British National Formulary For Children Research Articles

The Use of Off-label and Unlicensed Drugs for Neonates: A Report from a Teaching Hospital in Baghdad

Background: Neonates who are admitted to hospitals will need various drugs. The use of unlicensed or off-label drugs without scientific evidence makes this exposure unsafe. Aim of study: We aimed to assess the use of drugs for neonates based on the British National Formulary for Children and IBM Micromedex Neofax. Patients and methods: This is a descriptive study which reviewed the clinical files of enrolled neonates who have stayed in the hospital for more than 24 hours and received at least one drug. It was conducted in the neonatal care unit of the Children Welfare Teaching Hospital/ Medical City Complex in Baghdad during the period from 1st of January to 30th of June/2018. The data was entered on a predesigned format and analyzed by using the appropriate statistical methods. Results: A total number of 1079 neonates were admitted to the NCU during the study period, of whom 967 were included in the current study with 597 (61.7%) males and 370 (38.3%) females. There were 424 (43.8%) preterm, 496 (51.3%) term and post term neonates, and 47 (4.9%) neonates with unknown gestational age. Different classes of drugs were used with a total of 56 drugs, of which 33.9% were unlicensed and 66.1% were off-label. Accordingly, 42.5% of the neonates received unlicensed drugs and almost all patients received at least one off-label drug. Major risk factors for such use include mechanical ventilation, male sex and prolonged hospitalization. Conclusions: In hospitalized neonates, drugs were more frequently prescribed as an off-label rather than unlicensed. Almost all neonates were exposed to off-label formulations.

Using the British National Formulary app to support safe prescribing: a practical guide

This article is a practical guide to using the British National Formulary (BNF) and BNF for Children (BNFC) App more effectively, to support safe prescribing. It provides a brief overview of app layout and navigation. Features that support safe prescribing are then explored, focusing on drug monographs and the Interactions Checker tool; examples are used for illustration. Location of information that is particularly relevant to prescribers is highlighted. The BNF app provides prescribers with fast, convenient access to validated, current information. However, it may need to be supplemented by other sources, and knowledge is only one element of the competencies needed to be a safe, effective prescriber.

A qualitative exploration of digital medicines information usage: Insights from an evaluation of the BNF

Objectives: To explore the driving and resisting forces to the use of digital medicines information in the context of the British National Formulary (BNF) and British National Formulary for Children (BNFc). Methods: Qualitative semi-structured interviews were carried out with 25 doctors, pharmacists and nurses. Data were analysed via thematic analysis. Results: Key drivers identified included organisations making digital use of BNF/BNFc easier through measures such as electronic prescribing systems, compatible handheld devices and training/induction sessions for staff. The COVID-19 pandemic had expedited the shift to digital BNF/BNFc usage in some settings. A strong driver of digital usage was the desire by staff to use the most up-to-date information. Reduced access to print copies was a common initial driver of digital usage, whilst ease of searching and speed of access often acted to consolidate digital usage. Important resisting forces included lack of supporting organisational digital infrastructure and an onus on individuals to obtain access to digital platforms, particularly through personal smartphones. Poor prior experience of earlier digital BNF/BNFc platforms had also prevented participants from using them again. Conclusions: More driving than resisting forces were identified and, in most settings, a transition to digital BNF/BNFc usage is underway, which has been expedited by the COVID-19 pandemic. However, this is not happening uniformly across the NHS and there continue to be strong resisting forces to digital BNF/BNFc usage, particularly at organisational level. Public interest summary: The British National Formulary (BNF) and British National Formulary for Children (BNFc) provide information about all medicines prescribed in the UK. They are available as a book, a website and an app. As healthcare information becomes increasingly digital, it is important to understand how this is used by healthcare staff and we spoke to doctors, nurses and pharmacists about how they use the BNF/BNFc. We found that staff are increasingly using the digital BNF/BNFc and that the COVID-19 pandemic has speeded up this transition. Staff are likely to use the digital BNF/BNFc where their organisation makes it easy to do so, such as through access to IT equipment and electronic prescribing systems. However, many NHS organisations lack the facilities for widespread digital usage and staff are not routinely trained in using digital resources. Future efforts should focus on the digital technology itself, and on upskilling healthcare staff to use it.

