Pediatric Advisory Committee Meeting September 15, 2004

Slides:

Advertisements

Similar presentations

Bill Stockdale, MBA, Celeste Beck, MPH, Lisa Hulbert, PharmD, Wu Xu, PhD Utah Department of Health Comparison with other methods of analysis: 1) Assessing.

Advertisements

1 Proposed Pharmacovigilance Plan for H5N1 Influenza Virus Vaccine Patrick Caubel, MD, PhD Head of Pharmacovigilance North America February 27, 2007.

Safety Review for Plan B Daniel Davis, MD, MPH Division of Reproductive/Urologic Drugs.

1 One Year Post Exclusivity Adverse Event Review: Fentanyl Transdermal System Pediatric Subcommittee of the Anti-infective Drugs Advisory Committee Meeting.

1 Drug Utilization for Immediate- and Modified Release Opioids in the U.S. Gianna C. Rigoni, Pharm.D., M.S. Epidemiologist Division of Surveillance, Research.

FDA Perspective Sally Loewke, M.D. Acting Division Director

Pharmacovigilance and Risk Management Chapter 17.

Field Investigators: ADE Detectives. Section One Introduction to the Team and Their Roles.

Postmarketing Risk Assessment of Drug Products Division of Drug Risk Evaluation Office of Drug Safety Center for Drug Evaluation and Research.

Basic Pharmacovigilance Training

FDA’s MedWatch Program Outreach to Healthcare Professionals and the Public n Managing the Risks of Medical Product Use.

Joint NDAC/PAC meeting October 18, 2007 OTC Cold and Cough Products: Use in Children Advisory Committee Meeting October 18, 2007 Joel Schiffenbauer, MD.

1 One Year Post-Exclusivity Adverse Event Review: Ertapenem Pediatric Advisory Committee Meeting November 16, 2006 Alan M. Shapiro, MD, PhD, FAAP Medical.

FDA MedWatch and Patient Safety. Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006  The Act defines a ‘serious adverse event’

Prescription Drug Abuse Sharon Hertz, M.D. Medical Officer Division of Anesthetic, Critical Care and Addiction Drug Products Food and Drug Administration.

1 One Year Post Exclusivity Adverse Event Review as Mandated by the Best Pharmaceuticals for Children Act Presented at the Psychopharmacologic Drugs Advisory.

DSaRM Advisory Committee May 18, 2005 Active Surveillance for Drug Safety Signals: Past, Present, and Future Mary Willy, Ph.D. Division of Drug Risk Evaluation.

POSTMARKETING ADVERSE DRUG EXPERIENCE INSPECTIONAL PROGRAM CDR Thomas R. Berry, RPh FDA, Investigator RAL-RP / ATL-DO.

1 Adverse Event Review and Reporting as Mandated by Best Pharmaceuticals for Children Act: Summary of Committee Feedback and Options for Improvement Solomon.

Adverse Event Tracking as mandated by the Best Pharmaceuticals for Children Act Dr. Solomon Iyasu Medical Team Leader Division of Pediatric Drug Development.

1 One Year Post Exclusivity Adverse Event Review: Ofloxacin Ophthalmic Pediatric Advisory Committee Meeting September 15, 2004 Hari Cheryl Sachs, MD, FAAP.

Overview of Issues for Psychopharmacological Drugs Advisory Committee June 16, 2003 WBC Monitoring for Clozapine Judith A. Racoosin, MD, MPH Safety Team.

ADVERSE EFFECTS OF DRUGS Phase II May Adverse Drug Reaction An adverse reaction to a drug is a harmful or unintended response. ADRs are claimed.

Postmarketing Safety Assessment of Osteonecrosis of the Jaw Pamidronate & Zoledronic Acid Division of Drug Risk Evaluation Office of Drug Safety FDA Carol.

PROPRIETARY NAME EVALUATION AT FDA Jerry Phillips, RPh Associate Director for Medication Error Prevention Office of Drug Safety December 4, 2003.

Reproductive Health Drugs, Pregnancy Labeling Subcommittee Meeting March 28-29, 2000 Holli A. Hamilton, M.D., M.P.H. Pregnancy Labeling Team Office of.

