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According to the FDA, a generic drug is "identical, or bioequivalent to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use."1 Many patients have expressed concern about the true equivalence of generic and brand name drug products. Senior patients, who as a group purchase the largest number of medications per year, often put up the most resistance to generic products. The elderly population (aged 65 and older) in 2030 is projected to be twice as large as in 2000, growing from 35 million to 72 million, and to represent nearly 20% of the total US population.2 Because of the projected population growth within this group of patients, cheaper generic drug products with equivalent efficacy are becoming more important to provide optimal health care.
The Generic Pharmaceutical Association (GPhA) has published statistics that describe the use of generic versus brand drug products. In 2005, brand pharmaceutical sales reached $229.5 billion, whereas generic pharmaceutical sales amounted to $22.3 billion. Generic medicines accounted for 56% of all prescriptions dispensed in the United States in 2005, but only 13% of all dollars spent on prescription drugs.3 These and other data have shifted the focus to using generic medications as a way to achieve the same clinical goals at reduced health care costs. On the heels of the new Medicare Part D benefit, other programs are being instituted at various levels to push for increased generic utilization. One such program is the $4 generics offered by Wal-Mart and other chains. Challenges exist for the implementation of these programs, including patient and sometimes prescriber resistance. As pharmacists, we can provide key information to our patients and health care partners to ensure that informed decisions are made, which will ideally result in lower health care costs.
Perceptions of Generics
The perception of generics in the elderly is varied; both sides of the argument seem to have a similar number of supporters. Many of the elderly have negative perceptions of generics because they have lived the majority of their lives identifying with only brand name products and now find it difficult to accept the "newer" generic alternatives. Many patients express the concern that only their brand name products have any efficacy. On the other hand, the resistance to generics by many patients is low due to the necessity to stretch small incomes. It becomes a financial choice rather than a personal one.
In June 2006, the Kaiser Family Foundation conducted a survey entitled "Seniors' Early Experiences with Their New Medicare Drug Plans." One of the questions in this survey concerned the number of patients who have been forced to switch from a brand-name drug to a generic drug because the brand name drug was not covered by their specific plan. Among the 37% who made this substitution, 55% of these patients reported that the generic worked just as well, 8% stated that it worked better, and 20% reported that it did not work as well as the brand name product. The remaining 17% responded that they did not know or refused to answer.4 From these data, it does appear that more senior patients are making the switch to generics due to their drug plans, and while the opinions are varied, a considerable number agree that these agents are equally effective, compared with their previous products.
In 2004, the average price of a generic prescription drug was $28.87, while the average price of a brand name prescription drug was $95.01, according to the National Association of Chain Drug Stores.5 This totals an average savings of $66.14 per prescription. For those who receive a number of prescriptions, these savings can be impressive. Thus, patients are able to better afford food, utilities, and other necessities. This is an important consideration in the elderly and other low-income households.
According to GPhA, US generic pharmaceutical sales increased by 10% between 2003 and 2004.3 With patents on brand name products now expiring, more and more generics are becoming available. Due to strong competition in the drug market, generics are priced fairly low in relation to their brand name counterparts. The FDA notes that generic prescription products cost, on average, 30% to 80% less than brand name drugs.6
The $4 generic plan of the chains is also targeted to seniors with Medicare Part D who have fallen into the gap in coverage. Some seniors may be enrolled in a plan that contains the coverage gap. A coverage gap means that after a patient has spent a certain amount of money for covered drugs (no more than $3850), that patient then has to pay all costs for drugs while he or she is in the gap.7 The availability of $4 generics makes it possible for those that do end up in the gap to afford their medications. This program may even offer a solution to the millions of uninsured Americans.
Benefits of Generic Utilization
The use of generics has increased since the start of the Medicare Part D prescription drug program. The Centers for Medicare & Medicaid Services reports that generic usage among all Part D plans was 60.1% during the first 2 quarters of 2006.8 These data show that more of the elderly population enrolled in Part D plans are relying on the use of generics as an alternative to brand name products. It also suggests that they are becoming more educated on the cost savings of generic drugs. The percentage of generic drug usage by patients enrolled in Part D plans should increase throughout 2007, as more of the beneficiaries become educated on the effectiveness and financial prudence of their use.
The benefits of using generic drugs are clear. Although some groups still resist this practice, the trend is beginning to pick up speed. Of note to many senior patients, a recent study by the Pharmaceutical Care Management Association found that beneficiaries who use more generic drugs may be able to delay (by an average of 74 days) or even avoid the gap in coverage with Part D plans.8 This is yet another potential benefit to be gained by using generic drug products.
As health care costs continue to rise, the search for economical and effective medication therapies is becoming more important. Barriers exist to the proposed shift in prescribing generic drug products but are balanced by the benefits that they offer to patients. Pharmacists and physicians can play a key role in changing patients' traditional perceptions by educating patients about the definition of generics, the cost savings of these products, and also their importance to those patients who have Medicare Part D plans. By collaborating as physicians, pharmacists, and patients, we can optimize treatment while cutting costs at the same time.
Drs. Caldwell and Jaubert are both ambulatory care residents at the University of Louisiana at Monroe (ULM) College of Pharmacy, Monroe, La. Dr. Zagar is an assistant professor at the ULM College of Pharmacy. Dr. Sherman is an associate professor at the ULM College of Pharmacy.
1. What Are Generic Drugs? Office of Generic Drugs. FDA/Center for Drug Evaluation and Research. Available at: www.fda.gov/cder/ogd/#Introduction. Accessed October 27, 2006.
2. He W, Sengupta N, Velkoff V, DeBarros K. Current Population Reports: Special Studies. 65+ in the United States: 2005. 2005:1.
3. Statistics. Generic Pharmaceutical Association Web site. Available at: www.gphaonline.org/Content/NavigationMenu/AboutGenerics/Statistics/default.htm. Accessed October 17, 2006.
4. Seniors' Early Experiences with Their New Medicare Drug Plans?June 2006. July 27, 2006. Henry J. Kaiser Family Foundation. Available at: www.kff.org/kaiserpolls/pomr072706pkg.cfm. Accessed October 18, 2006.
5. Facts and Resources: Industry Facts-at-a-Glance. National Association of Chain Drug Stores. Available at: www.nacds.org/wmspage.cfm?parm1=507. Accessed October 19, 2006.
6. More Cost-Saving Generic Drugs Available. Medical News Today. September 10, 2006. Available at: www.medicalnewstoday.com/medicalnews.php?newsid=51526. Accessed October 17, 2006.
7. Medicare & You 2007. Centers for Medicare & Medicaid Services. Sept 2006:45.
8. McClellan M. Generic Drugs and the Medicare Prescription Drug Benefit. Centers for Medicare & Medicaid Services, US Department of Health and Human Services. September 21, 2006. Available at: www.cms.hhs.gov/apps/media/press/testimony.asp?Counter=1971. Accessed October 18, 2006.