Awareness about and views of parents on the off‐label drug use in children (Bang et al., 2014)
14
|
India
|
To explore awareness among parents regarding both off‐label drug use in children |
Cross‐sectional study (1 year) |
Face‐to‐face interview using structured questionnaire |
Parents (n = 400) |
Validated, structured questionnaire |
Parental views on safety and labelled use of drugs in children |
98.8 (400/405) |
Participants felt that drugs used in children in hospital (89.5%) and community setting (80.3%) were either safe or extremely safe |
To explore willingness to allow their child to participate in clinical research |
Comprised of 18 questions |
Awareness regarding off‐label use in children |
30% parents were aware of off‐label drug use in children |
Face validity done for translated version of questionnaire (English to Hindi and Marathi languages) |
Communication from healthcare worker about off‐label drug use in children |
93% wanted to be informed whenever drug prescribed in off‐label manner |
Parental views on off‐label drug use in children |
73% felt the off‐label drug use is illegal and 57% would ask for a change to labelled drug |
Willingness of allowing child participation in clinical trial |
Participants not keen to allow their healthy children to participate in clinical trials participate |
Results from the 2012–2013 paediatric national survey on off‐label drug use in children in Spain (OL‐PED study) (Pérez et al., 2014)
15
|
Spain
|
To estimate the current state of knowledge on off‐label use of drugs among Spanish paediatricians |
Multicentre, descriptive, cross‐sectional study (8 months) |
Online questionnaire |
Paediatricians (n = 673) |
Comprised of 10 questions |
Knowledge and views on off‐label prescribing |
7.5 (673/9027) |
75.1% of participants knew the meaning of off‐label use |
To assess the need to adopt measures to improve current practice |
Distributed via email |
Informing parents/guardians and documentation |
47% knew the importance of noting the off‐label use in medical records. However only 22% wrote it in the medical records |
To estimate how well informed they are about legal liabilities arising from off‐label use of medications and to ascertain the sources paediatricians use to obtain information on drugs |
View on factors of support from the point of view of medical liability |
Sources of information used to obtain information on drugs |
A questionnaire‐based study in Calabria on the knowledge of off‐label drugs in paediatrics (Saullo et al., 2013)
20
|
Italy
|
To evaluate the knowledge of off‐label drugs in paediatricians of Calabria region in Italy
|
2‐phase cross‐sectional study (8 months) |
Online anonymous questionnaire |
Paediatricians (n = 85) |
Comprised of 10 questions; all question had tick box answers |
Drugs and their off‐label use |
47.3 (85/180) |
40% used off‐label drugs ‘sometimes’ |
General guidelines on risk and limitation of off‐label drugs in clinical practice |
74% did not have good knowledge about this practice |
Children's view on unlicensed/off‐label paediatric prescribing and paediatric clinical trials (Mukattash et al., 2012)
22
|
Northern Ireland
|
To explore the views and perspectives of children on the unlicensed/off‐label use of medicines in children and on the participation of children in clinical trials |
Cross‐sectional study (not reported) |
Focus group discussions |
School children (n = 123) |
Sessions moderated by trained researcher |
Views on the unlicensed use of medicines in children |
63.4 (123/194) |
Pupils viewed unlicensed/off‐label use of medicine in children as unsafe and unethical |
Facilitator was familiarized with focus group sessions by conducting 2 simulation sessions |
Informing parents/guardians and children |
Pupils felt it is necessary to test medicines in children to improve availability of licensed products |
Study guide was used to ensure uniformity of focus group discussions |
Clinical trials and willingness to participate |
They felt that older children and parents should be informed when drug used in off‐label manner |
Illness and participation in clinical trials |
Healthcare professional experiences and attitudes on unlicensed/off‐label paediatric prescribing and paediatric clinical trials (Mukattash et al., 2011)
16
|
Northern Ireland
|
To investigate the knowledge and views of a range of healthcare professionals regarding the use of unlicensed/off‐label medicines in children and the participation of children in clinical trials |
Cross‐sectional study (not reported) |
Prospective questionnaire survey |
Consultant paediatricians, general practitioners, community pharmacists, paediatric nurses (n = 563) |
Survey instrument designed after an extensive review of the literature |
Experiences and views of healthcare professionals regarding the use of unlicensed and off‐label medicines in children |
46.5 (563/1212) |
More familiarity with the term unlicensed compared to off‐label prescribing |
Comprised of 39 questions |
Parental involvement in decision making regarding the medicine being prescribed for their child |
30.7% reported informing parents/guardians on the use of unlicensed/off‐label medicines in children |
Questionnaire was piloted using a small number of healthcare professionals (n = 20; pharmacists and doctors) and respondents indicated that the questionnaire was clear and easy to understand |
Information sources that healthcare professionals use when prescribing, dispensing and administering unlicensed/off‐label medicines to children |
Willingness to be actively involved in clinical trials is highest among consultant paediatricians |
Distributed via postal services and email |
Paediatric clinical trials |
4‐week window to complete the questionnaire |
Dose‐related issues when prescribing unlicensed and off‐label medicines in children |
Perceptions and attitudes of Jordanian paediatricians towards off‐label paediatric prescribing(Mukattash et al., 2011)
17
|
Jordan
|
