Review considerations on the design and evaluation of the oral sensory features in pediatric medications / 药学学报

Recent years, China has released a series of policies to encourage drug research and development in pediatric populations, aiming to meet pediatric populations' medical needs. Because of the physical and psychological developmental characteristics, tolerance of aversive feelings when taking medications are different between pediatric population and adults. So pediatric populations are at a relatively higher risk of not taking medications as prescribed when the medication tasted unpleasant. Therefore, sound design and evaluation of oral sensory features have important clinical significance and value in developing pediatric medications. "Technical guidance for the design and evaluation of the oral sensory features of pediatric drugs (trial version) " was released in November 2022, by Centre for Drug Evaluation, National Medical Products Administration of China. Based on the guidance, this article will introduce the drafting background and review considerations, hoping to provide reference for the design and evaluation of oral sensory features, and promote drug developing in pediatric population.

Investigation and Analysis of Pedi atric Medication Information of Microecological Preparations in China / 中国药房

OBJECTIVE： To provide suggestions for improving pediatric medication information in drug instructions of microecological preparations in China. METHODS： Using text analysis method， the pediatric medication information in the instructions of 36 approval number of microecological （29 varieties from 23 enterprises） is statistically analyzed. RESULTS： Among the 36 microecological preparations， there were 2 medicines for children （5.56％）. There were 2 granules （5.56％）， 9 dispersants （25.00％）， 9 tablets （25.00％） and 16 capsules （44.44％）； there were 6 national essential medicines （16.67％）； there were 13 products in the list of national essential medical insurance （36.11％）； there were 22 OTC products （61.11％）. The proportion of children’s indications， children’s usage and dosage， child-related adverse reactions， taboos and matters needing attention in the drug instructions for children were 19.44％， 55.56％， 2.77％， 5.56％ and 8.33％， respectively. The proportion of specific information about children’s drug use marked in the item of  “children’s drug use” was 25.00％. CONCLUSIONS： There is a lack of information on pediatric medication in the instructions of microecologial preparations in China， and there are some problems such as unclear wording， scattered labeling position of the medication information for children， and the content is not practical. It is recommended that medical institutions should strengthen the rational use of medical guidance for medical personnel， implement the scientific management process of over-instruction medications； the relevant departments should introduce more incentive policies， encourage enterprises to improve the basis of children’s medications， and make standardized labeling of children’s medication information in drug specifications. In addition， a database of information on children’s medications can be established to provide a reference for rational use of pediatric drugs.

Analysis of Pediatric Medication Information Labelling in 46 Pieces of Package Inserts for Skin External Drugs in Our Hospital / 中国药房

OBJECTIVE： To investigate the labelling problems of pediatric medication in the package inserts of skin external drugs in our hospital， and to put forward the suggestions. METHODS： A total of 46 package inserts for skin external medicine were collected from outpatient pharmacy of our hospital during Jan.-Dec. in 2018. Information on pediatric medication， precautions for pediatric medication， pediatric usage and dosage， and pediatric pharmacokinetic labelling in those package inserts was analyzed and summarized according to the types of domestic， imported and joint enterprises， classification of western medicine and Chinese patent medicine and labelling clarity， etc. RESULTS： Among 46 package inserts， 37 western medicines and 9 Chinese patent medicines were included； 31 domestic enterprises， 9 import enterprises and 6 joint ventures were involved. The ratio of pediatric medication， precautions （for pediatric medication）， pediatric usage and dosage， and pediatric pharmacokinetics labelling were 38.7％， 58.1％，  29.0％ and 0 for domestic drugs； 88.9％， 55.6％， 44.4％ and 33.3％ for imported drugs； 33.3％， 83.3％， 16.7％ and 0 for joint venture drugs； 59.5％， 62.2％， 32.4％ and 8.1％ for western medicine； 0， 55.6％， 22.2％ and 0 for Chinese patent medicine. 5 （10.9％） drug package inserts clearly indicated the usage and dosage of children； 12 （26.1％） drug package inserts were clearly labeled for the usage and dosage involving children； 12 （26.1％） drug package inserts were clearly marked to remind children to use under the supervision of doctors and adults； 11 （23.9％） drug package inserts clearly indicated that pediatric medication was not clear and the safety of pediatric medication was not yet established； 1 （2.2％） package insert clearly indicated that children should be cautious and forbidden； 3 （6.5％） package inserts did not involve package insert for pediatric medication； 2 （4.3％） package inserts clearly indicated that the drugs were stored in places not accessible to children. CONCLUSIONS： There are some problems in the package inserts of skin external drugs in our hospital， such as the marked rate of pediatric medication is quite different； the contents of the labels of pediatric medication are ambiguous and pharmacokinetic data is absent； the contents of the package inserts are inconsistent and the patients are not easy to understand professional terms. The standardization， strictness and guidance of drug package inserts for children can be improved by strengthening the supervision and management of drug package inserts by drug regulatory authorities， increasing the research and development of children’s special drugs， increasing the attention of pharmaceutical enterprises to pediatric medication， paying the attention to the revision of standard package inserts， advancing the clinical trials of children， and raising the awareness of safe drug use of patients and users.

