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. 2024 Sep 27;12(5):149.
doi: 10.3390/pharmacy12050149.

Off-Label Pediatric Medication Prescribing and Dispensing: Awareness and Attitudes among Community Pharmacists: A Questionnaire-Based Study

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Off-Label Pediatric Medication Prescribing and Dispensing: Awareness and Attitudes among Community Pharmacists: A Questionnaire-Based Study

Carmen-Maria Jîtcă et al. Pharmacy (Basel). .

Abstract

Off-label practice in pediatrics requires relentless engagement from all the health professionals involved. Community pharmacists are the last ones in the prescribing-dispensing chain; therefore, they have the key responsibility of verifying the correctness of a treatment. A cross-sectional study was conducted for assessing the awareness and views of Romanian community pharmacists, regarding off-label drugs in the pediatric population, through a 28-item questionnaire comprising five sections of different topics (general knowledge, frequency of prescribing and dispensing off-label medication, views, and attitudes). The sample size was 236 questionnaires with a response rate of 41.11%. A statistical analysis of the obtained data was performed with GraphPad Prism v.9. The results indicate that 55.1% of the community pharmacists have a good general knowledge and awareness regarding the off-label practice, although the legal frame is unclear. The responses highlight a high frequency of prescribing and request of medication for respiratory conditions (45.3%) and antibiotics (23.5%), with a concerning gap regarding the adverse events related to the off-label treatments (56.7%). A very small percentage of pharmacists (7.1%) contact a fellow healthcare professional when encountering an off-label prescription. In conclusion, in addition to the pharmacist's conduct towards the best interest of the patient, there is a clear need to improve the doctor-pharmacist collaboration in order to make an off-label treatment successful.

Keywords: community pharmacy; off label; pediatrics; pharmacy; survey.

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Conflict of interest statement

The authors declare no conflicts of interest.

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References

    1. Likic R., Maxwell S.R. Prevention of medication errors: Teaching and training. Br. J. Clin. Pharmacol. 2009;67:656–661. doi: 10.1111/j.1365-2125.2009.03423.x. - DOI - PMC - PubMed
    1. Radley D.C., Finkelstein S.N., Stafford R.S. Off-label prescribing among office-based physicians. Arch. Intern. Med. 2006;166:1021–1026. doi: 10.1001/archinte.166.9.1021. - DOI - PubMed
    1. Gray S.G., McGuire T.M. Navigating off-label and unlicensed medicines use in obstetric and paediatric clinical practice. J. Pharm. Pract. Res. 2019;49:389–395. doi: 10.1002/jppr.1605. - DOI
    1. Stafford R.S. Regulating off-label drug use—Rethinking the role of the FDA. N. Engl. J. Med. 2008;358:1427–1429. doi: 10.1056/NEJMp0802107. - DOI - PubMed
    1. Van Norman G.A. Off-Label Use vs Off-Label Marketing of Drugs: Part 1: Off-Label Use-Patient Harms and Prescriber Responsibilities. JACC Basic Transl. Sci. 2023;8:224–233. doi: 10.1016/j.jacbts.2022.12.011. - DOI - PMC - PubMed

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