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Rheumatic Heart Disease Australia

RHD Resouces

Global Status of BPG Report

RHD Action Global report: BPG has been subject to global stock outs over the last decade in both high and low resource settings. The fragmented melee of manufactures, suppliers and procurement agencies has complicated attempts to describe the sources of drug or the scale of shortages. Irrespective of cause, it is clear that global shortages have had significant worldwide impact on countries and procurement agencies trying to purchase BPG. Benzathine penicillin G (BPG) is an injectable antibiotic which provides a prolonged level of penicillin in the blood. There are two major global indications for BPG and a number of minor indications. Syphilis and rheumatic heart disease are both major global public health challenges. Access to reliable, high quality formulations of BPG is a prerequisite for the treatment and control of both diseases. The importance of BPG is widely recognised, through inclusion on the World Health Organization’s Essential Medicines List and associated Special Indication Lists. Despite considerable clinical need BPG has been the subject of widespread global shortages in recent years. Shortages have largely been attributed to difficulty securing quality assured active pharmaceutical ingredient for the manufacture of formulated product. Shortages of active pharmaceutical ingredient reflect the vulnerabilities of the global BPG market: procurement is fragmented by clinical indication, the number of manufacturers is small and total price of the drug is low. BPG shortages interrupt treatment regimens and increase the use of more expensive, less effective drugs which may accelerate development of resistance in other organisms. A reliable supply of high quality BPG is urgently needed to provide gold standard care and to support rational use of antibiotics. However, BPG and other older, off-patent antibiotics have been licensed on historic data which is insufficient for contemporary regulatory standards. Improving the quality and supply of BPG requires collective global action to redevelop the drug: answering outstanding scientific questions, integrating new data in regulatory bodies and communicating clearly about how, when and why the drug should be used. BPG remains an essential medicine and tangible, multi-stakeholder, steps are needed for it to be made safe and available to the vulnerable populations who need it most.
Author / Authors 
RHD Action
Year of publication 
2016
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Resource Topics