scholarly journals Current Impact and Application of AbuseDeterrent Opioid Formulations in Clinical Practice

2017 ◽  
Vol 7 (20;7) ◽  
pp. E1003-E1023
Author(s):  
Hsiang-Yin Chen
Keyword(s):  
Clinical Practice ◽  
New Products ◽  
Opioid Abuse ◽  
Mitigation Strategies ◽  
Time Data ◽  
Routes Of Administration ◽  
Fda Guidance ◽  
Advantages And Disadvantages ◽  
Post Marketing ◽  
Alternative Routes

Background: Abuse-deterrent formulations (ADFs) represent one novel strategy for curbing the potential of opioid abuse. Objective: We aim to compare and contrast the characteristics and applications of current abusedeterrent opioid products in clinical practice. Methods: Literature searches were conducted in databases (Pubmed Medline, International Pharmaceutical Abstracts, Google Scholar) and official reports. Relevant data were screened and organized into: 1) epidemiology of opioid abuse, 2) mitigation strategies for reducing opioid abuse, 3) development of ADFs, and 4) clinical experience with these formulations. Results: Increasing trends of opioid abuse and misuse have been reported globally. There are 5 types of abuse-deterrent opioid products: physical chemical barrier, combined agonist/antagonist, sequestered aversive agent, prodrug, and novel delivery system. The advantages and disadvantages of the 5 options are discussed in this review. A total of 9 products with abuse-deterrent labels have been approved by the Food and Drug Administration (FDA). The rates of abuse, diversion, and overdose deaths of these new products are also discussed. A framework for collecting in-time data on the efficacy, benefit and risk ratio, and cost-effectiveness of these new products is suggested to facilitate their optimal use. Limitations: The present review did not utilize systematic review standards or meta-analytic techniques, given the large heterogeneity of data and outcomes reviewed. Conclusions: ADFs provide an option for inhibiting the abuse or misuse of oral opioid products by hindering extraction of the active ingredient, preventing alternative routes of administration, or causing aversion. Their relatively high costs, uncertain insurance policies, and limited data on pharmacoeconomics warrant collaborative monitoring and assessment by government agencies, pharmaceutical manufacturers, and data analysis services to define their therapeutic role in the future. Key words: Opioid abuse, abuse-deterrent formulations, ADF, post-marketing, FDA guidance, cost impact, abuse liking, physician attitude, generic abuse-deterrent formulation, clinical application

Emerging trends in Abuse-Deterrent Formulations: Technological insights and Regulatory considerations

2021 ◽  
Vol 18 ◽  
Author(s):  
Dhwani Rana ◽  
Sagar Salave ◽  
Derajram Benival
Keyword(s):  
Drug Abuse ◽  
Severe Pain ◽  
Public Health Problem ◽  
Opioid Overdose ◽  
Opioid Epidemic ◽  
Fda Guidance ◽  
Post Marketing ◽  
Chronic Severe Pain ◽  
Alternative Routes

Background: Opioid medications are an integral part in the management of acute and chronic severe pain. However, non-medical practice of these prescription drug products is emerging as a serious public health problem. To control this opioid epidemic, USFDA is encouraging pharmaceutical companies to develop Abuse Deterrent Formulations (ADFs). Abuse Deterrent Formulations are much more difficult to manipulate and abuse when compared to their conventional formulations. This feature of ADFs is due to their ability to incumber extraction of active ingredients, to prevent administration through alternative routes and making abuse of altered product less rewarding. Objective: The main objective of this review is to abridge different ADFs and various laboratory-based in vitro manipulation and extraction studies, demonstrating that these approved ADFs have capabilities to deter abuse. Methods: The method includes collection of data from different search engines like PubMed, FDA guidance documents, ScienceDirect, Google Patents to get coverage of literature in order to get appropriate information regarding ADFs. Results: Various in vitro studies demonstrate that ADFs are effective in minimizing opioid drug abuse including opioid overdose. However, real impact of these ADFs on reducing the drug abuse can be concluded only after receiving the post marketing data. Conclusion: ADFs are embracing fundamentally different paradigm in management of severe pain. We believe that development of abuse deterrent technologies would shift the architype, deterring multipill abuse and can prove as a breakthrough strategy in controlling this opioid epidemic menace.

