[Epidemiology of attempted suicide using drugs. An inquiry from the Dresden University Clinic]. / Epidemiologie medikamentöser Parasuizide. Eine Erhebung aus dem Universitätsklinikum Dresden.

BACKGROUND AND OBJECTIVE: Little representative data of the epidemiology of attempted suicide exists in Germany. In this study the frequency of parasuicidal drug intoxication, the distribution of age and gender, as well as the kind and origin of used drugs were evaluated. Furthermore the knowledge about used drugs and possible adverse effects of a previously given medication were analysed. PATIENTS AND METHODS: Over a period of 2 years (January 1998-December 1999) 155 patients (41 males, 114 females, average age 40.5 years) with drug intoxication by attempted suicide were recruited at the University Hospital of Dresden, Germany, for further retrospective analysis. RESULTS: 74 % of these patients were women. Sedatives and hypnotics were most frequently used for parasuicide (44 %), followed by analgesics (18 %) and antidepressants (12 %). Benzodiazepines and benzodiazepine-agonists were the most commonly used drugs (32 %). Moreover, 80 % of all drugs used had been prescribed by physicians. Approximately half of the patients were well-informed about drugs taken. In 43 (47 %) of 92 patients with long-term medication an adverse effect was considered as a possible cause of the attempted suicide. CONCLUSION: Our data underline the importance of attempted suicide in view of the frequency of their use, the need of hospitalization, the required intensive care and possible relapses. Because the majority of drugs used were prescribed by physicians, before giving any medication to their possible suicidal use should be considered.

[Psychopharmaceutical prescriptions to older people. A comparison between patients in aged- and nursing homes, outpatient treatment with nursing care and outpatients without nursing care]. / Psychopharmakaverordnungen an älteren Menschen. Ein Vergleich zwischen Patienten aus Alten- und Pflegeheimen, ambulant behandelten Pflegefällen und ambulanten Patienten ohne Pflegebedarf.

To determine, whether age, sex, grade of need of care and living in nursing homes can influence prescribing behavior in elderly. In a retrospective and longitudinal study, the pattern of psychoactive drug prescriptions of nursing home residents was compared with non-institutionalized people with and without need of care. During 1999, the computerized files of 3592 people (> 60 years), insured by a health insurance fund (BKK) in Berlin, Germany, were obtained. Nursing home residents received significantly more prescriptions of psychoactive drugs than the others, especially more neuroleptics (40.1% versus 12.4% and 7.4%). Quality of prescriptions seemed to be higher in nursing homes (use of drugs with fewer side effects and less possible interactions), psychoactive drug prescriptions were given more frequently by psychiatrists and neurologists (37%). Non-institutionalized patients received them most from general practitioners (45%). Women received more prescriptions of psychoactive drugs than male patients. With rising grade of need of care, proportionately more patients received psychoactive drugs. The results of this study show some evidence of the lacking quality in the prescriptions of psychopharmaceuticals to the elderly.

Pattern of prescriptions issued by nursing home-based physicians versus office-based physicians for frail elderly patients in German nursing homes.

PURPOSE: The purpose of this study was to describe the physician prescription pattern for frail elderly patients in German nursing homes and to identify differences, if any, between that of physicians based in the nursing homes (A) and those with office-based practices (B). METHODS: Retrospective, longitudinal study of medication prescriptions on the basis of the database of a health insurance (Betriebskrankenkasse) in Berlin, Germany. We assessed the medication prescriptions for all 996 unselected insured individuals aged > or = 60 years who were insured throughout 1999 and lived in nursing homes. We analyzed selected patient characteristics and prescription data. Drugs were classified according to the WHO ATC code and were assigned a mean daily defined dose (DDD). RESULTS: 816 individuals were women and 180 were men. A total of 78% of women and 43% of men were aged 80 years or older. Two hundred sixty three patients were seen by nursing home-based physicians (A) and 733 by office-based physicians (B). The median of prescriptions per patient and year was 31 (A) and 37 (B) (p between groups < 0.001). Patients in Group A also received a lower number of DDDs in comparison to Group B (1109 vs 1250; p < 0.01). Costs were substantially higher in group B, and in both groups higher in the 60-69 years old in comparison to the more senior patients. The prescription pattern suggested a considerable frequency of inappropriate drug use in both groups in the following classes: psychopharmacological agents (neuroleptics, antidepressants, hypnotics), pain medication, digitalis glycosides, laxants and loop diuretics. On an average, office-based physicians (B) prescribed relatively more medications in all major classes with the exception of non-opiate analgesics, laxants and anxiolytics. CONCLUSIONS: These data are indicative of a considerable use of inappropriate medication for frail geriatric patients. Differences between the prescribing pattern among nursing home-based and office-based physicians were not substantial, however, the latter group prescribed relatively more drugs.

