Does newer always mean better? Electronics, cars, and other items are being invented faster and are more technologically advanced but they are not without their problems. Recent reports have detailed massive product recalls from phones to car airbags. In the pharmaceutical industry, the same assumption that newer medications are better holds true in the minds of health care professionals and patients alike. But is this assumption true? Many factors need to be taken into consideration when deciding if a medication is safe, effective, and the best option for you.
Canadian Drug Approval Process and Safety
For medications to be approved for sale in Canada, drug companies have to submit a new drug application to evaluate the quality, safety, and effectiveness of the new medication. In many cases, the new medication is not tested for as long as similar medications in the market. To prove it is effective, it is tested against a placebo (a sugar pill) in a clinical study. The study only has to show that medication is more effective than the placebo to be approved. Only after the drug is approved will there be more studies that evaluate how effective the medication is compared to a similar medication currently in the market. The studies are also conducted for a relatively short period of time in a small group (approximately 1,500 people). It requires a much larger population of people to detect rarer side effects (e.g. a side effect that affected 1 in 10,000 people). As you can see, the initial studies of a new medication usually do not provide enough good quality evidence to properly assess safety in a bigger population. This may lead to unexpected side effects when the medication becomes readily available. There have been many cases of widely used medications that are eventually withdrawn form the market because of harmful and serious side effects. Examples include thalidomide, which caused serious birth defects in infants as result of women who took the medication early in pregnancy, and rofecoxib, that resulted in serious events such as heart attacks and strokes when used long term.
Old vs. New Medications
In the last 30 years, there have been numerous new medications released to treat diseases such as HIV, cancer, heart disease, and many types of infections. These have been instrumental in improving and extending the life of countless patients worldwide. But in many cases, some new medications offer no distinct advantage over current similar therapies. These medications are known as “me-too” drugs and are ways for drug companies to establish market share for a particular disease state. In recent years, drug companies have also been bringing back older drugs as new versions of the medication by way of an extended release tablets or other slightly modified forms of the medication. There may be added benefit if they are shown to improve safety and effectiveness, but often this is an attempt to extend the patent of the medication so the drug companies can maintain market share over the generic medication. Generic medications have to be essentially identical to their brand name medication and are as effective as their brand name counterpart.
The price of the new medication must also be considered. New medications are usually very expensive compared to other similar medications or generic versions on the market. Health care professionals and patients should consider the price and any advantages in effectiveness of the new medication compared to the price of well-established similar medications in the same therapeutic area.
Talk to your Health Care Professional
There are many factors when considering what medication is best for you. Your health care professional, such as your doctor or pharmacist, is your best resource. They will weigh the advantages and disadvantages of new medications and assess their safety, effectivness, and cost versus current similar medications on the market.
- Fugh-Berman, A. Prescribing evidence: the effectiveness and safety of new drugs. American Family Physician. (2010): 82(1), 37.
- Pegler S, Underhill J. Evaluating the safety and effectiveness of new drugs. Am Fam Physician. (2010);82(1):53-57.
- How Drugs are Reviewed in Canada, Health Canada. (2015, December 15). Retrieved from http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/fs-fi/reviewfs_examenfd-eng.php
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This article was provided by the clinical pharmacy at Rx Infinity. Rx Infinity provides optimal and sustainable patient management solutions through customized programs, innovative technology and added value services that improve the overall patient experience; while helping payers and plan sponsors achieve sustainability in the management of drug plans expenditures.
This information is not intended to be a substitute for professional medical advice, diagnosis or treatment. Always seek the advice of your physician or other qualified health provider with any questions about your medical condition. Do not disregard professional medical advice or delay seeking advice or treatment because of something you have read here.