Healthcare professionals' level of medication knowledge in Africa: a systematic review.

AIMS: Understanding how much healthcare professionals (HCPs) know about medication can help in devising strategies to improve rational medication use. This study aimed to synthesize information on the level of medication knowledge of HCPs in Africa. METHOD: We performed a systematic literature study in Embase and PubMed. We included original studies quantifying HCPs' medication knowledge, published between 2012 and 2016. We extracted disease focus, country, number and type of HCPs included and all medication-related knowledge questions and scored the quality of papers. The outcome measure was the percentage of HCPs who correctly answered medication knowledge questions. RESULTS: We identified 64 studies from 12 African countries, comprising 13 911 HCPs, mostly nurses/midwifes and physicians. We extracted 306 medication-related knowledge questions, and only 52% (SD 28) of HCPs correctly answered them. Knowledge questions were mainly about medication prescribed for communicable diseases (70%), followed by non-communicable diseases (11%), and family planning/gynaecology (10%). Most papers concluded that there was a considerable medication knowledge gap among HCPs. CONCLUSION: We found a low level of medication knowledge across different disease areas, countries and HCPs. This underlines the continuous need to strengthen the undergraduate and postgraduate education in (clinical) pharmacology and therapeutics in Africa.

Views of general practice staff about the use of a patient-oriented treatment decision aid in shared decision making for patients with type 2 diabetes: A mixed-methods study.

BACKGROUND: Decision aids can be used to support shared decision making (SDM). A patient-oriented treatment decision aid (DA) was developed for type 2 diabetes but its use by general practice staff appeared to be limited. OBJECTIVES: To explore views of practice staff towards SDM and the DA. DESIGN: A mixed-methods study within the Dutch PORTDA-diab trial. SETTING AND PARTICIPANTS: Included were 17 practices with staff members who were responsible for routine diabetes care and had worked with the DA, and 209 of their patients. METHODS: Interviews were conducted focusing on applicability, usefulness and feasibility of the DA. Interviews were tape-recorded, transcribed verbatim and subjected to content analysis for identifying and classifying views. Patient-reported data about the use of the DA were collected. Associations between specific views and use of the DA were tested using Pearson point-biserial correlation. RESULTS: The majority of practice staff expressed positive views towards SDM, which was associated with making more use of the DA. Most of the staff expressed that the DA stimulated a two-way conversation. By using the DA, several became aware of their paternalistic approach. Some staff experienced a conflict with the content of the DA, which was associated with making less use of the DA. CONCLUSIONS: The DA was considered useful by practice staff to support SDM. A positive view towards SDM was a facilitator, whereas experiencing a conflict with the content of the DA was a barrier for making use of the DA.

Impact of adverse drug events and treatment satisfaction on patient adherence with antihypertensive medication - a study in ambulatory patients.

AIMS: The aim of the present study was to evaluate the impact of adverse drug events (ADEs) and treatment satisfaction on antihypertensive medication adherence. METHODS: A cross-sectional study was conducted in six public hospitals in Ethiopia. We included adult ambulatory patients on antihypertensive medication. Adherence was measured using the eight-point Morisky Medication Adherence Scale, which categorizes as low (0-5), medium (6-7) and high (8) adherence. Treatment satisfaction was measured using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4, which included questions about ADEs. Data were analysed using generalized ordered logistic regression with 95% confidence intervals (CIs). RESULTS: We included 925 out of 968 patients. Overall, 42% of patients scored low, 37% medium and 21% high adherence. Satisfaction with treatment was low, with a mean (standard deviation) TSQM score for global satisfaction of 51 (14). A total of 193 (21%) patients experienced 421 ADEs - mainly dyspeptic symptoms (12%), headache (11%) and cough (11). Experiencing more ADEs reduced the odds of being adherent [low vs. medium/high: odds ratio (OR) OR1 0.77 (95% CI 0.67, 0.89), and low/medium vs. high: OR2 0.55 (05% CI 0.41, 0.73)]. Being more satisfied increased the odds of being adherent [low vs. medium/high: OR1 1.02 (95% CI 1.01, 1.03)]. Taking medication >1 year [OR1 = 2 , 0.60 (95% CI 0.43, 0.83)] and taking calcium channel blockers [OR1 = 2 0.71 (95% CI 0.54, 0.92)] decreased the odds for both low vs. medium/high and low/medium vs. high adherence. CONCLUSIONS: Only one in five patients reported perfect (high) adherence to their antihypertensive treatment regimen. Experiencing ADEs and being dissatisfied with treatment were associated with lower adherence. In addition to addressing treatment satisfaction and drug safety in first-world countries, these should also be addressed in resource-poor settings, within patient consultations, to enhance adherence.

