Regards Investigative Drug Administration


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Final Summary of Food and Drug Administration (FDA) Action Items – Doing What Counts for Patient Safety: Federal Actions to Reduce Medical Errors and Their Impact1
Food and Drug Administration
I. Introduction

This report outlines the steps the Food and Drug Administration (FDA) has taken to meet the action items outlined in the February 2000 Report to the President from the Quality Interagency Coordination Task Force (QuIC) entitled “Doing What Counts for Patient Safety: Federal Actions to Reduce Medical Errors and Their Impact.” The February 2000 report responded to the report released in 1999 by the Institute of Medicine (IOM) that estimated up to 98,000 deaths occurred every year as a result of preventable medical errors.2

Many of the action items, as noted below, are ongoing activities that FDA will continue to support. FDA is committed to improving patient safety and will continue to take necessary steps to reduce medical errors.

II. National Summit on Drug Safety and Other National Meetings

FDA has participated in many national meetings related to improving patient safety, including attention to reducing drug, biologic and medical device errors. The following are some of the meetings in which FDA played a major role.

On March 27, 2000, FDA co-sponsored a workshop with the National Patient Safety Foundation (NPSF) entitled “Safe Medical Treatments: Everyone Has a Role: Ensuring the Safety of Drugs, Biologics, and Medical Devices in Health Care.” This workshop was designed to provide a forum for consumer and patient organizations to discuss how to help consumers become more involved in their own medical care. It brought together the leadership of many active and influential organizations to find ways for the public and private sectors to work collaboratively on the issue of safe medical products. The workshop was organized by a steering committee comprised of representatives from both patient and consumer groups.

On June 21, 2000, FDA and the American Society for Healthcare Risk Management (ASHRM) co-sponsored a satellite video teleconference entitled, “Preventing Errors using Medical Products.” This teleconference was designed to help healthcare professionals identify, understand, prevent, and resolve errors related to the use of medical products.

On June 22, 2000, FDA’s Center for Drug Evaluation and Research (CDER) and the Drug Information Association (DIA), presented a live video teleconference (CDER Live) entitled, “CDER and Industry’s Role in Minimizing the Pharmaceutical Contribution to Medical Errors.” Among other features, the program provided an in-depth discussion of the sources of medical errors associated with pharmaceuticals and how FDA is working toward building a comprehensive postmarketing surveillance system to address the important issues. Several recent high-profile postmarketing regulatory actions and research initiatives were highlighted to illustrate the mission and priorities. There was active participation and very positive feedback from the viewing audience.
On August 7, 2000, FDA participated in a conference entitled “Promoting and Standardizing Bar Coding on Medication Packaging: Reducing Errors and Improving Patient Care” in Chicago, Illinois. The National Coordinating Council for Medication Error Reporting and Prevention, which FDA and the pharmaceutical industry are members, sponsored the conference. Numerous recommendations and suggestions were discussed and will be released in a White Paper by the Council in the near future.
On August 28 and 29, 2000, FDA participated in a meeting sponsored by the Kaiser Permanente Institute for Health Policy, in San Jose, California. The participants in this workshop examined the components and features of a comprehensive patient safety reporting system that would meet the needs of all stakeholders.
On September 7 and 8, 2000, in a follow-up to the aforementioned meeting, FDA participated in a workshop sponsored by the Department of Veterans Affairs (VA) in Washington, DC. Participants worked on designing a taxonomy of medical errors that would meet the needs of all stakeholders if implemented in a new VA reporting system. The taxonomy included adverse events to medical products and medication errors.
On October 5 and 6, 2000, FDA participated in a major drug safety think tank sponsored by Wake Forest University in Winston-Salem, North Carolina. This meeting brought together thought leaders from academia, industry and FDA to discuss the challenges in minimizing the occurrence of patient injury due to pharmaceuticals.
On February 14, 2001, FDA presented a live video teleconference entitled: “Integrating Human Factors Engineering into Medical Device Design and Development.” The video teleconference focused on the roles of the medical device industry and FDA in reducing medical device errors by addressing user needs. The discussion included how individuals innately respond to their physical environment.
FDA has been working with the Centers for Education and Research on Therapeutics (CERTs) to develop a workshop on risk communication scheduled for April 30-May 1, 2001. This meeting will bring together leaders from FDA, Pharmaceutical Research and Manufacturers of America (PhRMA), and experts in the field of risk communication. This workshop will examine the challenges of changing inappropriate prescribing behavior through communication, and will set a research agenda.3
FDA will continue to support future workshops and meetings on patient safety initiatives to help reduce medical errors.