1 Non-Sedating Antihistamines Rx-to-OTC Switch NDAC & PADAC Joint Meeting May 11, 2001 François Nader, MD Senior Vice-President Medical & Regulatory Affairs,

Available Types of National Drug Use Data DSARM Advisory Committee Meeting Silver Spring, Maryland May 18, 2005 Judy Staffa, PhD, RPh, Epidemiology Team.

Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Advisory Committee February 26 & 27, Overview Isotretinoin Pregnancy Exposures:

1 One Year Post Exclusivity Adverse Event Review: Fexofenadine Pediatric Subcommittee of the Anti-infective Drugs Advisory Committee Meeting June 9, 2004.

1 One Year Post Exclusivity Adverse Event Review: Topotecan Pediatric Subcommittee of the Anti-infective Drugs Advisory Committee Meeting June 9, 2004.

Population-Based Epidemiologic Safety Studies: Overview and Challenges Drug Safety and Risk Management Advisory Committee Silver Spring, Maryland June.

DEVELOPING EVIDENCE ON VACCINE SAFETY Susan S. Ellenberg, Ph.D. Center for Clinical Epidemiology and Biostatistics U Penn School of Medicine Global Vaccines.

1 One Year Post Exclusivity Adverse Event Review Update: Orlistat Pediatric Advisory Committee Meeting April 11, 2007 Hari Cheryl Sachs, MD, FAAP Medical.

1 Lotronex Postmarketing Experience Ann Corken Mackey, R.Ph., M.P.H. Allen Brinker, M.D., M.S. Zili Li, M.D., M.P.H., formerly of ODS Office of Drug Safety.

METHODS TO STUDY DRUG SAFETY PROBLEMS animal experiments clinical trials epidemiological methods –spontaneous reporting case reports case series –Post-Marketing.

Sidney M. Wolfe M.D and Sherri Shubin M.D., M.P.H. Public Citizen’s Health Research Group FDA Drug Safety and Risk Management and Dermatologic and Ophthalmic.

Summary of Issues on Urticaria as an OTC Indication Charles Ganley, M.D. Division of OTC Drug Products April 22, 2002 Non-Prescription Drug Advisory Committee.

DIVISION OF REPRODUCTIVE AND UROLOGIC PRODUCTS Physician Labeling Rule Lisa Soule, M.D.

1 One Year Post Exclusivity Adverse Event Review: Carboplatin Pediatric Advisory Committee Meeting November 18, 2005 Susan McCune, M.D. Medical Officer.

1 One Year Post-Exclusivity Adverse Event Review: Meloxicam Pediatric Advisory Committee Meeting November 16, 2006 Hari Cheryl Sachs, MD, FAAP Medical.

Smallpox Vaccine Safety and Reporting Adverse Events Department of Health and Human Services Centers for Disease Control and Prevention December 2002.

1 One Year Post-Exclusivity Adverse Event Review: Insulin Aspart Recombinant Pediatric Advisory Committee Meeting November 16, 2006 Hari Cheryl Sachs,

1 One Year Post Exclusivity Adverse Event Monitoring as mandated by the Best Pharmaceuticals for Children Act Dr. Solomon Iyasu Medical Team Leader Dr.

FDA Regulatory and Compliance Symposium

Food and Drug Administration Amendments Act of 2007 Reauthorization of Pediatric Initiatives Lisa L. Mathis, M.D. Pediatric and Maternal Health Staff Office.

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.

July 15, Postmarketing Safety Evaluation of Approved Drugs and Risk Management Victor F. C. Raczkowski, MD, MS Director, Office of Drug Safety July.

1 Presentation of the Pharmaceutical Research and Manufacturers of America at FDA Part 15 Hearing on Communication of Drug Safety Information December.

1 One Year Post Exclusivity Adverse Event Review: Sumatriptan Pediatric Advisory Committee Meeting November 18, 2005 Susan McCune, M.D. Medical Officer.

1 One Year Post Exclusivity Adverse Event Review: Ciprofloxacin Pediatric Subcommittee of the Anti-infective Drugs Advisory Committee Meeting June 9, 2004.

