Interactive Computer File

The DQRS reported information is now easily entered and retrieved using an on-line interactive computer language. The new software designs take advantage of existing Agency databases. These files began in the early 1970's and are mandated by regulation 21 CFR 207, Drug Registration and Listing System (DRLS). The DRLS includes standardized information involving; product name, active and inactive product ingredients, strength, package type and size, and the manufacturer's name and location(s), as some of the data elements. This database provides DQRS with a standardized dictionary, maintained by a separate FDA group and available throughout FDA. The DRLS links and identifies individual products and firms to any DQRS report involving that product via the product's National Drug Code (NDC). This NDC number is all that is necessary for drug and labeler entry of the report information into the DQRS system.

The NDC is a unique number made up of three distinct segments. The first portion is the labeler code. All drug manufacturers or repackagers are required to register with the FDA. The first segment of this unique 11-digit number is assigned by the Agency to each registrant. The second and third segments of this number are related to the product identity and package type or size. The individual firms are allowed to assign whatever numbers they wish for each product and package configuration, but they must conform to the format established by the Agency and must provide to FDA all the required information relating to that specific product. As a result of these filings, the Agency has a database with extensive information on every product distributed in the U.S. This information requirement is ongoing and is supported by regulation. The DRLS file is the primary dictionary for the DQRS program, and the use of NDC numbers allows for rapid and accurate entry of product and labeler information. Secondary dictionaries or tables were developed to meet some special needs of monitoring drug quality issues and facilitate the uniform entry of DQRS reported information.

The concept of "quality" is not promoted as a set or defined term but is left to the reporting pharmacist's or other health care provider's interpretation. This allows for anything the reporter believes to be of concern to him or her in their dispensing or administering of prescription or non-prescription drug products to be reported. However, the variety of terms or phrases used to report an observation are coded in a standardized manner. A system of 10 primary defect categories and a "Thesaurus of Drug Defects," (TODD) has been developed to accomplish this standardization and capture the reported observation(s). These categories are designed to be used in search and retrieval strategies relating to CGMP's inspection needs. The system also has the ability to monitor new or unique dosage or packaging forms, i.e., unit dose, prefilled syringes, aerosols, etc.

DQRS has demonstrated its ability to identify trends in product quality problems, either product specific or industry wide. Several general examples of these trends can be seen from the following: The lack of product stability of certain products manufactured in soft-shelled capsules was identified and reported by individual reporters using a variety of phrases such as "leaking capsules," "capsules sticking together," and "congealed mess." Investigation of these individual reports showed a common problem. The active drug substance inside these capsules had a very long shelf life, but the stability of this drug in this dosage form and marketed container/closure system was much shorter and not reflected in the product's labeled expiration date. The marketed product did not meet the stability requirements (21 CFR 211.166).

Another situation involved a variety of different labelers of antacid products. Many of the labelers were using the same manufacturer for their individual products. What appeared to be isolated contamination problems identified with a variety of differently labeled products was quickly found to be a contamination problem involving a common manufacturer (21 CFR 211.67). These products posed a situation in which their use may cause temporary or medically reversible health consequences and usually resulted in their recall from the market. These examples show that isolated reports from across the nation when entered into a database can immediately interface with other Agency computer files and quickly identify drug quality problems and trends and mitigate situations which can impact on the public's health.

Since starting the drug quality surveillance program (DQRS) and the current data management approaches in 1988, this voluntary reporting of drug quality issues has helped support over 240 recalls and more than 700 corrective actions voluntarily made by the pharmaceutical industry for their respective products.

The development in this on-line data management approach has been to put this file information into the hands of the investigator as quickly and easily as possible. This capability is available to the investigator while on-site at an inspection or in the field office. A system of menu features enables the investigator to obtain detailed or summary reports by such groups as:

• active ingredient
• specific labelers
• specific lot number(s)
• defect categories
• combinations of the above
  

Voluntarily submitted drug quality information can greatly assist the FDA and the pharmaceutical industry in assuring that the highest quality prescription and non-prescription drugs are in U.S. distribution. The original concepts developed in the late 1960's are a viable reality today due to computerization, electronic communications, and most importantly your voluntary reporting of concerns.

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