Perceptions and experiences of community pharmacists with off-label prescribing in the pediatric population.

OBJECTIVES: This study aimed to investigate and provide insight into the prevalence and patterns of off-label drug use in the pediatric population from the perspective of community pharmacists, addressing the existing data gap in a developing setting. METHODS: A questionnaire-based cross-sectional study was conducted on Albanian community pharmacists in June 2021. The online administered survey explored the participants' demographic details, perceptions, and experiences with off-label prescriptions in pediatric patients. The statistical analysis conducted on the survey data comprised the construction of frequency tables and the application of the chi-square test for independence. KEY FINDINGS: Three hundred and thirty-six community pharmacists nationwide completed the survey, out of which 186 (55.3%) were practiced in Tirana, the capital of Albania. Over 80% of surveyed pharmacists (n = 275) had encountered off-label drug prescriptions in pediatric patients, yet only 40% of participants reported dispensing medicines for off-label use. Community pharmacists reported that general pediatricians tended to prescribe off-label medications more frequently than pediatric subspecialists or general practitioners. It was found that off-label prescriptions were more frequently observed among children aged between 2 and 11 years. Antibiotics were the most reported medicines for off-label use in this study mentioned in almost all off-label categories. CONCLUSIONS: Prescribing medicines for unapproved uses for the treatment of pediatric patients is present in community settings in Albania. This indicates the need for further data collection and analysis to understand off-label practices in our country's pediatric population comprehensively.

Occurrence of Types A and B Trichothecenes in Cereal Products Sold in Romanian Markets.

In view of the frequent occurrences of mycotoxins in cereals, this study assessed the presence of trichothecenes in 121 samples from Romanian markets. These samples were divided into five groups based on product type: (1) bread and bakery products containing white flour, (2) half-brown bread with whole wheat flour, (3) brown bread containing rye flour, (4) pasta, and (5) raw wheat. Gas Chromatography-Mass Spectrometry was used to detect 13 different mycotoxins, which included the Type A compounds HT-2 toxin and T-2 toxin, as well as the Type B compounds deoxynivalenol and nivalenol. Results indicated trichothecene contamination in 90.08% of our samples, with deoxynivalenol predominating by at least 78% in each examined group. Co-occurrence of three or four trichothecenes were found in 23.85% of our samples. Our study underscores the necessity of consistent monitoring of staple foods to prevent the intake of harmful trichothecenes by consumers.

The Occurrence of Aflatoxins in Nuts and Dry Nuts Packed in Four Different Plastic Packaging from the Romanian Market.

Mycotoxins are secondary metabolites produced by various fungi. A very important category of mycotoxins are aflatoxins, considered to be the most dangerous in humans. Aflatoxin B1, well known as a favorable factor in the occurrence of hepatocellular carcinoma in humans, is the most controversial of all mycotoxins. Aflatoxins, found in naturally contaminated food, are resistant to degradation by heat. Current food processing practices and conventional storage conditions do not completely eliminate aflatoxin contamination from the food supply chain. Long storage food products-such as peanuts, pistachio, nuts in general, and dried fruits-are susceptible to aflatoxins contamination. The type of plastic material can influence the concentration of aflatoxins during storage due to the permeability to gas and moisture exchange with the external milieu. Nuts in general and dried fruits are consumed in large quantities worldwide. Therefore, herein we investigated the effect of plastic material on the total aflatoxins and aflatoxin B1 content in 64 samples of nuts and dried fruits packed and stored in low-density polyethylene (LDPE), polypropylene (PP), polyethylene (PE), and polyethylene terephthalate (PET). The method consisted in a cleanup procedure using immunoaffinity columns coupled with RIDASCREEN FAST immunoenzymatic competitive assays based on the ELISA technique. Collected data were subjected to statistical analysis and multiple comparisons tests were applied. From the total analyzed samples, 14.06% exceeded the maximum admitted European levels for total aflatoxins. The highest concentrations of total aflatoxins were obtained from samples packed in LDPE, followed by PP, PE, and PET. Aflatoxin B1 was detected in all samples packed in LDPE, PP, and PE. Most of the samples packed in PET had concentrations <1 µg/kg. These results indicate that nuts in general packed and stored in LDPE are more prone to contamination with aflatoxins, while PET is more suitable for maintaining the quality and safety of these products.

TV-based assistive integrated service to support European adults living with mild dementia or mild cognitive impairment (TV-AssistDem): study protocol for a multicentre randomized controlled trial.

BACKGROUND: Mild cognitive impairment and mild dementia progressively compromise the ability of people to live independently and can have a negative impact on their quality of life. Within the current European Active and Assisted Living programme (AAL), project TV-AssistDem has been developed to deliver a TV-based platform service to support patients with mild cognitive impairment or mild dementia and provide relief to their caregivers. The application is intended to be used daily at home, mainly by the participants themselves, with the help of their informal caregivers. The aim of this study is to evaluate the effectiveness of TV-AssistDem to improve quality of life in people with mild cognitive impairment or mild dementia. METHODS: This is a 12-month European multicentre randomized controlled trial which will be performed in two countries: Spain and Romania. Two hundred and forty older adults will be recruited using identical inclusion/exclusion criteria. The primary outcome will be the change from baseline of TV-AssistDem on patient quality of life at 12 months. The secondary outcomes will be the changes from baseline of: 1) informal caregiver quality of life, 2) informal caregiver burden, 3) patient treatment adherence, 4) patient treatment compliance, 5) patient functional status, and 6) healthcare cost-effectiveness at 12 months. Patients in the intervention group will have access to an interactive platform which offers remote assistive services through a device connected to the television. The core services of the platform are: 1) Calendar and reminders, 2) Health monitoring and data transmission to a health server and 3) Videoconference; service-oriented applications are: 4) Cognitive stimulation; 5) Reminiscences; and 6) Patient and caregiver healthcare education. The analysis will be made following an intention-to-treat procedure. Linear and Generalized Mixed Model analysis will be performed. DISCUSSION: We hypothesize that the regular use of TV-AssistDem will result in an improvement in patient quality of life. The uniqueness of this home TV-based intervention lies on its widespread accessibility and its integrative approach to quality of life in people with mild cognitive impairment or mild dementia and their informal caregivers. However, several anticipated challenges will need to be faced: poor engagement and connectivity problems. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT03653234 , Date of registration: 31 August 2018.