Perceptions of practicing pharmacists in Idaho about a potential behind-the-counter drug program.

BACKGROUND: In late 2007, the Food and Drug Administration (FDA) held public hearings exploring the establishment of a new behind-the-counter (BTC) drug program. However, little is known about the views of pharmacists regarding such a program. OBJECTIVE: To assess the overall perceptions of Idaho's practicing pharmacists about the creation of a formal BTC drug program, the appropriateness of including certain drug categories, specific barriers to its adoption, and the impact of the new program on access to medicines. METHODS: A survey of practicing pharmacists in Idaho was conducted by mail, utilizing anonymous responses. Key questions exploring the views of pharmacists about the new BTC drug program utilized 5-point Likert scales. Data were also collected on respondent characteristics. RESULTS: A total of 357 practicing pharmacists in Idaho (31% response rate) returned the mail survey; 84% of pharmacists agreed that the FDA should be exploring an expanded BTC program, and 88% of pharmacists agreed that this program would improve access to some prescription-only products and convenience for patients. Almost 71% of pharmacists reported a personal willingness to both initiate and monitor certain BTC drug therapies. When focusing on specific drug categories for BTC status, the highest support was for selected agents within smoking cessation therapies (85%), nasal corticosteroids for allergies (81%), and vaccines (75%). Pharmacists who reported low barriers to the adoption of a new BTC program were significantly more likely to support this program than were those reporting high barriers. Only 39% of pharmacists agreed that adequate facilities were currently available for private evaluation and counseling of BTC patients. CONCLUSIONS: Pharmacists in a statewide survey of perceptions regarding a new BTC drug program overwhelmingly believe that patients would benefit. Pharmacists strongly support the development of the new program, and more than two thirds indicate that they would likely participate, given the necessary supporting institutional framework. Perceived barriers are related to willingness to participate and likely can be minimized through education and provision of private consulting areas.

Willingness to pay for cancer prevention.

Cancer inflicts great pain, burden and cost upon American society, and preventing cancer is important but not costless. The aim of this review was to explore the upper limits that American society is paying and appears willing to pay to prevent cancer, by enforced environmental regulations and implemented clinical practice guidelines. Cost-effectiveness studies of clinical and environmental cancer-prevention policies and programmes were identified through a comprehensive literature review and confirmed to be officially sanctioned and implemented, enforced or funded. Data were collected in 2005-6 and analysed in 2007. The incremental cost-effectiveness ratios (ICERs) for clinical prevention policies ranged from under $US2000 to over $US6 000 000 per life-year saved (LYS), exceeding $US100 000 per LYS for only 11 of 101 guidelines. Median ICERs for tobacco-related ($US3978/LYS), colorectal ($US22 694/LYS) and breast ($US25 687/LYS) cancer prevention were within generally accepted ranges and tended not to vary greatly, whereas those for prostate ($US73 603/LYS) and cervical ($US125 157/LYS) cancer-prevention policies were considerably higher and varied substantially more. In contrast, both the median and range of the environmental policies were enormous, with 90% exceeding $US100 000 per LYS, and ICERs ranging from $US61 004 to over $US24 billion per LYS. Notwithstanding a relatively large and accessible literature evaluating the cost effectiveness of clinical and environmental cancer-prevention policies as well as the availability of ICERs for the policies identified in this study, the apparent willingness to pay to prevent cancer in the US still varies greatly and can be extremely high, particularly for many of the environmental cancer-prevention policies.

Counter sampling combined with medical provider education: do they alter prescribing behavior?

