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Research

Assessment of compliance to packaging and labeling regulatory requirements of locally manufactured alcohol-based hand sanitizers marketed in Addis Ababa, Ethiopia

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Article: 60 | Received 11 Apr 2022, Accepted 02 Oct 2022, Published online: 04 Dec 2023

References

  • Huddleston T. The history of hand sanitizer: how the coronavirus staple went from mechanic shops to consumer shelves, CNBC LLC. 2020. https://www.cnbc.com/2020/03/27/coronavirus-the-history-of-hand-sanitizer-and-why-its-important.html. Accessed 12 Feb 2022.
  • Prajapati P, Desai H, Chandarana C. Hand sanitizers as a preventive measure in COVID-19 pandemic, its characteristics, and harmful effects: A review. J Egypt Public Health Assoc. 2022. https://doi.org/10.1186/s42506-021-00094-x.
  • Hassan AO, Hassan RO, Muhibi MA, Adebimpe WO. A survey of Enterobacteriaceae in hospital and community acquired infections among adults in a tertiary health institution in Southwestern Nigeria. Afr J Microbiol Res. 2012;6:5162–5167.
  • WHO. Guidelines on Hand Hygiene in Health Care. World Health Organization. 2009. https://apps.who.int/iris/bitstream/handle/10665/44102/9789241597906_eng.pdf?sequence=1. Accessed 21 Jul 2020.
  • Li Y, Wang Y, Yan D, Rao CY. Self-reported hand hygiene practices, and feasibility and acceptability of alcohol-based hand rubs among village healthcare workers in Inner Mongolia. China J Hosp Infect. 2015;90:338–343.
  • Leslie RA, Zhou SS, Macinga DR. Inactivation of SARS-CoV-2 by commercially available alcohol-based hand sanitizers. Am J Infect Control. 2021;49:401–402.
  • Babeluk R, Jutz S, Mertlitz S, Matiasek J, Klaus C. Hand hygiene–evaluation of three disinfectant hand sanitizers in a community setting. PLoS ONE. 2014;9:e111969.
  • Bauer-Savage J, Pittet D, Kim E, Allegranzi B. Local production of WHO-recommended alcohol-based handrubs: feasibility, advantages, barriers and costs. Bull World Health Organ. 2014;91:963–969.
  • Kampf G. Potential role of inanimate surfaces for the spread of coronaviruses and their inactivation with disinfectant agents. Infect Prev Pract. 2020;2(2):100044.
  • Centers for disease control and prevention (CDC). Handwashing in community settings. Hand sanitizer use out and about; 2020. https://www.cdc.gov/handwashing/hand-sanitizer-use.html. Accessed 14 Sept 2021.
  • FDA. Safely Using Hand Sanitizers. U.S. Food and drug Administration. 2021. https://www.fda.gov/consumers/consumer-updates/safely-using-hand-sanitizer. Accessed 29Aug 2020.
  • Jing JLJ, Pei YT, Bose RJ, McCarthy JR, Tharmalingam N, Madheswaran T. Hand sanitizers: a review on formulation aspects, adverse effects, and regulations. Int J Environ Res Public Health. 2020. https://doi.org/10.3390/ijerph17093326.
  • Nyamweya NN, Abuga KO. A survey of alcohol-based hand sanitizers in Nairobi: packaging, labelling and regulatory compliance. East Cent Afr J Pharm Sci. 2020;23:72–76.
  • Adigwe O, John J, Isimi C, Oloye S, Onavbavba G, Emeje M. Quality Assessment of some alcohol-based hand sanitizers circulating in the Federal Capital Territory Abuja. Nigeria Res Square. 2021. https://doi.org/10.21203/rs.3.rs-1208457/v1.
  • Berhe AG, Erena DB, Hassen IM, Mamaru TL, Soressa YA. City profile: Addis Ababa. Report prepared in the SES (Social Inclusion and Energy Management for Informal Urban Settlements) project, funded by the Erasmus+ Program of the European Union. 2017. https://mdl.donau-uni.ac.at/ses/pluginfile.php/314/mod_page/content/4/City%20Profil%20Addis%20Ababa.pdf. Accessed 24 Dec 2021.
  • EFDA. Certification of corona virus input manufacturer, importer and distributor interim certification of certification. Ethiopian Food and Drug Authority (EFDA). 2020. http://www.fmhaca.gov.et/wp-content/uploads/2020/04/Temporary-LicensingProcedures-pdf. Accessed 24 Jun 2021.
