Class of 2009 Abstract / OBJECTIVES: To explore the viewpoints of physicians, pharmacists, and other healthcare professionals on the creation of a behind- the-counter class of drugs. METHODS: This was a descriptive study of testimony contained in public hearings that were held by the FDA regarding behind-the- counter availability of certain medications. A data collection form was created to classify the testimony into categories according to the list comprised of 14 general issues, 11 logistical issues, and 11 miscellaneous issues. Testifiers were divided into three groups: medical, pharmacy, and health care related. Testimonies were analyzed for issues addressed by each speaker and marked pro, con, or neutral next to the corresponding issue. Frequencies and percentages were derived from the count data and groups were compared using a Yate’s Chi-square test. RESULTS: The medical, pharmacy, and health care related groups had a significantly different number of responses (p<0.001). The responses of the medical testifiers were significantly more opposed to a BTC class than the pharmacy testifiers (p<0.001). The pharmacy testimony was also significantly more in favor of a BTC class compared to the health care related groups testimony (p=0.014). The medical testimony was not significantly different from the health care related testimony (p=0.064). CONCLUSIONS: Pharmacists supported and physicians opposed the creation of a BTC class of drugs. Other healthcare related professionals had mixed opinions as a group.

The U.S. pharmaceutical industry has been remarkably successful in developing new treatments for many of the leading causes of morbidity and mortality. These new treatments and their high prices lead government and private parties to increase spending and raise the issue of access. Price and cost increases have stimulated insurance costs, raising questions about the value of new technologies. A key way to address the increase in pharmaceutical prices is to investigate the impact of newer therapies on overall health expenditure. There is a conflict among researchers about the benefits and costs of newer and better drugs. Some researchers argue that newer and better drugs keep people out of hospitals and provide significant cost savings. Another group of researchers argue in their work that newer drugs do not really provide significant cost savings. This dissertation investigates the impacts of break-through drug classes on overall health care expenditures. Empirical evidence presented in this dissertation shows that drugs belonging to new drug classes provide significant advances in treatment of conditions compared to other drugs. The results indicate that all new drug classes except Fluoroquinolones provide substantial cost savings on overall health care expenditures. This dissertation also explores the relations between FDA Therapeutic Drug Classification and total health care expenditures. It offers a better methodology by incorporating both the quality and the age of the drugs to capture their effects on total health care expenditures. It studies the impacts of the quality and the age of the drugs on the diseases of following therapeutic classes: musculoskeletal system and connective tissue, skin and subcutaneous tissue, neoplasm, mental disorders, nervous system and sense organs, circulatory system, respiratory system, digestive system, genitourinary system. The nature of therapeutic conditions coupled with their duration lead us to conclude that for some therapeutic categories newer priority drugs are preferable, for others newer standard drugs are better. The results suggest that there is no general rule to state that newer priority drugs decrease health care expenditures.

The U.S. pharmaceutical industry has been remarkably successful in developing new treatments for many of the leading causes of morbidity and mortality. These new treatments and their high prices lead government and private parties to increase spending and raise the issue of access. Price and cost increases have stimulated insurance costs, raising questions about the value of new technologies. A key way to address the increase in pharmaceutical prices is to investigate the impact of newer therapies on overall health expenditure. There is a conflict among researchers about the benefits and costs of newer and better drugs. Some researchers argue that newer and better drugs keep people out of hospitals and provide significant cost savings. Another group of researchers argue in their work that newer drugs do not really provide significant cost savings. This dissertation investigates the impacts of break-through drug classes on overall health care expenditures. Empirical evidence presented in this dissertation shows that drugs belonging to new drug classes provide significant advances in treatment of conditions compared to other drugs. The results indicate that all new drug classes except Fluoroquinolones provide substantial cost savings on overall health care expenditures. This dissertation also explores the relations between FDA Therapeutic Drug Classification and total health care expenditures. It offers a better methodology by incorporating both the quality and the age of the drugs to capture their effects on total health care expenditures. It studies the impacts of the quality and the age of the drugs on the diseases of following therapeutic classes: musculoskeletal system and connective tissue, skin and subcutaneous tissue, neoplasm, mental disorders, nervous system and sense organs, circulatory system, respiratory system, digestive system, genitourinary system. The nature of therapeutic conditions coupled with their duration lead us to conclude that for some therapeutic categories newer priority drugs are preferable, for others newer standard drugs are better. The results suggest that there is no general rule to state that newer priority drugs decrease health care expenditures.

