scholarly journals Preclinical efficacy in therapeutic area guidelines from the U.S. Food and Drug Administration and the European Medicines Agency: a cross-sectional study

2018 ◽  
Vol 175 (22) ◽  
pp. 4229-4238 ◽  
Author(s):  
Holger Langhof ◽  
William Wei Lim Chin ◽  
Susanne Wieschowski ◽  
Carole Federico ◽  
Jonathan Kimmelman ◽  
...  
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
Cross Sectional Study ◽  
European Medicines Agency ◽  
Therapeutic Area ◽  
Sectional Study ◽  
Cross Sectional ◽  
Preclinical Efficacy ◽  
The U.S

scholarly journals Do drug package inserts meet the rules and regulations of Iran’s Food and Drug Administration in terms of informing patients?

2019 ◽  
Vol 9 (3) ◽  
pp. 214-222
Author(s):  
Tahereh Eteraf-Oskouei ◽  
Saeid Abdollahpour ◽  
Moslem Najafi ◽  
Vahideh Zarea Gavgani
Keyword(s):  
Drug Administration ◽  
Mobile Apps ◽  
Food And Drug Administration ◽  
Cross Sectional Study ◽  
Sectional Study ◽  
Microsoft Excel ◽  
Cross Sectional ◽  
Reference Category ◽  
Package Inserts ◽  
Source Of Information

Background: Drug package inserts (PIs) are the most accessible source of information for users and are designed to aid the safe use of medicines and avert adverse events. This study measured the conformity of PIs with the health communications standards of Iran’s Food and Drug Administration (FDA). Methods: This descriptive cross-sectional study evaluated 92 PIs related to 22 best-selling neurological and psychiatric drugs in Iran based on criteria approved by Iran’s FDA. Six categories of criteria were considered in evaluating the extent of conformity: I) writing and formatting, II) references, III) drug description, IV) warnings and precautions, V) interactions, and VI) side effects. Each PI was scored based on observation of standards; data was analyzed using Microsoft Excel pivot tables. Results: In total, 2929 items from 92 PIs were evaluated, of which 37 (40.2%) were related to antidepressants, 31 (33.7%) to sedatives and hypnotics, and 24 (26%) to anticonvulsant drugs. The PI content was insufficient in various aspects of conformity with standards in each category. Among the six categories, the best match was found in warnings and precautions with 667 items (72.5%), followed by writing and formatting with 663 (69.1%). The lowest conformity was found in the reference category with 194 (26.4%) items. Conclusion: The PIs of Iranian neurological drugs do not fully meet Iran’s FDA standards. It is strongly recommended that smart PIs be developed using mobile apps to overcome this problem.

Highlights on the Labels of Packaged Foods Sold in Jordanian Market from A Cross-Sectional Study

2021 ◽  
Vol 9 (3) ◽  
pp. 770-782
Author(s):  
Narmeen J. Al-Awwad ◽  
Hiba F. Al-Sayyed ◽  
Hamzah Safi ◽  
Salma M. Al-Bosta ◽  
Summer Al-Zawawi
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
Cross Sectional Study ◽  
Food Labels ◽  
Trans Fat ◽  
Food Label ◽  
Sectional Study ◽  
Cross Sectional ◽  
Added Sugars ◽  
Packaged Foods

Jordan has adapted a strategy to prevent chronic diseases. Accordingly, Ministry of Health is looking for controlling food labeling particularly food fat, trans-fat, and caloric content. This study aimed to screen the food label of products that are sold in Jordanian market in terms of serving size, energy, macronutrient, fiber, total and added sugars, saturated and trans fat, cholesterol, dietary fiber, and micronutrient contents. A cross-sectional study was performed to screen the food label for the food products based on the standards of The United States Food and Drug Administration (FDA) regulations of 2016 and Jordan Food and Drug Administration (JFDA). Generally, food labels were not clear. The screened products were compliant with JFDA standards and not in compliance with some FDA standards. In addition, many products were found to be sources of added sugars, Na, and saturated fats. Stakeholders and legislators are called to focus on developing new laws, regulations, and polices for developing food label. Food manufacturers are needed to work hardly on developing informative, clear, easy-to-understand, and attractive food labels. The legislators of food label policies are called to look for ways to indicate the presence of high amounts of dietary risk factors such as sugars, added sugars, Na, saturated, and trans fats in packaged foods.

