Post Market Reporting And The Use Of Terminologies: MedDRA And WHO-DD.

By Samina Qureshi, M.D. PSI International, Inc.

The pharmaceutical Industry is ever changing with novel drug development and research.

The use of pharmaceutical products is carefully regulated from the initial submission of an Investigational New Drug application to the reporting of adverse events once the drug has been marketed. Federal Regulations make it mandatory for manufacturers to report any occurrence of serious adverse events to the Food and Drug Administration (FDA).

Historically, the loose regulation of drugs was sporadically assigned to various branches of government. For example, in 1862: The Bureau of Chemistry, under the Department of Agriculture, was assigned this task. As various hallmark events in the realm of public health occurred, this resulted in the need for legislation and passage of various acts. In 1902, the Biologics Control Act was passed in reaction to the contamination of sera used to produce a diphtheria antitoxin that caused the deaths of thirteen children in St. Louis, Missouri and the contamination of smallpox vaccine which killed nine children. As a result, in 1906 The Pure Food and Drug Act was passed to prevent the manufacture and sale of poisonous and adulterated products. This was the first time any type of label requirements were put into place, but still no real legal power was established against false claims.

About The Author: Dr. Samina Qureshi is a physician by training and is working for PSI INTERNATIONAL Inc. She has worked on PSI's FDA CDER AERPS contract involving coding/quality assurance on Post Marketing Surveillance (PMS) reports from CDER, CBER, and Vaccine Adverse Event Reporting System (VAERS). She is proficient in various dictionaries to include the Medical Dictionary for Regulatory Activities (MedDRA) and the World Health Organization (WHO) Drug Dictionary, and risk assessment and risk intervention activities.