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1.
Eur J Clin Pharmacol ; 2024 Aug 26.
Artigo em Inglês | MEDLINE | ID: mdl-39183195

RESUMO

PURPOSE: To comprehensively evaluate and compare all the available reference guides for the safe use of drugs during pregnancy, with the goal of determining the scientificity and reliability of these reference guides. METHODS: We searched PubMed, EMbase, CNKI, Wanfang Database, and VIP database to comprehensively identify the available reference guides. Moreover, we selected 103 drugs based on relevant literatures, and compared the recommendations of each drug from different reference guides. RESULTS: A total of 14 available reference guides were identified. However, none of these reference guides assessed the risk of bias of original studies or the quality of current evidence. Seven reference guides adopted expert consensus method to formulate pregnancy recommendations, while the rest reference guides did not report the formation method. Moreover, 77.7% of the selected drugs had inconsistent recommendations among different reference guides. In addition, the referenced human and animal studies for the same drug differed among different reference guides. CONCLUSION: Our results indicate that current reference guides for the safe use of drugs during pregnancy are less scientific and reliable, and there are considerable discrepancies in recommendations from different reference guides concerning drug use during pregnancy. The reasons for the discrepancies in recommendations include ① the literature search in most reference guides was not comprehensive, ② none of the available reference guides assessed the risk of bias of original studies or the quality of current evidence, and ③ the method adopted by current reference guides to formulate recommendations had obvious subjectivity and lacked of scientificity.

2.
BMC Complement Med Ther ; 24(1): 252, 2024 Jul 03.
Artigo em Inglês | MEDLINE | ID: mdl-38961355

RESUMO

BACKGROUND: The use of finished herbal products (FHPs) among Malaysians today is expanding rapidly leading to a huge market of FHPs in the country. However, the mass production of FHPs in today's market is alarming due to safety-use issues that could lead to serious adverse effects. Nevertheless, demands are still high for FHPs as most consumers perceived it as safe to consume as it is made from natural substances as the active ingredients. This study aims to explore the safe use elements of FHPs identified by two stakeholders: consumers and practitioners in Malaysia and further compare these elements with the current regulations. METHODS: As an exploratory study, its approach is to investigate at an in-depth level of understanding of safe use elements from the involved stakeholders: consumers and practitioners. We had a total of 4 focus group discussion sessions (1 FGD session with consumer and 3 FGD sessions with practitioners) as a method of collecting data from the participants. The FGDs were conducted in local native Malaysian and then being translated by researchers without changing their meanings. Thematic analysis was done which involves methodically reading through the verbatim transcripts and consequently segmenting and coding the text into categories that highlight what the participants have discussed. RESULTS: From the result, we found that both practitioners and consumers agreed a safe FHP must be in compliance with the guidelines from the Ministry of Health Malaysia (MOH). There are other safe use elements highlighted including halal certification, trusted over-the-counter outlets, and published reports on the safety, efficacy, and quality. CONCLUSIONS: In conclusion, both practitioners and consumers agreed that the most important safe-use element is compliance with MOH guidelines, but the depth of discussion regarding the safety elements among these stakeholders holds a very huge gap. Thus, initiatives must be planned to increase the knowledge and understanding about the MOH guidelines towards achieving a sustainable ecosystem in the safe use of FHPs.


Assuntos
Grupos Focais , Malásia , Humanos , Adulto , Masculino , Feminino , Pessoa de Meia-Idade , Preparações de Plantas/normas , Fitoterapia
3.
Data Brief ; 54: 110548, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38912420

RESUMO

This study evaluated the level of knowledge of effects, knowledge of safe use, information complexity of natural health products and consumers' perceived safety and efficacy toward natural health products used to control or cure Covid-19 viruses in Malaysia. The validated questionnaires were used to survey randomly selected stakeholders in Malaysia, who were asked to participate voluntarily in an online survey from 1st September 2020 to 31st December 2020. 723 respondents of adults above 18 years old returned completed questionnaires. The survey used for data collection consisted of 5 questions on knowledge of effects, 4 questions on knowledge for safe-use, 9 questions on perception towards safety and efficacy and 4 questions on the information complexity of natural health products. Besides that, 8 questions are being asked on the demography of respondents at the very end of the survey. The Statistical Package for the Social Sciences (SPSS) version 26 was used to analyse the data. The mean score, correlation and regression values were the focus of this study. The findings provide various opportunities to investigate Malaysian consumers' perceptions which facilitates the development of regulation and strategic plans related to health, and encourage additional research by other researchers interested in the measures and data given.

