Development and Validation of a Questionnaire for the Assessment of the Factors that Influence ADR Reporting by Pharmacists
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Submitted
14 December 2023
Published
29 February 2024
Keywords:
-
Pharmacovigillance, Pharmacist, Spontaneous reporting, reliability, validity
Abstract
Drug safety is a significant concern in many countries, as side effects (AE) and adverse drug reactions (ADR) have caused many deaths worldwide. One of the reasons is the low contribution of pharmacists in spontaneously reporting AE/ADR. This study aims to develop a questionnaire to assess factors that correlate with spontaneous reporting by pharmacists. A questionnaire pilot was tested on 30 pharmacist respondents who worked in type C hospitals in Surabaya and Sidoarjo, Indonesia. Respondents' responses were then evaluated for face validity, construct validity, and reliability. The results showed that the face validity of the questionnaire was ideal. Then, the results of the construct validity of the knowledge section using point biserial correlation showed that two items were invalid because the r-value was smaller than the r-table (r = 0.361). Then, construct validity uses the factor analysis method for psychological, environmental, and practical variables by paying attention to the Kaiser-Mayer-Olkin Measure (KMO) value, which must be greater than 0.5, the significance of the Bartlett test, which must be less than 0.05 and the factor loading value which conditions must be greater than 0.5. As a result, most of the psychological, environmental, and practical variables show valid and reliable results. However, further consideration should be given to eliminating some items that do not meet the requirements. In conclusion, this validated questionnaire can be used to obtain additional information regarding factors influencing spontaneous reporting by pharmacists.
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References
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21. Guest G. Using Guttman Scaling to Rank Wealth: Integrating Quantitative and Qualitative Data. Field Methods. 2000;12(4):346-57. DOI: 10.1177/1525822X0001200406
22. Setiawan MH, Supriyadi, Bharati DAL. Analysis of Instrument Development Recount Text Writing Test HOTS for Vocational High School using Exploratory Factor Analysis (EFA). J Educ Sci Technol. 2022;8(1):74-86. DOI: 10.26858/est.v8i2.25910
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25. Oluwatayo JA. Validity and Reliability Issues in Educational Research. J Educ Soc Res. 2012;2(2):391-400.
26. Brown JD. Statistics corner: Questions and answers about language testing statistics: Point-biserial correlation coefficients. Shiken. 2001;4(3):13-7.
27. Santoso S. Analisis SPSS pada statistik parametrik. Jakarta: Elex Media Komputindo; 2012.
28. Streiner DL. Starting at the beginning: An introduction to coefficient alpha and internal consistency. J Pers Assess. 2003;80(1):99–103. DOI: 10.1207/s15327752jpa8001_18; PMID: 12584072
29. Basuki I, Hariyanto. Asesemen pembelajaran. Bandung: Remaja Rosdakarya; 2014.
30. Surapranata S. Analisis, Validitas, Reliabilitas dan Interpretasi Hasil Tes Implementasi Kurikulum 2004. Bandung: Remaja Rosdakarya; 2009.
31. Roy R, Sukumar GM, Philip M, Gopalakrishna G. Face, content, criterion and construct validity assessment of a newly developed tool to assess and classify work–related stress (TAWS– 16). PLoS One. 2023;18(1):e0280189. DOI: 10.1371/journal.pone.0280189; PMCID: PMC9821462; PMID: 36608043
32. Perinetti G. StaTips Part VI: Bivariate correlation. South Eur J Orthod Dentofac Res. 2019;6(1):2–5. DOI: 10.5937/sejodr6-21664
33. Bonett DG. Point-biserial correlation: Interval estimation, hypothesis testing, meta-analysis, and sample size determination. Br J Math Stat Psychol. 2020;73(Suppl 1):113–44. DOI: 10.1111/bmsp.12189; PMID: 31565811
34. Chan LL, Idris N. Validity and Reliability of The Instrument Using Exploratory Factor Analysis and Cronbach’s alpha. Int J Acad Res Bus Soc Sci. 2017;7(10):400-10. DOI: 10.6007/IJARBSS/v7-i10/3387
35. Purwanto. Instrumen penelitian sosial dan pendidikan : pengembangan dan pemanfaatan. Yogyakarta: Pustaka Pelajar; 2007.
