Learning from Medication Errors in Healthcare : How to Make Medication Error Reporting Systems Work?

Medication errors are one of the most common incidents leading to adverse events in healthcare worldwide. Tackling these major problems requires the implementation of a systems approach to healthcare, stating that risks should be managed proactively by improving the healthcare system. One of the recommended key strategies for learning from medication errors and risk prone processes is the establishment of local and national medication error reporting (MER) systems in healthcare. This study explored national and local MER systems in different countries and what makes them work in learning from medication errors. The study also explored how continuing education in medication safety could be organised for practicing healthcare professionals. The study applied both qualitative and quantitative research methods and utilized various data sources. The study was based on the theory of Human Error and the systems approach to risk management. The study comprised of three phases. Phase I explored the existing MER systems in different countries and their development and implementation. 16 medication safety experts from different countries responded to an online-survey. A national or local MER system existed in 11 of the countries. Blaming for errors, and a lack of time, training and coordination of reporting continue to be the major barriers to reporting. Learning from errors and a non-punitive approach are essential features of a MER system. There is also a need for promoting international networking of medication safety experts and bodies for sharing information and learning from others. Several factors associated with the successful development and implementation of MER systems were also identified. Phase II assessed the inter-rater reliability of medication error classifications in a voluntary Reporting System for Safety Incidents in Health Care Organizations (HaiPro) widely used in Finland. Also medication errors (n=32 592) reported in 2007-2009 and their contributing factors were explored. The inter-rater reliability was found acceptable (κ ≥0.41) in 11 out of 42 (26%) variables (e.g., near miss or actual error) describing the reported medication errors. Thus, the medication errors reaching the acceptable level of inter-rater reliability could be pooled from different healthcare units for the exploration of medication errors at the level of all reporting organisations. The most frequently reported medication errors were: dispensing errors (33%, n=10 906); administration errors (24%, n=7 972); and documentation errors (17%, n=5 641). The most commonly reported contributing factor was deficiencies in communication and course of information related to patients medications. In Phase III educational approaches were developed for introducing medication safety for healthcare professionals as a three-day interdisciplinary course. International higher education experts in pharmacy (n=19) brainstormed four syllabi with teaching and assessment methods. Following this, a combined syllabus was developed. All four syllabi were based on constructive, problem-based learning methods and focused on understanding a systems approach in managing medication safety. Learning linked to learners practice through assignments at the workplace appeared to be the key. The study suggests that MER systems need to be improved in many countries together with their operational environments. Moreover, the operational environments of MER systems must support the functionality of these systems. The key factor for successful MER systems and learning from medication errors is having a systems approach as a theoretical context in all reporting and learning processes throughout the operational environments of MER systems. The current work also suggests that constructive problem-based learning linked to learners practice through assignments