Ankara İlinde Reçetelenen İlaçlara Bağlı İstenmeyen Etkilerin İzlenmesi ve Farmakovijilans Konusunda Farkındalığın Artırılması

Abstract

Temiz Nemutlu N. Monitoring the Unintended Effects of Prescribed Drugs in Ankara and Improving the Awareness of Pharmacovigilance. Hacettepe University Institute of Health Sciences, Thesis of Master in Pharmaceutical Toxicology, Ankara, 2017. When the both negative effects of adverse drug reactions (ADR) on the human health and magnitude of the resources spent for treatment of the noxious effects of drugs were considered, importance of the prediction and prevention of the potential unintended effects of drugs are understood. With the awareness of pharmacovigilance, increasing the ADR reporting by patients and health professionals has great importance in terms of safe drug use. With this thesis study, it was aimed to collect data for determination of the frequency of observed ADR in Ankara province; the drug groups causing the ADRs and the most frequently affected system-organ classes. On the other hand, it was also planned to identify possible regional differences within Ankara and to improve the awareness of patients about ADR reporting was aimed. The research was carried out as a questionnaire survey conducted face to face with patients who applied to pharmacies determined by random sampling method in Çankaya, Yenimahalle and Elmadağ. A total of 428 questionnaires were completed, of which 359 were adults and 69 were children. 19.6% (n=84) of the questionnaires included one or more ADRs. There was no significant difference for frequency of ADR seen among these districts. When the ADR’s were evaluated according to the System Organ Classes, it was determined that the most frequently affected system-organ class was "Skin and Subcutaneous Tissue Diseases" (19.8% ). The most frequent ADR causing drug group was "Antiinfectives For Systemic Use” (21.1% ), among which fluoroquinolone group antibiotics were the first. When the all questionnaires were examined, it was seen 9.6% (n=41) of the ADR’s were reported to a pharmacist or a doctor and 7.7% (n=33) of ADR’s were classified as serious. The rate of "yes" answers given to the question of "Do you know that ADRs should be reported to TÜFAM?" is 7.7% . The relationship of the ADRs with the suspected drugs were evaluated, and the relationship was determined as "probable" in 20% of the ADRs and "possible" in 80% of the ADRs. 86.8% of the detected ADRs are found in the Summary of Product Characteristics of the drug. When ADR and the drug groups causing the ADR were evaluated according to the gender, although the incidence of ADR and severe ADR in female patients was higher, the difference between male and female patients was not statistically significant. In conclusion, it was observed that patients in Ankara experienced ADR’s depending on prescription drugs at a significant level and some of the ADRs were recovered only after treatment; it has been determined that awereness of reporting of the ADRs to a pharmacist or a physician was very low among patients and the importance of the ADR reporting was not sufficiently understood. There is a need educational programmes for improving awareness of pharmacovigilance and to strengthen the community pharmacists place in this system. It is predicted that, increase of the knowledge and awareness of pharmacists will lead to increase of ADR reporting.