DOCSLIB.ORG

Pharmacogenetics & Introduction to Treatgxplus

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Pharmacogenetics & Introduction to Treatgxplus Guide to Pharmacogenetics & Introduction to TreatGxplus Designed and tested in Canada LifeLabs Genetics 1 Table of Contents Pharmacogenetics (PGx) ..................................................................................................................................................................4 1. Definition & role in personalized medicine ..........................................................................................................................................5 2. Types of genetic variations .........................................................................................................................................................................6 Single Nucleotide Polymorphisms ..........................................................................................................................................................6 Copy Number Variants .................................................................................................................................................................................6 Human Leukocyte Antigens .....................................................................................................................................................................6 3. Pharmacokinetic vs pharmacodynamic effects ................................................................................................................................7 Pharmacokinetics ..........................................................................................................................................................................................7 Pharmacodynamics ......................................................................................................................................................................................7 4. Commonly prescribed medications affected by PGx......................................................................................................................8 5. Who can benefit from pharmacogenetic testing? ............................................................................................................................9 6. Implementation in pharmaceutical care ............................................................................................................................................10 6.1. Benefits ............................................................................................................................................................................................11 6.2. Barriers ............................................................................................................................................................................................12 7. Literature and guidelines ..........................................................................................................................................................................14 2 LifeLabs Genetics Guide toTreatGxplus ............................................................................................................................................................................16 1. TreatGxplus pharmacogenetic test .........................................................................................................................................................17 1.1. Kit contents ....................................................................................................................................................................................17 1.2. Sample collection .........................................................................................................................................................................17 1.3. Patient account creation ..........................................................................................................................................................18 1.4. Healthcare provider account creation ................................................................................................................................18 1.5. Accepting patient invitations for corporate accounts .................................................................................................18 1.6. Lab technology ............................................................................................................................................................................19 1.7. Processing time ............................................................................................................................................................................19 1.8. Conditions covered by TreatGx ..............................................................................................................................................19 2. TreatGxplus pharmacogenetic report ....................................................................................................................................................20 2.1. Report overview ...........................................................................................................................................................................20 2.2. Medication summary..................................................................................................................................................................20 2.3. Medication report ........................................................................................................................................................................20 2.4. Levels of evidence .......................................................................................................................................................................21 2.5. Guidelines .......................................................................................................................................................................................21 2.6. Laboratory report ........................................................................................................................................................................21 3. TreatGx clinical decision support software ..................................................................................................................................22 3.1. Conditions .......................................................................................................................................................................................22 3.2. Patient factors ...............................................................................................................................................................................22 3.3. Medication options ......................................................................................................................................................................23 3.4. Drug-drug, drug-condition, drug-gene interactions .....................................................................................................23 3.5. Limitations ......................................................................................................................................................................................23 4. Comparison of TreatGxplus with other PGx testing services ......................................................................................................24 5. Support ............................................................................................................................................................................................................25 5.1. Resources ........................................................................................................................................................................................25 6. Patient communication & education ...................................................................................................................................................26 Frequently Asked Questions ..............................................................................................................................................................................28 References .................................................................................................................................................................................................................31 LifeLabs Genetics 3 Pharmacogenetics (PGx) 4 LifeLabs Genetics 1. Definition & role in personalized medicine Pharmacogenetics: how a single genetic variant influences medication response Pharmacogenomic: how all genes (the genome) influence medication response Personalized or ‘precision’ medicine involves using patient-specific information to tailor therapy, and incorporates many different patient factors, but usually refers to the use of genetic information. Pharmacogenetic information can help clinicians optimize medication selection, dose, treatment duration and avoid adverse drug reactions (Figure 1). In addition, pharmacogenetics can provide new insights into mechanisms of drug action and contribute to the development of new therapeutic agents.1 It has been suggested that pharmacogenetics should be integrated into clinical pharmacy practice through medication therapy management to improve the quality and safety of patient care.2 Figure 1. Effects of pharmacotherapy with and without pharmacogenetics3
Load more

Recommended publications
  • Is It Compatible with Breastfeeding?