Application of the STOPP/START criteria to a medical record database.

PURPOSE: The STOPP/START criteria are increasingly used to assess prescribing quality in elderly patients at practice level. Our aim was to test computerized algorithms for applying these criteria to a medical record database. METHODS: STOPP/START criteria-based computerized algorithms were defined using Anatomical-Therapeutic-Chemical (ATC) codes for medication and International Classification of Primary Care (ICPC) codes for diagnoses. The algorithms were applied to a Dutch primary care database, including patients aged ≥65 years using ≥5 chronic drugs. We tested for associations with patient characteristics that have previously shown a relationship with the original STOPP/START criteria, using multivariate logistic regression models. RESULTS: Included were 1187 patients with a median age of 75 years. In total, 39 of the 62 STOPP and 18 of the 26 START criteria could be converted to a computerized algorithm. The main reasons for inapplicability were lack of information on the severity of a condition and insufficient covering of ICPC-codes. We confirmed a positive association between the occurrence of both the STOPP and the START criteria and the number of chronic drugs (adjusted OR ranging from 1.37, 95% CI 1.04-1.82 to 3.19, 95% CI 2.33-4.36) as well as the patient's age (adjusted OR for STOPP 1.30, 95% CI 1.01-1.67; for START 1.73, 95% CI 1.35-2.21), and also between female gender and the occurrence of STOPP criteria (adjusted OR 1.41, 95% CI 1.09-1.82). CONCLUSION: Sixty-five percent of the STOPP/START criteria could be applied with computerized algorithms to a medical record database with ATC-coded medication and ICPC-coded diagnoses.

Adverse drug reaction reports for cardiometabolic drugs from sub-Saharan Africa: a study in VigiBase.

OBJECTIVE: Identifying key features in individual case safety reports (ICSR) of suspected adverse drug reactions (ADRs) with cardiometabolic drugs from sub-Saharan Africa (SSA) compared with reports from the rest of the world (RoW). METHODS: Reports on suspected ADRs of cardiometabolic drugs (ATC: A10[antidiabetic], B01[antithrombotics] and C[cardiovascular]) were extracted from WHO Global database, VigiBase(®) (1992-2013). We used vigiPoint, a logarithmic odds ratios (log2 OR)-based method to study disproportional reporting between SSA and RoW. Case-defining features were considered relevant if the lower limit of the 99% CI > 0.5. RESULTS: In SSA, 3773 (9%) of reported ADRs were for cardiometabolic drugs, in RoW for 18%. Of these, 79% originated from South Africa and 81% were received after 2007. Most reports were for drugs acting on the renin-angiotensin system (36% SSA & 14% RoW). Compared with RoW, reports were more often sent for patients 18-44 years old (log2 OR 0.95 [99 CI 0.80; 1.09]) or with non-fatal outcome (log2 OR 1.16 [99 CI 1.10; 1.22]). Eight ADRs (cough, angioedema, lip swelling, face oedema, swollen tongue, throat irritation, drug ineffective and blood glucose abnormal) and seven drugs (enalapril, rosuvastatin, perindopril, vildagliptin, insulin glulisine, nifedipine and insulin lispro) were disproportionally more reported in SSA than in the RoW. CONCLUSIONS: 'In recent years, the number of adverse drug reactions (ADRs) reported in Sub-Saharan Africa (SSA) has sharply increased. The data showed the well-known population-based differential ADR profile of ACE inhibitors in the SSA population.'

Understanding drug preferences, different perspectives.

