Come from the wife of the tall gentleman of Xi'an, had been pregnant 6 weeks, appeared recently vomitive symptom, will to Xi'an mayor bring a district then examination of a courtyard, the doctor suggests the infusion of wife be in hospital of tall gentleman is treated, what let him did not think of as a result is, when the liquid is hanged to the 2nd bottle he discovers drug period of efficacy comes inadvertently in January 2019!
This bottle of overdue medicine is " fluid of dextrose vein inject " , manufacturing date is in Feburary 2017, period of efficacy comes in January 2019, that is to say, this bottle of medicine expired near 3 months! But when tall gentleman discovers medicine expires, had injected half.
Subsequently this pregnant woman undertakes the body is checked, the examination shows value of the fungus inside body of tall gentleman wife has exceeded bid as a result, later period also says to forbid to fetal influence doctor.
Actually, we use drug in oneself at ordinary times when, a lot of people oversight see medicines and chemical reagents produce date and period of efficacy, even if go to a hospital seeing a doctor to also should have this habit.
Does medicaments expire what harm is there?
Do you share clear period of efficacy and failure period?
How does medicaments period of efficacy look?
...
Are these not quite clear still? Fasten urgent, small make up taking you to look downward together, the answer some:
One, the controversy about drug period of efficacy
With afore-mentioned 10% dextrose inject fluid is exemple.
Tag on bottled label " manufacturing date: 2017.02.26 " , "Period of efficacy comes 2019.01 " .
Tag on manual of medicines and chemical reagents " period of efficacy 24 months " .
So, can be fluid of inject of this bottle of 10% dextrose used after all when?
Someone says to be able to be used to December 31, 2018, someone says to be able to be used to January 31, 2019, return somebody to say to be able to be used to Feburary 25, 2019.
Right answer is: Can use to January 31, 2019.
Basis " manual of medicines and chemical reagents and label management set " , if drug period of efficacy tags day, date calculates to be manufacturing date since before today; If tag a month, before month calculating to be those who produce date since in January.
The manufacturing date of fluid of 10% dextrose inject is 2017.02.26, of period of efficacy case calculate date for 2017.02.25, month calculates since for 2017.01.
The period of efficacy of fluid of 10% dextrose inject is 24 months (see a manual) .
If this factory chooses period of efficacy to tag day, can tag for " period of efficacy comes 2019.02.25 " , can use to Feburary 25, 2019.
Because this pharmaceutical factory chooses period of efficacy to tag a month, can tag only so for " period of efficacy comes 2019.01 " , medicines and chemical reagents also can be used to 2019.01.31 only.
Drug period of efficacy is to show medicines and chemical reagents is below certain reserve requirement, can carry the term of quality.
" Pharmaceutical Affairs Law " the 49th regulation, must not use expire medicines and chemical reagents.
If apothecary will expire,medicines and chemical reagents is given out, press processing of sale bad medicine commonly; Lead to consequence, even according to " unskillful and faulty medical or surgical treatment handles byelaw " the accident grade of appraisal undertakes compensatory, investigate the duty of relevant responsibility person.
2, the format of drug period of efficacy and computation
The period of efficacy of medicines and chemical reagents and failure period, is your cent clear about?
About medicines and chemical reagents " period of efficacy " and " failure period " , appear from literal meaning with respect to can very good understanding, not be " to some effective a few days ago " and " to some day of invalidation " , seem to do not have how old distinction.
So the issue came: "Failure period: In April 2018 " and " does period of efficacy come in April 2018 " is there distinction? Be the same day invalidation that point to?
In fact, a lot of people show foolish foolish cent is not clear, even some of medicine learns professional personage a little promiscuous also.
Is 1. homebred appear on the market how does drug period of efficacy express?
(1) indicate directly failure period failure period: , it is the invalidation since 1 day when point to this medicine to be in this years this months. If mark has " failure period: In October 2016 " medicine, can use only on September 30, 2016.
(2) indicate effect period to press days order directly, general expression can come some year some month with period of efficacy, or with the number, it is to show this medicine can be used to period of efficacy most by the month of end month. If mark has " period of efficacy comes in July 2016 " medicine, this medicine can be used to July 31, 2016. Also can convey for " period of efficacy comes 2016.07 " " period of efficacy comes 2016/07 " " period of efficacy comes 2016-07 " etc, time shows with 4 digit, month shows with 2 digit (1 ～ 9 before add 0) .
