Renate Quinzler

The frequency of inappropriate tablet splitting in primary care

IntroductionWe assessed the frequency and determinants of tablet splitting in primary care in Germany and evaluated the quality of information on divisibility in the Summary of Product Characteristics (SPCs) and in the Package Leaflet (PL) as legal sources of information for health care providers and patients.MethodsWe performed a cross-sectional questionnaire survey among patients of 59 general practitioners in the German Federal State Saxony-Anhalt in 2005 in order to collect detailed information on all drugs of patients maintained on more than three drugs.ResultsThe response rate was 82.1% (n=905) and 3,158 drugs (tablets and dragées) were included in the analyses. Of all drugs, 24.1% were split (762 of 3,158): 8.7% of all split tablets were unscored (66 of 762) and 3.8% of all split tablets were not allowed to be split (29 of 762). Tablets of the higher price categories and higher strengths were twice as likely to be split. Only 22.5% of the SPCs (9 of 40) of the split unscored tablet brands contained explicit information on divisibility and only 36.4% of the PLs (8 of 22) of the split brands that were not allowed to be split stated that splitting was not appropriate.ConclusionThe splitting of tablets in primary care is a frequent habit likely driven by medical and economic considerations. Almost 1% of all tablets are split that must not be fragmented. However, the SPC and PL provide only limited information on divisibility stressing the need to improve this information promptly to avoid medication errors.

Impact of quality circles for improvement of asthma care: results of a randomized controlled trial

Rationale and aims Quality circles (QCs) are well established as a means of aiding doctors. New quality improvement strategies include benchmarking activities. The aim of this paper was to evaluate the efficacy of QCs for asthma care working either with general feedback or with an open benchmark. Methods Twelve QCs, involving 96 general practitioners, were organized in a randomized controlled trial. Six worked with traditional anonymous feedback and six with an open benchmark; both had guided discussion from a trained moderator. Forty-three primary care practices agreed to give out questionnaires to patients to evaluate the efficacy of QCs. Results A total of 256 patients participated in the survey, of whom 185 (72.3%) responded to the follow-up 1 year later. Use of inhaled steroids at baseline was high (69%) and self-management low (asthma education 27%, individual emergency plan 8%, and peak flow meter at home 21%). Guideline adherence in drug treatment increased (P = 0.19), and asthma steps improved (P = 0.02). Delivery of individual emergency plans increased (P = 0.008), and unscheduled emergency visits decreased (P = 0.064). There was no change in asthma education and peak flow meter usage. High medication guideline adherence was associated with reduced emergency visits (OR 0.24; 95% CI 0.07–0.89). Use of theophylline was associated with hospitalization (OR 7.1; 95% CI 1.5–34.3) and emergency visits (OR 4.9; 95% CI 1.6–14.7). There was no difference between traditional and benchmarking QCs. Conclusions Quality circles working with individualized feedback are effective at improving asthma care. The trial may have been underpowered to detect specific benchmarking effects. Further research is necessary to evaluate strategies for improving the self-management of asthma patients.

Incidence of thyroid hormone therapy in patients treated with sunitinib or sorafenib: a cohort study.

BACKGROUND Sunitinib and sorafenib can induce serious adverse drug reactions (ADR) such as hypothyroidism. However, the incidence has not been reliably determined in clinical trials. AIMS To determine incidence rates (IR) and hazard ratios (HR) of thyroid hormone (TH) therapy as a surrogate for sunitinib- and sorafenib-induced clinical hypothyroidism. METHODS A cohort study was performed using claims data for prescriptions covering >80% of German pharmacies. Patients with a first prescription of sunitinib or sorafenib in the period between June 2006 and December 2007 were followed until incident prescription of any TH (event of interest) or censoring (due to loss to follow-up, discontinuation or switch of therapy, prescription of antithyroid drugs or the end of the study). RESULTS One-hundred and seventy eight of 1295 sunitinib patients (13.7%) versus 77 of 1214 sorafenib patients (6.3%) received a TH. IR were 24.2 and 12.1 per 100 person-years, respectively. Unadjusted HR for TH therapy was 2.0 (95%confidence interval (CI) 1.5-2.6) for sunitinib compared to sorafenib and remained significant after adjustment for covariates, i.e. type of prescriber, region, insurance status, type of insurance fund, and relevant co-medication. CONCLUSIONS Sunitinib- and sorafenib-induced hypothyroidism is a more frequent ADR than currently labelled. Furthermore, patients treated with sunitinib have a two-fold increased risk of requiring TH therapy compared to sorafenib. Patients being treated with sunitinib or sorafenib are, therefore, at risk of thyroid function disturbances and routine monitoring both at baseline and throughout treatment with sunitinib and sorafenib is justified.

