DOCSLIB.ORG

Student Manual

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Student Manual STUDENT MANUAL Occupational Hygiene in the Pharmaceutical Industry Draft Version - September 2020 The draft training materials for this course are offered by the Occupational Hygiene Training Association and available free of charge though the OHTA website OHlearning.com. Copyright information This student manual is provided under the Creative Commons Attribution - NoDerivs licence agreement. It can only be reproduced in its entirety without change, unless with the prior written permission of OHTA. Occupational Hygiene Training Association, 5/6 Melbourne Business Court Millennium Way, Pride Park, Derby, DE24 8LZ Email: [email protected] ACKNOWLEDGEMENTS We would like to sincerely acknowledge the dedication and hard work contributed toward authoring and reviewing this module and would like to express appreciation to the following individuals or organisations for their support or contribution. Angelie Kasman Lilly Steve Bailey GSK Adrian Hirst Hirst Consulting Nancy McClellan AbbVie/OHM Consulting Maharshi Mehta ISS Consulting Erica Joseph GSK Charlyn Reihman Safebridge Greg Erexson AbbVie Lisa Cardo GSK Donna Heidel Bureau Veritas/Amazon Russell Collins GSK Pam Davison Len Morris BOHS Lesley Burgess AstraZeneca John Farris Safebridge Bob Sussman Safebridge Chun-Yip Hon Ryerson University Jerald Ovesen NIOSH Jill Kauker Naval Health Amanda Scott CHOP Amy Snow GSK Jeff Dinyer Thermofisher Stephen Nowakowski Safebridge Barry Ballinger HPA Consulting Dale Iddon Eli Lilly Lesley Burgess AstraZeneca Steve Lewis GSK Michael West Pfizer Jose Pedro Dias Janssen Pharmaceutica (Johnson & Johnson) Walter Spieler F. Hoffmann LaRoche AG Martin Foerster F. Hoffmann LaRoche AG Bie Lambert Janssen Pharmaceutica (Johnson & Johnson) Michel Vangeel Janssen Pharmaceutica (Johnson & Johnson) Juergen Fleckenstein Boehringer Ingelheim GmbH Lena Fahlqvist Kozicic AstraZeneca Ulrich Billerbeck Merck KGaA Chris Field Napp Pharmaceutical Holdings Limited Jan Wren GSK R&D Deborah Simpson GSK R&D David Newton GSK Biologicals Simon Nunn Pfizer UK Marc Abromovitz Johnson & Johnson and Novartis *Affiliations are listed as at the time of contributing and may not be current 1 UNDERSTANDING THE PHARMACEUTICAL INDUSTRY 1.1 Development of the Industry 1.1.1 Origins 1.1.2 The Story of Aspirin 1.1.3 The Development of Antibiotics 1.1.4 Rational Drug Design 1.1.5 The Growth of Regulation 1.1.6 Regulatory Regimes 1.2 Areas of the Business 1.2.1 Drug Discovery 1.2.2 Drug Development 1.2.3 Manufacturing 1.3 Commercial Pressures 1.3.1 The Blockbuster Model 1.3.2 The Generics Industry 1.3.3 Intellectual Property 1.3.4 Litigation and Liabilities 1.3.5 Commercial Responses 1.4 Present and Future Trends 1.4.1 Genetics and Personalised Medicines 1.4.2 Gene therapy 1.4.3 Epigenetics 1.4.4 Monoclonal Antibodies 1.5 Related industries 1.5.1 Biotechnology and Biopharmaceuticals 1.5.2 Vaccines 1.5.3 Medical devices 1.5.4 Other Related Industries Annex 1 Some Major Companies in the Pharmaceutical Industry Chapter 1: Understanding the Pharmaceutical Industry 1 1.1 Development of the Industry An awareness of how pharmaceuticals and the pharmaceutical industry have evolved makes it easier to understand the modern industry: its manufacturing methods, the strict regulatory environment, the health issues affecting workers, and the social and ethical issues faced today. Professional hygienists need such knowledge in order to be credible with their technical and managerial colleagues in industry. It is not necessary for students to remember all the details of the historical events mentioned below, or to know about all the individual pharmaceuticals discussed, but knowledge of the specific pharmaceuticals that your company works with will prove very useful. Key learning points for hygienists are summarised at the end of each section. 1.1.1 Origins The pharmaceutical industry is concerned with the manufacture of drugs. A drug can be defined as “any chemical substance, synthetic or natural, of known or unknown composition, which is used as a medication to prevent or cure a disease.” There are many types of drugs. They can be categorised into around 15 classes by site of primary action (gastro-intestinal system, cardiovascular system, respiratory system, etc.) then subdivided into around 100 further subgroups by drug type - antacids, laxatives, anticoagulants, analgesics, cytotoxics to name but a few. Up until the industrial revolution the pharmaceutical industry only existed in the form of apothecaries and pharmacies that offered traditional remedies. It was not until the 1800s that an industry involving large scale manufacture started to emerge. 