Evaluation of medication package inserts in Iran
Objective: Package inserts (PIs) provide information for the safe and effective use of medication. There is no study on the evaluation of PIs in Iran. The purpose of this study was to evaluate the completeness of PIs supplied with the 100 top-selling medications in Iran. Methods: This cross-sectiona...
| Main Authors: | , , , |
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| Format: | Article |
| Language: | English |
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Wolters Kluwer Medknow Publications
2019-01-01
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| Series: | Journal of Research in Pharmacy Practice |
| Subjects: | |
| Online Access: | http://www.jrpp.net/article.asp?issn=2319-9644;year=2019;volume=8;issue=2;spage=45;epage=51;aulast=Khamas |
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| author | Shahriyar Shahbazi Khamas Atefeh Jafari Morvarid Zarif-Yeganeh Hamidreza Taghvaye-Masoumi |
| author_facet | Shahriyar Shahbazi Khamas Atefeh Jafari Morvarid Zarif-Yeganeh Hamidreza Taghvaye-Masoumi |
| author_sort | Shahriyar Shahbazi Khamas |
| collection | DOAJ |
| description | Objective: Package inserts (PIs) provide information for the safe and effective use of medication. There is no study on the evaluation of PIs in Iran. The purpose of this study was to evaluate the completeness of PIs supplied with the 100 top-selling medications in Iran. Methods: This cross-sectional observational study was conducted during 3 weeks in January 2017. One hundred medications were chosen from a list supplied by the Iran Food and Drug Administration (IFDA). The PIs were assessed for the presentation and completeness of quality criteria, which was consisted of two parts. The first part was the criteria required by the IFDA, mentioned in Chapter 16 of the Pharmaceutical Regulations and Instructions provided by the IFDA. The second part of the criteria was defined according to the critical comments of clinical and industrial pharmacists. Findings: Thirty-seven out of 100 medications included no PIs. None of the PIs met all the criteria required by the IFDA. The highest score for completeness was 18 out of 21 (85.7%). Medication name, description, and adverse reaction were mentioned in all PIs. Other items such as patient counseling information (98%), warnings (95.2%), precautions (95.2%), pregnancy/lactation (95%), and storage condition (90.5%) have been mentioned in a high percentage of PIs. Conclusion: PIs have improved in recent years in Iran, but there is an absolute need for more accurate and up-to-date information. The IFDA should supervise pharmaceutical companies more strictly in this regard and should revise its regulations requiring PIs to conform to the FDA regulations. |
| first_indexed | 2024-12-10T06:28:06Z |
| format | Article |
| id | doaj.art-61c5fbcb0a7045a29f90f98a1a466d73 |
| institution | Directory Open Access Journal |
| issn | 2319-9644 2279-042X |
| language | English |
| last_indexed | 2024-12-10T06:28:06Z |
| publishDate | 2019-01-01 |
| publisher | Wolters Kluwer Medknow Publications |
| record_format | Article |
| series | Journal of Research in Pharmacy Practice |
| spelling | doaj.art-61c5fbcb0a7045a29f90f98a1a466d732022-12-22T01:59:10ZengWolters Kluwer Medknow PublicationsJournal of Research in Pharmacy Practice2319-96442279-042X2019-01-0182455110.4103/jrpp.JRPP_18_32Evaluation of medication package inserts in IranShahriyar Shahbazi KhamasAtefeh JafariMorvarid Zarif-YeganehHamidreza Taghvaye-MasoumiObjective: Package inserts (PIs) provide information for the safe and effective use of medication. There is no study on the evaluation of PIs in Iran. The purpose of this study was to evaluate the completeness of PIs supplied with the 100 top-selling medications in Iran. Methods: This cross-sectional observational study was conducted during 3 weeks in January 2017. One hundred medications were chosen from a list supplied by the Iran Food and Drug Administration (IFDA). The PIs were assessed for the presentation and completeness of quality criteria, which was consisted of two parts. The first part was the criteria required by the IFDA, mentioned in Chapter 16 of the Pharmaceutical Regulations and Instructions provided by the IFDA. The second part of the criteria was defined according to the critical comments of clinical and industrial pharmacists. Findings: Thirty-seven out of 100 medications included no PIs. None of the PIs met all the criteria required by the IFDA. The highest score for completeness was 18 out of 21 (85.7%). Medication name, description, and adverse reaction were mentioned in all PIs. Other items such as patient counseling information (98%), warnings (95.2%), precautions (95.2%), pregnancy/lactation (95%), and storage condition (90.5%) have been mentioned in a high percentage of PIs. Conclusion: PIs have improved in recent years in Iran, but there is an absolute need for more accurate and up-to-date information. The IFDA should supervise pharmaceutical companies more strictly in this regard and should revise its regulations requiring PIs to conform to the FDA regulations.http://www.jrpp.net/article.asp?issn=2319-9644;year=2019;volume=8;issue=2;spage=45;epage=51;aulast=KhamasCommunity pharmacypackage insertpatient informationregulations |
| spellingShingle | Shahriyar Shahbazi Khamas Atefeh Jafari Morvarid Zarif-Yeganeh Hamidreza Taghvaye-Masoumi Evaluation of medication package inserts in Iran Journal of Research in Pharmacy Practice Community pharmacy package insert patient information regulations |
| title | Evaluation of medication package inserts in Iran |
| title_full | Evaluation of medication package inserts in Iran |
| title_fullStr | Evaluation of medication package inserts in Iran |
| title_full_unstemmed | Evaluation of medication package inserts in Iran |
| title_short | Evaluation of medication package inserts in Iran |
| title_sort | evaluation of medication package inserts in iran |
| topic | Community pharmacy package insert patient information regulations |
| url | http://www.jrpp.net/article.asp?issn=2319-9644;year=2019;volume=8;issue=2;spage=45;epage=51;aulast=Khamas |
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