Procena zdravstvenih rizika u primeni supstitucione terapije tokom nestašice lekova

Abstract

Nestašice lekova narušavaju kontinuitet u primeni terapije pacijentu i uzrokuju brojne zdravstvene rizike tokom propisivanja, izdavanja i primene alternative u okviru terapijske supstitucije uzrokovane nestašicom. Rizici i greške do kojih dovode nisu dovoljno istraženi u okviru procesa upravljanja nestašicama kroz terapijsku supstituciju. Cilj istraživanja bio je procena modaliteta i ograničenja u upravljanju zdravstvenim rizicima, kao i identifikacija, rangiranje i analiza zdravstvenih rizika vezanih za antimikrobnu supstituciju u skladu sa njihovom ozbiljnošću i verovatnoćom. Istraživanje je sprovedeno kroz upitnik i detaljni intervju zdravstvenih radnika, a potom i kroz zdravstvenu analizu vrste i ishoda greške u 6 evropskih univerzitetskih bolnica u Austriji, Belgiji, Grčkoj, Hrvatskoj, Srbiji i Španiji. Više od 60% bolničkih farmaceuta vidi procenu zdravstvenih rizika kao strategiju za upravljanje nestašicama, od kojih je 26,4% upoznato sa analizom vrste ishoda i greške, 23,5% sa analizom ključnih uzroka, a po 14,7% sa zdravstvenom analizom vrste ishoda i greške i analizom opasnosti i kritičnih kontrolnih tačaka. Prema 29,4% bolničkih farmaceuta procena zdravstvenih rizika je deo protokola za upravljanje nestašicama, 14,7% je upoznato sa nacionalnom legislativom koja definiše njenu primenu, dok njih 35,5% sprovodi u okviru multidisciplinarnih timova, a njih 88,2% ne razmenjuje ishode procene sa nacionalnim regulatornim telima. Ključne barijere u primeni procene zdravstvenih rizika su neadekvatno znanje i veštine potrebne za sprovođenje procene, neadekvatna informaciono-tehnološka infrastruktura u bolnicama, neefikasna ekstrakcija i razmena podataka o pacijentu i leku od značaja za procenu. Zdravstvenom analizom vrste i ishoda greške u 6 evropskih bolnica identifikovano je 74 grešaka, od kojih 53 hazard skora iznad 8. Ozbiljnost grešaka se u bolnicama u Hrvatskoj, Grčkoj i Srbiji razlikovala pre i nakon sprovođenja korektivnih mera predloženih od strane istraživačkog tima (p<0,005). Verovatnoća grešaka se razlikovala između svih 6 bolnica pre i nakon primene korektivnih mera (p<0,005). Najveći broj uzroka grešaka je identifikovan u bolnici u Hrvatskoj 46 (28,2%), a najniži u bolnici u Španiji 16 (9,8%). Korektivne mere kojima se smanjuje vrednost hazard skora grešaka i do 83% su strukturirana komunikacija između svih zaintersovanih strana u sprovođenju zdravstvene zaštite tokom nestašica, uvođenje obaveznog elektronskog propisivanja lekova i veće učešće bolničkog farmaceuta u praćenju efikasnosti terapije i zaliha lekova na bolničkom odeljenju.

Medicine shortages disrupt the continuity of patient treatment and cause numerous clinical risks throughout prescribing, dispensing and administering of alternatives within therapeutic substitution occurring in the course of a shortage. Although clinical risks and associated failures emerging from managing shortages through therapeutic substitution are not thoroughly explored, the aim of this research is to determine current models and limitations in health risks assessments implementation as well as to identify, rank and analyse health risks in antimicrobial substitution according to seriousness and probability. A survey and a detailed interview were conducted among healthcare professionals, followed by healthcare failure mode and effect analysis in six European university hospitals in Austria, Belgium, Croatia, Greece, Serbia and Spain. Hospital pharmacists (61.7%) are aware of the use of risk assessment procedures as a coping strategy for medicine shortages, naming Failure Mode and Effect Analysis (26.4%), Root Cause Analysis (23.5%), and both the Healthcare Failure Mode and Effect Analysis and the Hazard Analysis and Critical Control Point (14.7%). While hospital pharmacists (29.4%) report risk assessment as integrated into mitigation strategy protocols, are aware of legislation stipulating risk assessment implementation in shortages (14.7%) and conduct risk assessment within multidisciplinary teams (35.3%), 88.2% claimed not to have reported risk assessment outputs to their respective authorities. The major obstacles facing health risk assessment are found to be not possessing sufficient knowledge and skills for their application, inadequate hospital information-technology support, as well as both the inefficient data extraction and exchange related to patients and the medicine needed for assessment. Healthcare Failure Mode and Effect Analysis conducted in 6 hospitals revealed 74 failure modes, with 53 of a hazard score higher than 8. The severity of failure modes differed before and after corrective actions in the hospitals in Croatia, Greece, and Serbia (p<0.005). Their probability differed in all study hospitals (p<0.005) when compared prior to and following corrective actions aimed to be implemented. The highest number of failure-mode causes was detected in the hospital in Croatia 46 (28.2%) and the lowest in the hospital in Spain 16 (9.8%). The proposed corrective actions addressing and lowering failure modes hazards scores up to 83% are structured communication among stakeholders, introducing electronic prescribing, strengthening pharmacists' involvement in treatment effectiveness and stock assessment at the wards.