scholarly journals Recognition of tramadol abuse, dispensing practices, and opinions about its control policy among community pharmacists in Bangkok, Thailand

2019 ◽  
Vol 12 (2) ◽  
pp. 91-99
Author(s):  
Tulaya Potaros ◽  
Suwimon Yeephu
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
Community Pharmacists ◽  
Control Policy ◽  
Cross Sectional Study ◽  
Community Pharmacies ◽  
Sectional Study ◽  
Cross Sectional ◽  
Dispensing Practices ◽  
Different Parts

AbstractBackgroundTramadol is classified as a pharmacist-only (restricted) medicine by the Food and Drug Administration of Thailand (Thai FDA). Because of concern about its abuse, in September 2013 the Thai FDA announced a policy to control the distribution of tramadol in community pharmacies.ObjectivesTo identify tramadol dispensing practices by community pharmacists in Bangkok, their recognition of tramadol abuse and the Thai FDA control policy announcement; and opinions about the tramadol control policy.MethodsThis descriptive cross-sectional study was conducted in community pharmacies located in Bangkok. Pharmacists on duty were interviewed from September 2015 to April 2016.ResultsData from 305 pharmacists working in 305 pharmacies revealed that tramadol, both single (tramadol alone) and combination (tramadol plus acetaminophen) formulations, was available in 185 pharmacies (60.7%). Most pharmacists dispensed tramadol to supply regular medicine along with previous prescriptions (74%). Among 305 pharmacists, 304 (99.7%) recognized tramadol abuse in combination with cold–cough remedies and carbonated beverages can create euphoria. Most (97.7%) knew about the announcement of the tramadol control policy, and most (82.6%) thought that the policy was practical. Approximately 43% of pharmacists agreed that the policy was effective in reducing the tramadol abuse problem, whereas 36.7% disagreed. Moreover, 60.3% disagreed with rescheduling tramadol as a prescription-only medicine. In their opinion, tramadol should still be available in pharmacies, to be dispensed by community pharmacists to patients with medical necessity.ConclusionsFurther studies nationwide in Thailand are likely to be useful to represent and compare information in different parts of the country.

scholarly journals Soil-Transmitted Helminth Reinfection and Associated Risk Factors among School-Age Children in Chencha District, Southern Ethiopia: A Cross-Sectional Study

2016 ◽  
Vol 2016 ◽  
pp. 1-7 ◽  
Author(s):  
Zerihun Zerdo ◽  
Tsegaye Yohanes ◽  
Befikadu Tariku
Keyword(s):  
Risk Factors ◽  
Drug Administration ◽  
Mass Drug Administration ◽  
Predictor Variable ◽  
Cross Sectional Study ◽  
School Age Children ◽  
School Age ◽  
Sectional Study ◽  
Cross Sectional ◽  
Associated Risk Factors

Mass drug administration (MDA) to the most risky population including school-age children (SAC) is the central strategy to control soil-transmitted helminth (STH) infection. The present study was aimed at estimating the prevalence of STHs reinfection three months posttreatment and associated risk factors among SAC in Chencha district. A cross-sectional study design was employed from April 20 to May 5, 2015, to enroll 408 SAC. Structured questionnaire and Kato-Katz thick smear technique were used to interview parents or guardians and quantify the number of eggs per gram of stool. Pearson chi-square and logistic regression were used to assess the association between predictor variable and STH reinfection. The prevalence of STHs within three months of mass chemotherapy among SAC was 36.8% which is 93.4% of the prevalence (39.4%) before treatment. The estimated prevalence of reinfection (95%CI) forAscaris lumbricoides,Trichuris trichiura, and hookworms was 23.8% (21.1–28.2), 16.2% (12.7–20.1), and 1.0% (0.3–2.5), respectively. Children of merchant fathers were more likely to be reinfected by STHs in Chencha district. In conclusion, there is rapid reinfection after mass chemotherapy among SAC in Chencha district. Further studies should be carried out to generate cost efficient methods that can supplement mass drug administration to accelerate the control of STHs.

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