4.
Ann Work Expo Health ; 68(6): 557-561, 2024 Jul 08.
Artigo em Inglês | MEDLINE | ID: mdl-38761129

RESUMO

In 2006, the revised chemicals management legislation mandated that manufacturers of hazardous chemical substances conduct risk assessments for the entire substance life cycle. Additionally, they must communicate use-specific safe handling advice (exposure scenarios) to their customer, as annex to the Safety Data Sheet (SDS). Despite significant efforts to develop workable solutions for chemical mixtures, this goal has not yet been fully achieved. Therefore, a Cefic research project (LRI B23) was commissioned on how to ensure meaningful health risk communication for workers across supply chains. The research project determined that risk-based safe use advice generated by manufacturers, often does not reach the intended end-user and was seen as not tailored to specific user needs. Recipients of the advice are also not prepared to act based on information developed by suppliers. From an industry perspective, the complexity of supply chains and substance life cycles are considered major barriers for effective safe use communication. Exposure scenarios for substance use in industrial work environments are often perceived as adding little value compared to existing safe use arrangements required by other health, safety, and environmental legislation applicable to employers and duty-holders. To attain meaningful use-specific safe handling advice for workers, including those at non-industrial premises who may benefit most from such advice, knowledge transfer and close collaboration between manufacturers and formulators remain key elements, supported by enhanced regulatory appreciation.


Assuntos
Exposição Ocupacional , Saúde Ocupacional , Humanos , Exposição Ocupacional/prevenção & controle , Saúde Ocupacional/legislação & jurisprudência , Indústria Química/legislação & jurisprudência , Comunicação , Substâncias Perigosas , Medição de Risco , Europa (Continente)
5.
GMS Hyg Infect Control ; 18: Doc25, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-38025890

RESUMO

Background: Intensified cleaning protocols to maintain a safe environment during the pandemic caused an increase in the use of disinfectants. The use of cleaning products in safer conditions by mothers is one of the important practices that will reduce the risk of household accidents. Objective: The aim of research was determine the practices of mothers about the safe use of cleaning and disinfectant products in the COVID-19. Methods: Data were collected by online survey among 255 mothers of the children 0-6 age from April and July 2021. Percentage, mean and chi-square tests were used to evaluate the data. Results: It was reported that the amount of cleaning product usage (69%) increased significantly, 26.3% of the mothers store the products in a locked cabinet and 29.4% use the product in the recommended amount. It was detected 28.7% of the mothers use disinfectants close to children. It was detected that 37.6% of the families were exposed to cleaning and disinfectant products. There was not significant difference between exposure situations and maternal age, education, employment status. Conclusions: It can be suggested that health workers should organize screening and training programs for the community about safe cleaning and disinfection practices.

6.
Transgenic Res ; 32(5): 423-435, 2023 10.
Artigo em Inglês | MEDLINE | ID: mdl-37415055

RESUMO

Fundamental to the safety assessment of genetically modified (GM) crops is the concept of negligible risk for newly expressed proteins for which there is a history of safe use. Although this simple concept has been stated in international and regional guidance for assessing the risk of newly expressed proteins in GM crops, its full implementation by regulatory authorities has been lacking. As a result, safety studies are often repeated at a significant expenditure of resources by developers, study results are repeatedly reviewed by regulators, and animals are sacrificed needlessly to complete redundant animal toxicity studies. This situation is illustrated using the example of the selectable marker phosphomannose isomerase (PMI) for which familiarity has been established. Reviewed is the history of safe use for PMI and predictable results of newly conducted safety studies including bioinformatic comparisons, resistance to digestion, and acute toxicity that were repeated to gain regulatory reapproval of PMI expressed from constructs in recently developed GM maize. As expected, the results of these newly repeated hazard-identification and characterization studies for PMI indicate negligible risk. PMI expressed in recently developed GM crops provides an opportunity to use the concept of familiarity by regulatory authorities to reduce risk-disproportionate regulation of these new events and lessen the resulting waste of both developer and regulator resources, as well as eliminate unnecessary animal testing. This would also correctly imply that familiar proteins like PMI have negligible risk. Together, such modernization of regulations would benefit society through enabling broader and faster access to needed technologies.