[Validity of diagnoses of mental disorders by primary care physicians]. / Validität von Krankenscheindiagnosen psychischer Störungen.

BACKGROUND AND OBJECTIVE: Even in young adult age, psychological disorders are highly prevalent. Family doctors and gynaecologists are the physicians most often consulted by young women. Hence, they have a special responsibility to diagnose psychiatric disorders and--if necessary--to refer to a specialist. PATIENTS AND METHODS: In a prospective epidemiological study, 342 young women (between 18 and 25 years of age) were questioned two times with a structured interview (F-DIPS) designed for mental disorders. In the time period (1997 and 1998), we also investigated, by analysing personal health insurance data, primary-care physicians' diagnoses and payments for services rendered. The diagnoses were compared. RESULTS: There was only a small accordance between F-DIPS and claimcards. Ambulant treating doctors diagnosed somatoform disorders in 28 % of the young women (F-DIPS: 3, 8 %). The F- DIPS found mostly phobic disorders (29 %) (claimcards: 6,1 %). A disorder-specific therapy was only rarely initiated. The treatment (psychotherapy and/or drug therapy) of women with psychiatric disorders appeared to be insufficient. CONCLUSION: The study indicates that primary-care physicians should be urgently trained in psychiatric diagnostics und therapy.

[Use of drugs in residents of homes for the elderly and nursing homes in comparison with patients in ambulatory care or without need of care]. / Arzneimittelanwendung bei Alten- und Pflegeheimbewohnern im Vergleich zu Patienten in ambulanter Pflege bzw. ohne Pflegebedarf.

BACKGROUND AND OBJECTIVE: Only a few studies have been done in Germany on the use of drugs in homes for the elderly and nursing homes. This is the first retrospective and longitudinal pharmaco-epidemiological study comparing the pattern of drug prescriptions for patients in nursing or for-the-elderly homes with that for health-insured ambulant patients or those not requiring care, all of them of the same age-group. PATIENTS AND METHODS: The samples were taken from a cohort of 3592 members of a company health insurance in Berlin, aged 60 years or over (912 men, 2680 women) who had been insured throughout 1999. The insurance company's database provided anonymous information on the insured and their doctors, details of drug prescriptions and hospital treatment. The patients were divided into three groups, group A: all those requiring care who lived in homes for the elderly or nursing homes (n=996); group B: all ambulant patients receiving care (n=1603), and group C: patients not requiring care, matched to the other groups for age and sex (n=993). All drugs were classified according to the anatomical-therapeutic-chemical WHO codes and listed by defined daily dosage (DDD). RESULTS: Those in group A received on average 3.6 DDD daily, those of group B 4.6 DDD, and those of group C 3.0 DDD. The relevant cost was 714 Euro (group A), 1126 Euro (group B) and 539 Euro (group C) per person in 1999. Indications of inadequate treatment concerned the use of psychopharmaceuticals (neuroleptics, antidepressives, hypnotics), analgesics, digitalis glycosides, antidiabetic drugs, diuretics, laxatives, and drugs of unproven efficacy. 15% of home residents received prescription from doctors on emergency call. These drugs were often continued beyond the immediate treatment. CONCLUSION: These data provide evidence of the lacking quality in the drug treatment of the elderly.

First results from an intensified monitoring system to estimate drug related hospital admissions.

