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Keywords = implementation of pharmacoeconomics

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24 pages, 11841 KiB  
Review
From Drug Discovery to Drug Approval: A Comprehensive Review of the Pharmacogenomics Status Quo with a Special Focus on Egypt
by Fadya M. Elgarhy, Abdallah Borham, Noha Alziny, Khlood R. AbdElaal, Mahmoud Shuaib, Abobaker Salem Musaibah, Mohamed Ali Hussein and Anwar Abdelnaser
Pharmaceuticals 2024, 17(7), 881; https://doi.org/10.3390/ph17070881 - 3 Jul 2024
Cited by 3 | Viewed by 3931
Abstract
Pharmacogenomics (PGx) is the hope for the full optimization of drug therapy while minimizing the accompanying adverse drug events that cost billions of dollars annually. Since years before the century, it has been known that inter-individual variations contribute to differences in specific drug [...] Read more.
Pharmacogenomics (PGx) is the hope for the full optimization of drug therapy while minimizing the accompanying adverse drug events that cost billions of dollars annually. Since years before the century, it has been known that inter-individual variations contribute to differences in specific drug responses. It is the bridge to what is well-known today as “personalized medicine”. Addressing the drug’s pharmacokinetics and pharmacodynamics is one of the features of this science, owing to patient characteristics that vary on so many occasions. Mainly in the liver parenchymal cells, intricate interactions between the drug molecules and enzymes family of so-called “Cytochrome P450” occur which hugely affects how the body will react to the drug in terms of metabolism, efficacy, and safety. Single nucleotide polymorphisms, once validated for a transparent and credible clinical utility, can be used to guide and ensure the succession of the pharmacotherapy plan. Novel tools of pharmacoeconomics science are utilized extensively to assess cost-effective pharmacogenes preceding the translation to the bedside. Drug development and discovery incorporate a drug-gene perspective and save more resources. Regulations and laws shaping the clinical PGx practice can be misconceived; however, these pre-/post approval processes ensure the product’s safety and efficacy. National and international regulatory agencies seek guidance on maintaining conduct in PGx practice. In this patient-centric era, social and legal considerations manifest in a way that makes them unavoidable, involving patients and other stakeholders in a deliberate journey toward utmost patient well-being. In this comprehensive review, we contemporarily addressed the scientific leaps in PGx, along with various challenges that face the proper implementation of personalized medicine in Egypt. These informative insights were drawn to serve what the Egyptian population, in particular, would benefit from in terms of knowledge and know-how while maintaining the latest global trends. Moreover, this review is the first to discuss various modalities and challenges faced in Egypt regarding PGx, which we believe could be used as a pilot piece of literature for future studies locally, regionally, and internationally. Full article
(This article belongs to the Special Issue Pharmacogenomics - A Genetic Approach to Drug Therapy and Development)
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15 pages, 1351 KiB  
Article
Pharmacogenetic Guided Opioid Therapy Improves Chronic Pain Outcomes and Comorbid Mental Health: A Randomized, Double-Blind, Controlled Study
by Laura Agulló, Isidro Aguado, Javier Muriel, César Margarit, Alba Gómez, Mónica Escorial, Astrid Sánchez, Alicia Fernández and Ana M. Peiró
Int. J. Mol. Sci. 2023, 24(13), 10754; https://doi.org/10.3390/ijms241310754 - 28 Jun 2023
Cited by 14 | Viewed by 3291
Abstract
Interindividual variability in analgesic response is at least partly due to well-characterized polymorphisms that are associated with opioid dosing and adverse outcomes. The Clinical Pharmacogenetics Implementation Consortium (CPIC) has put forward recommendations for the CYP2D6 phenotype, but the list of studied drug-gene pairs [...] Read more.
