For those who attended the CPhI Japan show last week, you might have learned about a topic with emerging importance in the pharmaceutical industry—the effects of supply chain interruptions on pharmaceutical trade.
Last Wednesday, Yasutaka Igari, Ph.D, the chairperson of quality and technology at the Japan Pharmaceutical Manufacturers Association (JPMA) and senior director, global quality assurance department, Takeda Pharmaceutical Companies, delivered a presentation centered on quality assurance.
In proportion to the rapid diversification of suppliers of raw materials, quality-related issues have grown rapidly in recent years. In order to achieve consistent quality assurance from upstream to downstream throughout supply chain, it is essential to verify quality management system of raw material suppliers through auditing and also to establish a quality assurance system for distributing released products to customers without jeopardizing product quality.
This phenomenon has already shown adverse effects in Canada, where quality isn’t the issue—simply obtaining the right drugs has caused supply gaps. Recent reports say the federal government is working with pharmaceutical companies to address shortfalls in the supply of some prescription drugs, including a request that they seek alternative sources of the medications outside Canada. Hospitals in several provinces are reporting looming supply gaps for dozens of medications used in operating rooms, emergency departments and intensive care units.
Supply gaps are being blamed on a number of factors, including a diminished supply of raw materials—many of them from countries such as China and India—and a burgeoning global patient demand for medications.
Mark Ferdinand, senior director of health and economic policy for Rx & D, the association of Canada’s brand-name pharmaceutical companies, said Health Canada has to make critical decisions in conjunction with drug makers when it comes to alternative sources of supply.
But exactly where these medications would come from isn’t clear, given that drug shortages are occurring around the globe. In an online survey of almost 6,000 adults commissioned by the Canadian Association of Chain Drug Stores, more than 30 percent of respondents reported they had been affected by drug shortages, often more than once, during the past year.
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