Before drugs are available for marketing to the U.S. public, they must undergo a stringent review and approval process by the Food and Drug Administration's Center for Drug Evaluation and Research. The purpose of this process is to ensure that safe and effective drugs are available to Americans. The review process includes reviews of clinical studies and trials and looks at the numbers of people involved in the studies. The process evaluates the benefits to many as compared to risks for a few people. It also considers things such as drug-drug interactions. The review process currently takes an average of 19 months per drug review.

Cautions

Even though there is a stringent process for approving drugs that are marketed to the public, not all risks and toxicities will be known prior to their widespread use in a population. Only substances categorized as drugs require regulation by the FDA. Dietary supplements, such as herbs, vitamins and minerals, are not studied and approved by the FDA. Consumers have the responsibility to determine the safety of such products.

Guidelines for Taking Medicine

Be sure you are taking the right drug. Prescription drugs can only be prescribed by doctor. OTC medicines may be recommended by a doctor or pharmacist or other health professional (such as a nutritionist). Be sure you understand all the directions for using the drug, including:

• how much to give (the dosage)
• how often to give it (the frequency)
• how to give it (the route of administration—by mouth, place under the tongue, apply to the skin, inject)
• how long to continue taking it (until the pain or symptom is gone or until the medicine is gone)

Additional Guidelines

• Read the label every time—always check for the proper dose.
• Read the label 3 times: when you take it from the shelf, when you pour it out (measure it), after you pour it out (measure it).
• Pour liquid medicines from the side away from the label – so that medicine won't drip down and cover the label.
• Measure correctly.
• Know the abbreviations for tablespoon (Tbsp.) and teaspoon (Tsp.) and don't confuse them.
• Use the correct measurer for the recommended dose. Example: if the medicine label says to give 2 tsp. and your measurer says “cc” or “ounces” only, find another measurer. Use a measuring teaspoon, not a serving spoon.
• Be aware of any special considerations in taking the medicine.
• Should it be taken with milk or should milk be avoided?
• Should it be taken with food or on an empty stomach?
• Store the medicine properly.
• Does it require refrigeration?
• Does it require storage in a dark cabinet or container?
• Discard medicine properly. Flush left over prescription medication or out-dated medication down the toilet.
• Check with the doctor or pharmacist before adding any new medicine – the doctor may not be aware of other medicines you are taking, let him/her know what medicines you currently take, including OTC medicines. Ask the pharmacist about using any OTC medication if you are taking other prescription or OTC medicines.
• Be aware of side effects of the medication and of allergic reactions. Allergic reactions typically include a rash, itching, hives, sometimes wheezing. You should contact the prescribing doctor immediately if you suspect an allergic reaction.
• Use the child-resistant cap, and re-lock the cap after each use.
• Check the packages of medications for signs of tampering.
• Ask your physician which OTC products you should avoid. Ingredients that may be safe for most people may be harmful for individuals with health problems such as diabetes, high blood pressure, allergies, asthma, or for individuals who are taking certain kinds of prescriptions. Ingredients in OTC medications can interact with those in the prescription medicine and either cause the prescription medication to become ineffective or create a dangerous situation. For example, products containing aspirin should not be taken if:
• You are taking blood-thinning medicine, because aspirin delays blood-clotting time. A small cut or bleed could become a serious one.
• You have an ulcer—it may cause severe bleeding.
• You have asthma.
• You are 19 years old or younger. Aspirin is associated with Reye's Syndrome.
• You are having surgery within two weeks (potential for excess bleeding).
• Do not take any OTC medications if you might be pregnant. Consult a doctor first. Ingredients in OTC medications can damage the unborn baby or threaten the pregnancy.
• Take special precautions when giving medications to young children.
• Never give more than the recommended dose—most medicines for children are based on the age and weight of the child. Children aren't just small adults. Their bodies handle medications differently since the organ systems may not be fully developed.
• Always follow the age-limit recommendations. If a medicine says do not give to children under age two, consult a doctor before using. Never guess the dose.