The Food and Drug Administration (FDA) yesterday said that thanks to emergency imports and increased production of about 1.12 million bags of intravenous (IV) fluids, no hospital is having a shortage of the item, and supply is expected to stabilize in October.
YF Chemical Corp (永豐化學), which supplies 70 percent of the nation’s IV fluids, was ordered to suspend production last month, as the FDA during an on-site inspection found that the factory failed to meet the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme’s Good Manufacturing Practice standards for medicinal products.
The FDA last month said it has initiated several measures in response to the likely shortage of IV fluids, including asking other local manufacturers to increase production, open solicitation for companies to import or manufacture IV fluids that cannot be supplemented by other manufacturers, and publicizing alternative products and assisting healthcare facilities to obtain them.
Photo: CNA
The agency had estimated that if the IV fluids are converted to 500ml per bag, there would be a shortage of about 1.1 million bags this month and a monthly shortage of 1.5 million bags starting from next month.
At a news conference at the Ministry of Health and Welfare yesterday morning, FDA Director-General Wu Shou-mei (吳秀梅) said that “currently there is no hospital having a shortage of IV fluids.”
To make up the monthly shortage of about 1.5 million bags, the agency approved special programs for imports and increased production, she said, adding that about 1.12 million bags have been received so far.
About 316,000 bags were imported from Vietnam and Malaysia last week, while 564,000 bags have been imported from Greece, Japan and Indonesia this week, adding up to 880,000 bags, Wu said.
Increased production by local manufacturers added about 130,000 bags last week and 110,000 bags this week, totaling to 240,000 bags, she said.
The FDA surveyed demand at healthcare facilities nationwide and had distributed about 680,000 bags of IV fluid among 174 facilities as of noon Tuesday, Wu said.
The agency would continue to dispatch IV fluid products, she said.
Healthcare facilities should not make bulk or repeated orders, and they should avoid wasteful, nonclinical or nonessential use at this time, she said.
YF Chemical Corp must make thorough improvements to resume production, she said, adding that the company’s report has flaws and another on-site inspection is required.
Talks with other local manufacturers to increase production are ongoing to reduce YF Chemical’s high market share, she said.
Steady supply is expected to be realized in October at the earliest, Wu added.
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