Off-Label Drug Use In Hospitalized Children: A Prospective Observational Study At Gondar University Referral Hospital, Northwestern Ethiopia

Tefera, YG; Gebresillassie, BM; Abebe, TB; Ab, Mekuria; Erku, Daniel Asfaw; Seid, N; Beshir, HB

doi:10.1016/j.jval.2017.08.685

Cited by 4 publications

(8 citation statements)

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“…Co-amoxiclav, ceftriaxone, and ciprofloxacin were frequently used as an off-label/unlicensed drug. This finding was different when compared to the other study conducted in Ethiopia which reported ceftriaxone, cloxacillin, and gentamicin as the commonly used offlabel antibiotic used [29]. Ciprofloxacin was frequently used as the off-label drug among neonates.…”

Section: Discussioncontrasting

confidence: 69%

“…Most of the drugs prescribed to pediatrics are utilized outside the specifications of licensed drug which include the indication, dose, route of administration, and age groups of patients [1][2][3][4]. Use of off-label/unlicensed drugs in the pediatric population is widespread that mainly occurs in medical and surgical wards as well as in intensive care units (ICUs) [2,5]. Use of off-label drugs gives rise to inconsiderable adverse drug event that requires hospitalization and additional therapies [6][7][8][9].…”

Section: Introductionmentioning

confidence: 99%

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Off-label antibiotic use in a specialized children care hospital in Punjab, Pakistan: Findings and implications

Hafeez

Saleem

Bukhari

et al. 2020

J Infect Dev Ctries

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Introduction: Most of the antibiotics currently used in pediatrics are either unlicensed or being prescribed outside the specifications of product label (off-label prescribing). The aim of this study was to assess the extent of off-label antibiotic use in pediatrics. Methodology: A six month longitudinal off-label antibiotic utilization survey was carried out from January to June, 2018. A structured questionnaire was designed to collect detailed information for each pediatric patient admitted to participating health center. The data included basic demographic and clinical diagnosis with details of prescribed antibiotics (formulation, dose, dosage, route of administration and indication for use). Data were analyzed using Social packages for Statistical Sciences (SPSS) version 21.0. Results: Of 1,810 admissions, 1,795 (99.2%) patients received antibiotics. Out of these, a total of 451 (25.1%) patients (326 patients admitted in the medical ward and 125 patients in ICUs) received at least one unlicensed/off-label antibiotic. Antibiotics were predominantly prescribed for the treatment of infections (n = 311, 69.0%). The majority of the pediatric patients who received off-label antibiotic suffered from respiratory tract infections (n = 223, 49.4%), skin and soft tissue infections (n = 53, 11.8%), gastrointestinal tract infections (n = 56, 12.4%) and other infections (n = 46, 10.2%). Co-amoxiclav (n = 190, 42.1%) was the most frequently off-label prescribed antibiotic to pediatric patients. An inappropriate dose for patients (n = 430, 95.3%) was the most frequent cause of prescribing off-label antibiotics. Conclusions: Further evaluation of health and economic outcomes of off-label prescribing and determinants influencing the drug choice is required.

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Section: Discussioncontrasting

confidence: 69%

Section: Introductionmentioning

confidence: 99%

Off-label antibiotic use in a specialized children care hospital in Punjab, Pakistan: Findings and implications

Hafeez

Saleem

Bukhari

et al. 2020

J Infect Dev Ctries

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“…10 Whereas the highest percentage (31.7% and 78.1%) was reported from Brazil and Ethiopia. 11,12 Although the majority of our practitioners irrespective of their status reported that 10% of their prescriptions to the children in the previous year were offlabel, 23% of our pediatricians reported that more than 26% of their prescriptions in the previous year were off-label in nature. A similar trend was observed in other studies within the country, of which 29.7% (173/583) and 12.9% (75/583) were classified as off-label and unlicensed drugs respectively.…”

Section: Discussionmentioning

confidence: 91%

“…It was observed that children at an age of 2-11 years old were routinely prescribed with off-label drugs (43%), which are in confirmation with previous studies from Ethiopia and Germany. 12,15 Irrespective of the age group of the children, pediatricians use off-label medications broadly, while specialists and general practitioners have limited the number of their off-label prescription in neonates and preterm (5%). The FDA policy undeniably declares the use of a pharmaceutical product once approved, for indications, dosages, routes, or age groups other than the approved on the label.…”

