Song reduce weight the intersection of medicine and delisting incident torture of our country medicines recall system

Song reduce weight the intersection of medicine and delisting incident torture of our country medicines recall system
Song reduce weight the intersection of medicine and delisting incident torture of our country medicines recall system
Lower shelf, quiting listing, retrieving, " the song is beautiful " in Israel Capsule say good-bye to the Chinese market for west the intersection of cloth and the intersection of song and bright the intersection of type and weight-reducing medicine of representative recently, " medicines recall the system " Also enter the visual field of common people again. What kind of medicine needs recalling? How should to recall information to release? How to find the medicines potential safety hazard in time? What difficulties are there medicines recall the system in execution? It is over that three -year-old domestic medicines recall the system that a series of question will be tortured soon. The intersection of reporter and dawn quick gentle flat big picture Li " Recall " How could be very quiet? For the last few days, about the delisting incident of weight-reducing medicine such as being beautiful of song, numerous medias have all carried on the report, the reporter notices, " quietly lower shelf " A word is used again and again. " quietly " this one ,That was refracted is that the public, especially the irrigation ditch in the know of consumer of these medicines are not unblocked. On October 28, Zhengzhou citizen Ms. Cai comes to the red large dispensary of a second scene of special way of Zhengzhou, want to buy weight-reducing medicine that she used before this " Qu Mei " Capsule, but is told " this medicine has not been allowed selling " . Why not allow selling? Who does not allow selling? Can medicine already bought be returned? A series of doubt of Ms. Cai has baffled the shop assistant, the other side says that does not know, "it was the company that notified and has not allowed selling. Whether can retreat, can help you to ask " . On October 31, the reporter goes to some pharmacies of Zhengzhou to interview in the capacity of ordinary consumer, the situation met is similar. "Since the medicine allow, sell, should someone give us consumer explain, really what has appeared? " Ms. Cai says, took many this kind of medicines in the past, did not know either whether to have any injury or not. The reporter gets in touch and produces " Qu Mei " Taiji group of capsule, Ms Zhang of the press center of this group says, they begin to recall " the song is beautiful " formally since October 25 ,it emphasize she by this initiative for behavior, at that time it is food medicineses national that last what administration bureau require. The concrete method about recalling, Ms Zhang says that mainly sends a letter for relevant sale enterprises. Meanwhile, group this retail pharmacy, set up west the intersection of cloth and the intersection of song and bright capsule send back goods, order in every large the whole country, open, meet an urgent need incident handle 4008877698 hot line, solve doubt of consumer and send back goods consultation. But ordinary consumer brief on, have channel know information the. At the intersection of Taiji and official website of group, reporter see one question for announcement of " the intersection of Taiji and group recall west cloth voluntarily song reduce weight preparation tomorrow ". Say in the announcement, this group " directs against the user of bright capsule of west cloth song, plan to write " letter on stopping taking bright capsule of west cloth song " " . Ms Zhang tells reporters in each pharmacy, this letter issues, issue to consumers through the pharmacy again. From October 31 to November 2, reporters interviewed many pharmacies of Zhengzhou, the sales force of no shop knows this letter and concrete content. It is large joins a person in charge in Zhengzhou area of forest dispensary and says, they receive the telephone of the head office, stopped selling " Qu Mei " Notify,No let's see this pieces of letter. In fact, recall the incident and enter the public visual field finally this time, after getting involved in the media. And beautiful except the song, other brands contain the recalling of bright weight-reducing medicine of west cloth song, also all here " Quietly " Go on. Ms. Cai says, since pharmacy enterprises should recall medicines, why can't at that time release an announcement through the news media? It is reported, in U.S.A., the general procedure that medicines recall is, by Food and Drug Administration (FDA) at first Release recalling the news release on one's own websites or to the media, then announce, recall the announcement by enterprise to the masses of consumer, at all levels distributor by detailed medicines that FDA check through the intersection of masses and media. Under the supervision of FDA finally, enterprises recall defective medicines, take the remedy or destroy to defective medicines, and compensate for consumer at the same time. Recall system reach the age of three west the intersection of cloth and the intersection of song and bright the intersection of type and weight-reducing medicine