance or in patients who are truly at risk of having an antibiotic resistant infection with bacteria such as Pseudomonas aeruginosa (meropenem) or mixed gram-‐positive/gram-‐negative/anaerobic infections (ertapenem). Additionally, because of their broad-‐spectrum coverage, ertapenem and meropenem do not require concomitant antibiotic therapy except in the case of anti-‐pseudomonal or MRSA coverage for ertapenem and double anti-‐pseudomonal or MRSA coverage for meropenem. Adherence to these usage criteria and close monitoring of culture and susceptibility reports to de-‐escalate antibiotic therapy will help to reduce the frequency of carbapenem use and the incidence of CRE.
Prevention of Carbapenem-Resistant Enterobacteriaceae (CRE) By Justin Booth, Pharm.D.
Ertapenem (Invanz®)
Utilization of ertapenem is to be restricted based on the following criteria: (1) Treatment of infection due to a documented resistant microorganism. (2) Empiric therapy of infection in a patient who is at high risk for polymicrobial infection with both gram-‐positive and gram-‐negative aerobic and anaerobic pathogens in the setting of: (a) complicated intra-‐abdominal infection. (b) complicated skin and skin structure infection, including diabetic foot ulcer without osteomyelitis (c) acute pelvic infection. (3) When used, concurrent antimicrobial therapy with ertapenem will be confined to providing activity against MRSA and/or anti-‐pseudomonal coverage.
Meropenem (Merrem®)
Utilization of meropenem is to be restricted based on the following criteria: (1) Treatment of infection due to a documented resistant microorganism. (2) Empiric treatment of infection in a patient who is at increase risk for infection due to Pseudomonas aeruginosa and has received broad-‐spectrum antibiotic therapy for more than 7 days in the past month in a setting of: Complicated intra-‐abdominal infections, bacterial meningitis, complicated skin and skin structure infections, Nosocomial pneumonia, febrile neutropenia, acute pelvic infection, liver abscess, septicemia, and prosthetic joint infections with potential for Pseudomonas aeruginosa involvement. (3) When used, concurrent antimicrobial therapy with meropenem will be confined to providing activity against MRSA and/or additional anti-‐pseudomonal coverage.
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The Script Summer 2014, Issue 5
The Serious Nature of Controlled Dangerous Substances: Wasting Edition By Stefanie Stogsdill, Pharm.D., BCPS
Welcome back to our pharmacy newsletter series over controlled dangerous substances (CDSs). Last time we defined what CDSs were and the specific requirements of their prescriptions. In this article we will discuss the importance of appropriate documentation when wasting medications that are considered CDSs in automated dispensing cabinets (ADCs).
Controlled substances, like many of the medications utilized in the health system, can be placed in ADCs. For safety these medications are kept in secure areas of the ADCs and access to the medications are restricted. A nurse caring for a certain patient can remove a CDS from the ADC for that patient but another nurse cannot. The EMR will assist in documentation of administration of the CDS, including patient name, medication, strength, route, time of administration and administering nurse.
Controlled substance orders may include ranges in dose, or request doses, which are not the same as the strengths commercially available (i.e. morphine 4-‐6 mg IV or lorazepam 1 mg IV). When a controlled medication is pulled from an ADC, it should require you to document how much medication will be given and how much medication will be wasted. If waste is required, then the ADC will request a co-‐signature for the waste. The ADC will only allow those users who are deemed certified to handle CDSs to assist with documentation of waste. The wasting of CDSs should render the medication unusable. For example, disposal of IV waste into a sharps bin would render the rest of a lorazepam 2 mg vial unusable. Similar principles apply when destroying fentanyl transdermal delivery systems.
Stay tuned for more information about the serious nature of controlled dangerous substances in our next issue!
RX2GO App Available for Employee Prescription Refills By Lisa Mayer, Pharm.D., BCPS
Critical Medication Shortages By Donna Wilk, CPhT
As most of you know, the Norman Regional Hospital Pharmacy has a website for employees who use the Porter pharmacy to request a prescription refill, but did you know there is also a free app “RX2GO” available for Android and iPhone devices that can be used to submit refill requests?
Once you set up your profile choosing Norman Regional Hospital Pharmacy, you may refill prescriptions one of several ways: (1) by scanning the barcode on the prescription bottle (2) by entering the Rx# of your prescription or (3) by viewing “Last 12 Months” under “My Profile”, then select the medication and choose “Request Refill”. It’s that simple! Remember to select “My Account Email Notifications” under “Preferences” to receive email notifications when your prescription(s) are ready.
An additional benefit of the app is that you may also view a monograph of your medication. To do this select “My Profile”, then choose “Last 12 Months”, select the medication and choose “View Monograph”.
The pharmacy refill line is still available at extension 73332 or (405) 307-‐3332. You can also receive text alerts for when your refills are ready, just ask. The website or RX2GO app are the preferred methods for refill requests. Remember when you use our pharmacy services for your prescriptions, you save and the NRHS benefits plan saves.
Medication Action Plan
Amiodarone IV Amiodarone IV is readily available, but due to nationwide shortage of the D5W 500 mL AVIVA bags, amiodarone drips will change from 900 mg/500 mL to 450 mg/250 mL
Dexmedetomidine IV Product has released and is now loaded in both ICUs and CVICU Pyxis machines. Diltiazem IV Diltiazem drips will change from 100 mg/100 mL to 125 mg/125 mL and will be compounded by pharmacy. Droperidol IV Out of stock with no release date. Alternatives: prochlorperazine, ondansetron, metoclopramide and scopolamine.
