Medication testing

Before a medication can be sold in Canada, it must go through rigorous safety testing. When a sponsor (the person or company taking responsibility for the development of the medication, usually a pharmaceutical company) develops a new medication, it works with doctors and researchers to study its safety and effectiveness. Before a medication can be sold to the public, it has to go through several stages and many years' worth of rigorous testing for safety and effectiveness. On average, it takes 10 to 15 years to develop and test a new medication to ensure that it's safe and effective for people.

Here's how a medication's safety is evaluated and monitored.

On average, it takes 10 to 15 years to develop and test a new medication to make sure that it's safe and effective for people.

Pre-clinical research
Pre-clinical research is the first stage in the medication testing process. This stage of research is performed in human cells in test tubes and in animals such as guinea pigs, rats, mice, and dogs. Pre-clinical research tests both effectiveness and safety. This stage takes between one and three years on average.

The goal of pre-clinical research is to thoroughly test the medication to see if it is safe and effective enough to be used in people. Pre-clinical research tests things such as how the medication works in the body, which doses may be effective, and whether the medication causes damage or unwanted side effects in any body areas. The standards for safety are so high that only 1 drug in 1000 actually makes it through this stage and goes on to be tested in people.

If the medication meets the rigorous safety standards set by the doctors and medical researchers from the sponsor, standards which are endorsed by the medical research community and approved by Health Canada, research moves on to the clinical trial stage.

Pre-clinical research is the first stage in the medication testing process. It takes one to three years on average. The goal is to thoroughly test the medication to see if it is safe and effective enough to be used in people.

Clinical trials
Clinical trials study the safety and effectiveness of the medication in people who have been informed of the potential risks and benefits and who have agreed to participate in the research. There are three phases to clinical trials:

Phase I: The medication is tested in healthy volunteers (usually 20 to100 people) to find out what doses of the medication you can give safely and to examine how the person's body processes the medication (how it is absorbed into the bloodstream and eliminated from the body).

Phase II: The medication is tested in people with the health condition it is intended to treat. Usually 100 to 300 people participate in phase II testing. This phase helps determine how well the medication works and how safe it is.

Phase III: The medication is tested in a larger group of people, usually 1000 to 3000 in total, who have the health condition it is intended to treat. The purpose of this phase is to further examine the safety and effectiveness of the medication in a larger group of people.

Clinical trials study the safety and effectiveness of the medication in people. There are three phases to clinical trials. Each phase tests a larger group of people.

If the medication makes it though all these stages and meets the safety standards approved by Health Canada, the sponsor can submit the study results and other information for a Health Canada review to determine whether it can be sold in Canada.

If you have questions about how drugs are tested for safety, or are wondering how to get involved with a clinical research study, contact your doctor or pharmacist.

All material copyright MediResource Inc. 1996 – 2021. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/healthfeature/gethealthfeature/Drug-Safety

Safe or not safe? Making the call

Who decides whether a medication is safe enough to be sold to the public? In Canada, Health Canada makes this decision. Health Canada is the federal government department responsible for reviewing all applications for new medications and deciding which ones are safe and effective enough to be sold in Canada.

Health Canada is responsible for deciding which medications are safe and effective enough to be sold in Canada.

To get permission from Health Canada to sell a medication in Canada, the sponsor (the person or company taking responsibility for the development of the medication, usually a pharmaceutical company) must submit a package called a "New Drug Submission" to Health Canada. This package must contain an application form, all the pre-clinical and clinical study data, detailed information on how the medication will be manufactured and tested, how the medication will be labeled, and what information will be provided to health care providers and people taking the medication. Often, the package contains thousands of pages of data. The sponsor must also submit a fee to Health Canada to cover the costs of performing the review.

During the review, Health Canada considers the data submitted by the sponsor and may also perform its own testing. Health Canada may also examine studies that have been done in other countries with the same drug. As well, they may consult with medical experts and medical committees outside Health Canada. This review process is also called the "drug approval process." It takes 12 to18 months on average. The process can be faster for medications used to treat life-threatening or debilitating conditions for which there are few effective treatments.

It takes an average of 12 to 18 months for Health Canada to review the research data and determine whether a drug should be sold in Canada.

If the medication meets Health Canada's high standards for safety and effectiveness, Health Canada will "approve" it. This means that the medication is considered safe and effective enough to be sold to the public in Canada. The medication will then receive a DIN (drug information number) to identify the medication. The DIN shows that the medication has been approved by Health Canada to be sold in Canada.

Do you have questions about DINs or the way Health Canada reviews new medications? Talk to your doctor or pharmacist.

All material copyright MediResource Inc. 1996 – 2021. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/healthfeature/gethealthfeature/Drug-Safety

Who protects you once a medication becomes available?

