A newly developed algorithm for switching outpatient medications to medications listed in the hospital formulary: a prospective real-word evaluation in patients admitted electively to hospital.

PURPOSE: In many countries, outpatient and inpatient care are separated. During hospitalization, therefore, switching the outpatient medication to medication of the hospital formulary is required. METHODS: We newly designed a switching algorithm in six switching steps (S0-S5) and conducted a study at Bundeswehr Hospital Hamburg (300 beds, 80% civilians). We performed (i) a medication reconciliation to obtain information on outpatient medications and (ii) a medication review to solve drug-related-problems, e.g., drug-drug interactions. We applied (iii) the algorithm to switch medications to the hospital formulary. RESULTS: (i) We identified 475 outpatient medications (median per patient: 4; Q25/Q75 2/7) in 100 patients consecutively admitted to hospital (median age: 71; Q25/Q75: 64/80 years). Of 475 medications, the switching algorithm could not be used since product names were missing in 23.9% and strength in 1.7%. In 3.2%, switching was not required since medication was not prescribed during the hospital stay. (ii) Drug-drug interactions were identified in 31 of 79 patients with more than one medication. (iii) Of 475 medications, 18.5% were on the hospital formulary and therefore did not need to be  switched (S0), 0.2% were on a substitution-exclusion list not allowing switching (S1), 42.0% were switched to a generic medication of the hospital formulary (S2), 1.7% to a therapeutically equivalent medication (S3), 0.4% were patient-individually switched (S4), and for 8.2% a standardized/patient-individual switching was not possible (S5). CONCLUSIONS: Despite comprehensive medication reconciliation, patient- and medication-related information for switching medications to the hospital formulary was often missing. Once all the necessary information was available, standardized switching could be easily carried out according to a newly developed switching algorithm.

Authorized or Off-Label Use? A Structured Analysis of Summaries of Product Characteristics with Regard to Authorization in Pediatrics.

PURPOSE: The Summary of Product Characteristics (SmPC) is required to provide unambiguous information on the authorized use of a medicinal product. Therefore, we performed a structured analysis of the information provided for pediatric patients in current SmPCs. METHODS: In the German SmPC of the medicinal products of 452 active substances, we analyzed for each of the listed indications whether information on pediatric use was available in Sects. 4.1-4.4 of the SmPC and, if so, whether it was unambiguous. Information was considered unambiguous if it indicated an exact age- or weight-related specification. The analysis also considered the type of marketing authorization and the date of marketing authorization, either before or after the Pediatric Regulation 2007 came into force. RESULTS: Among the 30,354 identified indications in 8464 SmPCs, unambiguous information was found for 72.4% (21,974/30,354) of the indications. Of these, 45.4% (9967/21,974) disclosed a contraindication for the entire population under 18 years of age. The proportion of unambiguous information was higher for medicinal products with centralized marketing authorization (86.5% [1449/1676]) than for those with a national one (71.6% [20,525/28,678]; p < 0.001). A higher proportion of unambiguous information was found for the marketing authorization period 2007-2021 compared with 1996-2006 (1996-2006: 63.8% [7466/11,694]; 2007-2021: 82.1% [12,349/15,040]; p < 0.001). CONCLUSION: For about a quarter of all indications, no or only ambiguous information was available for pediatric patients. The measures initiated in recent years to increase pediatric-specific information in SmPCs should be intensified in order to improve drug safety in children and adolescents.

How do children with focal epilepsies perceive the moment they realize that they are about to have a seizure? A pilot study.

