Unlicensed Drug Research Articles

Off‑label and unapproved pediatric drug utilization: A meta‑analysis.

Despite legislative enforcement on authorized drugs, off-label and unapproved pediatric drug use is prevalent. The present study aimed to assess the global prevalence of off-label and unlicensed prescriptions among hospitalized children via meta-analysis. A comprehensive examination of articles published between 1990 and 2023 from the PubMed, Scopus, Excerpta Medica Database, Web of Science and Google Scholar databases was conducted. Key word-based advanced searches were executed using the aforementioned databases. A total of 45 studies that reported the prescriptions of off-label and unlicensed drugs to pediatric patients were included. The global prevalence of off-label and unlicensed drug prescriptions to children in pediatrics or neonatal departments was 56%. Patient sample sizes varied from 40-13,426, with a range of 240-8,891 total prescriptions issued. Of the 45 studies examined, 22 studies originated from Europe, 13 from Asia, 3 from South America, 3 from Africa, and 2 each from North America and Australia. Africa had the highest prevalence rate at 66%, followed by Asia, South America, North America, Australia and Europe. The present meta-analysis demonstrated that the prevalence of off-label and unlicensed drug prescriptions given to pediatric patients was notably high and geographically diverse. Therefore, drug authorities should standardize pediatric prescription practices in future.

Younger Children with Respiratory Tract Infections Are More Exposed to Off-Label Treatments: An Exploratory Retrospective Study in a Pediatric Emergency Setting.

We performed a retrospective data analysis. All patients aged 0-18 referred to PED from 1 September to 1 October 2022, were included. Further analysis was performed when respiratory tract infections were diagnosed. gender, age, triage group, chronic diseases, vital signs, and PED-prescribed treatment (medications, dosages, methods of administration). Statistical analysis used SPSS 28.0, with significance at p < 0.05. Data from 473 patients were analyzed, median age 3.5 years. Chronic diseases were present in 17.1% of children. 387 medications were prescribed, 47.5% being off-label. Off-label treatment was common for external otitis, acute laryngitis, and acute bronchitis (p < 0.001). There was incorrect administration of tobramycin with dexamethasone for otitis (n = 16, 100%) and inappropriate use of salbutamol inhalations by age (34.8%, n = 16). Some medications were given orally instead of injections (ondansetron n = 5, 62.5%; dexamethasone n = 82, 98.7%) or intranasally instead of intravenously (IV) (midazolam n = 7, 87.5%). IV adrenalin was prescribed for inhalations (n = 46). Younger children were more likely to receive off-label treatment (p < 0.001). Our study highlights the widespread issue of off-label and unlicensed drug prescribing in pediatric emergency care. Further research is necessary, because this reliance on off-label prescribing raises concerns about patient safety and compliance, especially given the limited clinical trials and therapeutic options available.

Medicines management in children and young people: pharmacokinetics, drug calculations and off-label drug use.

Medicines management in children and young people presents specific challenges because children differ from adults in their response to medicines. The way in which medicines work inside the human body, or pharmacokinetics, varies according to age and stage of development. Accurate drug calculations for a child rely on the careful consideration of a series of factors, such as weight and height, pharmacokinetics and drug characteristics. This article focuses on three fundamental aspects: pharmacokinetics, drug calculations, and unlicensed and off-label drug use.

Observational Study for Clinical Trials Participation in Malaysia

Introduction: This observational study was conducted to assess the knowledge, attitudes, and perceptions (KAP) of Malaysians toward participating in clinical trials. It also aimed to look for factors that will influence people’s willingness to participate in trials. We planned and developed future outreach, education tools, and recruitment strategies to increase clinical trial enrolment. Methods: A cross-sectional study was carried out on a randomly selected sample of 398 Malaysian literate adults. An online questionnaire was created and distributed to the respondents. Descriptive statistics were presented in the form of frequency and percentages. The chi-square test was employed to find the association between independent variables. Results: The majority had good knowledge (61.3%) and high awareness (88.7%) of clinical trials. However, most of them were not willing to take part in a clinical trial if they were assigned to a group of unlicensed drugs (90.2%) or randomly assigned (66.1%). The main reasons for participating in trials were recommendations from doctors (46.5%) and the potential for their own benefit (45.7%). Younger age was positively associated with the necessity and confidentiality of clinical trials. Most respondents indicated negative perceptions towards the safety of clinical trials regardless of demographic variables. Conclusion: We gained a better understanding of Malaysian people who are potential participants in a future clinical trial. These findings could help clinical researchers improve their understanding of the participants and develop effective outreach strategies for clinical trial recruitment and retention.

