Flora Haaijer-Ruskamp

Self-medication with antimicrobial drugs in Europe

Antimicrobial drug self-medication occurs most often in eastern and southern Europe and least often in northern and western Europe.

Determinants of self-medication with antibiotics in Europe: the impact of beliefs, country wealth and the healthcare system

BACKGROUND Self-medication with antibiotics occurs among the population in Europe, particularly in southern and eastern countries. We studied the impact of predisposing factors (e.g. attitudes and knowledge concerning antibiotic use and self-medication) and enabling factors (country wealth and healthcare system factors) on self-medication with antibiotics in Europe. METHODS In this follow-up of a previous European survey, we interviewed a subsample of 1101 respondents. A multilevel analysis with two levels (respondent and country) was performed. Variables that were statistically significantly different between users and non-users of self-medication were considered for inclusion into the multilevel regression analyses. RESULTS Predisposing factors included individual-level characteristics. High perceived appropriateness of self-medication with antibiotics for bronchitis and an attitude favouring antibiotic use for minor ailments were related to a higher likelihood of self-medication. Enabling factors included individual and country data. At the individual level, perceived availability of antibiotics without a prescription was related to increased probability of self-medication. At the country level, higher gross domestic product (wealth) and exact dispensation of prescribed tablet quantities by pharmacies were independently associated with lower likelihood of self-medication. CONCLUSIONS Interventions aimed at preventing self-medication should include public education, enforcing regulations regarding the sale of antibiotics, and implementing laws for dispensing exact prescribed tablet quantities in pharmacies. With the included determinants, we explained almost all the variance at the country level, but not at the individual level. Future studies to increase our understanding of determinants of self-medication with antibiotics should focus on individual-level factors such as doctor-patient relationships and patient satisfaction.

Deprescribing medication in very elderly patients with multimorbidity: the view of Dutch GPs. A qualitative study

BackgroundElderly patients with multimorbidity who are treated according to guidelines use a large number of drugs. This number of drugs increases the risk of adverse drug events (ADEs). Stopping medication may relieve these effects, and thereby improve the patient’s wellbeing. To facilitate management of polypharmacy expert-driven instruments have been developed, sofar with little effect on the patient’s quality of life. Recently, much attention has been paid to shared decision-making in general practice, mainly focusing on patient preferences. This study explores how experienced GPs feel about deprescribing medication in older patients with multimorbidity and to what extent they involve patients in these decisions.MethodsFocusgroups of GPs were used to develop a conceptual framework for understanding and categorizing the GP’s view on the subject. Audiotapes were transcribed verbatim and studied by the first and second author. They selected independently relevant textfragments. In a next step they labeled these fragments and sorted them. From these labelled and sorted fragments central themes were extracted.ResultsGPs discern symptomatic medication and preventive medication; deprescribing the latter category is seen as more difficult by the GPs due to lack of benefit/risk information for these patients.Factors influencing GPs’deprescribing were beliefs concerning patients (patients have no problem with polypharmacy; patients may interpret a proposal to stop preventive medication as a sign of having been given up on; and confronting the patient with a discussion of life expectancy vs quality of life is ‘not done’), guidelines for treatment (GPs feel compelled to prescribe by the present guidelines) and organization of healthcare (collaboration with prescribing medical specialists and dispensing pharmacists.ConclusionsThe GPs’ beliefs concerning elderly patients are a barrier to explore patient preferences when reviewing preventive medication. GPs would welcome decision support when dealing with several guidelines for one patient. Explicit rules for collaborating with medical specialists in this field are required. Training in shared decision making could help GPs to elicit patient preferences.

The influence that electronic prescribing has on medication errors and preventable adverse drug events : an interrupted time-series study

OBJECTIVE This study evaluated the effect of a Computerized Physician Order Entry system with basic Clinical Decision Support (CPOE/CDSS) on the incidence of medication errors (MEs) and preventable adverse drug events (pADEs). DESIGN Interrupted time-series design. MEASUREMENTS The primary outcome measurements comprised the percentage of medication orders with one or more MEs and the percentage of patients with one or more pADEs. RESULTS Pre-implementation, the mean percentage of medication orders containing at least one ME was 55%, whereas this became 17% post-implementation. The introduction of CPOE/CDSS has led to a significant immediate absolute reduction of 40.3% (95% CI: -45.13%; -35.48%) in medication orders with one or more errors. Pre-implementation, the mean percentage of admitted patients experiencing at least one pADE was 15.5%, as opposed to 7.3% post-implementation. However, this decrease could not be attributed to the introduction of CPOE/CDSS: taking into consideration the interrupted time-series design, the immediate change was not significant (-0.42%, 95% CI: -15.52%; 14.68%) because of the observed underlying negative trend during the pre-CPOE period of -4.04% [95% CI: -7.70%; -0.38%] per month. CONCLUSIONS This study has shown that CPOE/CDSS reduces the incidence of medication errors. However, a direct effect on actual patient harm (pADEs) was not demonstrated.

