Cosmetovigilance: Public Health Perspective

A special issue of Cosmetics (ISSN 2079-9284).

Deadline for manuscript submissions: closed (30 September 2021) | Viewed by 62679

Special Issue Editors


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Guest Editor
Department of Clinical Pharmacy and Practice, Faculty of Pharmacy, Universiti Sultan Zainal Abidin, Terengganu 22200, Malaysia
Interests: cosmetovigilance; pharmacovigilance

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Guest Editor
Dermatopharmaceutics Research Group, Kulliyyah of Pharmacy, International Islamic University Malaysia, Kuantan, Pahang, Malaysia
Interests: topical and transdermal formulations for pharmaceutical and cosmeceutical applications
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Special Issue Information

Dear Colleagues,

Cosmetovigilance is the assemblage of actions correlated with the appraisal, compilation, and scrutinizing of unwanted adverse events reported/observed during or after the normal use of cosmetics. It is simply a term which was introduced in the context of a pharmacovigilance system for cosmetic products and coined in relation to post-marketing surveillance by the industry.  The identification of undesirable events from cosmetics is an arduous task, and limited reporting and estimation coupled with the lack of guidelines and standardized reporting forms places the user and healthcare professional in a catch-22 situation. A dearth of information also exists pertaining to safety monitoring-vigilance activities for cosmetics and cosmeceuticals.

This Special Issue calls for the manuscripts that explore areas related to the reporting of adverse effects, the assessment of reporting and validation, benefit–risk assessments, safety alert/recalls, and changes to product information pertaining to cosmetics and cosmeceuticals. We also welcome research pertaining to questionnaire validation in areas of safety, monitoring, and risk–benefit assessment of cosmeceuticals.

Dr. Shazia Jamshed
Dr. Hazrina Hadi
Guest Editors

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Keywords

  • cosmetovigilance
  • cosmeceuticals
  • safety
  • adverse events
  • causality assessment
  • signal detection

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Published Papers (7 papers)

