Prescription Medications: How to Make More Informed Choices

The Path of a Pill: How brand and generic medications come to market

It seems you hear about a new prescription drug every day. It can be confusing. By understanding how a new drug is approved and discussing it with your doctor, you can make more informed decisions about the medications you take.

New drugs: Finding solutions, safeguarding your health

In the laboratory, researchers try to determine whether a specific chemical or combination of chemicals can affect the way the body functions and whether it could be used to treat, prevent, or cure a condition. A new drug requires years of testing and clinical trials to determine if it is safe to take and is more effective than a placebofor treating a specified condition.

It’s only after the drug has completed the clinical trials that the manufacturer applies to the FDA for marketing permission. As part of the approval process, the FDA reviews all test results and studies, along with the information that will appear on the drug label and package insert.

Following a drug’s approval, the FDA continues to monitor the drug’s usage and safety. It may revise the product labeling, issue a health advisory to doctors and patients, or withdraw approval if new data about a medication’s side effects comes to light.

Generics offer you the same benefit, better savings

Early in the process, the manufacturer files a patent on its brand name to ensure that no one copies it. Typically, this patent lasts for 20 years, but most ofthat time might be spent ontesting and evaluation.

Long before the patent expires, another manufacturer may begin developing a generic equivalent.This generic drug must be bioequivalentto the brand-name product; that is, it must be expected to perform the same way in your body and achieve the same effect. The generic equivalent must have:

The same active ingredients
The same dosage form
The same quality, strength, and purity

Because it’s bioequivalent, the generic isn’t required to repeat the extensive clinical trials, though the FDA still reviews the generic. Also, because generic drugs cost less to develop, manufacture, and market than brand-name drugs, they’re less expensive for your health plan. By using generics, you can save money while receiving the same benefit to your health.

Naturally, brand-name manufacturers have an interest in protecting their patents and maintaining market share. A generic drug’s release can be delayed if the brand-name manufacturer claims that the generic is violating its patent or if it announces a new therapeutic use for the brand-name product, which may “restart the clock” on its patent.The manufacturer could also release a new drug that is only a slight variation on the original.

Well-produced advertisements may make you wonder if a new drug is better than what you’re taking now. If you’re thinking about switching to a new medication, talk to your doctorand be certain that the advantages to you outweigh the increased cost. Other current drugs may be more than sufficient for your needs.

Sidebar #1:

Talk to your doctor…

You’re an active partner in managing your health. You and your doctor should choose the medication that’s right for you. In some cases, a new brand-name drug might be the right choice. In others, a generic or over-the-counter (OTC) drug might work best—and may save you money.

Here are some questions to ask your doctor:

Is the new drug more safe and effective than the drug I’m taking now?
Are there any precautions or side effects that I should know about?
Are the side effects as well known as those of my current medication or another drug that’s been on the market longer?
If this new drug would cost me more, are the advantages (for example, fewer side effects or fewer doses per day) worth the extra cost?

Also, discuss your current medications on a regular basis. A generic equivalent may now be available or you might no longer need the strongest dosage—a lower-strength version might provide the same benefit with less chance of side effects.

Sidebar #2:

New patent expirations mean new opportunities for you

The following brand-name drugs may lose patent protection within the next 18months. If you are taking any of these medications, you may want to discuss less expensive generic alternatives with your doctor when they become available:

Advair Diskus®(fluticasone/salmeterol – GlaxoSmithKline)

Cialis®(tadalafil – Lilly)

EpiPen®(epinephrine – Mylan)

Gilenya®(fingolimod – Novartis)

Lyrica®(pregabalin – Pfizer)

Namenda XR®(memantine e.r. – Allergan)

Proair® HFA (albuterol - Teva)

Restasis® (cyclosporine ophthalmic emulsion – Allergan)

Visitexpress-scripts.com to see if a generic alternative is available for a medication you’re taking.