Drug-handling problems and expectations of the ideal pediatric drug-reported by children and their parents.

Experienced drug-handling problems and inadequately considered expectations for drug therapy have an unfavorable influence on therapy. We performed a questionnaire survey in (i) parents of 0-5-year-old children and (ii) 6-17-year olds and their parents. We assessed (A) experienced drug-handling problems and (B) expectations for drug therapy. (i) Forty-six parents and (ii) 103 children and their parents participated in the study. Experienced drug-handling problems were described by (i) 100% of parents and (ii) 62% of children and 70% of parents. Problems concerned with the preparation of the drug, dosing, compliance with the time interval, and acceptance. (i) Sixty-five percent of parents preferred a peroral route of drug administration, while (ii) 74% of children and 86% of parents did so. Preferred characteristics of peroral drug formulations, e.g., liquid versus solid drug formulations or flavor, were highly heterogeneous. Preferences of 6-17-year-old children and their parents matched in 43 to 66%.   Conclusion: Most children and their parents had already experienced drug-handling problems. Preferences concerning the ideal pediatric drug were highly heterogeneous and in about half of cases, preferences of children and their parents differed. Thus, the children should be approached directly. If information is solely gained from parents, the children's needs might remain unmet. What is Known: • Pediatric drug administration is complex and therefore error-prone. • Experiences and expectations of children and their parents should be considered. What is New: •Most pediatric patients and their parents have already experienced drug-handling problems. • Expectations concerning the ideal pediatric drug are highly heterogeneous. Parents are often insufficiently aware of those expectations in their children.

The intact nephron hypothesis as a model for renal drug handling.

PURPOSE: The intact nephron hypothesis (INH) states that impaired renal function results from a reduction in the number of complete (intact) nephrons. Under this model, renal drug clearance is assumed to be a linear function of glomerular filtration while tubular handling is ignored. The aims of this study were to systematically review published studies designed to test the INH and to assess the strength of the study designs used. METHODS: A systematic literature search was conducted in MEDLINE, EMBASE and Google Scholar. Studies specifically designed to understand the relationship between glomerular and tubular function across different levels of renal function were included. Studies that found a linear relationship between GFR and tubular clearance were deemed to support the INH while studies that found a non-linear relationship did not support the INH. Study design was accessed using a bespoke strength of evidence score. RESULTS: Thirty studies met the criteria for inclusion. Of these, 24 did not support the INH. Studies that did not support the INH used methods for measuring tubular clearance that were more robust and included subjects with a wider range of GFR values than studies that supported the INH. DISCUSSION: Our results suggest that the INH may not be a suitable general model for renal drug handling, particularly for drugs that are eliminated by tubular mechanisms. Further studies to assess the clinical importance of a non-linear relationship between drug clearance and GFR are warranted.

Optimizing parents' performance in anticonvulsant rescue medication administration.

OBJECTIVE: Parents of children with epilepsy are at risk of committing high-risk handling errors with a high potential to harm the patient when administering anticonvulsant rescue medication. We developed a training concept addressing identified high-risk handling errors and investigated its effects on parents' skills. STUDY DESIGN: In a controlled prospective intervention study, parents of children with epilepsy were asked to demonstrate their administration of rescue medication by using dummy dolls. A clinical pharmacist monitored rectal or buccal administration and addressed errors in the intervention group with training and information sheets. Three to 6weeks later, intervention's sustainability was assessed at a home visit. RESULTS: One hundred sixty-one parents completed full study assessment: 92 in the intervention group and 69 in the control group. The number of processes with at least one handling error was reduced from 96.4% to 56.7% in rectal tube administration and from 66.7% to 13.5% in buccal administration (both p<0.001). CONCLUSION: A one-time intervention for parents significantly and sustainably reduced high-risk handling errors. Dummy dolls and information sheet were adequate for an effective and feasible training to support the correct administration of anticonvulsant rescue medication.

Assessment of the association between drug disposal practices and drug use and storage behaviors.

