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Attitudes, knowledge and views on off-label prescribing in children among healthcare professionals in Malaysia

Balan S, Ahmad Hassali MA, Mak VSL

Int J Clin Pharm, 2019 Aug;41(4):1074-1084.
PMID: 31197546 DOI: 10.1007/s11096-019-00862-y

Background Off-label prescribing in children is associated with several prerequisites such as ensuring sound and scientific evidence and obtaining written consent prior to use of off-label drugs to ensure that protection is provided to patients and healthcare professionals. Adherence to the pre-requisites depends on the attitude, views and knowledge of the pharmacists and doctors involved in this practice. Objective To explore the attitudes, knowledge and views on off-label prescribing in children among hospital-based pharmacists and paediatric doctors. Setting The study was conducted in a 620-bedded general hospital located in the urban area of central Peninsular Malaysia. Method Face to face, semi-structured interviews with 12 pharmacists and 12 paediatric doctors. Interviews were audio-recorded, transcribed and analysed using constant comparison method. Main outcome measure Themes surrounding hospital-based pharmacists' and paediatric doctors' attitude, knowledge and views on off-label prescribing in children. Results Four themes were derived: knowledge on off-label prescribing in children, views on off-label prescribing in children, attitude towards off-label prescribing in children and guidance on off-label prescribing in children. Conclusion There is a need to increase the knowledge of hospital-based pharmacists and paediatric doctors and address several concerns on off-label prescribing in children. The decision to prescribe or dispense off-label drugs involved collective decision-making mechanisms and guidance is required with regards to offlabel prescribing in children.

Matched MeSH terms: Off-Label Use*
Fulltext Awareness, knowledge and views of off-label prescribing in children: a systematic review

Balan S, Hassali MA, Mak VS

Br J Clin Pharmacol, 2015 Dec;80(6):1269-80.
PMID: 26314841 DOI: 10.1111/bcp.12750

AIM: The aim of this review was to provide an updated overview of awareness, knowledge and views of off-label prescribing in children.
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.

Matched MeSH terms: Off-Label Use*
Two decades of off-label prescribing in children: a literature review

Balan S, Hassali MAA, Mak VSL

World J Pediatr, 2018 12;14(6):528-540.
PMID: 30218415 DOI: 10.1007/s12519-018-0186-y

BACKGROUND: In the past two decades, many legislative and regulatory initiatives were taken globally to improve drug use in children. However, children are still found to be prescribed with off-label drugs. This study was conducted to provide an overview of the worldwide trend in off-label prescribing in children from the year 1996 to 2016.
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.

Matched MeSH terms: Off-Label Use/statistics & numerical data*
Fulltext It is time to change the way we manage mild asthma: an update in GINA 2019

Muneswarao J, Hassali MA, Ibrahim B, Saini B, Ali IAH, Verma AK

Respir Res, 2019 Aug 14;20(1):183.
PMID: 31412856 DOI: 10.1186/s12931-019-1159-y

Asthma is a heterogeneous lung disease, usually characterised by chronic airway inflammation. Although evidence-based treatments are available in most countries, asthma control remains suboptimal, and asthma-related deaths continue to be an ongoing concern. Generally, it is believed that between 50 to 75% of patients with asthma can be considered as having mild asthma.Previous versions of Global Initiative for Asthma (GINA) suggested that mild asthma in adults can be well managed with either reliever medications, for example, short-acting beta2 agonists (SABA) alone or with the additional use of controllers such as regular low-dose inhaled corticosteroids (ICS). Given the low frequency or non-bothersome nature of symptoms in mild asthma, patients' adherence towards their controller medications, especially to ICS is usually not satisfactory. Such patients often rely on SABA alone to relieve symptoms, which may contribute to SABA over-reliance. Overuse of relievers such as SABAs has been associated with poor asthma outcomes, such as exacerbations and even deaths. The new GINA 2019 asthma treatment recommendations represent significant shifts in asthma management at Steps 1 and 2 of the 5 treatment steps. The report acknowledges an emerging body of evidence suggesting the non-safety of SABAs overuse in the absence of concomitant controller medications, therefore does not support SABA-only therapy in mild asthma and has included new off-label recommendations such as symptom-driven (as-needed) low dose ICS-formoterol and "low dose ICS taken whenever SABA is taken".The GINA 2019 report highlights significant updates in mild asthma management and these recommendations represent a clear deviation from decades of clinical practice mandating the use of symptom-driven SABA treatment alone in those with mild asthma. While the new inclusions of strategies such as symptom-driven (as-needed) ICS-formoterol and "ICS taken whenever SABA is taken" are based on several key trials, data in this context are still only emergent data, with clear superiority of as needed ICS-formoterol combinations over maintenance ICS regimens yet to be established for valid endpoints. Nevertheless, current and emerging data position the clinical asthma realm at a watershed moment with imminent changes for the way we manage mild asthma likely in going forward.

