Before any drug can be sold in the United States, it must be approved by the U.S. Food and Drug Administration (FDA). This is true whether it's a prescription or an over-the-counter drug. The FDA evaluates both the effectiveness and safety of a drug by looking at:

• How animal testing and human clinical trials affect the condition the drug is treating
• If any side effects occur
• How it's manufactured
• What the labeling says

The FDA also monitors a drug's safety after approval. Health care providers and patients can report drug side effects through the FDA's MedWatch website.

For you, drug safety means buying online only from licensed pharmacies located in the United States. It also means knowing how to take your medicines correctly.

What is the difference between prescription drugs and OTC drugs?

A drug is a substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Here are the main differences between OTC drugs and prescription drugs.

Prescription drugs are:

• Prescribed by a doctor
• Bought at a pharmacy
• Prescribed for and intended to be used by one person
• Regulated by FDA through the New Drug Application (NDA) process. This is the formal step a drug sponsor takes to ask that the FDA consider approving a new drug for marketing in the United States. An NDA includes all animal and human data and analyses of the data, as well as information about how the drug behaves in the body and how it is manufactured.

OTC drugs are:

• Drugs that do NOT require a doctor's prescription
• Bought off-the-shelf in stores
• Regulated by FDA through OTC Drug monographs. OTC drug monographs are a kind of "recipe book" covering acceptable ingredients, doses, formulations, and labeling. Monographs will continually be updated adding additional ingredients and labeling as needed. Products conforming to a monograph may be marketed without further FDA clearance, while those that do not, must undergo separate review and approval through the "New Drug Approval System."

Frequently asked questions about labeling for prescription drugs (medicines) on this webpage are primarily directed to healthcare professionals (for example, doctors, nurse practitioners, physician assistants, pharmacists, nurses) and patients and their caregivers.  For information about prescription drug labeling resources primarily directed to industry such as those for the Prescribing Information, FDA-approved patient labeling, carton and container labeling, biological product labeling, generic drug labeling, labeling databases, and product databases visit FDA’s Labeling Resources for Prescription Drugs.

Labeling for prescription medicines is FDA’s primary tool for communicating drug information to healthcare professionals, and patients and their caregivers.  Labeling for prescription medicines includes:

• Prescribing Information (labeling for healthcare professionals),
• Carton and container labeling (cartons and containers are outside packaging that contain information about prescription medicines), and
• Labeling for patients or caregivers (e.g., Medication Guides, Patient Package Inserts, and Instructions for Use). 

Labeling for prescription medicines is required for all FDA-approved prescription medicines. Such labeling is:

• Proposed by the drug company,
• Reviewed by the FDA, and
• If acceptable, approved by the FDA. If the labeling for a new medicine is found to be unacceptable by the FDA, the medicine will not be approved by the FDA.

All prescription medicines have Prescribing Information and carton and/or container labeling and many, but not all, have labeling for patients or caregivers.  See The Ins and Outs of Prescription Drug Labeling for a background about prescription drug labeling (2021 presentation).

What Is Prescribing Information?

The Prescribing Information is for healthcare professionals (e.g., doctors, nurse practitioners, physician assistants, pharmacists, nurses).  The Prescribing Information contains a summary of the essential scientific information needed for the safe and effective use of the medicine.  The most common type of Prescribing Information format is the Physician Labeling Rule (PLR) format which includes:

1. Highlights of Prescribing Information
2. Table of Contents, and
3. Full Prescribing Information.

What are the Highlights of Prescribing Information?

Highlights of Prescribing Information (referred to as Highlights) contain a concise summary of crucial prescribing information that the healthcare professional needs to use the medicine safely and effectively (Figure A includes the required and recommended format for Highlights). 

Figure A:  Highlights of Prescribing Information

What are the key features of Highlights of Prescribing Information?

Some key features of Highlights include:

• The Initial U.S. Approval is the four-digit year which FDA initially approved a new molecular entity, new biological product, or a new combination of active ingredients.  For example, the Initial U.S. Approval for LIPITOR is 1996 because the new molecular entity (atorvastatin) was first approved in 1996.
• Recent Major Changes pertains to substantive changes to the BOXED WARNINGS, INDICATIONS AND USAGE, DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS, or WARNINGS AND PRECAUTIONS sections.  Each recent major changes listing includes the section or subsection heading and number and the month and year when the labeling change was included.
• The established pharmacologic class (EPC) in the Indications and Usage heading is a group of active moieties or substances that share scientifically valid properties associated with an approved indication.  For example:
  • “angiotensin converting enzyme inhibitor” is the EPC for lisinopril,
  • “androgen” is the EPC for testosterone, and
  • “aminoglycoside antibacterial” is the EPC for tobramycin
• The Adverse Reactions Contact Reporting Statement encourages reporting of suspected adverse events.  This statement includes the phone number of the drug company responsible for collecting the information, and the phone number and webpage for the FDA to collect such information.
• The Revision Date is the month and year of the most recent revision to the Prescribing Information.  The most recent revision may include:
  • Significant updates to the Prescribing Information (e.g., adding a new indication and dosage), or
  • Minor updates (e.g., correctly a typographical error or updating the address of the manufacturer). 
• References in Highlights hyperlink to sections and subsections in the Full Prescribing Information when labeling is in an electronic format called Structured Product Labeling.  For example, the “(1)” reference in the Highlights hyperlinks to the INDICATIONS AND USAGE section (Section 1) in the Full Prescribing Information. 

What is the Table of Contents?

The Table of Contents includes the sections (bolded) and subsections (indented in regular font) of the Full Prescribing Information in a two-column format (see Figure B for an example of the Table of Contents).  Structured Product Labeling includes hyperlinks from the sections and subsections in the Table of Contents to the sections and subsections in the Full Prescribing Information.

Figure B:  Table of Contents

What is the Full Prescribing Information?

The Full Prescribing Information includes a summary of the essential scientific information for the healthcare professional for the safe and effective use of the medicine (see Table C for a summary of the information in each of the sections of the Full Prescribing Information).  The sections and many subsections in the Full Prescribing Information are consistently ordered and numbered.  More commonly referenced information generally appears in the first several sections of the Full Prescribing Information.

Table C:  Organization and Content of the Full Prescribing Information

If a section or information in a section is not pertinent to the specific medicine that section or information is not included in the Full Prescribing Information.

For the purposes of the Prescribing Information, an adverse reaction is an undesirable effect, reasonably associated with the use of a medicine, for which there is some basis to believe that there is a causal relationship between the medicine and the occurrence of the undesirable effect.

How Is Prescribing Information Approved?

When the drug company submits a marketing application for their medicine, they must include data to support the safety and effectiveness of their medicine and their proposed Prescribing Information.

1. Before Application Is Submitted

   Drug companies submit a marketing application to the FDA to approve a new prescription medicine in the United States and/or to add new uses of an approved prescription medicine.  Prior to submitting draft Prescribing Information to the FDA in a marketing application, the drug company may ask the FDA specific questions about their proposed Prescribing Information based on the studies they conducted or plan to conduct.  The drug company may use FDA’s Labeling Resources for Prescription Drugs available to them.

2. Drug Company Submits Draft Prescribing Information

   When the drug company submits a marketing application for their medicine, they must include data to support the safety and effectiveness of their medicine and their proposed Prescribing Information.

3. FDA Reviews Draft Prescribing Information

   The FDA Prescribing Information review team for the marketing application conducts an active and ongoing review of the Prescribing Information from the time an application is received and throughout the review cycle.  The review team identifies and addresses labeling issues that require resolution before the approval of the application. 

   • The FDA Prescribing Information review team typically consists of doctors with a specialty in the disease/condition being treated (e.g., endocrinologists review Prescribing Information for a medicine for diabetes), clinical pharmacology staff, labeling specialists, pharmacology/toxicology staff, product quality reviewers, promotional content specialists, regulatory project managers, safety experts (e.g., specialists in medication error prevention), statisticians, a cross-discipline team leader, and division and office management.
   • Additional FDA reviewers with specific subject matter expertise are often included in the Prescribing Information review team based on the medicine’s proposed uses.  For example, the following additional reviewers also review Prescribing Information: controlled substance specialists if the medicine is associated with abuse, misuse, addiction, dependence, or misuse; epidemiologists; engineers if the medicine is packaged or used with a device; microbiologists if the medicine is an antimicrobial; patient reported outcome specialists; pediatricians; and/or pharmacogenomic specialists.  The FDA review team helps ensure that the Prescribing Information:
     • Is scientifically accurate,
     • Provides a summary of the essential scientific information needed for the safe and effective use of a medicine,
     • Meets regulatory requirements,
     • Is consistent with FDA guidance (as appropriate),
     • Is informative and accurate, and
     • Is neither promotional in tone nor false or misleading.
4. FDA and Drug Company Discuss the Draft Prescribing Information

   The FDA review team frequently asks the drug company for additional data to support or to clarify statements in the proposed Prescribing Information. 

   Final Prescribing Information development is an iterative process, typically involving several rounds of editing and discussions between FDA and the drug company to arrive at a final agreed-upon Prescribing Information (the final version of the Prescribing Information agreed upon by both the FDA and the drug company).  If the FDA and the drug company cannot agree on the information in the Prescribing Information, the application will not be approved.

5. Prescribing Information Approval and Communication

   Upon approval of the application:

   • FDA’s Center for Drug Evaluation and Research posts the approved Prescribing Information for prescription medicines and therapeutic proteins to Drugs@FDA
   • FDA’s Center of Biologics Evaluation and Research posts approved Prescribing Information for vaccines, allergenic products, blood and blood products, plasma derivatives, and cellular and gene therapy products on CBER’s webpage. 

   Within 14 days of approval of the application (including the Prescribing Information), the drug company submits Structured Product Labeling to FDA’s electronic listing system. Subsequently electronic labeling is posted to several websites including FDA’s FDALabel and NIH’s DailyMed. See the 2017 presentation on the differences between labeling on Drugs@FDA versus DailyMed.

When Is Prescribing Information Updated?

After initial approval, drug companies are required to update their Prescribing Information when new information becomes available that causes the Prescribing Information to be inaccurate, false, or misleading.  Drug companies may submit supplements to their application and propose to include additional:

• Indications, uses, populations
• Dosages
• Safety information, or
• Other information on how to use the medicine safely and effectively.

The FDA may ask the drug company to voluntarily update their Prescribing Information by sending them a letter that asks them to submit a supplement to their application.  The letter may ask the drug company to include safety information and/or to improve the communication of how to use the medicine safely and effectively in their Prescribing Information.

The FDA may require the company to update their Prescribing Information with safety labeling changes if the FDA becomes aware of new safety information (about a serious risk or an unexpected serious risk associated with the use of the medicine) that should be included in the Prescribing Information.  

What Labeling is on the Packaging of Prescription Medicines?

Cartons and containers are the outside packaging that contain information about the prescription medicine.  Carton and container labeling (for healthcare professionals, patients, or caregivers) contain key information such as the:

• Proprietary name - the brand name of the medicine that is sometimes referred to as the medicine’s trade name.
• For drug products, the nonproprietary name (sometimes referred to as the generic drug name)
• For biological products, the nonproprietary name (also known as the proper name) for
• Dosage form (e.g., tablets, oral solution)
• Strength
• Route(s) of administration.  For example, topical (apply on top of skin), oral (take by mouth), and subcutaneous (inject directly under the skin).
• Warnings or cautionary statements (for example, “MYDRUG has multiple interactions with other drugs, consider the potential for these drug interactions prior to and during treatment with MYDRUG”), and
• For controlled substances, the controlled substance symbol. 

