Understanding How Consultants Help Startup Company Owners

Does a Drug Need Pharmacovigilance If It Already Passed Clinical Trials?

17 August 2020 by Byron Johnston

Pharmacovigilance, or the continued monitoring of licensed and marketed drugs for any unexpected side effects, is crucial for the health and safety of the public. But, if your company's drug has already passed through clinical trials or has even already been available to patients for years, you may wonder why it's necessary. However, working with a pharmacovigilance consulting company has many important benefits that you should be aware of. 

Catch Long-Term Side Effects

Clinical trials, though they are as thorough as they can be, do not last for years. Sometimes, effects from drugs can take years to manifest, such as cancer or heart disease. If this is the case, you'd want your drug removed from the market as soon as possible to protect the public. However, if your drug isn't monitored over the years, you won't know about these effects until many more lives are impacted. A pharmacovigilance company will pay close attention to any adverse effects, years after the clinical trials have ended.

Test Larger Groups of People

A clinical trial will certainly try to test a great sample of the population, but it's likely that only hundreds of people will be given the drug then, as opposed to the thousands or millions that would take it later on. Many times, the people involved in clinical trials don't have underlying health conditions that could make someone react more sensitively to a drug. Also, the elderly will be more prone to some side effects from drugs, which may not be clear at first if the clinical trials test only younger people. For these reasons, additional monitoring of the drug is absolutely necessary. 

Protect You Financially

You definitely want to have pharmacovigilance done on your company's drugs so that people will be safe. However, there are financial benefits as well. Your company appears responsible to the public when you continue to watch the drugs' effects. The patients will feel cared for. Having a good reputation is especially important for a company that creates such potentially life-altering products, and it will help your business to be seen in a positive light. You will also want your drugs continuously monitored so that you can avoid potential lawsuits. If people die or suffer severe effects from your drugs and you should have been tracking those effects, you will be in serious legal trouble, which can cost you millions. Making sure your drugs are safe should be your first priority, for both financial and moral reasons.

Working with a pharmacovigilance consulting company is in your best interest. Contact one near you for more information.

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