    International Journal of Medical Informatics 141 (2020) 104199 Contents lists available at ScienceDirect International Journal of Medical Informatics journal homepage: www.elsevier.com/locate/ijmedinf Is it compatible with breastfeeding? www.e-lactancia.org: Analysis of visits, T user profile and most visited products José María Paricio-Talayeroa, Desirée Mena-Tudelab,*, Águeda Cervera-Gaschb, Víctor Manuel González-Chordáb, Yasmin Paricio-Burtina, Marta Sánchez-Palomaresa, Nerea Casas-Maesoa,c, Silvia Moyano-Pellicera, Konstantina Gianniotia,c, Alberto Hearta, Leonardo Landa-Riveraa a Association for the Promotion of and Scientific and Cultural Research into Breastfeeding (APILAM), Spain b Department of Nursing. UniversitatJaume I. Castellón de la Plana, Spain c International Board Certified Lactation Consultant (IBCLC), Spain ARTICLE INFO ABSTRACT Keywords: Introduction: One of the factors to influence abandoning breastfeeding is mothers’ use of medications. The www. Breast feeding e-lactancia.org website is a reliable source in Spanish and English for online free-access information about the Pharmaceutical preparations compatibility of medications with breastfeeding. The aim of this study was to analyse the search profiles, and Information storage and retrieval groups and products, searched the most on this website. Product labelling Materials and methods: A retrospective and descriptive study of the e-lactancia.org website during 2014–2018. Drug labelling Google Analytics was used for data collection. The following variables were analysed: number of users and Telemedicine queries; professional profile; country; language; users’ and groups’ access modes/devices; most searched pro- ducts. Results: We found 16,821.559 users and 63,783.866 pages. Of users, 62.7 % were “mother/father”, and 31.9 % were health professionals.
    [Show full text]
  • Labelling Project 99/00
    PO Box 100 Woden ACT 2606 Australia Telephone: (02) 6232 8444 Facsimile: (02) 6232 8241 Labelling project 99/00 Effective by design A discussion paper on possible reforms to the regulation of the labelling of medicines in Australia April 2000 ii You are invited to comment All interested parties are invited to respond to this paper. Specific questions and recommendations are placed within the text as a guide for responses. However, while answers to these will be helpful to us, your responses do not have to be restricted by these. Please send submissions to: Labelling Project 99/00 Review of Drugs and Poisons Legislation Branch (MDP88) PO Box 100 WODEN ACT 2606 Submissions will normally be regarded as public documents. If you wish any material to remain confidential, please identify this material and provided the basis for its confidential nature. Because comments on the matter of moving warnings on medicine labels out of the Standard for the Uniform Scheduling of Drugs and Poisons is required to feed into the Review of Drugs, Poisons and Controlled Substances Legislation, but stakeholders may need more time to consider the other issues, it is necessary to split the comments deadline dates. Closing dates for submissions: Friday 26 May 2000 for comments on SUSDP warnings movement to therapeutic goods legislation Friday 23 June 2000 for comments on the paper as a whole i ii Contents You are invited to comment .................................................................. i Summary ....................................................................................