Carton and container labeling are designed to promote safe dispensing, administration, and use of the medicine to reduce the risk of medication errors. 

What Labeling for Prescription Medicines Is for Patients and Caregivers?

FDA-approved labeling for prescription medicines for patients and caregivers include:

• Medication Guides,
• Patient Package Inserts, and
• Instructions for Use

Not all prescription medicines have FDA-approved Medication Guides, Patient Package Inserts, or Instructions for Use.

Consumer medication information (CMI) is written information for patients and caregivers about a prescription medicine that is developed by an individual(s) or organization other than the drug company. FDA does not review or approve CMI, and the drug company does not review CMI. CMI is intended to be given to patients or caregivers at the time they receive a prescription.

If you have questions about your drug (medicine), talk with your healthcare professional (for example, your doctor or pharmacist).

What Are Medication Guides?

Medication Guides are a type of labeling for patients and caregivers that are required by the FDA when:

• The Medication Guide could help prevent serious side effects,
• The medicine has serious side effects in which patients should be made aware of, or
• Following directions for the use of the medicine is important for the medicine’s effectiveness. 

Medication Guides are developed by the drug company and reviewed and approved by FDA. 

Medication Guides include information about the medicine, how to take the medicine, who should not take the medicine, serious side effects of the medicine, and common side effects of the medicine.  A Medication Guide must be provided to the patient whenever the medicine is dispensed.  

What Are Patient Package Inserts?

Patient Package Inserts are also known as “Patient Information” and are a type of labeling for patients and caregivers.  Patient Package Inserts include information about the medicine, how to take the medicine, who should not take the medicine, serious side effects of the medicine, and common side effects of the medicine. 

Patient Package Inserts are required for contraceptives given orally and for medicines that have estrogen. These Patient Package Inserts are developed by the drug company and reviewed and approved by FDA.  Patient Package Inserts for these specific products must be given to each patient or their caregiver whenever the medicine is dispensed. 

Patient Package Inserts for other medicines may be voluntarily submitted by the drug company to the FDA on their initiative or by FDA request.  These Patient Package Inserts are approved by the FDA.  These Patient Package Inserts are not required to be given to each patient.  

What Are Instructions for Use?

Instructions for Use are a type of labeling for patients and caregivers for prescription medicines that have complicated or detailed instructions about use of the medicine.  For example, medicines administered by an autoinjector, a transdermal system (commonly known as a patch), or a syringe, or medicines that require mixing before use.  Instructions for Use provides detailed, step-by-step written and visual instructions for the patient or caregiver on how to:

• Use the medicine,
• Prepare the medicine,
• Administer the medicine,
• Handle the medicine,
• Store the medicine, and
• Throw away (dispose of) the medicine.  

Instructions for Use is developed by the drug company, and reviewed and approved by FDA, and provided to patients (or their caregivers) when the medicine is dispensed. Some IFUs are not approved by the FDA.

Whenever you use an over-the-counter (OTC) medicine, reading the drug product's labeling is important for taking care of yourself and your family. The label tells you what the medicine is supposed to do, who should or shouldn't take it, and how to use it. The labeling of OTC medicines has always contained usage and safety information for consumers. With the introduction of the "Drug Facts" label, the information is more uniform and easier to read and understand.

In the Federal Register of March 1999, the Food and Drug Administration published the OTC Drug Facts Label regulation. This regulation required most OTC drug products to comply with the new format and content requirements by May 2002. Manufacturers may continue to use old-format labels until their inventories are exhausted.

The OTC labeling rule applies to more than 100,000 OTC drug products.

Before simplifying the OTC label, the FDA conducted extensive research on how consumers use OTC drug product labels. One major problem has been the readability of the labels, especially for older Americans, who purchase almost 30 percent of the OTC drugs sold in the United States. The FDA also found that consumers thought words like "indications," "precautions," and "contraindications" were confusing and not easily understood.

Previously, information about product directions, warnings, and approved uses appeared in different places on the label depending on the OTC product and brand. Finding information about inactive ingredients has also been a challenge for those who may be allergic to an ingredient in a drug product.

Patterned after the Nutrition Facts food label, the Drug Facts label uses simple language and an easy-to-read format to help people compare and select OTC medicines and follow dosage instructions. The following information must appear in this order:

• The product's active ingredients, including the amount in each dosage unit.
• The purpose of the product.
• The uses (indications) for the product.
• Specific warnings, including when the product should not be used under any circumstances, and when it is appropriate to consult with a doctor or pharmacist. This section also describes side effects that could occur and substances or activities to avoid.
• Dosage instructions--when, how, and how often to take the product.
• The product's inactive ingredients, important information to help consumers avoid ingredients that may cause an allergic reaction.

Along with the standardized format, the label uses plain-speaking terms to describe the facts about each OTC drug. For example, "uses" replaces "indications," while other technical words like "precautions" and "contraindications" have been replaced with more easily understood words and phrases. The label also requires a type size large enough to be easily read and specific layout details--bullets, spacing between lines, and clearly marked sections--to improve readability.

If you read an OTC medicine label and still have questions about the product, talk to your doctor, pharmacist, or other health care professional.

What are generic drugs?

A generic drug is the same as a brand-name drug in:

• dosage
• safety
• strength
• quality
• the way it works
• the way it is taken
• the way it should be used

Are generic drugs as safe as brand-name drugs?

Yes. The FDA says that all drugs must work well and be safe. Generic drugs use the same active ingredients as brand-name drugs and work the same way. So they have the same risks and benefits as the brand-name drugs.

Are generic drugs as strong as brand-name drugs?

Yes. FDA requires generic drugs must be as:

• high quality
• strong
• pure, and
• stable as brand-name drugs

Are brand-name drugs made in better factories than generic drugs?

No. All factories must meet the same high standards. If the factories do not meet certain standards, the FDA won’t allow them to make drugs.

If brand-name drugs and generic drugs have the same active ingredients, why do they look different?

In the United States, trademark laws do not allow generic drugs to look exactly like the brand-name drug. However, the generic drug must have the same active ingredients. Colors, flavors, and certain other parts may be different. But these things don’t affect the way the drug works and they are looked at by FDA.

Does every brand-name drug have a generic drug?

No. When new drugs are first made they have drug patents. Most drug patents are protected for 17 years. The patent protects the company that made the drug first. The patent doesn’t allow anyone else to make and sell the drug. When the patent expires, other drug companies can start selling the generic version of the drug. But, first, they must test the drug and the FDA must approve it.

What is the best source of information about generic drugs?

Contact your doctor, pharmacist or other healthcare worker for information on your generic drugs. For more information, you can also visit the FDA website at:

http://www.fda.gov/genericdrugs

Do generic drugs take longer to work in the body?

No. Generic drugs work in the same way and in the same amount of time as brand-name drugs.

Why are generic drugs less expensive?

Creating a drug costs lots of money. Since generic drug makers do not develop a drug from scratch, the costs to bring the drug to market are less. But they must show that their product performs in the same way as the brand-name drug. All generic drugs are approved by FDA. Your medication guide should be kept with you and up to date. List your prescription and over-the-counter medicines as well as your dietary supplements.

Multivitamins, vitamin D, echinacea, and fish oil are among the many dietary supplements lining store shelves or available online. Perhaps you already take a supplement or are thinking about using one. Dietary supplements can be beneficial to your health, but they can also involve health risks. So, it’s important that you talk with a health care professional to help you decide if a supplement is right for you.

Read on to learn what dietary supplements are (and are not), what role the U.S. Food and Drug Administration has in regulating them, and how to make sure you and your family use supplements safely.

What Are Dietary Supplements?

Dietary supplements are intended to add to or supplement the diet and are different from conventional food. Generally, to the extent a product is intended to treat, diagnose, cure, or prevent diseases, it is a drug, even if it is labeled as a dietary supplement. Supplements are ingested and come in many forms, including tablets, capsules, soft gels, gel caps, powders, bars, gummies, and liquids.

Common supplements include:

• Vitamins (such as multivitamins or individual vitamins like vitamin D and biotin).
• Minerals (such as calcium, magnesium, and iron).
• Botanicals or herbs (such as echinacea and ginger).
• Botanical compounds (such as caffeine and curcumin).
• Amino acids (such as tryptophan and glutamine).
• Live microbials (commonly referred to as “probiotics”).

What Are the Benefits of Dietary Supplements?

Dietary supplements can help you improve or maintain your overall health, and supplements can also help you meet your daily requirements of essential nutrients.

For example, calcium and vitamin D can help build strong bones, and fiber can help to maintain bowel regularity. While the benefits of some supplements are well established, other supplements need more study. Also, keep in mind that supplements should not take the place of the variety of foods that are important for a healthy diet.

What Are the Risks of Dietary Supplements?

Before buying or taking a dietary supplement, talk with a health care professional—such as your doctor, nurse, registered dietician, or pharmacist—about the benefits and risks.

Many supplements contain ingredients that can have strong effects in the body. Additionally, some supplements can interact with medications, interfere with lab tests, or have dangerous effects during surgery. Your health care professional can help you decide what supplement, if any, is right for you.

When taking dietary supplements, be alert to the possibility of a bad reaction or side effect (also known as an adverse event).

Problems can occur especially if you:

• Combine supplements.
• Mix medicines and supplements.
• Take too much of some supplements.
• Take supplements instead of medications.

How Are Dietary Supplements Regulated?

The Law

The Federal Food, Drug, and Cosmetic Act (FD&C Act) was amended in 1994 by the Dietary Supplement Health and Education Act (often referred to as DSHEA), which defined “dietary supplement” and set out FDA’s authority regarding such products. Under existing law:

• The FDA does NOT have the authority to approve dietary supplements for safety and effectiveness, or to approve their labeling, before the supplements are sold to the public.
• Under the FD&C Act, it is the responsibility of dietary supplement companies to ensure their products meet the safety standards for dietary supplements and are not otherwise in violation of the law.
• Dietary supplement labels are required to have nutrition information in the form of a Supplement Facts label that includes the serving size, the number of servings per container, a listing of all dietary ingredients in the product, and the amount per serving of those ingredients. They also must have a statement on the front of the product identifying it as a “dietary supplement” or similar descriptive term (e.g., “herbal supplement” or “calcium supplement”). 

In general, even if a product is labeled as a dietary supplement, a product intended to treat, prevent, cure, or alleviate the symptoms of a disease is a drug, and subject to all requirements that apply to drugs.

The FDA’s Role and Actions to Help Keep You Safe

Even though the FDA does not approve dietary supplements, there are roles for the agency in regulating them.

• Since companies can often introduce a dietary supplement to the market without notifying the FDA, the agency's role in regulating supplements primarily begins after the product enters the marketplace.
• The FDA periodically inspects dietary supplement manufacturing facilities to verify companies are meeting applicable manufacturing and labeling requirements.
• The FDA also reviews product labels and other labeling information, including websites, to ensure products are appropriately labeled and that they do not include claims that may render the products drugs (e.g., claims to treat, diagnose, cure, or prevent diseases).
• The FDA monitors adverse event reports submitted by dietary supplement companies, health care professionals, and consumers as well as other product complaints for valuable information about the safety of products once they are on the market.
• If a product is found to be unsafe or doesn’t otherwise comply with the law, the FDA can:
  • Work with the company to bring the product into compliance.
  • Ask the company to voluntarily recall the product.
  • Take action to remove a dangerous product from the market.

