When a medication becomes available as a generic, the patient is offered a comparably safe and effective but more affordable treatment option, compared to the brand name product. In fact, the use of generics can result in significant savings for both the patient and the payer. However, many patients are reluctant to use generic medications, often due to a lack of understanding or to misinformation about the generic approval process. Pharmacists can address many of these concerns when interacting with patients. Effective communication can help patients make informed decisions about whether to take a generic or brand name product. Assisting a patient with identifying the most cost-effective drug regimen can be a pharmaceutical care intervention that improves adherence and outcomes. This article provides an overview of information that can be shared with the patient about generics, including suggestions on how to respond to patient concerns and counseling points.

The cost of health care in America is an important issue that receives a great deal of deserved focus in health care policy circles. The reasons for the escalating costs are multifactorial and associated with supply and demand. In regard to supply, newer technologies, treatment options, and pharmacotherapy are available today because of expensive research and development. As for demand, the aging population in the United States requires more medical services and is utilizing these resources. The result is ever-increasing costs for medical care and prescription drug coverage--an issue for governmental and private sectors.1

In light of these challenges, payers are often searching for cost-control measures. One logical intervention in a health plan is to maximize generic drug utilization. Generic medications are safe and effective, and generic substitution represents substantial cost savings for patients and payers.1 Most health plans provide incentives for generic drug use by placing generics in a tier with the lowest copay. Utilizing this tier can significantly reduce patients' out-of-pocket costs for their drug therapy and can also facilitate considerable savings for the health plan. In fact, Haas and colleagues2 have estimated that if generic substitution were maximized with multisource drugs (medications that are available as both a brand and a generic), it would result in approximately 11% savings annually in the U.S., which translates to billions of dollars.1,2 Furthermore, in many cases, as the patient's medication bill increases (for items or copays for which the patient is personally responsible), adherence to the prescribed regimen might decline. 1,3 Nonadherence may lead to loss of disease control and unsatisfactory patient outcomes, thus increasing medical expenditures. Therefore, identifying the most cost-effective regimen that reduces a patient's personal financial burden is an important pharmaceutical care intervention. Pharmacists have an integral role in identifying alternatives that the patient can afford.

The Generic Approval Process
In 1984, the Drug Price Competition and Patent Term Restoration Act (often referred to as the Hatch-Waxman Act)was passed, establishing the generic drug approval process that exists today. This act amended the Federal Food, Drug, and Cosmetic Act to outline a process whereby companies wishing to produce a generic drug could file an abbreviated new drug application (ANDA) for review by the FDA. This law is intended to encourage the production of cost-effective generic medications while maintaining incentives for continued research and development of new medications.4

When a company begins research and development on a new drug, it files for a patent and is guaranteed 20 years of exclusivity under patent protection. This patent may be extended up to five years to adjust for time that the drug remains in research and development before being marketed. However, if the drug is ready for marketing and has 14 or more years of patent life remaining, the patent is not eligible for an extension. Drug companies can also request a 30-month stay if the company that holds a patent files suit against a generic manufacturer that is challenging the terms of the patent.4,5

According to the law, the generic manufacturer does not have to repeat extensive and expensive research trials that demonstrate efficacy and safety. Both the new drug application (NDA) and the ANDA require sections on chemistry, manufacturing, controls, labeling, and testing. However, the NDA requires animal studies, human trials, and bioavailability data. With the ANDA, these three requirements are collapsed down to bioequivalence studies only. The FDA relies on the original research for the branded product and postmarketing surveillance that occurred during the patented period to provide evidence of efficacy and safety. Therefore, the generic manufacturer has to demonstrate only bioequivalence. The first manufacturer that files the ANDA for a branded product is given 180 days of exclusivity to market the generic product.4,5