OBJECTIVE: To observe if medical providers alter their prescribing patterns of three relatively expensive categories of medications provided as samples by manufacturers (focus medications) when they receive additional education from pharmacists concerning the appropriate use of lower cost alternatives (counter samples) that are made available to dispense. DESIGN: Pretest, post-test with a control group. SETTING: Two rural, private care clinics in southeastern Idaho providing immediate care services. PARTICIPANTS: Eight medical providers at a clinic where interventions were employed (active intervention group) and seven medical providers in a clinic where no interventions occurred (control group). INTERVENTIONS: Medical providers in the active intervention group had: 1) education from pharmacists concerning the appropriate use of lower-cost alternatives compared with expensive focus medications 2) counter samples and patient sample handouts available to dispense to patients at their own discretion. MAIN OUTCOME MEASURES: The percentage of the total yearly prescriptions for nonsteroidal anti-inflammatory drugs (NSAIDs), antihistamines, and acid-relief medications that consisted of focus-COX-2 NSAIDs, nonsedating antihistamines, and proton pump inhibitors (PPIs), respectively. RESULTS: The prescribing behavior of medical providers in the active intervention and control groups were significantly different at baseline in all three categories of focus medications. This suggested that the results should focus on changes across the two years of the study within the intervention and control groups rather than across the two groups. Medical providers in the intervention group significantly decreased the use of COX-2 NSAID prescriptions relative to total NSAID prescriptions following active intervention (38.9% in year 1 versus 23.7% in year 2, P < 0.05). Over the same two time periods, a nonstatistically significant decrease in COX-2 NSAID prescribing was seen at the control site (67.5% versus 62%, P > 0.05). Education and counter sampling did not stop medical providers from significantly increasing the total yearly prescriptions for antihistamines and acid-relief medications that consisted of focus-nonsedating antihistamines (86.7% versus 93.1%, P < 0.05) and PPIs (68.9% versus 86.2%, P < 0.05). Statistically significant increases in the prescribing of focus-nonsedating antihistamines (77.9% versus 98.3%, P < 0.05) and PPIs (77.5% versus 91.4%, P < 0.05) were also observed in the control group. CONCLUSIONS: Education by pharmacists, combined with access to counter samples, may or may not have an effect on medical provider prescribing, depending on the category of medication targeted for cost control.

Analyzing oncology clinical trial data using the Q-TWiST method: clinical importance and sources for health state preference data.

PURPOSE: The Quality-adjusted Time Without Symptoms of disease and Toxicity (Q-TWiST) analysis method is frequently applied to evaluating outcomes in cancer clinical trials, but there is little information on what constitutes a clinically important difference (CID). We reviewed the Q-TWiST, health-related quality of life (HRQL) and utility measurement literature to develop recommendations for CID for the Q-TWiST. We also provide recommendations for measuring health utilities and for the design of Q-TWiST studies. METHODS: The English language literature was searched between 1986 and 2003 for Q-TWiST studies in oncology. We estimated the percent differences between treatments based on median follow-up duration for overall, progression-free and quality-adjusted survival. We also reviewed the relevant HRQL and utility literature on clinical importance. RESULTS: The overall differences between treatments for most (56%) of the observed, published values for Q-TWiST analyses ranged between 12% and 19%. Three-fourths of the Q-TWiST studies had gains in survival of 12%-17%, while differences in progression-free survival ranged from 12% to 26%. Studies that have evaluated the clinical importance of changes in HRQL scores suggest that changes of 5%-10% are clinically meaningful, and other research suggests that 0.5 standard deviation is a reasonable threshold for changes in HRQL for chronic diseases. Similarly, one guideline from the health state utility literature is that a 5%-10% difference in standard gamble utility scores is clinically important. Various sources are available for health utilities for Q-TWiST studies and the most valid are derived from patients or the general public, although most studies rely on sensitivity analyses with no collection of utilities. CONCLUSIONS: We recommend that the CID for Q-TWiST is 10% of overall survival in a study, and differences of 15% are clearly clinically important. If less is known about a specific treatment and/or disease area, the CID should be greater than 5% but not more than 10% in planning sample size and statistical power. These CID estimates should be interpreted with caution, pending confirmation in future studies by direct patient assessment of the clinically relevant health states for Q-TWiST.

Use of colonoscopy for colorectal cancer screening: evidence from the 2000 National Health Interview Survey.

