ArticleJournal of research in pharmacy practice
Evaluation of Medication Package Inserts in Iran.
Article in Journal of research in pharmacy practice. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
- Provision and Need for Medicine Information in Asia and Africa: A Scoping Review of the Literature.Drug safety · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivePackage 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.
methodsThis 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.
findingsThirty-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.
conclusionPIs 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.
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