Ευθύνη του παραγωγού ελαττωματικού φαρμάκου

Η παρούσα εργασία πραγματεύεται το ζήτημα της αστικής ευθύνης από την παραγωγή ελαττωματικών φαρμακευτικών προϊόντων. Για την επίτευξη του αναγκαίου επιπέδου ασφάλειας και θεραπευτικής αποδοτικότητας του φαρμάκου, θεσπίζονται αυξημένες υποχρεώσεις στο πρόσωπο του κατόχου της άδειας κυκλοφορίας του, ο οποίος, στο πλαίσιο των θεμάτων που άπτονται της παρούσας μελέτης, ταυτίζεται με την έννοια του «παραγωγού». Οι υποχρεώσεις αυτές στοχεύουν στην αποφυγή κυκλοφορίας στην αγορά ελαττωματικών φαρμάκων και στη διασφάλιση της δημόσιας υγείας. Για το λόγο αυτό, η παρούσα εργασία εστιάζει στον προσδιορισμό της έννοιας του ελαττωματικού φαρμάκου από τη σκοπιά των υποχρεώσεων του κατόχου της άδειας κυκλοφορίας του, αναδεικνύοντας το ζήτημα πως η ελαττωματικότητα, κατά την συντριπτική της πλειοψηφία είναι άρρηκτα συνδεδεμένη με την ελλιπή ενημέρωση και όχι την ελλιπή κατασκευή. Εισάγονται οι έννοιες του Φύλλου Οδηγιών Χρήσεως και της Περίληψης Χαρακτηριστικών του Προϊόντος, το περιεχόμενο των οποίων τυγχάνει καίριας σημασίας. Επιπλέον, η παρακολούθηση του προϊόντος μετά τη θέση του στην κυκλοφορία αποτελεί αδήριτη ανάγκη, προκειμένου να διαπιστώνεται η διαρκής αξιολόγηση της σχέσης κινδύνου/οφέλους. Αναπόφευκτα όμως, όλα τα φάρμακα μπορούν να προκαλέσουν ανεπιθύμητες ενέργειες. Το ζήτημα αυτό έρχεται να καλύψει η φαρμακοεπαγρύπνηση, που αποτελεί ένα σύστημα ελέγχου της ασφάλειας των φαρμάκων με απώτερο στόχο τη μείωση των ανεπιθύμητων ενεργειών και την αντίστοιχη αύξηση των ωφελειών για τους ασθενείς. Στην παρούσα μελέτη, πέραν της εξέτασης των ανωτέρω ζητημάτων, θα επιχειρηθεί επιπλέον ο προσδιορισμός της αστικής ευθύνης του υπεύθυνου κυκλοφορίας ενός ελαττωματικού φαρμακευτικού προϊόντος υπό το πρίσμα των διατάξεων του ΑΚ και της ειδικής νομοθεσίας για την προστασία του καταναλωτή.This paper addresses the issue of producer's liability for the production of defective medicinal products

