Pay close attention to clinical application " The ashy

Pay close attention to clinical application " The ashy area "
This month, a hospital of Shanghai uses antineoplastic A to cut down the spit of fland of Sri Lankan (Avastin) Treat eye disease for more than one hundred patients, cause several dozen people eyes to be injured. At present, relevant injured patients are receiving treatment in the hospital, the judicial organization of Shanghai has already got involved in the investigation (relevant report and seen the 2nd for September 16 of this newspaper) .

Someone thinks, no matter how final investigation and result are, query and introspection that this case brings, how to investigate and prosecute their meanings will all surmount this case.

Is it legal to cure the eyes disease with antitumor medicine

It is a kind of biologicals that A cuts down parenteral solution of spit of fland of Sri Lankan, my traditional Chinese medicines supervise the clinical indication that the department sanctions in order to be used for treating " shifting rectal cancer of knot " . But at present, a lot of hospital ophthalmology departments including the People's Hospital of first in Shanghai use this medicine for treating urgent, chronic diseases of optical fundus such as pathological change of macula lutea of the optical fundus,etc.. The insider calls this kind of treatment " A cuts down the vitreous body of spit of fland of Sri Lankan and injects the skill " .

A registered as anticancer drugs cuts down the spit of fland of Sri Lankan, indication is turned from cancer into a optical fundus disease, change medicine route from intravenous injection to the injection in the eyeball. This kind of therapeutic method " Subvert " Medicines manual regulation. After this incident happens, some people begin to query " A cuts down the vitreous body of spit of fland of Sri Lankan and injects the skill " Legitimacy.

A lawyer of professional committee of medical law of bar association of Beijing introduces, the regulation that has legal effect to clinical application is fallen into three categories: First, national relevant laws and regulations and rules and regulations some sense of principle or prohibitive regulation done on administration, clinical must observe; Second, the medicines manual is clinical legal open guidance files with legal significance that used medicine; Third, " " in " of national pharmacopoeia The notice of clinical application " Solve the important legislative authority about dispute of using medicine.

This lawyer says, by the look of clinical practice, doctor's ultra manual range administration is mainly because of two respect factors: First, consult authoritative reference material, periodical literature; Second, the experience of using medicine which individual accumulates. And cut down A in the spit of fland of Sri Lankan and use for treating the eyes disease, obviously mainly use according to authoritative reference material, periodical literature, and these materials are only the accumulation of the clinical practice, it does not have legal effect itself.

But this lawyer says at the same time, all indication and usage of the impossible limit medicine of medicines manual, so, the law proclaimed in writing either forbids the doctor to follow the manual and use medicine, really have phenomenon that ultra manual range uses medicine in clinic too.

China medicine learns the Vice President, pharmacy expert Professor Li DaKui how to say, there must be rational scientific theoretical foundations in the out-of-range administration. The doctor should study the materials in shining on the bed, weigh to the pros and cons in information such as attentive matters, taboo disease, warning, and " the out-of-range purpose to use medicine can only be in order to benefit patient, but not other purposes such as experimental study " .

This lawyer of professional committee expresses the medical law of bar association of Beijing, though the clinical ultra manual range uses medicine the phenomenon is more general at present, but patients are injured, it is " rational but illegal " Method,will make hospital and doctor face to be legal risk of lawsuit.

This lawyer says, should legalize those rational out-of-range administration through certain legal procedure. So, need to issue the relevant regulation to standardize and need to establish one special Committee of Experts to screen.

How to supervise the source " Illegal " "real medicine "

On the night of the 22nd of September, national food medicines supervise the administration bureau notifying A cuts down the bad incident preliminary investigation result in the spit of fland of Sri Lankan and says: "Appraise respectively through Luo's general headquarters and Shanghai medicines appraisal organization of the company, confirm the medicine causing a large number of eye illness patients to produce the bad incident in first in Shanghai the People's Hospital is false medicine. "

Supervise personage of department, reveal, cut down the spit of fland of Sri Lankan and confirm A that the intersection of Shanghai and first the People's Hospital use this time as false medicine according to one medicine, do not say these medicines are that someone imitates production, it is the medicines source " illegal " .

It is reported, judge that stipulates in our country " law of medicine management " clearly for the basis of false medicine: " biologicals which the State Council pharmaceuticals administration department stipulates " , " medicines sold in China for the first time " ,While or import before selling, should appoint medicines to examine the organization to examine; Not up to the standards, can't sell or import. And " must sanction and produce, import without approval, or must examine and not examine selling promptly " ,Punish according to false medicine.

At present, our country sanction A used to import cut down the intersection of parenteral solution and Chinese name, spit of fland of Sri Lankan, ask " shellfish cut down the pearl form resist parenteral solution " ,The Chinese goods are called " An WeiTing " ,Mainly have two specifications. One is 100 milligrams ' 4 ml) /The bottle, one is 400 milligrams (16 ml) /The bottle, date is all February 26, 2010 that its import license issues licence.

That is to say until will it be February this year, A cut down parenteral solution, spit of fland of Sri Lankan, sanction allowing to sell and use at home.

But right away at the thematic scientific seminar of disease of national optical fundus held in Shanghai in March of this year, in the thesis submitted, more than 50 refer to A and cut down the spit of fland of Sri Lankan to inject and treat, involve more than 30 hospitals together. It is obvious, domestic many medical organizations have been using this kind of medicines to be used in the treatment of eye disease for a long time. This brings a query, since our country has not approved A for cutting down the spit of fland of Sri Lankan to import and sell yet, where do come from to cut down the spit of fland of Sri Lankan in A which these hospitals use? Is it legal that the doctor use these medicines?

Medicine supervises a personage of the department to say, according to relevant regulations, the administration of the hospital must be by the sanctioning and can call for bid or get in a manner to stock up alone through medicines of board of trustee of the medicine thing of the hospital. Even if it is clinical and urgently needed to belong to or individual uses by oneself but domestic without source of goods, also need to go through formalities of importing and can enter and use according to the regulation.

So far as this, it is " really " that A that some medical organizations use cuts down parenteral solution of spit of fland of Sri Lankan ,but channel source have "illegality " Suspicion. This personage says, trace to false medicine of first ophthalmology department of the People's Hospital in Shanghai this time, exposed one and paid attention to the question incompletely before, how to supervise the medical organization to use " illegally " Real medicine issue.

But some reputable oculists have stated such a view, at present, it is a very effective medicine of the old macula lutea changing the sex disease of treatment in the world that A cuts down the spit of fland of Sri Lankan, American state-run hygiene research institute is carrying on large-scale clinical verification at this point. According to this angle, the doctor uses this medicine to obviously have its rationality. In fact, the similar question is far not merely limited to A cuts down the spit of fland of Sri Lankan, the doctor lies in puzzledly, there the one that can cure the disease to save someone's life in hands " False medicine " When, in the face of feeling and law being awkward, how choose?

It is reported, Ministry of Public Health, national food medicines supervise the administration bureau fermenting and issuing " medicines quality surveillance management of medical organization " . With the issue of this management, medical organization uses medicine the question will be further standardized.



Pay close attention to clinical application " The ashy area "