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Background: Community pharmacists have an important task in the follow-up of patients treated with antithrombotics. When delivering these medicines, pharmacists can encounter drug-related problems (DRPs) with substantial clinical and economic impact., Objective: To investigate the amount and type of antithrombotic related DRPs as well as how community pharmacists handled these DRPs., Setting: Belgian community pharmacies., Methods: MSc pharmacy students of six Belgian universities collected data about all DRPs encountered by a pharmacist during ten half days of their pharmacy internship. Data were registered about DRPs detected at delivery and in an a posteriori setting, when consulting the medical history of the patient. Classification of the DRP, cause of the DRP, intervention and result of the intervention were registered., Main Outcome Measure: Amount and type of antotrombitocs related DRPs occurring in community pharmacies, as well as how community pharmacists handled these DRPs., Results: 3.1 % of the 15,952 registered DRPs concerned antithrombotics. 79.3 % of these DRPs were detected at delivery and 20.7 % were detected a posteriori. Most antithrombotic-related DRPs concerned problems with the choice of the drug (mainly because of drug-drug interactions) or concerned logistic problems. Almost 80 % of the antithrombotic-related DRPs were followed by an intervention of the pharmacist, mainly at the patient's level, resulting in 90.1 % of these DRPs partially or totally solved., Conclusion: Different DRPs with antithrombotic medication occurred in Belgian community pharmacies. About 20 % was detected in an a posteriori setting, showing the benefit of medication review. Many of the encountered DRPs were of technical nature (60.7 %). These DRPs were time-consuming for the pharmacist to resolve and should be prevented. Most of the DRPs could be solved, demonstrating the added value of the community pharmacist as first line healthcare provider.

Introduction: Patients with atrial fibrillation (AF) and treated with coumarins need a close follow-up of the international normalized ratio (INR)-values. This can be done by the general practitioner (GP) or by a haematologist in an outpatient hospital clinic., Objective: To compare both ways of follow-up and to investigate determinants of stable INR-patterns., Methods: Cross-sectional single-centre study in patients with AF treated at the UZ Brussel, a university hospital in Brussels. Of the 113 patients included in the study, 71 had their INR followed-up by their GP and 42 similar patients were followed-up by a haematologist. Data of these 113 patients were further analysed to identify possible determinants for stable INR-values., Results: The time in therapeutic range (TTR) did not significantly differ between both groups. However, patients in the GP-group had significantly more INR-values under 2.0 compared to patients from the haematologist-group (P =  0.044), whereas patients in the haematologist-group had significantly more INR-values above 3.0 compared to patients from the GP-group (P = 0.038). Reimbursement costs of both ways of follow-up were comparable, but the out-of-pocket costs for the patient were lower in the GP-group. The time since AF diagnosis was the only significant determinant predicting a higher TTR., Conclusion: Both approaches of follow-up seem to lead to the same TTR, yielding no reason to advocate one approach above the other. However, the patient costs were lower when followed-up by the GP.

Objectives: Developing and implementing clinical decision support systems (CDSSs) is time-consuming and costly. Therefore, prioritization of the most relevant systems is warranted. The physician's perceived usefulness has been identified as a decisive reason for using CDSSs. The objective of this study was to investigate the physician's perceived usefulness of different types of CDSSs and to identify the user needs and expectations regarding future CDSSs., Methods: Cross-sectional single-centre survey among physicians with a clinical assignment in a university hospital. Physicians were questioned about their current experiences with drug prescribing and the perceived usefulness and desired features of future CDSSs., Results: One hundred and sixty-four physicians completed the survey (52·6%). The majority acknowledged that it is very difficult to take all relevant information into account when prescribing drugs. Drug-drug interaction checking, drug-allergy checking, and dosing guidance were considered as most useful. Automated clinical guidelines and adverse drug event monitoring were considered as least useful. The user-friendliness of the systems, clinical relevance of the alerts, and prevention of alert fatigue were perceived as important aspects for a successful implementation., Conclusions: From the physicians' perspective drug-drug interaction checking, drug-allergy checking, and dosing guidance should receive the highest priority for development and implementation. Because the perceived usefulness has been identified as a decisive reason for using CDSSs, it seems feasible to take into account this prioritization when developing and implementing CDSSs. In order to overcome the physicians' perceived disadvantages, attention should go to the development of user-friendly systems that deliver clinical relevant alerts.

