Pfizer shut off supplies of pain drugs to veterinarians when a shortage of an injected opioid meant it couldn’t fill all of the orders it had from hospitals. But relief is now on the way for vets and their animal patients, the FDA says.
The FDA’s Center for Veterinary Medicine (CVM) says it has reached an agreement for Pfizer to divert part of a new source of the drugs for use by veterinarians.
“As a result of CVM’s recent discussion with Pfizer, this product is now available in limited quantities for pain management in animals,” the agency said. “ … Injectable opioids are used in animals to treat pain following severe trauma and to control pain during and after surgery. Adequate pain control is essential in animals, as in humans.”
The drugs will come from a supply the FDA earlier allowed (PDF) Pfizer to import from Canada. Because of the nationwide shortage, the FDA permitted the drug company to buy hydromorphone hydrochloride injection, USP, in 2 mg/ml strength, 1 ml volume ampules from Sandoz, which makes them at a plant in Canada for the Canadian market. Although the labeling is different from the same drug sold in the U.S., it is otherwise identical.
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In addition to making some of this supply available to the vet market, Pfizer has also agreed to make morphine sulfate injection, USP available to the U.S. veterinary market when supply increases.
Pfizer last summer suspended sales of injected pain drugs to the veterinary market, diverting those drugs to fill orders from hospitals. It said it would be unable to resume sales for animal use until the shortage at hospitals and surgical facilities has been resolved, which it did not expect to happen before the second quarter of 2019.
The shortage of the hospital-administered pain medications, including morphine and fentanyl, started in 2017 when Pfizer reduced output of prefilled syringes as part of an upgrade at its troubled Hospira sterile drug manufacturing site in McPherson, Kansas.
RELATED: Pfizer still unable to get on top of problems at Hospira injectables plant
Last year, Pfizer told customers that because upgrades were taking longer than expected, "full recovery dates of prioritized prefilled syringes” had moved to the first quarter of 2019 and deprioritized syringes to the second quarter of 2019.
While production has resumed, the FDA continues to find issues with the plant. An inspection in July and August resulted in eight observations, seven of them repeats. In response, Pfizer said the site developed and implemented a “robust corrective and preventive action plan” after the inspection. “While there is still additional work to be done against our plan, the site has made significant improvements and progress since the inspection.”
当注射的阿片类药物短缺意味着它无法填补医院的所有订单时，辉瑞公司停止向兽医供应止痛药。但 FDA 表示，兽医和他们的动物患者现在正面临救济。FDA 的兽医中心 (CVM) 表示，已经与辉瑞公司达成协议，将部分新的药物来源转用于兽医。“由于 CVM 最近与辉瑞公司的讨论，这种产品现在可用于动物疼痛管理的限量，”该机构说。“...... 可注射的阿片类药物在动物中用于治疗严重创伤后的疼痛，并在手术过程中和手术后控制疼痛。与人类一样，对动物进行充分的疼痛控制至关重要。“像这个故事一样免费的每日通讯？订阅 FiercePharma！Biopharma 是一个快速增长的世界，每天都有大的想法出现。我们的订户依赖 FiercePharma 作为他们的必读来源，了解有关药物及其制造公司的最新消息、分析和数据。今天注册获取药品新闻和更新传送到您的收件箱，并随时阅读。现在订阅这些药物将来自 FDA 早些时候允许 (PDF) 辉瑞从加拿大进口的供应。由于全国范围内的短缺，FDA 允许该制药公司从 Sandoz 公司购买浓度为 2 mg/ml 的盐酸氢吗啡酮注射液 USP，1 ml 体积安瓿，这使得他们在加拿大的一家工厂为加拿大市场。虽然标签与在美国销售的同一种药物不同。在其他方面是相同的。相关：辉瑞暂停向兽医销售可注射的阿片类药物，因为短缺持续存在。除了向兽医市场提供部分供应外，辉瑞还同意向美国提供硫酸吗啡注射液。当供应增加时，兽医市场。辉瑞去年夏天暂停了向兽医市场销售注射止痛药，将这些药物分流到医院以填补订单。该公司表示，在医院和手术设施的短缺得到解决之前，它将无法恢复动物用途的销售。包括吗啡和芬太尼在内的医院管理的止痛药的短缺始于 2017 年，当时辉瑞公司减少了预充式注射器的产量，作为其位于堪萨斯州麦克弗森的陷入困境的 Hospira 无菌药物生产基地升级的一部分。相关：辉瑞公司去年仍然无法在 Hospira injectables 工厂顶上出现问题，辉瑞公司告诉客户，由于升级比预期需要更长的时间，“优先预充式注射器的完全恢复日期”已经移至 2019 年第一季度，优先注射器移至 2019 年第二季度。在恢复生产的同时，FDA 继续发现该厂的问题。7 月和 8 月的一次检查得出了 8 个观察结果，其中 7 个重复。对此，辉瑞表示，检查结束后，该网站制定并实施了“强有力的纠正和预防行动计划”。“虽然我们的计划还需要做更多的工作，但自从视察以来，该场址已经取得了重大的改进和进展。”
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