Investigation and Analysis of Parents’Cognition,Attitude and Behavior on Pediatric Medication Safety in Part of Urban Area of Fujian Province / 中国药房

OBJECTIVE:To provide reference for guaranteeing safety and rationality of pediatric medication. METHODS:Questionnaire survey was designed to investigate and analyze the cognition,attitude and behavior of parents on pediatric medication safety in urban area of Fujian province. RESULTS:Totally 1 405 questionnaires were sent out,and 1 326 were effectively received with effective rate of 94.38%. The education level of the respondents was high,and the respondents with college degree or above accounted for 57.92%. The total monthly income was also high,the respondents with monthly income of 4 000 yuan or above accounted for 61.61%. The correct answer rates of the respondents about pediatric medication safety was above 55%,but the lowest correct rate of 3 questions was only 13.73%,14.25% and 23.83%,respectively. The average score of cognition was (13.92 ± 2.80). The scores of low educational background,low monthly income and farmers were relatively low (P＜0.01). 97.06% of the respondents had trouble or difficulty in giving children drugs;the frequency of choice for children who didn’t cooperate with medication due to the taste or dosage was 29.83%;14.58% of the respondents didn’t know the accurate dosage;12.13% lacked of pediatric medication guide. 11.37%of the respondents thought that there was no drug for child specific use or not enough child-specific varieties;when children suffered from common diseases,the majority of respondents would choose municipal level or above hospitals and community health service,accounting for 49.55% and 15.46%. 85.22% of respondents had the experience of giving drug to their children by themselves. As to medication information,10.94% of respondents hold that"wanted to know but did not have the channel"and 47.66%"would read when had opportunity". 40.05% of the respondents sometimes took the initiative to consult doctor or pharmacist about pediatric medication attention,but 19.60% of respondents took little or no initiative to that. For main sources of the respondents accessing to pediatric medication guidance,the frequency of choosing doctors was 65.53%,and that of choosing pharmacists was 20.31%. 61.09% of respondents wanted to get the medication education from doctors,while 19.76% from pharmacist. Information on pediatric medication information when the respondents visited doctors and purchased drugs were also relatively simple,and were mainly about the usage and dosage. CONCLUSIONS:At present,it is common for parents to give drug to children by themselves in Fujian province. But the cognition,attitude and behavior on medication safety of children still remain to be improved. There are shortcomings in the publicity and education of knowledge and information,and the pediatric pharmaceutical care functions of pharmacists have not been fully embodied. At the same time,the development and production of children specific drugs need to be strengthened,and the information about pediatric medication in drug instructions should be standardized and improved.

Conciliación farmacoterapéutica en las áreas de transición en la atención del paciente en un hospital pediátrico de alta complejidad / Medication reconciliation at areas of transition in the patient care at a tertiary pediatric hospital

Introducción: La Conciliación Farmacoterapéutica garantiza el tratamiento medicamentoso correcto (dosis, vía y frecuencia) en relación a la situación actual del paciente. Objetivos: Determinar el grado de seguridad farmacoterapéutica en todas las transiciones del cuidado del paciente. Métodos: estudio descriptivo, transversal. Se realizó conciliación en las primeras 24 hs del ingreso en CIM (salas de internación de cuidados intermedios o moderados), Emergencia o UCI. Se incluyeron pacientes crónicos, que recibían más de 4 medicamentos, con readmisiones frecuentes y/o fármacos de bajo índice terapéutico. Se entrevistó a los pacientes/cuidadores, con previa firma del consentimiento informado y se recolectaron datos de la HCE para comparar el "mejor listado de medicación" obtenido con la indicación médica actual para analizar las discrepancias encontradas y resolverlas. Resultados: Se conciliaron en total 320 pacientes, encontrándose 1343 discrepancias totales, de las cuales 220 (16%) fueron errores de medicación. Se conciliaron 105 pacientes en la etapa emergencia (donde hubo más errores) 101 en la etapa CIM y 92 en la etapa UCI. El 42% de los pacientes sufrió al menos 1 error de medicación (omisión de indicación, el más frecuente). La mayoría de los errores no llegaron al paciente, esto fue evitado en el 52% por el padre y en el 39% por el farmacéutico. El 7% de los errores que llegaron al paciente causaron daños. En la conciliación al alta se halló que no se asienta en la HC la farmacoterapia de base. Conclusiones: La magnitud de los errores hallados es considerable, por lo que debería implementarse en forma rutinaria un programa de conciliación terapéutica, con énfasis en Emergencia (AU)

Introduction: Medication reconciliation guarantees adequate drug treatment (dose, route, and frequency) according to the current state of the patient. Aims: To determine the degree of medication safety in all transitions of patient care. Methods: A descriptive cross-sectional study. Reconciliation was carried out in the first 24 hours after admission to the ward (intermediate or moderate care wards), emergency department, or ICU. Chronic patients receiving more than 4 different drugs, with frequent readmissions, and/or narrow therapeutic index medications were included. Patients/caregivers were interviewed after signing informed consent and data were collected from the medical chart to compare the "best list of medications" obtained with the current medical indications to analyze discrepancies and resolve them. Results: Overall, reconciliation was carried out in 320 patients and 1343 discrepancies were observed, of which 220 (16%) were found to be medication errors. Reconciliation was carried out in 105 patients at the emergency department (where most errors were made), in 101 on the wards, and in 92 in the ICU. In 42% of the patients at least one medication error was observed (being omission of the indication the most common). The majority of errors did not affect the patient; they were avoided by the parent in 52% and by the pharmacist in 39%. Seven percent of the errors that did affect the patient caused damage. At reconciliation at discharge we found that in the medical chart baseline pharmacotherapy was not recorded. Conclusions: The magnitude of errors found was considerable and therefore a program of medication reconciliation should be routinely implemented, with emphasis on the emergency department (AU)

Exploration of pediatric clinical pharmacist training model based on the characteristics of childhood diseases / 中国药学杂志

OBJECTIVE: This study aims to investigate the pediatric clinical pharmacist training model, to meet the clinical de¬mands, and to improve the level of pediatric rational drug use.