Generic Medications

Senior adults, while the leading consumers of prescription and OTC medications, often present with confusion, frustration, and economic difficulties relating to the procurement of their medication. The use of generic drugs has been a source of cost savings for both the patient and the provider. However, it is also a source of potentially inappropriate medication selection for seniors when a newer, brand pharmaceutical agent that is more pharmacokinetic appropriate for a geriatric patient is passed over in favor of a low-cost generic. Frequently, a switch from brand to generic may be across therapeutic classes and not within the same class. In fact, suboptimal medication selection is fairly common and has been associated with worse patient-reported health-related quality of life. ¹ Some brand pharmaceutical products facilitate the use of two or more active ingredients through a combination product dosage. Others are long-acting or extended-release dosage forms that provide 24-hour coverage, thereby reducing the number of administrations required per day. These conveniences come at a price. In fact, some are so prohibitive in cost that they actually hinder the effort to improve compliance, as seniors often split tablets and take only half doses, skip doses, or avoid using their medication because of its cost.²

One population-based survey of Americans age 70 and older aimed to determine which elderly patients are at the highest risk of restricting their medications because of cost and how prescription coverage modifies this risk.² The study identified risk factors for medication restriction in subjects who lacked prescription coverage and found that the strongest independent predictors of medication restriction were minority ethnicity, annual income less than $10,000, and out-of-pocket prescription drug costs greater than $100 per month.² Researchers concluded that medication restriction is common in seniors who lack prescription coverage. Seniors in the same high-risk groups who have prescription coverage are much less likely to restrict their medication usage. ²

Confusion, mistakes, and potentially harmful circumstances abound when a combination product is prescribed for a senior patient who is not aware it contains the same ingredient as the OTC product just purchased in the supermarket. Pharmacists can attest to the occurrence of dangerous duplicative therapy as a result of seniors being unfamiliar with the generic names of the active ingredients in the drugs that they receive. By educating seniors on both the brand and generic names of their medications (in verbal and written form) and alerting them to the potential dangers involved in confusing these names, therapy duplication may be avoided. This also concerns traveling seniors, as most drugs abroad are sold under different trade names yet contain the same active ingredients as a commonly used medication in the United States. Ideally, for safety, each medication should be labeled with the brand and generic names.

Generics and Provider Cost-Reduction Strategies
Many employer health plans and government payer plans have adopted incentive-based formularies to control prescription-drug costs.³ Elderly Medicare beneficiaries can lower out-of-pocket spending and increase their options for low-cost Medicare Part D plans by using generic drugs.⁴ However, many seniors become confused over the difference between a generic and a brand and whether they should accept a generic when it is substituted for a brand. Pharmacists can intervene by guiding seniors with their choices based on clinical, administrative, and economic circumstances. Assistance by a pharmacist with expertise in medication selection is a valuable service to seniors when choosing an appropriate pharmacy benefit plan, including a Medicare Part D plan, based on their current needs and potential issues related to comorbidities.

The importance of this concept is illustrated by the fact that various changes in the administration of a formulary may have dramatically different effects on utilization and spending and may lead plan enrollees to discontinue therapy in some cases.³ Changes in copayments can substantially alter out-of-pocket spending by plan members, the continuation of medication use, and the quality of care.³

A large proportion of patients in the U.S. are enrolled in three-tier pharmacy benefit plans. Tiered prescription copayments have been associated with a significant shift from nonpreferred to preferred brand medications.⁵ This concept constitutes a financial incentive, to help purchasers that provide open-access drug benefits, by guiding the use of medications toward lower-cost brands. ⁵ It has been suggested that further investigation is required to determine the clinical effects of changes in medication use brought about by differential copayments.⁵

Older patients of general practitioners and, to a greater extent, cardiologists, are often prescribed brand name drugs when generic equivalents are available (e.g., beta-blockers, thiazides, calcium channel blockers [CCBs], angiotensin-converting enzyme [ACE] inhibitors, and alpha-1–adrenergic receptor antagonists).⁴ Researchers suggest that promoting generic prescribing among specialists and generalists may increase opportunities to reduce spending on prescription drugs.⁴ One study involving six classes of chronic medications (coenzyme A reductase inhibitors, CCBs, oral contraceptives, orally inhaled corticosteroids, angiotensin receptor blockers, and ACE inhibitors) found that in three-tier pharmacy benefit plans, prescribing generic or preferred medications within a therapeutic class was associated with improvements in adherence to therapy.⁶