Access to innovative therapies in pediatric oncology: Report of the nationwide experience in Canada.

The need for new therapies to improve survival and outcomes in pediatric oncology along with the lack of approval and accessible clinical trials has led to "out-of-trial" use of innovative therapies. We conducted a retrospective analysis of requests for innovative anticancer therapy in Canadian pediatric oncology tertiary centers for patients less than 30 years old between 2013 and 2020. Innovative therapies were defined as cancer-directed drugs used (a) off-label, (b) unlicensed drugs being used outside the context of a clinical trial, or (c) approved drugs with limited evidence in pediatrics. We excluded cytotoxic chemotherapy, cellular products, and cytokines. We retrieved data on 352 innovative therapy drug requests. Underlying diagnosis was primary CNS tumor 31%; extracranial solid tumor 37%, leukemia/lymphoma 22%, LCH 2%, and plexiform neurofibroma 6%. RAS/MAP kinase pathway inhibitors were the most frequently requested innovative therapies in 28% of all requests followed by multi-targeted tyrosine kinase inhibitors (17%), inhibitors of the PIK3CA-mTOR-AKT pathway (8%), immune checkpoints inhibitors (8%), and antibody drug conjugates (8%). In 112 out of 352 requests, innovative therapies were used in combination with another anticancer agent. 48% of requests were motivated by the presence of an actionable molecular target. Compassionate access accounted for 52% of all requests while public insurance was used in 27%. Mechanisms of funding varied between provinces. This real-world data collection illustrates an increasing use of "out-of-trial" innovative therapies in pediatric oncology. This new field of practice warrants further studies to understand the impact on patient trajectory and equity in access to innovative therapies.

Knowledge map of thrombopoietin receptor agonists: A bibliometric analysis

BackgroundThrombopoietin receptor agonists (TPO-RAs) have been widely used to treat thrombocytopenia, however, a scientometric profile of TPO-RAs research is lacking. Methods: This study uses VOSviewer, CiteSpace, and R software to provide an overview of current research, highlight study hotspots, and predict future research directions of TPO-RAs. Results: One thousand seven hundred and nineteen relevant studies from 1993 to 2022 with 43962 citations were identified from the Web of Science Core Collection. Over three decades, the USA has been leading TPO-RAs publications. Industries and academic institutions have been actively involved in TPO-RAs research, with funding provided by pharmaceutical companies and public funding bodies. The most productive and cited journals are British Journal of Hematology and Blood, respectively. When author keywords were categorised into three clusters, i.e., cluster 1 (immune thrombocytopenic purpura (ITP)), cluster 2 (avatrombopag, lusutrombopag, and thrombocytopenia), and cluster 3 (TPO-RAs for ITP and off-label drug use), ITP was found to be the current research hotspot, while oral TPO-RAs and licensed or unlicensed drug indications of thrombocytopenic diseases require further investigation. Conclusion: This study has generated the knowledge map of TPO-RAs, which provides a dynamic roadmap for future research in this field.

Microencapsulation Techniques in HIV Pediatric Formulations: Advances and Future Outlook.