III. Report to the Public on the Safety of Drugs, Devices, and Biologics

In May 1999, FDA released a public document entitled, “Managing the Risks from Medical Product Use: Creating a Risk Management Framework.”4 This document is significant because it framed FDA’s role in medical product risk management and included many recommendations that were incorporated into the QuIC response to the IOM report. Most importantly, it antedated the release of the IOM report on medical errors and demonstrated that FDA was proactive in thinking about the issue of patient injury due to medical products.

FDA continually assesses the safety of the products it regulates and responds to safety reports by taking actions such as, providing important product safety information to the public, making changes in labeling, requiring a product design change, or withdrawing a product from the market. FDA promptly issues Safety Alerts, Public Health Advisories, Recalls, Talk Papers, and Notices in an effort to inform the public about patient safety issues as they are identified.

FDA is committed to providing the public with timely access to safety information about drugs, biologics and medical devices. For example, on August 14, 2000, FDA issued a final guidance on reuse of single-use medical devices.5 There has been concern about patient safety related to reusing devices that were intended to be used only once. The guidance was designed to protect the safety of the public by ensuring that the practice of reprocessing and reusing single-use devices is based on sound scientific principles. To ensure that this important information was disseminated to the public, FDA issued a Talk Paper and sent a letter to over 6000 hospitals to inform them about this guidance and to provide additional information about the reuse of devices.

The FDA web site also provides up-to-date information about drugs, biologics, and medical devices. For example, the aforementioned Safety Alerts, Public Health Advisories, etc. are all available on the FDA web site ( The new Medication Errors web pages provide information about medication error monitoring, drug products associated with medication errors, and other resources for finding information about medication errors The Consumer Drug Information web pages provide access to information about current safety issues in consumer-friendly language

IV. Expand Mandatory Reporting of Errors to all Registered Blood Establishments

On November 7, 2000, FDA published a regulation that requires the reporting of any event associated with biologics, including blood and blood components and source plasma that represents a deviation in manufacturing.6 These events include deviations from current good manufacturing practices, applicable regulations, applicable standards, or established specifications that may affect the safety, purity, or potency of a distributed product. Those who must report are licensed manufacturers of all biological products, unlicensed registered blood establishments, and transfusion services who had control over the product when a deviation occurred. This rule also requires the reporting of an unexpected or unforeseeable event associated with manufacturing that may affect the safety, purity, or potency of a distributed product. The rule requires the reports to be submitted as soon as possible but not to exceed 45 calendar days from the date the manufacturer acquires information reasonably suggesting that a reportable event has occurred.

In addition, FDA is proposing to amend the biologics regulations to require that blood establishments (including plasma establishments) prepare and follow written procedures for appropriate action when it is determined that blood and blood components at increased risk of transmitting hepatitis C virus (HCV) infection have been collected from a donor who tested repeatedly reactive for evidence of HCV infection at a later date.7 This proposed rule would require blood establishments to quarantine prior collections from such a donor, perform further testing on the donor, and notify transfusion recipients, as appropriate, when such a donor is identified at the time of a repeat donation or after performing a review of historical testing records to identify donations at increased risk of transmitting HCV. In addition, FDA is proposing to extend the record retention period to 10 years to create opportunities for disease prevention many years after exposure to such a donor.

V. Initiate Programs to Develop Additional Standards for Drug Names

FDA’s Office of Postmarketing Drug Risk Assessment (OPDRA) in the Center for Drug Evaluation and Research (CDER) initiated a new program in October 1999 for the review and risk-analysis of proprietary names for drug products. The program began in December of 1998 with the creation of a medication error staff. Before approval of a new drug application, OPDRA reviews every proposed proprietary name for possible sound- or look-alike confusion with marketed drug products. The multi-faceted review utilizes computers and simulated outpatient and inpatient prescriptions that are interpreted by 100 physicians, pharmacists and nurses within the FDA. In 2000, OPDRA provided reviews for approximately 300 proprietary names and developed standard operating procedures on the review process.

FDA is currently drafting a guidance document for the pharmaceutical industry that will outline methods of testing proprietary names for potential confusion with existing proprietary names. In addition, the guidance document will provide advice on minimizing medication errors with pharmaceutical products due to labeling and packaging problems.

VI. Initiate Development of Packaging Standards to Prevent Dosing and Drug Mix-ups

The use of machine-readable codes or bar codes, in a standardized format for packaging of medications, is a method for improving patient safety through the use of technology. As previously mentioned in this report, FDA participated in conference by the National Coordinating Council for Medication Error Reporting and Prevention that addressed standardizing bar coding on medication packaging to reduce errors and improve patient care. The recommendations and suggestions from this meeting will be released in the near future. The FDA is also working on a guidance document for the pharmaceutical industry that will address packaging pharmaceutical products to reduce the error potential.

