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Home » BRAZIL IMPLEMENTS DISPENSING REFORMS
BRAZIL IMPLEMENTS DISPENSING REFORMS
July 25, 2005
Brazilian drug regulator Anvisa has implemented two major reforms to pharmacy dispensing, with mixed results. One measure first announced earlier this year-which controversially allows pharmacists to split up and repackage drug packets-is already in effect. The other, which will limit on-site preparation of pharmaceuticals, looks set to be limited in scope.
The repackaging decree has been criticised by some manufacturers -- including the local unit of US drug major Merck & Co -- which claim that regulators have failed to clarify the complex process of re-sorting drug packets, not least as there is little clear guidance on the formats in which branded drugmakers are required to provide the new packaging. Although the practice is widely used in some developed markets, drugmakers fear it could allow copies to enter the retail market.
Meanwhile, one positive reform will be new limits placed on pharmacies which mix and prepare pharmaceuticals on-site according to prescriptions, a practice which carries significant health risks. This segment of the retail sector has grown rapidly in recent years, to about 5,200 outlets throughout Brazil, but the practice was linked to two deaths last year. The reform is now under public consultation, and some reports claim that on-site drug preparation could be limited solely to herbal remedies in future.
KEYWORDS Daily International Pharma Alert
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