Lotte Stig Haugbølle

Systematic Review of the Incidence and Characteristics of Preventable Adverse Drug Events in Ambulatory Care

Objective: To estimate the incidence and describe characteristics of preventable adverse drug events (pADEs) in ambulatory care. Data Sources: Studies were searched in PubMed (1966–March 2007), International Pharmaceutical Abstracts (1970–December 2006), the Cochrane database of systematic reviews (1993–March 2007), EMBASE (1980–February 2007), and Web of Science (1945–March 2007). Key words included medication error, adverse drug reaction, iatrogenic disease, outpatient, ambulatory care, primary health care, general practice, patient admission, hospitalization, observational study, retrospective studies, health services research, and follow-up studies. Additional articles were found in the reference sections of retrieved articles. Study Selection and Data Extraction: Peer-reviewed articles assessing pADEs in ambulatory care, with detailed descriptions/frequency distributions of (1) ADE/pADE incidence, (2) clinical outcomes, (3) associated drug groups, and/or (4) underlying medication errors were included. Study country, year and design, sample size, follow-up time, ADE/pADE identification method, proportion of ADEs/pADEs and ADEs/pADEs requiring hospital admission, and frequency distribution of adverse outcome, associated drug groups, or medication errors were extracted. Data Synthesis: Twenty-nine studies met inclusion criteria: 14 were ambulatory-based and 15 were hospital-based. Seven studies enrolled only elderly patients. The median ADE incidence was 14.9 (range 4.0–91.3) per 1000 person-months, and the pADE incidence was 5.6 per 1000 person-months (1.1–10.1). The median ADE preventability rate was 21% (11–38%). The median incidence of ADEs requiring hospital admission was 0.45 (0.10–13.1) per 1000 person-months, and the median incidence of pADEs requiring hospital admission was 4.5 per 1000 person-months. Cardiovascular drugs, analgesics, and hypoglycemic agents together accounted for 86.5% of pADEs, and 77.2% of pADEs resulted in symptoms of the central nervous system, electrolyte/renal system, and gastrointestinal tract. Medication errors resulting in pADEs occurred in the prescribing and monitoring stages. The most frequent drug therapy problem and error of commission reported in ambulatory-based studies on pADEs was the use of inappropriate drugs (42.7%; 40.4–45%). For pADEs requiring hospital admission, the most frequent drug therapy problem and error of omission reported was inadequate monitoring (45.4%; range 22.2–69.8%). Failure to prescribe prophylaxis to patients taking nonsteroidal antiinflammatory drugs or antiplatelet drugs frequently caused gastrointestinal toxicity, whereas lack of monitoring of diuretic, hypoglycemic, and anticoagulant use caused over- or under-diuresis, hyper- or hypoglycemia, and bleeding. Conclusions: ADEs in ambulatory care are common, with many being preventable and many resulting in hospitalization. Quality improvement programs should target errors in prescribing and monitoring, especially for patients using cardiovascular, analgesic, and hypoglycemic agents.

Drug-related problems in patients with angina pectoris, type 2 diabetes and asthma – interviewing patients at home