Tips to Be a Safe and Informed Consumer

Before taking a dietary supplement, talk with your health care professional. They can help you decide which supplements, if any, are right for you. You can also contact the manufacturer for information about the product.

• Take only as described on the label. Some ingredients and products can be harmful when consumed in high amounts, when taken for a long time, or when used in combination with certain drugs or foods.
• Do not substitute a dietary supplement for a prescription medicine or for the variety of foods important to a healthy diet.
• Do not assume that the term "natural" to describe a product ensures that it is safe.
• Be wary of hype. Sound health advice is generally based upon research over time, not a single study.
• Learn to spot false claims. If something sounds too good to be true, it probably is.

Why Is It Important to Report an Adverse Event?

If you experience adverse event, also known as a side effect or bad reaction, the FDA encourages both you and your health care professional to report the adverse event to the FDA.

You can help the FDA, yourself, and other consumers by reporting an adverse event. A single adverse event report can help us identify a potentially dangerous product and possibly remove it from the market.

Adverse events can also be reported to the product's manufacturer or distributor through the address or phone number listed on the product's label. Dietary supplement firms are required to report serious adverse events they receive about their dietary supplements to FDA within 15 days.

“FDA approved!”

Maybe you saw those words on a company’s website, or in a commercial promoting a new product or treatment. Some marketers may say their products are “FDA approved,” but how can you know for sure what the U.S. Food and Drug Administration approves?

FDA is responsible for protecting public health by regulating human drugs and biologics, animal drugs, medical devices, tobacco products, food (including animal food), cosmetics, and electronic products that emit radiation.

But not all those products undergo premarket approval — that is, a review of safety and effectiveness by FDA experts and agency approval before a product can be marketed. In some cases, FDA’s enforcement efforts focus on products after they are already for sale. That is determined by Congress in establishing FDA’s authorities. Even when FDA approval is not required before a product is sold, the agency has regulatory authority to act when safety issues arise.

Here is a guide to how FDA regulates products — and what the agency does (and doesn’t) approve.

FDA doesn’t approve companies.

FDA does not “approve” health care facilities, laboratories, or manufacturers. FDA does have authority to inspect regulated facilities to verify that they comply with applicable good manufacturing practice regulations.

Owners and operators of domestic or foreign food, drug, and most device facilities must register their facilities with FDA, unless an exemption applies. Blood and tissue facilities also must register with the agency.

Mammography facilities must be FDA certified and must display their FDA certificates where patients can see them. The certificate indicates that the facilities have met stringent standards for providing quality mammography.

FDA approves new drugs and biologics.

New drugs and certain biologics must be proven safe and effective to FDA’s satisfaction before companies can market them in interstate commerce. Some examples of biologics that require approval are therapeutic proteins, vaccines, cellular therapies, and blood and blood products. Manufacturers must also prove they are able to make the drug product according to federal quality standards.

FDA does not develop or test products before approving them. Instead, FDA experts review the results of laboratory, animal, and human clinical testing done by manufacturers. If FDA grants an approval, it means the agency has determined that the benefits of the product outweigh the known risks for the intended use.

See the directory of approved and unapproved finished drugs on the market.

FDA doesn’t approve compounded drugs.

Compounding is generally a practice in which a pharmacist or a doctor combines ingredients to create medications that meet the needs of individual patients, including those who are allergic to ingredients in FDA-approved medicines or who cannot swallow an FDA-approved pill. But consumers need to be aware that compounded drugs are not FDA approved. This means that FDA does not review applications for compounded drugs to evaluate their safety, effectiveness, or quality.

FDA uses a risk-based, tiered approach for regulating medical devices.

FDA classifies devices according to risk. The highest-risk devices (Class III), such as mechanical heart valves and implantable infusion pumps, generally require FDA approval of a premarket approval application before marketing. To receive FDA approval for these devices, manufacturers must demonstrate with sufficient, valid scientific evidence that there is a reasonable assurance that the devices are safe and effective for their intended uses.

Generally, FDA “clears” moderate-risk medical devices (Class II) (for example dialysis equipment and many types of catheters) for marketing once it has been demonstrated that the device is substantially equivalent to a legally marketed predicate device that does not require premarket approval.

Devices that present a low risk of harm to the user (Class I) (for example non-powered breast pumps, elastic bandages, tongue depressors, and exam gloves) are subject to general controls only, and most are exempt from premarket notification requirements.

FDA uses a risk-based approach for human cells and tissues.

All human cells and tissues intended for use in humans — collectively referred to as human cells, tissues, and cellular and tissue based products — are regulated to prevent the transmission of infectious disease. Those that pose an additional risk also require FDA approval before marketing. Examples of cells and tissues include bone, skin, corneas, ligaments, tendons, dura mater, heart valves, and reproductive tissue.

FDA doesn’t approve tobacco products.

There’s no such thing as a safe tobacco product, so FDA’s safe and effective standard for evaluating medical products is not appropriate for tobacco products. Instead, FDA regulates tobacco products based on a public health standard that considers the product’s risks to the population as a whole.

To legally sell or distribute a new tobacco product in the United States, manufacturers must receive a written order from FDA. There are three pathways are available to bring a tobacco product to market: premarket tobacco applications, substantial equivalence applications, or exemption from substantial equivalence.

A marketing order does not indicate that the tobacco product is either safe or “approved.” It means that the manufacturer has complied with the requirements under the law to bring its product to market.

FDA approves food additives in food for people.

Although FDA does not have premarket approval of food products, it has the authority to approve certain ingredients before they are used in foods. Those include food additives, such as substances added intentionally to food, and color additives.

Companies that want to add new food additives to food are responsible for providing FDA with information demonstrating that the additives are safe. FDA experts review the results of appropriate tests done by companies to ensure that the food additive is safe for its intended use. An approved food additive must be used in compliance with its approved uses, specifications, and restrictions.

Some food additives are food contact substances that could migrate into food, such as coatings, plastics, paper and adhesives, as well as colorants, antimicrobials, and antioxidants found in packaging. They undergo a different review process. The same safety standards still apply, but the food contact notification process is specific to the identified manufacturer or supplier. If at the end of the review period FDA does not object, the food contact notification becomes effective and the food contact substance may be legally marketed.

Certain food ingredients, such as those that are considered “generally recognized as safe” (GRAS) by scientific experts, do not require premarket approval as a food additive. FDA has a voluntary notification process under which a manufacturer may submit a conclusion that the use of an ingredient is GRAS.

FDA approves color additives used in FDA-regulated products.

This includes those used in food (including animal food), dietary supplements, drugs, cosmetics, and some medical devices. These color additives (except coal-tar hair dyes) are subject by law to approval by the agency, and each must be used only in compliance with its approved uses, specifications, and restrictions.

In the approval process, FDA evaluates safety data to ensure that a color additive is safe for its intended purposes.

FDA approves animal drugs and approves food additives for use in food for animals.

FDA is responsible for approving drugs for animals, including pets, livestock, and poultry. (Minor animal species include animals other than cattle, swine, chickens, turkeys, horses, dogs, and cats.)

Although FDA does not approve animal foods, including pet food, for marketing, it does approve food additives used in these products. FDA works to help ensure that food for animals (which includes livestock and poultry food, pet food and pet treats) is safe, made under sanitary conditions, and properly labeled.

The Preventive Controls for Animal Food rule, a new regulation mandated by the FDA Food Safety Modernization Act (FSMA), requires food companies to take steps to prevent foods from being contaminated and to use current good manufacturing practices (such as hygienic personnel practices, adequate sanitation practices, and proper equipment use) when making food for animals.

FDA does not approve cosmetics.

Examples of cosmetics are perfumes, makeup, moisturizers, shampoos, hair dyes, face and body cleansers, and shaving preparations. Cosmetic products and ingredients, and their labeling, do not require FDA approval before they go on the market. There’s one exception: color additives (other than coal-tar hair dyes). Cosmetics must be safe for their intended use and properly labeled.

FDA doesn’t approve medical foods.

A medical food is used for the dietary management of a disease or health condition that requires special nutrient needs. An example of a medical food is a food for use by persons with phenylketonuria, a genetic disorder. A person with this disorder may need medical foods that are formulated to be free of the amino acid phenylalanine. A medical food is intended for use under the supervision of a physician. It doesn’t include products such as meal replacements or diet shakes, or products for the management of diseases like diabetes, which can be managed through modification of the normal diet.

Medical foods do not have to undergo premarket approval by FDA. But medical food companies must comply with other requirements, such as good manufacturing practices and registration of food facilities. Medical foods do not have to include nutrition information on their labels, and any claims in their labeling must be truthful and not misleading.

FDA doesn’t approve infant formula.

FDA does not approve infant formulas before they can be marketed. But manufacturers of infant formula are subject to FDA’s regulatory oversight.

Manufacturers must ensure that infant formula complies with federal nutrient requirements. Manufacturers must register with FDA and provide the agency with a notification before marketing a new formula.

FDA conducts yearly inspections of all facilities that manufacture infant formula and collects and analyzes product samples. FDA also inspects new facilities. If FDA determines that an infant formula presents a risk to human health, the manufacturer of the formula must conduct a recall.

FDA doesn’t approve dietary supplements.

Unlike new drugs, dietary supplements are not reviewed and approved by FDA based on their safety and effectiveness. Unless an exception applies, dietary supplements that contain a new dietary ingredient (a dietary ingredient not marketed in the United States before Oct. 15, 1994) require a notification to FDA at least 75 days before marketing.

The notification must include the information that provides the manufacturer’s or distributor’s basis for concluding that the dietary supplement will reasonably be expected to be safe. When public health concerns arise about a dietary supplement after the product is on the market, FDA evaluates the product’s safety through research and adverse event monitoring.

FDA doesn’t approve the food label, including the Nutrition Facts panel.

FDA does not approve individual food labels before food products can be marketed. But FDA regulations require nutrition information to appear on most foods, including dietary supplements. Also, any claims on food products must be truthful and not misleading, and must comply with any regulatory requirements for the type of claim.

Manufacturers must provide the serving size of the food and specified information about the nutrient content of each serving on the “Nutrition Facts” panel of the food label (or on the “Supplement Facts” panel for dietary supplements).

FDA doesn’t approve structure-function claims on dietary supplements and other foods.

Structure-function claims describe the role of a food or food component (such as a nutrient) that is intended to affect the structure or function of the human body. One example is “calcium builds strong bones.”

Dietary supplement companies that make structure-function claims on labels or in labeling must submit a notification to FDA. This notification must be submitted no later than 30 days after first marketing the dietary supplement with the structure-function claim. Also, the notification must include the text of the claim, as well as other information, such as the name and address of the notifier. Structure-function claims on dietary supplements carry a disclaimer stating that the claim has not been reviewed by FDA, and that the product is not intended to diagnose, treat, cure, or prevent any disease.

