Pharmacy Administration, Policy and Regulation Commons^™

Comments Re: Commonsense Policy Options To Lower Drug Prices For Patients, Fred D. Ledley M.D., Edward Zhou Pharm. D.

CISI Publication

Thank you for the opportunity to provide written comment in response to the Senate Finance Committee Minority Staff’s “Request for Information: Commonsense Policy Options to Lower Drug Prices for Patients.” We are answering as academic researchers with experience in medicine and the biopharmaceutical industry. This comment will focus on sections I and III of the RFI.

We applaud the accomplishment of the Inflation Reduction Act (IRA) in establishing the precedent for the government to negotiate “fair market” prices for drugs on terms that address both patients’ needs for affordability and industry’s need for a reasonable return on investment. Our analysis …

Comments Re: Medicare Drug Price Negotiation Program And Medicare Prescription Drug Benefit Program, Fred D. Ledley M.D., Edward Zhou Pharm. D.

CISI Publication

Thank you for the opportunity to provide written comments in response to the Medicare Drug Price Negotiation Program proposed rule published on June 16, 2026 in the Federal Register. [1] We are answering as academic researchers with experience in medicine, pharmacy, biomedical research, and the biopharmaceutical industry. Our perspective is informed by extensive, published research on the economics and finance of pharmaceutical innovation, the value created by new medicines, and the impacts of the Inflation Reduction Act (IRA).

We applaud the accomplishment of the IRA in establishing the precedent for the government to negotiate “fair market prices” for drugs on …

Enhancing Patient Understanding: Standardizing Cardiac Medication Education Using Teach-Back For Heart Failure, Nicole Valerie Hediger

Master's Projects and Capstones

Problem: The transition from hospital to home places heart failure (HF) patients at risk for medication errors, nonadherence, deterioration, and rehospitalization. In a 28-bed medical-surgical telemetry microsystem, Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) scores indicated an opportunity for improvement: “Communication About Medicines” composite score of 47.9%; 62.5% of patients reported being informed about the medication purpose, and 33.3% reported that staff described potential side effects.

Context: A cohort of HF patients was selected to test teach-back methodology and improve patient understanding. Nurse champions volunteered for a 5-month improvement project.

Interventions: Teach-back methods were implemented. Nurse leader rounding …

Evaluation And Continuation Of Oncology Nurse Mentorship Program, Gurpreet K. Kang

Master's Projects and Capstones

Problem: Newly hired nurses on a busy inpatient leukemia and lymphoma subspeciality unit experienced challenges after transitioning into specialty oncology practice. This resulted in decreased confidence, increased risk of medication errors, and a 40% unit-based annual turnover rate. The cost of replacing one staff nurse is $61,000.  Exit interviews determined root causes of turnover rates, nurse confidence.

Context: A quality improvement program was envisioned to optimize patient and organizational outcomes on a 25-bed inpatient unit to evaluate and sustain an oncology nurse mentorship program.

Interventions: Over one year, cohort 1 (n=8) and follow up 2^nd cohort (n=7) was implemented …

Analisis Pengelolaan Persediaan Obat Menggunakan Integrasi Abc–Fsn Dan Economic Order Quantity (Eoq) Di Rsud Haji Provinsi Jawa Timur, Rina Kartika Sari, Irwan Syahrir, Musa Gufron

Jurnal Ekonomi Kesehatan Indonesia

This study aims to analyze the performance of pharmaceutical inventory at RSUD Haji, East Java Province using an integrated ABC–FSN and Economic Order Quantity (EOQ) approach. A quantitative descriptive method was employed using secondary data from 560 drug items during January–December 2025. ABC analysis was used to identify the concentration of investment value, while FSN analysis was applied to evaluate drug movement patterns. Furthermore, EOQ was utilized to determine the optimal order quantity to minimize total inventory costs. The results show that the majority of inventory value is concentrated in category A (70.08%) and is dominated by fast-moving items (89.15%). …

Strategies For Improving The Drug Importation Control System In Thailand: A Qualitative Investigation, Neeranart Potiyanon, Suntaree Watcharadamrongkun

