Use of point-of-service health status assessments by community pharmacists to identify and resolve drug-related problems in patients with musculoskeletal disorders.

STUDY OBJECTIVE: To determine whether community pharmacists can use point-of-service health status assessments to identify and resolve drug-related problems (DRPs) in ambulatory patients with selected musculoskeletal (MSK) disorders. DESIGN: Twelve-month, prospective, multicenter demonstration project. SETTING: Twelve independent community pharmacies in eastern Iowa. PATIENTS: Ambulatory patients with self-reported diagnosis of osteoarthritis, rheumatoid arthritis, or low back pain. MEASUREMENTS: During quarterly pharmacy visits for 1 year, patients used touch-screen computers to report their health status. Patients answered questions on the Short Form-36 (SF-36) general health survey, as well as questions assessing limitations associated with their MSK condition. Pharmacists used this data in interviewing patients to assess for DRPs. MAIN RESULTS: The study enrolled 461 patients, of whom 388 returned for the 12-month visit. During this 1-year period, community pharmacists identified 926 cumulative DRPs. Patients with no DRPs had significantly higher physical component summary scores on the SF-36 (p<0.05) than patients with more than one DRP at baseline (36.2 vs 31.6), 6 months (39.2 vs 33.3), and 12 months (40.1 vs 35.4). At 12 months, actions performed by pharmacists led to resolution or improvement of 70.7% of DRPs. CONCLUSION: Drug-related problems are numerous in community-dwelling patients with MSK disorders and correspond to decreased physical health status. Community pharmacists can use patient-reported measures of health status to identify DRPs and initiate processes to resolve them.

Functional status and health-related quality of life of elderly osteoarthritic patients treated with celecoxib.

BACKGROUND: This study evaluates the impact of celecoxib on functional status, health-related quality of life (HRQOL), and safety of elderly patients (> or =70 years) with osteoarthritis (OA) of the knee and/or hip. METHODS: Data were pooled from three prospective, randomized, multicenter, double-blind, parallel group trials, each having a 12-week treatment period. Multicenter studies were conducted in the United States and Canada. Data for patients diagnosed with active OA of the knee and/or hip in a flare state who were 70 years of age and older were included in the comparison of therapeutic doses of celecoxib or naproxen versus placebo (N = 768). Elderly patients from each of the three trials who were randomly assigned to groups treated with a placebo. 200 mg/day of celecoxib, 400 mg/ day of celecoxib, or 1000 mg/day of naproxen were included in this analysis. The Western Ontario and McMaster Universities Osteoarthritis Index was used to measure functional status. The Short Form-36 was used as a general measure of HRQOL. Safety was assessed according to the incidence and type of adverse reactions as reported by the patients and the rate of withdrawal due to adverse events. RESULTS: At the end of the treatment period, patients in the celecoxib groups had significant improvement in both functional status and HRQOL in comparison with the placebo group. The effects of total daily doses of 200 mg of celecoxib, 400 mg of celecoxib, and 1000 mg of naproxen on functioning and HRQOL were not found to be significantly different from each other. The incidence of serious adverse events and withdrawal from the studies due to adverse events were similar in the celecoxib groups as they were in the placebo group. Overall, the naproxen group reported a significantly higher incidence of gastrointestinal adverse events than did the placebo and the 200-mg-daily celecoxib groups. CONCLUSIONS: This study showed that celecoxib and naproxen significantly improved functional status and HRQOL in elderly patients compared with those treated with a placebo. Celecoxib-treated patients were also found to experience safety and tolerability similar to that of the placebo-treated patients.

Determining minimally important changes in generic and disease-specific health-related quality of life questionnaires in clinical trials of rheumatoid arthritis.

OBJECTIVE: To define clinically meaningful changes in 2 widely used health-related quality of life (HQL) instruments in studies of patients with rheumatoid arthritis (RA). METHODS: Patients with RA (n = 693) who were enrolled in 2 double-blind, placebo-controlled clinical trials completed the Short Form 36 (SF-36) modified health survey and the Health Assessment Questionnaire (HAQ) disability index at baseline and 6-week followup assessments. Data on 5 RA severity measures were also collected at baseline and at 6 weeks (patient and physician global assessments, joint swelling and tenderness counts, and global pain assessment). Comparison of changes in the SF-36 scales and HAQ scores was made between groups of patients known to differ in the level of change on each RA severity measure. RESULTS: With few exceptions, changes in the SF-36 and HAQ scores were different between patients who differed in the level of change on each RA severity measure. Changes in the SF-36 and HAQ scores were more strongly related to changes in the patient and physician global assessments and patient pain assessment than to changes in the joint swelling and tenderness counts. CONCLUSION: Based on these results, minimally important changes in the SF-36 scales and HAQ disability scores were determined, which will be useful in interpreting HQL results in clinical trials.

