From Syringe to Autoinjector

Total Page:16

File Type:pdf, Size:1020Kb

From Syringe to Autoinjector Volume 40 Number 6 Blow-Fill-Seal Data Integrity Using Modular JUNE 2016 Volume 40 Number 6 PLUS: Technology Training Construction PHARMACEUTICAL TECHNOLOGY From Syringe to JUNE 2016 2016 JUNE Autoinjector Building a Better Self-Injection Solution PharmTech.com PEER-REVIEWED Qualifying Personnel to Visually Inspect Cleaned Equipment, Part II SINGLE -USE SYSTEMS FORMULATION API SYNTHESIS & MANUFACTURING Integrating Single-Use Systems Customizing HPMC Adoption of Continuous Processing Advancing Drug Delivery Through Superior Polymer Design Safe and effective delivery of today’s complex drug molecules is increasingly a function of collaboration between polymer experts and pharmaceutical product development teams. Acting on enabling science, producing superior polymer excipient technology, and creating systems for optimum bioavailability, Ashland works alongside formulators to advance drug- specific delivery platforms. Explore how you can solve intricate drug formulation and development challenges with polymer expertise from Ashland. Visit us at Ashland.com/pharmaceutical Come visit us at Booth 610 Ashland [email protected] www.ashland.com/pharmaceutical ®Registered trademark, Ashland or its subsidiaries, registered in various countries ™Trademark, Ashland or its subsidiaries, registered in various countries ©2016, Ashland AD-13475.1 “Off-the-shelf solutions? No thank you. After all, our customers are something special.” Daniel Drossel Mechanical Engineering Technician (Design department) Each customer has its very own special requirements. That’s why we, at Optima, manufacture fi lling lines that are fi ne-tuned to our clients’ particular needs while off ering the benefi ts of an integrated and complete line: The complete machine package including high-precision functionalities, backed by consistent documentation and supported by an optimized and tailored software solution – in addition to a central point of contact who is passionate about your every concern… We are experts in special solutions, after all. Member of OPTIMA pharma GmbH | 74523 Schwaebisch Hall | Germany | www.optima-pharma.com OPTIMA Machinery Corporation | Green Bay, WI, 54304 | USA | www.optima-usa.com EDITORIAL SALES Editorial Director Rita Peters [email protected] Senior Editor Agnes Shanley [email protected] Publisher Mike Tracey [email protected] Managing Editor Susan Haigney [email protected] Mid-West Sales Manager Irene Onesto [email protected] Science Editor Adeline Siew, PhD [email protected] East Coast Sales Manager Joel Kern [email protected] Manufacturing Editor Jennifer Markarian [email protected] Science Editor Randi Hernandez [email protected] European Sales Manager Linda Hewitt [email protected] Community Manager Caroline Hroncich [email protected] European Senior Sales Executive Stephen Cleland [email protected] Art Director Dan Ward Executive Assistant Barbara Sefchick [email protected] Contributing Editors Jill Wechsler [email protected]; Jim Miller [email protected]; Hallie Forcinio [email protected]; Susan J. Schniepp ADDRESS [email protected]; Eric Langer [email protected]; and Cynthia A. Challener, PhD [email protected] 485 Route One South, Building F, Second Floor, Iselin, NJ 08830, USA Correspondent Sean Milmo (Europe, [email protected]) Tel. 732.596.0276, Fax 732.647.1235 485 Route One South, Building F, Second Floor, Iselin, NJ 08830, USA PharmTech.com Tel. 732.596.0276, Fax 732.647.1235, PharmTech.com EDITORIAL ADVISORY BOARD Sr. Production Manager Karen Lenzen Pharmaceutical Technology publishes contributed technical articles that undergo a rigorous, double-blind peer-review process involving members of our distinguished International Licensing Maureen Cannon [email protected], Editorial Advisory Board. Manuscripts should be sent directly to the managing editor. Below is a partial list of the Pharmaceutical Technology brand editorial advisory members. The full board, which includes advisory tel. 440.891.2742 or toll-free 800.225.4569 ext 2742, fax. 440.756.5255 members from Pharmaceutical