Objective of the studyThe objective of the overall study was to create a foundation for improving the quality of counselling practice in pharmacies. The research question addressed in this sub-study was to describe drug-related problems (DRPs) in terms of frequency as well as type in people with angina pectoris, type 2 diabetes and asthma, as the problems were identified through medication reviews and home interviews.Setting and methodDuring their pharmacy internships, fourth-year pharmacy students collected data for the study in 1999, 2000 and 2001 by carrying out medication reviews, conducting home interviews and registering DRPs for 414 patients. Data were collected from the following patient groups in the years indicated: in 1999, 123 angina pectoris patients; in 2000, 192 type 2 diabetes patients, and in 2001, 99 asthma patients. The interviews dealt with the patient’s drug-related experiences, knowledge, perceptions, problems and actions. The DRPs were registered according to the so-called PI-Doc system.ResultsA medication review was supplemented by qualitative interviews with the three patient groups, which revealed a relatively high number of DRPs compared to other studies. An average of 2.8 DRPs were identified per angina pectoris patient; 4.1 DRPs per type 2 diabetes patient and 4.0 DRPs per asthma patient. “Inappropriate use of medicines by the patient” and “Other problems” (such as limited knowledge of the illness, inappropriate lifestyle, fear of medication, lack of information, etc.) were the two most common DRP sub-categories identified in all three patient groups.ConclusionThe study provided a profile of a pharmacy-based population of 414 patients visiting the pharmacy, all of whom are at high risk of experiencing drug-related problems. Pharmacy staff needs to take this high rate of DRPs in people with angina pectoris, asthma and type 2 diabetes into account when dispensing medicines to and advising patients from the three groups, especially when explaining how to use medicines appropriately.

Developing a generic, individualised adherence programme for chronic medication users

Objective The scope of this article is to describe the background for and content of an adherence counselling programme with a specific focus on an individualised, multi-dimensional adherence model for patients with a potential adherence problem (a so-called ‘individualised systems model’). Methods An intervention programme based on WHO’s systems model for adherence was developed for implementation in primary health care and tested in a development project in Danish pharmacies in 2004-2005 in three pharmacies and 4 GP practices by 27 patients. Data were collected from the participants by registration forms, questionnaires, and focus groups. Since the programme was to support patients in the self-management process regarding choice and implementation of medication treatment, various strategies were used and different theoretical assumptions and choices made prior to setting up the study. These strategies include distinguishing between different types of non-adherence, a model for stages of change, self-efficacy, narratives, motivating interviewing strategies and coaching techniques. These strategic and theoretical choices are described in the article. Results The strategies and theoretical reflections formed the platform for the creation of a counselling programme, which was tested in two forms, a basic and an extended version - provided by either a pharmaconomist or a pharmacist. The result section also describes a toolbox of instruments to enable pharmacy staff and GPs to tailor a counselling programme for patients individually called ‘Safe and effective use of medicines’. Besides, the results include a description of how the WHO-model is transformed into an individualised counselling model.

A user perspective on type 1 diabetes: sense of illness, search for freedom and the role of the pharmacy

The aim of the study described in this article was to explore young type 1 diabetic patients self-perceived knowledge, perception of diabetes, ways of regulating insulin intake, purpose of behaviour and attitudes about and requirements of the pharmacy. The interest group for utilising this study comprises pharmacy practice researchers and staff at community pharmacies who plan to focus on type 1 diabetic patients. The study, based on 10 semi-structured qualitative interviews, showed how young type 1 diabetic patients can be divided into three different groups based on the way they regulate their insulin intake. These groups are described and discussed in detail in the article. What drives the diabetic patients in terms of regulating insulin intake is primarily their experience-based knowledge and their search for freedom.

Using an action research process in pharmacy practice research—A cooperative project between university and internship pharmacies

BACKGROUND Action research (AR) is a common research-based methodology useful for development and organizational changes in health care when participant involvement is key. However, AR is not widely used for research in the development of pharmaceutical care services in pharmacy practice. OBJECTIVES To disseminate the experience from using AR methodology to develop cognitive services in pharmacies by describing how the AR process was conducted in a specific study, and to describe the outcome for participants. METHODS The study was conducted over a 3-year period and run by a steering group of researchers, pharmacy students, and preceptors. The study design was based on AR methodology. The following data production methods were used to describe and evaluate the AR model: documentary analysis, qualitative interviews, and questionnaires. RESULTS Experiences from using AR methodology and the outcome for participants are described. A set of principles was followed while the study, called the Pharmacy-University study, was being conducted. These principles are considered useful for designing future AR studies. Outcome for participating pharmacies was registered for staff-oriented and patient-oriented activities. Outcome for students was practice as project leaders and enhancement of clinical pharmacy-based skills. Outcome for researchers and the steering group conducting the study was in-depth knowledge of the status of pharmacies in giving advice to patient groups, and effective learning methods for students. CONCLUSION Developing and implementing cognitive pharmaceutical services (CPS) involves wide-reaching changes that require the willingness of pharmacy and staff as well as external partners. The use of AR methodology creates a platform that supports raising the awareness and the possible inclusion of these partners. During this study, a set of tools was developed for use in implementing CPS as part of AR.