Razarajuće epidemije grčke populacije u novije doba

In the recent Greek ages the most devastating epidemics were plague, smallpox, leprosy and cholera. In 1816 plague struck the Ionian and Aegean Islands, mainland Greece, Constantinople and Smyrna. The Venetians ruling the Ionian Islands effectively combated plague in contrast to the Ottomans ruling all other regions. In 1922, plague appeared in Patras refugees who were expelled by the Turks from Smyrna and Asia Minor. Inoculation against smallpox was first performed in Thessaly by the Greek women, and the Greek doctors Emmanouel Timonis (1713, Oxford) and Jakovos Pylarinos (1715, Venice) made relevant scientific publications. The first leper colony opened in Chios Island. In Crete, Spinalonga was transformed into a leper island, which following the Independence War against Turkish occupation and the unification of Crete with Greece in 1913, was classified as an International Leper Hospital. Cholera struck Greece in 1853-1854 brought by the French troops during the Crimean War, and again during the Balkan Wars (1912-13) when the Bulgarian troops brought cholera to northern Greece. Due to successive wars, medical assistance was not always available, so desperate people turned many times to religion through processions in honor of local saints, for their salvation in epidemics.Posljednjih su stoljeća razarajuće za Grke bile epidemije kuge, boginja, gube i kolere. Godine 1816. kuga je pogodila otoke u Jonskom i Egejskom moru, kopnenu Grčku, Konstantinopol i Smirnu. Mlečani koji su vladali Jonskim otocima uspješno su se borili protiv kuge, za razliku od Osmanlija koji su upravljali ostalim regijama. Godine 1922. kuga se pojavila kod prognanika iz Patra, koje su Turci protjerali iz Smirne i Male Azije. Cijepljenje protiv malih boginja najprije je provedeno u Tesali i izvodile su ga grčke žene, a grčki liječnici Emmanouel Timonis (1713., Oxford) i Jakovos Pylarinos (1715., Venecija) napisali su relevantne znanstvene publikacije. Prva kolonija gubavaca otvorena je na otoku Chiosu. Na Kreti je Spinalonga pretvorena u otok gubavaca koji je nakon rata za nezavisnost protiv turske okupacije i ujedinjenja Krete s Grčkom 1913. bio klasificiran kao Međunarodna bolnica za gubavce. Kolera je pogodila Grčku 1853. – 1854., a donijeli su je francuski vojnici tijekom Krimskog rata i opet tijekom balkanskih ratova (1912. – 1913.) kada su bugarske postrojbe donijele koleru u sjevernu Grčku. Zbog uzastopnih ratova medicinska pomoć nije bila uvijek dostupna, tako da su se očajni ljudi više puta okretali religiji procesijama u čast lokalnih svetaca, za svoj spas u vrijeme epidemija

Abscess formation mimicking disease progression, in a patient with metastatic renal cell carcinoma during sunitinib treatment

<p>Abstract</p> <p>Background</p> <p>Renal cell carcinoma (RCC) represents approximately 3% of all adult cancers and is more common in males. Systemic treatment for RCC has improved following the introduction of tyrosine kinase inhibitors, such as sunitinib. The molecular targets of sunitinib are receptor tyrosine kinases (RTKs). Moreover, sunitinib has an additional anti-angiogenic effect through its inhibition of the vascular endothelial growth factor receptor activation.</p> <p>Case presentation</p> <p>We present a case of intra-abdominal abscess formation mimicking disease progression, in a patient with metastatic renal cell carcinoma during sunitinib treatment.</p> <p>Conclusion</p> <p>In the advancing era of molecular therapy of solid tumours, sunitinib has demonstrated significant efficacy in the post-cytokine setting treatment of metastatic renal cancer. Concurrently, however, increasing evidence has emerged to indicate that this class of drugs exert profound immunomodulatory effects on T cells and play major roles in immune tumor surveillance.</p

Chromophobe renal cell carcinoma with prolonged response to targeted therapy: a case report

Abstract Introduction Chromophobe renal cell carcinoma is universally accepted as a distinct subtype of renal cell carcinoma. There are conflicting reports on prognosis, and few data on response to treatment exist. Currently, we do not have any effective treatment for the metastatic disease apart from surgical procedures. Current strategies are based on results obtained in the context of clear cell-type renal cell carcinoma. Separate trials for rare histologies seem unfeasible and are unlikely to be performed. For these cases, clinical observations are an important part for advancing therapeutic insight. In recent years, novel tyrosine kinase inhibitors have been shown to have significant clinical benefit in advanced renal cell carcinoma. Case presentation We present the case of a 43-year-old Caucasian man with advanced chromophobe renal cell carcinoma treated with the tyrosine kinase inhibitor sunitinib and subsequently with sorafenib and the mammalian target of the rapamycin inhibitor everolimus, achieving a prolonged response and significant clinical benefit. We report an unexpectedly high efficacy of everolimus as a third-line treatment in a patient with metastatic chromophobe renal cell carcinoma. Conclusions Up to now, no published data from randomized clinical studies have addressed the question of efficacy of everolimus as a third-line treatment after failure of tyrosine kinase inhibitors. To the best of our knowledge, this case is the first report of chromophobe renal cell carcinoma treated successfully with sequential tyrosine kinase and mammalian target of rapamycin inhibitor therapy. Notably, the time on treatment with sunitinib exceeded four years. The case presented here implies that everolimus could be a viable option for patients with metastatic chromophobe renal cell carcinoma.</p

Achaiki Iatriki : official publication of the medical society of western Greece and Peloponnesus

