Strategies for Medication Safety : An Organization-Based Approach Focusing on High-Alert Medications and Clinical Pharmacy Services in Helsinki University Hospital

Medication errors are one the most important preventable factors jeopardizing patient safety. According to the ongoing World Health Organization’s third Global Patient Safety Challenge on medication safety, the key risk areas are high-risk situations, polypharmacy, and transitions of care. Extending pharmacists’ involvement in patient care and patient-safety work has been systematically addressed in patient safety initiatives since the early 2000s. Growing evidence on patient safety risks related to medications in the Finnish healthcare system has created a need to develop new strategies to manage these risks. This study explores strategies for medication safety in Finland with a special focus on hospitals by using Helsinki University Hospital (HUS) as a case. The strategic development areas researched from an organizational approach were managing high-alert medications (Studies I-II) and evolving clinical pharmacy services in assuring medication safety (Studies III-IV). The study applied a systems approach based on the Theory of Human Error as a theoretical framework. The study was conducted in two phases. In phase I (Studies I-II), HUS’s high-alert medications were identified using the hospital’s reports on medication errors (MEs) and adverse drug reactions (ADRs) which were compared with hospitals’ drug consumption and the Institute for Safe Medication Practices’ list of high-alert medications. This method was first developed and piloted with a strategic sample (n=249) of the MEs reported in 2007-2013 (Study I) and was used with larger data in Study II when ADR (n=401) and ME (n=11,668) reports of HUS from 2015-2016 were analyzed. The top therapeutic groups and active substances in ADR and ME reports were not similar. Medicines such as antineoplastic agents, antithrombotics, opioids, and insulins, should be considered high-alert medications in HUS. Phase II (Studies III-IV) assessed the clinical pharmacy services contributing to medication safety in Finnish hospitals. Study III explored pharmacist-led medication reconciliation and review procedures in two emergency departments (EDs) in HUS and Kuopio University Hospital (KUH). A sample of 150 patients, 75 from each hospital, aged ≥65 years, living at home and using ≥6 medicines were involved. All patients (100%) in HUS and 99% in KUH, had discrepancies in their admission medication chart. Admission diagnosis was linked to drug-related problems (DRPs) of 16% of patients in HUS and 29% in KUH. Of these, high-alert medications were linked to 11% in HUS and 8% in KUH. Other acute DRPs were identified in 19 patients (25%) in HUS and 54 patients (72%) in KUH. Furthermore, the majority of patients (89% in HUS and 100% in KUH) had non-acute DRPs, which needed actions in primary care. Study IV explored the recent evolution of clinical pharmacy services in Finnish hospitals to promote medication safety within a timeframe of 2011-2016 by using an online survey targeted at all hospital pharmacies (n=24) and medicine dispensaries (n=131 in 2011; n=28 in 2016). The overall response rate was 60% in 2011 and 52% in 2016. Clinical pharmacy services were provided by 85% of the responding units in 2016, while only 51% of the units in 2011. Pharmacists had extended their tasks towards patient-centered, system-based medication safety work. Participation in long-term continuing education focusing on clinical pharmacy and medication safety had clearly become more common in 2016 compared to 2011. This study provided a university hospital-specific approach to recent strategies and developments in medication risk management in Finland. Organizational high-alert medications can be identified using ADR and ME reports. More coordinated national collaboration is needed in order to combine the information gathered from ADR and ME incident data to better understand the risks of medication use. ED medication history-taking should be further developed with clinical pharmacists’ involvement in medication reconciliation and reviews. Patient-centered work by clinical pharmacists contributing to medication safety has recently increased remarkably in Finnish hospitals. This is in line with international and national systems-based patient safety guidelines and policy initiatives and it should be continued.Lääkehoitoon