Medication Reconciliation as a Medication Safety Initiative

Medication errors and their adverse outcomes are the most common cause of patient injuries in hospitals. Medication reconciliation is the safety strategy usually called for, to prevent medication errors that occur at care transitions. This strategy has been adopted as a standard practice in many developed countries. However, in Ethiopia, there were no published studies on medication reconciliation, nor evidence-based interventions aimed to tackle the burden of medication errors. This thesis was a medication safety initiative focusing on medication reconciliation intervention overall, and explored the journey to medication reconciliation service implementation as a medication safety strategy in Ethiopian public hospitals. Given the lack of consistent reports regarding the impact of this strategy, the journey to implementation was guided by synthesise of the evidence supporting the effectiveness of this intervention. The findings of our systematic reviews have shown that medication reconciliation interventions carried out through pharmacist assessment at hospital transitions were found to be an effective strategy for improving clinical outcomes (e.g. adverse drug event-related hospital visits, all-cause readmissions, and emergency department visits), as well as process outcomes, such as the occurrence of medication errors. Therefore, the overarching aim of this thesis was to implement a pharmacist-led medication reconciliation intervention in resource-limited settings. Implementation of medication reconciliation is not an ultimate end but sustainability is an issue, and this should be corroborated by corresponding changes in attitudes, teamwork, communication, culture and leadership. For this purpose, the thesis employed methods from both safety and implementation sciences for successful implementation of the medication reconciliation program. System approaches to patient safety, such as patient safety culture has been explored, and patients’ experiences of medication-related adverse events have been discussed followed by a theoretically robust evidence-based exploration of the barriers to implementation. Patient safety culture in Ethiopian public hospitals has been found lower than the benchmark studies. Importantly, understaffing followed by problems during handoffs and care transitions and punitive response to error were identified as major safety problems. Particularly, handoffs and care transitions were largely affected by the lack of teamwork across units, punitive response to error reporting and managerial inaction for promoting patient safety. In addition to system factors presumed to affect patient safety, other factors such as individual healthcare professionals, patient, and task factors have been identified as challenges to achieve an optimal patient safety in the Ethiopian public hospitals. Resource limitations (e.g. material deficiencies, poor infrastructure) have been indicated as the greatest barriers for patient safety. Patients expressed a range of perceived experiences related to their medication, and a number of strategies required to improve patient safety practices have been suggested. Changes in practice, processes, structure, and systems were believed to help improve patient safety in the Ethiopian health care system. The results of this thesis have demonstrated that hospital pharmacists were very much enthusiastic for their extended roles and were positive towards the future of the profession; however, there were many factors that likely influenced their behaviour in the clinical practice, and these behavioural determinants were predominantly related to ‘Knowledge’, ‘Skills’, ‘Environmental constraints’, ‘Motivation and goals’, ‘Social influences’, and ‘Social/professional role’. While medication errors were highly prevalent at the time of hospital admission, this thesis has also found that pharmacist-led medication reconciliation was able to minimize medication errors significantly. Thus, implementation of medication reconciliation as a medication safety strategy is feasible, and pharmacists may be regarded as key resource personnel for the safe use of medications at the time of hospital admission. However, the sustainability of this service utilization is highly dependent on other behavioural determinants, such as knowledge and skill, competing priorities, and reimbursement for clinical services

The Rising Costs of Hospital Pharmaceutical Shortages and the Impact on Patient Care: Exploring the Use of Predictive Analytics in New York Area Hospitals

This qualitative case study examined the rising cost of hospital pharmaceutical shortages and the impact on patient care. This study also explored the use of predictive analytics to reduce costs and improve patient care efficiency. Increased health-care spending is partially due to prescription medication prices. Management of hospital drug procurement affects patient health, quality care, and hospital budgets, while risk management needs to minimize possible medication shortages. For patients to get the drugs that they need, pharmacists need to have resources at their fingertips to obtain a deep insight into the knowledge of drugs through the supply chain. The research questions concentrated on the causes of rising costs, the role of supply and demand, and the possibility of predictive analytics as a tool for inefficiencies relating to rising costs of hospital pharmaceutical shortages. The unexpected factor in this study was the impact of the Coronavirus (COVID-19) pandemic. Not only did COVID-19 alter the data collection method, but the data itself. Hospital pharmaceuticals were and still are greatly affected by the pandemic. The findings from this study was applied to the professional practice of business. Additionally, the researcher discussed the implication of the biblical worldview and the implication of the strategic management field of study. The report finished with suggestions for practice, suggestions for further analysis, reflections, and conclusions. The researcher also recommended that the study be conducted again with a specific pharmaceutical shortage and no global pandemic

