Displaying publications 21 - 40 of 423 in total

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  1. Ang WC, Cheah YK
    PMID: 37081820 DOI: 10.1177/27551938231170831
    Pharmaceuticals play an important role in health improvements. This study is the first of its kind to examine the influences of household heads' sociodemographic characteristics and household profiles on pharmaceuticals expenditure among households of different income levels. The country of interest is a fast-growing developing country. Data from the Malaysian Household Expenditure Surveys 2014 and 2016 were used in the pooled cross-sectional analyses. Double-hurdle models were used to analyze consumption and amount decisions of pharmaceuticals. Analyses stratified by income were conducted. Results showed that households headed by younger adults (<60 years), males, less educated individuals, Bumiputera, and divorced/widowed adults were less likely to consume and spent less on pharmaceuticals compared with households headed by older adults (≥60 years), females, more educated individuals, non-Bumiputera, and single adults. These differentials varied across income groups. In conclusion, household heads' age, gender, educational levels, ethnicity, marital status, and household profiles are important determining factors of expenditure on pharmaceuticals among low-, middle- and high-income households.
    Matched MeSH terms: Pharmaceutical Preparations
  2. Husain Khan A, Abdul Aziz H, Palaniandy P, Naushad M, Cevik E, Zahmatkesh S
    Chemosphere, 2023 Oct;339:139647.
    PMID: 37516325 DOI: 10.1016/j.chemosphere.2023.139647
    Hospital wastewater has emerged as a major category of environmental pollutants over the past two decades, but its prevalence in freshwater is less well documented than other types of contaminants. Due to compound complexity and improper operations, conventional treatment is unable to remove pharmaceuticals from hospital wastewater. Advanced treatment technologies may eliminate pharmaceuticals, but there are still concerns about cost and energy use. There should be a legal and regulatory framework in place to control the flow of hospital wastewater. Here, we review the latest scientific knowledge regarding effective pharmaceutical cleanup strategies and treatment procedures to achieve that goal. Successful treatment techniques are also highlighted, such as pre-treatment or on-site facilities that control hospital wastewater where it is used in hospitals. Due to the prioritization, the regulatory agencies will be able to assess and monitor the concentration of pharmaceutical residues in groundwater, surface water, and drinking water. Based on the data obtained, the conventional WWTPs remove 10-60% of pharmaceutical residues. However, most PhACs are eliminated during the secondary or advanced therapy stages, and an overall elimination rate higher than 90% can be achieved. This review also highlights and compares the suitability of currently used treatment technologies and identifies the merits and demerits of each technology to upgrade the system to tackle future challenges. For this reason, pharmaceutical compound rankings in regulatory agencies should be the subject of prospective studies.
    Matched MeSH terms: Pharmaceutical Preparations
  3. Thevendran R, Maheswaran S
    Biotechnol J, 2023 Sep;18(9):e2300077.
    PMID: 37179485 DOI: 10.1002/biot.202300077