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37. Wu RMX, Zhang Z, Zhang H, Wang Y, Shafiabady N, Wan W, et al. An FSV analysis approach to verify the robustness of the triple-correlation analysis theoretical framework. Sci Rep. 2023;13(1):9621. DOI: 10.1038/s41598-023-35900-3; PMCID: PMC10267157; PMID: 37316559
38. Sürücü L, Maslakçi A. Validity and Reliability in Quantitative Research. Bus Manag Stud Int J. 2020;8(3):2694–726. DOI: 10.15295/bmij.v8i3.1540
39. Rusilowati A. Pengembangan Instrumen Penilaian. Semarang: UNNES Press; 2014.
40. Hendryadi. Editorial Note: Uji Validitas Dengan Korelasi Item-Total? J Manajemen Strategi Aplikasi Bisnis. 2021;4(1):315–20. DOI: 10.36407/jmsab.v4i2.404
41. Azwar S. Reliabilitas dan Validitas. 4th ed. Yogyakarta: Pustaka Pelajar; 2012.
42. Slamet R, Wahyuningsih S. Validitas dan Reliabilitas terhadap Instrumen Kepuasan Kerja. J Manajemen Bisnis Aliansi. 2022;17(2):51–8. DOI: 10.46975/aliansi.v17i2.428
43. Bolarinwa OA. Principles and Methods of Validity and Reliability Testing of Questionnaires Used in Social and Health Science Researches. Niger Postgrad Med J. 2015;22(4):195-201. DOI: 10.4103/1117-1936.173959; PMID: 26776330
44. Lakens D. Sample Size Justification. Collabra Psychology. 2022;8(1):33267. DOI: 10.1525/collabra.33267
45. Jenn C. Designing a Questionnaire. Malays Fam Physician. 2006;1(1):32-5.
2. Zhou N, Fang Z, Liang D, Lian J, Han H, Li R. Hospital information system-based pharmacovigilance for elderly patients: practices and results. J Pak Med Assoc. 2023;73(3):525–32. DOI: 10.47391/jpma.6428; PMID: 36932754
3. Katyal J, Arora E, Gupta YK. Impact of increased focus on pharmacovigilance on knowledge and attitude towards adverse drug reaction reporting among medical students in India. Int J Risk Saf Med. 2020;31(1):15–24. DOI: 10.3233/jrs-195012; PMID: 31594254
4. Asiamah M, Akuffo KO, Nortey P, Donkor N, Danso-Appiah A. Spontaneous reporting of adverse drug reaction among health professionals in Ghana. Arch Public Health. 2022;80(1):33. DOI: 10.1186/s13690-021-00783-1; PMCID: PMC8772084; PMID: 35057859
5. Yawson AA, Abekah-Nkrumah G, Okai GA, Ofori CG. Awareness, knowledge, and attitude toward adverse drug reaction (ADR) reporting among healthcare professionals in Ghana. Ther Adv Drug Saf. 2022;13:20420986221116468. DOI: 10.1177/20420986221116468; PMCID: PMC9364224; PMID: 35966898
6. Bahlol M, Bushell M, Khojah HMJ, Dewey RS. Spontaneous adverse drug reaction reporting by community pharmacists: preparedness and barriers. Saudi Pharm J. 2022;30(7):1052–9. DOI: 10.1016/j.jsps.2022.04.006; PMCID: PMC9315256; PMID: 35903525
7. Kobayashi T, Noda A, Obara T, Tsuchiya M, Akasaka K, Yoshida M, et al. Knowledge, Attitudes, and Practice of Hospital Pharmacists Regarding Pharmacovigilance and Adverse Drug Reaction Reporting in Japan. Hosp Pharm. 2021;56(1):7–16. DOI: 10.1177/0018578719851455
8. Ampadu HH, Hoekman J, de Bruin ML, Pal SN, Olsson S, Sartori D, et al. Adverse Drug Reaction Reporting in Africa and a Comparison of Individual Case Safety Report Characteristics Between Africa and the Rest of the World: Analyses of Spontaneous Reports in VigiBase®. Drug Saf. 2016;39(4):335–45. DOI: 10.1007/s40264-015-0387-4; PMCID: PMC4796322; PMID: 26754924
9. Kopciuch D, Zaprutko T, Paczkowska A, Ratajczak P, Zielińska-Tomczak Ł, Kus K, et al. Safety of medicines—Pharmacists' knowledge, practice, and attitudes toward pharmacovigilance and adverse drug reactions reporting process. Pharmacoepidemiol Drug Saf. 2019;28(12):1543–51. DOI: 10.1002/pds.4792; PMID: 31148344
10. Hailu AD, Mohammed SA. Adverse Drug Reaction Reporting in Ethiopia: Systematic Review. Biomed Res Int. 2020;2020:8569314. DOI: 10.1155/2020/8569314; PMCID: PMC7439161; PMID: 32851089
11. Bhattacharyya S, Kaur R, Kaur S, Ali SA. Validity and reliability of a questionnaire: a literature review. Chron Dent Res. 2017;6(2):16-22.