Interindividual variability in analgesic response is at least partly due to well-characterized polymorphisms that are associated with opioid dosing and adverse outcomes. The Clinical Pharmacogenetics Implementation Consortium (CPIC) has put forward recommendations for the CYP2D6 phenotype, but the list of studied drug-gene pairs continues to grow. This clinical trial randomized chronic pain patients (n = 60), referred from primary care to pain unit care into two opioid prescribing arms, one guided by CYP2D6, μ-opioid receptor (OPRM1), and catechol-O-methyl transferase (COMT) genotypes vs. one with clinical routine. The genotype-guided treatment reduced pain intensity (76 vs. 59 mm, p < 0.01) by improving pain relief (28 vs. 48 mm, p < 0.05), increased quality of life (43 vs. 56 mm p < 0.001), and lowered the incidence of clinically relevant adverse events (3 [1–5] vs. 1 [0–2], p < 0.01) and 42% opioid dose (35 [22–61] vs. 60 [40–80] mg/day, p < 0.05) as opposed to usual prescribing arm. The final health utility score was significantly higher (0.71 [0.58–0.82] vs. 0.51 [0.13–0.67] controls, p < 0.05) by improving sleepiness and depression comorbidity, with a significant reduction of 30–34% for headache, dry mouth, nervousness, and constipation. A large-scale implementation analysis could help clinical translation, together with a pharmaco-economic evaluation. Full article
(This article belongs to the Special Issue Pharmacogenetics and Personalized Medicine 3.0)
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18 pages, 1787 KiB  
Review
Barriers and Facilitators of Pharmacoeconomic Studies: A Review of Evidence from the Middle Eastern Countries
by Abdulaziz Ibrahim Alzarea, Yusra Habib Khan, Abdullah Salah Alanazi, Muhammad Hammad Butt, Ziyad Saeed Almalki, Abdullah K. AlAhmari, Saud Alsahali and Tauqeer Hussain Mallhi
Int. J. Environ. Res. Public Health 2022, 19(13), 7862; https://doi.org/10.3390/ijerph19137862 - 27 Jun 2022
Cited by 8 | Viewed by 6800
Abstract
The world is facing a continuous increase in medical costs. Due to the surge in disease prevalence, medical science is becoming more sensitive to the economic impact of medications and drug therapies. This brings about the importance of pharmacoeconomics, which is concerned with [...] Read more.
The world is facing a continuous increase in medical costs. Due to the surge in disease prevalence, medical science is becoming more sensitive to the economic impact of medications and drug therapies. This brings about the importance of pharmacoeconomics, which is concerned with the effective use of health resources to optimize the efficiency and costs of medications of treatment for the best outcomes. This review was conducted to find out the potential barriers and facilitators to implementing pharmacoeconomic studies in the Middle Eastern region having both high- and low-income countries. The varying economies in the region depict diverse healthcare systems where implementation of pharmacoeconomics faces a large number of challenges and is also aided by numerous facilitators that contribute to the growth of its implementation. In this context, we have reviewed the status of pharmacoeconomics in Middle Eastern countries in research databases (Google Scholar, MEDLINE, Science Direct and Scopus) using keywords (“pharmacoeconomics”, “barriers”, “facilitators”, “Middle East”). The study reported that Yemen, Syria, Palestine, Iran, Iraq, Jordan and Lebanon are the lowest-income countries in the Middle East and the implementation of pharmacoeconomics is the poorest in these states. The UAE, Saudi Arabia and Israel are high-income rich states where economic aspects were comparatively better but still a large number of barriers hinder the way to its effective implementation. These include the absence of national governing bodies, the lack of data on the effectiveness of medications, the absence of sufficient pharmacoeconomic experts and the lack of awareness of the importance of pharmacoeconomics. The main facilitators were the availability of pharmacoeconomic guidelines, the encouragement of pharmacoeconomic experts and the promotion of group discussions and collaborations between researchers and policymakers. Cost-benefit analysis is still evolving in Middle Eastern countries, and there is a great need for improvement so that states can effectively benefit from cost analysis tools and utilize their health resources. In this regard, governments should develop national governing bodies to evaluate, implement pharmacoeconomics at the local and state levels and bring about innovation in the field through further research and development incorporating all sectors of pharmacy and pharmaceutics. The data presented in this research can further be extended in future studies to cover the various domains of pharmacoeconomics including cost-minimization analysis, cost-effectiveness analysis and cost-benefit analysis and their applications within the healthcare sectors of Middle Eastern countries. Full article
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15 pages, 2226 KiB  
Article
Interprofessional Collaboration between ICU Physicians, Staff Nurses, and Hospital Pharmacists Optimizes Antimicrobial Treatment and Improves Quality of Care and Economic Outcome
by Stephan Schmid, Sophie Schlosser, Karsten Gülow, Vlad Pavel, Martina Müller and Alexander Kratzer
Antibiotics 2022, 11(3), 381; https://doi.org/10.3390/antibiotics11030381 - 13 Mar 2022
Cited by 22 | Viewed by 6916
Abstract
(1) Background: Antibiotic resistance is a worldwide health threat. The WHO published a global strategic plan in 2001 to contain antimicrobial resistance. In the following year, a workshop identified crucial barriers to the implementation of the strategy, e.g., underdeveloped health infrastructures and the [...] Read more.