OBJECTIVE: Keeping unnecessary drugs at home is a situation showing both causes and consequences of irrational use of medicine. This study aimed to evaluate the approaches of a company's employees regarding drug storage, use, and disposal. METHOD: This online-based descriptive study was held in a multi-centered private-sector company in a voluntary basis. The survey assessing participants' drug handling and storage behaviors was answered by 1121 employees from across eight provinces of Turkey in 2016. Main outcome measures were storage and disposal of unused/unwanted drugs at home in a rational way. RESULTS: The percentage of participants who declared that they keep unused/unwanted drugs at home was 28.0%. About one-third of participants disposed their unused/unwanted drugs via the "garbage, sink, toilet, etc.". Participants ≥30 years old and living with <4 household members significantly tended to bring their unused/unwanted drugs to the company's drug-box. Nearly half of all participants (46.5%) stated a recent change in their disposal behavior. The vast majority of participants (94.6%) who previously took drugs back to the company's drug-box stated that they either had, or would, help their contacts adopt such behaviors. These participants were also significantly less likely to dispose of drugs inappropriately, practice self-medication, be unaware of expired drugs at home, or fail to store drugs according to the labelling. CONCLUSION: While our findings showed that a substantial number of participants still had unused drugs at home and disposed of them inappropriately, it is understood that they started to exhibit more favorable behaviors in recent years.

A prospective three-step intervention study to prevent medication errors in drug handling in paediatric care.

AIMS AND OBJECTIVES: To prevent medication errors in drug handling in a paediatric ward. BACKGROUND: One in five preventable adverse drug events in hospitalised children is caused by medication errors. Errors in drug prescription have been studied frequently, but data regarding drug handling, including drug preparation and administration, are scarce. DESIGN: A three-step intervention study including monitoring procedure was used to detect and prevent medication errors in drug handling. METHODS: After approval by the ethics committee, pharmacists monitored drug handling by nurses on an 18-bed paediatric ward in a university hospital prior to and following each intervention step. They also conducted a questionnaire survey aimed at identifying knowledge deficits. Each intervention step targeted different causes of errors. The handout mainly addressed knowledge deficits, the training course addressed errors caused by rule violations and slips, and the reference book addressed knowledge-, memory- and rule-based errors. RESULTS: The number of patients who were subjected to at least one medication error in drug handling decreased from 38/43 (88%) to 25/51 (49%) following the third intervention, and the overall frequency of errors decreased from 527 errors in 581 processes (91%) to 116/441 (26%). The issue of the handout reduced medication errors caused by knowledge deficits regarding, for instance, the correct 'volume of solvent for IV drugs' from 49-25%. CONCLUSION: Paediatric drug handling is prone to errors. A three-step intervention effectively decreased the high frequency of medication errors by addressing the diversity of their causes. RELEVANCE TO CLINICAL PRACTICE: Worldwide, nurses are in charge of drug handling, which constitutes an error-prone but often-neglected step in drug therapy. Detection and prevention of errors in daily routine is necessary for a safe and effective drug therapy. Our three-step intervention reduced errors and is suitable to be tested in other wards and settings.

Oral chemotherapy handling and storage practices among Veterans Affairs oncology patients and caregivers.

PURPOSE: This questionnaire-based study was designed to identify the oral chemotherapy medication handling, storage, and disposal practices among cancer patients and their caregivers. METHODS: This was a single-center observational survey study approved by the Investigational Review Board and VA Research & Development Committee. Patients were eligible for inclusion if they had an active order for an oral antineoplastic medication and an appointment at the oncology clinic. A questionnaire related to the storage, handling, disposal, patient education and counseling, and patients' perception of safety of oral antineoplastic medications was developed and given to patients in the clinic. Survey responses were analyzed using descriptive statistics. RESULTS: A total of 45 surveys were given to eligible patients in the oncology clinic and 42 surveys were returned to the study team. The majority, 40 participants (95%) were male. Participants ranged in age from 51 to 85 years (median, 65 years). Thirty-eight patients (90.5%) responded that the medication was stored away from extreme heat, cold, and humidity. Thirty-two patients (76%) reported keeping their medications in the original container. Hand washing was not a consistent practice among patients. Eleven patients (26%) reported always washing their hands after handling their anticancer medication; another 6 (14%) responded "sometimes". Of the 42 participants who answered, only 6 patients (14%) reported always or sometimes wearing gloves. CONCLUSION: The majority of patients responding to this survey store their oral anticancer medications appropriately, but patients' and caregivers' handling and disposal practices are inconsistent and frequently do not follow the published recommendations.

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.

Counseling patients on correct drug handling in German community pharmacies: experiences and opinions of pharmaceutical staff.