The treatment of human immunodeficiency virus (HIV) in children has persistently been complex and tedious on a global scale. This is because adult and pediatric HIV treatments follow a similar therapeutic approach. Due to the dearth of clinically licensed pediatric antiretroviral drug (ARVD) therapy, children with HIV worldwide are prescribed unlicensed drugs each year. This has triggered likelihood of poor drug adherence, therapeutic failure, and even adverse reactions brought on by a variety of factors, including pill size and quantity, which is the main cause of swallowing difficulties, repeated administration of these various ARVDs, many of which have poor solubility and cause severe side effects in children, and unpalatability of the drug, which is one of the criteria for pediatric formulations. Thus, there is a necessity for investigation into several advanced microencapsulation techniques that could curb these challenges. Microencapsulation techniques have explored in drug delivery for encapsulation and manufacture of different nanoparticles that have shown significant potential in mitigating and surmounting different constraints, such as taste masking, enhanced drug solubility and bioavailability, and production of micronized fine powders for treatment of varying diseases. Nevertheless, the usage of these technologies in HIV pediatric formulations has garnered relatively little attention. Thus, this review has paid a keen interest in examining several microencapsulation strategies for potential utilization in the development of HIV pediatric formulations.

Off-label and unlicensed drug use in a Spanish Neonatal Intensive Care Unit

ObjetiveTo describe off-label and unlicensed drugs in clinical practice in a Neonatal Intensive Care Unit (NICU). MethodThe design of the study was a descriptive and retrospective three months research in a NICU of a Spanish University Hospital. All prescriptions were classified as approved, off-label and unlicensed drug used, according to the information available on the Summary of Product Characteristics. Off-label drugs prescriptions were divided into four groups (dose, frecuency, age and indication of use) depending on the reason of disconformity. ResultsForty-one neonates were included (46.3% premature patients) and a total of 273 drug prescriptions were evaluated. Of them, 53.1% (145) were classified as an approved drug prescriptions, 41.4% (113) were off-label use and 5.5% (15) were unlicensed drugs. 90.2% of the patients (37/41) received at least one off label prescription, with a median of 3 (range 1-7). Age was the foremost reason for off-label use (42.5%), followed by dose (31.0%), frecuency (16.8%) and dose-frecuency off-label drug use (8.8%). The last place was reserved for off-label drug use by indication (0.9%). Group J (corresponding with antiinfectives for systemic use) was the most frecuently prescribed, with ampicillin (18.6%) and gentamicin (16.8%) as the drugs most commonly use as off-label prescriptions. Finally, caffeine citrate was the unlicensed drug most frecuently prescribed. ConclusionsOff-label and unlicensed drug use prescriptions in our NICU clinical practice are highly frecuent as other authors have previously published in other countries where they were studied. Although there are few studies in newborn patients, both off-label and unlicensed drug prescriptions are commonly recomended in Paediatrics Guidelines.

Unlicensed drugs in Iceland in the years 2020 and 2021 with comparison to Sweden in 2020

Prescriptions of unlicensed drugs along with public discussion have increased in recent years. The cause of this increase is unclear. This is a retrospective descriptive study of applications of unlicensed drugs in Iceland in the years 2020 and 2021, as well as applications in Sweden for the year 2020. Information was collected on unlicensed prescription applications, registered drugs and stock-out time. Information was analyzed and categorized to describe the scope of unlicensed prescriptions in the two countries during the study time. In Iceland, 49.161 applications were approved in 2020 and 46.581 in 2021. The most common reason for using unlicensed products was that no registered drug was on the market with the same ATC-number (Anatomical Therapeutic Chemical code) and formulation. Shortage of drug was the reason for unlicensed prescription in 8.8% of cases in 2020 and 7.6% in 2021. The list of the 50 most prescribed drugs included the same drugs in 70% of the cases in both years. The five most prescribed drugs were the same in both years. In Sweden, 38.458 applications were approved in 2020. Of the most prescribed unlicensed drug, 46% were as no registered drug with same ATC-number and dosage form was marketed. Many unlicensed drugs, prescribed in Iceland, are the same year after year. Only a small part of the applications approved were due to shortage of drug. The use of drugs without marketing license in Iceland in 2020 was higher than in Sweden when adjusted for the size of the market and population. Getting the five most prescribed unlicensed drugs licensed in Iceland could reduce largely, the total of prescription of unlicensed drugs in Iceland.