(1) Background: Antibiotic resistance is a worldwide health threat. The WHO published a global strategic plan in 2001 to contain antimicrobial resistance. In the following year, a workshop identified crucial barriers to the implementation of the strategy, e.g., underdeveloped health infrastructures and the scarcity of valid data as well as a lack of implementation of antibiotic stewardship (ABS) programs in medical curricula. Here, we show that interprofessional learning and education can contribute to the optimization of antibiotic use and preserving antibiotic effectiveness. We have initiated interprofessional rounds on a medical intensive care unit (MICU) with a focus on gastroenterology, hepatology, infectious diseases, endocrinology, and liver transplantation. We integrated ICU physicians, hospital pharmacists, nursing staff, and medical students as well as students of pharmacy to broaden the rather technical concept of ABS with an interprofessional approach to conceptualize awareness and behavioral change in antibiotic prescription and use. Methods: Clinical performance data and consumption figures for antibiotics were analyzed over a 10-year period from 2012 to 2021. The control period covered the years 2012–2014. The intervention period comprised the years 2015–2021, following the implementation of an interprofessional approach to ABS at a MICU of a German university hospital. Data from the hospital pharmacy, hospital administration, and hospital information system were included in the analyses. A specific electronic platform was developed for the optimization of documentation, interprofessional learning, education, and sustainability. The years 2020 and 2021 were analyzed independently due to the SARS-CoV-2 pandemic and the care of numerous COVID-19 patients at the MICU. Results: Implementation of an interprofessional ABS program resulted in the optimization of antibiotic management at the MICU. The suggestions of the hospital pharmacist for optimization can be divided into the following categories (i) indication for and selection of therapy (43.6%), (ii) optimization of dosing (27.6%), (iii) drug interactions (9.4%), (iv) side effects (4.1%), and (v) other pharmacokinetic, pharmacodynamic, and pharmacoeconomic topics (15.3%). These suggestions were discussed among the interprofessional team at the MICU; 86.1% were consequently implemented and the prescription of antibiotics was changed. In addition, further analysis of the intensive care German Diagnosis Related Groups (G-DRGs) showed that the case mix points increased significantly by 31.6% during the period under review. Accordingly, the severity of illness of the patients treated at the ICU as measured by the Simplified Acute Physiology Score (SAPS) II increased by 21.4% and the proportion of mechanically ventilated patients exceeded 50%. Antibiotic spending per case mix point was calculated. While spending was EUR 60.22 per case mix point in 2015, this was reduced by 42.9% to EUR 34.37 per case mix point by 2019, following the implementation of the interprofessional ABS program on the MICU. Through close interprofessional collaboration between physicians, hospital pharmacists, and staff nurses, the consumption of broad-spectrum antibiotics, e.g., carbapenems, was significantly reduced, thus improving patient care. In parallel, the case mix and case mix index increased. Thus, the responsible use of resources and high-performance medicine are not contradictory. In our view, close interprofessional and interdisciplinary collaboration between physicians, pharmacists, and nursing staff will be of outstanding importance in the future to prepare health care professionals for global health care to ensure that the effectiveness of our antibiotics is preserved. Full article
(This article belongs to the Special Issue Antimicrobial Agents Used in Intensive Care Unit)
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12 pages, 705 KiB  
Article
Exploring Community-Based Options for Reducing Youth Crime
by Kim Edmunds, Laura Wall, Scott Brown, Andrew Searles, Anthony P. Shakeshaft and Christopher M. Doran
Int. J. Environ. Res. Public Health 2021, 18(10), 5097; https://doi.org/10.3390/ijerph18105097 - 12 May 2021
Cited by 3 | Viewed by 5223
Abstract
BackTrack is a multi-component, community-based intervention designed to build capacity amongst 14–17-year-old high risk young people. The aim of the current study seeks to explore community value and preferences for reducing youth crime and improving community safety using BackTrack in a rural setting [...] Read more.
