RESUMO
This publication presents criteria and bases for the work organization in the safe practice of Hospital Radiopharmacy, in order to minimize the risk of viral transmission during the COVID-19 pandemic, in a reference facility of the National Energy Commission Atomic of Argentina, while continuing to perform essential services for the health system. For this purpose, documents from the National Energy Commission Atomic, IAEA, WHO and other scientific publications were consulted as reference. These recommendations are under constant review and are permanently updated. Within this framework, the present model of work organization for this essential activity is proposed, including general and specific recommendations and its epidemiological and immunological basis.
Assuntos
COVID-19/epidemiologia , Medicina Nuclear/organização & administração , Pandemias , Serviço de Farmácia Hospitalar/organização & administração , SARS-CoV-2 , Argentina/epidemiologia , COVID-19/diagnóstico , COVID-19/imunologia , COVID-19/prevenção & controle , Teste para COVID-19/métodos , Humanos , Higiene/normas , Medicina Nuclear/normas , Objetivos Organizacionais , Admissão e Escalonamento de Pessoal/organização & administração , Serviço de Farmácia Hospitalar/normas , Compostos Radiofarmacêuticos/normas , SARS-CoV-2/imunologia , Local de Trabalho/organização & administração , Local de Trabalho/normasRESUMO
Abstract To present optimized chromatographic systems for radiochemical purity (RCP) evaluation of 99mTc-eluate and 99mTc-radiopharmaceuticals, as well as to assess doses calibrator reliability for routine purposes in hospital radiopharmacies. RCP was determined by different systems and radioactivity was quantified by TLC-scanner, doses calibrator and gamma-counter. Suitable and optimized systems were presented for RCP analyses. No significant differences were observed between radioactivity counting devices and, thus, doses calibrator showed reliability for RCP determination in hospital radiopharmacies.
Assuntos
Radioquímica/métodos , Compostos Radiofarmacêuticos/normas , Cromatografia/métodos , Dosímetros de RadiaçãoRESUMO
Radiopharmaceuticals are compounds that have a radionuclide and may be gamma-radiation emitter (γ) or positrons emitter (β+), linked to a molecule with specific diagnostic and therapeutic purposes. The progress in the use of radiopharmaceuticals has culminated to a sector in common with other types of drugs: regulation and surveillance. From 2006 on, production, marketing and use of these drugs were open to the Brazilian market granting much more freedom due to the Constitutional Amendment 49, resulting from the previous Constitutional Amendment 199/03 which removes the Union monopoly for this kind of manipulation and granted this production to other nuclear medicine. From this date on, the amount of this type of sold product have been greatly increased, and the nucleus of surveillance and regulation in Brazil have also advanced in the legislative processes, creating documents that are now more focused on radiopharmaceuticals in the national territory (Resolutions No. 63 and No. 64). In international overview, there is too much to be done in regulatory terms in Brazil, such as adding mainly issues of drugs surveillance to pharmacovigilance practice in radiopharmaceuticals drugs.
Radiofármacos são compostos que possuem um radionucleotídeo, podendo ser emissor de radiação gama (γ) ou emissor de pósitrons (β+), ligado a uma molécula específica com finalidade diagnóstica e terapêutica. O avanço no uso dos radiofármacos tem culminado a um setor em comum com outros tipos de medicamentos: a regulamentação e fiscalização. Após 2006, a produção, a comercialização e a utilização destes medicamentos foram abertas ao mercado interno brasileiro com maior liberdade, pois a Emenda Constitucional 49, vinda da Emenda Constitucional 199/03, que retira da União o monopólio deste tipo de manipulação, ofereceu a outros centros de medicina nuclear a oportunidade desta produção. A partir desta data, a quantidade comercializada deste tipo de medicamento aumentou absurdamente e os núcleos de vigilância e regulamentação do Brasil avançaram também nos processos legislativos, criando os documentos mais voltados a Radiofármacos existentes no território nacional, as Resoluções n° 63 e n° 64. Em visão internacional, há muito ainda a ser feito em termos regulatórios no Brasil somando principalmente os assuntos vigilantes dos medicamentos como a prática de Farmacovigilância em Radiofármacos.
