The use of licensed, mass-produced medicines represents the gold standard for ensuring quality, safety, and efficacy in patient care ([9]). However, there are frequent clinical scenarios where no licensed product fully meets the needs of a specific patient ([4]; [12]). This is particularly true for pediatric and geriatric populations, who often face difficulties swallowing solid dosage forms and require personalized, weight-based dosing ([10]; [11]). The deficit of age-appropriate formulations forces healthcare professionals to resort to the unauthorized use of adult medications, a practice associated with dosing errors and compromised therapeutic outcomes ([14]).

Extemporaneous Preparation (EP) is the process by which a pharmacist combines, mixes, or alters ingredients to create a customized medication for an individual patient in response to a licensed practitioner’s prescription ([13]). While the prevalence of EPs has declined in high-income countries due to the wider availability of specials and licensed alternatives, it remains a vital service in many parts of the world ([5]; [7]). In Sudan, economic challenges, drug shortages, and a lack of a National List of Essential Medicines for Children have created an environment where EPs are not just an exception but a necessity ([8]; [1]).

Despite its critical role, the practice of extemporaneous compounding carries inherent risks, including formulation errors, microbial contamination, and a lack of stability data ([3]; [4]). Understanding the extent and nature of this practice is the first step toward mitigating these risks and ensuring patient safety. While a previous study in Khartoum reported that community pharmacists compound 1 - 5 prescriptions weekly ([7]), there is a notable lack of data from hospital settings, where the demand for complex and critical care medications is higher. Therefore, this study aimed to evaluate the patterns, prevalence, and drivers of oral extemporaneous preparations in a major tertiary hospital in Sudan, to provide a foundational evidence base for future interventions and policy decisions.

This study provides the first comprehensive analysis of extemporaneous compounding in a Sudanese hospital, revealing it as a widespread and essential practice. The high volume of 502 prescriptions over three months underscores the heavy reliance on EPs to bridge critical gaps in the drug supply.

The National Medicine and Poisons Board in Sudan mandates that pharmacies engaged in compounding must have a dedicated facility. The compounding unit at Royal Care Hospital adhered to basic quality control measures: it was a separate room with adequate lighting, ventilation, and a water supply. The unit was equipped with electronic scales, glass mortars and pestles, calibrated flasks, and magnetic stirrers. Surfaces were cleaned with appropriate detergents and sanitized with 70% alcohol before and after use. Personnel used personal protective equipment such as gloves and masks. While this describes a structured environment, it is important to note that formal stability testing and rigorous analytical assays for the final compounded products were not routinely performed.

A key finding is the disproportionate impact on vulnerable populations. The fact that 41.85% of EPs were for children under one year of age is a stark indicator of the severe lack of licensed pediatric formulations in Sudan. This aligns with studies from Ghana and Nigeria, which also reported high use of EPs in children due to market failures ([2]; [15]). Similarly, the significant use in elderly patients (20.61%) highlights challenges such as dysphagia, which are not adequately addressed by available adult dosage forms ([11]).

The profile of the most compounded drugs is highly revealing. The top three—hydroxyurea for sickle-cell disease, KCL for hypokalemia, and NaHCO3 for acidosis—are not obscure medications but essential, life-saving drugs. Their unavailability in suitable forms points to a systemic failure in the pharmaceutical market to serve patients with chronic and acute conditions. The high prevalence of cardiovascular EPs further confirms that this is not a niche issue but affects core therapeutic areas.

Geographical Context and Frequency The percentage of prescriptions allocated to extemporaneous compounding (19.7%) in this Sudanese hospital is significant and underscores a vital reliance on this procedure. Although direct, comparable hospital-based prevalence data from sub-Saharan Africa are limited, our findings indicate a greater dependence on compounding than what has been reported in many bordering countries. A study in Nigeria, which encounters comparable pharmaceutical issues, documented significant extemporaneous compounding but did not quantify it as a percentage of overall prescriptions, concentrating instead on the categories of medications compounded ([15]). The elevated incidence at Royal Care Hospital probably indicates the cumulative impact of Sudan’s particular economic difficulties, foreign currency deficits, and supply chain interruptions, which have been intensified by recent worldwide occurrences ([6]). This disparity highlights that compounding is not a marginal activity but a fundamental aspect of the medication-use system, addressing needs that in countries with stronger regulatory and manufacturing capabilities may be fulfilled by the commercial market or imported “specials” ([14]). The results necessitate additional systematic, multi-center research to establish a standard for compounding prevalence in the region, which is crucial for promoting policy reforms and securing investment in local pharmaceutical production of key pediatric and specialist formulations.

The primary rationale for compounding in this investigation was the unavailability of medications (63.3%) and the unavailability of required dosage forms or strengths (36.7%). This suggests that EPs in this context are not merely for personalization but are a fundamental public health response to drug stockouts and market absence. This situation is likely exacerbated by Sudan’s economic instability and the COVID-19 pandemic, which have severely disrupted pharmaceutical supplies ([6]). Our findings on therapeutic classes are consistent with regional studies. Research from Nigeria also identified cardiovascular drugs and electrolyte replacements as leading categories for compounding ([15]), indicating a common pattern of pharmaceutical gaps across similar healthcare systems.

Limitations:

This study was conducted in a single, large tertiary hospital in the capital city, which may limit the generalizability of findings to rural or smaller healthcare facilities in Sudan. Furthermore, the study design was descriptive and did not assess clinical outcomes or the quality of the compounded products.

Moreover, the study design was descriptive and failed to evaluate clinical outcomes or the quality of the compounded medicines. The absence of demographic data for 17 prescriptions, including a mere 3.4%, may introduce a slight bias; nonetheless, it is improbable that it will substantially affect the reported age distribution, which was predominantly skewed towards pediatric patients.

This study demonstrates that extemporaneous compounding is a cornerstone of clinical care at Royal Care Hospital, essential for managing a wide range of conditions, especially in pediatric and geriatric patients. The practice is predominantly driven by the profound unavailability of essential medicines in suitable dosage forms. These findings serve as a critical call to action for hospital administrators, policymakers, and the pharmaceutical industry. There is an urgent need to develop a National List of Essential Medicines for Children, encourage the local production of pediatric formulations, and establish standardized, quality-assured compounding protocols to ensure that this vital practice is conducted as safely and effectively as possible.

The authors acknowledge the staff of the Royal Care Hospital pharmacy department for their assistance in data collection.