Over-the-Counter Monograph Safety, Innovation, and Reform Act

2021 ◽  
Vol 49 (2) ◽  
pp. 321-327
Author(s):  
Jason Gardiner ◽  
Aaron S. Kesselheim
Keyword(s):  
Over The Counter ◽  
Safety Issues ◽  
Otc Drugs ◽  
The Us

AbstractOver-the-counter (OTC) drugs are ubiquitous in the US. Policymakers have long debated how to modernize the system for making determinations of safety and effectiveness and addressing safety issues with OTC drugs.

scholarly journals Behavior of Medical Students toward Over-the-Counter Drugs in Comparison to Students from Other Faculties, Riyadh, Saudi Arabia

2021 ◽  
pp. 129-135
Author(s):  
Amar Fathi Mohamed Khalifa ◽  
Yasser Nabil AlKhudairy ◽  
Adel Ahmed Algahtani ◽  
Bandar Mohammed Abduljabbar ◽  
Fahad Majed Aldawsari ◽  
...  
Keyword(s):  
Saudi Arabia ◽  
Medical Students ◽  
Cross Sectional Study ◽  
P Value ◽  
Online Questionnaire ◽  
Self Medication ◽  
Cross Sectional ◽  
Over The Counter ◽  
Otc Drugs ◽  
Professional Guidance

Background: Over-the-counter-drugs (OTC) are drugs that can be obtained by patients without a prescription from a physician. In Saudi Arabia, it has been reported that more than half of university students practiced self-medication and used OTC drugs. Methods: An institutional-based cross-sectional study, among medical and non-medical students in Riyadh. The sample size was 421, by systemic random sampling. A pre-coded pre-tested online questionnaire was used. Data was analyzed using SPSS V 23. P-value ≤ 0.05 was considered significant. Results: There was no significant relationship between what the participants were majoring in and the usage of OTC drugs (p value= 0.373). Gender also had no relation with the use of OTC (p value= 0.168). Panadol appeared as the most commonly used OTC drug 62.9% for the relief of the most commonly mentioned factor which is headache 50.12%.  Conclusion: Medical education didn’t have much of an effect on the use of OTC drugs. Moreover, professional guidance or advice was not considered most of the time for taking OTC, but the majority of respondents portrayed good behavior towards usage of OTC.

scholarly journals Evaluate use of over the counter drugs among medical students in a tertiary care teaching hospital

2019 ◽  
Vol 8 (5) ◽  
pp. 973
Author(s):  
Megha Sood ◽  
Jagminder Kaur Bajaj ◽  
Nipunjot Grewal
Keyword(s):  
Medical Students ◽  
Drug Use ◽  
Tertiary Care ◽  
Easy Access ◽  
Self Medication ◽  
Cross Sectional ◽  
Over The Counter ◽  
Care Teaching ◽  
Otc Drugs ◽  
Abdominal Symptoms

Background: In our country there is easy availability of drugs over the counter leading to their unintentional misuse and abuse. Over the counter availability of drugs does offer the benefit of easy access to medicines and allows individuals to become in charge of their own health. It is important to understand that medical education can impact the OTC drug use amongst medical students. In order to observe the pattern of OTC drug use among the first and second professional MBBS students we planned this study. The aim of the study was to evaluate use of over the counter (OTC) drugs among medical students in a tertiary care teaching hospital.Methods: Our study was a cross sectional study conducted on first and second professional MBBS students. Authors administered a self structured, prevalidated questionnaire to the students. The data obtained was tabulated, analyzed and the results calculated in percentages.Results: The use of OTC drugs is common amongst undergraduate students.  All (100%) the students who participated in the study had used OTC drugs at some point in their life. The common conditions prompting use of OTC drugs include head ache, body aches (74%), fever (72%), respiratory conditions such as: cold (60%), cough (28.5%), abdominal symptoms such as: abdominal pain (14%), gastritis (7.5%), diarrhea (6%), vomiting (5%) and allergies (10%). Very few students reported adverse drug reactions with these drugs.Conclusions: From our study we have concluded that OTC drugs are commonly used amongst medical students. So, periodic training and talks on self medication are necessary for them. Student knowledge in this aspect will help them in future counseling of their patients.

scholarly journals People’s expectations in Ho Chi Minh City when buying over - the - counter drugs to self - treatment

