scholarly journals Abuse-deterrent opioid analgesics: a guide for clinicians

2020 ◽  
Vol 10 (1) ◽  
pp. 55-62 ◽  
Author(s):  
Adam J Carinci
Keyword(s):  
Real World ◽  
Opioid Analgesics ◽  
Prescription Opioid ◽  
Pharmacokinetic Studies ◽  
Regulatory Issues ◽  
The Us ◽  
Us Fda ◽  
The Impact ◽  
Prescription Opioid Abuse

The US FDA has encouraged the development of abuse-deterrent formulations (ADFs) of opioid analgesics as one component in a comprehensive effort to combat prescription opioid abuse. Guidance issued by the FDA outlines three types of premarket studies for evaluating abuse deterrence: laboratory-based in vitro manipulation and extraction studies, pharmacokinetic studies and human abuse potential studies. After approval, postmarket studies are needed to evaluate the impact of an ADF product on abuse in real-world settings. This review summarizes the regulatory issues involved in the development of ADF opioids and clarifies abuse-deterrence claims in product labels, in order to assist clinicians in critically evaluating the available evidence pertaining to the abuse-deterrent features of opioid analgesics.

Impact of Curcumin on Microsomal Enzyme Activities: Drug Interaction and Chemopreventive Studies

2021 ◽  
Vol 28 ◽  
Author(s):  
Habibeh Mashayekhi-Sardoo ◽  
Adeleh Mashayekhi‐Sardoo ◽  
Basil D. Roufogalis ◽  
Tannaz Jamialahmadi ◽  
Amirhossein Sahebkar
Keyword(s):  
Curcuma Longa ◽  
Significant Inhibition ◽  
Microsomal Enzyme ◽  
Scientific Databases ◽  
Protein Levels ◽  
Curcumin Analogs ◽  
The Us ◽  
Natural Polyphenol ◽  
The Impact

: Curcumin, a yellow pigment in Asian spice, is a natural polyphenol component of Curcuma longa rhizome. Curcuminoid components include curcumin, demethoxycurcumin (DMC), and bisdemethoxycurcumin (BDMC). Previous studies established curcumin as a safe agent based on preclinical and clinical evaluations and curcuminoids have been approved by the US Food and Drug Administration (FDA) as “Generally Recognized as Safe” (GRAS). The present review collects and summarizes clinical and preclinical studies of curcumin interactions, with an emphasis on the effect of curcumin and curcumin analogs on the mRNA and protein levels of microsomal CYP450 enzymes (phase I metabolism) and their interactions with toxicants, drugs and drug probes. The literature search was conducted using keywords in various scientific databases, including Web of Science, Scopus, PubMed, and Google Scholar. Studies concerning the impact of curcumin and curcumin analogs on microsomal enzyme activity are reviewed and include oral, topical, and systemic treatment in humans and experimental animals, as well as studies from in vitro research. When taken together the data identified some inconsistent results between various studies. The findings showed significant inhibition of CYP450 enzymes by curcumin and its analogs. However such effects often differed when curcumin and curcumin analogs were coadministered with toxicant and other drugs and drug probes. We conclude from this review that herb-drug interactions should be considered when curcumin and curcumin analogs are consumed.

scholarly journals Extended storage of SARS-CoV-2 nasopharyngeal swabs does not negatively impact results of molecular-based testing across three clinical platforms

2020 ◽  
pp. jclinpath-2020-206738
Author(s):  
Karin A Skalina ◽  
D Y Goldstein ◽  
Jaffar Sulail ◽  
Eunkyu Hahm ◽  
Momka Narlieva ◽  
...  
Keyword(s):  
Real World ◽  
Nasopharyngeal Swab ◽  
Molecular Testing ◽  
Clinical Tests ◽  
Ambient Conditions ◽  
Long Term Stability ◽  
The Us ◽  
Us Fda ◽  
World Environment

With the global outbreak of COVID-19, the demand for testing rapidly increased and quickly exceeded the testing capacities of many laboratories. Clinical tests which receive CE (Conformité Européenne) and Food and Drug Administration (FDA) authorisations cannot always be tested thoroughly in a real-world environment. Here we demonstrate the long-term stability of nasopharyngeal swab specimens for SARS-CoV-2 molecular testing across three assays recently approved by the US FDA under Emergency Use Authorization. This study demonstrates that nasopharyngeal swab specimens can be stored under refrigeration or even ambient conditions for 21 days without clinically impacting the results of the real-time reverse transcriptase-PCR testing.

