Drug Safety free essay sample

Drug Safety Process By Fahad Alahmari B. S. Pharmacy, King Saud University, 2007 Table of content Introduction Methods Results 1- Introduction to drug safety 2- The Drug Studies on Safety. 1- Pre-Approval studies 2- Post-Approval studies 3- Post marketing Studies Discussion References Introduction Pharmaceutical companies today like to produce many new drugs, but there are several potential risks associate with the production of any new medicine. In addition, there is numerous new side effects come from approved drugs.This paper aims to help understand and perform the safety of drug uses. Method A literature search for articles that discuss Drug safety before, during, and after its approval was performed using PubMed and Food and Drug Administration (FDA) websites. Review articles, between 2000- 2009, related to drug safety and pharmacovigilance (detecting, assessing and preventing drugs side effects) were discussed to investigate the adverse effects of any drug. Results Introduction to drug safetyAfter the introduction of Sulfanilamide in 1983, the first sulfa antimicrobial drug, one hundred and five patients died due to its toxicity. We will write a custom essay sample on Drug Safety or any similar topic specifically for you Do Not WasteYour Time HIRE WRITER Only 13.90 / page Because of this tragedy, the American Congress established the Food, Drug and Cosmetic Act, which asked the pharmaceutical companies to provide sufficient researches about the safety of any new drug before its release. Since that time, the Food and Drug Administration requires proofs of safety and efficacy for the new drugs before approval. These proofs should include sufficient clinical trials on human to validate both efficacy and safety. (Liu, 2007) Pre-Approval studies: Drug safety is more important than its efficacy, therefore the FDA requires extensive animal studies for any new drug before its approval and before any clinical trials. After the approved effects on animals, human trials start in three stages to insure its safety on human, stage 1 focuses on the assessment of the side effects and to determine the optimal doses.The most important goal of this phase is to collect information about the drug metabolic effects and drug-drug interactions. Stage 2 recognizes the short-term side effects, and it includes a few hundreds of participant. Stage 3 usually depends on the results of the former stages; it may include more studies on a larger group of people. (Galson, 2005) Post-Approval studies: This stage includes watching the drug after its release, drug-drug interactions is considered one of the crucial a spects that need to be monitored at this stage. Assessing the effects of the inactive ingredients to the effectiveness of any drug occurs after marketing. Drug-Drug interactions, long-term side effects, which appear after using any drug for a long time, and many side effects cannot be detected before the wide distribution of the drug among divers and huge rang of people. In addition, because some inactive ingredients have specific effects on a group of people but not everyone like immunocompromised patients, the effects of the inactive ingredients can be monitored much better after marketing. ((FDA), 2009)Post-Marketing Studies: The FDA may ask the pharmaceutical companies to provide more clinical trials after marketing, to evaluate a known side effect, or to identify any potential risks. In addition, pharmaceutical companies are required to provide studies to assess the consumption of the drug, the quantity or the rout of administration, for example, they need to observe the dynamics that affect the known risks, such as drug dose and time of treatment. They need also to provide sufficient information and numbers about the drug effects on pregnancy and fetus.