A clinical-pharmaceutical medication reconciliation with patient interview for a medication review to identify drug-related problems in elective patients during hospital admission.

Background and aim: Drug-related problems (DRPs), e.g.drug-drug interactions (DDI), can lead to adversedrug reactions (ADRs) and thus complications during hospitalization. For this reason, such DRP, DDI and ADR should be identified and characterized as early as possible during hospital admission. We aimed to perform a clinical-pharmaceutical medication reconciliation in which patient-related information was collected and compared to drug-related information in a medication review. Investigations: During a 24-week-period, we consecutively invited patients electively admitted to Urology, Otolaryngology, Oral and Maxillofacial Surgery, General and Visceral Surgery, and Oncology Departments of a 300-bed hospital. A clinical pharmacist performed a patient interview asking for medication, ADR, and adherence. The medication reconciliation considered packages for a brown-bag analysis, medication lists, and data from the clinical information-system (CIS). In a medication review, we matched patient-related information to drug-related information from the drug label, guidelines, drug-databases and websites to identify DRPs. Results: In the study, 356 patients (median age: 58 years) taking 1,712 drugs participated. Of all patients, 7.3% reported ADR and 10.7% missing adherence. 5.3% brought packages that enabled a brown-bag analysis and 21.1% a medication list. In 76.7% of patients, information from CIS was incomplete or not up-to-date. Among the most frequently identified DRPs were "Medication without diagnosis" (31.2%) and "Inappropriate timing of administration" (11.5%). The proportion of patients affected by severe DDI ranged from 0.8%-16.6%, depending on the drug information source. Conclusions: Incomplete patient data, frequently identified DRPs and inconsistent drug-based information make pharmaceutical involvement in medication reconciliation on admission a necessity.

A comprehensive study of prescribing, administering and drug handling medication errors in ten wards of a university hospital after implementation of electronic prescribing, clinical pharmacists or medication reconciliation.

Background and aim: Medication errors lead to preventable risks. Preventing strategies such as e-prescribing, clinical pharmacists and medication reconciliation have been implemented in recent years. However, information on long-term medication error rates in routine procedures is missing. Investigations: We aimed to identify predefined medication errors in ten wards of a university hospital where e-prescribing, clinical pharmacists and medication reconciliation have been partially implemented. Patient files were reviewed and routine processes were monitored for drug prescription errors (missing, unclear, outdated information), administration errors (wrong dispensed drugs) and drug handling errors (no light-, moisture-protection, wrong splitting, no separation of drugs, which ought to be taken by an empty stomach). Results: We analyzed 959 prescriptions with 933 solid peroral drugs for 182 patients (98 female, median age 66.5 years [Q25-Q75: 56-78 years]; the median number of drugs was 5 [Q25-Q75: 3-7]). The most frequent prescription error was a not specified drug form (91.1%). The most common administration error was a not adequately provided release dose formulation (72.7%). The lack of light protection for observed photosensitive drugs was the most frequent drug handling error (100%). We found a significantly higher amount of complete drug prescriptions with one of the implemented measurements e-prescribing, medication reconciliation and clinical pharmacists (Fisher's exact test two tailed, each p<0.001; CI 95%). Drug administration errors and drug handling errors were not significantly improved. Among the most frequently involved drug were drugs for acid-related disorders, immunosuppressant, and antineoplastic drugs. Conclusions: In the nearly 1,000 prescriptions and drugs analyzed, medication errors were still common. Various preventive strategies had been implemented in recent years, positively influencing the predefined errors rates.

How do parents perceive their children's epileptic seizures? Experiences of the first seizure and changes during the course of the epilepsy.