FDA does not require conventional food manufacturers to notify FDA about their structure-function claims or to carry a disclaimer.

Misuse of FDA’s logo may violate federal law.

FDA’s logo is for official government use only. FDA’s logo should not be used to misrepresent the agency or to suggest that FDA endorses any private organization, product, or service.

These are just some of the many ways FDA is responsible for protecting the public health.

From Minor to Life Threatening

Unwanted or Unexpected Drug Reactions

Drugs approved by the U.S. Food and Drug Administration (FDA) for sale in the United States must be safe and effective - which means that the benefits of the drug must be greater than the known risks. However, both prescription and over-the-counter (OTC) drugs have side effects. Side effects, also known as adverse reactions, are unwanted undesirable effects that are possibly related to a drug. Side effects can vary from minor problems like a runny nose to life-threatening events, such as a heart attack or liver damage.

Several things can affect who does and does not have a side effect when taking a drug – age; use of other drugs, vitamins, or dietary supplements; or other underlying diseases or conditions (for example, diseases that weaken the immune system or effect the function of the kidneys or liver).

Common side effects include upset stomach, dry mouth, and drowsiness. A side effect is considered serious if the result is: death; life-threatening; hospitalization; disability or permanent damage; or exposure prior to conception or during pregnancy caused birth defect.

Side effects can happen when you:

• start taking a new drug or dietary supplement (for example, vitamins)
• stop taking a drug that you’ve been on for a while, or
• increase or decrease the dose (amount) of a drug that you take.

Reducing Your Risk

There are several ways to learn about side effects for your prescription drugs and to reduce your risk of experiencing a side effect.

• Ask your health care professional about any possible side effects and what, if any steps should be taken to reduce the risk when you are prescribed a drug. For example, your health care professional may recommend taking the drug with food to lower the chance of getting nausea or to not take the drug with other drugs.
• Ask your health care professional for information about the drug when you receive your prescription (FDA approved labeling for patients include Medication Guides and Patient Information). These documents will include possible common and serious side effects.
• Read the pharmacy label and any stickers that may be attached to the prescription bottle or box. The label and stickers may have information on how to take the drug and possible side effects.

When a Side Effect Occurs

Should you experience a side effect, you may be able to lessen or eliminate the effects. Work with your health care professional to see if adjusting the dosage or switching to a different medication will ease or eliminate the side effect. Other options, such as a lifestyle or dietary change, may be suggested by your health care professional.

Reporting Side Effects

When side effects do occur, you are encouraged to report them to FDA’s MedWatch, a program for reporting serious problems with human medical products including drugs.

MedWatch has a consumer reporting form, FDA 3500B. Written in plain language and designed to be consumer friendly, the form starts off with a page of some commonly asked questions and answers to help guide you in submitting the form, and then asks simple questions about the problem. In addition to formal reports, MedWatch has a toll free line (1-800-332-1088) to answer questions.

Be an active member of your health care team. By taking time to learn about the possible side effects of a drug and working with your health care provider and pharmacist, you will be better prepared to reduce your chance of experiencing a side effect or coping with any side effect that you may experience.

Where Can I Find Detailed Side Effect Information for a Drug?

FDA’s FDALabel database is used to perform customizable searches of thousands of drug labeling including searching for side effects for a drug. Please use these instructions to find side effect information about a particular drug.

• Go to: https://nctr-crs.fda.gov/fdalabel/ui/search
• If you are looking for a prescription drug for humans, click on “Human Rx”:
  • Go to the “Product Name(s)” search box and enter the entire or part of the drug name.
  • Consider looking for the trade name of the drug you are looking for and then click on “SPL Document” in that row.
  • Go the “6 ADVERSE REACTIONS” to find the side effects for the drug.
• If you are looking for an over-the-counter drug for humans, click on “Human OTC”:
  • Go to the “Product Name(s)” search box and enter the entire or part of the drug name.
  • Consider looking for the trade name of the drug you are looking for and then click on “SPL Document” in that row.
  • Go to the “Warnings” to find the side effects for the drug.

There are more opportunities today than ever before to learn about your health and to take better care of yourself. It is also more important than ever to know about the medicines you take. If you take several different medicines, see more than one doctor, or have certain health conditions, you and your doctors need to be aware of all the medicines you take. Doing so will help you to avoid potential problems such as drug interactions.

Drug interactions may make your drug less effective, cause unexpected side effects, or increase the action of a particular drug. Some drug interactions can even be harmful to you. Reading the label every time you use a nonprescription or prescription drug and taking the time to learn about drug interactions may be critical to your health. You can reduce the risk of potentially harmful drug interactions and side effects with a little bit of knowledge and common sense. Drug interactions fall into three broad categories:

• Drug-drug interactions occur when two or more drugs react with each other. This drug-drug interaction may cause you to experience an unexpected side effect. For example, mixing a drug you take to help you sleep (a sedative) and a drug you take for allergies (an antihistamine) can slow your reactions and make driving a car or operating machinery dangerous.
• Drug-food/beverage interactions result from drugs reacting with foods or beverages. For example, mixing alcohol with some drugs may cause you to feel tired or slow your reactions.
• Drug-condition interactions may occur when an existing medical condition makes certain drugs potentially harmful. For example, if you have high blood pressure you could experience an unwanted reaction if you take a nasal decongestant.

Drug Interactions and Over-the-Counter Medicines

Over-the-counter (OTC) drug labels contain information about ingredients, uses, warnings and directions that is important to read and understand. The label also includes important information about possible drug interactions. Further, drug labels may change as new information becomes known. That's why it's especially important to read the label every time you use a drug.

• The "Active Ingredients" and "Purpose" sections list:
  • the name and amount of each active ingredient
  • the purpose of each active ingredient

• The "Uses" section of the label:

  • tells you what the drug is used for
  • helps you find the best drug for your specific symptoms

• The "Warnings" section of the label provides important drug interaction and precaution information such as
  • when to talk to a doctor or pharmacist before use
  • the medical conditions that may make the drug less effective or not safe
  • under what circumstances the drug should not be used
  • when to stop taking the drug

• The "Directions" section of the label tells you:
  • the length of time and the amount of the product that you may safely use
  • any special instructions on how to use the product

• The "Other Information" section of the label tells you:
  • required information about certain ingredients, such as sodium content, for people with dietary restrictions or allergies

• The "Inactive Ingredients" section of the label tells you:
  • the name of each inactive ingredient (such as colorings, binders, etc.)

• The "Questions?" or "Questions or Comments?" section of the label (if included):
  • provides telephone numbers of a source to answer questions about the product

Learning More About Drug Interactions

Talk to your doctor or pharmacist about the drugs you take. When your doctor prescribes a new drug, discuss all OTC and prescription drugs, dietary supplements, vitamins, botanicals, minerals and herbals you take, as well as the foods you eat. Ask your pharmacist for the package insert for each prescription drug you take. The package insert provides more information about potential drug interactions.

Before taking a drug, ask your doctor or pharmacist the following questions:

• Can I take it with other drugs?
• Should I avoid certain foods, beverages or other products?
• What are possible drug interaction signs I should know about?
• How will the drug work in my body?
• Is there more information available about the drug or my condition (on the Internet or in
• health and medical literature)?

Know how to take drugs safely and responsibly. Remember, the drug label will tell you:

• what the drug is used for
• how to take the drug
• how to reduce the risk of drug interactions and unwanted side effects

If you still have questions after reading the drug product label, ask your doctor or pharmacist for more information

Remember that different OTC drugs may contain the same active ingredient. If you are taking more than one OTC drug, pay attention to the active ingredients used in the products to avoid taking too much of a particular ingredient. Under certain circumstances — such as if you are pregnant or breast-feeding — you should talk to your doctor before you take any medicine. Also, make sure you know what ingredients are contained in the medicines you take. Doing so will help you to avoid possible allergic reactions.

The following are examples of drug interaction warnings that you may see on certain OTC drug products. These examples do not include all of the warnings for the listed types of products and should not take the place of reading the actual product label.

Drug Interaction Information

This information is brought to you by the Council on Family Health in cooperation with the National Consumers League and the U.S. Food and Drug Administration.

If you think you've heard it before, you're dead wrong.
How many times has someone told you a "party" drug could lead to more serious problems - like addiction, brain damage, or even death? You've probably heard it so many times, it's getting hard to believe. Especially when kids around you are smoking, drinking, and rolling. But all drugs have real potential for harm - even prescription pain relievers. When abused alone, or taken with other drugs, prescription pain medications can kill you. And the death toll from misuse and abuse is rising steadily. 

Think twice-because you only die once.
Prescription pain relievers, when used correctly and under a doctor's supervision, are safe and effective. But abuse them, or mix them with illegal drugs or alcohol, and you could wind up in the morgue. Even using prescription pain relievers with other prescription drugs (such as antidepressants) or over-the-counter medications (like cough syrups and antihistamines), can lead to life-threatening respiratory failure. That's why people just like you are dropping pills at parties, and dropping dead. They're not downing handfuls of pills, either. With some prescription pain relievers, all it takes is one pill.

Drugs to watch out for.
The most dangerous prescription pain relievers are those containing drugs known as opioids, such as morphine and codeine. Some common drugs containing these substances include Darvon, Demerol, Dilaudid, OxyContin, Tylenol with Codeine, and Vicodin. Your friends probably call these drugs by their street names: ac/dc, coties, demmies, dillies, hillbilly heroin, o.c., oxy, oxycotton, percs and vics to name a few. Whatever you call them, remember one thing - they can be killers.

Symptoms of overdose.
If you, or any of your friends, have taken prescription pain relievers, here are the danger signs to watch for:

• Slow breathing (less than ten breaths a minute is really serious trouble)
• Small, pinpoint pupils
• Confusion
• Being tired, nodding off, or passing out
• Dizziness
• Weakness
• Apathy (they don't care about anything)
• Cold and clammy skin
• Nausea
• Vomiting
• Seizures

A lot of these symptoms can make people think your friend is drunk. And you may be tempted to let them sleep it off, or tell their parents they had too much to drink. But don't. Your friend could go to sleep and never wake up.

What you can do if a friend is overdosing.
Make an anonymous call to 911 or your friend's parents if you're too scared to identify yourself. Try to get your friend to respond to you by calling out his/her name. Make your friend wake up and talk to you. Shake him/her if you have to. Otherwise, your friend could suffer brain damage, fall into a coma, or die.

Addiction can be a living death.
If you abuse prescription pain relievers and are lucky enough to cheat death, you're still in big trouble. Prescription pain relievers can be addictive. The longer you take them, the more your body needs. Try to stop, and you could experience withdrawal symptoms.

Addiction to prescription pain relievers is like being hooked on heroin and the withdrawal isn't much different: bone and muscle pain, diarrhea, vomiting, cold flashes and insomnia.

If you, or someone you know, is abusing or is addicted, get professional help. You'll find many resources listed here. You can also ask for help from parents, doctors, relatives, teachers, or school guidance counselors. Substance abuse ruins lives. Don't let it happen to your friends - or you.

If you, or someone you know, is hooked on prescription pain relievers, call the substance abuse treatment 24-hour helpline:

1.800.662.HELP

Ever since antibiotics became widely available about 50 years ago, they have been hailed as miracle drugs--magic bullets able to destroy disease-causing bacteria.