Real-world treatment outcomes of medicines used in special situations (off-label and compassionate use) in oncology and hematology: A retrospective study from a comprehensive cancer institution.

Medicines in special situations (MSS) refer to off-label or to unlicensed drugs under investigation (compassionate use). Our objectives were to evaluate characteristics and to estimate overall survival (OS), event-free survival (EFS), and the duration of treatment (DT) of MSS used for cancer treatment at a multicentre comprehensive cancer institution. Retrospective cohort study on adult cancer patients for whom an MSS treatment was requested (January 2011-December 2020). A descriptive analysis was performed and median OS and EFS and 95% confidence intervals (CIs) were estimated. Survival curves were stratified by type of tumor, ECOG (Eastern Cooperative Oncology Group) performance status (PS), age, sex, treatment stage and type of drug (mechanism of action and target). Treatment was initiated in 2092 episodes (1930 patients) out of 2377 MSS episodes (2189 patients) requested, 33% for hematological treatment and 87% for advanced stage cancer. Median OS (months) was 21.1 (95% CI 19.4-22.7), median EFS was 5.6 (95% CI 5.1-6.0) months, and median DT was 4.5 [0.0; 115.3] months. OS and EFS statistically significantly favored female patients, ECOG PS ≥2 episodes showed worse OS and EFS outcomes (p < 0.0001). Statistically significant differences in survival were found within solid and hematological cancer, disease stage, drug mechanism of action, and type of cancer (p < 0.001) but not for age. Survival outcomes by tumor subtype and drug are presented both globally and separately based on disease stage. MSS uses are practiced across almost all cancer types, mostly for advanced disease. ECOG PS ≥2, along with advanced disease, was related to worse survival. Information about real-world outcomes is valuable and contributes to better decision-making regarding MSS and our experience in this field could be of interest for other colleagues.

Problems of Falsification of Medicinal products in the conditions of the COVID-19 Pandemic: Adaptation of Ukrainian legislation to the norms of the European Union

The problem of distribution of low-quality medicinal products in Ukraine has become especially relevant against the background of the spread of the COVID-19 pandemic. The challenge to the national medical system became more tangible, as the fight against the virus and quarantine restrictions became heavy psychological blows for patients who sought appropriate treatment in an unofficial way. The purpose of the article is to analyze the problem of falsification of medicines in the conditions of a pandemic and to develop development models against the background of the study of European legislative norms. General scientific methods (synthesis, analysis, induction and deduction) became the main methods for writing the article. The methods of content analysis, systematic review of scientific literature, SMART and FINER principles were also used. The results highlighted one of the most important problems of the distribution of falsified and unlicensed drugs during the spread of COVID-19 - the semi-legal activity of pharmacies that work exclusively in the field of online sales. The requirements for their activities are quite loyal, and the distribution of low-quality or uncertified medicinal products is punished only administratively. The possibility of using European (primarily German) experience to counter the distribution of falsified medicines was discussed. Attention was also drawn to the geopolitical factor in the fight against COVID-19 – the use of the Russian vaccine “SPUTNIK V”, which in the conditions of Russian aggression can be assessed as a hybrid threat. The problematic nature of using this vaccine has been demonstrated, given the secrecy of the mechanism of conducting experiments. Resolutions of the European regulatory bodies allowed Ukrainian doctors not to use this vaccine either. This episode can be considered a positive moment of using European experience to establish medical rules for work in Ukraine. The conclusions note the need to reform Ukrainian legislation, take into account the European experience and harmonize with European regulations on the circulation of medical drugs. Such a step will make it possible to face modern challenges and significantly complicate the entry of counterfeit medicines into Ukraine.

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.

