Birthe Søndergaard

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.

Improving the well-being of elderly patients via community pharmacy-based provision of pharmaceutical care: a multicentre study in seven European countries.

ObjectiveThis study aimed to measure the outcomes of a harmonised, structured pharmaceutical care programme provided to elderly patients (≥65 years of age) by community pharmacists in a multicentre international study performed in 7 European countries.Design and settingThe study was a randomised, controlled, longitudinal, clinical trial with repeated measures performed over an 18-month period. A total of 104 intervention and 86 control pharmacy sites participated in the research and 1290 intervention patients and 1164 control patients were recruited into the study.Main outcome measures and resultsA general decline in health-related quality of life over time was observed in the pooled data; however, significant improvements were achieved in patients involved in the pharmaceutical care programme in some countries. Intervention patients reported better control of their medical conditions as a result of the study and cost savings associated with pharmaceutical care provision were observed in most countries. The new structured service was well accepted by intervention patients and patient satisfaction with the services improved during the study. The pharmacists involved in providing pharmaceutical care had a positive opinion on the new approach, as did the majority of general practitioners surveyed. The positive effects appear to have been achieved via social and psychosocial aspects of the intervention, such as the increased support provided by community pharmacists, rather than via biomedical mechanisms.ConclusionsThis study is the first large-scale, multicentre study to investigate the effects of pharmaceutical care provision by community pharmacists to elderly patients. Future research methodology and implementation will be informed by the experience gained from this challenging trial.

Provision of pharmaceutical care by community pharmacists: a comparison across Europe

Objective To investigate the provision of pharmaceutical care by community pharmacists across Europe and to examine the various factors that could affect its implementation. Methods A questionnaire-based survey of community pharmacies was conducted within 13 European countries. The questionnaire consisted of two sections. The first section focussed on demographic data and services provided in the pharmacy. The second section was a slightly adapted version of the Behavioral Pharmaceutical Care Scale (BPCS) which consists of three main dimensions (direct patient care activities, referral and consultation activities and instrumental activities). Results Response rates ranged from 10–71% between countries. The mean total score achieved by community pharmacists, expressed as a percentage of the total score achievable, ranged from 31.6 (Denmark) to 52.2% (Ireland). Even though different aspects of pharmaceutical care were implemented to different extents across Europe, it was noted that the lowest scores were consistently achieved in the direct patient care dimension (particularly those related to documentation, patient assessment and implementation of therapeutic objectives and monitoring plans) followed by performance evaluation and evaluation of patient satisfaction. Pharmacists who dispensed higher daily numbers of prescriptions in Ireland, Germany and Switzerland had significantly higher total BPCS scores. In addition, pharmacists in England and Ireland who were supported in their place of work by other pharmacists scored significantly higher on referral and consultation and had a higher overall provision of pharmaceutical care. Conclusion The present findings suggest that the provision of pharmaceutical care in community pharmacy is still limited within Europe. Pharmacists were routinely engaged in general activities such as patient record screening but were infrequently involved in patient centred professional activities such as the implementation of therapeutic objectives and monitoring plans, or in self-evaluation of performance.

Agreement between self-reported data on medicine use and prescription records vary according to method of analysis and therapeutic group

OBJECTIVE This study compared national self-reported data on medicine use and national prescription records at the individual level. STUDY DESIGN AND SETTING Data from the nationally representative Danish health survey conducted in 2000 (n=16,688) were linked at the individual level to national prescription records covering 1999-2000. Kappa statistics and 95% confidence intervals were calculated. RESULTS Applying the legend time method to medicine groups used mainly on a chronic basis revealed good to very good agreement between the two data sources, whereas medicines used as needed showed fair to moderate agreement. When a fixed-time window was applied for analysis, agreement was unchanged for medicines used mainly on a chronic basis, whereas agreement increased somewhat compared to the legend time method when analyzing medicines used as needed. CONCLUSION Agreement between national self-reported data and national prescription records differed according to method of analysis and therapeutic group. A fixed-time window is an appropriate method of analysis for most therapeutic groups.

