Pharmacists' and Parents' Awareness and Attitudes Toward Off-Label Drug Prescribing in Pediatrics, Zawia (Libya)
DOI:
https://doi.org/10.55940/medphar2025116Keywords:
Awareness and Attitudes, Cross-Sectional Studies, Off-Label Drugs, Pharmacists, and ParentsAbstract
Background: Off-label medicine prescriptions—where medications are used in a manner not specified in the official labeling—are commonly practiced across the globe, particularly in pediatric care. However, many of these prescriptions are made without adequate clinical evidence to support their safety and efficacy in children.
Objective: This study aimed to assess and compare the knowledge, awareness, and perspectives of both pharmacists and parents regarding the off-label use of medications in pediatric patients.
Methods: A descriptive cross-sectional survey was conducted over a three-month period, from January to March 2023, targeting pharmacists and parents residing in Al Zawia city. Data collection was carried out through a structured questionnaire, which was divided into two main sections: one for pharmacists and one for parents. The instrument was carefully designed based on prior validated studies and was translated into Arabic to facilitate comprehension and encourage prompt responses. The questionnaire collected both demographic information and opinions related to off-label drug use in children. A total of 150 participants were enrolled, including 100 parents and 50 pharmacists. The surveys were self-administered, with each taking approximately five minutes to complete. Participants were randomly selected to ensure a representative sample.
Results: Analysis of the collected data revealed a relatively high level of awareness and understanding among both pharmacists and parents regarding the concept and implications of off-label drug use in pediatric populations. Pharmacists demonstrated a more in-depth knowledge, likely due to their professional background, while parents showed a basic yet important awareness of the subject. Most respondents expressed concerns about the lack of proper guidelines and scientific validation for such prescriptions.
Conclusion: The findings suggest that there is a commendable level of knowledge and awareness among both pharmacists and parents concerning off-label prescribing for children. This highlights the importance of ongoing education, clear regulatory policies, and open communication between healthcare professionals and caregivers to ensure safe and effective pediatric pharmacotherapy.
References
Mazariego C, Daly R, McGill B, et al. Barriers to access of precision guided therapies for children with high‐risk cancer. Pediatr Blood Cancer. 2024;71(11):e31147. DOI:10.1002/pbc.31147.
Lenk C, Koch P, Zappel H, et al. Off-label, off-limits? Parental awareness and attitudes towards off-label use in paediatrics. Eur J Pediatr . 2009; 168(12):1473–1478. DOI:10.1007/s00431-009-0956-6.
Buchholz C, Bell LA, Adatia S, et al. Medications for Opioid Use Disorder for Youth: Patient, Caregiver, and Clinician Perspectives. J Adolesc Health. 2024;74(2):320–326. DOI:10.1016/j.jadohealth.2023.08.047.
Van Der Zanden TM, Mooij MG, Vet NJ, et al. Benefit‐Risk Assessment of Off‐Label Drug Use in Children: The Bravo Framework. Clin Pharmacol Ther . 2021;110(4):952–965. DOI:10.1002/cpt.2336.
Rose K, Grant-Kels JM, Striano P. Therapeutic orphans, off-label, pediatric drug development: towards reasonable pharmacotherapy for minors. Expert Opin Pharmacother . 2024;25(18):2375–2384. DOI:10.1080/14656566.2024.2426678.
Van Norman GA. Off-Label Use vs Off-Label Marketing of Drugs. JACC Basic Transl Sci . 2023;8(2):224–233. DOI:10.1016/j.jacbts.2022.12.011.
Beatriz G-C, María José O, Inés J-L, et al. Medication errors in children visiting pediatric emergency departments. Farm Hosp. 2023; 47(4):141–147. DOI:10.1016/j.farma.2023.03.006.
Roy RR, Sultana N. Hypertension in Children. Paediatr Nephrol J Bangladesh . 2021 ;6(2):59–69. DOI:10.4103/pnjb.pnjb_23_21.
Chin C-Y, Huang W-T, Wang J-H, et al. Overview of clinical status, treatment, and long-term outcomes of pediatric autosomal-dominant polycystic kidney disease: a nationwide survey in Taiwan. Sci Rep . 2024;14(1):16280. DOI:10.1038/s41598-024-67250-z.
Silva-Velasco DL, Cervantes-Pérez LG, Sánchez-Mendoza A. ACE inhibitors and their interaction with systems and molecules involved in metabolism. Heliyon. 2024;10(2):e24655. DOI:10.1016/j.heliyon.2024.e24655.
Ettienne EB, Grant-Kels JM, Striano P, et al. Melanoma and pediatric drug development: clinical progress vs. regulatory activism in minors - a narrative review. Expert Opin Pharmacother . 2025;1–9. DOI:10.1080/14656566.2025.2475184.
David Bradford W, Turner JL, Williams JW. Off‐Label Use of Pharmaceuticals: A Detection Controlled Estimation Approach. J Ind Econ . 2018;66(4):866–903. DOI:10.1111/joie.12189.
