Considerations for Generic Drug Use in the Elderly

According to the FDA, a genericdrug is "identical, or bioequivalentto a brand name drug indosage form, safety, strength, route ofadministration, quality, performancecharacteristics, and intended use."¹ Manypatients have expressed concern aboutthe true equivalence of generic andbrand name drug products. Seniorpatients, who as a group purchase thelargest number of medications per year,often put up the most resistance togeneric products. The elderly population(aged 65 and older) in 2030 is projectedto be twice as large as in 2000, growingfrom 35 million to 72 million, and to representnearly 20% of the total US population.² Because of the projected populationgrowth within this group of patients,cheaper generic drug products withequivalent efficacy are becoming moreimportant to provide optimal health care.

The Generic Pharmaceutical Association(GPhA) has published statistics thatdescribe the use of generic versus branddrug products. In 2005, brand pharmaceuticalsales reached $229.5 billion,whereas generic pharmaceutical salesamounted to $22.3 billion. Generic medicinesaccounted for 56% of all prescriptionsdispensed in the United States in2005, but only 13% of all dollars spent onprescription drugs.³ These and other datahave shifted the focus to using genericmedications as a way to achieve thesame clinical goals at reduced healthcare costs. On the heels of the newMedicare Part D benefit, other programsare being instituted at various levels topush for increased generic utilization.One such program is the $4 genericsoffered by Wal-Mart and other chains.Challenges exist for the implementationof these programs, including patient andsometimes prescriber resistance. Aspharmacists, we can provide key informationto our patients and health care partnersto ensure that informed decisionsare made, which will ideally result in lowerhealth care costs.

Perceptions of Generics

The perception of generics in the elderlyis varied; both sides of the argumentseem to have a similar number of supporters.Many of the elderly have negativeperceptions of generics because theyhave lived the majority of their lives identifyingwith only brand name productsand now find it difficult to accept the"newer" generic alternatives. Manypatients express the concern that onlytheir brand name products have any efficacy.On the other hand, the resistance togenerics by many patients is low due tothe necessity to stretch small incomes. Itbecomes a financial choice rather than apersonal one.

In June 2006, the Kaiser FamilyFoundation conducted a survey entitled"Seniors' Early Experiences with TheirNew Medicare Drug Plans." One of thequestions in this survey concerned thenumber of patients who have beenforced to switch from a brand-name drugto a generic drug because the brandname drug was not covered by their specificplan. Among the 37% who made thissubstitution, 55% of these patientsreported that the generic worked just aswell, 8% stated that it worked better, and20% reported that it did not work as wellas the brand name product. The remaining17% responded that they did notknow or refused to answer.⁴ From thesedata, it does appear that more seniorpatients are making the switch to genericsdue to their drug plans, and while theopinions are varied, a considerable numberagree that these agents are equallyeffective, compared with their previousproducts.

Cost Considerations

In 2004, the average price of a genericprescription drug was $28.87, while theaverage price of a brand name prescriptiondrug was $95.01, according to theNational Association of Chain DrugStores.⁵ This totals an average savings of$66.14 per prescription. For those whoreceive a number of prescriptions, thesesavings can be impressive. Thus, patientsare able to better afford food, utilities,and other necessities. This is an importantconsideration in the elderly andother low-income households.

According to GPhA, US generic pharmaceuticalsales increased by 10% between2003 and 2004.³ With patents onbrand name products now expiring,more and more generics are becomingavailable. Due to strong competition inthe drug market, generics are priced fairlylow in relation to their brand namecounterparts. The FDA notes that genericprescription products cost, on average,30% to 80% less than brand name drugs.⁶

The $4 generic plan of the chains isalso targeted to seniors with MedicarePart D who have fallen into the gap incoverage. Some seniors may be enrolledin a plan that contains the coverage gap.A coverage gap means that after apatient has spent a certain amount ofmoney for covered drugs (no more than$3850), that patient then has to pay allcosts for drugs while he or she is in thegap.⁷ The availability of $4 genericsmakes it possible for those that do endup in the gap to afford their medications.This program may even offer a solutionto the millions of uninsured Americans.

Benefits of Generic Utilization

The use of generics has increasedsince the start of the Medicare Part Dprescription drug program. The Centersfor Medicare & Medicaid Servicesreports that generic usage among allPart D plans was 60.1% during the first2 quarters of 2006.⁸ These data showthat more of the elderly populationenrolled in Part D plans are relying onthe use of generics as an alternative tobrand name products. It also suggeststhat they are becoming more educatedon the cost savings of generic drugs.The percentage of generic drug usageby patients enrolled in Part D plansshould increase throughout 2007, asmore of the beneficiaries become educatedon the effectiveness and financialprudence of their use.

The benefits of using generic drugs areclear. Although some groups still resistthis practice, the trend is beginning topick up speed. Of note to many seniorpatients, a recent study by the PharmaceuticalCare Management Associationfound that beneficiaries who use moregeneric drugs may be able to delay (by anaverage of 74 days) or even avoid the gapin coverage with Part D plans.⁸ This is yetanother potential benefit to be gained byusing generic drug products.

Final Thoughts

As health care costs continue to rise,the search for economical and effectivemedication therapies is becoming moreimportant. Barriers exist to the proposedshift in prescribing generic drug productsbut are balanced by the benefits thatthey offer to patients. Pharmacists andphysicians can play a key role in changingpatients' traditional perceptions byeducating patients about the definition ofgenerics, the cost savings of these products,and also their importance to thosepatients who have Medicare Part Dplans. By collaborating as physicians,pharmacists, and patients, we can optimizetreatment while cutting costs at thesame time.

Drs. Caldwell and Jaubert are bothambulatory care residents at theUniversity of Louisiana at Monroe(ULM) College of Pharmacy, Monroe,La. Dr. Zagar is an assistant professorat the ULM College of Pharmacy. Dr.Sherman is an associate professor atthe ULM College of Pharmacy.

References

1. What Are Generic Drugs? Office of Generic Drugs. FDA/Center for Drug Evaluation andResearch. 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 DrugStores. 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. AccessedOctober 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 forMedicare & 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.