AIMS: To compare the values regulators attach to different drug effects of oral antidiabetic drugs with those of doctors and patients. METHODS: We administered a 'discrete choice' survey to regulators, doctors and patients with type 2 diabetes in The Netherlands. Eighteen choice sets comparing two hypothetical oral antidiabetic drugs were constructed with varying drug effects on glycated haemoglobin, cardiovascular risk, bodyweight, duration of gastrointestinal complaints, frequency of hypoglycaemia and risk of bladder cancer. Responders were asked each time which drug they preferred. RESULTS: Fifty-two regulators, 175 doctors and 226 patients returned the survey. Multinomial conditional logit analyses showed that cardiovascular risk reduction was valued by regulators positively (odds ratio 1.98, 95% confidence interval 1.11-3.53), whereas drug choices were negatively affected by persistent gastrointestinal problems (odds ratio 0.24, 95% confidence interval 0.14-0.41) and cardiovascular risk increase (odds ratio 0.49, 95% confidence interval 0.27-0.87). Doctors and patients valued these effects in a similar manner to regulators. The values that doctors attached to large changes in glycated haemoglobin and that both doctors and patients attached to hypoglycaemia and weight gain also reached statistical significance. No group's drug choice was affected by a small absolute change in risk of bladder cancer when presented in the context of other drug effects. When comparing the groups, the value attached by regulators to less frequent hypoglycaemic episodes was significantly smaller than by patients (P = 0.044). CONCLUSIONS: Regulators may value major benefits and risks of drugs for an individual diabetes patient mostly in the same way as doctors and patients, but differences may exist regarding the value of minor or short-term drug effects.

Construct and concurrent validity of a patient-reported adverse drug event questionnaire: a cross-sectional study.

BACKGROUND: Direct patient-reported information about adverse drug events (ADEs) is important since it adds to healthcare professional-reported information about the safety of drugs. Previously, we developed an instrument to assess patient-reported ADEs in research settings. The aim of this study is to assess the construct and concurrent validity of the questionnaire. METHODS: Patients on at least an oral glucose-lowering drug completed the ADE questionnaire, the World Health Organization Quality of Life-BREF, and the Treatment Satisfaction Questionnaire for Medication (TSQM). The ADE questionnaire assesses ADEs for any drug that the patient uses. Construct validity was assessed by testing whether patients reporting an ADE had a lower general quality of life and physical health than those not reporting an ADE, using Mann-Whitney U-tests and t-tests (significance level <0.05). For concurrent validity, we tested whether ADEs that patients associate with particular drugs in the ADE questionnaire are documented in the Summary of Product Characteristics (SPC) of those drugs, and whether patients who report an ADE with the use of metformin on the TSQM, mention metformin as a drug associated with an ADE on the ADE questionnaire. Agreement of 70% with the SPC was considered satisfactory. Sensitivity and positive predictive value (PPV) were calculated for the comparison with the TSQM, where 70% was used as the cut-off level for sufficient concurrent validity. RESULTS: We included 135 patients (mean age 64 years, 35% women). Patients who reported an ADE (N = 37) had a lower general quality of life and physical health than those not reporting an ADE (P < 0.05). For 78 of the 146 reported ADEs (53%), patients mentioned at least 1 particular drug associated with the ADE. After clustering related ADEs, this resulted in 56 patient-reported ADE-drug associations. Of these, 41 (73%) were in agreement with information in the SPC. Finally, the questionnaire had a sensitivity of 38% and PPV of 79% for assessing ADEs associated with metformin. CONCLUSIONS: The construct validity of the patient-reported ADE questionnaire was sufficient for reporting any versus no ADE, but the concurrent validity was only partly demonstrated. Therefore, the questionnaire needs to be adapted before it can be used.

The validity of a patient-reported adverse drug event questionnaire using different recall periods.