is the key when developing a course for continuing education in medication safety for healthcare professionals.Lääkehoitoihin liittyvät poikkeamat ovat yleisiä sosiaali-ja terveydenhuollossa niin Suomessa kuin muualla maailmassakin. Poikkeama voi tapahtua missä vaiheessa lääkehoitoa tahansa. Lääkäri saattaa epähuomiossa määrätä potilaalle väärän lääkkeen, hoitaja annostella lääkkeen väärällä annoksella tai farmasian ammattilainen toimittaa väärän lääkevalmisteen apteekista. Lääkehoidon turvallisuuden edistämiseksi keskeistä ei kuitenkaan ole syyllisen selvittäminen vaan se, miksi virhe tapahtui. Tavoitteena on oppia tapahtuneista poikkeamista, niihin johtaneista tekijöistä ja terveydenhuollon organisaatioiden toimimattomista prosesseista jotka edesauttavat virheiden syntymistä. Yhtenä keskeisenä lääkehoidon riskien hallinnan työvälineenä ovat lääkehoidon vaaratapahtumien raportointijärjestelmät, joiden kautta terveydenhuollon organisaatiot saavat tietoa lääkehoitoon liittyvistä poikkeamista ja riskeistä. Tässä väitöstutkimuksessa tutkittiin lääkehoidon vaaratapahtumien raportointijärjestelmiä eri maissa. Tutkimuksessa pyrittiin myös selvittämään, kuinka nämä järjestelmät saataisiin toimimaan tavalla, joka tuottaisi mahdollisimman laadukasta tietoa lääkehoidon riskien hallinnan tueksi sosiaali-ja terveydenhuollon arjessa. Lisäksi tutkittiin kuinka sosiaali-ja terveydenhuollon ammattilaisille voitaisiin järjestää täydennyskoulutusta lääkitysturvallisuuden ja riskienhallinnan osaamisen varmistamiseksi. Tutkimuksen ensimmäisessä osassa tutkittiin lääkehoidon vaaratapahtumien raportointijärjestelmiä 16 eri maassa. Kansallinen tai paikallinen (esim. yhdessä sairaalassa käytössä oleva) raportointijärjestelmä oli käytössä useimmissa tutkimukseen osallistuneista maista (n=11), joista valtaosa oli kehittyneitä maita. Raportointijärjestelmien käytön suurimpia esteitä olivat virheistä syyllistävä kulttuuri, ajanpuute, sekä raportoinnin koulutuksen ja koordinaation puute. Tutkimuksen toisessa osassa tutkittiin Suomessa laajassa käytössä olevan Sosiaali-ja terveydenhuollon vaaratapahtumien raportointijärjestelmään (HaiPro) vuosina 2007-2009 raportoituja lääkehoidon vaaratapahtumia (n=32 592), sekä aineiston laatua. Tutkimuksessa havaittiin, että vaaratapahtumailmoitusten sisällön laatua ja aineiston analysointia tulisi kehittää terveydenhuollon organisaatioissa erityisesti vaaratapahtumien myötävaikuttavien tekijöiden osalta. Yleisimmin raportoidut vaaratapahtumat liittyivät lääkkeiden jakoon (33%, n=10 906), annosteluun (24%, n=7 972); sekä kirjaamiseen (17%, n=5 641). Yleisin raportoitu poikkeamiin myötävaikuttava tekijä oli puutteet potilaan lääkehoitoon liittyvän tiedon kulussa ja kommunikaatiossa. Lääkitysturvallisuuden kannalta on keskeistä, että sosiaali-ja terveydenhuollon ammattilaiset hallitseva lääkehoidon riskienhallinnan perusteet. Väitöskirjan viimeinen osa perustui tutkimukseen, jossa kehitettiin tieteellisin menetelmin moniammatillinen lyhytkurssi tämän osaamisen varmistamiseksi. Koulutus perustuu konstruktiiviseen oppimiseen, jossa keskeisenä on lääkitysturvallisuuden järjestelmälähtöinen kehittäminen. Koulutuksessa keskeisimpänä oppimisen menetelmänä on ongelmalähtöinen oppiminen, ohjattu teoriatiedon soveltaminen käytäntöön ja työssä oppiminen koulutuksen osana. Väitöstutkimuksen perusteella lääkehoidon vaaratapahtumien raportointijärjestelmiä ja niiden toimintaympäristöjä tulee kehittää useissa maissa. Raportointijärjestelmien toimivuuden kannalta keskeisintä on, että raportointi, aineiston analysointi ja tiedon hyödyntäminen terveydenhuollon prosessien parantamiseksi perustuu järjestelmälähtöisyyteen ja poikkeamista oppimiseen. Konstruktiivinen ongelmalähtöinen oppiminen yhdistettynä osallistujien käytännön työhön ovat keskeisimmät menetelmälliset tekijät kehitettäessä koulutusta sosiaali-ja terveydenhuollon ammattilaisille lääkitysturvallisuudesta ja lääkehoidon riskienhallinnasta