Another analysis reviewed data from a Medicare Beneficiary Survey of noninstitutionalized patients over age 65 with hypertension who used one or more multisource cardiovascular drugs.⁷ Seniors with low incomes or no prescription coverage were only somewhat more likely to use generic cardiovascular drugs than more affluent and insured seniors.⁷ The findings suggested that physicians and policy makers may be missing opportunities to decrease costs for Medicare and its economically disadvantaged beneficiaries.⁷

Generic-Only Pharmacy Benefits
While some believe generic-only drug benefits are a means of providing some coverage, as opposed to no coverage, one group examined how switching from brand name to generic-only drug coverage affected seniors' medication use and financial burden.⁸ Study participants belonged to a Medicare managed care plan and were changed from a capped brand name benefits plan one year to a generic-only benefits plan the next.⁸ Rates of switching medications (e.g., from brand name drugs to generic equivalents, to nonequivalent generics, and to different brand name drugs) increased after discontinuation of brand name coverage.⁸ Interestingly, changing from brand name benefits to generic-only medication coverage caused many participants to switch to less expensive medications and also decreased medication use and increased financial burden.⁸ The researchers suggested that insurers need to assist patients in adjusting to a discontinuation of brand name coverage.⁸

In addition, generic-only plans may present more of a burden to patients with morbidities requiring therapy where generic choices are more limited.⁹ One study found that elderly patients with chronic obstructive pulmonary disease who participated with a generic-only pharmacy benefit plan were more likely to use several strategies to reduce their out-of-pocket costs (e.g., discuss out-of-pocket costs with their physician, purchase medications from another country, reduce spending on food and clothing) compared with similar patients with single-tier or two-tier copayment pharmacy benefits.⁹ Furthermore, patients reported taking less than the prescribed amount of a regular medication and completely stopped taking one or more of their regular medications.⁹

Educating the Patient
Assessing the patient's and/or caregiver's level of health literacy is critical to the patient education process, thereby enabling the pharmacist to tailor the written and verbal communications to the appropriate level of comprehension. Patients should be encouraged to discuss their pharmacy benefit plans with their primary care physician at the point of prescribing, consult their physician and pharmacist about the appropriateness of brand or generic medications for their particular conditions, and, when options are available, obtain advice on which is the most appropriate employer pharmacy benefit plan or Medicare Part D plan based on their particular medication utilization. Teaching seniors to ask the right questions about generic medications is crucial.

References
1. Chin MH, Wang LC, et al. Appropriateness of medication selection for older persons in an urban academic emergency department. Acad Emerg Med. 1999;6:1232-1242.
2. Steinman MA, Sands LP, Covinsky KE. Self-restriction of medications due to cost in seniors without prescription coverage. J Gen Intern Med. 2001;16:793-799.
3. Huskamp HA, Deverka PA, Epstein AM, et al. The effect of incentive-based formularies on prescription-drug utilization and spending. N Engl J Med . 2003;349:2224-2232.
4. Federman AD, Halm EA, Siu AL. Use of generic cardiovascular medications by elderly Medicare beneficiaries receiving generalist or cardiologist care. Med Care. 2007;45:109-115.
5. Rector TS, Finch MD, Danzon PM, et al. Effect of tiered prescription copayments on the use of preferred brand medications. Med Care. 2003;41:398-406.
6. Shrank WH, Hoang T, Ettner SL, et al. The implications of choice: prescribing generic or preferred pharmaceuticals improves medication adherence for chronic conditions. Arch Intern Med. 2006;166:332-337.
7. Federman AD, Halm EA, Zhu C, et al. Association of income and prescription drug coverage with generic medication use among older adults with hypertension. Am J Manag Care. 2006;12:611-618.
8. Tseng CW, Brook RH, Keeler E, et al. Effect of generic-only drug benefits on seniors' medication use and financial burden. Am J Manag Care. 2006;12:525-532.
9. Spence MM, Hui R, Chan J. Cost reduction strategies used by elderly patients with chronic obstructive pulmonary disease to cope with a generic-only pharmacy benefit. J Manag Care Pharm. 2006;12:377-382.

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