Factors that Affect on Drug Quality Problems at Songklanagarind Hospital

Main Article Content

Thitichaya Udomratn
Chanon Kongkamol
Jinda Preechaveerakul


Background: Drug quality problem is a global concern which affects both patients and societies. It yields to economic losses and lack of confidence in the quality of healthcare facilities. Hence, examing the factors that effect on drug quality problems is necessary for the further solutions. 

Objectives: This study examined prevalence and severity of drug quality problems, identified factors affecting drug quality, and association between the therapeutic groups and drug quality problems at the Songklanagarind hospital.

Methods: All record forms of drug quality problems were collected between October 2017 and September 2019. Details of drugs, severity of problems, and factors affecting drug quality problems were studied. Descriptive statistics were used to assess drugs data and severity while the association between factors and drug quality problems were measured by using a logistic regression model.

Results: The results showed that 69 of 80 record forms during the study period met the inclusion criteria. Among the 69 records, only 44 items of drugs were found. The average drug quality problem per year was 1.4%. Most types of problems were packaging at 53.6% followed by physical appearance changes 27.5%, labeling 10.1%, and packing 8.7%. Most drug quality problems reported were at low to moderate level of seriousness. No serious drug quality problem was reported. Two significant factors affecting drug problems were found in therapeutic groups and primary packaging materials. Statistics by odds ratio showed as follow; nutrition and blood in the therapeutic group (OR=4.07, 95% CI, 1.90–8.71), primary packaging materials of bag (OR=3.93, 95% CI, 1.49–10.4) and primary packaging materials of bottle (OR=2.88, 95% CI, 1.46–5.70). Dosage forms and generic medicines were negatively correlated with drug problems.

Conclusions: The factors that affect on drug quality problems at our hospital were nutrition and blood in the therapeutic group, primary packaging materials of bag and bottle. As a result, we recommended that it should more  further study comparing packaging materials of same drug especially in the therapeutic group of nutrition and blood which affecting drug quality problems.

Article Details

How to Cite
Udomratn T, Kongkamol C, Preechaveerakul J. Factors that Affect on Drug Quality Problems at Songklanagarind Hospital. TFDJ [Internet]. 2021 Jun. 23 [cited 2024 May 30];28(2):27-40. Available from: https://he01.tci-thaijo.org/index.php/fdajournal/article/view/250316
Research Article


1. World Health Organization. Global surveillance and monitoring system for substandard and falsified medical products [monograph on the internet]. Geneva: World Health Organization; 2017 [cited 2020 May 16]. Available from: https://apps.who.int/iris/bitstream/handle/10665/326708/9789241513425-eng.pdf

2. World Health Organization. A study on the public health and socioeconomic impact of substandard and falsified medical products [monograph on the internet]. Geneva: WHO; 2017.[cited 2020 May 16].Available from: https://www.who.int/medicines/regulation/ssffc/publications/SE-Study_EN_web.pdf?ua=1

3. Alghannam AF, Aslanpour Z, Evans S, Schifano F. A systematic review of counterfeit and substandard medicines in field quality surveys. Integr Pharm Res Pract 2014; 3:71-88. https://doi.org/10.2147/IPRP.S63690

4. Ozawa S, Evans DR, Bessias S, Haynie DG, Yemeke TT, Laing SK, et al. Prevalence and estimated economic burden of substandard and falsified medicines in low and middle-income countries: A systematic review and meta-analysis. JAMA 2018;1(4):1-22. doi: 10.1001/jamanetworkopen.2018.1662. PMID: 30646106; PMCID: PMC6324280.

5. Hajjou M, Krech L, Barlow CL, Roth L, Pribluda VS, Phanouvong S, et al. Monitoring the quality of medicines: results from Africa, Asia, and South America. Am J Trop Med Hyg 2015;92(6 Suppl):68-74. doi: 10.4269/ajtmh.14-0535. Epub 2015 Apr 20. PMID: 25897073; PMCID: PMC4455073.

6. Kaur H, Allan EL, Mamadu L, Hall Z, Ibe O, Sherbiny ME, et al. Quality of artemisinin-based combination formulations for malaria treatment: Prevalence and risk factors for poor quality medicines in public facilities and private sector drug outlets in Enugu, Nigeria. PLoS One 2015;10(5):e0125577. doi: 10.1371/journal.pone.0125577. PMID: 26018221; PMCID: PMC4446036.

7. Ongoagchai S, Rashid MH, Sakamoto J. Factors affecting drug quality problems in Thailand. Qual Assur J 2011;14(1-2):9-17. https://doi.org/10.1002/qaj.484.

8. จันทนา พัฒนเภสัช, สมศักดิ์ สุนทรพาณิชย์, สุรัชนี เศวตศิลา, โสมขจี หงษ์ทอง. คุณภาพยาในประเทศไทย: ข้อมูลจาก 15 ปี โครงการประกันคุณภาพยา กรมวิทยาศาสตร์การแพทย์ กระทรวงสาธารณสุข. วารสารวิจัยระบบสาธารณสุข 2561;12(1):124-36.

9. ผันสุ ชุมวรฐายี. การวิเคราะห์ต่อปัญหาผลิตภัณฑ์ยาของโรงพยาบาลศรีนครินทร์. ศรีนครินทร์เวชสาร 2551;23(4):396-401.

10. ฐิติพร ตันรัตนาวงศ์, เยาวลักษณ์ อำรำไพ. สถานการณ์การเรียกเก็บยาคืนของประเทศไทยในปี 2545-2551. วารสารอาหารและยา 2553;17(2):59-67.

11. The National Statistical Office. Sampling and estimation technic [homepage on the Internet]. Bangkok: The National Statistical Office Thailand (NSO Thailand); 2008 [cited 2020 May 26]. Available from: http://service.nso.go.th/nso/nsopublish/Toneminute/files/55/A3-16

12. U.S. Food and Drug Administration. Generic drugs: Questions & answers [monograph on the Internet]. Maryland: FDA; 2018 [cited 2020 May 24]. Available from:https://www.fda.gov/drugs/questions-answers/generic-drugs-questions-answers

13. U.S Food and Drug Administration. FDA's role in drug recalls [homepage on the Internet]. Maryland: FDA; 2018 [cited 2020 May 17]. Available from: https://www.fda.gov/drugs/drug-recalls/fdas-role-drug-recalls

14. European Medicine Agency. Quality defects and recalls: assessment of reports of product quality defects [Internet]. Amsterdam: European Medicines Agency; 2018 [cited 2020 May 17]. Available from: https://www.ema.europa.eu/en/ human-regulatory/post-authorisation/compliance/quality-defects-recalls#assessment-of-reports-of-product-quality-defects-section

15. Khurelbat D, Dorj G, Bayarsaikhan E, Chimedsuren M, Sanjjav T, MorimotoT, et al. Prevalence estimates of substandard drugs in Mongolia using a random sample survey. Springer Plus 2014; 3:1-10. doi: 10.1186/2193-1801-3-709. PMID: 25525570. PMCID: PMC4265637.

16. Glass BD, Haywood A. Stability considerations in liquid dosage forms extemporaneously prepared from commercially available products. J Pharm Sci 2006;9(3):398-426. PMID: 17207422.

17. Savale SK. Pharmaceutical solid dosage forms: In process quality control tests. Asian J Pharm Clin Res 2018;6(8):44-5. doi: 10.21276/sajp.