INTRODUCTION

Radiopharmacy is scientifically recognised as an essential sub-speciality of nuclear medicine. Without radiopharmaceuticals, the “food” of nuclear medicine, no radiodiagnostic or radiotherapeutic procedures could be performed, and without progress in radiopharmacy medical speciality, like nuclear medicine, will, ultimately, wither and die. Radiopharmaceuticals serve two complementary roles. The first is a pragmatic one in which the labeled compound is administered to the patient and some aberrant physiological or biochemical process leads to an abnormal distribution of the compound. In the second role the radiopharmaceutical is a tracer for particular physiological or biochemical process and the time course of its distribution is used to quantitate the biological process. Since the introduction of radionuclides, latter called radiopharmaceuticals, in the medicine practice, a great number of diseases have been treated using this kind of drug. The most commun applications of radiopharmaceuticals are in the nuclear medicine and oncology, but now cardiology and neurology are using radiopharmaceuticals too. They may be used for a variety of applications from cancer to heart and infectious diseases.
Since the introduction of radionuclides, latter called radiopharmaceuticals in the medicine practice, a great number of diseases have been treated using this kind of drug. The most commun applications of radiopharmaceuticals are in the nuclear medicine and oncology, but now cardiology and neurology are using radiopharmaceuticals too.

PRODUCTION & QUALITY CONTROL

The production of radiopharmaceuticals has some peculiarities and involves two basic aspects: radiological protection and the work in asepsis conditions. The handling of radiopharmaceuticals is potentially hazardous. The level of risk depends in particular upon the types of radiation emitted and the half-lives of the radioactive isotopes. Special attention must be paid to the prevention of cross-contamination, to the retention of radionuclide contminants, and to waste disposal. The radiopharmaceuticals as a injectable drug must fulfill with all the barren medicine conditions, for in such a way, the production environment and quality control must be classified, that is made using laminar flow and filters HEPA, beyond procedures of adequate cleanness and sterilization for sterile products. The working zone where products or containers may be exposed should comply with appropriate environmental requirements as described above. It is recommended that a prospective program of radiochemical testing on products should be undertaken as part of a planned regular activity of quality assurance. The personnel involved in release of the prepared radiopharmaceuticals should be appropriately trained in quality systems and regulatory requirements specific to this type of product.The synthesis of a radiopharmaceutical is the principal step off all the process, since it is the limitant one. However the subsequent steps like quality control and quality assurance are very important too. For diagnostic procedures, the quality of the radiopharmaceuticals is very important and is a result of a variety of procedures and guidelines related specif to GMP procedures.

LEGISLATIVE ASPECTS: REGULATIONS

Amendment 49, 8^th february 2006, excludes from the monopoly of the Brazilian Goverment the production, the commercialization and the use of short half-life radiopharmaceuticals for medical, agricultural and industrial uses . The most recent modification of the Brazilian Constitution was gave for the alteration of the writing in the “alínea b”, addition of a “alínea c” to the interpolated proposition XXIII of the caput of article 21 and for the new writing given to interpolated proposition V of the caput of article 177.

PROSPECTIVE

The Brazilian Regional Centre of Nuclear Sciences of Northeast (Centro Regional de Ciências Nucleares do Nordeste/ Comissão Nacional de Energia Nuclear) (CRCN/CNEN) started the implementation of his first “Research and Radiopharmaceuticals Production Unit” (RRPU) in 2006. A new centre created to produce, validate and develop FDG-18 and new radiopharmaceuticals using F-18 as tracer. As the most modern centre in production of radiopharmaceuticals in Brazil the RRPU intends to produce others radiopharmaceuticals than FDG-18, like fluorodopa, fluorothymidine. The syntheses of different (18)F-labeled radiopharmaceuticals using the highly effective synthesis route associated with quality controls tests and quality assurance system for the development of (18)F-radiopharmaceuticals for oncological and neurological positron emission tomography (PET) is the goal of this project. Besides, the another goal of the this unit is evaluate the new radiopharmaceutical produced and than start to produce in a industrial scale, suppling the regional marketing with the new radipharmaceutical and in this way help the growth of the Nuclear Medicine in Brazil.

The PET with FDG has its principal clinical indications in the field of oncology, neurology and cardiology, specially the former.

By way of indication and with general nature, the generic clinical circumstances in which the PET is deemed useful are detailed below:

ONCOLOGY

• Differential diagnostics of benign and malign lesions

• Study of the extension of the disease (staging)

• Study of patients with biochemistry evidence of recurrence of the tumor (increased tumor marker levels) but that fail to show clinical or morphological evidence of the disease through other diagnostic imaging techniques.

• Differential diagnostics between recurrent or residual malign disease versus changes induced by the treatment.

• Study of patients with metastasis of unknown primary tumor.

• Diagnostics of the malignancy level of the tumors.

• Determination of the most aggressive part of the tumor for planning the biopsy.

• Monitoring of the tumor response to chemotherapy or radiotherapy.

• Planning of the therapeutic or palliative radiotherapy

CARDIOLOGY

• Detection of viable myocardic tissue in patients with coronary cardiopathy and left ventricular insufficiency

• Diagnostics of coronary disease where other investigations are equivocal

NEUROLOGY

• Epilepsy: Detection and localization of the epileptogenic focus.

• Differential diagnosis between recidivation or residual disease versus radionecrosis in treated brain tumors.

• Diagnosis of dementia: early diagnosis of the Alzheimer’s and differential diagnosis of other forms of dementia such as vascular dementia, Parkinson’s disease, Huntingdon’s, etc.