PROBLEM: A seizure is a challenging situation for children with epilepsy. Little is known regarding the experience of children who perceive in advance that they are about to have a seizure. METHODS: From September 2020 to February 2021, we invited children with focal epilepsies aged 6-18 years to participate in a semi-structured interview. RESULTS: Of 52 children with focal epilepsies, 22 (42 %) said they perceive in advance that they are about to experience a seizure [11 with self-limited epilepsy with centro-temporal spikes (SELECTs), 11 with other focal epilepsies]. All 22/22 (100 %) children described physical symptoms such as headache or a numb feeling in one half of the body. Of those children, 17/22 (77 %) stated they try to do something about the seizure. Those strategies were perceived as helpful by 0/11 (0 %) children with SELECTs and 9/11 (86 %) children with other focal epilepsies (p < 0.001). Of the children with SELECTs 5/11 (45 %), and of those with other focal epilepsies 9/11 (86 %) stated they would like to know in the morning if they are to experience a seizure that day (n.s.). CONCLUSION: Children who perceive in advance that they are about to have a seizure are well able to describe their experience. Most children take measures to manage their seizures. Those measures were regarded as helpful by most children with other focal epilepsies, but by no child with SELECTs. Larger studies are necessary to determine the factors contributing to the child's perception as well as the nature of the support that they require.

How Intuitive Is the Administration of Pediatric Emergency Medication Devices for Parents? Objective Observation and Subjective Self-Assessment.

BACKGROUND: to assess the intuitiveness of parents' administration of pediatric emergency devices (inhalation, rectal, buccal, nasal, and auto-injector). METHODS: We invited parents without prior experience to administer the five devices to dummy dolls. We observed whether the parents chose the correct administration route and subsequently performed the correct administration procedures without clinically relevant errors. We interviewed parents for their self-assessment of their own administration performance and willingness to administer devices in actual emergencies. RESULTS: The correct administration route was best for the inhalation device (81/84, 96% of parents) and worst for the intranasal device (25/126, 20%). The correct administration procedures were best for the buccal device (63/98, 64%) and worst for the auto-injector device (0/93, 0%). Their own administration performance was rated to be best by parents for the inhalation device (59/84, 70%) and worst for the auto-injector device (17/93, 18%). The self-assessment of the correct administration overestimated the correct administration procedures for all the devices except the buccal one. Most parents were willing to administer the inhalation device in an emergency (67/94, 79%), while the fewest were willing to administration procedures the auto-injector device (28/93, 30%). CONCLUSIONS: Intuitiveness concerning the correct administration route and the subsequent correct administration procedures have to be improved for all the devices examined. The parents mostly overestimated their performance. Willingness to use a device in an actual emergency depended on the device.

A prospective intervention study to identify drug-related emergency department visits comparing a standard care group and a pharmaceutical care group.

BACKGROUND AND IMPORTANCE: Adverse drug reactions impose a major burden. Those adverse drug reactions might lead to hospitalization but are often not correctly identified in the emergency department (ED). Clinical pharmacists, although not routinely implemented, can help identify adverse drug reactions. OBJECTIVE: The primary objective was to examine the drug association of ED visits in a pharmaceutical group with a clinical pharmacist integrated in the ED team compared with a standard group without additional support. DESIGN/SETTING/PARTICIPANTS: This prospective intervention study was performed in the ED of a tertiary care university hospital in Leipzig, Germany. Patients who were ≥50 years old were included. From 1 March 2020 to May 31, 2020 patients were enrolled in the standard group. From 1 March 2021 to 31 May 2021, the pharmaceutical group was enrolled. The clinical pharmacist supported the ED team with patient´s detailed medication history and medication analysis. In both groups, patients were evaluated whether their ED visit was drug-related. OUTCOME MEASURES AND ANALYSIS: The number of identified drug-related ED presentations were compared between the two groups. Interventions performed on adverse drug reaction management, causative drugs and patient characteristics were evaluated. MAIN RESULTS: A total of 798 patients were enrolled in the standard group and 827 patients in the pharmaceutical group. Patients whose ED visit was drug-related had a median age of 77 years [(Q25-Q75) 63.5-83.5] and took 7 [(Q25-Q75) 5-8] drugs in standard group. In the pharmaceutical group median age was 78 years [(Q25-Q75) 66-83] and number of drugs taken was 9 [(Q25-Q75) 5.25-11]. 31 (3.9%) drug-related ED visits were identified in the standard group compared to 104 (12.6%) in the pharmaceutical group (OR 3.56; 95% CI 2.35-5.38). An intervention on the patient's pharmacotherapy was performed in 16 drug-related ED visits in standard group compared to 77 in the pharmaceutical group. CONCLUSION: In this study the implementation of a clinical pharmacist was associated with improved identification of drug-related ED visits. Discontinuations of causal medications and dose reductions were significantly higher in the pharmaceutical group compared to the standard care group.