scholarly journals Dexmedetomidine: What’s New for Pediatrics? A Narrative Review

2020 ◽  
Vol 9 (9) ◽  
pp. 2724 ◽  
Author(s):  
Mohamed Mahmoud ◽  
Egidio Barbi ◽  
Keira P. Mason
Keyword(s):  
Clinical Practice ◽  
Animal Studies ◽  
Neurocognitive Function ◽  
Clinical Applications ◽  
Protective Effects ◽  
Comprehensive Review ◽  
Routes Of Administration ◽  
The Past ◽  
Growing Body ◽  
Alternative Routes

Over the past few years, despite the lack of approved pediatric labelling, dexmedetomidine’s (DEX) use has become more prevalent in pediatric clinical practice as well as in research trials. Its respiratory-sparing effects and bioavailability by various routes are only some of the valued features of DEX. In recent years the potential organ-protective effects of DEX, with the possibility for preserving neurocognitive function, has put it in the forefront of clinical and bench research. This comprehensive review focused on the pediatric literature but presents relevant, supporting adult and animal studies in order to detail the recent growing body of literature around the pharmacology, end-organ effects, organ-protective effects, alternative routes of administration, synergetic effects, and clinical applications, with considerations for the future.

Allergy immunotherapy for inhalant allergens: Strategies to improve efficacy

2020 ◽  
Vol 41 (1) ◽  
pp. 26-37
Author(s):  
Harold S. Nelson
Keyword(s):  
Subcutaneous Immunotherapy ◽  
Comparative Efficacy ◽  
Allergy Immunotherapy ◽  
Routes Of Administration ◽  
Advantages And Disadvantages ◽  
Dosing Regimens ◽  
Inhalant Allergens ◽  
Alternative Routes ◽  
Allergen Extracts ◽  
Evidence Based Guidelines

Background: Allergy immunotherapy (AIT), both subcutaneous immunotherapy (SCIT) and sublingual immunotherapy (SLIT), is an effective and safe treatment for allergic rhinitis and allergic asthma due to inhalant allergens. However, there are many variables in how it is administered. Objective: To review the evidence that suggests the optimum practices to enhance the efficacy of AIT. Methods: Articles that reported the results of various approaches to the practice of AIT and evidence-based guidelines were consulted for guidance on what approaches would enhance the efficacy of AIT. Results: Evidence is presented that supports optimum dosing for SCIT, a discussion of dosing with liquid SLIT, the management of the patient who is polyallergic, considerations in mixing allergen extracts, advantages and disadvantages of different up-dosing regimens with SCIT, the optimum duration of AIT, the comparative efficacy of SCIT and SLIT, and improving adherence to AIT. Also reviewed were two approaches, the use of adjuvants and of alternative routes of administration of currently available extracts, which may be useful in the future after further studies have defined their effectiveness. Conclusion: Although there is still controversy about some aspects of AIT, there is literature to support approaches that enhance the efficacy of both SCIT and SLIT.

scholarly journals Potential Impact of the Current and Future Climate on the Yield, Quality, and Climate Suitability for Tea [Camellia sinensis (L.) O. Kuntze]: A Systematic Review

Agronomy ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. 619
Author(s):  
Sadeeka Layomi Jayasinghe ◽  
Lalit Kumar
Keyword(s):  
Climate Change ◽  
Future Climate ◽  
Mitigation Strategies ◽  
Extreme Weather Events ◽  
Impact Of Climate Change ◽  
Advantages And Disadvantages ◽  
Tea Quality ◽  
Climate Suitability ◽  
Yield Quality ◽  
The Impact