Technology Europe, can be found online at PharmTech.com. Audience Development Manager Rochelle Ballou [email protected] James P. Agalloco Ruey-ching (Richard) Hwang, PhD Wendy Saffell-Clemmer President, Senior Director, Director, Research Agalloco & Associates Pharmaceutical Sciences, Baxter Healthcare Pfizer Global R&D Larry L. Augsburger, PhD Gurvinder Singh Rekhi, PhD Professor Emeritus Maik W. Jornitz Department of Pharmaceutical and University of Maryland President Biomedical Sciences, G-CON Manufacturing Inc. The University of Georgia College David H. Bergstrom, PhD of Pharmacy Senior Vice-President, Mansoor A. Khan, PhD Pharmaceutical Development & Professor & Vice Dean Susan J. Schniepp Corporate Quality Assurance Irma Lerma Rangel College of Fellow Antares Pharma, Inc. Pharmacy, Texas A&M Health Regulatory Compliance Associates © 2016 UBM. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any Phil Borman Science Center David R. Schoneker means, electronic or mechanical including by photocopy, recording, or information storage and retrieval without per- QbD Lead & Data Management & Russell E. Madsen Director of Global Regulatory Affairs, Analysis Manager President, The Williamsburg Colorcon mission in writing from the publisher. Authorization to photocopy items for internal/educational or personal use, or the GlaxoSmithKline Group, LLC Aloka Srinivasan internal/educational or personal use of specific clients is granted by UBM for libraries and other users registered with Rory Budihandojo Heidi M. Mansour, PhD Principal Consultant, the Copyright Clearance Center, 222 Rosewood Dr. Danvers, MA 01923, 978-750-8400 fax 978-646-8700 or visit http:// Lachman Consultants PAREXEL International Assistant Professor www.copyright.com online. For uses beyond those listed above, please direct your written request to Permission Dept. Metin Çelik, PhD College of Pharmacy President, & The BIO5 Research Institute, Read board members’ fax 440-756-5255 or email: [email protected]. Pharmaceutical Technologies University of Arizona–Tucson biographies online at International (PTI) Jim Miller PharmTech.com/ UBM Americas provides certain customer contact data (such as customers name, addresses, phone numbers, and President, pharmtech-editorial- e-mail addresses) to third parties who wish to promote relevant products, services, and other opportunities that may Zak T. Chowhan, PhD advisory-board. Consultant, Pharmaceutical PharmSource Information be of interest to you. If you do not want UBM America’s to make your contact information available to third parties for Development Services Bio/Pharmaceutical Outsourcing Report marketing purposes, simply call toll-free 866.529.2922 between the hours of 7:30 a.m. and 5 p.m. CST and a customer Suggy S. Chrai, PhD service representative will assist you in removing your name from UBM America’ lists. Outside the US, please phone President and CEO, Colin Minchom, PhD Chrai Associates, Inc. Senior Director Pharmaceutical 218.740.6477. Sciences, Shire Pharmaceuticals Roger Dabbah, PhD Principal Consultant, R. Christian Moreton, PhD Pharmaceutical Technology does not verify any claims or other information appearing in any of the advertisements Tri-Intersect Solutions Partner, Finnbrit Consulting contained in the publication, and cannot take responsibility for any losses or other damages incurred by readers in Robert Dream Fernando J. Muzzio, PhD reliance of such content. Managing Director Director, NSF Engineering HDR Company Research Center on Structured Pharmaceutical Technology welcomes unsolicited articles, manuscripts, photographs, illustrations, and other materials Organic Particulate Systems, Tim Freeman Dept. of Chemical and Biochemical but cannot be held responsible for their safekeeping or return. Managing Director, Engineering, Rutgers University FreemanTechnology Single issues, back issues: Call toll-free 800.598.6008. Outside the US call 218.740.6480. Reprints of all articles in this Moheb M. Nasr, PhD Sanjay Garg, PhD Vice-President, CMC Regulatory issue and past issues of this publication are available. Call 877-652-5295 ext. 121 or email [email