Symptoms of older orthopedic and rheumatic patients : A telephone survey about symptoms, symptom communication, treatment and further support after hospital discharge.

BACKGROUND: In older multimorbid orthopedic and rheumatic patients, data on symptoms besides pain or reduced mobility are rarely published. OBJECTIVE: We investigated patients' perspectives on their symptoms after hospital discharge. MATERIAL AND METHODS: Orthopedic and rheumatic patients aged over 70 years were asked via telephone interviews about (i) their symptoms, (ii) communication, (iii) treatment, and (iv) support. RESULTS: (i) The 60 participants (35 women and 25 men) reported a median of 6 (min-max: 1-14) different symptoms, of which 86% (356 of 415) had existed before hospitalization, (ii) patients did not communicate 28% (117) of symptoms to either healthcare professionals, family or friends and (iii) 52 (87%) patients desired improvement. Of the 280 most impairing symptoms, 19% (52) were not treated at all. (iv) Almost all patients (59; 98%) considered it easy to obtain support. CONCLUSION: Remarkably, many symptoms were not communicated or treated despite the patients having been hospitalized.

Parents' Perceptions Regarding Their Children's Medications and Expert-Assessed Drug-Related Problems in Pediatric Patients with Inborn Errors of Metabolism.

We aimed to explore parents' perceptions of their children's medication use for inborn errors of metabolism (IEM), including the importance of medication intake, potential complications, and concerns about adverse drug reactions (ADR). Additionally, we aimed to determine expert-assessed clinically relevant drug-related problems, particularly those attributable to IEM. We interviewed 108 parents of 119 pediatric patients with IEM using a questionnaire relating to their perceptions regarding their children's IEM medication. In affected siblings, a questionnaire was used for each child. We performed medication analyses to evaluate the patient's complete medication regimen for clinically relevant drug-related problems, including medication for conditions other than IEM. It was very important to the parents of 85% of the patients to use IEM medication exactly as prescribed. The parents of 41% of patients perceived complications in their children's use of IEM medication. The parents of 47% of patients reported fears concerning ADR because of IEM medication. Parents observed ADR in 27% of patients because of IEM medication. In 44% of patients, medication for conditions other than IEM was inadequate because of drug-related problems not associated with the IEM; a safe alternative existed in 21% of patients. In summary, almost half of the parents of patients with IEM reported complications with their child's IEM medication intake and fears of ADR. Medication analyses showed that drug-related problems occurred regardless of IEM, emphasizing the general need to prescribe and dispense adequate, child-appropriate medication to minimize clinically relevant drug-related problems in pediatric patients.

[Adverse drug reactions as cause of nonspecific symptoms in patients in the emergency department]. / Unerwünschte Arzneimittelwirkungen als Ursache unspezifischer Symptome bei Patienten in der zentralen Notaufnahme.

BACKGROUND: In a large proportion of patients admitted to the emergency department (ED), the initial main symptom is nonspecific. One possible reason for this, especially in older patients, may be adverse drug reactions (ADR) due to their frequent polypharmacy. AIM: To illustrate the incidence of ADRs, the affected patient population including risk factors, and drug classes with ADRs leading to nonspecific symptoms. To provide practice recommendations for the management of ADRs in the ED. MATERIAL AND METHODS: Presentation of the pharmacological principles on ADRs, statistics of pharmacovigilance centers as well as original literature including experiences from clinical practice and own projects. RESULTS: In 10% of patients with nonspecific symptoms an ADR is responsible for presentation in the ED. In 60% of cases these ADRs are not correctly identified in the ED setting. A small number of drug classes are responsible for most of these referrals. Databases, risk stratification, clinical pharmacists, or clinical decision support systems are available to improve ADR identification and management. As these options are partly associated with considerable costs or the validation for German EDs is missing, a widespread application does not take place. CONCLUSION: Correct identification of ADRs in patients with nonspecific symptoms in the ED is necessary to initiate adequate treatment. These ADRs are often overlooked because processes and tools for identification and management are not applied in the ED, leading to a lack of awareness. For high-risk patients in the ED, the focus should be on drug history, ideally considering patient-specific risk factors and specific drug classes.

