Literature review: Determination and role of pharmacy personnel in providing information of beyond use date

Main Article Content

Lusy Noviani
Putriana Rachmawati

Keywords

Beyond Use Date, in-use stability, quality control, expired date, efficacy

Abstract

One of the pharmaceutical jobs that are closely related to the quality control of pharmaceutical preparations is ensuring drug stability. Drug stability must be guaranteed not only in pharmaceutical manufacturers but also continue until the product is handed over to patients/consumers or health workers. In daily practice, it is common for errors to occur regarding the limit of use of drugs after the packaging is opened or beyond the use date and expiration date. Many people in the general public assume that drugs that have been opened and used have the same use limit as the expiration date. Products that have been repackaged or whose original packaging has been opened due to repeated use may have a risk that the preparation lacks the potency, efficacy, and safety of the product in its original sealed packaging. Many factors affect drug stability and quality, including temperature, solvents, storage techniques, and other factors. Various studies have also examined how information and education provided by health workers are related to drug stability. To what extent does the research impact changes in community behavior, and what needs to be developed so that an understanding of drug stability can be successfully implemented in the community. This literature review is expected to provide an overview and input related to the use of drugs to ensure the quality of pharmaceutical preparations.

Abstract 268 | PDF Downloads 315

References

1. Engel J, Lazar N. Guidelines for the Establishment of Appropriate beyond Use Dating of Sterile Compounded Admixtures. Hosp Pharm. 2016 Sep;51(8):654–703.
2. USP’s Compounding Expert Committee. USP Compounding Standards and Beyond-Use Dates (BUD) [Internet]. 2019 [cited 2022 Dec 28]. Available from: https://www.usp.org/sites/default/files/usp/document/our-work/compounding/usp-bud-factsheet.pdf
3. The United States Pharmacopeial Convention. United State Pharmacopeia <795> Pharmaceutical Compounding-Nonsterile Preparations . 2013.
4. Badan Pengawas Obat dan Makanan. Peraturan Badan Pengawas Obat dan Makanan Nomor 34 tahun 2018 tentang Pedoman Cara Pembuatan Obat yang Baik . 2018;
5. Badan Pengawasan Obat dan Makanan. Pedoman Mengenal Obat Kedaluwarsa dan/atau rusak di rumah tangga dan cara penanganannya. 2019;
6. Christina F. Beyond Use Date Produk Non Steril. Rasional. 2012 Dec;10(3):19.
7. International Conference on Harmonisation. Stability Testing of new Drug Substances and Products Q1A(R2). 2003. 8. Committee for Proprietary Medicinal Products. Note for Guidance on In-use stability Testing of Human Medicinal Products [Internet]. 2001. Available from: http://www.emea.eu.int/
9. Asean Guideline On Stability Study Of Drug Product (R1). 1997.
10. Badan Pengawas Obat dan Makanan Republik Indonesia. Peraturan Kepala BPOM RI No HK.03.1.23.06.10.5166 tentang Pencantuman Asal Bahan Tertenru, Kandungan Alkohol, dan Batas Kedaluwarsa pada Penandaan/Label Obat, Obta Tradisional, Suplemen Makanan dan Pangan. 2010.
11. Food and Drug Administration. Guidance for Industry #242 - In-Use Stability Studies and Associated Labeling Statements for Multiple-Dose Injectable Animal Drug Products [Internet]. 2020. Available from: https://www.fda.gov/animal-veterinary
12. Lachman L, Liberman HA, Kanigh JL. The Theory and Practice of Industrial Pharmacy By Lachman and Lieberman (3rd Edition) (SaMeep104). 1987;
13. Park O, Jang KW, Ha DM. Comparative Study on the Regulations about In-Use Stability, and Analysis the In-Use Stability Application on Approved Syrups. Journal of the Korea Academia-Industrial cooperation Society. 2020;21(3):137–46.
14. Garus AW. Tingkat pengetahuan masyarakat RT 40, RW 13, kelurahan Oesapa tentang Beyond use date obat [Internet]. 2018 [cited 2022 Dec 28]. Available from: https://core.ac.uk/download/pdf/236673179.pdf
15. Cokro F, Arrang ST, Solang JA, Sekarsari P. The Beyond Use date Perception of Drugs in North Jakarta, Indonesia. Jurnal Farmasi Klinik Indonesia. 2021;
16. Roque F, Rama AC, Sousa JJ, Pina ME. Development and stability assessment of liquid paediatric formulations containing sildenafil citrate. Brazilian Journal of Pharmaceutical Sciences. 2013 Jun;49(2):381–8.
17. Kementerian Kesehatan Republik Indonesia. Peraturan Menteri Kesehatan Republik Indonesia Nomor 72 Tahun 2016 tentang Standar Pelayanan Kefarmasian di Rumah Sakit.
18. Nurbaety B, Rahmawati C, Anjani Blp. Edukasi Tentang Beyond Use Date Obat Kepada Ismakes Kota Mataram. Selaparang. 2022;6(3).
19. Nilansari AF, Wardani S, Widyawarman D. Edukasi Beyond Use Date Obat Rumah Tangga Di Desa Demangan Kecamatan Gondokusuman. Reswara: Jurnal Pengabdian Kepada Masyarakat. 2022 Jul 23;3(2):771–7.
20. Kusuma IY, Octaviani P, Muttaqin C darwis. Upaya Peningkatan Pemahaman Masyarakat Terhadap Beyond Use Date Didesa Kecepit, Kecamatan Punggelan, Kabupaten Banjarnegara. Journal Pelita Medika. 2020 Nov 4;1(1).
21. Hendra GA, Aditya M, Tambun Sh. Analisis Tingkat Pemahaman Masyarakat Terkait Pengelolaan Obat Dan Beyond Use Date. Kopemas. 2021;2:67–72.
22. Komite Akreditasi Rumah Sakit. SNARS ( Standar Nasional Akreditasi RS ) 2018 – Pelayanan Kefarmasian Dan Penggunaan OBAT (PKPO) [Internet]. 2018 [cited 2022 Dec 28]. Available from: http://snars.web.id/2018/fokus-pasien/pkpo/