protected]. Professor and Director, Strategy, Global Regulatory Affairs, Outside US, UK, direct dial: 281-419-5725. Ext. 121. Direct mail lists: Contact Tamara Phillips, Marketing Services, Centre for Pharmaceutical GlaxoSmithKline Innovation and Development, tel. 440.891.2773, [email protected]. Display, Web, Classified, and Recruitment Advertising: Contact Tod University of South Australia Garnet E. Peck, PhD McCloskey, tel. 440.891.2739, [email protected]. Permissions: Contact Maureen Cannon, tel. 440.891.2742 Professor Emeritus of Industrial R. Gary Hollenbeck, PhD Pharmacy, Purdue University or toll-free 800.225.4569 ext 2742, fax. 440.756.5255, [email protected]. Chief Scientific Officer, UPM Pharmaceuticals To subscribe: Call toll-free 888.527.7008. Outside the U.S. call 218.740.6477. Pharmaceutical Technology’s eNewsletter Team: tePT, Editor Caroline Hroncich, [email protected] tSourcing and Management, Editor Rita Peters, [email protected] tEquipment & Processing Report, Editor Jennifer Markarian, [email protected] tSend news and product releases to [email protected] 4 Pharmaceutical Technology JUNE 2016 PharmTech.com Veltek Associates, Inc. offers two garment product
Recommended publications
  • Sodium Chloride Injection USP 0.9% Prefilled Syringes, for Intravascular Use Only ------WARNINGS and PRECAUTIONS ------Initial U.S
    HIGHLIGHTS OF PRESCRIBING INFORMATION --------------------- DOSAGE FORMS AND STRENGTHS --------------------- These highlights do not include all the information needed to use • Supplied as a clear, colorless, odorless, sterile solution of Sodium Sodium Chloride Injection USP 0.9% safely and effectively. See Chloride 0.9% for intravenous administration (3) full prescribing information for Sodium Chloride Injection USP • Supplied in 50 mL and 125 mL prefilled syringes (3) 0.9%. ------------------------------- CONTRAINDICATIONS ------------------------------- • None (4) Sodium Chloride Injection USP 0.9% Prefilled Syringes, For Intravascular Use Only ----------------------- WARNINGS AND PRECAUTIONS ----------------------- Initial U.S. Approval: 2006 • Remove all air from the syringe and associated tubing prior to injection. (5.1) ----------------------------INDICATIONS AND USAGE ---------------------------- • For use in flushing compatible contrast agents through Liebel- • May cause fluid overload in patients with congestive heart failure, Flarsheim intravenous administration sets into indwelling severe renal insufficiency, and in clinical states with edema, sodium retention, or hypernatremia. (5.3) intravascular access devices (1) • Establish intravascular catheter patency prior to administration. ----------------------- DOSAGE AND ADMINISTRATION ----------------------- (5.4) • For single patient use only. (2) • Determine the volume of flush based on the imaging procedure, ------------------------------ ADVERSE REACTIONS ------------------------------
    [Show full text]
  • Migraine Specialty Care Program Tm
    MIGRAINE SPECIALTY CARE PROGRAM TM Phone: 833-796-6470 • Fax: 844-841-3401 Community Led Specialty Pharmacy Care 1 PATIENT INFORMATION: 2 PRESCRIBER INFORMATION: Name: ___________________________________________________ Name: ___________________________________________________ Address: _________________________________________________ Address: _________________________________________________ City: _________________________ State: ____ Zip: ____________ City: _________________________ State: ____ Zip: ____________ Phone: ___________________ Alt. Phone: ____________________ Phone: _____________________ Fax: _______________________ Email: ____________________________________________________ NPI: ________________________ DEA: _______________________ DOB: ___________ Gender: M F Caregiver: _____________ Tax I.D.: __________________________________________________ Height: ________ Weight: ________ Allergies: ________________ Office Contact: __________________ Phone: __________________ 3 STATEMENT OF MEDICAL NECESSITY: (Please Attach All Medical Documentation) Prior Failed Indicate Drug Name v10.0_060821 Length of Symptoms: ___________________________ ICD-10: _________________________ Treatments: and Length of Treatment: Other diagnosis _______________ Number of Migraine Days per month: ________________ Preventative: Headache Days per month: _________________ Migraine Hours per day: __________________ ACE-I/ARBs ___________________ Patient has been evaluated and does not have medication overuse headache? No Yes Antiepileptics ___________________