When two medications are found to be bioequivalent, this means that the rate and extent of absorption of the two products do not vary significantly when given at the same molar dose of the active ingredient(s) under similar experimental conditions.6 The FDA provides a full description of the experimental methodologies, data collection, statistical testing, and interpretation of bioequivalence data in the preface of the Orange Book.6,7 These methodologies are designed to protect the patient against use of a generic medication that is not interchangeable. Current research and statistical methodologies ensure that there is no more than a 5% chance that a drug product that is not bioequivalent will receive approval.6,7

An updated list of medications that have an FDA-approved generic alternative is provided in the Orange Book , which can be accessed at www.fda.gov/cder/ob.7 This is a searchable reference that provides information about generic medications, including therapeutic equivalence (TE) codes concerning whether products are considered interchangeable based on data reviewed by the FDA. It is important that pharmacists check these codes carefully. Medications found to be interchangeable are coded "A," and those that cannot be substituted for the brand name product are coded "B." This code is followed by a second character that provides more information about the data submitted to the FDA. For example, a code of "AB" indicates that all problems with bioequivalence have been resolved after further testing, and in vivo and/or in vitro evidence supports bioequivalence.6,7 Pharmacists can also check  www.fda.gov/cder/ogd/approvals/default.htm, which provides updated information on new generic approvals that might not be listed in the Orange Bookdue to lag time for publication of these data. First-time generic products are updated monthly at this site.8

Common Patient Concerns
Some patients are resistant to taking generic medications even if this results in personal financial savings. If you interviewed patients who "do not like generics," you would probably receive a wide variety of responses. Most likely, many of the reasons would stem from a lack of understanding of the generic approval process, misinformation, and misconceptions. Health care providers can have an important role in the patient's perception. If patients do not receive a clear message from their physician and pharmacist about the quality of generics, they are often reluctant to take them. Let's review a few common concerns. 4

Patients might think that generic medications are not high-quality medications.

Some patients may think that "you get what you pay for" and that if a medication costs more, then it must work better. They may reflect on their past experiences with generic foods and dry goods. For instance, they may think about how the store brand cereal just does not taste as good as the brand name cereal they usually buy; or they might think about how the off-label perfumes do not smell as good as the designer fragrances. Therefore, they might think that generic medications do not work as well as the branded alternatives.

Pharmacists and physicians should address these concerns and provide reassurance about the quality of FDA-approved generic medications and explain that these products are carefully tested to ensure they are bioequivalent. The generic alternative must have the same active ingredient(s), strength, dosage form, administration route, and labeling. The drug must deliver the same amount of the active ingredient into the bloodstream within the same amount of time as the branded drug.4-6 It might be interesting to the patient that this same type of documentation and bio­ equivalence testing is required if a brand name manufacturer wants to change the formulation of its own brand name drug. It has to compare the reformulated product to the original branded drug just as the generic manufacturer has to compare its generic product to the original branded drug. 4

Patients might worry that a generic alternative might not look or taste like the brand name option and therefore might not be equivalent.

Again, patients might think about generic medication substitution much as they think of selecting generic foods. They might focus on the shape, size, color, or taste of a product to decide if the generic is really like the brand name product. If the product does not look the same, they may have decreased confidence that it works the same. This can be significant for products that have a characteristic smell or taste (e.g., some nasal corticosteroids or oral inhalers).

This is a key communication point to discuss with patients. Although generic medications must have the same active ingredients, they may differ in shape, imprints, scoring, release mechanisms, packaging, excipients, expiration date/time, and labeling. Therefore, products can definitely have a different shape, size, or taste. These differences will not impact the bio­ equivalence of the product. As noted earlier, bioequivalence testing must acceptably demonstrate that the blood levels of the active ingredient reach the same concentrations within the same time period in order to be found equivalent and receive approval.4,6,7

It is important to listen to patients carefully when they discuss their response to a particular generic drug and compare it to their personal experiences with a brand name product. A patient might have valid concerns about the smell or taste of a generic product that might impact adherence. Also, although rare, the patient might have an allergy or sensitivity to an excipient such as a dye or preservative in the generic that was not in the branded product. Also, there might be differences in the stability of a generic product when compared to the branded product if it is not stored under the conditions recommended by the manufacturer.5,6 Therefore, it is very important to counsel patients to follow the storage conditions recommended in the product-specific packaging. If a patient reports a perception of decreased efficacy with a generic product, this is one area that might be explored.