Evaluation of health-related quality of life of rheumatoid arthritis patients treated with celecoxib.

OBJECTIVE: To study the functional status and health-related quality of life (HRQOL) of patients with rheumatoid arthritis (RA) after treatment with celecoxib, compared with placebo and naproxen. METHODS: This was a prospective, randomized, double-blind, parallel group trial conducted at 79 sites in the United States and Canada over a 12-week treatment period. Patients were randomly assigned to 5 groups: placebo, 100 mg twice a day of celecoxib, 200 mg twice a day of celecoxib, 400 mg twice a day of celecoxib, and 500 mg twice a day of naproxen. The Health Assessment Questionnaire (HAQ) disability index was used to measure functional status. The Medical Outcomes Study Short Form 36 (SF-36) was used to measure general HRQOL. RESULTS: Enrollees were 1,149 patients with diagnosed and active RA. At the end of the treatment period, patients in the 4 active treatment groups had significant improvement in both functional status and overall HRQOL in comparison with the placebo group. Patients in the twice-daily 100 mg celecoxib group significantly differed from placebo at weeks 2 and 6 on HAQ scores and at week 12 on 5 domains and both summary scores of the SF-36. Patients treated with twice-daily 200 mg celecoxib had significantly better functional status than placebo at all times of testing with the HAQ, and also had significantly better function than those treated with naproxen after 2 and 12 weeks of treatment. Patients in the twice-daily 200 mg and 400 mg celecoxib groups showed similar improvement in HRQOL as determined by the 8 domain scores and 2 summary scores of the SF-36. CONCLUSION: Celecoxib was better than placebo and comparable with naproxen in improving functional status and overall HRQOL among RA patients.

Evaluation of the functional status aspects of health-related quality of life of patients with osteoarthritis treated with celecoxib.

STUDY OBJECTIVE: To evaluate the functional status of patients with signs and symptoms of osteoarthritis of the knee after treatment with celecoxib compared with placebo and naproxen. DESIGN: Prospective, randomized, double-blind, parallel-group, 12-week trial. SETTING: Multicenter study conducted at 71 sites in the United States and Canada. PATIENTS: One thousand four patients with active osteoarthritis of the knee in a flare state. INTERVENTIONS: Patients were assigned randomly to one of five treatment groups: placebo; celecoxib 50 mg twice/day, 100 mg twice/day, and 200 mg twice/day; and naproxen 500 mg twice/day. MEASUREMENTS AND MAIN RESULTS: The Western Ontario and McMaster Universities Osteoarthritis Index was used to measure functional status. At the end of the treatment period, patients in the four active treatment groups had significantly better functional status than those receiving placebo. Patients treated with celecoxib 100 mg twice/day had significantly better improvements in pain scores than those treated with placebo and naproxen. CONCLUSION: Celecoxib was better than placebo and comparable with naproxen in improving aspects of functional status in patients with osteoarthritis.

Development and validation of the Migraine-Specific Quality of Life Questionnaire.

This paper describes the development and validation of a migraine-specific quality-of-life instrument that is capable of measuring health-related quality-of-life impairments attributed to migraine. Item selection, item reduction, and pretesting and finalization of items during the instrument development phase resulted in a total of 16 questions which were incorporated into the Migraine-Specific Quality of Life Questionnaire (Version 1:0) (1992 Glaxo Wellcome Inc). Three meaningful dimensions were hypothesized: Role Function-Restrictive, Role Function-Preventive, and Emotional Function. In the instrument validation phase, the Migraine-Specific Quality of Life Questionnaire was mailed to 1109 migraine patients, providing a response rate of 45% (n = 458). Initial psychometric evaluation of the questionnaire indicated that it possessed adequate reliability with Cronbach's alpha for the three dimensions ranging between 0.70 to 0.85. The Migraine-Specific Quality of Life Questionnaire possessed adequate content and criterion validity. All but three items satisfied the test of construct validity. In conclusion, the Migraine-Specific Quality of Life Questionnaire has acceptable psychometric properties and can be used to estimate the effect of migraine and its treatment on the patient's health-related quality of life.

Patient preferences for migraine therapy: subcutaneous sumatriptan compared with other medications.

