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BACKGROUND: QTc interval prolongation can result in potentially lethal arrhythmias. One risk factor is QTc-prolonging drugs, including some antifungals often used in hemato-oncology patients. Screening tools for patients at risk have not yet been investigated in this patient population. AIM: Our aim was to evaluate the sensitivity and specificity of five QTc risk scores in hemato-oncology patients receiving systemic antifungal therapy. METHOD: Data were retrieved from an internal study database including adult hemato-oncology patients prescribed systemic antifungal therapy. Data on QTc-prolonging medication, risk factors for QTc prolongation, and electrocardiograms (ECG) were collected retrospectively for a period of 12 months. The QTc risk scores according to Tisdale, Vandael, Berger, Bindraban, and Aboujaoude as well as their sensitivity and specificity were calculated. RESULTS: During the evaluated period, 77 patients were prescribed systemic antifungals resulting in 187 therapy episodes. Regarding therapy episodes, median age was 56 years (IQR 44-68), 41% (77) were female, and a median of 3 QTc-prolonging drugs were prescribed (range 0-6). ECGs were available for 45 (24%) of the therapy episodes 3-11 days after initiation of the antifungal therapy, 22 of which showed QTc prolongation. Regarding these 45 therapy episodes, sensitivity and specificity of the risk scores were calculated as follows: Tisdale 86%/22%, Vandael 91%/35%, Berger 32%/83%, Bindraban 50%/78%, Aboujaoude 14%/87%. CONCLUSION: The QTc risk scores according to Tisdale and Vandael showed sufficient sensitivity for risk stratification in the studied patient population. In contrast, risk scores according to Berger, Bindraban, and Aboujaoude cannot be considered suitable due to poor sensitivity.
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BACKGROUND: To investigate the impact of children's inborn error of metabolism (IEMs) on the children's and their parents' lives from the parents' perspective. We focused on disease-related restrictions in various issues of daily life, experienced discrimination, parental family planning, and management of metabolic emergencies. METHODS: We conducted a questionnaire-based survey with 108 parents of 119 children with IEM who attended a metabolic outpatient clinic. The children were categorized into 4 cohorts, based on increasing disease severity (cohort 1: IEMs with lowest severity, cohort 4: IEMs with highest severity), and compared by using Tobit regressions. RESULTS: The severity of the child's IEM was associated with an increase in the intensity of perceived restrictions from the parents' perspective for themselves and their children in all aspects of life: in general, in contact with friends, in the pursuit of hobbies, in childcare/school/occupation, and due to emotional stress. The highest intensity of restrictions in all cohorts was found for the parents themselves in contact with friends (compared to cohort 1: cohort 2: c. 3.556, p = 0.002; cohort 3: c. 4.159, p = 0.003; cohort 4: c. 7.224, p < 0.001). Parents of 8% of children reported that their children were discriminated against because of IEM, with the highest proportion of affected children (43%) in cohort 4. Parental family planning decisions were influenced in 34% of parents, with fear of recurrence being a predominant aspect. Of the parents of children diagnosed with IEMs associated with metabolic emergencies, 68% stated that they felt well or very well prepared for the occurrence of a metabolic emergency, and 100% of parents were able to name the necessary action steps from memory. Nevertheless, 58% stated that they experienced an occurring emergency as rather or very stressful. CONCLUSIONS: From the parents' perspective, the intensity of restrictions increased with the severity of the child's IEM. The study shows the high impact of IEM on parents of children with IEM and the daily challenges they face. These findings emphasize the importance of comprehensive support for parents of children with IEM.
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Erros Inatos do Metabolismo , Pais , Humanos , Pais/psicologia , Feminino , Masculino , Criança , Inquéritos e Questionários , Erros Inatos do Metabolismo/psicologia , Pré-Escolar , Adolescente , Adulto , Serviços de Planejamento Familiar , LactenteRESUMO
Complete medication reconciliation during hospital admission is the rationale for further treatment decisions. A consecutive, controlled intervention study was conducted to assess discrepancies in medication reconciliation performed by nurses of the Urology Department compared to the Best Possible Medication History (BPMH) established by pharmacists. This study included pre-intervention (control group, CG), nursing training as a pharmaceutical intervention, and post-intervention (intervention group, IG) groups. The discrepancies were classified as "Missing" (not recorded but taken), "Added" (additionally recorded) "Strength" (incorrect documented dosage), "Intake" (incorrect intake time/schedule), "Double" (double prescription), and "Others" (no clear assignment). Additionally, high-risk drug subgroup discrepancies were particularly prevalent and were evaluated. Training success was compared concerning discrepancies in the CG and IG. Generally, the percentage of discrepancies per patient found was lower in the IG than in the CG (78.1% vs. 87.5%, significantly). The category most identified was "Missing" (IG, 33.3% vs. CG, 35.2%). Overall, a discrepancy of 7.4% each (discrepancies: IG, 27 vs. CG, 38) was determined for high-risk drugs while "Missing" occurred (77.8% vs. 52.6%, out of 7.4%). Despite nursing training only partially reducing discrepancies, the implementation of medication reconciliation using BPMH by pharmacists could improve the process, especially for high-risk drugs.