AIMS: An intensified monitoring system was set up to identify drug related hospital admissions and estimate population-based incidences for commonly prescribed medications. METHODS: Pharmacovigilance-centres systematically screened nonelective admissions to emergency rooms or departments of internal medicine for drug related hospitalizations (DRH). Clinical pharmacologists used standardized causality assessment. Service areas of each acute care hospital were defined by 5 digit postal codes that covered 60% of all admissions. Drug dispensing information was available through claims processed by regional pharmacy computing centres. Quarterly incidences were estimated by dividing the number of events by the number of treated patients. RESULTS: 435 DRHs were reported during five quarters. The incidence of ADRs leading to admissions varied for specific drug groups from 1.5/10 000 treated patients to 24/10 000. Quarterly variation of incidences was moderate except for insulin and calcium antagonists. 95% confidence intervals overlap for all quarters within each group. Incidences are sensitive to changes in the definition of the source population. CONCLUSIONS: Our pharmacovigilance monitoring system allows comparisons of population-based incidences of drug-related hospitalizations among drugs and over time. It provides important information for risk management and monitoring outcomes of pharmaceutical quality management programmes.

[Confidentiality within the scope of secondary data research--approaches to a solution of the problem of data concentration]. / Die Vertrauensstelle im Rahmen der Sekundärdatenforschung--Lösungsansätze zum Problem der Datenkonzentration.

In order to implement general data protection requirements and internationally recognised ethical requirements, research with personal health and social data demands a specific framework for the secure handling of confidential data. In the process of transferring data from the health service providers to the place where they are analysed, an important role is played by a so-called trust centre, responsible for pseudonymisation of personal and institutional identifiers. An undesirable concentration of data in the trust centre can be avoided by early separation of data in the data transfer institution: the trust centre receives only the identifier to be pseudonymised, while the health provision data are sent direct to the analysing institution, where they can be matched with the pseudonyms from the trust centre, with the help of a unique case number. The possibility of reidentification, which exists mainly in large (pseudonymised) data sets, can be reduced by use of an appropriate pseudonymisation process (e.g. insuree-based pseudonymisation by health service providers for sampling of insurees). The measures described here are suitable for protecting confidentiality and for further improving data security in the handling of confidential personal and institutional data.

Adolescents' drug use and drug knowledge.

UNLABELLED: Self-medication is a common event. To use drugs correctly, a basic knowledge about drugs is required. Poor data are available about adults' drug knowledge. Furthermore, adolescents' basic drug knowledge has not been investigated. This study was designed in order to explore adolescents' drug use and knowledge and the factors that influence them. A total of 56 tenth grade students between 15-17 years of age at a secondary school in Dresden, Germany were enrolled in a pilot study by answering a self-completion questionnaire. Of adolescents, 57% took from one to six different drugs in the 2 weeks before questioning. In particular, a chronic consumption of non-opioid analgesics was found. Some 15% of adolescents took headache remedies at least several times per month. Self-acquisition occurred more often for these drugs than for any other drug group. The best score for drug knowledge was 10 out of 13 possible points and only 43% of students attained from 7 to 10 points. Astonishingly, more than two-thirds of adolescents could not describe in their own words how a medicinal agent is ingested. Female gender and a chronic drug consumption were detected as influencing factors of better drug knowledge. CONCLUSION: The results indicate that adolescents gain drug knowledge through drug consumption and not before taking drugs. This leads to a potential risk particularly in the case of self-medication.

P-glycoprotein inhibitor erythromycin increases oral bioavailability of talinolol in humans.

OBJECTIVE: Increased bioavailability of the P-glycoprotein (Pgp) substrates digoxin and cyclosporin due to erythromycin has been observed in vivo. The aim of the present study was to investigate the effect of orally administered erythromycin on the oral bioavailability of the beta-blocker talinolol. Talinolol is a suitable model compound for Pgp drug-drug interaction studies due to its Pgp-related active intestinal secretion and lack of any significant metabolism. METHODS: In a randomized crossover study, the oral pharmacokinetics of talinolol (50 mg) after a concomitant single oral dose of erythromycin (2 g) or placebo were investigated in 9 healthy men. Concentrations of talinolol were measured in serum and urine by HPLC. RESULTS: The area under the curve of talinolol serum concentrations from 0 to 24 h (AUC(0-24)) and the maximum serum concentrations (Cmax) were significantly increased after administration of erythromycin compared to placebo. t(max) values were significantly reduced. The renal clearance (CLR) of talinolol was unchanged after co-administration of erythromycin and there was a small but statistically significant decrease in elimination half-life (t1/2). Serum pharmacokinetics correlate with the results derived from urine concentration measurement. One subject suffered from moderate diarrhea after erythromycin and was excluded from the analysis. CONCLUSION: We suggest that the increase in oral bioavailability of talinolol after concomitant erythromycin is caused by increased intestinal net absorption due to Pgp inhibition by erythromycin.