Master of Science

thesisPatient safety has received unprecedented attention over the past decade. Some of that attention has been focused on the occurrence and prevention of harm from Adverse Drug Events (ADEs). Between 19 and 61 percent of ADEs are preventable. In order to prevent ADEs, they must first be detected. Several methods have been used to detect ADEs, including voluntary reporting, intensified surveillance, and computerized monitoring. Computerized monitoring has been shown to be complimentary to other methods in detecting ADEs. However, very little research has been completed on this method in pediatrics. Pediatric patients pose unique challenges and risks because of physiological immaturity, lack of testing and information on medications, availability of appropriate medication formulations and strengths, and incomplete cognitive and communication development. This study examined the modification and implementation of an adult computerized ADE monitoring tool at one pediatric medical center. It was implemented into the daily practice of pharmacy operations without increasing the pharmacy resources. Pharmacists printed daily reports containing alerts of possible ADEs. They investigated each of the alerts and noted whether an ADE occurred and how much time was needed to investigate. The main objective of this study was to increase the detection of ADEs in the pediatric population. iv Over the 12-week study, 181 ADEs were identified via the computerized monitoring tool. An additional 88 ADEs were voluntarily reported. Overall, this represented a rate of 6.6 ADEs per 100 admissions and 14.8 ADEs per 1,000 patient days. This result represented a significant increase in the detection of ADEs (p<0.0001) as compared to the same timeframe from the previous year. The computerized monitoring tool had a positive predictive value (PPV) of 4.8 percent. It took an average of 6.1 minutes to investigate alerts associated with an ADE, which was significantly higher than the time it took to investigate alerts not associated with an ADE (p<0.0001). Of the ADEs found with this tool, 10.5 percent were considered preventable. The use of a modified computerized ADE monitoring tool in the pediatric environment increased the overall detection of ADEs and warrants continued research

Patient Safety: A Nobody’s Concern

Patient safety is a global concern and is the most important domains of health-care quality. Medical error is a major patient safety concern, causing increase in health-care cost due to mortality, morbidity, or prolonged hospital stay. A definition for patient safety has emerged from the health care quality movement that is equally abstract, with various approaches to the more concrete essential components. Patient safety was defined by the IOM as “the prevention of harm to patients.” Emphasis is placed on the system of care delivery that prevents errors; learns from the errors that do occur; and is built on a culture of safety that involves health care professionals, organizations, and patients. Patient safety culture is a complex phenomenon. Patient safety culture assessments, required by international accreditation organizations, allow healthcare organizations to obtain a clear view of the patient safety aspects requiring urgent attention, identify the strengths and weaknesses of their safety culture, help care giving units identify their existing patient safety problems, and benchmark their scores with other hospitals

Manipulation of medicines, necessary in everyday practice for individualised doses in paediatric care

