[Which Factors Affect Out-of-pocket Payments for Health Care Services Among Elderly Germans? Results of a Longitudinal Study]. / Welche Faktoren beeinflussen die privaten Zuzahlungen zu Gesundheitsleistungen im Alter? Ergebnisse einer Längsschnittstudie.

Background: In Germany, out-of-pocket payments (OOPP) account for a large proportion of total health expenditure. However, there are only few investigations on how morbidity-related, sociodemographic and lifestyle factors affect OOPP particularly in the older population. The aim of this study was to identify factors affecting OOPP for health care services among elderly Germans in a longitudinal setting. Methods: This longitudinal study used data from 2 follow-up waves (3-year interval) from a population-based prospective cohort study (ESTHER study) collected in Saarland, Germany. At the first follow-up wave, subjects were between 57 and 84 years old. Participants provided comprehensive data including individual OOPP for the preceding 3 months. Fixed effects (FE) regressions were used to determine factors affecting OOPP. Results: Mean individual OOPP (3-month period) rose from € 119 (first wave) to € 136 (second wave). Longitudinal regressions showed that higher morbidity did not affect OOPP. Moreover, changes in sociodemographic as well as lifestyle factors were not related to changes in OOPP. Solely, exemption of OOPP reduced the dependent variable significantly. Conclusion: In contrast to cross-sectional findings for Germany, OOPP are not related to morbidity and income in this study. This underlines the complex nature of OOPP in old age and the need for longitudinal studies to gain some insight into the underlying causal factors.

[Use and potential risks of over-the-counter analgesics]. / Gebrauch und potenzielle Risiken durch nicht verschreibungspflichtige Schmerzmittel.

BACKGROUND AND AIM: We investigated the use of prescription and non-prescription (over-the-counter, OTC) analgesics and the associated risks in elderly patients with multiple morbidities. METHODS: Pain medication use was evaluated from the baseline data (2008/2009) of the MultiCare cohort enrolling elderly patients with multiple morbidities who were treated by primary care physicians (trial registration: ISRCTN89818205). We considered opioids (N02A), other analgesics, and antipyretics (N02B) as well as nonsteroidal anti-inflammatory drugs (NSAIDs; M01A). OTC use, duplicate prescription, dosages, and interactions were examined for acetylsalicylic acid, diclofenac, (dex)ibuprofen, naproxen, and acetaminophen. RESULTS: Of 3,189 patients with multiple morbidities aged 65-85 years, 1,170 patients reported to have taken at least one prescription or non-prescription analgesic within the last 3 months (36.7 %). Of these, 289 patients (24.7 % of 1,170) took at least one OTC analgesic. Duplicate prescription was observed in 86 cases; 15 of these cases took the analgesics regularly. In two cases, the maximum daily dose of diclofenac was exceeded due to duplicate prescription. In 235 cases, patients concurrently took a drug with a potentially clinically relevant interaction. In 43 cases (18.3 % of 235) an OTC analgesic, usually ibuprofen, was involved. DISCUSSION: About one third of the elderly patients took analgesics regularly or as needed. Despite the relatively high use of OTC analgesics, the proportions of duplicate prescription, medication overdoses, and adverse interactions due to OTC products was low.

Design and evaluation of an ontology-based drug application database.

OBJECTIVES: Several recently published cases of preventable adverse drug reactions were associated with flaws in drug application. However, current clinical decision support (CDS) systems do not properly consider drug application issues and thus do not support effective prevention of such medication errors. With the aim to improve CDS in this respect, we developed a comprehensive model precisely describing all aspects of drug application. METHODS: The model consists of 1) a schema comprising all relevant attributes of drug application and 2) an ontology providing a hierarchically structured vocabulary of terms that describe the possible values of the schema's attributes. Finally, medical products were annotated by a semi-automatic term assignment process. For evaluation, we developed an algorithm that uses our model to compute a meaningful similarity between medicinal products with respect to their drug application characteristics. RESULTS: Our schema consists of 22 attributes. The ontology contains 248 terms, textual descriptions, and synonym lists. More than 58,700 medicinal products were automatically annotated with >386,600 terms. 2,450 drugs were manually reviewed by experts, adding >4500 terms. The annotation and similarity measure allow for (similarity) searches, clustering, and proper discrimination of drugs with different drug application characteristics. We demonstrated the value of our approach by means of a set of case studies. CONCLUSION: Our model enables a detailed description of drug application, allowing for semantically meaningful comparisons of drugs. This is an important prerequisite for improving the ability of CDS systems to prevent prescription errors.