The prescribing of lipid lowering drugs during a 1-year period: analysis of 7490 health insurance files.

A study of prescription patterns by office-based physicians was conducted to analyse the use of lipid lowering drugs (LLD) in a Germany area of 1,768,874 inhabitants during a 1-year period. The prescription database consisted of health insurance files from a random sampling of persons (n=7490) belonging to a large statutory health insurance organization during 1993-1994. During the study period LLD were prescribed to about 2.8% of the study population. Fibrates (43.7%) were the most frequently prescribed drugs followed by HMG-CoA reductase inhibitors (29.5%) and nicotinic acid with derivatives (21.7%). The prevalence of treatment rose with increasing age peaking among 60- to 69-year-olds (7.5%). More than two-thirds of the patients were not treated continuously, receiving LLD for less than 6 months. Thus, in patients being treated with LLD, the therapy seems to be ineffective due to the short episodes of drug administration. The presence of hyperlipidaemia plus additional risk factors such as hypertension led to a higher rate of LLD prescriptions than that for hyperlipidaemia alone. Only half of the patients with a history of previous myocardial infarction and hyperlipidaemia received LLD. Furthermore, patients with hyperlipidaemia and additional risk factors such as arterial hypertension, diabetes mellitus and coronary heart disease (CHD), in whom administration of LLD has often been shown to be effective, were by far too infrequently treated with these drugs. Copyright (c) 2000 John Wiley & Sons, Ltd.

Regional drug information service.

BACKGROUND: Drug information centers (DICs) were established in Europe more than two decades ago. The majority of German DICs were created in the 90s. The regional University hospital-based DIC, which offers services to physicans, is now in operation for three and a half years . OBJECTIVE: To evaluate the types of enquiries received and the profile of the users of a drug information service. METHODS: The working procedure at a regional center in Dresden, Germany, is described. The topics for consultation (adverse reactions, pharmacokinetics, etc.) are presented, and the types of drugs involved are classified according to the Anatomical Therapeutic Chemical (ATC) classification. Users are grouped by medical specialty. Future plans for the DIC are discussed. RESULTS: A total of 516 enquiries were received. Questions concerning therapeutic use (34%), adverse drug reactions (28%), pregnancy/lactation (16%), and pharmacokinetics/dosage (15%) were asked most frequently. Cardiovascular drugs (20%), systemic antiinfectives (19%) as well as drugs targeting the central nervous system (15%) and alimentation/metabolism (9%) were the predominant foci of enquiries. The major users of the DIC were internists (19%), general practitioners (19%), pediatricians (18%), and gynecologists (11%). CONCLUSIONS: The types of questions and users of this service were generally similar to those recorded at many other European DICs. The service has begun producing educational bulletins on drug-related topics of clinical relevance.

Unexpected effect of verapamil on oral bioavailability of the beta-blocker talinolol in humans.

PURPOSE: To quantitate the effect of verapamil administered orally, a calcium channel blocker and potent inhibitor of P-glycoprotein on oral pharmacokinetics of the beta1-adrenergic receptor antagonist talinolol, a substrate of P-glycoprotein. SUBJECTS AND METHODS: In a randomized, crossover placebo-controlled study, oral pharmacokinetics of talinolol (50 mg) after concomitant administration of single doses of R-verapamil (120 mg) or placebo were investigated in 9 healthy volunteers. Concentrations of talinolol, verapamil, and its main metabolite norverapamil were measured in serum with HPLC. Concentrations of talinolol were also measured in urine by HPLC. Standard pharmacokinetic parameters were calculated with noncompartmental procedures. RESULTS: The area under the concentration-time curve for talinolol from 0 to 24 hours was significantly decreased after R-verapamil versus placebo (721+/-231 ng x h x mL(-1) versus 945+/-188 ng x h x mL(-1); P < .01). Maximum serum concentration of talinolol was reached significantly earlier after R-verapamil compared with placebo (P < .05). Coadministration of R-verapamil did not affect the renal clearance or half-life of talinolol. Serum pharmacokinetics are paralleled by the results derived from urine concentrations of talinolol. CONCLUSION: This is the first study to show a decreased oral bioavailability of a P-glycoprotein substrate (talinolol) in humans as a result of coadministration of verapamil. This effect is assumed to be caused by changes of the intestinal net absorption of talinolol because its renal clearance remains unaffected by administration of R-verapamil. This unexpected effect of R-verapamil is most likely dose dependent as a result of an interplay between intestinal P-glycoprotein and gut metabolism.

