Pharmacy Administration, Policy and Regulation Commons^™

Analysis Of Pharmacotherapy And Non-Pharmacotherapy Burden From The Ina-Cbgs Package For Cesarean Section Surgery At The Regional General Hospital Dr. Soedarso In 2023, Ananda Rizky Awwaliyah, Nurmainah Nurmainah, Ridha Ulfah

Pharmacology and Clinical Pharmacy Research

The prevalence of cesarean sections has been increasing each year. Previous studies show that the cost of medications and medical supplies for cesarean patients accounts for one-third of the total care costs. In the era of National Health Insurance (NHI), medications and medical supplies are considered operational expenses for hospitals rather than sources of income. This condition requires proper medication management and the use of medical supplies. This study aims to analyze the percentage of pharmacotherapy and non-pharmacotherapy, including the types and quantities of medications as well as disposable medical supplies used on patients undergoing cesarean section procedures at the …

Medicare Drug Price Negotiation Program Draft Guidance, Fred Ledley M.D., Edward Zhou Pharmd, Paula Chaves Da Silva Ph.D.

CISI Publication

This comment focuses on Section 50.1, provisions 1 & 3 of the draft guidance regarding the negotiation of a “maximum fair price” under the Inflation Reduction Act (IRA), research and development (R&D) costs of the primary manufacturer, and prior federal financial support for novel therapeutic discovery and development. Specifically, we argue that a negotiated, “maximum fair price” must consider both public sector (federal) and private sector (manufacturer) investments and provide returns to both commensurate with the scale and risk of their investments. This comment addresses three issues and makes specific recommendations regarding each:

1. In negotiating a “maximum fair price,” both …

Association Between Expedited Review Designations And The Us Or Global Burden Of Disease For Drugs Approved By The Us Food And Drug Administration, 2010–2019: A Cross-Sectional Analysis, Matthew J. Jackson, Gregory Vaughan, Fred D. Ledley

Natural & Applied Sciences Faculty Publications

Pharmaceutical innovation can contribute to reducing the burden of disease in human populations. This research asks whether products approved by the US Food and Drug Administration (FDA) from 2010 to 2019 and expedited review programmes incentivising development of products for serious disease were aligned with the US or global burden of disease.

Artificial Intelligence Is Revolutionizing Controlled Substance Diversion Detection, Brian Cox, Alberto Coustasse, Craig Kimble

Management Faculty Research

In community and institutional health care sectors, artificial intelligence (AI) use is expanding. AI is being tapped broadly in operations, customer service, and scheduling, with major pharmacy chains such as Kroger, CVS, and Walgreens, already starting to implement AI applications in their pharmacies. So far, Kroger has begun to use AI for employee onboarding and training processes, CVS is applying AI in negotiations with suppliers, and Walgreens is using it to streamline vaccine scheduling. With these advances in major pharmacy chains, the next extensive application for AI has become clearer: diversion monitoring. Diversion occurs in health care settings when a …

Keeping An Eye On The Fda, Rodney Richmond

Faculty Research ​and Publications

No abstract provided.

Making Do In Making Drugs: Innovation Policy And Pharmaceutical Manufacturing, W. Nicholson Price Ii

Law Faculty Scholarship

Despite increasing recalls, contamination events, and shortages, drug companies continue to rely on outdated manufacturing plants and processes. Drug manufacturing’s inefficiency and lack of innovation stand in stark contrast to drug discovery, which is the focus of a calibrated innovation policy that combines patents and FDA regulation. Pharmaceutical manufacturing lags far behind the innovative techniques found in other industries due to high regulatory barriers and ineffective intellectual property incentives. Among other challenges, although manufacturers tend to rely on trade secrecy because of the difficulty in enforcing patents on manufacturing processes, trade secrecy provides limited incentives for innovation. To increase those …