But with each passing decade, bacteria that resist not only single, but multiple, antibiotics--making some diseases particularly hard to control--have become increasingly widespread. In fact, according to the Centers for Disease Control and Prevention (CDC), virtually all significant bacterial infections in the world are becoming resistant to the antibiotic treatment of choice. For some of us, bacterial resistance could mean more visits to the doctor, a lengthier illness, and possibly more toxic drugs. For others, it could mean death. The CDC estimates that, each year, nearly 2 million people in the United States acquire an infection while in a hospital, resulting in 90,000 deaths. More than 70 percent of the bacteria that cause these infections are resistant to at least one of the antibiotics commonly used to treat them.

Antibiotic resistance, also known as antimicrobial resistance, is not a new phenomenon. Just a few years after the first antibiotic, penicillin, became widely used in the late 1940s, penicillin-resistant infections emerged that were caused by the bacterium Staphylococcus aureus (S. aureus). These "staph" infections range from urinary tract infections to bacterial pneumonia. Methicillin, one of the strongest in the arsenal of drugs to treat staph infections, is no longer effective against some strains of S. aureus. Vancomycin, which is the most lethal drug against these resistant pathogens, may be in danger of losing its effectiveness; recently, some strains of S. aureus that are resistant to vancomycin have been reported.

Although resistant bacteria have been around a long time, the scenario today is different from even just 10 years ago, says Stuart Levy, M.D., president of the Alliance for the Prudent Use of Antibiotics. "The number of bacteria resistant to many different antibiotics has increased, in many cases, tenfold or more. Even new drugs that have been approved are confronting resistance, fortunately in small amounts, but we have to be careful how they're used. If used for extended periods of time, they too risk becoming ineffective early on."

How Resistance Occurs

Bacteria, which are organisms so small that they are not visible to the naked eye, live all around us--in drinking water, food, soil, plants, animals, and in humans. Most bacteria do not harm us, and some are even useful because they can help us digest food. But many bacteria are capable of causing severe infections.

The ability of antibiotics to stop an infection depends on killing or halting the growth of harmful bacteria. But some bacteria resist the effects of drugs and multiply and spread.

Some bacteria have developed resistance to antibiotics naturally, long before the development of commercial antibiotics. After testing bacteria found in an arctic glacier and estimated to be over 2,000 years old, scientists found several of them to be resistant against some antibiotics, most likely indicating naturally occurring resistance.

If they are not naturally resistant, bacteria can become resistant to drugs in a number of ways. They may develop resistance to certain drugs spontaneously through mutation. Mutations are changes that occur in the genetic material, or DNA, of the bacteria. These changes allow the bacteria to fight or inactivate the antibiotic.

Bacteria also can acquire resistant genes through exchanging genes with other bacteria. "Think of it as bacterial sex," says David White, Ph.D., a microbiologist in the Food and Drug Administration's Center for Veterinary Medicine. "It's a simple form of mating that allows bacteria to transfer genetic material." The bacteria reproduce rapidly, allowing resistant traits to quickly spread to future generations of bacteria. "The bacteria don't care what other bacteria they're giving their genes to," says White. This means that resistance can spread from one species of bacteria to other species, enabling them to develop multiple resistance to different classes of antibiotics.

Combating Resistance

In 1999, 10 federal agencies and departments, led by the Department of Health and Human Services, formed a task force to tackle the problem of antimicrobial resistance. Co-chaired by the CDC, the FDA, and the National Institutes of Health, the task force issued a plan of action in 2001. Task force agencies continue to accomplish the activities set forth in the plan. The success of the plan--known as the Public Health Action Plan to Combat Antimicrobial Resistance--depends on the cooperation of many entities, such as state and local health agencies, universities, professional societies, pharmaceutical companies, health care professionals, agricultural producers, and the public.

All of these groups must work together if the antibiotic resistance problem is to be remedied, says Mark Goldberger, M.D., director of the FDA office responsible for reviewing antibiotic drugs. "This is a very serious problem. We need to do two things: facilitate the development of new antimicrobial therapy while at the same time preserve the usefulness of current and new drugs."

Preserving Antibiotics' Usefulness

Two main types of germs--bacteria and viruses--cause most infections, according to the CDC. But while antibiotics can kill bacteria, they do not work against viruses--and it is viruses that cause colds, the flu, and most sore throats. In fact, only 15 percent of sore throats are caused by the bacterium Streptococcus pyogenes, which results in strep throat. In addition, viruses cause most sinus infections, coughs, and bronchitis. And fluid in the middle ear, a common occurrence in children, does not usually warrant treatment with antibiotics unless there are other symptoms.

Nevertheless, "Every year, tens of millions of prescriptions for antibiotics are written to treat viral illnesses for which these antibiotics offer no benefits," says David Bell, M.D., the CDC's antimicrobial resistance coordinator. According to the CDC, antibiotic prescribing in outpatient settings could be reduced by more than 30 percent without adversely affecting patient health.

Reasons cited by doctors for overprescribing antibiotics include diagnostic uncertainty, time pressure on physicians, and patient demand. Physicians are pressured by patients to prescribe antibiotics, says Bell. "People don't want to miss work, or they have a sick child who kept the whole family up all night, and they're willing to try anything that might work." It may be easier for the physician pressed for time to write a prescription for an antibiotic than it is to explain why it might be better not to use one.

But by taking an antibiotic, a person may be doubly harmed, according to Bell. First, it offers no benefit for viral infections, and second, it increases the chance of a drug-resistant infection appearing at a later time.

"Antibiotic resistance is not just a problem for doctors and scientists," says Bell. "Everybody needs to help deal with this. An important way that people can help directly is to understand that common illnesses like colds and the flu do not benefit from antibiotics and to not request them to treat these illnesses."

Following the prescription exactly is also important, says Bell. People should not skip doses or stop taking an antibiotic as soon as they feel better; they should complete the full course of the medication. Otherwise, the drug may not kill all the infectious bacteria, allowing the remaining bacteria to possibly become resistant.

While some antibiotics must be taken for 10 days or more, others are FDA-approved for a shorter course of treatment. Some can be taken for as few as three days. "I would prefer the short course to the long course," says Levy. "Reservoirs of antibiotic resistance are not being stimulated as much. The shorter the course, theoretically, the less chance you'll have resistance emerging, and it gives susceptible strains a better chance to come back."

Another concern to some health experts is the escalating use of antibacterial soaps, detergents, lotions, and other household items. "There has never been evidence that they have a public health benefit," says Levy. "Good soap and water is sufficient in most cases." Antibacterial products should be reserved for the hospital setting, for sick people coming home from the hospital, and for those with compromised immune systems, says Levy.

To decrease both demand and overprescribing, the FDA and the CDC have launched antibiotic resistance campaigns aimed at health care professionals and the public. A nationwide ad campaign developed by the FDA's Center for Drug Evaluation and Research emphasizes to health care professionals the prudent use of antibiotics and offers them an educational brochure to distribute to patients.

The FDA published a final rule in February 2003 that requires specific language on human antibiotic labels to encourage doctors to prescribe them only when truly necessary. The rule also requires a statement in the labeling encouraging doctors to counsel their patients about the proper use of these drugs.

Stimulating Drug Development

The FDA is working to encourage the development of new antibiotics and new classes of antibiotics and other antimicrobials. "We would like to make it attractive for the development of new antibiotics, but we'd like people to use them less and only in the presence of bacterial infection," says Goldberger. This presents a challenge, he says. "Decreased use may result in sales going down, and drug companies may feel there are better places to put their resources."

Through such incentives as exclusivity rights, the FDA hopes to stimulate new antimicrobial drug development. Exclusivity protects a manufacturer's drug from generic drug competition for a specific length of time.

The FDA has a variety of existing regulatory tools to help developers of antimicrobial drugs. One of these is an accelerated approval process for drugs that treat severely debilitating or life-threatening diseases and for drugs that show meaningful benefit over existing prescription drugs to cure a disease.

The FDA is also investigating other approaches for speeding the antimicrobial approval process. One approach is to reduce the size of the clinical trial program. "We need to streamline the review process without compromising safety and effectiveness," says Goldberger. "One of the things that we are trying to look at now is how we can substitute quality for quantity in clinical studies." It has been difficult to test drugs for resistance in people, says Goldberger. "Although these resistant organisms are a problem, they are still not so common that it is very easy to accumulate patients."

Research

Scientists and health professionals are generally in agreement that a way to decrease antibiotic resistance is through more cautious use of antibiotic drugs and through monitoring outbreaks of drug-resistant infections.

But research is also critical to help understand the various mechanisms that pathogens use to evade drugs. Understanding these mechanisms is important for the design of effective new drugs.

The FDA's National Center for Toxicological Research (NCTR) is studying the mechanisms of resistance to antibiotic agents among bacteria from the human gastrointestinal tract, which can cause serious infections.

In addition, the NCTR has studied the amount of antibiotic residues that people consume in food from food-producing animals and the effects of these residues on human intestinal bacteria. This information led to a new approach for assessing the safety of antibiotic drug residues in people, which may be adopted by the FDA to help review drugs for food animals.

To find out more about the broad range of issues associated with antimicrobial resistance, see the FDA's Web site at Combating Antibiotic Resistance, and the CDC's Web site at www.cdc.gov/drugresistance/

Upper Respiratory Infections and Antibiotics
Most upper respiratory infections are usually caused by viruses--germs that are not killed by antibiotics. Talk with your doctor about ways to feel better when you are sick. Ask what you should look for at home that might mean you are developing another infection for which antibiotics might be appropriate.

CDC

Fluid in the Middle Ear
Fluid in the middle ear, also called otitis media with effusion, is a common condition in children. Fluid often accumulates in the ear, just like in the nose, when a child has a cold. In the absence of other symptoms, fluid in the middle ear usually doesn't bother children, and it almost always goes away on its own without treatment, says Janice Soreth, M.D., director of the FDA's Division of Anti-Infective Drug Products. "It usually does not need to be treated with antibiotics unless it is accompanied by additional signs or symptoms or it lasts a couple of months."

If your doctor does not prescribe an antibiotic for your child, do not insist on one. Taking an antibiotic when it is not necessary can be harmful. It increases the risk of getting an infection later that antibiotics cannot kill.

Instead, "observe your child," says Soreth. "If symptoms change, call your doctor to seek further help." Symptoms to watch for include fever, irritability, decreased appetite, trouble sleeping, tugging on the ear, or complaints of pain. "If symptoms occur, it doesn't mean the doctor misdiagnosed the condition," says Soreth. "What started out as a viral condition may have morphed into a bacterial infection several days later. If this happens, an antibiotic may be appropriate."

What You Can Do to Help Curb Antibiotic Resistance

Don't demand an antibiotic when your health care provider determines one isn't appropriate. Ask about ways to help relieve your symptoms.

Never take an antibiotic for a viral infection such as a cold, a cough, or the flu.

Take medicine exactly as your health care provider prescribes. If he or she prescribes an antibiotic, take it until it is gone, even if you're feeling better.

Don't take leftover antibiotics or antibiotics prescribed for someone else. These antibiotics may not be appropriate for your current symptoms. Taking the wrong medicine could delay getting correct treatment and allow bacteria to multiply.

Taking out-of-date drugs carries certain risks

Out with the old! Be it the fresh start of a new year or a spring cleaning, consumers are encouraged to take stock of what has surpassed its usefulness. Medicines are no exception.