Postmarketing Pharmacovigilance Practice at FDA Lanh Green, Pharm.D., M.P.H. Office of Surveillance and Epidemiology June 21, 2006.

Initiatives Drive Pediatric Drug Development January 30, 2002.

1 Robert J. Spiegel, M.D. Sr. V. P. Medical Affairs Chief Medical Officer Schering Plough FDA ADVISORY COMMITTEE 5/11/01.

Risk Management of Modified- Release Opiate Analgesics: Palladone Sharon Hertz, M.D. Medical Team Leader, Analgesics Division of Anesthetic, Critical Care,

Questions to Committee about Potential Cancer Risk with Use of Topical Immunosuppressants (Calcineurin Inhibitors) Question 1: Messages about Risk A. Based.

1 Overview of Pediatric Safety Reporting and Role of the Committee Pediatric Advisory Committee Meeting November 18, 2005 Solomon Iyasu, M.D., M.P.H. Acting.

Comments on FDA Concept Paper Sidney N. Kahn, MD, PhD President Pharmacovigilance & Risk Management, Inc. Risk Assessment of Observational.

Food and Drug Administration Division of Pulmonary and Allergy Drug Products Summary Comments - Orally Inhaled and Intranasal Budesonide and Fluticasone.

Overview of Pediatric Drug Development Dianne Murphy, MD Director Office of Counterterrorism and Pediatric Drug Development Center for Drug Evaluation.

1 One Year Post Exclusivity Adverse Event Review: Glimepiride Pediatric Advisory Committee Meeting November 16, 2006 Hari Cheryl Sachs, MD, FAAP Medical.

1 BETTER APPROACHES TO MONITORING MEDICAL PRODUCT SAFETY ARE NEEDED.

Pediatric Advisory Committee: Overview of Role and Evolution of Process Dr. Dianne Murphy Director, Office of Pediatric Therapeutics, OC, FDA November.

Uses of the NIH Collaboratory Distributed Research Network Jeffrey Brown, PhD for the DRN Team Harvard Pilgrim Health Care Institute and Harvard Medical.

1 One Year Post Exclusivity Adverse Event Review: Glyburide-Metformin Pediatric Advisory Committee Meeting February 14, 2005 Hari Cheryl Sachs, MD, FAAP.

27 June 2000Victor F. C. Raczkowski, M.D.1 Risk-Management Options Victor F. C. Raczkowski, M.D., M.S. Gastrointestinal Drugs Advisory Committee 27 June.

1 Psychopharmacologic Drugs Advisory Committee and Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee February 2, 2004 Office of Drug.

Mortality and Antithrombotics: Focus on FAERS Repository

Available Types of National Drug Use Data

Presentation transcript:

Pediatric Advisory Committee Meeting September 15, 2004 Adverse Event Tracking as mandated by the Best Pharmaceuticals for Children Act Pediatric Advisory Committee Meeting September 15, 2004 Good afternoon. Dr. Chen Min Chu has provided you with a overview of FDA's postmarketing adverse event surveillance system. I will be talking with you about one specific surviellance activity, namely, 'adverse event tracking as mandated by the Best Pharmaceuticals for Children Act. Solomon Iyasu MD, MPH Medical Epidemiologist Office of Pediatric Therapeutics Office of the Commissioner

Best Pharmaceuticals for Children Act (1/4/02) Section 17: Adverse Event (AE) Reporting Review AE reports during the one-year after pediatric exclusivity is granted Report to the Pediatric Advisory Sub-Committee for review and recommendations (changed to Pediatric Advisory Committee by the Pediatric Equity Act, 2003) Under section 17 of the BPCA, FDA is required to perform the following activities. - One, promulgate a rule to require the inclusion in labeling a of toll free number for the purpose of reporting adverse events -review AEs reports for a period of one year after a drug is granted pediatric exclusivity. -report AEs to the Pediatric Advisory Sub-Committee for their review.

