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India is one of the top producers of generics globally and is currently being recognized as the "pharmacy of the world" for the generic drug products. Thus, there is a need that it has best health-care systems in place to regulate and provide better quality drugs by monitoring the possible risk associated with the use of drugs. Being the generic hub, physicians, pharmacists, etc., should be erudite to provide an alternative cost-effective generic medicine, which is one of the education-related aspects of pharmacovigilance. We need a more systematic approach to surveillance of drug-related problems, which is at the heart of pharmacovigilance. The health-care system requires new processes to understand the risk-benefit ratio of drugs. The challenges in implementation of better pharmacovigilance in country due to nonavailability of trained staff in pharmacovigilance, lack of training of health-care professionals on drug safety, and adverse drug reaction reporting which comprises adverse interactions of medicines with chemicals, other medicines, and food are often neglected leading to under-reporting by health-care professionals as well as patients, lack of expertise, etc., should be overcome by Indian regulatory body via practical oriented knowledge-based system. The web market monitoring, global electronic database, education, association of stakeholders and regulation of herbal medicines standards and allied medicinal systems are vital restructurings needed to be introduced for a better pharmacovigilance system in India.

BACKGROUND: Cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors are changing the management of the patients with hormone receptor-positive/HER2-negative metastatic breast cancer (HR+/HER2- MBC). The addition of CDK4/6 inhibitors to endocrine therapy is more efficacious than endocrine therapy alone for HR+/HER2- MBC patients, but it is also more expensive. This cost-effectiveness analysis study was designed to evaluate the economic value of adding CDK4/6 inhibitors to letrozole, an aromatase inhibitor. OBJECTIVE: We aimed to evaluate the cost-effectiveness of abemaciclib plus letrozole or ribociclib plus letrozole or palbociclib plus letrozole versus letrozole monotherapy in the first-line treatment of HR+/HER2− MBC in the United States. METHODS: We constructed a Markov-based decision-analytic model using TreeAge Software LLC, Cambridge, MA. Our model simulates lifetime costs and health outcomes over a 40-year lifetime horizon from a third-party payer perspective. The model incorporated the clinical course of a progression-free or stable disease, progressed disease, death, Neutropenia as a major adverse effect, and cancer-specific mortality. All clinical and utilities data were derived from the literature and clinical trials, including PALOMA-2, MONALEESA-2, and MONARCH-3. For consistent comparison, only letrozole specific data was derived from MONARCH-3. Outcomes were measured by costs, quality-adjusted life-years (QALYs), incremental cost-effectiveness ratios (ICERs). Deterministic and probabilistic sensitivity analyses were performed to evaluate the robustness of the results against uncertainties in the model parameters. RESULTS: In our base case, the total health care costs for Palbociclib, Ribociclib, and Abemaciclib plus letrozole were $680,596, $ 676,292, and $ 635,606, respectively while the cost of letrozole monotherapy was $162,378. Palbociclib plus letrozole and Ribociclib plus letrozole were dominated strategies by Abemaciclib plus letrozole. Higher QALYs was associated with Abemaciclib plus letrozole (6.91 QALYs vs 5.83 QALYs for letrozole). Compared to letrozole monotherapy, Abemaciclib plus letrozole resulted in ICER of $ 436,855 per QALY. At willingness-to-pay thresholds of $100,000 per QALY gained, none of the strategies was found to be cost-effective. Letrozole monotherapy was the optimal choice. The model was sensitive to certain parameters such as cost of Abemaciclib, and transition probability of stable to the progressed state for Abemaciclib and letrozole. Base case results were consistent with the findings from the Monte Carlo simulation. CONCLUSIONS: Our study found that none of the CDK4/6 inhibitors were cost-effective. Because of the current cost of CDK4/6 inhibitors, letrozole monotherapy was found to be an optimal choice for the first-line treatment of HR+/HER2- MBC. Citation Format: Prajakta P. Masurkar, Haluk Damgacioglu, Ashish Deshmukh, Meghana Trivedi. Cost-effectiveness of CDK4/6 inhibitors in the first-line treatment of HR+/HER2- metastatic breast cancer in postmenopausal women in the United States [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2021; 2021 Apr 10-15 and May 17-21. Philadelphia (PA): AACR; Cancer Res 2021;81(13_Suppl):Abstract nr 891.

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Objective: This study evaluated medication counseling procedures and trends at retail pharmacies in the Houston metropolitan area through a naturalistic observational study. Methods: A blinded cross-sectional observational study was conducted at retail pharmacies in the Houston metropolitan area. Data were collected by trained observers utilizing an observational log, to record various parameters that could have an impact on the duration of patient-pharmacist interaction in a naturalistic pharmacy practice setting. Additionally, indicators of counseling such as utilization of the counseling window and performance of show-and-tell were recorded. Statistical analyses included descriptive statistics, t-tests, Pearson correlations, ANOVAs, and multiple linear regressions. Results: One hundred and sixty-five interactions between patients and pharmacy staff were recorded at 45 retail pharmacies from 7 retail pharmacy chains. The counseling window was utilized in only 3 (1.81%) out of 165 observations and the show-and-tell process was observed in just 1(0.61%) interaction during this study. Mean (SD) interaction time between patient and pharmacists [159.50 (84.50)] was not statistically different (p>0.05) from the mean interaction time between patients and pharmacy technicians [139.30 (74.19)], irrespective of type of the retail chain observed. However, it was influenced by the number of patients waiting in queue. Patient wait time significantly differed by the time of the day the interaction was observed, weekends and weekdays had significantly different wait times and patient interaction times Multiple linear regression analyses indicated that, patient interaction time, pharmacy chain type, initial contact (pharmacist/technician), and time of the day, were significantly associated with patient wait time whereas patient wait time, pharmacy chain type, number of patients in queue, and number of pharmacy technician were significantly associated with interaction time. Conclusions: Our study found that the key indicators of counseling including the use of the counseling window and the show-and-tell process were absent, suggesting lack of adequate pharmacists counseling. Further studies are needed to evaluate the validity of this conclusion and the role of pharmacy services and its value towards medication use and safety.