Matched MeSH terms: Off-Label Use
Fulltext An open labelled randomized clinical trial of Fluoxetine versus Dapoxetine treatment among men with premature ejaculation and its effect on marital satisfaction

Mohammad Che Man, Faridah Mohd Zain, Najib Majdi Yaacob, Shahidah Che Alhadi, Shaiful Bahri Ismail

International Medical Journal Malaysia, 2017;16(11):34-34.
MyJurnal

Premature ejaculation (PE) reduces sexual satisfaction and quality of life.
Both SSRI Fluoxetine and Dapoxetine have been used in the treatment of PE. Fluoxetine
is used as off-label treatment meanwhile Dapoxetine is the first SSRI specifically
designed for PE with short half-life and few side effects. (Copied from article).

Matched MeSH terms: Off-Label Use
Non-regulatory related factors leading to off-label prescribing in children: A concept map

Balan S, Hassali MA, Mak VSL

Res Social Adm Pharm, 2017 Nov;13(6):1219-1221.
PMID: 28576615 DOI: 10.1016/j.sapharm.2017.05.013
Matched MeSH terms: Off-Label Use*
Allopurinol-induced severe cutaneous adverse drug reactions: Risk minimization measures in Malaysia

Panickar R, Wo WK, Ali NM, Tang MM, Ramanathan GRL, Kamarulzaman A, et al.

Pharmacoepidemiol Drug Saf, 2020 10;29(10):1254-1262.
PMID: 33084196 DOI: 10.1002/pds.5033

PURPOSE: To describe risk minimization measures (RMMs) implemented in Malaysia for allopurinol-induced severe cutaneous adverse drug reactions (SCARs) and examine their impact using real-world data on allopurinol usage and adverse drug reaction (ADR) reports associated with allopurinol.
METHODS: Data on allopurinol ADR reports (2000-2018) were extracted from the Malaysian ADR database. We identified RMMs implemented between 2000 and 2018 from the minutes of relevant meetings and the national pharmacovigilance newsletter. We obtained allopurinol utilization data (2004-2018) from the Pharmaceutical Services Programme. To determine the impact of RMMs on ADR reporting, we considered ADR reports received within 1 year of RMM implementation. We used the Pearson χ2 test to examine the relation between the implementation of RMMs and allopurinol ADR reports.
RESULTS: The 16 RMMs for allopurinol-related SCARs implemented in Malaysia involved nine risk communications, four prescriber or patient educational material, and three health system innovations. Allopurinol utilization decreased by 21.5% from 2004 to 2018. ADR reporting rates for all drugs (n = 144 507) and allopurinol (n = 1747) increased. ADR reports involving off-label use decreased by 6% from 2011. SCARs cases remained between 20% and 50%. RMMs implemented showed statistically significant reduction in ADR reports involving off-label use for August 2014 [χ2(1, N = 258) = 5.32, P = .021] and October 2016 [χ2(1, N = 349) = 3.85, P = .0499].
CONCLUSIONS: RMMs to promote the appropriate use of allopurinol and prescriber education have a positive impact. We need further measures to reduce the incidence and severity of allopurinol-induced SCARs, such as patient education and more research into pharmacogenetic screening.