To investigate the knowledge and views of Jordanian paediatricians regarding off‐label prescribing in children |
Cross‐sectional study (not reported) |
Prospective questionnaire survey |
Hospital based paediatricians (n = 250) |
Survey instrument designed after an extensive review of the literature |
Experiences and views of paediatricians regarding off‐label prescribing to children |
83 (250/300) |
69% of participants were familiar with the term off‐label medicines but only 28% knowingly prescribed off‐label medicine to children |
Comprised of 39 questions |
Parental involvement in decision making regarding the medicine being prescribed for their child |
|
Majority did not obtain informed consent or tell parents when they prescribe off‐label medicine |
Face and content validity done by panel of experts |
Survey instrument was piloted prior to use |
Dose – related issues with off‐label prescribing |
Survey instrument was personally delivered |
Collected after 4 weeks
|
Off‐label, off‐limits? Parental awareness and attitudes towards off‐label use in paediatrics (Lenk et al., 2009)
13
|
Germany
|
To explore knowledge and view regarding off‐label prescribing and participation in clinical trials |
Cross‐sectional study (4 months) |
Questionnaire survey |
Parents (n = 94) |
Comprised of three sections |
Knowledge and view of off‐label use in paediatrics |
Parents of children with renal disease: 54 (43/80) Parents of healthy children 64 (51/80) |
Knowledge about off‐label drug use was poor in both groups |
Participation in clinical trials |
Refusal to off‐label drug use was low |
Parents with poor knowledge about off‐label drug use tend to refuse to volunteer their child for participation in clinical trials |
Public awareness and views on unlicensed use of medicines in children (Mukattash et al., 2008)
12
|
Northern Ireland
|
To explore awareness and views of the general public on unlicensed use of medicines in children |
Multicentre, cross‐sectional study (4 months) |
Face‐to‐face interview using structured questionnaire |
Parents (n = 1000) |
Draft survey was examined for fitness for purpose and face validity in focus group |
Views on safety and labelled use of drugs in children |
Not reported |
Majority had no previous knowledge about unlicensed/off‐label drug use |
To explore participation of children in clinical trials |
Final version was piloted in a sample of 20 members of public |
Awareness regarding off‐label use in children |
Most parents felt that they should be told when drug prescribed unlicensed/off‐label manner |
Interview conducted by trained interviewer |
Communication from healthcare worker about off‐label drug use in children |
Views on clinical participation varied according health status of children |
Views on off‐label drug use in children |
Willingness of allowing child participation in clinical trial |
Attitudes and experiences of community pharmacists towards paediatric off‐label prescribing: a prospective study (Stewart et al., 2007)
21
|
United Kingdom
|
To identify community pharmacist experiences of, and attitudes towards paediatric off‐label prescribing |
Cross‐sectional study (not reported) |
Prospective questionnaire survey |
Community pharmacists (n = 482) |
Comprised of 21 questions with combination of tick‐box responses and written comments |
Knowledge of and reasons for paediatric off‐label prescribing |
32.1 (482/1500) |
Familiarity with concept of off‐label prescribing (73%), mainly gained through dispensing experience (64%) |
Piloted prior to use |
Classes of drugs dispensed off‐label |
40% knowingly dispensed off‐label prescription to children |
Most common reasons for concerns when dispensing off‐label |
Most common reason of off‐label prescription was age (84.6%) |
Sources of information for dispensing to children |
Major concern regarding off‐label drug use is lack of dosage data (60%) |
Transfer of information to parents and prescribers |
Majority feels that pharmacist should inform parents and prescribers if drug is used in off‐label manner (66% and 78%) |
A prospective questionnaire assessment of attitudes and experiences of off‐label prescribing among hospital based paediatricians (McLay et al., 2006)
18
|
Scotland
|
To assess current attitudes of hospital based paediatricians to off‐label prescribing, and the performance of clinical trials in children |
Cross‐sectional study (1 year) |
Prospective questionnaire survey |
Hospital based consultants and specialist registrars (n = 151) |
Comprised of 24 questions with combination of tick‐box responses and written comments |
Perceived reasons for off‐label prescribing |
59 (151/257) |
Familiarity with concept of off‐label prescribing (92.8%) |
Concerns about off‐label prescribing |
90% knowingly prescribed off‐label prescription to children |
Parental and GP involvement |
Most common reason of off‐label prescription was age |
Paediatric clinical trials |
Major concern regarding off‐label drug use is lack of efficacy data (63.8%) |
Off‐label prescribing to children: attitudes and experience of general practitioners (Ekins‐Daukes et al., 2005)
19
|
Scotland
|
To identify experience with and attitudes towards paediatric off‐label prescribing in primary care |
Cross‐sectional study (not reported) |
Prospective questionnaire survey |
General practitioners (n = 202) |
Questionnaire was piloted prior to use |
Prior knowledge of off‐label prescribing and licensing recommendations |
58 (202/346) |
Majority familiar with off‐label concept (705) but 40% admitted knowingly prescribing off‐label dugs |
Attempt to increase response rate was made |
Acknowledgement of and perceived problems with off‐label prescribing Prescribing information sources used in practice |
Ranked development of paediatric formulations and clearer dosage information highly as a means to reducing off‐label prescribing |
Comprised of 13 questions |
Importance of proposed methods or reducing off‐label prescribing |
Collected after 4 weeks |
|