2020 ◽  
Vol 5 (1) ◽  
Author(s):  
Nguyen Minh Ha ◽  
Nguyen The Hung
Keyword(s):  
Factor Analysis ◽  
Exploratory Factor Analysis ◽  
Prescription Drugs ◽  
Quantitative Method ◽  
Information Behavior ◽  
Ho Chi Minh City ◽  
Over The Counter ◽  
Factors Affecting ◽  
Otc Drugs ◽  
Common Diseases

This objective is to study determinants of people’s expectation in Ho Chi Minh city when buying over – the counter drugs to self – treatment. With a directly surveyed dataset of 403 citizens over 18 years old who purchased medicines for self-treatment, and using the quantitative method by exploratory factor analysis (EFA), the study found factors affecting people’s expectations when buying over – the – counter (OTC) drugs to heal themselves are past purchase and use of non-prescription drugs, experience treating common diseases with OTC drugs, seeking information behavior when intending buying non-prescription drugs, the impression of the-over-counter medications and the impression of pharmacist at pharmacy by Ho Chi Minh city (HCMC) citizens.

scholarly journals Expanded access with intravenous hydroxypropyl-β-cyclodextrin to treat children and young adults with Niemann-Pick disease type C1: a case report analysis

2019 ◽  
Vol 14 (1) ◽  
Author(s):  
Caroline Hastings ◽  
Camilo Vieira ◽  
Benny Liu ◽  
Cyrus Bascon ◽  
Claire Gao ◽  
...  
Keyword(s):  
Disease Type ◽  
Lysosomal Storage ◽  
Safety Issues ◽  
Expanded Access ◽  
Niemann Pick Disease ◽  
The Us ◽  
Progression Of Disease ◽  
Report Analysis ◽  
Niemann Pick ◽  
Pick Disease

Abstract Background Niemann-Pick Disease Type C (NPC) is an inherited, often fatal neurovisceral lysosomal storage disease characterized by cholesterol accumulation in every cell with few known treatments. Defects in cholesterol transport cause sequestration of unesterified cholesterol within the endolysosomal system. The discovery that systemic administration of hydroxypropyl-beta cyclodextrin (HPβPD) to NPC mice could release trapped cholesterol from lysosomes, normalize cholesterol levels in the liver, and prolong life, led to expanded access use in NPC patients. HPβCD has been administered to NPC patients with approved INDs globally since 2009. Results Here we present safety, tolerability and efficacy data from 12 patients treated intravenously (IV) for over 7 years with HPβCD in the US and Brazil. Some patients subsequently received intrathecal (IT) treatment with HPβCD following on average 13 months of IV HPβCD. Several patients transitioned to an alternate HPβCD. Moderately affected NPC patients treated with HPβCD showed slowing of disease progression. Severely affected patients demonstrated periods of stability but eventually showed progression of disease. Neurologic and neurocognitive benefits were seen in most patients with IV alone, independent of the addition of IT administration. Physicians and caregivers reported improvements in quality of life for the patients on IV therapy. There were no safety issues, and the drug was well tolerated and easy to administer. Conclusions These expanded access data support the safety and potential benefit of systemic IV administration of HPβCD and provide a platform for two clinical trials to study the effect of intravenous administration of HPβCD in NPC patients.

scholarly journals An Interim Protocol for the Mitigation of Radon in Non-Residential Buildings

1994 ◽  
Vol 56 (1-4) ◽  
pp. 9-11 ◽  
Author(s):  
D.L. Wilson ◽  
C.S. Dudney ◽  
R.B. Gammage
Keyword(s):  
Environmental Protection Agency ◽  
Residential Buildings ◽  
Health And Safety ◽  
Protection Agency ◽  
Safety Issues ◽  
The Us ◽  
Process Studies ◽  
Radon Testing ◽  
Fire Codes ◽  
Large Building

Abstract To date, the US Environmental Protection Agency has not published guidance for radon testing, diagnostics, or mitigation within large, non-residential buildings. Current research indicates that large buildings may contain construction features or mechanical systems that could inhibit the installation or operation of a mitigation system. Health and safety issues such as asbestos and fire codes may further interfere with the installation process. Studies also show that elevated radon can be restricted to a particular area or room within a building and not be uniformly distributed. A four-step, sequential protocol has been developed to address these issues and facilitate large building radon mitigation.

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