How to make medication error reporting systems work : Factors associated with their successful development and implementation

This study explored factors associated with successful development and implementation of medication error reporting (MER) systems in different healthcare contexts. A descriptive online questionnaire comprising of structured and open-ended questions was responded to by 16 medication safety experts in 16 countries. The present paper describes the rich and multidimensional qualitative data from the experts’ narratives from open-ended questions. Several factors related to the national context of MER systems, i.e., the operational environment, were identified to impact successful development and implementation of these systems. The factors were: awareness of deficiencies in medication safety at local and national levels to justify the need for MER systems; gaining political will for the development and implementation actions together with international and governmental support; creating or reforming legislation and national regulations, guidelines and strategies to support MER; allocation of adequate human and financial resources; establishment of an organisation or centre to coordinate and lead MER; and extending systems approach and safety culture to all parts of the operational environment to facilitate openness on and learning from medication errors. In conclusion, operational environments of MER systems must be constructed to support functionality of these systems, and need to be improved in many countries.Peer reviewe

Integrating medication risk management interventions into regular automated dose dispensing service of older home care clients – a systems approach

Background Automated dose dispensing (ADD) services have been implemented in many health care systems internationally. However, the ADD service itself is a logistic process that requires integration with medication risk management interventions to ensure safe and appropriate medication use. National policies and regulations guiding ADD in Finland have recommended medication reconciliation, review, and follow-up for suitable risk management interventions. This implementation study aimed to develop a medication management process integrating these recommended risk management interventions into a regular ADD service for older home care clients. Methods This study applied an action research method and was carried out in a home care setting, part of primary care in the City of Lahti, Finland. The systems-approach to risk management was applied as a theoretical framework. Results The outcome of the systems-based development process was a comprehensive medication management procedure. The medication risk management interventions of medication reconciliation, review and follow-up were integrated into the medication management process while implementing the ADD service. The tasks and responsibilities of each health care professional involved in the care team became more explicitly defined, and available resources were utilized more effectively. In particular, the hospital pharmacists became members of the care team where collaboration between physicians, pharmacists, and nurses shifted from parallel working towards close collaboration. More efforts are needed to integrate community pharmacists into the care team. Conclusion The transition to the ADD service allows implementation of the effective medication risk management interventions within regular home care practice. These systemic defenses should be considered when national ADD guidelines are implemented locally. The same applies to situations in which public home care organizations responsible for services e.g., municipalities, purchase ADD services from private service providers.Peer reviewe

Systemic Causes of In-Hospital Intravenous Medication Errors: A Systematic Review

Peer reviewe

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

Lääkitysturvallisuuden kansallisen koordinaation tarve Suomessa

Peer reviewe

Developing a procedure for medication reconciliation and review on admission to geriatric wards

Peer reviewe

Keskitetyn lääkkeiden jakelumallin kehittäminen sairaalan sisätautiosastolla: kokemuksia pilottihankkeesta

English summary.Peer reviewe

Inter-rater reliability of medication error classification in a voluntary patient safety incident reporting system HaiPro in Finland

Background Medication errors are common in healthcare. Medication error reporting systems can be established for learning from medication errors and risk prone processes, and their data can be analysed and used for improving medication processes in healthcare organisations. However, data reliability testing is crucial to avoid biases in data interpretation and misleading findings informing patient safety improvement. Objective To assess the inter-rater reliability of medication error classifications in a voluntary patient safety incident reporting system (HaiPro) widely used in Finland, and to explore reported medication errors and their contributing factors. Method The data consisted of medication errors (n = 32 592), including near misses, reported by 36 Finnish healthcare organisations in 2007–2009. The reliability of the original classifications was tested by an independent researcher reclassifying a random sample of errors (1%, n = 288) based on narratives. The inter-rater reliability of agreement (κ) of the classifications was calculated to describe the degree of conformity between the researcher and the original data classifiers. Descriptive statistics were used to describe the medication errors. Results The inter-rater reliability between the researcher and the original data classifiers was acceptable (κ ≥ 0.41) in 11 of 42 (26%) medication error classes. Thus, these errors could be pooled from different healthcare units for the exploration of medication errors at the level of all reporting organisations. Contributing factors were identified in 48% (n = 137) of the medication error narratives in the random sample (n = 288). The most commonly reported errors were dispensing errors (34%, n = 10 906), administration errors 25% (n = 7972), and documentation errors 17% (n = 5641). Conclusions The data classified by different classifiers can be pooled for some of the medication error classes. Consistency of the classification and the quality of narratives need improvement, as well as reporting and classification of contributing factors to provide high quality information on medication errors.Peer reviewe