BACKGROUND: The use of colonoscopy as a primary screening tool for colorectal cancer is gaining momentum owing to several studies suggesting superior effectiveness and the recent, favorable decision by Medicare to cover all routine screening colonoscopies. This study documents the use of colonoscopy versus other tests to screen for colorectal cancer. MATERIALS AND METHODS: Data from the 2000 National Health Interview Survey were analyzed. Fecal occult blood test (FOBT), sigmoidoscopy, and colonoscopy done for any reason and for routine screening only were analyzed for those >/=50 years without previously diagnosed colorectal cancer (n = 12,505). RESULTS: The proportion of the total eligible population receiving any of the recommended tests for all possible reasons and for screening purposes only is 34.6% and 25.1%, respectively. For routine screening purposes, the test most commonly utilized was FOBT (55.6%) followed by colonoscopy (29.1%) and sigmoidoscopy (15.3%). When usage was assessed for all reasons, FOBT was still most commonly utilized (45.8%) followed by colonoscopy (38.7%) and sigmoidoscopy (15.5%). The elderly, non-White males and those with private insurance have a higher probability of receiving colonoscopy than FOBT. Several regional differences exist, including higher probability of undergoing sigmoidoscopy versus colonoscopy in the West. CONCLUSIONS: Only one fourth (upper limit one third) of the study population complied with colorectal cancer screening recommendations. Nearly one third of the routine screening tests done in 2000 were colonoscopies. This study provides baseline values that can be used to project future colonoscopy demand and identify potential supply barriers.

Surveillance patterns and polyp recurrence following diagnosis and excision of colorectal polyps in a medicare population.

OBJECTIVE: Study objectives were to determine surveillance and polyp recurrence rates among older, increased-risk patients who have been diagnosed and excised of colorectal polyps. The high incidence of colorectal cancers in the Medicare-eligible population, the strong evidence linking reductions in mortality from colorectal cancer by removal of colorectal polyps, and the paucity of postpolypectomy surveillance data in this population all supported the need for this study. METHODS: This retrospective study used Medicare claims data to identify a cohort of 19,895 beneficiaries ages >/=65 years diagnosed and excised of colorectal polyps in 1994. Survival analysis was used to compute surveillance and polyp recurrence rates over 5 years. Log-rank test was used for all statistical comparisons. RESULTS: Median time to first surveillance was 2.6 years. Surveillance rates for 1, 3, and 5 years were 17.6%, 55.8%, and 74.5%, respectively. Twenty-six percent had no surveillance event. Polyp recurrence rates for 1, 3, and 5 years were 10.9%, 38.2%, and 52.6%, respectively. Males and younger patients were more likely to undergo surveillance and showed higher polyp recurrence rates. CONCLUSIONS: The high likelihood of polyp recurrence underscores the need for continued efforts to promote awareness of and compliance with postpolypectomy surveillance. Efforts to increase surveillance rates among individuals diagnosed with colorectal polyps and making available additional treatment options that may prevent the recurrence of polyps and/or their possible progression to colorectal cancer should help make significant progress in reaching the Healthy People 2010 goal of reducing colorectal cancer deaths by 34% by the year 2010.

The impact of urinary urgency and frequency on health-related quality of life in overactive bladder: results from a national community survey.

OBJECTIVES: Overactive bladder (OAB) is described as urinary urgency, with and without urge incontinence and usually with frequency and nocturia. Most attention to OAB's impact on health-related quality of life (HRQL), however, has focused on urge incontinence. The objective of this study was to evaluate the burden of OAB, specifically urinary urgency and frequency on HRQL. METHODS: In the National Overactive Bladder Evaluation Program (NOBLE), a computer-assisted telephone interview survey was conducted to assess the prevalence of OAB in the United States. Based on interview responses, respondents were classified into three groups: continent OAB, incontinent OAB, and controls. To evaluate the HRQL impact of OAB, HRQL questionnaires were mailed to all respondents with OAB and age- and sex-matched controls as a performed nested case-control study. Continuous data were compared using Student's t tests and analysis of variance with post hoc pairwise comparisons; results were adjusted for age, sex, and comorbid conditions. Multivariable regressions were performed to assess the impact of each urinary variable on symptom bother and HRQL. RESULTS: A total of 919 participants responded to the questionnaires (52% response rate) with a mean age of 54.2 years (SD 16.4 years); 70.4% were female and 85% were white. Continent OAB participants comprised 24.8% of the sample, incontinent OAB 18.3%, and controls 56.9%. In each regression analysis, urinary urge intensity accounted for the greatest variance for increases in symptom bother and decreases in HRQL. CONCLUSIONS: The experience of urinary urgency has a significant negative effect on HRQL and increases symptom bother, an effect that, in this community sample, is greater than that of incontinence, frequency, or nocturia.

