Nazanin Abolhassani1, Ali Akbari Sari1,2, Arash Rashidian2,3, Mansoor Rastegarpanah4,5. 1. School of Public Health, Tehran University of Medical Sciences, Tehran, Iran. 2. Department of Health Sciences, University of York, York, UK. 3. Department of Health Management and Economics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran. 4. Department of Pharmacy, University of Nebraska Medical Center, Omaha, NE, USA. 5. Department of Clinical Pharmacy, College of Pharmacy, University of Medical Sciences, Tehran, Iran.
Abstract
BACKGROUND: Medication errors is a prominent issue on the health policy agenda due to its significant human and financial costs; confusing drug names are one of the most common causes of them. This issue necessitates the adoption of a mechanism to restrict such a confusion before approving drug names. OBJECTIVE: Following the establishment of a committee and developed relevant criteria as mechanisms to address the issue of drug names similarity Iran, there were problems in this process. This study explores the process of adopting this mechanism. METHODS: This qualitative study was conducted using date gathered through documents, observation and 31 semi-structured interviews. Ethical approval was achieved from the Research Ethics Committee in TUMS. Confidentiality was ensured at all the interviews. The interviews were recorded verbatim, transcribed and coded, using the MAXQDA ver.12 software. Data were analyzed utilizing the Health Policy Triangle Framework. RESULTS: High rate of medication errors and warning from the WHO about drug names in Iran pushed the issue of drug proprietary names to the FDO agenda. A National Drugs Naming Committee was established and relevant criteria were developed by the Food and Drug Organization (FDO). This committee was dissolved for four years; the function was delegated to the General Office of Trademarks Registry. However, the committee was reestablished and resumed functioning. Finings mainly indicated a higher rate of medication errors during dissolving the committee. CONCLUSION: Health policy-makers have a public responsibility for making a decision and the consequences. Regarding the process of naming drugs, it is important for policy makers to consider two issues: patient safety and trademarks rights. However, the Iran FDO adopted an approach to address these issues, a more multifaceted, integrated approach to initial naming of drugs is suggested. The committee' function is seen to hold the most promise. However the function is partially complete to ensure patient safety. Given the change experienced by altering relevant organizational authorities in the FDO, the sustainability of the committee cannot hope to be guaranteed. Yet, the need for such a guarantee is particularly important.
BACKGROUND: Medication errors is a prominent issue on the health policy agenda due to its significant human and financial costs; confusing drug names are one of the most common causes of them. This issue necessitates the adoption of a mechanism to restrict such a confusion before approving drug names. OBJECTIVE: Following the establishment of a committee and developed relevant criteria as mechanisms to address the issue of drug names similarity Iran, there were problems in this process. This study explores the process of adopting this mechanism. METHODS: This qualitative study was conducted using date gathered through documents, observation and 31 semi-structured interviews. Ethical approval was achieved from the Research Ethics Committee in TUMS. Confidentiality was ensured at all the interviews. The interviews were recorded verbatim, transcribed and coded, using the MAXQDA ver.12 software. Data were analyzed utilizing the Health Policy Triangle Framework. RESULTS: High rate of medication errors and warning from the WHO about drug names in Iran pushed the issue of drug proprietary names to the FDO agenda. A National Drugs Naming Committee was established and relevant criteria were developed by the Food and Drug Organization (FDO). This committee was dissolved for four years; the function was delegated to the General Office of Trademarks Registry. However, the committee was reestablished and resumed functioning. Finings mainly indicated a higher rate of medication errors during dissolving the committee. CONCLUSION: Health policy-makers have a public responsibility for making a decision and the consequences. Regarding the process of naming drugs, it is important for policy makers to consider two issues: patient safety and trademarks rights. However, the Iran FDO adopted an approach to address these issues, a more multifaceted, integrated approach to initial naming of drugs is suggested. The committee' function is seen to hold the most promise. However the function is partially complete to ensure patient safety. Given the change experienced by altering relevant organizational authorities in the FDO, the sustainability of the committee cannot hope to be guaranteed. Yet, the need for such a guarantee is particularly important.
Entities:
Keywords:
Orthographic similarity; look-alike proprietary drug names; medication errors
Authors: Irene Lizano-Díez; Carlos Figueiredo-Escribá; M Ángeles Piñero-López; Cecilia F Lastra; Eduardo L Mariño; Pilar Modamio Journal: BMC Health Serv Res Date: 2020-01-29 Impact factor: 2.655