    Clustered regularly interspaced short palindromic repeats (CRISPR) have established itself as a frontier technology in genetic engineering. Researchers have successfully used the CRISPR/Cas system as precise gene editing tools and have further expanded their scope beyond both imaging and diagnostic applications. The most prominent utility of CRISPR is its capacity for gene therapy, serving as the contemporary, disease-modifying drug at the genetic level of human medical disorders. Correcting these diseases using CRISPR-based gene editing has developed to the extent of preclinical trials and possible patient treatments. A major impediment in actualizing this is the complications associated with in vivo delivery of the CRISPR/Cas complex. Currently, only the viral vectors (e.g., lentivirus) and non-viral encapsulation (e.g., lipid particles, polymer-based, and gold nanoparticles) techniques have been extensively reviewed, neglecting the efficiency of direct delivery. However, the direct delivery of CRISPR/Cas for in vivo gene editing therapies is an intricate process with numerous drawbacks. Hence, this paper discusses in detail both the need and the strategies that can potentially improve the direct delivery aspects of CRISPR/Cas biomolecules for gene therapy of human diseases. Here, we focus on enhancing the molecular and functional features of the CRISPR/Cas system for targeted in vivo delivery such as on-site localization, internalization, reduced immunogenicity, and better in vivo stability. We additionally emphasize the CRISPR/Cas complex as a multifaceted, biomolecular vehicle for co-delivery with therapeutic agents in targeted disease treatments. The delivery formats of efficient CRISPR/Cas systems for human gene editing are also briefly elaborated.
    Matched MeSH terms: Pharmaceutical Preparations
  4. Sapkota B, Pariatamby A
    Waste Manag, 2023 Aug 01;168:83-97.
    PMID: 37285639 DOI: 10.1016/j.wasman.2023.05.052
    Most households and healthcare facilities usually dispose of contaminated, unused, or expired (CUE) medicines with municipal wastes, the disposal of which usually amounts to $790/ton in the USA and £450/ton in the UK. Solid (e.g., tablets, capsules, powders) and semi-solid (e.g., ointment, creams) pharmaceuticals are managed with incineration/pyrolysis, encapsulation, and engineered landfills, whereas wastewater treatment plants (WWTPs) are recommended for liquid pharmaceutical wastes (PWs). However, to date, the sustainability and eco-friendliness profile of these techniques are only subjectively ensured, leading to controversial viewpoints in many guidelines. Each technique has relative strengths and weaknesses, and their comparative weighting to maximize these profiles is sought after. The present comprehensive review aims to fulfil knowledge gaps in this regard. Four electronic databases (e.g., PubMed/MEDLINE, Scopus, and ScienceDirect) were searched for PW management (PWM)-related qualitative and quantitative articles published till December 31, 2022. Articles without details of waste disposal techniques and their health and environmental impacts were excluded. Based on the literature review, we determine that incineration can be considered a sustainable option for solid and semi-solid PWs, and WWTPs can be eco-friendly for liquid PWs, whereas encapsulation and landfilling are less sustainable. It is high time that objectively proven sustainable and eco-friendly techniques be implemented for PWM based on their dosage forms or nature of hazards. Medicine take-back, eco-pharmacovigilance, extended producer responsibility, co-payment, and life cycle analysis of pharmaceuticals focusing on reduction, reuse/re-dispensing can be integrated to make existing models sustainable, circular, and eco-friendly.
    Matched MeSH terms: Pharmaceutical Preparations
  5. Sallom H, Abdi A, Halboup AM, Başgut B
    BMC Public Health, 2023 Jul 17;23(1):1364.
    PMID: 37461105 DOI: 10.1186/s12889-023-16199-1
    INTRODUCTION: Pharmaceutical care services (PCs) have evolved significantly over the last few decades, with a greater focus on patient's safety and proven effectiveness in a wide range of contexts. Many of the evidence supporting this technique comes from the United States, the evaluation and adoption of (PCs) which differ greatly across the globe.