PURPOSE: To assess the validity of a patient-reported adverse drug events (ADEs) questionnaire with a 3-month or 4-week recall period. METHODS: Patients receiving at least one oral glucose-lowering drug were asked to report potential ADEs they experienced related to any drug in a daily diary for a 3-month period. Thereafter, they completed the ADE questionnaire with either a 3-month or 4-week recall period. The validity was assessed by comparing ADEs reported in each version with those reported in the diary at class level and at specific ADE level. At class level, a comparison was made using (1) primary system organ classes (SOCs) of the medical dictionary for regulatory activities and (2) other related SOCs. Sensitivity and positive predictive value (PPV) were calculated. RESULTS: Each version of the questionnaire was completed by 39 patients. In the 3-month group, 21 patients reported 70 ADEs in the diary. In the 4-week group, six patients reported seven ADEs in the last 4 weeks of the diary. Sensitivity to assess ADEs at primary SOC was low for both recall groups (33 %). PPV was 51 and 10 % for, respectively, the 3-month and 4-week group. Taking other related SOCs into account slightly increased the sensitivity for the 3-month group (38%). Sensitivity of reporting the same ADE was 41 and 43 % for, respectively, the 3-month and 4-week group. CONCLUSIONS: Regardless of the recall period and level of comparison, the validity for assessing ADEs was low with the patient-reported ADE questionnaire. Further refinement is needed to improve the validity.

Economic evaluations of angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers in type 2 diabetic nephropathy: a systematic review.

BACKGROUND: Structured comparison of pharmacoeconomic analyses for ACEIs and ARBs in patients with type 2 diabetic nephropathy is still lacking. This review aims to systematically review the cost-effectiveness of both ACEIs and ARBs in type 2 diabetic patients with nephropathy. METHODS: A systematic literature search was performed in MEDLINE and EMBASE for the period from November 1, 1999 to Oct 31, 2011. Two reviewers independently assessed the quality of the articles included and extracted data. All cost-effectiveness results were converted to 2011 Euros. RESULTS: Up to October 2011, 434 articles were identified. After full-text checking and quality assessment, 30 articles were finally included in this review involving 39 study settings. All 6 ACEIs studies were literature-based evaluations which synthesized data from different sources. Other 33 studies were directed at ARBs and were designed based on specific trials. The Markov model was the most common decision analytic method used in the evaluations. From the cost-effectiveness results, 37 out of 39 studies indicated either ACEIs or ARBs were cost-saving comparing with placebo/conventional treatment, such as amlodipine. A lack of evidence was assessed for valid direct comparison of cost-effectiveness between ACEIs and ARBs. CONCLUSION: There is a lack of direct comparisons of ACEIs and ARBs in existing economic evaluations. Considering the current evidence, both ACEIs and ARBs are likely cost-saving comparing with conventional therapy, excluding such RAAS inhibitors.

Errors in preparation and administration of insulin in two urban Vietnamese hospitals: an observational study.

BACKGROUND: Medication errors involving insulin are common, particularly during the administration stage, and may cause severe harm. Little is known about the prevalence of insulin administration errors in hospitals, especially in resource-restricted settings, where the burden of diabetes is growing alarmingly. OBJECTIVES: The aim of this study was to determine the prevalence, type, and potential clinical outcome of errors in preparation and administration of insulin in resource-restricted setting hospitals. METHODS: This study was conducted on six wards in two urban public hospitals in Vietnam using a direct observation method. Details of insulin preparation and administration were collected by pharmacy students 12 hours per day for 7 consecutive days on each ward. Potential clinical outcome was judged by a panel of four experts using a validated scale. RESULTS: The error rate was 28.8% (95% confidence interval [23.1%, 35.2%], n = 66 out of 229 insulin doses)-all with potentially moderate/severe outcome. Higher error rates were observed for infusion doses than for subcutaneous ones (80.0% vs. 22.5%, p < .01). Incorrect time, incorrect preparation/administration technique, and omissions were mostly encountered. DISCUSSION: Interventions suitable for resource-restricted settings need to be developed and tested to improve insulin preparation and administration, probably starting with education and providing information, especially infusion doses.

Association between performance measures and glycemic control among patients with diabetes in a community-wide primary care cohort.

