Costs to physician offices of providing medications to medically indigent patients via pharmaceutical manufacturer prescription assistance programs.

BACKGROUND: Prescription assistance programs (PAPs) are offered by pharmaceutical manufacturers to provide medications at no out-of-pocket cost to various categories of medically indigent patients. some PAPs require only 1 application whereas others require as many as 4 applications per year per drug per patient, depending on the manufacturer's requirements. OBJECTIVE: to measure the costs incurred by a medical clinic that provides chronic prescription medications via PAPs. METHODS: this project was conducted in a free-standing, inner-city, Midwestern health clinic on the PAP application process for 1 representative drug for 32 pharmaceutical manufacturers that offered PAPs for drugs taken on a long-term basis for chronic conditions. time and motion studies were conducted using a medical assistant with the greatest amount of PAP experience. Assessment of time-to-access and time-to-complete forms was performed outside of normal clinic business hours to avoid interruptions. Personnel time costs also included receipt and delivery of drug to the patient (drug distribution time), which were assessed during normal business hours for actual medications received for 10 patients and included the time required to notify the patient of the arrival of the drug and to dispense the medication to the patient. supply costs for this PAP service included printing and copying costs. submission costs associated with mailing or faxing the documents were determined and calculated using the price of materials only. total application cost was calculated by adding the personnel time cost, supply cost, and submission cost. Annual PAP time was the time spent completing PAPs for 1 medication for 1 patient for 1 year. the time and resources required and the associated costs were aggregated separately for the pharmaceutical manufacturers that required 1, 2, or 4 applications per drug per patient per year. RESULTS: The total average application cost for all 32 companies was $25.18 [SD, $17.23]. Personnel time costs accounted for half or more of the total application cost, regardless of submission mode. the time to complete the form for any PAP was 0:06:20 [SD, 0:05:03] minutes with a range from 0:03:01 to 0:34:22 minutes. Printing costs were $0.20 [SD, $0.10] and copying costs were $1.96 [SD, $0.21]. Average supply costs were $2.16 [SD, $0.23]. Faxing versus mailing PAPs saved $17.90 per application. total annual clinic cost to assist patients in obtaining drugs through a PAP ranged from $10.42 per patient for a drug that requires 1 application per year (15 manufacturers, 47%) to $46.30 per patient for a drug in a PAP that requires 4 (re)applications per year (12 manufacturers, 38%). PAPs transmitted by mail required 0:49:18 [SD, 0:32:18] minutes, approximately 0:25:00 [SD, 0:21:00] minutes more than by fax (0:24:13 [SD, 0:11:32] minutes) or by Internet submissions (0:28:20 minutes), respectively. CONCLUSION: The number of PAP applications required per patient per medication annually has the greatest impact on clinic time and financial resources. Application submission method also influences the overall costs of providing this service in the clinical setting. Medical clinics should base their decision to provide a PAP application service to patients on the time and costs associated over the course of 1 year and not on the 1-time application cost.

A prospective, randomized, multicentered controlled trial to compare the annual glycemic and quality outcomes of patients with diabetes mellitus monitored with weekly fructosamine testing versus usual care.

Fructosamine is an indicator of overall glycemic control for a 10-14-day time frame, medium-term marker, versus the 90-day average indicated by the hemoglobin A1c (A1C) test. The utility of the home fructosamine test for management of persons with diabetes remains undefined. The primary objectives of this study were (1) to compare the annual A1C results of subjects monitoring weekly fructosamine with those receiving usual care, (2) to identify the number of subjects achieving goal A1C, and (3) to determine if the addition of a weekly fructosamine test changed a subject's quality of life. This was a prospective, randomized, multicenter, controlled trial. Subjects were recruited from three sites and randomly assigned to collect weekly fructosamine in addition to daily glucose (Group 1) or to receive usual care of daily glucose collection (Group 2). Follow-up occurred at 3-month intervals for a year. Baseline and quarterly A1C tests were collected. Quality of life assessment was conducted at baseline and at the final study visit. Seventy-two subjects were randomized. Demographic and whole blood assessments were similar between the two groups at baseline. The mean percent change of A1C from baseline to final study visit in Group 1 (-0.52 +/- 1.5) was not statistically different than Group 2 (-0.86 +/- 1.4) (P = 0.320). Seven subjects in each group achieved A1C of less than 7% (P = 0.532). No change in quality of life between or within the two groups was observed (P > 0.05) for each area of concern. Blood glucose monitoring alone was shown to be superior to the additional fructosamine testing after 1 year of treatment; however, weekly fructosamine testing demonstrated a decrease in A1C earlier and more consistently throughout the study. Despite glycemic improvement, the number of subjects attaining American Diabetes Association-defined A1C goals was not different between the treatment groups. Quality of life did not change with the addition of a weekly fructosamine test.

Identifying at-risk patients through community pharmacy-based hypertension and stroke prevention screening projects.