Matched MeSH terms: Off-Label Use
Fulltext Off-label use of 0.4 % sodium hyaluronate teardrops: a safe and effective solution for submucosal injection in gastric endoscopic submucosal dissection

Aliaga Ramos J, Arantes V, Abdul Rani R, Yoshida N

Endosc Int Open, 2020 Dec;8(12):E1741-E1747.
PMID: 33269305 DOI: 10.1055/a-1265-6598

Background and study aims Submucosal (SM) injection is a critical step in endoscopic submucosal dissection (ESD). In Japan, use of viscous solutions such as sodium hyaluronate are recommended; the commercially product available is MucoUp (Seikagaku Co. and Boston Scientific Japan Co., Japan). Nevertheless, MucoUp is expensive and unavailable in many Western countries. For the past 8 years, we have been using low-cost sterile teardrops solution composed of 0.4 % sodium hyaluronate (Adaptis Fresh, Legrand Laboratory, Brazil). This solution is readily available in drugstores with a cost of approximately US$ 10.00 for each 10-cc bottle. The aim of this study was to present the clinical outcome with off-label sodium hyaluronate use for SM injection in gastric ESD. Patients and methods A single-center retrospective study of collected data investigating consecutive patients that underwent gastric ESD between 2012 and 2019. ESD was performed using 0.4 % sodium hyaluronate teardrop for SM injection and Flush Knife BT 2.5 (Fujifilm Co., Japan). The following data were analyzed: clinical-pathological features, en-bloc, R0 and curative resection rate, procedure duration, adverse events, and clinical outcome. Results ESD was performed with sodium hyaluronate for submucosal injection in 78 patients. The en-bloc resection rate and R0 resection rate were 96.1 % and 92.3 %, respectively. The curative resection rate for epithelial lesions was 83.8 %. Adverse events occurred in 5 cases (6.3 %): delayed bleeding (3.8 %, 3 cases) and perforation (2.5 %, 2 cases); all managed successfully by clipping and thermal coagulation. The mean volume of sodium hyaluronate solution used per patient was 10 cc (SD: ± 8 cc). During follow-up (mean: 17 months; SD: ± 14.5 months), two patients developed metachronous lesions (2.5 %). Conclusions Off-label use of teardrops with 0.4 % sodium hyaluronate for submucosal injection was demonstrated to be safe and able to provide an effective submucosal cushion that facilitates SM dissection in gastric ESD procedures.

Matched MeSH terms: Off-Label Use
Successful treatment of paediatric generalized pustular psoriasis with secukinumab: a case series

Albela H, Begum S, Leong KF

J Dermatolog Treat, 2021 Mar 11.
PMID: 33706651 DOI: 10.1080/09546634.2021.1899111

Generalized Pustular Psoriasis (GPP) is a rare, severe, life-threatening form of psoriasis and accounts for up to 13.1% of all childhood psoriasis. Common first-line systemic treatment for pediatric patients with GPP include oral acitretin, cyclosporin and methotrexate which have varying efficacy and side effects but multiple interventions are often needed to induce remission and maintain long term control. Recently, the anti IL 17 A monoclonal antibody secukinumab have been shown to be effective in adult patients with GPP; however, there is lack of evidence of its usage in the pediatric population. We describe a case series of 4 pediatric patients with GPP who were treated with off-label use of secukinumab. All four patients had marked clearance and reduction in Generalized Pustular Psoriasis Area & Severity Score (GPPASI) within first 48 h of first injection with subsequent almost complete to complete clearance of skin lesions by 1 month follow up. In conclusion, secukinumab was found to be successful in inducing remission, with rapid clearance and maintaining remission, with or without combination with other systemic agents for pediatric GPP.

Matched MeSH terms: Off-Label Use
A systematic review on the off-label use of montelukast in atopic dermatitis treatment

Chin WK, Lee SWH

Int J Clin Pharm, 2018 Oct;40(5):963-976.
PMID: 29777328 DOI: 10.1007/s11096-018-0655-3

Background Atopic dermatitis (AD) is the most common form of eczema. As leukotriene mediators are involved in the inflammatory phase of atopic dermatitis, montelukast has been suggested as a possible therapy. Aim of the review To evaluate the safety and efficacy of montelukast off-label use for the treatment atopic dermatitis. Method A search was performed from database inception until March 2018 in six electronic databases for randomized-controlled-trials examining the use of montelukast for AD. Results Among 301 articles screened, 11 studies met the inclusion criteria and were included in the review. The study populations consist of paediatric and adult subjects with moderate-to-severe AD. Montelukast use was shown to improve symptoms such as pruritus in four studies. Another 2 studies reported that montelukast could improve symptoms similar to the standard regimen of topical steroid and oral antihistamine. However, five studies reported that montelukast had no effects in symptoms alleviation. The use of montelukast was associated with a similar safety profile to placebo and well-tolerated with minimal adverse effects. Conclusion There is limited evidence to suggest that the off-label use of montelukast is effective in treating moderate-to-severe AD. Further research with larger study populations employing standardized endpoint measuring instrument is warranted to further investigate the off-label use of montelukast in AD treatment. Until then, the use of conventional treatments including optimal daily skin hydration should remain the mainstay in the management of atopic dermatitis. In fact, for moderate-to-severe condition, steroid sparing immune-suppressants should still be used clinically until more effective and safer alternative is discovered.