BACKGROUND: This study was conducted to identify, from the patient's perspective, the important attributes of a migraine therapy and to assess the performance of subcutaneous sumatriptan, aspirin, acetaminophen, and patients' usual therapies with respect to these attributes. METHODS: Six hundred forty-eight patients who had received subcutaneous sumatriptan (one or two doses, 6 mg per dose, for a single migraine episode) or placebo in a clinical trial completed questionnaires. RESULTS: According to patients, the four most important attributes of a migraine therapy are "how well it works," "how safe it is," "how fast it works," and "side effects." The least important attribute is "cost of drug." Subcutaneous sumatriptan received significantly more favorable scores than did aspirin, acetaminophen, or patients' usual therapies with respect to the attributes of how well it works, how fast it works, and number of doses needed to relieve pain. Subcutaneous sumatriptan was also rated more favorably than either aspirin or patients' usual therapies with respect to side effects. Acetaminophen and aspirin were rated significantly more favorably than subcutaneous sumatriptan on the attributes "easy to take" and "easy to buy." Asked which drug they would use again for migraine, more patients selected subcutaneous sumatriptan than any other single medication. More patients also ranked subcutaneous sumatriptan as the best overall performer compared with other migraine medications taken in the last 12 months. CONCLUSIONS: These data indicate that according to patients' preferences, subcutaneous sumatriptan possesses many of the attributes of an ideal migraine therapy.

Emergency department resource use by patients with migraine and asthma in a health maintenance organization.

OBJECTIVE: To identify and compare the resources consumed by patients with symptoms of asthma or migraine who presented to the Walk-In Emergency Department (WIED). DESIGN: Chart review. SETTING: WIED, Group Health Cooperative of Puget Sound, Seattle, WA. PATIENTS: Identified via WIED records as having visited the WIED between October 1991 and February 1992 for migraine or asthma. MAIN OUTCOME MEASURES: Time spent in the WIED, medications administered during visit and prescribed at discharge, diagnostic procedures performed, referrals, and hospitalizations. RESULTS: Of 16,755 WIED visits during the study period, 323 (1.9%) were migraine related and 159 (1.0%) were asthma related. Ninety percent of the asthma patients and 62% of the migraine patients reported having self-medicated prior to going to the WIED; 89% of the migraine patients received additional medication at the WIED versus 57% of the patients with asthma. Fifty-four (35.5%) of the migraine patients and 7 (4.6%) of the asthma patients had more than 1 WIED visit during the study period. CONCLUSIONS: Patients with asthma and migraine present striking contrasts in the types of resources used during WIED visits. This descriptive research highlights the need for further evaluation of the appropriateness of the healthcare services provided.

Migraine. Patterns of healthcare use.

Data on use of healthcare from several sources reflect low rates of consultation among migraineurs, many of whom are severely disabled, and limited detection of migraine among those seeking care. Most migraineurs who seek medical care are motivated by the need for pain relief and are initially seen by a general practitioner. Use of healthcare seems to follow a pattern, with a maximum use of services and technology within the first year, followed by a precipitous decrease over the ensuring years. The use of services appears to be concentrated among a small proportion of the migraineurs who seek care. In total volume, the migraineur uses two to five times more healthcare services than nonmigraineurs, reflecting the contribution of comorbidities and help-seeking behavior. Use of emergency departments and sophisticated diagnostic testing appears to be greater in the United States than in other countries. Hospitalization of the migraineur is uncommon and remains costly.

Measuring the functional status and well-being of patients with migraine headache.

OBJECTIVE: Compare adult migraineurs' health related quality of life to adults in the general U.S. population reporting no chronic conditions, and to samples of patients with other chronic conditions. METHODS: Subjects (n = 845) were surveyed 2-6 months after participation in a placebo-controlled clinical trial and asked to complete a questionnaire including the SF-36 Health Survey, a migraine severity measurement scale and demographics. Results were adjusted for severity of illness and comorbidities. Scores were compared with responses to the same survey by the U.S. sample and by patients with other chronic conditions. RESULTS: Response rate was 67%. After adjustment for comorbid conditions, SF-36 scale scores were significantly (P 0.001) lower in migraineurs, relative to age and sex-adjusted norms for the U.S. sample with no chronic conditions. Some health dimensions were more affected by migraine than other chronic conditions, while other dimensions were less affected by migraine. Measures of bodily pain, role disability due to physical health and social functioning discriminated best between migraineurs, the U.S. sample, and patients with other chronic conditions. Patients reporting moderate, severe and very severe migraines scored significantly (P < or = 0.001) lower on five of the eight SF-36 scales than the U.S. sample. CONCLUSIONS: Migraine has a unique, significant quality of life burden.

