Limitations and obstacles of the spontaneous adverse drugs reactions reporting: Two "challenging" case reports.

INTRODUCTION: Nowadays, based on several epidemiological data, iatrogenic disease is an emerging public health problem, especially in industrialized countries. Adverse drugs reactions (ADRs) are extremely common and, therefore, clinically, socially, and economically worthy of attention. Spontaneous reporting system for suspected ADRs represents the cornerstone of the pharmacovigilance, because it allows rapid detection of potential alarm signals related to drugs use. However, spontaneous reporting system shows several limitations, which are mainly related to under-reporting. In this paper, we describe two particular case reports, which emphasize some reasons of under-reporting and other common criticisms of spontaneous reporting systems. MATERIALS AND METHODS: We performed a computer-aided search of Medline, PubMed, Embase, Cochrane library databases, national and international databases of suspected ADRs reports in order to identify previous published case reports and spontaneous reports about the ADRs reviewed in this paper, and to examine the role of suspected drugs in the pathogenesis of the described adverse reactions. RESULTS: First, we reported a case of tizanidine-induced hemorrhagic cystitis. In the second case report, we presented an episode of asthma exacerbation after taking bimatoprost. Through the review of these two cases, we highlighted some common criticisms of spontaneous reporting systems: under-reporting and false causality attribution. DISCUSSION AND CONCLUSION: Healthcare workers sometimes do not report ADRs because it is challenging to establish with certainty the causal relationship between drug and adverse reaction; however, according to a key principle of pharmacovigilance, it is always better to report even a suspicion to generate an alarm in the interest of protecting public health.

Darbepoetin alfa administered every three weeks (Q3W) in anemic cancer patients receiving chemotherapy (CT).

BACKGROUND: Darbepoetin alfa, has a longer halflife than epoetin alfa (rHuEPO) due to its increased sialylated carbohydrate content and can be administered less frequently. Its advantage in terms of response is not entirely clear. PATIENTS AND METHODS: From August 2005 until October 2006, 64 anemic patients (hemoglobin < or =11.5 g/dl) with advanced metastatic cancer receiving chemotherapy (CT), median age 65 years (range 33-77), median Eastern Cooperative Oncology Group (ECOG) performance status (PS) 1 (range 0-1), were treated with subcutaneous (s.c.) darbepoetin alfa 500 microg every 3 weeks (Q3W) and a single intravenous (i.v.) dose of 125 mg of elemental iron at the beginning of the treatment period followed by an oral daily iron supplement (200 mg of elementary iron). The treatment effect was evaluated as a response (Hb increase > or =1 g/dl) or a major response (Hb increase > or =2 g/dl) after 2, 4, 6 and 8 weeks. The patients were questioned about fatigue. RESULTS: After 8 weeks of treatment, a treatment response was observed in 11 out of the 29 evaluable patients (38%) with a major response in 10%. The mean Hb change was 0 g/dl, +0.9 g/dl, +0.75 g/dl and +0.7 g/dl respectively at 2, 4, 6 and 8 weeks. Blood transfusions were required in 9 patients (31%). At baseline, 39 out of the 64 patients (61%) reported grade 1 or 2 fatigue. At 8 weeks the patients with a major response did not show any evidence of fatigue. CONCLUSION: Darbepoetin alfa Q3W is moderately effective in reducing anemia in heavily pretreated and advanced stage chemotherapy treated patients.

[Health in indoor settings: old and new risks]. / Salute in ambiente confinato: fra vecchi e nuovi rischi.

Improved socio-economic and cultural conditions in industrialized countries have brought public health workers to focus greater attention to the comfort conditions of indoor settings, where people spend as much as 90% of their time. This study examines the interaction between man and the indoor environment and highlights conditions that may pose health risks in the workplace and home because of the presence of chemical, physical, and/or biological pollutants. Achieving healthy indoor air quality currently represents a challenge for international health organizations, governments and citizens alike.

[Water supply and public health]. / Approvvigionamento idrico e salute.

EU legislative framework on water for human consumption has recently been deeply modified. As from 25 December 2003, the Directive 80/778/EEC has been abrogated by the Directive 98/83/EC, transposed into the Italian legislation with the law 31/2001, which establishes as an inspiring principle the observance of laws common to all Member States while leaving them the discretion to introduce secondary parametric values. The directive provides that the parametric values should be respected until water distribution, by making the final user fall into the sphere of responsibility as a responsible of either a public commercial concern or a privately-run concern. This piece of legislation lays the foundation for an actual cultural revolution and the involvement of all the institutional, political and technical components of the territory, the aim being to safeguard a property that "belongs to future generations" and, thus, to be protected.