Class of 2014 Abstract / Specific Aims: To determine what the general public understands about sunscreen and to see if specific groups need more targeted marketing and education about sunscreen. Methods: Questionnaires administered to eligible participants that rated the participants’ knowledge of general sun safety, sunscreen application, and FDA labeling on sunscreen products compared to demographic data. Demographic data were collected on age, gender, years resided in Arizona, whether participants has or known anyone with a history of skin cancer and ethnicity. Main Results: Questionnaires were completed by 62 participants. When comparing skin cancer versus no skin cancer using student’s t-test, there was no significant difference (P=0.09). When comparing gender versus total using student’s t-test, there was no significant difference (P=0.62). When comparing ethnicity versus total using ANOVA, F < Fcritical indicating there was no difference. When comparing age versus total using ANOVA, F < Fcritical indicating there was no difference. When comparing years residing in Arizona versus total using ANOVA, F < Fcritical indicating there was no difference. Conclusion: Consumer knowledge of general sun safety, sunscreen application, and FDA labeling on sunscreen products appears to have little to no difference between each demographic category.

Class of 2010 Abstract / OBJECTIVES: To explore the viewpoints of physicians, pharmacists, and other healthcare professionals on the creation of a behind- the-counter class of drugs. METHODS: This was a descriptive study of testimony contained in public hearings that were held by the FDA regarding behind-the- counter availability of certain medications. A data collection form was created to classify the testimony into categories according to the list comprised of 14 general issues, 11 logistical issues, and 11 miscellaneous issues. Testifiers were divided into three groups: medical, pharmacy, and health care related. Testimonies were analyzed for issues addressed by each speaker and marked pro, con, or neutral next to the corresponding issue. Frequencies and percentages were derived from the count data and groups were compared using a Yate’s Chi-square test. RESULTS: The medical, pharmacy, and health care related groups had a significantly different number of responses (p<0.001). The responses of the medical testifiers were significantly more opposed to a BTC class than the pharmacy testifiers (p<0.001). The pharmacy testimony was also significantly more in favor of a BTC class compared to the health care related groups testimony (p=0.014). The medical testimony was not significantly different from the health care related testimony (p=0.064). CONCLUSIONS: Pharmacists supported and physicians opposed the creation of a BTC class of drugs. Other healthcare related professionals had mixed opinions as a group.

Class of 2012 Abstract / Specific Aims: To perform a pilot survey assessing the user benefit perceived by University of Arizona students regarding topical photoprotectants and their ability to prevent solar skin damage, including sunburn and carcinogenesis. In addition, to analyze the data obtained from the survey to identify incongruence between the FDA defined indication for the OTC sun protectants and the anticipated benefit expressed by University of Arizona students. Methods: An anonymous, paper based questionnaire consisting of four demographic questions and ten questions pertaining to sunscreen knowledge and use was distributed to students at the beginning of a full class. Questionnaires that were not at least ninety percent complete were excluded. All available students in the college of pharmacy in years one, two, and three were invited to participate. Main Results: Based on the survey analysis, 75% of pharmacy students have insufficient knowledge of FDA-approved use and guidelines for this class of OTC drugs. Conclusions: A need for training/instructional measures that aim at increasing adequate drug competency and consumer counseling skills has been identified in the area of FDA-regulated sunscreen products. An opportunity for an increased involvement of professional pharmacists in optimizing consumers' sunscreen selection and use has been identified.

Direct-to-Consumer advertisements allow pharmaceutical companies to advertise prescription drugs directly to consumers. Increasingly, marketing executives employed by pharmaceutical companies are shifting the focus of these advertisements from promoting the drug as a product, to promoting illness in general. Pharmaceutical companies defend this movement saying the advertisements have an educational function to "inform" consumers.