Adherence with colorectal cancer screening guidelines: a review.

OBJECTIVE: To review screening rates and factors impacting patient utilization of colorectal cancer screening tests. METHODS: We searched Medline, CancerLit, and PsycInfo for articles on colorectal cancer screening adherence. US studies on average-risk individuals were reviewed to identify: (1) utilization/adherence rates, (2) predictors of patient adherence, (3) correlation between long-term adherence and type of test selected, (4) predictors of physician recommendation of screening tests, and (5) patterns in the type of test recommended by physicians. RESULTS: In 2000, only 34% of the US population obtained screening within recommended time frames (fecal occult blood test annually, flexible sigmoidoscopy every 5 years, or colonoscopy every 10 years). Positive attitude toward screening and physician recommendation result in high adherence while fear of finding cancer and the belief that cancer is fatal result in low adherence. Physician specialty impacts the type of test recommended, while perceived lack of patient adherence is not a consistent barrier to recommending screening tests. Matching individuals with their choice of screening test and newer technology, such as virtual colonoscopy, may help increase adherence. CONCLUSION: Additional studies are required on differences in adherence between tests, whether patient preferences impact adherence, and how the physician-patient relationship can be fostered to increase adherence.

Properties of polarization evolution in spun fibers.

We study the properties of polarization evolution in sinusoidally spun fibers. It is found that, similar to linear birefringent fibers, the evolution of the state of polarization exhibits periodicity, which can be measured by distributed measurement, such as those made with a polarization optical time domain reflectometer. The spatial period is linked with the spin parameters and fiber beat length in a simple equation. In combination with a previous finding, it is shown that the spatial period is uniquely related to spun-fiber polarization mode dispersion. This suggests that distributed fiber polarization mode dispersion can be determined throughthe measurement of the spatial period obtained in a distributed measurement.

Estimated economic costs of overactive bladder in the United States.

OBJECTIVES: To estimate the economic costs of overactive bladder (OAB), including community and nursing home residents, and to compare the costs in male versus female and older versus younger populations. METHODS: The National Overactive Bladder Evaluation Program included a representative telephone survey of 5204 community-dwelling adults 18 years and older in the United States and a follow-up postal survey of all individuals with OAB identified and age and sex-matched controls. The postal survey asked respondents about bladder symptoms, self-care use, treatment use, work loss, and OAB-related health consequences. Survey data estimates were combined with year 2000 average cost data to calculate the cost of OAB in the community. Institutional costs were estimated from the costs of urinary incontinence in nursing homes, limited to only those with urge incontinence or mixed incontinence (urge and stress). RESULTS: The estimated total economic cost of OAB was 12.02 billion dollars in 2000, with 9.17 and 2.85 billion dollars incurred in the community and institutions, respectively. Community female and male OAB costs totaled 7.37 and 1.79 billion dollars, respectively. The estimated total cost was sensitive to the estimated prevalence of OAB; therefore, we calculated the average cost per community-dwelling person with OAB, which was 267 dollars per year. CONCLUSIONS: By quantifying the total economic costs of OAB, this study-the first obtained from national survey data-provides an important perspective of this condition in society. The conservative estimates of the total cost of OAB were comparable to those of osteoporosis and gynecologic and breast cancer. Although this provides information on the direct and indirect costs of OAB, quality-of-life issues must be taken into account to gain a better understanding of this condition.