The Analysis of Health Professional’s Knowledge and Attitudes Related to The Implementation of Pharmacovigilance in Pharmaceutical Service Facilities

Authors

  • Ema Nillafita Kusuma Program Study of Pharmacy, Faculty of Mathematics and Natural Sciences, Pakuan University, Bogor, 16143 Author
  • Aas Sa’adah Program Study of Pharmacy, Faculty of Mathematics and Natural Sciences, Pakuan University, Bogor, 16143 Author
  • Dian Farida Ismyama Program Study of Pharmacy, Faculty of Mathematics and Natural Sciences, Pakuan University, Bogor, 16143 Author

DOI:

https://doi.org/10.24071/jpsc.v23i1.1080

Keywords:

Attitude, Health Professional, Knowledge, Pharmacovigilance

Abstract

In May 2024, the Indonesia Food and Drug Authority received less than 10,000 reports of adverse events (AEs), or around 3,773 reports. A lack of understanding of the urgency of pharmacovigilance results in a small number of reports compared to the population. This potentially poses unidentified safety risks, reduces quality of life and increases the cost of therapy. This research aims to describe and provide information related to the knowledge and attitudes of healthcare professionals in responding to safety information or AEs, as well as explain the types of drugs and side effects seen by healthcare professionals. This is a non-experimental prospective study and uses a descriptive-analytic research design. The data was taken from August to October 2024, by using a structured questionnaire. The respondents of this study are healthcare professionals, who are 72% females and 28% male. Almost 54% have received and found AEs. The most frequently reported AEs were related to Antibiotics, Analgesics, Anticonvulsants, Anti-Tuberculosis, and Bronchodilators. Based on Pearson Correlation Analysis, there was a moderately significant relationship between knowledge and attitudes (p<0.05). It can be concluded that the number of AEs reported will be increased if there is an increase in healthcare professional knowledge continuously.    

References

Anonym. 2024. Global Strategy for Asthma Management and Prevention. URL https://www.ginaasthma.org/ (accessed 18.11.2024).

BPOM. 2022. Keputusan Badan Pengawas Obat dan Makanan Nomor 15 Tahun 2022 Tentang Penerapan Farmakovigilans. Badan Pengawas Obat dan Makanan RI: Jakarta.

BPOM. 2024. Statistik Jumlah Laporan Tahun 2024. URL https://e-meso.pom.go.id/subsite/?zpukom%2FXrJnEm6OfyInQmKKmmpd1ZlyjlZ6m0aRwe9PPlw%3D%3D (accessed 30.07.24).

BPS. 2024. Bonus Demografi dan Visi Indonesia Emas 2045, Edisi Ketiga. Badan Pusat Statistik RI: Jakarta.

Campobasso, C. P., Procacci, R. and Caligara, M. 2008. Fatal adverse reaction to ketorolac tromethamine in asthmatic patient. The American Journal of Forensic Medicine and Pathology, 29(4), pp.358-363.

Corea, L., Bentivoglio, M., Verdecchia, P., Motolese, M., Sorbini, C.A., Grassi, V. and Tantucci, C. 1984. Noninvasive assessment of chronotropic and inotropic response to preferential beta‐1 and beta‐2 adrenoceptor stimulation. Clinical Pharmacology & Therapeutics, 35(6), pp.776-781.

Dean L. 2015. Carbamazepine Therapy and HLA Genotype. In: Pratt, V. M., Scott, S. A., Pirmohamed, M., Esquivel, B., Kattman, B. L., Malheiro, A. J., editors. Medical Genetics Summaries [Internet]. National Center for Biotechnology Information (US); Bethesda (MD).

Eff, A. R. Y., Utami, L. M. and Indrawati, R. 2024. Pharmacovigilance and Adverse Drug Reaction Reporting by Nurses to Improve Patient Safety Goals at Hospital in Bekasi, West Java. Unnes Journal of Public Health, 13(1), pp.49-60.

Ferrell, P. B. and McLeod, H. L. 2008. Carbamazepine, HLA-B* 1502 and risk of Stevens–Johnson syndrome and toxic epidermal necrolysis: US FDA recommendations. Pharmacogenomics, 9(10), pp.1543-1546.