    [Show full text]
  • Sandoz Closes in on US Filgrastim Biosimilar
    Gen 16-1-15 Pg.1_Gen 18/11/05 Pg. 1 13/01/2015 16:40 Page 1 16 January2015 COMPANY NEWS 2 Sandoz closes in on US Abdi Ibrahim teams with Algerian player 2 Kremers deal falters 3 after US FDAaction Tianyin teams up to tackle its troubles 4 filgrastim biosimilar nod Apotex and Panacea allyovertwo drugs 5 US business booms to aid Zydus Cadila 6 andoz has taken amajor step towards securing the first approvalthrough the US Strides starts work on Malaysian facility 7 Sbiosimilar pathway after an advisory panel to the US Food and Drug Administration Walgreens completes 8 (FDA) recommended the agency should approve the company’s EP2006 filgrastim Alliance Boots deal candidate with all the same indications as its reference product, Amgen’s Neupogen. “Weare pleased with the Oncologic Drugs Advisory Committee’s(ODAC’s)recommendation MARKET NEWS 9 to approve our biosimilarfilgrastim and we look forward to continuing to work with FDAas it completes its reviewof our filing,”said Sandoz’ Mark McCamish. If the agencyfollows Suspensions in EU followGVK review 9 the committee’snon-binding advice, Sandoz proposes to market biosimilarfilgrastim pre- Four firms shareinSouth African tender 11 filled syringes in the US under the brand name Zarxio. Abriefing documentfor the ODAC meeting on 7January stated that “considering the Te va takes top spot among AOKawards 12 totality of the evidence, the data submitted by the applicant showthat EP2006 is highly similar GPhA voices concern 13 to US-licensed Neupogen. The clinical data have shown that there are no clinically meaningful over TPP provisions differencesbetween EP2006 and US-licensed Neupogen, suggesting that EP2006 should receive Russia mayconsider compulsorylicensing 14 licensure for each of the five indications for which Neupogen is currently licensed”.
    [Show full text]
  • Precision Medicine and Adverse Drug Reactions Related to Cardiovascular Drugs †
    diseases Review Precision Medicine and Adverse Drug Reactions Related to Cardiovascular Drugs † James D. Noyes 1 , Ify R. Mordi 1 , Alexander S. Doney 2, Rahman Jamal 3 and Chim C. Lang 1,* 1 Division of Molecular and Clinical Medicine, School of Medicine, University of Dundee, Dundee DD1 9SY, UK; [email protected] (J.D.N.); [email protected] (I.R.M.) 2 Division of Population Health and Genomics, School of Medicine, University of Dundee, Dundee DD1 9SY, UK; [email protected] 3 UKM Medical Molecular Biology Institute, Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur 56000, Malaysia; [email protected] * Correspondence: [email protected]; Tel.: +44-1382-383283 † Precision medicine in cardiology. Abstract: Cardiovascular disease remains the leading global cause of death. Early intervention, with lifestyle advice alongside appropriate medical therapies, is fundamental to reduce patient mortality among high-risk individuals. For those who live with the daily challenges of cardiovascular disease, pharmacological management aims to relieve symptoms and prevent disease progression. Despite best efforts, prescription drugs are not without their adverse effects, which can cause significant patient morbidity and consequential economic burden for healthcare systems. Patients with cardiovascular diseases are often among the most vulnerable to adverse drug reactions due to multiple co-morbidities and advanced age. Examining a patient’s genome to assess for variants that may alter drug efficacy and susceptibility to adverse reactions underpins pharmacogenomics. This strategy is increasingly being implemented in clinical cardiology to tailor patient therapies. The Citation: Noyes, J.D.; Mordi, I.R.; Doney, A.S.; Jamal, R.; Lang, C.C.
    [Show full text]
  • Therapeutic Consequences of the Drug Lag 93 X Recent Developments, 1972 to 1974 ...•
    REGULATION AND DRUG DEVELOPMENT William M. Wardell and Louis Lasagna American Enterprise Institute for Public Policy Research Washington. D. C. CONTENTS INTRODUCTION .. ................... 1 PART ONE Science. Government, and the Current State of Affairs I PRE-1962 PRACTICES: THE EVOLUTION OF CON- TROLS OVER THERAPEUTIC DRUGS 5 II POST-1962 GUIDELINES AND PRACTICES 19 III THE NATURE OF EVIDENCE 27 IV WEIGHING THE EVIDENCE 37 V ECONOMICS AND DRUG DEVELOPMENT 45 PART TWO Lessons from Other Countries VI APPROACHES TO INTERNATIONAL COMPARISONS 51 VII PATTERNS OF INTRODUCTION OF NEW DRUGS IN BRITAIN AND THE UNITED STATES 55 VIII BRITISH USAGE AND AMERICAN AWARENESS OF SOME NEW DRUGS 79 IX THERAPEUTIC CONSEQUENCES OF THE DRUG LAG 93 X RECENT DEVELOPMENTS, 1972 TO 1974 ...•....... 109 PART THREE The Wider Issues XI THE INTENT OF CONGRESS AND THE NEEDS OF PATIENTS 127 XII THE RUBRICS REEXAMINED 135 XIII SUGGESTIONS FOR IMPROVEMENT. ............. .. 143 XIV CONCLUSIONS.................................... 161 APPENDIX: Definition of "Substantial Evidence" 167 NOTES 171 INTRODUCTION In the late 1950s the Congress of the United States began holding subcommittee hearings on various matters pertaining to the pharma­ ceutical industry. Two of the most vigorous and sensational were those chaired by Congressman Blatnik and by Senator Kefauver. They were highly critical of the quality of drug advertising, theevi­ dence for effectiveness of marketed pharmaceuticals, the allegedly monopolistic nature of the drug industry, and the price of medicines. The drug industry, accustomed to respect and gratitude from physicians and the public, was suddenly confronted with hostile, sensational newspaper headlines and stories and a rising wave of angry criticism.
