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.
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6636423 | PMC |
| http://dx.doi.org/10.4103/jrpp.JRPP_18_32 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
The Association Between Aspartate Transaminase to Alanine Transaminase Ratio and Perioperative Ischemic Stroke in Patients With Diabetes: A Retrospective Cohort Study.
CNS Neurosci Ther
January 2025
Department of Anesthesiology, The First Medical Center of Chinese PLA General Hospital, Beijing, China.
Background: Patients with diabetes are at a high risk for perioperative ischemic stroke (PIS). The use of biomarkers to identify high-risk patients and predict PIS may provide considerable reference value in clinical decision-making. The aspartate transaminase/alanine transaminase ratio (De Ritis ratio) has been proven to be associated with specific diabetic complications.
View Article and Find Full Text PDFHealthcare Costs of Pressure Injuries among Patients with a Spinal Cord Injury within a Dutch Rehabilitation Center.
Adv Skin Wound Care
January 2025
Boas J. Wijker, BSc, is PhD Candidate, Department of Human Movement Sciences, Faculty of Behavioural and Movement Sciences, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands. Sonja de Groot, PhD, is Associate Professor, Department of Human Movement Sciences, Faculty of Behavioural and Movement Sciences, Vrije Universiteit Amsterdam, the Netherlands, and Senior Researcher, Amsterdam Rehabilitation Research Center, Reade, the Netherlands. Anne-Fleur Boertje, MSc, is Student, Department of Health Sciences, Vrije Universiteit Amsterdam. Jacinthe J. E. Adriaansen, MD, PhD, is Rehabilitation Physician, Amsterdam Rehabilitation Research Center. Wendy J. Achterberg-Warmer, MD, is Rehabilitation Physician, Amsterdam Rehabilitation Research Center. Amber Wighman, NP, is Nurse Practitioner, Triade Vitree, Lelystad, the Netherlands. Maurits W. van Tulder, PhD, MSc, is Dean, Department of Human Movement Sciences, Faculty of Behavioural and Movement Sciences, Vrije Universiteit Amsterdam. Thomas W. J. Janssen, PhD, is Full Professor, Department of Human Movement Sciences, Faculty of Behavioural and Movement Sciences, Vrije Universiteit Amsterdam, and Senior Researcher, Amsterdam Rehabilitation Research Center. Johanna M. van Dongen, PhD, MSc, is Associate Professor, Department of Health Sciences, Vrije Universiteit Amsterdam.
Objective: To assess the healthcare costs of pressure injuries (PIs) among patients with a spinal cord injury (SCI) in a Dutch rehabilitation center and determine if those costs were associated with patients' age or sex.
Methods: The direct healthcare costs of PIs were estimated using data from electronic health records of a Dutch rehabilitation center. This dataset contained demographic, clinical, and resource use information of all patients with an SCI or a PI who were treated at the rehabilitation center because of a PI between 2009 and 2022.
Prevalence of drug resistance mutations in low-level viremia patients under antiretroviral therapy in Southwestern China: a cross-sectional study.
J Antimicrob Chemother
January 2025
Department of Laboratory Medicine, Yunnan Provincial Infectious Disease Hospital, Kunming 650301, China.
Objectives: This study aimed to evaluate the prevalence and characteristics of drug resistance mutations (DRMs) in patients with low-level viremia (LLV) in Southwestern China, as it has become a growing challenge in AIDS clinical practice.
Methods: This cross-sectional study was performed in Yunnan Province, Southwestern China. LLV was defined as 50-999 copies/mL of plasma viral load with antiretroviral therapy (ART) for at least 6 months.
First-time use of electronic patient-reported outcome measures in a cluster randomized trial: a qualitative study.
J Patient Rep Outcomes
January 2025
Department of Health Sciences Ålesund, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Ålesund, Norway.
Background: Although there is clear evidence supporting the beneficial effects of regularly assessing patient-reported outcomes (PROs), the comprehensive integration of patient-reported outcome measures (PROMs) into routine cancer care remains limited. This study aimed to explore the facilitators and barriers encountered by principal investigators (PIs) (oncologists) and study nurses during the implementation of the Eir ePROM within a cluster randomized trial (c-RCT) in cancer outpatient clinics. Additionally, we sought to examine the influence of Eir on the working routines of the participants.
View Article and Find Full Text PDFReforming the innovation system to deliver affordable medicines: a conceptual framework of pharmaceutical innovation as a complex adaptive system (forest) and theory of change.
J Pharm Policy Pract
January 2025
Global Health Centre, Graduate Institute of International and Development Studies, Geneva, Switzerland.
Background: The current mainstream pharmaceutical innovation system (PIS) is driven by the market-based logic of charging the highest prices societies will bear. Outcomes include unaffordable medicines, restricted access and pressure on health budgets. How can the innovation system change to deliver fairly-priced medicines?
Methods: We inductively developed a novel conceptual framework of the PIS as a complex adaptive system (CAS) analogous to a forest.
Want AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!