Healthcare resource use and costs associated with migraine in a managed healthcare setting.

OBJECTIVE: To compare healthcare use and associated costs in patients with migraine and patients without migraine headache. DESIGN: Retrospective review of a managed care organization's medical and pharmacy claims databases for claims filed between January 1, 1989 and June 30, 1990. PATIENTS: Patients between 18 and 64 years old with a 12-month minimum enrollment in the health plan, including enrollment for the prescription drug benefit. Migraine group (n = 1336) inclusion required a medical claim with the diagnosis of migraine headache and a pharmacy claim for a medication potentially used for migraine treatment. Comparison group (n = 1336) inclusion required at least one medical claim with no diagnosis of migraine; a pharmacy claim was not required. Comparison group patients were matched to migraine group patients by age, gender, enrollment status, and subscriber or dependent enrollment status. OUTCOME MEASURES: Total health services use, diagnosis-specific use of services, diagnostic procedures performed, comorbid conditions, medication use, and associated costs were tallied. RESULTS: Migraineurs generated nearly twice as many medical claims as comparison group patients, and nearly 2.5 times as many pharmacy claims. Number of claims generated and numbers of patients who generated claims within each of 19 diagnostic categories indicated greater comorbidity in the migraine group. Migraineurs used emergency services more than did patients in the comparison group. Total medical and pharmacy claims costs were $3.4 million for the migraine group and $2.1 million for the comparison group. The average amount paid per member-month of enrollment was significantly greater in the migraine group than in the comparison group. Comorbid conditions were responsible for a significant portion of costs in the migraine group. The migraine group incurred $83,537 for diagnostic procedures compared with $13,140 incurred by the comparison group. CONCLUSIONS: Patients with migraine had greater morbidity in general and incurred 64 percent greater costs in healthcare resource use compared with patients without migraine.

Efficacy of subcutaneous sumatriptan in repeated episodes of migraine.

This double-blind, placebo-controlled, multicenter, crossover study investigated the efficacy and tolerability of sumatriptan administered for up to three separate migraine attacks. One hundred twenty adults received sumatriptan (SC, 6 mg; three attacks) and placebo (one attack). Patients completed questionnaires assessing the impact of migraine on their lives and the performance of sumatriptan relative to their usual acute therapies. Sumatriptan statistically outperformed placebo on all efficacy measures, including pain severity; presence/absence of nausea, vomiting, phonophobia, and photophobia; rescue medication use; and clinical disability. Efficacy was consistently maintained with repeated administration. For all attacks, pain relief 90 minutes postdose occurred in 86% to 90% of sumatriptan-treated patients, compared with 9% to 38% of placebo-treated patients. Sumatriptan was well tolerated, and the frequency and severity of adverse events did not change with repeated administration. Patients' perceptions of sumatriptan were consistent with clinical data demonstrating the drug's high degree of efficacy and tolerability.

Impact of migraine in the United States: data from the National Health Interview Survey.

Data from the 1989 National Health Interview Survey concerning migraine occurrence and impairment were analyzed to assess the impact of migraine on the US population. About four of every one hundred persons in the United States were found to have migraine, accounting for nearly 10 million individuals. Migraine was most prevalent in those aged 25 to 44 years and was about 2.5 times more frequent in females than males. Migraine was most common in whites (85%) and those with low household income. In women, migraine prevalence increased with the level of education. About 10% of migrainous children missed at least one day of school over a two-week period due to migraine; nearly 1% missed four days. Migraineurs were bedridden for about three million days per month and had an estimated 74.2 million days per year of restricted activity due to migraine. The potential cost of lost productivity was estimated at $1.4 billion per year for the estimated 6,196,378 migraineurs who worked outside the home. It is difficult to derive similar estimates for costs of lost productivity in housewives; however, housewives experienced an estimated 38 million days per year of restricted activity. Eighty-five percent of females and 77% of males reported a physician visit at some point for their migraine. Migraine is a relatively common disease whose social and financial impact has been poorly understood.

Quality of life consequences of chemotherapy-induced emesis.

