2017 Drug Safety Updates

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Consumers are often confident when taking products off the shelf, that they are not harmful, but it is not always like this. Availability of safe drug in the market is of great importance. This applies all over the world. Drug testing is incredibly important and yet complicated process. It is necessary for all products before the sale of the drug begins. Before drug testing became compulsory, many people suffered the side effects. Also, many people lost their lives as a result of harmful substances contained in new products released to the public.

What are the requirements for drug testing?

For a new product or drug to be available to the general public, it requires vast amounts of research as well as adequate testing to ensure it is safe to use. This has been set out by the Food and Drug Administration of the US, in the Federal Food, Drug and Cosmetic Act of 1938 which requires that food, cosmetics and drugs be tested for safety before making them available for human consumption or use.

The Testing Process

Any drug that we place on the market must go through a rigorous, multi-phase battery of tests. Drugs need to be tested for not only their safety but also for efficacy and ability to effectively treat the ailments they aim to treat.

Phase I

The first phase of testing takes place in the laboratory where the drugs undergo extensive studies, both chemical and animal. This gives us an idea of how the drug will work. This phase can take a number of years to complete in order to ensure the drug is safe enough for humans.

Phase II

During the second phase of testing, we test the drug on a small group of human subjects. The subjects that we test on here are all healthy, human volunteers. Once deemed safe for human use, we test the drug on a second group made up of patients with the targeted condition.

Phase III

Once the drug successfully passes through the first two testing phases, we are able to conduct more advanced clinical trials. These are also known as Phase III studies, where the drug is administered to a much larger group of patients with the targeted condition. This phase allows us to evaluate the efficacy of the drug as well as dosage requirements and the side effects, if any. If the drug passes this phase, an application is made to FDA for review. Once we have received approval from the FDA that a drug is safe as well as effective, it receives FDA approval and can now be marketed and sold to the general public.

Phase IV

We use this phase to evaluate the long-term effects of the new drug. This phase spans a much longer length of time and involves a much larger group of patients. This phase is important to continuously evaluate the drug to uncover new information about its safety, side effects and efficacy. This phase also helps to uncover how the drug works amongst various demographic groups. We also examine it to know how the drug interacts with other drugs that patients may be taking. This phase is extremely intensive and highly important for the continued production and use of the drug.

Global Operation for Protection

It is highly important that we protect consumers from drugs that have not gone through these phases and passed the rigorous testing. Recently, the FDA together with international agencies for regulation and law enforcement have taken action to shut down over 500 websites that were found to be illegally selling a variety of prescription medications that have failed to be approved by the FDA. These medications included antibiotics, opioids as well as injectable epinephrine.

A major global operation was conducted to target this illegal, online trade of drugs. The FDA has since taken action by issuing warning letters to operators of these illegal websites and with the help of internet registrars have successfully confiscated over 100 website domains.

It is pertinent that consumers buying from these illegal pharmacies are aware of the dangers of their actions. Although these medicines are advertised as and appear to be authentic, oftentimes they are counterfeit, have expired, contaminated or unsafe for other reasons. This is putting your health at great risk.

Besides the consumption of unsafe medication, we are also concerned for our patients becoming victims of identity theft, credit card fraud as well as computer viruses. We encourage consumers to report any suspicious activity in this regard to the FDA’s Office of Criminal Investigation. The FDA is committed to improving this situation and have set up a means for consumers to buy safe and approved medicines online with BeSafeRx.

Improved Report Access

In an attempt to ensure transparency when it comes to medicines, the FDA has launched a new tool, designed to provide consumers, service providers and researchers with access to all information regarding drugs and related products that are on the market. This information includes data on any adverse events relating to the particular drug in question. This tool is known as the FDA’s Adverse Event Reporting System.

This user-friendly tool can be used to obtain information as well as report on personal experiences with a drug or biological product. The dashboard allows for users to filter the information based on a number of factors like age, year or timeframe of occurrence, product or type of reaction.