Liu R, Wang L, Rizzo S, et al. Systematic analysis of off-label and off-guideline cancer therapy usage in a real-world cohort of 165,912 US patients. Cell Rep Med. 2024; 5(3):101444. DOI:10.1016/j.xcrm.2024.101444.
Díaz Hernández M, Roslin W, Mansnérus J. Paving the Path for Sustainable and Responsible Off-Label Use of Pharmaceutical Products in Europe. Eur J Health Law. 2024;31(2):129–152. DOI: 10.1163/15718093-bja10123.
Habib S, Bailey KA, Griffin M. Off-Label: Lived, Embodied, and Temporal Experiences of Premenstrual Dysphoric Disorder (PMDD) in Canada. Womens Reprod Health. 2024;1–20. DOI:10.1080/23293691.2024.2436925.
AbuAlsaud Z, Alshayban D, Joseph R, et al. Off-label Medications Use in the Eastern Province of Saudi Arabia: The Views of General Practitioners, Pediatricians, and Other Specialists. Hosp Pharm. 2020;55(1):37–43. DOI:10.1177/0018578718817861.
Bazzano ATF, Mangione-Smith R, Schonlau M, et al. Off-Label Prescribing to Children in the United States Outpatient Setting. Acad Pediatr. 2009;9(2):81–88. DOI:10.1016/j.acap.2008.11.010.
Pérez RP, Ruiz Antorán MB, Avedaño Solá C, et al. Results from the 2012–2013 paediatric national survey on off-label drug use in children in Spain (OL-PED study). An Pediatría Engl Ed. 2014;81(1):16–21. DOI:10.1016/j.anpede.2013.10.003.
Jîtcă C-M, Jîtcă G, Silvia I. Off-Label Pediatric Medication Prescribing and Dispensing: Awareness and Attitudes among Community Pharmacists: A Questionnaire-Based Study. Pharmacy. 2024;12(5):149. DOI:10.3390/pharmacy12050149.
Bhopal MP. Community medicine and health. Int J Health Sci. 2022;6166–6276. DOI:10.53730/ijhs.v6nS8.13751.
Awad MM, Elsahar MI. Asymptomatic Bacterial Infection in Pregnancy: A new update. Med Pharm J. 2022;1(2):1–11. DOI:10.55940/medphar20228.
Beshna E, Malod J, Benyusef N. Assessment of the Distribution of Antibiotics without a Prescription at Community Pharmacies in Zawia, Libya. Tikrit J Pharm Sci. 2023;17(2):64–71. DOI:10.25130/tjphs.2023.17.2.6.64.71.
Ibrahem KM, Said WA, Beshna EA, et al. Knowledge, Principles, and Clinical Consequences of Drug Interaction: A Cross-Sectional Study in Subratha Teaching Hospital, Libya. Med Pharm J. 2024;3(2):71–81. DOI:10.55940/medphar202482.
Al-Hussaniy HA, Hassan AF, Oraibi AI, et al. Clinical Pharmacogenetics of Angiotensin II Receptor Blockers in Iraq. J Pharm Bioallied Sci. 2023;15(3):101–106. DOI:10.4103/jpbs.jpbs_313_23.
Beshna EA, Alahrish RA. Pharmacists’ knowledge and attitudes toward Pharmacogenomics in Zawia, Libya. Med Pharm J. 2023;2(3):158–166. DOI:10.55940/medphar202355.
Magola-Makina E, Abuzour AS, Ashcroft DM, et al. Exploring the challenges to safer prescribing and medication monitoring in prisons: A qualitative study with health care staff. Cowley H, editor. PLOS ONE. 2022 ;17(11):e0275907. DOI:10.1371/journal.pone.0275907.
Beshna EA, Amir S, Swead RT, et al. Perception, knowledge and attitude of solar radiation diseases and use of sun screen among Al Zawia Medical University Students in Libya. Med Pharm J. 2022;1(2):34–44. DOI:10.55940/medphar202223.
Jîtcă C-M, Jîtcă G, Silvia I. Off-Label Pediatric Medication Prescribing and Dispensing: Awareness and Attitudes among Community Pharmacists: A Questionnaire-Based Study. Pharmacy. 2024;12(5):149. DOI:10.3390/pharmacy12050149.
Gray SG, McGuire TM. Navigating off‐label and unlicensed medicines use in obstetric and paediatric clinical practice. J Pharm Pract Res . 2019;49(4):389–395. DOI:10.1002/jppr.1605.
Ahmed MT, Mohammed ZN, Tawfeeq KT. Endoscopic characteristics and management of Subepithelial Lesions in Video-Gastascopie. Med Pharm J . 2022;1(1):4–13. DOI:10.55940/medphar20222.
Rusz C-M, Ősz B-E, Jîtcă G, et al. Off-Label Medication: From a Simple Concept to Complex Practical Aspects. Int J Environ Res Public Health . 2021;18(19):10447. DOI:10.3390/ijerph181910447.
