[U.S. Food and Drug  Administration]


Communication Dynamics:
A Resource in Assuring Drug Quality

George Bolger, R. Ph.

"Communication Dynamics: A Resource in Assuring Drug Quality" is a self-study continuing education program for pharmacists that has been developed by the U.S. Food and Drug Administration, Center for Drug Evaluation and Research.

Center for Drug Evaluation and Research is approved by the American Council on Pharmaceutical Education (ACPE) as a provider of continuing pharmaceutical education (and complies with the Criteria for Quality for continuing pharmaceutical education programming).

This program is acceptable for one hour of continuing education credit (0.1 CEU) in states that recognize ACPE-approved providers (#601-000-95-091-C04). Certification will be issued upon successful completion of the post-test (with a score of 70% or better).

Pharmacists completing this program before March 31, 1998 may receive credit

Table of Contents

  • Learning Objectives

  • Background

  • Drug Shortage

  • Data Management

  • Interactive Computer File

  • Table 1. FDA Recall Classifications

  • Table 2. Examples of Commonly-Reported Drug Quality Concerns

  • Learning Objectives

    Successful completion of this continuing education program will enable the pharmacist to:

    1. Identify the three major participants in assuring the quality of prescription and non - prescription drug products in U.S. distribution.

    2. Obtain an appreciation of the impact an individual report can have in assuring drug quality.

    3. Obtain an appreciation of how drug quality observations are quickly available electronically throughout FDA and immediately shared with the pharmaceutical industry.

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    One of the U.S. Food and Drug Administration's missions is to assure the quality of prescription and non-prescription drug products in commercial U.S. distribution. The Agency utilizes a variety of information gathering strategies. One of the best ways of acquiring marketplace surveillance information has been through voluntary reporting by the Nation's pharmacists.

    This program has had a variety of names over the last 25 years and is currently known as the Drug Quality Reporting System (DQRS) and identifies the type of information the Agency is seeking. DQRS is part of the agency's overall MedWatch system. This approach has provided timely product information and has pinpointed significant product quality issues.

    A two-pronged approach of:

    1. freely sharing the reported information with the respective pharmaceutical manufacturer or labeler for inclusion as part of their current good manufacturing practices (CGMP's) into their complaint file system (21 CFR 211.198), and

    2. the investigation of all reports by FDA field investigators

      has made for the quick resolution of real problems.

      Other improvements are made to many other products through voluntary changes instituted by the pharmaceutical industry for their specific products. The dual action of both FDA and the pharmaceutical industry makes the prescription and non-prescription drug products distributed in the U.S. the best in the world.

      The timeliness, specificity of the information provided, especially the product's lot or batch number(s), and the continued professionalism demonstrated by pharmacists and other health care providers make this voluntary surveillance system an unparalleled source of information and helps maximize FDA's limited resources.

      To make this system a responsive surveillance tool, the reported information must be freely shared with the pharmaceutical industry, quickly prioritized and be available to the Agency to support current investigations as well as trend analyses. There have been a number of changes in these areas over the past 25 years. First, the reporting mechanisms have been expanded to accommodate four different ways to quickly make individual observations known to the FDA and the pharmaceutical firm - a prepaid U.S. mail reporting form (FDA FORM3500) and three mechanisms for direct electronic reporting:

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      Drug Shortage

      The dynamics of the pharmaceutical industry has periodically shown problems with the availability of certain drug products. This may have been the result of a lack or limited amount of bulk raw materials, changes in manufacturing procedures or a firm's marketing decision. Whatever the cause, the lack of availability can be a concern for the pharmacist and their patients. To address this problem, DQRS instituted the Drug Shortage Program (DSP) to respond to questions pertaining to the status of drug products that are in short supply.

      Drug shortage reports received at DQRS are first reviewed to determine the severity of the shortage. Next, the manufacturer and/or labeler is contacted to determine the reason for the shortage and when the product will be available in sufficient quantity. All reporters of drug shortages are contacted and informed of the findings. A drug shortage report is immediately filed with the FDA and entered into the agency's online DQRS database for tracking.

      Drug shortage reports are submitted just as drug quality issues are (by completed FDA form 3500, calling 1-800-FDA-1088, faxing to 1-800-FDA-0178 or by modem to 1-800-FDA-7737).

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      Data Management

      This information is immediately made available to FDA through online entry into the Agency's DQRS database. This availability of the reporter's observations makes the initial evaluation a quicker and simpler process by eliminating the delays incurred by processing and handling hard copy reports. This capability also allows several different segments of the Agency to simultaneously access and review current and previously filed report data.

      The managing of drug quality information since the late 1960's has undergone important changes. At that time, computer applications were just making inroads into the FDA's work routine, and the lack of uniformity and the unavailability of standardized dictionaries or terms greatly detracted from the utility and power of these early computer database ventures. Computers and programs have advanced greatly since our early efforts. Some of those developments have met the needs of the DQRS program and now make information from these databases immediately accessible to every FDA investigator at the site of their investigations.

      I will address some of the mentioned changes, their impact on inspection and regulatory actions and the daily utility they now provide to the FDA.

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