    OBJECTIVE: The goal of this study was to identify and assess the efficacy of pharmaceutical care services in various pharmaceutical aspects throughout seventeen Middle Eastern nations.

    METHOD: The Arkesy and O'Malley technique was used to conduct a scoping review. It was conducted using PubMed/Medline, Scopus, Cochrane Library, Springer Link, Clinical Trials, and Web of Science etc. The Van Tulder Scale was utilized in randomized trials research, whereas the dawn and black checklists were used in non-randomized trials research. A descriptive and numerical analysis of selected research was done. The scope of eligible PCs, pharmaceutical implementers, study outcomes, and quality were all identified by a thematic review of research.

    RESULTS: There were about 431,753 citations found in this study, and 129 publications were found to be eligible for inclusion after analysing more than 271 full-text papers. The study design was varied, with 43 (33.3%) RCTs and 86 (66.7%) n-RCTs. Thirty-three (25.6%) of the studies were published in 2020. Jordan, Saudi Arabia, and Turkey were home to the majority of the studies (25.6%, 16.3%, and 11.6%) respectively. Thirty-seven studies (19.7%) were concerned with resolving drug related problems (DRPs), whereas 27 (14.4%) were concerned with increasing quality of life (QOL) and 23 (12.2%) with improving drug adherence. Additionally, the research revealed that the average ratings of the activities provided to patients improved every year.

