ABSTRACT
Abstract Pharmacists acting in pharmacies and drugstores stores are some of the most accessible healthcare providers and the last to intervene before the patient takes their medicine. This puts the pharmacist in a position of authority that should be harnessed for the benefit of health. Thus, this professional is strategic for performing pharmacovigilance. Our objective of this study was to interrogate the practice of pharmacists in relation to pharmacovigilance activities, and to identify difficulties and possible stimuli for the improvement these activities in pharmacies and drugstores. The information was collected through an online questionnaire via Survey Monkey®. The data were analyzed statistically using SPSS software. Responses were received from 5174 pharmacists: mostly young women within five years of graduation and experience in pharmaceutical retail. 81% of them reported having identified suspected substandard medicines, but only 16% used the Brazilian notification system Notivisa. More than 85% of pharmacists agreed with the importance of pharmacovigilance and the recognition of reporting services as part of pharmacist duties and pharmaceutical care. The main barriers to making notifications were the lack of access and knowledge about Notivisa. Pharmacists agreed that simplifying the system would be a stimulus for notifications, and requested more feedback from notifications, as well as material and courses to understand the notification process. Pharmacists have important data to feed into pharmacovigilance systems, recognize their responsibilities and are willing to contribute, but still demonstrate low compliance. Simplification of the system and training on it are likely to increase notifications.
Subject(s)
Humans , Male , Female , Pharmacists/ethics , Pharmaceutical Services/organization & administration , Health Personnel , Pharmacovigilance , Patients , Pharmacies/supply & distribution , Software , Surveys and Questionnaires/statistics & numerical data , Substandard DrugsABSTRACT
En Colombia, los Enterobacterales (Escherichia coli, Klebsiella spp y Enterobacter spp) ocupan los primeros lugares en la epidemiología de las infecciones asociadas a la atención en salud (IAAS) y de las adquiridas en comunidad. Estas bacterias pueden desarrollar resistencia a carbapenemicos (Ertapenem, Imipenem, Meropenem y Doripenem) por una combinación de mecanismos que incluye la producción de enzimas hidrolíticas (como las betalactamasas de espectro extendido o BLEEs, las cefalosporinasas AmpC y las carbapenemasas) y las mutaciones en proteínas de la membrana externa. Desde su aparición en 1996, las carbapenemasas han sido las enzimas más temidas. Klebsiella pneumoniae carbapenemase (KPC) Verona integron-mediated metallo- ß-lactamase (VIM), New Delhi metallo-ß-lactamase (NDM), Imipenemase (IMP) y oxacillinase-48-like carbapenemase (OXA-48) han sido las más estudiadas por su diseminación y alta mortalidad. En 2006 se reportó por primera vez la presencia de carbapenemasas en Colombia correspondiente a una KPC-24 . Desde entonces, varios reportes de diversas enzimas han sido publicados por grupos de investigación y por el Instituto Nacional de Salud (INS) en cuyo último informe 66% de los Enterobacterales resistentes a carbapenémicos expresan KPC, 23% expresan NDM y 6% expresan VIM. Llama la atención un 12% de aislamientos sin carbapenemasas detectables.
In Colombia, Enterobacteriaceae (Escherichia coli, Klebsiella spp and Enterobacter spp) occupy the first places in the epidemiology of healthcare-associated infections (HAI) and community-acquired infections. These bacteria can develop resistance to carbapenemics (Ertapenem, Imipenem, Meropenem and Doripenem) by a combination of mechanisms including the production of hydrolytic enzymes (such as extended-spectrum beta-lactamases or BLEEs, AmpC cephalosporinases and carbapenemases) and mutations in outer membrane proteins. Since their emergence in 1996, carbapenemases have been the most feared enzymes. Klebsiella pneumoniae carbapenemase (KPC) Verona integron-mediated metallo- ß-lactamase (VIM), New Delhi metallo-ß-lactamase (NDM), Imipenemase (IMP) and oxacillinase-48-like carbapenemase (OXA-48) have been the most studied because of their dissemination and high mortality. In 2006, the presence of carbapenemases in Colombia corresponding to a KPC-24 was reported for the first time. Since then, several reports of various enzymes have been published by research groups and by the National Institute of Health (INS) in whose last report 66% of carbapenem-resistant Enterobacteriaceae express KPC, 23% express NDM and 6% express VIM. It is noteworthy that 12% of isolates had no detectable carbapenemases.
Subject(s)
Humans , Drug Resistance, Bacterial , Gram-Negative Bacteria , Carbapenems , Ceftazidime , Health Care Costs , Colombia , Diagnostic Techniques and Procedures , Substandard DrugsABSTRACT
SUMMARY INTRODUCTION: There is a worldwide increase in the number of invasive aesthetic procedures, and there is a general apprehension in medical societies towards the assurance of patient safety, that is dependent on the quality and certification of providers, of the materials and substances used, and where they take place. It is the main objective of this study to determine the perception of the gravity of non-authorized substances for clinical use in invasive aesthetic procedures among Portuguese plastic surgeons and its variation by the clinical sector of practice. METHODS: We proceeded to an inquiry by using a questionnaire, measured in a Linkert scale, and the collected data were statistically treated with a non-parametric Kruskal-Wallis test. RESULTS: We obtained a 41,4% answer rate and a global perception that this is a serious problem - a median of 8,00 and mean of 7,45 points on a 1 to 10 scale. 70% of the plastic surgeons that answered the questionnaire work both in the private and public sector, 19% exclusively in the public sector and 11% only in private practice. The perception of the problem was most serious among those that work exclusively in the private sector (statistically significant difference). CONCLUSION: The causes of the observed difference may reside in various reasons: the higher number of patients submitted to invasive aesthetic procedures exclusively in private practice; the higher perception of regulatory deficits in the private sector; scarce specific health politics for procedures outside the traditional boundaries of medicine; the difficulty for independent regulatory agencies to adopt effective measures.
RESUMO INTRODUÇÃO: Os procedimentos estéticos invasivos estão a aumentar globalmente, e são acompanhados por uma apreensão das sociedades médicas sobre a segurança desses procedimentos, dependentes da qualidade e certificação dos prestadores, dos dispositivos e substâncias utilizados e do local onde são efetuados. O presente estudo procura aferir a percepção dos cirurgiões plásticos portugueses sobre a gravidade da utilização de substâncias não autorizadas para uso clínico em procedimentos estéticos, e a sua variação consoante o setor em que exercem a atividade clínica. MÉTODOS: Foi utilizado um inquérito sob a forma de questionário, medido numa escala de Likert, e os dados foram tratados estatisticamente pelo teste não paramétrico de Kruskal-Wallis. RESULTADOS: Obteve-se uma taxa de resposta de 41,4% e a perceção global é a de que o problema é grave — mediana de 8,00 e média de 7,45 numa escala de 1 a 10. Setenta por cento dos cirurgiões plásticos que responderam ao inquérito trabalham num regime misto, 19% exclusivamente no setor público e 11% apenas no setor privado. A percepção do problema como mais grave (diferença estatisticamente significativa) foi observada na atividade exclusiva no setor privado. CONCLUSÕES: A diferença observada pode dever-se a vários fatores: à maior observação de pacientes submetidos a esses procedimentos exclusivamente no setor privado; à maior percepção de déficits de regulação no setor privado; ao déficit de políticas de saúde específicas a técnicas utilizadas fora do contexto tradicional da medicina; à dificuldade de as agências administrativas reguladoras independentes adotarem práticas efetivas no setor privado da saúde.