Introduction: Manipulation of medicines is often necessary in the paediatric setting due to lack of medicines suitable for paediatric patients. There are previous short-term frequency studies in different paediatric settings, but no long-term studies and no comparison between two different years in the same setting. In 2007 the Paediatric Regulation was implemented in Europe to stimulate drug companies to develop more information around medicines for children and new dosage forms suitable for paediatric patients. An alternative to manipulation of medicines is to use extemporaneous preparations in correct strengths. Aim: The overall research aim of this thesis was to study how and to what extent manipulation of medicines is being done and its effect on dosing accuracy in paediatric care. A specific aim was to compare the use of extemporaneous preparations in two different years. Methods: The setting for three of the four studies was a large paediatric university hospital in Sweden, and the fourth study was performed at a hospital pharmacy. Data for paper I and IV were extracted from a large registry containing material regarding patient data, care, and medicines from the hospital electronic health record, TakeCare. In Paper I data regarding all solid oral and rectal administrations where a part of a solid dosage form needed to be administered were counted. Comparisons were then made between the included study years 2009 and 2019 and between inpatients and patients at the emergency department. Semi-structured interviews with registered nurses and pharmacists were performed in Paper II. All interviews were audio recorded, transcribed verbatim, and analysed qualitatively using content analysis. In Paper III five different brands of tablets were split into halves and quarters. The resulting parts were then weighed and compared with expected weight, according to criteria in the European Pharmacopoeia and the United States Pharmacopoeia. The frequency of patients with at least one oral extemporaneous preparation was counted from the registry data and compared for inpatients in 2009 and 2019 in Paper IV. Results: There was no difference in the frequency of inpatients with manipulated oral medicines, when comparing data from 2009 and 2019. For manipulations of rectal medicines there was a statistically significant decrease for both inpatients and patients at the emergency department, as well as for manipulations of oral medicines to patients at the emergency department. Registered nurses and pharmacists state that manipulation of medicines to paediatric patients is frequent, and forces both professions to work outside the box. Splitting of tablets into halves results in more correct parts than splitting further into quarters. The frequency of patients with extemporaneous preparations increased between the study years. Conclusion: There is still a lack of suitable dosage forms and strengths of medicines to paediatric patients in 2019 which leads to manipulation of medicines, or the use of extemporaneous preparations. For individual substances the introduction of a dosage form suitable for paediatric use, decreases, or even erases the need to manipulate or use extemporaneous preparations. Pharmacists are valued members in the ward team, contributing with specific knowledge around medicines

From Paper to Cyber : Medicines Information as a Strategic Goal in Finland and the European Union

