Browsing by Subject "medication safety"

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  • Mäkinen, Emilia (Helsingin yliopisto, 2021)
    Background and objectives: Documenting and processing of dispensing errors at both organizational and national levels is one of the basic preconditions for effective medication risk management. Since the most recently accomplished national register research of dispensing errors in Finland, there have been several changes in the medication dispensing process that advance medication safety. Thus, the previous study does not provide an up-to-date picture of the current situation. The primary objective of this study was to find out the trends in dispensing errors that were reported to the Finnish Pharmacy Association's registry of dispensing errors in 2015–2019. The secondary objective was to identify risk factors expository to dispensing errors in the dispensing process and to review the measures utilized by community pharmacies to prevent dispensing errors. Materials and methods: The retrospective registry study, in which the register of dispensing errors maintained by the Finnish Association of Pharmacists for the period from 1 January 2015 to 31 December 2019, was analyzed. Cases that did not fulfil the definition of a dispensing error (n=829) were removed from the original data (n=17763). In addition, clear errors (n=2130) were corrected in the data and cases (n=499) that were initially insufficiently entered in the register were added. 17433 dispensing errors were included in the study. The data was analyzed using Microsoft Excel. The number, qualities, prescription types, observers, therapeutic harms and contributory factors of the dispensing errors were investigated in the data. The most common groups of medicinal substance, high-alert medications and risk factors in the medication dispensing process were identified in the data. In addition, interventions reported by community pharmacies to prevent dispensing errors were collected from the data. Results: The number of cases reported to the dispensing error register has decreased annually (2015 n=3913, 2016 n=3795, 2017 n=3708, 2018 n=3578, 2019 n=2439). The most common types of dispensing errors are incorrect strength (51 % of all the reported dispensing errors) and incorrect quantity or package size (14 %). Slightly more than a half (51 %) of the reported dispensing errors were noticed by medicine users. The percentage of electronic prescriptions in dispensing errors has increased and is clearly the most common prescription type in dispensing errors (2015: 79 %, 2016: 84 %, 2017: 93 %, 2018: 96 %, 2019: 95 %). The majority of dispensing errors occurred with cardiovascular medicines (29 %) and medicines affecting the nervous system (26 %). 7 % of dispensing errors caused therapeutic harm to the medicine user. As a result of dispensing errors, 21 medicine users were hospitalized. 13 % of dispensing errors occurred with high-alert medications (n=2244). The high-alert medications were involved in one-third (n=7) of dispensing errors that led to hospitalization. Factors related to the employee (25 %), similar packaging (19 %), and similar medicine name (15%) were most commonly considered to be the main contributory factors for the occurrence of the dispensing errors. The risk factors identified in the medicine dispensing process were related to the pharmacy system, the characteristics of the prescription, the storage method of the medicine and the characteristics of the medicine packaging. In the automated dose dispensing process, the risk of dispensing error increased if changes had to be made to the dose dispensing order. The risk factors for automated dose dispensing were related to the pharmacy system and the characteristics of the prescription. The community pharmacies had mentioned taking measures to prevent dispensing errors in one-fifth (21 %) of the reported cases. In addition to developing their own operations, community pharmacies saw cooperation with other healthcare professionals as an important factor in preventing medication errors. In addition, community pharmacies reported exposing properties for dispensing errors of pharmaceutical products and systems to pharmaceutical companies and providers of pharmacy systems and automated dose dispensing. Conclusions: Trends, risk factors of the dispensing process and interventions to prevent dispensing errors can be identified in the dispensing errors reported to the Finnish Association of Pharmacists’ dispensing error registry. The dispensing error register provides valuable information on dispensing errors at the national level, but it is no longer able to fulfil completely the current medication safety needs. In the future, the role of the pharmacy as a promoter of medication safety should be perceived as more comprehensive. In the development of medication safety, special attention should be paid to the risk factors of the dispensing process, the high-alert medications and to new risks arising from the increase of electronic prescriptions and automated dose dispensing. In addition, cooperation between pharmacies and other healthcare professionals and the medication safety culture of pharmacies should be further strengthened.
  • Falck, Jenni (Helsingfors universitet, 2019)
    Biological medicines are gaining ground in drug therapy. However, biological medicines are considerably expensive. Top ten drugs that caused the most drug reimbursement expenses included six biological drugs in Finland in 2017. A biosimilar is a biological medicine which is highly similar to another biological medicine (the reference medicine) that has already approved. Biosimilar prices are cheaper than the original medicines because their clinical development program does not have to be as extensive. A wide use of biosimilars save costs for both the patient and society without changing the effectiveness of drug therapy. The aim of this study is to investigate the automatic substitution of biological drugs containing the same active ingredient, especially from the point of view of medication safety. The study was conducted as a systematic literature review. Literature search was carried out by using Pubmed and Scopus databases. The literature was also searched manually from references of the articles and from the industry experts. The literature search produced a total of 454 articles after the deletion of duplicates. A title, abstract and full text screening was conducted by two independent researchers. All in all, 65 articles met the inclusion criteria of the study. As no studies were found on the automatic substitution of biological medicines from the point of view of medication safety, it was decided to include in the study original studies investigating the substitution of biological drugs from the point of view of doctors (n=8), pharmacists (n=3), patients (n=1) and various stakeholders (n=2). The original studies were all surveys except one study. In addition, the review included statements of various medical associations and organizations (n=23), descriptive reviews (n=27), and expert views (n=2) on the automatic substitution of biological drugs. According to the results of the original studies (n=13), it can be stated that automatic substitution is not considered generally acceptable. Doctors consider it is very important that the pharmacist informs them if substitution occurs. They also think it’s critical that doctors should be able to prevent substitution. Patients are also sceptical about the substitution of biological drugs. The quality of the original studies was assessed by the generalizability of the research results. The generalizability of the results of the original studies is weak due to the methodological shortcomings of the studies. Although the automatic substitution of biological drugs is legal in some countries, such as in France and in Australia, it has not been studied from the point of view of medication safety. In order to be safe to implement automatic substitution of biological medicines, more should be investigated on the subject. From the point of view of medication safety, healthcare professionals and patients will need further target group education on biosimilars. In addition, it should be clarified what kind of education the healthcare professionals and patients would need if the automatic substitution of biological medicines was to be realized.
