The Pattern of Off-label and Unlicensed Drug Use in Adult and Pediatric Patients in the Kingdom of Saudi Arabia: Multicenter Retrospective Study
Nagham Sheblaq1*, Zainab Albahooth2, Fatmah Alfawzan2, Khalid Alanazi2, Sawsan Alshouli3, Amal Alghalbi3, Sameera Alshnaiber4, Moyasar Alkurdi4, Hajer Almudaiheem4, Sattam Almutairi5, Mohammed Alkuzaee5, Anoud Alanazi6, Abeer Alshareef6, Nawaf Alotibi7, Samia Almurshadi7, Mohammed Alotaibi7, Fatimah Aljohani8, Lama Almutairi9, Marwan ElBagoury10, Ahmed M. Elagouz11, Omar M. Hussein12, Amal Najjar3
1Ministry of National Guard Health Affairs, Saudi Arabia
2Prince Mohammed bin Abdulaziz Hospital, Saudi Arabia
3Security Force Hospital, Saudi Arabia
4Alyamamah Hospital, Saudi Arabia
5Maternity and Children Hospital, Makkah, Saudi Arabia
6Prince Sultan Cardiac Center, Saudi Arabia
7Prince Imam Abdulrahman Alfaisal Hospital, Saudi Arabia
8Prince Sultan Armed Force Hospital, Madinah, Saudi Arabia
9King Saud University Medical City, Riyadh, Saudi Arabia
10Universität Ulm - Medizinische Fakultät, Ulm, Deutschl
11University of the People, Pasadena, CA, USA
12Uxbridge Institute, UK
Citation: Sheblaq N, Albahooth Z, Alfawzan F, Alanazi K, Alshouli S et al (2020) The Pattern of Off-label and Unlicensed Drug Use in Adult and Pediatric Patients in the Kingdom of Saudi Arabia: Multicenter Retrospective Study. SciTech Infectious Diseases 2020. Mauritius
Received: December 30, 2019 Accepted: January 02, 2020 Published: January 02, 2020
Background: Screening approved medications to identify therapeutics for drug repurposing is an effective tactic, and a deep research into off label drug use (OLDU) is required. Unfortunately, OLDU has not been extensively studied in Middle East. Our study aimed to evaluate the extent of OLDU in Saudi Arabia.
Methods: Retrospective study carried out during 12 months period at six tertiary hospitals in Saudi Arabia. Each prescription was evaluated as unlicensed or OLDU based on the product information or based on Food and drug Administration (FDA) approval.
Results: A total of 288 prescriptions were analyzed, where the reasons for off-label prescribing were OLDU by indication (94.42%), OLDU by different age group (2.09%), and other reasons represented (3.48%). Adults/geriatrics (≥18 years) received (89.05%) of the orders, and children (1-11 years) received (7.78%) of the orders. Both adolescents (12-18 years) and neonates (1-29 days) received (1.42%) of the orders per each category, while infants (1 month-1 year) received (0.36%) of the orders. The therapeutic classes most often prescribed were antidepressants (21.88%), antidiabetics (17.71%), and atypical antipsychotics (10.06%).
Conclusions: Off-label prescribing was found in most adults/geriatrics suffering from depression, and diabetes mellitus. The most common reason for off-label prescription was off-label by indication. The results call for the need to conduct more studies with larger sample size, do more investigations on the OLDU in the whole kingdom, and develop policy for OLDU across hospitals.
Keywords: Off-label medication, Guidelines, Prescriptions