Establishing “abuse-deterrence equivalence” for generic abuse-deterrent opioid formulations: A proposed development framework

2016 ◽  
Vol 12 (2) ◽  
pp. 96
Author(s):  
Beatrice Setnik, PhD ◽  
Edward J. Cone, PhD
Keyword(s):  
Opioid Abuse ◽  
Prescription Opioid ◽  
Regulatory Guidance ◽  
Development Framework ◽  
Novel Drugs ◽  
In Vivo Testing ◽  
Guidance Documents ◽  
Prescription Opioid Abuse

Abuse-deterrent formulations are one strategy for mitigating the epidemic of prescription opioid abuse. Regulatory guidance documents describe the requirements for developing abuse-deterrent formulations of novel drugs and formulations; however, they do not address “abuse-deterrence equivalence” for generic formulations. As generics may be produced with different excipients and formulations compared to reference drugs, differences in their properties may impact their abuse-deterrent features. Currently, it is unclear what specific studies are needed to support generic abuse-deterrence claims. This commentary outlines several recommendations on the in vitro and in vivo testing required, including the conditions for conducting a human abuse potential study.

scholarly journals Factors Associated with Prescription Opioid Analgesic Use in the US Population, 2011–2014

Pain Medicine ◽  
2018 ◽  
Vol 20 (7) ◽  
pp. 1338-1346 ◽  
Author(s):  
Steven M Frenk ◽  
Susan L Lukacs ◽  
Qiuping Gu
Keyword(s):  
Opioid Analgesic ◽  
Opioid Analgesics ◽  
Opioid Use Disorder ◽  
Prescription Opioid ◽  
Opioid Use ◽  
Factors Associated ◽  
The Past ◽  
The Us ◽  
Opioid Users ◽  
Analgesic Use

Abstract Objective This study examined factors associated with prescription opioid analgesic use in the US population using data from a nationally representative sample. It focused on factors previously shown to be associated with opioid use disorder or overdose. Variations in the use of different strength opioid analgesics by demographic subgroup were also examined. Methods Data came from respondents aged 16 years and older who participated in the National Health and Nutrition Examination Survey (2011–2014). Respondents were classified as opioid users if they reported using one or more prescription opioid analgesics in the past 30 days. Results Opioid users reported poorer self-perceived health than those not currently using opioids. Compared with those not using opioids, opioid users were more likely to rate their health as being “fair” or “poor” (40.4% [95% confidence interval {CI} = 34.9%–46.2%] compared with 15.6% [95% CI = 14.3%–17.1%]), experienced more days of pain during the past 30 days (mean = 14.3 [95% CI = 12.9–15.8] days compared with 2.3 [95% CI = 2.0–2.7] days), and had depression (22.5% [95% CI = 17.3%–28.7%] compared with 7.1% [95% CI = 6.2%–8.0%]). Among those who reported using opioids during the past 30 days, 18.8% (95% CI = 14.4%–24.1%) reported using benzodiazepine medication during the same period and 5.2% (95% CI = 3.5%–7.7%) reported using an illicit drug during the past six months. When opioid strength was examined, a smaller percentage of adults aged 60 years and older used stronger-than-morphine opioids compared with adults aged 20–39 and 40–59 years. Conclusions Higher percentages of current opioid users than nonusers reported having many of the factors associated with opioid use disorder and overdose.

Parental Prescription Opioid Abuse and the Impact on Children

2011 ◽  
Vol 37 (6) ◽  
pp. 532-536 ◽  
Author(s):  
Lisham Ashrafioun ◽  
Christina M. Dambra ◽  
Richard D. Blondell
Keyword(s):  
Opioid Abuse ◽  
Prescription Opioid ◽  
The Impact ◽  
Prescription Opioid Abuse

scholarly journals The Impact of Animal Agriculture on Human Health

2021 ◽  
Author(s):  
Andrea Kassay
Keyword(s):  
Antibiotic Resistance ◽  
Infectious Diseases ◽  
Health Problems ◽  
Human Diseases ◽  
Meat Industry ◽  
Animal Agriculture ◽  
The Us ◽  
Excessive Consumption ◽  
Us Fda ◽  
The Impact

