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Office of Drug Safety Annual Report 2002

April 9, 2004

Table of Contents

  • I.  Introduction                                                                       

  • II.  AERS                                                                                            

  • III.  Cooperative Agreement Program                                               

  • IV.  International Activities                                                                 

  • V.  DSaRM                                                                                            

  • VI.  CERTs                                                                                             

  • VII.  DDRE Activities                                                                       

  • VIII.  DMETS Activities                                                                      

  • IX.  DSRCS Activities                                                                        

  • X.  Other ODS Activities                                                                      

  • XI.  Conclusion                                                                                       

I.  Introduction 

In January 2002, the Office of Drug Safety (ODS) was formally reorganized and divided into an Immediate Office Staff and three distinct Divisions, the Division of Drug Risk Evaluation (DDRE), the Division of Medication Errors and Technical Support (DMETS) and the Division of Surveillance, Research and Communication Support (DSRCS).  ODS staff is comprised of a broad spectrum of health professionals from a variety of disciplines including physicians, epidemiologists, pharmacists, nurses, project managers, social scientists, and technical information specialists, as well as administrative and support staff.  ODS staff collaborate with colleagues in the Center for Drug Evaluation and Research (CDER) to evaluate drug safety profiles, effectively communicate drug risk information to health care professionals and patients and reduce medication errors through improving drug packaging and labeling and evaluating proprietary drug names.   In addition, ODS maintains a system of post-marketing surveillance and risk assessment programs to identify adverse events that did not appear during the drug development process.  Dr. Peter Honig left his position as ODS Director in February 2002.  From February until September 2002, ODS was led by Dr. Paul Seligman.  In September 2002, the Office welcomed a new Director, Dr. Victor Raczkowski.

Significant accomplishments and events during FY02 for the Office included:

  • Filling key leadership roles on the three working groups charged with the development of guidance documents on good risk assessment, risk management and pharmacovigilance practices.

  • Establishment and utilization of the new Drug Safety and Risk Management Advisory Committee.

  • Participation in the development of two proposed regulations:  1) Requiring Barcodes on Human Drug
    Labels and Blood; and 2) the Suspected Adverse Drug Reaction Reporting Rule.

  • Utilization of managed care databases to evaluate important safety questions employing formal epidemiological studies with cooperative agreement partners. 

  • Formalization of a risk communication program with the Consumer Information and Research team in DSRCS (i.e., evaluating consumer oriented materials including Medication Guides and Patient Product Information) to ensure that product information is clearly communicated.

  • Continued work in partnerships with the international community to improve public health, the timely sharing of drug safety information, and maintaining consistent global standards.

  • Expansion of the MedWatch program to provide safety alert information to our MedWatch partners
    that include clinicians and healthcare organizations.

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II.  Adverse Event Reporting System (AERS)  

In FY2002, AERS received 184,702 Individual Safety Reports (ISRs) + 136,451 non-serious periodic ISRs (Total = 321,135)1 .  At the present time, AERS is entering reports for direct2, 15-day (expedited)3 and serious periodic4 ISRs.  AERS captures all of the ISRs for current New Molecular Entities (NMEs).  The chart below shows the reporting trend over time.

CDER Post-Marketing Adverse Events Reports Received for last five fiscal years.

AERS - Postmarket

1. Data collected as of December 31, 2002.
2. Adverse events reported directly to the FDA.
3. Adverse events which are both serious and unexpected reported to the FDA via the manufacturer
4. Adverse events which are serious and expected or are nonserious reported to the FDA via the manufacturer.

 Electronic Submission of Adverse Event Reports Initiative:

The successful implementation of electronic submissions is a high priority for the Center.  It will result in more timely receipt and evaluation of adverse events at considerable cost savings to FDA and those submitting the reports.  By the end of 2002, the electronic submissions (e-sub) pilot successfully established a mechanism for companies to send e-sub reports into AERS.  CDER implemented the Electronic Submission Product Test Pilot for AERS in October 2000.  This pilot provided a mechanism for companies to test and send electronic submissions of expedited reports via physical media or gateway (without attachments).  In the Fall 2002, periodic report submission was tested with manufacturers.  This effort will enable the FDA to accept both the individual reports (ICSRs) as well as the summary and analysis portion of the periodic report by Spring 2003.  In FY 2002, over 20,000 individual safety reports were submitted electronically in a standard generalized markup language (SGML) format using ICH E2B under the production pilot (see figure below).

