Skip to main content
SpringerLink
Log in

Identification of Confusing Medicine Proprietary Names: Toward Safe Medicine Use—A Cross-Sectional Study in Sri Lanka

  • Original Research
  • Published:
Therapeutic Innovation & Regulatory Science Aims and scope Submit manuscript

Abstract

Background

Look-alike sound-alike (LASA) medications have similar pronunciation (phonetic) and/or manifestation (orthographic), which could create confusion among users and challenge the safe use of medicines. The availability of foreign products in local markets aggravates the situation. This study was designed to examine the registered medicine proprietary names in Sri Lanka to discern the presence of similar medicine names in the industry.

Methods

A cross-sectional study was conducted on the registered drug proprietary names in Sri Lanka. Using the RAND and RANK functions in Microsoft® excel® 365, a random sample of 385 proprietary names was selected. Two evaluators independently evaluated each proprietary name in the sample against the other registered proprietary names following a stepwise text filtering method. After each filter, the resulting proprietary names were manually examined for identical, similar-looking, and similar-sounding proprietary names to the name under evaluation. The observations were matched, categorized, and collated into ten groups.

Results

Among the 385 names evaluated, 138 (35.84%) proprietary names had no similarity to existing other registered proprietary names. The rest of the names (n = 247, 64.15%) were found to be either identical (n = 03 pairs), look-alike (n = 91 pairs), or sound-alike (n = 80 pairs) to the registered proprietary names.

Conclusion

The findings revealed the presence of equal and similar proprietary names in the system. A multifactorial strategy led by the National Medicine Regulatory Authority (NMRA) is recommended to minimize the confusing names entering the system. Primarily the NMRA’s call for action should include adequate industry guidance with specific guidelines, a significant pre-submission assessment process, and denying approval of LASA proprietary names.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Figure 1

Similar content being viewed by others

Data Availability

The datasets generated and/or analyzed during the current study, including Tables 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10. Due to the presence of brand names table 1-10 are NOT publicly available. I hope evenhtough the tables are present in the article they won't appear in the published version.

Abbreviations

FDA:

Food and Drug Administration

INN:

International nonproprietary names

ISMP:

Institute for Safe Medication Practices

LA:

Look-alike

LASA:

Look-alike sound-alike

MHRA:

Medicines and Healthcare products Regulatory Agency

NMRA:

National medicines regulatory authority

POCA:

Phonetic and Orthographic Computer Analysis

SA:

Sound-alike

TML:

Tall-man lettering

References

  1. US FDA. Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products. Drug Saf. USA; 2020. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htmand/or.

  2. Health Canada. Guidance document for industry-Review of drug brand names. Ottawa; 2014. https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/pdf/pubs/medeff/guide/2014-review-examen_drug-medicament_names-marques/2014-review-examen_drug-medicament_names-marques-eng.pdf.

  3. MHRA. Mhra Guideline for the Naming of Medicinal Products and Braille Requirements for Name on Label. London; 2019. https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/pdf/pubs/medeff/guide/2014-review-examen_drug-medicament_names-marques/2014-review-examen_drug-medicament_names-marques-eng.pdf

  4. EMA, CHMP. Guideline on the acceptability of names for human medicinal products processed through the centralised procedure. 2014.

  5. Centre for Patient Safety Solutions. Look-Alike, Sound-Alike Medication Names. WHO Press. World Heal. Organ. WHO Press, World Health Organization; 2007. https://linkinghub.elsevier.com/retrieve/pii/S1553725007330493

  6. Emmerton LM, Rizk MFS. Look-alike and sound-alike medicines: Risks and “solutions.” Int J Clin Pharm. 2012;34:4–8.

    Article  PubMed  Google Scholar 

  7. Aronson JK. Confusion over similar drug names problems and solutions. Drug Saf. 1995;12:155–60. https://doi.org/10.2165/00002018-199512030-00001

    Article  CAS  PubMed  Google Scholar 

  8. Ostini R, Roughead EE, Kirkpatrick CMJ, Monteith GR, Tett SE. Quality use of medicines–medication safety issues in naming; look-alike, sound-alike medicine names. Int J Pharm Pract. 2012;20:349–57.

