[Reporter's View] The reality of drug shortage reports

based on oxytocin's case in Korea

Reports of shortages of oxytocin, an injectable drug used primarily as a labor inducer, have caused confusion in the obstetrics and gynecology field.

 

Most obstetrics and gynecology centers that have a large number of expectant mother visits stock enough oxytocin to last 2-3 weeks, but JW Pharmaceuticals, which holds more than 70% of the prescription market, has announced a shortage of its oxytocin supply that will last until January next year.

 

In the case of childbirth, there is no reason for a sudden surge in a drug’s demand like infectious diseases or colds, but oxytocin is designated as a national essential medicine that must ensure a stable supply as it is used to induce labor in mothers.

 

In Korea, only two companies, JW Pharmaceutical and Yuhan Corp, manufacture oxytocin drugs.

 

Since it is a national essential medicine with a small number of manufacturers, it seemed natural that supply and demand management would be in place, but out of the blue, the clinics and hospitals were suddenly just told that “there was no medicine.” A small hospital in a rural area with a low birth rate would have ordered the medicine on a case-by-case basis rather than keep two to three weeks' worth on hand, so the news that it would soon be out of stock must have been like a bolt from the blue.

 

The question that first came to mind was, why is there a national essential medicine system in place if it cannot manage the supply of essential drugs?

 

When looking closer into the situation, the cause was clear: the system was not well established enough to ensure a stable supply of the necessary drugs.

 

The discontinuation of the manufacture, import, and supply of finished drugs must be reported to the Ministry of Food and Drug Safety 60 days before the discontinuation date.

 

However, as the criteria for reporting shortages are set differently in each company's SOP, and there is no absolute threshold set for determining drug shortages.

 

In the case of oxytocin, the MFDS was able to identify the shortage only after looking into Yuhan Corp’s shortage report, a company that only accounts for about 30% of the oxytocin market share.

 

On October 28, the company reported a shortage of oxytocin on the market, stating, “There is also supply disruption for Choongwae Oxytocin Inj..

 

which is approved with the same ingredient.

 

With no substitute drug available containing the same ingredient, a supply shortage is expected for a period of time, but we will be able to ensure supply from November 14, 2024.” Up until this point, JW Pharmaceutical had not notified the MFDS of its shortage.

 

The problem was that the MFDS was not informed, but the letter sent to obstetrics and gynecology clinics and wholesalers indicated that the drug would be “out of stock until January.” Even if the drug is designated as a national essential medicine, the KFDA cannot know about the shortage without a report from the pharmaceutical company.

 

The MFDS began to investigate the situation when it learned about JW Pharmaceutical’s oxytocin shortage via Yuhan Corp’s supply shortage report.

 

JW Pharmaceutical, which has a higher market share, was unable to manufacture finished drugs due to issues with the API, and the MFDS reportedly supported the necessary measures and moved up the manufacturing date from January next year to December this year.

 

This situation seems to have occurred because the threshold for shortages was not specified.

 

Each company had a different threshold set for sending “out of stock” reports to the MFDS.

 

Yuhan Corp reported a shortage when it crossed its threshold of shipments this year, while JW Pharmaceuticals did not report a shortage until it was likely to run out on site.

 

It's not easy for the MFDS to keep track of the shortages of more than 500 national essential medicines every day.

 

Unless the ministry receives a proper report, they cannot provide the necessary support, but if the product becomes out of stock even before the ministry can consider support, there is no opportunity for the authorities to take action.

 

As a result, no medicine is available on site, with the government ending up taking countermeasures after the damage is made.

 

Last year, the Ministry of Food and Drug Safety revised the Ordinance of the Prime Minister to pull forward the drug shortage report from 60 days to 180 days, with implementation scheduled for April next year.

 

However, if the regulation is revised without a baseline for reporting not established, cases like oxytocin will only repeat itself.

 

We need a system to address stockouts before there is “no medicine” on site.