Additionally, for blood and blood components, FDA issued guidance and is engaged in rulemaking that would remove existing barriers to the use of an international bar code labeling system.8 The use of a uniform container label for blood and blood components in the United States and internationally will enable critical information, such as ABO and Rh blood groups, to be clearly understood by health care professionals transfusing the blood product. Furthermore, a computerized system will enable tracking of blood and blood products for safety.

VII. Develop New Label Standards for Drugs to Address Errors Related to Medications

Because misadministration of drugs is one of the most common types of medical error, the FDA is improving the management of and communication about the risks of prescription drugs.

On December 22, 2000, FDA proposed new regulations that will greatly improve the format and content of prescription drug labeling written for prescribing health care professionals (also known as package inserts and prescribing information).9 This proposed rule would require that the labeling of new and recently approved products include an introductory section containing highlights of the labeling information that practitioners most commonly refer to and view as most important. In addition, the rule proposes to add an index to labeling, reorder and reorganize the comprehensive information, and establish minimum graphical requirements for the format of labeling. These revisions will make it easier for health care practitioners to find, read, and use labeling information and enhance the safe and effective use of prescription drug and biological products. The proposed new labeling is expected to accomplish this by reducing practitioner time spent looking for information, improving treatment effectiveness, and decreasing the number of preventable medical errors caused by inadequate communication of critical prescribing information. In addition, FDA plans to initiate an educational campaign to inform health care professionals about the new labeling.

The rule also proposes revisions to the required information that appears on the container labels of prescription drug products. The changes are intended to reduce overcrowding of container labels by eliminating unnecessary statements and moving less critical information to the package insert. Overcrowded drug product labels are more difficult to read, and may be one possible cause of medication errors by health care practitioners. Simplifying container labels is also expected to reduce the number of preventable medication errors.

On June 21, 2000, FDA released a draft guidance for industry that proposes revisions to the content and format of the adverse reactions section of the labeling for prescription drugs and biologics.10 This guidance provides information on criteria for including adverse reactions in labeling, presentation of adverse reactions in a table, and organization of the section. FDA expects that these revisions will make the adverse reactions section more useful and accessible to prescribers and more consistent across different drugs and drug classes.

In March 1999, FDA developed new standards for the format of over-the-counter (OTC) drug product labeling that should increase patient knowledge about the medication and decrease errors in use.11 Subsequently, FDA implemented a nationwide media campaign to inform consumers how to use new over-the-counter drug product labeling.

VIII. Implement Phase II of MeDSuN

MeDSuN is a pilot program designed to educate and encourage hospital personnel to accurately identify and report injuries, deaths and close calls associated with medical products. MeDSuN includes a representative network of hospitals. The initial phase of the MeDSuN pilot was a success, with actual adverse event reports from participating hospitals increasing 15-fold for medical devices.

The implementation of Phase II of MeDSuN is ahead of schedule. An internet data entry system is under development. A contract has been awarded to begin determining appropriate outcome measures, drawing a national sample, and recruiting and training 25 hospitals. Receipt of the first data transmissions is targeted for October 2001.

An analysis of resource requirements for expanding the MeDSuN program to incorporate drugs and biologic product surveillance is underway.

IX. Intensify Efforts to Ensure Manufacturers Comply with Standards

FDA is continuing to develop Human Factors Engineering Standards that include the American Association for the Advancement of Medical Instrumentation (AAMI), the International Electrotechnical Commission (IEC), and the development of a Human Factors Engineering guidance document. Human factors, the study of the interaction of people and devices, is a technology for designing devices that can be used easily, safely and effectively by human operators. On July 18, 2000, FDA issued a guidance that describes how to incorporate human factors techniques and theory into risk management during medical device design and development.12 The FDA expects that the guidance will decrease problems with the use of medical devices that impact safety and effectiveness, and reduce the likelihood of use error and patient injury.

FDA is actively working with the pharmaceutical industry to develop standards for minimizing medication errors associated with the naming, labeling and/or packaging of pharmaceutical products. Since October 1999, FDA substantially increased its efforts, through its Office of Postmarketing Drug Risk Assessment, to assure that manufacturers comply with the current regulations and standards that the proprietary name does not sound or look like other names of marketed products. FDA also increased its postmarketing surveillance of medication errors associated with the labeling and packaging of drug products and asked pharmaceutical manufacturers to take appropriate risk reduction efforts.

