Validity of laboratory-based surveillance for detection of respiratory syncytial virus seasons.

In this study, we validated the Centers for Disease Control and Prevention's use of a 10% threshold of median proportion of positive laboratory tests (median proportion positive (MPP)) to identify respiratory syncytial virus (RSV) seasons against a standard based on hospitalization claims. Medicaid fee-for-service recipients under 2 years of age from California, Florida, Illinois, and Texas (1999-2004), continuously eligible since birth, were categorized for each week as high-risk or low-risk with regard to RSV-related hospitalization based on medical and pharmacy claims data and birth certificates. Weeks were categorized as on-season if the RSV hospitalization incidence rate in high-risk children exceeded the seasonal peak of the incidence rate in low-risk children. Receiver operating characteristic (ROC) curves were used to measure the ability of MPP to discriminate between on-season and off-season weeks as determined from hospitalization data. Areas under the ROC curve ranged from 0.88 (95% confidence interval: 0.83, 0.92) in Illinois to 0.96 (95% confidence interval: 0.94, 0.98) in California. Requiring at least 5 positive tests in addition to the 10% MPP threshold optimized accuracy, as indicated by minimized root mean square errors. The 10% MPP with the added requirement of at least 5 positive tests is a valid method for identifying clinically significant RSV seasons across geographically diverse states.

Evaluation of FDA safety-related drug label changes in 2010.

PURPOSE: This study characterizes drug safety-related label changes by evidence source contribution, time from drug approval to label change, initiator (FDA or sponsor), and drug class. METHODS: A retrospective review of the FDA's internal files was used to obtain regulatory documentation on drugs undergoing a 2010 label change. Contribution of evidence sources were identified and label change initiator and drug class were determined for each drug. RESULTS: A total of 371 drugs were analyzed. Spontaneous reports contributed to 52% and 55% of label changes when analyzed by unique safety issue and drug, respectively. The median time from approval to 2010 safety-related label change was 11 years. The sponsor was more likely than the FDA to initiate a label change (58% and 42%). Label changes were most common among nervous system drugs (23%), antiinfectives for systemic use (17%), and cardiovascular system drugs (14%). CONCLUSIONS: Drug label changes involve contributions from multiple evidence sources. The findings from this comprehensive review are consistent with previous findings and demonstrate (i) the continued importance of the spontaneous reporting system and complementary evidence sources and (ii) safety-related label changes take place years after postmarket approval, emphasizing the importance of continued drug safety surveillance throughout a product's lifecycle.

Developing great research questions.

PURPOSE: The process for developing a good research question is described. SUMMARY: Three steps comprise the formulation of a great research question: (1) ask interesting questions, (2) select the best question for research, and (3) transform the research question into a testable hypothesis. Research is designed to generate information that cannot be gained from any other source. A research question is a narrow, challenging question addressing an issue, problem, or controversy that is answered with a conclusion based on the analysis and interpretation of evidence. A variety of strategies can be applied to stimulate creative thinking and generate new insights into old problems. A good research question challenges researchers to see matters from a new perspective and to learn something new. Practice research questions are evaluated by the probability of achieving their goal, along with the potential impact and feasibility of the project. The proposed research must meet important professional and societal goals, fit with the mission of the organization, garner administrative support, and be accomplished with available resources in a reasonable time frame. The research question should be refined to generate one or more hypotheses that specify the nature of the relationships to be observed and measured. Properly formulated questions yield findings to inform decisions that enhance practice, transfer to other settings, and make efficient use of resources. CONCLUSION: Developing a good research question is the most important part of the research process. The question should be narrow and address an important issue that fits within the mission of the organization.

Pharmacy practice-based research networks: why, what, who, and how.