BACKGROUND: Performance measures are used for assessing quality of care. Higher performance shown by these measures is expected to reflect better care, but little is known whether they predict better patient outcomes. OBJECTIVE: To assess the predictive value of performance measures of glucose management on glycemic control, and evaluate the impact of patient characteristics on this association. RESEARCH DESIGN: Cohort study (2007-2009). SUBJECTS: A total of 15,454 type 2 diabetes patients (mean age, 66.5 y; 48% male) from the GIANTT cohort. MEASURES: We included performance measures assessing frequency of HbA1c monitoring, glucose-lowering treatment status, and treatment intensification. Associations between performance and glycemic control were tested using multivariate linear regression adjusted for confounding, reporting estimated differences in HbA1c with 95% confidence intervals (CI). Impact of patient characteristics was examined through interactions. RESULTS: Annual HbA1c monitoring was associated with better glycemic control when compared with no such monitoring (HbA1c -0.29%; 95% CI -0.37, -0.22). This association lost significance in patients with lower baseline HbA1c, older age, and without macrovascular comorbidity. Treatment status was associated with better glycemic control only in patients with elevated baseline HbA1c. Treatment intensification after elevated HbA1c levels was associated with better glycemic control compared with no intensification (HbA1c -0.21; 95% CI -0.26, -0.16). CONCLUSIONS: Performance measures of annual HbA1c monitoring and of treatment intensification did predict better patient outcomes, whereas the measure of treatment status did not. Predictive value of annual monitoring and of treatment status varied across patient characteristics, and it should be used with caution when patient characteristics cannot be taken into account.

Development of a minimal set of prescribing quality indicators for diabetes management on a general practice level.

OBJECTIVE: To identify the relevant prescribing quality domains of type 2 diabetes mellitus care as a basis for the selection of a minimal set of prescribing quality indicators from a set of previously validated indicators. METHODS: We used the principal factor analysis to identify the underlying dimensions or domains of prescribing quality for 76 general practitioners participating to the Groningen Initiative to Analyse Type 2 Diabetes Treatment project in the Netherlands. From a set of 10 prescribing quality indicators covering various aspects of cardiovascular and metabolic management, we selected a subset of indicators with the highest loading within each identified domain. Next, we evaluated the effect of using this subset on the quintile ranking of practices on their prescribing quality scores. RESULTS: We identified five prescribing quality domains in our data set: two assessing initiation of pharmacotherapy for different risk factors in diabetic patients, two on stepwise intensification of treatment, and one on treatment of patients with cardiovascular disease. A composite score comprising the indicators selected from each of the domains showed good agreement with the composite score comprising all indicators with 82% of general practitioners either not changing their position or shifting their ranking by only one quintile. CONCLUSIONS: We showed that a minimal set of prescribing quality indicators for type 2 diabetes mellitus care should not just focus on the management of different clinical risk factors but also reflect different steps of treatment intensification. The results of our study are relevant for stakeholders when selecting quality indicators to assess the quality of prescribing in diabetic patients.

A pilot qualitative study to explore stakeholder opinions regarding prescribing quality indicators.

BACKGROUND: Information on prescribing quality of diabetes care is required by health care providers, insurance companies, policy makers, and the public. Knowledge regarding the opinions and preferences of all involved parties regarding prescribing quality information is important for effective use of prescribing quality indicators. METHODS: Between June and December 2009 we conducted semi structured interviews with 16 key-informants representing eight different organizations in the Netherlands involved in healthcare quality measurement and improvement. The interview guide included topics on participants' opinions and preferences regarding existing types of prescribing quality indicators in relation to their aim of using quality information. Content analysis methods were used to process the resulting transcripts following the framework of predetermined themes. RESULTS: Findings from this qualitative study of stakeholder preferences showed that indicators focusing on undertreatment are found important by all participants. Furthermore, health care providers and policy makers valued prescribing safety indicators, insurance companies prioritized indicators focusing on prescribing costs, and patients' organization representatives valued indicators focusing on interpersonal side of prescribing. Representatives of all stakeholders preferred positive formulation of the indicators to motivate health care providers to participate in health improvement programs. A composite score was found to be most useful by all participants as a starting point of prescribing quality assessment. Lack of information on reasons for deviating from guidelines recommendations appeared to be the most important barrier for using prescribing quality indicators. According to the health care providers, there are many legitimate reasons for not prescribing the recommended treatment and these reasons are not always taken into account by external evaluators. The latter may cause mistrust of health care providers towards external stakeholders and limit the use of PQI in external quality improvement programs. CONCLUSION: Prescribing quality indicators are considered to be an important tool for assessing quality of provided diabetes care by all participants, although the preferences for specific types of indicators may differ by stakeholder depending on their user aim. Introduction of information systems to register the reasons for deviating from the recommended drug treatment may contribute to a more widespread use of PQI for assessment of provided health care quality to diabetic patents. This study identified the potential preferences regarding quality indicators for diabetes care, and this could be used for development of questionnaires to conduct a survey among a larger group of participants.