The drug safety process doesn't end when a drug makes it into your medication bottle. Instead, programs are in place to monitor the medication's safety even after it is already being sold in Canada. These programs provide valuable data to help keep you safe.

Pre-clinical and clinical trials are designed to give a good picture of the safety and effectiveness of the medication, and the Health Canada review uses these trials to make a decision about whether to approve it. Medications must meet high standards for safety and must have been tested by thousands of patients before they can be sold in Canada.

But some medication side effects occur very rarely. Some happen only once in a million people. Because they are so rare, these side effects may not have been discovered in pre-clinical and clinical trials and may only become apparent when the medication is being used by a very large number of people. This is not common, but it can happen with any medication.

The drug safety process doesn't end when a drug makes it into your medication bottle.

That's why Health Canada works together with pharmaceutical companies, doctors, and people taking the medications to keep track of side effects that occur after a medication has become available to the public. This is called post-marketing surveillance, and provides a database of information on side effects that can then be used to make future decisions about the medication. Sometimes, this stage of research is called Phase IV.

Some medications may require new restrictions or warnings, and others may be removed from the market (which means they can no longer be sold in Canada). Because of the extensive safety testing that is done before a medication becomes available to the public, this situation is rare.

Be a part of medication safety! Report unexpected side effects to your doctor.

Health Canada has developed a Canada-wide program called MedEffect to keep track of side effects. It encourages people taking medications and their healthcare providers to report any unexpected side effects (i.e., ones not listed in the medication leaflet) that occurred while they were taking the medications. Pharmaceutical companies are required to inform Health Canada of any new reports of side effects.

All material copyright MediResource Inc. 1996 – 2021. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/healthfeature/gethealthfeature/Drug-Safety

Should I take this? Putting side effects into perspective

Are you concerned about possible side effects from your medication? Do you wonder if the medication is worth it? Here are the answers to some frequently asked questions on how to put side effects into perspective.

Where do those lists of side effects come from, anyway?
The lists of side effects you see in your medication leaflet are side effects that have been reported by people taking the medication (whether it is actually related to the medication or not) during clinical research both before and after the medication became available to the public. The medication's manufacturer is required to keep track of all side effects that occur and list them in the medication leaflet.

How do I know which side effects I will get?
Unfortunately, there's no way to know beforehand exactly which side effects you may experience. The list of side effects shown in your medication leaflet can give you some idea of the types of side effects you may experience. However, it's important to know that just because a side effect is listed doesn't mean you will experience it. The list includes everything that's happened to a large number of people (usually in the thousands) who have taken the medication, whether it is related to the medication or not. You may or may not experience any of these side effects.

Good to know: You may or may not experience the side effects listed in your medication leaflet. Just because a side effect is listed doesn't mean you will experience it.

Help! I'm not sure whether I should take my medication now that I've read the list of side effects. How can I decide what to do?
Concerned about possible side effects from your medication? You're not alone. Weighing the risks and benefits of treatment is part of being an informed patient.

In the end, it's up to you whether or not you decide to take the medication. But to make the decision that's best for you, you need to have the whole picture. Here's how to get the information you need for your decision:

Concerned about side effects? Not sure if you should take your medication? Talk to your doctor or pharmacist about how to weigh the risks and benefits of the medication to you.
  • Get personal! The information sheet you get from your pharmacy or in your medication package will give you good general information about the risks and benefits of the medication. But you need to understand how these risks and benefits apply to you, specifically!
  • Know your risks: Talk to your doctor or pharmacist about which side effects you are most likely to experience, and which side effects are most serious. Find out how likely it is that you may experience these side effects. Ask for specific numbers. For example, you could ask "If 100 people took this medication for a year, how many of them would experience this side effect?" Next, ask your doctor or pharmacist whether these side effects are temporary or permanent and how to manage them. Find out whether your medical history and whether you're pregnant or breast-feeding may change your risks.
  • Know health benefits to you: The risks alone don't give you the whole picture. You'll also need to weigh the risks against the benefits you may receive from the medication. Ask your doctor or pharmacist what exactly the medication will do to help you. Will it relieve your symptoms? Will it prevent future complications? Will it slow down the progress of your disease? Find out how likely you are to experience these benefits, how much improvement you can expect, and when the medication is likely to start working.
  • Find a balance: Now that you know the risks and benefits of the medication as they apply to you, you can weigh them against each other. Consider whether you'd consider taking the risk of the possible side effects in order to get the benefits. You can ask your doctor or pharmacist for help or an opinion if it will help with your decision.

If you're concerned about side effects and not sure whether you should take your medication, talk to your doctor or pharmacist about weighing the risks and benefits of the medication for you.

All material copyright MediResource Inc. 1996 – 2021. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/healthfeature/gethealthfeature/Drug-Safety