Medications

 
What Is a Medication?
The Drug Approval Process
Generic and Brand Name Medications
Problems of Noncompliance
Alternative Medicines

Modern medications represent a wondrous tool in modern health care. When used properly they can alleviate pain, slow the progression of illness, and in some cases even cure disease and save lives. But their power must be respected. Medications are not magic; all medications can cause side effects, and all too often medications are taken improperly, sometimes to disastrous effect.

This chapter will help you understand the diverse ways medications work, while advising you on ways to use them wisely. Modern medications can help you and your family stay healthy, fight off disease, and ease many aches and pains over the years if you use them properly.

What Is a Medication?

Medications (or medicines) are substances commonly referred to as drugs that a person swallows, smoothes onto the skin, has injected into a vein, or takes in a myriad of other different ways for the purposes of healing. In common vernacular the word drugs also refer to substances that influence behavior and mood and that pose the risk of dependence. Caffeine is a widely used drug in this sense, as are illegal substances such as marijuana and cocaine. Unless otherwise noted, the word drugs in this text refers to medications that are used to heal the body.

While some medications actually cure disease, most simply enable the body's natural recuperative powers to take over. Many antibiotics work this way; for instance, by interfering with the growth or multiplication of bacteria, antibiotics make it easier for the body's natural defense system to eliminate the invader. Some antibiotics, however, kill germs. There are drugs that are designed to kill abnormal cells, such as cancer cells, directly, while other medications are used to replace substances that need replenishing, such as insulin for people with diabetes and thyroid hormone for people with hypothyroidism. Some drugs actually alter the way cells work by intensifying or increasing their activity; others, by reducing their activity. Often scientists are not yet sure exactly how a drug works.

Medications are available either by prescription or over-the-counter. The US Food and Drug Administration (FDA) decides which medications can be obtained only with a prescription through a licensed pharmacy with a doctor's written order and which medications can be sold over-the-counter without a doctor's written order and at various retail stores including, but not limited to, pharmacies.

[top of page]

The Drug Approval Process

Before a drug enters the US marketplace it must undergo a rigorous approval process overseen by the FDA. The drug developer must not only prove that the drug is effective in humans meaning it produces the intended effect but also that it is acceptably safe. To prove safety, the developer first tests the drug in small animals such as mice, rats, dogs, and monkeys. Promising results lead to studies in which carefully controlled doses are given to small numbers of healthy human volunteers. Observers carefully monitor reactions to the drug.

If the drug passes these and other safety tests, double-blind trials in large groups of both healthy and sick people are initiated to measure its effectiveness. In a double-blind trial, neither the participant nor the doctors running the trial know whether the participant is taking the test drug or a placebo (or in some cases, a particular concentration of a drug); this is done to minimize bias.

A company that has developed a drug that manages to fulfill all of these safety and efficacy qualifications a lengthy process costing many millions of dollars will then petition the FDA for the right to market the drug. FDA approval endows the manufacturer with the right to market the drug exclusively under a brand (or trademark) name of their choosing. This right to exclusive manufacture and sale, called a patent on a drug, lasts for a period of time; when the patent expires other manufacturers may produce the same drug under a different brand name or in a generic form.

Occasionally, authorities will recall a drug released onto the market because a severe, unintended reaction develops in some of the thousands of consumers taking the drug which had not shown up in smaller test groups. In order to recall a drug, the adverse reaction must be deemed excessive in comparison with the drug's benefits, or unnecessarily risky given the existence of other drugs that can be used for the same problem.

[top of page]

Generic and Brand Name Medications

You may know the medication you take by two names: its generic name and its brand name. The generic name reflects the medication's active substance and fits into a classification scheme that holds meaning for doctors and pharmacists. The generic name is designated during development of a drug. An organization called the US Adopted Name Council decides on this name. The US Adopted Name Council consists of representatives of the American Medical Association (doctors), the American Pharmaceutical Association (pharmacists), and the US Pharmacopoeia (doctors and pharmacists). A medication's brand name represents its registered trade name; the manufacturer chooses (or creates) this name for marketing purposes, usually selecting a name that they hope will be easy for the public to recognize and remember. Zantac is the brand name for ranitidine, for example. Drugs also have chemical names, but these are usually too technical for consumers to understand or retain ranitidine's chemical name, for example, is extremely long and complex. Chemical names are generally only used by scientists and developers.

A patent on a drug lasts 20 years from the date of filing. Once it has expired, other companies may start to competitively manufacture and market the substance under their own brand name. The differences among these brand name medications are often negligible, although manufacturers often try to distinguish their product by giving it a memorable name, packaging it in a particularly appealing way, or offering it in a convenient or easy-to-digest form. Competition among manufacturers often results in lower prices for the consumer.