1827 – Heinrich Emanuel Merck worked in the family pharmacy in Darmstadt, Germany and started to isolate all the known alkaloids and sold them to other chemists and physicians. 1842 – Thomas Beecham started selling “Beecham’s Pills”, a laxative tablet, building up a network of sales throughout the north of England and by 1859 opening the world’s first pharmaceutical factory. 1849 – In the USA Pfizer is founded, initially making Sanonin, an antiparasitic. During the American Civil War they expanded to meet the demand for painkillers, preservatives and disinfectants. 1858 - Edward Robinson Squibb, set up a laboratory supplying the union armies in the civil war. Despite being badly burned by an ether explosion and the laboratory being burned a further two times, by 1883 the company was manufacturing 324 products and selling them around the world. 1876 - Colonel Eli Lilly a pharmacist and veteran of the American Civil War began his medical wholesale company. Lilly pioneered new methods in the industry, being one of the first to focus on R&D as well as manufacturing. 1888 - As a result of the demand for more exact dosing and sophistication of drug formulation, the physician and pharmacist Dr. Wallace C. Abbott, using the active part of a medicinal plant, known Chapter 1: Understanding the Pharmaceutical Industry 2 as the "alkaloid," formed tiny pills called "dosimetric granules," which provided more accurate and effective dosing for his patients than other treatments available at the time. From these modest origins inside a physician’s residence, was born Abbott which is now AbbVie Inc. During the latter half of the 19th Century Switzerland also developed a pharmaceutical manufacturing industry. Companies set up to manufacture dyestuffs realized that their products had antiseptic qualities and started to market them as pharmaceuticals. A lack of patent laws in the country allowed companies to manufacture and sell products invented by other companies. Novartis, Roche and the Basel hub of the pharmaceutical industry all have their roots in this boom. Key learning points: o The first pharmaceutical companies grew out of traditional pharmacies. o Early pharmaceuticals were based on natural remedies. o There was no clear dividing line between prescription medicines and other products. th o Modern pharmaceutical manufacturing has its origins in the fine chemicals industry of the 19 century. o Even today, the geographic distribution of the major companies reflects this history. 1.1.2 The Story of Aspirin Aspirin was perhaps the first synthetic pharmaceutical and remains the one of the most widely taken drugs in the world. The story of its development and subsequent use illustrates several principles that have come to typify the pharmaceutical industry. Ancient Sumerian and Egyptian texts recommended willow bark for various complaints. Greek, Roman and Islamic medical authors noted its power to reduce pain and relieve fevers. However, its tendency to cause inflammation and occasionally bleeding of the stomach lining considerably diminished its utility. In 1828 the German chemist Joseph Buchner isolated the active ingredient, a yellowish, bitter tasting substance that he called salicin (salix being the Latin for willow). Two years later Johann Pagenstecher, a Swiss apothecary, extracted the same material from the meadowsweet plant, whose botanical name spirea later suggested the brand name aspirin. In 1838 Raffaele Pirea succeeded in converting salicin to salicylic acid. This compound proved to be a more useful remedy, but unfortunately it irritated the stomachs of some patients. In 1853, the French chemist Charles Gerhardt prepared its acetyl ester, which had similar analgesic, anti- inflammatory and fever-reducing properties to salicylic acid but was less harmful to the stomach. The ester was not hydrolysed until it reached the alkaline environment of the small intestine. Bayer, a dyestuffs company established in 1863, developed a new industrial synthesis for acetyl salicylic acid and commercialised