  • Porru, Anna (Helsingin yliopisto, 2020)
    Medication-related errors have been identified as the single most important risk factor for patient safety across the world. According to previous research, medication errors are common in nursing homes. However, the existing data on medication errors in Finnish nursing homes is scarce, although the challenges and defects in nursing home care services, including drug treatments, are well known. Furthermore, nursing home residents are typically characterized by old age, multimorbidity and polypharmacy. Therefore, they are particularly vulnerable to potential adverse events caused by medication errors. The aim of this study was to investigate the rates and causes of medication errors reported in nursing homes and evaluate their impact on medication safety. Additionally, the proportions of potentially inappropriate medication (PIMs) and high-risk medication involved in the medication errors were determined. The data of the study consisted of 251 medication errors reports that were submitted to the safety incident report system (HaiPro) in nursing homes located in Central Uusimaa healthcare and social welfare joint municipal authority (Keusote) in 2019. Quantitative analysis of the data provided an overview of the medication errors that had occurred in nursing homes and the medicines most commonly involved in them. Content analysis and simplified root cause analysis enabled to study more in-depth the contributing factors of medication errors and potential risks associated with the medication process in nursing homes, as well as the possibilities of preventing similar errors in the future. James Reason's human error theory and in particular its system perspective was applied as a theoretical framework in this study. Medication errors were reported regularly in nursing homes during the follow-up period of the study. The most frequent medication error type was administration error. The majority of these errors were medication omissions, followed by the wrong time of administration and administration to the wrong patient. The most common drug classes causing medication errors were antithrombotics, opioids, antidementia drugs, diuretics, antipsychotics, antidiabetics, and antidepressants. Nearly a quarter of the reported medicines were high-risk medications, most commonly opioids, antithrombotics, or antidiabetic drugs. PIMs accounted for approximately 13% of all medications in the data. Errors were most often caused by unsafe medication practices, communication problems, and deficiencies in the work environment such as excessive workload or time pressure. A significant part of the medication errors were related to transdermal medication patches. The study also showed that the quality of medication error reporting in nursing homes is in part insufficient and should be improved so that the reports can be better used for learning purposes. The results of the study provide valuable additional information on medication errors in Finnish nursing homes and their contributing factors. The information can be used to improve medication safety practices in nursing homes. Safe and uninterrupted medication use process is a goal that should be pursued not only in health care but also in social welfare services such as nursing homes.
  • Oravainen, Taina; Airaksinen, Marja; Hannula, Kaija; Kvarnström, Kirsi (2021)
    In long-term pharmacotherapies, the renewal of prescriptions is part of the medication use process. Although the majority of medicines are used with renewed prescriptions, little research has focused on renewal practices. The aim of this study was to explore current renewal practices from a primary care physician's perspective to identify system-based challenges and development needs related to the renewal practices. This qualitative study was conducted in two phases in public primary health care centres of Kirkkonummi, Finland. First, five physicians were shadowed on-site while they renewed prescriptions. The findings of the shadowing phase were further discussed in two focus group discussions with seven other physicians than in the shadowing phase. Inductive content analysis was used for data analysis utilizing Reason's risk management theory as a theoretical framework. Due to problems in the renewal process, including impractical information systems, a lack of reconciled medication lists, and a lack of time allocated for renewing prescriptions, physicians felt that monitoring and reviewing each patients' medications for renewal was complicated. Therefore, they felt that renewing, at times, became a technical task rather than a therapeutic decision. The physicians suggested information system improvements, enhanced interprofessional cooperation, and patient involvement as strategies to ensure rational pharmacotherapy and patient safety in the renewal of prescription medicines.
  • Sinnemäki, Juha; Airaksinen, Marja; Valaste, Maria; Saastamoinen, Leena K. (2017)
    Objective: In an automated dose dispensing (ADD) service, medicines are dispensed in unit-dose bags according to administration times. When the service is initiated, the patient’s medication list is reconciled and a prescription review is conducted. The service is expected to reduce drug use. The aim of this national controlled study was to investigate whether the ADD service with medication review reduces drug use among geriatric primary care patients. Design, setting and patients: This is a nationwide cohort study with matched controls. The study group consisted of all primary care patients ≥65 years enrolled in the ADD service in Finland during 2007 (n = 2073). Control patients (n = 2073) were matched by gender, age, area of patient’s residence and number of the prescription drugs reimbursed. The data on all prescription drugs reimbursed during the 1 year periods before and after the ADD service enrollment were extracted from the Finnish National Prescription Register. Drug use was calculated as defined daily doses (DDD) per day. Results: The studied 20 most used drugs covered 86% of all reimbursed drug use (in DDD) of the study group. The use of 11 out of these 20 active substances studied was reduced significantly (p < .001–.041) when the drug use was adjusted by the number of chronic diseases. Two of these drugs were hypnotics and six were cardiovascular system drugs. Conclusions: Drug use was decreased after initiation of the ADD service in primary care patients ≥65 years compared to matched controls in this 1 year cohort study. Further studies should be conducted in order to explore the causality, assess the ADD service’s impact on drug use quality and costs, as well as impact of accompanied prescription review on positive outcomes.