Patients' Use of a Standardized Medication List - A Mixed Methods Study.

Purpose: A medication list (ML) is a document listing the patient's entire medication, instructions for use, and indications. In Germany, a national standard was established in 2016 by law. However, data on patients' use of this standardized ML are scarce. We investigated (i) patients' practical use of the ML, (ii) patients' understanding of the ML, (iii) completeness and correctness of the current ML version, and (iv) reasons why patients did not adhere to their ML. Patients and Methods: Community pharmacists recruited patients possessing a standardized ML with ≥5 medications. Information sources to evaluate the ML were: (a) brown bag analysis, (b) practical demonstration, (c) patient interview, and (d) patient file. Data were analyzed using qualitative and quantitative methods. Results: Two hundred and eighty-eight patients (median age: 76 years, range: 27-95) were enrolled. (i) 38.5% of the patients used their ML regularly to prepare their medication and 73.3% to inform their physician. (ii) Overall, patients' understanding of the ML was good, with >80% of the patients being able to identify all relevant information. (iii) While n = 2779 medications were actually taken, n = 2539 were documented on the ML. No ML was fully correct and complete. Regarding particularly relevant items, ie, active ingredient, strength, dosage, medication missing or listed but not taken, 79.2% of ML were incorrect or incomplete. Handwritten modifications on the ML were frequent. (iv) Almost 60% of all patients did not follow their ML with "fear of adverse drug reactions" being the most frequently (n = 50) mentioned reason. Conclusion: Completeness and correctness of the current ML version was poor with handwritten modifications being frequent. Additionally, most of the patients did not adhere to their ML. This indicates that measures that lead to correct and up-to-date ML and improvements in patient counseling about their medication should be developed and implemented into routine practice.

Assessing Parental Competence and Self-Ratings in Management of Pediatric Type 1 Diabetes and Emergency Glucagon Administration-An Exploratory Observational Study.

BACKGROUND: Parents of pediatric patients with type I diabetes require competence in hypoglycemia management and skills in glucagon administration to deal with potentially life-threatening severe hypoglycemia. We aimed to compare parents' subjective self-ratings to an objective expert assessment of competences and skills in dealing with severe hypoglycemia. METHODS: We interviewed 140 participants to assess their subjective self-ratings. The objective expert assessments used a standardized clinical case scenario of severe hypoglycemia and a practical demonstration of glucagon administration. RESULTS: The participants self-rated their competence in hypoglycemia management as good (5) or very good (6), and their skills in administering glucagon as acceptable (3) [Scale: very poor (1) to very good (6)]. In the standardized clinical case scenario, 1.4% (2/140) of participants named all relevant steps of severe hypoglycemia management. In the practical demonstration of glucagon administration, 92.9% (130/140) of participants committed at least one drug handling error; 52.1% (73/140) committed at least one drug handling error rated with high clinical risk. CONCLUSIONS: We found discrepancies regarding participants' subjective self-ratings compared to their performance in the respective objective expert assessments. These discrepancies indicate a lack of error awareness and the need for intervention studies to improve competence in hypoglycemia management and glucagon administration.

Avoiding incompatible drug pairs in central-venous catheters of patients receiving critical care: an algorithm-based analysis and a staff survey.