SP3 Optimising prescribing of medicines to children by formulary interface pharmacists

ContextUnlicensed and off label drug use in children is common and leads to well recognised problems. It has been shown that there is an association between unlicensed drug use in children and particularly neonates, and increased risks of medication errors, due to prescribing, dispensing and administration.1Alongside this, the variation in strengths of oral liquid products, adds to the potential for harm to be caused to children due to a lack of awareness and education on these issues.Quality improvement initiativeA UK CCG funded two specialist paediatric pharmacist posts with the aim of rationalising, standardising, and optimising the prescribing of unlicensed medicines to children. The aim was that these pharmacists would create an interface link between primary and secondary care, to empower healthcare professionals to prescribe and supply medicines to children safely and effectively.Work undertaken ePACT2 prescribing data highlighting variation in strength, formulation and cost of unlicensed medicines supplied; feedback from colleagues across all sectors of healthcare; NPPG position statements and MHRA alerts were used to identify areas to focus interventions. Examples of the work undertaken includes:Led webinars on prescribing medicines to children to healthcare professionals across the CCGMet with ~70% of GP practices, either individually or as groups e.g. PCNs across the CCGInitiated standardisation of liquid strengths kept across 3 hospital trust and primary careIdentified areas for medication safety team work e.g. prescribing of multiple strengths of medicines to children, prescribing of alcohol–containing phenobarbital to childrenWorked with CCG Medication Safety Officers to provide a response, advice and information on MHRA alerts e.g. chloral hydrate prescribing to childrenWorked with medicines optimisation CCG teams on communication tools e.g. bulletinsCreated a paediatric guidelines and pathways section on the CCG webpageCreated a paediatric formulary pharmacist group with representatives across all 3 hospital trusts to meet monthly and foster collaborative working.Measure of improvementThrough regular feedback, meetings, and email communication it can be noted that the links between primary and secondary care have been strengthened. Praise has been received for the help and support provided and for the openness to amend and adjust work plans based on the priorities and needs of the CCG. Through monthly ePACT2 data in the form of excel specials dashboard the reduction in variation of strengths being supplied to children can be seen, with in most cases an accompanying reduction in spend.Lessons learnedAlthough much has been publicised on the importance of nationally standardising concentrations of liquid medicines2, this initiative has shown that there is still much work to be done. Dedicated pharmacists have been able to make progress in standardising the range of unlicensed medicines recommended in the local formulary and ensure that this is well communicated across both primary and secondary care. Interface links between care settings are vital if we are to achieve substantial harmonisation of medicines prescribed to children.ReferencesConroy S. Association between licence status and medication errors.Arch Dis Child2011;96:305-306.Rawlence E,et al. Is the provision of paediatric oral liquid unlicensed medicines safe?Arch Dis Child Educ Pract Ed.2018;103:310-3.

Prosecutor's Review of Unlicensed Drug Trafficking Prosecution

The purpose of this research is to know and analyze about what is the impact of drug users without a permit at the Bone Bolango State Attorney. The type of research used is empirical research, using data types consisting of primary data and secondary data. Data collection techniques were carried out using interviews, observation, and documentation techniques. The results of the study show that the prosecutor's considerations in imposing criminal charges against the perpetrators in drug distribution cases without a license include objective and subjective considerations. To achieve legal certainty and the purpose of sentencing the accused. The impact of drug distribution without a permit in the Bone Bolango Region is that it is very disturbing to the community and also endangers physical, mental, and social health conditions.

A Survey of Off-label and Unlicensed Antibiotic and Respiratory Medications Prescribed for Toddler Patients

Background: Many medications are unlicensed for use in toddlers and many drugs are prescribed as off-label in this age group. Different studies showed high prevalence of prescribing such medications in children. Prescribing off-labeled or unlicensed drugs can cause adverse drug events (ADEs) and harm to the patients. To evaluate the rate of off-label and unlicensed drugs prescribed for toddlers.&#x0D; Methods: Out-patient prescriptions within the electronic database from a main governmental health insurance company in Tehran, Iran were evaluated for off-label and unlicensed drugs in a two-month period (November-December 2019).&#x0D; Results: 5358 prescriptions for toddlers reached to the insurance database, of these, 461 prescriptions were randomly selected. Three hundred and fifty prescriptions contained antibiotics and/or respiratory medications, from them, 183 (52.3%) had at least one off-labeled or unlicensed medication.&#x0D; Conclusion: Our study showed high rates of off-label and/or unlicensed medication use in pediatric population.

