Side effects of non-opioid and opioid analgesics reported to Agency for Medicinal Products and Medical Devices from 2007. to 2014. : diploma thesis

Cilj istraživanja: Analizirati nuspojave neopioidnih i opioidnih analgetika koje su prijavljene Hrvatskoj Agenciji za lijekove i medicinske proizvode u razdoblju od 2007. do 2014. godine. Materijal i metode: Podatci o nuspojavama analgetika dobiveni su od HALMED-a. Odnose se na nuspojave opioidnih i neopioidnih analgetika zaprimljene u osmogodišnjem razdoblju od početka 2007. do kraja 2014. godine. Prikupljeni su sljedeći podatci: generičko ime lijeka, godina prijave nuspojave, vrsta prijave, je li nuspojava kategorizirana kao ozbiljna ili ne, ustanova u kojoj je prijavljena nuspojava, kvalifikacija osobe koja je prijavila nuspojavu, godina rođenja i dobna skupina pacijenta, spol pacijenta, vrsta reakcije. Prikupljeni podatci bili su anonimizirani i nisu sadržavali nikakve osobne podatke pacijenata koji bi omogućili njihovu identifikaciju. Svi podatci ubačeni su u elektroničke tablice i analizirani su pomoću deskriptivne statistike. Rezultati: U analiziranom razdoblju zabilježeno je 796 prijava nuspojava analgetika, od čega 365 (46%) ozbiljnih nuspojava i 424 (53%) ostalih nuspojava. Ukupni broj prijava nuspojava kroz analizirano razdoblje se kontinuirano povećavao te se čak 2014. utrostručio s obzirom na 2007. godinu. Pet i više prijava zabilježeno je za 20 analgetika, koji su detaljnije analizirani. Tih dvadeset lijekova činilo je ukupno 597 (75%) prijava nuspojava analgetika u analiziranom razdoblju. Među tih 20, najčešće prijave nuspojava odnosile su se na pojedinačne lijekove (N=16; 80%). Najviše nuspojava su prijavljivali liječnici (N=257; 43%), a ljekarnici su bili na drugom mjestu sa svega nekoliko prijava manje u odnosu na liječnike (N=252; 42%). Većina nuspojava (N=572; 96%) prijavljena je spontanim putem preko odgovarajućih obrazaca koje ispunjavaju pacijenti ili zdravstveni djelatnici. Nuspojave su se u najvećem broju javile kod žena (N=352; 59%) i najčešće su se javljale u odrasle dobi (N=354; 59%). Najčešće nuspojave opioidnih i neopioidnih analgetika zabilježene su na koži i sluznicama, a ozbiljne nuspojave su najčešće rezultat djelovanja opioidnih analgetika. Zaključci: Broj prijava nuspojava analgetika kontinuirano se povećava i velik broj prijava odnosi se na ozbiljne nuspojave. Potrebno je provesti još istraživanja na tu temu kako bi zdravstveni djelatnici, ali i sami pacijenti znali odrediti prikladniju terapiju, tj. terapiju koja će prouzrokovati što manje nuspojava. Kako bi praćenje lijekova i nuspojava bilo uspješnije potrebno je zdravstvene djelatnike, ali i same pacijente educirati i poticati na prijavu nuspojava.Diploma Thesis Title: Adverse events of non-opioid and opioid analgesics reported to Croatian Agency for Medicinal Products and Medical Devices from 2007 to 2014. Objectives: To analyze the adverse events (AEs) of non-opioid and opioid analgesics that have been reported to Croatian Agency for Medicinal Products and Medical Devices (HALMED) from 2007 to 2014. Patients and Methods/material and Methods: Information about AEs of analgesics were obtained from the HALMED. The following data were collected: generic name, year of the AE report, type of report , was it as a serious AE or not, institution in which AE was reported, the qualifications of the person who reported AE, the patient's date of birth and age group, sex, type of AE. Prior to analysis data were anonymized, and any personal information removed, so patients could not be identified. All data were inserted into the electronic spreadsheets and descriptive statistics was calculated. Results: There were 796 AEs of analgesics reported in the analyzed period, among which 365 (43%) were serious AEs. Total number of AE reports was continuously increasing during the analyzed period, and in year 2014 this number was three times higher compared to 2007. There were 20 analgesics that had ≥5 reports, and these were analyzed in more detail. AE reports of those 20 analgesics made 597 (75%) of all AE reports for analgesics. The most common adverse reaction reports of those 20 analgesics referred to individual drugs (N=16; 80%). Most of the AE reports were filed by physicians (N=257; 43%). Pharmacists were in second place with only a few reports less than physicians (N=252; 42%). Most side effects (N=572; 96%) were reported spontaneously through appropriate forms by patients or health professionals. AEs were mostly commonly reported in women (N=352; 59%) and most of them have occurred in adults (N=354; 59%). The most common AEs of opioid and nonopioid analgesics have been reported on the skin and mucous membranes. Most serious AEs were result of action of opioid analgesics. Conclusion: Number of AE reports is continuously increasing and a considerable number of them refers to serious AEs. More research in this field is necessary so that health care professionals and patients can choose the appropriate therapy that will cause less AEs. To keep better track of medications and AEs it is necessary to educate and encourage health professionals and patients in reporting side effects