عناوین برنامه واهداف ADR ونقش آن در ایمنی دارویی محاسبات دارویی

Slides:



Advertisements
Similar presentations
429 pharmaceutical care Plan Refa’a AlAjmi. Goal of therpay A goal of therapy is the desired response or endpoint that you and your patient want to achieve.
Advertisements

Objectives Why we need DHCPL Situations that call for a DHCPL Definitions DHCPL itself–content, presentation, process Target audience Current and future.
Biomedical research methods. What are biomedical research methods? An integrated approach using chemical, mathematical and computer simulations, in vitro.
FDA’s MedWatch Program Outreach to Healthcare Professionals and the Public n Managing the Risks of Medical Product Use.
FDA MedWatch and Patient Safety. Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006  The Act defines a ‘serious adverse event’
Clinical pharmacy Dr. Mohammed Al-Rekabi Lecture One First Semester.
Stages of drug development
Pharmacologic Principles Chapter 1, 2, 3. Understanding Nurses must understand both + and – effects of drugs Pharmacotherapeutics –u–use of drugs and.
 Pharmacovigilance – Patient’s standpoint Steve Arlington May 2007.
Eureka Pre-Clinical Investigation Animal toxicology Animal pharmacokinetics/ pharmacodynamics Clinical Investigation Phase I Safety and pharmacology Phase.
POSTMARKETING ADVERSE DRUG EXPERIENCE INSPECTIONAL PROGRAM CDR Thomas R. Berry, RPh FDA, Investigator RAL-RP / ATL-DO.
Cellular Products for Cardiac Diseases Dwaine Rieves, MD Center for Biologics Evaluation and Research FDA Perspective on:
Dr. Rosaline Kinuthia Clinical pharmacist KNH. Optimize patients outcomes through the judicious, safe, efficacious, appropriate and cost effective use.
PHARMACOVIGILANCE AND CLINICAL TRIALS DIVISION 20 August 2015 Victoria Falls Protecting Your Right to Quality Medicines and Medical Devices.
INTRODUCTION TO TOXICOLOGY SIDNEY GREEN, PH.D. DEPARTMENT OF PHARMACOLOGY COLLEGE OF MEDICINE HOWARD UNIVERISTY.
Biomedical Research Objective 2 Biomedical Research Methods.
Investigational Drugs in the hospital. + What is Investigational Drug? Investigational or experimental drugs are new drugs that have not yet been approved.
Dietary Supplements. Definition by DSHEA Product that is to supplement a healthy diet. Includes ingredients such as vitamins, minerals, herbs, botanicals,
Sten Olsson WHO Programme Expert Uppsala Monitoring Centre Sweden
Application of Pharmacovigilance in post- marketing traditional Chinese medicine Hua-Wen Xin Wuhan General Hospital, Wuhan, China.
1 Best Practices in Stakeholder Involvement Paul J. Seligman, M.D., M.P.H. Associate Director, Safety Policy & Communication Center for Drug Evaluation.
METHODS TO STUDY DRUG SAFETY PROBLEMS animal experiments clinical trials epidemiological methods –spontaneous reporting case reports case series –Post-Marketing.
Definitions. Clinical pharmacy is the branch of Pharmacy where pharmacists provide patient care that optimizes the use of medication and promotes health,
DIETARY SUPPLEMENTS Dietary supplements are products that can be added to people’s diets. They include vitamins, minerals, herbs, and amino acids.
Technical Briefing Seminar September |1 | Methods to study medicine safety problems Mary R Couper Quality Assurance and Safety of Medicines.
Dr Shanthi Pal Quality Assurance and Safety of Medicines WHO
The FDA: Basic Facts It takes 12 to 15 years to develop a single drug Only 1 in 10,000 potential medications makes it completely through the process Only.
Defining Dietary Supplements Provided Courtesy of RD411.com Where dietitians go for information Review Date 11/11 G-0519.
Evidence Based Guidelines. Learning objectives Be familiar with the evidence based guidelines used in rural and remote practice Understand the use for.
In the early 1900 s Paul Ehrlich described an ideal drug as a magic bullet. magic bullet. Such a drug would be aimed precisely at a disease site and would.
The Dilemma of Diclofenac Injection for the Iranian Health System Authors: Shalviri G, Cheraghali M, Gholami K, Kamali E, Daryabari N Institution: Ministry.
Patient’s Medication Experience 1. Notes One of the important variables that if succeed it will affect in providing good pharmaceutical care. It is an.
PV of ARVs, November 2009, Dar Es Salaam 1 |1 | The need for Pharmacovigilance Shanthi Pal Quality Assurance and Safety of Medicines.
© 2007 Dechert LLP Pharmacovigilance Reporting and Analysis: Product Liability Concerns Diane P. Sullivan.
FDA1 Overview of Postmarketing Safety Surveillance in FDA (For Drugs and Biologics) Min Chen, M.S., R.Ph. Min Chen, M.S., R.Ph. Associate Director Division.
Signal identification and development I.Ralph Edwards.
Dr Mary Couper Quality Assurance and Safety of Medicines WHO
Pharmacovigilance WHO definition
European Patients’ Academy on Therapeutic Innovation Introduction to pharmacovigilance Monitoring the safety of medicines.
Pharmacovigilance Convention Centre, Symbiosis Lavale Campus, Pune.
Nutritional Supplements An Issue Everyone Needs to Know.
1 Pharmacovigilance & the New National Adverse Drug Reaction (ADR) Reporting System Michael Bonett, Quality Assessor Post-Licensing Directorate Medicines.
Clinical Trials.
CLINICAL TRIALS.
The Stages of a Clinical Trial
Efficacy and Safety of Medicines
By Rebecca Moulder GRIT 700
1 Introduction to Pharmacology.
Veterinary Pharmacovigilance Discussion
Mortality and Antithrombotics: Focus on FAERS Repository
Dietary Supplements: What you should know
9. Introduction to signal detection
Quality Assurance and Safety of Medicines
An Endocrinology Clinic in Dyslipidemia
Pharmacovigilance (PV)
Black Box Warning What You Need To Know.
7. aDSM slides - Indicators of aDSM implementation and programme management Multi-partner training package on active TB drug safety monitoring and management.
Government Regulations for Disease Prevention
Understanding PAD.
Professional Organizations
Pharmacovigilance & Adverse Drug Reactions Dr. Habab Khalid Elkheir
Pharmacovigilance Systems: Drug Safety Surveillance
The Role of the Private Vet
Medicines Safety Mary R. Couper
Patient Involvement in the Development and Safe Use of
Iranian Pharmacovigilance Center
Quality Assurance and Safety of Medicines
Objective 2 Biomedical Research Methods
Pharmacovigilance.
Design Issues in Human studies of Psychopharmacology placebo controls double blind studies.
Presentation transcript:

عناوین برنامه واهداف ADR ونقش آن در ایمنی دارویی محاسبات دارویی نحوه رقیق کردن داروها و گاواژداروهای خوراکی خطاهای دارویی پزشکی

اهمیت ایمنی دارویی آسیب های جانی آسیب های اقتصادی آسیب های اجتماعی بی اعتمادی به کادر درمانی

What is an ideal drug? In the early 1900s Paul Ehrlich described an ideal drug as a magic bullet.. Such a drug would be aimed precisely at a disease site and would not harm healthy tissues.

تعریف WHO از ADR هر گونه پاسخ ناخواسته و زیان آور که در مقادیر مصرف معمول دارو جهت تشخیص پیشگیری و درمان ایحاد شود. .

انواع ADR

Limitations of Clinical Trials Limited size Narrow population Narrow indications Short duration Ref: J. Russell May. Adverse drug Reactions and interaction, In: Pharmacotherapy, A pathophysiologic Approach. 1997, Appleton & Lange.

Prevention of ADRs in Human. Pharmacovigilance Detection, Assessment & Prevention of ADRs in Human. Ref: World Health Organization.

فارماکوويژيلانس به تمام شيوه وروش های ارزيابی و پيشگيری از ADRs گويند. شناسايی ، ارزيابی ، گزارش عوارض ناخواسته دارويی و پيشگيری از وقوع آنها در انسان رافارماکوويژيلانس گويند.

The ultimate goal of pharmacovigilance is improving pharmacotherapy Ref:World Health Organization

نمودار گزارشات مربوط به دانشگاه علوم پزشکی اصفهان در سال های 95-86

The FDA Safety Information and Adverse Event Reporting Program: MedWatch The FDA Safety Information and Adverse Event Reporting Program: www.fda.gov/medwatch/ Safety alerts Recalls Withdrawals Important labeling changes Biologicals, Drugs, Dietary supplements