Browsing by Subject "patient safety"
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(2018)Drug shortages have become a global issue and reasons for drug shortages are several and multifactorial. Definition of drug shortages is not unambiguous. However, in literature are numerous different suggestions to determine the phenomenon of drug shortages. This study provides more focused information on drug shortages and the reasons behind them. The study was performed in cooperation with Orion Corporation. The aim of this study was to explore the in-depth reasons behind medicine shortages from the perspective of one European pharmaceutical company with special focus on Finland, Germany, the United Kingdom and Sweden. Interviews of the company employees were used to achieve this aim and build a few case studies. Further the aim was to investigate in-depth reasons for drug shortages using data from case studies. Case studies were provided by Orion since this enabled use of unpublished information compare the case studies with relevant legal and regulatory measures in the European pharmaceutical framework which influence drug shortages. Reviewing available data from literature and from EUDRA GMDP database for drug shortages and investigate if the data is detailed enough to understand in-depth reasons for drug shortages. Based on the interview results the most common reasons behind drug shortages in Europe are mainly pharmaceutical market structure 38%. It contains many different factors, such as small stock size, local and foreign manufacturing issues, logistics and distribution issues, changes in demand and regulatory issues. However, the manufacturing (33%) or regulatory (29%) reasons are almost as numerous as pharmaceutical market structure issues. Pharmaceutical market structure issues include most common reasons which are categorized in supply-related and demand-related reasons. According to this study supply-related reasons are more common (73%) than demand-related reasons (27%). Some reasons behind drug shortages overlap and often cause a domino effect, whilst other are unique or stand alone, like reasons resulting from natural disasters. The results of this study seem generalizable because the EUDRA GDMP database shows same results and case studies illustrative same reasons behind drug shortages. This study provides more focused information on drug shortages and the reasons behind them from the perspective of pharmaceutical company and authorities.
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(2023)This qualitative study was carried out as a semi-structured interview study, which was supplemented with quantitative information from centralized cytotoxic preparation units in Finland hospital pharmacies and with information about interviewees. Quantitative information was collected using questionnaires. The proportion of centralized cytotoxic preparation units that responded to the background information questionnaire was 95% (19/20) of all centralized cytotoxic preparation units in mainland Finland. In the autumn of 2022, hospital pharmacy employees (n=23) participating in the reconstitution of cancer drugs were interviewed. On average, the interviewees had 14 years of work experience in the reconstitution of anticancer medicines. They represented 75% (15/20) of the centralized cytotoxic preparation units in mainland Finland, covering centralized cytotoxic preparation units of different sizes and locations in different parts of Finland. In 2021, 88% of the anticancer medicines in all centralized cytotoxic preparation units in Finland were reconstituted at the workplaces of interviewed. According to the interviews, the reconstitution of anticancer medicinal products involves the possibility of an error in several stages of the process. An error can occur when prescribing the medicine, transferring prescription information, when selecting the raw materials, reconstituting of the cancer medicine and during transport. The interviewees identified 24 risks associated with these stages, that could lead to patient safety incidents. Safeguards have been built to avert errors or promote the detection of the errors. Based on the research data, the safeguards were classified into six categories: the development of the technology, guiding work through guidelines, strengthening competence, standardizing practices, controlled working environment and learning from deviations. In Finland, it has not previously been studied or classified with which functions and principles the centralized cytotoxic preparation units have built safeguards to prevent patient safety incidents. This study shows that reconstitution of cancer medicines is a risky process. To improve the quality of reconstituted cancer medicines and patient safety, both the system- and person-focused safeguards have been built into the risk points of the processes of the centralized cytotoxic preparation units, but their utilization varied between centralized cytotoxic preparation units. Based on comprehensive data, the research result can be generalized to centralized cytotoxic preparation units in Finland hospital pharmacies.
