BAPW backs international shortages prevention plan
It is "of vital importance" that manufacturers communicate with regulatory bodies, says BAPW executive director Martin Sawer
Recommendations by an international trade body could reduce medicine shortages by improving communication between manufacturers and regulators, the British Association of Pharmaceutical Wholesalers (BAPW) has told C+D. BAPW chief executive Martin Sawer branded a shortages prevention plan by the International Society for Pharmaceutical Engineering (ISPE) a "positive and important piece of work" that could help address the "global issue". In its plan, published on Tuesday (October 14), the ISPE urged manufacturers to communicate with regulators around the world to help identify when certain drugs were out of stock and provide a "rapid response" to address the impact on patients. Mr Sawer told C+D it was "of vital importance" that manufacturers in the UK followed this recommendation for a "holistic approach" to shortages, which would help the government "get a grip" on the problem. Wholesalers could find alternative sources for medicines if they knew about stock shortages in advance, he said, but it was a "challenge" to continue to supply pharmacies when shortages occurred without any warning. It was "particularly helpful" that the plan had been written by an independent body with the backing of regulators around the world, said Mr Sawer, who was hopeful it would put pressure on the European Medicines Agency (EMA) and national regulators such as the MHRA to ensure that manufacturers adhered to the ISPE's recommendations. But Mr Sawer suggested that the ISPE's drug shortages team, which includes representatives from manufacturers such as Novartis and Johnson & Johnson, was not broad enough. The team should consider either expanding or designating separate teams to focus on different drug markets across the world, he said. In its plan, which the ISPE published in response to a request from the EMA last year, the trade body recommended that manufacturers implement "robust" quality systems to ensure good practice and put in place measures to predict the likelihood of shortages. These measures could help address the "underlying root causes behind shortages", it said. The recommendations were limited to shortages caused by manufacturing and supply issues, but the ISPE stressed that there were other factors that could impact the availability of medicines, such as regional or economic causes. In August, pharmacy minister Earl Howe told C+D that the government dealt with stock shortages "very effectively" and warned that their effect on patients should not be "exaggerated".
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