Even though climate change is having an increasing impact on tea plants, systematic reviews on the impact of climate change on the tea system are scarce. This review was undertaken to assess and synthesize the knowledge around the impacts of current and future climate on yield, quality, and climate suitability for tea; the historical roots and the most influential papers on the aforementioned topics; and the key adaptation and mitigation strategies that are practiced in tea fields. Our findings show that a large number of studies have focused on the impact of climate change on tea quality, followed by tea yield, while a smaller number of studies have concentrated on climate suitability. Three pronounced reference peaks found in Reference Publication Year Spectroscopy (RYPS) represent the most significant papers associated with the yield, quality, and climate suitability for tea. Tea yield increases with elevated CO2 levels, but this increment could be substantially affected by an increasing temperature. Other climatic factors are uneven rainfall, extreme weather events, and climate-driven abiotic stressors. An altered climate presents both advantages and disadvantages for tea quality due to the uncertainty of the concentrations of biochemicals in tea leaves. Climate change creates losses, gains, and shifts of climate suitability for tea habitats. Further studies are required in order to fill the knowledge gaps identified through the present review, such as an investigation of the interaction between the tea plant and multiple environmental factors that mimic real-world conditions and then studies on its impact on the tea system, as well as the design of ensemble modeling approaches to predict climate suitability for tea. Finally, we outline multifaceted and evidence-based adaptive and mitigation strategies that can be implemented in tea fields to alleviate the undesirable impacts of climate change.

scholarly journals AB0249 SAFETY OF BARICITINIB IN JAPANESE PATIENTS WITH RHEUMATOID ARTHRITIS (RA): THE 2020 INTERIM REPORT FROM ALL-CASE POST MARKETING SURVEILLANCE IN CLINICAL PRACTICE

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1150.1-1150
Author(s):  
T. Fujii ◽  
T. Atsumi ◽  
N. Okamoto ◽  
N. Takahashi ◽  
N. Tamura ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Adverse Events ◽  
Aspiration Pneumonia ◽  
Japanese Patients ◽  
Research Support ◽  
Serious Adverse Events ◽  
Chugai Pharmaceutical ◽  
Post Marketing Surveillance ◽  
Otsuka Pharmaceutical ◽  
Post Marketing