    [Show full text]
  • DDT Cover/Back April 2006.Qx
    March 2007 Vol 7 No 3 www.drugdeliverytech.com IN THIS ISSUE INTERVIEW WITH DPT’S PRESIDENT MR. PAUL JOHNSON In Situ Gel Systems 30 Mitan Gokulgandhi, BPharm Dharmesh M. Modi, MPharm COX-II Microspheres 38 Lakshmi Sivasubramanian Madhumathi Seshadri Undermining CEO’s 82 John A. Bermingham FEATURING Parkinson’s Disease 59 Steven Damon Yogi R. Patel The science & business of specialty pharma, biotechnology, and drug delivery Specialty Pharma Indices 64 Dr. Barath Christopher Avani Amin, Josef Bossart, PhD Shankar Robinson, PhD Drug Delivery’s PhD Current Status of Clinical Trials Increasing New Ways to Non-Invasive In Asia 68 Importance to Partner With Insulin Delivery Ames Gross, MBA Big Pharma & the Federal Technologies Specialty Pharma Government Momoko Hirose March 2007 Vol 7 No 3 PUBLISHER/PRESIDENT Ralph Vitaro EXECUTIVE EDITORIAL DIRECTOR Dan Marino, MSc [email protected] CREATIVE DIRECTOR Shalamar Q. Eagel CONTROLLER Debbie Carrillo CONTRIBUTING EDITORS Cindy H. Dubin Debra Bingham Jason McKinnie TECHNICAL OPERATIONS Mark Newland EDITORIAL SUPPORT Nicholas D. Vitaro ADMINISTRATIVE SUPPORT Kathleen Kenny Corporate/Editorial Office 219 Changebridge Road, Montville, NJ 07045 Tel: (973)299-1200 Fax: (973) 299-7937 www.drugdeliverytech.com Advertising Sales Offices East & Midwest Victoria Geis - Account Executive Cheryl S. Stratos - Account Executive 103 Oronoco Street, Suite 200 Alexandria, VA 22314 Tel: (703) 212-7735 Fax: (703) 548-3733 E-mail: [email protected] E-mail: [email protected] West Coast Warren
    [Show full text]
  • Medication Permission Form
    CHARDON LOCAL SCHOOLS MEDICATION PERMISSION FORM Student Name :__________________________________________ Grade/Class _______ Teacher :______________________ School ____________________ Student Address:____________________________________________________________________________ Date of Birth____________________________ TO BE COMPLETED BY HEALTH CARE PROVIDER Please print clearly and complete ALL sections. Time/Frequency Adverse Reaction to Report to (Include minimum time Physician and/or Special Name of Medication Dose Route (circle) Interval for prn dosing) Reason for Medication Start Date Stop Date Instructions Tablet/Capsule PO Liquid PO _________________ __/__/__ ___/___/___ Inhaler/Nebulizer OR OR Other__________ As needed every __hrs. ___ End of School year Tablet/Capsule PO Liquid PO _________________ __/__/__ ___/___/___ Inhaler/Nebulizer OR OR Other__________ As needed every __hrs ___ End of School year EPINEPHRINE AUTOINJECTOR Not Applicable SELF -CARRY AUTHORIZATION Yes, as the prescriber I have determined that this student is capable of possessing and using this autoinjector appropriately and have provided the student with training in the proper use of the autoinjector. ASTHMA INHALER Not Applicable SELF -CARRY AUTHORIZATION Yes, as the prescriber I have determined that this student to capable of possessing and using this inhaler appropriately and have provided the student with training in the proper use of the inhaler. Reminder note for prescriber: ORC 3313.718 requires backup epinephrine autoinjector and best practice recommends backup asthma inhaler Health Care Provider Name _______________________________________ Health Care Provider Signature: ______________________________________ Date_________________ Phone Number: _______________________________________ Fax Number: _________________________________________ TO BE COMPLETED BY PARENT OR GUARDIAN I authorize an employee of the school board to administer the above medication. I understand that additional parent/prescriber signed statements will be necessary if the dosage of medication is changed.