Section: Discussionmentioning

confidence: 99%

Off-label Medications Use in the Eastern Province of Saudi Arabia: The Views of General Practitioners, Pediatricians, and Other Specialists

et al. 2018

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Background: Off-label drug prescribing remains a major pediatric health concern worldwide. The lack of studies in this vulnerable population causes many practitioners to prescribe drugs outside their license. This study aims to investigate and compare the current knowledge and views of general practitioners, pediatricians, and other specialists toward off-label pediatric prescribing. Methods: A descriptive, cross-sectional–based study conducted on a random sample of physicians who work in three different hospitals in the Eastern Province of Saudi Arabia. Results: Data were obtained from three hospitals, comprising a total of 160 practitioners. Overall, more than half of the participated practitioners (54%) were familiar with the definition of off-label prescribing. Thirty percentage of participated practitioners agreed that more than 10% of their prescribed medicines to children were off-labeled. A majority of participants expressed concerns over the efficacy (83%) and safety (92%) of off-label prescribing to children. Importantly, a noticeable proportion of the responders claimed that they sometimes observed an adverse drug reaction (n = 23; 20%) or treatment failure (n = 43; 37%) following off-label prescribing medicines to children. Only 46% participants have always informed the parents or guardian about the off-label prescription of medications to their children. Conclusion: A Large number of physicians are familiar with the concept of off-label prescribing of medicines to children in the Eastern Province of Saudi Arabia. Safety and efficacy are the main concerns of prescribing such medications. Policies toward improving pediatric clinical research and supporting the safety and efficacy of the drugs should be encouraged.

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“…Sebagian besar anak-anak sering menderita infeksi saluran pernapasan akut (ISPA) hal ini karena sistem kekebalan tubuh anak belum berkembang sempurna, respon imunitas yang masih berkembang dan dilihat dari faktor lingkungan berupa gizi dan polusi udara dimana dalam kelompok usia yang tergolong masih anak-anak lebih bayak beraktivitas diluar rumah, lebih suka bermain ditempat kotor dan berdebu sehingga lebih rentan terhadap penyakit [5]. Demam tifoid da dehidrasi (kekurangan cairan) juga sering terjadi pada anak-anak [6], [7].…”

Section: Hasil Dan Pembahasanunclassified

Gambaran Penggunaan Obat Off-Label Pada Pasien Pediatrik Rawat Inap di Rumah Sakit

Tuloli

Rasdianah²,

Datau³

2022

IJPE

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Off-label drugs can be interpreted as drugs that are used not in accordance with drug information, distribution permits and sales licenses from the Marketing Authorization (MA) related to indications, age, dosage, route of administration and contraindications. The use of off-label drugs in children occurs because of incomplete data on pharmacokinetics, pharmacodynamics and side effect of a drug. It is because clinical research in children is quite difficult and not in accordance with research ethics and morals, so it has the potential to cause errors in treatment and unwanted drug reactions. This study aims to describe the use of off-label drugs in hospitalized pediatric patients at RSUD of Dr. M.M Dunda Limboto, Gorontalo District, Gorontalo Province. This is an obsevational study using cross sectional design and retrospective data collection. The sampling technique applies a purposive sampling technique with a total of 155 patiens who meet the inclusion criteria during the January-June 2020 period. The finding shows that from 155 patient medical records, there are 172 (16,51%) off-label drug used with a total of 1042 drugs. The off-label drugs used in the indication category are 64,53%, the off-label drugs used in dose category are 17,44%, the off-label drugs used in age category are 14,53%, the off-label drugs used in route of administration category are 3,49% and the off-label drugs used in contraindictions category are not found. The are the most off-label drugs used in each category, including domperidone (off-label in indications and dose), rhinofed (off-label in age) and salbutamol (off-label in route of administration).

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Off-Label Drug Use In Hospitalized Children: A Prospective Observational Study At Gondar University Referral Hospital, Northwestern Ethiopia

Cited by 4 publications

References 0 publications

Off-label antibiotic use in a specialized children care hospital in Punjab, Pakistan: Findings and implications

Off-label antibiotic use in a specialized children care hospital in Punjab, Pakistan: Findings and implications

Off-label Medications Use in the Eastern Province of Saudi Arabia: The Views of General Practitioners, Pediatricians, and Other Specialists

Gambaran Penggunaan Obat Off-Label Pada Pasien Pediatrik Rawat Inap di Rumah Sakit

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