The Pattern of Off-Label and Unlicensed Drug Use in Adult and Pediatric Patients in the Kingdom of Saudi Arabia: Multicenter Retrospective Study

    Nagham Sheblaq, Zainab Albahooth, Fatmah Alfawzan, Khalid Ahmed Al-Anazi, Sawsan Alshouli, Amal Alghalbi, Sameera Alshnaiber, Moyasar Alkurdi, Hajer Almudaiheem, Sattam Almutairi, Mohammed Alkuzaee, Amal Sulaiman Alanazi, Abdulaziz Alshareef, Nawaf Marzog Alotibi, Samia Zaben Almurshadi, Mohammed Alotaibi, Fatimah Aljohani, Lama Almutairi, Marwan ElBagoury, Ahmed M. Elagouz, Omar Hussein, Amal Hassan Al-Najjar
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    TLDR Most off-label drug prescriptions in Saudi Arabia are for adults with depression and diabetes.
    In a retrospective study conducted over a 12-month period at six tertiary hospitals in Saudi Arabia, 288 prescriptions were analyzed to evaluate the extent of off-label drug use (OLDU). The study found that 94.42% of off-label prescriptions were due to OLDU by indication, 2.09% were due to OLDU by different age group, and 3.48% were due to other reasons. The majority of the orders (89.05%) were received by adults and geriatrics (≥18 years), while children (1-11 years) received 7.78% of the orders. The most frequently prescribed therapeutic classes were antidepressants (21.88%), antidiabetics (17.71%), and atypical antipsychotics (10.06%). The study concluded that off-label prescribing was most common in adults and geriatrics suffering from depression and diabetes mellitus, and the most common reason for off-label prescription was off-label by indication. The authors called for more studies with larger sample sizes and the development of a policy for OLDU across hospitals.
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