Feitoza, M. D. S., Melo, J. R. D., Medeiros, W. M., Cucato, G. G., Stelmach, R., Cukier, A., Carvalho, C. R. F. D. and Mendes, F. A. R. 2017. Effect of salbutamol on the cardiovascular response in healthy subjects at rest, during physical exercise, and in recovery phase: a randomized, double-blind, crossover study. Motriz: Revista de Educação Física, 23(03), p.e101737.

Huang, E. S., Strate, L. L., Ho, W. W., Lee, S. S. and Chan, A. T. 2011. Long-term use of aspirin and the risk of gastrointestinal bleeding. The American journal of medicine, 124(5), pp.426-433.

Hussain R, Akram T, Hassali MA, Muneswarao J, Rehman AU, Hashmi F, Babar ZU. Barriers and facilitators to pharmacovigilance activities in Pakistan: A healthcare professionals-based survey. PLoS One. 2022 Jul 29;17(7):e0271587. doi: 10.1371/journal.pone.0271587. PMID: 35905133; PMCID: PMC9337632.

Kemenkes RI. 2023. Profil Kesehatan Indonesia Tahun 2022. Kementerian Kesehatan RI: Jakarta.

McQuaid, K. R. and Laine, L. 2006. Systematic review and meta-analysis of adverse events of low-dose aspirin and clopidogrel in randomized controlled trials. The American journal of medicine, 119(8), pp.624-638.

Nasir, S. A., Tan, H. L., Tan, H. J., Hussaini, H. M. and Ramli, R. 2017. Stevens‐Johnson Syndrome following Failure of Genetic Screening prior to Carbamazepine Prescription. Case Reports in Dentistry, 2017(1), p.4201357.

Oteri, A., Trifirò, G., Gagliostro, M. S., Tari, D. U., Moretti, S., Bramanti, P., Spina, E., Caputi, A. P. and Arcoraci, V. 2010. Prescribing pattern of anti‐epileptic drugs in an Italian setting of elderly outpatients: a population‐based study during 2004–07. British journal of clinical pharmacology, 70(4), pp.514-522.

Pfizer. 2005. Lyrica® (pregabalin) [package insert]. New York: Pfizer Inc.

Price, A. H. and Clissold, S. P. 1989. Salbutamol in the 1980s: a reappraisal of its clinical efficacy. Drugs, 38(1), pp.77-122.

Quint, J. K., Arnetorp, S., Kocks, J. W., Kupczyk, M., Nuevo, J., Plaza, V., Cabrera, C., Raherison-Semjen, C., Walker, B., Penz, E. and Gilbert, I. 2022. Short-acting beta-2-agonist exposure and severe asthma exacerbations: SABINA findings from Europe and North America. The Journal of Allergy and Clinical Immunology: In Practice, 10(9), pp.2297-2309.

Sabiti, F. B., Purnami, I. D., Arief, T. A., Sofa, N. A., Yanto, A., Permatasari, J. D. 2023. Hubungan Pengetahuan Tenaga Kesehatan Tentang Pharmacovigilance Terhadap Sikap Pelaporan ADR di Kota Semarang. JPSCR: Journal of Pharmaceutical Science and Clinical Research, 8(2), 218-225.

Sharma, R. K., Verma, G. K., Tegta, G. R., Sood, S., Rattan, R. and Gupta, M. 2020. Spectrum of cutaneous adverse drug reactions to anti-tubercular drugs and safe therapy after re-challenge-A retrospective study. Indian Dermatology Online Journal, 11(2), pp.177-181.

Shenoy, A. K., Kamath, A., Chowta, M. N., Boloor, A., Aravind, A., Thakur, P. B. and Kumar, S. 2023. Knowledge of pharmacovigilance among healthcare professionals and the impact of an educational intervention. Medicine and Pharmacy Reports, 96(4), p.406.

Shi, C., Yang, B., Yang, J., Song, W., Chen, Y., Zhang, S., Zhan, H., Xiong, Y., Rong, P., Luo, Y. and Yang, J. 2024. Evaluation of adverse reactions induced by anti-tuberculosis drugs among hospitalized patients in Wuhan, China: A retrospective study. Medicine, 103(20), p.e38273.