Additional safety risk to exceptionally approved drugs in Europe?

AIMS: Regulatory requirements for new drugs have increased. Special approval procedures with priority assessment are possible for drugs with clear 'unmet medical need'. We question whether these Exceptional Circumstances (EC) or Conditional Approval (CA) procedures have led to a higher probability of serious safety issues. METHODS: A retrospective cohort study was performed of new drugs approved in Europe between 1999 and 2009. The determinant was EC/CA vs. standard procedure approval. Outcome variables were frequency and timing of a first Direct Healthcare Professional Communication (DHPC). An association between approval procedure and the time from market approval to DHPC was assessed using Kaplan-Meyer survival analysis and Cox-regression to correct for covariates. RESULTS: In total 289 new drugs were approved. Forty-six (16.4%) were approved under EC or CA, of which seven received a DHPC (15%). This was similar to the standard approval drugs (243), of which 33 received one or more DHPC (14%, P= 0.77). The probability of acquiring a DHPC for standard approval drugs vs. EC/CA drugs during 11-year follow-up is 22% (95% CI 14%, 29%) and 26% (95% CI 8%, 44%), respectively (log-rank P= 0.726). This difference remained not significant in the Cox-regression model: hazard ratio 0.94 (95% CI 0.40, 2.20). Only drug type was identified as a confounding covariate. CONCLUSION: The EC/CA procedure is not associated with a higher probability of DHPCs despite limited clinical development data. These data do not support the view that early drug approval increases the risk of serious safety issues emerging after market approval.

A review of methods used in assessing non-serious adverse drug events in observational studies among type 2 diabetes mellitus patients.

Clinical drug trials are often conducted in selective patient populations, with relatively small numbers of patients, and a short duration of follow-up. Observational studies are therefore important for collecting additional information on adverse drug events (ADEs). Currently, there is no guidance regarding the methodology for measuring ADEs in such studies. Our aim was to evaluate whether the methodology used to assess non-serious ADEs in observational studies is adequate for detecting these ADEs, and for addressing limitations from clinical trials in patients with type 2 diabetes mellitus. We systematically searched MEDLINE and EMBASE for observational studies reporting non-serious ADEs (1999-2008). Methods to assess ADEs were classified as: 1) medical record review; 2) surveillance by health care professionals (HCP); 3) patient survey; 4) administrative data; 5) laboratory/clinical values; 6) not specified. We compared the range of ADEs identified, number and selection of patients included, and duration of follow-up. Out of 10,125 publications, 68 studies met our inclusion criteria. The most common methods were based on laboratory/clinical values (n = 25) and medical record review (n = 18). Solicited surveillance by HCP (n = 17) revealed the largest diversity of ADEs. Patient surveys (n = 15) focused mostly on hypoglycaemia and gastrointestinal ADEs, laboratory values based studies on hepatic and metabolic ADEs, and administrative database studies (n = 5) on cardiovascular ADEs. Four studies presented ADEs that were identified with the use of more than one method. The patient population was restricted to a lower risk population in 19% of the studies. Less than one third of the studies exceeded pre-approval regulatory requirements for sample size and duration of follow-up. We conclude that the current assessment of ADEs is hampered by the choice of methods. Many observational studies rely on methods that are inadequate for identifying all possible ADEs. Patient-reported outcomes and combinations of methods are underutilized. Furthermore, while observational studies often include unselective patient populations, many do not adequately address other limitations of pre-approval trials. This implies that these studies will not provide sufficient information about ADEs to clinicians and patients. Better protocols are needed on how to assess adverse drug events not only in clinical trials but also in observational studies.

