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References 1. Revuz J, Valeyrie-Allanore L. Drug Reactions. In: Bolognia J, Jorizzo J, Rapini RP, editors. Dermatology. London: Mosby- Elsevier; 2008. 2. Bachot N, Roujeau JC. Diff erential diagnosis of severe cutaneous drug eruptions. Am J Clin Dermatol 2003;4(8):561-72. 3. Shear NH, Knowles SR, Shapiro L. Cutaneous reactions to drugs. In: Fitzpatrick’s dermatology in general medicine. New York: McGraw-Hill; 2003. p. 355-62. 4. Mockenhaupt M. Epidemiology of cutaneous adverse drug reactions. Chem Immunol Allergy 2012;97:1-17. 5. Fiszenson-Albala F, Auzerif V


Methotrexate (MTX) is a cytostatic agent used in oncology. Because of its immunosuppressive properties, MTX is also used in autoimmune disorders. Low-dose MTX regimens in the treatment of rheumatoid arthritis and severe psoriasis are considered to be safe. However, pharmacovigilance centers warn of serious and even fatal incidents due to errors in oral MTX administration. The aim of this case series presentation was to identify the specific factors related to the development of adverse drug reactions (ADRs) induced by MTX. A prospective pharmacovigilance study was conducted at the Clinic of Dermatology, University Hospital, Stara Zagora. We report 3 cases of patients with psoriasis vulgaris in which severe haematological abnormalities associated with previous administration of MTX were detected during hospitalization. A 73-year old female with malaise, vomiting and oral ulcers who had taken approximately 120 mg MTX was found to have pancytopenia. A 59-year old male hospitalized for psoriatic erythroderma who had erroneously taken 10 mg MTX daily instead of weekly for 8 days, was diagnosed with bicytopenia and toxic hepatitis. An 88-year old male with psoriatic arthritis presented with aphthous stomatitis, erosive crusted lesions, ecchymoses and aplastic anemia 2 weeks after treatment with 12.5 mg MTX once weekly plus i.m. Movalis®, followed by Diclophenac Duo®. The main predisposing factors for the development of these ADRs were patient-related dosage errors and concomitant administration of NSAIDs. Safe use of oral MTX requires clear dosing instructions and strict patient compliance. Potential drug interactions of MTX with other drugs should also be considered.

REFERENCES 1. Härmark L, van Hunsel F, Grundmark B. ADR reporting by the general public: lessons learnt from the Dutch and Swedish systems. Drug Saf 2015;38(4):337-47. 2. Rolfes L, van Hunsel F. The impact of experiencing adverse drug reactions on the patient’s quality of life: a retrospective cross-sectional study in the Netherlands. Drug Saf 2016;39(8):769-76. 3. Lopez-Gonzalez E, Herdeiro MT, Figueiras A. Determinants of under-reporting of adverse drug reactions: a systematic review. Drug Saf 2009;32(1):19-31. 4. Stoynova V, Getov I, Naseva E, et al

References Bates DW, Spell N, Cullen DJ. (1997). The costs of adverse drug reactions in hospitalised patients. JAMA 277 : 301-307. Bergman US. Wilholm BF. (1981). Drug related problems causing admission to a medical clinic. Eur J Clin Pharmacol 20 : 193-200. Bremnan T, Leape L, Iared N. (1991). Incidence of adverse events and negligence in hospitalised patients. New Eng J Med 324 : 370-376. Caranasos GJ, Stewart RB, Cluff LE. (1974). Drug induced illness leading to hospitalization. JAMA 228 : 713-717. Coelo HL, Arrais PS.D, Parente AP, Brizeno MOB. (2002

. Gaceta Sanitaria, 2014, 1-2, s. 48-54. 3. Gautier S., Bachelet H., Bordet R., Caron J.: The cost of adverse drug reactions. Expert Opin. Pharmacother. 2003, 4, 3, s. 319-326. 4. Pattanaik S., Dhamija P., Malhotra S., Sharma N., Pandhi P.: Evaluation of cost of treatment of drug-related events in a tertiary care public sector hospital in Northen India: a prospective study. British Journal of Clinical Pharmacology. 2009, 67, 3, s. 363-369. 5. Pliki parametryzujące. online:, Access: 2014.01.06. 6. Rozporządzenie Ministra Zdrowia z 2

References 1. Bates D.W. et al.: The cost of adverse drug events in hospitalized patients. JAMA, 277, 4, 1997. 2. Borovicka J.H. et al.: Economic burden of dermatologic adverse events induced by molecularly targeted cancer agents. Arch Dermatol., 147, 12, 2011. doi: 10.1001/archdermatol.2011.719. 3. Classen D.C. et al: Adverse drug events in hospitalized patients. Excess length of stay, extra costs, and attributable mortality. JAMA, 277, 4, 1997. 4. Dubey A.K. et al.: Dermatological adverse drug reactions due to systemic medications. A review of literature