  • Lias, Noora (Helsingin yliopisto, 2021)
    Medication reviews can be used to assess the appropriateness of a patient’s medication and to identify and resolve clinically significant drug-related problems. Medication reviews have been highlighted in several health and medicines policy documents as ways to improve medication safety in older adults. Collaborative practices and their development are key strategies in promoting the coordinated care of patients. Medication reviews have been previously defined from a multi-professional perspective but no definition based on multi-professional consensus has been established. The aim of this study was to harmonize the definition of medication review from a multi-professional perspective to suit various healthcare contexts in Finland. The goal was to create a shared understanding for physicians, nurses, pharmacists, information management professionals for their collaboration in reviewing medications. Furthermore, the aim was to define the tasks and responsibilities of different professional groups in collaborative medication reviews in order to support its implementation. The study was conducted as a 3-round survey using the Delphi method. The Delphi method is a qualitative consensus method based on the views of experts aiming at reaching consensus on the studied subject. The Delphi rounds were conducted as electronic surveys in September-December 2020. Expert panelists assessed the proposed definition of a collaborative medication review and the tasks and responsibilities of health care professionals involved in conducting it. The expert panel consisted of 41 participants: 12 physicians, 13 pharmacists, 10 nurses, and 6 information management professionals. The results of the study were analyzed both quantitatively and qualitatively. Consensus was reached on the definition of medication review from a multi-professional perspective, while no consensus was reached on most of the responsibilities and tasks of different healthcare professionals involved. Most challenging was to define patient groups benefiting from medication reviews and the situations in which medication reviews should be performed. Therefore, further research is needed to define the division of responsibilities between care team members, for example by defining separately the responsibilities and tasks in different healthcare contexts. This is the most comprehensive attempt taken in Finland to define medication review as a concept from a multi-professional perspective. The results of the study imply to the development and harmonizing of medication review practices and standardizing patient data documentation. The expected outcomes relate to enhanced patient and medication safety, improved coordination in medication management with integrated medication reviews.
  • Luoma, Elisa (Helsingin yliopisto, 2020)
    Family caregiving refers to the organization of home care for an older adult, disabled or sick person with the assistance of a relative or other close person. The number of elderly carers (> 65 years) of all family garegivers is significant. There are challenges concerning family caregiving for the older adults, due to increased age is in connection with decreased physical performance and increased number of medications and polypharmacy. Despite these factors, there has been little research on the medication safety in the family caregiving among older adults. The aim of this Master's thesis was to identify factors influencing the ability of a caregiver to cope with the medication management of the older adults. These factors were divided into subgategories: factors associated a family caregiver, associated a care recipient and system-oriented factors. The research was conducted as a method triangulation, in which the data were collected through two interviews with home visits (n = 21) and related questionnaires. The questionnaire data were quantitatively analyzed by calculating the frequencies and relative frequencies. The transcribed interviews were analyzed by abductive content analysis, combining both deductive and inductive approach. James Reason's theory of human error was used as the theoretical framework. Caregiving families participating in this research were very different compared with each other. Some family caregivers and care recipients were in good physical condition while others were severely disabled. However, the situation of the families was not individually considered when considering appropriate support services for the families. The workload of family caregivers due to the pain and the absence of days off contributed to the difficulty of medication management. The foremost system-oriented challenges in the management of the medications were: 1) difficult for the families to reach the physician and 2) for those families where assisted home care helped the caregiver, the families were not satisfied with its functioning. Due to the poor availability of physicians and the lack of a family physician, there was no one in control of the medication as a whole and there was inadequate monitoring of the medication. In the assisted home care, challenges were caused by the fact that home care visits were conducted over a wide period of time, which created challenges for giving the medications. Carers do not receive sufficient support from the society for the management of the medications. The medication safety of the older adults in the family caregiving is particularly affected by the difficulty of reaching a physician, the inadequacy of support from the assisted home care, the failure to recognize the individuality of caregiving families, and the caregivers’ burden due to pain and lack of days off. Support for caregivers must be at the forefront of society in the future, so that caregivers can cope with heavy nursing care and complicated medications, even without excessive self-activity.