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(2015)Background: Medication errors are the most important individual factor that jeopardizes patient safety in human care. The patient's medication process is a chain of successive operations which involves different health care providers and the medicine user. All the stages of the medication process are susceptible to the medication errors. Medication errors are approached from the system's point of view by James Reason`s (1990) theory of Human Error. Instead of blaming individuals the theory concentrates on developing operations models which enable identification of medication errors in the organizations. The development of medication safety culture in the human medication has led to systems which tolerate human mistakes and prevent errors. The increasing number of animals and pets and their changing status in the society have raised discussion about the medication safety in veterinary care. Little research has been conducted in this field. Objective: The objective of the study was to identify the most typical veterinary medication errors and their root causes. The medication management processes of veterinary care can be developed safer by becoming aware of the root causes of medication errors. Study design and data: All the cases investigated by the Assessment Board for Damages in Veterinary Practice in 2002-2013 considering medication errors (n=79) were analysed with the help of the structured data collection sheet by using descriptive statistics. The most typical cases were studied more in detail by using simplified Root Cause Analysis (RCA). Results: The medication errors found were related to the care of dogs (n=34), horses (n=26), bovines (n=10), cats (n=7) and pigs (n=2). The most general therapeutic groups that had caused medication errors were antibacterials for systemic use (17% of all the medicines related to the medication errors), NSAIDs and antirheumatic drugs (12%), neuroleptics and tranquillizers (12%), and analgesics (12%). Of the drugs, 39% were high alert medicines. Of the errors, 36% were related to the off label use (usage deviating from the summary of product characteristics, SPC). The error types which appeared most commonly in the cases were wrong route of administration (18% of all the medication errors), wrong dose (16%) and untreated diagnosed conditions left without the medicine by the veterinarian (15%). Because of the character of the data the majority of the medication errors occurred in the beginning of the medication process. It was estimated that 81% of the medication errors would have been preventable. Some of the root causes found were the lack of the commitment to the established care practice, environmental factors, communication problems, availability of tools, hurry and factors related to management, information and staff. Conclusion: The material of Assessment Board for Damages in Veterinary Practice gives valuable information about the veterinary medication errors. It is possible to influence the root causes of veterinary medication errors by paying attention to the management related factors and communication in veterinary care and improving access to therapeutic guidelines and electronic databases, and by expanding the electronic prescribing to veterinary care. The highest priority is to get Pharmaca Fennica Veterinaria to an electronic form.
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(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.
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(2015)In hospital care many medicines should be usually prepared before they are administered to patients. In Finland Finnish Medicines Agency (Fimea) gives regulatory requirements and instructions for preparation of medicines in hospital pharmacies and action in hospital pharmacies is strictly controlled regularly by Fimea. According to Fimea's instructions hospital pharmacies should also ensure that medicines are prepared properly before they are administered to the patients in hospital wards. Preparing of medicines in hospital wards should be done in accordance with instructions given from the hospital pharmacy. Medicines should be prepared by using aseptic technique in order to protect patient safety. Aim of this study was to develop an assessment tool which can be used to assess the quality of ward- prepared medicines. The assessment tool should be suitable for self-assessment and external audit. Aim of the assessment tool is to ensure the safety of preparation of medicines in the wards and at the end improve patient safety. For the assessment tool ISMP Guidelines for safe preparation of sterile compounds were translated to Finnish. The assessment tool was then developed from the translated ISMP-guideline and other literature. The assessment tool was validated by using two-rounded Delphi-method. Delphi-method is a consensus method in which selected experts evaluate the data. At the first Delphi-round suitability and feasibility of the tool were evaluated and new items were created based on the consensus of experts. At the second round the feasibility of the tool items, which were developed by the first round, were evaluated once again. A total of 19 experts were participated to the Delphi-rounds. After the Delphi-rounds the developed assessment tool contained 64 items for safe preparing of medicines in hospital wards. The developed assessment tool reviews the entire process of preparing medicines and it can be used to identify which items are not followed in preparing of medicines before administering to patients in hospital wards. The developed assessment tool for safe preparation of medicines in hospital wards can be used widely in Finnish hospitals in order to ensure the quality of preparing medicines and detect the deficiencies and errors in preparation processes. By detecting deficiencies and errors in preparing medicines, they can be corrected and processes can be modified appropriate. In this way patient safety can be improved.
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(2016)Healthcare professionals in patient care, including practical nurses, need medicines in-formation in their work. One strategic goal in national Medicines Information Strategy in Finland is to make sure, that healthcare professionals use reliable information sources and services. One part of the national medicines information network in Finland is work-ing group on medicines information for healthcare professionals. It's central aim is to advance availability of reliable medicines information in different environments in social- and healthcare. Objective of this study was to explore medicines information sources and needs among practical nurses. This study concentrated on practical nurses who work in atypical areas of medical care (for example at school and day care), homecare and social care and were members of The Finnish Union of Practical Nurses. Survey was made in co-operation by working group on medicines information for healthcare professionals and The Finnish Union of Practical Nurses. The survey was carried out in December 2013 - January 2014 by e-mail. The random sample consisted of 1 000 practical nurses. The material was analyzed using direct distributions, cross tabulation, Kruskal-Wallis -test and Mann-Whitney U-test. Open ended questions were analyzed by qualitative methods. The response rate was 67 (n = 666). The most commonly utilized medicines information among practical nurses were package leaflets (PL) and medical database Terveysportti. Those sources were also the most preferred ones. Practical nurses reported they would like to have additional medicines information about drug-drug interactions (86 %) and adverse effects (63 %). Information was also needed about generic drugs. The majority of practical nurses in this study were satisfied with current medicines information sources. Additional information about pharmacological treatment was needed by respondents, 14 % daily and 31 % weekly. 82 % of respondents would benefit from pharmacy's services in their work. 64 % of practical nurses had always or usually and 28 % had never mobile device for information seeking. 73 % of practical nurses took part in education concerning pharmacological care less than once in one to two years. Package leaflets and Terveysportti were the most commonly utilized and preferred medicines information sources. There is still need for detailed information about practical nurses' medicines information sources in various working environments.
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(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.
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(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.
Now showing items 1-8 of 8