    [Show full text]
  • Aerogen Nebulizer)
    Page 1 of Date of Original: 11/15/18 Date of Review: Date of Revision: 9/4/19 Respiratory Therapy POLICY & PROCEDURE MANUAL RIBAVIRIN ADMINISTRATION (Aerogen nebulizer) PURPOSE: 1. Standardize the administration and delivery of ribavirin by aerosol 2. To protect the patient and caregivers by standardizing precautions for ribavirin delivery POLICY: The patient room must be set up according to St Jude’s Environmental Health and Safety policy prior to the administration of Ribavirin. Room preparation is to be done by the nursing staff. *See procedure section below https://home.stjude.org/ehs/Pages/ribavirin-precautions.aspx • Negative pressure room is mandatory for Ribavirin administration. • Preparation of the room is the responsibility of the nursing staff. • Ribavirin will be delivered from pharmacy in primed Aerogen syringe set appropriate for use on the MedFusion 3500 syringe pump. • The syringe pumps will be used, maintained, and stored by the respiratory therapy department. • The PPE cart is the shared responsibility of the respiratory therapist who administers the first dose of ribavirin and the nursing coordinator for that area. • Proper sign including contact precautions and STOP will be shared responsibility of the nursing and respiratory care. • All instances of spilled or leaked ribavirin must be documented in the event reporting system. • Ribavirin may be delivered to a patient during mechanical ventilation in a very specific set of circumstances. The final decision on the use of ribavirin is at the discretion of the ICU physician on service. EQUIPMENT: • Negative pressure room • DeMistifier 2000 HEPA filtration system. • DeMistifier negative pressure bed enclosure with canopy. • MedFusion 3500 Syringe pump • Flowmeter • Aerogen vibrating mesh nebulizer • Delivery Supplies (O2 tubing, O2 reducer, large bore tubing, T adaptor, and aerosol face mask) • Prescribed medication • STOP sign for the door during drug administration PPE • N95 or Positive Air Pressure mask required • Chemo resistant Gown • Double Gloves • Shoe covers PROCEDURE: 1.