PURPOSE: In a critical care setting, we aimed to identify and solve physico-chemical drug incompatibilities in central-venous catheters considering the staffs' knowledge and assumptions about incompatibilities. METHODS: (i) After positive ethical vote, an algorithm to identify incompatibilities was developed and applied. The algorithm was based on KIK® database and Stabilis® database, the drug label, and Trissel textbook. (ii) A questionnaire was created and used that asked staff for knowledge and assumptions about incompatibilities. (iii) A 4-step avoidance recommendation was developed and applied. RESULTS: (i) At least one incompatibility was identified in 64 (61.4%) of 104 enrolled patients. Eighty one (62.3%) of 130 incompatible combinations affected piperacillin/tazobactam and in 18 (13.8%) each furosemide and pantoprazole. (ii) 37.8% (n = 14) of the staff members participated in the questionnaire survey (median age: 31, IQR: 4.75 years). The combination of piperacillin/tazobactam and pantoprazole was incorrectly judged to be compatible by 85.7%. Only rarely felt the majority of respondents unsafe in administering drugs (median score: 1; 0, never to 5, always). (iii) In those 64 patients with at least one incompatibility, 68 avoidance recommendations were given, and all were fully accepted. In 44 (64.7%) of 68 recommendations "Step 1: Administer sequentially" was suggested as a avoidance strategy. In 9/68 (13.2%) "Step 2: Use another lumen", in 7/68 (10.3%) "Step 3: Take a break", and in 8/68 (11.8%) "Step 4: Use catheters with more lumens" were recommended. CONCLUSIONS: Although incompatibilities were common, the staff rarely felt unsafe when administering drugs. Knowledge deficits correlated well with the incompatibilities identified. All recommendations were fully accepted.

A Complex Intervention to Prevent Medication-Related Hospital Admissions.

BACKGROUND: Children are often treated off-label and are at a disadvantage in pharmacotherapy. The aim of this study was to implement and evaluate a quality assurance measure (PaedPharm) for pediatric pharmacotherapy whose purpose is to reduce medication-related hospitalizations among children and adolescents. METHODS: PaedPharm consisted of the digital pediatric drug information system PaedAMIS, pediatric pharmaceutical quality circles (PaedZirk), and an adverse drug event (ADE) reporting system (PaedReport). The intervention was implemented in a cluster-randomized trial (DRKS 00013924) in 12 regions, with a pediatric and adolescent medicine clinic in each and a total of 152 surrounding private practitioners, in 6 sequences over 8 quarters. In addition to the proportion of ADE-related hospital admissions (primary endpoint), comprehensive process evaluation included other endpoints such as coverage, user acceptance, and relevance to practice. RESULTS: 41 829 inpatient admissions were recorded, of which 5101 were patients of physicians who participated in our study. 4.1% of admissions were ADE-related under control conditions, and 3.1% under intervention conditions (95% CI: [2.3; 5.9] and [1.8; 4.5], respectively). A model-based comparison yielded an intervention effect of 0.73 (population-based odds ratio; [0.39; 1.37]; p = 0.33). PaedAMIS achieved moderate user acceptance and PaedZirk achieved high user acceptance. CONCLUSION: The introduction of PaedPharm was associated with a decrease in medication-related hospitalizations that did not reach statistical significance. The process evaluation revealed broad acceptance of the intervention in outpatient pediatrics and adolescent medicine.

Enhancing Evidence-Based Pharmacy by Comparing the Quality of Web-Based Information Sources to the EVInews Database: Randomized Controlled Trial With German Community Pharmacists.