PROBLEM: Experiencing a child's seizure can be challenging for parents. METHODS: We investigated parental experiences of their child's first seizure and how their perception and management of seizures changed over time. From September 2020 to March 2021, we invited parents who had witnessed at least two of their child's seizures to take part in a semi-structured interview. Parents whose children experienced solely absence seizures were excluded. RESULTS: Of the parents, 52/74 (70%) did not recognize their child's first epileptic seizure and assumed the event to be due to a different cause, for instance teething. Parents overwhelmingly reported fear (48/74; 65%) and surprise (13/74; 18%) as the predominant emotional responses to the first seizure. In response to the most recently observed seizure parents reported feelings related to fear (33/74; 45%) and happiness (16/74; 22%), with regard to the latter, especially "being calm" or "feeling safe". Asked for thoughts in response to the first seizure, 22/74 (30%) reported concerns about their child's future, with regard to the most recent seizure, 15/74 (20%) expressed such thoughts. Of the parents, 53/74 (72%) did not know how to respond to the first seizure. Concerning the most recent seizure, 48/74 (65%) said they felt confident in managing the seizure. CONCLUSION: Experiencing the child's first seizure was very challenging for parents. During the course of the epilepsy, changes were observed in both parental perception of and confidence in managing the seizures. Physicians should consider these changes when counselling parents in order to better target their evolving needs.

An Observational Study to Identify Drug-related Problems (DRP) in Routine Care and An Expert Panel Assessment to Rate Clinical Risk and Preventability by Unit-dose Dispensing Systems (UDDS) with Computerized Physician Order Entry (CPOE) and Clinical Decision-Support Systems (CDSS).

Background and aim: Drug-related problems (DRP) jeopardize patient safety. Unit-dose dispensing systems (UDDS) with computerized-physician-order-entry (CPOE) and clinical-decision-support-systems (CDSS) were reported as a promising concept for preventing DRP. We aimed at identifying and categorizing DRP in peroral drug administration considering their clinical risk and preventability by UDSS/CPOE/CDSS. Investigations: In surgical and internal-medicine departments, we observed routine procedures in peroral drug administration for DRP. An expert panel including pharmaceutical and nursing expertise categorized the identified 18 DRP categories into three levels: DRP that have not yet resulted in medication errors (ME) (Level-I), DRP where ME have occurred but have not yet reached the patient (Level-II), and DRP where ME have occurred and have reached the patient (Level-III). Additionally, the panel categorized DRP according to their clinical risk and whether the implementation of UDSS/CPOE/CDSS can prevent them. Results: In 77 surgical patients, 1,849 peroral drug administration procedures, and in 149 internal-medicine patients, 1,405 procedures were observed. The 18 DRP categories were identified with a frequency of 0.6%-26.7% (Level-I), 0.1%-21.5% (Level-II), and 0.0%-1.0% (Level-III). Of those, four categories were considered of high clinical risk: "Name of the medication is not readable", "Prescribed medication is not prepared for administration", "An incorrect or non-prescribed medication is prepared", and "A medication is prepared for the wrong patient (mix-up)". Twelve DRP categories were categorized as highly preventable by UDSS/CPOE/CDSS. Conclusions:Under routine conditions, we identified a substantial number of DRPs. An expert panel categorized many of those DRPs as clinically highly relevant and highly preventable by UDSS/CPOE/CDSS.

An online cross-sectional survey of community pharmacists to assess information needs for evidence-based self-medication counselling.

BACKGROUND: Community pharmacists play an important role in healthcare. They are frequently visited by patients to receive advice on self-medication products. Little research has been conducted to investigate pharmacists' information needs for evidence-based self-medication counselling. AIM: To assess community pharmacists' information needs in five predefined areas: general and specific individual needs, quality needs, utilisation needs, implication needs, and access needs for evidence based self-medication counselling. METHOD: After ethical approval, we conducted an exploratory, semi-quantitative, cross-sectional online survey. Members of three different chambers of pharmacists in Germany were invited to participate anonymously in the survey. They gave informed consent and received no incentive for their participation. Quantitative outcome: Frequency of relevance / importance of items within predefined information needs areas, except for access needs. Qualitative outcome: Open-text responses concerning all information needs. RESULTS: We analysed data from a total of 823 participants who completed the survey. General and specific information such as dosage (74.2% [611/823]) and when to refer to a physician (64.6% [532/823]) as well as an over-the-counter product's effectiveness according to medical guidelines (71.4% [588/823]) were rated as very important. Participants reported to prefer digital information sources (50.5% [416/823] strongly agreed), especially in the form of an easily accessible database (61.6% [507/823] strongly agreed) that contains regularly updated, manufacturer-independent, critically appraised, concise information. CONCLUSION: Community pharmacists expressed distinct information needs for evidence-based self-medication counselling. Further information services on essential evidence-based pharmacy knowledge may be necessary to support implementation.