    [Show full text]
  • IFU for Bioglue Surgical Adhesive (Outside USA)
    Instructions for Use Syringe BioGlue® Adhésif BioGlue® Collante Chirurgico Adhesivo Quirúrgico Chirurgical Mode Chirurgischer Klebstoff BioGlue® Istruzioni d’uso BioGlue® Instrucciones d’emploi Seringue Gebrauchsanwei sung Siringa de Uso Jeringuilla Spritze BioGlue® Adesivo BioGlue® Kirurgisk BioGlue® Kirurgisk Lim BioGlue® Vävnadslim Cirúrgico Instruções de Klæbemiddel Bruksanvisning Sprøyte Bruksanvisning Spruta Utilização Seringa Brugsanvisning Sprøjte Χειρουργική συγκολλητική BioGlue® Cerrahi Chirurgické adhezivum BioGlue® ουσία BioGlue® Οδηγίες Yapışkan Kullanım BioGlue® Návod k použití Chirurgische Kleefstof χρήσης Σύριγγα Talimatları Şırınga Stříkačka Gebruiksinstructies Spuit Chirurgické Lepidlo BioGlue® Sebészi Klej Chirurgiczny Хирургический клей BioGlue® Návod na Szövetragasztó BioGlue® Sposób Użycia BioGlue® Инструкция по Použitie Striekačka Használati útmutató Strzykawka применению Шприц Fecskendő CryoLife, Inc. 1655 Roberts Boulevard, NW • Kennesaw, Georgia 30144 • USA • +1 (770) 419-3355 • Fax +1 (770) 590-3753 http://www.cryolife.com 25°C 0°C L6313.009 Rev (07/2010) ENGLISH PRODUCT DESCRIPTION BioGlue® Surgical Adhesive is composed of bovine serum albumin and glutaraldehyde. The product’s two components are mixed within the applicator tip of the syringe during application to tissue. Polymerization of the surgical adhesive begins immediately upon application, reaching bonding strength within 2 minutes. INDICATIONS • Do not peel away BioGlue from an unintended site, as 3. While firmly grasping the syringe, nose upward, BioGlue Surgical Adhesive is indicated for use as an this could result in tissue damage. turn the cap 90° counterclockwise and remove the adjunct to standard methods of surgical repair (such • An animal study12 has shown that the circumferential cap by rocking it from side-to-side. Align the tip with as sutures, staples, electrocautery, and/or patches) to application of BioGlue restricts dilatation on growing the syringe using the corresponding notches on bond, seal, and/or reinforce soft tissue.
    [Show full text]
  • Instructions For
    Instructions for Use Please see page 2 Instructions for Use Please see page 3 SIMPONI® (SIM-po-nee) (golimumab) SIMPONI® (SIM-po-nee) (golimumab) SmartJect® autoinjector Prefilled Syringe SINGLE-DOSE Important Important If your doctor decides that you or a caregiver may be able to give your SIMPONI® injections at home, you should SIMPONI® comes as a single-dose prefilled syringe containing one 50 mg or one 100 mg dose. Each SIMPONI® prefilled receive training on the right way to prepare and inject SIMPONI® using SmartJect®. syringe can only be used one time. Throw away (dispose of) the used prefilled syringe (See Step 3) after one dose, even Do not try to inject SIMPONI® yourself until you have been shown the right way to give the injections by your doctor if there is medicine left in it. Do not reuse your SIMPONI® prefilled syringe. or nurse. If your healthcare provider decides that you or a caregiver may be able to give your injections of SIMPONI® at home, Please read this Instructions for Use before using SIMPONI® SmartJect® and each time you get a refill. There may be you should receive training on the right way to prepare and inject SIMPONI® using the prefilled syringe before new information. This leaflet does not take the place of talking with your doctor about your medical condition or attempting to inject. Do not try to inject yourself until you have been shown the right way to give the injections by your your treatment. healthcare provider. Read this Instructions for Use before using your SIMPONI® prefilled syringe and each time you get a refill.
    [Show full text]
  • Veterinary Anesthetic and Analgesic Formulary 3Rd Edition, Version G
    Veterinary Anesthetic and Analgesic Formulary 3rd Edition, Version G I. Introduction and Use of the UC‐Denver Veterinary Formulary II. Anesthetic and Analgesic Considerations III. Species Specific Veterinary Formulary 1. Mouse 2. Rat 3. Neonatal Rodent 4. Guinea Pig 5. Chinchilla 6. Gerbil 7. Rabbit 8. Dog 9. Pig 10. Sheep 11. Non‐Pharmaceutical Grade Anesthetics IV. References I. Introduction and Use of the UC‐Denver Formulary Basic Definitions: Anesthesia: central nervous system depression that provides amnesia, unconsciousness and immobility in response to a painful stimulation. Drugs that produce anesthesia may or may not provide analgesia (1, 2). Analgesia: The absence of pain in response to stimulation that would normally be painful. An analgesic drug can provide analgesia by acting at the level of the central nervous system or at the site of inflammation to diminish or block pain signals (1, 2). Sedation: A state of mental calmness, decreased response to environmental stimuli, and muscle relaxation. This state is characterized by suppression of spontaneous movement with maintenance of spinal reflexes (1). Animal anesthesia and analgesia are crucial components of an animal use protocol. This document is provided to aid in the design of an anesthetic and analgesic plan to prevent animal pain whenever possible. However, this document should not be perceived to replace consultation with the university’s veterinary staff. As required by law, the veterinary staff should be consulted to assist in the planning of procedures where anesthetics and analgesics will be used to avoid or minimize discomfort, distress and pain in animals (3, 4). Prior to administration, all use of anesthetics and analgesic are to be approved by the Institutional Animal Care and Use Committee (IACUC).