Obat Off-label pada Pasien Pediatri Rawat Jalan: Penelitian Observasi Retrospektif di RSUD Dr. H. Abdul Moeloek Lampung

Several medications are prescribed for infants and children, but adequate information about these drugs are unavailable. Previous studies also revealed that the use of off-label drug is prevalent among pediatric outpatients. Therefore, this study aimed to determine the prevalence of off-label drug use in pediatric outpatients at Dr. H. Abdul Moeloek Lampung Hospital from January–June 2019. This observational descriptive was conducted using simple random and retrospective sampling methods. Drugs were identified using a brochure, British National Formulary for Children (BNF), and Specialist Health Science Formulary from the Indonesian Pediatrician Association (IDAI), followed by classification with the Anatomical Therapeutical Chemical (ATC). The results showed that there were 120 samples, of which 56% are males, while 42% are within the age range of 6–12 years. The most common diagnoses were SNRS, followed by epilepsy and anemia. A total of 393 drugs were used in this study and analgesic-antipyretic was the most prescribed. The prevalence of off-label drug usage in pediatric patients was 19.6%, where the off-label age was higher (16.29%) than indication (2,81%) and doses (0,5). Furthermore, most of these medications were for the cardiovascular, respiratory, digestive, and metabolic systems. There has been a 19,6% prevalence in the use of off-label drug among pediatric outpatients, where off-label age was the highest, and most of the medication are used for the treatment of the cardiovascular system.

Педіатрична клініка Одеського національного медичного університету: якість невідкладної медичної допомоги дітям

Мета роботи — обговорити питання підвищення якості невідкладної допомоги дітям при найбільш поширених захворюваннях. Матеріали та методи. Якість медичної допомоги включає 6 показників: ефективність, обґрунтованість, економічна доступність, прийнятність/зосередженість на пацієнта, рівність, безпека. Результати. У педіатричній клініці Одеського національного медичного університету (ОНМедУ) створений блок інтенсивного спостереження, основним завданням якого є надання невідкладної допомоги дітям, які потребують моніторингу дихання та серцевої діяльності, проведення кисневої терапії та регідратаційної терапії великого об’єму. У клініці діє система сортування пацієнтів за тяжкістю стану з урахуванням даних обстеження і пульсоксиметрії. Запорукою ефективності медичної допомоги є локальні протоколи, розроблені на принципах доказової медицини; всі ліки, включені в них, входять у Лист необхідних ліків Всесвітньої організації охорони здоров’я. Прийнятність медичної допомоги визначають пацієнторієнтовані технології: спільне перебування матері та дитини; перевага надається оральній регідратації, а не внутрішньовенному введенню рідини; мінімізація болю і відмова від внутрішньом’язових ін’єкцій; зволоження повітря навколо пацієнта та ін. Середня тривалість перебування у блоці інтенсивного спостереження — 2 дні. Культура безпеки пацієнтів є пріоритетом і включає в себе: зміну ставлення співробітників до медичної безпеки; виявлення тригерів і ризиків медичної допомоги; виявлення медичних помилок і промахів; використання безпечних технологій і простих алгоритмів дій; навчання медичного персоналу. Було проведено більше 40 лекцій і практичних занять для медичного персоналу, включаючи тренінги на манекенах Code Blue. Висновки. Заходи, спрямовані на підвищення якості невідкладної медичної допомоги дітям в педіатричній клініці ОНМедУ, включають: 1) організацію блоку інтенсивного спостереження і його оснащення сучасним обладнанням для діагностики та лікування дітей; 2) сортування пацієнтів за тяжкістю стану за об’єктивними критеріями; 3) скорочення термінів госпіталізації; 4) стандартизацію медичної допомоги шляхом розробки локальних протоколів на принципах доказової медицини; 5) підвищення прийнятності медичного обслуговування за рахунок впровадження технологій, орієнтованих на пацієнта; 6) впровадження культури безпеки пацієнта; 7) постійне навчання медичного персоналу.