    [Show full text]
  • Contents Regulatory Matters Safety of Medicines
    Prepared in collaboration with the WHO Collaborating Centre for International Drug Monitoring, Uppsala, Sweden The aim of the Newsletter is to No. 5, 2014 disseminate information on the safety and efficacy of pharmaceutical products, The WHO Pharmaceuticals Newsletter provides you with based on communications received the latest information on the safety of medicines and from our network of "drug legal actions taken by regulatory authorities across the information officers" and other world. It also provides signals from the Uppsala sources such as specialized Monitoring Centre's SIGNAL document. bulletins and journals, as well as partners in WHO. The information In addition to the usual features, this issue includes the is produced in the form of résumés summary of discussions from the eleventh meeting of in English, full texts of which may the WHO Advisory Committee on Safety of Medicinal be obtained on request from: Products (ACSoMP). Safety and Vigilance, EMP-HIS, World Health Organization, 1211 Geneva 27, Switzerland, E-mail address: [email protected] This Newsletter is also available on our Internet website: http://www.who.int/medicines Further information on adverse reactions may be obtained from the WHO Collaborating Centre for International Drug Monitoring Box 1051 751 40 Uppsala Tel: +46-18-65.60.60 Fax: +46-18-65.60.80 E-mail: [email protected] Internet: http://www.who-umc.org Contents Regulatory matters Safety of medicines Signal Feature © World Health Organization 2014 All rights reserved. Publications of the World Health Organization can be obtained from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: [email protected]).
    [Show full text]
  • Tallman Lettering. Project Report [Internet]
    Drug Labelling and the Application of TALLman Lettering Project Report March 2016 Institute for Safe Medication Practices Canada Institut pour l’utilisation sécuritaire des médicaments du Canada [email protected] www.ismp-canada.org 4711 Yonge Street, Suite 501 Toronto, Ontario M2N 6K8 telephone: 416-733-3131 1 toll free: 1-866-54-ISMPC (1-866-544-7672) fax: 416-733-1146 The Institute for Safe Medication Practices Canada (ISMP Canada) is an independent national not-for- profit agency committed to the advancement of medication safety in all healthcare settings. ISMP Canada works collaboratively with the health care community, regulatory agencies and policy makers, provincial, national and international patient safety organizations, the pharmaceutical industry and the public to promote safe medication practices. ISMP Canada’s mandate includes collection, review and analysis of medication incident and near-miss reports, identifying contributing factors and causes and making recommendations for the prevention of harmful medication incidents. Information on safe medication practices for knowledge translation is published and disseminated. Additional information about ISMP Canada, and its products and services, is available on the website: www.ismp-canada.org. Disclaimer The utmost care has been taken to ensure the accuracy of information presented in this report. Nonetheless, any person seeking to apply or consult the report is expected to use independent judgement in the context of individual circumstances. ISMP Canada makes no representation
    [Show full text]
  • NEW ERA in US PRESCRIPTION DRUG LABELING Ch.Teja *, Ch
    7572 Ch.Teja et al./ Elixir Pharmacy 44 (2012) 7572-7575 Available online at www.elixirpublishers.com (Elixir International Journal) Pharmacy Elixir Pharmacy 44 (2012) 7572-7575 NEW ERA IN US PRESCRIPTION DRUG LABELING Ch.Teja *, Ch. Dheeraj Reddy and G. Krishna Chaitanya, Balamuralidhar.V, T.M. Pramod Kumar, Department of Pharmaceutics, JSS College of Pharmacy, JSS University, Sri Shivarathreeshwara Nagar, Mysore- 570 015. ARTICLE INFO ABSTRACT Article history: The overview of the paper is to give an idea of prescription drug labeling in United States. Received: 15 January 2012; Prescription drug labeling helps in making labels more user friendly and which is an Received in revised form: immediate and important source of medication information for patients. Although patients 15 March 2012; may obtain useful information from prescription drug labeling, its main purpose is to give Accepted: 29 March 2012; healthcare professionals the information they need to