Substantial reduction of inappropriate tablet splitting with computerised decision support: a prospective intervention study assessing potential benefit and harm

BackgroundCurrently ambulatory patients break one in four tablets before ingestion. Roughly 10% of them are not suitable for splitting because they lack score lines or because enteric or modified release coating is destroyed impairing safety and effectiveness of the medication. We assessed impact and safety of computerised decision support on the inappropriate prescription of split tablets.MethodsWe performed a prospective intervention study in a 1680-bed university hospital. Over a 15-week period we evaluated all electronically composed medication regimens and determined the fraction of tablets and capsules that demanded inappropriate splitting. In a subsequent intervention phase of 15 weeks duration for 10553 oral drugs divisibility characteristics were indicated in the system. In addition, an alert was generated and displayed during the prescription process whenever the entered dosage regimen demanded inappropriate splitting (splitting of capsules, unscored tablets, or scored tablets unsuitable for the intended fragmentation).ResultsDuring the baseline period 12.5% of all drugs required splitting and 2.7% of all drugs (257/9545) required inappropriate splitting. During the intervention period the frequency of inappropriate splitting was significantly reduced (1.4% of all drugs (146/10486); p = 0.0008). In response to half of the alerts (69/136) physicians adjusted the medication regimen. In the other half (67/136) no corrections were made although a switch to more suitable drugs (scored tablets, tablets with lower strength, liquid formulation) was possible in 82% (55/67).ConclusionThis study revealed that computerised decision support can immediately reduce the frequency of inappropriate splitting without introducing new safety hazards.

Tablet splitting: patients and physicians need better support.

Because of numerous reimbursement restrictions, tablet splitting is becoming a growing challenge in Germany. Indeed, one in two ambulatory patients breaks tablets and about one fourth of all tablets are broken before ingestion, with over 2% being split even though they are not suitable for splitting [1]. Whereas this former study suggested that a substantial fraction of tablets is being destroyed before ingestion, the reason for tablet splitting at such a high frequency was unclear and appropriate measures for prevention of inappropriate tablet splitting were difficult to design. In a second questionnaire survey in the same patient population, we therefore assessed why patients split tablets and what their attitudes towards tablet splitting are. A structured questionnaire was sent to all patients who had completed the questionnaire of the initial study and for whom a valid postal address was available (n=897). In addition to the collection of sociodemographic and medication data [1], we assessed the patients’ reasons for tablet splitting (by prescription, at patient’s own initiative to lower dose, to ease swallowing, or any other reason; multiple answers were possible). Furthermore, we included eight questions to evaluate their attitudes towards and experiences with tablet splitting (Table 1). Five hundred and ninety-six patients returned the questionnaire (response rate 66.4%). Of them, 580 completed the medication list and only those questionnaires were included into the analysis (mean number of drugs per patient 6.6; mean age 68 years; 55% women). Of these patients, 67.2% (390/580) stated that they currently split at least one tablet before ingestion. The 94.1% of patients breaking tablets (352 of 374, 16 patients did not respond) stated that they split tablets because their prescription mandated splitting, whereas only 21 patients (5.6%) indicated they split tablets on their own initiative to ease swallowing (n=12) or to modify the dose (n=9). Seventeen patients (4.5%) split tablets for any other reasons, with ten of them to reduce medication costs. Almost two thirds of the patients splitting tablets considered tablet splitting to be useful to reduce medication costs (Table 1). However, only about 55% of these patients (132/241) stated that their physician should indeed promote tablet splitting as far as possible for economic reasons. More than 70% of responding patients agreed that tablets are sometimes difficult to break and that score lines do not necessarily guarantee that two equal parts are obtained. More than one third of patients splitting tablets erroneously believed that all tablets may be split, and more than 80% of patients expected to find the respective information in the package leaflet (Table 1). This survey confirmed that a large fraction of ambulatory patients on combination therapy are splitting tablets. Our findings indicate that in the overwhelming majority of patients, tablet splitting was prescribed by physicians, suggesting that the rather high frequency of inappropriate tablet splitting found earlier in this population [1] was Eur J Clin Pharmacol (2007) 63:1203–1204 DOI 10.1007/s00228-007-0382-5

