Generic Drugs: The Good, the Bad, and the Unknown

Edward D. Frohlich

All physicians are acutely concerned about the role of healthcare costs as they relate to our patients. We are constantly aware of the cost of the drugs we prescribe, and when possible, we make a conscious effort to prescribe medications that are generic in formulation. However, in the recent past I have been stimulated by patients' concerns that are related to more than the basic drug formulation. They are concerned about the supposedly insignificant vagaries of the formulations not dictated by federal regulation.

Because of my longstanding clinical and academic interests in the need for patients to remain adherent to their prescribed medications, I frequently ask patients to bring their medications to their appointment should any questions arise. On a number of instances, I have been confronted with the following problems: inconsistencies in the color, size, or shape of the tablets; experiences with new or fewer side effects; and the inability of the patient to receive enough medication for each prescription because of a contractual relationship between the patient's employer and health insurer that limits the number of tablets prescribed at a time. The following are examples of these specific types of problems. You may have encountered others with greater or lesser frequency.

The following is perhaps the most common experience with which you have been confronted. The patient asks whether the current tablets are for the same medication he or she had been taking. The old pill was white, and the new one is green. The patient then volunteers that he or she has already contacted the pharmacist, who politely offered assurances that this indeed was the generic prescribed medication. Or is it?

This is an unusual experience, but I have seen it in my practice. A patient stated that he had several side effects with one drug and was informed by an experienced nurse that he may not encounter those side effects if he switched to the generic formulation. So, I wrote a new prescription for the generic and suggested that he save the nongeneric, and more costly, medication just in case the nurse's suggestion did not pan out. Like magic, the side effects soon disappeared. Searching for more scientific proof, I asked the patient to rechallenge himself with the nongeneric medication he had saved. Sure enough, the side effects returned.

One patient recently confronted me with a problem I had not previously encountered. Because his career required frequent trips to the Congo for more than 30 days at a time, he was unable to receive the necessary number of tablets to get through the trip. He explained this problem to his employer, who shifted the issue to the patient's Human Relations office. The response was that the contract with the large health insurance company did not allow for exceptions, and it was impossible for the patient to receive more than a 30-day supply. Fortunately, his pharmacist was innovative and temporarily solved the problem.

Perhaps you, our readers, have had similar or other encounters. Please let me know by e-mail (efrohlich{at}ochsner.org), and I will collate our joint experiences for a subsequent report. If our overall institutional experience is similar to mine, then I think that we have several recourses for action.

I have learned that our institution, in an effort to reduce its costs as well as those of our patients, purchases medications from a large pharmaceutical supplier that places orders with a multiplicity of generic drug houses. As a result, our pharmacist indicated to me that he frequently learns of patients' complaints of changes in the color, size, and shape of tablets. One answer from our institution's point of view is to use our influence as a major multispecialty clinic to join with other large national health systems in insisting that the pharmaceutical supplier use the stronger purchasing power to formulate uniform drug tablet appearances. If the combined purchasing power of the large healthcare systems is inadequate, I would then suggest that we inform our elected representatives to share our collective experiences with the Food and Drug Administration for stronger regulatory efforts.

I look forward to hearing from you and to seeing the power of the press and our collective efforts.