  • FDA. Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products during the Public Health Emergency (COVID-191): Guidance for Industry. Center for Drug Evaluation and Research (CDER), Food and Drug Administration, USA. 2020. https://downloads.regulations.gov/FDA-2020-D-1106-0020/attachment_2.pdf. Accessed 24 Jun 2021.
  • USP. Excerpted USP-NF and FCC Standards: A Hand Sanitizer Resource, A collection of standards provided as a resource to assist with the challenges posed by COVID-19. United States Pharmacopoeia (USP). 2020. https://algimed.com/pdf/usp_monographs_for_covid_response.pdf. Accessed 24Jun 2021.
  • Abuga K, Nyamweya N. Alcohol-based hand sanitizers in COVID-19 prevention: a multidimensional perspective. Pharmacy. 2021;9:64. https://doi.org/10.3390/pharmacy9010064.
  • Fortune Business insights. COVID-19 analysis. Impact of COVID-19 on Hand Sanitizer Market Size, Share, Industry Analysis and Regional Forecast, 2019–2026. Fortune Business insights. 2020. https://www.fortunebusinessinsights.com/impact-of-covid-19-on-hand-sanitizer-market-102719. Accessed 12 Feb 2022.
  • Gold NA, Mirza TM, Avva U. Alcohol Sanitizer. [Updated 2022 Jun 21]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK513254/. Accessed 05 September 2022.
  • McDonnell G, Russell AD. Antiseptics and disinfectants: activity, action, and resistance. Clin Microbiol Rev. 1999;12(1):147–179.
  • Haft RJF, Keating DH, Schwaegler T, Schwalbach MS, Vinokur J, Tremaine M,et al. Correcting direct effects of ethanol on translation and transcription machinery confers ethanol tolerance in bacteria. Proc Natl Acad Sci USA. 2014;111(25):E2576–E2585.
  • Muleba L, Wyk RV, Pienaar J, Ratshikhopha E, Singh T. Assessment of anti-bacterial effectiveness of hand sanitizers commonly used in South Africa. Int J Environ Res Public Health. 2022;19:9245.
  • Kramer A, Pittet D, Klasinc R, Krebs S, Koburger T, Fusch C, Assadian O. Shortening the application time of alcohol-based hand rubs to 15 seconds may improve the frequency of hand antisepsis actions in a neonatal intensive care unit. Infect Control Hosp Epidemiol. 2017;38:1430–1434.
  • Harnoss JC, Dancer SJ, Kaden CF, Baguhl R, Kohlmann T, Papke R, Zygmunt M,et al. Hand Antisepsis without decreasing efficacy by shortening the rub-in time of alcohol-based handrubs to 15 seconds. J Hosp Infect. 2020;104:419–424.
  • Santos C, Kieszak S, Wang A, Law R, Schier J, Wolkin A. Reported adverse health effects in children from ingestion of alcohol-based hand sanitizers, United States, 2011–2014. Morb Mortal Wkly Rep. 2017;66(8):223. https://doi.org/10.15585/mmwr.mm6608a5.
  • Mahmood A, Eqan M, Pervez S, Ahmed H, Bari A, Yasar A,et al. COVID-19 and frequent use of hand sanitizers; human health and environmental hazards by exposure pathways. Sci Total Environ. 2020;742:140561. https://doi.org/10.1016/j.scitotenv.202.
  • Atolani O, Baker MT, Adeyemi OS, Olanrewaju IR, Hamid AA, Ameen OM, Oguntoye SO, Sman LA. COVID-19: Critical discussion on the applications and implications of chemicals in sanitizers and disinfectants. EXCLI J. 2020;19:785–799.
  • Guertler A, Moellhoff N, Schenck TL, Hagen CS, Kendziora B, Giunta RE, French LE,et al. Occupational Hand Eczema among Healthcare Workers during the SARS-CoV-2 Pandemic: Comparing a Single Surgical Site with a COVID-19 Intensive Care Unit. Contact Dermatol. 2020;83:108–114.
  • O’Leary FM, Price GJ. Alcohol Hand Gel: a Potential Fire Hazard. J Plast Reconstr Aesthet Surg. 2011;64:131–132.
  • Jayasinghe M, Srilal TLI, Prasadi DGP, Madushika WSS, Silva SMDU, Subasinghe S. Regulatory requirements and labeling of commercially available prescription (oral) medicines in Sri Lanka: there is room for improvement. J Pharm Policy Pract. 2022;15:13.
  • RegASK. Regulatory Labeling Compliance Best Practices in FMCG Industry. 2022. Available from: https://regask.com/regulatory-labeling-compliance-best-practices-in-fmcg-industry/. Accessed 05 Sept 2022.
  • Shah S, Singh A. Drug labeling: The study of compliance of regulatory requirements for prescription drugs in India. Perspect Clin Res. 2020;11:164–167.