    CONCLUSION: Studies in the Middle East continue to provide evidence supporting the positive impact of pharmaceutical care services on both hard and soft outcomes measured in most studies. Yet there was rare focus on the value of the implemented services. Thus, rigorous evaluation of the economic impact of implemented pharmaceutical care services in the Middle East and assessment of their sustainability is must.

    Matched MeSH terms: Pharmaceutical Preparations
  6. Tawalbeh M, Mohammed S, Al-Othman A, Yusuf M, Mofijur M, Kamyab H
    Environ Res, 2023 Jul 01;228:115919.
    PMID: 37072081 DOI: 10.1016/j.envres.2023.115919
    The rapid increase in the global population and its ever-rising standards of living are imposing a huge burden on global resources. Apart from the rising energy needs, the demand for freshwater is correspondingly increasing. A population of around 3.8 billion people will face water scarcity by 2030, as per the reports of the World Water Council. This may be due to global climate change and the deficiency in the treatment of wastewater. Conventional wastewater treatment technologies fail to completely remove several emerging contaminants, especially those containing pharmaceutical compounds. Hence, leading to an increase in the concentration of harmful chemicals in the human food chain and the proliferation of several diseases. MXenes are transition metal carbide/nitride ceramics that primarily structure the leading 2D material group. MXenes act as novel nanomaterials for wastewater treatment due to their high surface area, excellent adsorption properties, and unique physicochemical properties, such as high electrical conductivity and hydrophilicity. MXenes are highly hydrophilic and covered with active functional groups (i.e., hydroxyl, oxygen, fluorine, etc.), which makes them efficient adsorbents for a wide range of species and promising candidates for environmental remediation and water treatment. This work concludes that the scaling up process of MXene-based materials for water treatment is currently of high cost. The up-to-date applications are still limited because MXenes are currently produced mainly in the laboratory with limited yield. It is recommended to direct research efforts towards lower synthesis cost procedures coupled with the use of more environmentally friendly materials to avoid secondary contamination.
    Matched MeSH terms: Pharmaceutical Preparations
  7. Muthuraman A, Ramesh M, Mustaffa F, Nadeem A, Nishat S, Paramakrishnan N, et al.
    Molecules, 2023 May 26;28(11).
    PMID: 37298835 DOI: 10.3390/molecules28114358
    Molecular docking is widely used in the assessment of the therapeutic potential of pharmaceutical agents. The binding properties of beta-carotene (BC) to acetylcholine esterase (AChE) proteins were characterized using the molecular docking method. The mechanism of AChE inhibition was assessed by an experimental in vitro kinetic study. In addition, the role of BC action was tested by the zebrafish embryo toxicity test (ZFET). The results of the docking ability of BC to AChE showed significant ligand binding mode. The kinetic parameter, i.e., the low AICc value shown as the compound was the competitive type of inhibition of AChE. Further, BC also showed mild toxicity at a higher dose (2200 mg/L) in ZFET assessment with changes in biomarkers. The LC50 value of BC is 1811.94 mg/L. Acetylcholine esterase (AChE) plays a pivotal role in the hydrolysis of acetylcholine, which leads to the development of cognitive dysfunction. BC possesses the regulation of acetylcholine esterase (AChE) and acid phosphatase (AP) activity to prevent neurovascular dysfunction. Therefore, the characterization of BC could be used as a pharmaceutical agent for the treatment of cholinergic neurotoxicity-associated neurovascular disorders such as developmental toxicity, vascular dementia, and Alzheimer's disease due to its AChE and AP inhibitory actions.
    Matched MeSH terms: Pharmaceutical Preparations
  8. Khairul Hasni NA, Anual ZF, Rashid SA, Syed Abu Thahir S, Veloo Y, Fang KS, et al.
    Environ Pollut, 2023 May 01;324:121095.
    PMID: 36682614 DOI: 10.1016/j.envpol.2023.121095
    Contamination of water systems with endocrine disrupting chemicals (EDCs) is becoming a major public health concern due to their toxicity and ubiquity. The intrusion of EDCs into water sources and drinking water has been associated with various adverse health effects on humans. However, there is no comprehensive overview of the occurrence of EDCs in Malaysia's water systems. This report aims to describe the occurrence of EDCs and their locations. Literature search was conducted electronically in two databases (PubMed and Scopus). A total of 41 peer-reviewed articles published between January 2000 and May 2021 were selected. Most of the articles dealt with pharmaceuticals (16), followed by pesticides (7), hormones (7), mixed compounds (7), and plasticisers (4). Most studies (40/41) were conducted in Peninsular Malaysia, with 60.9% in the central region and almost half (48.8%) in the Selangor State. Only one study was conducted in the northern region and East Malaysia. The Langat River, the Klang River, and the Selangor River were among the most frequently studied EDC-contaminated surface waters, while the Pahang River and the Skudai River had the highest concentrations of some of the listed compounds. Most of the risk assessments resulted in a hazard quotient (HQ) and a risk quotient (RQ)  1 in the Selangor River. An RQ > 1 for combined pharmaceuticals was found in Putrajaya tap water. Overall, this work provides a comprehensive overview of the occurrence of EDCs in Malaysia's water systems. The findings from this review can be used to mitigate risks and strengthen legislation and policies for safer drinking water.
