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Information from Your Family Doctor
Safety and Effectiveness of New Medicines
Am Fam Physician. 2010 Jul 1;82(1):58.
See related article on the safety and effectiveness of new drugs
How can I help my doctor choose a medicine for me?
There is a tool called the STEPS mnemonic. It stands for Safety, Tolerability, Effectiveness, Price, and Simplicity. This tool summarizes the five things doctors should use to make a good decision about prescribing new medicines. The STEPS tool can help you ask your doctor the right questions before you start a new medicine. It can also help you evaluate the advertising claims about the medicine.
Safety. New medicines may have been tested in only a few hundred patients. Information on a new medicine's safety, especially the less common side effects, is limited. Doctors should know about the major safety concerns of a new medicine before prescribing it. Be sure to ask your doctor how safe a medicine is before taking it.
Tolerability. Evidence from studies of new medicines can tell your doctor how many patients kept taking the medicine during the study, and how many stopped taking it because of side effects. This gives your doctor an idea of how many patients will take the medicine when it is used in the “real world.” As a patient, you should be aware of any possible side effects that you have after starting a new medicine, such as feeling sick or very tired. Tell your doctor right away if you think you are having side effects.
Effectiveness. Your doctor should consider if there is good evidence that patients are more likely to live a longer or better life if they take a certain medicine. Many new medicines only have proof that they change a symptom of disease, such as lowering blood pressure or cholesterol, which does not automatically prove that a new medicine makes patients live longer or better. Some medicines are later shown to cause more harm than good. Ask your doctor if your overall health is more likely to be improved by taking a new medicine instead of an older medicine with a better safety record.
Price. New medicines almost always cost more than those that are already available. Thinking about cost can help you and your doctor make informed decisions about medicine.
Simplicity. It is important to take your medicine correctly every day. For some people, reducing the number of pills they take or how many times a day they need to take the medicine can make this easier. But, taking a medicine once a day rather than twice a day may not always help. Ask yourself if you will be able to take the medicine exactly as your doctor tells you to.
This handout is provided to you by your family doctor and the American Academy of Family Physicians. Other health-related information is available from the AAFP online at http://familydoctor.org.
This information provides a general overview and may not apply to everyone. Talk to your family doctor to find out if this information applies to you and to get more information on this subject.
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