Assuntos
Produtos Agrícolas , Manose-6-Fosfato Isomerase , Animais , Manose-6-Fosfato Isomerase/genética , Produtos Agrícolas/genética , Plantas Geneticamente Modificadas/genética
7.
BMC Public Health ; 23(1): 488, 2023 03 14.
Artigo em Inglês | MEDLINE | ID: mdl-36918823

RESUMO

BACKGROUND: Although patients frequently use patient information leaflets (PILs) to obtain information about medicine, their confidence in using it may be diminished after reading it. This study aimed to assess the public perception of PIL's quality and the perceived impact of its use on medication adherence. METHODS: A community-based cross-sectional study of 1,138 adult individuals in Saudi Arabia, April-May 2020, was conducted via Survey Monkey using an anonymous validated e-questionnaire. Data were collected on personal characteristics, PIL readership and preferences, perception towards PIL quality and impact of its use on taking medication, and reasons for not reading PIL. In addition, logistic regression analysis was performed to identify the significant predictors of reading PIL. Significance was considered at p < 0.05. RESULTS: Nearly all participants (91.1%) reported reading PIL. The more read PIL's sections were directions of use (52.7%) and side effects (30.3%). Female gender (OR = 5.64, 95%CI: 3.53,9.02), age over 40 years (OR = 2.80, 95%CI: 1.69,4.64), and secondary education or more (OR = 1.74, 95%CI: 1.06,2.85) were the significant predictors of reading PIL. The majority of PIL readers reported their preference for verbal information (65.8%), hard copy presentation (77%), adding graphics (71.1%), and concise content of PIL (68.8%). In addition, most participants reported PIL always/usually adds to their knowledge of medicines (70.6%) and said that PIL reading positively impacted their medication adherence (64.9%). For only 8.8%, PIL reading negatively impacted their adherence, primarily because of reading information on medicine's side effects and complications (74.4%). More than one-half of participants perceived the PIL quality as good/excellent in terms of; font size (51.3%), language comprehensiveness (64.9%), paper quality (68.0%), and general appearance (64.9%). Getting sufficient information from doctors and pharmacists was the main reason for not reading the PIL (59.2%). Most participants (92.5%) agreed on standardizing how information is displayed in the PIL among all PILs of all companies. CONCLUSION: PIL is read by nearly all the study sample, especially females, older, and educated subjects. It was perceived as beneficial in upgrading medication adherence. Effective designing of PILs should focus on patients' literacy level and age. Standardization of the PIL structure in all pharmaceutical companies is recommended.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Folhetos , Feminino , Humanos , Estudos Transversais , Adesão à Medicação , Publicações , Inquéritos e Questionários , Adulto
8.
Luminescence ; 38(1): 28-38, 2023 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-36327139

RESUMO

To promote the rational use of cabozantinib (CBZ), this paper studied the influence of several nutritional supplements on the interaction between CBZ and bovine serum albumin (BSA), an appropriate alternative model for human serum albumin (HSA) that is one of the important transporter proteins in plasma, by fluorescence spectroscopy and UV-vis spectroscopy. The results showed that CBZ could quench the fluorescence of BSA via a dynamic-static quenching process, and the six nutritional supplements did not change the quenching mode of BSA by CBZ. However, all of them could reduce the binding constant of the CBZ-BSA system at 293 K and increase the polarity around tryptophan residues. Among them, nicotinamide and vitamin B12 (VB12 ) had a greater effect on the binding constants of the CBZ-BSA system. In the meantime, the thermodynamic parameters of the CBZ-BSA system were examined, indicating that the interaction of CBZ with BSA was spontaneous and dominated by hydrophobic forces. Further research discovered that the combining of CBZ with BSA was primarily located within Site I of BSA, and the binding distance r was 2.48 nm. Consequently, while taking CBZ, patients should use VB12 and nicotinamide carefully, which may interfere with the transport of drugs.