Objectives: To investigate determinants of medication use among multi-ethnic pregnant women., Methods: A total of 641 pregnant women participated in this cross-sectional study in a Brussels university hospital. A questionnaire was used to obtain data on socio-demographic characteristics and medication use. Chi-squared tests and binary logistic regression analyses were performed using SPSS 19., Results: Medication use during pregnancy (37%) was positively associated with age older than 35 years, Western origin, being born in Belgium, high education and employment status. Highly educated Western women had a greater exposure to drugs with an unknown safety profile than Arab/Turkish and 'Other (non-Western) origins' women. In the latter two groups, low education and nulliparity were the most important determinants of lower drug use. Nulliparous Arab/Turkish women used significantly less medications (17%) during pregnancy than parous women with the same ethnic background (34%; p = 0.024)., Conclusions: Medication use during pregnancy is considerable but differs according to ethnicity. Age, parity, educational level, occupational status and duration of stay in Belgium are important determinants that should be taken into account for risk assessment and preventive measures targeting pregnant women.

Purposes: Relative efficacy and effectiveness assessment (REA) of a pharmaceutical product is critical in reimbursement decisions. The Pharmaceutical Forum (2005-2008) asked European Union (EU) member states (MS) to strengthen the methodological quality and rigor of REA and identify any scope for common approaches. Here, we have compared REA practices and results within three EU MS with similar reimbursement procedures for the period 2007-2010 to describe the actual situation., Methods: Assessment procedures and reports from the Belgian, Dutch and French Agency websites were retrieved and corresponding products matched. The REA-outcome was coded as added therapeutic value (ATV) yes or no. The strength of agreement between the three MS was estimated and analyzed in relation to some explanatory variables., Results: Of the 144 Belgian, 122 Dutch and 236 French assessment reports retrieved, ATV was granted in 35, 39 and 23 % of cases, respectively, with 72 matches between the three MS. In all MS the results of at least one randomized trial were available in >90 % of reports. Between two MS significant agreement was achieved in ≥ 72 % of cases; this was 54 % between the three MS. Differences in ATV existed for treatments in severe chronic diseases. Assessment procedures were poorly documented in Belgium and France., Conclusions: Our findings reveal that the three similar EU MS under study agree on the REA-outcome of only half of the new drugs. Differences in applied methodology (e.g. inferences from study results, handling of uncertainty) between MS may exist. We suggest that a joint REA approach would benefit from a common understanding and application of the scientific assessment process using shared guidelines.

Objective: To investigate the differences in exposure to medications in a cohort of multi-ethnic pregnant women., Methods: Six hundred and forty-one pregnant women of Western, Arab/Turkish and "other origins" participated in this cross-sectional study using a questionnaire in a university hospital in Brussels, Belgium. Assessment of the drug safety was done using the food and drug administration (FDA) risk classification system. Data analysis was performed using SPSS (Chicago, IL)., Results: In overall cohort, 83.8% used at least one preparation (including multivitamins) during pregnancy and 37.0% of women used at least one drug (excluding multivitamins). Significantly more Western women (43.7%) used one or more medications compared to Arab/Turkish women (28.7%; p = 0.000). This difference in exposure was most pronounced for over-the-counter (OTC) drugs for occasional and pregnancy-related complaints, and was observed for potentially unsafe drugs or drugs with unknown safety. None of the women reported use of FDA X category drugs., Conclusions: The use of drugs known to be harmful was not observed, but a higher prevalence of exposure to potentially harmful drugs (FDA C/D) was found among Western women who also consumed more OTC drugs. This highlights the need for cautious prescribing for women in the fertile age in general and for continuous monitoring of medication use during pregnancy.

