The original research is really better than the imitation "fragrance"?

"The'little magic drug' Gehuazhi, which has been eaten for ten years, is out of stock in public hospitals.

Recently, news of Gehuazhi’s out-of-stocks in public hospitals has spread like wildfire.

"In fact, imported drugs are not expensive.

Why do the original research drugs that are sought after by patients "disappear" from time to time in public hospitals and even pharmacies? If there are really no original drugs to buy, can the domestic generic drugs that have won the bids in centralized procurement can make patients feel relieved to use them?

01 Gehuazhis are disappearing

A diabetic patient who has been taking Gehuazhi for nearly 10 years told the E-drug manager, “It’s difficult to drive Gehuazhi in the hospital now.

Ghivazhi, commonly known as Metformin Hydrochloride Tablets, is produced by Sino-US Shanghai Bristol-Myers Squibb.

As the first-line medication for hyperglycemia control of type II diabetes patients and the basic medication in the drug combination recommended in the diabetes diagnosis and treatment guidelines formulated by many countries and many international organizations, studies have shown that metformin not only has a good hypoglycemic effect, but also has a variety of hypoglycemic effects.

In 2020, metformin hydrochloride tablets surpassed acarbose tablets and became the top variety of non-insulin hypoglycemic drugs

As a star-hypoglycemic drug, metformin was included in the third batch of nationally organized drug centralized procurement in 2020, and it has become the most competitive product among the five batches and six rounds of centralized procurement so far.

Obviously, the absolute dominant position of Gehuazhi was broken after the collection.

The classic original research drugs that have gone through the baptism of centralized procurement and have not won the bid disappear in public hospitals.

This is not the first time that a brand-name original drug has been out of stock in a public hospital.

The doctor complained that “every day, I met patients who could not prescribe the original medicine but cursed them”, and the patients complained that “the medicines they had been using for many years were suddenly replaced with domestic medicines, which was unacceptable”

In fact, in the past few years, a number of well-known original research drugs such as Lipitor, Luohuoxi, Boludin, and Veride have all fallen into the cloud of out-of-stock suspects

As early as the 4+7 collection in Shanghai in 2019, Entecavir tablets (Bludine) and Tenofovir (Veride) had been discontinued in major top three hospitals

The impact of centralized procurement on the original research drug is obvious

According to the centralized procurement rules, public hospitals in various regions must complete the dosage of the selected varieties.

02 Say goodbye to "no medicines available" and accelerate the replacement of original research

According to the knowledge of the E-pharmaceutical manager, in the process of implementing the centralized procurement results, the most explained by doctors and patients is the "consistency evaluation": "The drugs that enter the centralized procurement have been evaluated for consistency, as long as they are consistent.
Sexual evaluation, the quality and effect are not much different from the original research drug
.
"

A biliary tract doctor of the Eastern Hepatobiliary Surgery Hospital once publicly stated that in clinical situations, such as when the original drug of Entecavir tablets is out of stock, the doctor will use the latest centralized procurement winning product
.
The advantage is that the price of the bid-winning product has dropped significantly compared to the previous one, but problems also follow.
The huge difference in the price of the medicine has caused patients to have a lot of doubts about the collected bid-winning product, and they often encounter patients in clinical promotion.
Distrust low-cost generic drugs or insist on using original research drugs
.
Just as the patients worry at the beginning of the article, how can the curative effect be guaranteed for such a low price?

On the other hand, doctors are also worried: Will the quality of domestic generic drugs remain stable after they pass the consistency evaluation and start mass production? In terms of pharmaceutical excipients, will the difference between domestic and imported materials cause different side effects.
.
.

Regarding the effectiveness and safety of centralized procurement of generic drugs, are the generic drugs and the original drugs that have passed the consistency evaluation really clinically equivalent? As early as two years ago, the National Medical Insurance Bureau established a real-world research project on the clinical efficacy and safety of selected drugs in centralized procurement
.
The analysis of clinical data collected from more than 110,000 real-world patients over the past two years shows that a large amount of real-world data has been preliminarily confirmed.
The 14 generic drugs that passed the consistency evaluation and the original research drugs included in the study are clinically equivalent.
Sex
.

The above mentioned entecavir is an example.
The study of 35450 patient data shows that the efficacy of generic entecavir in the treatment of hepatitis B patients is not statistically different from that of the original drug, the incidence of adverse reactions is not different, and compliance is better.

.

The National Medical Insurance Bureau also stated that it has explored and initially established an evaluation model for the clinical efficacy and safety of centralized medicines, which is scalable
.
Follow-up can further improve the indicators and evaluation system, continue to expand the efficacy and safety evaluation of generic drugs selected in centralized procurement to more varieties, wider areas, and longer-term use of drugs, so as to ensure that the people enjoy high-quality and affordable drugs
.

Even so, when the price of centralized medicines drops sharply, patients still have multiple concerns.
Generic medicines with such a low price must be different from high-priced medicines.
Is the efficacy discounted? Will adverse reactions worsen and so on
.

In fact, it is an international practice for high-quality generic drugs to replace high-priced original drugs, and China has officially launched the quality and efficacy consistency evaluation of generic drugs since 2016, and the centralized procurement initiated in 2018 requires that participating products must pass the consistency evaluation.
Accelerate the replacement process of the original research
.
However, due to long-term medication habits, some patients still have superstitions and look up to the original research drugs.
People have always worried about the quality of generic drugs.
Even generic drugs that have passed the consistency evaluation are still difficult to use, which affects to a certain extent.
The process of replacing patented drugs
.

Relevant experts from the National Medical Insurance Bureau also called on Chinese patients to have the right to use drugs of high quality and reasonable price.
Both patients and medical staff should break the "superstition" of the original research drugs, and treat generic drugs in a fair, fair and objective manner.
The original research drug has the concept of superstition, looking up or super national treatment, creating a good market environment for domestic generic drugs
.

The centralized procurement of drugs is based on the premise of passing the consistency evaluation.
After entering the centralized procurement and selection, real-world research data proves that there is no significant statistical difference between the clinical efficacy and safety of the over-rated generic drugs and the original drugs, and the clinical efficacy of the selected drugs It was confirmed with security, filled up the gaps in the previous real data, formed a closed loop in the evidence chain, and provided strong support for centralized procurement
.

As centralized procurement moves towards normalization, ensuring the quality and safety of selected drugs in centralized procurement, strictly abiding by the bottom line of drug quality and safety, and achieving "high quality and reasonable price" for selected drugs is the face of all levels of drug regulatory authorities, selected drug holders, and manufacturers.
Top priority
.
When massive, real clinical data proves that generic drugs selected in centralized procurement are effective and safe, they are no different from the original drugs in clinical application, and doctors and patients can choose and use them with confidence
.

In the future, when the stock-out of the original research drug is no longer regarded by patients as a major event of "no drug available", we can say that domestically produced generic drugs have made important progress in the process of replacing the original research
.