Introduction to Post-marketing Drug Safety wmshp.org/sg_current_event_content_new/Pharmacovigilance_2015_05.pdf1 Introduction to Post-marketing Drug Safety Surveillance: Pharmacovigilance in FDA/CDER. Sara Camilli, PharmD, BCPS, Safety Evaluator Team Leader

Embed Size (px)

Text of Introduction to Post-marketing Drug Safety...

  • 1

    Introduction to Post-marketing Drug Safety Surveillance: Pharmacovigilance in FDA/CDER

    Sara Camilli, PharmD, BCPS, Safety Evaluator Team Leader Selena Ready, PharmD, CGP, Safety Evaluator Division of Pharmacovigilance Office of Surveillance and Epidemiology Center of Drug Evaluation and Research May 30, 2015

    PresenterPresentation NotesThank you, Kara. Welcome and Good afternoon to everyone joining us for todays webinar. My name is XYZ and Im excited to present an Introduction to Postmarketing Drug Safety Surveillance. In particular, I will discuss Pharmacovigilance in FDAs Center for Drug Evaluation & Research (CDER). Ill start with our objectives (slide change)

  • Acronyms

    CDER Center for Drugs Evaluation & Research

    CFR Code of Federal Regulations

    DEPI I & II Division of Epidemiology I & II

    DILIN Drug-Induced Liver Injury Network

    DMEPA Division of Medication Error & Prevention Analysis

    DPV I & II Division of Pharmacovigilance I & II

    DRISK Division of Risk Management

    DSC Drug Safety Communication

    EMA European Medicines Agency

    FDA Food & Drug Administration

    2

  • Acronyms, contd

    FDAAA Food & Drug Administration Amendment Act

    FAERS FDA Adverse Events Reporting System

    HCP Health Care Provider

    MO Medical Officer NDA New Drug

    Application OND Office of New Drugs

    PMC Postmarketing Commitment

    PMR Postmarketing Requirement

    REMS Risk Evaluation & Mitigation Strategy

    SE Safety Evaluator WHO-UMC World Health

    Organization Uppsala Monitoring Centre

    3

  • 4

    Objectives

    Define Pharmacovigilance Describe the Division of Pharmacovigilances (DPVs) key

    safety roles in FDAs Center for Drug Evaluation and Research (CDER).

    Understand components of postmarketing drug safety surveillance.

    Understand regulatory requirements and the role of MedWatch for reporting postmarketing safety information.

    Describe how adverse event reports are collected and analyzed by FDA/CDER/DPV

    PresenterPresentation NotesBy the end of this presentation, participants will be able to. READ objectives And hopefully, at the end of this presentation, youll realize how important YOU (as healthcare providers) are in Pharmacovigilance.

  • 5

    Outline Pharmacovigilance Background Postmarketing Surveillance Spontaneous Adverse Event Reports and the FDA Adverse

    Event Reporting System (FAERS) Signal Detection Components of a Good Case Report Case Series Development and Evaluation

    PresenterPresentation NotesTo fulfill these objectives I have organized the talk into the following sectionsFirst I will discuss the FDA and where PV fits into the big picture of drug regulationNext, I will cover Postmarketing Surveillance and Spontaneous Adverse Event Reports and the FDA Adverse Event Reporting System (FAERS)I will then cover Signal DetectionAnd finally I will detail Components of a Good Case Report and Case Series Development and Evaluation

  • 6

    Office of Regulatory Affairs (ORA)

    Center for Food Safety & Applied Nutrition (CFSAN)

    Center for Drug Evaluation & Research (CDER)

    Center for Biologics Evaluation & Research (CBER)

    Center for Devices & Radiological Health (CDRH)

    Center for Veterinary Medicine (CVM)

    Center for Tobacco Products (CTP)

    PresenterPresentation NotesThis slide briefly reviews FDAs overall organizational structure and the 7 main centers that carry out the FDAs public heath mission, which are divided by product type. This includes the centers for food, veterinary medicine, medical devices, biologic products, drugs, tobacco, and regulatory affairs. We love acronyms at FDA, and I included the acronyms for each center. The talk today will focus on drug safety activities within the Center of Drug Evaluation and Research or CDER (animation).