    Matched MeSH terms: Pharmaceutical Preparations
  9. Ben Chabchoubi I, Lam SS, Pane SE, Ksibi M, Guerriero G, Hentati O
    Environ Pollut, 2023 May 01;324:120698.
    PMID: 36435277 DOI: 10.1016/j.envpol.2022.120698
    The uncontrolled or continuous release of effluents from wastewater treatment plants leads to the omnipresence of pharmaceutical active compounds (PhACs) in the aquatic media. Today, this is a confirmed problem becoming a main subject of twin public and scientific concerns. However, still little information is available about the long-term impacts of these PhACs on aquatic organisms. In this review, efforts were made to reveal correlation between the occurrence in the environment, ecotoxicological and health risks of different PhACs via toxicological evaluation by zebrafish (Danio rerio). This animal model served as a bioindicator for any health impacts after the exposure to these contaminants and to better understand the responses in relation to human diseases. This review paper focused on the calculation of Risk Quotients (RQs) of 34 PhACs based on environmental and ecotoxicological data available in the literature and prediction from the ECOSAR V2.2 software. To the best of the authors' knowledge, this is the first report on the risk assessment of PhACs by the two different methods as mentioned above. RQs showed greater difference in potential environmental risks of the PhACs. These differences in risk values underline the importance of environmental and experimental factors in exposure conditions and the interpretation of RQ values. While the results showed high risk to Danio rerio of the majority of PhACs, risk qualification of the others varied between moderate to insignifiant. Further research is needed to assess pharmaceutical hazards when present in wastewater before discharge and monitor the effectiveness of treatment processes. The recent new advances in the morphological assessment of toxicant-exposed zebrafish larvae for the determination of test compounds effects on the developmental endpoints were also discussed. This review emphasizes the need for strict regulations on the release of PhACs into environmental media in order to minimize their toxicity to aquatic organisms.
    Matched MeSH terms: Pharmaceutical Preparations
  10. Lim SYM, Al Bishtawi B, Lim W
    Eur J Drug Metab Pharmacokinet, 2023 May;48(3):221-240.
    PMID: 37093458 DOI: 10.1007/s13318-023-00826-8
    The major human liver drug metabolising cytochrome P450 (CYP) enzymes are downregulated during inflammation and infectious disease state, especially during coronavirus disease 2019 (COVID-19) infection. The influx of proinflammatory cytokines, known as a 'cytokine storm', during severe COVID-19 leads to the downregulation of CYPs and triggers new cytokine release, which further dampens CYP expression. Impaired drug metabolism, along with the inevitable co-administration of drugs or 'combination therapy' in patients with COVID-19 with various comorbidities, could cause drug-drug interactions, thus worsening the disease condition. Genetic variability or polymorphism in CYP2C9 across different ethnicities could contribute to COVID-19 susceptibility. A number of drugs used in patients with COVID-19 are inducers or inhibitors of, or are metabolised by, CYP2C9, and co-administration might cause pharmacokinetic and pharmacodynamic interactions. It is also worth mentioning that some of the COVID-19 drug interactions are due to altered activity of other CYPs including CYP3A4. Isoniazid/rifampin for COVID-19 and tuberculosis co-infection; lopinavir/ritonavir and cobicistat/remdesivir combination therapy; or multi-drug therapy including ivermectin, azithromycin, montelukast and acetylsalicylic acid, known as TNR4 therapy, all improved recovery in patients with COVID-19. However, a combination of CYP2C9 inducers, inhibitors or both, and plausibly different CYP isoforms could lead to treatment failure, hepatotoxicity or serious side effects including thromboembolism or bleeding, as observed in the combined use of azithromycin/warfarin. Further, herbs that are CYP2C9 inducers and inhibitors, showed anti-COVID-19 properties, and in silico predictions postulated that phytochemical compounds could inhibit SARS-CoV-2 virus particles. COVID-19 vaccines elicit immune responses that activate cytokine release, which in turn suppresses CYP expression that could be the source of compromised CYP2C9 drug metabolism and the subsequent drug-drug interaction. Future studies are recommended to determine CYP regulation in COVID-19, while recognising the involvement of CYP2C9 and possibly utilising CYP2C9 as a target gene to tackle the ever-mutating SARS-CoV-2.
    Matched MeSH terms: Pharmaceutical Preparations
  11. Low BY, Ting KN, Lee MK
    Int J Pharm Pract, 2023 Apr 10;31(2):261-265.
    PMID: 36534990 DOI: 10.1093/ijpp/riac101
    OBJECTIVE: To assess the knowledge, attitude and practice of community pharmacists (CP) towards household pharmaceutical waste disposal.