this withdraw from the market finally, hands are that medicines recall the system to push away directly. Set up medicines to recall the country that make in some such as U.S.A. earlier, procedure, supervision and compensating for that relevant medicines recall,etc. stipulate very clearly. It is set up progressively in practice in recent years that medicines of our country recall the system. Perhaps people still remember, that big disturbance that the medical trade of our country happened of 2003, plant letting " Rough gentian clear away the liver-fire pill " Traditional Chinese medicine get into serious trouble,is it included by it Fructus Aristolochiae acid cause patient by injury. After this incident happens, the voice set up and pursued medicines and recalled the system in an all-round way of the medical trade field is held on day. Will it be December 2007, national the intersection of food and medicines supervise administration bureau issue and implement first one of our country " medicines recall management ", by December of this year, medicines of China recall the system and reach the age of three soon. Stipulate clearly, medicines are recalled, refer to the medicines manufacturing enterprise (including importing the external pharmaceutical factory Shang of medicines in " medicines recall management ", same below) Retract medicines of existence potential safety hazard sold of already going on the market according to the procedures regulated. Medicines of our country are recalled and divided " Recall voluntarily " With " order to recall " Two kinds. If medicines manufacturing enterprise violates the regulation of this method, find there is potential safety hazard without recalling medicines voluntarily in medicines, the pharmaceuticals administration department should order it to recall medicines, and should recall the penalty of 3 times of the amount of money of the medicines goods value in the place; Ones that cause serious consequence, are issued licence originally the department cancels medicines to sanction the documentary evidenced, until revoking the medicines production licence. Press center Ms Zhang of Taiji group says, recalls " the song is beautiful " this time Capsule is company's initiative behavior, do not supervise the department to require for national medicine. It is the stopping production released on October 30 that national food medicines supervise the administration bureau, stop selling the notice. It contain medicines when it is bright in song at home not only" Qu Mei " One. The Australia song is light, very beautiful, S�� ez is beautiful, Qu Ting, Pu beautiful, set up at pavilion, that, song scene, Lins Americans fragrants new, wishing blue and green and counting for ten times Le, promise pavilions beautiful,etc. at flower, weighing apparatus musical sound, Miao explains beautiful, it is after national Bureau of Drugs Supervision send out and recall the notice, helpless lower shelf one. To medicines recalled, " medicines recall management " to stipulate: Medicines of our country should notify relevant medicines to recall within corresponding time and manage enterprises, the stop of applying unit to sell and use according to different grades, report to local pharmaceuticals administration department of province, autonomous region and municipality directly under the Central Government at the same time. " fire wall " Is not it high enough? Zhengzhou citizen Mr. Liu has been paying close attention to the bright delisting disturbance of this west cloth song all the time, after reading the reports of numerous medias, he has produced such doubt: Why is only after medicine in foreign countries supervises the organization and forces this kind of medicine to quit listing, do we have actions? Have we found measure and system of the medicines potential safety hazard? It Real, as far back as 2004, issued " medicines bad reaction report and monitor management " if national medicine supervised the department, according to this method, our country has set up one set from central to local, and involve medicines manufacturing enterprise's, medicines managing the medicines bad reaction monitoring systems of enterprises, the medical health organ. After " medicines recall management " to issue and implement in 2007, the medicines bad reaction monitoring system become also to investigate and assess the medicines potential safety hazard, important foundation of recalling medicines. According to the introduction of medicines Cai ZhongQin, director of monitoring center of bad reaction of municipal Bureau of Drugs Supervision in Zhengzhou, Zhengzhou set up this centre in 2004, this supervised unit, manufacturing enterprise, selling enterprise, monitoring network which the hospital and patient linked to monitored the network. But reality is, what the national medicines bad reaction monitoring center received is reported to the overwhelming majority and come from the hospital. A lot of understanding of bad reaction of medicines enterprise is not enough, not merely a personnel or department does not collect the bad reaction case, and write some fewer side effects in the manual painstakingly, even the bad reaction to medicines is concealed. As to the thing that be recalled the incident tomorrow