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BACKGROUND: Children treated in a pediatric intensive care unit (PICU) often receive several drugs together, among them drugs defined as high-alert medications (HAMs). Those drugs carry a high risk of causing patient harm, for example, due to a higher potential for interactions. HAMs should therefore be administered with caution, especially in a PICU. OBJECTIVES: The objective of the current study was to identify drug-drug interactions involving HAMs that increase the risk of interaction-associated symptoms in pediatric intensive care. METHODS: In a retrospective study, we analyzed the electronic documentation of patients hospitalized for at least 48 h in a general PICU who received at least two different drugs within a 24-h interval. We assessed potential drug-drug interactions involving HAM on the basis of the two drug information databases UpToDate and drugs.com. Furthermore, we analyzed whether symptoms were observed after the administration of drug pairs that could lead to interaction-associated symptoms. For drug pairs involving HAM administered on at least 2% of patient days, and symptoms observed at least ten times after a respective drug pair, we calculated odds ratios, 95% confidence intervals, and p-values by using a univariate binary logistic regression. RESULTS: Among 315 analyzed patients, 81.3% (256/315) received drugs defined as high-alert medication for pediatric patients. Those high-alert medications were involved in 20,150 potential drug-drug interactions. In 14.0% (2830/20,150) of these, one or more symptoms were observed that could be a possible consequence of the interaction, resulting in 3203 observed symptoms affecting 56.3% (144/256) of patients receiving high-alert medication. The odds ratios for symptoms observed after a drug-drug interaction were increased for eight specific symptoms (each p ≤ 0.05), especially hemodynamic alterations and disturbances of electrolyte and fluid balance. The odds ratio was highest for decreased blood pressure observed after the administration of the drug pair fentanyl and furosemide (OR 5.06; 95% confidence interval 3.5-7.4; p < 0.001). Increased odds ratios for specific symptoms observed after drug-drug interactions resulted from eight combinations composed of eight different drugs: digoxin, fentanyl, midazolam, phenobarbital, potassium salts and vancomycin (high-alert medications), and the diuretics furosemide and hydrochlorothiazide (non-high-alert medications). The resulting drug pairs were: potassium salts-furosemide, fentanyl-furosemide, vancomycin-furosemide, digoxin-furosemide, digoxin-hydrochlorothiazide, fentanyl-phenobarbital, potassium salts-hydrochlorothiazide, and midazolam-hydrochlorothiazide. CONCLUSIONS: In a cohort of PICU patients, this study identified eight specific drug pairs involving high-alert medications that may increase the risk of interaction-associated symptoms, mainly hemodynamic alterations and electrolyte/fluid balance disturbances. If the administration of those drug pairs is unavoidable, patients should be closely monitored.
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Interações Medicamentosas , Unidades de Terapia Intensiva Pediátrica , Humanos , Estudos Retrospectivos , Criança , Masculino , Pré-Escolar , Feminino , Lactente , Adolescente , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologiaRESUMO
Drug therapy in patients who have undergone bariatric surgery is challenging. We aimed to investigate the patients' perspective on their drug therapy. This should allow deriving tailored measures to better support patients and their healthcare professionals with drug therapy after bariatric surgery. We conducted a quantitative telephone-based interview study with patients who have undergone bariatric surgery. The interview consisted of assessments in three parts: (i) current drug therapy: prescription, administration and adherence, (ii) changes after bariatric surgery and (iii) adverse events. (i) The 105 enrolled patients were taking a median of 10 (range: 3-30) drugs. In 1017 of 1080 drugs (94%), expectations in drug effectiveness were (rather) met. Of the 105 patients, 27% reported difficulties in drug administration, 44% forgot to take their drugs at least one time and 20% reported deviations from the prescription. (ii) Sixteen percent of the patients observed changes in drug effectiveness or tolerability-additionally to therapy adjustment by physicians. (iii) Seventy-four percent recognised at least one adverse event right before and/or after bariatric surgery, most frequently in gastrointestinal disorders. Patients who have undergone bariatric surgery have to deal with many difficulties in drug handling and adverse events. Our study emphasises the need for better and more individual support for patients with their drug therapy after bariatric surgery and, therefore, suggests a multidisciplinary approach that includes pharmacists. The stronger involvement of the patients' perspective seems to be a valuable source in research and practice.
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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.
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Algoritmos , Interações Medicamentosas , Formulários de Hospitais como Assunto , Reconciliação de Medicamentos , Humanos , Idoso , Pessoa de Meia-Idade , Masculino , Feminino , Idoso de 80 Anos ou mais , Reconciliação de Medicamentos/métodos , Estudos Prospectivos , Pacientes Ambulatoriais , Hospitalização , Substituição de MedicamentosRESUMO
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.
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Aprovação de Drogas , Uso Off-Label , Pediatria , Humanos , Criança , Uso Off-Label/estatística & dados numéricos , Adolescente , Alemanha , Pré-Escolar , Lactente , Rotulagem de Medicamentos , Marketing/legislação & jurisprudênciaRESUMO
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.
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Epilepsias Parciais , Epilepsia , Criança , Humanos , Projetos Piloto , Eletroencefalografia , Convulsões/diagnóstico , Epilepsias Parciais/diagnósticoRESUMO
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.
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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.
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Hospitalização , Alta do Paciente , Masculino , Humanos , Feminino , Idoso , Idoso de 80 Anos ou mais , Comunicação , Telefone , HospitaisRESUMO
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.
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Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Assistência Farmacêutica , Humanos , Idoso , Pessoa de Meia-Idade , Estudos Prospectivos , Visitas ao Pronto Socorro , Preparações Farmacêuticas , Serviço Hospitalar de EmergênciaRESUMO
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.
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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.
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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.
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Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Humanos , Idoso , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Fatores de Risco , Farmacêuticos , Serviço Hospitalar de Emergência , HospitalizaçãoRESUMO
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.
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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.
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Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Hospitalização , Adolescente , Criança , Humanos , Hospitais , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controleRESUMO
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.
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Algoritmos , Cuidados Críticos , Humanos , Adulto , Pantoprazol , Combinação Piperacilina e Tazobactam , CatéteresRESUMO
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.
Assuntos
Prática Farmacêutica Baseada em Evidências , Farmácias , Humanos , Farmacêuticos , Fonte de Informação , Estudos Prospectivos , InternetRESUMO
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.
RESUMO
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.