2006; 7: 223-45. 8. Simon T, Verstuyft C, Mary-Krause M, Quteineh L, Drouet E, Meneveau N, Steg PG, Ferrieres J, Danchin N, Becquemont L. Genetic determinants of response to clopidogrel and cardiovascular events. N Engl J Med 2009; 360: 363-75. 9. Mega JL, Close SL, Wiviott SD, Shen L, Hockett RD, Brandt JT, Walker JR, Antman EM, Macias W, Braunwald E, Sabatine MS. Cytochrome p-450 polymorphisms and response to clopidogrel. N Engl J Med 2009; 360: 354-62. 10. Kongkaew C, Noyce PR, Ashcroft DM. Hospital Admis - sions Associated with Adverse Drug Reactions: A Syste


Herein synchronous occurrence of Hodgkin lymphoma and secondary myelodysplastic syndrome in a 60 year old male patient with small cell lung cancer treated with combined chemotherapy (carboplatin and paclitaxel) and radiotherapy is presented. The objective of this report is to stress the importance of documenting and monitoring adverse drug reactions that arise from chemotherapy.

After four years of treatment with the combined chemotherapy, the patient presented inguinal lymphadenopathy and enlarged lymph nodes and histopathology rapport was suggestive for plasmacytoid variant of Castleman disease. Three years later, biopsy of lymph node was performed and diagnosis of Hodgkin lymphoma – mixed cellularity has been established. Molecular analyses revealed presence of dominant monoclonal population of the immunoglobulin genes in the oligo/monoclonal background. Bone marrow biopsy findings suggested secondary myelodysplasia and revealed signs of hematopoietic cells dismaturation with signs of megaloblastic maturation of the erytropoetic lineage, appearance of ALIP (abnormal localization of immature precursors) in the myeloid lineage and dysplastic megakaryocytes. In addition, an increased level of polyclonal plasmacytes (lambda vs kappa was 60%:40%) was found.

Hodgkin lymphoma and MDS occurring after 4 years of carboplatin/paclitaxel therapy might be contributed to the accumulation of alkylator-related DNA damage. This emphasize the need of outlining a monitoring plan regarding development of secondary leukemia and other malignant hematological proliferations should be outlined in the protocols.


Background: Multiple sclerosis (MS) treatment aims not only to prevent the rate of relapse, but also to slow down patient’s disability progression. Monoclonal antibodies constitute a new class of therapeutic agents and are administered by intravenous (IV) infusion. Treatment satisfaction and incidence of adverse drug events influence the patient’s treatment adherence which is essential to ensure patients obtain the best treatment outcomes and also to make that treatment cost-effective. Our primary objective was to assess the current IV treatment satisfaction among MS patients.

Methods: A standard questionnaire was developed which contained 20 questions about patient’s disease, IV treatment satisfaction and drug safety awareness. Analyzed data was presented as a percent of the respondents.

Results: The cross-sectional study included 13 MS patients on IV treatment, with mean age of 35 years. 54% of them had relapse-remitting MS, while 46% had secondary progressive MS. The most common onset symptoms were tingling reported in 46% and numbness in 31% patients. 70% of patients were satisfied, while 23% were not satisfied with the conditions under which they were receiving their IV treatment that lasts in average 2 hours. Well-established pharmacovigilance practice enhanced the patient’s knowledge that was reflected through 100% reporting of adverse drug reactions in the past.

Conclusion: High level of satisfaction from the current IV treatment conditions and high drug safety awareness among MS patients was shown. Establishment of infusion centre as a proposed strategy by MS patients would substantially increase their IV treatment satisfaction and adherence.


Interindividual variability in drug metabolism is an important cause of adverse drug reactions and variability in drug efficiency. Polymorphisms of cytochrome P450 (CYPs) genes have a significant effect on drug metabolism and toxicity. This review brings an update about how genetic polymorphisms of CYP2C8 and CYP2C9 enzymes affect the disposition and clinical outcomes of ibuprofen and diclofenac, two of the most common pain relievers. The most common side effects associated with the influence of CYP2C8*3 and CYP2C9*2*3 variants on ibuprofen and diclofenac pharmacokinetics are hepatotoxicity and gastrointestinal bleeding. CYP genotyping may therefore identify patients at increased risk of these adverse reactions, and these patients could have their doses adjusted or start receiving another NSAID that does not share the same metabolic pathways with ibuprofen or diclofenac. However, before genotyping is introduced into regular clinical practice, more research is needed to evaluate the effectiveness of this strategy in improving treatment with ibuprofen and diclofenac.