FDA also intensified its efforts at monitoring industry compliance with adverse drug experience reporting regulations. This has had an impact on the quality, completeness, and timeliness of adverse event reporting for drug products by industry to FDA.

X. Provide Access to Databases Linked to Healthcare Systems

Currently, FDA has access to databases linking pharmaceutical use to outcomes in population-based settings through the Cooperative Agreements Grant Program (FD-U-016000). FDA grantees include Boston University, Harvard Pilgrim Health Cooperative, Johns Hopkins University, Vanderbilt University and the United Health Group. This program allows FDA to conduct pharmacoepidemiological studies to confirm and quantify postmarketing safety concerns. It has also proven to be a valuable tool for quantifying the effectiveness of risk management and risk communication strategies in changing behavior that may lead to patient injury.13,14

The Centers for Education and Research on Therapeutics (CERTs) have access to large healthcare databases including the HMO Research Network, VA, AETNA, several State Medicaid databases and others. FDA has been working with CERTs to catalog shared database resources. A database working group has been formed that includes FDA representatives. This group provides a forum for sharing knowledge about databases and for discussing joint database research efforts.

FDA has been working with other Federal entities such as Health Care Finance Administration (HFCA), Department of Veterans Affairs (VA), Agency for Heath Care Research and Quality (AHRQ), and Centers for Disease Control (CDC) to evaluate the feasibility of shared initiatives in existing databases.

FDA has also been involved in developing active surveillance strategies and identifying appropriate settings for pilot projects in active surveillance.15 Several pilot initiatives are planned and have been funded by FDA. Examples include a hospital-based program for detecting medication errors, and emergency room-based surveillance for drug-induced injury. Ongoing discussions with international colleagues include evaluating the feasibility of utilizing existing systems such as the Prescription Event Monitoring (PEM) System in the United Kingdom. The Center for Biologics Evaluation and Research (CBER) is piloting a large-linked database project that utilizes databases of several managed-care providers, which will provide the opportunity to study potential rare adverse outcomes associated with use of medical products.

XI. Complete Online Adverse Drug Event Reporting System

Adverse drug event reporting has been the cornerstone of FDA’s postmarketing surveillance activities. The continued development of Adverse Event Reporting System (AERS) has been a top priority for the past several years. AERS replaced the Spontaneous Reporting System and went online in 1997. AERS was designed to provide state-of-the-art analytic capabilities and to be compliant with International Conference on Harmonization (ICH) agreements. FDA continues to invest considerable resources in the further development of AERS. AERS version 2.0 was released in 2000.

AERS was designed to allow and facilitate electronic submissions of adverse event reports from industry. FDA and industry have been working together under a pilot program to test and refine electronic submissions of these reports. A major priority of FDA in 2001 will be to develop and propose new regulations requiring electronic submission of adverse event reports by manufacturers. This will increase the efficiency and timeliness of detection of safety problems.

XII. Strengthen FDA’s Analytic and Investigative Capacity

FDA supported the human resource requirements necessary for a comprehensive postmarketing surveillance program. For example, the establishment of the Office of Postmarketing Drug Risk Assessment (OPDRA) in 1998 heralded CDER’s commitment to support postmarketing drug safety efforts. OPDRA has been provided increased resources and staffing to meet these ends. This is a necessity to be able to optimally analyze the information from additional data resources from linked healthcare databases.

FDA is providing and developing tools that allow enhanced drug safety activities. Some examples include, development and application of Bayesian datamining methods to spontaneous reports and longitudinal medical records, and the use of computational toxicological methods to analyze suspected or potential adverse drug reactions.

XIII. Strengthen FDA’s Outreach Activities and Collaboration with Federal Agencies

FDA’s commitment to outreach activities to industry, health care professionals, users of medical products, and consumers has been described in previous sections of this report. Participation in public meetings, development of guidance documents and dissemination of safety information in various media are some of the ways FDA achieves this commitment. Examples of other ongoing outreach activities include:

FDA will continue MedWatch, the FDA Medical Products Reporting Program that is designed to educate all health care professionals about the critical importance of being aware of, monitoring for, and reporting adverse events and problems related to medical products. Over 140 organizations representing health professionals and industry support MedWatch. Individual consumers may also submit reports to MedWatch.
FDA publishes case reports and articles in the scientific literature describing reported medical errors, potential adverse effects of products in use, and overviews of postmarketing safety reports (e.g., safety of new vaccines).
FDA designed and published a brochure for consumers and health care professionals to educate them in making safe choices when medical devices are to be used in the home.16 This brochure focuses on user limitations, environment, and device characteristics that may impact the safe use of a device.
FDA is currently developing an educational outreach program designed to reach health care professionals by providing measures that practitioners may use to minimize medication errors.
FDA held public and advisory committee meetings to inform consumers and health care professionals about the FDA’s work in making the pregnancy section of labeling more useful.
FDA designed and implemented a multi-media campaign designed to increase consumer awareness about the problems related to online drug purchases.
Various materials are under development by a diverse working group of public and private organizations led by FDA to develop and disseminate hospital bedrail safety information.
FDA is working with the National Patient Safety Foundation on outreach activities targeting consumers to educate them about the safe use of pharmaceuticals.
The Council on Family Health, FDA, and the National Consumers League released an updated version of a consumer guide entitled “Drug Interactions: What You Should Know” in December 2000. The guide was designed to help consumers avoid potential drug interactions when taking prescription or nonprescription medications.
FDA plans to continue to work with all interested governmental agencies and private organizations to coordinate the collection of data. In cooperation with FDA, the National Heart Lung Blood Institute (NHLBI), NIH funded an RO-1 grant for the development of a Medical Event Reporting System for Transfusion Medicine (MERS-TM). The system that was developed is now being pilot tested for implementation in a small number of blood collection and blood transfusion services. FDA is taking steps to examine the feasibility for use of MERS-TM as a standard mechanism for investigation and reporting of transfusion related errors, product deviations and adverse medical events.

FDA is actively working with HCFA, VA, AHRQ and CDC to evaluate the feasibility of sharing existing data.

XIV. Conclusions

Preventable patient deaths and injuries associated with the use of medical products are an important public health concern. This summary of actions taken exemplifies FDA’s dedication to preventing patient harm and improving patient safety. FDA contributed to reducing preventable deaths and injuries through collecting, identifying and learning from medical errors, setting safety standards for industry, collaborating with Federal agencies and private organizations, and increasing public awareness of medical errors. Improving patient safety continues to be a challenge. FDA remains committed to continue activities to support the reduction of preventable medical errors and their impact.

1 Report of the Quality Interagency Coordination Task Force (QuIC) to the President. Doing What Counts for Patient Safety: Federal Actions to Reduce Medical Errors and Their Impact, February 2000.

2 Institute of Medicine (IOM). To Err is Human: Building a Safer Health System. Washington, DC: National Academy Press, 1999.

3 Centers for Education & Research on Therapeutics. Annual Report, October 2000.

4 Report to the FDA Commissioner from the Task Force on Risk Management. Managing the Risks from Medical Product Use: Creating a Risk Management Framework, May 1999.

5 65 FR 49583. Guidance for Industry on Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals; Availability, August 14, 2000.

6 65 FR 66621. Biological Products: Reporting of Biological Product Deviations in Manufacturing, November 7, 2000.

7 65 FR 69377. Current Good Manufacturing Practice for Blood and Blood Components; Notification of Consignees and Transfusion Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting HCV Infection (“Lookback”), November 16, 2000.

8 65 FR 35944. Guidance for Industry: Recognition and Use of a Standard for the Uniform Labeling of Blood and Blood Components, June 6, 2000.

9 65 FR 81081. Requirements on Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Prescription Drug Product Labels, December 22, 2000.

10 65 FR 38563. Draft Guidance for Industry on the Content and Format of the Adverse Reactions Section of Labeling for Human Prescription Drugs and Biologics; Availability, June 21, 2000.

11 64 FR 13253. Over-the Counter Human Drugs; Labeling Requirements, March 17, 1999.

12 65 FR 44539. Guidance for Industry and FDA Reviewers on Medical Device Use — Safety: Incorporating Human Factors Engineering into Risk Management; Availability, July 18, 2000.

13 Burkhart GA, Sevka MJ, Temple R, Honig PK. Temporal decline in filling prescriptions for terfenadine closely in time with those for either ketoconazole or erythromycin. Clinical Pharmacology and Therapeutics, 1997;61:93-6.

14 Smalley W, Shatin D, Wysowski DK, et al. Contraindicated use of cisapride: impact of Food and Drug Administration regulatory action. JAMA, 2000;284:3036-9.

15 Office of Postmarketing Drug Risk Assessment, Center for Drug Evaluation and Research, FDA. A White Paper: Active Surveillance for Adverse Drug Events, January 3, 2001.

16 Center for Devices and Radiological Health, FDA. Make Sure the Medical Device You Choose is Designed for You, September 20, 2000. [].

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