Background:An all-case post marketing surveillance (PMS) of baricitinib (Bari), that started in Sep 2017, collects safety and effectiveness for the first 24 wks of treatment and continues to collect serious adverse events (SAEs) for 3 yrs.Objectives:To evaluate Bari safety in RA patients (pt) in clinical practice.Methods:We report pt baseline demographics and adverse events (AEs) up to 24 wks for pts whose case report files for 24-wk data were completed as of Jun 2020.Results:Data from 3445 pts were analyzed (females=80%, mean age=64yr, mean RA duration 12yr). Bari dose regimen was as follows: 4mg, 60%, 2mg, 27%, 4mg→2mg, 5%, 2mg→4mg, 5%, and others, 2%. Concomitant use of MTX and glucocorticoid was 65% and 48%, respectively. 74% continued treatment for 24 wks. AE and SAE were recognized in 887 (26%) and 122 pts (4%), respectively. 6 pts died of pneumonia, aspiration pneumonia, bacterial pneumonia, cerebral infarction/ILD/aspiration pneumonia, adenocarcinoma, and colorectal cancer. Major AEs were as follows: herpes zoster=3%, liver dysfunction=3%, serious infection=1%, anemia=1%, hyperlipidemia=1%, malignancy=0.3%, interstitial pneumonia=0.2%, MACE=0.1%, and VTE=0.1%.Conclusion:Data do not show new safety concerns and encourage guideline-compliant use of Bari.Disclosure of Interests:Takao Fujii Speakers bureau: Chugai Pharmaceutical Co. Ltd.; Eisai Co. Ltd; Eli Lilly Japan K.K.; Janssen Pharmaceutical K.K.; Ono Pharmaceutical Co. Ltd., Consultant of: Asahikasei Pharma Corp, Grant/research support from: Asahikasei Pharma Corp; AbbVie Japan GK; Chugai Pharmaceutical Co. Ltd., Eisai Co. Ltd; Eli Lilly Japan K.K.; Mitsubishi-Tanabe Pharma Co.; Ono Pharmaceutical Co., Ltd., Tatsuya Atsumi Speakers bureau: AbbVie Japan GK; Astellas Pharma Inc.; Bristol-Myers Squibb Co. Ltd; Chugai Pharmaceutical Co. Ltd.; Daiichi Sankyo Co. Ltd.; Eisai Co. Ltd.; Eli Lilly Japan K.K.; Mitsubishi Tanabe Pharma Co.; Pfizer Japan Inc.; Takeda Pharmaceutical Co. Ltd., UCB Japan Co. Ltd., Consultant of: AbbVie Japan GK; AstraZeneca plc.; Boehringer Ingelheim Co. Ltd.; Medical & Biological Laboratories Co. Ltd.; Novartis Pharma K.K.; Ono Pharmaceutical Co. Ltd.; Pfizer Japan Inc., Grant/research support from: Astellas Pharma Inc., Alexion Inc.; Chugai Pharmaceutical Co. Ltd., Daiichi Sankyo Co. Ltd., Mitsubishi Tanabe Pharma Co., Otsuka Pharmaceutical Co., Ltd.Pfizer Japan Inc.; Takeda Pharmaceutical Co. Ltd., Nami Okamoto Speakers bureau: AbbVie Japan GK; Asahikasei Pharma Co.; AYUMI Pharmaceutical Co.Eisai Co. Ltd; Bristol-Myers Squibb Co. Ltd.; Eli Lilly Japan K.K.; Mitsubishi-Tanabe Pharma Co.; Pfizer Japan Inc.Sanofi K.K.; Chugai Pharmaceutical Co. Ltd.; Novartis Pharma Co.; Teijin Pharma Ltd.; Torii Pharmaceutical Co., Ltd., Nobunori Takahashi Speakers bureau: AbbVie Japan GK; Eisai Co. Ltd.; Mitsubishi Tanabe Pharma Co.; Pfizer Japan Inc.; Chugai Pharmaceutical Co., Ltd.; Eli Lilly Japan K.K.; Janssen Pharmaceutical K.K.; UCB Japan Co. Ltd.; Astellas Pharma Inc.; Bristol Myers Squibb Co. Ltd., Grant/research support from: Bristol Myers Squibb Co. Ltd., Naoto Tamura Speakers bureau: AbbVie Japan GK; Bristol Myers Squibb Co. Ltd.; Chugai Pharmaceutical Co. Ltd.; Eisai Co. Ltd.; Eli Lilly Japan K.K.; Glaxo Smith Kline K.K.; Janssen Pharmaceutical K.K.; Mitsubishi-Tanabe Pharma Co.; Novartis Pharma Co., Atsuo Nakajima: None declared, Ayako Nakajima Speakers bureau: AbbVie Japan GK; Actelion Pharmaceuticals Japan Ltd., Asahi Kasei Pharma Co., Astellas Pharma Inc., Ayumi Pharmaceutical Co., Bristol Myers Squibb Co., Ltd.,Chugai Pharmaceutical Co., Ltd., Eisai Co., Ltd., Eli Lilly Japan K.K., Glaxo Smith Kline K.K., Hisamitsu Pharmaceutical Co. Inc., Kyorin Pharmaceutical Co. Ltd., Mitsubishi Tanabe Pharma Co., Otsuka Pharmaceutical Co. Ltd., Pfizer Japan Inc., Teijin Pharma Ltd., Grant/research support from: Chugai Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Co., Pfizer Japan Inc., Hiroaki Matsuno Speakers bureau: Chugai Pharmaceutical Co., Ltd., Daiichi Sankyo Co., Ltd., Eli Lilly Japan K.K., Consultant of: Mochida Pharmaceutical Co., Ltd., Grant/research support from: Astellas Pharma Inc., Eli Lilly Japan K.K.; Janssen Pharmaceutical K.K, Naoto Tsujimoto Shareholder of: Eli Lilly, Employee of: Eli Lilly Japan K.K., Atsushi Nishikawa Shareholder of: Eli Lilly, Employee of: Eli Lilly Japan K.K., Taeko Ishii Shareholder of: Eli Lilly, Employee of: Eli Lilly Japan K.K., Tsutomu Takeuchi Speakers bureau: AbbVie Japan GK, Ayumi Pharmaceutical Co., Bristol Myers Squibb Co., Ltd., Chugai Pharmaceutical Co, Ltd. Daiichi Sankyo Co., Ltd. Eisai Co., Ltd. Eli Lilly Japan K.K.; Gilead Sciences, Inc. Janssen Pharmaceutical K.K.; Mitsubishi-Tanabe Pharma Co.; Novartis Pharma Co.; Pfizer Japan Inc.; Sanofi K.K.; UCB Japan Co., Ltd., Consultant of: AbbVie Japan GK, Astellas Pharma, Inc.; Chugai Pharmaceutical Co, Ltd.; Eli Lilly Japan K.K.; Eisai Co., Ltd.; Gilead Sciences, Inc.; Janssen Pharmaceutical K.K.; Mitsubishi-Tanabe Pharma Corp., Pfizer Japan Inc., Grant/research support from: AbbVie Japan GK, Asahikasei Pharma Corp., Chugai Pharmaceutical Co, Ltd., DNA Chip Research Inc.; Eisai Co., Ltd., Eli Lilly Japan K.K.; Mitsubishi-Tanabe Pharma Corp., UCB Japan Co., Ltd., Masataka Kuwana Speakers bureau: AbbVie Japan GK, Astellas Pharma Inc., Asahi Kasei Pharma Co., Boehringer-Ingelheim, Chugai Pharmaceutical Co., Ltd., Eisai Co., Ltd., Janssen Pharmaceutical K.K., Medical &Biological Laboratories Co., Ltd.; Mitsubishi Tanabe Pharma Co.; Mochida Pharmaceutical Co., Ltd., Nippon Shinyaku Co., Ltd.; Ono Pharmaceutical Co., Ltd.; Pfizer Japan Inc., Consultant of: Boehringer-Ingelheim, Chugai Pharmaceutical Co., Ltd., Corbus Pharmaceuticals Holdings, Inc.; Medical &Biological Laboratories Co., Ltd.; Mochida Pharmaceutical Co., Ltd., Grant/research support from: Boehringer-Ingelheim, Chugai Pharmaceutical Co., Ltd., Eisai Co., Ltd., Medical &Biological Laboratories Co., Ltd; Mitsubishi Tanabe Pharma Co., Ono Pharmaceutical Co., Ltd., Michiaki Takagi Speakers bureau: Yes, but sponsored lectures without COI in the academic meetings, only.