  • Karasti, Eveliina (Helsingfors universitet, 2019)
    The amount of informal caregiving has increased in Finland, with a growing emphasis on the older adults. Although the medication management process in informal caregiving has been studied and is known to have significant risks, research data focusing on the older adults is still limited. The aim of this study was to describe the medication management process of informal carers and care recipients of at least 65 years old. The aim was to identify medication errors and medication risks in the medication management process and to find out how the caregivers manage them. In addition, the study examined the informal carers and care recipients own development proposals to improve medication management process. A total of 21 volunteer informal carers and care recipients living in the Helsinki metropolitan area were recruited to this study. The study was conducted as a qualitative interview survey in the homes of the participants. The interviews were a combination of semi-structured interviews and narrative approach. The material to this study was collected during spring and summer 2018. The study was analysed with abductive content analysis combining both deductive and inductive approach. The aim was to find repetitive elements by encoding and grouping expressions. The results of this study were compared with previous theory and the results were supplemented with a picture of the medication management process and a fishbone diagram was drawn from the risk factors and contributing factors of the medication management process. The families had medication errors in all stages of the medication management process. The most frequent medication errors were found in counselling, medication administration and in medication treatment monitoring. As a contributing factor, the healthcare professionals’ haste and the responsibility of the caregiver recurred in the background of the medication errors. Family caregivers and care recipients wish to have more counselling, more monitoring of medication and better interaction with health care. Carers often felt left alone to take care of another person's medications and felt they lack support from healthcare. By facilitating access to a physician, improving the availability of a physician, increasing the amount of counseling and support provided by healthcare, including pharmacies, could the safety of medication management at home be improved.
  • Mononen, Anna (Helsingfors universitet, 2012)
    Herbal preparations are widely used nowadays and the information given has developed a lot during the last decades. Herbal preparations haven`t been acknowledged as medicines and therefore their efficacy and adverse effects are still often underrated. In 2005 along the changes in legislation differently legislated group of herbal preparations was retired. Nowadays herbal preparations are divided to drugs and food products. The aim of the study was to make oneself familiar with the legislation of these products and the evolution of the pharmaceutical information given. The aim also was to compare warnings, prohibitions, contraindications and their evolution to prevalent legislation. The material of the study consisted of product information summaries, patient information leaflets and labeling of herbal medicines, traditional herbal medicines and their predecessors. In addition to this there was also other legislative material. Only herbal medicines and traditional herbal medicines according to directive 2004/24/EY of the European parliament and the council`s definition were taken in to account. According to 2004/24/EY herbal medicinal products is any medicinal product, exclusively containing as active ingredients one or more herbal substances or one or more herbal preparations, or one or more such herbal substances in combination with one or more such herbal preparations. There were all together 194 products included in the study. Documentation of 184 products was found on paper in Fimea`s archives. Of the remaining five out of ten products it was found some basic information in electronic rohdos-register and of one product on an on paper final act. Data of these six products was only used partly because of its deficiencies. The data of four products wasn`t found. Under a more detailed study there was all together 184 products between 1964 and 2011. The material was divided to time periods 1964 - 1983, 1984 - 1987, 1988 - 1995, 1996 - 2005 and 2006 - 2011 by the changes in legislation. The information given of herbal preparations was the most affected by the changes in legislation in 1994 and 2005. The amount of new licenses was increasing until the time period 1988 - 1995. Licenses were granted the most during 1988 - 1955. After 1996 the amount of warnings, prohibitions and contraindications rose and many of the products that got the license in previous time period 1966 - 1955 left the market or transferred under the food legislation. As well many products with less consumption left the market because new studies demanded were expensive and cumbersome. In 2005 along the changes in legislation a clear change in attitudes came true, when a vague group of herbal preparations was removed and herbal preparations were divided into pharmaceuticals and food products. Along this change it has become easier for health care professionals to assess the risks and benefits of herbal preparations and advise the clients while making the decisions.
  • Tikkanen, Johanna (Helsingin yliopisto, 2020)
    Between 5% and 57% of patients experience an adverse drug event during their hospitalization. Reducing medication errors can help prevent adverse drug events. A particular risk for medication errors arises when a patient moves between home and care centers if accurate medication information is not transferred with the patient. Medication reconciliation is a process to ensure accurate and comprehensive medication information across transitions of care. The aim of the study was to find out how many and what kind of discrepancies can be detected by performing medication reconciliation in a primary care unit. In addition, pharmacists and nurses experiences of the medication reconciliation process and the medication reconciliation form were examined. Both quantitative and qualitative data were used in the study. Quantitative study data consisted of all Medication reconciliation forms (PASQ) completed in January-June 2014. Data were analyzed using quantitative descriptive methods. The qualitative research material consisted of six individual interviews conducted in June 2014. The material was subjected to inductive thematic content analysis. Patients (n = 117) had a mean age of 81 years and almost all (n = 105) had at least six regularly used medications after medications were reconciled. Almost every patient (n = 115, 98.3%) had at least one discrepancy in their medication compared to the patient information system. On average, patients had seven discrepancies in their medication lists. The most discrepancies were associated with psycholeptics (9.5% of all discrepncies). The most common types of discrepancies were new drug (45.4% of all discrepancies) and discontinued drug (19.6%). Nurses and pharmacists saw the medication reconciliation process as an important part of successful patient care. Challenges associated with reconciling medications were caused by lack of time, the fragmentation of information systems and the health status of patients (information given by patients could not be trusted). Only one-third of the patients were interviewed, although international publications on medication reconciliation strongly emphasize patient involvement. The results of this study are in line with previous research and confirm the view that medication reconciliation should always be done across all transitions in care. The role of the patient as part of the medication reconciliation process should be further emphasized in the future, as only interviewing the patient can provide a true picture of the patient's medication.
