Acceptability of different oral dosage forms in paediatric patients in hospital setting.

OBJECTIVE: The understanding of acceptability of existing dosage forms is limited in most of the world and hinders the development of acceptable, age-appropriate medicines. The attributes of paediatric medicine acceptability may differ from country to country based on culture, healthcare infrastructure and health policies. This study was designed to map the acceptability of oral medicines in paediatric patients treated in hospital in India. METHODS: An observational, cross-sectional study was conducted in patients aged below 18 years and taking any form of oral medication. Acceptability scores were obtained using CAST-ClinSearch Acceptability Score Test tool. FINDINGS: 490 patients were recruited and 193 evaluations of different pharmaceutical products available in 20 dosage forms and 7 routes of administration were studied. Oral liquids (50%) and tablets (35%) were the most commonly prescribed and administered forms. Regardless of the therapeutic class and age, the oral liquids were 'positively accepted' in infants and toddlers. Acceptability of tablets improved with age and appeared to be generally good from the age of 6. CONCLUSION: This study indicates the limited progress towards adoption of age-appropriate dosage forms in India and thus impact on the acceptability of existing oral dosage forms. The key challenges posed by the adoption of age-appropriate formulations in India are (1) awareness of importance of appropriate administration and acceptability of medicines to children in India, (2) availability of age-appropriate dosage forms and (3) lack of child-appropriate medicine policies.

Exploring Acceptability Drivers of Oral Antibiotics in Children: Findings from an International Observational Study.

Antibiotics are among the most commonly prescribed drugs in children. Adherence to the treatment with these drugs is of the utmost importance to prevent the emergence of resistant bacteria, a global health threat. In children, medicine acceptability is likely to have a significant impact on compliance. Herein we used a multivariate approach, considering simultaneously the many aspects of acceptability to explore the drivers of oral antibiotic acceptability in children under twelve, especially in toddlers and in preschoolers. Based on 628 real-life observer reports of the intake of 133 distinct medicines, the acceptability reference framework highlighted the influence of many factors such as age and sex of patients, previous exposure to treatment, place of administration, administration device, flavor agent in excipients and active pharmaceutical ingredient. These findings from an international observational study emphasize the multidimensional nature of acceptability. Therefore, it is crucial to consider all these different aspects for assessing this multi-faceted concept and designing or prescribing a medicine in order to reach adequate acceptability in the target population.

Quantifying and Categorizing ADRs in Psychiatric Residential Long-Stay Patients Utilizing UKU-SERS Scale.

BACKGROUND: Psychotropic drugs are essential but not devoid of adverse drug reactions (ADRs), which lead to non-compliance and further failure of therapy, hampering the patient's quality of life. METHODS: A cross-sectional, observational study was carried out in a residential nursing home in Pune, India, from October 2018 to March 2019. Psychiatric inpatients of both genders and all ages receiving psychotropic drugs for at least one month were enrolled. Patients who were not alert or oriented enough to give a detailed history and response to a questionnaire, including dementia patients, and those who were not willing to give informed consent were excluded. The ADRs were categorized, and their management was documented using the Udvalg for Kliniske Unders gelser (UKU) side effect rating scale. ADRs were assessed for causality and severity using the WHO-Uppsala Monitoring Centre (WHO-UMC) causality assessment scale and the Modified Hartwig and Siegel scale. RESULTS: In our study, 115 patients (76.6%) experienced 273 adverse drug events. Atypical antipsychotics accounted for the maximum number of ADRs (54.94%; n = 150). The most common ADRs were weight gain, constipation, and tremors. The majority of ADRs were "mild" and had a "possible" causality relationship. CONCLUSION: The study demonstrated a high incidence of ADRs, which was primarily managed either by reduction of dose or continued drug use with the treatment of side effects.

Assessment of the effectiveness of a pharmacist approach for improving disease-specific knowledge and treatment in patients with chronic obstructive pulmonary disease.