Assuntos
Suplementos Nutricionais , Interações Medicamentosas , Piridinas , Soroalbumina Bovina , Humanos , Sítios de Ligação/fisiologia , Ligação Proteica/efeitos dos fármacos , Ligação Proteica/fisiologia , Soroalbumina Bovina/química , Soroalbumina Bovina/farmacologia , Espectrometria de Fluorescência , Espectrofotometria Ultravioleta , Termodinâmica
9.
China Pharmacy ; (12): 868-871, 2023.
Artigo em Chinês | WPRIM (Pacífico Ocidental) | ID: wpr-969587

RESUMO

OBJECTIVE To mine adverse drug event (ADE) signals related to baloxavir marboxil, and to provide reference for clinically safe drug use. METHODS The ADE signals related to baloxavir marboxil from January 1, 2018 to May 31, 2022 in the US FDA adverse event reporting system (FAERS) were mined using the proportional reporting odds ratio (PRR) method. ADE with report number≥3, PRR≥2 and χ2≥4 was defined as a positive signal, and PRR method was used to analyze the ADE signal. RESULTS A total of 1 424 ADE reports with baloxavir marboxil as the main suspected drug were collected, involving 460 ADE signals. The femininity and patient under 18 years old were reported more, the country with the highest number of reports was the United States, and the main indication of drug reported was influenza. A total of 37 ADE positive signals were obtained after PRR calculation and screening exclusion, the first three ADE signals in the list of the reported number were diarrhea, vomiting and immediate hypersensitivity, and the first three ADE signals in the list of PRR value were febrile delirium, ischaemic colitis and hemorrhagic cystitis. Compared with the instructions of baloxavir marboxil, 18 ADE signals had not yet been included, such as abnormal liver function, hematuria, hemorrhagic cystitis, etc. Five new SOCs were involved, such as kidney and urinary system diseases, hepatobiliary system diseases, investigations, nervous system disorders and musculoskeletal and connective tissue disorders. CONCLUSIONS When clinical application of baloxavir marboxil, in addition to the adverse drug reactions mentioned in the drug instructions, attention should be paid to abnormal liver function, hematuria, hemorrhagic cystitis, etc, so as to guarantee the safety of drug use.

10.
Lisboa; s.n; 2023.
Tese em Português | BDENF - Enfermagem | ID: biblio-1570148

RESUMO

Introdução: O aumento da esperança de vida, é um facto, no entanto esse facto acarreta consigo a multimorbilidade e consequentemente a polimedicação, em esquemas terapêuticos muitas vezes complexos, podendo levar a problemas de segurança no uso de medicamentos. As Pessoas Idosas, fruto das alterações fisiológicas e da diminuição das capacidades físicas e/ou cognitivas representam um grupo especialmente vulnerável a esta problemática. Aos enfermeiros, é reconhecida competência para intervir na capacitação da Pessoa Idosa, mobilizando estratégias que possam dar resposta às necessidades identificadas, capacitando-as para o autocuidado e promovendo o uso seguro da medicação. Objetivo: "Promover a capacitação para o uso seguro da medicação, num grupo de idosos residentes na área de intervenção duma Unidade de Cuidados na Comunidade do ACeS Oeste Sul". Metodologia: Este projeto foi desenvolvido recorrendo a metodologia do Planeamento em Saúde, como suporte teórico foi ancorado na Teoria de Enfermagem do Défice de Autocuidado. Para o diagnóstico de situação foi utilizada a escala de Medida de Adesão ao Tratamento, complementada por questões sobre gestão do regime terapêutico e dados sociodemográficos através da aplicação dum questionário a uma amostra de 80 Pessoas Idosas. Identificaram-se problemas, definiram-se objetivos e metas. Tendo em conta que o diagnóstico de situação revelou défice de autocuidado na gestão do regime medicamentoso e défice de conhecimentos relacionados com uso do medicamento, foi selecionada como estratégia de intervenção a Educação para a Saúde. Foram realizadas sessões em grupo e elaborados ferramentas de suporte em complementaridade à informação transmitida nessas sessões. Resultados: A avaliação do projeto demonstrou que após as intervenções de enfermagem desenvolvidas houve aquisição de conhecimentos sobre uso seguro da medicação por parte dos participantes. As metas propostas foram atingidas e 100% dos participantes recomendariam estas sessões de Educação para a Saúde a outras pessoas, o que demonstra a sua satisfação com as mesmas.(AU)