12. Mohajan HK. Two Criteria for Good Measurements in Research: Validity and Reliability. Ann Spiru Haret Univ Econom Ser. 2017;17(4):59-82. DOI: 10.26458/1746
13. Ramu P, Osman M, Mutalib NAA, Aljaberi MA, Lee KH, Lin CY, et al. Validity and Reliability of a Questionnaire on the Knowledge, Attitudes, Perceptions and Practices toward Food Poisoning among Malaysian Secondary School Students: A Pilot Study. Healthcare. 2023;11(6):853. DOI: 10.3390/healthcare11060853; PMCID: PMC10047946; PMID: 36981510
14. Radhakrishna RB. Tips for Developing and Testing Questionnaires/Instruments. J Ext. 2007;45(1):25.
15. World Health Organization. The importance of pharmacovigilance. Geneva: World Health Organization; 2002. p. 48.
16. Badan Pengawas Obat dan Makanan Republik Indonesia. Buletin Berita MESO Juni 2023 Vol 41 No. 1. Jakarta: Badan Pengawas Obat dan Makanan Republik Indonesia; 2023.
17. Badan Pengawas Obat dan Makanan Republik Indonesia. Peraturan Badan Pengawas Obat dan Makanan Nomor 15 Tahun 2022 tentang Penerapan Farmakovigilans. Jakarta: Badan Pengawas Obat dan Makanan Republik Indonesia; 2022.
18. Badan Pengawas Obat dan Makanan Republik Indonesia. Modul Farmakovigilans Dasar: Project for Ensuring Drug and Food Safety. Jakarta: Badan Pengawas Obat dan Makanan Republik Indonesia; 2020. Available from: https://e-meso.pom.go.id/web/useruploads/files/reference/5eaa2698c3abc_Modul%20Farmakovigilans%20Dasar.pdf
19. Badan Pengawas Obat dan Makanan Republik Indonesia. Modul Farmakovigilans untuk Tenaga Profesional Kesehatan: Project for Ensuring Drug and Food Safety. Jakarta: Badan Pengawas Obat dan Makanan Republik Indonesia; 2020. Available from: https://e-meso.pom.go.id/web/useruploads/files/reference/5efb0dbc8d7eb_MODUL%20FARMAKOVIGILANS%20BAGI%20TENAGA%20PROFESIONAL%20KESEHATAN.pdf
20. Badan Pengawas Obat dan Makanan Republik Indonesia. Lampiran – Daftar Produk yang Mengandung Policresulen Cairan Obat Luar Konsentrat. Jakarta: Badan Pengawas Obat dan Makanan Republik Indonesia; 2018. Available from: https://www.pom.go.id/storage/dat/20180215/Lampiran_penjelasan_Kabadan.pdf
21. Guest G. Using Guttman Scaling to Rank Wealth: Integrating Quantitative and Qualitative Data. Field Methods. 2000;12(4):346-57. DOI: 10.1177/1525822X0001200406
22. Setiawan MH, Supriyadi, Bharati DAL. Analysis of Instrument Development Recount Text Writing Test HOTS for Vocational High School using Exploratory Factor Analysis (EFA). J Educ Sci Technol. 2022;8(1):74-86. DOI: 10.26858/est.v8i2.25910
23. Trisnantoro L, Listyani E. Jumlah Rumah Sakit di Indonesia Pertumbuhan Rumah Sakit Publik. Jakarta: Perhimpunan Rumah Sakit Seluruh Indonesia; 2018. Available from: https://web.persi.or.id/analis-data/441-jumlah-rs-di-indonesia-pertumbuhan-rs-publik
24. Hertzog MA. Considerations in determining sample size for pilot studies. Res Nurs Health. 2008;31(2):180–91. DOI: 10.1002/nur.20247; PMID: 18183564
25. Oluwatayo JA. Validity and Reliability Issues in Educational Research. J Educ Soc Res. 2012;2(2):391-400.
26. Brown JD. Statistics corner: Questions and answers about language testing statistics: Point-biserial correlation coefficients. Shiken. 2001;4(3):13-7.