Knowledge and attitudes towards epilepsy: A survey of people with epilepsy.

PROBLEM: Many studies focus on knowledge and attitudes of unaffected people towards epilepsy and people with epilepsy (PWE). The perspective of PWE themselves is much less explored. METHODS: We invited PWE in Germany to answer a questionnaire on their knowledge and attitudes towards epilepsy and PWE. RESULTS: The questionnaire was completed by 230 PWE (median age: 40 years; min./max.: 19/83; 66 % female). Of PWE, 22 % thought that PWE are more helpful, and 10 % thought that PWE are friendlier than other people. Nevertheless, reservations about relationships and friendships with other PWE existed: of the participants, only 74 % would definitely go on a date with another PWE, and 90 % would definitely include another PWE they liked into their circle of friends. Swimming was judged as more dangerous for PWE than for healthy people by 71 % of PWE. Of PWE, 86 % correctly assumed it was not useful to hold a person having a seizure to the ground. Putting a solid object in the mouth was considered not useful by 85 % of PWE. Of PWE, 20 % would definitely administer an available emergency medication if another PWE had a seizure. For 67 % of PWE, certain preconditions should have to be fulfilled such as an available document with instructions. Of PWE, 11 % stated they would not administer an available emergency medication if another PWE had a seizure. CONCLUSION: Although positive attitudes of PWE towards other PWE exist, we also found some reservations calling for psychosocial support. Most PWE had sufficient knowledge about risks of certain activities and about measures to be taken during a seizure. Nevertheless, a small group of PWE showed knowledge gaps. Thus, educational support still seems essential.

Determine the impact of a structured pharmacist-led medication review - a controlled intervention study to optimise medication safety for residents in long-term care facilities.

BACKGROUND: Medication reviews contribute to protecting long-term care (LTC) residents from drug related problems (DRPs). However, few controlled studies have examined the impact on patient-relevant outcomes so far. OBJECTIVE: We examined the impact of a one-time, pharmacist-led medication review on medication changes (primary endpoint) including discontinued medication, the number of chronic medications, hospital admissions, falls, and deaths (secondary endpoints). METHODS: A prospective, controlled intervention study was performed in three LTC facilities. In the intervention group (IG), after performing a medication review, a pharmacist gave recommendations for resolving DRPs to physicians, nurses and community pharmacists. The control group (CG) received usual care without a medication review. (i) We assessed the number of medication changes and the secondary endpoints in both groups before (t0) and after (t1, t2) the intervention. (ii) Additionally, the medication review was evaluated in the IG with regard to identified DRPs, the healthcare professional's feedback on the forwarded pharmacist recommendations and whether DRPs were finally resolved. RESULTS: 107 (IG) and 104 (CG) residents were enrolled. (i) More medication changes were identified in the IG than in the CG at t1 (p = 0.001). However, no significant difference was identified at t2 (p = 0.680). Mainly, medication was discontinued in those medication changes. Chronic medications increased in the CG (p = 0.005) at t2 while hospital admissions, falls, and deaths showed no differences. (ii) Overall, 1252 DRPs (median: 10; minimum-maximum: 2-39) were identified. Recommendations for 82% of relevant DRPs were forwarded to healthcare professionals, of which 61% were accepted or clarified. 22% were not accepted, 12% required further review and 6% remained without feedback. 51% of forwarded DRPs were finally resolved. CONCLUSIONS: We found more medication changes in the IG compared to controls. Mostly, medication was discontinued. This suggests that our intervention was successful in discontinuing unnecessary medication. Other clinical outcomes such as falls, hospitalisations, and deaths were not improved due to the one-time intervention. The medication review further identified a high prevalence of DRPs in the IG, half of which were finally resolved. TRIAL REGISTRATION: German Clinical Trials Register, DRKS00026120 ( www.drks.de , retrospectively registered 07/09/2021).

