With a shortage guarantee mechanism, why is there still a "drug shortage" for cheap life-saving drugs?

Medical Network News on July 8 Recently, several cheap drugs such as dapsone tablets have been out of stock, and the phenomenon of “drug shortage” of cheap life-saving drugs has once again attracted social attention
.
The reporter of "Xinhua Viewpoint" conducted research in Shanghai, Yunnan, Zhejiang, Sichuan and other places and found that despite the establishment of a national small-species medicine (shortage medicine) supply guarantee consortium by relevant departments, some cheap medicines and "orphan medicines" are listed as national shortage medicines.
However, because some measures have not been implemented, the production of enterprises is still insufficient
.

Dapsone tablets are hard to find a single medicine.

"Quite!" Recently, some parents of children with linear IgA bullous skin disease are looking for dapsone tablets everywhere on the Internet
.
Due to the unsuccessful request for medicine, some children had to use the expired medicine left by other patients
.
What kind of medicine is dapsone tablets? Why is there no trace? According to Zhu Xuejun, a professor of dermatology at Peking University First Hospital, dapsone tablets are an old medicine
.
As a medicine in the national essential medicine list, it is widely used in the treatment of leprosy
.
Later, this drug was found to have good effects in most patients with linear IgA bullous skin diseases
.
"Under normal circumstances, for autoimmune skin diseases such as linear IgA bullous skin diseases, doctors will give priority to glucocorticoids
.
Dapsone tablets will be prescribed only when the effect is not good.
Combination medication
.
The anti-inflammatory effects of dapsone tablets help control the disease and help patients reduce hormone consumption more quickly
.
” Ren Yunqing, director of the Department of Dermatology, Children’s Hospital of Zhejiang University School of Medicine, said that at present dapsone tablets are indeed difficult to treat.
Requirement, only a few hospitals in China have medicines in stock
.
According to Lu Yonghong, director of the Dermatology Department of Chengdu Second People's Hospital, linear IgA bullous skin disease mainly occurs in children, and there is no authoritative statistical data on the incidence at home and abroad
.
"I see more than 10 patients in one year, and there are other drugs that can treat linear IgA bullous skin diseases, such as immune preparations, hormones, etc.

.
"It is understood that there are currently 4 domestic pharmaceutical companies holding the production number of dapsone tablets, namely Shanghai Xinyi Tianping Pharmaceutical Co.
, Ltd.
, Kunyao Group Co.
, Ltd.
, Guangzhou Baiyunshan Guanghua Pharmaceutical Co.
, Ltd.
, and Guangzhou Baiyunshan Huacheng Pharmaceutical Co.
, Ltd.
The
reporter visited the above four pharmaceutical companies and learned that all dapsone tablets have been discontinued
.
Cao Qi, general manager of Kunyao Group Manufacturing Center, said that the company’s production capacity for dapsone tablets is about 30 million per month.
film, but is now suspended stage
.
in addition to dapsone tablets, shortages in recent years between outages case of cheap life-saving drugs as well as the treatment of myasthenia gravis cure bromine pyridostigmine tablets, heart surgery drug protamine, treatment Primaquine for vivax malaria and ovarian malaria, cedilan injection for the treatment of heart failure, and pingyangmycin, a commonly used drug for children on tumors
.
According to a doctor from a third-class hospital in Sichuan, the brompistine tablets have been broken several times.
Patients can only purchase high-priced drugs through informal channels, and some criminals take the opportunity to make huge profits
.
Nitroglycerin is a life-saving medicine for patients with coronary heart disease and angina pectoris at critical moments.
It has a wide range of clinical applications, but stocks are out of stock in many parts of the country.
, And the price of a box of imported nitroglycerin tablets is more than 50 yuan more expensive than domestically produced
.
The
　　cost is rising, the demand is low, and the profit is low
　　.
Why do companies no longer produce these drugs?
A person in charge of a dapsone tablet manufacturer said that the current supply cost of raw materials is relatively high.
Adding other production costs, etc.
, the price of each bottle requires tens of yuan
.
Compared with the original price of a few yuan per bottle, the price is higher, and I am worried that the market will not accept it
.
However, if the company sells at the original price, it will be difficult for the company to continue
.
A person in the pharmaceutical industry said , APIs have high energy consumption and serious pollution, and are mostly listed as restricted investment projects in the industrial structure adjustment guidance catalog
.
With the increase in environmental protection requirements, some small enterprisesUnsustainable, resulting in unstable upstream raw materials, untimely supply, and ultimately leading to rising drug prices
.
At the same time, the terminal demand for some life-saving drugs is not large
.
Dapsone tablets were once used as a leprosy drug.
As the prevalence of leprosy in China has declined, the demand for the drug has decreased, and companies have ceased production
.
According to statistics, there are 200 cases of leprosy in China in 2020, which is 33 cases less than in 2019
.
Ren Yunqing said that the effectiveness of dapsone tablets for autoimmune bullous disease is also a small part of clinical research reports and case reports, and there are no large-scale clinical studies to evaluate its effectiveness and safety
.
Coupled with the frequent emergence of some new drugs, the market demand for dapsone tablets is not large, and enterprises lack production motivation
.
Zhu Xuejun believes that the main reason for the shortage of cheap drugs is that the prices are too low
.
For example, "orphan drugs" are relatively seldom used.
The production cost of a company cannot be calculated solely based on the raw materials of the drug, but other costs must be considered
.
For example, after a medicine is produced, all the equipment must be cleaned to produce other types of tablets.
This cleaning cost is quite high
.
Gu Haoliang, vice president of Shanghai Pharmaceutical Group Co.
, Ltd.
and chairman of Shanghai Shangyao Xinyi Pharmaceutical Co.
, Ltd.
, said that if dapsone tablet production is restarted, the process of resuming production needs to be verified, and the enterprise investment cost is high
.
Cao Qi said that this product has not been produced for a long time, and it will take at least 6 months to resume the production process in accordance with the national drug regulatory regulations
.
During the interview, some industry insiders also mentioned that because some cheap life-saving drugs are only supplied by one or two companies, the "buyout underwriting" model of some intermediate commercial companies has drastically increased prices and malicious "speculation" has exacerbated the shortage
.