Can parents believe websites’ information about methylphenidate’s side effects?

BackgroundAttention deficit and hyperactivity disorder (ADHD) is one of the most common behavioural disorders, affecting around 5% of the global population. Methylphenidate is recommended as the first-line drug treatment for...

Outcomes of ondansetron use in children with gastroenteritis in the emergency department: a literature review.

In the UK, the use of antiemetics in children with gastroenteritis is not standardised. The antiemetic ondansetron is often administered, in clinical practice, to children presenting with gastroenteritis. However, it is not listed in the British National Formulary for Children for use in gastroenteritis and it is not included in the National Institute for Health and Care Excellence algorithm for the management of gastroenteritis in children under 5 years. This article discusses the findings of a literature review of the outcomes of ondansetron use in children with gastroenteritis in the emergency department. The article concludes that ondansetron appears to be a beneficial and useful adjunct to the treatment of gastroenteritis in children.

Population Pharmacokinetics and Dosing Optimization of Amoxicillin in Chinese Infants.

Amoxicillin is used to treat various bacterial infections (eg, pneumonia, sepsis, meningitis) in infants. Despite its frequent use, there is a lack of population pharmacokinetic studies in infants, resulting in a substantial variability in dosing regimens used in clinical practice. Therefore, the objective of this study was to evaluate the population pharmacokinetics of intravenous amoxicillin in infants and suggest an optimal dosage regimen. Blood samples were collected for the determination of amoxicillin concentrations using an opportunistic sampling strategy. The amoxicillin plasma concentrations were determined using high-performance liquid chromatography. Population pharmacokinetic analysis was performed using NONMEM. A total of 62 pharmacokinetic samples from 47 infants (age range, 0.09 to 2.0 years) were available for analysis. A 2-compartment model with first-order elimination was most suitable to describe the population pharmacokinetics of amoxicillin, and covariate analysis showed that only current body weight was a significant covariate. Monte Carlo simulation demonstrated that the currently used dosage regimen (25mg/kg twice daily) resulted in only 22.4% of infants reaching their pharmacodynamic target, using a minimum inhibitory concentration (MIC) break point of 2mg/L, whereas a dosage regimen (60mg/kg thrice daily), as supported by the British National Formulary for Children, resulted in 80.9% of infants achieving their pharmacodynamic target. It is recommended to change antibiotics for infections caused by Escherichia coli (MIC= 8.0mg/L) because only 27.9% of infants reached target using 60mg/kg thrice daily.

Pediatric Antibiotic Pack Size Compliance With the Dosage Regimen: A Descriptive Study.

The unavailability of appropriate pediatric drug pack size is a global issue. Antibiotics are the lifesaving and most frequently prescribed therapeutic agents given to pediatrics. The objective of this study was to assess the compliance of pediatric antibiotic pack size with the standard dosage regimen. A descriptive study design was employed. Data were collected from a community pharmacy in Bahawalpur, Pakistan, between August 1, 2017, and September 30, 2017. Five most commonly prescribed antibiotics were selected and calculations were made to check the appropriateness of packaging size by comparing the quantity of product in the available pack with the dosage regimen recommended by the British National Formulary for Children (BNFC). Only 16 clarithromycin, 9 amoxicillin, 1 cefotaxime, and 1 metronidazole packaging sizes were sufficient to meet the dosage regimen for treatment. None of the available pack sizes for gentamicin matched the recommended duration of treatment. The study findings revealed that the available pack sizes either had leftover or a shortfall of antibiotic formulation. Highly inappropriate dosage forms (containing either excess and less quantity) of antibiotics were intravenous infusions and oral suspensions. The study concluded that the packaging sizes of antibiotics failed to supply the recommended dosage regimen to pediatrics for common indications. This may contribute to development of antibiotic resistance among pediatric patients. Health policy makers should devise strict rules and regulations to ensure the availability of child-specific antibiotic pack sizes.

