Prospective systemic risk analysis of the medicines dispensing process in the community pharmacy setting - perspective of pharmaceutical service quality and patient safety improvement

[T. Z. Stojković]

138 listova

Farmacija - Socijalna farmacija i istraţivanje farmaceutske prakse / Pharmacy - Social pharmacy and pharmacy practice research

Izdavanje lekova, jedna od osnovnih aktivnosti u farmaceutskoj praksi, predstavlja proces koji je rizičan i sklon nastanku grešaka, zbog čega potencijalno moţe ugroziti bezbednost pacijenata. Sa porastom nivoa svesti o značaju ovog problema, došlo je i do povećanja broja studija u ovoj oblasti tokom protekle decenije, koje su primarno fokusirane na ispitivanje incidence, tipova i uzroka propusta u izdavanju lekova. Ipak, sa razvojem modernog pristupa medicinskim greškama, u sve većoj meri se naglašava značaj proaktivnog upravljanja rizicima, pre nanošenja štete pacijentu. Primena alata za prospektivnu analizu rizika već je počela u velikom broju procesa zdravstvene zaštite, uključujući izdavanje lekova. Ipak, ove studije se uglavnom sprovode u bolnicama, dok ih na primarnom nivou gotovo uopšte nema, posebno u javnim apotekama, gde se najvećem broju pacijenata vrši izdavanje lekova. Ova doktorska disertacija imala je za cilj sprovoĎenje prospektivnih sistemskih analiza rizika u procesima izdavanja lekova u javnim apotekama u Republici Srbiji i SR Nemačkoj, radi identifikacije potencijalnih grešaka, kvantifikacije i rangiranja prioriteta pridruţenih rizika, kao i definisanja korektivnih mera za smanjenje rizika za bezbednost pacijenata. Cilj je takoĎe bilo sprovoĎenje komparativne analize dobijenih rezultata u Republici Srbiji, kao zemlji u razvoju, i SR Nemačkoj, kao razvijenoj zemlji. Analize načina (oblika) i efekata otkaza (FMEA) su sprovedene u periodu od januara do maja 2016. godine u Republici Srbiji i u oktobru 2016. godine u SR Nemačkoj. Najpre su multidisciplinarni timovi, koji su se sastojali od moderatora i eksperata u izdavanju lekova, primenom tehnike „oluja ideja‖ kreirali dijagram toka analiziranog procesa, i identifikovali potencijalne greške, zajedno sa njihovim uzrocima i posledicama. Zatim je izvršena kvantifikacija pridruţenih rizika, izračunavanjem broja prioriteta rizika (RPN) za svaku potencijalnu grešku, na osnovu njene ozbiljnosti, učestalosti i detektabilnosti. Najzad, definisane su korektivne mere i njihovi potencijalni efekti su procenjeni za greške sa najvišim vrednostima RPN-ova. Identifikovane greške, korektivne mere, kao i potencijal za smanjenje rizika u Republici Srbiji i SR Nemačkoj su zatim uporeĎeni sprovoĎenjem kvalitativne komparativne analize...

Dispensing of medicines, one of the central activities in pharmaceutical practice, is considered to be inherently risky and susceptible to errors, thereby posing a constant potential threat to patient safety. Raising awareness of this issue has resulted in an increasing number of studies over the last decade, focusing primarily on the incidence, types and causes of dispensing incidents. However, the modern approach to medication errors emphasizes the importance of proactive risk mitigation, i.e. acting before the patient harm has occurred. The application of prospective risk analyses tools to various health care processes, including dispensing of medicines, has already started. However, these studies are mostly conducted in the hospital setting, while they are almost nonexistent at the primary level of health care, particularly in community pharmacies, where the greatest number of patients are habitually issued medicines. This doctoral dissertation aimed to conduct prospective systemic risk analyses of the medicines dispensing processes in the community pharmacy settings in Serbia and Germany, so as to identify, quantify and prioritize potential failure modes, as well as to define adequate measures for patient safety risk reduction. Furthermore, the aim was to perform a comparative risk analysis of the findings obtained in Serbia, as developing country, and Germany, as developed country. Failure Mode and Effects Analyses (FMEA) were conducted from January to May 2016 in Serbian and in October 2016 in German community pharmacies. First, multidisciplinary teams consisting of a leader and process experts employed brainstorming techniques to map medicines dispensing processes and identify failure modes, along with their causes and effects. Then, the associated risks were quantified by calculating Risk Priority Numbers (RPNs) for each failure mode based on its severity, occurrence and detectability. Finally, corrective actions were developed and their potential effects were evaluated for the failure modes with the highest RPNs. The identified failure modes, corrective actions as well as the potential for risk reduction in Serbia and Germany were further compared by performing qualitative analysis...

greške u izdavanju lekova, javna apoteka, bezbednost pacijenata, prospektivno upravljanje rizicima, analiza načina i efekata otkaza, stavovi farmaceuta

dispensing errors, community pharmacy, patient safety, prospective risk management, failure mode and effects analysis, risk reduction, pharmacists‘ attitudes

615:614.2:34(043.3)

Tekst