emu sept 2012
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SEPT 121)
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3)
Public health danger from counterfeit medications and
adulterated food supplementsBy Mickey Arieli Pharmacist, Director of Division of Enforcement and Inspection, MOH, Israel
AlinaPoperno Pharmacist, MPH, Division of Enforcement and Inspection, MOH Israel
Counterfeit medicines and supplementsposean enormous public health threat. The World Health
Organization estimates that 10% of global pharmaceutical commerce is in fakes [1].Apart fromcounterfeit prescription medicines there are products labeled "natural supplements" that are illegally
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adulterated with active pharmaceutical ingredients, such as, sibutramine,PDE-5
inhibitors(sildenafil,tadalafil and vardenafil), lidocaine, benzocaine, benzodiazepines, SSRIs,
phenolphthalein and more. The most common weight loss and anti-impotence adulterants found on
Israeli market are sibutramine and sildenafil. As a consequence of sibutramine adulteration, a few
dozen people, mainly young women, were hospitalized due to cardiovascular events, some of which
were life-threatening.In addition, there were hospitalizations following sever psychiatric events
associated withthe use of sibutramine adulterated weight-loss natural products.Health risks of
PDE-5 inhibitors adulterationsare vast, they include, headaches, sudden hearing loss, heart attack,arrhythmias, hypotension etc. The greatest risk isinpatients, to whom PDE-5 inhibitors are
contradicted so they are turning to natural remedies for impotence or when concentration of the
active ingredient/s significantly exceeds therapeuticlimits. Moreover, in recent years, clandestine
laboratories replace known pharmaceutical compounds with their chemical analogues. In many
cases, these analogues are significantly more potent than original compounds and they are much
more difficult for detection.
In the past few months, our division has confiscated quantities of new and dangerous "natural" food
supplements. Our toxicological analysis discovered in a "natural" product called "ManUp" a
combination of sibutramine and sildenafil. We have also received reports regarding two new natural
products, which claim to lower blood sugar "Balins" and "Diabetico". Toxicological analysis
revealed that these "natural" products contain a high dosage of a potent sulfanylurea drug.
Recently, anti-cancer drug, Avastin, found to be devoid of an active ingredient (Bevacizumab) so in
a number of clinics in the US cancer patients were not actually receiving a life-saving treatment.
The extent of the problem and the amount of harm from counterfeit drugs are underestimated, since
detection and clinical reports are limited. Increasing the awareness among physicians of possible
natural supplement that contain active pharmaceutical substances and effective cooperation
between health care professionalsare crucial for combating the illicit pharmaceutical trade.
We encourage cooperation and communication between health professionals and our division. We
can be contacted through following emails:[email protected] (cell phone 972-506-
243137), [email protected] .
References:
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1. Newton PN, White NJ, Rozendaal JA, Green MD. Murder by fake drugs.BMJ. 2002
Apr 6;324(7341):800-1.
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I just don't know why they'reshooting at us. All we want to do is bring them democracy and whitebread. Transplant the American dream. Freedom. Achievement.Hyperacidity. Affluence. Flatulence. Technology. Tension. The
inalienable right to an early coronary sitting at your desk while plottingto stab your boss in the back.
Your picture's in mywallet and I'm sitting on it. And if that isn't love, I don't know what is.
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similar :
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12)
13) paracetamol
paracetamol
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Reviewers comment (GilShlamovitz): While no evidence to support this practice it has been myexperience that some blunt trauma patients go into a PEA state as aresult of spinal shock that sometimes is not that apparent especially ifthe patient has low GCS. While anecdotal, IV epinephrine followed bypressors were able to restore peripheral pulses and BP to allow further
workup and survival. Not always easy to identify those patients but agood place to start is no BP and HR lower than what one would have
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expected, no blood in the chest or pericardium (US +/- chest tubes),no blood in the belly (US), YES blood in the big vessels (Vena Cavaand RV by US). While some of those patients might haveretroperitoneal bleeds or minimal fluid in the belly, IV fluids, bloodproducts and sometimes a #10 blade for an exlap will be indicatedbefore they can safely unergo a CT +/- an MRI to make the finaldiagnosis. Thanks Gil- very good tip!