  • 7

    Office of Surveillance & Epidemiology

    Office of Surveillance

    & Epidemiology

    Office of

    Pharmacovigilance & Epidemiology

    Office of Medication Error Prevention & Risk

    Management

    Division of

    Medication Error Prevention &

    Analysis (DMEPA)

    Division of Risk

    Management (DRISK)

    Division of

    Pharmacovigilance I and II

    (DPV I and II)

    Division of

    Epidemiology I and II

    (DEPI I and II)

    PresenterPresentation NotesLooking closer at CDER, the drug safety activities and surveillance discussed today take place in CDERs Office of Surveillance and Epidemiology or OSE. This slide displays the structure of OSE, and the main divisions and disciplines that work to fulfill our drug safety missions. In the bottom row, the Divisions of Pharmacovigilance is highlighted; Other divisions include epidemiology, medication error prevention and analysis, and risk management.

  • 8

    The science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.

    * The Importance of Pharmacovigilance, World Health Organization 2002

    Pharmacovigilance

    PresenterPresentation NotesWhat is Pharmacovigilance? Pharmacovigilance is defined by the World Health Organization as the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.Examples of other drug-related problems include:Wrong doseDrug interactionsRisk assessmentName confusion, labeling

  • 9

    Divisions of Pharmacovigilance Evaluate the safety of drug and therapeutic biologic

    products Advance public health by detecting and analyzing safety

    signals from all available data sources, utilizing evidence-based methods

    Recommend appropriate regulatory actions, including labeling changes, Risk Evaluation and Mitigation Strategies (REMS), etc.

    Communicate relevant safety information

    PresenterPresentation NotesBased on the Pharmacovigilance definition and our placement in the Office of Surveillance and Epidemiology this slide details the major responsibilities of the Division of Pharmacovigilance, which are,-Evaluating the safety of drug and therapeutic biologic products-Advancing public health by detecting and analyzing safety signals, utilizing evidence-based methods-Recommending appropriate regulatory actions, including labeling changes, Risk Evaluation and Mitigation Strategies (REMS), or other necessary means.AND finally Communicating relevant safety information

    we will go into detail on each of these aspects.

  • 10

    Safety Evaluators (SEs) 10 teams of SEs

    Majority clinical pharmacists Provide critical analysis of sources of postmarketing data to

    identify and evaluate safety signals

    Team coverage aligned with the Office of New Drugs (OND) review divisions therapeutic areas

    ~ 4-7 SEs per team (including Team Leader) Each SE covers assigned product group(s) aligned with therapeutic

    area

    PresenterPresentation NotesThe Pharmacovigilance activities are carried out by safety evaluators (or SEs) divided into 10 teams. SEs are typically clinical pharmacists. They provide critical analyses of sources of postmarketing data to identify and evaluate safety signals. Team coverage is based on relevant clinical therapeutics area and is aligned with the Office of New Drugs in CDER, which is also divided by therapeutic area. There are approximately 4-7 SEs on each team, and each SE has particular product assignments in the respective clinical area. For example, my team covers metabolic and endocrine products and is aligned with the Division of Metabolic and Endocrine Products in the Office of New Drugs.

  • 11

    Medical Officers (MOs) Provide clinical expertise in various therapeutic areas such

    as dermatology, oncology, rheumatology, etc. Collaborate with DPV teams on safety evaluation Collaborate with Office of New Drugs (OND) on safety

    evaluation

    PresenterPresentation NotesIn addition to the Safety Evaluators, the Divisions of Pharmacovigilance have Medical officers who provide clinical expertise in various therapeutic areas such as dermatology, hematology, oncology, rheumatology, and geriatrics.These Medical Officers collaborate with Pharmacovigilance teams and the Office of New Drugs (OND) on safety evaluationBACKUPDermatologyEpidemiologyGastroenterologyGeriatricsHematology/OncologyInfection DiseaseInternal MedicinePathologyPediatricsPulmonaryRheumatology

  • 12

    Postmarketing Surveillance

    PresenterPresentation NotesNow, I will discuss the science and principles of post marketing surveillance/

  • 13

    Challenge Question #1

    True or False Safety data is only collected during the later phases of

    the clinical development program for a medical product.

    PresenterPresentation NotesThis brings us to our first challenge question.

    True or False, Safety data is only collected during the later phases of the clinical development program for a medical product.

    You can answer this question by selecting the appropriate radio button next to each answer choice.For those who answered False you are correct. Safety data collection is NOT limited to the later phases of the clinical development program. Answer: False

  • 14

    Phase 1

    Safety &

    Dosage

    Phase 2

    Safety &

    Efficacy

    Phase 3

    Safety &

    Efficacy

    APP R