Introduction: The increase in life expectancy, albeit a positive, carries with it multimorbidity, which in turn is treated via polimedication, consisting in often complex therapeutical schemes, that can create health problems related to the way by which the necessary medicines are taken. The elderly people, due to physiological changes and their decreased motor and/or cognitive functions, represent an especially vulnerable group. It is expected of nurses to Empower elderly people, by employing strategies adequate to the identified needs, improving their ability to take care of themselves and promoting the safe use of their medications. Objective: To promote the safe use of medications, amongst a group of elderly people residing in the intervention area of community care unit in the ACeS Oeste Sul. Methodology: This project was developed using Health Planning Methodology, with theoretical support in the Self-care Deficit Nursing Theory. For monitoring the development of the situation, the adherence-to-treatment scale was used, complemented by questions on the therapeutical regimen and sociodemographic data of 80 elderly people, gathered via survey. Problems were identified and goals were established. Shortcomings in self-care regarding the medicine taking regiment, and knowledge pertaining to the usage of medications were discovered, thus education for health was used as an intervention strategy. Group sessions were carried out, and tools were developed to support and complement the information transmitted in these sessions. Results: After the nursing interventions, the knowledge in safe use of medication ta of the participants increased. The goals were achieved and 100% of participants would recommend the education for health sessions to others, showing their satisfaction with them.(AU)


Assuntos
Idoso , Enfermagem em Saúde Comunitária , Tratamento Farmacológico , Conduta do Tratamento Medicamentoso/educação , Segurança do Paciente , Empoderamento , Idoso , Erros de Medicação/prevenção & controle
11.
J Interprof Educ Pract ; 29: 100524, 2022 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-35935734

RESUMO

Telemedicine may provide equitable, accessible, and affordable healthcare to individuals globally. Recently tele-medicine has emerged as a vital resource for interdisciplinary healthcare professionals to provide critical medical care on the frontlines during the combined COVID-19 pandemic and the drug and opioid crisis. With the recent 2020 expansion of insurance coverage of telemedicine services by the United States Centers for Medicare & Medicaid Services, there has been an uptick in the need to understand how to comprehensively train physicians and health care professionals on telemedicine during a public health crisis. This study gathered 98 survey responses from interdisciplinary healthcare professionals regarding their telemedicine experience, focusing on trends of use with the drug and opioid crisis during the COVID-19 pandemic. The results demonstrate that during the COVID-19 pandemic, telemedicine provided a novel, innovative way to address an unmet need in healthcare and may aid to improve safe medication stewardship (SaMS) practice guidelines. Further expanded population-based research and randomized clinical trials are necessary to confirm these preliminary recommendations and form best practices for use in digital health and telemedicine. In addition, further studies will confirm the benefits of interdisciplinary healthcare professionals' engagement in harm reduction strategies via telemedicine to address improving safe medication use.

12.
Huan Jing Ke Xue ; 43(8): 4190-4198, 2022 Aug 08.
Artigo em Chinês | MEDLINE | ID: mdl-35971716

RESUMO

The safe use of arable land is one of the important measures to ensure food security and to realize the construction of ecological civilization. In order to solve the problem of blindly selecting technical measures in the process of safe use and restoration of pollution-risk cultivated land, 244 surface soil samples and 100 sets of rice-root soil samples were collected in Echi Town, Qianjiang District, Chongqing. Based on the contents of five heavy metals of Cd, Hg, Pb, As, and Cr, as well as soil oxides, organic matter, and pH and other indicators, a prediction model was established using multiple regression and geostatistical analyses, and the plots were assigned values, combined with the soil and soil in the plots. The total amount of heavy metals in the rice, the available content of heavy metals in the soil, and the pH of the soil guided suggestions for the safe use of cultivated land at the corresponding plot scale. The results showed that the soil in the study area was mainly and strongly acidic. The percentages of Cd exceeding the soil pollution risk screening value and control value were 33.61% and 2.05%, respectively. The effective content of Cd accounted for 60%, and the Cd exceeding rate of rice was 28%. There was an obvious ecological risk of Cd in the study area. The available Cd content of the soil was mainly affected by the total amount of soil Cd and pH. The enrichment of Cd in rice was mainly affected by the content of soil organic matter, Mn, and CaO. The zoning results showed that the priority protection category of the soil in the study area accounted for 59.30%; the safe use category accounted for 40.44%, of which safe use (IAa), safe use (IAb), safe use (IBa), safe use (IIAa), safe use (IIAb), and safe use (IIBa) accounted for 19.49%, 8.01%, 1.43%, 7.04%, 1.41%, and 3.06%, respectively; and strict control accounted for 0.26%. This method combined the safety risks of soil and agricultural products and aided formation of specific recommendations for safe use, which provided a method of reference for the safe use of contaminated farmland in accordance with local conditions.