    [Show full text]
  • Nurseadviseerr201805.Pdf
    May 2018 Volume 16 Issue 5 Safety with nebulized medications requires an interdisciplinary team approach Consider implementing the following recom - ebulization of inhaled medications provides an excellent delivery route for mendations to reduce the risk of errors with the treatment of both pulmonary and nonpulmonary conditions. The mist is nebulized medications. Neasily inhaled by breathing normally, without requiring coordinated breaths to inhale the medication (as required with metered dose inhalers). This delivery Communicate orders. Establish a reli - method generally provides a rapid onset of drug action, and minimizes systemic ef - able system for communicating new and fects. An additional advantage is that the nebulizer is adaptable and can be used changed orders for nebulized medications with a mouthpiece, adult or pediatric face mask, tracheostomy collar, T piece, or to respiratory therapy staff. Test the system ventilator circuit. before use, monitor its reliability, and inves - tigate all failed communication of orders to Unfortunately, there can also be errors with nebulized medications that are linked to determine opportunities for improvement. a wide variety of common system failures and human factors. However, review of errors reported to the ISMP National Medication Errors Reporting Program (ISMP Collaborate on assessments. Consider MERP) and other sources during 2016 and 2017, revealed patterns among error types collaboration between nursing and respi - and causative factors that were relatively unique to nebulized medications and/or ratory staff to determine if a dose of neb - the conditions under which they are prescribed, dispensed, and administered. ulized medication should be held based on an assessment of the patient. Deter - Omissions due to unavailability of respiratory therapist or failed communication mine conditions that require prescriber By far, the most frequently reported errors related to the use of nebulized medications notification of a held nebulizer treatment.
    [Show full text]
  • Medfusion® 3500 Syringe Infusion Pump with Pharmguard® Medication Safety Software
    Medfusion® 3500 Syringe Infusion Pump with PharmGuard® Medication Safety Software Smart and simple with added safety The Department of Health estimates we will be facing a shortage of over 800,000 nurses by the year 2020.1 Current shortages are having serious effects on day-to-day healthcare, and many nurses feel overworked and stressed – a situation that may lead to medication errors. The Joint Commission estimates 25% of hospitalized patient deaths are related to nurse understaffing.2 The dangers of medication errors n As many as 19 patients die every day from ® MR Conditional: The Medfusion pump may be used in static 3 magnetic fields up to 150 Gauss when secured to a non-movable medication errors in the United States object. Tested using 1.5 Tesla 64MHz shielded MRI system. n More than 770,000 injuries and deaths are due to preventable drug errors, which cost 3 hospitals up to $5.6 million per year n 61% of serious and life-threatening errors 3 are associated with infusion therapy n Infusion devices account for up to 35% of all medication errors, with 67% due to 4 programming errors n 38% of medication errors occur during the administration process; 51% harmed 5 the patient 1 National Center for Workforce Analysis, U.S. Department of Health and Human Services 2 The Joint Commission, 2002 3 Materials Management in Health Care, Oct. 2005 4 Tourville, 2003 5 JAMA, 1995 The total solution Post-occlusion bolus reduction ® The Medfusion syringe pump removes the possibility of a safety system has been the leader patient receiving an automatic bolus following an occlusion in infusion pump technology for over 15 years.