it as aspirin in 1899. Early synthetic drugs were tested haphazardly and often failed to fulfil all the marketing claims made but Bayer took a more systematic approach. Chapter 1: Understanding the Pharmaceutical Industry 3 Both commercial and medical factors contributed to the drug’s success. Aggressive advertising hammered aspirin’s reassuringly non-technical name into the public consciousness, while astute lawyers defended its trademark status in every important marketplace. Taking a tablet to relieve distress quickly became an integral part of western culture. The national rivalries and conflicts that characterised this period also had their impact on the developing industry. Bayer had the aspirin trademark and its US assets seized during World War I, whilst “American” Merck (now Merck & Co. in the US or Merck Sharp & Dohme [MSD] elsewhere) was compulsorily
Load more

Recommended publications
  • Pain-Relievers
    Pain-Relievers Pain. It is a common experience though the cause Ibuprofen/Naproxen and severity differ greatly. Lucky for us there are pain-relievers (analgesics). Purpose: To reduce inflammation, reduce pain (E.g. Headache, mild or moderate pain. More Which pain- effective than aspirin or reliever will be acetaminophen for relief the most menstrual cramps effective one (dysmenorrhea). for you? Adverse Reactions: Commonly used nausea, heartburn, pain relievers diarrhea, indigestion, are not only abdominal discomfort, used for mild bleeding and ulcers. pain but also fever reduction and inflammation. Choose your pain reliever wisely for the most Examples: Advil, Motrin, Nuprin, Metaprin. effective treatment possible. The following Aleve and naproxen are similar to ibuprofen, information will give you a brief outline for each but last longer. All must be taken with food. commonly used pain relieving substance. Not recommended for use by pregnant or There are generic forms of each of the pain breast-feeding women. relievers. The generic pain relievers are as effective as the “Name Brand” pain relievers, and Avoid if any history of aspirin sensitivity. cost considerably less. For more information ask your pharmacist or health practitioner. Acetaminophen Aspirin Purpose: reduce pain, reduce fever Purpose: To reduce inflammation, pain, fever, (E.g. headache, and low intensity pain (E.g. headache, joint fever) pain, muscle pain) Adverse Adverse Reactions: skin rash, hives, shortness Reactions: of breath, asthma, shock, edema (swelling), Stomach irritation, stomach irritation, bleeding and ulcers. skin rash much less common than with Examples: Bayer aspirin. Aspirin, Bayer Timed Release, generic Examples: Tylenol, Panadol, Aspirin Free, aspirin. Anacin and Apap.
    [Show full text]
  • Synthesis of Aspirin
    SYNTHESIS OF ASPIRIN I. OBJECTIVES AND BACKGROUND You will: synthesize acetylsalicylic acid (aspirin) by carrying out a simple organic reaction, separate your product from the reaction mixture by vacuum filtration, purify your product by recrystallization, perform a chemical test to identify the change in functional group from reactant to product, and determine the success of your synthesis by calculating the percentage yield of your product. INTRODUCTION Aspirin is one of the most widely used medications in the world. It is employed as an analgesic (pain relief), an anti-pyretic (fever control) and an anti-inflammatory. More recently, studies have indicated that daily intake of small doses of aspirin can lower the risk of heart attack and stroke in high-risk patients. The history of aspirin and its precursor dates back to ancient times. Documents attributed to Hippocrates, the father of modern medicine, from the 4th century B.C. refer to the alleviation of pain by chewing on the bark of a willow tree or ingesting a powder made from the bark and leaves of the willow. This remedy was passed on from generation to generation. Fast forward now to the 19th century, where the field of organic chemistry began to experience tremendous growth. By 1838, chemists had managed to isolate, purify and identify the component of willow bark that provided the analgesic benefit. The compound was named salicylic acid, which was based on the genus name of the willow. Efforts to market salicylic acid met with failure, due to an unfortunate side effect-- prolonged ingestion of salicylic acid led to stomach pain, and in some cases, ulcers.