AE Review Process Collaboration between Office of Drug Safety (ODS) Division of Pediatric Drug Development, OCTAP Office of Pediatric Therapeutics (OPT)

AE Review Process (cont.) ODS Responsibilities Review adverse events reported during the year after the date of exclusivity determination Immediately discuss any serious unexpected events including deaths with OPT and OCTAP Submit a written safety review within 90 days of the one-year post exclusivity date to OCTAP, OPT and Office of New Drugs

AE Review Process (cont.) OCTAP and OPT Responsibilities Notifies Office of Drug Safety (ODS) of drugs granted/or denied exclusivity Review ODS reports, individual AE reports and summaries of the pediatric clinical studies done for exclusivity Develops presentations to the Pediatric Advisory Committee (AC) in consultation with ODS and OND Focus the AC discussion on any serious AEs/Issues (e.g. SSRI and suicidality)

Adverse Event Report Review Template Executive Summary AERS search result: Counts of AE reports including any deaths from drug approval date to one-year post exclusivity determination date Adults (>16 year old) and Pediatric Ages ( 0-16 year old) Domestic and foreign reports Most frequently reported pediatric and adult adverse events

Adverse Event Report Review Template (cont.) Detailed Review of Pediatric AEs for the One-Year Period Following the Granting of Pediatric Exclusivity Counts and labeling status of top 20 most frequently reported adverse event terms Demographics, serious outcomes, indications and doses Unexpected or unique pediatric adverse events Increased frequency of known pediatric adverse events Pediatric death reports Summary adverse event profile

Drug Utilization Review Template Executive Summary Drug utilization data for adults and pediatric patients for 2 years prior and 1 year post exclusivity Outpatient use Inpatient use

Role of the Pediatric Advisory Committee Assess and discuss the presented adverse events If appropriate, recommend additional pediatric review and/or regulatory action Role is evolving

Components of the U.S. Comprehensive Postmarketing Drug Surveillance Program Drug Utilization data: Outpatient Inpatient Longitudinal External Health care databases: General popn Special popn’s Passive surveillance (AERS) Repository of background incidence rates, Litr, HDS Active Surveillance DAWN, NEISS, TESS

Overview of FDA’s Adverse Event Reporting System (AERS) Good afternoon. Dr. Chen Min Chu has provided you with a overview of FDA's postmarketing adverse event surveillance system. I will be talking with you about one specific surveillance activity, namely, 'adverse event tracking as mandated by the Best Pharmaceuticals for Children Act.

FDA Adverse Event Reporting System (AERS) Origin 1969 (Safety Reporting System until 1997) ~ 2 million reports in database Contains drug and "therapeutic" biologic adverse event reports Exception = vaccines VAERS 1-800-822-7967

Voluntary/spontaneous reporting Source of Reports Voluntary/spontaneous reporting Health care professionals, consumers/ patients, or others Manufacturers: Required for postmarketing reporting (>90%) All adverse drug experience information obtained or otherwise received from any source, foreign or domestic

one form for all voluntary reporting [1993- present] What to report? Adverse events product problems medical errors associated with: Drugs [Rx and OTC] Biological products Medical devices Dietary supp/herbal one form for all voluntary reporting [1993- present]

What Manufacturers Must Report (21CFR 314.80) Commercial marketing experience Postmarketing studies Scientific literature All domestic spontaneous reports Foreign and literature reports - Serious, Unlabeled Study reports - Serious, Unlabeled, "Reasonable Possibility" that event is related to drug

FDA Postmarketing Definitions (21 CFR 314.80 ) Adverse Drug Experience: any adverse event associated with the use of a drug, whether or not considered drug related, including Accidental or intentional overdose Occurring from abuse or drug withdrawal Failure of expected pharmacological action

FDA Postmarketing Definitions (21 CFR 314.80) Serious ADE: any event occurring at any dose that results in any of the following outcomes: Death Life-threatening ADE (immediate risk) Hospitalization or prolongation of hospitalization Persistent/significant disability/incapacity Congenital anomaly/birth defect Other/requiring intervention (eg. bronchospasm)

FDA Postmarketing Definitions (21 CFR 314.80) Unexpected ADE: any event not listed in the current labeling for the drug product including events that may be symptomatically and pathophysiologically related to a labeled event, but differ because of greater severity or specificity (e.g. hepatic necrosis vs hepatitis)