BackTrack is a multi-component, community-based intervention designed to build capacity amongst 14–17-year-old high risk young people. The aim of the current study seeks to explore community value and preferences for reducing youth crime and improving community safety using BackTrack in a rural setting in Armidale, New South Wales, Australia. The study design used discrete choice experiments (DCEs), designed in accordance with the 10-item checklist outlined by the International Society for Pharmacoeconomics and Outcomes Research. The DCE was pilot tested on 43 participants to test feasibility and comprehension. A revised version of the survey was subsequently completed by 282 people over a 12-day period between 30 May 2016 and 10 June 2016, representing a survey response rate of 35%. Ninety per cent of respondents were residents of Armidale, the local rural town where BackTrack was implemented. The DCE generated results that consistently demonstrated a preference for social programs to address youth crime and community safety in the Armidale area. Respondents chose BackTrack over Greater Police Presence 75% of the time with an annual benefit of Australian dollars (AUD) 150 per household, equivalent to a community benefit of AUD 2.04 million. This study estimates a strong community preference for BackTrack relative to more policing (a community willing to pay equivalent to AUD 2.04 million) highlighting the clear value of including community preferences when evaluating community-based programs for high-risk young people. Full article
(This article belongs to the Section Adolescents)
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9 pages, 950 KiB  
Review
Government Pharmaceutical Pricing Strategies in the Asia-Pacific Region: An Overview
by Naina R. Verghese, Jon Barrenetxea, Yukti Bhargava, Sagun Agrawal and Eric Andrew Finkelstein
J. Mark. Access Health Policy 2019, 7(1), 1601060; https://doi.org/10.1080/20016689.2019.1601060 - 11 Apr 2019
Cited by 38 | Viewed by 1283
Abstract
Background and objectives: Governments in Asia Pacific (APAC) are increasingly using pharmaceutical pricing strategies to contain rising healthcare costs. The objective of this narrative review is to discuss formal pricing strategies for reimbursed prescription medication in APAC, supported by relevant examples of implementation [...] Read more.
Background and objectives: Governments in Asia Pacific (APAC) are increasingly using pharmaceutical pricing strategies to contain rising healthcare costs. The objective of this narrative review is to discuss formal pricing strategies for reimbursed prescription medication in APAC, supported by relevant examples of implementation differences across countries. In the discussion section, we examine key advantages and disadvantages of each strategy. Methods: A narrative review of the peer-reviewed and grey literature was undertaken to retrieve information, including strategy definitions, practising countries, country-specific implementation considerations, and merits and demerits of each strategy. Results: Seven strategies (Internal Reference Pricing, External Reference Pricing, Special Pricing Agreements, Pharmacoeconomic Evaluation, Cost plus pricing, Price Maintenance Premium, and Tendering and negotiations) were identified as most commonly practised in APAC through the review process. Most countries use multiple strategies that differ in how they are implemented. Conclusion: APAC countries use multiple strategies simultaneously with varying implementation methods, including different formulae and sub-types of medication that a strategy applies to, whether the strategy is a mandate or guideline, and the extent of negotiations and transparency. Strategies are instituted partly with the aim of cost containment, and may also promote price stability, innovation, and increased access in the short and longer term. Abbreviations: APAC—Asia Pacific; WHO—World Health Organisation; IRP—Internal Reference Pricing; ERP—External Reference Pricing; SPA—Special Pricing Agreement; MES—Managed Entry Scheme; PVA—Price-Volume Agreement; RSA—Risk Sharing Agreement; NHIS—National Health Insurance System; PE—Pharmacoeconomic Evaluation; CEA—Cost-Effectiveness Analysis; QALY—Quality-adjusted Life Year; BIA—Budget Impact Analysis; PMP—Price Maintenance Premium; R&D—Research & Development. Full article
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