pharmacovigilance-congress-2016_posters-accepted-abstracts

Page 60

conferenceseries

.com

Volume 4, Issue 5 (Suppl)

J Pharmacovigil 2016

ISSN:2329-6887 JP, an open access journal

Pharmacovigilance Congress 2016

September 28-30, 2016

September 28-30, 2016 Toronto, Canada

Pharmacovigilance Congress

J Pharmacovigil 2016, 4:5 (Suppl)

Evaluation of drugs removed from the United States market from 2000 to 2015

Ramie Fathy

South College School of Pharmacy, Knoxville, TN

his study was conducted to collect and analyze data on prescription drugs removed from the United States market from 2000 to

2015. Information was initially obtained from the FDA website and then augmented with data from primary literature. Medline

was the primary bibliographic database utilized with withdrawn drug names as keywords. Inquiry was also done on drugs that

were later reinstated and drugs that only had a single dosage form removed from the market. A total of 26 drugs were withdrawn

from the market during the time period researched. Three drugs were withdrawn then reinstated and 5 drugs had a certain dosage

form withdrawn. The top 3 drug classes removed were: Biological response modifiers (19.2%), gastrointestinal agents (15.3%) and

psychotropic agents (15.3%). The top three reasons drugs were withdrawn from the market were cardiotoxicity, hepatotoxicity and

stroke. Of the agents withdrawn, the average time on the market was 9.0 years +/- 6.2. The median and mode were 8.5 and 4.0 years

respectively. These were calculated removing the outliers which are propoxyphene (52.0 years) and pemoline (30.3 years). It appears

that the top classes of drugs withdrawn from the market and the reasons for removal have changed in the past 13 years as compared

to earlier findings by others. Reported prolonged periods of drugs in the market before removal may necessitate a strict monitoring

of both efficacy and toxicity once drugs are approved.

Pharmacovigilance education for medical students

Raymond R Mattingly

Wayne State University School of Medicine, USA

n 2006, the Institute of Medicine reported in Preventing Medication Errors that at least 1.5 million preventable adverse drug events

occur each year in the USA. A related concern may be whether there is an increase in poor patient outcomes in July, when newly

trained medical residents enter practice. Although most such reports are anecdotal, such as “Don’t get sick in July”, there are also

peer-reviewed studies. For example, the highest risk myocardial infarction patients suffer increased mortality in July in hospitals that

are categorized as teaching intensive. Most pharmacology education in USA medical schools occurs in the early years of the medical

school curriculum through some introduction to basic principles of pharmacodynamics and pharmacokinetics and then system-

specific drug coverage that is often integrated into system-based pathophysiology units. Clinical pharmacology coverage in later years

of the curriculum is rarely required but more often offered as an elective. To provide consistent and universal education on the topics

of adverse drug events and pharmacovigilance, we instituted a four-part module in the year-2 medical student curriculum. We first

provide a concise self-study packet of principles and then have faculty facilitation for 3 case-based, small group discussion sessions,

with the adverse event cases specifically designed to integrate material across systems. We assess knowledge through multiple-choice

questions in the regular course examinations. Student evaluation of these sessions has been very positive. The pharmacovigilance

curriculum has become a key component of our longitudinal curricular theme on patient safety and quality improvement.