METHODS: Literature search using electronic databases including PubMed, Google Scholar and National Medical Research Register was conducted. Additional articles were identified by reviewing the bibliography of the retrieved articles. The articles were searched with any of the Medical Subject Headings (MeSH) terms in the title: adverse drug reaction, attitude, awareness, behaviour, experience, knowledge, Malaysia, perspectives, pharmacovigilance, practice and view. Studies were selected based on fulfilment of inclusion and exclusion criteria. The articles were scrutinised using thematic analysis.
KEY FINDINGS: Nine studies conducted among doctors, pharmacists and nurses met the inclusion criteria. Five themes emerged which included knowledge, attitude, practice, barriers and facilitators of adverse drug reaction reporting among healthcare professionals.
CONCLUSION: In general, healthcare professionals in Malaysia have good knowledge on and positive attitudes towards adverse drug reaction reporting. However, the practice of adverse drug reaction reporting was found to be unsatisfactory among healthcare professional in Malaysia. The approaches taken to enhance ADR reporting among Malaysian healthcare professionals should focus on alleviating lethargy and ignorance associated with ADR reporting.
METHOD: A literature search using electronic databases including PubMed, Medline, Scopus, Science Direct, Springer Link, Proquest, Ebsco Host and Google Scholar was conducted. Additional articles were identified by reviewing the bibliography of retrieved articles. The articles were searched with any of the following medical subject headings (MeSH) terms in the title: attitude, awareness, knowledge, experience, view, off-label, pediatric, paediatric and children. The inclusion criteria were full text articles published in English between January 2004 and February 2015 and reported outcome related to awareness, knowledge and views regarding off-label prescribing in children. Editorials, reviews, notes, conference proceedings, letters and studies reporting prevalence of off-label prescribing were excluded. The articles were scrutinized using thematic analysis.
RESULTS: Eleven studies conducted among doctors, community pharmacists, paediatric nurses, parents and children met the inclusion criteria. Nine themes were developed through document analysis which included main domains such as knowledge, awareness and views on off-label drug use in children, choice of information sources, reasons and suggestions to reduce off-label prescribing, concern regarding obtaining consent and participation in clinical trials.
CONCLUSION: The studies reviewed reported that the majority of doctors and community pharmacists were familiar with the term off-label prescribing but knowledge among parents was low. Awareness on off-label prescribing in children remains low among all study participants. There is a mismatch between views on off-label prescribing in children of study participants and the finding of previous studies.
DATA SOURCES: The articles published in PubMed, MEDLINE and Google Scholar were searched using text words: off-label, unlicensed, paediatric and children. Additional articles were identified by reviewing the bibliography of the retrieved articles. Full-text articles published in English which reported on the prevalence of off-label prescribing in children between January 1996 and December 2016 were included.
RESULTS: A total of 101 studies met the inclusion criteria. Off-label prescribing definition included four main categories: age, indication, dose and route of administration. The three most common reference sources used in the studies were summary of product characteristics, national formularies and package inserts. Overall, the off-label prescribing rates in children ranged from 1.2 to 99.7%. The most common category of off-label prescribing in children was dose and age.
CONCLUSIONS: This review highlighted that off-label prescribing in children was found to be highly prevalent throughout the past two decades, persistently in the neonatal intensive care units. This suggests that besides legislative and regulatory initiatives, behavioural, knowledge aspects and efforts to integrate evidence into practice related to off-label prescribing also need to be evaluated and consolidated as part of the concerted efforts to narrow the gaps in prescribing for children.
OBJECTIVES: To examine and characterize the use of SAMs among children in a Malaysian tertiary care hospital.
METHODS: The named-patient basis SAM application forms, cover letter, pharmacist review summary and patient monitoring forms available at the Pharmacy Department between 1st January 2019 and 31st December 2020 were reviewed. Unprocessed, unapproved and stock-basis applications were excluded. The outcome measures were categories, scope, off-label use and cost of SAM. Per-patient data were analyzed descriptively.
RESULTS: Overall, 1010 patients (mean age of 8.7 ± 5.6 years) were involved in 328 SAMs applications. The most common SAMs pharmacological groups were nervous system (n = 371, 36.7%) and antineoplastic and immunomodulating agents (n = 332, 32.9%). Top three SAMs were melatonin (11.5%), scopolamine (7.6%) and cholecalciferol (7.1%). A total of 837 (82.9%) and 513 (50.8%) patients were involved in the SAMs applications for non-formulary and unregistered medicines, respectively. Unregistered, non-formulary medicines were applied for 47.3% (n = 478) of the patients. The majority of the scope for SAMs (64.7%) were to substitute the available alternatives in the national formulary which were ineffective or sub-optimal for the patients. Among the 262 patients with repeat applications, 93.8% reported disease or symptom improvement while 1.9% experienced side effects. Up to 17% of SAMs analyzed in this study were used for off-label indications. The total cost of the SAMs was RM8,748,358.38 (USD 2,090,418.86).
CONCLUSION: The use of SAMs among children in this hospital involved unregistered, non-formulary medicines used to substitute the available alternatives in the formulary. A concerted effort is warranted in exploring supplementary mechanisms to enhance the medicine registration process and formulary system towards facilitating enhanced provision of treatment for children.
OBJECTIVE: This qualitative systematic review aims to determine, evaluate, and summarize the perceptions, attitudes, and behaviors towards the use of SABA from the patients' perspectives.
METHODS: The databases searched included PubMed, Scopus, PsycINFO, CINAHL, and Cochrane database. Original research articles reporting the perceptions, attitudes, or behaviors of asthma patients towards the use of SABA, which was available as full text, published in the English language between the year 2000 and February 2023 were included in the review. Commentaries, letters to editor, review articles, and conference proceedings were excluded.
RESULTS: A total of five articles were included. Six overarching themes were obtained: (1) perceptions on health status; (2) perceptions and attitudes towards the impact of asthma; (3) perceptions towards asthma control; (4) perceptions towards asthma knowledge; (5) risk perceptions; (6) perceptions, attitudes, and behaviors towards the use of SABA.
CONCLUSION: Despite the fact that SABA could rapidly alleviate asthma symptoms, SABA over-users were less likely to describe their health status and asthma control as 'excellent'. Most SABA over-users did not know that frequent SABA usage would worsen their asthma control, and they exhibited psychological linkage towards the use of SABA. Collaborative efforts between policymakers, healthcare professionals and patients are warranted to reconstruct SABA prescribing practice and usage.