Investigation and Analysis of the Information Available for Pregnant Women in 1102 Antibiotic Package Inserts

Shaoli Tang; Jiawen Huang; Zhidong Zhang; Jufeng Li; Xiaofei Feng

doi:doi:10.11648/j.ijcm.20200402.11

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Investigation and Analysis of the Information Available for Pregnant Women in 1102 Antibiotic Package Inserts

Shaoli Tang, Jiawen Huang, Zhidong Zhang, Jufeng Li, Xiaofei Feng

Published in International Journal of Chinese Medicine (Volume 4, Issue 2)

Received: 26 April 2020 Accepted: 11 May 2020 Published: 15 May 2020

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Abstract

Objective To understand the current status of information on use by pregnant women in antibiotic package inserts. Methods Information related to use by pregnant women, was obtained from the package inserts of 66 commercially available antibiotics and was investigated and analyzed. The drugs were classified as follows according to their pharmacological effects: penicillins; first-, second-, third-, and fourth-generation cephalosporins; cephamycins; aminoglycosides; macrolides; tetracyclines; lincosamides; glycopeptide antibiotics; carbapenems; third- and fourth-generation quinolones; sulfonamides; and nitroimidazoles. Results A total of 1102 package inserts of 66 common commercially available antibiotics were obtained. Among them, 72.14% (795) package inserts included labels with advice for pregnant women, backed by relevant research data, whereas 23.23% (256) included labeling on the use by pregnant women without such experimental or relevant research data. In addition, 2.00% (22) of these inserts included unclear information, whereas the information was missing in 2.63% (29). Finally, 10.60% (7) of the package inserts contained contradictory information across manufacturers. Package inserts of some antibiotics are either not standardized or lack relevant information for use of these drugs by pregnant women, making it difficult to meet the needs of users and ensure medication safety. Conclusion Standardized management of drug package inserts must thus be enhanced.

Published in	International Journal of Chinese Medicine (Volume 4, Issue 2)
DOI	10.11648/j.ijcm.20200402.11
Page(s)	16-20
Creative Commons	This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited.
Copyright	Copyright © The Author(s), 2020. Published by Science Publishing Group

Keywords

Antibiotics, Package Inserts, Pregnant Women, Medication Labeling, Investigation and Analysis

References

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[7]	D. S. Xia, “Recommendations on risk control and analysis of the problems existing on labeling contents of medicines used for pregnant and lactating women in package inserts in China,” Chinese Journal of Pharmacovigilance, vol. 12, pp. 211-218, 2015.
[8]	J. H. Yang, J. Tang, Y. T. Zhang, et al, “Analysis of the labeling contents of drug instructions for pregnant women and lactating women in China,” Chinese Journal of Drug Evaluation, vol. 33, pp. 235-238, 2016.
[9]	J. W. Huang, J. F. Li, Z. D. Zhang, X. Q. Liu, and M. Yang, “Analysis of drug information on pregnant women in 247 package inserts of antiviral drugs,” Pharmacy Today, vol. 26, pp. 522-524, 2016.
[10]	X. Q. Chen, Y. Y. Jin, and G. Tang, Pharmacology New Edition, 17th ed. Beijing: People ’s Medical Publishing House, 2011, pp. 21.
[11]	H. Lan, F. Qu, S. C. Jiang, et al, “Immunohistochemistry study of ciprofloxacin on fetal cartilage,’ Chinese Journal of Antibiotics, vol. 26, pp. 298-301, 2001.
[12]	R. Bi and X. J. Hong, “Analysis of the drug package inserts of 4 different specifications of piperacillin sodium and tazobactam sodium,” China Pharmaceuticals, vol. 23, pp. 10-11, 2014.
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[15]	J. R. Niu, J. Li, S. Wu, et al, “Analysis of drug use labeling for pregnant and lactating women in 762 drug package inserts,” China Pharmacy, pp. 992-994, 2016.
[16]	Pizzol TDSD, Moraes CG, Arrais PSD, et al, “Medicine package inserts from the users' perspective: are they read and understood?” Brazilian Journal of Epidemiology, vol. 22, e190009, 2019.
[17]	Pires C, Vigário M, Cavaco A. “Factors influencing subjects' comprehension of a set of medicine package inserts,” International Journal of Clinical Pharmacy, vol 4, pp. 888-898, 2016.
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APA Style

Shaoli Tang, Jiawen Huang, Zhidong Zhang, Jufeng Li, Xiaofei Feng. (2020). Investigation and Analysis of the Information Available for Pregnant Women in 1102 Antibiotic Package Inserts. International Journal of Chinese Medicine, 4(2), 16-20. https://doi.org/10.11648/j.ijcm.20200402.11

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ACS Style

Shaoli Tang; Jiawen Huang; Zhidong Zhang; Jufeng Li; Xiaofei Feng. Investigation and Analysis of the Information Available for Pregnant Women in 1102 Antibiotic Package Inserts. Int. J. Chin. Med. 2020, 4(2), 16-20. doi: 10.11648/j.ijcm.20200402.11