OBJECTIVE: To demonstrate whether a community pharmacist can be successful in identifying and referring patients with elevated blood pressure and/or increased risk of stroke. SETTING: An independent community pharmacy and well-elderly housing facility in rural Iowa. PRACTICE DESCRIPTION: The pharmacy had dedicated space for patient care activities, had a community pharmacy practice resident, and served as a clerkship site for a local school of pharmacy. One of three well-elderly housing facilities in the same community was used as a screening site for the stroke prevention program. PRACTICE INNOVATION: All adults entering the pharmacy duringthe time the blood pressure project was underway were offered a free blood pressure screening. If readings were elevated, patients were referred to their primary care provider. For stroke prevention, a screening using the American Heart Association stroke risk assessment protocol was held at the pharmacy and the well-elderly housing facility. MAIN OUTCOME MEASURES: Blood pressure categories and stroke risk (normal, mild, moderate, and high) categories obtained during the screening. RESULTS: A total of 351 patients werescreened for hypertension. Of these, 216 (62%) had readings greater than 140/90 mm Hg. Of the 121 patients referred to their physician, 43 (36%) had a regimen change. A total of 50 patients were screened for stroke risk. Results of the risk assessments for patients screened were normal, 4%; mild, 26%; moderate, 32%; high, 38%. CONCLUSION: These projects demonstrated that, through ongoing screening programs, community pharmacists are in an ideal position to screen patients at risk for cardiovascular and cerebrovascular disease and refer patients to their physicians for further evaluation.

Identifying at-risk patients through community pharmacy-based hypertension and stroke prevention screening projects.

OBJECTIVE To demonstrate whether a community pharmacist can be successful in identifying and referring patients with elevated blood pressure and/or increased risk of stroke. SETTING An independent community pharmacy and well-elderly housing facility in rural Iowa. PRACTICE DESCRIPTION The pharmacy had dedicated space for patient care activities, had a community pharmacy practice resident, and served as a clerkship site for a local school of pharmacy. One of three well-elderly housing facilities in the same community was used as a screening site for the stroke prevention program. PRACTICE INNOVATION All adults entering the pharmacy during the time the blood pressure project was underway were offered a free blood pressure screening. If readings were elevated, patients were referred to their primary care provider. For stroke prevention, a screening using the American Heart Association stroke risk assessment protocol was held at the pharmacy and the well-elderly housing facility. MAIN OUTCOME MEASURES Blood pressure categories and stroke risk (normal, mild, moderate, and high) categories obtained during the screening. RESULTS A total of 351 patients were screened for hypertension. Of these, 216(62%) had readings greater than 140/90 mm Hg. Of the 121 patients referred to their physician, 43 (36%) had a regimen change. A total of 50 patients were screened for stroke risk. Results of the risk assessments for patients screened were normal, 4%; mild, 26%; moderate, 32%; high, 38%. CONCLUSION These projects demonstrated that, through ongoing screening programs, community pharmacists are in an ideal position to screen patients at risk for cardiovascular and cerebrovascular disease and refer patients to their physicians for further evaluation.

A prospective, randomized, multicentered controlled trial to compare the annual outcomes of patients with diabetes mellitus monitored with weekly fructosamine testing versus usual care: a 3-month interim analysis.

The recent introduction of a home monitoring system that measures whole blood glucose and whole blood fructosamine values by fingerstick blood drop adds a previously unavailable estimate of overall glycemic control via the fructosamine component. Fructosamine serves as an indicator of overall glycemic control for a 10-14-day time frame versus the 90-day average indicated by the hemoglobin A1c (A1C) test. The utilization of the fructosamine test for management of patients with diabetes mellitus remains unclear. The primary objectives of this study are to compare the quarterly A1C results of subjects monitoring weekly fructosamine with those receiving usual care, to identify the number of patients achieving goal A1C, and to determine if the addition of a weekly fructosamine test changes a patient's quality of life. Secondary objectives include determining if specific patient demographics predict success or difficulty in achieving improved A1C. This is a prospective, randomized, multicenter controlled trial. Patients were randomly assigned to collect weekly fructosamine in addition to daily glucose (Group 1) or usual care of daily glucose (Group 2) and had study visits every 3 months. Baseline and quarterly A1C tests were collected. Quality of life assessment was conducted at baseline and will be evaluated at the final study visit. Sixty subjects have been randomized into the study since May 2001 with enrollment ongoing. Baseline demographics, glucose, fructosamine, and A1C were similar between the two groups. The 3-month interim analysis demonstrated no statistically significant difference in fructosamine (p = 0.265) between Group 1 (293.00 +/- 111.22 micromol/L) and Group 2 (336.69 +/- 111.12 micromol/L), respectively. No statistical difference at 3 months (p = 0.676) in A1C values for Group 1 (7.921 +/- 1.848% vs. 7.755 +/- 1.408%) and Group 2 (7.800 +/- 1.505% vs. 7.971 +/- 1.797%) were noted when compared with baseline. The interim data suggest that the fructosamine group has had a net decrease in A1C over the 3-month time frame, whereas the control group has had a net increase in A1C values. Ongoing follow-up will determine if this trend continues and becomes statistically and clinically significant.