    Article  PubMed  Google Scholar 

  9. Kenagy JW, Stein GC. Naming, labeling, and packaging of pharmaceuticals. Am J Health Syst Pharm. 2001;58:2033–41.

    Article  CAS  PubMed  Google Scholar 

  10. Lambert BL, Lin SJ, Chang KY, Gandhi SK. Similarity as a risk factor in drug-name confusion errors: the look-alike (orthographic) and sound-alike (phonetic) model. Med Care. 1999;37:1214–25.

    Article  CAS  PubMed  Google Scholar 

  11. Rataboli PV, Garg A. Confusing brand names: nightmare of medical profession. J Postgrad Med. 2005;51:13–6.

    CAS  PubMed  Google Scholar 

  12. Merchant L, Lutter R, Chang S. Drug names that look or sound alike. Br Med J. 1979;2:1073.

    Google Scholar 

  13. Lebanova H, Getov I, Grigorov E. Descriptive study for look-alike and sound-alike medicines based on local language peculiarities. Afr J Pharm Pharmacol. 2012;6:2161–5.

    Google Scholar 

  14. Davis NM, Cohen MR, Teplitsky B. Look-alike and sound-alike drug names: the problem and the solution. Hosp Pharm; 27:95–8, 102–5, 108–10. 1992. https://pubmed.ncbi.nlm.nih.gov/10183617/

  15. Godinho LF, Carreira C, Martins C. Medicamentos look-alike, sound-alike: um velho conceito sempre em atualização. Rev da Soc Port Anestesiol. 2018;27:20–4.

    Google Scholar 

  16. Lambert BL, Chang KY, Lin SJ. Effect of orthographic and phonological similarity on false recognition of drug names. Soc Sci Med. 2001;52:1843–57.

    Article  CAS  PubMed  Google Scholar 

  17. US Pharmacopeia. USP quality review. 2001; 1–6. https://www.pbm.va.gov/vacenterformedicationsafety/othervasafetyprojects/appendixiiusplasa.pdf.

  18. Dilsha RAN, Kularathne HMIP, Mujammil MTM, Irshad SMM, Samaranayake NR. Nature of dispensing errors in selected hospitals providing free healthcare: a multi-center study in Sri Lanka. BMC Health Serv Res. 2020;20:1140. https://doi.org/10.1186/s12913-020-05968-y.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  19. Solomon KJ. Medication errors from similar trademarks. JAMA. 1978;239:1130. https://doi.org/10.1001/jama.1978.03280390026003.

    Article  CAS  PubMed  Google Scholar 

  20. Lambert BL. Medication errors Article. Health Care. 1997;54:1161–71.

    CAS  Google Scholar 

  21. ISMP. ConfusedDrug Names ISMP 2019. 2019. https://www.ismp.org/recommendations/confused-drug-names-list

  22. Galanter WL, Bryson ML, Falck S, Rosenfield R, Laragh M, Shrestha N, et al. Indication alerts intercept drug name confusion errors during computerized entry of medication orders. PLoS ONE. 2014;9:101977. https://doi.org/10.1371/journal.pone.0101977.

    Article  CAS  Google Scholar 

  23. Naunton M, Nor K, Bartholomaeus A, Thomas J, Kosari S. Case report of a medication error. Medicine. 2016;95:e4186.

    Article  PubMed  PubMed Central  Google Scholar 

  24. Shaw KN, Lillis KA, Ruddy RM, Mahajan PV, Lichenstein R, Olsen CS, et al. Reported medication events in a paediatric emergency research network: sharing to improve patient safety. Emerg Med J. 2013;30:815–9.

    Article  PubMed  Google Scholar 

  25. Chanakit T. The survey of look alike/sound alike (LASA) drugs available in hospitals in Thailand. Afr J Pharm Pharmacol. 2013;7:227–39.

    Article  Google Scholar 

  26. Central Bank of Sri Lanka. Economics and social statistics of Sri Lanka [Internet]. Volume XLI. Department of Statistics, editor. Central Bank of Sri Lanka; 2020. http://www.cbsl.gov.lk

  27. NMRA. Registered Medicines. https://www.nmra.gov.lk/index.php?option=com_drugs&view=drugs&Itemid=221&lang=en

  28. Athuraliya N, Walkom EJ, Dharmaratne S, Robertson J. Assessing medication packaging and labelling appropriateness in Sri Lanka. J Pharm Policy Pract. 2016;9:38. https://doi.org/10.1186/s40545-016-0091-5.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  29. Perera T, Ranasinghe P, Perera U, Perera S, Adikari M, Jayasinghe S, et al. Knowledge of prescribed medication information among patients with limited English proficiency in Sri Lanka. BMC Res Notes. 2012;5:658. https://doi.org/10.1186/1756-0500-5-658.