(3) indicate effect period year number or the drug period of efficacy that the month counts line out of this kind of means, can produce date according to medicines and chemical reagents computative, general provision produces date namely lot number expresses with 6 digit word, before two represent time, among two show month, fine expresses date twice. Be like mark " lot number 150815 " , period of efficacy medicine of 2 years, its period of efficacy is to August 15, 2017.
2. How does entrance drug period of efficacy express?
Entrance medicines and chemical reagents constant with " Expiry Date " (date of expiration) represent failure period, or with " Use Before " (in... before use) express period of efficacy. Of period of efficacy of each country drug tag not identical, discern hard sometimes, to avoid to cause accident, should understand write a law differently, notice to identify.
The United States: By the month - day - year arrange orderly, be like 9/10/2016 or Sep.10th 2016, namely on September 10, 2016.
European country: By day - month - year arrange orderly, be like 10/9/2016 or 10th Sep.2016, namely on September 10, 2016.
Japan: By year - month - day is arranged, be like 2016-9-10, namely on September 10, 2016.
In indicate effect period while, general still mark has manufacturing date, because this can come according to manufacturing date,computative period of validity is how long.
Notable is, the period of efficacy of medicines and chemical reagents is not absolutely, restrict conditionally however, this is the method of keep in storage of demonstrate of the place in the label of medicines and chemical reagents and manual. If method of keep in storage produced a change, the period of efficacy of medicines and chemical reagents can serve as reference only, is not keep quality time certainly. Once medicines and chemical reagents from pack formerly inside cent goes out, if ravel box, open cap to wait when beginning to use, suit to be saved for a long time no longer, and should use in time.
3, the factor that affects drug period of efficacy
: of 1. outside element? Xin of Qiong of Tun reel silk from cocoons breaks closely question of of ┢ phenol travel to flinch postscript? is in early has attention, like: ? Dew takes ⑹ to take? of magpie of small cup of ⒐ arm spread to there also is a regulation in standard of medicines and chemical reagents,
Is 2. person element: ? Does Ci Song seek Xu travel to closely question male form? is like: ? Teach badger of Wei to bring up of which gallopping ┮ skip this itself of? of Pai a pavilion or house on a terrace breaks the law one kind namely, ought to give corresponding legal sanction, we also discuss more nevertheless.
: of 3. craft element?
For example, do obeisance to be the same as newly (saltpetre benzene n accuses commentate piece, aluminous model is packed) requirement shading, 30 ℃ are the following and sealed save, from aluminium after be being taken out in model board, should take instantly.
Do obeisance to aspirin (aluminous model is packed) the requirement is saved under sealed, 25 ℃ . After be being taken out, should take instantly.
Again for instance, calcic Er strange D is masticatory piece (bottled) ask airtight room temperature is dry save.
The Chinese pharmacopoeia explanation about a few commonly used term:
4, expire the harm of medicines and chemical reagents
Drug period of efficacy is the main index that measures security of medicines and chemical reagents and effectiveness, expire what medicines and chemical reagents reachs people to normal drug market is healthy have serious effect with life safety. Accordingly, recognize expires the harm sex of medicines and chemical reagents, take effective measures to reclaim expire medicines and chemical reagents, it is to ensure human body uses the medical safety, external demand that maintains people health.
Expire medicines and chemical reagents not only itself does not have value, and can produce a lot of harms, basically have the following sides:
1.Cause the safety that use drug
After problem medicines and chemical reagents expires, lose original remedial intention possibly not only, and wait possibly still because of immanent quality produce a change, produce harmful to human body material. If people was used,expire medicines and chemical reagents, light likely bungle treats an opportunity, the health that causes other is damaged, heavy minatory even life is safe. According to " Pharmaceutical Affairs Law " regulation, the medicines and chemical reagents that exceeds period of efficacy belongs to bad medicine, prohibit produce and be being sold.