    [Show full text]
  • New Autoinjector Technology for the Delivery of Subcutaneous Methotrexate in the Treatment of Rheumatoid Arthritis
    Expert Review of Medical Devices ISSN: 1743-4440 (Print) 1745-2422 (Online) Journal homepage: http://www.tandfonline.com/loi/ierd20 New autoinjector technology for the delivery of subcutaneous methotrexate in the treatment of rheumatoid arthritis Michael Schiff, Jonathan Jaffe, Bruce Freundlich & Patrick Madsen To cite this article: Michael Schiff, Jonathan Jaffe, Bruce Freundlich & Patrick Madsen (2014) New autoinjector technology for the delivery of subcutaneous methotrexate in the treatment of rheumatoid arthritis, Expert Review of Medical Devices, 11:5, 447-455, DOI: 10.1586/17434440.2014.929492 To link to this article: http://dx.doi.org/10.1586/17434440.2014.929492 Published online: 17 Jun 2014. Submit your article to this journal Article views: 112 View related articles View Crossmark data Citing articles: 1 View citing articles Full Terms & Conditions of access and use can be found at http://www.tandfonline.com/action/journalInformation?journalCode=ierd20 Download by: [Rosa Weiss] Date: 14 February 2017, At: 10:26 Device Profile New autoinjector technology for the delivery of subcutaneous methotrexate in the treatment of rheumatoid arthritis Expert Rev. Med. Devices 11(5), 447–455 (2014) Michael Schiff*1, Methotrexate (MTX) is the cornerstone of treatment for rheumatoid arthritis (RA), and is Jonathan Jaffe2, widely used both as first-line therapy and as an important component of long-term therapy. Bruce Freundlich3,4 Although subcutaneous MTX is typically delivered orally, parenteral administration offers benefits with respect to tolerability and systemic exposure, and may be an underutilized and Patrick Madsen5 treatment option. The RA patient population presents specific challenges for safe and 1 Department of Rheumatology, accurate administration of parenteral therapies, because of common symptoms of joint pain University of Colorado, Denver, CO, USA and limited manual dexterity.
    [Show full text]
  • Access Tier 4 PPO Prescription Drug List CDI Version
    Pharmacy | PDL | California 2021 California Access Large Group 4-Tier PPO Prescription Drug List Please note: This Prescription Drug List (PDL) is accurate as of September 1, 2021 and is subject to change after this date. All previous versions of this PDL are no longer in effect. Your estimated coverage and copay/coinsurance may vary based on the benefit plan you choose and the effective date of the plan. This PDL can also be accessed online at myuhc.com > Pharmacy Information > Prescription Drug Lists > California plans > Large Group - Access. Plan-specific coverage documents may be accessed online at uhc.com/statedruglists > Large Group Plans > California. If you are a UnitedHealthcare member, please register or log on to myuhc.com, or call the toll-free number on your health plan ID card to find pharmacy information specific to your benefit plan. This PDL is applicable to the following health insurance products offered by UnitedHealthcare: • Navigate • Navigate Plus • Choice • Choice Plus • Select • Select Plus • Core • Core Essential • Options PPO • Non-Differential PPO Updated 7/13/2021 8/21 © 2021 United HealthCare Services, Inc. All Rights Reserved. WF4335930-A Contents At UnitedHealthcare, we want to help you better understand your medication options. ................................................. 3 How do I use my PDL? .................................................. 4 What are tiers? ........................................................ 5 When does the PDL change? ............................................. 5 Utilization Management Programs ......................................... 6 Your Right to Request Access to a Non-formulary Drug ....................... 6 Requesting a Prior Authorization or Step Therapy Exception ................... 7 How do I locate and fill a prescription through a retail network pharmacy? . 7 How do I locate and fill a prescription through the mail order pharmacy? .
    [Show full text]