[Medical problems and risks of switching drugs according to legal requirements of drug discount contracts in Germany]. / Medizinische Probleme und Risiken bei der rabattvertragsgerechten Umstellung von Medikationen in Deutschland.

INTRODUCTION: Since 2007 German health insurance funds may conclude discount contracts with pharmaceutical companies for individual drugs. According to German legislation pharmacies are liable to preferentially dispense these drugs to patients of the respective funds if the prescribed drug is identical regarding active ingredient, strength, package size, and route of administration, and is approved for the same indication. We aimed to assess the number and nature of clinically relevant differences between prescribed drug and its legal alternatives. METHODS: Using databases and expert systems of the drug information system AiD KLINIK we evaluated all 258 412 exchangeable drug pairs of the German market currently regulated by discount contracts. RESULTS: 15,7 % of the drug pairs differed in dosage, in one quarter each colour or shape was significantly different, and in roughly 3 % the size of the substituted drug differed by more than 50 %. In 9,43 % splitting characteristics of solid oral doses differed and in 1,87 % the substituted drug contained additives with allergenic potential not present in the primarily selected drug. On average 0,44 clinically relevant differences could be calculated in each substitution. CONCLUSION: This study has revealed that current legal provision ignore important medical criteria of the substitution process including individual risks (e. g. allergies). Patients will have to change the drug application process and will therefore need appropriate information and training. All these differences between substitutional drug pairs should already be known when prescribing so as to maintain patient safety in the face of this merely cost-saving measure.

Optimizing information on drug exposure by collection of package code information in questionnaire surveys.

PURPOSE: The thorough analysis of special drug characteristics requires information on the specific brand of a drug. This information is often not sought in pharmacoepidemiologic surveys although in many countries packages are labelled with an unequivocal code (in Germany called Pharmazentralnummer (PZN)). We aimed to assess the benefit and quality of PZN information collected in self-completed questionnaires. METHODS: We performed a survey in 905 ambulatory patients who were asked to list brand name, strength, and the PZN of all drugs they were taking. RESULTS: The medication list was completed by 97.5% (n = 882) of the responding patients (mean age 67.3 years). Altogether 5543 drugs (100%) were mentioned in the questionnaires and for 4230 (76.3%) the exact drug package could be allocated on the basis of the PZN. When PZN was considered in addition to the drug name the quality of drug coding was significantly improved (p < 0.001) with regard to the allocation of drug package (74% versus 2%), brand (90% versus 70%), and strength (96% versus 86%). The time needed for drug coding was three times shorter. CONCLUSIONS: The high response rate and high fraction of correct PZN indicate that the collection of package code information is a valuable method to achieve more accurate drug data in questionnaire surveys and to facilitate the drug coding procedure.

The frequency of inappropriate tablet splitting in primary care.

INTRODUCTION: We 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. METHODS: We 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. RESULTS: The 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. CONCLUSION: The 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.

[Tablet splitting]. / Tabletten teilen.

The splitting of scored tablets provides many advantages. One benefit is to achieve dose flexibility to account for the huge interindividual differences in dose requirements for instance in paediatric and geriatric patients, which are often not covered by the available strengths in the market. Moreover, large-sized tablets can easier be swallowed if broken before swallowing and medication costs can often be reduced by splitting brands with higher strength. But not all tablets, mostly unscored tablets, are suitable for splitting. Splitting of extended release formulations can result in an overdose by uncontrolled release of the active component and degradation of the compound can occur if an enteric coating is destroyed by the splitting process. Whether tablets are suitable for splitting depends on the properties of the active component (e.g. light sensitivity), the galenics, the shape of the tablet, and the shape of the scoreline. Moreover, not all patients are informed, able, or willing to split tablets and the majority of the elderly population is not capable to break tablets. When split tablets are prescribed it is therefore important to view the shape of the tablet, to assess the patients ability and willingness to break tablets, to properly inform the patient about the appropriate way of splitting, and if necessary to suggest (and instruct) the use of a tablet splitting device.