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Pattern and Quality of Scientific Communications on Drug Safety Produced by a Regional Pharmacovigilance Center in Nepal

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Pattern and Quality of Scientific Communications on Drug Safety Produced by a Regional Pharmacovigilance Center in Nepal Palaian S, Ibrahim MIM, Mishra P. Pattern and quality of scientific communications on drug safety produced by a regional pharmacovigilance center in Nepal. Pharmacy Practice (Internet) 2010 Jul-Sep;8(3):179-186. Original Research Pattern and quality of scientific communications on drug safety produced by a regional pharmacovigilance center in Nepal Subish PALAIAN, Mohamed I. M. IBRAHIM, Pranaya MISHRA. Received (first version): 22-Mar-2010 Accepted: 26-Jul-2010 ABSTRACT* Conclusion: A high percentage of the scientific Analyzing the pattern and quality of scientific communications were ‘case reports’. A high communications on pharmacovigilance can help the proportion of the case reports produced by the regional centers in Nepal and other developing center were of international standards. There were countries to develop approaches for communicating lacunae in ‘patient disposition’ in few of the reports. effectively medicine safety issues. This kind of research is lacking in developing countries. Keywords: Adverse Drug Reaction Reporting Objectives: To analyze the pattern and quality of Systems. Periodicals as Topic. Nepal. scientific communications on drug safety produced by the regional pharmacovigilance center at western Nepal. PATRÓN Y CALIDAD DE LAS Methodology: Various conference abstracts and COMUNICACIONES CIENTÍFICAS SOBRE journal publications produced by the center during SEGURIDAD DE MEDICAMENTOS its initial four years of establishment (14th September 2004 till 13th September 2008) were PRODUCIDAS POR UN CENTRO identified. These communications were categorized REGIONAL DE FARMACOVIGILANCIA EN in to case reports, review articles, conference NEPAL presentations, short communications, newsletter and bulletin articles, original research and case RESUMEN series. In addition, the quality of the case reports Analizar el patrón y la calidad de las were evaluated as per International Society of comunicaciones científicas en farmacovigilancia Pharmacovigilance/International Society of puede ayudar a los centros regionales de Nepal y Pharmacoepidemiology (ISoP/ISPE) guidelines on de otros países en desarrollo a desarrollar abordajes the requirements for submitting case reports on de comunicación efectiva de los problemas de adverse event reports in biomedical journals. seguridad de los medicamentos. Este tipo de Results: During the study period, 53 scientific investigación no existe en los países en desarrollo. communications were produced by the staff of the Objetivos: Analizar el patrón y la calidad de las regional pharmacovigilance center in relation with comunicaciones científicas sobre seguridad de drug safety. Among these, 18 (34%) were related to medicamentos producidas por el centro regional de case reports and letters. The median (interquartile farmacovigilancia de Nepal oriental. range) age of the patients described in the case Métodos: Se identificaron los resúmenes de reports was 46.5 (21.7-51.2) years. Among the total conferencias y las publicaciones en revistas 18 ADRs, four were fixed drug eruptions, followed producidas pro el centro durante sus cuatro años by contact dermatitis (n=2). Majority of the iniciales desde el establecimiento (14 de septiembre published case reports were related to skin (n=13; de 2004 a 13 de septiembre de 2008). Estas 72.2%). Antimicrobials were responsible for 27.8% comunicaciones fueron clasificadas en reporte de (n=5) of the case reports. Among the 18 case casos, artículos de revisión, presentaciones en reports published by the pharmacovigilance center, conferencias, comunicaciones breves, newsletter y a majority followed the ISoP/ISPE guidelines. Few artículos de boletín, investigaciones originales y parameters like physical examination of the patient series de casos. Además, se evaluó la calidad de los experiencing ADR, patient disposition, dosage and reportes de casos según las guías requisitos para administration of the suspected drugs, and drug- enviar a revistas biomédicas los reportes de casos reaction interface were missing in few of the cases. sobre comunicaciones de eventos adversos de la International Society of Pharmacovigilance / * International Society of Pharmaepidemiology Subish PALAIAN. Discipline of Social and Administrative (ISoP/ISPE). Pharmacy, School of Pharmaceutical Sciences. Universiti Resultados: Durante el periodo de estudio, se Sains Malaysia. Penang, (Malaysia) and Department of produjeron 53 comunicaciones científicas por el Hospital and Clinical Pharmacy/ Pharmacology. Manipal Teaching Hospital/ Manipal College of Medical Sciences. personal del centro regional de farmacovigilancia Pokhara (Nepal). sobre