OBJECTIVES: To describe practice innovations that can lead to measurable advances in the safety and effectiveness of medication use and to recommend a course of action that is likely to lead to practicable improvements in the medication use system. DATA SOURCES: Proceedings of a national conference; review of the medical literature. DATA SYNTHESIS: Only those interventions that can be reliably implemented by typical practitioners in a wide range of practice settings can produce lasting benefits for considerable numbers of patients. Teamwork between and among disciplines is needed for new insights and novel approaches to delivering pharmaceutical products and services. Building on the experience of other health disciplines, a cross section of pharmacy practitioners, researchers, educators, and leaders were able to identify the key questions, strategies, and actions needed to form collaborations for devising and testing new ideas and transferring the findings into everyday practice. CONCLUSION: Pharmacy practice research that leads to improvements in the medication use process is needed. Practice-based research networks provide a model for building a synergy among pharmacists and other stakeholders to devise improvements that provide sustainable and systemwide improvements in medication use.

Physicians' intent to comply with the American Medical Association's guidelines on gifts from the pharmaceutical industry.

OBJECTIVE: To identify factors that predict physicians' intent to comply with the American Medical Association's (AMA's) ethical guidelines on gifts from the pharmaceutical industry. METHODS: A survey was designed and mailed in June 2004 to a random sample of 850 physicians in Florida, USA, excluding physicians with inactive licences, incomplete addresses, addresses in other states and pretest participants. Factor analysis extracted six factors: attitude towards following the guidelines, subjective norms (eg, peers, patients, etc), facilitating conditions (eg, knowledge of the guidelines, etc), profession-specific precedents (eg, institution's policies, etc), individual-specific precedents (physicians' own discretion, policies, etc) and intent. Multivariate regression modelling was conducted. RESULTS: Surveys were received from 213 physicians representing all specialties, with a net response rate of 25.5%. 62% (n = 133) of respondents were aware of the guidelines; 50% (n = 107) had read them. 48% (n = 102) thought that following the guidelines would increase physicians' credibility and professional image; 68% (n = 145) agreed that it was important to do so. Intent to comply was positively associated with attitude, subjective norms, facilitators and sponsorship of continuing medical education (CME) events, while individual-specific precedents had a negative relationship with intent to comply. Predictors of intent (R(2) = 0.52, p <0) were attitude, subjective norms, the interaction term (attitude and subjective norms), sponsorship of CME events and individual-specific precedents. CONCLUSIONS: Physicians are more likely to follow the AMA guidelines if they have positive attitudes towards the guidelines, greater subjective norms, fewer expectations of CME sponsorship and fewer individual-specific precedents. Physicians believing that important individuals or organisations expect them to comply with the guidelines are more likely to express intent, despite having fewer beliefs that positive outcomes would result through compliance.

Using social cognitive theory to explain consumers' behavioral intentions in response to direct-to-consumer prescription drug advertising.

BACKGROUND: Previous research describing consumers' communication behaviors in response to direct-to-consumer advertising (DTCA) suggests a social cognitive rationale to explain DTCA-related communication behavior. OBJECTIVE: Guided by social cognitive theory, the objective of this study was to explore outcome expectancy and self-efficacy beliefs as predictors of individuals' intentions to communicate with their physicians about an advertised drug. METHODS: One hundred and seven female college students completed a questionnaire, read an advertisement for an oral contraceptive drug, and completed a second questionnaire. The questionnaires assessed participants' self-efficacy and outcome expectancy beliefs, intended communication behavior, and demographic information. RESULTS: Pearson product-moment correlation analyses showed that outcome expectancy (r=0.75, P<.01) and self-efficacy (r=0.21, P<.05) beliefs were associated positively with intentions to communicate with physicians in response to DTCA. However, ordinary least squares regression analyses revealed that only outcome expectancy beliefs predicted intended communication behavior (B=1.56, P<.01). Results also showed that participants had a relatively greater likelihood of requesting information about, than requesting a prescription for, the advertised drug [t(106)=14.75, P<.01]. CONCLUSIONS: The results identify cognitive factors that guide consumers' plans for interacting with physicians in response to DTCA. Health care providers can use these results to guide communication with patients regarding DTCA and meet patients' drug-related informational expectations.

Predicting physician guideline compliance: an assessment of motivators and perceived barriers.

