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Harvard Commentaries
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Harvard Commentaries
Reviewed by the Faculty of Harvard Medical School


What Your Doctor Is Saying What Your Doctor Is Saying
 

What Makes a Drug a Drug?


October 10, 2013

By Robert H. Shmerling M.D.

Beth Israel Deaconess Medical Center


Imagine you have a bad cold. Your mother tells you take vitamin C. A television commercial suggests Theraflu (a combination of acetaminophen, diphenhydramine, and phenylephrine). An online medical site recommends a homeopathic approach. And your doctor prescribes an antibiotic "just in case" you have a bacterial infection.

Never mind which medication is best. (Most colds will be better in a few days no matter what you do). Consider these questions instead: Which of these remedies is a drug? Which are "nutraceuticals"? Which is neither?

The answers matter. Read on to learn when a drug is a drug (also called a pharmaceutical) and when it's something else.

So Many Drugs

In the United States alone there are a staggering number of prescription and over-the-counter (OTC) drugs available: about 15,000. Each has its own purpose, benefits and risks. Other countries may have more or less, as approval of a drug in one country does not guarantee its approval elsewhere. Interestingly, experts from the World Health Organization estimate that it would take less than 500 of all available drugs to treat or cure 99% of human diseases or symptoms.

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What Makes a Drug a Drug?

The U.S. Food and Drug Administration (FDA) defines a drug as:

  • "Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease"
  • "Articles (other than food) intended to affect the structure or any function of the body of man or other animals."

Based on these definitions, drugs can fall into several categories. Some of these include:

  • Prescription drugs – These must be approved by the FDA, a process that can take years. In general, the FDA requires extensive testing to reduce the risk of unexpected side effects and to prove the drug actually works in the way it's intended.
  • Over-the-counter (OTC) drugs – Sunscreens and dandruff shampoos are examples of OTC drugs. These drugs may be approved by the FDA, similar to prescription drugs. Or they must follow rules previously established for that class of product. For example, OTC pain relievers must include a list of ingredients and a clear statement of the drug's intended use. In general, to become an OTC drug, the FDA must agree that the drug is exceptionally safe and can be safely administered and monitored without the involvement of a physician. The FDA also must agree that consumers can self-diagnose any conditions for which an OTC drug is used. Finally, OTC drugs must have low potential for abuse. Some forms of prescription drugs may be available over the counter, usually in a lower dose. Common examples include omeprazole (Prilosec) and ibuprofen (Advil). There are more than 80 categories of OTC drugs.
  • Nutraceuticals – These are foods that also have a proven health benefit. Examples include cereals that help lower cholesterol and lycopene (as found in cooked tomatoes) that may reduce the risk of prostate cancer.
  • Cosmetics – The FDA defines cosmetics as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance." It's the intended use that separates cosmetics from other categories of drugs. The product's label must clearly describe its purpose so the consumer is aware.
  • "Cosmeceuticals" – This is not an official term recognized by the FDA but it refers to cosmetics with "drug-like effects." Examples include cosmetic skin creams containing retinol. Retinol is converted in the skin to retinoic acid (the active form of vitamin A). Many creams used to treat aging skin, acne and other skin conditions contain retinol.
  • Supplements – These are oral preparations intended to supplement the diet. They contain vitamins, minerals, plant-based compounds (herbs or other botanicals), and protein (including specific amino acids, the building blocks of proteins). Supplements do not have to be approved by or registered with the FDA. But, the FDA takes action if an unsafe supplement reaches the market or if labeling is misleading.
  • Combinations – Some products are cosmetics and drugs at the same time. Dandruff shampoo has a hair cleansing product (shampoo, a cosmetic) and anti-dandruff treatment (a drug). Such combination products must follow the regulations for both drugs and cosmetics.

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Why Drug Categories Matter

It may seem unnecessarily complicated to divide up the world of drugs into so many categories and subcategories. After all, they are all substances we ingest, apply, inhale, spray or inject into our bodies in the hope that we'll achieve some benefit.

All drugs carry risk. For this reason alone, we need a system of defining and regulating all of the different types of drugs whether it's OTC, by prescription, a supplement or a nutraceutical. That's why the FDA puts acetaminophen (as in Tylenol) and morphine in different categories. Here are two other reasons:

  • If all drugs were lumped together, it would probably be impossible for the FDA to stick to its mission to keep the public informed about drugs and to "assure the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation."
  • Different categories of medicines are regulated differently. For example, a prescription drug maker is not allowed to promote its medication for any conditions other than those diseases for which it is specifically FDA-approved. Meanwhile, a non-prescription supplement must come with a disclaimer that it is "…not intended to diagnose, treat, cure or prevent any disease."

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The Bottom Line

It can be difficult to keep up with the growing list of medicines available to you or your loved ones. Here are my suggestions.

  • Consult reliable sources about medicines your doctor recommends and about any non-prescription drugs you consider taking. (If you aren't sure whether a particular source is reliable, ask your doctor. Or look at online government sites or the Drug Resource Center on this site).
  • Talk to your doctor or your pharmacist about what's on your medication list and find out whether each one is important to continue. Remember that OTC and all-natural remedies may be just as dangerous (or even more so) than certain prescription medications.
  • When your doctor prescribes a medicine ask about the benefits and common side effects. Ask about the risks of not taking the medication. Similarly, don't take an OTC drug, supplement or nutraceutical without first asking some basic questions about its safety and effectiveness. Remember that marketing information is not intended to provide a complete or balanced view of the situation. It's intended to get you to buy and take the medicine. The FDA requires that ads not have misleading or untrue information.

It might seem like there should be a simpler way. But as modern medicine has become increasingly complex and the number of medicines has increased, confusion over what makes a drug a drug and how it's regulated has become increasingly confusing as well.

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Robert H. Shmerling, M.D. is associate physician at Beth Israel Deaconess Medical Center and associate professor at Harvard Medical School. He has been a practicing rheumatologist for over 20 years at Beth Israel Deaconess Medical Center. He is an active teacher in the Internal Medicine Residency Program, serving as the Robinson Firm Chief. He is also a teacher in the Rheumatology Fellowship Program

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