2.Cause an environment to pollute a problem
Expire medicines and chemical reagents handles undeserved meeting to cause certain effect to the environment. On one hand, discard directly expire medicines and chemical reagents may pollute an environment. Concerned investigation shows, most person opposite period rubbish of medicines and chemical reagents and average life is coequal treat, any processing are not done before discarding. The composition in medicaments scatters in the environment to cause pollution easily, and the remedy with a few simple characteristic, if send quick sex, volatile medicaments by force, more serious to contaminative degree of the environment; On the other hand, expire destroy by melting or burning of medicines and chemical reagents pollutes an environment possibly also.
3, medical effect drops or disable
Exceed period of efficacy, the active ingredient content of medicines and chemical reagents can be reduced commonly. Take overdue drug, can bring about medical effect to drop or complete invalidation.
For example, monobel is easy volatilize, quick result saves the borneol in heart bolus to volatilize easily also, take overdue monobel, quick result to save heart bolus, the likelihood pays life price.
4, poisonous side effect is big
After certain medicines and chemical reagents expires, can produce noxiousness material, can endanger human body directly, light cause unwell reaction, endanger life again.
For example, vitamin C places time to grow too in air, be oxidized easily, and the vitamin C after oxidation is harmful to human body.
Aspirin is decomposed easily for salicylic acid, salicylic acid is not had not only fight plaque action, what to gastric bowel is excitant be more than aspirin, and can bring about audition to drop.
Expire degenerative tetracycline, can generate the poor Xiang Sihuan with a kind of effect that fight bacterium is very little and bigger noxiousness element and dehydration tetracycline, can cause loss of kidney canaliculus cell.
Again for instance, bao of overdue Amoxilin, head kind antibiotic, can arise a series of polymer that can cause irritability shock or disclose result.
5, mix after open of medicines and chemical reagents the term of service after repackage
The term of service after open: Point to what after opening medicines and chemical reagents, fall in formulary reserve requirement to save time. This concept is to be aimed at much dosage to pack medicines and chemical reagents normally. The much dosage medicines and chemical reagents that pack is to point to to the drug that measures to drug is contained for many times inside unit of the smallest sale, can take for many times with, if major key point uses preparation, bazoo to wait with preparation, open hind still can have the rest after use period of time.
" pharmacopoeia of People's Republic of China " (2015 edition) middle finger goes out, divide outside having a regulation additionally, the eye uses agent of preparation, besmear, film agent to wait to be able to use 4 weeks at most after enable with preparation, bazoo.
＜ of the term of service after open packs gross / day dosage.
For example, saltpetre benzene n piece, every bottles 100, daily 3, every time 2. The term of service after open does not exceed: 100 / (6 / day) ＝ 17 days.
The medicines and chemical reagents that eye of aluminous model bleb packs, because of separate powder charge, as completely cut off as air, if press requirement requirement to store, can use normally to period of efficacy before.
Term of service of the repackage after medicines and chemical reagents unseals:
American FDA guideline sets: The solid preparation after repackage (tablet, capsule) , use since the day of repackage do not exceed 6 months, or 25% of period of efficacy of the rest of medicines and chemical reagents, and it is with prior time accurate.
My state-owned hospital pharmacy can divide ram to taste with paper bag, this kind of drug term of service that pack cannot exceed 7 days.
Special remind:
6, medical the term of service of alcohol
Medical alcohol is in no matter clinical still be in the home, use very extensive.
According to " infection of ill area hospital administers a standard " regulation, divide outside having special demand, use continuously the longest should not exceed 7 days.
In view of the regulation medium " use continuously " the concept is vaguer, somebody did the test that period of efficacy uses after alcohol disinfectant open technically.
The conclusion that reachs finally and proposal are:
Wait to dip in from inside alcohol container directly with alexipharmic cotton autograph the method that cancels toxic, should regard as use continuously, term of service should not exceed 7 days;
From disinfectant of part of the teem in alcohol container, blame is direct dip in from inside alcohol container cancel toxic, cannot regard as use continuously, pack the term of service after opening to be formerly do not exceed a month.
Want finally special those who remind everybody is, drug term of service, be sure to be with the manual of medicines and chemical reagents of manufacturer and specific requirement please accurate!
Partial data sources judges the professional platform such as the center at medicine, rectify tonsorial cloth by net of good medical service
