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

2014 ◽  
Vol 50 (2) ◽  
pp. 285-290 ◽  
Author(s):  
Maryelle Moreira Lima Gamboa ◽  
Heveline Rayane Moura Roesch ◽  
Vanessa Pinheiro Amaral Lemos ◽  
Bruna Oliveira Rocha ◽  
Ralph Santos-Oliveira

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.

2018 ◽  
Vol 21 (1) ◽  
pp. 51-56
Author(s):  
Mahdiyeh Mirnam Niha ◽  
Mehdi Salehi Barough

Background and aims: Gamma radiation is widely being used in medical-imaging centers. The aim of this study was to measure possible alterations in serum zinc and selenium levels among nuclear medicine staff. Methods: This cross-sectional study was carried out on 30 nuclear medicine staff as well as on 10 individuals as the control group. Blood samples (20 mL) were obtained from the participants and the serum specimens were isolated by centrifugation at 4000 rpm for 7 minutes. The samples were then used for measurement of zinc and selenium levels. Zinc and selenium levels were measured using atomic absorption spectroscopy (AAS) with a graphite furnace. The mean serum levels of zinc and selenium were compared using SPSS. Results: The mean level of zinc in the radiated group (70.91±14.46 μmol/L) was significantly lower than that in the control group (89.75±17.35 μmol/L) (P=0.002). A negative significant correlation was found between the duration of exposure to radiation and zinc levels (P=0.005). Furthermore, a negative significant relationship was observed between the mean radiation dose after 5 years and zinc concentration (P=0.019). Non-significant difference was found in the mean level of selenium between control (1.71±0.35 μmol/L) and radiation (2.13±1.12 μmol/L) groups. Furthermore, no significant correlation was found between selenium level and exposure time. Conclusion: Based on the results, declined level of zinc can be considered as one of the possible mechanisms caused by gamma radiation on cells which may be associated with oxidative damage. Therefore, zinc therapy can be helpful for those who work at medical radiation centers; however, it merits further studies.


2020 ◽  
Vol 78 ◽  
pp. 48-57 ◽  
Author(s):  
Nadin Jamal AbuAlRoos ◽  
Mira Natasha Azman ◽  
Noorfatin Aida Baharul Amin ◽  
Rafidah Zainon

1982 ◽  
Vol 29 (1) ◽  
pp. 457-460 ◽  
Author(s):  
A. Levi ◽  
M. Roth ◽  
M. Schieber ◽  
S. Lavy ◽  
G. Cooper

Author(s):  
K. Cowden ◽  
B. Giammara ◽  
T. Devine ◽  
J. Hanker

Plaster of Paris (calcium sulfate hemihydrate, CaSO4. ½ H2O) has been used as a biomedical implant material since 1892. One of the primary limiting factors of these implants is their mechanical properties. These materials have low compressive and tensile strengths when compared to normal bone. These are important limiting factors where large biomechanical forces exist. Previous work has suggested that sterilization techniques could affect the implant’s strength. A study of plaster of Paris implant mechanical and physical properties to find optimum sterilization techniques therefore, could lead to a significant increase in their application and promise for future use as hard tissue prosthetic materials.USG Medical Grade Calcium Sulfate Hemihydrate Types A, A-1 and B, were sterilized by dry heat and by gamma radiation. Types A and B were additionally sterilized with and without the setting agent potassium sulfate (K2SO4). The plaster mixtures were then moistened with a minimum amount of water and formed into disks (.339 in. diameter x .053 in. deep) in polyethylene molds with a microspatula. After drying, the disks were fractured with a Stokes Hardness Tester. The compressive strengths of the disks were obtained directly from the hardness tester. Values for the maximum tensile strengths σo were then calculated: where (P = applied compression, D = disk diameter, and t = disk thickness). Plaster disks (types A and B) that contained no setting agent showed a significant loss in strength with either dry heat or gamma radiation sterilization. Those that contained potassium sulfate (K2SO4) did not show a significant loss in strength with either sterilization technique. In all comparisons (with and without K2SO4 and with either dry heat or gamma radiation sterilization) the type B plaster had higher compressive and tensile strengths than that of the type A plaster. The type A-1 plaster however, which is specially modified for accelerated setting, was comparable to that of type B with K2SO4 in both compressive and tensile strength (Table 1).


1990 ◽  
Vol 137 (3) ◽  
pp. 163 ◽  
Author(s):  
V.A. Oliveira ◽  
J.M. Nightingale

1999 ◽  
Vol 96 (1) ◽  
pp. 143-146 ◽  
Author(s):  
J.-P. Pouget ◽  
J.-L. Ravanat ◽  
T. Douki ◽  
M.-J. Richard ◽  
J. Cadet

2020 ◽  
Vol 59 (04) ◽  
pp. 294-299 ◽  
Author(s):  
Lutz S. Freudenberg ◽  
Ulf Dittmer ◽  
Ken Herrmann

Abstract Introduction Preparations of health systems to accommodate large number of severely ill COVID-19 patients in March/April 2020 has a significant impact on nuclear medicine departments. Materials and Methods A web-based questionnaire was designed to differentiate the impact of the pandemic on inpatient and outpatient nuclear medicine operations and on public versus private health systems, respectively. Questions were addressing the following issues: impact on nuclear medicine diagnostics and therapy, use of recommendations, personal protective equipment, and organizational adaptations. The survey was available for 6 days and closed on April 20, 2020. Results 113 complete responses were recorded. Nearly all participants (97 %) report a decline of nuclear medicine diagnostic procedures. The mean reduction in the last three weeks for PET/CT, scintigraphies of bone, myocardium, lung thyroid, sentinel lymph-node are –14.4 %, –47.2 %, –47.5 %, –40.7 %, –58.4 %, and –25.2 % respectively. Furthermore, 76 % of the participants report a reduction in therapies especially for benign thyroid disease (-41.8 %) and radiosynoviorthesis (–53.8 %) while tumor therapies remained mainly stable. 48 % of the participants report a shortage of personal protective equipment. Conclusions Nuclear medicine services are notably reduced 3 weeks after the SARS-CoV-2 pandemic reached Germany, Austria and Switzerland on a large scale. We must be aware that the current crisis will also have a significant economic impact on the healthcare system. As the survey cannot adapt to daily dynamic changes in priorities, it serves as a first snapshot requiring follow-up studies and comparisons with other countries and regions.


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