Assuntos
Metais Pesados , Oryza , Poluentes do Solo , Cádmio/análise , China , Monitoramento Ambiental , Metais Pesados/análise , Oryza/química , Medição de Risco , Solo/química , Poluentes do Solo/análise
13.
Toxicol Rep ; 9: 541-548, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35371923

RESUMO

Paracetamol/Acetaminophen was widely used as a first-line antipyretic and analgesic for COVID-19 patients without giving any attention to the potential risk of related toxicities. A survey was conducted on 176 Egyptians using an online survey portal to assess their knowledge, and attitude regarding potential risk of paracetamol toxicities and whether COVID-19 pandemic affected their practices regarding safe use of paracetamol. The self-administered questionnaire was developed by the researchers and was validated by expert opinions. A pilot testing of the questionnaire was done. Alpha Cronbach test used to assess the internal consistency reliability of the survey revealed good reliability. Overall percent-score revealed that only 24.4% of participants had good knowledge about paracetamol and its related potential toxicities. 62.5% of participants considered paracetamol safer than other medications of the same indications. 42.6% of participants could advise others to use paracetamol without prescription. According to the participants' responses, physicians were less concerned to give instructions about possibility of overdosage. Our results also revealed that participants' administration of paracetamol without physician prescription was more during COVID-19. Practice of paracetamol administration more than the allowed number of tablets/day was significantly more evident during the pandemic. We concluded that the unsupervised use of paracetamol is an alarming sign that should be addressed as this could lead to a high rate of accidental paracetamol toxicity. A lesson learnt from COVID-19 pandemic is the need to implement behavior change measures to mitigate the risk of accidental paracetamol toxicity.

14.
Artigo em Inglês | MEDLINE | ID: mdl-35270352

RESUMO

Over-the-counter (OTC) medicine is defined as safe and effective for the general public to use, without seeking therapy from a health professional. As primary social media and internet users, university and college students are more likely to be exposed to unverified sources of health information. This study aims to assess the knowledge, attitudes, and behaviour of students at institutions of higher learning in Brunei with regard to the safe use of OTC medicines. A cross-sectional study was performed using a self-administered online questionnaire, adapted from the literature with additional information from the United States Food and Drug Administration (FDA) on the educational resources in understanding OTC medicine for consumers. The questionnaire consisted of 4 sections: demographic information, knowledge of OTC medicines, attitudes, and practice. Descriptive and inferential statistics were used for data analysis. A total of 335 students returned a completed questionnaire. The students had a mean knowledge score of 7.1 out of 9, with more than half (53.4%) having good knowledge (knowledge score > 7), and only a small percentage (5.7%) with poor knowledge. Almost all of the students (99.7%) had a positive attitude toward OTC medicine use. Few of the students practiced improper habits in terms of OTC medicine use, such as not reading the instructions or taking more than the recommended dose. Awareness of proper OTC medicine use among students in institutions of higher learning is necessary to prevent the rise of inappropriate user practices.


Assuntos
Medicamentos sem Prescrição , Estudantes , Atitude , Brunei , Estudos Transversais , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Inquéritos e Questionários , Universidades
15.
J Pharm Policy Pract ; 15(1): 13, 2022 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-35232496

