It’s not just cough medicine!　Drugs to treat cancer and diabetes…global “drug shortages” may cause “buyers to lose out”!

Cough medicines, antibacterial drugs… Manufacturers are reluctant to produce drugs with low prices and low profit margins.

Influenza is prevalent this winter. There is also an ongoing shortage of medicines, making for an anxious New Year’s Eve.

Regarding the current shortage of medicines, Mr. S., a pharmacist at a large hospital in Tokyo and a volunteer for asTas, a general incorporated association, has experience in creating DSJP (Database of Supply of Ethical Drugs), which provides information on the supply status of medicines,

There is a shortage of cough medicines and expectorants, but usually these medicines are made up during the summer. However, this year, because of the influenza epidemic that began in the summer, we were unable to stockpile them.

In addition, hand-foot-and-mouth disease and other infectious diseases, especially among children, also broke out during the summer, and there is currently a shortage of antimicrobials for use against infectious diseases.

Seeing this situation, on November 7, Minister of Health, Labor, and Welfare Keizo Takemi asked 24 pharmaceutical companies that manufacture and sell cough medicines and other drugs to take action to ensure a stable supply,

Cough medicines are inexpensive to begin with and have low profit margins, so pharmaceutical companies are reluctant to produce them.

Furthermore, the competition to lower prices has intensified, and the more they sell, the more they lose money.

The price of cough medicine, which has been used for a long time, is low, Moreover, drug prices themselves are also declining. The government sets the official price of pharmaceuticals uniformly across the country (NHI price), which used to be reviewed every two years, but starting in 2006, the price will be reviewed once a year.

The NHI price revision is the same as a price cut. Although patients are happy, drug makers are finding it tougher and tougher to manage their business.

For example, the price of Opdivo, a cancer drug, was 730,000 yen per 100 mg when it was first launched in 2002. This is a hard situation for pharmaceutical companies considering the development cost.

The government’s policy of promoting “generic drugs” has had its revenge…

It is said that the drug shortage was triggered by the fraud of Kobayashi Kako, a generic drug manufacturer, which was discovered in 2008. The company’s drug for athlete’s foot and other skin diseases was adulterated with a sleep-inducing drug, resulting in health problems for more than 240 people and the death of two.

Until then, inspections of pharmaceutical companies had been conducted only after the companies had been notified in advance of the inspection date, a system that made it possible to conceal the fraudulent activities. As a result, manufacturing irregularities were uncovered one after another, and to date, 15 companies have been subjected to administrative penalties such as business suspension.

Why does so much fraud occur?

One reason, I believe, is the expansion of the generic market.

Generics are drugs made after the patent for the original drug has expired. They have the same ingredients as the original drug, but are less expensive to develop, so their prices are kept low.

The government has promoted their use because they reduce medical costs and the burden on patients, and many manufacturers have entered the market.’ Until 2011, the percentage of generic drugs used was 40%, but by 2009 it had risen to nearly 80%.

Many generic drug makers are small to medium-sized companies and don’t have many production lanes; when they finish making drug A, they clean that lane to make drug B, and so on. They are operating at near their limits, so they are probably more prone to mistakes.”

However, drug shortages had been occurring even before that.

The drug shortage began with the Cefazolin Shock that occurred in February 2007. Cefazolin is an antibacterial drug used to prevent infection during surgery. Cefazolin is an antibacterial drug used to prevent infections during surgery, etc. The bulk drug is imported from overseas.

Nichi-Iko imported the drug. Nichi-Inko discovered that the API it imported was contaminated with a foreign substance, and the supply of the drug was stopped for nine months. At the time, Nichi-Iko had a 60% share of the domestic market for cefazolin, so when the supply stopped, there was a huge panic.

Subsequently, Nichi-Iko was found to be illegally crushing and reprocessing tablets that had failed quality tests, and was ordered to cease operations. As a result, a drug shortage ensued. In October, another major generic drug manufacturer, Sawai Pharmaceutical, was also found to be involved in drug fraud and is now voluntarily recalling its products.

The world is fighting over medicines… Shortage of “cancer drugs” and “diabetes drugs

The shortage of medicines is not limited to Japan, according to Mr. S. In the United States, the shortage of medicines has been a problem since 2011.

According to the U.S. Food and Drug Administration (FDA, similar to Japan’s Ministry of Health, Labor, and Welfare), there is an ongoing shortage of 191 drugs, including antibiotics, cancer drugs, and anesthetics.

“With the global shortage of medicines, people are fighting over them. Japan, with its low drug prices, may end up “outbidding” other countries.

Japan was unable to obtain vaccines for the COVID-19 crisis, and a similar situation is occurring with various medicines.

There were already shortages of Abraxane, a drug used to treat pancreatic cancer, and Leuprorelin, a drug used to treat prostate and other cancers.

One of the most pressing problems facing relatively large hospitals that receive acute care patients is the shortage of globulin, a blood product. This drug is used to treat Kawasaki disease and Guillain-Barré syndrome, but since it is now used to treat a wide range of diseases, it is difficult to obtain the necessary quantities.”

Diabetics are also at risk.

A diabetes drug called GLP-1 receptor agonist is in short supply because it is now being used in cosmetic clinics for weight loss, which has not been approved in Japan.

The shortage of medicines is caused by a combination of various factors. Minister of Health, Labor and Welfare Takemi’s request to pharmaceutical companies,

Minister Takemi’s request to drug companies is superficial. Unless the fundamental problems are solved, it will be difficult to maintain universal health insurance.

Mr. S. is very critical.

In order to avoid losing out to foreign competitors, it is necessary to increase subsidies to the pharmaceutical industry and make Japan an attractive market for foreign drug makers.

This may not be the time to be spending the budget on tax cuts for one year only.

Click here for the website of DSJP, a database on the supply status of ethical drugs.