Generic switch after ramipril patent expiry is not associated with decreased pharmacy refill compliance: a retrospective study using the DAPI database.

Objective For treatment success in chronic diseases such as hypertension, adequate adherence to long-term pharmacotherapy is a prerequisite. The purpose of this study was to evaluate whether switching from brand name ramipril to a generic product after patent expiry may negatively affect patients’ refill compliance. Methods Claims data for ambulatory prescriptions within the statutory health insurance system were evaluated. Patients were included if they had filled a ramipril prescription (index) for either brand name or generic ramipril products between September 2003 and June 2004. Patients had to be continuously treated with ramipril for at least 12 months before and after the index date. Patients with a change from brand name to generic product or vice versa during follow-up after the index date were excluded from the analyses, as were patients who could not be unequivocally allocated to characteristics of covariates. Refill compliance was analysed by calculating the medication possession ratio (MPR), assuming that patients were prescribed one unit dose per day (MPRUD). Results In total, 142 690 and 79 191 patients were classified as brand name or generic therapy, respectively. Median MPRUD values were 0.95 and 0.96 (P < 0.001). In a logistic regression model adjusting for covariates, the probability for noncompliance (MPRUD < 0.8) was marginally lower in the generic compared with the brand name group (odds ratio 0.926, 99% confidence interval 0.901–0.951, P < 0.001). Conclusion These results suggest that refill compliance is not negatively affected by a physician-induced switch from brand name to generic ramipril products after patent expiry.

Medication Underuse in Aging Outpatients with Cardiovascular Disease: Prevalence, Determinants, and Outcomes in a Prospective Cohort Study

Background Cardiovascular disease is a leading cause of death in older people, and the impact of being exposed or not exposed to preventive cardiovascular medicines is accordingly high. Underutilization of beneficial drugs is common, but prevalence estimates differ across settings, knowledge on predictors is limited, and clinical consequences are rarely investigated. Methods Using data from a prospective population-based cohort study, we assessed the prevalence, determinants, and outcomes of medication underuse based on cardiovascular criteria from Screening Tool To Alert to Right Treatment (START). Results Medication underuse was present in 69.1% of 1454 included participants (mean age 71.1 ± 6.1 years) and was significantly associated with frailty (odds ratio: 2.11 [95% confidence interval: 1.24–3.63]), body mass index (1.03 [1.01–1.07] per kg/m2), and inversely with the number of prescribed drugs (0.84 [0.79–0.88] per drug). Using this information for adjustment in a follow-up evaluation (mean follow-up time 2.24 years) on cardiovascular and competing outcomes, we found no association of medication underuse with cardiovascular events (fatal and non-fatal) (hazard ratio: 1.00 [0.65–1.56]), but observed a significant association of medication underuse with competing deaths from non-cardiovascular causes (2.52 [1.01–6.30]). Conclusion Medication underuse was associated with frailty and adverse non-cardiovascular clinical outcomes. This may suggest that cardiovascular drugs were withheld because of serious co-morbidity or that concurrent illness can preclude benefit from cardiovascular prevention. In the latter case, adapted prescribing criteria should be developed and evaluated in those patients.