Outpatient costs of osteoporosis in a national health insurance population.

There are few valid data on the outpatient diagnosis and treatment of osteoporosis in Germany, despite the high prevalence of this disease and the high costs associated with its complications. We therefore conducted a retrospective cohort study to investigate the prevalence of documented osteoporosis and the use of health care resources in its outpatient treatment in a representative random sample of 7490 patients from the Dresden area who were insured under the national health insurance program for a 1-year period from the 3rd quarter of 1993 to the 2nd quarter of 1994. Documented cases of osteoporosis were identified by International Statistical Classification of Diseases, 10th Revision diagnostic codes M80 to M82, and the costs of diagnostic services for osteoporosis were calculated using a uniform fee schedule. Specific and nonspecific osteoporosis medications were classified using a published anatomic-therapeutic-chemical code, and their costs were calculated on the basis of pharmacy sales prices. Three age- and sex-matched controls without documented osteoporosis (n = 705) were assigned for each case patient in estimating the net use of resources. Data for the region, as well as age-standardized information for the overall German national health insurance system, were calculated. The 1-year prevalence of documented osteoporosis in the region was 3.14% (5.20% in women, 0.89% in men), and the age-standardized prevalence in the German national health insurance system was 2.25%. During the study period, 51.1% of the cases and 2.1% of the controls were examined by osteodensitometry. Patients received 106 defined daily doses of osteoporosis medications during the year; 37.0% of the prescribed daily doses were for sodium fluorophosphate/calcium combinations, 4.3% were for sodium fluoride, and 7.7% were for calcium alone. Sex hormones and calcitonin each accounted for 7.7% of the prescribed daily doses. Only a fraction of epidemiologically expected cases of osteoporosis have been identified and documented in the outpatient sector. Only approximately 50% of these receive osteoporosis-specific therapy, and compliance with therapy is low. To reduce osteoporosis-associated fracture rates, which are extremely cost intensive and greatly impair patients' quality of life, more consistent treatment is needed.

Digitoxin intoxication with lethal outcome.

A 65-year old woman with known history of reactive depression and failed suicide attempts ingested 7 mg digitoxin at 09.00 h. After vomiting 4 hours later, she reported the drug intake to her husband who thereupon summoned a physician. Arriving at 16.00 h, the physician was informed about the suicide attempt, but failed to initiate any specific measures. After a second doctor's visit at 22.00 h, the patient was rushed to hospital in a moribund state. In spite of a gastric lavage, treatment with activated charcoal and insertion of a transvenous pacemaker, the patient died at 23.45 h with signs of total atrioventricular block. Digitalis fab fragments could not be administered in time. A calculation based on the plasma digitoxin concentration of 212 ng.ml-1 measured at 23.00 h indicated that nearly the entire ingested dose had been absorbed. Thus, neither the vomiting nor the gastric lavage eliminated significant amounts of the drug which had left the stomach without delay. Under these circumstances, the failure to initiate timely therapy with specific digitalis fab fragments ultimately contributed to the lethal outcome.

[Use of drugs by women in the federal Saxony district based on survey data]. / Der Arzneimittelgebrauch bei Frauen im Bundesland Sachsen auf der Grundlage von Survey-Daten.