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Research

13 pages, 1969 KiB  
Article
Global Trends in Cosmetics Use-Related Adverse Effects: A Bibliometric Analysis of Literature Published during 1957–2021
by Manjula Nayak, Dharmagadda Sreedhar, Smitha S. Prabhu and Virendra S. Ligade
Cosmetics 2021, 8(3), 75; https://doi.org/10.3390/cosmetics8030075 - 24 Aug 2021
Cited by 5 | Viewed by 11558
Abstract
Cosmetic and beauty products, though not essential for physical health, go a long way in providing mental well-being and confidence, and hence are used substantially. Increasing utilization of varying cosmetic products leads to a multitude of adverse effects. There is more awareness about [...] Read more.
Cosmetic and beauty products, though not essential for physical health, go a long way in providing mental well-being and confidence, and hence are used substantially. Increasing utilization of varying cosmetic products leads to a multitude of adverse effects. There is more awareness about cosmeceutics, cosmetic products and their adverse effects, and studies on the same are currently trending. Bibliometrics has become a prominent and growing field of research in recent years. The aim of this research was to assess bibliometric features and conduct systematic trend analysis on the literature available on cosmetics’ adverse effects. We analyzed all the published documents that included the keywords “cosmetics” and “adverse effects” between 1957 and 2021. We performed a detailed scientometric and bibliometric assessment in this field. A total of 4127 articles were retrieved from the databases provided by Scopus, which most were original articles. The United States ranked first and dominated the literature with 1292 (31.44%) documents followed by South Korea 7.47%. Harvard medical school was the most productive institution (1.16%). The study of the adverse effects of cosmetics should be supported and taken up by the researchers/authors from developing and underdeveloped countries. Full article
(This article belongs to the Special Issue Cosmetovigilance: Public Health Perspective)
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14 pages, 1256 KiB  
Article
Pharmacists’ Insights and Behaviors in Preventing the Misuse of Topical Corticosteroids in Pakistan: A Mixed-Method Study
by Sadia Shakeel, Shagufta Nesar, Wajiha Iffat, Hina Rehman, Samreen Aziz, Tayyaba Mumtaz, Hazrina Hadi and Shazia Jamshed
Cosmetics 2021, 8(3), 72; https://doi.org/10.3390/cosmetics8030072 - 12 Aug 2021
Cited by 5 | Viewed by 5142
Abstract
Topical corticosteroids (TCs) misuse has become a common issue for healthcare professionals and patients, particularly in Pakistan, as no stringent laws or rules are prohibiting the selling of over-the-counter medicines. The present study was designed to examine pharmacists’ insights and behaviors regarding TCs [...] Read more.
Topical corticosteroids (TCs) misuse has become a common issue for healthcare professionals and patients, particularly in Pakistan, as no stringent laws or rules are prohibiting the selling of over-the-counter medicines. The present study was designed to examine pharmacists’ insights and behaviors regarding TCs and their potential role in preventing the misuse of TCs in Pakistan. The study was a cross-sectional mixed-methods research design (phase 1, quantitative; and phase 2, qualitative) conducted from January to June 2021. The pharmacists working in various settings in Karachi were approached through different social media platforms. Data were collected through a web link of an online questionnaire with 30 closed-ended questions. Different statistical methods were employed for tabulating the quantitative data, while inductive thematic analysis was directed to classify themes from the qualitative data and to conclude findings. The mean cumulative knowledge score was 10.59 ± 1.63. The community pharmacists knew more about the available over-the-counter TCs (p = 0.041). The experienced pharmacists were more conversant than fresh pharmacists, regarding the mode of action (p = 0.008), choice of TC potency (p = 0.001), and most common local and systemic adverse effects of TCs (p = 0.001). Overall, respondents had a favorable attitude, with more than 80% agreeing that pharmacists could ensure that important safety issues are communicated with patients, and assist considerably in avoiding TC misuse. Analysis of data has produced 7 themes, 10 sub-themes, and 30 categories. Major themes included: use and misuse of TCs, adverse drug events due to TCs, cosmeto-vigilance, patient education, referral to a physician, and future perspectives for preventing TC misuse. The respondents were well versed with the dilemma of TCs misuse, and they considered patient characteristics, free availability of TCs, and lack of physician-pharmacist coordination as the major reasons. The major barriers for patient education stated by nearly all the respondents were a lack of time and lack of material/information for counseling. They emphasized the need for stringent legal strategies and the enforcement of current drug-control regulations, so that TCs are not supplied without appropriate prescriptions. The present findings indicate that pharmacists had appropriate knowledge and a positive attitude towards their potential role in preventing the misuse of TCs. Further education and sensitization in areas of deprived knowledge will undoubtedly aid in the prevention of TCs misuse by the community. Full article
(This article belongs to the Special Issue Cosmetovigilance: Public Health Perspective)
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14 pages, 3818 KiB  
Article
Lightening Effect of Skin Lightening Cream Containing Piper betle L. Extract in Human Volunteers