    [Show full text]
  • Attenuated Total Reflection Infrared Spectroscopy (ATR-IR) As an in Situ Technique for Dissolution Studies Abe S
    Seton Hall University eRepository @ Seton Hall Seton Hall University Dissertations and Theses Seton Hall University Dissertations and Theses (ETDs) Summer 8-2011 Attenuated Total Reflection Infrared Spectroscopy (ATR-IR) as an In Situ Technique for Dissolution Studies Abe S. Kassis Seton Hall University Follow this and additional works at: https://scholarship.shu.edu/dissertations Part of the Biochemistry Commons Recommended Citation Kassis, Abe S., "Attenuated Total Reflection Infrared Spectroscopy (ATR-IR) as an In Situ Technique for Dissolution Studies" (2011). Seton Hall University Dissertations and Theses (ETDs). 1432. https://scholarship.shu.edu/dissertations/1432 Attenuated Total Reflection Infrared Spectroscopy (ATR-IR) as an In Situ Technique for Dissolution Studies by Abe S. Kassis Ph.D. DISSERTATION Submitted in partial fulfillment of the requirements for the degree of Doctor of Philosophy in the Department of Chemistry and Biochemistry of Seton Hall University Seton Hall University Department of Chemistry and Biochemistry 400 South Orange Avenue South Orange, New Jersey 07079 August 2011 DISSERTATION COMMITTEE APPROVALS We certify that we have read this thesis and that in our opinion it is sufficient in scientific scope and quality as a dissertation for the degree of Doctor of Philosophy APPROVED BY: Advisor, Seton Hall University Nicholas H. Snow, Ph.D. Member of Dissertation Committee, Seton Hall University Tarun ~el, Ph.D. Member of Dissertation Committee, Novartis Pharmaceuticals Corporation Q\A"b A lM~ en P. KeI;y, Ph.D. Chair, Department ofChemistry and Biochemistry, Seton Hall University [ii] "Although nature commences with reason and ends in experience it is necessary for us to do the opposite, that is to commence with experience and from this to proceed to investigate the reason." -Leonardo da Vinci [iii] Abstract Attenuated Total Reflection Infrared Spectroscopy (ATR-IR) as an in situ Technique for Dissolution Studies Dissolution studies are critical tests for measuring the performance, or rate of release, of a drug product.
    [Show full text]
  • A History of Aspirin
    Physicians, Fads, and Pharmaceuticals: A History of Aspirin Anne Adina Judith Andermann*, B.Sc., M.Phil. Cantab * To whom correspondence should be addressed: Faculty of Medicine, McGill University, 3655 Drummond St., Montreal, QC, Canada H3G 1Y6"Politics is not out there in society. Politics is down there in the laboratory." --Bruno Latour (1). Aspirin is a product of the late-nineteenth-century laboratory, pharmaceutical industry, and medical community. The prevailing scientific techniques, industrial approaches, and medical beliefs were instrumental in the development, promotion and reception of the drug. As a result, the present account does not extend further back than a few decades prior to the release of aspirin from the laboratories of Farbenfabriken vormals Friedrich Bayer & Co. in 1899. In contrast, much of the current literature on aspirin (2,3,4) attempts to trace the compound back to antiquity through the Ebers papyrus, the Hippocratic writings, and the works of Galen. Such histories tell a simple, linear tale of the numerous "discoveries" proposed to have led to the use of certain salicylate-containing plants, such as willow bark and wintergreen, or salicylate-related compounds, including salicilin and salicylic acid, as cures for a variety of ailments. Indeed, according to Mann and Plummer: Both [salicilin and salicylic acid] attacked fever and pain, and their partisans advocated the salicylates' use as antiseptics, mouthwashes, and water preservatives for ocean voyages; one important chemist further suggested (erroneously) that sodium salicylate, a chemical relative, would successfully treat scarlet fever, diphtheria, measles, syphilis, cholera, rabies and anthrax (5). However, it is difficult to establish what effect, if any, these examples of the "historical" uses of "proto-aspirin" had on the impetus for and modes of developing and using the actual drug called aspirin.
