The use of Special-Order products in England between 2012 and 2020: An insight into the need for Point-of-Care manufacturing.

Point-of-care manufacturing such as 3D printing has recently received significant attention from regulatory bodies and the pharmaceutical industry. However, little information is available on the quantity of the most prescribed patient-specific items, their dosage form, and why they were required to be dispensed. In England, 'Specials' are unlicensed medicines formulated to meet the requirements of a specific prescription, prescribed if no suitable licensed alternative exists. This work aims to quantify and examine trends in the prescribing of 'Specials' in England during 2012-2020, using the NHS Business Services Authority (NHSBSA) database. Quarterly prescription data from NHSBSA for the top 500 'Specials' by quantity from 2012 to 2020 were compiled yearly. The changes in net ingredient cost, the number of items, British National Formulary (BNF) drug category, dosage form, and a potential reason for requiring a 'Special' were identified. In addition, the cost-per-unit was calculated for each category. The total spending on 'Specials' decreased by 62 % from £109.2 M in 2012 to £41.4 M in 2020, primarily due to a 55.1 % reduction in the number of 'Specials' items issued. The most frequently prescribed dosage form type of 'Special' was oral dosage forms (59.6 % of all items in 2020) particularly oral liquids. The most common reason for prescribing a 'Special' was an inappropriate dosage form (74 % of all 'Specials' in 2020). The total number of items dropped over the 8 years as commonly prescribed 'Specials' such as melatonin and cholecalciferol became licensed. In conclusion, the total spending on 'Specials' dropped from 2012 to 2020 primarily due to a reduction in the number of 'Specials' items issued and pricing changes in the Drug tariff. Based on the current demand for 'special order' products, these findings are instrumental for formulation scientists to identify 'Special' formulations to design the next generation of extemporaneous medicine to be produced at the point of care.