Medicines information (MI) is an essential part of rational pharmacotherapy. Intensified clinical research and more matured pharmacovigilance systems have produced more information on therapeutic effects of pharmacotherapies to facilitate more detailed profiling of their benefits and risks. In turn, more open communication on medications with patients has been facilitated by drug safety issues, patients’ right to know about their treatments and by a significant increase in electronic information sources. Even though a wide variety of evidence-based MI sources for patients and consumers is currently available, the coordination between MI sources and their providers has been limited. The need for coordination has become more evident as the number of MI sources and providers has substantially increased over time. Improved communication on medicines to patients and consumers has been a strategic priority in developing MI practices in the European Union, including Finland, during the 2000s. To enhance the coordination of MI practices in Finland, the Finnish Medicines Agency Fimea published the first national MI strategy in 2012. The primary goal of the national MI strategy is to influence MI practices in all social and healthcare settings to reach the ultimate goal of well-informed patients who adhere to their medication. This thesis examines MI practices and policies in Finland during the 2000s. The primary goal of the thesis is to support the strategic development of MI and the implementation of the national MI strategy. The thesis comprises three independent studies (I–III) in which both quantitative and qualitative research methods were applied. They investigated development targets for MI practices in Finland based on a systematic review of the existing literature (I), assessed long-term trends in the receipt of MI among the Finnish adults (II), and evaluated how well the ultimate goal of the national MI strategy regarding well-informed adherent patients with chronic diseases had been achieved at the midpoint of the strategy period in 2015 (III). The systematic review on MI research conducted in Finland during 2000–2016 found 126 studies that covered a wide range of approaches applying various research methods (Study I). More than half of the studies were qualitative (54% of all studies, n=68), although surveys were the most commonly used individual method (47%, n=59). Twelve studies were interventions and only six studies applied a theory. Patient counselling in community pharmacies was the most commonly studied topic (19%, n=24). Regardless of some methodological pitfalls, MI research provides a multifaceted understanding of MI practices and their development needs in Finland. Research should shift towards larger research lines having a stronger theory base and study designs. Future research should be focused on the effectiveness of MI in different healthcare settings, along with the use of electronic MI sources and services, MI literacy, MI needs among patients and healthcare professionals (HCPs). Based on the nationally representative repeated postal survey “Health Behaviour and Health among the Finnish Adult Population” conducted by the National Institute for Health and Welfare during 1999–2014, physicians, community pharmacists and package leaflets were the main MI sources among adult medicine users aged 15–64 years (n=18862) throughout the study period (Study II). The use of the Internet as a MI source increased the most noticeably, being used by 1% of the adult medicine users in 1999 and 16% in 2014. The number of medicine users who did not receive MI from HCPs more than doubled (17% to 38%), and the number of medicine users who did not receive MI from any sources increased by sevenfold (4% to 28%) during the study period. It is necessary to continue research on trends in the receipt of MI at the population level and to identify population groups requiring special attention, such as senior citizens with multiple medications. Further evidence is also needed on factors contributing to a growing number of medicine users not receiving MI. According to the interviews among stakeholder representatives (n=79, 71%) involved in the implementation of the national MI strategy, the medication use processes for patients with chronic diseases requires development at every level of implementation (i.e., macro, meso, micro) (Study III). Medication counselling and other care advice by HCPs, particularly by community pharmacists, were the best implemented actions in general. The major actions needing development at the infrastructure level (macro) concern the coordination of care, transfer of patient information between care units, lack of reconciled medication lists, and local and national agreements on the responsibilities of patients and HCPs involved in the medication use process; at the HCP level (meso), focus on implementing the entire medication use process in primary and social care, particularly in geriatric units; and at patient level (micro), related to limited patient involvement in their care, lack of patients’ adherence to treatment and the inability of patients to retrieve information. Patients need to be better involved in implementing their treatment by improving empowerment and partnership to achieve the goal of well-informed adherent patients. KEYWORDS Medicines information, medicine user, patient, strategy, FinlandLääkeinformaatio