PHARMACEUTICAL SURVEILLANCE 1

Development of Pharmaceutical Surveillance

Said Tufik Abdo Rodríguez

A013336897

Tecnológico de Monterrey, Campus Ciudad de México

Escuela de Medicina Ignacio Santos

Fundamentos históricos en ciencias de las salud

Héctor Ongay Delhumeau

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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

development of drugs back in the 1900s.

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

sickness which made it popular within pregnant women.

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

caused the development of drug regulations that were more developed.

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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

and prices of drugs.

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

until 2001 known as COFEPRIS (Comisión Federal para la Protección de Riesgos

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
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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).

When we focus on the quality of drugs according to pharmacosurveillance protocols,

we can observe that it has been an improvement worldwide. For instance, we can base on

them to stablish a correlation between methodological issues to estimate possible risk by

adverse events in a patient having a treatment. Whenever a problem is detected with a specific

compound, it should be reported to the corresponding institution in order to have a record

and later on use this information to take off the market a product and report it to the

pharmaceutical company.

Technologies such as electronic health records in different countries led us to

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

increasing the risk of cardiovascular events (Tamblyn et al., 2016).

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Vigilance guidance documents are used nowadays to describe a system of incidents

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

conclude that there is a correlation between development of new technologies and

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

the draft guidelines, keeping updated the manufacturers with regulations.

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References

COFEPRIS. (2010). Historia. Retrieved November 22, 2016, from

http://www.cofepris.gob.mx/cofepris/Paginas/Historia.aspx

DiMasi, J. A., Hansen, R. W., & Grabowski, H. G. (2003). The price of innovation: New

estimates of drug development costs. Journal of Health Economics, 22(2), 151–185.

Elsevier. Retrieved November 22, 2016, from

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/

Rahalkar, H. (2012). Historical overview of pharmaceutical industry and drug regulatory

affairs. Pharmaceutical Regulatory Affairs: Open Access. OMICS International.

Retrieved November 22, 2016, from http://www.omicsgroup.org/journals/historical-

overview-of-pharmaceutical-industry-and-drug-regulatory-affairs-2167-7689.S11-

002.php?aid=8937

Science Museum. (n.d.). Thalidomide. Retrieved November 22, 2016, from

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.

(2016). Pharmacosurveillance without borders: Electronic health records in different

countries can be used to address important methodological issues in estimating the

risk of adverse events. Journal of clinical epidemiology., 77, 101–111. Retrieved

November 22, 2016, from https://www.ncbi.nlm.nih.gov/pubmed/27212138

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