Assuntos
Precauções Universais/classificação , Compostos Radiofarmacêuticos/classificação , Compostos Radiofarmacêuticos/normas , Elementos de Resposta , FarmacovigilânciaRESUMO
The national traceability chain for (131)I activity measurements performed in nuclear medicine in Cuba is described. At the highest (primary) level, liquid scintillation counting employing the CIEMAT/NIST method is used; at the secondary level, a secondary standard radionuclide calibrator is utilized that allows for a quick and simple transference of the measurement unit to the tertiary level of end-users' instruments. The equivalence of Cuban standards and the assessment of measurement uncertainties at the end-user level are determined through the results of measurement comparisons.
Assuntos
Radioisótopos do Iodo/análise , Radioisótopos do Iodo/normas , Medicina Nuclear/normas , Radiometria/normas , Compostos Radiofarmacêuticos/análise , Compostos Radiofarmacêuticos/normas , Cuba , Padrões de Referência , Valores de ReferênciaRESUMO
OBJETIVO: Determinar os fatores de correção para a variação volumétrica dos radiofármacos contidos em recipientes de diferentes geometrias. Comparar a influência desses fatores na determinação da atividade de 99mTc e 123I utilizando dois tipos de calibradores: um com câmara de ionização e outro com detector Geiger-Müller (G-M). Avaliar o desempenho de calibradores de alguns serviços de medicina nuclear em medição de atividade de 99mTc e 123I. MATERIAIS E MÉTODOS: Foram utilizados oito calibradores, frascos de vidro 10R, seringas de plástico de 3 e 5 mL e soluções de 99mTc e 123I. Os fatores de correção foram determinados a partir das medições práticas da variação da leitura do calibrador com a variação do volume da solução no recipiente. O desempenho foi avaliado em relação ao critério de aceitação de ±10% de exatidão exigida pela norma brasileira. RESULTADOS: A variação da resposta do calibrador com a variação do volume do frasco foi bem maior no calibrador que utiliza G-M. Ela também foi maior para 123I do que para 99mTc. CONCLUSÃO: Os resultados confirmam que a resposta dos calibradores depende do volume contido nos recipientes. Essa dependência é mais crítica para os calibradores equipados com detector G-M e para 123I quando comparado com 99mTc.
OBJECTIVE: To determine correction factors for the variation in volume of radiopharmaceuticals in containers of different geometries, comparing the influence of such factors on the determination of 99mTc and 123I activity with two types of calibrators - one with ionization chamber and another with Geiger-Müller (G-M) detector -; and to evaluate calibrators performance in the measurement of 99mTc and 123I activities. MATERIALS AND METHODS: Eight calibrators, 10R glass vials, 3 and 5 mL plastic syringes and 99mTc and 123I solutions were utilized. The correction factors were determined with basis on practical measurements of the variation in the calibrators' response according to the volume of radionuclide solution in the glass vials. The performance was evaluated according to the acceptance criterion of ±10% accuracy required by the Brazilian standard. RESULTS: The variation of the calibrators' response according to the variation in radionuclide volume was reasonably greater in the calibrator with G-M detector. It was also greater for 123I than for 99mTc. CONCLUSION: The results confirm that the calibrators' response depends on the radionuclide volume contained in the vials. Such dependence is more critical for the calibrators equipped with G-M detector and for 123I as compared with 99mTc.