prescribe drugs appropriately to the patients. FDA focused its effort on making labeling more informative and easy-to-read and Keywords minimize patient confusion and promote patient awareness on how to use a prescribed Prescription drug label, medicine safely and effectively, thereby reducing risk of medication error. The new drug United States, labeling requirements was initially applied to recently approved prescription drugs and the Labeling Preference, drugs that received approval for new use, and later it was applied in gradually to other drugs. Boxed Warning. As per the new format, the prescription information for newly approved products must meet specific graphical requirements, including the reorganization of critical information so that physicians can find the information quickly.
    [Show full text]
  • June 2017 Volume 40 Number 3
    June 2017 Volume 40 Number 3 AN INDEPENDENT REVIEW nps.org.au/australianprescriber CONTENTS EDITORIAL Retail genetics K Harvey, B Diug 86 ARTICLES Peptic ulcer disease and 91 non‑steroidal anti‑inflammatory drugs M Drini Management of Bell’s palsy 94 D Somasundara, F Sullivan Changing Australian medicine 98 names J Yik Genomic testing as a tool 101 to optimise drug therapy AA Somogyi, E Phillips DIAGNOSTIC TESTS Testing for coeliac disease 105 D Lewis, J Haridy, ED Newnham LETTERS TO THE EDITOR 88 FEATURES Medicinal mishap 109 Fatal azathioprine toxicity Book reviews Therapeutic Guidelines: Palliative Care. 110 Version 4 Therapeutic Guidelines: Gastrointestinal. 111 Version 6 NEW DRUGS 112 Brivaracetam for epilepsy Conjugated oestrogens/bazedoxifene for menopause Suvorexant for insomnia Venetoclax for chronic lymphocytic leukaemia VOLUME 40 : NUMBER 3 : JUNE 2017 EDITORIAL Retail genetics Ken Harvey General practitioners are increasingly encountering Some GPs have expressed disquiet at receiving test Adjunct associate professor1 patients who have paid for a genetic profile.1,2 These results they have not ordered and the interpretation Basia Diug direct-to-consumer tests are promoted through may be difficult. While knowledge in this area is Head of Undergraduate community pharmacies or other retailers, by mail increasing, in many specific clinical situations more Courses order or via the internet. They usually involve the work is required to ensure that test results will be Medical Education Research and Quality Unit1 collection of cellular material from cheek swabs or meaningfully translated into clinical practice in order saliva which is sent to a laboratory that analyses the 5 1 School of Public Health and to achieve best outcomes for the patient.
    [Show full text]
  • Prediction of Oral Drug Bioavailability: from Animal-Based Extrapolation Towards the Application of Physiologically-Based Pharmacokinetic Modelling and Simulation
    Prediction of oral drug bioavailability: from animal-based extrapolation towards the application of physiologically-based pharmacokinetic modelling and simulation A thesis submitted to the University of Manchester for the degree of Doctor of Philosophy in the Faculty of Medical and Human Sciences 2016 Andrés Miguel Olivares Morales Manchester Pharmacy School Table of contents Table of contents ........................................................................................................ 2 List of Figures ............................................................................................................. 7 List of Tables ............................................................................................................ 11 List of Abbreviations ............................................................................................... 13 Abstract ..................................................................................................................... 18 Declaration ................................................................................................................ 19 Copyright .................................................................................................................. 20 Acknowledgements ................................................................................................... 22 Chapter 1: General Introduction ............................................................................ 23 1.1 Introduction .....................................................................................................
