Cost Analysis of Clinical Compounding in Saudi Arabia : Oral Electrolyte Pediatrics Formulations

Yousef Ahmed Alomi* , General Administration of Pharmaceutical Care, Ministry of Health, Riyadh, Saudi Arabia. Faiz A. Bahadig, Informatics Pharmacist, Pharmaceutical Care Department, King Abdul-Aziz Medical, City-WR-Jeddah, Ministry of National Guard, Saudi Arabia. Malika Alhadab, Head, Pharmacy Services, Alyamma Hopsital, Ministry of Health, Riyadh, Saudi Arabia. Mona Lubbad, Former Head, Extemporaneous Preparation Unit, Pharmacy services, Alyamma Hopsital, Ministry of Health, Riyadh, Saudi Arabia. Ebtesam Nazal, Head, Extemporaneous Preparation Unit, Pharmacy Services, Alyamma Hopsital, Ministry of Health, Riyadh, Saudi Arabia.


INTRODUCTION
The national pharmacy nutrition support program was established as part of the Pharmacy strategic plan. [1,2] The program consisted of several elements neonatal parenteral nutrition, parenteral pediatrics nutrition, adults' parental nutrition, home total parental nutrition for adults, pediatrics and neonates, [3] in addition to enteral feeding for all types of populations. During Total Parenteral Nutrition (TPN) administration for chronic disease in the neonates or pediatrics and adults sometimes needs supplements of oral electrolyte. Most of neonatal or pediatrics supplements of electrolyte have not existed in the local market (Table 1). [4] The formulations with different concentrations need to prepare as extemporaneously in the pharmacy with new Saudi vision 2030 and updated Pharmacy strategic plan. The goal of any health care intervention is to implement health economic and pharmacoeconomic services, [2] that is including a cost analysis of medication formulations, for instance, pediatrics electrolyte preparation, cost analysis of pediatrics pharmacy services and cost avoidance of pharmacist impact. Several investigations had been done about cost analysis in Saudi Arabia. That's included the cost analysis of drug information services, cost analysis of the TPN and cost analysis of clinical pharmacy activities. [5][6][7][8] The authors based on their best knowledge; they are not aware of any local or international publications about cost analysis of oral electrolyte pediatrics formulations in Saudi Arabia or Gulf and the Middle East countries. The aim of the current study is to explore the cost analysis of oral electrolyte pediatrics formulation in the Kingdom of Saudi Arabia.

METHODS
It is a retrospective cost analysis of drug information services from past one year at 300-beds pediatrics and maternity hospital in Riyadh city, Saudi Arabia. It had inpatient admission, ambulatory care clinics and emergency departments. The hospital has a different specialty for women adults and pediatrics. It has several specialties including adult's endocrinology, adult's nephrology,

Cost Analysis of Clinical Compounding in Saudi Arabia: Oral Electrolyte Pediatrics Formulations
S25 pediatrics, adult's cardiology, adult's internal medicine, adult's surgery, adult's critical care, NICU, PICU, obstetrics and gynecology. The hospital treats the common neonatal, pediatrics and women health disease. The hospital has serve the patient including inpatient pharmacy with units' dose drug distribution system, outpatient pharmacy and extensive extemporaneous pediatrics section and drug information center. The pharmacy computerized physician order entry with an electronic prescription in addition to the pharmacy had medications safety program. The pharmacy trained clinical and pharmacy student training programs. The extemporaneous section had very comprehensive evidence-based pediatrics formulations for neonates and pediatrics in the central region of Ministry of Health hospitals. The section received the specific formulation from physician and then the expert pharmacist applied the international standard of clinical compounding through providing to healthcare staff over eight hours per days for five days per a week. The pediatrics formulation consisted of antibiotics, anti-tuberculosis (TB) medications, anticonvulsant medications, Gastrointestinal (GI) drugs, anti-hypertension medications, electrolyte supplements, renal preparations, diuretics formulation, steroid perorations and other supportive substances formulation. The analysis of the cost was included the variable expenses like personal cost, material and supply cost. Fixed costs include direct cost, nonsalary cost and overhead cost. [6,7] In addition to the cost of compounding substances, number of preparations and time of preparations. The price was derived from the Ministry of Health information database. All cost was used US dollar currency. The study analyzed pediatrics electrolytes pediatrics formulations through the Microsoft Excel sheet version 10 th .