QTc-time-prolongating drugs and additional risk factors for long-QT-syndrome at hospital admission of surgical patients - risk assessment by pharmacists.

Drugs can cause long-QTc-syndrome (LQTS), thereby elevating the risk for palpitations, syncopes, and sudden cardiac death. Additional risk factors such as the intake of more than one QTc-prolongating drug (QTPD) and surgery (cardiac and non-cardiac) increase the risk considerably. Therefore, a good knowledge of patients perioperative risk is important. Data concerning this issue in surgical patients is, however, scarce. We aimed to determine the number of surgical patients taking QTPD at hospital admission and to assess the presence of additional risk factors for LQTS. In addition, we determined the LQTS-risk at hospital admission by calculating the Tisdale Risk Score, enabling early detection of patients at risk. In a retrospective study, the pre-hospital medication of a 4-month cohort of surgical patients admitted to a tertiary teaching hospital was evaluated for QTPD-intake. For these patients, additional risk factors for LQTS were assessed and the Tisdale Risk Score was calculated. Of 837 surgical patients, 419 (50%) took at least one QTPD. In total, 3,376 drugs were taken and 723 (21%) classified as QTPD with a median number of 2 (range 1-8) per patient. The median number of LQTS-risk factors for these patients at hospital admission was 2 (range 0-5). The Tisdale Risk Score classified 23 patients (5%) as high, 187 (45%) as moderate, and 209 (50%) as low risk. These findings indicate a high number of surgical patients with QTPD and additional risk factors. The Tisdale Risk Score can be used as a screening instrument for patients at risk for QTc-prolongation during medication reconciliation by pharmacists at hospital admission. Patients identified as high and moderate risk should be evaluated for adjustable risk factors and monitored adequately. Medical treatment needs to be chosen carefully in view of in-hospital patient safety.

Knowledge of epilepsy among German pharmacists.

PROBLEM: Pharmacists can have a large impact on attitude, acceptance and adherence in patients with long-term conditions. They should be able to give appropriate advice. METHODS: We invited pharmacists in Mecklenburg-Vorpommern and Saxony, Germany, to complete a questionnaire mainly containing multiple-choice-questions. RESULTS: Overall, 238 pharmacists took part in the survey. 199 (84%) said they were insecure counselling people with epilepsy or had no experience at all. 205 (86%) rightly assumed a seizure can result in death. Concerning an acute seizure, administration of a rescue medication was considered as possible useful measure by 127 (53%) participants. Of the participants, 206 (87%) stated a physician should be consulted for every first afebrile seizure, 188 (79%) for every first febrile seizure. Exanthema as especially clinically relevant adverse drug event was rightly chosen for carbamazepine by 18 (8%) and for lamotrigine by 12 (5%) participants. 60 (25%) rightly chose liver toxicity for valproate. The increase of carbamazepine plasma concentration when adding erythromycin was chosen by 66 (28%) of pharmacists. 13 (5%) knew about the reduction of effectiveness of lamotrigine when adding hormonal contraceptives. For valproate, 201 (84%) stated that it is important to counsel patients concerning contraception. CONCLUSION: Pharmacists are insecure counselling people with epilepsy. Some of them would not suggest to seek medical advice for every first seizure. This can lead to reduced patient safety. The adverse drug events of valproate are well known, important adverse drug events and interactions of other anticonvulsants are less present to the pharmacists and should be regularly addressed in training courses.

A prospective follow-up study on the role of clinical pharmacists in sustainably optimized pain measurement and pain therapy consequences.

