ASHP Guidelines on the Pharmacy and Therapeutics Committee and the Formulary System

Ciccarello, Christy; Leber, Molly Billstein; Leonard, Mandy C.; Nesbit, Todd; Petrovskis, Mary G; Pherson, Emily; Pillen, Heidi A; Proctor, Celia; Reddan, Jennifer G.

doi:10.1093/ajhp/zxab080

Cited by 17 publications

(16 citation statements)

References 19 publications

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“…The pharmacy department is not presently competent for relevant responsibilities. Thus, the cooperation of medical and other departments is needed to determine the division of labor and truly ensure the smooth development of rational drug use hospital-wide ( Björkman et al, 2007 ; Ciccarello et al, 2021 ). The joint efforts and full cooperation of all members of the DTC are the basis for effective rational drug use ( Alefan et al, 2019 ).…”

Section: Discussionmentioning

confidence: 99%

Drug and therapeutics committee interventions in managing irrational drug use and antimicrobial stewardship in China

Yang

Zheng²,

Guan³

et al. 2022

Front. Pharmacol.

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Aim: This study aimed to investigate the key points in the transformation of the functions of the Drug and Therapeutics Committee (DTC) of the Shandong Provincial Third Hospital and how to provide full authority to its role in the control of rational drug use, especially in the management of antibiotic use.Method: A prescription review management group, antimicrobial stewardship group, and rational drug use service group were established under the DTC. From January 2016 to December 2021, each group played a role in promoting rational drug use and antimicrobial stewardship. In addition, we performed statistics on typical management cases, irrational drug use, bacterial resistance rate, and drug costs from 2015 to 2021 to evaluate the effect of management by the DTC.Results: Intervention by the DTC led to a significant reduction in prescribing errors (71.43%, p < 0.05), the intervention acceptance rate increased by 16.03%, and the problem solved rate increased by 32.41% (p < 0.05). Resistance rates of general spectrum antibiotics were reduced remarkably after the intervention. The quality of drug treatment was improved and patient drug expenses was continuously reduced.Conclusion: Giving full play to the functions of the DTC can significantly improve the level of drug treatment and reduce unreasonable drug use to save unnecessary drug expenses and slow the development of drug resistance.

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Section: Discussionmentioning

confidence: 99%

Drug and therapeutics committee interventions in managing irrational drug use and antimicrobial stewardship in China

Yang

Zheng²,

Guan³

et al. 2022

Front. Pharmacol.

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“…Members of institutions evaluating biosimilars should be able to understand the differences between generic drugs and biosimilars. 3,[10][11][12] Table 1 presents a comparison between generics and biosimilars. 13,14…”

Section: Development Of Institutional Guidementioning

confidence: 99%

“…In addition to the standard considerations of formulary management, there are specific day-to-day formulary questions to be answered such as: which biosimilar to introduce among many approved biosimilar for a reference product; whether to keep the reference product and biosimilar in the formulary; how to make decisions on interchangeability of products; what are main considerations for pharmacoeconomic, pharmacovigilance assessments; and how to educate patients, and healthcare providers. 10 Therefore, we aim to present an institutional guide to inform these formulary decisions.…”

Section: Introductionmentioning

confidence: 99%

An Institutional Guide for Formulary Decisions of Biosimilars

et al. 2022

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Biologics have changed the landscape for the management of many debilitating chronic diseases but account for a significant expenditure of medications globally. Fortunately, advances in technology paved the way for the introduction of biosimilars, which are highly similar to the originator biologics. In the quest to reduce the budget impact of biologics, organizations have begun to adopt biosimilars. Institutions evaluating biosimilars for inclusion in the hospital formulary must make informed formulary decisions by conducting a thorough review of key elements for evaluation of biosimilars and address the multidimensional aspects during the selection process of different biosimilar products. Therefore, we aim to present an institutional guide of these elements to inform formulary decisions. These key elements include biosimilar evaluation for formulary addition; regulatory approval; substitution, interchangeability, and switching; extrapolation; product characteristics, manufacturing, and supply chain issues; pharmacoeconomic evaluations; traceability, nomenclature, and coding; education; and pharmacovigilance.

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“…7 A drug formulary is a continually updated list of medications and related information representing the clinical review of experts in the management of diseases and health promotion. 8 Previously, the supply chain department in MOH processed all nonformulary medication (NFM) requests without clinical review of medication appropriateness and efficacy compared with the available formulary medication. There were few pharmacists working in the supply chain, but the majority were purchasers focusing on procurement and inventory management.…”

Section: Introductionmentioning

confidence: 99%

The outcomes of a national clinical review process for nonformulary medication requests in Saudi Arabia

Khardaly

Almudaiheem

Alkhnaizi

et al. 2022

J Am Coll Clin Pharm

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Background Medications often constitute a significant percentage of health care budgets; therefore ensuring rational medication use is essential. In December 2017, the Saudi Ministry of Health (MOH) introduced a national clinical review process for nonformulary medications (NFMs) requests across 284 MOH institutions to standardize review and approval process under the governance of Pharmacy and Therapeutics Committee (PTC). Objectives This study aims to describe the effectiveness of implementing a national clinical review process for NFMs on the approval rate, decision turnaround time, and potential cost savings within MOH institutions. Methods This was a retrospective, observational cohort study undertaken over 36 months. All NFM requests were received through an electronic system, linking all the ministry's regions and departments with a single coding system. Quantitative descriptive statistics: frequency, percentage, median, and interquartile range were used to present the results of this study. A P value ≤.05 was considered statistically significant. Results The approval rate among a total of 2388 NFM requests was 1733 (74%). The median submission turnaround time for NFM requests in 2018 to 2020 were 12.5 (interquartile range [IQR]: 5‐24), 7 (IQR: 3‐15), and 7 (IQR: 4‐14) working days, respectively (P ≤ .001). The median decision turnaround time for NFM requests in 2018 to 2020 were 7 (IQR: 4‐10), 5 (IQR: 3‐9), and 5 (IQR: 4‐8) working days, respectively (P = .019). Of the 615 disapproved requests, 514 (83.6%) were disapproved for a single reason. Moreover, disapproval of requests equated to a potential cost savings which exceeded 14.8 million United States dollars. Conclusions This initial study showed that implementing a structured, systematic review process for NFM requests resulted in potential cost savings and acceptable turnaround times for nonurgent requests. However, further studies are needed to examine the actual cost savings and clinical impact on patient outcomes.

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ASHP Guidelines on the Pharmacy and Therapeutics Committee and the Formulary System

Cited by 17 publications

References 19 publications

Drug and therapeutics committee interventions in managing irrational drug use and antimicrobial stewardship in China

Drug and therapeutics committee interventions in managing irrational drug use and antimicrobial stewardship in China

An Institutional Guide for Formulary Decisions of Biosimilars

The outcomes of a national clinical review process for nonformulary medication requests in Saudi Arabia

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