    METHODS: All pharmacists attending the Malaysian Community Pharmacy Guild event held in-person were invited to self-administer a web-based survey.

    KEY FINDINGS: The response rate was 61% (168/276). Overall, community pharmacists have mixed knowledge (mean ± SD: 5.89 ± 1.38) and positive attitude (mean ± SD: 9.58 ± 0.81) towards household pharmaceutical waste disposal. However, few community pharmacists (18/168, 10.7%) have promotional materials encouraging safe medication disposal in their pharmacies.

    CONCLUSIONS: Community pharmacists do not proactively promote safe household pharmaceutical waste disposal to mitigate pharmaceutical pollutants entering the environment although they have satisfactory knowledge and attitude.

    Matched MeSH terms: Pharmaceutical Preparations
  12. Setyawan D, Amrillah T, Abdullah CAC, Ilhami FB, Dewi DMM, Mumtazah Z, et al.
    J Drug Target, 2023 Apr;31(4):369-389.
    PMID: 36721905 DOI: 10.1080/1061186X.2023.2175833
    The development of two-dimensional (2D) materials for biomedical applications has accelerated exponentially. Contrary to their bulk counterparts, the exceptional properties of 2D materials make them highly prospective for contrast agents for bioimage, drug, and heat delivery in biomedical treatment. Nevertheless, empty space in the integration and utilisation of 2D materials in living biological systems, potential toxicity, as well as required complicated synthesis and high-cost production limit the real application of 2D materials in those advance medical treatments. On the other hand, green technology appears to be one of strategy to shed a light on the blurred employment of 2D in medical applications, thus, with the increasing reports of green technology that promote advanced technologies, here, we compile, summarise, and synthesise information on the biomedical technology of 2D materials through green technology point of view. Beginning with a fundamental understanding, of crystal structures, the working mechanism, and novel properties, this article examines the recent development of 2D materials. As well as 2D materials made from natural and biogenic resources, a recent development in green-related synthesis was also discussed. The biotechnology and biomedical-related application constraints are also discussed. The challenges, solutions, and prospects of the so-called green 2D materials are outlined.
    Matched MeSH terms: Pharmaceutical Preparations
  13. Matsui R, Yamaguchi K, Lee JJV, Ting I, Khairilisani D, Chang J, et al.
    Ther Innov Regul Sci, 2023 Mar;57(2):251-260.
    PMID: 36215028 DOI: 10.1007/s43441-022-00462-5
    Under the COVID-19 pandemic, various electronic labeling initiatives have accelerated worldwide in the healthcare and pharmaceutical fields as part of a wider digital transformation [1, 2]. Although there is no universal definition of electronic labeling (e-labeling) globally, it is widely understood that e-labeling refers to the product information that is distributed via electronic means. There are 5 factors to be considered in e-labeling, and these are discussed in this publication. APAC is an industry-driven initiative with 13 R&D-based pharmaceutical associations joining from 11 markets in Asia. e-labeling was discussed as a new topic starting in 2020, and a 22-question survey was conducted in November 2021 to understand the current e-labeling status. The survey results showed that e-labeling initiatives were at different levels of maturity in the Asian region, although most markets have started to discuss e-labeling initiatives. Various challenges exist around e-labeling initiatives due to a variety of different approaches being taken in the region. It would be advisable to develop regional guidance on how to proceed with e-labeling initiatives in the Asian region to have a consistent and efficient approach. The close collaboration between agencies, Health Care Professionals (HCPs), patients, and industry associations is important to move e-labeling initiatives forward in Asia.
    Matched MeSH terms: Pharmaceutical Preparations
  14. Ibrahim N, Foo LK, Chua SL
    PMID: 36833984 DOI: 10.3390/ijerph20043289
    Osteoporosis is a serious bone disease that affects many people worldwide. Various drugs have been used to treat osteoporosis. However, these drugs may cause severe adverse events in patients. Adverse drug events are harmful reactions caused by drug usage and remain one of the leading causes of death in many countries. Predicting serious adverse drug reactions in the early stages can help save patients' lives and reduce healthcare costs. Classification methods are commonly used to predict the severity of adverse events. These methods usually assume independence among attributes, which may not be practical in real-world applications. In this paper, a new attribute weighted logistic regression is proposed to predict the severity of adverse drug events. Our method relaxes the assumption of independence among the attributes. An evaluation was performed on osteoporosis data obtained from the United States Food and Drug Administration databases. The results showed that our method achieved a higher recognition performance and outperformed baseline methods in predicting the severity of adverse drug events.
    Matched MeSH terms: Pharmaceutical Preparations
  15. Al-Japairai K, Hamed Almurisi S, Almonem Doolaanea A, Mahmood S, Alheibshy F, Alobaida A, et al.
    Int J Pharm, 2023 Feb 05;632:122571.
    PMID: 36587776 DOI: 10.1016/j.ijpharm.2022.122571
    Taste refers to those sensations perceived through taste buds on the tongue and oral cavity. The unpleasant taste of drugs leads to the refusal of taking the medicine in the paediatric population. It is widely known that a pharmaceutical product's general acceptability is the result of numerous contributing components such as swallowability, palatability (taste, flavour, texture, and mouthfeel), appearance, ease of administration, and patient characteristics. Multiparticulate as a dosage form is a platform technology for overcoming paediatrics' incapacity to swallow monolithic dosage forms, masking many medications' inherent nasty taste, and overcoming the obstacles of manufacturing a commercially taste masked dosage form. This review will discuss the considerations that must be taken into account to prepare taste masked multiparticulate dosage forms in the best way for paediatric use.
    Matched MeSH terms: Pharmaceutical Preparations
  16. Henry Basil J, Premakumar CM, Mhd Ali A, Mohd Tahir NA, Seman Z, Mohamed Shah N
    BMJ Paediatr Open, 2023 Feb;7(1).
    PMID: 36754439 DOI: 10.1136/bmjpo-2022-001765
    INTRODUCTION: Medication administration errors (MAEs) are the most common type of medication error. Furthermore, they are more common among neonates as compared with adults. MAEs can result in severe patient harm, subsequently causing a significant economic burden to the healthcare system. Targeting and prioritising neonates at high risk of MAEs is crucial in reducing MAEs. To the best of our knowledge, there is no predictive risk score available for the identification of neonates at risk of MAEs. Therefore, this study aims to develop and validate a risk prediction model to identify neonates at risk of MAEs.