An Emergency Preparedness Response to Opioid-Prescribing Enforcement Actions in Maryland, 2018-2019

2021 ◽  
Vol 136 (1_suppl) ◽  
pp. 9S-17S
Author(s):  
Jessica C. Acharya ◽  
B. Casey Lyons ◽  
Vijay Murthy ◽  
Jennifer Stanley ◽  
Carly Babcock ◽  
...  
Keyword(s):  
Emergency Preparedness ◽  
Data Access ◽  
Opioid Use Disorder ◽  
Lessons Learned ◽  
Mitigation Strategies ◽  
Federal State ◽  
Opioid Use ◽  
Time Data ◽  
Enforcement Action ◽  
State And Local

Federal and state enforcement authorities have increasingly intervened on the criminal overprescribing of opioids. However, little is known about the health effects these enforcement actions have on patients experiencing disrupted access to prescription opioids or medication-assisted treatment/medication for opioid use disorder. Simultaneously, opioid death rates have increased. In response, the Maryland Department of Health (MDH) has worked to coordinate mitigation strategies with enforcement partners (defined as any federal, state, or local enforcement authority or other governmental investigative authority). One strategy is a standardized protocol to implement emergency response functions, including rapidly identifying health hazards with real-time data access, deploying resources locally, and providing credible messages to partners and the public. From January 2018 through October 2019, MDH used the protocol in response to 12 enforcement actions targeting 34 medical professionals. A total of 9624 patients received Schedule II-V controlled substance prescriptions from affected prescribers under investigation in the 6 months before the respective enforcement action; 9270 (96%) patients were residents of Maryland. Preliminary data indicate fatal overdose events and potential loss of follow-up care among the patient population experiencing disrupted health care as a result of an enforcement action. The success of the strategy hinged on endorsement by leadership; the establishment of federal, state, and local roles and responsibilities; and data sharing. MDH’s approach, data sources, and lessons learned may support health departments across the country that are interested in conducting similar activities on the front lines of the opioid crisis.

scholarly journals Non-Invasive Assessment of Left Ventricle Ejection Fraction: Where Do We Stand?

2021 ◽  
Vol 11 (11) ◽  
pp. 1153
Author(s):  
Alessandra Scatteia ◽  
Angelo Silverio ◽  
Roberto Padalino ◽  
Francesco De Stefano ◽  
Raffaella America ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Ejection Fraction ◽  
Systolic Function ◽  
Left Ventricular ◽  
Left Ventricle Ejection Fraction ◽  
Advantages And Disadvantages ◽  
Non Invasive ◽  
Lv Ejection Fraction ◽  
Lv Systolic Function ◽  
Invasive Evaluation

The left ventricular (LV) ejection fraction (EF) is the preferred parameter applied for the non-invasive evaluation of LV systolic function in clinical practice. It has a well-recognized and extensive role in the clinical management of numerous cardiac conditions. Many imaging modalities are currently available for the non-invasive assessment of LVEF. The aim of this review is to describe their relative advantages and disadvantages, proposing a hierarchical application of the different imaging tests available for LVEF evaluation based on the level of accuracy/reproducibility clinically required.

scholarly journals Robust Estimation of Infection Fatality Rates during the Early Phase of a Pandemic

2020 ◽  
Author(s):  
Perikles Simon
Keyword(s):  
Robust Estimation ◽  
Case Fatality ◽  
Mitigation Strategies ◽  
Global Burden ◽  
Data Sets ◽  
Serological Testing ◽  
Time Data ◽  
Age Cohorts ◽  
Spanish Influenza ◽  
And Control

AbstractDuring a pandemic, robust estimation of case fatality rates (CFRs) is essential to plan and control suppression and mitigation strategies. At present, estimates for the CFR of COVID-19 caused by SARS-CoV-2 infection vary considerably. Expert consensus of 0.1–1% covers in practical terms a range from normal seasonable Influenza to Spanish Influenza. In the following, I deduce a formula for an adjusted Infection Fatality Rate (IFR) to assess mortality in a period following a positive test adjusted for selection bias.Official datasets on cases and deaths were combined with data sets on number of tests. After data curation and quality control, a total of IFR (n=819) was calculated for 21 countries for periods of up to 26 days between registration of a case and death.Estimates for IRFs increased with length of period, but levelled off at >9days with a median for all 21 countries of 0.11 (95%-CI: 0.073–0.15). An epidemiologically derived IFR of 0.040 % (95%-CI: 0.029%– 0.055%) was determined for Iceland and was very close to the calculated IFR of 0.057% (95%-CI: 0.042– 0.078), but 2.7–6-fold lower than CFRs. IFRs, but not CFRs, were positively associated with increased proportions of elderly in age-cohorts (n=21, spearman’s ρ=.73, p =.02).Real-time data on molecular and serological testing may further displace classical diagnosis of disease and its related death. I will critically discuss, why, how and under which conditions the IFR, provides a more solid early estimate of the global burden of a pandemic than the CFR.

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