Matched MeSH terms: Off-Label Use*
Respiratory drugs prescribed off-label among children in the outpatient clinics of a hospital in Malaysia

Mohamad NF, Mhd Ali A, Mohamed Shah N

Int J Clin Pharm, 2015 Feb;37(1):127-32.
PMID: 25488318 DOI: 10.1007/s11096-014-0049-0

BACKGROUND: Prescribing medicines in an unlicensed and off-label manner for children is a widespread practice around the world.
OBJECTIVES: To determine the extent and predictors of off-label respiratory drug prescriptions for children in the outpatient clinics of a hospital in Malaysia.
SETTING: Outpatient clinics at the Universiti Kebangsaan Malaysia Medical Centre, a tertiary teaching hospital in Malaysia.
METHODS: The pharmacy-based computer system and medical records of the patients were utilized to collect data from 220 pediatric patients who were prescribed at least one respiratory drug from July 2011 to December 2011.
MAIN OUTCOME MEASURE: Characteristics of the off-label respiratory drug prescriptions were measured.
RESULTS: A total of 134 children (60.9 %) received at least one respiratory drug prescribed in an off-label manner. The most common reasons for the off-label prescribing of drugs were off-label use by indication (31.5 %), followed by higher than the recommended dose (24.9 %) and lower than the recommended frequency (17.1 %). Diphenhydramine was the most common respiratory drug prescribed off-label. The number of medications prescribed was the only significant predictor of off-label prescription of respiratory drugs. Pediatric patients receiving 4-6 medications were 7.8 times more likely to receive at least one off-label respiratory drug compared to pediatric patients that received 1-3 medications (OR 7.8, 95 % CI 1.74-37.44).
CONCLUSION: There was substantial prescribing of respiratory drugs for children in an off-label manner at the outpatient clinics at the Universiti Kebangsaan Malaysia Medical Centre. This highlights the need for more research to be carried out on respiratory drugs in the pediatric population.

Study site: Pusat Perubatan Universiti Kebangsaan Malaysia (PPUKM)

Matched MeSH terms: Off-Label Use/standards*
Unlicensed and off-label use of medicines in children admitted to the intensive care units of a hospital in Malaysia

Lee JL, Redzuan AM, Shah NM

Int J Clin Pharm, 2013 Dec;35(6):1025-9.
PMID: 24022725

BACKGROUND: Unlicensed and off-label use of medicines in paediatrics is widespread. However, the incidence of this practice in Malaysia has not been reported.
OBJECTIVE: To determine the extent of unlicensed and off-label use of medicines in hospitalised children in the intensive care units of a tertiary care teaching hospital.
METHODS: A prospective, observational exploratory study was conducted on medicines prescribed to children admitted to the 3 intensive care units of Universiti Kebangsaan Malaysia Medical Centre (UKMMC).
RESULTS: A total of 194 patients were admitted to UKMMC, 168 of them received one or more drugs. Of 1,295 prescriptions, 353 (27.3 %) were unlicensed and 442 (34.1 %) were for off-label use. Forty-four percent of patients received at least one medicine for unlicensed use and 82.1 % received at least one medicine off-label. Preterm infants, children aged 28 days to 23 months, patients with hospital stays of more than 2 weeks, and those prescribed increasing numbers of medicines were more likely to receive medicines for unlicensed use. Term neonates and patients prescribed increasing numbers of medicines had increased risk of receiving medicines for off-label use.
CONCLUSION: Prescribing of medicines in an unlicensed or off-label fashion to the children in the intensive care units of UKMMC was common. Further detailed studies are necessary to ensure the delivery of safe and effective medicines to children.

