Applying a pharmacist recommended medicine categorisation framework

Abstract

Evidence based processes to categorise medicines that are suitable to be considered for pharmacist recommendation in order to promote safe access to medicines. A score-based framework was developed to categorise medicines according to three categories: Category May be considered as Pharmacist Recommended Medicines (PRM) (67%-100%), Category 2 May be considered as PRMs with strict guidelines, and Category 3: Shall only be recommended by physician. The aim was to apply a pre-developed structured framework to categorise feasibility of medicines to be made available as PRMs. A comprehensive list of all medicines authorised for use in Malta was retrieved from the Malta Medicines Authority database. This dataset was systematically filtered to exclude paediatric only formulations, intravenous preparations, and medicines primarily indicated for chronic conditions, as these were outside the scope of the intended assessment. The refined dataset was then categorised into three distinct groups: (i) medicines already licensed as pharmacist recommended medicines (PRMs), (ii) prescription only medicines (POMs) with direct over the counter (OTC) equivalents, and (iii) POMs without direct OTC equivalents. To verify real world market availability, all products within these lists were cross checked across two independent community pharmacies. Medicines identified as discontinued or no longer commercially available were removed to ensure the lists reflected the current Maltese market landscape. Two medicines from each of the three lists were randomly selected using an online randomisation tool for subsequent evaluation through the developed framework. The six identified medicines were appraised using the pre-developed framework to determine their PRM category. The two licensed PRM products (i) selected were levonorgestrel 1500 micrograms film coated tablets and sildenafil 50 mg film coated tablets. The two POMs with direct OTC equivalents (ii) were naproxen 500 mg gastro resistant tablets and betamethasone 0.1% w/w cream, while the two POMs without direct OTC equivalents (ii) were chloramphenicol 1% w/w eye ointment and nitrofurantoin 50 mg hard capsules. According to the framework, 4 of the 6 medicines scored between 68%-80% and were classified as Category 1. The mean score for the category 1 medicines was: 275 out of 300 for patient safety, 78 out of 100 for access to medicines, 164 out of 200 for overall cost to patient and the healthcare system, and 78 out of 600 for threats to patient. The remaining 2, sildenafil 50mg and chloramphenicol 1%, were classified as Category 2 (46%-66%). The mean scores obtained by the category 2 medicines were 233 out of 300 for patient safety, 86 out of 100 for access to medicines, 155 out of 200 for overall cost to patient and the healthcare system, and 138 out of 600 for threats to patient. The framework was practical to be applied in a real-world scenario for the different groups of medicines. The framework identified the medicine that is currently licensed as a PRM with guidelines to retain the same status (category 2). The framework demonstrated sensitivity to differentiate current POM medicines between category 1 and category 2 mainly through the risk assessment inbuilt within the framework.