BACKGROUND: Self-medication counseling in community pharmacies plays a crucial role in health care. Counseling advice should therefore be evidence-based. Web-based information and databases are commonly used as electronic information sources. EVInews is a self-medication-related information tool consisting of a database and monthly published newsletters for pharmacists. Little is known about the quality of pharmacists' electronic information sources for evidence-based self-medication counseling. OBJECTIVE: Our aim was to investigate the quality of community pharmacists' web-based search results for self-medication-related content in comparison with the EVInews database, based on an adjusted quality score for pharmacists. METHODS: After receiving ethics approval, we performed a quantitative web-based survey with a search task as a prospective randomized, controlled, and unblinded trial. For the search task, participants were instructed to search for evidence-based information to verify 6 health-related statements from 2 typical self-medication indications. Pharmacists across Germany were invited via email to participate. After providing written informed consent, they were automatically, randomly assigned to use either web-based information sources of their choice without the EVInews database (web group) or exclusively the EVInews database (EVInews group). The quality of the information sources that were used for the search task was then assessed by 2 evaluators using a quality score ranging from 100% (180 points, all predefined criteria fulfilled) to 0% (0 points, none of the predefined criteria fulfilled). In case of assessment discrepancies, an expert panel consisting of 4 pharmacists was consulted. RESULTS: In total, 141 pharmacists were enrolled. In the Web group (n=71 pharmacists), the median quality score was 32.8% (59.0 out of 180.0 points; IQR 23.0-80.5). In the EVInews group (n=70 pharmacists), the median quality score was significantly higher (85.3%; 153.5 out of 180.0 points; P<.001) and the IQR was smaller (IQR 125.1-157.0). Fewer pharmacists completed the entire search task in the Web group (n=22) than in the EVInews group (n=46). The median time to complete the search task was not significantly different between the Web group (25.4 minutes) and the EVInews group (19.7 minutes; P=.12). The most frequently used web-based sources (74/254, 29.1%) comprised tertiary literature. CONCLUSIONS: The median quality score of the web group was poor, and there was a significant difference in quality scores in favor of the EVInews group. Pharmacists' web-based and self-medication-related information sources often did not meet standard quality requirements and showed considerable variation in quality. TRIAL REGISTRATION: German Clinical Trials Register DRKS00026104; https://drks.de/search/en/trial/DRKS00026104.

Overcoming Barriers in Nurse-Pharmacist Collaborations on Wards - Qualitative Expert Interviews with Nurses and Pharmacists.

Purpose: Interprofessional collaboration in healthcare is an essential element in promoting patient safety. However, little research is available on the collaboration between nurses and pharmacists. To optimize processes, mutual understanding is needed, which can be gained by examining the perspectives of those collaborating professional groups. We aimed to identify barriers to the interprofessional collaboration of nurses and pharmacists as well as preconditions and solution strategies to devise approaches for optimizing teamwork in inpatient settings. Methods: We recruited pairs of collaborating nurses and pharmacists from different hospitals in German-speaking countries and conducted qualitative expert interviews by phone with each of them individually. Transcribed interviews were assessed using qualitative content analysis. Results: We conducted 12 interviews each with the collaborating nurses and pharmacists. The most frequently mentioned barriers to optimal collaboration were "skepticism due to perception as controller" (reported mainly by pharmacists), "organizational implementation", and "limited (possibilities of) presence" (reported by both professional groups). A solution strategy proposed to overcome such barriers was "explaining added value". This added value was found in "clinical-pharmaceutical activities as complement by additional perspective" and "reducing workload in tasks distant from the patient". Conclusion: Nurses, pharmacists and hospital management should recognize the added value of intensifying their collaboration regarding patient-related services. A combination of logistical and clinical-pharmaceutical activities should be established at the level of drug application since interviewees endorsed collaboration. A stepwise process must be anticipated to address existing barriers, including some redefinition of professional roles.

Self-care and self-medication as central components of healthcare in Germany - on the way to evidence-based pharmacy.

In Germany, self-care is, above all interpreted as the prevention and treatment of minor injuries and illnesses by the patients themselves - that is, without a physician's prescription or medical advice. Maintaining one's health in the sense of a preventive approach through non-medicinal measures also plays an important role. Self-medication in this context is the treatment with approved over-the-counter-(OTC)-medications. In addition, other OTC-products such as dietary supplements as well as complementary and alternative medicines including homeopathic medications are frequently requested options by pharmacy customers. OTC-medications are central components of the German healthcare system, with expert advice from pharmacists in community pharmacies (CP) enabling safe and effective treatment. Additionally, screening for appropriate self-medication by pharmacists ensures that serious illnesses receive timely medical attention. In addition to prescribed medication, self-medication is an important part of the CP business in Germany. In contrast to prescription products, the price of OTC-products is not regulated. As a consequence, the price of OTC-products (including also pharmacy-only drugs) is influenced by competition among CPs and mail-order pharmacies, respectively. The sales of OTC-products for self-medication outside pharmacies, e.g. in drugstores and supermarkets, is restricted to a limited number of specific products. Evidence-based counseling in CPs, while generally advocated still remains a challenge. The evidence for the usage of OTC-products from clinical studies is not yet optimally integrated into everyday pharmacy practice. Information tools such as EVInews offering regular newsletters and a database have been developed to reduce the evidence-to-practice gap and to improve the overall counseling quality. Furthermore, the switching of drugs from prescription-only to pharmacy-only status also challenge CPs to provide adequate and updated guidance.

