A Comparative Study of Drug Package Inserts of High Selling Cardiac Drugs against the Drug Regulations of Iranian Food and Drug Administration

Q: How can I download an article?

To download an article from SID, first log in to the site, search for the article title, and click on the 'Download Article' option.

Q: How can I download an ISI article?

To download an ISI article on SID, enter the keyword or article title in the search bar, view the relevant results, click on the desired article, and select the 'Download Article' option.

Q: How can I access the SID database?

To access the SID database, visit SID.ir, create an account, and log in to access scientific resources.

Q: Is downloading articles from SID free?

Some articles on SID are available for free, while others require payment. Details are specified on the article's page.

Mirzadeh Qasabeh Sedigheh; ZAREA GAVGANI VAHIDEH

مرکز اطلاعات علمی Scientific Information Database (SID) - Trusted Source for Research and Academic Resources

Journal Paper

Paper Information

Journal: Depiction of Health Year:2019 | Volume:10 | Issue:2 Page(s): 110-119

Download Full-Text

Persian Verion

View:

645

Download:

Cites:

Information Journal Paper

Title

A Comparative Study of Drug Package Inserts of High Selling Cardiac Drugs against the Drug Regulations of Iranian Food and Drug Administration

Author(s)

Mirzadeh Qasabeh Sedigheh | ZAREA GAVGANI VAHIDEH | Issue Writer Certificate

Keywords

Drug LabelingQ3

Drug Package InsertsQ3

Drug BrochureQ3

Cardiac MedicationQ3

Drug InformationQ3

Patient InformationQ3

Abstract

Background and Objectives: The Drug Package Insert (PI) is a written information provided by drug manufacturers to deliver essential information for the consumer. This study aimed to investigate quality of the labeling and content of PIs to identify if they meet the criteria of Iran’ s Food and Drug Administration (FDA). Material and Methods: A cross-sectional descriptive study was used to evaluate the PPIs of top selling Cardiac Medications in Iran during March and September 2015 formed the population of this study. We used comparative and descriptive methods in conduction of the study. An evaluation checklist was built based on the regulations of PPI of Iranian Food and Drug Administration (FDA). The presence of criteria was considered as conformity and scored “ 1” and lacking the criteria was scored “ zero” . The descriptive statistics parameters were used for data analysis using SPSS v. 20. Results: A total of 66 PPIs of 13 cardiac drugs from top 33 selling medicines were evaluated using 27 criteria. None of the drug boxes included patient and professional package inserts separately, but the criteria of ‘ general guidance to patients’ was observed in 59(89. 39)of package inserts. About 64. 59% of the information in PPI was consistent with the regulations of drug regulation of the FDA of Iran. All PPIs (100%) included brand name, contraindication, keeping conditions, and the name of the manufacturer. the revision date and resources observed in 4 (6. 06%) and 19 (28. 71%), respectively. Of total 64. 59%. Conclusion: PPIs need to be improved by both quantity and quality to be appropriate use of patients and consumers.

Cites

No record.

References

The roleof type D personality and emotional intelligencewith mediating of perceived stress and coping stylesin the quality of life of coronary heart diseasepatients

Cite

APA: Copy

Mirzadeh Qasabeh, Sedigheh, & ZAREA GAVGANI, VAHIDEH. (2019). A Comparative Study of Drug Package Inserts of High Selling Cardiac Drugs against the Drug Regulations of Iranian Food and Drug Administration. DEPICTION OF HEALTH, 10(2 ), 110-119. SID. https://sid.ir/paper/265172/en

Vancouver: Copy

Mirzadeh Qasabeh Sedigheh, ZAREA GAVGANI VAHIDEH. A Comparative Study of Drug Package Inserts of High Selling Cardiac Drugs against the Drug Regulations of Iranian Food and Drug Administration. DEPICTION OF HEALTH[Internet]. 2019;10(2 ):110-119. Available from: https://sid.ir/paper/265172/en

IEEE: Copy

Sedigheh Mirzadeh Qasabeh, and VAHIDEH ZAREA GAVGANI, “A Comparative Study of Drug Package Inserts of High Selling Cardiac Drugs against the Drug Regulations of Iranian Food and Drug Administration,” DEPICTION OF HEALTH, vol. 10, no. 2 , pp. 110–119, 2019, [Online]. Available: https://sid.ir/paper/265172/en

Related Journal Papers