Famotidine IV Release date of October 2014. Current supply is reserved for critical care patients in both ICUs and CVICU, in heart recovery carts, and patients with anaphylaxis. Alternatives include famotidine PO, pantoprazole PO/IV, or ranitidine IV.
Fosphenytoin IV Release date of third quarter 2014. Pharmacy has an adequate supply. Alternatives: phenytoin and levetiracetam.
IV Fluid Bags All plain IV fluid bags (i.e. Normal Saline, Lactated Ringers and Dextrose) are currently on shortage. At this time, it’s only affecting large volume bags (i.e. 250 mL, 500 mL and 1000 mL).
Prochlorperazine IV Available again. It has been added back to OR surgery trays and Pyxis machines.
Sincalide IV Release date of third quarter 2014. Nuclear medicine is using an alternative product (Ensure), reserving what small supply we have left for those patients with intractable nausea and vomiting.
TPN Components All TPN components are available again and we have lifted all restrictions. PharmD to dose per patient need.
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The Big Bang: Why Go-Live with CPOE By Stefanie Stogsdill Pharm.D., BCPS
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A patient’s height and weight are used in many formulas and nomograms to calculate specific doses of different medications. Incorrect height and weights can often times result in a significantly higher or lower dose of the prescribed medication, which can in turn lead to under-‐dosing or adverse events related to toxicity. Oncology, elderly, and pediatric/neonatal patients are at greater risk for adverse drug events because they may be more vulnerable to the effects of an error and their weight may change frequently over a short period of time. Along with medication dosing accuracy, weight can be a clinical indicator of nutritional status and diuretic status on a day-‐to-‐day basis.
It is estimated that 25% of patient weight errors occur during the conversion of pounds to kilograms, and vice versa. When obtaining a patient weight, please make sure the units being measured correspond to the units being documented. For example, a patient that weighs 100 pounds incorrectly documented as 100 kilograms can potentially receive two or more times the correct dose of a weight-‐based medication such as vancomycin or heparin.
Prescribers should confirm with the nurses and nursing aides that the patient’s weight is correct for weight-‐based dosages and if applicable write or type the weight on each new medication that is ordered. The weight of a patient can help pharmacists in their clinical double-‐check of the appropriate drug and dose. Prescribers should include the calculated dose and the dosing determination, such as the dose per weight (e.g., milligrams per kilogram) or body surface area, to facilitate an independent double-‐check of the calculation by a pharmacist, nurse, or both.
It is best to obtain a patient’s weight is at the same time every day, preferably before the patient has breakfast. If obtaining a bed scale weight, make sure all extra items are
removed from the bed, including the sequential compression device (SCD) machine. So remember: don’t wait to get an accurate weight!
In the past, all orders for patient care were written by providers, or transcribed from verbal/telephone orders from providers. The process of writing orders inherently has many hazards. Hand-‐written orders are prone to misinterpretation of abbreviations, missing information and illegibility. In order to improve patient safety, the Institute of Medicine proposed the idea of Computerized Provider Order Entry (CPOE) to minimize errors in 2001. In this article we will discover a little history about CPOE and why the “Big Bang” is important.
In 2003, the Medicare Modernization Act was passed, encouraging physicians to utilize e-‐prescribing for the transmission of outpatient prescriptions. In 2005, the Health Information Technology for Economic and Clinical Health (HITECH) act was passed. This act created the use of electronic health records (EHR) and promotes electronic prescribing. This act also introduced the concept of “meaningful use”. The Center for Medicare/Medicaid Services (CMS) set up EHR incentive programs that would provide financial incentives for the “meaningful use” of certified EHR technology to improve patient care. To receive an
incentive payment, providers must show “meaningful use” by meeting thresholds for a number of objectives. CMS has established the objectives for “meaningful use” that eligible providers (professionals/Hospitals/critical access hospitals) must meet in order to receive the incentive payment.
As you know, NRHS recently converted to CPOE. This conversion will help us show that we are meaningfully using our EHR to improve patient care. There are currently two stages for the EHR incentive program, where CPOE plays an important role. The CPOE objective for the first stage of meaningful use requires more than 30% of patients have at least one CPOE order. The CPOE objective for the second stage of meaningful use, which began July 1, 2014, requires more than 60% of medicine orders, 30% of lab orders, and 30% of radiology orders to be entered via CPOE. More information can be found at
http://www.cms.gov/Regulations-‐and-‐Guidance/Legislation/EHRIncentivePrograms/index.html
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Importance of Accurate Patient Height and Weight By Kim Whitley, Pharm.D.
Editor in Chief: Lisa Mayer, Pharm.D., BCPS Clinical Pharmacy Specialist
Contributors: Justin Booth, Pharm.D. Staff Pharmacist
Stefanie Stogsdill, Pharm.D., BCPS Staff Pharmacist
Minh Truong, Pharm.D. PGY1 Pharmacy Resident
Kim Whitley, Pharm.D. Staff Pharmacist
Donna Wilk, CPhT Pharmacy Technician
The Script The Quarterly Newsletter of the
Department of Pharmacy
Top 5 Pharmacy Order Entry Dates
1) August 18th, 2014 8,573 orders 2) July 7th, 2014 7,970 orders 3) August 21st, 2014 7,904 orders 4) May 19th, 2014 7,878 orders 5) June 30th, 2014 7,852 orders