    [Show full text]
  • Aspirin a Curriculum Resource for Post-16 Chemistry and Science Courses
    Aspirin A curriculum resource for post-16 chemistry and science courses 1 Aspirin (2nd edition) Compiled by David Lewis Edited by Colin Osborne and Maria Pack Designed by Imogen Bertin and Sara Roberts First published by the Royal Society of Chemistry in 1998 Second edition published by the Royal Society of Chemistry in 2003 Printed by the Royal Society of Chemistry Copyright © Royal Society of Chemistry 2003 Registered charity No. 207890 Apart from any fair dealing for the purposes of research or private study, or criticism or review, as permitted under the UK Copyright Designs and Patents Act, 1988, this publication may not be reproduced, stored, or transmitted, in any form or by any means, without the prior permission in writing of the publishers, or in the case of reprographic reproduction, only in accordance with the terms of the licences issued by the Copyright Licensing Agency in the UK, or in accordance with the terms of licences issued by the appropriate Reproduction Rights Organisation outside the UK. Enquiries concerning reproduction outside the terms stated here should be sent to the Royal Society of Chemistry at the London address printed on this page. Notice to all UK Educational Institutions. The material in this book may be reproduced by photocopying for distribution and use by students within the purchasing institution providing no more than 50% of the work is reproduced in this way for any one purpose. Tutors wishing to reproduce material beyond this limit or to reproduce the work by other means such as electronic should first seek the permission of the Society.
    [Show full text]
  • 30. Synthesis of an Analgesic: Aspirin
    30. Synthesis of an Analgesic: Aspirin A. Background Aspirin (acetylsalicylic acid) belongs to a class of drugs known as nonsteroidal anti-inflammatory drugs (NSAIDs), which work by blocking the synthesis of prostaglandins in the body. Before exploring the chemistry of aspirin, one should understand the biological process of inflammation. Inflammation in the body occurs in response to the presence of harmful stimuli including: the presence of a foreign organism, nerve damage, and tissue irritation. Symptoms of inflammation include: redness, swelling, pain, and loss of mobility at the affected site. The experience of pain in the body begins with some stimulus that invokes an immune response. To combat the stimulus, the brain signals the body to begin a number of biological cascade reactions that include the synthesis of histamine, bradykinin, and prostaglandins, all of which contribute to the experience of inflammation and pain. During an inflammation response, prostaglandins are synthesized from the ω-6 fatty acid, arachidonic acid, which O comes from our diet and can be OH synthesized in the body from linoleic acid. An important enzyme arachidonic acid in the conversion of arachidonic acid to prostaglandins is Cyclooxygenase-1 (COX-1) cyclooxygenase-1 (COX-1) which abstracts a hydrogen atom from O arachidonic acid to produce a radical intermediate. This reactive OH intermediate then undergoes a number of subsequent steps, eventually leading to the Steps production of prostaglandins (PGE2 is shown). Most anti- inflammatory drugs work by O inhibiting the prostaglandin synthesis pathway in some O OH manner. In the case of Aspirin, the COX-1 enzyme is deactivated by Prostaglandin PGE2 transfer of the aspirin acetyl group to an important –OH moiety of the HO COX enzyme.