Patients might be concerned that generic medications could be counterfeit and might not contain the active ingredient.

There has been increased publicity and consumer education about the risk of counterfeit drugs that are being sold over the Internet. There have been reports of medications obtained in this manner containing no active drug at all or ingredients that are not consistent with the product labeling.9 When consumers hear these reports, it might lower their confidence in the drug market and make them suspicious of generic medications. They might want the brand name product just to make sure they receive a quality product.

In this case, it is important to educate the patient about the FDA supervision of the generic medication approval process. The FDA requires clear documentation of the generic drug manufacturer's procedures. The manufacturers must document the drug's chemistry, manufacturing process, and quality-control measures. It must use raw materials that meet United States Pharmacopeia (USP) specifications to ensure purity. The manufacturer must also provide a description of the facilities where the product is manufactured, processed, tested, packaged, and labeled. These facilities must abide by good manufacturing practices (GMP) and undergo FDA inspection. The manufacturer must seek FDA approval before it makes any adjustments in the manufacturing process or formulation of the drug. Therefore, if the patient is obtaining an FDA-approved generic product from a licensed pharmacy in the U.S., he or she can be assured that the drug is a quality product that contains the active ingredient and is bioequivalent. 4,6,7

Communication Considerations
As you can see, patients might have a variety of concerns about taking a generic product. It is important for pharmacists to use effective interviewing, listening, and counseling skills while exploring the underlying cause of this resistance. If patients express unease about taking a generic, be respectful, patient, and kind. Do not dismiss or minimize their concerns. Instead, interview patients to ascertain the exact cause of their apprehension, and then provide appropriate patient-specific counseling.

Pharmacists can obtain brochures, articles, PowerPoint presentations, posters, counter mats, and other resources that might be useful in initiating a dialogue with a patient concerning generic medications by visiting the FDA's Web site at www.fda.gov/cder/consumerinfo/generic_all_ resources.htm#you KnowQuestion.

Inappropriate Dialogue
Pharmacist: Mrs. Kent, I have the prescription ready that your doctor phoned in.
Patient: This is not the medicine I got last time. It has a different name.
Pharmacist: Actually, it is. You got the brand name last time, and the doctor approved a generic version this time. It's cheaper.
Patient: That's the problem. I've heard that generics aren't as effective, and I don't really want to take one.
Pharmacist: Well, this one is just fine, and you won't have any problem with it.
Patient: I really don't want to take a generic drug. I need this to work, and I don't trust generics. I have gotten generics with food and they don't taste as good.
Pharmacist: That's completely different. This will work and save you some money.
Patient: I really don't want a generic. I don't trust the quality.
Pharmacist: OK, it's your money.
Patient: That's right, it is.
Pharmacist: Let me redo this and I will be right back….

Discussion: This pharmacist actually started off inappropriately by using the word "cheaper" in referring to the generic drug, which has negative connotations, indicating an inferior product. In addition, the patient has concerns about the quality of generic drugs, and rather than exploring those concerns, the pharmacist is condescending. The pharmacist is paternalistic and argumentative rather than understanding and supportive. As a result, the patient digs in even more and refuses to use the generic product.