The current industry participants in the e-sub pilot include: Bristol-Myers Squibb, GlaxoSmithKline, Merck, Roche, Pharmacia, Sanofi-Synthelabo, Pfizer, MedImmune, Dupont Pharmaceuticals, J&J Pharma Group, Eli Lilly, AstraZeneca, Immunex, Celgene, Bayer Vital Pharmaceuticals (Germany) and Abbott.

 


eSubs Received vs ISRs 

Public Access to AERS Data

The National Technical Information Service (NTIS) receives extracts of the AERS data including the name of the drug, the reaction, outcome, reporter, as well as some patient data on a quarterly basis.  These data are available to general public through the NTIS.

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III. Cooperative Agreement Program 

ODS' cooperative agreement program in pharmacoepidemiology provides CDER with access to population-based pharmacoepidemiologic databases and with the ability to study important postmarketing drug safety questions.  Last year, the following sites received grant support through this program:   

  • Harvard Pilgrim Health Plan/Health Partners to assess the role of health plans in improving drug safety

  • Vanderbilt University to study the role of rofecoxib dose on the risk of acute myocardial infarction

  • UnitedHealth Group to conduct a variety of  post-marketing drug safety surveillance studies

  • The following studies under the auspices of the Cooperative Agreements were completed in 2002:  

  • Shatin D, Schech SD, Brinker A.  Ambulatory use of ticlopidine and clopidogrel in association with
    percutaneous coronary revascularization procedures in a national managed care organization.  J Interven Cardiol 2002; 15:181-6.

  • Willy ME, Manda B, Shatin D, Drinkard CR, Graham DJ.  A study of compliance with FDA recommendations for pemoline (Cylert).  J Amer Acad Child Adolesc Psychiatry 2002; 41: 785-90.

  • Cooper WO, Staffa JA, Renfrew JW, Graham DJ.  Systemic corticosteroid use among children  enrolled in Tennessee Medicaid (TennCare).  Ambulatory Pediatrics 2002; 2: 375-81.

The following feasibility studies were performed during 2002:

  • Usage patterns of drugs for erectile dysfunction

  • Usage patterns of sibutramine and orlistat

  • Comorbidity among metformin users

  • Usage patterns of leflunomide

  • Triptan use and myocardial infarction

  • Thiazolidinedione use and risk of congestive heart failure

The following in-depth studies were completed or are in progress during 2002:

  • Statin use and risk of rhabdomyolysis

  • High dose cyclooxygenase inhibitor (COX-2) use and risk of hypertension

  • Patterns of COX-2 utilization

  • Prescription drug use and risk of thrombotic thrombocytopenia purpura (TTP)

  • Uterine sarcoma and tamoxifen

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IVInternational Activities  

ODS staff are major contributors to many important activities that impact on international public health activities including the following:

International Conference on Harmonization (ICH)

The ICH launched three new topics during the year: V1 is an addendum to the existing E2C guideline that will provide further guidance on Periodic Safety Update Reports (PSURs); V2 is an expansion of the E2A guideline to post-marketing expedited reporting; and V3 is the Prospective Planning of Pharmacovigilance (PPP) whose purpose is to aid industry and regulators in planning pharmacovigilance activities, especially during the early post-marketing period of a new drug. 

E2B Implementation 

In September 2002, a concept paper was presented to the ICH Steering Committee to establish an ICH E2B Implementation Working Group to promote uniform standards in the three ICH regions; to identify and reconcile implementation issues; to develop new standards to meet the needs and the technology changes; and to evaluate the need for a permanent maintenance group within ICH.

MedDRA 

ODS remains actively involved in the continued management and maintenance of the Medical Dictionary for Regulatory Activities (MedDRA).   ODS staff are represented on the MedDRA Management Board and have played a major role in developing and maintaining coding criteria for the entry of reports into the FDA AERS database using MedDRA.  In addition, staff have been active members of the ICH working group that produces a continuously updated version of a helpful document entitled MedDRA Term Selection: Points to Consider.  A new, updated version of this document based on MedDRA version 5.1 was produced in September 2002. 