Appropriate analgesic therapy requires adequate pain measurement. A few studies have already demonstrated benefits of clinical pharmacists supporting physicians' prescribing. Nevertheless, there are still open questions about pharmaceutical interventions at the nursing level in order to optimise pain therapy sustainably. We performed a prospective controlled follow-up intervention study to analyse the sustainability of improved pain measurement performance (PMP) and its therapeutic consequences. Half a year after a successful guidance implementation in two study units (control and intervention unit), pharmacists performed an individual coaching for nurses only in the intervention unit. We consecutively monitored patient-nurse contacts and evaluated PMP with a 7-point scale (from 0: no pain measurement to 6: optimal pain measurement) in three 4-week periods (t1 : before guidance implementation, t2 : directly after guidance implementation, t3 : half a year after guidance implementation) on both units. Therapeutic consequences of PMP were evaluated in a post-hoc patient chart review. In the t1 period, we found a median PMP of 0 in both units which rose to 6 (control unit) vs. 5 (intervention unit) in t2 period due to guidance implementation in both units. In the t3 period, we found a decrease of PMP to 0 in controls vs. to 4 in the intervention unit (p<0.001). We also found, that improved PMP did not lead to a more individualised analgesic prescribing and administration of more on-demand analgesics. A coaching concept of clinical pharmacists improved the sustainability of nurses' PMP after a successful guidance implementation. Our results illustrate the potential of including clinical pharmacist in interprofessional pain therapy teams.

Incompatibilities in paediatric intensive care - pitfalls in drug information.

Drug incompatibilities can lead to loss of effectiveness of drugs or to increased risk for undesirable effects that can even be life-threatening. Especially children are at high risk. Databases are an important source of information in routine care to avoid incompatibilities. However, they were supposedly developed considering drugs for use in adults. Thus, we analysed to what extent databases are appropriate for the identification of incompatibilities in intravenous (i.v.) drug therapy in paediatric intensive care. We analysed the information provided by two databases (Database A and B) on all pairs of two drugs prescribed to be administered via the same i.v. access line in a university paediatric intensive care unit during the study period of 50 days. A total of 50 different i.v. drugs was prescribed in 318 different combinations (drug pairs). We found information on (in)compatibilities in 23.0 % (73/318) in Database A and in 31.1 % (99/318) in Database B. Only in 11.0 % (35/318) of the drug pairs, both databases provided information. Considering those drug pairs, in 17.1 % (6/35) Database B indicated compatibility whereas Database A indicated incompatibility. Compatibility information delivered by databases on drugs used in paediatric intensive care is incomplete, heterogeneous, and partly contradictory. Thus, an increased awareness on the strengths and limitations of different databases is necessary to avoid patient harm.

How do parents perceive adverse drug events of their children's anticonvulsant medication?

BACKGROUND: The main source of knowledge on adverse drug events (ADE) are physicians' reports in controlled clinical trials. In contrast, little is known about the parents' perception of ADE of anticonvulsants their children receive. METHODS: After approval by the local ethics committee, we performed a survey in a neuropediatric outpatient clinic of a university hospital. Based on a structured questionnaire, we interviewed parents of children with current anticonvulsant treatment regarding (i) their fears about potential ADE, (ii) experienced ADE according to parents, and (iii) implications of ADE on the child's life. RESULTS: Parents of 150 patients took part in the interview. (i) 95 (63.3%) parents expressed fears concerning ADE, mostly liver injury/liver failure (33 [22%]). (ii) 129 (86%) parents reported experienced ADE, mostly sedation (65 [43.3%]) and abnormal behavior (54 [36%]). (iii) Parents reported substantial implications of ADE on the child's daily life for 84 (56%) children, and 63 (42%) parents expressed a negative impact on the child's development. CONCLUSION: We recognized a great discrepancy between those ADE that were feared and those that were experienced. Parents feared life-threatening ADE and experienced less severe ADE that nevertheless have a negative impact on the child's daily life.

[Discharge medication - what do patients know about their medication on discharge?]. / Entlassungsmedikation - Was weiß der Patient bei Entlassung über seine Arzneimittel?