  • Kallio, Rosanna (Helsingfors universitet, 2017)
    A large part of patient safety incidents in health care is related to medicines and medication treatment. Medication safety is an important part of patient safety. In particular, transitions of care endangers continuity of care and patient safety. A poor flow of information between health care units increases a risk of medication errors. An accurate and up-to-date medication list can improve transfer of correct medical information with the patient. In addition to the medication list other organization-level defences are important to patient and medication safety. This study is part of a larger regional development project concerning reformation of service delivery in health and social care. One of the purposes of the project is to integrate health and social services of municipalities in central Uusimaa (Hyvinkää, Mäntsälä, Pornainen, Järvenpää, Nurmijärvi and Tuusula). The aim of this study was to investigate what kinds of medication lists are available in these municipalities and to design a medication list maintained by the patient which is regionally shared. The second aim of the study was to identify defences used by the municipal healthcare systems and to develop a medication management process model for the municipalities. The material consisted of medication lists from the municipalities participating in the study. Twelve (12) lists were selected for analysis. The medication list of Lääkekortti.fi was also included in the analysis (N=13). Data of the defences was collected by a questionnaire. In Hyvinkää the material was collected from primary health care and Hyvinkää hospital. Both the medication list and the defence data were systematically reviewed and collected in a Microsoft Excel table. The regional medication list for patients was developed based on the medication list data and the existing literature. The process model for medical treatment was developed based on the defence data. Almost every medication list contained space for personal data (n=11) and basic medication information, such as the name of the drug (n=12), strength (n=12) and dosage (n=13). Regular medication was usually separated from as-needed medication (n=8). Only two of the lists had a column for periodic medication. There were only two lists with columns for over-the-counter medicines and herbal products. Less than half of the lists (n=5) had space for indication. According to the survey, most of the defences listed in the questionnaire were used in all or almost all municipalities. According to the responses, medication lists, for example, are regularly reviewed. Some gaps in defences also emerged. Only in two municipalities high-alert medications were identified. Also only in two municipalities attention was paid to the storage of look-alike medicines. Written instructions for managing medication errors was available only in two municipalities. There are many different medication lists available in health care. A regionally shared medication list maintained by the patient can improve the transfer of the up-to-date medical information with the patient. The list must be comprehensive and easy to use. Both the patient and the healthcare professionals should be responsible for maintaining the accurate medication list. Most of the defences asked in the questionnaire have been taken into account in pharmacotherapy plans. In practice, however, the implementation of defences is unclear. For example patients' medication lists often contain errors even though lists should be reviewed regularly. There should be exact instructions as well as clearly defined roles and responsibilities for medication reconciliation. More attention should also be paid to the use of high-alert and look-alike medicines. Since errors occur despite the defenses, every health care unit should have written instructions in case of medication errors.
  • Kuitunen, Sini (Helsingfors universitet, 2014)
    The role of community pharmacy is to ensure and promote medication safety in treatment of outpatients. In Finland a national four-year medication safety program Apila was launched in 2012. The Apila program aims to improve medication safety with pharmaceutical counselling and followup, support development and implementation of new tools and practices promoting medication safety, increase awareness of medication safety as part of patient safety and increase co-operation between community pharmacies and other social- and healthcare services. The objective of this study was to investigate medication safety situation of Finnish pharmacies in the beginning of Apila program. Research data was collected electronically at the end of 2012 by using a two structured survey instruments. Target of the study was the whole pharmaceutical staff of Finnish community pharmacies. There were two separated study samples. Survey instruments were alike for both samples with the exception of one section. One survey was sent to all independent pharmacy owners (n=593) and managers of university pharmacies (n=18). The other survey was sent to one member of pharmaceutical staff in every community pharmacy (n=618) and university pharmacies (n=17). The response-rate of pharmacy owners (O) was 39 % (n=241) and response-rate of pharmaceutical staff (S) was 29 % (n=182). Representativeness of data was good compared to standard population. According to study the barriers built into the dispensing process worked well. Verifying dose (O: 100 %, S: 98 %), interactions (O: 97 %, S: 94 %) and duplicated medications (O: 79 %, S: 70 %) was a common part of dispensing process. Over half of pharmacies had a written standard operating procedure to medication counselling given when dispensing prescribed (O: 74 %, S: 60 %) and over the counter medicines (O: 60 %, S: 60 %). About 90 % of the pharmacies had a standard operating procedure to reporting and managing dispensing errors (O: 92 %, S: 84 %). According to almost all respondents (O: 96 %, S: 91 %) medication errors were reported in their workplace. Though discussing dispensing errors with whole staff (O: 73 %, S: 53 %) and changing course of action after managing dispensing errors (O: 85 %, S: 63 %) was not as common. The respondents were of the opinion that pharmacy had closer co-operation with home care and social services than with health care services. Some pharmacies had agreed with local healthcare how to manage interactions (O: 39 %, S: 23 %), contraindications (O: 36 %, S: 19 %) and prescribing errors (O: 28 %, S: 15 %) discovered in pharmacy. The study indicates that Finnish community pharmacies have good abilities to identify medication related problems. Co-operation between community pharmacies and other social- and health care services should be promoted, because it seems to be superficial. The biggest challenges in risk management are complete invocation of data collected through error reporting and including medication safety audits into quality management. Pharmacy owners' answers to the questionnaire were more positive than staff members', which indicates that actions to promote medication safety should be made more visible. Coordination of medication safety should be emphasized both national and individual pharmacy level. Low response-rates weaken the reliability of the study, but the results are suggestive.