CIOMS Working Groups

ODS is represented on various “Council for International Organizations of Medical Sciences” (CIOMS) working groups including the one on surveillance and assessment of drug safety data from clinical trials (CIOMS VI) and the CIOMS Working Group on Standardized Search Queries based on the MedDRA Terminology.

World Health Organization (WHO)

ODS staff respond to requests from medical reviewers at WHO-Uppsala Monitoring Centre (UMC) for copies of case reports.  Such reports are redacted of personal identifiers and forwarded on to WHO-UMC for assessment in a larger dataset and possible discussion in the WHO publication “SIGNAL.”  A majority of the WHO-UMC's 70 participating national centers participate in a listserv (Vigimed) that provides a mechanism for the rapid exchange of pharmacovigilance information to regulatory agencies worldwide.  ODS staff monitor this listserv and prepare responses to queries that appear in the Vigimed forum.

In addition, ODS provides an AERS data extract on a quarterly basis to the WHO-UMC, which enters a large proportion of these reports into their adverse reactions database to be made available to participating member countries for review and analysis.  Late in 2002, ODS staff began assessing the changes needed to the AERS extract to meet the evolving needs of the UMC as they prepared to implement their new database, Vigibase.

Pharmacovigilance Videoconferences

Two separate series of regular video-conferences are held with counterpart regulators in other countries.  One series consists of bi-monthly meetings with representatives from the Health Protection and Food Branch of Health Canada, the Therapeutic Goods Administration of Australia, and Medsafe of New Zealand. The second series consists of eight scheduled video-conferences during the year with the European Agency for the Evaluation of Medicinal Product (EMEA) and involve topics including specific safety concerns, medication errors, epidemiological investigations, international initiatives, and regulatory practices.

Consult Requests to and from Various Regulatory Authorities

ODS staff responds to international regulatory authorities seeking drug product safety information from the FDA. Confidentiality agreements are in place with several individual national regulatory authorities, which allow discussion of issues such as open investigations, deliberative processes, and pre-decisional issues, opinions and recommendations.

International Visitors

ODS also hosts international visitors on a regular basis. During 2002, ODS hosted regulators from Australia and Japan as well as a large delegation from Singapore. An International Regulator Series presentation was provided by Japan, addressing information on the Japanese post-marketing drug safety surveillance system.

Building and strengthening relationships with international regulatory counterparts has permitted FDA to gather and share information and contribute to informed regulatory decision making, as well as prepare for industry, press and public inquiries.

AERS to Canada

ODS, in conjunction with staff from the Office of Information Technology and the Office of International Programs, provides technical assistance to Health Canada's Health Products and Food Branch, with the goal of sharing the AERS software application and data.

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V.  Drug Safety and Risk Management Advisory Committee 

In June 2002, the Drug Safety and Risk Management (DSaRM) Advisory Committee gained full committee status.  In December 2001, it began as a subcommittee to the Advisory Committee for Pharmaceutical Science (ACPS).   DSaRM includes experts in the areas of medication errors, risk communication, risk perception, risk management, clinical trial methodology, evidence-based medicine, biometrics and pharmacoepidemiology.  DSaRM members are often asked to participate in other FDA advisory committees when issues relating to the safe use and risk management of a particular drug are raised. The full committee discussed the following issues in 2002:

  • Consumer Medication Information (CMI) - The Committee recommended that FDA take an active
    role to improve the quality of drug leaflet information received by patients. 

  • As a subcommittee to ACPS, DSaRM discussed the following issues in 2002:

  • Lotronex (alosetron safety update) – A combined meeting with the Gastrointestinal Drugs Advisory Committee review of postmarketing experience, submitted pharmcoepidemiologic studies, and considered a variety of risk management options.

  • Non-prescription analgesics – A combined meeting with the Non-Prescription Drugs Advisory
    Committee reviewed adverse events associated with these drugs including hepatic and renal injury.