Class of 2015 Abstract / Objectives: To retrieve data from RCTs for lorcaserin and phentermine and topiramate combination on weight loss, BMI reduction, and other factors from the placebo groups and to determine if there is a difference in weight loss between those groups. Methods: Design: Meta-analysis Inclusion criteria: RCTs that compared lorcaserin or phentermine/topiramate to placebo as submitted to the FDA and posted to the FDA website. The studies needed to report weight loss or BMI values at baseline and post-treatment. Measures: The primary dependent variables were weight lost in kilograms, change in BMI, and percent who achieved 5% weight loss in the placebo arm. Data Collection: A standardized data collection form was used to extract data from the selected trials. Data was independently extracted by 3 researchers and discrepancies were resolved by consensus. Data Analysis: Data was analyzed by constructing a forest plot of the amount of weight lost in the placebo arm stratified by type of drug. A funnel plot and Kendall’s tau were used to assess publication bias. Heterogeneity was assessed with I2. The a priori alpha level was 0.05. Results: Statistically significant weight loss was achieved in the placebo arm in all 6 RCTs Weight loss was consistent across type of study Lorcaserin studies, mean = 2.42 kg Phentermine/topiramate studies, mean = 2.14 kg Overall rate of 5% weight loss was 0.32 No data was reported on actual caloric intake or actual quantity of exercise Funnel plot and Kendall’s tau (p = 0.85) indicated there was no publication bias There was heterogeneity in the lorcaserin studies resulting from one study reporting a large effect Conclusions: Participants in the placebo arm lost weight with monthly counseling on calorie intake and exercise, however, actual caloric intake or quantity of exercise that resulted in the weight loss is unknown.

Class of 2015 Abstract / Objectives: To characterize the types of renal dosing recommendations provided in the prescribing information (aka package insert) before and after the FDA guidance for industry document regarding renal dosing, released in 1998. Methods: The prescribing information (PI) for all new molecular entities (NMEs) for three time periods was collected from the FDA website. Time period 1 was January 1995 to December 1997 and represents dosing recommendations prior to the FDA guidance statement. Time period 2 was January 2000 to December 2002 and time period 3 was January 2011 to December 2013. These represent recommendations after the FDA guidance statement. The renal dosing recommendations for each NME were reviewed and classified as either specific (includes CrCl, serum creatinine), nonspecific (mild, moderate, or severe impairment), caution, unnecessary, no information or other by two investigators independently. A further analysis was conducted for NMEs in time periods 1 and 2 with LexiComp and the most recent PIs located on FDA or company website. Presence of dialysis (hemodialysis or peritoneal) dosing recommendations was also recorded. Results: Time period 1 had significantly less NMEs characterized as No information in Lexicomp in comparison to original PIs (p= 0.02). A statistically significant decrease in original PIs characterized as Caution was observed between time periods 2 and 3 (p= .0004) and time periods 1 and 3 (p= 0.001). Conclusions: Terminology used in renal dosing recommendations in PIs does not seem to be clearer over the past years. There remains a need for improved quality of dosing information within PIs.

Polyetheretherketone (PEEK) is a Federal and Drug Administration (FDA) approved biomaterial that has been used as an orthopedic implant material due to its inherent properties. Laser etching has become a popular means to create identication markers on the individual implants as required by the FDA. The interaction of laser energy with polymeric materials could potentially cause changes in the material's biocompatibility and mechanical properties. The objective of this study was to determine the effect of laser energy on the biocompatibility and mechanical properties of implantable PEEK by measuring contact angle, micro-tensile testing, nite-element modeling (FEM), and biocompatibility testing according to International Organization for Standardization (ISO) 10993 for cytotoxicity. The results of the study showed that the etching characteristics were mostly in by the laser power and the laser pulse spacing. The mechanical properties were degraded by the laser and the tensile strength of the material was decreased by 50% is some cases. The laser, however, did not affect the biocompatibility. The biocompatibility testing of the material showed no cytotoxic effect using an agar overlay method. The contact angle measurements demonstrated that the laser etching produced a hydrophobic effect to the surface. The FEM model demonstrated a good correlation between the laser power and the vaporization of the PEEK material. The results of the study showed the effect of laser energy on biocompatibility and mechanical properties.