    [Show full text]
  • Chemistry: Essay
    CHEMISTRY: ESSAY The History of Aspirin "The active ingredient in Aspirin, acetylsalicylic acid, was synthesised for the first time in a chemically pure and thus stable form in 1897 by a young chemist working for Bayer, Dr. Felix Hoffmann.” – Bayer Aspirin, chemically known as acetylsalicylic acid, is a versatile drug that treats a number of pains, from reducing fever to relieving joint pains. Acetylsalicylic acid was first produced in 1853 by French chemist Charles Frederic Gerhardt. However, 1897 saw German chemist Felix Hoffmann study Gerhardt’s experiments and as a result, truly “rediscovered” acetylsalicylic acid. Bayer, a German chemical and pharmaceutical company soon dubbed this drug as we now know it – aspirin, or the wonder drug. Aspirin-like substances date back to the Ancient Romans, in which willow bark was used as a means of reducing fever. The leaves and bark of the willow tree contain a similar chemical to acetylsalicylic acid called salicin, a naturally occurring compound. In 1763, English chaplain Edward Stone discovered this active ingredient, announcing at the Royal Society its potent ability to treat aches, fatigue, inflammation and other fever-like symptoms. Following this, several scientists of 19th century Europe sought to extract modest yields of salicin from willow bark. By the 1830s, salicylic acid was first discovered by Swiss pharmacist Johann Pagenstecher and later by Italian chemist Raffaele Piria. Initially, both scientists had not realised that they had discovered the same, new pain-reducing substance. However, it was only until 1890 that Carl Duisberg, head of research at Bayer, expanded the company’s research program by employing several pharmaceutical research teams, one of which included young Felix Hoffmann.
    [Show full text]
  • The Aspirin Wars: Money, Medicine, and 100 Years of Rampant Competition
    Georgetown University Law Center Scholarship @ GEORGETOWN LAW 1992 Book Review: The Aspirin Wars: Money, Medicine, and 100 Years of Rampant Competition Joseph A. Page Georgetown University Law Center, [email protected] This paper can be downloaded free of charge from: https://scholarship.law.georgetown.edu/facpub/1146 47 Food & Drug L.J. 459-481 (1992) (reviewing Charles C. Mann & Mark Plummer, The Aspirin Wars: Money, Medicine, and 100 Years of Rampant Competition (1991)) This open-access article is brought to you by the Georgetown Law Library. Posted with permission of the author. Follow this and additional works at: https://scholarship.law.georgetown.edu/facpub Part of the Food and Drug Law Commons, and the Marketing Law Commons Book Review jOSEPH A. PAGE* The Aspirin Wars: Money, Medicine, and 100 Years of Rampant Com­ petition, by Charles C. Mann and Mark Plummer. Published by Alfred A. Knopf, Inc. (201 E. 50th St., New York, N.Y. 10022) (1991). 420 pages. $25.00. l. INTRODUCTION The recent identification of a possible link between the long-term use of aspirin and a reduced incidence of colon and rectal cancer1 has directed renewed attention to a familiar household medication whose origins reach back to antiquity.2 Competition from other painkillers had begun to cut deeply into the market once dominated by aspirin-based products3 when studies indicated the possibilities, first that the regular consumption of aspirin might pre­ vent second heart attacks,4 and later that it might lower the risk of heart attacks in healthy individuals.5 If these two discoveries, as well as the new finding about colon and rectal cancers, hold up under further scientific scrutiny and gain acceptance within the medical and regulatory communi­ ties, the growth potential for the sale of medicines made from acetylsali­ cylic acid (the chemical name for aspirin) would be virtually unlimited.