The Thai Journal of Pharmaceutical Sciences

Background: Drug importation plays a critical role in Thailand’s healthcare system; however, barriers affecting its regulatory control and their public health implications remain inadequately examined. This study compared international drug importation procedures and evaluated Thailand’s control system with strategies for improvement.
Methods: Conducted in Bangkok between 2020 and 2023, this two-phase study employed a qualitative design. Phase 1 involved content analysis comparing drug importation procedures across Thailand, Singapore, Australia and the United States to identify best practices and potential solutions. Phase 2 utilized semistructured, in-depth interviews with 19 key informants from government and private-sector agencies. Data collection was guided by …

Evaluating The Market Withdrawal Of Andexanet Alfa, Jordyn Linfield, Addisyn Cooper, Alexander Defranco, Emma Gerding, Jessica Kelley, Tyler Henney, Connor Dains, Brenna Hissong, Brittany Bates

Pharmacy and Wellness Review

The coagulation cascade comprises intrinsic, extrinsic, and common pathways that converge when thrombin converts fibrinogen (factor I) into fibrin, leading to fibrin mesh formation, stabilization of the platelet plug, and ultimately thrombus formation. Inhibition of the coagulation cascade can be achieved with a variety of anticoagulant medications, including direct oral anticoagulants (DOACs). The mechanism of action of DOACs is to inhibit either factor Xa or thrombin. Reversal of anticoagulation remains an important clinical consideration when managing patients on DOACs who experience serious bleeding events. Andexanet alfa is a recombinant, modified human factor Xa protein previously indicated for patients receiving rivaroxaban …

Quality Improvement (Qi) Project Aimed At Reducing Unnecessary Antibiotic Usage Among Older Adult Patients By Addressing Inappropriate Antibiotic Prescribing In Primary And Long-Term Care Settings, Pamela M. Thomas

Seton Hall University Dissertations and Theses (ETDs)

Antibiotic overuse among older adults remains a significant patient safety and public health concern. Recent national data indicate that approximately 30%–50% of outpatient antibiotic prescriptions may be unnecessary, particularly for viral or self-limiting conditions (Chua et al., 2021). Antimicrobial resistance has been associated with more than 1.27 million deaths globally (Murray et al., 2022). This quality improvement project evaluated a multifaceted antimicrobial stewardship intervention in primary and long-term care settings. Baseline review of 167 antibiotic cases revealed 37.1% were inappropriate or questionable, and 28.7% lacked adequate diagnostic documentation. The intervention incorporated provider education, electronic health record decision-support tools, audit and …

Quantifying Black Carbon Concentrations In Georgia And Analyzing Associated Public Health Risks, Khloe R. Osborne

Honors Theses

Quantifying Black Carbon Concentrations in Georgia and Analyzing Associated Public Health Risks

One of the most daunting challenges of the industrial world is air pollution. Within this broad spectrum, there is an inhalable particle group named PM2.5, which contains black carbon. Black carbon has evidence that supports the generation and worsening of adverse health impacts, which may include birth complications, cognitive deficits in children, pulmonary aggravation, asthma, cardiovascular issues, neurological degenerative patterns, and cancer risk. This is especially seen in vulnerable populations, like children, elderly, and those who already suffer from weakened health, many of which reside in the southern …

"First, Do No Harm": Ethical Failures And Preventive Solutions In The United States Pharmaceutical System - A Narrative Review, Rebekah R. Bailey

Honors Theses

The United States pharmaceutical system is highly advanced but faces growing ethical concerns related to drug development and marketing, overprescription, and high drug costs. This thesis examines how pharmaceutical marketing, regulatory practices, and prescribing behaviors may conflict with the ethical principle of “first, do no harm.”