Perceived adverse drug events in heart failure: patients' perception and related factors.

BACKGROUND: Patients with heart failure (HF) often perceive adverse drug events (ADEs), affecting quality of life. For weighing the benefits and burden of medication in HF care, knowledge on patients' perception of ADEs is needed. Our aim was to assess these ADE perceptions and to identify factors related to these perceptions. METHODS: A cross-sectional study was performed including HF patients recruited from primary care and outpatient clinics. Patients were included in the analysis if they perceived an ADE in the past 4 weeks. This information was collected using an open-ended question and a symptom checklist. Data on ADE perception were obtained using a modified version of the Revised Illness Perception Questionnaire. Demographic, clinical, and ADE characteristics were collected by self-administered questionnaire and chart review. The relations between these factors and ADE perceptions were analyzed using regression analyses. RESULTS: In total, 261 HF patients perceived an ADE and completed the questionnaire. Patients reported 814 ADEs, of which 26% of the patients reported dizziness and 24% reported dry mouth as being the most prevalent. Almost half of the patients (46%) perceived their ADE as something serious, with major consequences for their daily life (40%) and reported to be worried (36%) about the ADE. Patients perceived the ADE as a chronic problem (91%), and the majority believed more in the ability of the health care provider to control the ADE (61%) than in their own ability (46%). Demographic and clinical variables had a limited contribution to the explained variance of ADE perceptions after adjusting for ADE characteristics, such as perceived severity. CONCLUSION: Patients with HF perceive particular negative consequences and emotional distress of symptomatic ADE. Open communication between patients and providers with attention for patients ADE perceptions would be valuable during the decision process of ADE management and may result in a regimen aligned with patients' preferences and needs.

The impact of perceived adverse effects on medication changes in heart failure patients.

BACKGROUND: Given the importance of patient safety and well-being, we quantified the likelihood and type of medication changes observed after 5 possible adverse effects (AE) perceived by heart failure (HF) patients. METHODS AND RESULTS: We conducted a retrospective cohort study using 18 months follow-up data from the Coordinating study evaluating Outcomes of Advising and Counseling in HF study on 754 patients previously hospitalized for HF (NYHA II-IV, mean age 70 years). Data used for this secondary analysis included problem checklists that patients had completed at 3 points in time, and medication data collected from chart review. Changes in potential causal cardiovascular medication and relevant alleviating medication were classified. Within group and relative risks (RR) for medication changes were calculated. Of the 754 patients, 50% reported dizziness, 44% dry cough, 19% nausea, 19% diarrhea, and 12% gout on the first checklist. Overall, the likelihood of a medication change was increased by 38% after a perceived AE. Dry cough had the highest increased likelihood of an associated cardiovascular medication change (RR 1.83, CI 1.35-2.49). Patients reporting gout had a four fold higher likelihood of alleviating medication started or intensified. CONCLUSIONS: A considerable number of HF patients perceived possible AE. However, the likelihood of medication being changed after a possible AE was rather low. There seems to be room for improving the management of AE.

A systematic literature review: prescribing indicators related to type 2 diabetes mellitus and cardiovascular risk management.

