by Sherri DeCoursey

Turn on the television and you may see a commercial featuring cancer survivor and athlete extraordinaire Lance Armstrong. In it, he talks about the impact a leading drug manufacturer's research and products can have on a patient's life. He is living proof of such impact.

Armstrong's triumph over late-stage testicular cancer was due in part to his spectacular physician team and the treatment plan it proposed, a treatment plan that included prescription drugs.

Today's prescription drugs are one of the modern miracles of medicine. They do more than simply cure illness; they can minimize or alleviate troublesome symptoms, mitigate pain, and improve quality of life for a wide range of diseases and ailments.

The FDA's role

The Food & Drug Administration (FDA) is responsible for overseeing the drugs manufactured, marketed and sold in the United States. Within the FDA, a division called the Center for Drug Evaluation and Research oversees prescription and over-the-counter (OTC) drug practices, manufacturing, safety, approval and regulation.

The FDA requires that all drug manufacturers conduct extensive testing of a proposed drug and submit findings for review. The data is then reviewed and evaluated by an FDA advisory committee, which makes recommendations about the approval of the product. Drug manufacturers also are required to register their manufacturing operations and allow FDA quality inspections.

After a drug's evaluation, the FDA determines if it should be made available as a prescription drug or an OTC drug. Some products initially approved by the FDA as prescription drugs later are approved for OTC distribution once found to be effective and safe for broad populations.

According to the FDA, drugs that are approved as OTC drugs differ from prescription drugs in that:

¥ Their benefits outweigh risks.

¥ There is a low potential for misuse or abuse.

¥ Adequate labeling keeps the patient informed.

¥ The patient can self-diagnose the condition accurately.

¥ The expertise of health practitioners is not required.

It is important to note that drugs approved in other countries may not be approved by the FDA, and it would be illegal to import them. However, in some cases the FDA will allow the import and usage of an unapproved drug provided the drug is administered to an individual experiencing a significant health crisis, such as AIDS.

Drug manufacturers, physicians and pharmacists

For drug manufacturers, researching, developing, submitting and manufacturing a product involves years of effort and funding with no guarantee that the research will yield marketable results and no guarantee that the FDA will approve the proposed product.

Jennifer Reddan, pharmacist and coordinator for the Drug Information/Drug Use Policy of Clarian Health Partners, observes, "It's a very time-consuming process. From chemical structure discovery to availability for patient use, it sometimes takes 10 years or more. Different study 'phases' are required before a drug receives FDA approval."

Even after the FDA approves a product, Reddan notes that a drug manufacturer may continue its research.

"Many times post-marketing clinical trials are performed to evaluate the use of the product in selected patient populations, to monitor adverse drug reactions or to compare it against other products" she says.

Cost considerations

Because of the time and money invested in drug research, it's not surprising that prescription drugs are often expensive to the consumer despite insurance co-pays.

"The cost of prescription drugs is high to help balance the cost of research to develop and bring new drugs to market," Reddan says.

"Drug companies state they spend $800 million on average to develop new drugs. Of the hundreds of chemical entities that are discovered each year, only a small percentage of those ever make it to market."

The need for an effective and reasonably priced prescription-drug program in America has received much attention. Until the time such a program is instituted, people who can't afford prescription drugs will continue to bypass appropriate medical care, receive care from illegal backroom clinics, or illegally purchase affordable prescription drugs with questionable origins and contents.

According to the American Association of Retired People, both the Senate and the House of Representatives passed bills this year proposing a prescription-drug program within Medicare. The two bills, which differ significantly, are now in the hands of a joint House-Senate conference committee charged with finding common ground.

Online or over-the-border ordering

Access to prescription drugs via the Internet brings risks to consumers in addition to a valid healing opportunity. Buying drugs online can put a person at risk of receiving contaminated or counterfeit product, of introducing untested substances into the body, of receiving the wrong product, or labeling or language issues, each of which can have serious consequences.

When purchasing online drugs, be aware of the following:

¥ Don't buy from a site that does not require a prescription or that does not have a registered pharmacist available to answer questions.

¥ Don't buy from a site that dispenses a drug new to you without a physical examination.

¥ Always talk to your physician before using a drug for the first time.

¥ Don't buy from foreign sites since it is illegal to import drugs into the United States under the Federal Food, Drug and Cosmetic Act and you have no way of knowing the validity, origin and history of the drug.

Despite the many questionable sites found online, others are credible and patient-focused. Buying online can be helpful if a person is homebound, or if a person wants additional anonymity due to his or her ailment, such as a sexually transmitted disease.

If you choose to have prescriptions filled online, check with the National Association of Boards of Pharmacy at www.nabp.net or call (847) 698-6227 to determine if the Web site is licensed and in good standing.

Some consumers have obtained a prescription from physicians licensed in both the United States and Canada so that they can have the prescription filled in Canada at lower cost. However, over-the-border purchases carry many of the same risks that online ordering does, especially outside of North America.

Although Canada has its own FDA-equivalent organization, drugs approved by that group are still not necessarily FDA approved, which means a person has no protection or recourse should the drug prove troublesome.

The wise consumer

The majority of people will use prescription drugs at some time in their lives, and many people will use more than one medication at a time. Practice safe medicine practices by following a few simple guidelines.

Discuss your medication with your doctor. Tell your doctor and pharmacist what other medicines, including herbal supplements, you take to ensure drug interactions won't occur.

If a prescription looks different than what you usually receive, ask the pharmacist about the difference. Report adverse reactions.

Take the prescribed dose of medication at the scheduled times. Ask a friend or relative to help you with medicine if you are extremely ill. Assist elders if they need help with medication. Carry a current list on your person of what medicine you are taking in case of emergency.

Store drugs in a childproof location with controlled temperature and low humidity. Do not use drugs that have expired; they can become toxic or lose their effectiveness after the expiration date.

Top 10 Meds

In 2002, the 10 prescription drugs most dispensed in outpatient pharmacies were:

1. Lortab (for pain)

2. Lipitor (for cholesterol lowering)

3. Synthroid (for hypothyroidism)

4. Premarin (for menopause)

5. Norvasc (for blood pressure)

6. Zoloft (for anti-depression)

7. Zocor (for cholesterol lowering)

8. Paxil (for anti-depression)

9. Prevacid (for stomach acid)

10. Albuterol (for asthma)

Judging Generics

It is estimated that half of all prescriptions filled today are done so with generic drug versions. Generic drugs offer consumers a less-costly option to brand-name drugs without compromising quality and effectiveness.

Generic drug manufacturers can apply to the FDA to sell generic versions of brand-name drugs once the patent given to the original developer expires.

The FDA requires that a generic drug be exactly the same as the corresponding brand-name drug in terms of dosage, safety, strength, method of introduction to the body, quality, performance and intended use.

DeCoursey is a self-proclaimed "professional dabbler" and works in the fields of professional writing, public relations, marketing, event management and drawing.

Article appears as published in the IW November 2003 issue.