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加纳霍市口服液体药物包装给药装置的可用性和准确性评估。

Assessment of the Availability and Accuracy of Dosing Devices Packaged with Oral Liquid Medications in the Ho Municipality of Ghana.

作者信息

Saaka Yussif, Nyamadi David M, Amekyeh Hilda, Mensah Adelaide

机构信息

Department of Pharmaceutics, School of Pharmacy, University of Health and Allied Sciences, PMB 31, Ho, Ghana.

出版信息

Scientifica (Cairo). 2022 Oct 20;2022:9223858. doi: 10.1155/2022/9223858. eCollection 2022.

Abstract

INTRODUCTION

Administering the right dose of medications is essential in avoiding potentially life-threatening adverse drug reactions. Industry guidelines for manufacturers of oral, over-the-counter, and liquid medications recommend including dose-delivery devices with packaging to limit dosing inaccuracy. This study describes the prevalence and accuracy of dosing devices packaged with oral liquid medications in the Ho municipality of Ghana.

METHODS

Dosing device accuracy was determined after deviation of the measured volume from the expected volume was evaluated using the United States Pharmacopoeia criteria.

RESULTS

A total of 78.6% of the oral liquid medications were packaged with a dosing device. The most common dosing devices were cups (83.6%), followed by spoons (14.3%), droppers (1.4%), and syringes (0.7%). The volumes measured with cups (5.14 ± 0.52 mL, = 0.006) and spoons (5.3 ± 0.67 mL, < 0.001) were significantly different from the desired 5 mL volume; this was dissimilar to the volume measured using syringes (5.01 ± 0.02 mL, > 0.999). Further, the measured volumes for 38.6% and 72.2% of the cups and spoons, respectively, deviated by more than 15% of 5 mL.

CONCLUSION

Dosing cups and spoons are associated with significant inaccuracy. Yet, manufacturers continually favour them over syringes in packaging for oral liquid medications. This is unacceptable and of considerable concern due to the risk of variations in therapeutic outcomes. Therefore, strict regulatory directives on the inclusion of accurate dosing devices in the packaging of oral liquid medicines are needed to reduce the possibility of medication errors.

摘要

引言

给予正确剂量的药物对于避免潜在的危及生命的药物不良反应至关重要。针对口服、非处方和液体制剂制造商的行业指南建议在包装中配备剂量输送装置,以减少剂量不准确的情况。本研究描述了加纳霍市口服液体制剂所配备的剂量装置的普及率和准确性。

方法

使用美国药典标准评估测量体积与预期体积的偏差后,确定剂量装置的准确性。

结果

共有78.6%的口服液体制剂配备了剂量装置。最常见的剂量装置是杯子(83.6%),其次是勺子(14.3%)、滴管(1.4%)和注射器(0.7%)。用杯子(5.14±0.52 mL,P = 0.006)和勺子(5.3±0.67 mL,P < 0.001)测量的体积与期望的5 mL体积有显著差异;这与使用注射器测量的体积(5.01±0.02 mL,P > 0.999)不同。此外,分别有38.6%的杯子和72.2%的勺子测量的体积偏差超过5 mL的15%。

结论

量杯和勺子的剂量准确性存在显著问题。然而,在口服液体制剂的包装中,制造商仍然更倾向于使用它们而不是注射器。由于治疗效果存在差异的风险,这是不可接受的,也令人相当担忧。因此,需要严格的监管指令,要求在口服液体制剂的包装中配备准确的剂量装置,以减少用药错误的可能性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/48f8/9613386/e46f44d77720/SCIENTIFICA2022-9223858.001.jpg

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