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VI. Centers for Education and Research on Therapeutics (CERTs) 

The CERTs were established under Section 409 of the Food and Drug Administration Modernization Act as a field laboratory for FDA issues to conduct research and provide education that will improve the use of drugs, medical devices, and biologics.  The CERTs program is managed and funded by the Agency for Healthcare Research and Quality (AHRQ) program, and seeks to increase the awareness of the benefits and risks of new, existing, or combined uses of therapeutics, thereby improving their effectiveness and safe use.  All Centers work with public and private collaborators on projects, allowing the Centers to expand numbers of research projects.

In 2002, ODS partnered with the CERTs by participating in a series of workshops focusing on the risks of therapeutics.  The goal of the Risk Series was to develop a research agenda to improve the assessment, communication, and management of therapeutic risk.    

VII. Division of Drug Risk Evaluation (DDRE)  

Drs. Julie Beitz and Mark Avigan acted as the Director and Deputy Director of DDRE respectively. DDRE's safety evaluators and epidemiologists monitor drug safety by critically reviewing adverse experience reports that are submitted by manufacturers, health care professionals and consumers.  The staff works closely with review division staff to develop the scientific basis for the assessment of safety signals and labeled warnings of serious adverse events, postmarketing safety studies, compliance and other regulatory activities.  DDRE staff also participate in advisory committee meeting preparation, risk management program development and pre-approval safety conferences. Internationally DDRE continues to interact with our regulatory counterparts in Australia, Canada, New Zealand and the European Union to share and discuss information about drug safety issues. The following are selected risk assessment activities and regulatory actions that were supported in DDRE:

Safety Review of Drugs

A total of 576 consults were received and processed in fiscal year 2002 by DDRE

  • 302 Consults From OND Review Divisions

  • 165 Consults Self-generated within DDRE

  • 109 Consults From Other Sources

Summary data are presented graphically by requestor (OND review division, self-generated, other sources) and by review division.

Consults by Requestor:



Consults by Requestor

Consults by Review Division:


Consults by Review Division

Preapproval Safety Conferences

Preapproval safety conferences are held with the Office of New Drugs prior to marketing approval of a new drug.  During these meetings, specific safety concerns are identified that ODS will monitor after product launch.  Other topics may include the need for postmarketing safety studies, patient registries or risk management programs.  Examples of approved drugs and safety issues discussed at pre-approval safety conferences in this year included:

  • Forteo: (teriparatide [rDNA origin] injection): increased incidence of oseosarcoma in preclinical studies.

  • Zetia (ezetimibe): combination with HMG-Co-A reductase inhibitors and contraindications in patients with active Liver disease or unexplained persistent elevations of transaminases.

  • Eloxatin (osaliplatin): hypersensitivity and anaphylaxis, neuropathy, pulmonary fibrosis.

  • Extraneal (icodextrin): drug interactions with blood glucose test strip.

Risk Management Plans

When drug risks can not be adequately managed by modifying the package insert, a risk management program may be necessary.  The following drugs were identified as candidates for a risk management program:

  • Xyrem (GHB):  approved under Subpart H regulations with a restricted distribution system involving patient and prescriber registries and a centralized pharmacy to limit illicit use.

  • Lotronex (alosetron): reintroduced under Subpart H regulations with restriction to enrolled physicians along with a MedGuide, healthcare professional and patient education, a prescription sticker program, and studies in claims databases.

Boxed Warnings

The following drugs required new boxed warnings to appear in the label:

  • Lotronex (alosetron) after reintroduction: serious gastrointestinal events, including ischemic colitis and serious complications of constipation 

  • Nolvadex (tamoxifen citrate): life threatening uterine sarcoma in women at high risk for cancer 

  • Cafergot (ergotamine tartrate and caffeine) and other products: serious peripheral ischemia and
    vasospasm leading to cerebral ischemia associated with the coadministration of potent CYP 3A4 inhibitors including protease inhibitors and macrolide antibiotics 

  • Lioresal (baclofen) Injection: abrupt discontinuation has resulted in high fever, altered mental status, rebound spasticity and muscle rigidity; careful attention to infusion system, refill procedures and pump alarms is needed

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VIII. Division of Medication Errors and Technical Support (DMETS) 

The DMETS director is Captain Jerry Phillips and the deputy director is Commander Carol Holquist. The Division completed seventy-eight (78) post-marketing safety reviews for the following review divisions*:

Division of Medication Errors and Technical Support (DMETS)

*Please note that the post-marketing numbers by HFD may reflect one review being sent to multiple HFD's.

