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

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.

A prospective observational study on psychotropic drug use in non psychiatric wards.

BACKGROUND: Psychotropic medications are the first line for the management of psychiatric illnesses; in addition, they are also being used in an off-labeled manner. Inappropriate prescribing of psychotropic medications either can cause serious harm or may be of no benefit to the patients. However, there is a dearth of information on the pattern of psychotropic drug use in the nonpsychiatry wards. AIM: The aim of this study is to assess the use of psychotropic drugs in general medicine and surgical wards of a teaching hospital. MATERIALS AND METHODS: An observational study was conducted in the general medicine and surgical wards of a university teaching hospital over 6 months. Patients admitted to the medicine and surgical ward were observed for a prescription of psychotropic medications. Once they were prescribed with a psychotropic medication, the patients were included in the study and were followed until discharge. All the necessary information such as dose, route, class of psychotropic and prescriber's status were documented and analyzed. RESULTS: A total of 322 patients were prescribed with 452 psychotropic medications. The average number of psychotropic per patient was 1.40 ± 0.76 (range: 1-4). The rate of psychotropic medications prescription in the nonpsychiatric ward is 10.73%. Alcohol dependence syndrome (n = 90 [26.71%]) and pain (n = 43 [43.87%]) were the observed psychiatric and nonpsychiatric indications. The frequently prescribed psychotropic classes were benzodiazepines (n = 165 [36.50%]) and antidepressants (n = 144 [31.86%]). Nonpsychiatrists (n = 250 [55.3%]) were the common prescribers and benzodiazepines (n = 124 [27.43%]) were the preferred class for nonpsychiatrist, whereas psychiatrist prescribed different class of psychotropic drugs. CONCLUSION: This study emphasizes that nonpsychiatrist irrespective of their specialty prescribed psychotropic medication for psychiatric and nonpsychiatric indications.

A Prospective Surveillance of Pharmacovigilance of Psychotropic Medicines in a Developing Country.

AIMS/OBJECTIVES: Psychotropic drugs are associated with significant short-term and long-term safety issues which may affect patients' mental health, physical health and cost of care. EXPERIMENTAL DESIGNS: This was a prospective study conducted in psychiatry department of a tertiary care hospital. Study included patients of any age and either sex who presented with psychiatric illness as diagnosed by ICD-10 and were receiving at least one psychotropic agent. The study involved both intensive and spontaneous reporting methods to identify ADRs. Causality, Severity, Preventability of reported ADR was assessed using standard scales. PRINCIPLE OBSERVATION: Of 4321 patients reviewed, 1630 patients met study criteria, 990 ADRs were identified from 613 patients at an overall incidence rate of 37.6%. Antidepressants were the commonest group of agents implicated in ADRs (42%) followed by Antipsychotics (41%). Escitalopram (15.9%) and Olanzapine (12.1%) were the most commonly implicated medications. Most commonly involved system organ class was Gastrointestinal system (22.7%) followed by Central and peripheral nervous system (17.8%). Dry mouth (10.2%), weight gain (8.18%) and tremors (5.85%) were the commonly reported ADRs. Female gender (p = 0.002), Co-morbid conditions (p = 0.001) and drug- drug interactions (p = 0.000) were found as risk factors in developing ADRs in psychiatry patients. CONCLUSION: Patients receiving psychotropic medicines need routine monitoring to ensure their safety and adherence.

Identification and management of adverse effects of antipsychotics in a tertiary care teaching hospital.

OBJECTIVE: Antipsychotics have revolutionized psychiatry by allowing significant numbers of patients in long-term hospital settings to be discharged and successfully maintained in the community. However, these medications are also associated with a range of adverse events ranging from mostly annoying to rarely dangerous. This study is carried out to identify the adverse drug reactions (ADRs) to antipsychotics and its management in psychiatric patients. METHODS: Prospective interventional study was conducted in the psychiatric unit of a tertiary care hospital. Patients of any age and either sex prescribed with at least one antipsychotic were included and monitored for ADRs. FINDINGS: Among the 517 patients receiving antipsychotics, a total of 289 ADRs were identified from 217 patients at an overall incidence rate of 41.97%. Sixty-seven different kinds of ADRs were observed in the study patients. Central and peripheral nervous system was the most commonly affected system organ class (n = 59) and weight gain (n = 30) was the most commonly observed ADR. Olanzapine was most commonly implicated in reported ADRs (n = 92) followed by risperidone (n = 59). Of the 289 ADRs, 80% required interventions including cessation of drug and/or specific/symptomatic/nonpharmacological treatment. CONCLUSION: This post marketing surveillance study provides a representative data of the ADR profile of the antipsychotics likely to be encountered in psychiatric patients in an Indian tertiary care hospital.