Inequalities in out-of-pocket payments for health care services among elderly Germans – results of a population-based cross-sectional study

IntroductionIn order to limit rising publicly-financed health expenditure, out-of-pocket payments for health care services (OOPP) have been raised in many industrialized countries. However, higher health-related OOPP may burden social subgroups unequally. In Germany, inequalities in OOPP have rarely been analyzed. The aim of this study was to examine OOPP of the German elderly population in the different sectors of the health care system. Socio-economic and morbidity-related determinants of inequalities in OOPP were analyzed.MethodsThis cross-sectional analysis used data of N = 3,124 subjects aged 57 to 84 years from a population-based prospective cohort study (ESTHER study) collected in the Saarland, Germany, from 2008 to 2010. Subjects passed a geriatric assessment, including a questionnaire for health care utilization and OOPP covering a period of three months in the following sectors: inpatient care, outpatient physician and non-physician services, medical supplies, pharmaceuticals, dental prostheses and nursing care. Determinants of OOPP were analyzed by a two-part model. The financial burden of OOPP for certain social subgroups (measured by the OOPP-income-ratio) was investigated by a generalized linear model for the binomial family.ResultsMean OOPP during three months amounted to €119, with 34% for medical supplies, 22% for dental prostheses, 21% for pharmaceuticals, 17% for outpatient physician and non-physician services, 5% for inpatient care and 1% for nursing care. The two-part model showed a significant positive association between income (square root equivalence scale) and total OOPP. Increasing morbidity was associated with significantly higher total OOPP, and in particular with higher OOPP for pharmaceuticals. Total OOPP amounted to about 3% of disposable income. The generalized linear model for the binomial family showed a significantly lower financial burden for the wealthiest quintile as compared to the poorest one.ConclusionsThis is the first study providing evidence of inequalities in OOPP in the German elderly population. Socio-economic and morbidity-related inequalities in OOPP and the resulting financial burden could be identified. The results of this study may contribute to the discussion about the mechanisms causing the observed inequalities and can thus help decision makers to consider them when adapting future regulations on OOPP.

Association of hypertension with depression and generalized anxiety symptoms in a large population-based sample of older adults.

Objective: The aim of the study was to assess the association of hypertension and symptoms of depression and generalized anxiety in a large cohort of elderly people. Methods: Data were derived from the 8-year follow-up (2008–2010) of the epidemiological ESTHER-cohort study. A total of 3124 randomly chosen participants aged 57–84 were visited at their homes by trained study doctors. General practitioner based diagnosis, self-reported status of hypertension, medication, and blood pressure measurement were considered to define the existence of hypertension. Depression and general anxiety severity were assessed using validated questionnaires. Logistic regression analyses were performed to determine cross-sectional associations between hypertension and clinically significant symptoms of depression (CSD) and generalized anxiety. Well known lifestyle risk factors for hypertension such as obesity were included in multivariate cross-sectional analyses. Results: Hypertension was prevalent in 1659 participants [53.1%; 95% confidence interval (CI) = (51.3; 54.9)]. CSD was detected in 163 participants [5.2%; 95%-CI = (4.4; 6.0)]. Symptoms of generalized anxiety were found in 434 participants [13.9%; 95%-CI = (12.7; 15.1)]. Patients with CSD showed significantly higher odds of being hypertensive [odds ratio (OR) = 1.76; 95%-CI = (1.14; 2.74)]. Participants with symptoms of generalized anxiety were found to have no higher odds for a hypertension diagnosis [OR = 1.1; 95%-CI = (0.85; 1.44)]. Overweight [OR = 1.86; 95%-CI = (1.53; 2.25)] as well as obesity [OR = 3.58; 95%-CI = (2.84; 4.52)] was significantly associated with hypertension. Conclusion: CSD appear to be related to hypertension in elderly adults. No association was found between symptoms of generalized anxiety and hypertension.

Two Techniques to Make Swallowing Pills Easier

To evaluate whether 2 techniques (the pop-bottle method for tablets and the lean-forward technique for capsules) ease swallowing of tablets and capsules, we conducted a cross-sectional study including 151 adults of the general German population. Participants swallowed 16 differently shaped placebos, rated their ease of swallowing on an 8-point Likert scale, and swallowed the 2 dosage forms that they had rated most difficult again using the appropriate technique. The pop-bottle method substantially improved swallowing of tablets in 59.7% (169/283) and the lean-forward technique for capsules in 88.6% (31/35). Both techniques were remarkably effective in participants with and without reported difficulties swallowing pills and should be recommended regularly.