Pharmacovigilance in Post-Marketing: Risk Assessment and Reporting Standards

<p>While there has been new targeted drug therapies released into the market over the recent years, pulmonary arterial hypertension (PAH) remains to be a rapidly progressive disease with poor prognosis. Over time the arteries stiffen and tighten subsequently leaving the heart to pump harder to try and provide enough blood to the body. The extra stress of the increased pumping leads to weakening and enlargement of the heart. The endothelin targeted therapy, Letairis (ambrisentan), is an oral tablet proven to improve quality of life in patients suffering from PAH, WHO Group I – functional class II and III by helping the arteries loosen and relax so that blood can flow steadily to the rest of the body. Although Letairis improves the quality of life for patients, there is a known serious risk of teratogenicity for females of reproductive potential. The risk of teratogenicity is so prominent that the Food and Drug Administration (FDA) required Letairis be placed on the risk evaluation and mitigation strategy program (REMS) to continually assess the risks and benefits of the product during post-marketing. In order to prevent and reduce harm in patients, mechanisms for evaluation and monitoring are vital to drug and patient safety.</p>

Name thesis:degree_name

Master of Public Health (MPH)

Level thesis:degree_level

Project/Capstone - Global access

Year dc:date.available

2016

Author dc:creator

• Jee, Tiffany

• pharmacovigilance
• adverse events
• risk evaluation
• Other Public Health
• Pharmacy Administration, Policy and Regulation

Repository record dc:identifier

https://repository.usfca.edu/capstone/557

OAI identifier oai:identifier

oai:repository.usfca.edu:capstone-1501