One of the many causes of drug shortages is the inability to get raw materials, which leads to production troubles, regulatory concerns, commercial decisions, and other disruptions in supply chains. They compromise, delay medical operations resulting in pharmaceutical errors, and cause safe remedies to be replaced with alternative medicines. However, the shortage of Gonak is not due to these, and in this article, we will go into further detail regarding that.
Eye lubricant Gonak Hypromellose is used to relieve dry, itchy eyes. It is also administered during surgery to preserve the eye shape and protect tissues from harm. Additional uses of Gonak Hypromellose involve cornea protection during eye exams and checking the fluid drainage from the eyes.
Why was Gonak Hypromellose Discontinued?
American Society of Health-System Pharmacists® (ASHP) mentioned two reasons for the discontinuation of Gonak; Manufacturing Issues and voluntary recall [1]. ASHP did not provide further explanation. When we dug deeper, we found the primary reason for Gonak’s discontinuation is not specific to Gonak itself; instead, it is related to the FDA disapproval of the Manufacturing procedure at the Somerset, New Jersey facility by its primary manufacturer Akorn [2].
FDA issued Akorn a Form 483 in 2018. An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that, in their judgment, may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. FDA investigators are trained to ensure that each observation noted on the FDA Form 483 is clear, specific and significant. Observations are made when in the investigator’s judgment, conditions or practices observed would indicate that any food, drug, device or cosmetic has been adulterated or is being prepared, packed, or held under conditions whereby it may become adulterated or rendered injurious to health.” [4]
In 2019, FDA warned Akorn [5] regarding the maintenance of quality standards in their Somerset, New Jersey facility and significant violations of good manufacturing practices (cGMP), leading to the non-sterility of sterile products [5].
Pipeline Medical inquired about the discontinuation of Gonak from Akorn on September 26, 2022; their customer service representative informed us that they had decided to discontinue manufacturing and distribution from their Somerset, New Jersey facility. Their representative further explained that all current open orders for all products manufactured/distributed from that facility had been cancelled, and no new orders would be accepted. Regrettably, Gonak was one of those products.
The reason for voluntary recall [1] involved administrative concerns about the adequacy of Quality Assurance procedures over critical systems in their manufacturing plant in Somerset, New Jersey[6].
Drug Shortage in the United States
Over the past ten years, medicine shortages have occurred more frequently in the United States [7]. The Drug Information Service at the University of Utah Health Care (UUHC), which works in partnership with the American Society of Health-System Pharmacists (ASHP) to manage its drug shortage program, recorded a total of 211 drug shortages in 2010, making it the highest number of shortages ever recorded in a single calendar year [8]. Furthermore, according to ASHP, 71 drugs are currently in short supply 168 new drug shortages were reported in 2021, while 80 were resolved in 2021 [9].
Even though some drug categories are more prone to shortages, many different drugs have been reported to be limited. These include cardiovascular drugs, painkillers, intravenous (IV) fluids, and numerous others.
While it is hard to forecast or plan for each medicine shortage, proper planning can avoid several issues before they become a crisis. It is crucial to establish clear policies and processes for handling medicine shortages. An efficient drug scarcity management strategy must include appropriate information gathering, cooperation, and communication techniques.
Pipeline Medical In The Times Of Shortage
Drug shortages can cause patient treatment disruption or supply issues. Pipeline Medical offers the best products with an uninterrupted supply of drugs. In case of shortage or discontinuation, we also provide alternative drug supplies. Please visit the website or connect with us to check out these deals. We will be glad to assist you.
