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

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.

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

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.


2019 ◽  
Vol 12 (2) ◽  
pp. 91-99
Author(s):  
Tulaya Potaros ◽  
Suwimon Yeephu

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.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Dania Jaber ◽  
Rafat Abu Ghannam ◽  
Waleed Rashed ◽  
Mohammad Shehadeh ◽  
Sa’ed H. Zyoud

Abstract Background Generally, complementary and alternative therapies (CAT) are accepted methods of treatment by patients with various types of conditions. Their use is becoming especially prevalent among patients with eye problems even in developed countries. Thus, we aimed to determine the pattern of use of CAT in this patient population, to identify the patient characteristics associated with the use of CAT, and to assess the types of CAT used. Methods A descriptive, cross-sectional study was conducted in Palestine at An-Najah National University Hospital between the time periods of October 2019 to May 2020, using questionnaire-based face to face interviews. Data were collected through convenience sampling. Patients responded to the questionnaire, which was focused on information adapted from previous research in this area, covering socio-demographic and clinical characteristics, types of CAT, source of information, and side effects on CAT use. Results A total of 86 patients were interviewed for our study. Over two thirds, 67% reported using CAT for the specific purpose of improving their eye condition, and about one third (29.1%) received more than one therapy. The most common therapies reported were duea’ (i.e. supplication) (47.1%) and herbal therapies (24.1%). It was shown that patients with bilateral involvement of their eyes were almost twice more likely to describe using CAT than patients with unilateral eye pathology (p = 0.006). Also, patients who underwent surgery as their route of treatment were significantly less likely to use CAT (p = 0.043). Most of our study participants mentioned a non-physician source as their source of information regarding CAT with family members being the most frequently mentioned (30.2%) followed by the internet (25.6%) and friends (19.8%). Conclusions The prevalence of CAT use among patients with eye disease is somewhat high in our study population. Because CAT may trigger adverse reactions, influence the progression of the disease, and interfere with conventional treatment, the ophthalmologist should frequently be asked patients with such diagnostics regarding the use of these therapies. Further work is required to analyze the mechanisms of action and to establish realistic guidelines for the use of these modalities.


2021 ◽  
pp. 20-24
Author(s):  
Radhika Vijay

OBJECTIVES: Nobody is refrained from the use of medications in today's times, not even kids,The objective of this study is to focus on the knowledge and awareness level, perception, of children of primary and secondary grade towards medicines , prevention of Infections and Diseases and drug compliance. This descriptive, cross sectional observational study was done METHODS: amongst the kids of North West Rajasthan ,India from August 2020 to October 2020 via an online questionnaire . A sample size of 100 kids , 50 each from Primary and Secondary grade was chosen for the study. The data was entered in Microsoft Excel and was statistically analysed. Results are outcomes of various RESULTS: questions put up to conduct detailed analysis of kids' awareness and medicinal knowledge, drug preferences, factors inuencing and attitude related to hygiene, safety and protection from Covid 19 infection. Kids are the young budding phys CONCLUSION: icians and their childhood beliefs and perceptions might affect their behaviour and decisions in adult lives. Parents and schools can play a great role through educational programs . It's well said, “Children are like wet cement, whatever falls on them, leaves an impression.”


Author(s):  
Pramod P. Kulkarni ◽  
Bhaskar S. Gaikawad ◽  
Anant A. Takalkar ◽  
Mukund D. Bhise

Background: India is currently experiencing rapid epidemiological transition with rising prevalence of obesity which may be due to sedentary lifestyle and changing dietary pattern. Certain occupations like the job of bank employees are sedentary which predispose individuals to obesity. Hence the present study was carried out to study the prevalence of obesity in bank employees in Latur city of Maharashtra.Methods: A cross-sectional study was carried out amongst 400 bank employees of Latur city. Banks were listed according to sectors i.e. government, co-operative and private. The study subjects were interviewed by predesigned and pretested proforma including bio-social characteristics like age, gender, height, weight etc. The anthropometric measurements were taken like height, weight etc. Data was entered in Microsoft Excel and analysed by using appropriate test whenever necessary.Results: According to body mass index (BMI) classification by WHO classification 34.5% subjects were overweight and obese and 25.75% of bank employees had obesity by waist-hip ratio as per WHO classification and 18.5% of bank employees had isolated abdominal obesity.Conclusions: The prevalence of generalized as well as abdominal obesity by WHO classification was more in bank employees. The associated risk factors like age, gender and designation was found to be significant.


2016 ◽  
Vol 2016 ◽  
pp. 1-7 ◽  
Author(s):  
Zerihun Zerdo ◽  
Tsegaye Yohanes ◽  
Befikadu Tariku

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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