In 1979, the U.S. Food and Drug Administration began requiring an expiration date on prescription and over-the counter medicines. The expiration date is a critical part of deciding if the product is safe to use and will work as intended.

The expiration date can be found printed on the label or stamped onto the bottle or carton, sometimes following “EXP.” It is important to know and stick to the expiration date on your medicine. Using expired medical products is risky and possibly harmful to your health.

Expired medicines can be risky

Expired medical products can be less effective or risky due to a change in chemical composition or a decrease in strength. Certain expired medications are at risk of bacterial growth and sub-potent antibiotics can fail to treat infections, leading to more serious illnesses and antibiotic resistance. Once the expiration date has passed there is no guarantee that the medicine will be safe and effective. If your medicine has expired, do not use it.

According to the DEA many people don’t know how to properly clean out their medicine cabinets. Failing to safely dispose of old medications, especially opioids, all too often leads to dangerous drugs ending up in the wrong hands. The CDC reports that 50,000 young children end up in emergency rooms each year because they got into medicines while an adult wasn’t looking.

Finally, expired medicines are also not just a risk to the person they were prescribed for and can injure children and pets if taken by mistake. For all these reasons, proper disposal of unneeded medicines is essential.

What to do with expired meds

First, read the medicine’s label and follow any specific disposal instructions that may be included. A drug take-back program, if available, is the preferred way to dispose of expired, unwanted, or unused medicine. For example, the National Prescription Drug Take-Back Day, coordinated by the DEA, addresses a vital public safety and public health issue by focusing attention on this important issue and reminding everyone to get rid of unneeded and outdated medicines. Through this important program many tons of unneeded and out-date drugs have been removed for proper disposal.

When drug take-back programs aren’t available, federal guidelines recommend throwing the medicines away in the household trash after mixing them with a substance like dirt or kitty litter and then sealing the mixture in a container (see graphic at right). However, certain medicines are specifically recommended for flushing down a toilet or sink because they could be especially harmful, even fatal, to a child, pet, or anyone else if taken accidentally. For a list of medicines recommended for disposal by flushing, as well as other information on proper disposal, please see the Disposal of Unused Medicines page.

A place for everything

Proper storage is one way to help make sure your medicines will remain safe and effective up to their expiration date. Be sure to read the label to see if there are specific storage instructions for your medicine. Certain medicines need to be stored in the refrigerator and others cannot be exposed to high temperatures. Improper storage – such as a damp bathroom cabinet – can contribute to decreased effectiveness in medicines that have not reached their posted expiration date. For most medicines, to help ensure the proper shelf life of your medicine, it is better to store medicine in a cool, dry place such as a dresser drawer, storage box, closet shelf, or kitchen cabinet.

When storing medicine in a kitchen cabinet make sure that it is away from hot appliances and the sink due to changing temperatures and humidity, which can affect the medicine. When storing medicine in a high traffic area, like a kitchen, care should be taken to prevent access by children at risk of accidental poisoning or others who may be tempted to take for abuse/misuse.

Remember to store medicines properly and don’t use expired medicines -- it’s not worth the risk!

Have you ever been tempted to buy your medicines from an online pharmacy or another website?

You can protect yourself and your family by being cautious when buying medicine online. Some pharmacy websites operate legally and offer convenience, privacy, cost savings and safeguards for purchasing medicines.

Not all websites are the same. The U.S. Food and Drug Administration warns that there are many unsafe online pharmacies that claim to sell prescription drugs at deeply discounted prices, often without requiring a prescription. These internet-based pharmacies often sell unapproved, counterfeit or otherwise unsafe medicines outside the safeguards followed by licensed pharmacies.

Many unsafe online pharmacies use fake “storefronts” to mimic licensed pharmacies or to make you think their medicines come from countries with high safety standards. But the medicines they sell could have been made anywhere, with little care or concern for safety and effectiveness. Also, these drugs could be fake, expired or otherwise unsafe for you and your family.

How can you tell if an online pharmacy is operating legally? The FDA’s BeSafeRx page has resources and tools to help you make safer and more informed decisions when buying prescription medicines online.

Warning Signs of an Unsafe Online Pharmacy

Beware of online pharmacies that:

• Do not require a doctor’s prescription.
• Are not licensed in the U.S. and by your state board of pharmacy.
• Do not have a licensed pharmacist on staff to answer your questions.
• Send medicine that looks different than what you receive at your usual pharmacy, or arrives in packaging that is broken, damaged, in a foreign language, has no expiration date, or is expired.
• Offer deep discounts or prices that seem too good to be true.
• Charge you for products you never ordered or received.
• Do not provide clear written protections of your personal and financial information.
• Sell your information to other websites.

These pharmacies often sell medicines that can be dangerous because they may:

• Have too much or too little of the active ingredient you need to treat your disease or condition.
• Not contain the right active ingredient.
• Contain the wrong ingredients or other harmful substances.

The active ingredient of an approved drug product is what makes the medicine effective for the illness or condition it is intended to treat. If a medicine has unknown active ingredients, it could fail to have the intended effect, could have an unexpected interaction with other medicines you are taking, could cause dangerous side effects, or could cause other serious health problems, such as serious allergic reactions.

Also, these drugs may not have been stored properly, such as in a warehouse without necessary temperature controls, which may cause the medicine to be ineffective in treating your condition.

Know the Signs of a Safe Online Pharmacy

There are ways you can identify a safe online pharmacy. These pharmacies:

• Always require a doctor’s prescription.
• Provide a physical address and telephone number in the U.S.
• Have a licensed pharmacist on staff to answer your questions.
• Are licensed with a state board of pharmacy.

Another way to help ensure you are using a safe and legal online pharmacy is to check the pharmacy’s license in the state’s board of pharmacy license database by using the location tool on the FDA’s BeSafeRx website. If your online pharmacy is not listed, don’t use that pharmacy.

Things you should know about purchasing medicines from outside the United States.

If you buy foreign medicine from an Internet site, from a storefront business that offers to order medicine for you, or during visits outside the United States, you are taking a risk. The U.S. Food and Drug Administration (FDA) cannot guarantee the safety of these medicines.

QUALITY ASSURANCE CONCERNS. Medicines that have not been approved for sale in the United States may not have been manufactured under quality assurance procedures designed to produce a safe and effective product.

COUNTERFEIT POTENTIAL. Some imported medicines - even those that bear the name of a U.S.-approved product - may, in fact, be counterfeit versions that are unsafe or even completely ineffective.

PRESENCE OF UNTESTED SUBSTANCES. Some imported medicines and their ingredients, although legal in foreign countries, may not have been evaluated for safety and effectiveness in the United States. These products may be addictive or contain other dangerous substances.

RISKS OF UNSUPERVISED USE. Some medicines, whether imported or not, are unsafe when taken without adequate medical supervision. You may need a medical evaluation to ensure that the medicine is appropriate for you and your condition. Or, you may require medical checkups to make sure that you are taking the medicine properly, it is working for you, and that you are not having unexpected or life-threatening side effects.

LABELING AND LANGUAGE ISSUES. The medicine’s label, including instructions for use and possible side effects, may be in a language you do not understand and may make medical claims or suggest specific uses that have not been adequately evaluated for safety and effectiveness.

LACK OF INFORMATION. An imported medicine may lack information that would permit you to be promptly and correctly treated for a dangerous side effect caused by the medicine.

Remember, medicines you buy outside the U.S. may be unsafe or ineffective. It’s not worth risking your health!

If you have any questions about the use of any medicine, FDA encourages you to contact your physician, your local pharmacist or the board of pharmacy for the state in which you live.

Your pharmacist can help you learn how to use your prescription and nonprescription (over-the-counter) medicines safely and effectively. You can also use these tips when talking with your other healthcare providers.

Tell your pharmacist

• Every medicine you use, especially if you use multiple pharmacies, even if it is the same pharmacy chain.
  • Keep a record and give it to your pharmacist. List all the prescription and over-the-counter medicines, vitamins, herbals, and other supplements you use. Tell your pharmacist exactly how you are taking the medicine.
  • Don’t forget to tell your pharmacist about any changes to your medicines. This includes anything you have stopped taking.
• If you've had any allergic reactions or problems with medicines, dietary supplements, food, medical devices or other medical treatments.
  • What kind of reaction did you have? Did your throat swell up? Did you get a rash? Or was it a stomach ache or diarrhea?
• Any medical conditions you have or have had, including any abnormal lab results.
• Anything that could affect your use of medicine, such as trouble with swallowing, reading small labels, understanding English, remembering to take your medicine, distinguishing the look of one medicine from another, paying for medicines, or transportation to the pharmacy. Your pharmacist may be able to help, so just ask!
• If you plan to start or have started something new such as a new medicine, supplement, diet, or exercise regime. Your pharmacist can help you avoid medicines, supplements, foods, and other things that don't mix well with your medicines.
• If you are pregnant, plan to become pregnant, breastfeeding or plan to breastfeed.
• The best phone number to reach you and your current address. . This is in case the pharmacist has any questions for you or if there are any issues. If you prefer to receive text messages instead of phone calls, let your pharmacy know! Many pharmacies have the ability to text.
• If there have been any changes to your insurance plan/policy/card.

Ask your pharmacist

• What is the most important information I should know about this medicine?
• How do I pronounce the name of my medicine? Does it go by any other name(s)? What are the brand and generic (non-brand) names?
• Are there any cheaper options? Is a generic available? Are there any co-pay assistance coupons?
• How does this medicine work and what is it used for?
• How and when should I use it? How much do I use? Should I take it with food or without food, before a meal or after a meal? What time of the day should I use it? How many times a day is it used? Is there a limit on how often I should use it?
• How long should I use it? Can I stop using the medicine or use less if I feel better? In what circumstances should I stop taking this medicine?
• What should I do if I …miss a dose? ….throw up shortly after taking a dose? ….use too much? ….lose the medicine?
• Will this take the place of anything else I am taking?
• When will the medicine start working? How should I expect to feel?
• Are there any special directions for using this?
• Should I avoid any other medicines, dietary supplements, drinks, foods, activities, or other things? Do I have to space this medicine out from any other medicines or food?
• Does this medicine contain any ingredients I am allergic to?
• Is there anything I should watch for, like allergic reactions or side effects? What are the serious side effects? What do I do if I get any?
• Will I need any tests to check the medicine's effects (blood tests, x-rays, other)? When will I need those?
• How and where should I store this medicine? Is it stored at room temperature or refrigerated or frozen? What should I do if I left it in a hot car?
• When should I throw out this medicine? When does it expire?
• Is there a medication guide or other patient information for this medicine?
• Where and how can I get more written information?
• When should I contact my doctor about this medicine? In what situation should I call 911?

Before you leave the pharmacy after picking up your prescription

• Look to be sure you have the right medicine. If you've bought the medicine before, make sure this medicine has the same shape, color, size, markings, and packaging. Anything different? Don’t hesitate to ask your pharmacist. If it seems different when you use it, tell your pharmacist, doctor, or other healthcare professional.
• Be sure you know the right dose for the medicine and you know how to use it. Unsure about anything? Ask your pharmacist.
• For liquid medicines, make sure there is a measuring spoon, cup, or syringe. If the medicine doesn't come with a special measuring tool, ask your pharmacist for one. (Spoons used for eating and cooking may give the wrong dose. Don't use them.)
• Be sure you have any information the pharmacist can give you about the medicine. Read it and save it.
• Get the pharmacy’s phone number and hours, so you can call back for any questions or refills.