Label Confusion

DMETS worked closely with review division staff to negotiate several labeling revisions designed to prevent medication errors or to manage known risks associated with the use of certain drug products.  Areas often cited as potential sources of medication errors included similar looking labels and packaging.  In addition, areas identified as problematic were route of administration, drug name modifier confusion, tablet color and lack of information on net quantity per ampul.  Selected examples of drug packaging labeling and packaging revisions based on DMETs recommendations are as follows:

  • Bicillin LA – Errors were reported from inadvertent administration of Bicillin by the wrong route.  There was also confusion between Bicillin LA and CR because of similar looking labels, labeling and packaging.  The labels and labeling were revised to differentiate the two products.

  • Celebrex – Overdoses occurred due to confusion over the amount of drug contained in each physician
    sample pack.  The label was revised accordingly.

  • Roxanol – Medication errors associated with Roxanol, Roxane Laboratories' brand of concentrated
    morphine sulfate solution for oral administration were identified.  Several label and labeling recommendations were implemented including a calibrated dropper for measuring, warning labels to the outer packaging, and expression of all morphine solutions in mg/ml. Additionally, a “Dear Doctor/Health Care Provider” letters was issued addressing the medication errors involving the high concentration morphine sulfate oral solution.

Name Confusion

DMETS received and processed 274 proprietary name consults in fiscal year 2002 by the following review divisions:

 

Name Confusion

In total, DMETS found eighty-six (86) names or (31%) unacceptable.  In conjunction with the proprietary name review, the Division provided numerous label, labeling, and packaging recommendations in an effort to minimize user error.  Since the inception of the two medication error review teams, DMETS has had an average review time of 90 days for all NDAs, INDs, and ANDAs.

In addition, DMETS was involved in contract procurement for the development of software that will aid in the pre-marketing identification of possible sound and look-alike confusion between proposed proprietary names and currently marketed drug/biologic products, names pending approval, and medical terminology due to phonetic and orthographic similarity.  The contract was awarded to Project Performance Corporation on September 30, 2002 with expected completion of the project by September 30, 2003.

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IX. Division of Surveillance, Research and Communication Support (DSRCS) 

DSCRS, led by Drs. Anne Trontell (Director) and Toni Piazza Hepp (Deputy Director), provides critical safety data and risk communication resources to ODS and CDER.  DSRCS maximizes the Center's ability to:

  • utilize and interpret safety and epidemiological data resources;

  • communicate risk effectively to health care professionals, patients and international regulators;

  • design and evaluate successful risk management programs; and

  • enhance the Center's science base through research.

Important Division initiatives include: 

Drug Utilization Data Resources 

The DSRCS Epidemiologic Data Resources team is involved with acquisition, analysis, interpretation and maintenance of the following databases. 

                 a.  IMS Health

This contract provides ODS with access to the following databases: National Disease and Therapeutic IndexTM (NDTI), National Prescription Audit PlusTM (NPA), Provider PerspectiveTM (PP), and Retail PerspectiveTM (RP).  New services contracted in 2002 include subscriptions to Message Insight (MI) and JARScan.  MI is an automated tool for searching and analyzing information on detailing to physicians.  JARScan similarly provides access to an electronic library of professional journal advertisements related to pharmaceuticals.   The most frequent uses of IMS data include: quantifying the number of prescriptions dispensed to the population and obtaining demographic information on the population exposed to pharmaceutical products.  These data are also used in association with spontaneous case report data to understand the context within which ADRs occur. 

Figures 1 and 2 show requests for IMS Health data by quarter, and by division or office of the requestor.  Requests gradually increased over the past year, with ODS continuing to be the primary users of these data.  Figure 3 shows data requests by audit.  NDTI is used most often (54% of data runs), with NPA following closely behind at 32%.  Retail and Provider Perspectives constitute only 14% of data runs, most likely because they provide data on sales to retail outlets and health care providers, rather than more direct measures of patient exposure such as dispensed prescriptions or mentions of drugs during physician office visits.  However, these audits are the predominant resources used by other offices in FDA to examine the economic impact of regulation.