BACKGROUND: Patients' lack of knowledge about their discharge medication can endanger patients' safety after their hospital stay. This is especially the case with regard to medications that were newly prescribed during the hospital stay and are intended to be used after discharge or medications with an increased risk for adverse drug reactions (high-risk drugs). The aim of this study was to analyse the patients' level of knowledge about their discharge medication and to identify influence factors. METHODS: In a bicentric survey patients were interviewed prior to their discharge from an acute and a geriatric rehabilitation hospital. They were asked about their discharge medication in a structured interview. Influence factors were statistically analysed by Tobit regression. RESULTS: In total, 179 patients were interviewed. On average, patients named 48% of their discharge medication correctly (95% CI: 46-50%). Influence factors for knowledge deficits were the lack of a medication plan, an older age, the hospitalization in a rehabilitation hospital and a long hospitalization. 81% of the patients had at least one drug in their discharge medication, which was newly prescribed during the hospital stay. 11% of those drugs were named correctly, the potency was named correctly in 6%, the indication in 8%. For almost two-thirds of the patients at least one high-risk drug was recommended in the discharge letter, among them most frequently oral anticoagulants and opioid analgesics. 38% of these high-risk drugs were named correctly. CONCLUSION: Our results demonstrate an urgent need to train patients about their discharge medication, especially if medications are included that were newly prescribed during the hospital stay and recommended for further use after discharge or medications with an increased risk of adverse drug reactions. Particularly older patients and patients of a rehabilitation hospital after long hospitalization should be intensively counselled and obtain a medication plan upon discharge.

Biomonitoring of prenatal analgesic intake and correlation with infantile anti-aeroallergens IgE.

An association between prenatal acetaminophen or ibuprofen intake and an increased risk of asthma and increased IgE level in children is discussed in various epidemiological studies. Although the molecular mechanistic link is still unknown, the question whether or not acetaminophen and/or ibuprofen are safe pain medications during pregnancy arose. In this study, we associate maternal acetaminophen and ibuprofen intake during pregnancy and breastfeeding to infantile asthma phenotypes and elevated IgE level. Therefore, we analysed questionnaires from a local mother-child cohort and monitored drug intake by LC-MS biomonitoring in urine. No association was found between drug intake and any analysed health outcome using questionnaire data. For the information obtained from biomonitoring, no association was found for ibuprofen and acetaminophen intakes during breastfeeding. However, an association between prenatal acetaminophen intake and increased infantile IgEs related to aeroallergens was statistically detected, but not for asthma phenotypes.

[Pain assessment in routine care : A prospective observational study in an orthopedic unit]. / Schmerzerfassung in der Routineversorgung : Eine prospektive Beobachtungsstudie auf einer orthopädischen Station.

INTRODUCTION: Although well-established guidelines give advice on how to use analgesics, measure pain, and organize pain treatment, many patients still suffer from avoidable severe pain. We assume one reason for this is that pain is inadequately addressed in routine patient contacts. Thus, we aimed to evaluate the extent to which pain was addressed during patient contacts in routine orthopedic care. MATERIALS AND METHODS: In a prospective observational study in an orthopedic unit of a university hospital, we invited physicians and nurses during their routine patient contacts to be observed by independent, trained monitors. The monitors systematically assessed all pain-related aspects, which were analyzed descriptively afterwards. RESULTS: The monitors documented 572 physician-patient contacts with 7 physicians and 108 patients and 578 nurse-patient contacts with 12 nurses and 102 patients. Physicians and nurses asked their patients about pain in 20 and 16 % of the patient contacts, respectively. While in physician-patient contacts, patients most frequently addressed their current pain situation (in 35 % of contacts), in nurse-patient contacts, patients most frequently addressed their need for analgesics (52 %). Patients rated their pain intensity in 16 % of physician-patient contacts vs. 17 % of nurse-patient contacts. CONCLUSIONS: Using a comprehensive external monitoring procedure, we found that systematic pain assessment was not optimally standardized and implemented for systematic, individualized pain therapy by physicians or nurses in our routine care setting.

Drug handling in a paediatric intensive care unit--can errors be prevented by a three-step intervention?

