The Appropriate Use of Generic Drugs (Published April 22, 2002)

Healthcare expenditures have again (and predictably) assumed double digit annual increases, driving up the costs paid by employers and patients. As recent reports in the Wall Street Journal, Los Angeles Times and the Star have emphasized, most of the increase has been driven by the cost of new medications. Although many of these medications represent clear improvements in efficacy and/or safety, many also represent the pharmaceutical industry's attempts to maintain patentable agents for which a premium can be charged. Thus there is a potential conflict between what the pharmaceutical business plans desire and what the health plans and patients can afford.

Of course, to be used, medications must be prescribed. Here's where it gets tricky and a bit ugly. The pharmaceutical industry spends a great deal of money and effort to get doctors to prescribe their particular brand of drug, citing alleged superior features in very slick marketing material. These can be presented in the doctor's office, at a social function like a dinner meeting, or an “educational” meeting at a nicer venue. There is nothing necessarily nefarious about all of this, as long as the promotional aspects of these encounters are recognized.

But the pharmaceutical industry has gotten even smarter about its marketing strategies. It now has something called “direct to consumer” marketing. By this, I mean all the ads you all are now seeing on television and in magazines describing condition and a solution that involves a pharmaceutical product, and then asking you to “talk to your doctor” about it. This places you in the position of pressuring your doctor for the prescription, which often prompts the desired result of your getting the prescription the pharmaceutical industry wants you to get. You may have not even known about the drug before. Viagra and the cholesterol lowering drugs are some of the best examples of this style of marketing. And it works. And often the patient benefits from the intervention.

On the other side of this drive to expensive medications is the cost control efforts of the health plans. These health plans have something called “formularies”, which are approved drugs for certain conditions that have been sorted out by their own panel of pharmacists, doctors, and health economists. This is why you may get notified by your health plan that the drug your doctor prescribed is “not approved”, but that lists of “approved” drugs, often including generic drugs, may be given as alternative choices.

So the question is, are generic drugs the same as the prescribed drugs? Well, yes and no.

Generic or “approved” name brand drugs make formulary lists based on cost, i.e., they are cheaper than the other name brands. They generally are in the same category of drug class, e.g., blood pressure, cholesterol, diuretic, but I have seen some pretty bizarre ideas of equivalency. Do they work as well? Aha! That should be the gold standard criterion.

For many conditions, generic/approved drugs may be perfectly appropriate. If the approved agent is able to engender the desired result, everybody wins. The patient is successfully treated, the doctor has fulfilled his responsibility, and the health plan has saved some money. Salaried doctors working for HMO's are the most vulnerable to the pressure to use the least expensive treatments. If the desired result is not achieved, then somebody loses, and it's usually the patient.

For generic or “approved” drugs to be appropriately used, the patient needs to know ahead of time what the desired result being sought is. This is the only bottom line. Is the drug doing what it is supposed to do? If it's a normal blood pressure, what are the numbers? If it's a goal blood fat result, what are the numbers? If it's a blood sugar result, what is the number?

We are developing better clinical guidelines for targeted therapy all the time. Most patients can probably be treated to these guideline levels with less expensive agents than the higher priced name brands. But the only way to get the care needed is for you to know what the medication is for, and how you will know it's working. If the approved drug is not getting you to the pre-defined goal levels, you (and your doctor) need to make noise so that perhaps more effective interventions can be used, even if they are more costly. HMOs, for-profit health plans and hospitals are under pressure to make as much money as possible. It just should not be on the patient's back.



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