ODS has initiated two third-party collaborative agreements using IMS Health data to investigate drug safety issues of concern to both FDA and to other academic or government researchers.  One of these agreements is with the Centers for Disease Control (CDC) to collaborate on an ongoing study of certain birth defects and their possible relationship with prescription drug use.  The other agreement is with Duke University on a collaborative effort to examine the use of dofetilide and other antiarrhythmics and the impact of risk management programs.

To share IMS Health data with others outside of the Agency, FDA staff must send documents to be disseminated through a clearance process for approval by IMS Health.  A total of 45 clearance requests were submitted to IMS during fiscal year 2002.  About 38 percent of clearances were necessary for regulatory actions or for presentations to Advisory Committees.  Close to 25 percent were for a variety of external meetings with other U.S. and international health authorities, indicating dissemination of information that FDA staff maintains as part of its public health mission.  Finally, over 37 percent of clearances this past year were for manuscripts and presentations/posters at professional conferences or lectures at academic institutions.    

Request For IMS Health Data

Requests For IMS Health Data by Division/ Office (2002)

Requests for IMS Health Data By Audi (2002)

 

                  b. Premier's Perspective On-lineTM

ODS completed its first year of accessing Premier's data warehouse, which contains information on the use of drugs by hospitalized patients.  The database has been queried to examine the use of multiple classes of drug products, including intravenous antibiotics, anticoagulants, drugs used during surgical procedures, and agents used during diagnostic procedures.  These data provide an important context for understanding adverse event reports related to the use of drug products in hospitals. 

                 c. AdvancePCS Dimension RxTM 

The AdvancePCS database allows FDA to examine how long non-hospitalized patients stay on prescription medication therapy and to learn about drug combinations that may be prescribed to the same patients at the same time.   AdvancePCS data are complementary to IMS Health data and the Agency frequently uses both resources to increase understanding of outpatient drug use.  AdvancePCS data have been used primarily in this first year of the contract to address specific needs relating to age-specific use of drug products, particularly among children, concomitant use of multiple products and to explore patterns of drug use by geographic area.  For example, ODS staff recently published a paper which examined dispensed prescriptions for ciprofloxacin by state, both before and after the anthrax exposures in the fall of 2001.  AdvancePCS data (along with IMS Health data) were also used in a collaborative study with the Centers for Disease Control and Prevention (CDC) to examine certain birth defects and their possible relationship with prescription drug use.

                 d. Child Health Corporation of America's (CHCA) Pediatric Health Information System (PHIS) 

CHCA's PHIS database contains information on the use of medicines in hospitalized children. This information continues to support the ongoing initiative at FDA to approve more prescription drugs for use in children.  Access to the CHCA database is supported jointly by the Office of Counterterrorism and Pediatric Drug Development (OCTAP) and ODS, and it has become a valuable resource for understanding the extent to which drugs are used to treat seriously ill children. 

Consumer Information and Research Team

The DSRCS Consumer Information and Research Team review consumer-oriented materials to ensure that product information is communicated clearly and effectively to patients, especially those with limited literacy.   The team reviews Medication Guides, patient package inserts and other consumer-oriented materials for content, format, and the effectiveness of the communication.  The team is also involved with research aimed at enhancing the understanding, usefulness, and acceptability of these and other forms of patient communication.  Social science expertise is also provided to CDER in designing research and in evaluating studies involving patient comprehension or behavioral issues.  From January to September, the team reviewed and evaluated 12 Medication Guides, 44 patient package inserts and 13 labeling comprehension studies.

MedWatch Program

The Safety Information and Adverse Event Reporting Program (MedWatch) joined ODS/DSRCS in January 2002.  MedWatch reports can be submitted online, by phone, or by submitting the MedWatch 3500 by mail or fax.  A current focus of the program is to provide important and timely clinical information on safety issues involving medical products, including prescription and over-the-counter drugs, biologics, medical and radiation-emitting devices, and special nutritional products (e.g., medical foods, dietary supplements and infant formulas).  Medical product safety alerts, recalls, withdrawals, and important labeling changes that may affect the health of all Americans are disseminated to the medical community and the general public via the MedWatch web site and the MedWatch E-list. 

                  a. MedWatch's Central Triage Unit (CTU):

DSRCS oversees the MedWatch Central Triage Unit that supports the identification and appropriate routing of direct reports on all medical products received through MedWatch. In FY02, CTU processed 24,936 MedWatch reports for products regulated in all of FDA's centers. As shown below, 67% of the reports were triaged to CDER and CBER and entered into AERS.  The single-leading source of direct reports to FDA is pharmacists. Thirty four percent of the reports are being submitted to MedWatch via the Internet.
 