  • Vironen, Aleksi (Helsingin yliopisto, 2021)
    Evidence based medicines alongside with age-appropriate dosage forms are essential in enabling appropriate treatment for any patient group. Pediatric pharmacotherapy, however, is lacking age-appropriate dosage forms and research-based evidence regarding the dosing, efficacy, and safety of medicines. Orally administered drugs require manipulation to enable administration and are often used against the indications approved in the marketing authorization and summary of product characteristics (SmPC). This off-label use puts pediatric patients at risk for medicational errors and adverse drug reactions. The aim of this study was to investigate recent trends in oral dosage forms used in pediatric randomized controlled trials (RCTs), with emphasis on age appropriateness. The results could be utilized in developing evidence-based dosage forms, suitable for all pediatric patients aged 0-17 years, and manufacturable in a small scale in a hospital pharmacy. This study was conducted as a systematic review following the PRISMA Statement. The literature search was carried out from Pubmed and Scopus databases and it covered a five-year period of 2015-2020. References from the databases were entered to the Covidence systematic review platform. After removing duplicates 3333 articles were left for screening. Two independent researchers selected the articles first screening by title and abstract, and then by full text review. A qualitative content analysis was conducted on the included articles. Altogether 77 articles met the inclusion criteria. Dosage forms included were tablets (n=37), liquids (n=21), capsules (n=18) and multiparticulates (n=6). Majority of the dosage forms were conventional (n=49) compared to more advanced novel modified release and fixed-dose combination formulations (n=33). Based on our results, orally administered dosage forms used in the recent pediatric RCTs are still limited by poor acceptability, palatability, and the need to manipulate dosage forms to enable administration. These issues are similar to the ones related to the off-label use of medicine that compromise patient safety. Majority of the dosage forms included in our study were tablets, indicating a positive shift towards more safe and acceptable dosage form. Formulations were also evolving towards dispersible, extended-release and fixed-dose combinations that offer additional benefits for pediatric patients. The low number of children < 2 years old included in study populations and the poor acceptability profile reported by most studies limit our conclusions on an ideal age-appropriate dosage form. Further research is needed on unifying the guidelines used in pediatric drug development.
  • Aronpuro, Kirsi (Helsingfors universitet, 2017)
  • Pottonen, Riitta-Liisa (Helsingfors universitet, 2015)
    Medication safety is safety related to the use of medicines. Medication errors are drug treatment related events which can lead to medication safety incidents. Medication process is multi-professional teamwork which contains a risk of medication error on every step. It is important to identify potential safety risks in order to prevent the risk events. Medication errors can occur for example during the transfer of the prescription information in to the medication list. It is important that medication lists are accurate and up to date so that patient's medication therapy is optimal. The aim of this study was to assess whether the primary health care medication lists are up to date, accurate and easy to read. The aim was also to identify what kind of information in medication lists was open to interpretation. In one of the municipalities, the medication lists at home were compared to the medication lists at primary care to see whether both lists had identical information on the medication. The data of this study consisted of 240 medication lists from primary care units in three Finnish municipalities. The lists contained altogether 3062 medications. Most of the lists were printed from the patient information systems. Some of the lists were copied from the home medication lists. All medication lists were systematically reviewed and issues open to interpretation were documented in a structured Microsoft Excel table. The data were transferred to SPSS 20 Program for statistical analysis. Most (73%, n=174) of the medication lists (n=240) were incomplete. One-fifth (n=612) of the medications in use (n=3062) contained missing information on medicines. The total number of discrepancies was 807 (mean 3.4 discrepancies per medication list). The most common discrepancies were related to the time of administration (n=277) and dosages (n=241). Duplicate medications included a lot of confusing information. Discontinued medications were not always clearly marked. In only one of the municipalities the medication lists had a space for marking the indication. There were some differences between home medication lists (n=62) and primary care medication lists. ™ Based on this study medication lists have a lot of discrepancies and ambiguities in their information content. The medication lists do not always accurately tell the patient's current medication. Interpretation of inaccurate medication lists consumes unnecessarily doctors' and nursing staff's time. Inaccurate medication lists are a risk to patient safety. It is also important that the medication lists would be similar in all health care units. Electronic prescriptions, the National Health Archive and medication list developed by Information Management Service of Healthcare are expected to solve at least some of the problems related to medication lists.
