The generic option and patient education

As the cost of health care in general and medications specifically continues to rise with no end in sight, the option of a generic substitution for a prescribed medication has saved many patients' budgets as well as the budgets of their respective health plans. When this option is available, there is clearly a need for the pharmacist as a patient educator.

However, the specific actions the pharmacist should take may be less clear. How can pharmacists let patients know about the option of using generic drugs? How accepting are patients and physicians of such substitutions? When is a "dispense as written" (DAW) prescription appropriate, and how often are pharmacists seeing DAWs? In separate interviews with Drug Topics, several experts discussed these issues.

The role of the pharmacist

Pharmacists are obvious resources to patients regarding generic formulations, but they often do not initiate these conversations, said Donald L. Sullivan, Ph.D. Sullivan is an associate professor of pharmacy practice at the Raabe College of Pharmacy at University of Northern Ohio in Ada and is the author of The Consumer's Guide to Generic Drugs. "We did a study that involved interviews with consumers about generic drugs and their use of them," he said. "We found that 29% of patients reported that their pharmacists never even discuss generic drugs with them, and 62% reported that the pharmacists had discussed this topic 'somewhat.' Pharmacists haven't done a good job of educating patients about this choice."

These conversations should happen because, among other things, patients would probably receive the information well. "I think patients are very receptive to generic drugs," Sullivan said. "In 90% of cases, the generic is the exact equivalent of the brand-name drug, and it can save patients money."

FDA public education program

The Food & Drug Administration is very much interested in helping consumers wade through the information regarding generic substitutions so that they can make informed choices, said Ellen Shapiro, director of public affairs for the FDA's Center for Drug Evaluation and Research (CDER). She agreed with Sullivan regarding the FDA approval process, and added that, as part of the ANDA submission, the FDA has a series of requirements that generic drugs have to meet.

"We want to educate consumers so they understand that, when they're given a generic drug, it's just as safe and effective as the brand name," said Shapiro. "Some studies done at FDA show that consumers and some physicians don't have confidence when they use generic drugs. Our goal is to let patients know that there is a strict drug approval process for generic drugs, and that patients should feel confident that such drugs are safe and effective."

A public education project being launched is called the Generic Drug Education Program. Several health maintenance organizations and other managed care plans have partnered with the FDA to get the message out, Shapiro said.

Physician reactions

Depending on the prescribing physician, pharmacists can see a variety of reactions to generic substitutions, ranging from outright opposition to open enthusiasm. One issue might be how the physician views the pharmacist's taking the initiative to make the substitution.

The American Medical Association draws a clear distinction between generic substitutions and therapeutic substitutions. The AMA generally prefers that pharmacists call physicians when making a generic substitution, but it opposes therapeutic substitutions of different drugs within the same class, said Edward L. Langston, M.D., R.Ph. Langston, a member of the AMA board of trustees, said, "Most of us are comfortable with generic substitutions of FDA-approved medications."

FDA literature

As patient educators, pharmacists may want to counsel patients so they can make informed decisions regarding generic substitutions. The Food & Drug Administration has several resources on generic drugs that pharmacists can share with patients:

• The Office of Generic Drugs (OGD), housed within the FDA's Center for Drug Evaluation and Research ( http:// www.fda.gov/cder/ogd/ ), has published on its Web site several information pieces about generic drugs, including "Generic Drugs: Questions and Answers" ( http://www.fda.gov/cder/consumerinfo/generics_q&a.htm ).

• The FDA has also prepared several posters and brochures to be distributed in pharmacies, as well as public service announcements for print and broadcast media, regarding generic drugs.