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AMA Style

Shaoli Tang, Jiawen Huang, Zhidong Zhang, Jufeng Li, Xiaofei Feng. Investigation and Analysis of the Information Available for Pregnant Women in 1102 Antibiotic Package Inserts. Int J Chin Med. 2020;4(2):16-20. doi: 10.11648/j.ijcm.20200402.11

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@article{10.11648/j.ijcm.20200402.11,
  author = {Shaoli Tang and Jiawen Huang and Zhidong Zhang and Jufeng Li and Xiaofei Feng},
  title = {Investigation and Analysis of the Information Available for Pregnant Women in 1102 Antibiotic Package Inserts},
  journal = {International Journal of Chinese Medicine},
  volume = {4},
  number = {2},
  pages = {16-20},
  doi = {10.11648/j.ijcm.20200402.11},
  url = {https://doi.org/10.11648/j.ijcm.20200402.11},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.ijcm.20200402.11},
  abstract = {Objective To understand the current status of information on use by pregnant women in antibiotic package inserts. Methods Information related to use by pregnant women, was obtained from the package inserts of 66 commercially available antibiotics and was investigated and analyzed. The drugs were classified as follows according to their pharmacological effects: penicillins; first-, second-, third-, and fourth-generation cephalosporins; cephamycins; aminoglycosides; macrolides; tetracyclines; lincosamides; glycopeptide antibiotics; carbapenems; third- and fourth-generation quinolones; sulfonamides; and nitroimidazoles. Results A total of 1102 package inserts of 66 common commercially available antibiotics were obtained. Among them, 72.14% (795) package inserts included labels with advice for pregnant women, backed by relevant research data, whereas 23.23% (256) included labeling on the use by pregnant women without such experimental or relevant research data. In addition, 2.00% (22) of these inserts included unclear information, whereas the information was missing in 2.63% (29). Finally, 10.60% (7) of the package inserts contained contradictory information across manufacturers. Package inserts of some antibiotics are either not standardized or lack relevant information for use of these drugs by pregnant women, making it difficult to meet the needs of users and ensure medication safety. Conclusion Standardized management of drug package inserts must thus be enhanced.},
 year = {2020}
}

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TY  - JOUR
T1  - Investigation and Analysis of the Information Available for Pregnant Women in 1102 Antibiotic Package Inserts
AU  - Shaoli Tang
AU  - Jiawen Huang
AU  - Zhidong Zhang
AU  - Jufeng Li
AU  - Xiaofei Feng
Y1  - 2020/05/15
PY  - 2020
N1  - https://doi.org/10.11648/j.ijcm.20200402.11
DO  - 10.11648/j.ijcm.20200402.11
T2  - International Journal of Chinese Medicine
JF  - International Journal of Chinese Medicine
JO  - International Journal of Chinese Medicine
SP  - 16
EP  - 20
PB  - Science Publishing Group
SN  - 2578-9473
UR  - https://doi.org/10.11648/j.ijcm.20200402.11
AB  - Objective To understand the current status of information on use by pregnant women in antibiotic package inserts. Methods Information related to use by pregnant women, was obtained from the package inserts of 66 commercially available antibiotics and was investigated and analyzed. The drugs were classified as follows according to their pharmacological effects: penicillins; first-, second-, third-, and fourth-generation cephalosporins; cephamycins; aminoglycosides; macrolides; tetracyclines; lincosamides; glycopeptide antibiotics; carbapenems; third- and fourth-generation quinolones; sulfonamides; and nitroimidazoles. Results A total of 1102 package inserts of 66 common commercially available antibiotics were obtained. Among them, 72.14% (795) package inserts included labels with advice for pregnant women, backed by relevant research data, whereas 23.23% (256) included labeling on the use by pregnant women without such experimental or relevant research data. In addition, 2.00% (22) of these inserts included unclear information, whereas the information was missing in 2.63% (29). Finally, 10.60% (7) of the package inserts contained contradictory information across manufacturers. Package inserts of some antibiotics are either not standardized or lack relevant information for use of these drugs by pregnant women, making it difficult to meet the needs of users and ensure medication safety. Conclusion Standardized management of drug package inserts must thus be enhanced.
VL  - 4
IS  - 2
ER  -

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Author Information

Shaoli Tang

Department of Pharmacy, The First Affiliated Hospital, Jinan University, Guangzhou, China
Jiawen Huang

Department of Pharmacy, The First Affiliated Hospital, Jinan University, Guangzhou, China
Zhidong Zhang

Department of Pharmacy, The First Affiliated Hospital, Jinan University, Guangzhou, China
Jufeng Li

Department of Pharmacy, The First Affiliated Hospital, Jinan University, Guangzhou, China
Xiaofei Feng

Department of Pharmacy, The First Affiliated Hospital, Jinan University, Guangzhou, China