  • Eronen, Anna-Kaisa (Helsingfors universitet, 2016)
    Medication safety meaning the safety of using medication is an important part of patient safety. Medication errors are the most common preventable threats of patient safety. Medication errors can occur in all stages of the medication process. Rather than blaming individuals involved in the process, incidents should be evaluated based on system thinking with an aim of identifying system and process-based weaknesses allowing errors to happen. James Reason's human error theory provides a good framework to investigate the topic from this perspective. The objective of this study was to gather information on the medication errors based on the Patient Insurance Centre 2013-2014 data of compensated medication errors. One of the aims was to identify different types of medication errors and gather information on their backgrounds and drugs involved. Another aim was to investigate the causes behind the medication errors and the views of the people involved on the contributin factors of these errors. Additionally the study aimed at identifying situations where interprofessional collaboration could have prevented medication errors from occurring. Finally the results of the study were also compared with the results of the earlier studies done using similar data. The data of the study consisted of 205 cases where medication error had caused compensated patient injury. Factors behind the errors were analyzed using descriptive statistics. The examples of most common cases were investigated more in depth through simplified root-cause analysis. Content analyses were used to gather information on the views of the people involved in errors as well as on the possibilities of preventing errors through interprofessional collaboration. The most frequent error type was omission of medication. The majority of the errors occurred in the early stages of the process when decisions on medication and treatment were done. There were altogether 250 drugs in the data out of which 98 different active ingredients were identified. Antithrombotic agents were the most common therapeutic group causing medication errors. 37% of all drugs included in data were classified as high alert medicines. More efficient use of the interprofessional collaboration could have prevented several medication errors. The number of medication errors had somewhat increased compared to earlier studies but the profiles of errors were very similar. The data of Patient Insurance Centre provides valuable information on medication errors across Finland. More accurate information on factors leading to medication errors could be obtained by improving voluntary nationwide reporting. This would make it easier to develop operating models that improve patient safety.
  • Nieminen, Emmi (Helsingfors universitet, 2016)
    Adverse drug events (ADE) are a major problem which deteriorates the quality of drug therapy. They cause significant morbidity and mortality each year. ADEs are often caused by incompatible drug combinations, drug-drug interactions (DDIs). Interprosessional collaboration between health care professionals is important in improving medication safety and preventig drug interactions. The aim of this study was to investigate the most common clinically significant drug-drug interactions in outpatient care and the role of pharmacist in preventing them. The study material was an interaction data which was collected in Helsinki University Pharmacy during August 2015. DDIs and the action needed by presecribers or pharmacists to handle them were collected. Only clinically significant interactions of the SFINX interaction database i.e. D- and C-interactions were recorded. The most common D-interactions (interactions to be avoided) were fluoroquinolones or tetracyclines combined with metal ions (calcium, iron, magnesium, aluminium) (14.7 % of D-interactions) and codeine or tramadol combined with CYP2D6 enzyme inhibiting antidepressants (12.6 %). C-interactions concerned most commonly interactions between antihypertensive drugs and NSAIDs (26.2 % of C-interactions). 59.6 % of D-interactions were interactions that might result in adverse drug reactions and 40.4 % were interactions that might result in therapeutic failure. For C-interactions numbers were 49.4 % and 50.6 %, respectively. Only a few interactions (1.6 %) led to contact with the prescriber from the pharmacy, and more often (1.8 %) the pharmacist advised the patient to contact the prescriber. 32.6 % of the interactions led to pharmacist's advice. The most typical interactions which can be prevented by pharmacist's advice were chelation interactions which can be prevented by taking drugs many hours apart from each other. 59.7 % of the interactions produced no action in pharmacy. Those concerned situations where the prescriber had planned the treatment and weighed up the benefits and risks of the medication, or interactions where the drugs had been in contemporary use for a long time, and thus the pharmacist assumed that the prescriber had planned the treatment. Pharmacists should intervene in drug-drug interactions easier. To avoid unnecessary calls, communication between prescribers and community pharmacies should be developed. Pharmacists' role in preventing DDIs could be improved for example by education and by updating the operations models in collaboration with other health care. Safe and efficient drug treatment should be ensured with interprofessional collaboration, and the responsibility should not be shifted to the patient alone.
  • Kuitunen, Sini Karoliina; Niittynen, Ilona; Airaksinen, Marja; Holmström, Anna-Riia (2021)
    Objectives Intravenous medication delivery is a complex process that poses systemic risks of errors. The objective of our study was to identify systemic defenses that can prevent in-hospital intravenous (IV) medication errors. Methods A systematic review adhering to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines was conducted. We searched MEDLINE (Ovid), Scopus, CINAHL, and EMB reviews for articles published between January 2005 and June 2016. Peer-reviewed journal articles published in English were included. Two reviewers independently selected articles according to a predetermined PICO tool. The quality of studies was assessed using the Grading of Recommendations Assessment, Development and Evaluation system, and the evidence was analyzed using qualitative content analysis. Results Forty-six studies from 11 countries were included in the analysis. We identified systemic defenses related to administration (n = 24 studies), prescribing (n = 8), preparation (n = 6), treatment monitoring (n = 2), and dispensing (n = 1). In addition, 5 studies explored defenses related to multiple stages of the drug delivery process. Systemic defenses including features of closed-loop medication management systems appeared in 61% of the studies, with smart pumps being the defense most widely studied (24%). The evidence quality of the included articles was limited, as 83% were graded as low quality, 13% were of moderate quality, and only 4% were of high quality. Conclusions In-hospital IV medication processes are developing toward closed-loop medication management systems. Our study provides health care organizations with preliminary knowledge about systemic defenses that can prevent IV medication errors, but more rigorous evidence is needed. There is a need for further studies to explore combinations of different systemic defenses and their effectiveness in error prevention throughout the drug delivery process.