Background: Medication discrepancies have the potential to cause harm. Medication reconciliation by clinical pharmacists aims to prevent discrepancies and other drug-related problems., Objective: To determine how often discrepancies in the physician-acquired medication history result in discrepancies during hospitalization and at discharge. Secondary objectives were to determine the influence of clinical pharmacists' interventions on discrepancies and to investigate possible patient-related determinants for experiencing discrepancies., Methods: This was a retrospective, single-center, cohort study of patients who were admitted to the acute geriatric department of a Belgian university hospital and followed up by clinical pharmacists between September 2009 and April 2010. Patients were limited to those 65 years or older who were taking 1 or more prescription drug. Medication reconciliation at admission, during hospitalization, and at discharge was conducted by an independent pharmacist who gathered information via chart reviews., Results: The reconciliation process at admission identified 681 discrepancies in 199 patients. Approximately 81.9% (163) of patients had at least 1 discrepancy in the physician-acquired medication history. The clinical pharmacists performed 386 interventions, which were accepted in 279 cases (72.3%). A quarter of the medication history discrepancies (165; 24.2%) resulted in discrepancies during hospitalization, mostly because the intervention was not accepted. At discharge, 278 medication history discrepancies (40.8%) resulted in discrepancies in the discharge letter, accounting for 50.2% of all 554 discrepancies identified in the discharge letters. The likelihood for experiencing discrepancies at admission increased by 47% for every additional drug listed in the medication history., Conclusions: Discrepancies in the physician-acquired medication history at admission do not always correlate with discrepancies during hospitalization because of clinical pharmacists' interventions; however, discrepancies at admission may be associated with at least half of the discrepancies at discharge. Clinical pharmacist-conducted medication reconciliation can reduce these discrepancies, provided the erroneous information in the physician-acquired medication history is corrected and each intentional change in the medication plan is well documented during hospitalization and at discharge.

Aims: To investigate the possible differences in folic acid use and to identify the determinants of antenatal folic acid use among multi-ethnic pregnant women., Methods: Three hundred and fifty pregnant women participated in this cross-sectional study in a university hospital in Brussels, Belgium. A questionnaire was used to obtain data on socio-demographic characteristics and folic acid use. χ(2)-tests and binary logistic regression analyses were performed using SPSS 17., Results: In the overall cohort, 59.2% used folic acid supplements during pregnancy. This supplement use was associated with an age of 26-35 years, being of Western origin, with high education and employment status, understanding physician's instructions, and early booking for antenatal care. Education (odds ratio, OR: 2.24; 95% confidence interval, CI: 1.08-4.63) and early booking for antenatal care OR: 2.45; 95% CI: 1.11-5.40) were the most important determinants. In particular for Arab/Turkish women, a lower employment status OR: 0.42; 95% CI: 0.24-0.73) was associated with a higher risk of not using folic acid supplements., Conclusions: The lower use of folic acid supplements in Arab/Turkish ethnicities, which may be associated with an increased risk of neural tube defects, is related to socio-economic factors rather than to lower educational attainment. As recommended by other studies, fortification of ethnic minority food may be warranted to reduce the risk of neural tube defects.

Aim: We analysed the Belgian reimbursement decisions of orphan drugs as compared with those of innovative drugs for more common but equally severe diseases, with special emphasis on the quality of clinical evidence., Methods: Using the National Health Insurance Agency administrative database, we evaluated all submitted orphan drug files between 2002 and 2007. A quality analysis of the clinical evidence in the orphan reimbursement files was performed. The evaluation reports of the French 'Haute Autorité de Santé', including the five-point scale parameter 'Service Médical Rendu (SMR), were examined to compare disease severity. Chi-squared tests (at P < 0.05 significance level) were used to compare the outcome of the reimbursement decisions between orphan and non-orphan innovative medicines., Results: Twenty-five files of orphan drugs and 117 files of non-orphan drugs were evaluated. Twenty-two of 25 (88%) submissions of orphan drugs were granted reimbursement as opposed to 74 of the 117 (63%) non-orphan innovative medicines (P= 0.02). Only 52% of the 25 orphan drug files included a randomized controlled trial as opposed to 84% in a random control sample of 25 non-orphan innovative submissions (P < 0.01). The duration of drug exposure was in most cases far too short in relation to the natural history of the disease., Conclusions: Orphan drug designation predicts reimbursement despite poor quality of clinical evidence. The evidence gap at market authorization should be reduced by post-marketing programmes, in which the centralized regulatory and the local reimbursement authorities collaborate in an efficient way across the European Union member states., (© 2011 The Authors. British Journal of Clinical Pharmacology © 2011 The British Pharmacological Society.)