    METHODS AND ANALYSIS: This is a prospective direct observational study that will be conducted in five neonatal intensive care units. A minimum sample size of 820 drug preparations and administrations will be observed. Data including patient characteristics, drug preparation-related and administration-related information and other procedures will be recorded. After each round of observation, the observers will compare his/her observations with the prescriber's medication order, hospital policies and manufacturer's recommendations to determine whether MAE has occurred. To ensure reliability, the error identification will be independently performed by two clinical pharmacists after the completion of data collection for all study sites. Any disagreements will be discussed with the research team for consensus. To reduce overfitting and improve the quality of risk predictions, we have prespecified a priori the analytical plan, that is, prespecifying the candidate predictor variables, handling missing data and validation of the developed model. The model's performance will also be assessed. Finally, various modes of presentation formats such as a simplified scoring tool or web-based electronic risk calculators will be considered.

    Matched MeSH terms: Pharmaceutical Preparations
  17. Ab Rahman AS, Strother RM, Paddison J
    Asia Pac J Clin Oncol, 2023 Feb;19(1):179-186.
    PMID: 35686690 DOI: 10.1111/ajco.13801
    BACKGROUND: Immune checkpoint inhibitors (ICIs) have increased overall survival (OS) in metastatic melanoma in all clinical trials to date. However, pivotal trial populations were not representative of the real-world population in New Zealand. Real-world treatment effectiveness studies help evaluate the value of public pharmaceutical expenditure.

    AIM: To determine the survival outcomes of New Zealand patients with unresectable or metastatic melanoma treated with pembrolizumab or nivolumab.

    METHODS: This is a national retrospective cohort study. Patients with advanced unresectable or metastatic melanoma who received publicly funded immune-checkpoint inhibitors (ICIs) from 2017 to 2019 were included. Individual patient data were extracted from national administrative databases. The primary endpoint was OS, and secondary endpoints included OS by age, duration of treatment, posttreatment survival, and 30-day mortality from last pharmaceutical claim.

    RESULTS: Five hundred ninety-seven patients were included, with a median follow-up of 25 months. One-year OS was 72%, the 2-year OS estimate was 60%, and median OS not reached. Survival did not differ by dichotomized age (≥70 vs. <70 year old), hazard ratio (HR) .94 (95% confidence interval (CI): .72-1.22; p = .62). Median duration of treatment was 9.0 months (95% CI: 7.9-10.1). Median post-treatment survival for the subgroup who had ceased treatment was 12.0 months (95% CI: 9.0-14.0). For the sample as a whole, the estimated 30-day mortality from last pharmaceutical claim was 15.7%.

    CONCLUSION: OS in our New Zealand real-world population is comparable to pivotal clinical trials and real-world data (RWD) from other countries. These findings support the achievement of health gains from use of ICI in advanced unresectable and metastatic melanoma.