seguridad de medicamentos. De estas, 18 Mohamed I. M. IBRAHIM. Discipline of Social and (34%) estaban relacionadas con reportes de casos y Administrative Pharmacy, School of Pharmaceutical cartas. La media (rango inter-cuartilico) de edad de Sciences. Universiti Sains Malaysia. Penang, (Malaysia). los pacientes descritos en los reportes de casos fue Pranaya MISHRA. Department of Pharmacology. Saba de 46,5 (21,7 – 51,2) años. Del total de 18 RAM, 4 University School of Medicine, Saba (Netherlands- fueron erupciones de medicametnos, seguidas de Antilles). www.pharmacypractice.org (ISSN: 1886-3655) 179 Palaian S, Ibrahim MIM, Mishra P. Pattern and quality of scientific communications on drug safety produced by a regional pharmacovigilance center in Nepal. Pharmacy Practice (Internet) 2010 Jul-Sep;8(3):179-186. dermatitis de contacto (n=2). La mayoría de los of Pharmacoepidemiology (ISPE) has developed reportes de casos publicados estaban relacionados guidelines for submitting adverse event reports for con la piel (n=13; 72,2%). Los antimicrobianos publication.5 This guideline provides the minimum fueron responsables por el 27,8% (n=5) de los criteria required in a scientific publication related to reportes de casos. Entre los 18 reportes publicados individual case reports. por el centro de farmacovigilancia, la mayoría Even in developed countries, a poor understanding siguió las guías de la ISoP/ISPE. En unos pocos 6-8 casos faltaban algunos elementos como examen among the healthcare professionals suggested físico del paciente que sufrió la RAM, disposición the need for better communications about the del paciente, dosis y administración del existing pharmacovigilance programs. In developing medicamento sospechoso, y medio de la reacción countries, there are only a limited medicamentosa. pharmacovigilance programs in place or often there Conclusión: Un elevado porcentaje de las are no such program existing in the countries. The comunicaciones científicas eran reportes de casos. little information available on drug safety issues are Una alta proporción de los reportes producidos por often not communicated well. In Nepal, there is very el centro seguían los estándares internacionales. little information available on medicine safety. The Existe una laguna en ‘la disposición del paciente’ Department of Drug Administration (DDA), the en algunos de los reportes. national drug regulatory authority of Nepal publishes a quarterly bulletin, the Drug Bulletin of Nepal Palabras clave: Sistemas de comunicación de (DBN) that focuses on the medicine safety issues. reacciones adversas medicamentosas. Revistas But, the information presented are from the como tema. Nepal. developed countries and hence difficult to generalize for the local population. Moreover, in Nepal there are only limited facilities for communication in terms of biomedical journals, and bulletins. Hence, there is a need to explore the possible mechanism to communicate the available INTRODUCTION information on medicine safety issues in the country. In spite of several available mechanisms to ensure safe use of medicines, it is often inevitable to Moreover, there are no mandatory requirements for prevent the occurrence of harmful effects due to clinical trial data from local population prior to the medicines. Many times, the effects produced by the drug approval. Thus, institutional based medicines are unique and hence may not be pharmacovigilance programs are the key for predicted by everyone. For a better patient care, the ensuring drug safety in the country. These centers healthcare professionals need to know about the should disseminate medicine safety information harmful effects of the existing medicines. Similarly, obtained from the local population and should the drug regulatory authority and the consumers consider drug safety communications as a priority also need to know about the drug safety issues. area. One of the objectives of the regional These information can help in early detection and pharmacovigilance center in the western Nepal is to prevention of similar Adverse Drug Reactions communicate medicine safety issues to the (ADRs) occurring in the future. Thus, regulatory authority, healthcare professionals, communicating the medicine safety information is general public and students related to healthcare very important in any pharmacovigilance programs. programs. This center has taken several initiatives Many times, even a single case report can make a to communicate available drug safety issues. The major difference. For example, the case report on center publishes a ‘drug information bulletin’ and a thalidomide causing phocomelia by the Australian pharmacovigilance bulletin named ‘vigil’. These obstetrician had created a huge awareness among bulletins are distributed in Manipal Teaching the drug regulatory authorities and healthcare Hospital (MTH) and the other educational and 1 healthcare
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