RESULTS
The estimated average total standard cost of pediatric formulations per hour was (53.82 USD) and consisted of 58.58% (31.53 USD) for personal cost, 25.14% (13.53 USD) for overhead cost, 3.34% (1.8 USD) for material and supply cost, 12.93% (6.96 USD) for non-salary cost (Table 1 and 2). The average estimated cost of potassium chloride 10% per each preparation was (2.053 USD) with consisted of standard cost (0.48 USD) and the direct cost was (1.573 USD). The total annual cost of potassium chloride 10% was (172.452 USD) ( Table  3). The average estimated cost of potassium chloride 7.5% per each preparation was (1.342 USD) with consisted of a standard value (0.158 USD) and the direct cost was (1.184 USD). The total annual cost of potassium chloride 7.5% was (228.14 USD) ( Table 4). The average estimated cost of sodium bicarbonate 8.4% per each preparation was (0.7551 USD) with consisted of standard cost (0.37 USD) and the direct cost was (0.3851 USD). The total annual cost of sodium bicarbonate 8.4% was (54.36 USD) ( Table 5). The average estimated cost of calcium carbonate 200 mg/mL per each preparation was (5.45 USD) with consisted of standard cost (0.84 USD) and the direct cost was (4.61USD). The total annual cost of calcium carbonate 200 mg/mL was (1,046.4 USD) ( Table 6). The average estimated cost of sodium chloride 5.8% per each preparation was (1.117 USD) which consisted of a standard value (0.179 USD) and the direct cost was (0.938 USD). The total annual cost of sodium chloride 5.8% was (167.55 USD) ( Table 7).

DISCUSSION
Several electrolyte products registered in the Kingdom of Saudi Arabia and overseas countries (Table 1). For most of the potassium chloride syrup with came with specific concentration and mixed multivitamins or other electrolytes. However, still, most of oral electrolytes were not manufactured and non-available in the Saudi or International Market. [9][10][11][12] Those electrolytes with different concentration badly demand for pediatrics. As results, the current extemporaneous preparation unit at the local hospital pharmacy prepared those products for patients referred to the hospital. Those need to determine the cost analysis to calculate the extemporaneous budget and clarify the income and expenses of the hospital pharmacy through the current study. The findings showed the standard necessary foundations for all pediatrics formulations as indirect cost while the direct cost different from one product to another. Most of the cost foundations came from personal cost and a lesser amount from overhead cost that is related to pediatric formulations need mostly the pharmacist prepares the medications while less amount of equipment needed. The majority of the product came from a direct cost more than indirect cost. There were two different concentration of potassium chlorine 10% and 7.5% with size 100 ml. Both of them was used in Potassium supplements for pediatrics. The cost of lower concentrations were cheaper than registered medications in UK only that is related to direct cost higher than indirect cost with a low number of products. The calcium carbonate syrup cost was higher then what is not registered in the Saudi or UK and USA. [9][10][11][12] The number of calcium carbonate products was low while     the manufactures produced a higher number of products. In sodium bicarbonate pediatric formulations syrup was not available in the market with calcium carbonate. However, calcium carbonate only registered in UK with higher cost that prepared in the extemporaneous preparation unit. [11,12] It was difficult to compare with the local or international market. [9,10] In the sodium chloride syrup was not registered in the local market and it's challenging to compare with it. [9][10][11][12] Most of the product came as a solid dosage form. All electrolyte pediatrics formulation should continue to prepare them because of much cheaper and most of them was not available in the market. [9][10][11][12] The cost analysis of electrolyte pediatrics formulation was essential to calculate the income and expenses through privatization changing and to meet new Saudi vision 2030. [2,13] All pediatrics formulations with mainly emphasis on new formulations, the cost analysis should be conducted updated annually.

CONCLUSION
The total parental nutrition is essential services for neonates and pediatrics. Besides, enteral nutrition is the next steps of oral feeding. Some of oral pediatrics formulation may be required for neonatal disease and crucial electrolyte among them. Most of the oral electrolyte pediatrics formulation is not available in the market. The extemporaneous preparation of oral Electrolyte and cost related is essential for medication availability and subsequently, the patient satisfaction. The cost analysis of pediatrics oral electrolyte formulation is part of pharmacoeconomic services within hospital pharmacy strategic plan implementation. The annual or biannually of a cost analysis of oral electrolyte pediatrics formulation is highly recommended in the kingdom of Saudi Arabia.