Are cultural dimensions relevant for explaining cross-national differences in antibiotic use in Europe?

BackgroundAntibiotics are widely-used medicines for which a more prudent use has been advocated to minimize development of resistance. There are considerable cross-national differences that can only partially be explained by epidemiological difference and variations in health care structure. The aim of this study was to explore whether cross-national differences in use of antibiotics (prescribed and non-prescribed) are associated with differences between national cultures as described in Hofstedes model of cultural dimensions (Power Distance, Individualism, Masculinity, Uncertainty Avoidance and Long-Term Orientation).MethodsCountry-level data of prescribed antibiotic use and self-medication with antibiotics were correlated to country-specific scores of cultural dimensions obtained from Hofstede. Data on use of antibiotics were provided by three European studies, based on different methods and/or countries: Self-medication with Antibiotics and Resistance in Europe (SAR), based on a survey in 2003 on reported use of antibiotics in 19 countries, the European Surveillance on Antimicrobial Consumption, based on distribution and reimbursement of antibiotics in ambulatory care (1997–2002), and the 2002 interview-based Eurobarometer study, asking whether respondents had taken antibiotics in the previous 12 months. These studies provided data on antibiotics use for 27 European countries in total, for which scores of cultural dimensions were also available. The SAR-study differentiated between prescribed antibiotics and self-medication with antibiotics.ResultsSignificant positive correlations were found for Power Distance Index with use of prescribed antibiotics in the three studies (rho between 0.59 and 0.62) and with self-medication (rho = 0.54) in the SAR study. Positive significant correlations were found for the Uncertainty Avoidance Index with the use of antibiotics as reported in two studies (rho between 0.57 and 0.59; for the SAR study the correlations were insignificant). Masculinity was not significantly correlated, except in one study after controlling for GDP (r = 0.81). For Individualism and Long-Term Orientation no significant correlations were found.ConclusionPower Distance is a cultural aspect associated with antibiotic use, suggesting that the culture-specific way people deal with authority is an important factor in explaining cross-national differences in antibiotic use. There are indications that Uncertainty Avoidance also plays a role but further research is needed to better understand the complex effect of cultural dimensions.

Impact of Safety-Related Regulatory Action on Clinical Practice A Systematic Review

AbstractBackground: After market approval, new serious safety issues are regularly identified for drugs that lead to regulatory action to inform healthcare professionals. However, the effectiveness of these safety-related regulatory actions is under question. We currently lack a comprehensive overview of the effects of these drug safety warnings on clinical practice to resolve the debate about their effectiveness. Objective: The aim of this systematic review is to provide an overview of studies that assessed the impact of safety warnings. Study Selection: A systematic search was performed for articles assessing the impact of Direct Healthcare Professional Communications or ‘Dear Doctor’ letters, Black Box Warnings and Public Health Advisories on clinical behaviour published between January 1996 and January 2010. The following variables were extracted: publication year, country, name of the drug, safety issue, specific safety warning (Direct Healthcare Professional Communication/Black Box Warning/Public Health Advisory), effect (intended/unintended) of the safety warning, outcome measure and study design. Papers were checked for several quality aspects. Study data were summarized using descriptive analyses. Results: A total of 50 articles were identified. Two articles assessed two different drugs and were therefore counted twice (n = 52). Thirty-three articles described the impact of safety warnings issued for three drugs and drug groups, i.e. third-generation oral contraceptives, cisapride and selective serotonin reuptake inhibitors. The remaining 19 articles described a broad variety of 14 drugs and drug groups. Twenty-five studies applied an interrupted time series design, 23 a controlled or uncontrolled before/after design, and four articles applied both. None of the articles could rule out the influence of confounding factors. The intended effects were reported in 18 (72%) of the 25 before/after analyses, whereas only 11 (41%) of the 27 interrupted time series analyses reported an impact. Only two (8%) of the before/after analyses against 11 (41%) of the interrupted time series analyses reported mixed impacts. When unintended effects were assessed in case of selective serotonin reuptake inhibitors and third-generation oral contraceptives, these were almost always present: in 19 of 22 and 4 of 5 articles, respectively. Our review shows that safety-related regulatory action can have some impact on clinical practice but firm conclusions are difficult to draw. Evidence is primarily based on three drugs and drug groups. Almost half of the studies had inadequate before/after designs and the heterogeneity in analyses and outcome measures hampered the reporting of overall effect sizes. Studies with adequate interrupted time series design reported a more mixed impact of safety warnings than before/after studies. Furthermore, this review shows the relevance of considering not only the intended but also the unintended effects of safety warnings. Conclusions: There is a clear need for further research with appropriate study designs and statistical analyses, with more attention to confounding factors such as media coverage, to understand the impact of safety-related regulatory action.