  • Oravainen, Taina (Helsingfors universitet, 2019)
    Pitkäaikaiset lääkitykset lisääntyvät jatkuvasti kroonisten sairauksien yleistymisen ja väestön ikääntymisen takia. Pitkäaikaisten sairauksien hoidossa lääkehoitojen rationaalisuus korostuu, mutta WHO:n arvioiden mukaan noin puolet lääkkeiden määräämisestä, toimittamisesta, käytöstä ja myynnistä toteutuu epärationaalisesti. Tämä lisää terveydenhuollon ammattilaisten vastuuta lääkehoidon vaikutusten seurannassa ja potilaan hoitoon sitouttamisessa myös reseptien uudistamisessa. Reseptien uudistamiskäytäntöjä on kuitenkin tutkittu vähän niin Suomessa kuin maailmanlaajuisesti. Tässä pro gradu -tutkielmassa tavoitteena oli tarkastella nykyisiä reseptien uudistamiskäytäntöjä perusterveydenhuollon lääkäreiden näkökulmasta. Tavoitteena oli tarkastella, minkälaiset tekijät vaikuttavat lääkäreiden työskentelyyn sekä potilaan lääkehoidon kokonaisuuden hallintaan ja turvallisuuteen reseptien uudistamistilanteissa. Lisäksi kartoitettiin lääkäreiden ratkaisuehdotuksia uudistamiskäytäntöjen kehittämiseksi. Tutkimus toteutettiin laadullisena monimenetelmätutkimuksena Kirkkonummen terveysasemilla. Tutkimuksessa hyödynnettiin triangulaatiota ja tutkimusaineisto koostui reseptien uudistamistilanteiden varjostuksesta sekä kahdesta lääkäreiden ryhmähaastattelusta. Tutkimukseen osallistui yhteensä 12 lääkäriä, joista viisi osallistui varjostusvaiheeseen ja seitsemän haastatteluvaiheeseen. Aineisto kerättiin huhti-heinäkuun 2019 aikana. Tutkimuksen teoreettisena viitekehyksenä oli inhimillisen erehdyksen teoriaan perustuva järjestelmälähtöinen näkökulma. Tutkimusaineisto analysoitiin aineistolähtöisellä sisällönanalyysillä, jossa varjostus- ja haastatteluaineistosta etsittiin tutkimuksen tavoitteiden kannalta merkittäviä ilmaisuja. Reseptien uudistaminen on lääkäreiden näkökulmasta monivaiheinen prosessi. Prosessiin vaikuttivat useat uudistamista helpottavat ja vaikeuttavat järjestelmä-, potilas- ja lääkelähtöiset tekijät. Lääkärit tunnistivat ongelmakohtia uudistamisprosessin jokaisesta vaiheesta. Lääkäreiden mukaan etenkin tietojärjestelmien epäkäytännölliset ominaisuudet ja tekniset ongelmat sekä ajantasaisten lääkitystietojen ja tiedonkulun puutteet olivat uudistamistilanteissa ongelmallisia ja tekivät uudistamisesta työlästä. Myös kiire ja uudistettavien reseptien suuri määrä vaikeuttivat uudistamista. Ongelmien takia lääkärit kokivat, ettei lääkehoitojen seurantaa voitu tehdä uudistamistilanteessa perusteellisesti. Lääkäreiden ehdotuksia uudistamisprosessin kehittämiseen olivat uudistamisen parempi koordinointi, tietojärjestelmien ja tiedonvälityksen kehittäminen sekä moniammatillisen yhteistyön ja potilaan osallistamisen lisääminen.
  • Takala, Anna (Helsingfors universitet, 2019)
    Medication safety is a part of patient safety, and means safety related to the use of medicines. Medication safety covers the principles and functions of individuals and organizations working in the healthcare sector to ensure the safety of drug treatment and to protects patient from harm. Medication error is any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional, patient or consumer. Medication errors are the leading cause of preventable harm in health care across the world. Therefore, improving medication safety is important from the point of view of the promotion of patient safety. The aim of this study was to gather information about serious medication errors at national level by utilizing data from Valvira to learn from the cases outside the organizations where they occurred. The data of this study consisted of complaints and regulatory statements resolved by Valvira in 2013–2017, in which drug treatment were identified as a main reason and where inappropriateness was found (n=58). Cases were classified with predetermined classification system, and inductive content analysis was used to identify the causes and contributing factors of medication errors. The theoretical framework of the study was the Human Error Theory by James Reason (1990). According its systems-based approach, this study focused on the processes and circumstances of organizations. Of the included 58 cases, medication errors caused patient’s death in 21 cases (36 %) and severe harm in nine cases (16 %). A majority (n=53; 91%) of the errors were estimated to be either definitely or possibly preventable. Most of the patients were older adults (mean age 74 years). The most commonly related drugs in medication errors were enoxaparin (n=7; 6%) and oxycodone (n=7; 6%). The most common therapeutic group causing medication errors was antithrombotic agents (n=17; 13%). Most errors occurred in hospital settings (n=29; 45%) and in elderly care units. Doctors (n=37; 50%) were most often involved in the errors. Most of the medication errors occurred in the prescribing (n=38; 47%), administrating (n=15; 19%) and monitoring stage (n=14; 17%), drug-related problems being most often connected to the drug selection. In severe and fatal cases, there are often several drug related problems identified at different stages of the patient’s drug treatment process. The data of Valvira provide valuable information about medication errors at national level. Qualitative analysis is important especially for learning purposes as it provides better understanding of the causes and contributing factors of medication errors, as well as the complexity of drug treatment processes. Based on this study, it seems that healthcare organizations involved in severe medication error cases have taken into consideration the importance of process development and focused on identifying latent risks in organizational conditions and processes rather than blaming individuals.