Animal agriculture contributes to many health problems that exist today, such as the spread of infectious diseases, antibiotic resistance, and chronic human diseases like heart disease and cancer. With regards to infectious diseases, most modern day infections were unknown before the domestication of animals. Industrial agriculture forces a large number of genetically similar animals into unsanitary situations, providing the perfect conditions for viruses to emerge and spread to different species. With regards to antibiotic resistance, the US FDA estimates that each year, 80% of microbial drugs are sold to the meat industry. Countries that have the most microbial resistance also have the highest use of antimicrobials, such as penicillins, tetracyclines, and sulfonamides in animal agriculture. With regards to chronic human diseases, there is extensive evidence that the excessive consumption of animal-based products can lead to chronic diseases such as cardiovascular disease and some types of cancer. The purpose of this article is to further discuss how animal agriculture may be a cause of these current health problems and how adopting a plant-based diet can be a potential solution.

scholarly journals Daratumumab utilization and cost analysis among patients with multiple myeloma in a US community oncology setting

2021 ◽  
Author(s):  
Lucio N Gordan ◽  
Stanley M Marks ◽  
Mei Xue ◽  
Neil Nagovski ◽  
J Hunter Lambert ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Treatment Patterns ◽  
Cost Of Care ◽  
Dosing Schedule ◽  
Community Oncology ◽  
Improved Outcomes ◽  
The Us ◽  
Us Fda ◽  
The Cost ◽  
The Impact

Background: The introduction of daratumumab into the treatment of multiple myeloma has improved outcomes in patients; however, community oncologists often dose more frequently than the US FDA-approved label. Materials and methods: Integra analyzed its database to elucidate daratumumab treatment patterns and the impact of increased utilization on the cost of care for multiple myeloma. Results: Following week 24, 671 (65%) of 1037 patients remained on daratumumab-containing regimens, with 330 patients continuing more frequent treatments than the expected once-every-4-weeks dosing described in the standard dosing schedule. Patients received an average of 14% more daratumumab doses than the FDA-approved label indicates, increasing the 1-year daratumumab costs by an estimated US$31,353. Conclusion: Daratumumab is utilized more frequently than the FDA-recommended dosing, leading to higher multiple myeloma treatment costs.

scholarly journals Dynamic Changes in Prescription Opioids from 2006 to 2017 in Texas

2019 ◽  
Author(s):  
Ebuwa T Ighodaro ◽  
Kenneth L McCall ◽  
Daniel Y Chung ◽  
Stephanie D Nichols ◽  
Brian J Piper
Keyword(s):  
Rural Areas ◽  
Opioid Analgesics ◽  
Opioid Use Disorder ◽  
Prescription Opioid ◽  
Prescription Opioids ◽  
Opioid Use ◽  
Study Objective ◽  
The Us ◽  
Urban And Rural Areas ◽  
Opioid Diversion

AbstractStudy ObjectiveThe US is experiencing an epidemic of opioid overdoses which may be at least partially due to an over-reliance on opioid analgesics in the treatment of chronic non-cancer pain and subsequent escalation to heroin or illicit fentanyl. As Texas was reported to be among the lowest in the US for opioid use and misuse, further examination of this state is warranted.Study DesignThis study was conducted to quantify prescription opioid use in Texas.Data SourceData was obtained from the publically available US Drug Enforcement Administration’s Automation of Reports and Consolidated Orders System (ARCOS) which monitors controlled substances transactions from manufacture to commercial distribution.Measurement and Main ResultsData for 2006-2017 from Texas for ten prescription opioids including eight primarily used to relieve pain (codeine, fentanyl, hydrocodone, hydromorphone, meperidine, morphine, oxycodone, oxymorphone) and two (buprenorphine and methadone) for the treatment of an Opioid Use Disorder (OUD) were examined. The change in Morphine Mg Equivalent (MME) of all opioids (+23.3%) was only slightly greater than the state’s population gains (21.1%). Opioids used to treat an OUD showed pronounced gains (+90.8%) which were four-fold faster than population growth. Analysis of individual agents revealed pronounced elevations in codeine (+387.5%), hydromorphone (+106.7%), and oxycodone (+43.6%) and a reduction in meperidine (−80.3%) in 2017 relative to 2006. Methadone in 2017 accounted for a greater portion (39.5%) of the total MME than hydrocodone, oxycodone, morphine, hydromorphone, oxymorphone, and meperidine, combined. There were differences between urban and rural areas in the changes in hydrocodone and buprenorphine.ConclusionsCollectively, these findings indicate that continued vigilance is needed in Texas to appropriately treat pain and an OUD while minimizing the potential for prescription opioid diversion and misuse. Texas may lead the US in a return to pre opioid crisis prescription levels.