BACKGROUND: Although clinical practice guidelines are widely accepted as "best practices," provider compliance remains low. OBJECTIVES: To examine the relationship between providers' behavioral intentions and their compliance with practice guidelines; to assess the impact of perceived barriers that were most inhibiting to compliance; and to examine the ability of factors in the Physician Guideline Compliance Model to predict intention to comply and compliance with guidelines implemented at specific practice sites. METHODS: Survey research methods were used to assess effects of antecedents (attitudes, subjective norms, past behavior, and perceived behavioral control) on providers' intentions to comply and compliance with clinical practice guidelines. Provider survey I was conducted at the time of guideline introduction and survey II 4 months after implementation. RESULTS: Scores for the antecedents to behavior and behavioral intention reflected favorable responses toward the use of guidelines. The mean self-reported compliance behavior was 65%, whereas compliance as assessed by chart review was 54%. Approximately 68% of the variance in the physicians' behavioral intentions was accounted for by variables included in the Physician Guideline Compliance Model. A significant negative correlation was found between perceived barriers and self-reported behavior but not between perceived barriers and chart-review-assessed behavior. CONCLUSIONS: Some variables, particularly perceived barriers to guideline implementation, predicted a provider's practice intentions and self-reported behavior. Future guideline intervention efforts should identify and reduce these barriers to guideline compliance prior to implementation.

Association between hospital size and quality improvement for pharmaceutical services.

PURPOSE: The relationship between hospital size and quality improvement (QI) for pharmaceutical services was studied. METHODS: A questionnaire on QI was sent to hospital pharmacy directors in Michigan and Florida in 2002. The questionnaire included items on QI lead-team composition, QI tools, QI training, and QI culture. RESULTS: Usable responses were received from 162 (57%) of 282 pharmacy directors. Pharmacy QI lead teams were present in 57% of institutions, with larger teams in large hospitals (> or = 300 patients). Only two QI tools were used by a majority of hospitals: root-cause analysis (62%) and flow charts (66%). Small hospitals (< 50 patients) were less likely than medium-sized hospitals (50-299 patients) and large hospitals to use several QI tools, including control charts, cause-and-effect diagrams, root-cause analysis, flow charts, and histograms. Large hospitals were more likely than small and medium-sized hospitals to use root-cause analysis and control charts. There was no relationship between hospital size and the frequency with which physician or patient satisfaction with pharmaceutical services was measured. There were no differences in QI training or QI culture across hospital size categories. CONCLUSION: A survey suggested that a majority of hospital pharmacies in Michigan and Florida have begun to adopt QI techniques but that most are not using rigorous QI tools. Pharmacies in large hospitals had more QI lead-team members and were more likely to use certain QI tools, but there was no relationship between hospital size and satisfaction measurements, QI training, or QI culture.

Time savings associated with dispensing unit-of-use packages.

OBJECTIVES: To determine how much time can be saved with the use of unit-of-use packaging in a community pharmacy, the distribution of work between the pharmacist and the pharmacy technician when unit-of-use packaging is used, and the number of errors that occur when either unit-of-use or bulk packaging is used in dispensing prescriptions. DESIGN: A simulation comparing count-and-pour dispensing with unit-of-use package dispensing. SETTING: An independent community pharmacy. PARTICIPANTS: Two teams, each composed of one pharmacist and one pharmacy technician. INTERVENTION: Each team prepared 50 typical prescription orders, once using unit-of-use packaging and once by transferring medication from a bulk container. MAIN OUTCOME MEASURES: Time needed to dispense 50 prescriptions, dispensing activities performed by technicians and pharmacists, and number of dispensing errors. RESULTS: The time saved with unit-of-use packaging compared with count-and-pour dispensing was 46.5 minutes per 100 prescriptions, which represents an average time savings of more than 27 seconds per prescrition. In the bulk package dispensing simulation, the pharmacists assisted in retrieving and counting medication for 26% of the prescriptions. This percentage dropped to 4% when unit-of-use packaging was used because the technicians dispensed prescriptions at a rate that occupied the pharmacist with verifying the prescription orders and dispensed products. Each team committed two counting errors when executing the bulk package trial and no errors when using unit-of-use packaging. CONCLUSION: Unit-of-use packaging can reduce the time needed for and increase the efficiency of pharmacists' dispensing activities. Unit-of-use packaging may also reduce the number of counting errors.