　　While being included in the shortage list, production needs to be promoted.
In
order to solve the plight of the "drug shortage" of cheap life-saving drugs, relevant state departments have taken a number of measures in recent years.

.
In June 2017, the former National Health and Family Planning Commission and other 9 departments jointly issued the "Implementation Opinions on Reforming and Improving the Supply Guarantee Mechanism of Shortage Drugs", proposing a reasonable layout of monitoring sentinels, establishing and improving the management system of shortages of drugs, implementing designated production and other key points Mission measures
.
In February 2018, the Ministry of Industry and Information Technology, together with the former National Health and Family Planning Commission, the National Development and Reform Commission, and the former State Food and Drug Administration jointly issued the "Notice on Organizing the Construction of Centralized Production Bases for Small Varieties of Medicines (Short Drugs)"; July 2018, China The first national supply guarantee consortium for small-species drugs (drugs in shortage) was established to alleviate the shortage or shortage of some clinically necessary drugs and explore a new long-term mechanism for ensuring the supply of small-species drugs (drugs in shortage)
.
The current supply guarantee mechanism for cheap and shortage drugs is becoming more and more perfect, but more concrete measures are urgently needed
.
Cao Qi expressed the hope that the state can provide stable supply support for the procurement of raw materials; the drug supervision system can enable emergency resumption procedures to enable companies to quickly resume production and supply them in time; at the same time, in accordance with the drug reserve mechanism, companies that have produced dapsone tablets Fixed-point production can ensure both quality and output
.
Some heads of manufacturing companies stated that all government departments need to build a shared information platform with industry associations, drug manufacturers, and patients to alleviate shortages.
After receiving drug shortage reports, the health department or drug regulatory department communicates with other stakeholders in a timely manner, monitors and monitors the shortage in real time Update relevant data; when pharmaceutical companies encounter difficulties in the production process, the government provides administrative guidance in a timely manner
.
As a member unit of the National Supply Guarantee Consortium for Small Variety Medicines (Drugs in Shortage), Gu Haoliang said that the drug consortium has played a relatively obvious role in the past two years.
By the end of 2020, 6 small-variety drug consortia have achieved a total of 100 small-variety medicine Production guarantee
.
"The current key lies in solving the problem of organizational sustainability.
I hope that the government will give more policy support and guidance, and form a long-term supply plan
.
"
Medicines are related to the lives and health of ordinary people and cannot be regarded as ordinary commodities to be regulated by market rules
.
West China Hospital of Sichuan UniversityClinical pharmacist Yu Lei believes that these cheap life-saving drugs will soon disappear if they are only adjusted by market forces
.
The state should carry out certain subsidized rescue reserves and practical guarantee methods to guide the production of enterprises.
For the rescue drugs and rare disease drugs that are clinically necessary, irreplaceable, uncertain in dosage, and infrequently produced by enterprises, this should be established on a provincial or regional basis.
With regard to the reserve system for such drugs, a specialized agency is responsible for the purchase, storage and allocation of such drugs
.
(Reporters Huang Xiao, Gong Wen, Lin Miaomiao, Dong Xiaohong, Yue Ranran)