Thu, Jan 11, 2024 page3

• FDA declares temporary eye drop supply shortage

  ALTERNATIVES RECOMMENDED: There is a shortage of an NHI-covered eye drop used to relieve burning, irritation and discomfort caused by dry eyes, the agency said

  • By Lee I-chia / Staff reporter
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  The Food and Drug Administration (FDA) yesterday said that there is a temporary supply shortage of Artelac eye drops, as demand for the product increased after another brand withdrew from National Health Insurance (NHI) coverage.

  Pharmacist Shen Tsai-ying (沈采穎), a Chinese Nationalist Party legislative-at-large nominee, on Tuesday wrote on her Facebook page: “There is a big shortage of Artelac eye drops. Does everyone know it is caused by the National Health Insurance Administration [NHIA]?”

  FDA Deputy Director Cheng Hwei-fang (陳惠芳) yesterday said the NHI-covered Artelac eye drops contain active ingredient hydroxypropyl methylcellulose and are used to temporarily relieve burning, irritation and discomfort caused by dry eyes.

  

  FDA Deputy Director Cheng Hwei-fang, center, speaks at a news conference in Taipei yesterday.

  Photo: CNA

  The FDA on Jan. 13 last year received a report from the pharmaceutical company saying that due to the shortage of packaging material and ingredients, it would not be able to provide sufficient amounts of the eye drops, Cheng said.

  The company imported extra amounts — about seven months’ worth — of eye drops in October last year, but as another brand of eye drops named Tears Naturale with the same active ingredient withdrew from NHI system, there has been a shortage, Cheng said.

  FDA Medicinal Products Section senior specialist Yang Bo-wen (楊博文) said before the other brand withdrew from NHI coverage, in one month about 40,000 bottles of Artelac eye drops used to be prescribed under NHI coverage.

  Yang said the pharmaceutical company plans to import another batch in April, which should help the supply situation.

  In the meantime, while there is a temporary shortage, people who need eye drops are advised to purchase alternative drugs with the same active ingredient and dosage form, but in different sizes, including the NHI-covered Wu-Fu Artificial Tear (五福滴視點眼液), or self-paid Min Young Lubricant Eye Drops (明漾人工淚液點眼液), Chen said.

  Separately, the NHIA yesterday said Artelac eye drops are classified as an instruction drug (instructed by physicians, pharmacists or assistant pharmacists) for relieving discomfort caused by dry eyes.

  There are 17 types of drugs with the same indications covered by the NHI, including one with the same active ingredient and dosage form, so physicians can instruct people to use the alternative drugs based on their needs, it said.

  Regarding Tears Naturale’s withdrawal from the NHI, the NHIA said it has negotiated with the company several times, but the company expressed its wish to withdraw due to a business strategy adjustment.

  After two NHI drug coverage and reimbursement criteria meetings, they agreed that it is an instruction drug that is not irreplaceable and should be allowed to return to the self-paid market, the NHIA said, adding that according to the National Health Insurance Act (全民健康保險法), the NHI does not cover the drug anymore.
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