Background For a safe drug therapy, outpatients have to self-administer their medications correctly. However, these procedures are known as error-prone. In community pharmacies, the pharmaceutical staff has to recognize patients' counseling needs and to use adequate strategies to prevent possible handling errors. Objective Assessing the experiences and opinions of pharmaceutical staff on counseling patients on practical drug handling. Setting Community pharmacies in a German city and surrounding area. Method Descriptively evaluating a self-administered questionnaire to be completed by members of the pharmaceutical staff involved in patient counseling. Main outcome measures Estimated counseling needs of patients, current counseling strategies and limitations of counseling. Results 520 staff members of 119 pharmacies (59.8%, 199 invited) participated. The majority prioritized counseling on dosage over counseling on practical drug handling. Participants saw a particular need when medication was dispensed for the first time compared to repeated use (all medication types, each p < 0.001). The need and counseling strategy depended on the dosage form with a special focus on practical demonstration in bronchopulmonary (83.9%) and oral liquid formulations (54.3%). As one main limitation, they cited the refusal of patients to accept information on drug handling (34.4%). Conclusion Participants considered drug handling an important counseling topic. However, reduced awareness for handling errors made at repeated use and at administration of certain dosage forms may affect the safety and success of medication therapy. Additionally, patients' resistance to information may limit the intent on counseling. Still, it is important to verify patients' abilities to handle their medication as intended.

Antineoplastic drug occupational exposure: a new integrated approach to evaluate exposure and early genotoxic and cytotoxic effects by no-invasive Buccal Micronucleus Cytome Assay biomarker.

Health-care personnel handling antineoplastic drugs could be at risk for adverse health effects. We aimed to evaluate genotoxic and cytotoxic effects of antineoplastic drug exposure of personnel preparing and administering such drugs in three Oncology Hospitals in Italy enrolling 42 exposed subjects and 53 controls. Furthermore, we aimed to study the possible influence of XRCC1 and hOGG1 DNA repair genes polymorphisms on genotoxicity induced on buccal cells. We performed workplace and personal monitoring of some drugs and used exposure diary informations to characterize the exposure. Urinary 5-FU metabolite (α-fluoro-ß-alanine) was measured. Buccal Micronucleus Cytome (BMCyt) assay was used to evaluate DNA damage and other cellular anomalies. GEM and 5-FU contamination was found in 68% and 42% of wipe/swab samples respectively. GEM deposition was found on workers' pads while no α-fluoro-ß-alanine was found. BMCyt-assay showed higher genotoxicity and cytotoxicity on nurses administering antineoplastics than on preparators and controls. Among micronucleus (MN) positive (with MN frequency higher than 1.5‰) exposed subjects, the percentage of those carrying XRCC1 mut/het genotype was higher than in MN positive-controls. Using the sensitive BMCyt assay, we demonstrated that handling antineoplastics still represents a potential occupational health risk for workers that should be better trained/informed regarding such risks.

In vitro gastrointestinal model (TIM) with predictive power, even for infants and children?

There is a need for information on the bioavailability in pediatric patients of drugs from manipulated dosage forms when applied in combination with food and/or co-medication under realistic daily practice circumstances. We describe the development, validation and application of a dynamic, computer-controlled in vitro system mimicking the conditions in the upper gastrointestinal tract of neonates, infants and toddlers: TIMpediatric. Paracetamol and diclofenac in age-related food matrices and with esomeprazole co-medication were tested. The experiments showed relevant results on the impact of drug manipulation and co-medication on the availability for absorption of active compounds. Without ethical constraints, alternative approaches for oral dosing and new pediatric formulations can be studied in TIMpediatric with a high predictive value.

Investigation on Shanxi Provincial Drug Handling Enterprises after Passing GSP Authentication / 中国药房

OBJECTIVE:To study the status quo of the drug handling enterprises that passed GSP authentication.METHODS:Targeted at part of GSP authentication-passed drug handling enterprises in Shanxi province,research methods like interview,direct observation,questionnaires etc.were adopted in the study.RESULTS&CONCLUSION:Some items in the current GSP need to be further specified and quantified.The GSP authentication should be conducted in strata.Drugs handling enterprises should emphasis the training of staffs to improve their comprehensive qualities,utilize and improve hard-ware facilities to improve business running conditions and warehouse conditions,strengthen the checking system through the evolvement of quality management rules and post responsibility regulations and to strengthen drug handling enterprises’man-agement on drug sources.

Qualitation on Behavior of“Drug Handling Beyond Limits” / 中国药房

OBJECTIVE:To discuss the laws applicable to the behavior of“drug handling beyond limits”.METHODS:The concerned contents of the related laws,codes,administrative rules and regulations issued at different time were analyzed comparatively.RESULTS:Under different laws and regulations,the same illegal behavior had different qualitations and treatments.CONCLUSION:Under the current laws and regulations,the behavior of“drug handling beyond limits”was qualitatively regarded as“drug handling without license”remains to be further consulted.