Skoner, D. P. 2000. Pharmacokinetics, pharmacodynamics, and the delivery of pediatric bronchodilator therapy. Journal of allergy and clinical immunology, 106(3), pp.S158-S164.

Smith, W. G. 2008. Does gender influence online survey participation? A record-linkage analysis of university faculty online survey response behavior. Online submission.

Spiller, H. A. 2005. Carbamazepine, in: Encyclopedia of Toxicology, Second Edition. Academic Press.

Sugiyono. 2016. Metode Penelitian Kuantitatif, Kualitatif, dan Research and Development. Alfabeta, Bandung.

Syamsudin. 2011. Buku Ajar Farmakologi : Efek Samping Obat. Salemba Medika, Jakarta.

Maker, J. H., Stroup, C. M., Huang, V. and James, S. F. 2019. Antibiotic hypersensitivity mechanisms. Pharmacy, 7(3), p.122.

WHO. 2024. Reported Potential Side Effects: Pregabalin. WHO Collaborating Center for International Drug Monitoring. URL https://www.vigiaccess.org/ (accessed 17.11.24).

WHO. 2024. Reported Potential Side Effects: Carbamazepin. WHO Collaborating Center for International Drug Monitoring. URL https://www.vigiaccess.org/ (accessed 17.11.24).

WHO. 2024. Reported Potential Side Effects: Salbutamol. WHO Collaborating Center for International Drug Monitoring. URL https://www.vigiaccess.org/ (accessed 18.11.24).

WHO. 2024. Reported Potential Side Effects: Terbutaline. WHO Collaborating Center for International Drug Monitoring. URL https://www.vigiaccess.org/ (accessed 18.11.24).

WHO. 2024. Reported Potential Side Effects: Ketorolac. WHO Collaborating Center for International Drug Monitoring. URL: https://www.vigiaccess.org/ (accessed 13.12.24).

WHO. 2024. Reported Potential Side Effects: Pyrazinamin, Rifampicin, Ethambutol, Isoniazid. WHO Collaborating Center for International Drug Monitoring. URL https://www.vigiaccess.org/ (accessed 31.12.24).

WHO. 2024. Reported Potential Side Effects: Levofloxacin, Cefadroxil, Amoxicillin, Cefotaxime, Metronidazole, and Sulphonamide. WHO Collaborating Center for International Drug Monitoring. URL : https://www.vigiaccess.org/ (accessed 31.12.24).

WHO. 2025. Reported Potential Side Effects: Mefenamic Acid. WHO Collaborating Center for International Drug Monitoring. URL https://www.vigiaccess.org/ (accessed 05.01.25).

Winter, R. J., Langford, J. A. and Rudd, R. M. 1984. Effects of oral and inhaled salbutamol and oral pirbuterol on right and left ventricular function in chronic bronchitis. Br Med J (Clin Res Ed), 288(6420), pp.824-825.

Yasin, M. and Priyono, J. 2016. Analisis faktor usia, gaji dan beban tanggungan terhadap produksi home industri sepatu di sidoarjo (studi kasus di kecamatan krian). Jurnal Ekonomi dan Bisnis, 1(1), pp.95-120.

Yeung, W. Y. W. and Park, H. S. 2020. Update on the management of nonsteroidal anti-inflammatory drug hypersensitivity. Yonsei Medical Journal, 61(1), pp.4-14.

Yogi, T. N., Bhusal, A., Kafle, R., Labh, S. and Pokhrel, S. 2023. Ketorolac-induced anaphylaxis following oral administration: a case series. Annals of Medicine and Surgery, 85(10), pp.4662-4666.

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Published

2026-06-12

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How to Cite

The Analysis of Health Professional’s Knowledge and Attitudes Related to The Implementation of Pharmacovigilance in Pharmaceutical Service Facilities. (2026). Jurnal Farmasi Sains Dan Komunitas (Journal of Pharmaceutical Sciences and Community), 23(1), 53-64. https://doi.org/10.24071/jpsc.v23i1.1080