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31)
Gangrenosum
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fluctuance
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Aerophilous
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35)
I downplay the diagnosis of PBPV in the ED because my
readings say it only lasts 10-40 seconds and as such, would be over before someone presented to the ED.The diagnosis that we are dealing with is, I believe, vestibular neuronitis -- persisting positional vertigo that can
result in a person begin hospitalized for symptom control. Cause is really unknown. If I may add mythoughts- it is true we see a lot of vestibular neuronitis in the ED,and many of us have not found re positioning maneuvers to helpmuch in the ED and end up admitting a lot of these patients. But Ido believe recurrent BPPV does occur just like biliary colic anddo succeed in sending some of these folks home. Thanks Rick for
writing. And yes-if you do not yet know who Rick is-go up to theCCME website and get a hold of his monthly programs. If you area primary care doc- he has audio programs for you too.36)
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all of these may pan out,
but none are ready for prime time. Large scale, well performed trials have an unfortunate tendency to destroy
promising new therapies like this. And of course we must always remember that doctors have a name fornatural supplements that work: medications
Scott and Simcha- thanks for writing, and Scott if you are stillreading let me quote HL Mencken for you as you do practice inNew York: Every great wave of popular passion that rolls up on the prairies is dashed tospray when it strikes the hard rocks of Manhattan.
H. L. Mencken
And a warm Hello to Dr. Y , our cardiology consultant(unfortunately efforts to get Amal Mattu to subscribe to EMU have
not been successful but we are still trying) whose comment onlast months' article about ST elevation with Q waves- Icommented that they also do not know when it is real and when itis an aneurysm. His comment was **&%$#@+)~@@!
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EMU LOOKS AT: EARs and hEARtsThis month we in honor of all our articles above from the uroliterature- we will dedicate our articles this month to kids. Howeverbefore you close the computer- these are diseases we could see inadults as well- you just missed them or didn't care. Our sources for the
essays are J Paed Child Health 45:554 and Pediatric Rheumatology9:17 2011
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1) OK smart alack, we are going to toughen you up on otitis media.This article had a real bent towards Australian indigenous childrenand I am not sure how that applies to the rest of the world(apparently there is a difference between indigenous and notindigenous children in Australia) but aside from that caveat- a welldone article. Otitis media is defined as a spectrum of three separate
entities. Acute otitis media, otitis media with effusion and chronicsuppurative otitis media. And if you understand that that is quitean accomplishment. In a recent survey of 165 clinicians they got147 different clinical definitions of AOM, with no definition agreedon by more than six clinicians. So this says: if you just say I donot know what this so I'll just slide them over to an ENT- you're arean idiot and he probably is one too, being that he is probably one ofthe 165 clinicians. Let's use their definitions. AOM requires acuteonset- less than 48 hours; fever, and middle ear fluid bulges or
absent movement of the tympanic membrane (you need apneumatic otoscopy) and redness. Think about the last time youdiagnosed AOM and tell me if you had all three of these criteria.Effusion is shows signs of fluids. Chronic suppurative OM showspus though a perforated tympanic membrane- but this is apersistent problem and usually isn't called CSOM unless two weekshave passed.2) Who is at risk for OM? Cleft palates, day care, tobacco smoke,pacifier use, and breast feeding and lack of breast feeding.
Confused? All of these "risks" are modest. And what they meantwith breastfeeding is that breast fed but not for a long time or not
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at all is a risk. However a look at the relative risks finds that highestrisk- and the best p value- was family history- which is myexperience too.3) Diagnostic aids- pneumatic otoscopy is cheap and easy. If hasgood sensitivity and fair specificity. Tympanometry is like anultrasound of the ear. It has good sensitivity but poor specificity.
