African swine fever has destroyed about a quarter of pigs worldwide, especially have suffered from it the territory of China. In this regard, doctors and drug manufacturers are sounding the alarm: there is a threat of a shortage of heparin for a long period. Heparin — anticoagulant that is produced from enzymes in the intestine of the pig. Widely used in the treatment of heart attacks and prevents blood clots.
Since China was the main supplier of drugs, then the current in this region a crisis forces you to develop alternative ways of supply.
1. What is heparin?
Heparin is a molecule of natural origin on the basis of polysaccharides. It is injected into the body by injection or infusion to prevent:
- blood clotting;
- of developing blood clots in the blood vessels, which can cause oxygen starvation of organs.
The drug was discovered over 100 years ago. Today in the U.S. alone heparin is used to treat 10 to 12 million people annually, with sales worldwide exceeds 200 tons, which is $ 5 billion a year. Despite the fact that one dose costs less than a package of gauze bandages.
2. Why heparin important?
The drug is usually administered to the following patients:
- who have had a heart attack, because they have a blocked coronary artery;
- have suffered serious orthopedic and cardiac surgery;
- c Central venous catheter;
- after blood transfusion, kidney dialysis or mechanical support of the heart and lungs (ecmo);
- stationary for a long time.
Heparin is often used for coating of medical devices such as coronary stents in contact with the blood.
This is the preferred anticoagulant for hospitalized: he works quickly, easily introduced, there is an effective antidote — Protamine sulfate.
A study conducted by the Royal children’s hospital in Melbourne, showed that up to 15% of patients are daily exposed to heparin in one form or another.
3. What is the problem?
Researchers warn of “imminent threat” of a shortage of medicines because of the scale culling of cattle. Most drugs based on heparin obtained from the intestinal sheath of pigs. About 60-80% of the active pharmaceutical ingredient is produced in Chinese factories, and pharmaceutical companies around the world made from his medications. China, which has half the pig population of the entire planet, is the only state that can meet the global demand for raw materials.
The who recommends governments keep stocks of heparin.
The loss of the pigs
The lack of heparin has been observed annually since it reduces the number of dead pigs.
4. What is the supply situation now?
The agricultural Committee of the U.S. Congress in July, appealed to the Management on sanitary inspection behind quality of foodstuff and medicines (FDA) to conduct monitoring of supplies of heparin, noting that there is a time gap of 6 to 9 months before the shortage of drugs will affect the U.S. market. In October, the Agency stated that no impact was seen. This may be due to the fact that the outbreak has led to the extermination of the pig, which ensured the supply of heparin in the period.
However, as the number of dead pigs in China reduced the amounts of raw materials are also reduced. Pharmaceutical companies, including German Fresenius SE and the South African Aspen Pharmacare Holdings Ltd., mentioned shortages of heparin associated with rising prices for raw materials.
In July, the division of Fresenius Kabi announced to its customers in the United States that it places the heparin in a special distribution plate due to the potential shortage of raw materials, reports “КазахЗерно.kz”.
Hospital of Massachusetts in August, said about the impending shortage of medicine; Director of the supply Department of the hospital said that at some point the stock level was so low that for another two weeks, and the Boston centre would not be able to conduct heart surgery.
5. Are there other sources of heparin?
Yes. Heparin can be extracted from the other cattle: it was originally extracted from the lungs of cows and sheep intestines.
The outbreak of mad cow disease in Europe in the 1990s, made pigs the main source of raw materials in many countries.
FDA approves receiving heparin from cows as opposed to pigs.
However, drugs from other raw materials may require lengthy security checks, which can also lead to delays in supply.
Anticoagulants of alternative resources, as a rule, less safe, effective or cheap.
6. Has it happened before?
Yes, although the current outbreak of ASF is of great magnitude that enhances the quality problems of raw materials and supplies.
Recent shortages reported by the FDA concerned the Baxter International Inc. and Hospira Inc., which is now part of Pfizer Inc., was in 2017, when hurricane “Maria” has destroyed manufacturing in Puerto Rico.
In Australia, Pfizer informed the authorities in November on the temporary shortage of two types of drugs based on heparin due to production problems not related to ASF in China.
The outbreak of swine reproductive and respiratory syndrome (blue ear disease) in 2006-2007 in China has led to reduced supplies of heparin and caused the falsification of the raw materials. American and European authorities have found that the cheaper stuff from shark cartilage was mixed with Chinese raw materials. Drugs based on this fake hit the international market: has killed 149 people in 11 countries, including 81 people in the United States.
Baxter withdrew their injectable drugs from the U.S. market in 2008, but has faced more than 1,000 lawsuits in the case. China has never officially taken responsibility for the incident. In October 2018 the Italian medicines Agency found serious manufacturing violations during inspections of the plant for production of heparin in Sichuan, and recommended to forbid the company to supply ingredients for medicines in the European Union