PPT-Improving Adverse Drug Reaction Information in Product Labe

PSI Conference May 2017 Sally Lettis GlaxoSmithKline The views and opinions expressed in the following slides are those of the individual presenter and should not be attributed to any organization with which the presenter is employed or affiliated . Zarif Jabbar-Lopez, MBBS, MPH. FY2, East of England Deanery. Visiting Research Fellow, Uppsala Monitoring Centre. Disclosure. No conflicts of interest. The . research leading to these results was conducted as part of the PROTECT consortium (. Presentation to HL7 Patient Care WG . Draft Recommendations for Canadian Standards (being discussed). NB: HL7 . meeting discussion notes are included on slide 21. . Post meeting notes from . Russell B. Leftwich, M.D.,  . www.dentalelle.com. Pharmacology . ADVERSE REACTIONS. CHAPTER THREE. OBJECTIVES. Define and explain . the adverse reactions to drugs.. Explain the different types of adverse reactions that can occur such as . Teaching Aims. You will learn all about adverse donor reaction and prevention of certain reactions. . You will learn to define, identify/diagnose and handle all the reactions.. Adverse Donor Reactions. Objectives . Explain . Pharmacovigilance & various types of adverse drug reactions. . List . some common adverse effects & toxicities with examples. . Discuss . drug dependence & its public health importance. . PSI Conference . May 2017 . Sally Lettis GlaxoSmithKline. The . views and opinions expressed in the following . slides . are those of the individual . presenter and should not be attributed to any organization with which the presenter is employed or affiliated. . The Elephant in the Room: Meaningful Communication of Near Synonyms as Suspected Adverse Reactions A Perspicacious CIOMS View of a Sometimes Tangled Mass of Adverse Reaction Communication Challenges Session #282 Product BenefitsLABE ARMORTMTypical PropertiesColorBlueHardness Shore ATensileStrength MPa88Elongation Contact UsFeatured BenefitsApplicationsSeals for Plasma Equipment Plasma AshingEquipmentChillers 1149Pharmacovigilance149Adverse event149Adverse reaction150Unexpected adverse reaction150Serious adverse reaction 149Side effect149Signal149Causality2Definitions149Organisationsinvolved150WHO -World . Serious Adverse Drug Reaction . and Medical Device Incident . Reporting. . Outline . Protecting Canadians from Unsafe Drugs Act . (also known as Vanessa’s Law). Mandatory Reporting . Who is required to report?. Dermatitis. Diarrhea/colitis . Endocrinopathies. including hyper or hypothyroidism, adrenal insufficiency or diabetes (including diabetic ketoacidosis). Other toxicities including: cardiac, ocular, hematological, myopathies and neurological (including paresis, Guillain-Barré and encephalitis). Yousef Ahmed . Alomi. , . Nouf. Hassan . Alamoudi. , . Sabah . Alanazi. , . Abeer. . Hussin. . Almasoudi. ABSTRACT: . Objective: . . To state the physicians and dentists’ knowledge and responsiveness of the adverse drug reaction (ADR) and reporting system in Saudi Arabia. . . Any noxious change which is . Suspected to be due to a drug. At. doses normally . used in man. May requires treatment or decrease in dose or . Caution in the future use of the same drug. ADVERSE DRUG EVENT (ADE. Investigator Kick-off Meeting. January 30-31, Clearwater, Florida. Jodie Riley, MISM and Robert Silbergleit. Adverse Events. Adverse Events (AEs) are “. . . any . untoward. medical occurrence in a subject that was not previously identified which does not necessarily have a causal relationship to the study drug…” .