PURPOSE: Valid prescribing indicators (PI) are needed for reliable assessment of prescribing quality. The purpose of this study is to describe the validity of existing PI for type 2 diabetes mellitus and cardiovascular risk management. METHODS: We conducted a systematic literature search for studies describing the development and assessment of relevant PIs between January 1990 and January 2009. We grouped identified PI as drug- or disease-oriented, and according to the aspects of prescribing addressed and the additional clinical information included. We reviewed the clinimetric characteristics of the different types of PI. RESULTS: We identified 59 documents describing the clinimetrics of 16 types of PI covering relevant prescribing aspects, including first-choice treatment, safety issues, dosing, costs, sufficient and timely treatment. We identified three types of drug-oriented, and five types of disease-oriented PI with proven face and content validity as well as operational feasibility in different settings. PI focusing on treatment modifications were the only indicators that showed concurrent validity. Several solutions were proposed for dealing with case-mix and sample size problems, but their actual effect on PI scores was insufficiently assessed. Predictive validity of individual PI is not yet known. CONCLUSION: We identified a range of existing PI that are valid for internal quality assessment as they are evidence-based, accepted by professionals, and reliable. For external use, problems of patient case-mix and sample size per PI should be better addressed. Further research is needed for selecting indicators that predict clinical outcomes.

Comparison of potential risk factors for medication errors with and without patient harm.

PURPOSE: To compare determinants for medication errors leading to patient harm with determinants for medication errors without patient harm. METHODS: A two-way case-control design was used to identify determinants for medication errors without harm (substudy 1) and determinants for medication errors causing harm (substudy 2). Data of patients admitted to five internal medicine wards of two Dutch hospitals during 5 months were collected prospectively by chart review. Medication errors were detected and classified by two pharmacists. Consensus between five pharmacists was reached on the causal relationship between medication errors and patient harm. Data analysis was performed by multivariate logistic regression. RESULTS: We included 7286 medication orders, of which 3315 without errors (controls), and 5622 medication errors without harm (cases substudy 1) and 102 medication errors causing harm (cases substudy 2) were identified. Hospital, ward and the therapeutic class anti-infectives were associated with both medication errors without harm (hospital odds ratio (OR) 1.40; 95% confidence interval (CI) 1.21-1.63), TweeSteden hospital (TSh) geriatrics OR 2.03; 95% CI 1.73-2.38, TSh general internal medicine OR 1.44; 95% CI 1.23-1.69 and anti-infectives OR 1.28; 95% CI 1.06-1.56) and medication errors with harm (hospital OR 4.91; 95% CI 3.02-7.79, TSh geriatrics OR 5.76; 95% CI 2.52-13.15, TSh general internal medicine OR 6.51; 95% CI 2.82-15.02 and anti-infectives OR 4.20; 95% CI 2.24-7.90). CONCLUSIONS: This study shows that organisational determinants (hospital, ward) are comparable for medication errors with and without harm. For conclusions on patient- and medication-related determinants studies with larger sample sizes are needed.

Methods to identify the target population: implications for prescribing quality indicators.

BACKGROUND: Information on prescribing quality is increasingly used by policy makers, insurance companies and health care providers. For reliable assessment of prescribing quality it is important to correctly identify the patients eligible for recommended treatment. Often either diagnostic codes or clinical measurements are used to identify such patients. We compared these two approaches regarding the outcome of the prescribing quality assessment and their ability to identify treated and undertreated patients. METHODS: The approaches were compared using electronic health records for 3214 diabetes patients from 70 general practitioners. We selected three existing prescribing quality indicators (PQI) assessing different aspects of treatment in patients with hypertension or who were overweight. We compared population level prescribing quality scores and proportions of identified patients using definitions of hypertension or being overweight based on diagnostic codes, clinical measurements or both. RESULTS: The prescribing quality score for prescribing any antihypertensive treatment was 93% (95% confidence interval 90-95%) using the diagnostic code-based approach, and 81% (78-83%) using the measurement-based approach. Patients receiving antihypertensive treatment had a better registration of their diagnosis compared to hypertensive patients in whom such treatment was not initiated. Scores on the other two PQI were similar for the different approaches, ranging from 64 to 66%. For all PQI, the clinical measurement -based approach identified higher proportions of both well treated and undertreated patients compared to the diagnostic code -based approach. CONCLUSIONS: The use of clinical measurements is recommended when PQI are used to identify undertreated patients. Using diagnostic codes or clinical measurement values has little impact on the outcomes of proportion-based PQI when both numerator and denominator are equally affected. In situations when a diagnosis is better registered for treated than untreated patients, as we observed for hypertension, the diagnostic code-based approach results in overestimation of provided treatment.