Paediatric off-label and unlicensed prescribing in primary care in Malta: Prospective observational drug utilisation study

Santos

J Evidence Based Medicine

et al. 2020

Objective To evaluate unlicensed and off‐label prescription and use of drugs to children in primary health care. Methods This is a systematic review that was written based on Preferred Reporting Items for Systematic Reviews and Meta‐Analysis (PRISMA). The studies were extracted from the databases: LILACS, PubMed/MEDLINE, and Scopus. Studies in English, Spanish or Portuguese with abstract available regarding the use and prescription of off‐label and unlicensed drugs to children aged 0‐18 years in primary health care were included. The evaluation of the titles, abstracts and Full‐text were performed independently by two reviewers, and the divergences were resolved by a third reviewer. Results Six studies were included. The incidence of off‐label prescription varied from 29.5% to 51.7% in relation to the total number of drugs prescribed. The prevalence of off‐label drugs ranged from 31.7% to 93.5% in relation to the total number of drugs prescribed. It was observed a higher proportion of off‐label prescription related to age and dose. For unlicensed drugs, there was a small variation in incidence between 2.4% and 3.9%, relative to the total number of prescriptions, or between 2.4% and 10.0%, relative to the sample size. It was observed a higher proportion of unlicensed prescription related to children under 2 years of age. Conclusions The unlicensed and off‐label prescription of drugs is recurring in the pediatric population of primary health care. It is necessary to have better information on these drugs by the regulatory agencies and the pharmaceutical industries for rational use of drugs in children.

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

See 1 more Smart Citation

Unlicensed and off‐label prescription of drugs to children in primary health care: A systematic review

Santos

J Evidence Based Medicine

et al. 2020

“…Similar findings have been reported by other investigators. [26][27][28][29][30][31] In view of this fact, the authors reviewed the product literature of those respiratory medicines and antibiotics that had been prescribed in an off-label manner in the study by Ellul et al 18 These medicines were classified according to the Anatomical Therapeutic Chemical (ATC) system by using the Guidelines for ATC classification and Defined Daily Dose assignment. 32 Subsequently, the product literature, containing the same active ingredient(s) but produced by different marketing authorization holders, were compared with each other to screen for inconsistencies between them.…”

Section: Methodsmentioning

confidence: 99%

“…Although medicines may be identical with respect to the active ingredient and formulation, if marketed by different marketing authorization holders, the information found in the summaries of product characteristics may differ, leading to off-label prescribing by physicians. 18,19 One of the most compelling illustrations of inconsistencies in the product literature that has given rise to off-label use concerns etanercept powder for injection. The summary of product characteristics of etanercept, centrally authorized by EMA, includes as an indication the treatment of juvenile idiopathic arthritis (JIA) in patients ''who have had an inadequate response to, or who have proved intolerant of, methotrexate.…”

mentioning

confidence: 99%

Can Registration Procedures of Pharmaceuticals Inadvertently Contribute to Off-Label Prescribing in Children?

Ellul

Grech

Attard-Montalto

2016

Ther Innov Regul Sci

Self Cite

Background: In Malta, off-label prescribing of medicines in children stands at 45%, mainly because of failure by prescribers to follow the dosing recommendations in the product literature. In addition, registration procedures of pharmaceuticals may inadvertently contribute to this high incidence of off-label prescribing. Methods: A literature review was conducted to identify regulatory provisions relating to the registration of medicines in Malta that could give rise to off-label use. Furthermore, the product literature of the 2 classes of medicines most commonly prescribed in children, antibiotics and respiratory medicines, were reviewed. This was done in order to gauge whether the different registration routes implemented in Malta to market these medicines could give rise to off-label use. Results: The national registration procedure relating to Article 126a of Directive 2001/83/EC and, to a lesser extent, line extensions, parallel importation, and the provision detailed in Article 11 of Directive 2001/83/EC were found to lead to discrepancies and potentially misleading inclusions in the product literature. These, in turn, may well contribute to off-label use of medicines in children. Conclusions: Off-label prescribing does not necessarily mean that efficacy and safety data are unavailable. Variances in the product literature of medicines having the same active ingredients but imported from different countries may cause divergent prescribing practices, leading to inadvertent off-label use. The various stakeholders, including member states such as Malta, should devise strategies to harmonize the most recent labeling information in order to support the safe and effective use of pediatric medicines, thereby decreasing off-label use.

Maltese prescribers use of off-label and unlicensed medicines in children: perceptions and attitudes

2016

Background Reviews of paediatric prescriptions in the community setting have quantified off-label use to reach 52 % and unlicensed use to reach 17 %. Objective To investigate the attitudes and perceptions of a sample of paediatricians and family doctors practising in primary care on off-label and unlicensed prescribing in children in Malta. Methods A validated de novo 18-item questionnaire was used to conduct face-to-face, semi-structured interviews with 24 family doctors and 6 paediatricians during 2014. Results Although only 10 % of participants correctly defined off-label/unlicensed use, after the definitions were provided, 97 % admitted to knowingly prescribe medicines in this manner. Such use primarily involved prescribing to younger age groups and different indications to those recommended in the product literature. The main contributing factor for prescribing in an off-label/unlicensed manner was a lack of appropriately licensed paediatric medicines. The most commonly implicated class of medicines was cough/cold medicines. The principal concerns were medico-legal and safety concerns. Conclusion Participants knowingly prescribed medicines in an off-label/unlicensed manner. The perceived reasons were prescribing for a younger age and for indications outside the Summary of Product Characteristics. Divergent prescribing recommendations in different sources of information, prescribers' personal experience and reliance on medical representatives contribute to inadvertent off-label/unlicensed prescribing.