RESUMO

BACKGROUND: The consistency and the quality of medicine labels are sought through the regulatory frameworks. This study aims at investigating the secondary labels of medicines based on the labeling regulations and guidelines issued by the National Medicines Regulatory Authority (NMRA), Sri Lanka. METHODS: A descriptive cross-sectional study was conducted on 53 commonly used prescription-only oral medicines selected using the price regulations published for most commonly used drugs. High-resolution images of 216 brands/branded generics/generic products' secondary labels were collected in April 2021 from six community pharmacies in six districts chosen as a convenience sample. Each label was manually assessed using a checklist prepared based on the regulatory requirements by four trained investigators. The status of registration of each product was assessed using the NMRA website. Descriptive statistics were performed. RESULTS: There was a variation observed in labeling regulations and information present on packages. Among the 216 products evaluated, only 148 (68%) products appeared as registered medicines on the NMRA website, and 2.3% of medicines fulfilled all stipulated labeling parameters set out by the NMRA, 3% of products abided by the general labeling requirements, and 76% of the products complied with labeling requirements for API. Major deficiencies were observed in the presentation of registration numbers and the details of the local agent, which were unaccounted for in 210 (97%) and 131 (61%) products, respectively. The highest consistency (100%) of information was noted with the dosage form, date of manufacture, date of expiry, and batch numbers. Among the restricted information, attractive pictures (2%), web addresses (6%), and over-stickers (34%) were found. CONCLUSIONS: The results highlighted a gap between regulatory requirements and practice in medicine labeling information. Regular post-market examination of medicinal labels is highly advised in a country that relies largely on imports. Similarly, careful adherence to the labeling regulations is required. Furthermore, suppliers and local agents should be held accountable for ensuring accurate medicine labeling through increased awareness, education, and sanctions.

16.
Future Oncol ; 18(13): 1595-1607, 2022 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-35105158

RESUMO

For drugs with enhanced serious safety risks, Risk Evaluation and Mitigation Strategy (REMS) may be required. Pexidartinib is approved for treatment of adult symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery. Its approval was conditional on its prescription via a mandatory REMS due to serious and potentially fatal liver injury seen in clinical trials. Turalio® REMS aims to mitigate this risk by ensuring provider education on pexidartinib use and required REMS components, prescriber adherence to baseline and periodic monitoring, and enrolling patients in a registry to further assess safe use and acute, chronic and irreversible hepatotoxicity. Through Turalio REMS, benefits of treating patients with pexidartinib may be preserved.


For drugs with serious side effects, specific safety measures may be put in place to manage these serious side effects in the form of Risk Evaluation and Mitigation Strategy (REMS) programs. Pexidartinib (Turalio®) is approved for treatment of adults who have symptoms of severe tenosynovial giant cell tumor or have limitations in function that do not improve with surgery. Turalio® has an REMS program because liver injuries that can be serious or fatal were seen in Pexidartinib clinical trials. This program aims to decrease the seriousness of the liver injuries by assuring doctors and pharmacists are educated on how to use the drug, patients are advised of this potential risk and that baseline and periodic monitoring of patients are conducted.


Assuntos
Tumor de Células Gigantes de Bainha Tendinosa , Avaliação de Risco e Mitigação , Adulto , Aminopiridinas/uso terapêutico , Tumor de Células Gigantes de Bainha Tendinosa/tratamento farmacológico , Humanos , Pirróis/uso terapêutico , Estados Unidos , United States Food and Drug Administration
17.
J Environ Sci (China) ; 112: 106-114, 2022 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-34955193

RESUMO

Wastewater reclamation and reuse is an increasing global project, while the reclamation treatment on wastewater does not completely remove all pollutants in water. The residual pollutants in reclaimed water would cause potential risk on human health and ecosystem safety during the long-term use. It is impossible to analyze and control all pollutants one by one in practice, therefore, identification and control of priority pollutants will be efficient strategy to ensure the safe use of reclaimed water. An integrated three-step methodology for identifying priority pollutants in reclaimed water was proposed in this study. First, a comprehensive literature survey on the occurrence of pollutants in reclaimed water was conducted, and a dataset DPR for pollutants occurrence in reclaimed water was established, containing 1,113 pollutants. Second, 611 chemicals that had been recommended as hazardous pollutants for various water bodies in previous literatures were summarized, and a dataset DHP for hazardous pollutants in water was obtained. Third, meta-analysis on these two datasets (DPR and DHP) was performed, a new dataset DHPR for hazardous pollutants in reclaimed water was established, including 265 candidates. Finally, 59 substances out of dataset DHPR were identified as priority pollutants for reclaimed water based on their recommendation frequency. It is expected that this synthetical methodology will provide powerful support for scientific evaluating and managing water pollution and ensuring safe use of reclaimed water.