    [Show full text]
  • The Novel Aspirin As Breakthrough Drug for COVID-19: a Narrative Review
    IBEROAMERICAN JOURNAL OF MEDICINE 00 (2020) XXX–XXX Journal homepage: www.iberoamericanjm.tk Review The Novel Aspirin as Breakthrough Drug for COVID-19: A Narrative Review Bamidele Johnson Alegbeleyea,* , Oke-Oghene Philomena Akpovesob, Adewale James Alegbeleyec, Rana Kadhim Mohammedd, Eduardo Esteban-Zuberoe aDepartment of Surgery, St Elizabeth Catholic General Hospital, Shisong, Northwestern Region, Cameroon bDepartment of Pharmacology, American International University West Africa, Kainifing, Gambia cDepartment of Geriantology, Basildon & Thurrock University Hospitals NHS Foundation Trust Nethermayne-Basildon, United Kingdom dDepartment of Biotechnology, College of Science, University of Baghdad, Iraq eEmergency Department, Hospital San Pedro, Logroño, Spain ARTICLE INFO ABSTRACT Article history: Introduction: Aspirin has justifiably been called the first miracle drug. In this article, we highlight the Received 30 June history of Aspirin, a novel mechanism of action, and its use in cardiovascular and other diseases. Also 2020 included is a brief statement of emerging new applications. Received in revised Objective: We highlight principal mechanisms by which Aspirin inhibits acute inflammation and alters platelet-biology; therefore, hypothesized that Aspirin might prove highly beneficial as a novel form 26 July 2020 therapeutic drug for combating severe acute inflammation and thrombosis associated with the Accepted 28 July cytokine storm in COVID -19 patients. The communiqué also suggests possible strategies for 2020 maximizing the gain of Aspirin as a wonder-drug of the future. Discussion: Interestingly, some fascinating studies demonstrated Aspirin's superior benefits with Keywords: dangerous side effects. Aspirin inhibits COX-1 (cyclooxygenase-1). Its impact on COX-2 is more Aspirin delicate because it “turns off” COX-2's production of prostaglandins but “switches on” the enzymatic COVID-19 ability to produce novel protective lipid mediators.
    [Show full text]
  • Take an Aspirin (Or Two) and Call (Or Text Or Email) Me (Or Us) in the Morning (Or Later)
    Take an Aspirin (or Two) and Call (or Text or Email) Me (or Us) in the Morning (or Later) Michael Mendoza, MD, MPH, MS Assistant Professor, Department of Family Medicine and Department of Public Health Sciences Medical Director, Highland Family Medicine Public Health Grand Rounds November 7, 2014 Objectives At the end of this presentation, I hope you will: 1. Understand the complexity surrounding aspirin use for primary and secondary prevention of cardiovascular disease, 2. Define evidence based practice and describe two major barriers to evidence based practice, and 3. Appreciate that eliminating these barriers can pave the way for advances in clinical care and population health. 2 Early History of Aspirin . 1543 BC – Medicines made from willow and other salicylate-rich plants appear in Egyptian pharonic pharmacology papyri . 460 BC – Hippocrates described the use of powder of the willow tree, so-called “salicylic tea” to reduce fevers . 1763 – Edward Stone comes upon the bark of the willow tree by accident, credit with discovering aspirin 3 4 Modern Discovery of Aspirin . 1800s – Lewis and Clark allegedly used willow bark tea as a remedy for fever for members of the famous expedition. 1838 – Salicylic acid is discovered and used by physicians throughout the mid-19th century to treat pain, fever, inflammation. Gastric irritation is well-described. 1853 – Charles Frederic Gerhardt isolated acetylsalicylic acid. 1897 – Chemists (Felix Hoffman) produced a pure (and stable) form of ASA, named Aspirin® by Bayer o Felix Hoffman goes on to develop diacetylmorphine which Bayer named “heroin” because it made people feel heroic. o Jewish chemist Arthur Eichengrun claimed ownership, records expunged by Nazis.