Appropriate Dialogue
Pharmacist: Mrs. Kent, I have the prescription ready that your doctor phoned in.
Patient: This is not the medicine I got last time. It has a different name.
Pharmacist: That is the generic name. You got the brand name last time, and the doctor approved a generic version this time. It's less expensive yet as effective as the brand.
Patient: I've heard that generics aren't as effective, and I don't really want to take one.
Pharmacist: You're worried that the generic version won't work as well for you?
Patient: That's correct.
Pharmacist: I wouldn't want you to take something that wasn't as effective either. I have other patients who have switched to this generic and have reported excellent results. I can assure you that this product is equivalent to the brand name product. Does this help, or do you need some other information or assurance?
Patient: I don't know. I just want this to work.
Pharmacist: I do, too. Would you be willing to take this generic for two weeks and let me know if you have any problems or changes? I really think you will do well on this generic, and it will save you quite a bit of money on your copay. I am confident that it will work as well as the brand name product you were using.
Patient: I would be willing to try that, but if I see any problems or changes, I want the brand name medication again.
Pharmacist: No problem. That's fair.

Discussion: The pharmacist indicated his understanding of the patient's concerns and explored them with the patient. The pharmacist also supported the patient's desire to have an effective medication. Note that the pharmacist expressed confidence in the efficacy of the generic product. This is very important in helping the patient accept the product and believe that it will be effective.

Conclusion
Misconceptions and misunderstandings about generic drugs are not unusual. When pharmacists engage patients in a dialogue about their hesitation to take a generic, the pharmacist has an opportunity to assist the patient with selecting the most cost-effective medication regimen. When their concerns are respected and their issues are addressed, patients are more likely to listen to information that will help them make an informed decision about generic utilization. This can result in savings to the patient and the health care system.

References
1. Kravitz RL. Underuse of generic medications. Medical Care. 2007;45(2):107-108.
2. Haas JS, Phillips KA, Gerstenberger EP, Seger AC. Potential savings from substituting generic drugs for brand-name drugs: medical expenditure panel survey, 1997-2000. Ann Intern Med. 2005;142(11):891-897.
3. Shrank WH, Hoang T, Enner SL, et al. The implication of choice: prescribing generic or preferred pharmaceuticals improves medication adherence for chronic conditions. Arch Intern Med. 2006;166(3):332-337.
4. FDA ensures equivalence of generic drugs. [homepage on the Internet]. Rockville, MD: Food and Drug Administration, Center for Drug Evaluation and Research, c2007 [updated 2003 Jan 6; cited 2007 May 5]. Available at: www.fda.gov/cder/consumerinfo/generic_equivalence.htm.
5. Frequently asked questions on the patent term restoration program [home page on the Internet]. Rockville, MD: Food and Drug Administration, Center for Drug Evaluation and Research, c2007 [updated 2005 July 22; cited 2007 May 5]. Available at: www.fda.gov/cder/about/smallbiz/patent_term.htm.
6. Approved drug products with therapeutic equivalence evaluations. The Orange Book. 27th ed. [home page on the Internet]. Rockville, MD: Food and Drug Administration, Center for Drug Evaluation and Research, c2007 [updated 2007 Jan 22; cited 2007 May 5]. Available at: www.fda.gov/cder/orange/obannual.pdf.
7. Electronic Orange Book. Approved drug products with therapeutic equivalence evaluations [database on the Internet]. Rockville MD: Food and Drug Administration. Center for Drug Evaluation and Research, c2007 [updated 2007 March 31; cited 2007 May 5]. Available at: www.fda.gov/cder/ ob/default.htm.
8. Generic approvals, information on first time approved generics [home page on the Internet]. Rockville, MD: Food and Drug Administration, Center for Drug Evaluation and Research, c2007 [updated 2007 May; cited 2007 May 5]. Available at: www.fda.gov/cder/ogd/approvals/default.htm.
9. Combating counterfeit drugs: a report of the Food and Drug Administration [home page on the Internet]. Rockville, MD: Food and Drug Administration, c2004 [updated 2004 Feb 18; cited 2007 May 5]. Available at: www.fda.gov/oc/initiatives/counterfeit/report02_04.pdf. Page 5.

To comment on this article, contact editor@uspharmacist.com.