The new version of drug quality management practices

On June 1, 2013, the new version of the "Policy Quality Management Practice" was formally implemented. Compared with the original specifications, it greatly increased the threshold of retail pharmacies, such as requiring pharmacies must be equipped with licensed pharmacists, but also requires monitoring and control of temperature equipment, special refrigeration equipment and other business equipment. At the same time, the new version of the specification clearly requires that pharmacies should explicitly inform customers when they sell drugs for the immediate period.

At noon on May 29th, at the Shou Chuntang pharmacy in Hualidi Xi Li, Chaoyang District, Beijing, the reporter saw that in the prominent position next to the cash register, a “Drug Business License” and two licensed pharmacist registration certificates were hung. . There is a thermometer and hygrometer in the shop, and the temperature is obviously lower than that outside the shop. The store's door also posted an eye-catching reminder: “In order to ensure the quality of medicines, the interior temperature of our restaurant is low.”

Retail pharmacies are not grocery stores

“There is no difference between a pharmacy without a licensed pharmacist and a grocery store,” said Li Guoqing, director of the Department of Drug Safety Supervision at the State Food and Drug Administration.

According to the new version of the regulations, the legal representative of a retail pharmaceutical company or the person in charge of a company should have the qualification of a licensed pharmacist. The company should also be equipped with licensed pharmacists in accordance with regulations to be responsible for the review of prescriptions and to guide the rational use of drugs. This means that a pharmacy should have at least two licensed pharmacists.

The new version requires that prescriptions be assigned after approval by licensed pharmacists; drugs listed in prescriptions must not be changed or replaced on their own, and prescriptions with incompatibility or overdose should be refused, but may be rectified by a prescription doctor or re-signed with confirmation. Distribution; prescription review, deployment, verification personnel should sign or seal the prescription.

The "Legal Daily" reporter visited two retail pharmacies near the newspaper, one is the above-mentioned Shou Chun Tang pharmacy, and the other is a Beijing Tong Ren Tang Runfeng pharmacy in Hualidi Nanli, both of whom saw two licensed pharmacists on the wall. According to the license, but there was no licensed pharmacist at the latter site, the on-duty manager explained that the pharmacist had gone out temporarily.

In fact, to buy drugs at pharmacies, if there is a licensed pharmacist to help check it, everyone will feel more practical. In April of this year, Beijing boy Xiao Xu traveled to Sanya, Hainan to travel and get married. During this time, he felt that his throat had hurt a local pharmacy. Instead of selling drugs, the clerk proposed to look at Xiao Xu’s nephew before recommending drug purchase. Xiao Xu said that this made him feel very good. "The pharmacy should be a bit professional."

In Tongrentang Runfeng pharmacy, Wu Meilan, the on-duty manager, told reporters that she knows that the new version has been implemented in accordance with the requirements of the parent company and some work is still being done. The reporter asked what requests were made by the head office. She replied: “If you want to interview, I must apply to the head office for approval.” So, the reporter produced the press card and left a contact phone number as requested, but he did not receive it at the time of writing. Reply from Tong Ren Tang.

According to industry insiders, the biggest challenge for the retail pharmacies to implement the new version of the regulations is to pass the practice of pharmacists. The following data released by the State Food and Drug Administration has been quoted repeatedly: At present, there are more than 200,000 licensed pharmacists who have obtained qualifications in the country, of which only 80,000 are registered, and there are more than 400,000 retail pharmacies across the country. The shortage of licensed pharmacists is huge. .

Wu Qiong, director of the Food and Drug Administration of Jining City, Shandong Province, believes that “if the former competition is capital competition, then the future will be the competition of professionals. For those monopolistic pharmacies that do not have the concept of quality control, they are destined. To be eliminated. In the future, more professionals will set up pharmacies themselves, which is more conducive to the quality and safety of medicines."

Improve the value of drugs

For foods that are going to expire, supermarkets discount them. So, what should be done for pharmacies in the near-term drugs?

The new version of the specification requires that sales of drugs for the period of near-term validity should be notified to customers.

So, what is the near-term drug? Drugs with a short-lived period refer to drugs whose effective period is ≥ 5 years, drugs whose expiration date is less than 1 year and a half before the expiration date, or drugs whose expiration date is ≥ 2 years and whose expiration time is only 1 year. In the drug wholesaler's warehouse, the general drug is the drug in the immediate period when it is within six months from the specified expiration date.

Many people have had the experience of buying drugs in the near-term. Someone wrote an article saying that the eye drops that were bought near home were drugs for the immediate period. The heart could not help but give birth to a jealousy: Is there any hidden danger in using this stuff?

The article believes that in terms of drugs, the effectiveness of drugs is its use value, and drug safety is its perceived value. For consumers, medicines are special commodities. Their greatest feature is that they cannot be used after they expire. Everyone, of course, hopes that the medicine they buy is the latest one. In fact, many pharmacies have short-acting drugs, and most pharmacies sell their products to customers in the form of main pushes. From a legal point of view, drugs do not exceed the expiration date, and there are no other anomalies, and pharmacies can, of course, continue to sell. Pharmacies can also reduce the losses caused by expired drugs by promoting drugs in the immediate period. However, in today's public demand for improved safety and efficacy of drugs, why can some pharmacies not increase the value of drugs while ensuring the value of drug use?

Starting from June 1, 2013, pharmacies selling products for near-term drugs should inform customers of the validity period, which can be said to be a win-win move. The decision by the customer to decide whether to purchase the drug in the near-term, reflects the customer's right to know and the right to choose, and sincerely treats customers. At the same time, it has also improved the pharmacy quality management.

Wu Meilan, duty manager of the Beijing Tongrentang Runfeng pharmacy, told reporters: “We have all the medicines that are valid for three months, and our stores are all required to be taken off the shelves. There are no drugs in the store.”