Regional Disparity in First-in-Class Anticancer Drug Development in the US, EU, and Japan.

A cancer diagnosis is devastating for both patients and their caregivers. With high morbidity and mortality, cancer is a serious disease area with unmet medical needs. Thus, innovative anticancer drugs are in high demand worldwide but are unequally available. Our study focused on first-in-class (FIC) anticancer drugs and investigated their actual development situation in the United States (US), European Union (EU), and Japan over the last two decades to obtain fundamental information for understanding how the aforementioned demands are met, especially to eliminate drug lags among regions. We identified FIC anticancer drugs using pharmacological classes for the Japanese drug pricing system. Most FIC anticancer drugs were first approved in the US. The median approval time for anticancer drugs in new pharmacological classes during the last two decades in Japan (5072 d) was significantly different (p = 0.043) from that in the US (4253 d), though it was not significantly different from that in the EU (4655 d). Submission and approval lags between the US and Japan were more than 2.1 years, and those between the EU and Japan were more than 1.2 years. However, those between the US and the EU were less than 0.8 years. The development rate of FIC anticancer drugs in Japan is slower than in other regions. Even among developed countries, FIC anticancer drug lags exist. Considering the high impact of FIC anticancer drugs on society worldwide, we should work together to reduce drug lag among regions using an improved international cooperative framework.

Impact of a pharmaceutical care intervention on blood pressure control in a chain pharmacy practice.

BACKGROUND: Hypertension affects over 50 million Americans, with only 50% of patients being adequately controlled. Several pharmacist counseling and pharmacist-physician comanagement studies have documented that community pharmacist interventions improve blood pressure (BP) management. OBJECTIVE: To determine whether community pharmacists can improve clinical endpoints including hypertension control, drug therapy dosing, adherence to prescribed regimens, adverse drug reaction incidence, patient understanding, response to therapy, and quality-of-life. METHODS: The program included the education and training of a group of 18 chain community pharmacists in hypertension therapies, monitoring, and management. Protocols and documentation tools were based on nationally accepted clinical practice guidelines for hypertension in place at the time of the study. Pharmaceutical care (PC) was then compared with usual care (UC) over a 12-month period. RESULTS: The study initially enrolled 180 PC and 196 UC patients, with 44% (PC) and 32% (UC) of the patients reporting a final BP measurement. A larger proportion (50%) of PC patients who had poorly controlled hypertension at baseline (>140/90 mm Hg) were controlled compared with UC patients (22%). The average reduction in systolic BP was 9.9 mm Hg in PC patients compared with 2.8 mm Hg in UC patients (p < 0.05). Changes in diastolic BP were similar in the PC and UC groups. Based on patient self-report, PC patients were more likely to say that they take their medicines as prescribed compared with UC patients (p < 0.05). The 1- to 6-month antihypertensive adherence rate was higher in PC patients (0.91 +/- 0.15) compared to UC patients (0.78 +/- 0.30) (p = 0.02); there was no significant difference in adherence rate during the 7- to 12-month period. CONCLUSIONS: Community pharmacists can positively affect patient medication adherence during the 6-month period following counseling by a pharmacist along with an improvement in patient BP. However, there is much room for improvement in PC programs and in the number of patients who properly adhere to their medications.

A psychometric evaluation of an advanced pharmacy practice experience clinical competency framework.

OBJECTIVE: To assess the psychometric properties of the clinical competency framework known as the System of Universal Clinical Competency Evaluation in the Sunshine State (SUCCESS), including its internal consistency and content, construct, and criterion validity. METHODS: Sub-competency items within each hypothesized competency pair were subjected to principal components factor analysis to demonstrate convergent and discriminant validity. Varimax rotation was conducted for each competency pair (eg, competency 1 vs competency 2, competency 1 vs competency 3, competency 2 vs competency 3). Internal consistency was evaluated using Cronbach alpha. RESULTS: Of the initial 78 pairings, 44 (56%) demonstrated convergent and discriminant validity. Five pairs of competencies were unidimensional. Of the 34 pairs where at least 1 competency was multidimensional, most (91%) were from competencies 7, 11, and 12, indicating modifications were warranted in those competencies. After reconfiguring the competencies, 76 (94%) of the 81 pairs resulted in 2 factors as required. A unidimensional factor emerged when all 13 of the competencies were entered into a factor analysis. The internal consistency of all of the competencies was satisfactory. CONCLUSION: Psychometric evaluation shows the SUCCESS framework demonstrates adequate reliability and validity for most competencies. However, it also provides guidance where improvements are needed as part of a continuous quality improvement program.