8 Tips to Sticking to Your Medication Routine

Sticking to your medication routine (or medication adherence) means taking your medications as prescribed – the right dose, at the right time, in the right way and frequency. Why is doing these things important? Simply put, not taking your medicine as prescribed by a doctor or instructed by a pharmacist could lead to your disease getting worse, hospitalization, even death.

The High Cost of Not Taking Your Medicines as Prescribed

The Centers for Disease Control and Prevention (CDC) estimates that non-adherence causes 30 to 50 percent of chronic disease treatment failures and 125,000 deaths per year in this country. Twenty five to 50 percent of patients being treated with statins (cholesterol lowering medications) who stop their therapy within one year have up to a 25 percent increased risk for dying.

Statistically speaking: The problem of not taking medicine as prescribed

• 20 to 30 percent of new prescriptions are never filled at the pharmacy.
• Medication is not taken as prescribed 50 percent of the time.
• For patients prescribed medications for chronic diseases, after six months, the majority take less medication than prescribed or stop the medication altogether.
• Only 51 percent of patients taking medications for high blood pressure continue taking their medication during their long-term treatment.

Source: Centers for Disease Control and Prevention (CDC)

Why Some Don’t Take Medications as Prescribed

Many patients do not follow health-care provider instructions on how to take medications for various reasons. Such as, not understanding the directions, forgetfulness, multiple medications with different regimens, unpleasant side effects or the medication doesn’t seem to be working. Cost can also be a factor causing medication non-adherence -- patients can’t afford to fill their prescriptions or decide to take less than the prescribed dose to make the prescription last longer. “However, to help you get the best results from your medications taking your medicine as instructed is very important,” says Kimberly DeFronzo, R.Ph., M.S., M.B.A., a Consumer Safety Officer in FDA's Center for Drug Evaluation and Research.

Tips to Help You Take Your Medicine

Taking your medicine as prescribed or medication adherence is important for controlling chronic conditions, treating temporary conditions, and overall long-term health and well-being. A personal connection with your health-care provider or pharmacist is an important part of medication adherence. “Because your pharmacist is an expert in medications, they can help suggest how best to take your medications,” says DeFronzo. However, you play the most important part by taking all of your medications as directed.

Here are 8 tips that may help:

• Take your medication at the same time every day.
• Tie taking your medications with a daily routine like brushing your teeth or getting ready for bed. Before choosing mealtime for your routine, check if your medication should be taken on a full or empty stomach.
• Keep a “medicine calendar” with your pill bottles and note each time you take a dose.
• Use a pill container. Some types have sections for multiple doses at different times, such as morning, lunch, evening, and night.
• When using a pill container, refill it at the same time each week. For example, every Sunday morning after breakfast.
• Purchase timer caps for your pill bottles and set them to go off when your next dose is due. Some pill boxes also have timer functions.
• When travelling, be certain to bring enough of your medication, plus a few days extra, in case your return is delayed.
• If you’re flying, keep your medication in your carry-on bag to avoid lost luggage. Temperatures inside the cargo hold could damage your medication.

If you have questions about your medication, don’t be shy -- ask your health-care provider or pharmacist and don’t delay. Remember, the life you save may be your own!

About 50,000 young children end up in emergency rooms each year because they got into medicines while an adult wasn’t looking. These emergency visits can be prevented by always putting every medicine up and away and out of children’s reach and sight every time you use it.

Families take medications and vitamins to feel well and to stay well. However, any medication, including those you buy without a prescription, can cause harm if taken in the wrong way or by the wrong person. Practicing safe medication storage, while at home and when on-the-go, can help keep children safe.

Protect your children. Here’s how:

• Put medicines up and away and out of children’s reach and sight.
  • Children are curious and put all sorts of things in their mouths. Even if you turn your back for less than a minute, they can quickly get into things that could hurt them.
  • Pick a storage place in your home that children cannot reach or see. Different families will have different places. Walk around your house and decide on the safest place to keep your medicines and vitamins.
• Put medicines away every time.
  • This includes medicines and vitamins you use every day. Never leave medicine out on a kitchen counter or at a sick child’s bedside, even if you have to give it again in a few hours.
• Make sure the safety cap is locked.
  • Always relock the cap on a medicine bottle. If the bottle has a locking cap that turns, twist it until you hear the click or cannot twist anymore.
  • Remember, even though many medicines have safety caps, children may be able to open them. Every medicine must be stored up and away and out of children’s reach and sight.
• Teach your children about medicine safety.
  • Teach your children what medicine is and why you or a trusted adult must be the one to give it to them.
  • Never tell children medicine is candy to get them to take it, even if they don’t like to take their medicine.
• Tell your guests about medicine safety.
  • Ask family members, houseguests, and other visitors to keep purses, bags, or coats that have medicine in them up and away and out of sight when they are in your home.
• Be prepared in case of an emergency.
  • Call your poison control center at 800.222.1222 right away if you think your child might have gotten into a medicine or vitamin, even if you are not completely sure.
  • Program the Poison Help number into your home and cell phones so you will have it when you need it.
• Take Action.
  • Visit the Up and Away Campaign’s website to learn more about storing medications safely while at home and when traveling with young children. Share these safe storage tips with family and friends.

• Bring a list or a bag with ALL your medicines when you go to your doctor’s office, the pharmacy, or the hospital.  Include all prescription and over-the-counter medicines, vitamins, and herbal supplements that you use. If your doctor prescribes a new medicine, ask if it is safe to use with your other medicines. Remind your doctor and pharmacist if you are allergic to any medicines.

• Ask questions about your medicines.  Ask questions and make sure you understand the answers. Choose a pharmacist and doctor you feel comfortable talking with about your health and medicines. Take a relative or friend with you to ask questions and remind you about the answers later. Write down the answers.

• Make sure your medicine is what the doctor ordered.  Does the medicine seem different than what your doctor wrote on the prescription or look different than what you expected? Does a refill look like it is a different shape, color, or size than what you were given before? If something seems wrong, ask the pharmacist to double-check it. Most errors are first found by patients.

• Ask how to use the medicine correctly. Read the directions on the label and other information you get with your medicine. Have the pharmacist or doctor explain anything you do not understand. Are there other medicines, foods, or activities (such as driving, drinking alcohol, or using tobacco) that you should avoid while using the medicine? Ask if you need lab tests to check how the medicine is working or to make sure it doesn’t cause harmful side effects.

• Ask about possible side effects.  Side effects can occur with many medicines. Ask your doctor or pharmacist what side effects to expect and which ones are serious. Some side effects may bother you but will get better after you have been using the medicine for a while. Call your doctor right away if you have a serious side effect or if a side effect does not get better. A change in the medicine or the dose may be needed.

Simple checks could save your life!

Aging and Health: You and Your Medicines

As you age, it is important to know about your medicines to avoid possible problems. As you get older you may be faced with more health conditions that you need to treat on a regular basis. It is important to be aware that more use of medicines and normal body changes caused by aging can increase the chance of unwanted or maybe even harmful drug interactions.

The more you know about your medicines and the more you talk with your health care professionals, the easier it is to avoid problems with medicines.

As you age, body changes can affect the way medicines are absorbed and used. For example, changes in the digestive system can affect how fast medicines enter the bloodstream. Changes in body weight can influence the amount of medicine you need to take and how long it stays in your body.  The circulation system may slow down, which can affect how fast drugs get to the liver and kidneys. The liver and kidneys also may work more slowly affecting the way a drug breaks down and is removed from the body.

Because of these body changes, there is also a bigger risk of drug interactions for older adults. Drug-drug interactions happen when two or more medicines react with each other to cause unwanted effects. This kind of interaction can also cause one medicine to not work as well or even make one medicine stronger than it should be. For example, you should not take aspirin if you are taking a prescription blood thinner, such as Warfarin, unless your health care professional tells you to.

Drug-condition interactions happen when a medical condition you already have makes certain drugs potentially harmful. For example, if you have high blood pressure or asthma, you could have an unwanted reaction if you take a nasal decongestant.

Drug-food interactions result from drugs reacting with foods or drinks. In some cases, food in the digestive track can affect how a drug is absorbed. Some medicines also may affect the way nutrients are absorbed or used in the body.

Drug-alcohol interactions can happen when the medicine you take reacts with an alcoholic drink. For instance, mixing alcohol with some medicines may cause you to feel tired and slow your reactions.

It is important to know that many medicines do not mix well with alcohol. As you grow older, your body may react differently to alcohol, as well as to the mix of alcohol and medicines. Keep in mind that some problems you might think are medicine-related, such as loss of coordination, memory loss, or irritability, could be the result of a mix between your medicine and alcohol.

What Are Side Effects?

Some medicines can interact with other medicines, foods, drinks or health conditions. Side effects are unplanned symptoms or feelings you have when taking a medicine. Most side effects are not serious and go away on their own; others can be more bothersome and even serious. To help prevent possible problems with medicines, seniors must know about the medicine they take and how it makes them feel.

Keep track of side effects to help your doctor know how your body is responding to a medicine. New symptoms or mood changes may not be a result of getting older but could be from the medicine you're taking or another factor, such as a change in diet or routine. If you have an unwanted side effect, call your doctor right away.

Talk to Your Health Care Professionals

It is important to go to all of your medical appointments and to talk to your team of health care professionals (doctors, pharmacists, nurses, or physician assistants) about your medical conditions, the medicines you take, and any health concerns you have.

It may help to make a list of comments, questions, or concerns before your visit or call to a health care professional. Also, think about having a close friend or relative come to your appointment with you if you are unsure about talking to your health care professional or would like someone to help you understand and/or remember answers to your questions.

Here are some other things to keep in mind:

All Medicines Count: Tell your team of health care professionals about all the medicines you take, including prescription and over-the-counter medicines, such as pain relievers, antacids, cold medicines, and laxatives. Don't forget to include eye drops, dietary supplements, vitamins, herbals, and topical medicines, such as creams and ointments.

Keep in Touch with Your Doctors: If you regularly take a prescription medicine, ask your doctor to check how well it is working, whether you still need to take it, and, if so, whether there is anything you can do (like lowering fats in your diet or exercising more) to cut back or, in time, stop needing the medicine. Don't stop taking the medicine on your own without first talking with your doctor.

Medical History: Tell your health care professional about your medical history. The doctor will want to know if you have any food, medicine, or other allergies. He or she also will want to know about other conditions you have or had and how you are being treated or were treated for them by other doctors. It is helpful to keep a written list of your health conditions that you can easily share with your doctors. Your primary care doctor should also know about any specialist doctors you may see on a regular basis.

Eating Habits: Mention your eating habits. If you follow or have recently changed to a special diet (a very low-fat diet, for instance, or a high-calcium diet), talk to your doctor about this. Tell your doctor how much coffee, tea, or alcohol you drink each day and whether you smoke. These things may make a difference in the way your medicine works. Tell your health professionals about your medical history and about all medicines or supplements you take.