BACKGROUND: Drug handling in paediatric intensive care units (PICU) is prone to medication errors. We aimed to identify type and prevalence of those errors and to assess preventative interventions. METHODS: Prospective intervention study investigating a 3-step intervention for preventing errors in drug handling in a 10-bed PICU of a university hospital. Nurses' drug handling was monitored in daily routine to identify the number of patients affected by errors and overall prevalence and types of errors in drug handling. We implemented a comprehensive intervention consisting of an information handout, a training course, and a 76-page reference book tailored to reduce the prevalence. RESULTS: The prevalence of errors in drug handling decreased from 83 % (555 errors/668 processes)to 63 % (554/883; p < 0.001) after the intervention. The number of affected patients remained unchanged (95 % vs. 89 %, p = 0.370).Peroral (PO) drugs (1.33 errors/process) were more error-prone than intravenous (IV) drugs(0.64), despite being used less frequently (27 % vs.73 % of all processes, p < 0.001). The interventions decreased the prevalence to 0.77 errors/process(p < 0.001) in PO and to 0.52 in IV drugs (p = 0.025). CONCLUSION: Errors in drug handling were alarmingly frequent. PO drugs were frequently subject to errors, even though being used less frequently. The implementation of a comprehensive intervention succeeded in reducing the prevalence of errors. Yet further refinements are necessary to decrease also the number of affected patients.

[Off-label drug prescriptions among outpatient children and adolescents in Germany--a database analysis]. / Verwendung von Off-Label-Medikamenten bei ambulant betreuten Kindern und Jugendlichen in Deutschland.

BACKGROUND: Due to lack of respective studies children often receive medication that is applied beyond the approved indication. The consequence of this off-label use is often an increased risk of unexpected and undesirable side effects. This study deals with the amount of off-label drug prescriptions among children and adolescents receiving outpatient treatment in Germany. The aim is to outline age-, gender-, region-, and insurance specific differences and to determine risk factors for an off-label prescription. METHODS: This is a retrospective study that has been conducted by means of the IMS Patient Database Disease Analyzer for the year 2010 considering three therapy classes (analgesics, antibiotics and antidepressants). The evaluation of the risk factors for an off-label prescription resulted from a multivariate logistic regression. Age- and dose-specific prescriptions were analyzed but not indication-specific prescriptions. RESULTS: In total 189,285 children and adolescents with analgesics-, 147,089 with antibiotics-, and 15,405 with antidepressants prescriptions were identified. The percentage of patients with off-label prescriptions amounted to 0.9 % for analgesics, 2.5 % for antibiotics and 8.5 % for antidepressants. The off-label prescriptions made by general practitioners were significantly higher than those made by pediatricians and child psychiatrists. The number of off-label prescriptions in country sides was higher than in cities. In eastern states more off-label prescriptions were made than in western states of Germany. CONCLUSION: The study shows that outpatient treatment of children and adolescents occurs widely with drugs corresponding to age and dosage. Off-label prescriptions not conform to indication were not determined. However, off-label drug use should be reduced further for outpatient treatment to ensure a safe and low-risk medical treatment for children and adolescents.

Ambulatory care of children treated with anticonvulsants - pitfalls after discharge from hospital.

BACKGROUND: Anticonvulsants require special consideration particularly at the interface from hospital to ambulatory care. PATIENTS AND METHOD: Observational study for 6 months with prospectively enrolled consecutive patients in a neuropediatric ward of a university hospital (age 0-<18 years) with long-term therapy of at least one anticonvulsant. Assessment of outpatient prescriptions after discharge. Parent interviews for emergency treatment for acute seizures and safety precautions. RESULTS: We identified changes of the brand in 19/82 (23%) patients caused by hospital's discharge letters (4/82; 5%) or in ambulatory care (15/82; 18%). In 37/76 (49%) of patients who were deemed to require rescue medication, no recommendation for such a medication was included in the discharge letters. 17/76 (22%) of the respective parents stated that they had no immediate access to rescue medication. Safety precautions were applicable in 44 epilepsy patients. We identified knowledge deficits in 27/44 (61%) of parents. CONCLUSION: Switching of brands after discharge was frequent. In the discharge letters, rescue medications were insufficiently recommended. Additionally, parents frequently displayed knowledge deficits in risk management.