Discrepancies between sources providing the medication histories of acutely hospitalised patients

Objective The aim of this study was to clarify the number and type of discrepancies between four medication sources as well as their potential clinical significance to the patient. Method The study was conducted as a cross-sectional study comprising all patients hospitalised with hip fractures in the Orthopaedic Surgery Ward at Amager Hospital. Data were collected from four sources. All information was counted, and the potential clinical significance of discrepancies was evaluated on a five-point scale. The four sources are: patients, the Personal Electronic Medication Profile (PEM), the general practitioner (GP) and the in-home care provider. A discrepancy was defined as any disagreement or omission of information between the four sources concerning name, form, strength and dose for each drug with which the patient was being treated. Main outcome measure The number of discrepancies between the data sources. Results A total of 69 medications were registered for nine patients or an average of 7.7 medications per patient. 10.1 discrepancies per patient and 1.3 discrepancies per drug were registered. Two discrepancies were assessed as having potentially lethal clinical significance. Forty-one discrepancies were assessed as clinically significant, while 36 discrepancies were assessed as possessing minor clinical significance. The PEM added nine prescription drugs that no other sources mentioned. The addition of these medicines was largely clinically significant. Conclusion A total of 91 discrepancies were registered for nine patients. Two of these discrepancies were fatal and 41 were clinically significant.

The relationship between leadership style and provision of the first Danish publicly reimbursed cognitive pharmaceutical service--a qualitative multicase study.

BACKGROUND Evidence suggests that leadership style is important to the sustainability of cognitive pharmaceutical services, yet only scarce literature on the relationship exists. OBJECTIVES Support of the sustainability of the first publicly reimbursed cognitive service in Denmark, the Inhaler Technique Assessment Service (ITAS), was ascertained through a qualitative study to explore how leadership style shapes the implementation process of the service. Sustainability in this project was defined as the state where those asthma patients whose symptom status is negatively clinically affected (as defined by Global Initiative for Asthma guidelines) by inappropriate inhalation technique are identified and offered the service by pharmacy staff. METHODS The study was an exploratory qualitative multicase study that used triangulation of both data sources and methods. A theoretical framework of Bolman and Deal inspired the analysis of how leadership style influenced the local process of implementation of the ITAS. Four pharmacies were selected for the analysis because they differed in terms of leadership actions in their implementation process and achievement of ITAS sustainability. The analysis was inductive and linked factors that influence ITAS provision as perceived by employees with the interpreted leadership style of the owner. RESULTS Three main themes emerged: (1) the alignment of the owner and staff values, (2) whether owners perceived ITAS development as being under their own control, and (3) whether owners explicated the responsibilities of employees in the implementation process. The themes were interrelated. CONCLUSIONS Pharmacy owners leadership style was significant to sustainability of the ITAS. A strong wish by the owner to have ITAS implemented was important, followed by aligning the owners values and visions with those of the employees. The widespread perception by owners that experienced users are not interested in the ITAS needs to be addressed to achieve sustainability.