Pediatric Antibiotic Pack Size Compliance With the Dosage Regimen: A Descriptive Study.

The unavailability of appropriate pediatric drug pack size is a global issue. Antibiotics are the lifesaving and most frequently prescribed therapeutic agents given to pediatrics. The objective of this study was to assess the compliance of pediatric antibiotic pack size with the standard dosage regimen. A descriptive study design was employed. Data were collected from a community pharmacy in Bahawalpur, Pakistan, between August 1, 2017, and September 30, 2017. Five most commonly prescribed antibiotics were selected and calculations were made to check the appropriateness of packaging size by comparing the quantity of product in the available pack with the dosage regimen recommended by the British National Formulary for Children (BNFC). Only 16 clarithromycin, 9 amoxicillin, 1 cefotaxime, and 1 metronidazole packaging sizes were sufficient to meet the dosage regimen for treatment. None of the available pack sizes for gentamicin matched the recommended duration of treatment. The study findings revealed that the available pack sizes either had leftover or a shortfall of antibiotic formulation. Highly inappropriate dosage forms (containing either excess and less quantity) of antibiotics were intravenous infusions and oral suspensions. The study concluded that the packaging sizes of antibiotics failed to supply the recommended dosage regimen to pediatrics for common indications. This may contribute to development of antibiotic resistance among pediatric patients. Health policy makers should devise strict rules and regulations to ensure the availability of child-specific antibiotic pack sizes.

Modifying a Paediatric Rational Prescribing Tool (POPI) for Use in the UK.

Rational prescribing tools can be used by individual prescribers, organisations, and researchers to evaluate the quality of prescribing for research and quality improvement purposes. A literature search showed that there is only one tool for evaluating rational prescribing for paediatric patients in hospital and outpatient settings. The Pediatrics: Omission of Prescriptions and Inappropriate Prescriptions (POPI) tool was developed in France and comprises 105 criteria. The aim of this study was to modify this tool to facilitate its use in paediatric practice in the United Kingdom (UK). POPI criteria were compared to relevant UK clinical guidelines from the National Institute for Health and Care Excellence, the Scottish Intercollegiate Guideline Network and the British National Formulary for Children. Where guidelines differed, criteria were modified to reflect UK guidance. If there were no relevant guidelines or directly contradictory guidelines, criteria were removed. Overall, no change was made to 49 criteria. There were 29 modified to concord with UK guidelines. Four criteria were reduced to two criteria due to being linked in single guidelines. Twenty-three criteria were omitted, due to the absence of relevant UK guidance or directly conflicting UK practice, including one entire clinical category (mosquitos). One category title was amended to parallel UK terminology. The modified POPI (UK) tool comprises of eighty criteria and is the first rational prescribing tool for the evaluation of prescribing for children in hospital and outpatient settings in the UK.

The practice of off label prescribing and associated adverse drug reactions in pediatric inpatients in a tertiary care hospital in India