    [Show full text]
  • Off-Label Drug Treatment and Related Problems in Children -A Register Based Investigation OFF-LABEL Elin Kimland DRUG TREATMENT and RELATED PROBLEMS in CHILDREN
    Thesis for licentiate degree 2006 Thesis for licentiate degree 2006 Off-label drug treatment and related problems in children -A register based investigation OFF-LABEL Elin Kimland DRUG TREATMENT AND RELATED PROBLEMS IN CHILDREN AND RELATED DRUG TREATMENT Elin Kimland Stockholm 2006 The Department of Laboratory Medicine, Division of Clinical Pharmacology, Karolinska Institutet, Karolinska University Hospital Huddinge, Stockholm, Sweden Off-label drug treatment and related problems in children –A register based investigation Elin Kimland Stockholm 2006 The previously published papers have been reproduced with kind permission of the publishers Springer-Verlag (European Journal of Clinical Pharmacology) and John Wiley and Sons Ltd (Pharmacoepidemiology & Drug Safety). © Elin Kimland, 2006 The previously published papers have been reproduced with kind permission of the Published and printed by Repro Print AB, Stockholm, Sweden publishers Springer-Verlag (European Journal of Clinical Pharmacology) and John ISBN 91-7140-684-0 Wiley and Sons Ltd (Pharmacoepidemiology & Drug Safety). ©Gävlegatan Elin Kimland, 12B 2006 Published2100 31 Stockholm and printed by Repro Print AB, Stockholm, Sweden ISBN 91-7140-684-0 2 Abstract Introduction: There is a lack of pediatric documentation concerning efficacy and safety of many drugs, which may contribute to off-label drug treatment and increase the risk for adverse drug reactions (ADRs). Aims: To; (I) analyse the frequency and characteristics of pediatric off-label prescribing; (II) investigate frequency of off-label drug prescribing in pediatric ADR reports; (III) analyse drug related problems, the extent of off-label drug treatment in pediatric questions to a Drug Information Centre (DIC) and pediatric literature information adding to the labelling of the drug in DIC answers.
    [Show full text]
  • An Investigation Into Over the Counter Painkiller Use
    Cusack et al.: Over the Counter Painkiller Use IUJHS June 2021 Volume 1 Issue 1 An Investigation into Over the Counter Painkiller Use Shane Cusack, Angeline D. Lagali and Andreia Stavrianos Department of Biological Sciences, Munster Technological University, Bishopstown, Cork, Ireland. Fourth Year BSc (Hons) Biomedical Science, Munster Technological University/ University College Cork. ABSTRACT This study comprises a survey to examine the use, risks, and awareness of over-the-counter (OTC) pain medication. The survey was a paper-based survey extended to the general public in Cork, Ireland from February 24th 2020 to March 14th 2020. A Microsoft Excel template (16.34 2020) was used to analyse the results of the 106 valid responses that were received. Responses showed that 105/106 individuals had taken an OTC painkiller in their lifetime. Paracetamol was the most used OTC painkiller with 98.1% of people having taken it in the past. The overall majority of individuals were aware of the risks associated with OTC painkiller use. However, there were a large number of people that were unaware of the serious risks and dangers. A higher proportion of individuals were willing to take a second dose sooner than recommended (41.9%), rather than a higher dose (36.2%), if they were in significant pain. In terms of taking a dose sooner than recommended; 43.7% of ibuprofen users and 35% of paracetamol users were unaware of the adverse health consequences. Regular users of OTC painkillers were generally more aware of the risks when compared to irregular users. This study supports the need for further education on the risks of OTC painkiller use as there was a large proportion of individuals willing to take higher doses than recommended, and many were unaware of the drug’s associated risks.
    [Show full text]