In the current issue, the editorial by Cauchi et al. argues for eco-friendly measures in endoscopy and emphasies the role of healthcare providers in reducing waste. The editorial adeptly employs the three Rs (Reduce, Reuse, Recycle) framework to tackle waste management, offering practical solutions. The editorial by Milionis et al. focuses on the reverse cascade screening for paediatric familial hypercholesterolaemia (FH), which is an upcoming tool for public health. Advantages, practices, and challenges regarding FH are thoroughly discussed. Lastly, the editorial by Fousekis et al. presents the main aspects of a chronic immune-mediated cutaneous disease, dermatitis herpetiformis (DH), which constitutes an extraintestinal manifestation of celiac disease, including its diagnosis, pathogenesis, and management. Moreover, this issue includes three review articles. The review article by Krontira et al. discusses the evolving data on the epidemiology, diagnostic approach and appropriate management of foreign body and caustic substance ingestion, based on updated guidelines published by gastroenterological and endoscopic societies. The review by Halliasos et al. provides data on the clinical presentation, diagnosis, and management of metastatic acute spinal cord compression, focusing on the importance of a multidisciplinary team approach, including spine surgeons, radiation oncologists, medical oncologists, palliative care clinicians, physiotherapists, and psychologists. Lastly, the review by Schinas et al. outlines the potential of immune modulation in the treatment of infections and the need for individualised approaches in the modern world of personalised medicine by examining some of the key strategies and immune-based therapies being developed to combat infectious diseases.peer-reviewe

Successful treatment with the mTOR inhibitor everolimus in a patient with Perivascular epithelioid cell tumor

<p>Abstract</p> <p>Perivascular epithelioid cell tumor (PEComa) is an extremely rare neoplasm that appears to arise most commonly at visceral (especially gastrointestinal and uterine), retroperitoneal, and abdominopelvic sites. Malignant PEComas exist but are very rare. These tumors represent a family of mesenchymal neoplasms, mechanistically linked through activation of the mTOR signaling pathway. Metastatic PEComa is a rare form of sarcoma for which no effective therapy has been described previously and that has a uniformly fatal outcome. Although there is no known effective therapy, the molecular pathophysiology of aberrant mTOR signaling provides a scientific rationale to target this pathway therapeutically. The difficulty in determining optimal therapy, owing to the sparse literature available, led us to present this case. On this basis, we report a case of metastatic retroperitoneal PEComa treated with an oral mTOR inhibitor, with everolimus achieving significant clinical response.</p

Successful treatment with the mTOR inhibitor everolimus in a patient with Perivascular epithelioid cell tumor

Perivascular epithelioid cell tumor (PEComa) is an extremely rare neoplasm that appears to arise most commonly at visceral (especially gastrointestinal and uterine), retroperitoneal, and abdominopelvic sites. Malignant PEComas exist but are very rare. These tumors represent a family of mesenchymal neoplasms, mechanistically linked through activation of the mTOR signaling pathway. Metastatic PEComa is a rare form of sarcoma for which no effective therapy has been described previously and that has a uniformly fatal outcome. Although there is no known effective therapy, the molecular pathophysiology of aberrant mTOR signaling provides a scientific rationale to target this pathway therapeutically. The difficulty in determining optimal therapy, owing to the sparse literature available, led us to present this case. On this basis, we report a case of metastatic retroperitoneal PEComa treated with an oral mTOR inhibitor, with everolimus achieving significant clinical response

Muscle metastasis from hepatocellular carcinoma

Background: Hepatocellular carcinoma is the most common primary tumor of the liver. Disease dissemination occurs through hematogenous routes and frequently involves the lungs, bone, adrenal glands, and pancreas. The patterns of the extrahepatic manifestations are diverse. Soft tissue metastasis is extremely rare and mandates systematic pathological analysis, which may include the use of specific immunohistochemical staining. We report metastasis from a hepatocellular carcinoma, as a discrete subcutaneous mass to the right humerus muscle. Materials and Methods: We detail the approach to diagnosis and management of an unusual case of a patient with hepatocellular carcinoma, in whom we found a metastatic lesion as a subcutaneous mass to the right humerus muscle nine years after right hepatectomy. Conclusion: This condition poses differential diagnostic problems in the settings of clinical and pathological investigations. Metastasis of hepatocellular carcinoma should be included in the differential diagnosis of rapidly growing lesions