CME INDIA Presentation by Admin.

This is a very heart-breaking news (Dated 14/03/2021).

“This young Lady Doctor sadly passed away today, Injection Diclofenac was given to her for myalgia following Covid Vaccination by her husband, after developing severe anaphylaxis to Injection Diclofenac. She died at Meenakshi Mission Hospital, Madurai after a brief battle in ICU. She was doing MD Anaesthesia at Madurai Medical College and was married 4 months ago. Her husband is doing MS Gen Surg at Madurai Medical College.”

(Source: https://www.iraysmedia.in/heartbreaking-incident-in-madurai-happened-today and Times of India)

Dr R L Teles, Margaon, Goa shares in CME INDIA group

By Dr Padmakar Pandit, ex HoD Dept of Pharmacology, BJMC, Pune

But though rarely, we do make blunders

• Discussing something as primary as this is more important than recent advances. We all know undesired drug effects and adverse drug reactions. We classify them and are always worried about the acute and severe ones. We do take due precautions before giving risky drugs. But though rarely, we do make blunders. I feel guilty as a teacher when an incident that I come across incident like the one I am narrating today.

• I read a very sad news today. One member had informed about death of a young woman, recently married, doing PG in anaesthesia. Cause of death was anaphylactic reaction to inj. Diclofenac. It was administered by her husband (who is a surgery resident) to relieve her post covid myalgia. That too, at home. She was rushed to the hospital, struggled with death for some time in the ICU, but lost the battle.

• This is extreme (raised to n type) rarity. But it does occur. And when such death takes place, it shakes not only the health profession, but the society as a whole. Upon reading this sad story, I remembered similar past incidences. A young girl died of an acute reaction to inj chloroquine, a patient died of IV opioid premeditation induced respiratory depression, two others due to lignocaine in different cases. One by anaphylaxis; other by convulsions. Another lady succumbed to same inj. diclofenac. We know such ADRs can occur, we know how to prevent or deal with them. In spite of that, may be once in a dark moon; it does happen. Actually, it should NEVER happen.

• Why do we give a drug parenterally   for an emergency? So, it is almost always given in hospitals. We usually give IM   in clinics & OPDs. Rarely are injections given at home. That too only those with 100% safety record. We must teach our budding & practicing doctors, as well public in general, NOT to use or demand injections. Remember, a fatal reaction can occur to any drug in any individual, especially if given by injection; though extremely rarely.

Choice of the route may be the culprit

• In all the cases enumerated above, though it is NOT negligence, choice of the route may be the culprit. Two points I would like to emphasize upon: we must always be ready with all necessary preparations to manage an acute reaction if it occurs. It is like a mask or condom, but much more important than the two, because here is the risk of sudden death. Anaphylaxis is in first place, preventable; treatable in the 2nd.

• There is no need to give drugs by injection many a times. If it’s must, a detailed history of allergy in general and to any medication, as well as to the drug going to be injected, must be obtained. As far as possible, injection/s should be given in a well-equipped medical facility. If required, a test dose is to given to see if a reaction is likely. Of course, we may use the drugs with absolute safety. I doubt whether such safety exists.

• Another point is to clear the misunderstandings about the basis of classification of ADRs. That ‘a reaction is dose independent’ is to some extent a myth; not a fact. Tell me, otherwise how we can we use a very minute dose for testing? Or how do we desensitize by small dose increments? So, refrain from pricks on non-medical sets. It is likely, you will save a life or at least make genuine effort to do so.

Things that are simple are the most complicated

• Take care. Note that in some stories narrated above, the deceased was closely related to the doctor. Hope, we all will make these happenings almost unknown and do not carry the burden of such a mistake lifelong. Ask yourself: is it a dire emergency? Think twice, is the drug absolutely safe?

CME INDIA Discussion

 Dr. Vijay Datar, Tarapur, Maharashtra:

• Any legal action taken against the husband? It’s medical negligence. He gave the prick at home. He didn’t have any resuscitation measures/ equipment.

Dr Rajneesh Tyagi, Physician, Noida, UP:                                                                                                      

• I beg to differ sir. This is a mishappening, cannot be counted as negligence. Think of the mindset of poor husband what he must be feeling. We should not be judgemental without knowing the actual story.

Dr Anu Jain, Ambala Cant.:

• True sir, it’s a very difficult situation for the husband, he is just beginning his career & has suffered an irreparable loss, must be feeling so low.

Dr Rajeev Jayadevan Cochin:

• When something goes wrong it is easy to point fingers and find fault. This is a grey area. I don’t think we should use terms like medical negligence here. On the other hand, if injection was given in a place where resuscitation equipment was not available, it cannot be justified. Besides giving treatments out of proportion to severity is also a problem.
• (Haven’t we seen doctors use third-generation Cephalosporins IV for simple viral fevers?)
• This discussion is not specifically against the poor husband who obviously must have never “expected it to happen.” But therein lies the problem. When we do things in a manner that is outside the realm of safety, most often we get away with it, but once in a while we lose the gamble. This is particularly important.

