The term "Generic Drug" refers to a drug which is basically interchangeable with the brand name version if used in the same way for the same medical conditions. Generic drugs are permitted after the patent expires on a drug or if the drug was not patented.
Generic drugs have the same benefits and risks as a brand name drug. Yet, generic drugs are 40 - 80% less expensive than brand name drugs because they do not include money to repay development and related costs.
What A Generic Drug Is
A generic drug:
- Has the same active ingredients as a Brand Name drug
- Has the same dosage form and route of administration.
- Has identical strength or concentration.
- Meets the same safety, strength, purity and effectiveness standards set by the federal Food and Drug Administration (FDA) for the brand name drug.
- Is tested to assure the amount of the active ingredient absorbed into the blood stream is basically equivalent to the brand name drug. The generic must be absorbed in the body within 20% of the level of the original, branded version.
- May have other ingredients that may affect the absorption of the drug, how it is eliminated by the body, or other factors. For some people, a generic drug may not work as well as the brand name drug because of these other ingredients. For some others, a generic drug may work better.
It is a myth to think that Generic Drugs are not safe or that generic drugs are less expensive because they are not as effective as a more costly brand drug. Generic Drugs are usually less expensive than the brand name equivalent because someone else paid for:
- The research, development and testing costs.
- The initial advertising costs to educate the medical community and/or consumers about the product.
When Purchasing A Generic Drug
- Before buying a generic drug, check the benefits and risks, just as you would a brand name drug. Also check the rating. Be sure it is rated "A". (Your pharmacist can tell you).
- Check the rating. Ask your pharmacist about the rating of any generic drug you are taking or considering taking. Generic drugs that have been tested and approved by the FDA to be therapeutically equivalent to brand name drugs are published in a guide (referred to as the "Orange Book") which most pharmacies have. An "A" rating means the drug is therapeutically equivalent to a brand name drug. A "B" rating means it is not considered to be therapeutically equivalent.
- Be particularly careful with drugs that have a "narrow therapeutic index" (NTI). According to Johns Hopkins: Health insurers love generic drugs because they cost less money than branded versions. But there are some instances when your doctor may not think it's a good idea to switch to a generic. This is often the case for medications that have a narrow therapeutic range (NTR) [also known as a narrow therapeutic index (NTI)]. When you take an NTI drug, the most effective dosage with the fewest side effects lies in a narrow range between too little and too much. These are medications for which small changes in the dosage or amount of medication in the blood could result in clinically important changes in the drug's safety or effectiveness. Usually, these drugs require frequent adjustments in dosage, and blood tests measuring either the concentration or the effect of the medication are monitored carefully, regardless of whether the drug is a brand-name or generic product. Common NTI medications include warfarin, digoxin, and certain drugs used to control seizures.
Living With A Generic Drug.
- Keep track of your response. When you first switch to a generic drug, keep track of your responses. Depending on the drug, this may mean keeping copies of lab reports, or your numbers or subjective responses such as mood swings or pain. If you do not believe your response is the same as on the brand drug, consider experimenting on yourself. Keep a detailed diary of your subjective feelings and reactions. Then switch back to the brand name drug. (For instance, see our Symptoms Diary) Do this several times to see if there is a difference. If you want to return to the brand name drug, and if you have health insurance, you will have your diary as evidence to explain to the insurer why you should not have to pay more for the brand drug than you would if you purchased a generic version.
- Stick with the generic you know If there is more than one generic drug for a particular brand name drug, stick with the one that works for you. Reactions to different generic drugs can vary. To assure that each refill you get is the generic you want:
- Check refills to see whether they look like the drug you have been taking. If there is any question, ask a pharmacist.
If there are problems with a generic drug, report them. Report problems to the FDA through its MedWatch program www.fda.gov/medwatch (click on "Drugs," then "Safety", then "Reporting Safety Problems", or call: 888.463.6332
The FDA will need the following information which you can get from your pharmacist.
- The manufacturer of the generic drug
- The lot number
- When the drug was dispensed
The FDA will also need a brief description of what the drug did or did not do.