Wale A, Mantzourani E. Unlicensed “Special” Medicines: Using the Pillar Integration Model to Understand Stakeholder Perspectives Across Care Settings. Integr Pharm Res Pract . 2024;Volume 13:209–228. DOI:10.2147/IPRP.S477087.
Giurin MS, Trojniak MP, Arbo A, et al. Safety of Off-Label Pharmacological Treatment in Pediatric Neuropsychiatric Disorders: A Global Perspective From an Observational Study at an Italian Third Level Children’s Hospital. Front Pharmacol. 2022;13:837692. DOI:10.3389/fphar.2022.837692.
Paudyal V, Cadogan C, Fialová D, et al. Provision of clinical pharmacy services during the COVID-19 pandemic: Experiences of pharmacists from 16 European countries. Res Soc Adm Pharm. 2021; 17(8):1507–1517. DOI:10.1016/j.sapharm.2020.11.017.
Baz SA, Fang C, Carpentieri JD, et al. ‘I don’t know what to do or where to go’. Experiences of accessing healthcare support from the perspectives of people living with Long Covid and healthcare professionals: A qualitative study in Bradford, UK. Health Expect. 2023; 26(1):542–554. DOI:10.1111/hex.13687.
Stewart D, Rouf A, Snaith A, et al. Attitudes and experiences of community pharmacists towards paediatric off‐label prescribing: a prospective survey. Br J Clin Pharmacol. 2007;64(1):90–95. DOI:10.1111/j.1365-2125.2007.02865.x.
Russkikh SV, Tarasenko EA, Moskvicheva LI, et al. “Off-label” drugs: legal problems and socio-economic aspects of application practice. Pharm Pharmacol . 2023;11(2):149–160. DOI:10.19163/2307-9266-2023-11-2-149-160.
Dewan T, Birnie K, Drury J, et al. Experiences of medical traumatic stress in parents of children with medical complexity. Child Care Health Dev . 2023 [cited 2025 Mar 30];49(2):292–303. DOI:10.1111/cch.13042.
Howe K, Bourke S, Sansom L. The extent to which off-patent registered prescription medicines are used for off-label indications in Australia: A scoping review. Gericke C, editor. PLOS ONE. 2021;16(12):e0261022. DOI:10.1371/journal.pone.0261022.
Blankart KE, Lichtenberg FR. Prevalence and relationship with health of off-label and contraindicated drug use in the United States: a cross-sectional study. J Pharm Policy Pract . 2025;18(1):2472221. DOI:10.1080/20523211.2025.2472221.
Dubrall D, Leitzen S, Toni I, et al. Descriptive analysis of adverse drug reaction reports in children and adolescents from Germany: frequently reported reactions and suspected drugs. BMC Pharmacol Toxicol . 2021;22(1):56. DOI:10.1186/s40360-021-00520-y.
Sweileh WM. Global research publications on systemic use of off-label and unlicensed drugs: A bibliometric analysis (1990–2020). Int J Risk Saf Med. 2022; 33(1):77–89. DOI:10.3233/JRS-210012.
Lee JY, Ang ASY, Mohd Ali N, et al. Incidence of adverse reaction of drugs used in COVID-19 management: a retrospective, observational study. J Pharm Policy Pract. 2021;14(1):84. DOI:10.1186/s40545-021-00370-3.
Laroche M, Gautier S, Polard E, et al. Incidence and preventability of hospital admissions for adverse drug reactions in France: A prospective observational study (IATROSTAT). Br J Clin Pharmacol . 2023;89(1):390–400. DOI:10.1111/bcp.15510.
Shah J, Raut A, Krishna K, et al. Off-label Drug Prescription Pattern and Related Adverse Drug Reactions in the Medical Intensive Care Unit. Indian J Crit Care Med . 2021;25(8):872–877. DOI:10.5005/jp-journals-10071-23909.
Han N, Oh JM, Kim I-W. Adverse Events Related to Off-Label Drugs Using Spontaneous Adverse Event Reporting Systems. Ther Clin Risk Manag . 2021;Volume 17:877–887. DOI:10.2147/TCRM.S321789.
Kleiber N, Gariépy-Assal L, Coulombe J, et al. Off-Label Use and Safety of Drug Use in Vascular Anomalies. Dermatology. 2021;237(4):649–657. DOI:10.1159/000515980.
Nguyen KA, Mimouni Y, Jaberi E, et al. Relationship between adverse drug reactions and unlicensed/off-label drug use in hospitalized children (EREMI): A study protocol. Therapies . 2021;76(6):675–685. DOI:10.1016/j.therap.2021.01.057.
Mei M, Xu H, Wang L, et al. Current practice and awareness of pediatric off-label drug use in Shanghai, China -a questionnaire-based study. BMC Pediatr . 2019;19(1):281. DOI:10.1186/s12887-019-1664-7.
Zachry WM, Ginsburg DB. Patient autonomy and the regulation of direct-to-consumer advertising. Clin Ther. 2001;23(12):2024–2037. DOI: 10.1016/S0149-2918(01)80155-7.

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