Obligations, precautions and pending issues in regulatory development for radiopharmaceuticals in Brazil

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.

Side-by-side comparison of areas with and without cellulite depressions using magnetic resonance imaging.

BACKGROUND: Cellulite is characterized by alterations in the relief of the skin surface. Magnetic resonance imaging (MRI) is recognized as a reliable technique for measuring adipose volume according to body site and for the visualization of the subcutaneous structures. OBJECTIVE: To compare subcutaneous tissue in areas with and without cellulite on the buttocks of same subjects using a noninvasive technique. METHODS AND MATERIALS: Thirty female patients with cellulite on the buttocks underwent MRI. An area with cellulite and another without cellulite on the contralateral buttock were selected. Two soft gelatin capsules of different sizes were used as skin markers to differentiate the areas with and without cellulite. RESULTS: Fibrous septa were visualized in 96.7% of the area with cellulite depressions; most of them were ramified (73.3%) and presented a high-intensity signal on T2 images (70%). All fibrous septa found in the examined areas were perpendicular to the skin surface. The average fibrous septa thickness was 2.18 +/- 0.89 in the area with cellulite and 0.27 +/- 0.64 in the area without cellulite. CONCLUSION: Results of the MRI analysis showed that cellulite depressions on the buttocks were significantly associated with the presence of underlying fibrous septa.