This study examines sex-specific differences in drug use of the Saxon population and compares them with relevant studies in the old Federal States. This study is based on data of the Drug Survey East (1992) which were secondary analyzed for Saxony. The sample population was representative for Saxon inhabitants aged 18-79 years and encompassed 765 participants interviewed by physicians about their drug use in the last 7 days. The drug exposure in women younger than 60 years is significantly higher than in men of the same age group. The difference can only partially be explained by the intake of oral contraceptives. Compared with men women take a higher number of different drugs and take more often self-acquired drugs in addition to the drugs prescribed by physicians. A comparison Saxony-Bremen shows that the intake of hormonal contraceptives, antihypertensives and betablockers in Saxon women is much higher than in women in the old Federal States, thyroid therapeutics, however, are used less often. Possible reasons for sex-specific and regional particularities in drug use are discussed.

[Reversible thrombocytopenia due to digitoxin overdose]. / Reversible Thrombozytopenie bei Digitoxinüberdosierung.

A 65-year-old woman, known to have peptic ulcers, developed nausea and retching. Clinical examination demonstrated pain on pressure in the epigastrium with otherwise normative findings for age. Two gastric ulcers and gastritis with erosions were seen at endoscopy. The patient, who was being treated with digitoxin for heart failure, reported having taken up to four digitoxin tablets (0.07 mg each) daily because she had insomnia. The plasma digitoxin level was between 150 and 160 nmol/l (therapeutic range 17-33 nmol/l), while the ECG showed no signs of digitalis intoxication. Initially the platelet count was 40,000/microliter: there had been no history of thrombocytopenia or symptoms of abnormal haemostasis. Other laboratory tests were within normal limits. After digitoxin had been discontinued, the platelet count rose without further treatment to 373,000/microliter 3 weeks after hospital admission by which time the digitoxin level had fallen to 48.9 nmol/l. The gastrointestinal symptoms regressed completely on treatment with omeprazole (40 mg three times daily for 8 days) and ranitidine (150 mg twice daily).

[Chronic rheumatic symptoms and diseases: a representative longitudinal study based on data of the general local health insurance fund of Dortmund]. / Chronisch rheumatische Beschwerden und Erkrankungen: Eine repräsentative Längsschnittstudie auf der Grundlage von Daten der Allgemeinen Ortskrankenkasse Dortmund.

In a representative diachronous study, findings concerning the prevalence of utilisation of medical services by patients who chronically suffer from rheumatism, as well as the amount of X-ray diagnoses and temporary disablement of those patients are presented. In order to make this study, personal data of the local statutory health insurance fund of the city of Dortmund (a 5% random sample of insured in 1988) was collected. Diseases and complaints of the rheumatic variety are a frequent reason for the utilisation of out-patient medical services: 38.8% of the insured of the random sample (2513 out of 6478 insured of the random sample) were under medical treatment in 1988 because of rheumatic complaints. The study refers to the unselected totality of patients of established doctors, which means that it refers to all phases of the illness. The chronicity of the rheumatic complaints is investigated by means of an operational definition which aims at the continuity of treatment. 18.9% of the insured suffered from chronic rheumatic complaints. Vertebral syndromes and degenerative joint diseases represent the majority of chronic rheumatic complaints. 50% of the patients suffering from chronic rheumatism were X-rayed at least once a year; younger ones more frequently than the older ones. The percentage of rheumatic patients suffering from rheumatism who are at least once a year temporarily disabled does not vary with regard to the age-group; one can however state: the older the patients are, the longer does sick-leave per annum last.

Drug utilization research in primary health care as exemplified by physicians' quality assessment groups.

Drugs in primary health care are often prescribed for nonrational reasons. Drug utilization research investigates the prescription of drugs with an eye to medical, social and economic causes and consequences of the prescribed drug's utilization. The results of this research show distinct differences in drug utilization in different age groups and between men and women. Indication and dosage appear irrational from a textbook point of view. This indicates nonpharmacological causes of drug utilization. To advice successfully changes for the better quality assessment groups of primary health care physicians get information about their established behavior by analysis of their prescriptions. The discussion and the comparisons in the group allow them to recognize their irrational prescribing and the social, psychological and economic reasons behind it. Guidelines for treatment are worked out which take into account the primary health care physician's situation. After a year with 6 meetings of the quality assessment groups the education process is evaluated by another drug utilization analysis on the basis of the physicians prescription. The evaluation shows a remarkable improvement of quality and cost effectiveness of the drug therapy of the participating physicians.