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Plain Text BibTeX RIS

APA Style

Shaoli Tang, Jiawen Huang, Zhidong Zhang, Jufeng Li, Xiaofei Feng. (2020). Investigation and Analysis of the Information Available for Pregnant Women in 1102 Antibiotic Package Inserts. International Journal of Chinese Medicine, 4(2), 16-20. https://doi.org/10.11648/j.ijcm.20200402.11

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ACS Style

Shaoli Tang; Jiawen Huang; Zhidong Zhang; Jufeng Li; Xiaofei Feng. Investigation and Analysis of the Information Available for Pregnant Women in 1102 Antibiotic Package Inserts. Int. J. Chin. Med. 2020, 4(2), 16-20. doi: 10.11648/j.ijcm.20200402.11

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AMA Style

Shaoli Tang, Jiawen Huang, Zhidong Zhang, Jufeng Li, Xiaofei Feng. Investigation and Analysis of the Information Available for Pregnant Women in 1102 Antibiotic Package Inserts. Int J Chin Med. 2020;4(2):16-20. doi: 10.11648/j.ijcm.20200402.11

Copy | Download

@article{10.11648/j.ijcm.20200402.11,
  author = {Shaoli Tang and Jiawen Huang and Zhidong Zhang and Jufeng Li and Xiaofei Feng},
  title = {Investigation and Analysis of the Information Available for Pregnant Women in 1102 Antibiotic Package Inserts},
  journal = {International Journal of Chinese Medicine},
  volume = {4},
  number = {2},
  pages = {16-20},
  doi = {10.11648/j.ijcm.20200402.11},
  url = {https://doi.org/10.11648/j.ijcm.20200402.11},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.ijcm.20200402.11},
  abstract = {Objective To understand the current status of information on use by pregnant women in antibiotic package inserts. Methods Information related to use by pregnant women, was obtained from the package inserts of 66 commercially available antibiotics and was investigated and analyzed. The drugs were classified as follows according to their pharmacological effects: penicillins; first-, second-, third-, and fourth-generation cephalosporins; cephamycins; aminoglycosides; macrolides; tetracyclines; lincosamides; glycopeptide antibiotics; carbapenems; third- and fourth-generation quinolones; sulfonamides; and nitroimidazoles. Results A total of 1102 package inserts of 66 common commercially available antibiotics were obtained. Among them, 72.14% (795) package inserts included labels with advice for pregnant women, backed by relevant research data, whereas 23.23% (256) included labeling on the use by pregnant women without such experimental or relevant research data. In addition, 2.00% (22) of these inserts included unclear information, whereas the information was missing in 2.63% (29). Finally, 10.60% (7) of the package inserts contained contradictory information across manufacturers. Package inserts of some antibiotics are either not standardized or lack relevant information for use of these drugs by pregnant women, making it difficult to meet the needs of users and ensure medication safety. Conclusion Standardized management of drug package inserts must thus be enhanced.},
 year = {2020}
}

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TY  - JOUR
T1  - Investigation and Analysis of the Information Available for Pregnant Women in 1102 Antibiotic Package Inserts
AU  - Shaoli Tang
AU  - Jiawen Huang
AU  - Zhidong Zhang
AU  - Jufeng Li
AU  - Xiaofei Feng
Y1  - 2020/05/15
PY  - 2020
N1  - https://doi.org/10.11648/j.ijcm.20200402.11
DO  - 10.11648/j.ijcm.20200402.11
T2  - International Journal of Chinese Medicine
JF  - International Journal of Chinese Medicine
JO  - International Journal of Chinese Medicine
SP  - 16
EP  - 20
PB  - Science Publishing Group
SN  - 2578-9473
UR  - https://doi.org/10.11648/j.ijcm.20200402.11
AB  - Objective To understand the current status of information on use by pregnant women in antibiotic package inserts. Methods Information related to use by pregnant women, was obtained from the package inserts of 66 commercially available antibiotics and was investigated and analyzed. The drugs were classified as follows according to their pharmacological effects: penicillins; first-, second-, third-, and fourth-generation cephalosporins; cephamycins; aminoglycosides; macrolides; tetracyclines; lincosamides; glycopeptide antibiotics; carbapenems; third- and fourth-generation quinolones; sulfonamides; and nitroimidazoles. Results A total of 1102 package inserts of 66 common commercially available antibiotics were obtained. Among them, 72.14% (795) package inserts included labels with advice for pregnant women, backed by relevant research data, whereas 23.23% (256) included labeling on the use by pregnant women without such experimental or relevant research data. In addition, 2.00% (22) of these inserts included unclear information, whereas the information was missing in 2.63% (29). Finally, 10.60% (7) of the package inserts contained contradictory information across manufacturers. Package inserts of some antibiotics are either not standardized or lack relevant information for use of these drugs by pregnant women, making it difficult to meet the needs of users and ensure medication safety. Conclusion Standardized management of drug package inserts must thus be enhanced.
VL  - 4
IS  - 2
ER  -

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