by the concerned west cloth song at present, Cai ZhongQin thinks, the national medicines bad reaction monitoring center has been following the bright latest research of the right west cloth song both at home and abroad and reporting. In February of this year, the national food medicines supervision bureau released the bright security information of the west cloth song, the risks of possible this medicines of pointing out medical personnel and the public, and require enterprises to revise and improve the manual and warn the risk of using medicine. Will it be October this year, because of bright to assess result newly to west the intersection of cloth and song in the world, national the intersection of food and medicines supervise administration bureau organize relevant to assess, work again, synthesize it to assessment result and the domestic clinical expert's opinion monitoring and studying the materials both at home and abroad, have made the decision to recall bright medicines of west cloth song finally. But Law Aid Center, city of Zhengzhou, Su think present medicines bad reaction monitoring system yet enough to become, stop up the intersection of medicines and " fire wall " of potential safety hazard slowly . Xu Su says, the survey of medicines potential safety hazard at present, the main target is a bad incident of medicines that has happened, this is typical " The reverse investigation " . Xu Su thinks, according to " management that medicines recall ", the medicines potential safety hazard refers to the unreasonable danger of threatening the security of health and life that may make medicines have because of the reason of researching and developing, producing etc.. No matter enterprises or supervision departments, can all carry on " investigate forward " of the medicines potential safety hazard in terms of researching and developing and production . If enterprises find there may be potential safety hazards because of the scientific and technological progress or craft problem in originally qualified medicines, there is not a serious bad reaction yet to even have clinically, can recall too. Is it few why to recall voluntarily? An obvious fact is, in present cases, the domestic enterprises that recall medicines voluntarily are actually few. A staff member of municipal Bureau of Drugs Supervision of Zhengzhou says, enterprises fear that recalling medicines will damage reputation, enormous cost pressure that medicines recall that more important factor is. This west cloth song will recall the incident tomorrow, will undoubtedly bring big influence on medicine enterprises such as Taiji group,etc., it is its main products that the song quiting listing is beautiful. According to " Chengdu Business ", it is about 250 million yuan that the song of Taiji group is beautiful to list the annual sales amount total of sodium film 2009 of ketone with another Rogge, it is estimated 2010 annual sales amount totals over 300 million yuan, accounts for about 17% of industrial sales income of company, contribute about 30% of gross profit. The total amount, still in statistics, according to its October 30's announcement that Taiji group sends back goods this time, stopping selling will influence the income from sales of nearly 40 million yuan of this year of the company this time, account for 0.8% of income from sales of the company. Besides Taiji group, ten products which count a brand recalled this time, involving ranges spreads all over the whole weight-reducing medicine and produces the trade. Xu Su says, at present, the medicines enterprises of our country are generally small, once present medicines to recall the incident, they should face selling losses, will bear compensation responsibility possibly, for small medicine enterprise, it is undoubtedly a extinction. In this delisting incident, the beautiful statement that sent back goods without compensating for of song, the dispute. Also just because of these, there are few enterprises recalling medicines voluntarily at home. Xu Su thinks, sets up " medicines bad reaction compulsory insurance system " Solve domestic enterprises and recall a method that is worth exploring of the not high problem of enthusiasm voluntarily. According to " Chinese Medicine ", as far back as 2008, the insurance kind about medicines bad reaction has already been listed in some insurance companies in a low-key attitude, but there is no large-scale popularization. In countries such as U.S.A., Sweden,etc., this way has already existed. Enterprises can buy the insurance of medicines through two ways: First, single pharmacy enterprises buy the insurance of medicines, the insurance premium is undertaken by enterprises; Second, several big pharmacy enterprises jointly buy group's insurance, the premium spreads out, shared risks altogether. In this way, can unload " burden " of enterprises to a certain extent . However, the domestic medicine enterprise needs a long time to the acceptance of this kind of insurance, want to be institutionalized, not even the one that can realize overnight. "If the medicines bad reaction is dangerous to implement mandatory purchase like car insurance, that will be the most ideal result. " Xu Su says.


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