Analysis of Compounded Pharmaceutical Products to Teach the Importance of Quality in an Applied Pharmaceutics Laboratory Course

Objective. To assess the effectiveness of a product-analysis laboratory exercise in teaching students the importance of quality in pharmaceutical compounding. Design. Second-year pharmacy students (N=77) participated in a pharmaceutical compounding laboratory exercise and subsequently analyzed their final product using ultraviolet (UV) spectrometry. Assessment. Reflection, survey instruments, and quiz questions were used to measure how well students understood the importance of quality in their compounded products. Product analysis showed that preparations compounded by students had an error range of 0.6% to 140%, with an average error of 23.7%. Students’ reflections cited common sources of error, including inaccurate weighing, contamination, and product loss during both the compounding procedure and preparation of the sample for analysis. Ninety percent of students agreed that the exercise improved their understanding of the importance of quality in compounded pharmaceutical products. Most students (85.7%) reported that this exercise inspired them to be more diligent in their preparation of compounded products in their future careers. Conclusion. Integrating an analytical assessment during a pharmaceutical compounding laboratory can enhance students’ understanding of quality of compounded pharmaceutical products. It can also provide students a chance to reflect on sources of error to improve their compounding technique in the future

Correlation between prescribing quality and pharmaceutical costs in English primary care: national cross-sectional analysis

Background Both pharmaceutical costs and quality-indicator performance vary substantially between general practices, but little is known about the relationship between prescribing costs and quality Aim To measure the association between prescribing quality and pharmaceutical costs among English general practices Design and setting Cross-sectional observational study using data from the Quality and Outcomes Framework and the Prescribing Analysis and Cost database from all 8409 general practices in England in 2005-2006 Method Correlation between practice achievement of 26 prescribing quality indicators in eight prescribing areas and related pharmaceutical costs was examined. Results There was no significant association between the overall achievement of quality indicators and related pharmaceutical costs (P= 0.399). Mean achievement of quality indicators across all eight prescribing areas was 79.0% (standard deviation 4.4%). There were small positive correlations in five prescribing areas: influenza vaccination, beta blockers, angiotensin converting enzyme inhibitors, lipid lowering, and antiplatelet treatment (all

International Cooperation in Pharmaceutical Research

This paper aims at examining whether an increased stringency of Intellectual Property Right (IPR) protection is apt to stimulate international cooperation on research projects between developed and emerging countries. To address this issue, we look both at scientific and technological collaborations within the pharmaceutical domain, and we adopt a gravity framework to assess the impact of the IPR level on bilateral R&D cooperation. The analysis is conducted using data from patent and publication databases, and the results provide a sound test of conflicting theories on IPR enforcement and international collaborations in pharmaceutical research.IPRs, pharmaceutical products, R&D cooperation

Does Public Scientific Research Complement Industry R&D Investment? The Case of NIH Supported Basic and Clinical Research and Pharmaceutical Industry R&D

This research investigates the hypothesis that publicly funded scientific research complements private R&D investment in the pharmaceutical industry. New microlevel data on public research investment by the U.S. National Institutes of Health allow measures of basic and clinical research in seven medical areas to be included in a distributed lag model explaining pharmaceutical R&D investment. Using a panel of therapeutic classes observed over eighteen years, the analysis finds strong evidence that public basic and clinical research are complementary to pharmaceutical R&D and, thereby, stimulate private industry investment. However, differences in the relevance and degree of scientific and market uncertainty between basic and clinical public research lead to differences in the magnitude and timing of the pharmaceutical investment response. The results indicate that a dollar increase in public basic research stimulates an additional 8.38 in pharmaceutical investment after eight years. The industry R&D response to public clinical research is smaller in magnitude and shorter in duration with a dollar increase in public clinical research stimulating an additional 2.35 in pharmaceutical investment over a three year period. --R&D,pharmaceuticals,NIH,distributed lag models

Is Taking a Pill a Day Good for Health Expenditures? Evidence from a Cross Section Time Series Analysis of 19 OECD Countries from 1970 – 2000