Using a narrative review of interdisciplinary literature in public health, medical ethics, and applied ethics, this thesis analyzes patterns in drug development, marketing strategies, and regulatory oversight. The findings suggest that ethical issues are systemic, driven by commercial incentives, inconsistent regulatory standards, and an increasing reliance on pharmaceutical solutions. These factors contribute to overmedicalization, …

The Impact Of Patient Navigation On The Hepatitis C Care Continuum In Underserved Populations: A Scoping Review, Deauntaye Jones

Honors Theses

Hepatitis C virus (HCV) remains a significant public health concern and is a leading cause of cirrhosis, hepatocellular carcinoma, and liver transplantation when left untreated. Although direct-acting antiviral therapies have made HCV curable for most patients, many underserved populations continue to experience barriers to diagnosis, linkage-to-care, treatment completion, and sustained virologic response (SVR). This study evaluated how patient navigation programs influence progression through the HCV care continuum among underserved populations. Relevant studies published between 2014 and 2025 were identified through searches of PubMed and Embase using terms related to HCV, patient navigation, linkage-to-care, underserved populations, and treatment outcomes. Following title, …

Tale Of Two Pharmacies, Katie R. Jadin

Honors Theses

Community pharmacists are among the most accessible healthcare providers in the United States and play an increasingly important role in improving patient outcomes. This study observes whether geographical distance and demographic differences influence patient healthcare needs within community pharmacy settings. Communities in Wisconsin and Mississippi, approximately 800 miles apart, were compared due to differences in population demographics, socioeconomic factors, and disease burden.

A survey was distributed to community pharmacy employees, including pharmacists, pharmacy interns, and pharmacy technicians, to assess common disease states, medication patterns, pharmacy workload, and patients' barriers to care. Twelve responses were collected from pharmacy employees.

Despite the …

Navigating The Gray Area: The Unregulated Surge Of Unique Glp-1 And Glp-1/Gip Products, Jordyn Belcourt, Amy Sapowadia, Charles Michael White

Honors Scholar Theses

Purpose: To identify unique compounded semaglutide and tirzepatide products that existed after the shortage grace period ended and to assess their characteristics.

Methods: Researchers searched for compounding pharmacies using specific terms on Google. They collected the formulation, ingredients, dosage, and monthly cost of products. Researchers also contacted compounding company websites with available information to ascertain further information about products.

Results: Researchers identified 26 sites selling a total of 86 semaglutide or tirzepatide products. Of the included products, 33 were unique, and 41 products were essentially copies of FDA-approved products. Unique formulations included sublingual solution (n=9), sublingual tablets (n=5), and orally …

Comparative Analysis Of The Quality Of Life Of Schizophrenic Patients On Antipsychotic Treatment Between Aripiprazole Monotherapy And Combination Of Risperidone-Clozapine At Mental Hospital In West Java, Taufiqurahman Taufiqurahman, Sani Asmi Ramdani Lestari, Ardilla Kemala Dewi

Pharmacology and Clinical Pharmacy Research

Quality of life (QoL) is a critical outcome measure in schizophrenia management, yet antipsychotic side effects may negatively impact patients' well-being. Objective: This study aimed to compare the QoL of schizophrenia patients receiving aripiprazole monotherapy versus a risperidone-clozapine combination at West Java Mental Hospital. An analytical observational study with a cross-sectional design was conducted at the outpatient clinic of West Java Mental Hospital from March to May 2025. The Indonesian version of the WHOQOL-BREF questionnaire was used to assess QoL. A total of 58 outpatients with schizophrenia who met the inclusion criteria were enrolled, comprising 28 patients in the aripiprazole …

Balanced Scorecard In Healthcare Facilities: A Ten-Year Review Of Strategies To Improve Organizational Effectiveness, Larasati Tunggadewi, Sofa Dewi Alfian, Auliya A Suwantika

Pharmacology and Clinical Pharmacy Research

The Balanced Scorecard (BSC) has increasingly been adopted as a strategic performance management framework within healthcare organizations. Evidence from the past decade shows varied implementation outcomes, shaped by institutional readiness, leadership commitment, and the maturity of health information systems. This narrative review synthesizes findings from 47 scientific articles selected through a systematic screening process, covering studies conducted in hospitals, primary health centers, and pharmacy units in Indonesia, Morocco, Iran, China, and other countries. The studies employed case study and descriptive cross-sectional designs using both quantitative and qualitative approaches. Overall, BSC implementation contributed to improvements in service performance across the financial, …

Adherence To Malaria Treatment And Its Associated Factors: A Narrative Review, Lafie Urwatul Wutsqo, Eli Halimah, Sofa Dewi Alfian