ja sen toteutukseen liittyvät riskit ovat merkittävä potilasturvallisuutta uhkaava tekijä sosiaali- ja terveydenhuollossa. Maailman terveysjärjestön (WHO) globaalin potilasturvallisuushaasteen tavoitteena on lääkityspoikkeamien vähentäminen. Keskeisiksi riskeiksi on tunnistettu suuren riskin tilanteet (ympäristöt, lääkehoidot, potilasryhmät), monilääkitys ja potilassiirrot. Farmasian ammattilaisten tehtäväkentän laajentamista lääkitysturvallisuustyöhön on esitetty systemaattisesti kansainvälisissä potilasturvallisuusaloitteissa jo 2000-luvun alusta alkaen. Myös suomalaisissa tutkimuksissa on tunnistettu lääkitysturvallisuusriskejä, joiden hallitsemiseksi tarvitaan uusia strategioita. Tämä väitöskirjatutkimus käsittelee sairaaloiden lääkitysturvallisuusstrategioita käyttäen Helsingin yliopistollista keskussairaalaa (HUS) tapausesimerkkinä. Kohdennetuiksi kehitysalueiksi valittiin suuren riskin lääkkeet (osatyöt I-II) ja kliinisen farmasian palvelut (osatyöt III-IV). Tutkimuksen teoreettisena viitekehityksenä sovellettiin Inhimillisen erehtymisen -teorian systeeminäkökulmaa. Tutkimus jaettiin kahteen vaiheeseen. Ensimmäisessä vaiheessa I (osatyöt I-II) tunnistettiin suuren riskin lääkkeitä hyödyntämällä HUS:in haittavaikutus- ja lääkityspoikkeamailmoituksia, joita verrattiin sairaalan lääkekulutukseen ja yhdysvaltalaisen Institute for Safe Medication Practices -järjestön riskilääkelistaukseen. Menetelmää pilotoitiin ensin pienemmällä kohdennetulla otoksella (n=249), joka koostui HUS:iin vuosina 2007-2013 raportoiduista lääkityspoikkeamista (osatyö I). Menetelmä todettiin toimivaksi ja sitä käytettiin toisessa osatyössä laajempaan aineistoon, joka koostui HUS:ssa vuosina 2015-2016 raportoiduista haittavaikutus- (n=401) ja lääkityspoikkeamailmoituksista (n=11 668). Lääkeaineet ja terapiryhmät, joista oli tehty yleisimmin haittavaikutus- ja lääkityspoikkeamailmoituksia, olivat erilaisia. Esimerkiksi syöpälääkkeet, veren hyytymiseen vaikuttavat lääkkeet, opioidit ja insuliinit tulisi luokitella suuren riskin lääkkeiksi HUS:ssa. Tutkimuksen toisessa vaiheessa (osatyöt III-IV) tutkittiin lääkitysturvallisuutta edistävien kliinisen farmasian palveluiden kehittymistä suomalaisissa sairaaloissa. Osatyössä III tutkittiin farmasistin tekemää lääkitystiedon ajantasaistamista ja lääkehoidon kokonaisarviointia iäkkäillä päivystyspotilailla (n=150) HUS:issa (n=75) ja Kuopion yliopistollisessa keskussairaalassa (KYS, n=75). Potilaat olivat omatoimisesti tai omaishoitajan kanssa kotona asuvia, ≥65-vuotiaita ja käyttivät ≥6 lääkettä. Kaikilla potilailla HUS:ssa (100 %) ja 99 %:lla KYS:ssä oli puutteita tulovaiheen lääkitystiedoissa. Tulosyyhyn yhteydessä olevia lääkitysongelmia oli 16 %:lla HUS:ssa ja 29 %:lla KYS:ssä. Muita akuutteja, päivystyksessä toimia vaativia lääkitysongelmia oli 19 potilaalla (25 %) HUS:ssa ja 54 potilaalla (72 %) KYS:ssä. Lisäksi suurimmalla osalla potilaista (89 %:lla HUS:ssa ja 100 %:lla KYS:ssä) oli muita, kiireettömämpiä lääkitysongelmia. Osatyössä IV tutkittiin kliinisen farmasian palveluiden kehittymistä suomalaisissa sairaaloissa vuosina 2011 ja 2016 sairaala-apteekkeihin (n=24) ja lääkekeskuksiin (2011: n=131, 2016: n=28) lähetetyllä verkkokyselyllä. Vastausprosentit olivat 60 % (2011) ja 52 % (2016). Vuonna 2016 kliinisen farmasian palveluita tarjottiin 85 %:ssa vastanneista yksiköistä, kun vuonna 2011 vastaava luku oli 51 %. Osastofarmaseuttien ja kliinisten proviisorien tehtävät olivat laajentuneet järjestelmälähtöiseen lääkitysturvallisuustyöhön ja lähemmäs potilasta. Myös kliinisen farmasiaan ja lääkitysturvallisuuteen keskittyvään täydennyskoulutukseen osallistuminen oli selvästi yleisempää vuonna 2016 kuin 2011. Tämä tutkimus tarjosi yliopistosairaalakeskeisen näkökulman lääkehoitojen riskienhallintaan Suomessa. Organisaatiokohtaisia suuren riskin lääkkeitä voidaan tunnistaa haittavaikutus- ja lääkityspoikkeama-ilmoitusten avulla, mutta kansallista koordinaatiota tarvitaan näistä rekistereistä saatavan tiedon tehokkaampaan hyödyntämiseen. Päivystyspotilaiden lääkitystietojen ajantasaistamis- ja lääkehoidon arviointiprosesseja tulee kehittää moniammatillisesti hyödyntämällä tehokkaasti farmasian ammattilaisten osaamista. Kliininen farmasia ja farmasistien osallistuminen lääkitysturvallisuustyöhön on lisääntynyt suomalaisissa sairaaloissa. Tämä kehitys on linjassa kansainvälisten ja kansallisten potilasturvallisuussuositusten kanssa ja sen on syytä jatkua

