Detecting Medicine Safety Signals Using Prescription Sequence Symmetry Analysis of a National Prescribing Data Set.

INTRODUCTION: Medicine safety signal detection methods employed by the medicine regulator in Australia (Therapeutic Goods Administration [TGA], Department of Health) rely predominantly on analysis of spontaneous adverse event (AE) reports, sponsor notifications or information shared by international agencies. The limitations of these methods and the availability of large administrative health data sets has given rise to greater interest in the use of administrative health data to support pharmacovigilance (PV). OBJECTIVE: We explored whether prescription sequence symmetry analysis (PSSA) of Pharmaceutical Benefits Scheme (PBS) data can enhance signal detection by the TGA, using the AE, heart failure (HF) as a case study. METHODS: We applied the PSSA method to all single-ingredient medicines dispensed under the PBS between 2012 and 2016, using furosemide initiation as a proxy for new-onset HF. A signal was considered present if the lower limit of the 95% confidence interval for the adjusted sequence ratio was > 1. We excluded medicines known to cause HF, indicated for HF treatment or indicated for diseases that may contribute to HF. RESULTS: Of the 654 tested medicines, 26 potential new HF signals were detected by PSSA. Five signals had additional support for the possible association provided by biological plausibility, consistency and disproportionate reporting of cases of HF to the TGA and the World Health Organization; and clinical impact. CONCLUSION: PSSA was able to identify potential signals for further evaluation. With the increasing availability of different administrative health data sources, the strengths and weaknesses of methods used to analyse these data for the purpose of regulatory PV should be evaluated.

Price and utilisation differences for statins between four countries.

INTRODUCTION: Australia, England, France and New Zealand use different policies to regulate their medicines market, which can impact on utilisation and price. OBJECTIVES: To compare the prices and utilisation of statins in Australia, England, France and New Zealand from 2011 to 2013. METHODS: Utilisation of statins in the four countries was compared using Defined Daily Doses (DDD) per 1000 inhabitants per year. Pairwise Laspeyres and Paasche index comparisons were conducted comparing the price and utilisation of statins. RESULTS: The results showed that the price of statins in New Zealand was the cheapest. The price of statins in Australia was most expensive in 2011 and 2012 but France was more expensive in 2013. There were large differences between the Laspeyres index and Paasche index when comparing the price and utilisation of England with Australia and France. DISCUSSION: The policies that regulate the New Zealand and England medicines markets were more effective in reducing the price of expensive statins. The relative utilisation of cheaper statins was greatest in England and had a large effect on the differences between the two index results. The pricing policies in Australia have been only partly effective in reducing the price of statins compared to other countries.

Discounting of medicines in Australian community pharmacies.

OBJECTIVE: There are many medicines listed on the Australian Pharmaceutical Benefits Scheme (PBS) in which point of sale price is less than the level of the general patient co-payment. In these circumstances, the patient covers the total cost of the medicine from their own pocket with no government subsidy. The aim of the present study was to compare the consumer prices of under general co-payment prescription medicines between banner group pharmacies with open discounting policies and community pharmacies without; and to assess the impact of the April 2012 PBS price disclosure policies on the discounts offered. METHODS: The consumer prices of 31 under co-payment medicines were collected from banner group pharmacy websites and individual pharmacies both before and after April 2012. PBS maximum prices were obtained from the PBS website. Absolute and relative price differences between PBS and pharmacy groups were calculated. RESULTS: Before April 2012, banner group pharmacies provided discounts to patients of around 40% per prescription, whereas other pharmacies provided discounts of around 15%. Total price savings were on average $9 per prescription at banner group pharmacies and $3.50 at other pharmacies. Percentage discounts did not change greatly after April 2012, when price decreases occurred on the PBS. CONCLUSIONS: Banner group pharmacies with pricing strategies are able to provide greater discounts to patients compared with other pharmacies. Community pharmacies still have the ability to provide substantial discounts after the April 2012 price reductions. WHAT IS KNOWN ABOUT THE TOPIC?: There is currently little known about the under co-payment medicines market in Australia and the price discounts available to patients. WHAT DOES THIS PAPER ADD?: This research shows that patients who purchase under co-payment medicines are able to save money if they purchase from pharmacies with openly advertised discounting policies. Price reductions related to the implementation of the price disclosure policy had a small effect on the discounts offered by community pharmacies to patients. WHAT ARE THE IMPACTS FOR PRACTITIONERS?: The effect of discounting on under co-payment medicines to patients may increase their ability to afford essential medicines. Questions remain on whether the effect of discounting on under co-payment medicines may affect the quality of professional services provided to patients by pharmacists.