Intensive care drug therapy and its potential adverse effects on blood pressure and heart rate in critically ill children.

BACKGROUND: Owing to complex treatment, critically ill children may experience alterations in their vital parameters. We investigated whether such hemodynamic alterations were temporally and causally related to drug therapy. METHODS: In a university pediatric intensive care unit, we retrospectively analyzed hemodynamic alterations defined as values exceeding the limits set for heart rate (HR) and blood pressure (BP). For causality assessment, we used the World Health Organization-Uppsala Monitoring Center (WHO-UMC) system, which categorizes the probability of causality as "certain," "probable," "possible," and "unlikely." RESULTS: Of 315 analyzed patients with 43,200 drug prescriptions, 59.7% experienced at least one hemodynamic alteration; 39.0% were affected by increased HR, 19.0% by decreased HR, 18.1% by increased BP, and 16.2% by decreased BP. According to drug information databases, 83.9% of administered drugs potentially lead to hemodynamic alterations. Overall, 88.3% of the observed hemodynamic alterations had a temporal relation to the administration of drugs; in 80.2%, more than one drug was involved. Based on the WHO-UMC system, a drug was rated as a "probable" causing factor for only 1.4% of hemodynamic alterations. For the remaining alterations, the probability ratings were lower because of multiple potential causes, e.g., several drugs. CONCLUSIONS: Critically ill children were frequently affected by hemodynamic alterations. The administration of drugs with potentially adverse effects on hemodynamic parameters is often temporally related to hemodynamic alterations. Hemodynamic alterations are often multifactorial, e.g., due to administering multiple drugs in rapid succession; thus, the influence of individual drugs cannot easily be captured with the WHO-UMC system.

Pharmacoepidemiological Analysis of Oral Contraceptive Use in Adolescents in a German Longitudinal Cohort Study.

To assess the use of oral contraceptives (OC) in adolescents, using data from a longitudinal, population-based pediatric cohort study (LIFE Child). We also investigated associations between OC use and socioeconomic status (SES), and associations between OC use and potential adverse drug reactions such as effects on blood pressure. We included 609 female participants of the LIFE Child cohort, aged ≥13 to <21 years, who visited the study center between 2012 and 2019. Data collection compromised drug use in the past 14 days, SES, and anthropometric data such as blood pressure. An analysis of covariance was used to detect potential associations between participants' blood pressure and OC. Multivariate binary logistic regression was used to obtain odds ratios (aOR) adjusted for age and 95% confidence intervals (95% CI). The prevalence of OC use was 25.8%. OC intake was less common in participants with a high SES (aOR 0.30, 95% CI 0.15, 0.62). The mean age at OC initiation did not change between 2012 and 2019. We observed an increased use of second-generation OC (2013: 17.9%, 2019: 48.5%; p = 0.013) and a decreased use of fourth-generation OC (2013: 71.8%, 2019: 45.5%; p = 0.027). We found a higher systolic (mean: 111.74 mmHg, p < 0.001) and diastolic (69.15 mmHg, p = 0.004) blood pressure in OC users compared to non-users (systolic: 108.60 mmHg; diastolic: 67.24 mmHg). Every fourth adolescent took an OC. The share of second-generation OC increased during the study period. OC intake was associated with low SES. OC users had a slightly higher blood pressure than non-users.

Interviews with children and adolescents with epilepsy or asthma about the situation of their healthy siblings.