Nausea and vomiting following chemotherapy administration are common and often overlooked causes of impairment in cancer patients. The goal of this study was to explore the broad range of consequences associated with this specific acute toxicity of chemotherapy. Specific objectives were: (1) create and test scales specifically designed to assess the impact of chemotherapy-induced nausea and vomiting or patients' daily function; (2) examine changes in quality of life of cancer patients 3 days following chemotherapy administration; (3) assess the impact of chemotherapy-induced emesis on quality of life and patients' daily function; (4) identify medical and non-medical cost-related consequences associated with chemotherapy-induced emesis. Patients receiving intermittent bolus chemotherapy regimens on an outpatient basis were eligible for this survey. Four instruments were used: a patient maintained diary, the Functional Living Index-Cancer (FLIC), a newly created Functional Living Index-Emesis (FLIE) and an Item Check list for cost-related consequences. On Day 1, before chemotherapy, patients completed the FLIC and FLIE. Patients recorded episodes on vomiting, severity of nausea, anxiety, sedation, antiemetics self-administered, and adverse effects in diaries for 3 days following chemotherapy. The FLIC and FLIE were completed at the end of Day 3. The Item Check list of cost-related consequences was administered as a telephone survey on Day 5. Approximately 56% of 122 patients reported chemotherapy-induced emesis (CIE). A change in mean FLIC score indicating a decline in quality of life was observed for the CIE group (119 to 101) but not in the group who did not report emesis (124 to 122). Decline in FLIC and FLIE from before to after chemotherapy administration was greater for CIE patients (p = 0.001). FLIE scores indicated that CIE patients perceived that vomiting, and to a slightly lesser extent, nausea substantively influenced their ability to complete household tasks, enjoy meals, spend time with family and friends, and maintain daily function and recreation. Effect size calculations supported a significant negative relationship between occurrence of CIE and the direction and magnitude of functional living index change. An exploratory analysis (principal component followed by regression analysis) supported the hypothesis that side-effects produced by chemotherapy and antiemetic therapy significantly contributed to changes in quality of life observed.(ABSTRACT TRUNCATED AT 400 WORDS)

Healthcare resource and lost labour costs of migraine headache in the US.

Migraine headache is responsible for significantly more healthcare resource and lost labour costs than previously reported. Costs associated with migraine were assessed via a survey conducted in 940 patients, 70% of whom responded. All met the International Headache Society's diagnostic criteria for migraine and had participated in one of two multicentre, single-dose, parallel-group, randomised, placebo-controlled clinical trials designed to assess the efficacy of an anti-migraine compound. Migraine frequency and costs, in terms of healthcare resource utilisation and lost labour (decreased productivity and missed workdays), were assessed. Over 90% of respondents visited a clinic and nearly 50% presented to an emergency room for treatment of migraine-related symptoms at least once in the year prior to the survey. These 648 respondents used an estimated $US529 199 per year in healthcare services. 89% of employed respondents reported that job performance was adversely affected by migraine and over 50% of them missed at least two days of work per month. Depending on the estimates used for migraine prevalence and using 1986 estimates of median earnings for the US work force, the extrapolated costs to employers ranged from $US5.6 billion to $US17.2 billion dollars annually due to decreased productivity and missed work days. The cost of migraine is not fully appreciated by the medical community or by society.

Proposed drug-drug cost effectiveness methodology.

The advent of prospective reimbursement in hospitals has forced hospital administrators, pharmacy directors, and pharmacy and therapeutic committees to carefully compare the cost and benefits of similar drugs. Accomplishing this task is difficult. This paper reviews the literature on drug-drug cost effectiveness procedures and outlines a methodology that might be used to contrast and compare two drugs with similar therapeutic outcomes. The data to conduct this analysis can be obtained from published articles on clinical studies and company sources and entered into a microcomputer electronic spreadsheet. The study discusses the implications and use of cost effectiveness analysis to evaluate drugs by hospital formulary committees.

A survey of state board of pharmacy members and continuing education providers' views on continuing education.

Legally accountable to the public, state boards of pharmacy are continually confronted with the problem of maintaining the quality of pharmacy practice. One approach to accomplishing this task has been to implement mandatory continuing education requirements for relicensure. This study evaluated the perceived effectiveness and deficiencies of various states' continuing education regulations. A 40-question survey was mailed to 600 pharmacy board members and continuing education providers to determine their attitudes toward continuing education, support of mandatory continuing education, and their opinion of alternative methods for improving the quality of pharmacy practice. Responses from approximately one-half of those surveyed indicate board members and continuing education providers were positively disposed toward continuing education. However, there was room for improvement in most states' mandatory continuing education regulations. A relicensure examination was considered to be the best method to ensure competency, while mandatory continuing education was viewed as acceptable to pharmacists, and relatively easy to administer. The consequences of the study's findings for modifying state continuing education regulations is discussed.