These varieties require careful consideration of volume procurement.

With the full flowering of local volume procurement, which varieties are more suitable for inclusion in the provincial centralized procurement catalogue? Provincial collection, each has its own characteristics in recent days, Shandong, Zhejiang, Hebei and other major pharmaceutical provinces have implemented provincial centralized procurement catalogs and programs, causing widespread concern in the industry.
According to the incomplete statistics of Cypress Blue, there are now Heilongjiang, Hebei, Shandong, Jiangsu, Anhui, Qinghai, Fujian, Shanxi, Hunan and other dozens of provinces launched the provincial volume procurement, and formed their own characteristics of the procurement program: for example, Jiangxi Province for the unapprained varieties of "double envelope" recruitment, Hebei using a sub-area approach to centralized procurement, Hunan and Qinghai respectively for antimicrobial drugs, focus on monitoring the implementation of drug procurement ... To a certain extent, the national level of the volume of procurement, is the use of domestic generic drugs that have passed the consistent evaluation of the lowest price or the standard reduction of the winning bid, the corresponding product regulations of multinational enterprises to achieve clinical substitution of the original research drugs.
this model, the consistency evaluation is a ticket with volume purchase.
so from the current announcement of local procurement programs, the provinces intend to the key varieties not assessed to implement "provincial volume procurement", the formation of the pharmaceutical industry's supply side closed loop.
It is understood that Hebei, Shandong, Fujian, Jiangxi, Hainan, Qinghai, Shanxi and other provinces have published a specific catalog of provincial procurement, the number and variety of different, in the implementation and operation of a certain degree of flexibility.
In other words, the province's procurement varieties are mainly clinical use, high procurement amount or high unit price, adequate competition for drugs;
It is important to note, however, that adverse reactions to cancer injection drugs and treatment failure are associated with a higher risk and difficult to manage than for chronic and anti-infective drugs, especially injectable cytotoxic drugs such as oxalipari.
in the selection of varieties purchased in volume, the differences between the original and imitation of such drugs should be objectively examined, and the risks that may occur during clinical replacement should be strictly controlled in order to maximize the efficacy and safety of tumor treatment.
, higher quality and safety requirements and the national centralized procurement of oral preparations is not the same, provincial volume procurement involves injection-based dosage forms.
Indeed, from the public data, injection terminal consumption accounted for more than 60%, compared to oral solids, injection coverage is wider, the terminal amount is greater, more related enterprises - even though the growth rate of the chemical drug market is decreasing year by year, but the absolute value of the chemical injection market is still increasing year by year, from 408.5 billion in 2013 to 615.2 billion yuan in 2018.
According to the proportion of injectable market share, was included in the volume procurement, the first to bear the brunt of the biggest impact of injectable products than proton pump inhibitors, antibiotics and anti-tumor drugs, because the injection directly injected into blood vessels, tissues or organs, rapid absorption, rapid action, especially intravenous injections, drugs directly into the blood circulation to play a drug effect, is a higher risk in clinical use of the dosage form.
To this end, the national well-known oncologist, Zhejiang University Oncology Research Institute, Zhejiang University School of Medicine affiliated with the second hospital of the former president, the Chinese Society of Clinical Oncology (CSCO) colorectal cancer expert committee chairman Professor Zhang Su-Zhan told SaibaiLan during the CSCO National Annual Meeting: the vast majority of injections belong to intravenous drugs, as soon as they enter the body directly spread to the blood throughout the body, need to pay attention to clinical safety.
He explained that there are many excipitants in the injection to maintain the stability of the main material, thereby reducing some allergic reactions, so that the drug on the blood vessels less irritating - if these accessories, water quality, high temperature sterilization and other links are not strictly controlled, it is dangerous.
for these reasons, injections are more technically demanding for research and development and production.
this also shows that the original research products of injections, than generic drugs have a better advantage in terms of safety.
Professor Zhang Su-zhan said: Because in addition to the original drug listed in China, generally in the United States, the European Union, Japan, its drug regulatory experience, reporting is the basis for action in many countries, therefore, the safety of its listed products and the strictness of inspection are double protection.
if the injection itself is a high-risk dosage form, then the clinical adverse reactions of tumor injections are more obvious, especially need attention.
some of the drugs we typically use have a wider clinical treatment window - the difference between the treatment dose and the dose of poisoning (unsafe dose) is large, or even more than 10 times, and others have narrower treatment windows, such as cancer drugs, because it is less cell-selective, the experts said. Easy to bring harm to normal cells, the maximum effective dose and the minimum toxic dose difference is very small, only strictly control the process, raw materials, chemical composition, through consistent evaluation, to achieve and the original drug is fully consistent, in order to use the maximum dose will not cause damage to patients, otherwise these drugs will be more harmful than therapeutic.
According to the Canadian government's drug regulator's narrow treatment bed drug list, many anti-cancer drugs are narrow treatment bed drugs, such as oxalipari, such drugs are very close to the blood concentration of poisoned blood, so the risk of drug use is relatively high;
This is the future need to carefully consider the issue - anti-tumor injections due to the high amount of procurement, clinical drug use and into the multi-provincial volume procurement catalog, under the existing bidding mechanism, the unestailed varieties and the original drug price kill, may affect the patient's access to drugs, and bring the risk of drug replacement.
Such drugs, it is recommended to suspend the purchase of tumor injection clinical response is more obvious, the quality of the drug requirements are very high, the need to closely detect treatment indicators, even if only a small difference in drug quality may lead to serious treatment failure or serious adverse drug reaction events.
Respects the National Adverse Drug Reaction Monitoring Report (2018) issued by the National Drug Adverse Reaction Monitoring Center, intravenous drug administration accounted for 60% of the total number of adverse reactions/incidents reported, in anti-infective drugs, cardiovascular drugs, anti-tumor drugs and drug use related to the elderly Serious adverse reactions / events of the corresponding proportion of various dosage forms, anti-tumor needles accounted for the largest proportion, as high as 89.5% of this, Professor Zhang Su-Zhan frankly said: Personally, there is no consistent evaluation of the narrow treatment window of the drug, it is not appropriate to carry out volume procurement.
In a certain period of time, drugs that have not been evaluated consistently can be allowed to fill the gap in the drug market, but they cannot be included in the bidding varieties with volume procurement;
he added: If unested clinical anti-tumor injections are procured in bands and all doctors are forced to use the same drugs on a large scale, it will be difficult to recover the damage if something goes wrong.
the relevant interpretation of national mining, interpretation documents repeatedly put forward: "national mining is mainly for over-evaluation varieties, provincial and municipal production as a national harvest to make up, mainly for un-evaluated products."
"Since the unestamented varieties into the provincial harvest has become the main theme, then in the expert selection stage, how to combine the clinical application characteristics of pharmaceutical preparations and clinical use feedback and other factors, the truly suitable varieties into the provincial centralized procurement, it becomes the next stage to focus on the issue.
.