Yurt Dışı İlaçlar Hakkında Hastaya Yeterli ve Güvenilir Bilgi Sağlanmamasının İlaç Güvenliği ve Etik Sorunlar Açısından Analizi: Nitel Araştırma

Objective: The Imported Medicine List was published for the first time on October 11, 2013 by the Ministry of Health of the Republic of Türkiye. The purpose of importing drugs from abroad is to supply the human medicinal products that are not licensed in our country and/or that are not available in the market for various reasons despite being licensed, on prescription for use in the diagnosis and treatment of diseases in emergencies. The aim of this qualitative research is to examine the information presented about these medicines on the imported medicine list and to evaluate the possible ethical problems that may be caused by insufficient information presentation. Material and Methods: The medicines on the 25/02/2022 Turkish Medicines and Medical Devices Agency imported medicine list were included in the analysis. First, between the dates 07-27 February 2022, it was determined whether these medicines had short product information and instructions for use on the Turkish Medicines and Medical Devices Agency website by searching for active substances. Then, all medicines were searched in the RxMediaPharma database by the active substance name, and those not found by this method were searched by the ATC code. Finally, the ethical implications of the issue were discussed and suggestions were presented. Results: The change in the number of active substances in the imported medicine list by years and the presence of generic and medicine-specific information in different Informed Consent Forms have been determined. The ambiguity of the criteria for keeping the unlicensed essential drugs used to meet the priority health needs of the population in the foreign-dependent list has been determined. Conclusion: The risks to patients' right to autonomy have been determined as the result of the lack of sufficient, adequate, and accurate information in the Informed Consent Forms carries risks for patients' rights to autonomy.

Prevalence of Poisoned Google Search Results of Erectile Dysfunction Medications Redirecting to Illegal Internet Pharmacies: Data Analysis Study.

Illegal online pharmacies function as affiliate networks, in which search engine results pages (SERPs) are poisoned by several links redirecting site visitors to unlicensed drug distribution pages upon clicking on the link of a legitimate, yet irrelevant domain. This unfair online marketing practice is commonly referred to as search redirection attack, a most frequently used technique in the online illegal pharmaceutical marketplace. This study is meant to describe the mechanism of search redirection attacks in Google search results in relation to erectile dysfunction medications in European countries and also to determine the local and global scales of this problem. The search engine query results regarding 4 erectile dysfunction medications were documented using Google. The search expressions were "active ingredient" and "buy" in the language of 12 European countries, including Hungary. The final destination website legitimacy was checked at LegitScript, and the estimated number of monthly unique visitors was obtained from SEMrush traffic analytics. Compromised links leading to international illegal medicinal product vendors via redirection were analyzed using Gephi graph visualization software. Compromised links redirecting to active online pharmacies were present in search query results of all evaluated countries. The prevalence was highest in Spain (62/160, 38.8%), Hungary (52/160, 32.5%), Italy (46/160, 28.8%), and France (37/160, 23.1%), whereas the lowest was in Finland (12/160, 7.5%), Croatia (10/160, 6.3%), and Bulgaria (2/160, 1.3%), as per data recorded in November 2020. A decrease in the number of compromised sites linking visitors to illegitimate medicine sellers was observed in the Hungarian data set between 2019 and 2021, from 41% (33/80) to 5% (4/80), respectively. Out of 1920 search results in the international sample, 380 (19.79%) search query results were compromised, with the majority (n=342, 90%) of links redirecting individuals to 73 international illegal medicinal product vendors. Most of these illegal online pharmacies (41/73, 56%) received only 1 or 2 compromised links, whereas the top 3 domains with the highest in-degree link value received more than one-third of all incoming links. Traffic analysis of 35 pharmacy specific domains, accessible via compromised links in search engine queries, showed a total of 473,118 unique visitors in November 2020. Although the number of compromised links in SERPs has shown a decreasing tendency in Hungary, an analysis of the European search query data set points to the global significance of search engine poisoning. Our research illustrates that search engine poisoning is a constant threat, as illegitimate affiliate networks continue to flourish while uncoordinated interventions by authorities and individual stakeholders remain insufficient. Ultimately, without a dedicated and comprehensive effort on the part of search engine providers for effectively monitoring and moderating SERPs, they may never be entirely free of compromised links leading to illegal online pharmacy networks.