Background: Blood pressure (BP) control is far from optimal. Studies on factors influencing BP control in the elderly are limited, yet identification of factors contributing to the low rate of BP control is a prerequisite to improvement of clinical management., Objective: To evaluate the rate of BP control and the relationship between different clinical characteristics and BP control in treated hypertensive outpatients aged >or=65 years., Methods: The PAPY-65 Survey was a prospective cross-sectional survey conducted in primary care in Belgium in 2007. Participating primary-care physicians were required to include consecutive hypertensive patients aged >or=65 years and treated with antihypertensive drugs. Demographic and anthropometric data as well as data on cardiovascular risk factors and history were obtained. BP was measured in accordance with the European Society of Hypertension/European Society of Cardiology guidelines., Results: The mean +/- standard deviation (SD) age of the 1272 patients enrolled in the survey was 75 +/- 7 years; 702 (55%) patients were women. The mean +/- SD systolic/diastolic BP was 134/79 +/- 13/8 mmHg. BP was normalized (reduced to <140/90 mmHg, or <130/80 mmHg in patients with diabetes mellitus) in 617 (48.5%) patients overall and in 88 (24%) patients with diabetes (n = 371). The majority of patients (921; 72%) were treated with two or more antihypertensive drugs. Both general obesity (body mass index >or=30 vs <25 kg/m2) and abdominal obesity were associated with lack of BP control (unadjusted odds ratio [OR] 2.988, 95% CI 2.200, 4.057 and OR 2.066, 95% CI 1.649, 2.588, respectively). Abdominal obesity was no longer related to BP control when adjusted for the presence of diabetes. Diabetes was strongly associated with lack of BP control only when a stringent definition of BP control (<130/80 mmHg) was used. The combined presence of subclinical organ damage and a history of cardiovascular disease was associated with less uncontrolled BP (OR 0.62, 95% CI 0.48, 0.80)., Conclusion: Compared with previous data in the elderly in Belgium, a clear improvement in BP control was observed, probably related to the use of more antihypertensive agents. The presence of diabetes, excess bodyweight and abdominal obesity were all associated with poor BP control.

As many other countries, Belgium has a policy to promote the use of generic pharmaceutical products. In order to protect consumers, these generic products must be demonstrated to be essentially similar to the previously approved product, typically an innovator product. The therapeutic equivalence of a generic and an innovator product is most commonly based on the demonstration of bioequivalence, i.e. clinically insignificant differences in the rate and extent of drug absorption usually assessed from pharmacokinetic measurements, in a normal and healthy population. This article reviews the bioequivalence requirements for generic products and examines whether bioequivalence always adequately substantiates therapeutic equivalence and interchangeability. Clinical practice has identified a number of drug classes for which generic substitution should be approached with caution. Current bioequivalence requirements are based on a measure of average bioequivalence. There are fears that use of this measure may be inappropriate in the case of a drug with a narrow therapeutic range or high intrasubject or intersubject variability. Under these circumstances, measures of individual and population bioequivalence are proposed to be more accurate than measures of average bioequivalence. Bioequivalence issues are discussed together more general concerns about generic drug substitution, such as differences in product and packaging appearance and differences in excipients.

The European Transparency Directive requires that pricing and reimbursement decisions must be taken in a transparent, objective and verifiable way with respect of strict timelines. The Belgian competent authority integrated on January 1st, 2002 Evidence-Based Medicine (EBM) principles in the reimbursement evaluation. The present work describes the procedures and investigates whether the introduction of the EBM principles indeed affects the decision and whether it compromised the respect of strict timelines. The reimbursement decision for all new submissions except for generic drugs is preceded by an evaluation of the relative therapeutic value. There were 1285 submissions handled within the period 2002-2004 of which 159 (12.4%) related to new molecular entities. For the 824 files with valuation of the therapeutic value, the reimbursement decision was positive in 80.8% of cases. The percentage of positive decisions was dependent on the type of submission with the lowest percentages for new molecular entities and submissions for new indications (64%-71%). Line extensions and generics received a positive decision in nearly all cases (> 95%). Proof of added value by at least 1 positive superiority trial against active comparator is a requirement for obtaining a price premium: this was granted in less than 50% of the 67 submissions claiming such superiority and the odds for a negative reimbursement decision increased significantly if the applicant failed to prove added value: O.R. = 9.1 (2.3 - 35.6), indicating that clinical evidence of added therapeutic value clearly facilitates reimbursement. The introduction of the new procedure did not jeopardize the timelines. Introducing EBM principles had a significant impact on reimbursement decisions in Belgium by facilitating reimbursement with a price premium of new drugs with added value addressing unmet medical needs.