Pharmacology and Clinical Pharmacy Research

Malaria is an infectious disease that remains a global health concern, particularly in Asia and Africa. The success of malaria medication largely depends on patients' adherence to the prescribed therapeutic regimen. This article aims to identify the level of adherence to malaria treatment and the factors that influence it, based on observational studies. A narrative review was conducted using the PRISMA approach, involving 12 articles published between 2019 - 2023 from various countries. The results indicate that adherence levels vary widely, ranging from 15.6% to 93.31%, depending on respondent characteristics and the intervention strategies implemented. Factors influencing adherence include patient-related …

Evaluation Of Drug Use In Inpatient Care: A Retrospective Study At A Tertiary Hospital In Bandung, Indonesia (2024), Aliya Rosyidah Fitrianti, Athoya Delarosa, Husna Muharram Ahadi, Imam Adi Wicaksono, Falerina Puspita

Pharmacology and Clinical Pharmacy Research

Rational drug use is a critical component of improving healthcare quality. However, irrational prescribing remains a significant concern, particularly in developing countries like Indonesia. This study evaluates drug use patterns at a Type B hospital in Bandung using WHO standard: average number of drugs per prescription, percentage of generic drugs, antibiotics, injections, and adherence to the National Formulary. A retrospective, descriptive observational method was applied, using 2024 inpatient Drug Use Evaluation (DUE) data. Findings reveal an average of 3.4 drugs per prescription—slightly above the WHO standard (≤ 3.3); 68.4% of prescriptions used generic drugs (meeting the WHO standard ≥ 59%); …

Comparison Of Chop And R-Chop For Treatment Non-Hodgkin Lymphoma, Yogyakarta, Indonesia: A Cost-Effectiveness Analysis, Woro Supadmi, Rizky Gustinanda, Lalu M. Irham, Riat El Khair

Pharmacology and Clinical Pharmacy Research

CHOP and R-CHOP are commonly used chemotherapy regimens for Non-Hodgkin Lymphoma (NHL). While R-CHOP has demonstrated clinical benefits, its higher cost raises concerns regarding economic efficiency, particularly in middle-income countries such as Indonesia. This study aimed to compare direct medical costs and clinical outcomes of CHOP and R-CHOP regimens among NHL patients treated at a national referral hospital in yogykarta. A retrospective cohort study was conducted using medical record data of NHL patients who received CHOP or R-CHOP chemotherapy at Dr. Sardjito General Hospital Yogyakarta, between 2020 and 2023, with follow-up extended until April 30, 2025. Clinical outcomes included overall …

Exploring Protein-Protein Interactions: A Promising Avenue For Biomarker And Anti-Tb Drug Development, Rajwa Dwifauza Suryanto, Maritsa Widati Aqila Rumawan, Imam Adi Wicaksono

Pharmacology and Clinical Pharmacy Research

In 2023, tuberculosis (TB) reached its highest incidence with 8.2 million new cases reported by the World Health Organization (WHO). The virulence of Mycobacterium tuberculosis (MTB) is strongly governed by protein-protein interactions (PPIs) that regulate essential processes such as cell wall biosynthesis, immune evasion, and persistence. This study aims to map and analyze the mechanisms of key PPIs in MTB using a scoping review approach. Data was retrieved from PubChem and related literature with the keyword ``PPIs Network TB''. Our findings highlight crucial PPI-driven mechanisms, including the role of DprE1/DprE2 in arabinogalactan synthesis, VapB4/VapC4 in stress response and self-toxicity, ESX-1 …

Low To Moderate Intensity Home-Based And Online Exercise For Cognitive Health In Older Adults: A Narrative Review, Novita Salim, Melisa Intan Barliana, Anna Meiliana

Pharmacology and Clinical Pharmacy Research

Cognitive decline represents one of the most pressing public health challenges associated with global population ageing, prompting growing interest in accessible and scalable exercise-based interventions. This narrative review synthesizes evidence from 15 randomized controlled trials to compare the cognitive effects of 3 exercise modalities in older adults across varying cognitive and functional profiles: conventional aerobic and resistance training, exergame-based interventions, and dual-task or multicomponent training. Interventions were evaluated on their capacity to improve global cognition, executive function, working memory, and attention, with additional consideration of adherence, supervision format, and implementation feasibility. The evidence consistently demonstrates that dual-task and multicomponent training …