The relevance of political prestudies for implementation studies of cognitive services in community pharmacies

BACKGROUND Studies of cognitive services implementation in the pharmacy sector traditionally focus on individual and/or organizational factors to explain why some pharmacies are successful and others are not. The social and political context of the origins of these services is rarely part of the analysis. Researchers and practitioners in the field of pharmacy practice research are increasingly being encouraged to take into account the specific political and societal climate which often plays a defining role in the success or failure of cognitive services implementation in community pharmacies. OBJECTIVE The aim of this article is to argue for the inclusion of political pre-studies as part of the study design for implementation studies on reimbursed services in community pharmacy. METHODS A political pre-study of the Inhaler Technique Assessment Service (ITAS) introduced in Denmark in 2004 serves as an example of this approach and is described in detail. Documentary analysis was used in order to gain knowledge of the political background of the ITAS. RESULTS Political pre-studies provide a more precise understanding of the background of the cognitive services and the way they are being performed, thereby supporting more valid results for subsequent implementation studies. CONCLUSION Political pre-studies were shown to be a useful prerequisite when designing implementation studies of cognitive services in community pharmacies and can provide valuable insight into the ultimate success or failure of these services.

Adherence to treatment: practice, education and research in Danish community pharmacy.

Objective: To describe the practice, education and research concerning medication adherence in Danish community pharmacy. Methods: The authors supplemented their expertise in the area of medication adherence through their contacts with other educators and researchers as well as by conducting searches in the Danish Pharmacy Practice Evidence Database, which provides annually updated literature reviews on intervention research in Danish pharmacy practice. Results: Practice: Medication adherence is the focus of and/or is supported by a large number of services and initiatives used in pharmacy practice such as governmental funding, IT-supported medicine administration systems, dose-dispensing systems, theme years in pharmacies on adherence and concordance, standards for counselling at the counter, pharmacist counselling, medication reviews and inhaler technique assessment. Education: In Denmark, pharmacy and pharmaconomist students are extensively trained in the theory and practice of adherence to therapy. Pharmacy staff can choose from a variety of continuing education and post-graduate programmes which address patient adherence. Research: Nine ongoing and recently completed studies are described. Early research in Denmark comprised primarily smaller, qualitative studies centred on user perspectives, whereas later research has shifted the focus towards larger, quantitative, controlled studies and action-oriented studies focusing on patient groups with chronic diseases (such as diabetes, asthma, coronary vascular diseases). Conclusions: Our analysis has documented that Danish pharmaceutical education and research has focused strongly on adherence to treatment for more than three decades. Adherence initiatives in Danish community pharmacies have developed substantially in the past 5-10 years, and, as pharmacies have prioritised their role in health care and patient safety, this development can be expected to continue in future years.

Development of a qualitative exploratory case study research method to explore sustained delivery of cognitive services

Objective To develop, apply and evaluate a new research method to establish relationships between structural and process elements of the provision of cognitive services. In-depth knowledge about how local organisational structural elements of community pharmacies shape the implementation process of cognitive services is needed to develop targeted quality assurance systems to ensure that the services are continuously provided to the patients who need them. The first publicly reimbursed cognitive service in Denmark, the Inhaler Technique Assessment Service (ITAS) is used as the case. Setting The research method was developed at the Faculty of Pharmaceutical Sciences at the University of Copenhagen and later applied to seven community pharmacies geographically spread around Denmark. Methods A pilot study as well as a subsequent literature review was conducted to determine which structure–process elements to focus on in the research method as well as to select appropriate theories and methods. Results The developed research method was a qualitative exploratory multi-case study, that was based on method triangulation of field observations, semi-structured interviews, group interviews as well as collection of documentary material. The three main themes of the research method were: the administration of tasks, leadership style and professional values. We integrated the organisational theories of Mintzberg, Bolman and Deal as well as Sørensen to support and clarify the data collection process and analyses. A cross-case analysis and an exploratory contextual analysis relating the leadership style of the pharmacy owner to the ITAS provision were applied to the collected data. Conclusion The developed qualitative exploratory multi-case study research method was satisfactory with regard to achieving nuanced and in-depth results of some relationships between structural and process elements of provision of cognitive services. The research method can be considered an important supplement to the existing literature on the sustainability of cognitive services.