27. Santoso S. Analisis SPSS pada statistik parametrik. Jakarta: Elex Media Komputindo; 2012.
28. Streiner DL. Starting at the beginning: An introduction to coefficient alpha and internal consistency. J Pers Assess. 2003;80(1):99–103. DOI: 10.1207/s15327752jpa8001_18; PMID: 12584072
29. Basuki I, Hariyanto. Asesemen pembelajaran. Bandung: Remaja Rosdakarya; 2014.
30. Surapranata S. Analisis, Validitas, Reliabilitas dan Interpretasi Hasil Tes Implementasi Kurikulum 2004. Bandung: Remaja Rosdakarya; 2009.
31. Roy R, Sukumar GM, Philip M, Gopalakrishna G. Face, content, criterion and construct validity assessment of a newly developed tool to assess and classify work–related stress (TAWS– 16). PLoS One. 2023;18(1):e0280189. DOI: 10.1371/journal.pone.0280189; PMCID: PMC9821462; PMID: 36608043
32. Perinetti G. StaTips Part VI: Bivariate correlation. South Eur J Orthod Dentofac Res. 2019;6(1):2–5. DOI: 10.5937/sejodr6-21664
33. Bonett DG. Point-biserial correlation: Interval estimation, hypothesis testing, meta-analysis, and sample size determination. Br J Math Stat Psychol. 2020;73(Suppl 1):113–44. DOI: 10.1111/bmsp.12189; PMID: 31565811
34. Chan LL, Idris N. Validity and Reliability of The Instrument Using Exploratory Factor Analysis and Cronbach’s alpha. Int J Acad Res Bus Soc Sci. 2017;7(10):400-10. DOI: 10.6007/IJARBSS/v7-i10/3387
35. Purwanto. Instrumen penelitian sosial dan pendidikan : pengembangan dan pemanfaatan. Yogyakarta: Pustaka Pelajar; 2007.
36. Bewick V, Cheek L, Ball J. Statistics review 7: Correlation and regression. Crit Care. 2003;7(6):451-9. DOI: 10.1186/cc2401; PMCID: PMC374386; PMID: 14624685
37. Wu RMX, Zhang Z, Zhang H, Wang Y, Shafiabady N, Wan W, et al. An FSV analysis approach to verify the robustness of the triple-correlation analysis theoretical framework. Sci Rep. 2023;13(1):9621. DOI: 10.1038/s41598-023-35900-3; PMCID: PMC10267157; PMID: 37316559
38. Sürücü L, Maslakçi A. Validity and Reliability in Quantitative Research. Bus Manag Stud Int J. 2020;8(3):2694–726. DOI: 10.15295/bmij.v8i3.1540
39. Rusilowati A. Pengembangan Instrumen Penilaian. Semarang: UNNES Press; 2014.
40. Hendryadi. Editorial Note: Uji Validitas Dengan Korelasi Item-Total? J Manajemen Strategi Aplikasi Bisnis. 2021;4(1):315–20. DOI: 10.36407/jmsab.v4i2.404
41. Azwar S. Reliabilitas dan Validitas. 4th ed. Yogyakarta: Pustaka Pelajar; 2012.
42. Slamet R, Wahyuningsih S. Validitas dan Reliabilitas terhadap Instrumen Kepuasan Kerja. J Manajemen Bisnis Aliansi. 2022;17(2):51–8. DOI: 10.46975/aliansi.v17i2.428
43. Bolarinwa OA. Principles and Methods of Validity and Reliability Testing of Questionnaires Used in Social and Health Science Researches. Niger Postgrad Med J. 2015;22(4):195-201. DOI: 10.4103/1117-1936.173959; PMID: 26776330
44. Lakens D. Sample Size Justification. Collabra Psychology. 2022;8(1):33267. DOI: 10.1525/collabra.33267
45. Jenn C. Designing a Questionnaire. Malays Fam Physician. 2006;1(1):32-5.
Authors
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Firdaus FR, Nita Y, Setiawan CD, Zairina E. Development and Validation of a Questionnaire for the Assessment of the Factors that Influence ADR Reporting by Pharmacists. Borneo J Pharm [Internet]. 2024Feb.29 [cited 2024Nov.8];7(1):112-25. Available from: https://journal.umpr.ac.id/index.php/bjop/article/view/6334
Copyright (c) 2024 Favian Rafif Firdaus, Yunita Nita, Catur Dian Setiawan, Elida Zairina
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