Sustaining delivery of the first publicly reimbursed cognitive service in Denmark: a cross‐case analysis

Objectives The aim was to identify local organisational factors that affect sustained delivery of the first Danish publicly reimbursed cognitive service, the Inhaler Technique Assessment Service (ITAS). The ITAS is a 10‐min interactive counselling session during which pharmacy staff assess the inhalation technique of individual asthma patients at the pharmacy counter, and correct any errors. Knowledge of how the organisation of a local pharmacy influences ITAS provision will be used to develop quality indicators as part of a targeted quality‐assurance system to support the sustainability of the service in all Danish community pharmacies.

Development of new concepts of non-adherence measurements among users of antihypertensives medicines.

Objective To identify various types of non-adherence among users of antihypertensive medications by establishing components of adherence measures and use these components for measuring the prevalence of non-adherence. Setting Twelve community pharmacies from the Danish county of Funen. Method Users of antihypertensive medication were included in the study. 2,914 medication users received questionnaires by mail. Participating patients were asked to fill in two questionnaire regarding demographics, self-reported blood pressure, and various adherence measures. Two factor analyses were conducted based on responses to questions. Main outcome measures Medication-taking behaviour and self-efficacy (beliefs about ability and capacity to accomplish a task), respectively. Other measures of non-adherence collected by questionnaire were also addressed in the data for comparison of prevalence with the developed concepts. Results 1,426 (49%) participants answered the questionnaires. The analyses resulted in two sets of components: three adherence behaviour measures and two self-efficacy measures which showed similarities in concepts. The adherence behaviour measures included two concepts of intentional nonadherence (associated with aspects of self-regulation and effect concerns, respectively) and one measure of non-intentional non-adherence. Prevalence of the developed measures of behaviour related non-adherence ranged from 10.3 to 34.9% depending on which type of non-adherence measure was used. Established measures of non-adherence resulted in prevalence between 2.2 and 39.6%. Conclusions The study showed that concepts of non-adherence measurements could be determined including self-efficacy aspects, unintentional non-adherence and intentional non-adherence related to self-regulation and effect concerns respectively. The prevalence of the adherence behaviour components were found to be between 10.3 and 34.9%, which is in the range of expected values. Associations between the new concepts of non-adherence measurement and characteristics of nonadherers remain to be established and would be a subject for further studies.

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.

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.

Mobile phone short messaging service for optimizing asthma treatment has no healthcare related effects: A controlled trial

Context: One important aspect of modern asthma care is self-management: Allowing the patients to monitor their disease severity continuously and to adjust the dose of inhaled corticosteroid based on the symptoms, lung function, and the use of rescue medication. The Short Messaging Service (SMS) is a convenient, reliable, affordable, and secure means of telemedicine that may improve asthma control. Aim: The objective of this study is to assess the health-related effects of an SMS compliance and monitoring system for optimized asthma treatment. Settings and Design: In total, 244 asthmatics participated in a prospective controlled randomized trial (114 interventions, 130 controls). Materials and Methods: The intervention consisted of sequences of SMS messages sent to the intervention group, each containing two or three monitoring questions and one reminder to take the preventive medication. Both the intervention and control groups received questionnaires on days 0, 45, and 90. The primary outcome measures were a self-assessed outcome questionnaire that included a five question asthma control test, EQ-5D, use of health services, and questions on the use of preventive medicine. Statistical Analysis Used: The Pearson Chi-Square test was used for categorical variables (or Fisher′s Exact Test, if the expected count was less than five in one or more cells) and the two-sample t-test or Wilcoxon Rank Sum test was used for continuous variables, as appropriate. The distributional assumption was investigated using histograms and P-P plots. Results: The use of SMS monitoring yielded no health-related effects, no decrease in the use of healthcare services, and no change in the use of medicine between the control and intervention groups. The lack of outcomes for the intervention was neither due to recruitment or the randomizing of participants nor due to dropouts. This study furthermore supports other findings concerning the lack of asthma control in the asthma population. Conclusion: Short Messaging Service is a reliable, convenient, affordable, secure, widespread, and a feasible technology for communication between the patient and healthcare system. However, even given the poor level of asthma control determined at the baseline, this study clearly documents that an SMS compliance and monitoring intervention design, like the one presented in this article, does not improve asthma control, nor does it generate fewer contacts with the healthcare system or improve the use of medicines.