    [Show full text]
  • Women, Gender, and Health Susan L
    Keeling_FM_3rd.qxp 2/9/2007 4:43 PM Page i Women, Gender, and Health Susan L. Smith and Nancy Tomes, Series Editors Keeling_FM_3rd.qxp 2/9/2007 4:43 PM Page ii Keeling_FM_3rd.qxp 2/9/2007 4:43 PM Page iii Nursing and the Privilege of Prescription, 1893–2000 Arlene W. Keeling The Ohio State University Press Columbus Keeling_FM_3rd.qxp 2/9/2007 4:43 PM Page iv Copyright © 2007 by The Ohio State University. All rights reserved. Cataloging-in-Publication Data Keeling, Arlene W., 1948– Nursing and the privilege of prescription, 1893–2000 / Arlene W. Keeling. p. ; cm. — (Women, gender, and health) Includes bibliographical references and index. ISBN-13: 978-0-8142-1050-5 (cloth : alk. paper) ISBN-10: 0-8142-1050-3 (cloth : alk. paper) 1. Nursing—United States—History—20th century. 2. Drugs— Prescribing—United States—History—20th century. I. Title. II. Series. [DNLM: 1. Nursing Services—history—United States. 2. History, 19th Century—United States. 3. History, 20th Century—United States. 4. Nurse's Role—history—United States. 5. Prescriptions, Drug— history—United States. WY 11 AA1 K26n 2007] RT31.K444 2007 610.73—dc22 2006025073 Cover design by Jay Bastian Type set in Adobe Garamond Printed by Thomson-Shore, Inc. The paper used in this publication meets the minimum requirements of the American National Standard for Information Sciences— Permanence of paper for Printed Library Materials. ANSI Z39.48-1992. 9 8 7 6 5 4 3 2 1 Keeling_FM_3rd.qxp 2/9/2007 4:43 PM Page v This book is dedicated to my mother, Charlotte Elizabeth Prins Wynbeek, who introduced me to the world of the library and instilled in me a love of women’s history.
    [Show full text]
  • Pharmacodynamics and Pharmacokinetics of Aspirin in Pediatric Patients
    Research Article Annals of Clinical Pharmacology and Therapeutics Published: 15 Oct, 2019 Pharmacodynamics and Pharmacokinetics of Aspirin in Pediatric Patients Maddalena Padrini1, Luca Spiezia2, Giovanni De Rosa3, Paolo Simioni2, Ornella Milanesi1 and Roberto Padrini3* 1Department of Women’s and Children’s Health, Pediatric Cardiology Unit, University of Padova, Italy 2Department of Medicine, Thrombotic, Hemorrhagic and Coagulation Diseases Unit, University of Padova, Italy 3Department of Medicine, Clinical Pharmacology Unit, University of Padova, Italy Abstract Objective: To investigate pharmacodynamic and pharmacokinetic variability of aspirin in children and adolescents on antithrombotic prophylaxis for cardiac diseases. Methods: Twenty-nine patients, aged between 6 months and 18 years, on stable Aspirin (ASA) treatment for at least one week were the study population. At 4, 5 and 6 hours after drug administration blood samples were collected to assay plasma concentrations of ASA and Salicylic Acid (SA), and arachidonic-induced platelet aggregation (Multiplate® analyzer). Residual platelet reactivity was measured by impedance change over 6 min and expressed as arbitrary units (U). The area under the concentration-time curves of ASA (AUCASA) and SA (AUCSA) from 4 h to 6 h were calculated and correlated with the corresponding platelet reactivity measure (U). Results: Platelet reactivity, AUCASA, AUCSA and AUCSA/AUCASA were highly variable among subjects. According to pre-set U cut-off values (<21, 21-28, >28), 54.2% of patients were full responders, 8.3% partial responders and 37.5% poor responders. Antiplatelet effect of ASA correlated inversely with AUCASA and directly with AUCSA/AUCASA ratio (as a marker of ASA deacetylation rate). No thromboembolic or bleeding complications were recorded during follow-up.
    [Show full text]