Community Pharmacists\u27 Attitudes Toward An Expanded Class Of Nonprescription Drugs

Objectives: there has been considerable discussion about creating a third class of drugs which would not require a prescription, but require a pharmacist\u27s consultation upon purchase. Very recently the Food and Drug Administration (FDA) held a hearing which repositioned a third class as an expanded nonprescription drug class termed as the new paradigm using certain innovative technologies. The specific objectives of this study were to: 1) measure community pharmacists\u27 attitudes toward an expanded nonprescription drug class under the FDA’s proposed new paradigm ; 2) determine if attitudes of community pharmacists toward an expanded nonprescription drug class under the FDA’s proposed new paradigm differ by type of practice setting, location of community pharmacy, region in which the practice is located, degrees earned, years actively practicing pharmacy, position in the pharmacy, perceived workload, and pharmacy association affiliation; and 3) determine which drugs community pharmacists believe would be acceptable additions to an expanded definition of nonprescription drugs under the FDA’s proposed new paradigm . Methods: this cross-sectional study was conducted using a self-report, web-based survey. 462 completed responses from a national convenience sample of community pharmacists were obtained. The survey items were either obtained from the existing scales in the literature or developed based on the FDA’s proposed guidelines for the new paradigm. A principal components analysis (pca) with varimax rotation and reliability analyses were conducted to determine the factors affecting community pharmacists\u27 attitudes toward the new paradigm. Multivariate analysis of variance (manova) was used to determine whether attitudes toward the new paradigm differed based on aforementioned respondent characteristics. Results and conclusions: respondents were generally positive about the provision of patient care under the proposed new paradigm. The results from the pca suggested that community pharmacists\u27 attitudes toward the new paradigm is comprised of six factors including patient care, workflow, patient safety, non-pharmacist providers, pharmacist burden and access. Respondent attitudes differed based on certain practice and demographic variables. Not surprisingly, the majority of respondents indicated that plavixâ® and ambienâ® should still be dispensed as prescription drugs even upon implementation of the new paradigm while lipitorâ®, glucophageâ®, viagraâ® could be switched to the new paradigm

Community Pharmacists’ Classification of Prescription Drugs into an Expanded Class of Nonprescription Drugs under the FDA's Proposed NSURE Initiative

Objectives: There has been considerable debate over the last few decades about creating a third class of drugs that would not require a prescription or not be available freely over the counter, but require a pharmacist’s consultation upon purchase. These debates reignited again in 2012, when the Food and Drug Administration (FDA) held a hearing about a third class of drugs positioned as an expanded nonprescription drug class under the FDAs Nonprescription Safe-Use Regulatory Expansion (NSURE) Initiative. The objective of this study was to determine which prescription drugs community pharmacists believe are acceptable additions to an expanded definition of nonprescription drugs that would be available pending pharmacists’ consultation with a patient. Methods: This cross-sectional study was conducted using a self-report, web-based survey administered to a national panel of community pharmacists. The survey contained a list of 24 current “prescription-only” drugs which may be potential candidates for an expanded nonprescription drug class, based on criteria outlined by the FDA, and questions related to respondent demographic and practice characteristics. The respondents were asked to indicate whether a particular drug should be marketed as a prescription drug, nonprescription drug or as part of an expanded non-prescription drug class. Descriptive analyses were conducted to determine the drugs that community pharmacists believed would be suitable additions to an expanded non-prescription drug class under the NSURE initiative. Results: 462 completed surveys were received. Most respondents indicated that clopidogrel bisulfate (85.3%) and zolpidem (86.6%) should continue to be dispensed as prescription drugs. Atorvastatin, metformin, and sildenafil (among others) were considered appropriate to be marketed as an expanded nonprescription drug, in other words, dispensed without a prescription but upon pharmacist consultation. Desloratadine (64.6%) and pre-natal vitamins (50.2%) were considered appropriate for nonprescription status (over-the-counter, without pharmacist intervention). Conclusions: Respondents suggested that 18 out of 24 drugs (75%) on the list provided could be categorized into an expanded class of nonprescription drugs. Adding more drugs to an expanded nonprescription drug class has the potential to expand pharmacists’ provision of patient care under the FDA’s proposed NSURE program.   Type: Student Projec

An evaluation of the psychometric properties of the sf-12v2 health survey among adults with hemophilia

Abstract Background This study examined the psychometric properties of version 2 of the SF-12 Health Survey (SF-12v2) among adults with hemophilia in the United States. Methods This study employed a cross-sectional design using web-based and paper-based self-administered surveys. Hemophilia patients were recruited using an online panel and at a hemophilia treatment clinic. The psychometric properties of the SF-12v2 were assessed in terms of construct validity, internal consistency reliability, and presence of floor and ceiling effects. Results A total of 218 adults with hemophilia completed the survey, with most recruited via the online panel (78%). Confirmatory factor analysis using the WLSMV estimator in Mplus supported a two-factor model for the SF-12v2 where the physical functioning, role physical, bodily pain, and general health items loaded onto a latent physical factor (LPF) and the role emotional, mental health, social functioning, and vitality items loaded onto a latent mental factor (LMF). Model fit statistics for the two-factor model were: Chi-square [df] = 172.778 [48]; CFI = 0.972; TLI = 0.962; RMSEA [90% CI] = 0.109 [0.092–0.127]; WRMR = 0.947. Correlated residuals for items belonging to similar domains were estimated and there was a significant correlation between LPF and LMF. All standardized factor loadings were strong and statistically significant, indicating adequate convergent validity. Item-to-other scale correlations were lower than item-to-hypothesized scale correlations suggesting good item discriminant validity. Model testing revealed that LPF and LMF were not perfectly correlated, suggesting adequate construct discriminant validity. Increasing levels of symptom severity were associated with significant decreases in physical component summary (PCS) and mental component summary (MCS) scores, supporting known-groups validity. Internal consistency reliability was satisfactory, with Cronbach’s alpha of 0.848 for the LPF and 0.785 for the LMF items. Finally, none of the participants received the least or maximum possible PCS or MCS score, indicating the absence of floor and ceiling effects. Conclusions Overall, the SF-12v2 was found to have adequate psychometric validity in our sample of adults with hemophilia. These results add to the growing evidence of psychometric validity of the SF-12v2 in different patient populations including hemophilia