Impact of the Cost of Prescription Drugs on Clinical Outcomes

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Impact of the Cost of Prescription Drugs on Clinical Outcomes
Study Objective. To measure the impact that economic relief for prescription drugs to indigent patients with cardiovascular disease has on indicators of disease control.
Design. Prospective cohort study.
Setting. University inner-city outpatient clinic.
Patients. One hundred sixty-three indigent patients with heart disease who were uninsured or whose insurance plan did not provide prescription drug coverage and who had baseline data.
Intervention. Patients were assisted in obtaining prescription drugs, free of charge, in an attempt to improve adherence to their drug regimens.
Measurements and Main Results. The primary end point was to determine if cardiovascular outcome measures (i.e., international normalized ratio [INR], blood pressure, low-density lipoprotein [LDL] cholesterol, and hospitalizations) and drug adherence improved in all patients after 6 months of prescription assistance compared with a 6-month baseline period. In patients receiving warfarin, mean INR increased from 2.44 ± 0.64 at baseline to 2.61 ± 0.53 at 6 months (p<0.05). In patients with hypertension, mean blood pressure decreased from 138 ± 20/80 ± 11 mm Hg at baseline to 138 ± 19/78 ± 12 mm Hg at 6 months (p<0.05 for diastolic blood pressure only). The mean LDL level for patients on lipid-lowering drugs significantly decreased from 126 ± 39 mg/dl at baseline to 108 ± 38 mg/dl at 6 months (p<0.001). For each disease measure, the improved disease control seen at 6 months persisted throughout 24 months of follow-up. Hospitalizations for the entire cohort decreased from 85 at baseline to 49 at 6 months. Patient drug adherence improved from 48.5% at baseline to 72.7% at 6 months (p<0.001).
Conclusions. Drug adherence and clinical outcomes improved, and the number of hospitalizations declined when cardiovascular drugs were obtained for patients who could not afford to pay for them. Health care insurance plans that do not provide coverage for cardiovascular prescription drugs may be more costly secondary to poor disease control and increased hospitalizations.

Inadequate coverage for outpatient prescription drugs is a major problem for many Americans, particularly for impoverished elderly and disabled patients. Although elderly and disabled patients are eligible to receive Medicare benefits, they must obtain supplemental insurance to receive outpatient prescription drug coverage because Medicare does not cover outpatient drugs. Overall, greater than 40% of 1997 Medicare beneficiaries were without prescription drug coverage and had to pay out-of-pocket for their outpatient drugs.

The lack of drug coverage is problematic for these patients for many reasons. First, this patient population is more likely to have chronic diseases requiring long-term treatment with outpatient prescription drugs. Second, many elderly and disabled patients are indigent. In 1995, approximately 28% of elderly Medicare beneficiaries and 55% of disabled Medicare beneficiaries had annual incomes of $10,000 or less, near or below the federal poverty threshold. Finally, patients who do obtain supplemental prescription drug benefits are often faced with restricted benefits, high co-payments, or both.

Because many of these patients have annual incomes near the federal poverty threshold, drugs costs account for a substantial percentage of their monthly income. Consequently, impoverished patients are often faced with the choice of paying for basic needs like food or rent in lieu of paying for their drugs, often resulting in nonadherence with drug regimens. Poor adherence with prescription drug regimens often leads to poor health outcomes.

We noted alarming trends of poor adherence with cardiovascular drug regimens due to cost at our inner-city medical center that serves a large indigent population. Many patients who were nonadherent also tended to have poor control of their cardiovascular disease. To assist those indigent patients without prescription drug coverage, we developed a mechanism for patients with cardiovascular disease, who are followed up on an ambulatory basis, whereby they could obtain drugs, free of charge, and assistance in identifying potential pharmacy benefit options. We did this to determine if the clinical outcomes in these indigent patients with heart disease improved when the cost burden of prescription drugs was minimized by participation in this program.

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