Implementing a New Electronic Health Record System in a University Hospital : The Effect on Reported Medication Errors

Closed-loop electronic medication management systems (EMMS) have been seen as a potential technology to prevent medication errors (MEs), although the research on them is still limited. The aim of this paper was to describe the changes in reported MEs in Helsinki University Hospital (HUS) during and after implementing an EPIC-based electronic health record system (APOTTI), with the first features of a closed-loop EMMS. MEs reported from January 2018 to May 2021 were analysed to identify changes in ME trends with quantitative analysis. Severe MEs were also analysed via qualitative content analysis. A total of 30% (n = 23,492/79,272) of all reported patient safety incidents were MEs. Implementation phases momentarily increased the ME reporting, which soon decreased back to the earlier level. Administration and dispensing errors decreased, but medication reconciliation, ordering, and prescribing errors increased. The ranking of the TOP 10 medications related to MEs remained relatively stable. There were 92 severe MEs related to APOTTI (43% of all severe MEs). The majority of these (55%, n = 53) were related to use and user skills, 24% (n = 23) were technical failures and flaws, and 21% (n = 21) were related to both. Using EMMS required major changes in the medication process and new technical systems and technology. Our medication-use process is approaching a closed-loop system, which seems to provide safer dispensing and administration of medications. However, medication reconciliation, ordering, and prescribing still need to be improved.Peer reviewe

Implementing a New Electronic Health Record System in a University Hospital : The Effect on Reported Medication Errors

Closed-loop electronic medication management systems (EMMS) have been seen as a potential technology to prevent medication errors (MEs), although the research on them is still limited. The aim of this paper was to describe the changes in reported MEs in Helsinki University Hospital (HUS) during and after implementing an EPIC-based electronic health record system (APOTTI), with the first features of a closed-loop EMMS. MEs reported from January 2018 to May 2021 were analysed to identify changes in ME trends with quantitative analysis. Severe MEs were also analysed via qualitative content analysis. A total of 30% (n = 23,492/79,272) of all reported patient safety incidents were MEs. Implementation phases momentarily increased the ME reporting, which soon decreased back to the earlier level. Administration and dispensing errors decreased, but medication reconciliation, ordering, and prescribing errors increased. The ranking of the TOP 10 medications related to MEs remained relatively stable. There were 92 severe MEs related to APOTTI (43% of all severe MEs). The majority of these (55%, n = 53) were related to use and user skills, 24% (n = 23) were technical failures and flaws, and 21% (n = 21) were related to both. Using EMMS required major changes in the medication process and new technical systems and technology. Our medication-use process is approaching a closed-loop system, which seems to provide safer dispensing and administration of medications. However, medication reconciliation, ordering, and prescribing still need to be improved.Peer reviewe

Ammattien välinen yhteistyö osana turvallista lääkehoitoa

Teema : turvallinen lääkehoito

Dose error reduction software in medication safety risk management - optimising the smart infusion pump dosing limits in neonatal intensive care unit prior to implementation

Background Smart infusion pumps with dose error reduction software can be used to prevent harmful medication errors. The aim of this study was to develop a method for defining and assessing optimal dosing limits in a neonatal intensive care unit's smart infusion pump drug library by using simulation-type test cases developed based on medication error reports. Methods This mixed-methods study applied both qualitative and quantitative methods. First, wrong infusion rate-related medication errors reported in the neonatal intensive care unit during 2018-2019 were explored by quantitative descriptive analysis and qualitative content analysis to identify the error mechanisms. The researchers developed simulation-type test cases with potential errors, and a literature-based calculation formula was used to set upper soft limits to the drug library. The limits were evaluated by conducting programming of pumps without errors and with potential errors for two imaginary test patients (1 kg and 3.5 kg). Results Of all medication errors reported in the neonatal intensive care unit, 3.5% (n = 21/601) involved an error or near-miss related to wrong infusion rate. Based on the identified error mechanisms, 2-, 5-, and 10-fold infusion rates, as well as mix-ups between infusion rates of different drugs, were established as test cases. When conducting the pump programming for the test cases (n = 226), no alerts were triggered with infusion rates responding to the usual dosages (n = 32). 73% (n = 70/96) of the erroneous 2-, 5-, and 10-fold infusion rates caused an alert. Mix-ups between infusion rates triggered an alert only in 24% (n = 24/98) of the test cases. Conclusions Simulation-type test cases can be applied to assess the appropriateness of dosing limits within the neonatal intensive care unit's drug library. In developing the test cases, combining hospital's medication error data to other prospective data collection methods is recommended to gain a comprehensive understanding on mechanisms of wrong infusion rate errors. After drug library implementation, the alert log data and drug library compliance should be studied to verify suitability of dosing limits.Peer reviewe