on keskeinen osa rationaalista lääkehoitoa. Kliinisten lääketutkimusten lisääntyminen ja lääketurvatoiminnan kehittyminen ovat lisänneet tietämystä lääkkeiden vaikutuksista. Lääkitysturvallisuuden edistämistyö, potilaan oikeus saada tietoa käyttämistään lääkkeistä ja sähköisten lääkeinformaatiolähteiden määrän merkittävä kasvu ovat mahdollistaneet potilaille avoimemman tiedonsaannin lääkehoidoista. Vaikka näyttöön perustuvia lääkeinformaatiolähteitä potilaille ja kuluttajielle on nykyisin saatavilla yhä enemmän, koordinaatio informaatiolähteiden ja niiden tuottajien välillä on ollut puutteellista. Potilaiden ja kuluttajien lääkeinformaation saannin parantaminen on ollut strateginen tavoite Euroopan unionissa 2000-luvulla. Tähän liittyen Lääkealan turvallisuus- ja kehittämiskeskus Fimea julkaisi ensimmäisen kansallisen lääkeinformaatiostrategian vuonna 2012. Strategialla halutaan vaikuttaa lääkeinformaatiokäytänteisiin kaikkialla sosiaali- ja terveydenhuollossa, jotta saavutettaisiin tavoite hyvin informoiduista ja lääkehoitoihinsa sitoutuneista potilaista. Väitöskirjatutkimuksessa tutkittiin lääkeinformaatiokäytänteiden kehittymistä Suomessa 2000-luvulla sekä sitä, miten Euroopan unionin linjaukset ovat näkyneet siinä. Tutkimus jakautui kolmeen osatyöhön, joissa tutkittiin 1) lääkeinformaatiokäytänteiden kehittymistä Suomessa tutkimustiedon valossa 2000-luvulla, 2) aikuisväestön lääkeinformaation saannin kehittymistä vuosina 1999–2014 ja 3) kansallisen lääkeinformaatiostrategian toteutumista kolme vuottta sen käynnistymisen jälkeen vuonna 2015. Ensimmäinen osatyö toteutettiin järjestelmällisenä kirjallisuuskatsauksena Suomessa vuosina 2000–2016 julkaistuista lääkeinformaatiotutkimuksista (n=126). Yli puolet (54 %, n=68) tutkimuksista oli laadullisia, vaikkakin kysely oli yleisimmin käytetty yksittäinen tutkimusmenetelmä (47 %, n=59). Interventiotutkimuksia oli yhteensä 12. Kuudessa tutkimuksessa oli hyödynnetty teoriaa viitekehyksenä. Lääkeneuvonta avohoidon apteekeissa oli yleisimmin tutkittu teema (19 %, n=24). Huolimatta joistakin tutkimusmenetelmällisistä puutteista, lääkeinformaatiotutkimus antaa kattavan käsityksen Suomen lääkeinformaatiokäytänteistä ja kehitystarpeista. Jatkossa lääkeinformaatiotutkimuksen tulisi suuntautua laajempiin tutkimuskokonaisuuksiin, jotka pohjautuisivat vahvemmin teorioihin ja teoriasta johdettuihin tutkimusasetelmiin. Lääkeinformaation vaikuttavuutta eri terveydenhuoltoympäristöissä, sähköisten lääkeinformaatiolähteiden ja palvelujen käyttöä, lääkeinformaation lukutaitoa sekä kuluttajien ja terveydenhuollon ammattilaisten lääketiedon tarpeita tulisi tutkia syvällisemmin. Toinen osatyö perustui Terveyden ja hyvinvoinnin laitoksen valtakunnallisesti edustavaan vuosittaiseen postikyselyyn ”Suomalaisen aikuisväestön terveyskäyttäytyminen ja terveys” (AVTK) vuosiväliltä 1999–2014. Tulosten perusteella lääkärit, farmaseutit ja proviisorit sekä pakkausselosteet olivat yleisimmät lääkeinformaation lähteet aikuisilla lääkkeiden käyttäjillä (15–64-vuotiaat, n=18862) koko tutkimusajanjakson ajan. Eniten kasvoi internetiä lääketiedon lähteenä käyttävien osuus: vuonna 1999 osuus oli 1 % vastaajista ja vuonna 2014 osuus oli 16 %. Tutkimusajanjakson aikana niiden lääkkeen käyttäjien määrä yli kaksinkertaistui (17 %:sta 38 %:iin), jotka ilmoittivat, etteivät olleet saaneet tietoa käyttämistään lääkkeistä terveydenhuollon ammattilaisilta. Vastaavasti niiden lääkkeiden käyttäjien määrä seitsenkertaistui (4 %:sta 28 %:iin), jotka ilmoittivat, etteivät olleet saaneet mistään informaatiolähteestä tietoa käyttämistään lääkkeistä. Lääkeinformaation saannin trendejä väestötasolla tulee seurata jatkossakin ja tunnistaa potilasryhmät, joilla on erityistarpeita lääkeinformaation saannissa, kuten iäkkäät monilääkityt potilaat. Lisäksi tietoa tarvitaan niistä tekijöistä, jotka vaikuttavat kasvavaan määrään lääkkeiden käyttäjiä, jotka jäävät ilman tietoa. Kansallisen lääkeinformaatiostrategian toteutumista tutkittiin haastattelemalla strategian toteuttamiseen osallistuvien sidosryhmien edustajat (n=79, osallistumisprosentti 71). Tulosten perusteella pitkäaikaissairaiden lääkehoitoprosessi vaatii kehittämistä prosessin jokaisella toteutustasolla (makro-, meso- ja mikrotaso). Lääkeneuvonta, erityisesti apteekeissa, ja terveydenhuollon ammattilaisten toteuttama muu hoidon ohjaus olivat parhaiten toteutuneet toimenpiteet. Toimintaympäristön (makrotaso) merkittävimmät kehittämistarpeet koskivat lääkehoidon koordinointia, potilastiedon siirtymistä hoitoyksiköiden välillä, ajantasaisen lääkitystiedon saatavuutta sekä paikallisia ja kansallisia sopimuksia potilaiden ja terveydenhuollon ammattilaisten tehtävistä ja vastuista lääkehoitoprosessissa. Terveydenhuollon ammattilaisilla (mesotaso) suurimmat kehittämistarpeet tunnistettiin perusterveydenhuollossa ja sosiaalihuollossa tapahtuvassa lääkehoidon toteutuksessa, erityisesti vanhustenhuollon yksiköissä. Ensisijaisina puutteina potilailla (mikrotaso) esille nostettiin potilaiden rajoittunut osallistuminen omaan hoitoonsa, puutteellinen hoitoon sitoutuminen sekä riittämättömät tiedonhakutaidot luotettavan lääkeinformaation etsimiseen. Potilaita tulisi ottaa enemmän mukaan hoidon toteuttamiseen vahvistamalla potilaiden voimaantumista omaan hoitoonsa sekä tukemalla potilaiden kumppanuutta, jotta saavutettaisiin tavoite hyvin informoiduista ja hoitoonsitoutuneista potilaista