by Sharifah Shakirah Syed Omar, Hazrina Hadi, Nadzira Mohd Hanif, Hawa Mas Azmar Ahmad and Shiow-Fern Ng
Cosmetics 2021, 8(2), 32; https://doi.org/10.3390/cosmetics8020032 - 26 Apr 2021
Cited by 3 | Viewed by 9237
Abstract
Hyperpigmentation affects people globally with negative psychological impacts. Piper betle L. leaf (PBL) extract has many benefits including skin lightening which may reduce hyperpigmentation. The objective of this study was to develop an effective skin-lightening cream containing PBL with ideal characteristics. A formulation [...] Read more.
Hyperpigmentation affects people globally with negative psychological impacts. Piper betle L. leaf (PBL) extract has many benefits including skin lightening which may reduce hyperpigmentation. The objective of this study was to develop an effective skin-lightening cream containing PBL with ideal characteristics. A formulation of base cream and PBL cream was prepared and characterized by centrifugation, particle size and zeta potential analysis, rheological profile studies and physical properties’ observation. In vivo studies on 30 human subjects tested the effects of base and PBL cream on skin-lightening, hydration, trans-epidermal water loss (TEWL) and elasticity through weekly tests 4 weeks in duration. Base and PBL creams had a non-Newtonian property with acceptable color, odor, texture, zeta potential, particle size and showed no phase separation. The in vivo study indicated a significant reduction in melanin content and an improvement in skin tone for PBL cream but not in base cream. TEWL and elasticity also showed significant reduction for both formulations, indicating a healthier skin barrier and supple skin with consistent use, although hydration fluctuated with no significant changes. The developed PBL cream showed significant results in the reduction in melanin content and improving skin tone, which shows the formulation can confer skin-lightening effect. Full article
(This article belongs to the Special Issue Cosmetovigilance: Public Health Perspective)
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10 pages, 247 KiB  
Article
Hidden Formaldehyde Content in Cosmeceuticals Containing Preservatives that Release Formaldehyde and Their Compliance Behaviors: Bridging the Gap between Compliance and Local Regulation
by Ammar Abdulrahman Jairoun, Sabaa Saleh Al-Hemyari, Moyad Shahwan, Sa’ed H. Zyoud and Akram Ashames
Cosmetics 2020, 7(4), 93; https://doi.org/10.3390/cosmetics7040093 - 1 Dec 2020
Cited by 13 | Viewed by 9014
Abstract
Background: Many personal care products, and particularly cosmetic products, contain preservatives that release formaldehyde. These are potentially harmful to consumer health, especially considering that the levels of formaldehyde in some products are hidden and excessive. Objectives: To study the formaldehyde levels of preservatives [...] Read more.
Background: Many personal care products, and particularly cosmetic products, contain preservatives that release formaldehyde. These are potentially harmful to consumer health, especially considering that the levels of formaldehyde in some products are hidden and excessive. Objectives: To study the formaldehyde levels of preservatives in personal care products and cosmetics on the UAE market and determine the extent of compliance with health and safety requirements. Methods and Materials: Sixty-nine personal care and cosmetic product samples from the UAE market were collected and prepared to determine their formaldehyde content. According to the Second European Commission Directive 82/434/EEC of 2000 and as per the Gulf Technical Regulation, Safety Requirements of Cosmetics and Personal Care Products in GSO 1943:2016, quantitative analyses were performed to identify and quantify the content of formaldehyde as free formaldehyde. Results: With a maximum permissible limit of ≤0.2% w/w, the average formaldehyde content was found to be 0.083 with a 95% CI (0.039–0.13). Nine of the tested personal care and cosmetic products exceeded the recommended formaldehyde level, corresponding to 13% of all samples. None of these samples listed the free formaldehyde content or formaldehyde releaser. Conclusion: Applying good manufacturing practices (GMP), education, and regulatory control to improve the regulation and inspection of cosmetics containing formaldehyde releasers as preservatives, conducting research, and reporting the adverse side effects are highly recommended. There is an urgent need to monitor the incidence of skin sensitivity resulting from the use of cosmetics containing formaldehyde releasers as preservatives. Full article
(This article belongs to the Special Issue Cosmetovigilance: Public Health Perspective)
14 pages, 663 KiB  
Article
An Investigation into Incidences of Microbial Contamination in Cosmeceuticals in the UAE: Imbalances between Preservation and Microbial Contamination
by Ammar Abdulrahman Jairoun, Sabaa Saleh Al-Hemyari, Moyad Shahwan and Sa’ed H. Zyoud
Cosmetics 2020, 7(4), 92; https://doi.org/10.3390/cosmetics7040092 - 24 Nov 2020
Cited by 18 | Viewed by 10879
Abstract
In recent years, concern about certain personal care products and cosmetics suffering from microbial contamination has increased. In this research, we aimed to determine the types and incidence of the most common microorganisms found in unopened/unused personal care and cosmetic products in the [...] Read more.