FY02 Reported Outcomes

FY02 Professional Reporting

FY02 Method of Reporting


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 X. Other ODS Activities 

Waivers of Postmarketing Safety Reporting Requirements 

ODS has the authority to respond to requests for waivers of postmarketing safety reporting requirements (see MaPP 6004.1, Granting Waivers Under 21 CFR 314.90 for Postmarketing Safety Reporting Requirements Under 21 CFR 314.80 at MAPP 6004.1 (PDF - 18KB).   CDER encourages industry to request a waiver of the requirement to submit FDA form 3500A for each adverse experience that is determined to be both nonserious and labeled.  As of September 2002, over 70 firms had been granted this type of waiver for over 2700 applications (NDAs and ANDAs).

ODS also grants waivers to firms from requirements to submit postmarketing periodic safety reports in the format described in the regulations (21 CFR 314.80).  Instead firms may use the Periodic Safety Update Report (PSUR) format described in ICH E2C (with modifications to meet U.S. requirements).  When a firm asks to decrease the frequency of submission of a report, ODS consults with the appropriate review division before acting on the waiver request.  As of September 2002, more than 20 firms had been granted PSUR waivers (for PSUR format with or without frequency changes) for approximately 450 applications (NDAs and ANDAs).

Drug Safety Seminars  

In an effort to promote an atmosphere of collegiality with risk management experts from other federal agencies and outside of government, ODS, in cooperation with CDER's Office of Training and Communication's Visiting Professor Lecture Series, presents the drug safety seminar series.  Some examples of 2002 seminars include:

  • Scott Ratzan, M.D., Editor, Journal of Health Communication, “Reducing the Risk in Risk Communication”

  • Larry Gould, M.D., Senior Director, Scientific Staff, Merck Research Laboratories, “Practical
    Quantitative Pharmacovigilence Strategies”

  • Anne Holbrook, M.D., Centre for Evaluation of Medicines, “Integrating Population-Based Data into
    Care of Individual Patients”

XI. Conclusion 

2002 was a year of unprecedented growth and change for the Office of Drug Safety.  ODS underwent a major reorganization including the formation of three distinct divisions.  Internal procedures were identified for smooth implementation of newly assigned programs like MedWatch, patient labeling and assessing the risks associated with drugs through risk management programs.  The Drug Safety and Risk Management Advisory Committee was formally chartered and held its first meeting. ODS staff were pivotally involved in developing numerous Guidances, MaPPs and Regulations, including two major proposed rules, Barcoding Human Drugs and Vaccines and the Safety Reporting Requirements for Human Drug and Biological Products (also known as the Suspected Adverse Drug Reporting Proposed Rule).  ODS also supported Federal patient safety and medication error initiatives.  ODS leveraged resources by working cooperatively with other Federal Agencies, private organizations, industry and the Centers for Education on Research on Therapeutics (CERTs) on public/private initiatives to improve patient safety.  In the past year, ODS acquired access to mission-critical drug utilization information  including longitudinal, inpatient and pediatric inpatient data to aid in our understanding of product use as the context for the occurrence of adverse events.  In addition, we continued to access population-based data through our Cooperative Agreement Program to address important safety questions in formal epidemiological studies.

In 2003, ODS will continue its focus on making the Adverse Event Reporting System more efficient.  We will work on minimizing the incidence of medication errors by examining the methods used to screen proprietary drug names for similarities and continue to evaluate drug packaging and labeling for lack of clarity.  We will refine current techniques to assess drug risks through the development and evaluation of risk management programs.  We will carefully consider appropriate risk communication techniques in order to clearly articulate drug side effects and other related drug risk/benefit information to both health professionals and patients.  Finally, we will continue to collaborate with our international regulatory counterparts, health professionals and academia, private industry and our colleagues in the Center for Drug Evaluation and Research to further the mission of the Office and Center in order to improve patient safety and the public health.