The Food and Drug Administration (FDA) provides a barrier to market entry and use of unproven and unsafe products. For prescription drugs, the FDA approval process requires substantial evidence of efficacy and safety for specific clinical situations. Although approval is indication-specific, the FDA has a limited role once a drug is on the market. Recent draft guidelines covering manufacturers'...

BACKGROUND The transition of prescription drugs (Rx) to over-the-counter (OTC) status is a very complex and multifaceted process involving many parties and many issues. This article examines the regulatory history and process and presents a review of the issues involved, using recent Rx-to-OTC conversions as examples. FINDINGS Data are presented on the growth of the OTC market and the impact ...

BACKGROUND Abuse of prescribed controlled substance has become a serious social as well as health care issue over the past decade. A particularly alarming trend exists among patients aged 12 to 17. Common abuse behaviors include doctor shopping, drug theft, feigned pain symptoms to gain health care access, drug sharing, prescription forgery, and improper prescription practices. In response to t...

improper drug prescription by physicians due to wrong diagnosis, wrong drug choise or other causes will waste national funds. the annual drug costs in iran is 900 billions rials. with approvement of prescription, it can be reduced to 500 billions rials. effective factors in costs reduction are: 1) increasing medical knowledge and persistent education of physicians. 2) spending more time for eac...

The nonmedical use of prescription or over-the-counter (OTC) medications implies that the user is using them for reasons other than those indicated in the prescribing literature or on the box label. The abuse of these medications is a national issue. Intentional drug abuse of prescribed and OTC medicines has climbed steadily. Data from the 2005 National Survey on Drug Use and Health demonstrate...

background and objectives: the expanding field of psychopharmacology is constantly seeking new and improved drugs to treat psychiatric disorders. although psychotropic drugs have had a remarkable impact in psychiatry, their utilization, effectiveness, and side effects in the in clinical practice need continuous study. the present study was thus designed to analyze the pattern of psychotropic dr...

The aim of this paper is to empirically analyse the responses by general practitioners to promotional activities for ethical drugs by pharmaceutical companies. Promotion can be beneficial as a means of providing information, but it can also be harmful in the sense that it lowers price sensitivity of doctors and it merely is a means of maintaining market share, even when cheaper, therapeutically...