Strengths of AERS Includes all U.S. marketed drug products Simple, less expensive reporting system than active system Provides for early detection of safety signals Especially good for rare adverse drug events (anaphylaxis, liver failure, aplastic anemia, serious skin reactions)

Limitations of AERS Underreporting: varies from drug to drug and over time Quality and completeness of reports: variable, often poor Cannot estimate true adverse event risk rate Numerator uncertain Denominator must be estimated, virtually impossible for inpatient & OTC drugs

Pediatric Drug Utilization Data Good afternoon. Dr. Chen Min Chu has provided you with a overview of FDA's postmarketing adverse event surveillance system. I will be talking with you about one specific surveillance activity, namely, 'adverse event tracking as mandated by the Best Pharmaceuticals for Children Act.

Outpatient Drug Use: Data Sources and Limitations IMS Health, National Prescription Audit Plus provides an estimate of the total number of prescriptions dispensed from retail pharmacies in the U.S., but does not provide demographic information on prescription use. IMS Health, National Disease and Therapeutic Index is a survey based on a sample size of 2000 - 3000 office-based physicians. The small sample size can make these data projections unstable, particularly when use is not prevalent as in the case of the pediatric population.

Outpatient Drug Use: Data Sources and Limitations IMS Health, National Sales Perspectives™ Retail and Non-Retail does not provide a direct estimate of use but does provide a national estimate of units sold from the manufacturer to various channels of distribution. It does not include demographic information for the patients receiving these products, such as age and gender. The amount of products purchased by these retail and non-retail channels of distribution may be a possible surrogate for use, if we assume that facilities purchase drugs in quantities reflective of actual patient use.

Inpatient Drug Use: Data Sources and Limitations AdvancePCS, a wholly-owned subsidiary of Caremark Rx, Inc., is based on a large prescription claims database among an insured population of over 75 million patient lives, but data cannot be projected nationally Premier, Inc. contains inpatient drug use from 450 acute, short-stay, non-federal hospitals. National projection methodology is available but the ability to make accurate national estimates is selective; drug use cannot be linked to diagnosis or procedure; treatments administered at hospital outpatient clinics not included.

Inpatient Drug Use: Data Sources and Limitations Child Health Corporation of America™ (CHCA) Pediatric Health Information System (PHIS) Inpatient data from 29 free-standing children’s hospitals with charge level drug utilization data Not possible to directly link drug use with specific diagnoses or procedures; therefore, associations should be made with caution Data cannot be projected nationally

Drug Adverse Events Presented at Peds Adv. Committee Meetings June 2003 Sertraline Oxybutynin Atorvastatin Simvastatin Oct 2003 Busulfan Cetirizine Losartan Tamoxifen Quinapril Nefazodone Feb 2004 Paroxetine Pravastatin Citalopram Vinorelbine June 2004 Topotecan Temozolomide Venlafaxine Moxifloxacin ophthalmic Cipropfloxacin ophthalmic Fosinopril Fexofenadine Fentanyl transdermal

Examples of Outcomes of Prior Pediatric Advisory Sub-Committee Meetings SSRI/SNRIs Class labeling for suicidal behavior Class labeling for neonatal withdrawal Fentanyl Transdermal Strengthen black box warning by adding “inappropriate use resulting in deaths” Highlight prescriber qualifications Simplify language in patient information

Today’s Agenda for BPCA Mandated AE Review Ofloxacin and alendronate Hari Sachs, MD Fludarabine Susan McCune, MD, MA Ed Desloratadine Jane Filie, MD

Agenda (cont.) Perspective on safety for orally inhaled and intranasal Budesonide and Fluticasone Peter Starke, MD Studies performed for pediatric Written Request ShaAvhrée Buckman, MD, PhD Adverse Events reported in the one-year post-exclusivity period Joyce Weaver, PharmD Summary comments Badrul A. Chowdhury, MD, PhD

Question for the Committee Based on the presentations you have heard today regarding drugs containing fluticasone or budesonide, do you have any concerns about the use of these drug products as labeled?