    Article  PubMed  PubMed Central  Google Scholar 

  30. Taherdoost H. Determining sample size: how to calculate survey sample size. Int J Econ Manag Syst. 2017;2:237–9.

    Google Scholar 

  31. Bryan R, Aronson JK, Williams A, Jordan S. The problem of look-alike, sound-alike name errors: Drivers and solutions. Br J Clin Pharmacol. 2021;87:386–94. https://doi.org/10.1111/bcp.14285.

    Article  CAS  PubMed  Google Scholar 

  32. NMRA. Guidelines on labeling of medicines [Internet]. Natl. Med. Regul. Auth. Sri Lanka: National Medicines Regulatory Authority. 2019; pp. 1–9. https://nmra.gov.lk/images/PDF/guideline/Guideline_by_Praba/Labeling-guidelines-1.pdf

  33. Sri Lanka. National Medicines Regulatory Authority Act, No. 5 of 2015. Sri Lanka: The Democratic Socialist Republic of Sri Lanka. p. 1–99.

  34. Sri Lanka. National Medicines (Registration and Licensing of Medicine) Regulations, 2019. Sri Lanka: The Gazette Extraordinary. 2019; p. 1–68

  35. Merchant L, Lutter R, Chang S. Identical or similar brand names used in different countries for medications with different active ingredients: a descriptive analysis. BMJ Qual Saf. 2020;29:988–91. https://doi.org/10.1136/bmjqs-2019-010316.

    Article  PubMed  PubMed Central  Google Scholar 

  36. Institute for Safe Medication Practices. Safety briefs: Same name, different drug. 2005.

  37. Rathish D, Bahini S, Sivakumar T, Thiranagama T, Abarajithan T, Wijerathne B, et al. Drug utilization, prescription errors and potential drug-drug interactions: an experience in rural Sri Lanka. BMC Pharmacol Toxicol. 2016;17:27. https://doi.org/10.1186/s40360-016-0071-z.

    Article  PubMed  PubMed Central  Google Scholar 

  38. Joshi MC, Joshi HS, Tariq K, Ejaj A, Prayag S, Raju A. A prospective study of medication errors arising out of look-alike and sound-alike brand names confusion. Int J Risk Saf Med. 2007;19:195–201.

    Google Scholar 

  39. Dayasiri K, Jayamanne SF, Jayasinghe CY. Accidental and deliberate self-poisoning with medications and medication errors among children in rural Sri Lanka. Emerg Med Int. 2020;2020:1–8.

    Article  Google Scholar 

Download references

Funding

This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.

Author information

Authors and Affiliations

  1. Department of Pharmacy, Faculty of Allied Health Sciences, University of Ruhuna, Karapitiya, Galle, 80000, Sri Lanka

    Manori Jayasinghe & Sewwandi Subasinghe

  2. National Medicines Regulatory Authority, Colombo, Sri Lanka

    Thotawaththage Loshadhi Indunika Srilal

  3. Sydney School of Medicine (Central Clinical School), Faculty of Medicine and Health, The University of Sydney, Camperdown, Australia

    Shukry Zawahir

Authors
  1. Manori Jayasinghe
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Thotawaththage Loshadhi Indunika Srilal
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Sewwandi Subasinghe
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Shukry Zawahir
    View author publications

    You can also search for this author in PubMed Google Scholar

Contributions

MJ was the principal investigator. MJ, SS, and SZ designed the study. Label evaluation, analysis, and interpretation were performed by MJ, TLIS, and SS. MJ wrote the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Manori Jayasinghe.

Ethics declarations

Conflict of interest

The Authors declare that there is no conflict of interest.

Additional information

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Jayasinghe, M., Srilal, T.L.I., Subasinghe, S. et al. Identification of Confusing Medicine Proprietary Names: Toward Safe Medicine Use—A Cross-Sectional Study in Sri Lanka. Ther Innov Regul Sci 57, 1248–1259 (2023). https://doi.org/10.1007/s43441-023-00557-7

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s43441-023-00557-7

Keywords

Search

Navigation