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Mr. Lamb is a freelance pharmacy writer living in Virginia Beach, Virginia, and president of Thorough Cursor Inc.

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Of all prescriptions dispensed in the United States in 2006, 63% were filled with generic drugs. In retail pharmacy settings, where patients have the most choice over what they receive, the ratio of generics to brands was 57% to 43%.^1,2

These statistics are indicative of a trend illustrated in Table 1^3-6 for pharmacists, prescribers, and patients to opt for generics. With about 75% of reference drugs listed in the Orange Book having at least 1 generic equivalent approved by the FDA, however, considerable room for growth still exists in the generic drug market.

A key to realizing this growth is in changing some patients' negative views of the efficacy and safety of generics. Pharmacists have a role to play in this, with the payoff being increased adherence to medication therapy.

Myths of Inferiority Persist

In a 2006 Wall Street Journal Online/Harris Interactive poll, 68% of more than 2200 US adults who regularly purchase prescription medication said that they would be at least somewhat likely to choose generics over brand name drug products when given a chance.⁷ An earlier survey by the same organization indicated that their number-1 reason for preferring a generic was that it "was less expensive" than its branded counterpart.

Table 1

Growth in Generic Drug Prescription Volume in the United States, 2003-2006 Year Percent of Total Volume 2003 43 2004 47 2005 60 2006 63 Source: references 3-6.

These data, along with opinions expressed in recent surveys of German and Norwegian patients, confirm that patients worldwide understand at least 1 thing about generic drugs very well: they are inexpensive.^8,9

This perception of "cheapness," however, can unfortunately extend beyond price to quality. As the authors of the Norwegian study noted, "Generic substitution, for a number of patients, is not considered an equal alternative to branded drugs."⁹ More than 1 in 5 of the individuals surveyed had reported "an overall negative experience" with a substituted generic. Such negativity has persisted for decades. A report in the June 1980 issue of Journal of Consumer Affairs notes that patients, pharmacists, and physicians in Alabama expressed concerns about generic drugs' "safety, liability, and manufacturer performance."¹⁰

The FDA cites the following as the foremost "myths" patients continue to believe about generic drugs:

• They take longer to act in the body
• They are not as potent as brand name drugs
• They are not as safe as brand name drugs
• They are often made in substandard facilities, while brand name drugs are made in modern manufacturing facilities
• They are likely to cause more side effects¹¹

The agency offers the checklist in Table 2 as a tool pharmacists can use to dispel these myths. Other freely available patient education materials can be found at www.fda.gov/cder/consumerinfo/generic_all_resources.htm.

Patients' questions regarding generic drugs may not be limited to just quality, of course. Dosages of the same drug from different manufacturers will have different colors, shapes, and markings, and may sometimes differ in taste. Pharmacists must be ready to confirm that the generic product each patient receives is equivalent to what the patient has received previously and to discuss how characteristics such as tablet shape will not affect how a drug works. At the same time, all patient reports of problems with new products must be taken seriously.

Although the influence that health care providers have over patients' choice of generics has been found to be limited, this influence is by no means insignificant. Twenty-eight percent of US patients who chose an unbranded product said they did so primarily because their pharmacist or physician recommended doing so or had assured them that a generic would work as well as a brand.¹² Also, while acknowledging that "the patient view that inexpensive drugs [are] inferior may be difficult to rectify in the short term," authors of the report on German patients' views noted that health care providers "are in an ideal position to inform their patients adequately about the equivalence of brand name and generic drugs."⁸

Lower Costs, Better Drug Taking

Helping patients use more generics is important because all the available evidence shows that individuals are more adherent to drug therapy when they pay less for their medications.

Researchers at RAND Corporation recently conducted a meta-analysis of published studies of how insurance plan rules regarding copayments and coverage limitations affected patients' pharmacy use, drug spending, and health outcomes. Writing in the July 4, 2007, issue of the Journal of the American Medical Association, the researchers reported that findings from 132 studies showed that "increased cost sharing is associated with lower rates of drug treatment, worse adherence among existing users, and more frequent discontinuation of therapy. For each 10% increase in cost sharing, prescription drug spending decreases by 2% to 6%, depending on class of drug and condition of the patient."¹³ The researchers also determined that lower drug spending was positively associated with higher spending on other medical services such as hospitalizations, especially among patients with congestive heart failure, high cholesterol, diabetes, and schizophrenia.

Table 2

FDA Requirements for Brand Name and Generic Drugs   Brand Name Generic For reformulations of a brand name drug or generic versions of a drug, FDA reviews data showing the drug is bioequivalent to the one used in the original safety and efficacy testing. FDA evaluates the manufacturer's adherence to good manufacturing practices before the drug is marketed. FDA reviews the active and inactive ingredients used in the formulation before the drug is marketed. FDA reviews the actual drug product. FDA reviews the drug's labeling.     Manufacturer must seek FDA approval before making major manufacturing changes or reformulating the drug. Manufacturer must report adverse reactions and serious adverse health effects to the FDA. FDA periodically inspects manufacturing plants. FDA monitors drug quality after approval. Source: reference 11.

References

1. Generic Pharmaceutical Association. Statistics. GPhA Web site. www.gphaonline.org/Content/~default.htm. Accessed September 2, 2007.
2. New IMS Health Report Finds Generic Drugs Used More in Part D Than Commercial Market. Pharmaceutical Care Management Association press release. August 2, 2007.
3. IMS Reports 11.5 Percent Dollar Growth in '03 U.S. Prescription Sales. IMS Health press release. February 17, 2004.
4. IMS Reports 8.3 percent Dollar Growth in 2004 U.S. Prescription Sales. IMS Health press release. February 14, 2005.
5. Van Arnum P. Opportunities Abound for Generic Drugs. PharmTech.com. www.pharmtech.com/pharmtech/~id=434545. Accessed August 30, 2007.
6. IMS Reports U.S. Prescription Sales Jump 8.3 Percent in 2006, to $274.9 Billion. IMS Health press release. March 8, 2007.
7. Low-Priced Generics Likely to Attract Large Share of Prescription Drug Sales. Harris Interactive press release. October 19, 2006.
8. Hughes B. Almost All Americans Believe that the Financial Burden of Drug Costs for Chronically Ill Patients Is Greater in U.S. than in Canada. Wall Street Journal Online/Harris Interactive Web site. www.harrisinteractive.com/~NewsID=836. Accessed August 31, 2007.
9. Himmel W, Simmenroth-Nayda A, Nieblung W, et al. What do primary care patients think about generic drugs? Int J Clin Pharmacol Ther. 2005;43:472-479.
10. Kjoenniksen I, Lindbaek M, Granas A. Patients' attitudes towards and experiences of generic drug substitution in Norway. Pharm World Sci. 2006:28:284-289.
11. Mason JB, Bearden WO. Generic Drugs: Consumer, Pharmacist and Physician Perceptions of the Issues. J Consum Aff. 1980;14:193-206.
12. FDA Ensures Equivalence of Generic Drugs. FDA Web site. www.fda.gov/cder/consumerinfo/generic_equivalence.htm. Accessed August 30, 2007.
13. Goldman Dana P, Joyce GF, Zheng Y. Associations with Medication and Medical Utilization and Spending and Health. J Am Med Assoc. 2007;298:61-69.