Assuntos
Compostos Radiofarmacêuticos/normas , Iofetamina , Medicina Nuclear , Radioisótopos , Radioisótopos/normas , Tecnécio , Embalagem de MedicamentosRESUMO
Radiopharmaceuticals play an important role in modern nuclear medicine, and 18F-FDG (2-[18F] fluoro-2-deoxy-D-glucose) is the most frequently used in imaging examinations today. The pyrogen test represents an important parameter for the quality of radiopharmaceuticals since most of them, 18F-FDG included, are injectable solutions. However, the standard test proposed by the U.S. Pharmacopeia using limulus amebocyte lysates takes too long (about 1 h). An alternative test is the Portable Test System, which takes no more than 15 min. In order to compare both tests, 10 batches of 18F-FDG produced in the Nuclear Engineering Institute, Rio de Janeiro, Brazil, were analyzed. The results showed that in 40% of the samples analyzed, different results were found. From the total analyzed, 20% showed totally diverging results, and 80% demonstrated partial similarity. These differences have a great impact in the choice of the test used for radiopharmaceutical injectable solutions and the importance of validation tests before the implementation in the daily routine.
Assuntos
Fluordesoxiglucose F18/normas , Teste do Limulus , Farmacopeias como Assunto , Pirogênios/análise , Compostos Radiofarmacêuticos/normasRESUMO
The procedure followed by the Nuclear Metrology Laboratory (LMN), at the Nuclear and Energy Research Institute (IPEN), for the primary standardization of (177)Lu is described. This radionuclide is widely used in radiopharmacy due to its convenient half-life and emitted beta ray energies. The (177)Lu solution was supplied during an international comparison sponsored by BIPM in 2009 and the primary standardization has been accomplished by the 4pibeta-gamma coincidence method using a proportional counter in 4pi geometry coupled with two NaI(Tl) scintillation counters. The beta efficiency was varied by placing Collodion and aluminum absorbers over and under the radioactive source. The (177)Lu calibrated sources were also measured in a previously calibrated HPGe spectrometer, in order to obtain the emission probability per decay for the selected gamma-ray transitions. The experimental extrapolation curves were also compared with Monte Carlo simulations by means of code ESQUEMA developed at the LMN.
Assuntos
Raios gama , Lutécio/análise , Lutécio/normas , Métodos , Probabilidade , Compostos Radiofarmacêuticos/normas , Padrões de ReferênciaRESUMO
O aumento do uso de radiofármacos PET (Pósitron Emission Tomography) vem chamando a atenção dos profissionais da área de Medicina Nuclear e Farmácia, assim como das agências reguladoras. O objetivo é prover parâmetros estruturais e legais mínimos como uma referência nacional em radiofarmácia, que possam auxiliar as agências regulatórias, focando principalmente no projeto fabril.
The increasing use of radiopharmaceuticals for PET (Positron Emission Tomography) has come to the attention of nuclear medicine staff and regulatory bodies. The aim of this study is to provide a national reference in radiopharmacy that could help all nuclear medicine staff and specially the Brazilian's regulatory bodies focused on the industrial project.
Assuntos
Compostos Radiofarmacêuticos/normas , Legislação de Medicamentos , Brasil , Boas Práticas de FabricaçãoRESUMO
The traceability of activity measurements performed during the development phase of the radiopharmaceutical and in its clinical application is essential for establishing the comparability of clinical results reported in the nuclear medicine field. This paper presents and discusses the evaluation over time of the quality of activity measurement results obtained in Cuban nuclear medicine, on the basis of statistical samples taken during the radionuclide calibrator comparison program. An attempt is also made to evaluate the role played by such comparisons in quality measurement improvement in nuclear medicine, on the basis of results obtained in a number of countries and published by several authors over a period of time. Specifically, improvements of the measurement performance over time assessed by such exercises were found dissimilar in magnitudes for different countries. Two phases could be distinguished in the improvement process over time. Firstly, a fast improvement can be obtained resulting from the improvement in measurement accuracy of devices. After that, the achievement of new and sustained improvements goes slowly and requires an application of quality assurance programs where the qualification upgrading of personnel become an essential point.