PATTERN OF PRESCRIPTION AND UTILIZATION OF OFF-LABEL AND UNLICENSED DRUGS AMONG PEDIATRIC PATIENTS ATTENDING OUTPATIENTS DEPARTMENT OF TERTIARY CARE TEACHING HOSPITAL OF GUJARAT STATE

Objectives: To determine the pattern of prescription and utilization of off-label and unlicensed drugs among pediatric patients attending outpatients department of tertiary care teaching hospital of Gujarat state. Methods: A prospective study was conducted for 6 months among 140 pediatric patients attending outpatient department of Gujarat Medical Education and Research Society Medical College, Dharpur, Patan. The demographic details and complete prescription were noted in predesigned form. The off-label drugs were categorized by using National Formulary of India. Off-label drugs were classified by using Anatomical Therapeutic Chemical classification. Results: Out of 481 drugs prescribed, the pattern of distribution of off-label and unlicensed drugs were 215(44.7%) and 3(0.6%) respectively.Majority (n=151,70.2%) of off-label drugs prescribed among 1-12 years age group.Most of off-label drugs were prescribed for indication of respiratory system (68%). Conclusion: The findings of this study showed a high incidence of off-label prescribing mainly antibiotics for respiratory disease.

EXTENT AND PATTERN OF OFF-LABEL AND UNLICENSED DRUG UTILIZATION IN NEONATAL INTENSIVE CARE UNIT IN THE TERTIARY CARE TEACHING HOSPITAL

Background &amp; Objectives: Many drugs that are used to treat children have not undergone evaluation to assure acceptable standards for optimal dose, safety and efcacy. As a result, drugs that are used to treat children are either not licensed for use in pediatric patients (unlicensed) or prescribed outside the terms of the product license (off-label).The extent of off-label and unlicensed drug use in neonates is unknown. Hence the purpose of the study is to determine the extent and pattern of off-label and unlicensed use of drugs amongst neonates in neonatal intensive care unit of a tertiary care hospital. A prospective study was carried Materials and Methods: out on 69 patients admitted in a tertiary care hospital for the period of ve months. Demographic data and complete prescriptions were noted in predesigned case record form. The off-label drugs were categorized by using National Formulary of India. Off-label drugs were classied in regards to their indications by using Anatomical Therapeutic Chemical Classication. The frequency was measured in terms of percentage and multiple binary logistic regressions were used for selecting confounding factors. A Results: total of 329 drugs were prescribed out of which 183(55.6%) were off-label and 65(19.8%) were unlicensed remaining 81(24.6%) labelled drugs. Most off-label drugs were prescribed for indication of alimentary tract (93.6%) and anti-infective (38.6%). Signicant confounding factors for prescription of unlicensed drugs were single diagnosis (OR 0.20, P&lt;0.05) and hospital stay (OR 1.30, P&lt;0.05) Common reasons for off-label prescribing were dosage 52.4% and age 23.2%. There was a high extent of utilization of off-label and unlicensed drugs. Hence Conclusion: , national drug regulatory authorities need to review and revise existing guidelines for safe administration of such drugs.

An Overview of Off-Label Use of Humanized Monoclonal Antibodies in Paediatrics.

In recent years, off-label and unlicensed drug use has extensively developed in the paediatric population. For a long time, clinical trials in the paediatric population were considered complicated to perform because of ethical problems, causing frequent off-label use. Off-label drug use remains an important public health issue, especially for children with rare conditions or with diseases not responsive to conventional treatments. The present paper is a narrative review of the literature of off-label drug use in children. The aim of our study is to summarize the main works dealing with the off-label use of biological drugs in paediatrics. Further studies analyzing their efficacy, safety, and cost–benefit ratios are needed to extend the use of biological therapies to the paediatric population.