In recent years, concern about certain personal care products and cosmetics suffering from microbial contamination has increased. In this research, we aimed to determine the types and incidence of the most common microorganisms found in unopened/unused personal care and cosmetic products in the United Arab Emirates (UAE) market. This research involved an analysis of 100 personal care products and cosmetics. For every product, microbial (Candida albicans, Staphylococcusaureus, aerobic mesophilic bacteria, Escherichia coli, yeast and mold, and Pseudomonas aeruginosa) contamination was assessed, and levels were compared with the guidelines used in Europe. Of the total samples, 15% (95% CI: 0.79–22.1) were contaminated by aerobic mesophilic bacteria compared to the maximum microbial limit of 1000 CFU/g. In addition, 13% (95% CI: 0.63–19.7) of the samples were contaminated with yeast and mold compared to the maximum microbial limit of 1000 CFU/g. Of all samples, nine (9%) were contaminated with both aerobic mesophilic bacteria and yeast and mold. However, none of the tested samples were contaminated with Escherichia coli, Staphylococcus aureus, Candida albicans, or Pseudomonas aeruginosa. Manufacturers of cosmetics and personal care products should be developing and implementing best practices regarding quality control/quality assurance in partnership with government regulators. Additionally, there should be greater control of the quality and safety of this type of product regarding good manufacturing practice (GMP), regulation, research, education, and the reporting of adverse events. Full article
(This article belongs to the Special Issue Cosmetovigilance: Public Health Perspective)
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14 pages, 252 KiB  
Article
Insight of Malaysian Users of Cosmetic Regarding Cosmetovigilance
by Hazrina Hadi, Ammar Ihsan Awadh, Mazlina Zamli, Nur’ain Ai and Shazia Jamshed
Cosmetics 2020, 7(2), 45; https://doi.org/10.3390/cosmetics7020045 - 10 Jun 2020
Cited by 4 | Viewed by 7955
Abstract
Despite high popularity and demand for cosmetic products among users of cosmetics, there is paucity of work on cosmetovigilance. The objective of this study was to explore the cosmetovigilance-related insight encompassing the knowledge, practices, attitude, and perception of Malaysian users of cosmetics. A [...] Read more.
Despite high popularity and demand for cosmetic products among users of cosmetics, there is paucity of work on cosmetovigilance. The objective of this study was to explore the cosmetovigilance-related insight encompassing the knowledge, practices, attitude, and perception of Malaysian users of cosmetics. A cross-sectional study was conducted using a structured questionnaire comprising of 47 items reflecting on demographic profile, knowledge, practices, attitude, and perception toward cosmetics. The questionnaire was administered using the SurveyMonkey website, subject to a convenience sample of 552 users of cosmetics in Malaysia. The data collected were analyzed using the Statistical Package for Social Sciences (SPSS) version 20. Insufficient knowledge of cosmetic safety was found, especially in terms of the ingredients used and the adverse effects related to common cosmetic products. The total knowledge score showed a significant difference between gender (p < 0.001) and monthly expenditure (p = 0.001). The total attitude score showed a significant difference with respect to gender (p = 0.008), age (p < 0.001), marital status (p < 0.001), education (p = 0.014), occupation (p < 0.001), income range (p = 0.009) and monthly expenditure (p = 0.013). The levels of cosmetovigilance-related knowledge, practices, attitude and perception of users of cosmetics in Malaysia are still unsatisfactory. The current research is expected to offer baseline data which can further help in strengthening the knowledge and attitudes of cosmetic consumers, while reinforcing best practices towards cosmetic products. Full article
(This article belongs to the Special Issue Cosmetovigilance: Public Health Perspective)
10 pages, 234 KiB  
Article
Cosmetic Use-Related Adverse Events: Findings from Lay Public in Malaysia
by Hazrina Hadi, Nur’ain Ai, Mazlina Zamli, Ammar Ihsan Awadh, Muhammad Zeeshan Zafar and Shazia Jamshed
Cosmetics 2020, 7(2), 41; https://doi.org/10.3390/cosmetics7020041 - 4 Jun 2020
Cited by 7 | Viewed by 5860
Abstract
Objectives: Although the occurrence of adverse cosmetic reactions is often underestimated by the consumers, the documentation of the incident might be helpful for the authority in regulating the cosmetic products. The objectives of this study were to assess the prevalence and type of [...] Read more.
Objectives: Although the occurrence of adverse cosmetic reactions is often underestimated by the consumers, the documentation of the incident might be helpful for the authority in regulating the cosmetic products. The objectives of this study were to assess the prevalence and type of adverse cosmetic event (ACE), as well as the measures adopted by those experiencing the ACE. Methods: A cross-sectional descriptive study was conducted using a structured questionnaire comprised of 11 questions. The questionnaire was divided into two sections: demographic profile and adverse cosmetic reaction. A total of 552 cosmetic users in Malaysia participated in this study. Data were entered into Statistical Package for Social Sciences (SPSS) version 20 and descriptive statistics was applied. Findings: A total of 29% respondents have experienced ACEs. Eczema was found to be the most frequent type of ACE. Facial area (n = 178) was reported to be the most frequent body site affected by ACEs. A mere 41% attempted to consult health professionals. Conclusions: Few respondents consulted health professionals for recommendations, indicating that they misjudge occurrences related to adverse outcomes. The high diversity and non-specificity of cosmetic adverse reactions reported in the current research highlighted the need for a vigorous cosmetovigilance system. Full article
(This article belongs to the Special Issue Cosmetovigilance: Public Health Perspective)
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