Assuntos
Poluentes Ambientais , Poluentes Químicos da Água , Purificação da Água , Ecossistema , Humanos , Águas Residuárias/análise , Água , Poluentes Químicos da Água/análise
18.
Artigo em Inglês | MEDLINE | ID: mdl-34948557

RESUMO

Over the last decades, human activities prompted the high production and widespread use of household chemical products, leading to daily exposure of humans to several chemicals. The objective of this study was to investigate the frequency of chemicals' use by children and parents in Greece and estimate the level of risk awareness and understanding among them. A total of 575 parents and children were asked to answer an anonymous, closed-ended, validated, and self-administered questionnaire. One-third of the children and almost half of the parents participating in the study believed that commonly used chemical products do not pose any risk to human health or to the environment, despite the product labelling. The majority of both children (61.8%) and parents (70.6%) were informed about product safety via the product labelling. Around 20% in both groups could not differentiate between systemic toxicity and acute lethal effects depicted by pictograms on the label and milder hazards, such as skin irritation. Moreover, the information on hazard and precautionary statements appearing on the label was very poorly perceived. Therefore, as both children and parents seem not to clearly identify the hazards and risks arising from the use of everyday chemical products, targeted awareness policies should be implemented to support the safe use of household products.


Assuntos
Produtos Domésticos , Rotulagem de Produtos , Criança , Grécia , Humanos , Inquéritos e Questionários
19.
Ther Adv Vaccines Immunother ; 9: 25151355211032590, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34377928

RESUMO

BACKGROUND AND AIMS: Maintaining the quality and safety of immunization is as important as the efficacy of vaccines in vaccine-preventable diseases (VPD) programs. The aim of this study was to determine the problems associated with different stages of vaccine use and to assess the outcome of an educational intervention on safety and quality use of vaccines among health care providers. METHODS: A pilot prospective interventional study was conducted over a period of 2 years at 271 sites in Mysuru, India. The study population was health care professionals (HCPs) involved in immunization and a sample of parents (one per site). A validated questionnaire was used as a study tool. An educational intervention on best immunization practice was conducted for the enrolled HCPs and the impact of the educational intervention was assessed using the study tool after 3 weeks. RESULTS: The total number of the study population was 594 (323 HCPs and 271 parents). Of these, 41.49% were working at community health care facility and 33.13% were enrolled from primary care centers. There were statistically significant improvements in post interventional assessment of all stages of the immunization process including storage (p -0.001), transportation (p -0.001), administration (p 0.001), monitoring and reporting of adverse events following immunization (AEFIs) (p -0.001), knowledge of AEFIs (p 0.001), and HCP-parent communication (p 0.001). AEFI reporting improved by 30% in the post education phase. CONCLUSION: Continuous education and motivation can result in positive behavioral changes on best immunization practices amongst HCPs involved in immunization, which may help to improve and maintain the safety and quality use of vaccines in immunization centers irrespective of the type of facility.

20.
Crit Rev Toxicol ; 51(2): 183-191, 2021 02.
Artigo em Inglês | MEDLINE | ID: mdl-34032188

RESUMO

Safety in use of jamu consumption, as part of traditional medicine from Indonesia, is dependent on the complete and adequate assessment of potential hazards and risks of the botanicals and botanical constituents included. This includes especially hazards and risks related to the presence in jamu of active pharmaceutical ingredients (APIs) as well as of constituents that are genotoxic and carcinogenic. The present review presents an overview of the current state-of-the art on these hazards and risks based on case reports on adulteration, and the actual detection of genotoxic and carcinogenic ingredients of concern in jamu. Based on the overview thus obtained, it appears that drug-adulteration presents important hazards responsible for potential adverse effects, due to overdosing. The potential hazards of exposure to APIs mainly relate to the presence of constituents that may cause liver damage, renal impairment, kidney failure, steroid dependence or genotoxicity and carcinogenicity. For these APIs, a risk characterisation was performed based on comparison of health-based guidance values (HBGVs) and exposure, while for the genotoxic carcinogens the margin of exposure (MOE) approach was used. Results of this risk characterisation should be used by risk managers to impose specification for constituents of health concern to protect consumers. It is concluded that to manage the risks identified and further improve the safety in use of jamu, a collaboration between farmers, manufacturer/producers, academia, government, health professionals, and consumers is indicated.


Assuntos
Suplementos Nutricionais/toxicidade , Medicina Tradicional , Carcinógenos/toxicidade , Dano ao DNA , Contaminação de Medicamentos , Humanos , Medição de Risco
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