Recognizing and Remembering to Take Your Medicines: Let your health care professional know if you have trouble telling your medicines apart. The doctor can help you find better ways to recognize your medicines. Also tell your doctor if you have problems remembering when to take your medicines or how much to take. Your doctor may have some ideas to help, such as a calendar or pill box.

Swallowing Tablets: If you have trouble swallowing tablets, ask your doctor, nurse, or pharmacist for ideas. Maybe there is a liquid medicine you could use or maybe you can crush your tablets. Do not break, crush, or chew tablets without first asking your health professional.

Your Lifestyle: If you want to make your medicine schedule more simple, talk about it with your doctor. He or she may have another medicine or ideas that better fits your lifestyle. For example, if taking medicine four times a day is a problem for you, maybe the doctor can give you a medicine you only need to take once or twice a day.

Put It in Writing: Ask your health care professional to write out a complete medicine schedule, with directions on exactly when and how to take your medicines. Find out from your primary care doctor how your medicine schedule should be changed if you see more than one doctor.

Your Pharmacist Can Help Too

One of the most important services a pharmacist can offer is to talk to you about your medicines. A pharmacist can help you understand how and when to take your medicines, what side effects you might expect, or what interactions may occur. A pharmacist can answer your questions privately in the pharmacy or over the telephone.

Here are some other ways your pharmacist can help:

• Many pharmacists keep track of medicines on their computer. If you buy your medicines at one store and tell your pharmacist all the over-the-counter and prescription medicines or dietary supplements you take, your pharmacist can help make sure your medicines don't interact harmfully with one another.
• Ask your pharmacist to place your prescription medicines in easy-to-open containers if you have a hard time taking off child-proof caps and do not have young children living in or visiting your home. (Remember to keep all medicines out of the sight and reach of children.)
• Your pharmacist may be able to print labels on prescription medicine containers in larger type, if reading the medicine label is hard for you.
• Your pharmacist may be able to give you written information to help you learn more about your medicines. This information may be available in large type or in a language other than English. Your pharmacist can help keep track of your medicines.

What You Need to Know About Your Prescription Medicines

The following questions will help you get the information you need when you visit your doctor and pharmacist.

Before you leave the doctor's office with a new prescription, ask:

• What is the name of the medicine and what is it supposed to do? Is there a less expensive alternative?
• How and when do I take the medicine and for how long?
• Whether to take it with water, food, or with a special medicine, or at the same time as other medicines.
• Can it be taken with over-the-counter medicines? If so,when?
• What to do if you miss or forget a dose.
• Whether you take it before, during, or after meals.
• The timing between each dose. For example, does "four times a day" mean you have to take it in the middle of the night?
• What your doctor means by "as needed."
• Are there any other special instructions to follow?
• What foods, drinks, other medicines, dietary supplements, or activities should I avoid while taking this medicine?
• Will any tests or monitoring be required while I am taking this medicine? Do I need to report back to the doctor?
• What are the possible side effects and what do I do if they occur?
• When should I expect the medicine to start working, and how will I know if it is working?
• Will this new prescription work safely with the other prescription and over-the-counter medicines or dietary supplements I am taking?

At the pharmacy, or wherever you get your medicines, ask:

• Do you have a patient profile form for me to fill out? Does it include space for my over-the-counter drugs and my dietary supplements?
• Is there written information about my medicine? Ask the pharmacist if it's available in large print or in a language other than English if you need it.
• What is the most important thing I should know about this medicine? Ask the pharmacist any questions that may not have been answered by your doctor.
• Can I get a refill? If so, when?
• How and where should I store this medicine?

Keep a Record of Your Medicines; Give Your Medicine Chest a Yearly Check-Up

To help you organize information about your medicines, list all the prescription and over-the-counter medicines, dietary supplements, vitamins, and herbals you take. Bring this list with you when you see your doctors and any other health care professional. It is very important that each of them knows what medicines you are taking. The list should include: the name of the medicine, the doctor who prescribed it, how much and how often to take, instructions on how to take the medicine, what it is taken for and any expected side effects.

Remember to bring all over-the-counter medicines you take as well as any dietary supplements, vitamins, and herbals. It is also important to get rid of any expired medicines you may have.

Taking Prescription Medicines

Follow your doctor's instructions and read (and keep) the package insert information, if available. Have your doctor write down instructions if you don't understand or are worried about forgetting them.

Take your medicines for the whole time they are prescribed, even if you feel better.

Take only your own medicines. Taking someone else's medicine may hide your symptoms and make diagnosing your illness more difficult for your doctor.

Know about your medicines. If you take more than one medicine, be able to tell them apart by size, shape, color, number or name imprint, form (tablet or capsule), or container.

Plan for medicines you need to take during the night. If you need to take more than one medicine, try not to keep them by your bedside. If you must, and there are no small children or pets in your home, place the pills you will need during the night on your bedside table. Turn on the light and make sure you're taking the right medicine at the right time.

Before you travel, ask your doctor or pharmacist how to adjust your medicine schedule to account for changes in time, routine, and diet. Bring the phone numbers of your doctors and pharmacists with you. When flying, carry your medicines with you; do not pack them in your checked luggage. When traveling, always keep medicines out of heat and direct sunlight.

If there are children in your home, remember to put medicines out of their sight and reach, and don't take medicines in front of them. 

Get prescriptions refilled early enough to avoid running out of medicine, which may cause problems with your medicine schedule.

Organize your medicines at home. Many people use a chart or written schedule to keep track of their medicines. Some find containers with different colored caps, different sections or with alarms that go off at set times helpful.

Keep medicines in a cool, dry place, away from bright light. A kitchen cabinet or bedroom shelf may be good storage places. Medicines should not be kept in places where heat and moisture can alter their effectiveness. Do not keep medicines in the refrigerator, unless your doctor or pharmacist, or the label, tells you.

If you to buy medicines on the Internet, check the web site for the Verified Internet Pharmacy Practice Sites (VIPPS) program and seal of approval to make sure the site is properly licensed and has been successfully reviewed and inspected by the National Association of Boards of Pharmacy.

Always keeps medicines in their original containers, and never put more than one kind of medication in the same container.

Taking Over-the-Counter Medicines

Today's medicine cabinets contain a growing choice of over-the-counter, OTC, medicines to treat a growing number of health problems. Common OTC medicines include pain relievers, laxatives, cough and cold products, and antacids. Some OTC medicines however, can affect the way prescription medicines work or are used by the body. Always talk with your doctor about all OTC medicines you take. Here are some important tips to remember:

Always read and follow the directions on the medicine label. OTC medicine labels give you all the information you need to take the medicine the right way and tell you:

• Active and inactive ingredients,
• What the medicine is used for,
• Interactions or side effects that could happen,
• How and when (or when not) to take the medicine,
• Other warnings.

Choose OTC medicines that have only the ingredients you need. It is a good idea to only use medicines that treat the problems or symptoms you have. Ask your pharmacist for help. If you are taking more than one medicine, pay attention to the "active ingredients" to avoid taking too much of the same ingredient.

Check for package tampering and the expiration date. Don't buy medicines if the packaging has been broken or if the expiration date has passed. The expiration date tells you the date after which the product may not be as effective.

Talk to your doctor if taking an OTC medicine becomes a regular habit. Most OTC medicines are only to be used for a short time.

Cutting Medicine Costs

Medicines are an important part of treating an illness because they often allow people to remain active and independent. But medicine can be expensive. Here are some ideas to help lower costs:

Tell your doctor if you are worried about the cost of your medicine. Your doctor may not know how much your prescription costs, but may be able to tell you about another less expensive alternative.

Ask for a senior citizen's discount.

Shop around. Look at prices at different stores or pharmacies. Lower medicine prices may not be a bargain if you need other services, such as home delivery, patient medicine profiles, or pharmacist consultation, or if you cannot get a senior citizen discount.

Ask for medicine samples. If your doctor gives you a prescription for a new medicine, ask your doctor for samples you can try before filling the prescription. (Make sure you know the right way to use the sample medicine and ask for any other important product information.)

Buy bulk. If you need to take medicine for a long period of time and your medicine does not expire quickly, you may be able to buy a larger amount of the medicine for less money.

Try mail order. Mail-order pharmacies can provide medications at lower prices. However, it is a good idea to talk with your doctor before using such a service since there may not be a health care professional there to talk to and it may take a few weeks for medicine to get to you. Make sure to find a back-up pharmacy in case there is a problem with the mail service.

Buy OTC medicines when they are on sale. Check the expiration dates and use them before they expire. If you need help choosing an OTC medicine, ask the pharmacist.

Tips for Seniors on Safe Medicine Use

Learn about your medicines. Read medicine labels and package inserts and follow the directions. If you have questions, ask your doctor or other health care professionals.

Talk to your team of health care professionals about your medical conditions, health concerns, and all the medicines you take (prescription and OTC medicines), as well as dietary supplements, vitamins, and herbals. The more they know, the more they can help. Don't be afraid to ask questions.

Keep track of side effects or possible drug interactions and let your doctor know right away about any unexpected symptoms or changes in the way you feel.

Make sure to go to all doctor appointments and to any appointments for monitoring tests done by your doctor or at a laboratory.

Use a calendar, pill box or other things, to help you remember what you need to take and when. Write down information your doctor gives you about your medicines or your health condition.

Take along a friend or relative to your doctor's appointments if you think you might need help to understand or to remember what the doctor tells you.

Have a "Medicine Check-Up"at least once a year. Go through your medicine cabinet to get rid of old or expired medicines and also ask your doctor or pharmacist to go over all of the medicines you now take. Don't forget to tell them about all the OTC medicines or any vitamins, dietary supplements, and herbals you take.

Keep all medicines out of the sight and reach of children.

When it comes to taking medicines, kids aren’t just small adults. When using nonprescription medicines, here are 10 ways to be sure you’re giving your children the right medicine and the right amount.

1. Read and follow the label directions every time. Pay special attention to usage directions and warnings. If you notice any new symptoms or unexpected side effects in your child or the medicine doesn't appear to be working, talk to your doctor or pharmacist immediately.

2. Know how much medicine to give and when. Read and follow the label.

3. Know the abbreviations for tablespoon (tbsp.) and teaspoon (tsp.). You should also know: milligram (mg.), milliliter (mL.), and ounce (oz.).

4. Use the correct dosing device. If the label says two teaspoons and you're using a dosing cup with ounces only, don't guess – get the proper measuring device. Don't substitute another item, such as a kitchen spoon.

5. Never play doctor. Twice the recommended dose is not appropriate just because your child seems twice as sick as last time. When in doubt about your child's condition, call your doctor.

6. Talk to your doctor, pharmacist, or other health care professional before giving two medicines at the same time to avoid a possible overdose or an unwanted interaction.

7. Follow age and weight limit recommendations. If the label says don't give to children under a certain age or weight, don't do it. Call your doctor.

8. Always use the child-resistant cap and re-lock the cap after each use. Be especially careful with iron-containing vitamins or supplements, which have been a source of accidental poisoning deaths in children under three.

9. Follow the "KEEP OUT OF REACH" warning. Today's medicines are often flavored to mask the taste of the medicine, which is all the more reason to keep all drugs out of the sight and reach of children.

10. Always check the package and the medicine itself for signs of tampering. Don't buy or use any medicine from a package that shows cuts, tears, slices, or other imperfections. Report anything suspicious to the pharmacist or store manager.