Abstract Objectives To assess the extent of use, patterns, variables and Adverse Drug Reactions associated with off label prescribing in Pediatrics. Methods A prospective observational study was conducted for a period of 6 months for children of the age group 0-17 years in a tertiary care Hospital in Maharashtra, India. Off label drug use was assessed using Micromedex and British National Formulary for Children (BNFC 2016–2017). Adverse Drug Reactions (ADRs) were assessed according to the physicians' notes, recorded during the patient's hospital stay. Pearson correlation coefficient was computed to assess the relationship between age and the number of off-label drugs. Odds ratio was calculated for the occurrence of ADRs in on-label prescriptions Vs off label-prescriptions. A P value of <0.05 was considered as significant. Key findings A total of 1514 prescriptions were evaluated in 300 patients. Out of which 542 (35.79%) and 423 (27.9%) were off label according to Micromedex and BNFC respectively. The number of patients who received at least one off label was found to be 225 (75%) – Micromedex and 223 (74.3%) – BNFC Unspecified indication and use of drugs outside the specified age limit were identified as the main variables associated with off label prescribing. Highest proportion of off-label drugs was found in Alimentary system. A total of 35 ADRs (OR 6.92 CI 95%(OR 6.92, 95% CI, 3.13-15.27)) were identified in 31 patients. Conclusions Off-label drug use is prevalent in the pediatric population and warrants an evidence-based approach to improve prescribing practices in pediatrics.

Off-Label Prescribing in Pediatric Inpatients With Pneumonia in a Children's Hospitaal

Off-label is a term used in which a drug prescribed outside the official information of the marketing authorization. Off-label prescribing may occur as the result of several factors including lack of clinical trials data involving pediatrics and suitable formulations for medicines commonly prescribed to this fragile population. Objective: This study aimed to estimate the nature and prevalence of off-label prescribing in pediatric inpatients with pneumonia. Material and Methods: a retrospective study was conducted in a study hospital using medical records from pediatric inpatients with pneumonia during the period of January-December 2015. Patient and prescribing data were collected, and drugs were classified as on-label or off-label based on the Indonesia National Drug Information (IONI) and British National Formulary for Children (BNFC). Thereafter, off-label drugs were categorized with a hierarchical system of age, indication, route of administration and dosage. Results: There were 1141 drugs with 77 different types of drug were administered to 207 patient during the study period. The data uncovered that 405 (35,5%) of the drug prescriptions were used off-label based on IONI, and 319 (28%) of the drug were used off-label based on BNFC. Based on IONI and BNFC, most off-label drugs were from anti infection drugs. Conclusion: The prevalence of off-label use in pediatric inpatients with pneumonia is not high. The off-label prescribing may not be necessarily be considered irrational, yet this fact reveals that the use of drugs does not comply with the drug label. Clinical trials for pediatric drugs are essential to provide complete product information for pediatric use.

Antibiotic Use in a Cohort of Extremely Low Birth Weight Neonates: Focus on Off-Label Uses and Prescription Behaviour

Aim: To analyse antibiotic prescriptions in a cohort of extremely low birth weight neonates admitted to Italian level III Neonatal intensive Care Units. Methods: An online questionnaire was used to collect detailed information for each newborn. Antibiotic prescriptions were classified about their license status and compared with British National Formulary for Children (BNFC) and with a practical guide prepared by the Italian Society of Neonatology (ISN). Results: During the study period (May-July 2014) among 93 neonates admitted to 30 Italian Neonatal intensive Care Units, 56 (60%) received at least an antibiotic (92 prescriptions in total). Ampicillin, gentamicin and vancomycin were the antibiotics most commonly used for the prevention/treatment of bacterial infections. 56/92 antibiotic prescriptions (61%) resulted off-label mainly as regards dosing frequency, while 13 prescriptions (14%) regarded antibiotics used in absence of specific indication for newborns (meropenem, imipenem, piperacillin/tazobactam, clindamycin, clarithromycin). 50/56 neonates (89.3%) received at least one off-label antibiotic prescription. Differences have been observed in dosing regimens between current study and recommendations contained in BNFC, while prescriptions adhered more frequently to ISN indications. Conclusions: Our results confirm the high prevalence of off-label antibiotic use in ELBW neonates and underline a better adherence to indications based on clinical practice.

