A nationwide shortage of drug supplies has continued since last summer due to manufacturing fraud by generic drug manufacturers, but industry groups have found that shipments of at least 2,500 items are still stagnant. I understand.

Regarding the supply of pharmaceuticals, last year, eight companies, including the major generic drug maker Nichi-Iko, were found to have a manufacturing violation and were ordered to suspend operations. Supply shortages are becoming more serious nationwide.



Under these circumstances, when the "Japan Generic Pharmaceutical Association" made by a generic manufacturer summarized the supply status of 37 member companies, the shipment of 2516 items in total was delayed as of May 10, which is the total of generic drugs. That's about a quarter.



In addition, restrictions on shipments of innovator drugs, which have increased in demand in place of the shortage of drugs due to this effect, continue to be restricted, and it is still difficult for some drugs to be obtained at medical institutions and pharmacies nationwide.



In response to this situation, the Ministry of Health, Labor and Welfare has requested manufacturers to increase production, and so far two major generic companies, Sawai Pharmaceutical and Towa Pharmaceutical, have announced plans to expand their production systems on a large scale. However, it is expected that it will take about two years to expand the factory and obtain the approval of the government, so there is no immediate prospect that the current shortage of pharmaceutical supplies will be resolved.

What is a generic drug?

Generic drugs are those in which other manufacturers manufacture and sell drugs with the same active ingredient after the patent period of the manufacturer that developed the original drug has expired.



In order to reduce the cost of research and development to confirm efficacy and safety, the price of newly sold generic drugs is uniformly set at 50% of the original drugs.



Of these, if more than 10 generic drugs are manufactured and sold, the amount will be further reduced to 40%.



The government is promoting the spread of generic drugs as a condition for adding medical fees and dispensing fees to curb medical expenses, and the percentage of generics used has risen to 79% in a survey last September. I am.

Sudden change of usual medicine The effect on patients

Even at the internal medicine clinic in Moriguchi City, Osaka, the shortage of medicines continues, and 20% of generic medicines have been unavailable since last summer.



At the clinic, it is unavoidable to prescribe drugs with the same efficacy to patients who are unable to give them due to lack of generic drugs they were taking.



However, some patients who have changed their medicines complain that the new medicines are not suitable for their constitution and that the effects of the medicines are not fully felt.



Also, changing from cheaper generics to innovator drugs will increase the cost burden for patients.



On this day, a woman in her 70s who consulted with me that "the new drug doesn't suit me and I can't feel the effect" said, "It's the same effect, but it's completely different for me. ..



Dr. Misa Inoue of Kitahara Clinic said, "When a patient tells me that it is not effective, I have to apologize and prescribe the medicine. It is painful to bother the patient."

Increased production burden on manufacturing site

As the supply of medicines continues to be in short supply, many generic drug manufacturers are taking steps to increase production.



On the other hand, when interviewing employees working at manufacturing sites, there are voices concerned about the impact of the deterioration of the working environment, as the increase in production has to be dealt with by extending the operating hours of the factory.



A man working at a factory of a generic drug manufacturer in the Kanto region said, "Since the supply instability of Nichi-Iko has emerged, overtime work has continued to exceed 40 hours a month and work on holidays has increased. The number of mid-career employees is retiring one after another, and the number of work mistakes that we have never seen before is increasing. That's it. "

Professor Sakamaki "Considering the development of a supply status database"

Professor Hiroyuki Sakamaki of Kanagawa University of Health Services, who is familiar with the problem of medicines, said, "Due to insufficient information on which medicines are shipped and how much, medical institutions and pharmacies are trying to secure a large amount of stock and supply is insufficient. There is also a situation where there is a problem. It will take time to significantly increase production to completely eliminate the shortage, so public institutions such as the national government should consider establishing a database of supply status of each manufacturer. It is necessary for the government to work on the development of a mechanism for sharing information.

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