The Quality and Potency of Several Antibiotic Caplets/ Tablets/Capsules of e-Catalogue 2017, Their Substitutes and Originators

  • Prih Sarnianto
  • Syarmalina Syarmalina Fakultas Farmasi, Universitas Pancasila
  • Ferannisa Firdaus Fakultas Farmasi, Universitas Pancasila
  • Rike Farahiyah Fakultas Farmasi, Universitas Pancasila
  • Mustiko Aji Punto Baskoro Fakultas Farmasi, Universitas Pancasila
  • Esa Aulia Rizkita Fakultas Farmasi, Universitas Pancasila
DOI: https://doi.org/10.35814/jifi.v20i1.1208

Abstract

The price of drugs that win the e-Catalogue tender has long been considered too low by some pharmaceutical companies, and some even below their production cost. On the other hand, the fact that only pharmaceutical products with BPOM distribution licenses are eligible for the price tender, the quality of such e-Catalogue winners should not be of concern. This study aimed to evaluate the quality of several items of antibiotic products, an important drug category that can cause serious impacts if its quality is compromised. Samples used in the study were product items with the highest demands: Amoxicillin 500 mg, tetracycline 500 mg, cefadroxil 500 mg, and ciprofloxacin 500mg listed in the e-Catalogue 2017 as well as their generic and branded generic (OND) alternatives, and its respective originators. The quality parameters of the samples were evaluated according to the Indonesian Pharmacopoeia 5th Edition (FI-V). Antibiotic potency assays were conducted by using the Plate-Cylinder Method with S. aureus ATCC 25922 and E. coli ATCC 6538 as the testing bacteria. The results showed that all samples met the FI-V requirements on antibiotic content, weight uniformity, disintegration time, and dissolution. However, antibiotic potency of the e-Catalogue 2017 winners tend to be lower than their generic and OND alternatives as well as their respective originators, with a wide disparity: 10.3–18.2 percentage points, or a relative disparity of 12.0–26.4%, except for amoxicillin 500 mg caplet, in the assays using S. aureus. In conclusion, tetracycline 500 mg, cefadroxil 500mg, and ciprofloxacin 500 mg caplets/tablets/capsules listed in the e-Catalogue 2017 contain active pharmaceutical ingredients of lower qualities than their more expensive alternatives

References

1. Centers for Disease Control and Prevention (CDC). Indonesia Fact Sheet: CDC in Indonesia. Atlanta, August 2021. Diunduh dari https://www.cdc.gov/globalhealth/cou ntries/indonesia/default.htm pada 27 Desember 2021.

2. Institute for Health Metrics and Eva- luation (IHME). Indonesia. Seattle. 2021. Diunduh dari https://www.healthdata.org/indonesia pada 27 Desember 2021.

3. Tim Nasional Percepatan Penanggu- langan Kemiskinan (TNP2K). Kajian kebijakan pengadaan obat untuk Program Jaminan Kesehatan Nasional 2014–2018. Laporan Kelompok Kerja Kesehatan pada Sekretariat TNP2K [P. Sarnianto, Peneliti Utama]. Jakarta. 2020. pp116.

4. Tim Nasional Percepatan Penanggu- langan Kemiskinan (TNP2K). Kajian kebijakan pengadaan [e-Procurement] obat nasional tahun 2019. Laporan Penelitian pada Sekretariat TNP2K [S.P. Sari, Peneliti Utama]. Jakarta. 2020. pp88.

5. Anggriani Y, Ramadaniati HU, Sarnianto P, Pontoan J, Suryawati S. The impact of pharmaceutical policies on medicine procurement pricing in Indonesia under the implementation of Indonesia’s social health insurance system. Value in Health Reg Issues [Internet]. 2020. 21: 1–8. DOI 10.1016/j.vhri.2019.05.005

6. Departemen Kesehatan Republik Indo- nesia. Farmakope Indonesia. Edisi V. Jakarta. Direktorat Jenderal Pengawas- an Obat dan Makanan; 2014.

7. Departemen Kesehatan Republik Indo- nesia. Farmakope Indonesia. Edisi III. Jakarta. Direktorat Jenderal Pengawas- an Obat dan Makanan; 1979.

