Americans use 71 percent more prescription medicine than they did in the early 1990s.
Now more than ever, perhaps, more questions need to be asked about the prescription drugs that are an integral part of our lives and our health care.
ABC News posed five questions about prescription drugs to Dr. Sharon Levine of the Permanente Medical Group, the medical arm of Kaiser Permanente health plan:
1) Most of us believe new drugs are better than old drugs. Is this true?
Not necessarily. Many new drugs are simply minor modifications of existing drugs, with essentially comparable heath effects, or drugs with a new mechanism of action but not necessarily an improved health benefit. For the [Food and Drug Administration] to approve a "new drug," the manufacturer only has to demonstrate that it is "better than nothing," i.e., a "placebo." It is a good idea to ask the question about all new drugs, "Is this really likely to be a better, improved drug, or is it just 'new,' and what is the evidence?"
2) When a health plan like Kaiser has "preferred drugs," are they just being cheap and denying patients the latest and greatest medicines?
For a drug to make a "preferred drug list," it has to meet safety and quality standards before it is even considered. "Value" -- is there an equally effective, equally safe drug, which would be less expensive to achieve the same health outcome -- is not considered unless there are other safe, quality drugs to choose from for the condition being treated. "Preferred drugs" are those, which are either the best (sometimes only) available therapy, or the most cost effective choice in a category of drug where there are multiple options for treatment. It's not about denying access to a better, more effective therapy, but rather being sure that consumers are getting the most health value from their prescription drugs.
3) What are the lessons from a drug like Vioxx?
That "new" is not the same as "improved." That confirmatory safety data may take longer to accumulate than the FDA approval process, and careful postmarketing surveillance of new drugs is as important as the prerelease FDA approval. That physicians need better information about safety "concerns," which may or may not be ultimately proven to be risks, as they look at the appropriate use of a new drug. That manufacturers need to be more forthcoming about safety concerns and that "direct to consumer" marketing, and "direct to physician" drug promotion by industry of a new drug can lead to rapid use and uptake of the drug even without solid evidence that the drug is better or safer than existing alternatives.
4) Do consumers and physicians have enough reliable information to be confident in the quality, safety and effectiveness of the prescriptions drugs available to them?
While the FDA is trying to do the best job it can, it often takes years of observation -- of what happens as drugs are used in actual practice -- for the full picture to emerge on the safety and comparative effectiveness of prescription drugs. We need to be cautious and careful as we identify the proper role for a new drug when there are existing, effective therapies with established safety profile.
5) How can an individual patient be sure that the drug being prescribed is the right prescription for him/her?
By being prepared to ask the prescriber a set of questions to be certain that the right questions have been answered in the selection of the drug: Why this drug as opposed to other alternatives? Is there a generic version of this drug available, since generic drugs have the same effect in the body as the brand version? How long has the drug been on the market, and is there evidence that the drug is better than alternatives, or at least equal to alternatives in my situation? Have there been safety concerns raised about the drug, either during the drug approval process, or subsequent to its approval?
Be cautious about "drug samples" offered as an inducement to use a new drug. More often than not these are marketing efforts by the manufacturers to get new drugs into the hands of consumers, and may result in choosing and using a "new," more expensive drug which in fact offers little advantage over existing alternatives. … Remember, it is rare to see a "sample" of high quality effective generic drugs distributed by manufacturers.
Sharon Levine is a pediatrician and associate executive director for The Permanente Medical Group of Northern California -- the largest medical group in the country -- since 1991. Levine's responsibilities include government and community relations, health policy and external affairs, and pharmacy policy and drug use management.