A survey of caregivers of Nigerian children less than 6 years of age to determine the experience and perception of acceptability of oral solid dosage forms

ObjectivesThe World Health Organization (WHO) recommends flexible solid oral dosage forms such as dispersible tablet as the preferred formulation for (young) children, especially in developing/low- and middle-income countries, LMIC. The aim of this study was to assess experience, perceptions of acceptability, and formulation preferences, among 10 oral dosage forms for young children in a sample of end-users in Nigeria as an exemplar LMIC. MethodsUsing a semi-structured and validated questionnaire, 148 caregivers were surveyed. Acceptability was assessed by level of liking using a 3-point Likert scale and ease of administration. Preference was assessed from participants’ dosage form of choice. Oral dosage forms assessed were those mentioned in the British National Formulary for children, 2013. ResultsThe formulation perceived as the most acceptable was the chewable/suckable tablet. However, preference was for liquids. Specifically with the dispersible tablet, whilst 89% (n=111) of caregivers of young children found it easy-to-administer, only 50% of children liked it. ConclusionThere is a gap between the proposal of dispersible tablet as the preferred dosage form for young children and caregivers’ perceptions of acceptability and preference. Educational strategies to increase acceptability of dispersible tablets as the preferred formulation for young children would be required.

PP-37 Developing paediatric antimicrobial doses for the new zealand formulary for children

Background Many antimicrobial medications for chil-dren are used outside of the product license and prescrib-ers encounter a lack of evidence-based dosing guidance. The New Zealand Formulary for Children (NZFC) devel-oped a process to provide antimicrobial guidance based on the best available evidence from regulatory data, pro-fessional guidelines, clinical experience and clinical con-sensus. Methods Indications and doses for antimicrobial med-ications in the NZFC were originally derived from the British National Formulary for Children (BNFC). A clinical advisory group (CAG) from New Zealand’s national paedi-atric hospital was recruited to provide guidance relating to NZFC antimicrobial monographs. The CAG consisted of two paediatric infectious disease physicians and an antimicrobial stewardship pharmacist. The CAG identified monographs requiring review, and proposed changes to make theses more suited to New Zealand practice. NZFC clinical editors then compared the proposed alterations against the New Zealand approved medicine datasheet (NZAMD). If these did not agree, comparison with rep-utable resources such as New Zealand guidelines, in-ternational guidelines, and recognised references used in the clinical field. When supporting evidence was not available, the clinical editors sought further input from the CAG. Any indications and/or doses differing from the NZAMD were identified in the NZFC monographs. Results A total of 119 antimicrobial medications in the NZFC were identified as requiring review. Following re-view, 77 (65%) medications had indication and/or dosing information as unlicensed/unapproved. Of these 35 had no corresponding NZAMD information, 20 recommend-ed doses outside the NZAMD age ranges, 15 included indications not stated in the NZMAD, 5 with dosing dif-ferent to that in the NZAMD and 5 with an unapproved administration route Conclusion For a national formulary to be able to pro-vide suitable antimicrobial dosing in children, collabora-tion with national experts is essential. Validating dosing against reputable resources is an important step when providing unlicensed dosing to a recognised standard.

Did the accuracy of oral amoxicillin dosing of children improve after British National Formulary dose revisions in 2014? National cross-sectional survey in England

ObjectivesInaccurate antibiotic dosing can lead to treatment failure, fuel antimicrobial resistance and increase side effects. The British National Formulary for Children (BNFC) guidance recommends oral antibiotic dosing according to age...

Off-label prescribing for children with chronic diseases in Nigeria; findings and implications

ABSTRACTBackground: Prescribing medicines in an off-label manner for children with chronic conditions is sparsely documented, even more so among developing countries. This needs addressing. The objective of this research was to investigate the extent of off-label prescribing among children with epilepsy, asthma, and sickle cell anaemia in Nigeria.Methods: Prescriptions for children ≤16 years documented in their case files that attended paediatric clinics in Lagos, Nigeria, for these three conditions between January and October 2015, were reviewed retrospectively to extract data on the medicines prescribed. British National Formulary for children and American Hospital Formulary Service Drug information were used as references.Results: 477 patients received 1746 prescriptions. Off-label prescriptions were seen in 7.7% of prescriptions, related to dose (93; 68.9%), indication (22; 16.3%), and age (20; 14.8%). Nervous system (525; 30.1%) and anti-infective (441; 25.2%) medicines were the most prescribed but only 9.5% and 8.2% of the respective prescriptions were off-label. Children with epilepsy received the most number (94; 69.6%) of off-label prescriptions. The three chronic conditions did not associate significantly with the category of off-label medicine prescribed (p = 0.925).Conclusion: Off-label prescribing for children with epilepsy, asthma and sickle cell anaemia occurs. Encouragingly, the overall rate appears low in Nigeria.