Self-reports of prescription opioid abuse and diversion among recreational opioid users in a Canadian and a United States city

2015 ◽  
Vol 11 (6) ◽  
pp. 463 ◽  
Author(s):  
Beatrice Setnik, PhD ◽  
Carl L. Roland, PharmD, MS ◽  
Veeraindar Goli, MD ◽  
Glenn C. Pixton, MS ◽  
Naama Levy-Cooperman, PhD ◽  
...  
Keyword(s):  
United States ◽  
Salt Lake ◽  
Salt Lake City ◽  
The United States ◽  
Opioid Abuse ◽  
Prescription Opioid ◽  
Prescription Opioids ◽  
The Us ◽  
Opioid Users ◽  
Prescription Opioid Abuse

Objective: To explore behaviors related to prescription opioid abuse and diversion in individuals who self-reported past recreational (nonmedical) opioid use.Design: A questionnaire was developed and included in two abuse potential clinical studies conducted in Canada (Toronto, ON, August 2010 to January, 2011) and the United States (Salt Lake City, UT, February-May 2011).Participants: Recreational opioid users.Main outcome measure(s): Self-reported behaviors related to prescription opioid abuse and diversion.Results: The questionnaire was completed by 174 participants in the Canadian study and 80 participants in the US study. Most participants reported that they used prescription opioids for nonmedical purposes a few times a month. Most had taken their first prescription opioid between the ages of 12 and 24 years and the two most common reasons were to treat pain or to feel high/stoned. When asked about specific opioids taken for nonmedical purposes in the past year, oxycodone, acetaminophen with codeine, and morphine were commonly used by both cohorts, whereas hydrocodone use was substantially greater in the US cohort versus the Canadian cohort. Participants reported various tampering methods and routes of administration, with swallowed whole, crushed and snorted, and chewed/crushed and swallowed as the most prevalent. Most participants indicated taking other drugs with prescription opioids to get high, most commonly marijuana and alcohol. The most common sources for obtaining prescription opioids were family/friends. Conclusions: Two cohorts of recreational opioid users from Canada and the United States reported similar experiences with various prescription opioids and indicated a predominance of diversion from family/friends.

Use of real-world clinical lab data to reveal Asian NTRK fusion test availability patterns.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e15574-e15574
Author(s):  
Markus Eckstein ◽  
Kenneth Joel Bloom ◽  
Susanne Munksted Fosvig ◽  
Marieke Hoefsmit ◽  
Jordan Clark
Keyword(s):  
Real World ◽  
First Generation ◽  
Treatment Options ◽  
Laboratory Data ◽  
Clinical Pathology ◽  
Pathology Laboratory ◽  
Pediatric Cancer Patients ◽  
The Us ◽  
Trk Inhibitors ◽  
The Impact

e15574 Background: The development and launch of first-generation tropomyosin receptor kinase (TRK) inhibitors, such as larotrectinib and entrectinib, has brought targeted treatment options to neurotrophic tropomyosin-related kinase (NTRK) fusion–positive adult and pediatric cancer patients who may have been out of treatment options. Widespread adoption of NTRK fusion testing is needed to support successful selection of patients for these TRK inhibitors as well as other targeted therapies. The objective of this study was to investigate global availability of NTRK fusion testing, with a specific focus on Asia. Methods: For this study, real-world clinical pathology laboratory data, derived from Diaceutics’ proprietary Global Diagnostic Index (GDI) of more than 2500 labs, were investigated to assess the current footprint of NTRK fusion testing in Asia. Availability of clinical routine testing was analyzed in selected cohorts of laboratories across different regions, comparing Asia to the US and Europe. Laboratories were included based on their large volume of testing or on their importance (e.g., large academic and large commercial laboratories). Results: Data on availability of NTRK fusion testing by clinical laboratories reveal different patterns of NTRK fusion test adoption in Asia, depending on the region under study. In China and similarly in the US, Italy, and France clinical NTRK fusion testing is already being performed by the majority of laboratories from the selected cohort. In Japan, physicians have limited access to testing, with only a few laboratories from the selected cohort performing testing for NTRK fusions. Conclusions: NTRK fusion testing is essential for identifying patients eligible for first-generation TRK-inhibitors. Various laboratories across selected cohorts of labs in China and Japan lack the capability to initiate clinical NTRK fusion testing in-house, denying some patients the potential benefit from these breakthrough therapies. Consequently, patient outcomes will be suboptimal due to lack of testing infrastructure. The readiness of Asian markets to support patient selection successfully can affect the rate of testing and the impact of these innovative therapies on patients’ lives. [Table: see text]

Sign in / Sign up

Export Citation Format

Share Document