DRUG-USE IN PREGNANCY - A COMPARATIVE APPRAISAL OF DATA COLLECTING METHODS

SummaryWe have compared the reliability of the information about drug therapy and pregnancy retrieved by interviewing patients with that distilled from pharmacy records. In the initial phase of each interview we used the internationally accepted open-ended technique, and extended this with an indication-oriented set of questions and then a set of specific drug-oriented questions. These data were then compared with those from pharmacy records on dispensing for the same patients during their pregnancy.The results suggest that if drug consumption during pregnancy is evaluated by interview, one should not restrict oneself to open-ended questions but should include indication-oriented and, when appropriate, drug-oriented questions. Such specific questions offer the opportunity of detecting the use of over-the-counter medication and of constructing drug use/complaint profiles. By contrast, pharmacy records will give better information in case of long recall periods and in patients with multiple and/or repeated drug use. Investigators should use the complementary elements of both techniques where appropriate.

Medication errors: the impact of prescribing and transcribing errors on preventable harm in hospitalised patients

Background: Medication errors (MEs) affect patient safety to a significant extent. Because these errors can lead to preventable adverse drug events (pADEs), it is important to know what type of ME is the most prevalent cause of these pADEs. This study determined the impact of the various types of prescribing (administrative, dosing and therapeutic) and transcribing errors on pADEs in hospitalised patients. Methods: During a 5-month period, data for patients admitted to a total of five internal medicine wards of one university and one teaching hospital in The Netherlands were prospectively collected by chart review. In each hospital, MEs were detected and classified by the same pharmacist, using the classification scheme for MEs developed by The Netherlands Association of Hospital Pharmacists. The primary outcome measure was the prevalence of pADEs during hospital stay. In consensus meetings, five pharmacists assessed the causal relationship between MEs and pADEs. The association between type of ME and pADEs was determined by a multivariate regression analysis taking into account potential confounders. Results: The study included 592 hospital admissions with 7286 medication orders (MOs), of which 60% contained at least one prescribing or transcribing error. 1.4% of all MOs led to pADEs, concerning 14.8% of all admitted patients. The total number of pADEs was 103, and in 92 of these cases patients experienced temporary harm, in eight cases hospital admission was prolongued, two cases were life-threatening, and one was fatal. Therapeutic errors were most strongly associated with pADEs (OR 1.98; 95% CI 1.53 to 2.56). Conclusions: Although many prescribing and transcribing errors occur in the process of medication use of hospitalised patients, a minority lead to pADEs. In particular, therapeutic errors are the cause of these pADEs and are therefore clinically relevant. Intervention and prevention programmes should primarily focus on this type of medication error.

Adherence Barriers to Antimicrobial Treatment Guidelines in Teaching Hospital, the Netherlands

To optimize appropriate antimicrobial use in a university hospital and identify barriers hampering implementation strategies, physicians were interviewed regarding their opinions on antimicrobial policies. Results indicated that effective strategies should include regular updates of guidelines that incorporate the views of relevant departments and focus on addressing senior staff and residents because residents do not make independent decisions in a teaching-hospital setting.

THERAPEUTIC DECISION-MAKING OF PHYSICIANS

In this review the therapeutic decision-making process of physicians is described. This process is divided into two steps: the generation of a limited set of possible options (the ‘evoked set’) and the selection from this evoked set of a treatment for a specific patient. Factors that are important in both steps are reviewed. Behavioural and decision-making theories in general and decision-making analysis of physicians in particular are discussed to identify possible shortcomings in their decision-making process. Based on this information a model of the drug choice process is presented. With reference to this model possible ways of influencing drug choices of physicians are discussed.