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Throw the history of life, humanity has learned to formulate knowledge from the mistakes
made rather than preventing them. One big example is shown in the pharmaceutical
The global historical background for the development of protocols for pharmaceutical
surveillance, was establish in the 1950s with a revolutionary product made by Chemie
Grünenthal named Thalidomide. This drug was created to treat problems such as epilepsy,
later on when the company saw the product didn’t have a mortal dosage in animals they
decided to market the compound after 1956 license was approved, as prescription-free drug
in Germany. The company found out that their compound could be used for the treatment of
other problems such as nausea, it made people relaxed, sleepy and helped with morning
Ten year after this drug was created, worldwide some problems were reported.
Grünenthal did not provide any clinical evidence that was convincing in order to refute the
concerns. By 1961, this drug was sell in more than 40 countries legally and some more
illegally. The German scientist Widukind Lenz and the Australian scientist William McBride
independently report the possible link between Thalidomide and 10,000 born babies with
disabilities all around the world. After a big controversy and campaigns of discredit, the
German government with the pharmaceutical were made responsible and they had to pay for
the damage. The World Health Organization discussed the issue in their forums and conclude
that the drug should be removed from the market. The negative effects of the Thalidomide
The globalization and research of new technologies have propitiated the development
of new pharmaceutical surveillance protocols all around the world in order to elevate quality
The importance in the study of drugs development is a far new topic to analyze,
nevertheless since 1820 there have been made associations created to ensure safety of drugs.
The first one establish in United States was the United States Pharmacopoeia which stablish
a recommended drug list. In 1844 the Import Drugs Act focused on the control of imported
adulterated drugs which was an issue in XIX century. The Food and Drugs Act in 1902 ensure
safety and purity of biological products such as vaccines; they gave license numbers to these
products. Later on this corporation evolved to what we know now as the FDA (Tamblyn et
al., 2016).
Not until 1962, the government decided to control a big problem that worldwide was
happening with drugs not regulated such as the Thalidomide; the Kefauver-Harris Drug
Amendments Act was created to mandate all the pharmaceuticals to prove efficacy and better
safety of medicines in order to be market in the country (Tamblyn et al., 2016). In spite of
the development in USA, México made an institution in charge of the regulation of medicine
Sanitarios).
After all this new comities and regulations were stablish, we face a problem that affect
in every public health system. Due to the new protocols and clinical trial of investigation,
prices of production of drugs have risen making harder to low economies to access to specific
PHARMACEUTICAL SURVEILLANCE 4
treatments. A study published on the Journal of Health Economies stablish that in 2003 the
estimated average of total pre-approval cost was of US$ 802 million and when compared to
the same methodology a previous year from that show that the total capitalized cost were
increased at an annual rate of 7.4% above the general price of inflation (DiMasi, Hansen, &
Grabowski, 2003).
we can observe that it has been an improvement worldwide. For instance, we can base on
adverse events in a patient having a treatment. Whenever a problem is detected with a specific
and later on use this information to take off the market a product and report it to the
pharmaceutical company.
understand were a problem is present in the methodology resulting as a low quality treatment.
In USA, Canada and United Kingdom, a study was made in order recognize this
methodological issues in patient treated with type 2 diabetes. After a cohort of newly treated
diabetics in this countries from 2009 to 2012 using local electronic health records (EHR) was
made; it was found that from 44,913 patients, 13% of patients failed to fill initial prescriptions
evaluation and the notification of them. The FDA has created a post marketing surveillance
to ensure the safety in the drugs process. Despite this grate effort to have a higher quality in
medicine, there are often not sufficient data provided from special groups of study. We can
optimization of surveillance protocols with the cost and quality of product. This regulatory
network is based mainly in the communication between various health departments and the
industry. The health authorities play an important role in this communication process making
References
http://www.cofepris.gob.mx/cofepris/Paginas/Historia.aspx
DiMasi, J. A., Hansen, R. W., & Grabowski, H. G. (2003). The price of innovation: New
http://www.sciencedirect.com/science/article/pii/S0167629602001261
FDA. (2015, March 23). History. Retrieved November 22, 2016, from
http://www.fda.gov/AboutFDA/WhatWeDo/History/
overview-of-pharmaceutical-industry-and-drug-regulatory-affairs-2167-7689.S11-
002.php?aid=8937
http://www.sciencemuseum.org.uk/broughttolife/themes/controversies/thalidomide
Tamblyn, R., Girard, N., Dixon, W., Haas, J., Bates, D., Sheppard, T., Eguale, T., et al.
Tariah, I. (n.d.). Effective post-market surveillance. Retrieved November 22, 2016, from
http://www.bsigroup.com/LocalFiles/en-GB/Medical-devices/whitepapers/WP-
Post-market-surveillance.pdf