Counterfeiting and contamination of medicines is a serious problem today with public health, social and economic impact. The first tragedy associated with the use of medicines contaminated with toxic substances was due to the commercialization of an Elixir Sulfanilamide preparation tainted with diethylene Glycol (DEG), used as a solvent, that lead to the enactment of the Federal Food, Drug and Cosmetic Act, 1938, the most relevant regulatory change in the history of pharmaceutical regulation. Despite several legislation changes, guidelines implementation to improve medicine quality control and the recognition of the impact of this case in humans, 16 additional episodes of DEG intoxication were detected since 1937. In this thesis DEG-associated intoxication episodes that happened between 1990-2015 were analyzed with the following objectives: 1) To determine the epidemiological and sociological characteristics of main mass intoxications by DEG in medicines; 2) To analyze its impact on local general written press and global publications; and 3) To review the legislative initiatives implemented after DEG-relative massive intoxications and their impact on the prevention of new episodes. The systematic search in scientific databases (Medline and EMBASE) and in google Scholar resulted in the identification of 12 episodes from 9 countries, based on the analysis of 84 publications. Most episodes occurred in developing countries (11/12) and were associated with paracetamol liquid formulations (7/12). With the exception of one episode in a developed country (France), the manufacture of the final product was carried out in local laboratories. The critical factors for minimizing episodes’ impact were healthcare professionals’ knowledge and alertness, healthcare authorities’ awareness to early initiation of investigations and quick recall of medication after identification of the toxic substance. The New York Times journalistic research on the Haitian and Panamanian episodes was crucial for the identification of the origin of the toxic product. The written general press had its greatest impact on the episode of Panama contributing to the alert of the episode but especially in the process of defending the rights of those affected. Panama was also identified as the episode with the greatest impact on regulatory changes and implementation of legislation, with internal effects but also abroad, in other countries. Globally, this analysis identified 21 legislative measures associated with poisoning DEG episodes, including the establishment of regulatory agencies in two countries, Nigeria and Argentina. However, and despite the increase in quality control of medicines, resulting from legislation and regulations implemented over the last 25 years, these do not seem to be sufficient for the prevention of new episodes. The implementation of new measures should seek to adapt to each country specific characteristics and cultural aspects of developing countries. It should also be considered actions that allow training of healthcare professionals and population in the identification of episodes of poisoning by counterfeit medicines, as well as actions that increase awareness of the authorities of each country.
|Date of Award
|22 Sept 2017
|Josep Eladi Banos Diez (Director), Félix Bosch Llonch (Director) & Magi Farre Albaladejo (Tutor)
- Diethlene glycol