AIM: Chronic conditions can influence the situation of healthy siblings of affected children. We investigated the opinion of the affected child about the situation of their healthy sibling and the sibling relationship. METHODS: We performed a semi-structured interview with epilepsy or asthma patients aged 6-18 years and asked them to draw a picture: "Epilepsy/Asthma, my siblings and me." RESULTS: Of the 58 children with epilepsy, 67%, and of the 40 children with asthma, 60% thought that their siblings were worried about the condition. Among other aspects, they addressed helplessness during a seizure. Of the children with epilepsy, 83% and of those with asthma, 95% assumed that their siblings were not disadvantaged because of the participant's condition. Of the patients with epilepsy, 91% and of those with asthma, 93% thought that the sibling relationship would not be different without the condition. Of the participants with epilepsy, 86% and of those with asthma, 93% drew a picture; 30% with epilepsy and 14% with asthma visualised an interaction with their siblings in context of a seizure or episode of dyspnoea. CONCLUSION: According to the affected children, the condition worries their siblings but does not affect the siblings' lives or the sibling relationship.

Y-site administration of electrolyte solutions and injectable acetaminophen-A physical compatibility study with combinations frequently used in pediatric intensive care and anesthesia.

AIM: Determination of the physical compatibility of acetaminophen and two different electrolyte solutions (an isotonic, balanced electrolyte solution and a hypotonic, glucose containing electrolyte solution) with drugs frequently used in routine pediatric intensive care. METHODS: Analytical investigations for frequently used combinations without pre-existing data were performed. Visual and microscopic observations according to the European Pharmacopeia as well as pH measurements and ultraviolet visible spectrometry at wavelengths of 350, 410 and 550 nm were conducted to analyze physical compatibility. All measurements were performed immediately after mixing as well as 1, 4, and 24 h after. RESULTS: In total, 42 combinations were analyzed. Visual incompatibilities were found with pantoprazole and diazepam with both electrolyte solutions. For furosemide, a particle formation in mixture with the hypotonic glucose-containing electrolyte solution and a change in pH ≥ 0.5 after 24 h with both electrolyte solutions were observed. Ampicillin, cefuroxime, diazepam, furosemide, linezolid, meropenem, and pantoprazole showed an aberration of the absorbance ≥0.04 (350 nm/410 nm) or ≥0.01 (550 nm) in the photometric measurements with the electrolyte solutions. For acetaminophen, a physical incompatibility was observed with ampicillin, diazepam, furosemide, and pantoprazole. CONCLUSION: Most of the analyzed combinations showed no signs of physical incompatibility and may therefore be administered via the same Y-site. However, diazepam, furosemide, and pantoprazole should not be administered simultaneously with acetaminophen or both electrolyte solutions.

Assessment of Patients' Views on Drug Benefits and Risks: An Interview Study with Cardiovascular Patients.

Better and balanced information strategies supporting cardiovascular patients' adherence are required. Cardiovascular drugs have outstanding morbidity and mortality benefits. This can be counteracted by patients' perceptions of risks. Drug information should help the patient but not fuel unwarranted fears. We performed a cross-sectional survey of patients admitted to a cardiology ward. We evaluated (i) the patients' general benefit-risk estimation of their pharmacotherapy; (ii) views on benefits; (iii) views on risks; and (iv) information sources. Additionally, we assessed aspects of anxiety and depression with the Patient Health Questionnaire-4 (PHQ-4). (i) 67 patients (66%) rated expected drug benefits higher than potential risks. (ii) 72% of benefits motivated the patients to take their medication as prescribed. Patients more frequently mentioned surrogate markers as benefits than clinical benefits (p < 0.001). (iii) 56% of risks mentioned were perceived as bothersome and 35% as concerning. Risks were more often perceived as bothersome and concerning by patients with higher PHQ-4 scores (p=0.016). (iv) Physicians were the most frequent information source of benefits (92% of patients) and risks (45%), and pharmacy staff for 27% and 14%, respectively. Laymen or media served as sources of information on benefits in 39%, for risks in 40%, and package leaflets in 26% and 36%. 42% of the patients would like to receive more information on benefits versus 27% on risks. Our results suggest that knowledge of benefits motivates patients to take their drugs as prescribed. There is already good information on surrogate markers for process control with active patient involvement. However, a lack of knowledge still exists in relation to clinical benefits. Regarding risks, it has been shown that patients with higher PHQ-4 scores are more likely to be bothered or concerned. Both emphases on clinical benefits and individualization depending on PHQ-4 scores may be valuable resources for patient counseling to support adherence.