Medication reconciliation and review for older emergency patients requires improvement in Finland

BACKGROUND: 10-30% of hospital stays by older patients are drug-related. The admission phase is important for identifying drug-related problems, but taking an incorrect medication history often leads to medication errors. OBJECTIVES: To enhance medication history recording and identify drug-related problems (DRPs) of older patients admitted to emergency departments (EDs). METHODS: DRPs were identified by pharmacists-led medication reconciliation and review procedures in two EDs in Finland; Helsinki University Hospital (HUS), and Kuopio University Hospital (KUH). One-hundred-and-fifty patients aged >= 65-years, living at home and using >= 6 medicines were studied. RESULTS: 100% of patients (N = 75) in HUS and 99% in KUH (N = 75), had discrepancies in their admission-medication chart recorded by the nurse or physician. Associations between admission-diagnosis and drug-related problems were found in 12 patients (16%) in HUS and 22 patients (29%) in KUH. Of these, high-alert medications (e.g. antithrombotics, cytostatics, opioids) were linked to eight patients (11%) in HUS and six patients (8%) in KUH. Other acute DRPs were identified in 19 patients (25%) in HUS and 54 patients (72%) in KUH. Furthermore, 67 patients (89%) in HUS and all patients in KUH had non-acute DRPs. CONCLUSIONS: Medication reconciliation and review at admission of older ED patients requires improvement in Finland.Peer reviewe

Lääkitysturvallisuuden kansallisen koordinaation tarve Suomessa

Peer reviewe

"Vaaralliset" lääkkeet

Korjattu 12.12.2017 ks. oikaisu www.laakarilehti.fi > SisällysluettelotLääkkeitä, joiden käyttöön liittyy erityisiä turvallisuusriskejä, kutsutaan riskilääkkeiksi tai suuren riskin lääkkeiksi. Vaikka ne eivät välttämättä aiheuta enempää vaaratapahtumia kuin muutkaan lääkkeet, virheellisen käytön seuraukset ovat todennäköisemmin vakavia

Strategies for improving medication safety in hospitals: Evolution of clinical pharmacy services

Background Medication safety risks are the most important preventable factors jeopardizing patient safety. To manage these risks, extending pharmacists’ involvement in patient care and patient safety work has been systematically addressed in patient safety initiatives since the early 2000s. Objective To explore the extent and range of clinical pharmacy services in Finnish hospitals to promote medication safety: 1) in 2011, when the first National Patient Safety Strategy, the new Health Care Act and the Medicines Policy 2020 had been recently enacted; and 2) five years later in 2016. Methods The study was conducted in 2011 and 2016 as a national online survey targeted to hospital pharmacies (n = 24) and medical dispensaries (n = 131 in 2011; n = 28 in 2016). The questions were analyzed using descriptive statistics and qualitative content analysis. Results Overall response rate was 60% in 2011 and 52% in 2016. Clinical pharmacy services were provided by 51% of the responding units in 2011, whereas by 85% in 2016. The reported number of clinical pharmacists had increased during the five years. The most notable increase in reported tasks occurred in conducting medication reconciliations (+63% increase in the number of providing units). By 2016 pharmacists had extended their tasks particularly towards system-based medication safety work: e.g. developing instructions for medication-use (91% of the responding units), creating and updating medication safety plans (87%) and using medication error reports in developing the process of medication use safer (78%). Pharmacists’ participation in long-term continuing education became more common in 2016, which was perceived as helpful in extending their responsibilities to improve medication safety. Conclusion Pharmacists’ involvement in patient care and system-based medication safety work was reported to become more common in Finnish hospitals during 2011–2016. This development is in line with patient safety policy initiatives and its impact on patient care outcomes should be followed up.Peer reviewe