    Matched MeSH terms: Pharmaceutical Preparations
  18. Mishra D, Gade S, Glover K, Sheshala R, Singh TRR
    Curr Eye Res, 2023 Feb;48(2):208-218.
    PMID: 36036478 DOI: 10.1080/02713683.2022.2119254
    Purpose: Intravitreal administration of drug molecules is one of the most common routes for treating posterior segment eye diseases. However, the properties of vitreous humour changes with the time. A number of ocular complications such as liquefaction of the vitreous humour, solidification of the vitreous humour in the central vitreous cavity and detachment of the limiting membrane due to the shrinking of vitreous humour are some of the factors that can drastically affect the efficacy of therapeutics delivered via intravitreal route. Although significant research has been conducted for studying the properties of vitreous humour and its changes during the ageing process, there have been limited work to understand the effect of these changes on therapeutic efficacy of intravitreal drug delivery systems. Therefore, in this review we discussed both the coomposition and characteristics of the vitreous humour, and their subsequent influence on intravitreal drug delivery.Methods: Articles were searched on Scopus, PubMed and Web of Science up to March 2022.Results: In this review, we discussed the biological composition and biomechanical properties of vitreous humour, methods to study the properties of vitreous humour and the changes in these properties and their relevance in ocular drug delivery field, with the aim to provide a useful insight into these aspects which can aid the process of development of novel intravitreal drug delivery systems.Conclusions: The composition and characteristics of the vitreous humour, and how these change during natural aging processes, directly influence intravitreal drug delivery. This review therefore highlights the importance of understanding the properties of the vitreous and identifies the need to achieve greater understanding of how changing properties of the vitreous affect the therapeutic efficacy of drugs administered for the treatment of posterior eye diseases.
    Matched MeSH terms: Pharmaceutical Preparations
  19. Khan RA, Khan NA, El Morabet R, Alsubih M, Khan AR, Khan S, et al.
    Environ Res, 2023 Jan 01;216(Pt 1):114437.
    PMID: 36181898 DOI: 10.1016/j.envres.2022.114437
    Pharmaceutical compounds being able to alter, retard, and enhance metabolism has gained attention in recent time as emerging pollutant. However, hospitals which are part of every urban landscape have yet to gain attention in terms of its hospital wastewater treatment to inhibit pharmaceutical compounds from reaching environment. Hence this study evaluated performance of constructed wetland in combination with tubesettler and aeration based on removal efficiency and ecological risk assessment (HQ). The removal efficiency of constructed wetland with plantation was higher by 31% (paracetamol), 102% (ibuprofen), 46%, (carbamazepine), 57% (lorazepam), 54% (erythromycin), 31% (ciprofloxacin) and 20% (simvastatin) against constructed wetland without plantation. Constructed wetland with aeration efficiency increased for paracetamol, ibuprofen, carbamazepine, lorazepam, erythromycin, ciprofloxacin, and simvastatin removal efficiency were higher by 58%, 130%, 52%, 79%, 107%, 57%, and 29% respectively. In constructed wetland with plantation, removal efficiency was higher by 20% (paracetamol), 13% (ibuprofen), 4% (carbamazepine), 14% (lorazepam), 34% (erythromycin), 19% (ciprofloxacin) and 7% (simvastatin). High ecological risk was observed for algae, invertebrate and fish with hazard quotient values in range of 2.5-484, 10-631 and 1-78 respectively. This study concludes that if space is the limitation at hospitals aeration with constructed wetland can be adopted. If space is available, constructed wetland with tubesettler is suitable, economic and environmentally friendly option. Future research works can focus on evaluating other processes combination with constructed wetland.
    Matched MeSH terms: Pharmaceutical Preparations
  20. Chong SSF, Kanno M, Chee ASM, Long SM, Ong SHM, Harnpramukkul U, et al.
    Ther Innov Regul Sci, 2023 Jan;57(1):12-25.
    PMID: 36175790 DOI: 10.1007/s43441-022-00435-8
    PURPOSE: Asia Partnership Conference of Pharmaceutical Associations (APAC) promote regulatory agility of four important best practices i.e. reliance, digital platform, accepting electronic document and process integration. Dialogues and strong partnership witnessed reforms and efficiencies amidst the pandemic. In tracking the progress of regulatory agility, APAC identifies areas for improvement and recommends prioritizing these areas for change.

    METHODS: As one voice, 13 main industry associations under the umbrella of APAC sent joint letters to our National Regulatory Authorities (NRAs) with a call to maintain regulatory agility and consider new ways of working. Consequently, APAC surveyed its member associations to measure regulatory agilities implemented by the NRAs during 2020 and 2021 in view of the pandemic.

    RESULTS: This paper reports progress in implementing regulatory agility, e.g. the number of economies that can accept electronic Certificate of Pharmaceutical Products (eCPP) has reached 100% for the economies that require CPP and more than 90% can waive onsite inspection in the presence of Good Manufacturing Practice (GMP) certificate and/or inspection report. The paper also features the progress made in Malaysia, the Philippines, and the ASEAN (Association of South East Asian Nations) regional reliance initiative to reduce inefficiencies and duplications.

    CONCLUSIONS: We have demonstrated the power of working together to enable regulatory agilities and efficiencies. APAC will continue to track the progress of all economies including India within the areas for improvement prioritized and discussed in this paper. APAC is also committed to working with key stakeholders including our NRAs in Asia to sustain and enable a new era of innovation ushered in by COVID-19 to benefit patients.

    Matched MeSH terms: Pharmaceutical Preparations
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