This paper differs in two ways from previous comparative health system research. First, it focuses on the impact of pharmaceutical expenditures on total health expenditures as trends in pharmaceutical expenditures have been blamed of being a major driver of national health expenditures. In addition to pharmaceutical expenditures, other variables of interest are income, public financing, public delivery, ageing and urbanization. Second, the analysis includes a thorough sensitivity analysis on the proposed model using four samples (with and without the US, and imputed and not imputed data) to address the issue of robustness. Based on a typology of health care systems, trends of relevant explanatory variables are described using OECD Health Data 2003 data. Unlike any other of the variables, pharmaceutical expenditures show contradicting trends when measured as per capita pharmaceutical expenditures and pharmaceutical share of total health expenditures. Next, a regression analysis is performed on data from 1970 – 2000 for 19 OECD countries. Regression diagnostics indicated the absence of multicollinearity but the presence of heteroscedasticity and autocorrelation. Based on the Hausman test, a fixed effect model was chosen. As in all previous empirical research, per capita GDP turned out to be the most influential explanatory variable. While public financing of health care was always three out of four samples significantly inversely related to health expenditures, public delivery as a NHS dummy was always significantly positively related to the dependent variable. Unlike previous research, ageing is consistently and significantly related to higher total health expenditures and, so is urbanization. Finally, all samples show a highly negative relationship between share of pharmaceutical expenditures and health expenditures, suggesting support for the substitution theory.health care expenditure ; health care system ; health economics ; health policy ; comparative

Learning from Semantic Inconsistencies as the Origin of Dynamic Capabilities in MNCs: Evidence from Pharmaceutical MNCs

This paper focuses on origins of dynamic capabilities in multinational corporations (MNCs). Building on literature in the area of organizational memory and organizational learning, we investigate factors that contribute to subsidiaries of MNCs ability to detach themselves from obsolete knowledge and practices. To construct the theoretical framework, 11 extensive interviews with marketing and sales executives from three pharmaceutical MNCs operated in Iran were conducted. We test our hypotheses using statistical quantitative analysis of data related to 459 observations from subsidiaries of 51 pharmaceutical MNCs during years 2005-2009. We examine the quality of corrective actions taken by subsidiaries of pharmaceutical MNCs subsequent to subsidiaries failing to meet expected performance objectives. Our findings confirm a moderating role for internationalization, span, and the composition of human resources on the quality of corrective actions pursued

Pan-Canadian Pharmaceutical Alliance (pCPA): Timelines Analysis and Policy Implications

© 2019 Salek, Lussier Hoskyn, Johns, Allen and Sehgal. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY).This analysis follows our recent study showing that Canadian public reimbursement delays have lengthened from regulatory approval to listing decisions by public drug plans and delayed public access to innovative medicines, mainly due to processes following the Common Drug Review (CDR) and the pan-Canadian Oncology Drug Review (pCODR). Public drug plans participate in a pan-Canadian Pharmaceutical Alliance (pCPA) joint negotiation process before making decisions about whether or not to reimburse a product reviewed through CDR and pCODR. This research aims to report the findings from a comprehensive analysis of pCPA process times, times to reimbursement by public payers in Canada, and to explore the opportunities to reduce total delays in public reimbursement with a specific focus on the pCPA process. An analysis was conducted of pCPA timelines with respect to making decisions about products and indications reviewed through CDR/pCODR, and focusses on three separate time components: time to begin negotiating, time spent negotiating, and time to implement the negotiation (i.e., time to list) in each of nine jurisdictions (i.e., 10 provinces of Canada, excluding Quebec). This study demonstrates the role of post-CDR/pCODR processes in large and lengthening delays to listing new medicines. Notably, oncology products have experienced the longest increases in time to begin negotiating and to complete negotiations. Trends in listing times post-pCPA across provinces are less clear, however, it appears that consistency in terms of timelines across provinces is not happening quite so smoothly for oncology products compared to non-oncology products. Listing rates also appear to be declining for non-oncology products, although this trend is less conclusive for oncology products. Challenges need to be addressed to improve efficiency, transparency, and ultimately reduce pCPA timelines and total timelines to public reimbursement. Suggested ways to improve and streamline the listing process are: (1) transparent target timelines and associated performance incentives for the pCPA and public plan decisions, (2) parallel HTA-pCPA processes to enable pCPA negotiations to start part-way through the HTA review and allow pCPA negotiation information to be fed back into the HTA review, and (3) innovative agreements that consider patient input and earlier coverage with real-world evidence development.Peer reviewedFinal Published versio

An economic analysis of spatial patterns of research and development in the pharmaceutical industry

Economic analysis of spatial patterns of research and development in pharmaceutical industr