OBJECTIVE: Adequate knowledge is essential for the appropriate management of chronic conditions such as chronic obstructive pulmonary disease (COPD). However, some patients may not be able either to comprehend or obtain adequate information. This study aims to assess the effectiveness of the clinical pharmacist approach to refining disease-specific knowledge in patients with COPD treated in a tertiary care hospital. METHODS: A prospective observational longitudinal study was carried out in adult COPD patients for 9 months in the tertiary care hospital of Pune. At the time of enrolment, disease-specific knowledge of patients with COPD was assessed using the Bristol COPD Knowledge Questionnaire (BCKQ). After the assessment, patients were educated, counselled verbally and provided with a validated COPD information leaflet. The patients' knowledge was reassessed 1 month and 3 months after enrolment. Pre and post scores of BCKQ were compared by ANOVA followed by Tukey's post hoc test. The difference in the proportions was calculated using the χ2 test. RESULTS: Of 75 patients, the majority were men (53.33%), aged >60 years (72%), employed (62.67%) and had obtained secondary education (37.33%). The mean baseline BCKQ overall score of the patients was 25.87, which increased after education to 42.43 on the first visit (1 month) and to 45.62 on the second visit (3 months) (p<0.0001). At baseline, the topics 'vaccination', 'inhaled steroids' and 'antibiotics' returned the lowest mean scores of 0.37, 0.38 and 0.60, which were increased to 2.30, 2.70 and 2.72, respectively, after follow-up. CONCLUSION: The knowledge of patients with COPD about the disease and its treatment was poor at the time of enrolment. Proper counselling and education provided by the clinical pharmacist helped to improve the patients' knowledge about COPD and its treatment.

High-dose methotrexate-induced fulminant hepatic failure and pancytopenia in an acute lymphoblastic leukaemia paediatric patient.

Methotrexate treatment has been associated with an array of liver-related adverse events like asymptomatic transaminase elevations, fatal necrosis and fibrosis. Here we present a child with relapse Pre B cell acute lymphoblastic leukaemia who developed and died of fulminant hepatic failure and pancytopenia soon after the administration of high-dose MTX. This case is unusual due to a series of adverse events that led to severe toxicity. The child received 1 g/m2 dose of methotrexate infusion for 36 hours. The patient developed drowsiness with altered sensorium in the 72 hours after starting the infusion. Investigations revealed severe pancytopenia along with grossly deranged liver function tests and coagulation profile. On the fourth day of paediatric intensive care unit admission, the child went into cardiac arrest and could not be revived.

Serum Methotrexate Level and Side Effects of High Dose Methotrexate Infusion in Pediatric Patients with Acute Lymphoblastic Leukaemia (ALL).

Methotrexate (MTX) is an extensively prescribed antimetabolite especially in the treatment of several pediatric cancers, though managing toxicities associated with methotrexate in high dose continues to be a challenge. A prospective study was carried out from April 2017 to October 2018. Children of either sex below 18 years at the time of enrolment and receiving high dose Methotrexate intravenous infusion over 24 h as a 2 g/m2, 3 g/m2 and 5 g/m2 dose was included in the study. The serum methotrexate level was estimated after the start of 48 h HDMTX infusion by using the ARCHITECT methotrexate assay. Toxicity due to HDMTX was assessed by Common Terminology Criteria for Adverse Events v.5.0. A total of 244 HDMTX infusions were delivered to 62 ALL patients. From the total of 244 cycles, serum methotrexate level in 35 cycles after the start of 48 h HDMTX infusion was found to be ≥ 1.0 µmol/L with reported toxicities among 31 cycles (88.6%). In 209 cycles MTX level was found to be less than 1.0 is statistically significant as compared to other cycles (p < 0.0001). Highest toxicities reported were in cycle I (38.8%). The toxicities such as oral mucositis, neutropenia, the elevation of liver enzymes, dermatological toxicities were found more in cycles whose methotrexate level are greater than 1.0 µmol/L. Dose reduction, increased the length of stay and treatment delay occurred in patients with severe toxicities. Severe toxicities of methotrexate can be interrelated with serum methotrexate levels at 48 h after the start of HDMTX infusion.

Case report on hypersensitivity to methotrexate infusion in a pediatric acute lymphoblastic leukaemia patient.

Methotrexate is extensively used in the treatment of various malignancies and autoimmune conditions. Methotrexate is associated with several toxicities, while hypersensitivity reactions to methotrexate are unusual, but have been reported in adult cancer patients. Hereby, we detail the case of a child with acute lymphoblastic leukaemia who developed a hypersensitivity reaction to high-dose methotrexate infusion (HDMTX) during the fourth cycle of HDMTX. The child was rechallenged with another brand of methotrexate; she started complaining of itching on trunk within 5 min of infusion. Few studies have reported that desensitization has been helpful in children with hypersensitivity reactions allowing the continuation of HDMTX. However, it was decided to omit parenteral methotrexate for this child. Cranial radiotherapy was given for CNS prophylaxis. In conclusion, unexpected hypersensitivity with methotrexate should be kept in mind during the treatment especially with high-dose infusion.