Matched MeSH terms: Off-Label Use/statistics & numerical data*
Risk Minimization Measures in Off-Label Drug Use: A Survey of Community Pharmacists in Malaysia

Fatokun O

Curr Drug Saf, 2020;15(3):181-189.
PMID: 32538733 DOI: 10.2174/1573403X16666200615144946

BACKGROUND: While off-label drug use is common and sometimes necessary, it also presents considerable risks. Therefore, measures intended to prevent or reduce the potential exposure to off-label risks have been recommended. However, little is known about community pharmacists' beliefs regarding these measures in Malaysia.
OBJECTIVES: This study examined community pharmacists' beliefs towards risk minimization measures in off-label drug use in Malaysia and assessed the relationship between perceived risk of off-label drug use and beliefs towards risk minimization measures.
METHODS: A cross-sectional survey was conducted among 154 pharmacists practicing in randomly selected community pharmacies in Kuala Lumpur and the State of Selangor, Malaysia.
RESULTS: The majority agreed or strongly agreed that adverse drug events from the off-label drug should be reported to the regulatory authority (90.9%) and the off-label drug should only be used when the benefit outweighs potential risks (88.3%). Less than half (48.1%) agreed or strongly agreed that written informed consent should be obtained before dispensing off-label drugs and a majority (63.7%) agreed or strongly agreed that the informed consent process will be burdensome to healthcare professionals. Beliefs towards risk minimization measures were significantly associated with perceived risk of off-label drug use regarding efficacy (p = 0. 033), safety (p = 0.001), adverse drug rection (p = 0.001) and medication errors (p = 0.002).
CONCLUSION: The community pharmacists have positive beliefs towards most of the risk minimization measures. However, beliefs towards written informed consent requirements are not encouraging. Enhancing risk perception may help influence positive beliefs towards risk minimization measures.

Matched MeSH terms: Off-Label Use*
Antihistamines prescribed off-label among paediatric patients at a tertiary care hospital setting in Malaysia

Tan RW, Mohamed Shah N

Int J Clin Pharm, 2016 Oct;38(5):1277-85.
PMID: 27480982 DOI: 10.1007/s11096-016-0364-8

Background Antihistamines are widely prescribed to children but should be used with caution in young children. Objective To determine the paediatric prescribing pattern of antihistamines with a focus on the off-label prescribing and factors that influence such prescribing. Setting Paediatric wards of a tertiary care hospital setting in Malaysia. Methods The pharmacy-based computer system and medical records were used to collect the required data. Labelling status of each antihistamine was determined based on the information provided in the product leaflets. Main outcome measure Antihistamines prescribed off-label and factors associated with such prescribing. Results Of the 176 hospitalised children aged <18 years prescribed with an antihistamine in the year 2012, 60.8 % received it in an off-label manner. Of 292 antihistamine prescription items, 55.5 % were prescribed off-label. Loratadine (35.3 %) was the most frequently prescribed antihistamine and chlorpheniramine maleate (34.0 %) was the most common antihistamine prescribed off-label. The main reason for the off-label prescribing of antihistamines was prescribing at higher than the recommended dose (30.2 %). Binary logistic regression showed that children aged <2 years (OR 12.65; 95 % CI 2.87-55.67) and the number of medications received (OR 1.14; 95 % CI 1.00-1.29) were significant predictors for the off-label prescribing of antihistamines. Conclusion Prescribing antihistamines for children in an off-label manner was prevalent at the studied locations and warrants further investigation on the consequences of such prescribing.

Matched MeSH terms: Off-Label Use/standards*
Challenges in pediatric drug use: A pharmacist point of view

Balan S, Hassali MA, Mak VSL

Res Social Adm Pharm, 2017 May-Jun;13(3):653-655.
PMID: 27493130 DOI: 10.1016/j.sapharm.2016.06.014

The pediatric population is an enormously diverse segment of population varying both in size and age. The diversity caused pharmacists face various challenges primarily related to procuring, provision as well as use of drugs in this group of patients. Pediatric dose calculation is particularly a concern for pharmacists. Another challenge faced by pharmacists is unavailability of suitable formulations for pediatric use. This has also led many pharmacists to prepare extemporaneous liquid preparations, even though stability data on such preparations are scarce. Some extemporaneous preparations contain excipients which are potentially harmful in children. Besides that, inadequate labeling and drug information for pediatric drug use had not only challenged pharmacists in recommending and optimizing drug use in children, but also inadvertently caused many drugs used outside the approved terms of the product license (off-label use). Pharmacists are striving to stay connected to overcome the common and comparable challenges faced in their day to day duties and strive to maximize the safe and effective use of medicines for children.

Matched MeSH terms: Off-Label Use

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