 Dr Ashok Gupta, MD Medicine, Ajmer:

• Is Tramadol a better option for a patient if colicky pain in OPD settings?
• In our routine OPD practice it is not possible to refer colic pain patients all the time. In that scenario what should be the safest bet as regards Injectables to relieve pain?

Dr Rajeev Jayadevan, Cochin:

• I don’t know if I would use it in OPD setting. In a casualty setting yes. Colicky or sick people should not be treated in OPD, and must be triaged immediately at registration to casualty and be seen there.
• I have once seen a woman unconscious in her car in the middle of busy traffic after receiving some such “treatment” at a home OP setting. She was lucky she didn’t crash her car. We had to break the windows and pack her off to hospital after contacting her doctor.
• Let’s see the response of someone who sees such patients. My practice is attached to a hospital, and those are our protocols. Sick patients are to be triaged immediately to casualty.
• Seeing sick patients regularly in a lone OP clinic can involve substantial risk, and have caused disastrous outcomes to doctors too. In my opinion they can be referred directly by phone before they arrive at your clinic. You will always have a hospital attachment anyway. Try to refer when in acute abdominal pain, chest pain worsening, acutely short of breath, trauma etc

Dr S K Gupta, MBBS MD(Med) CFM (France), Max Hospital, Delhi:

We too had encountered anaphylaxis and pulmonary oedema in young male after diclofenac (inj voveran). Luckily our patient recovered

Dr Sanjay Gandhi, Diabetologist, Pune:

• I am just sure that at least one episode is experienced or witnessed by each of us
• We must understand that there are many nurses who also keep on putting saline or various injections at home for many patients. Few might come with simple ADR like abscess formation. But all that also can be stopped unless recommended or discussed by the Medical officer, but surely not at home.

Dr Anil Motta, Sr consultant, Internal medicine, Delhi:

• My personal opinion is that ideally this should be done. But then all is not possible to be done as per idealism or even realistic rationale.
• Laws cannot be differential…
• Our vast majority of patients are attended by alternative medicine practising people & even quacks & these people use injectables & IV fluids ad libum. Haven’t seen any restrictions or punishments meted out to such people, at least not to my knowledge.
• Small towns and villages don’t even have basic healthcare facilities.
• We saw how we suffered in various cities during Covid & how difficult it was to manage the deluge especially in places with inadequate treatment.
• We have now Ayush too approved.
• Finally, even if such laws come into being, I feel it will be people like us who, despite their best intentions, will find themselves in soup.

CME INDIA Learning Points

• Many instances are on record when Kounis syndrome triggered by diclofenac sodium injection occurred leading to myocardial infarction and cardiac arrest
• Kounis syndrome is the concurrence of acute coronary syndromes with conditions associated with mast cell activation including allergic or hypersensitivity and anaphylactic or anaphylactoid insults.
• Vasospasm occurring in normal coronary arteries (Type 1) and plaque rupture (Type 2) are two variants of this syndrome. Type 1 hypersensitive  reaction occurring by vasoactive amines such as histamine and serotonin plays a role in the pathophysiology of MI cases developing after drug administration 
•  It is caused by inflammatory mediators released through mast cell activation.
•  Inflammatory mediators includes  histamine, neutral proteases, arachidonic acid products, platelet activating factor and a variety of cytokines and chemokines 
• The release of mediators during allergic insults has been incriminated to induce coronary artery spasm and/or atheromatous plaque erosion or rupture.
• The evidence exists that mast cells not only enter the culprit region before plaque erosion or rupture but they release their contents before an actual coronary episode. 
•  Incidence of Kounis syndrome due to diclofenac is higher than reported.
• The risk of myocardial infarction probability due to allergic reactions after intake of these drugs must be kept in mind when prescribing diclofenac.
• Anti-inflammatory, antihistaminic, and antibiotic drugs are the most frequently responsible agents; especially when administered to atopic individuals.
• Abrupt onset after intake of the drug and high IgE levels are typical supportive clinical features.
•  The risk of MI probability due to allergic reactions after intake of these drugs must be kept in mind when prescribing.
• It is not a practical solution not to give injectables at home and OPDs.It is a widely used practice.
• Practical solution is to be alert and keep adrenaline, steroids, anti-allergic and other resuscitation measures at your place.

CME INDIA Tail Piece

(https://timesofindia.indiatimes.com/city/madurai/doctor-dies-hours-after-hubby-gives-her-injection-in-madurai/articleshow/81490373.cm)

References

• https://doi.org/10.1016/j.ijcard.2005.08.007

• M.A. Cakar, H. Gunduz, I. Kocayigit, D.F. Binak, M.B. Vatan, A. Tamer.Acute coronary syndrome due to diclofenac potassium induced anaphylaxis: two Kounis syndrome variants in the same patient. Anadolu Kardiyol Derg, 11 (2011), pp. 88

• D.J. Graham, D. Campen, R. Hui, M. Spence, C. Cheetham, G. Levy, S. Shoor, W.A. Ray Risk of acute myocardial infarction and sudden cardiac death in patients treated with cyclo-oxygenase 2 selective and non-selective non-steroidal anti-inflammatory drugs: nested case–control study.Lancet, 365 (2005), pp. 475-481

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