8. Schärfermann S, Hauk C, Wemakor E, Neci R, Mutombo G, Ndze EN, et al. Substandard and falsified antibiotics and medicines against noncommunic- able diseases in Western Cameroon and Northeastern Democratic Republic of Congo. Am. J. Trop. Med. 2020. 103(2): 894–908.

9. Tim Nasional Percepatan Penanggu- langan Kemiskinan (TNP2K). Kajian kebijakan pengadaan obat untuk Program Jaminan Kesehatan Nasional 2014–2017. Laporan Kelompok Kerja Kesehatan pada Sekretariat TNP2K [P. Sarnianto, Peneliti Utama]. Jakarta. 2018. pp86.

10. Pisani E, Nistor AL, Hasnida A, Parmaksiz K, Xu J, Kok MA. Identifying market risk for substandard and falsified medicines: An analytic framework based on qualitative research in China, Indonesia, Turkey and Romania. Wellcome Open Research. 2019. 4(70): 1–25. DOI: 10.12688/wellcomeopenres.15236.1

11. Hazmen P, Kumala S, Sarnianto P. Analisa biaya pengobatan demam tifoid berdasarkan clinical pathway di Rumah Sakit Harapan Bunda. Jurnal Profesi Medika. 2019. 13(2): 74–81. DOI: 10.33533/jpm.v13i2.1314

12. World Health Organization (WHO). WHO report on surveillance of anti- biotic consumption: 2016–2018 early implementation. Geneva. WHO. 2018. License: CC BY-NC-SA 3.0 IGO.

13. Kelesidis T, Falagas ME. Substandard/ counterfeit antimicrobial drugs. Clin Microbiol Rev 28(2): 443–464. DOI: 10.1128/CMR.00072-14

14. Almuzaini T, Choonara I, Sammons
H. Substandard and counterfeit medicines: A systematic review of the literature. BMJ Open 2013. 3:e002923. DOI: 10.1136/bmjopen-2013-002923

15. World Health Organization (WHO). WHO global surveillance and monitor- ing system for substandard and falsi- fied medical products. Geneva. WHO. 2017. License: CC BY-NC-SA 3.0 IGO.

16. Ozawa S, Evans DR, Bessias S, Haynie DG, Yemeke TT, Laing SK, Herrington JE. Prevalence and estim- ated economic burden of substandard and falsified medicines in low- and middle-income countries: A system- atic review and meta-analysis. JAMA Network Open. 2018. 1(4): e181662. DOI: 10.1001/jamanetworkopen.2018.1662
Published
2022-04-30
How to Cite
SARNIANTO, Prih et al. The Quality and Potency of Several Antibiotic Caplets/ Tablets/Capsules of e-Catalogue 2017, Their Substitutes and Originators. JURNAL ILMU KEFARMASIAN INDONESIA, [S.l.], v. 20, n. 1, p. 128-135, apr. 2022. ISSN 2614-6495. Available at: <http://jifi.farmasi.univpancasila.ac.id/index.php/jifi/article/view/1208>. Date accessed: 22 dec. 2024. doi: https://doi.org/10.35814/jifi.v20i1.1208.
Citation Formats
Issue
Vol 20 No 1 (2022): JIFI
Section
Articles
Creative Commons License

This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.

Licencing
All articles in Jurnal Ilmu Kefarmasian Indonesia are an open-access article, distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License which permits unrestricted non-commercial used, distribution and reproduction in any medium.

This licence applies to Author(s) and Public Reader means that the users mays :

  • SHARE:
    copy and redistribute the article in any medium or format
  • ADAPT:
    remix, transform, and build upon the article (eg.: to produce a new research work and, possibly, a new publication)
  • ALIKE:
    If you remix, transform, or build upon the article, you must distribute your contributions under the same license as the original.
  • NO ADDITIONAL RESTRICTIONS:
    You may not apply legal terms or technological measures that legally restrict others from doing anything the license permits.

It does however mean that when you use it you must:

  • ATTRIBUTION: You must give appropriate credit to both the Author(s) and the journal, provide a link to the license, and indicate if changes were made. You may do so in any reasonable manner, but not in any way that suggests the licensor endorses you or your use.

You may not:

  • NONCOMMERCIAL: You may not use the article for commercial purposes.

Creative Commons License

This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.