Generic medications tend to be less expensive than their brand-name equivalents. The price gap does not reflect a difference in quality as much as a difference in marketing and advertising costs. Your doctor and pharmacist may be able to help you select a generic version of a medication that is cheaper than the brand-name product you might be using. Be aware, however, that prices for the same generic medications as well as for brand-name medications can vary widely from one pharmacy or drug outlet to the next.

Most pharmacists will dispense the generic version of a drug unless your doctor specifies that you should be given a particular brand-name product by noting on the prescription itself to ìdispense as written.î However, the pharmacist is required to pass some savings along to the consumer if a generic is substituted for a brand. Laws regarding the pharmacist's ability to substitute generics or another brand-name version vary from state to state.

The Problem of Noncompliance

As many as one-third to one-half of Americans reportedly fail to comply with their medication regimen in one way or another. They may measure out an incorrect dose, take it at the wrong time, or even forget to take the medication altogether. The reasons for such behavior varies, from forgetfulness to a fear of adverse reactions (real or imagined), concerns about addiction, frustration over being dependent on a medication, avoidance of an unpleasant taste or smell, or a desire to cut costs. Some people stop taking their medication once symptoms are relieved even though the prescription calls for the medication to be taken until used up. Other people may avoid taking their medication because it reminds them that they are ill while still others may feel the medication causes more annoying symptoms than their condition does. This common reaction often occurs with so-called silent diseases that cause few if any symptoms, such as high blood pressure, and with certain chronic diseases that tend to flare in cycles, such as systemic lupus erythematosus.

Whatever the reason, the results of noncompliance can be extremely serious. Failing to take blood pressure medication, for example, can lead to potentially fatal consequences. Even something as mundane as failing to take a medication with food when the prescription recommends it can cause serious problems.

Talk to your doctor if you find yourself altering your medication regimen for any reason. Discuss your concerns about expected or unexpected reactions before stopping a medication, changing the dosage, or adding another medication on your own. There may be solutions that surprise you, such as an alternative medication with fewer side effects, or ways to consolidate or simplify your medication regimen.

[top of page]

Alternative Medicines

The popularity of alternative medicines has mushroomed over the past few years, as increasing numbers of Americans turn to herbs, homeopathic medicines, and other natural remedies for minor as well as occasionally for serious ailments. In fact, although the majority of medications available in industrialized countries today consist of chemical compounds synthesized in the laboratory, it was only a few decades ago that pharmacy shelves were stocked with formulations of roots, leaves, and other plant parts, not to mention animal extracts. Pharmaceutical companies continue to search for new drugs in the natural world as well as in the laboratory.

There is no question that many natural substances can be medicinally effective. As many as a quarter of all prescription medications are, in fact, derived from natural substances. Aspirin, for example, consists of a purified form of salicin (acetylsalicylic acid), originally isolated from the bark and leaves of certain willows and poplars. Some herbalists recommend taking willow bark as an aspirin substitute to break a fever, treat headache pain, control inflammation, and allay various other symptoms. This and other herbs contain active ingredients, and a few, such as saw palmetto for prostate enlargement and St. John's wort for mild to moderate depression, have proved somewhat effective in human trials.

Most herbs and other natural remedies, however, have yet to be carefully examined in humans to assess the safety and efficacy of these herbs. This situation is unlikely to change any time soon because herbs cannot be patented and their sale cannot be controlled. Thus manufacturers are unwilling to devote the time and money necessary to officially prove that an herb is medically safe and efficacious.

In America today, herbs and other natural remedies are officially categorized as dietary supplements, which means the packager or manufacturer is barred from making claims regarding their medicinal effect in humans. More importantly, it means that the careful review that the FDA provides for drugs is not extended to dietary supplements. At the same time, the packager is free to sell the substance without proving its safety or effectiveness to health authorities. As a result, the quality of dietary supplements varies widely. Random testing has shown that some herbal products on the market contain little if any of the designated herb.

If you are considering taking a dietary supplement, it is important to keep in mind not only general risks but risks that your particular condition may pose. Are you taking prescription medications, or are you pregnant, nursing, suffering from kidney or liver disease (organs involved in metabolizing and eliminating medications), or very old or very young? While everyone should talk to a doctor before taking a dietary supplement just as you would if you were going to take any medication it is particularly important to do so if any of these conditions apply to you. Potential risks almost always outweigh potential benefits in such cases unless the safety of the substance has been carefully studied. Remember that natural does not equal harmless. Consider the poppy flower: natural, no doubt, but also the source for the highly potent and potentially destructive substance we know as opium. The long-term effects of such popular hormones as melatonin and dehydroepiandosterone, or DHEA, have yet to be determined. Even certain common foods can be harmful if taken in high doses and under certain circumstances.

[top of page]

1