Safe prescribing for children

Nurse PrescribingVol. 15, No. 1 Calculation SkillsSafe prescribing for childrenAlison EggletonAlison EggletonSearch for more papers by this authorAlison EggletonPublished Online:12 Jan 2017https://doi.org/10.12968/npre.2017.15.1.13AboutSectionsView articleView Full TextPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareShare onFacebookTwitterLinked InEmail View article References National Patient Safety Agency (2009) Review of patient safety for children and young people. www.nrls.npsa.nhs.uk/resources/?entryid45=59864 (accessed 6 December 2016) Google ScholarInstitute for Safe Medication Practices (2015) Results of pediatric medication safety survey (part 2) http://www.ismp.org/newsletters/nursing/issues/NurseAdviseERR201511.pdf (accessed 6 December 2016) Google ScholarPaediatric Formulary Committee (2016) British National Formulary for Children 2016-2017. BMJ Books/Pharmaceutical Press, London Google ScholarRoyal Cornwall Hospitals NHS Trust (2015) Paediatric Analgesia Guidelines v 4.0. http://www.rcht.nhs.uk/DocumentsLibrary/RoyalCornwallHospitalsTrust/Clinical/Paediatrics/AnalgesiaGuidelinesPaediatric.pdf (accessed 6 December 2016) Google Scholar FiguresReferencesRelatedDetails 2 January 2017Volume 15Issue 1ISSN (print): 1479-9189ISSN (online): 2052-2924 Metrics History Published online 12 January 2017 Published in print 2 January 2017 Information© MA Healthcare LimitedPDF download

A prospective observational study on the attitude and experience of community pharmacists towards off-label and unlicensed prescriptions for the pediatric population

Off-label is defined as any drug use outside the terms of product license; while the unlicensed use refers to using a drug in children when it has not received marketing authorization for use in them. The objective of the study was to determine the attitude and experience of community pharmacists towards off-label and unlicensed prescriptions for the pediatric population. This study was carried out as a prospective observational study for a period of six months at the community pharmacies in and around Chennai. Validated questionnaire to assess the attitude and experience of community pharmacists towards unlicensed and off-label prescriptions for the paediatric population was given to those community Pharmacists who have registered in the State Pharmacy Council as Pharmacist. Questionnaires issued were self administered by the community pharmacists and the answers recorded by them were collected and then assessed. Over 70% of respondents were familiar with the concept of off-label prescribing, primarily through dispensing experience rather than education. Over 60% of respondents had been asked by the public to sell paediatric over-the-counter medicines, such as antihistamines, analgesics and steroid preparations for off-label use. Most common off-label drug was paracetamol being 32% (BNFC) of all prescribed in this manner. Most common information sources was British national formulary for children (BNFC), Current index medical specialities(CIMS) and local formularies. The majority of respondents (74%) admitted to being familiar with the concept of off-label prescribing .The majority of respondents, 88% agreed or strongly agreed that the pharmacist has a responsibility to inform the prescriber that they are prescribing off-label medicines for children, and 32% unsure that pharmacist also has a responsibility to inform the parents that the medicines prescribed for their children are off-label. Dispensing labeled and licensed drugs in pediatric patients should be promoted among the community pharmacist as well as pediatricians in order to avoid exposing children to unnecessary risk. Participation in Continuing Medical Education should be encouraged among community pharmacist to keep their knowledge updated.