Prescription & Over-the-Counter Drugs: Frequently Asked Questions
What is a drug?
The Federal government defines a drug as any substance (other than food) intended for use in the diagnosis, cure, relief, treatment, or prevention of disease, or intended to affect the structure or function of the body.
What is a package insert?
A package insert is a Food and Drug Administration required document that may be several pages in length and filled with complex terms about the medication. It is given to the pharmacy to accompany patient prescriptions. It contains valuable and lifesaving information and describes the risks and benefits of the medication.
What information should be listed on the label of a prescription?
The label of each medication should have a list of ingredients, warnings for drug interactions, and the expiration date.
How many prescriptions do doctors write each year?
According to the Pharmaceutical Manufacturers Association, doctors in the United States write an average of over 55 billion prescriptions per per year.
How many drugs are currently approved by the Food and Drug Administration?
To date, over 5,000 prescription medications are approved by the FDA. An average of five new prescription drugs are added to the list approved each month.
How much do pharmaceutical companies spend to research and develop a new drug?
According to the 1993 Congressional Offices of Technology Assessment, drug companies spend an average of $359 million dollars to develop a new drug for the general public. Since the 1993 study was completed, the cost of research and development for new drugs has no doubt skyrocketed.
What prompts a pharmaceutical company to research and develop a new drug?
Several factors may prompt a pharmaceutical company to begin development of a new drug. However, by and large, pharmaceutical companies develop new drugs to earn a profit.
How long does it take to get a drug approved by the FDA?
Typically, it takes eight and one-half years to study, test, and approve a drug for public consumption. However, this time period has been decreasing over the last several years.
What is the FDA's process for approval of a new drug?
The Federal Food, Drug, & Cosmetic Act requires the Food & Drug Administration (FDA) to evaluate the safety and effectiveness of prescription and over-the-counter drugs sold in the United States. The initial review process begins without the FDA's involvement. Typically, pharmaceutical companies initiate laboratory testing to estimate the effectiveness and safety of a proposed drug product, and if these tests are successful, then testing on animals begins. The FDA does not become involved until the pharmaceutical company requests permission to test the drug on humans. The FDA, through its Center for Drug Evaluation and Research (CDER), evaluates the results of laboratory and animal testing prior to approving testing in humans.
If approved, human trials are broken down into four phases. Phase I tests the drug on approximately 20-80 people, for effectiveness, safety, adverse reactions, and proper dosage. Phase II tests the drug on approximately 100-300 people. Phase III includes 1,000 to 3,000 participants who are monitored for their reaction to the drug and the drug's effectiveness when compared to existing treatments. Phase IV involves the FDA's tracking of any reported adverse events (injuries, adverse reactions, side effects, or deaths). During the clinical trials an Institutional Review Board (IRB) is appointed to monitor the research.
How many Americans are hospitalized each year due to adverse reactions to medications?
Each year, an average of 300,000 people are hospitalized due to adverse reactions to medications.
What are some of the possible reactions a person might experience if he or she misreads the medication directions or misuses the medication?
Possible reactions include, but are by no means limited to, the medication loosing its effect, leading to patient relapse, or causing serious, adverse reactions to the medication, including death.
Should I contact an attorney if I have had a serious adverse reaction to a drug?
Perhaps. It may be important for you to contact an attorney who can help you protect your legal rights. Only a licensed attorney can evaluate whether you have a case that is worth pursuing. Keep in mind however that there may be time limits (Statute of Limitations) which affect your ability to sue.
How much does an attorney evaluation cost in these types of cases?
Nothing! Attorneys associated with InjuryBoard.com will evaluate your case free of charge. If a participating attorney agrees to handle your case, you will owe no fees or other costs unless that attorney recovers money for you.
How do I submit my case for a free evaluation?
Simply click on the free Ask an Attorney button and complete the online intake form. An attorney will evaluate your case and respond to you via email.
-- Article Courtesy of InjuryBoard.com
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