"4 7" with volume procurement expansion how to ensure drug safety!-Zhejiang Jianfeng Pharmaceutical Co., Ltd.

"4 7" with volume procurement expansion how to ensure drug safety!

Release time:

2020-02-19

According to the People's Daily report, all localities will focus on the implementation of the results of the 47 expansion campaign to ensure that patients use the selected varieties with high quality and low price before the end of the year.

The expansion of the collection will further cover 25 provinces, 4 7 expansion of the results of the selection, has been officially implemented in various places.

▍ From the cardiovascular and cerebrovascular drug reform, look at 4 7Expanding the scope to solve the challenge of drug accessibility

Compared with the 4 7 pilot, in the 4 7 expansion, foreign original research drugs.EnterpriseThe strategy has been adjusted, more foreign-funded enterprises have participated in the bidding, and the prices have been greatly reduced to seize the market. The prices of some foreign companies' original research drugs are even comparable to generic drugs.

For example, Sanofi's Ambono (irbesartan hydrochlorothiazide tablets) and Plavix (clopidogrel bisulfate tablets), the price of which has dropped significantly, have successfully entered the band purchase list, and patients can purchase the classic original research imported drugs at the most favorable price.

According to the analysis of the "China Cardiovascular Disease Report 2018" compiled by the National Cardiovascular Disease Center, the prevalence and mortality of cardiovascular disease in China are still on the rise. The number of cardiovascular disease patients in my country is 0.29 billion, and the mortality rate ranks first, accounting for more than 40% of the disease deaths of residents. Among them, the prevalence rate of hypertension in adults is 27.9, and the prevalence rate of hypertension in residents over 15 years old is on the rise.

It can be seen that the clinical demand for cardiovascular and cerebrovascular diseases in China is very huge. Today, both Polivier and Ambono have entered the national collection, which will better meet the treatment needs of my country's cardiovascular disease market and meet the medication needs of patients."

Peking University PeopleHospitalProfessor Hu Dayi, director of the Heart Research Institute, said that 4 7 bandsProcurementIt is the current trend to promote it to the whole country. This is a reform to solve the problem of difficult and expensive medical treatment for the masses. Many drugs, such as the antihypertensive drug Ambono, and the antiplatelet therapy drug PLAVIV, which is often used by stent patients, myocardial infarction patients and stroke patients, have been greatly reduced in price, so that the majority of patients can enjoy practical benefits."

Choose the most effective and safe drug

Although under the national belt procurement, generic drugs and original research drugs that have passed the consistency evaluation compete on the same level, from the perspective of clinical drug use, doctors' attitudes towards original research drugs and generic drugs have also been widely concerned.

After the 4 7 pilot was implemented, the medical community investigated a set of data showing that when faced with generic drugs instead of the original research drug, the rightDrugsThe number of patients with skeptical attitude towards quality and curative effect is the largest (64%), followed by patients who can actively accept patients (47%), and thirdly, patients who insist on prescribe non-winning drugs (17%), such as imported original research drugs, and 15% of patients hold indifferent attitude.

As we all know, China is a big country of generic drugs. In the 1980 s, in order to solve the practical problem of lack of doctors and drugs at that time, there was no mandatory requirement for the consistency evaluation of approved drugs with the original drugs, resulting in a certain gap between the efficacy of some drugs and the original drugs. This is also an important reason for more than 60% of patients to question the replacement of prescription drugs.

Professor Li Yong, deputy director of the Department of Cardiology, Huashan Hospital Affiliated to Fudan University, said that the consistency evaluation of generic drugs is to screen out some high-quality products of generic drugs and compare them with the original developed or proven effective drugs. It is generally believed that if the chemical structure of the generic drug is the same as that of the original drug, then, in theory, the therapeutic effect that the two should obtain is about the same.

For example, after taking clopidogrel, the risk of recurrence of myocardial infarction is reduced, and the risk of recurrence of stroke is reduced. If the domestic generic drug can achieve the same blood drug concentration and metabolic process as the original drug, then it can be speculated that the generic drug can obtain the same therapeutic effect as the imported original drug.

But after all, this is a theoretical speculation, because the formulation process of generic drugs will not be 100 percent consistent with the original drug, so generic drugs and original drugs are not exactly the same. In clinical use, small differences may lead to significant differences in efficacy. For example, if the blood concentration of anticoagulants to prevent stroke in atrial fibrillation is too low, the patient will be at risk of stroke, but if the blood concentration is too high, bleeding will occur.

Professor Li Yong further introduced that although there is no difference in the chemical structure between generic drugs and the original research drugs, there is a big gap in the preparation process when a chemical becomes a drug, and the gastrointestinal tract may be caused by tablet adjuvants. The reaction is different, which also leads to differences in the therapeutic effects of the two.

He believes that if the price is equal, whether from the perspective of theory or clinical practice, the original research drug has more evidence to show its safety and effectiveness, and the direct evidence theory proves that doctors should choose cheap and good original research drugs.

From this point of view, whether from the economic burden of patients or the level of clinical efficacy, doctors will be more willing to choose the maximum security, the most effective treatment drugs for clinical treatment.

With the implementation of the national expansion of volume procurement, the centralized procurement list is used for treatment.HypertensionThe original research drug Ambono and anti-platelet therapy cornerstone Plavie and other imported original research drugs, will soon be able to purchase in most parts of the country at a more favorable price, so that patients can benefit the price, enjoy high-quality imported original research products.

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