Curiously, this fancy equipment test is no better than the otoscopy.Tympanometry cannot be done in the presence of a discharge fromthe ear drum.4) Treatment. Watchful waiting is now acceptable. Multiple studieshave shown a minimal benefit from antibiotics which may notnegate the side effects. Mastoiditis rates do not increase in kidswho were given this approach. Otorrhea and kids under two showthe greatest benefit of antibiotic use5) Effusion- what have I not seen used for this? I have seen
diuretics, I have seen multiple courses of antibiotics, I have seendecongestants, I have seen enemas (works only for those whoseears are in that vicinity). The truth is that most will clearspontaneously after three months no matter you do or don't do.Oral antibiotics are often used after three months, but with minimalresults. Steroids- they work for everything. Antihistamines anddecongestants have a higher number needed to harm than to treat.They recommend a hearing test, and if it is affecting hearing- put intubes (no not a rectal tube- I was joking above). This is all after
three months. CSOM- use ear cleaning either by irrigation or drycleaning with a cotton tip applicator ( I was always taught not to
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recommend this) and use antibiotic drops. Here is an importanttake home point- this condition is much more common than otitisexterna in kids. If you have an otitis externa that is not resolving-consider this- and check for a perforation where antibiotics mayhelp. I can't explain my twisted mind, but since I have a soft a spotfor Brits (Hi Angie), I will quote Winston Churchill, who was famous
for his bickering with Lady Astor, an American and the first womanto be seated in the House of Commons (his comment when she wasappointed was " I felt as if she had come into my bathroom and all Iwas left with was a sponge to defend myself". She was famous forher wit, once saying "I married below me- all women do". Well theyonce were verbally sparring at a weekend retreat and she stated"Winston, if I was your wife, I would put poison in your coffee" Hequipped" If I was you husband, I would drink it"
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The second essay is on Kawasaki Syndrome. You never saw this? Wellsince there is no diagnostic test for this, you probably have seen it andmissed it. So you shouldn't miss it again, here it is:
And in case you are afraid you might confuse it with another entity here is the most confusing similar condition
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1) So let's get started. This is as you know a necrotizingvasculitis, more commonly found in males and mostly seen in kidsfrom about half a year until 5 years old. Peak incidence of thisdisease is in less than one year in Japan where they see most ofthe cases. In the USA they see most cases in the less than twoyear old age group. As I said above you will not make this
diagnosis on a blood test- you need a prolonged fever (five days)and a rash, conjunctival injection, oral changes (lip fissuring,strawberry tongue, hyperemia) and cervical lymphadenopathywhich is the least seen.2) The current thought is that an RNA virus causes this, but itis far from clear.3) Yes there is an atypical Kawasaki. This has fever and signssuch as abdominal pain, pleural effusion, neck stiffness uveitis ora number of other signs that basically could look like anything. In
addition there is incomplete Kawasaki which has fever, 2 of theclinical criteria and coronary artery aneurysms on echo. So whatcan help you make the diagnosis in these two variants? CRP andESR can be much higher on day four or five of the illness thanother viral entities. They tend to be more irritable than other kids.And if they had BCG in the past they may have induration at theinoculation site. So you say- my patients are all irritable, and nonehave BCG inoculations. So that doesn't help. Furthermore,Idiopathic juvenile onset arthritis can look exactly like this with
the same lab findings. So what happens if you miss thediagnosis? Well, if they develop coronary artery aneurisms- you
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are in deep trouble. As Greg Henry would say (that was a pictureof his Harley above) you will get a new name- not the attendingdoctor but the defendant physician. Basically I get worried aboutkids with a prolonged fever and admit them. As Leibman says -any fever over five days has to be bad.4) IVIG is the therapy- use 2 gm/kg in a ten to twelve hour
infusion, and give aspirin 50-100 mg/kg) Clopidogrel is used inaspirin allergies.5) Steroids may help (they help for everything) but this hasbeen shown in only one study.6) If that doesn't work, Infliximab and Etanercept- both TNFblockers have help in small studies,7) . If you blew it, than these patients with aneurysms will needlife long anticoagulation. How to handle these patients and whatactivity, and testing should be done in the long term can be seen
on the chart in this article. Vaccinations should be given but atleast nine months after the last IVIG.8) If there is a doubt- echo!I'll like to take this opportunity to apologize to Greg Henry who Iwas a little hard on this month. I do like him and respect him and
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so I dedicate this picture to him:(and yes- Greg stills wears the suit jacket that this fellow is
wearing)9) And lastly one last M*A*S*H quote
Frank: I am a great doctor- just ask any of my patients.Trapper John: Frank, We cant dig people up just for that.