No injectable painkiller should be given without informed consent

 

A four-month-old baby reportedly died at a hospital in Delhi last week after administration of a painkiller injection in a case of alleged medical negligence. According to the family, the baby had suffered a cut in the upper lip for which a minor surgery was done and they were informed that the doctors were planning to put a stitch to treat the cut to which the family agreed. Because of persistent crying of the baby, a painkiller injection was given by the doctors to provide temporary relief from the pain caused by a stitch in the upper lip.

“The doctors took the baby away and administered some pain killer following which he became completely silent. We got afraid to see him completely silent and without any motion,” said the uncle of the deceased baby. “After checking, they immediately rushed him to the ICU where he was kept for nearly one hour. After one hour, the doctors came out and informed that the baby had died due to medicine reaction.” A police complaint against the hospital and the doctors involved in the treatment of the baby has been filed by the family.

Anaphylaxis is an acute, potentially life-threatening, multisystem syndrome caused by the sudden release of mast cell mediators into the systemic circulation and most often is a result of immunoglobulin E (IgE)-mediated reactions to foods, drugs, and insect stings. Typical symptoms of anaphylaxis include shortness of breath/wheezing due to bronchospasm or laryngeal edema and hypotension due to vascular collapse. These symptoms occur within minutes to several hours after exposure to the allergen.

Anaphylaxis is unpredictable; prompt recognition of anaphylaxis therefore is very crucial. It may be mild and resolve spontaneously due to endogenous production of compensatory mediators or it may be severe and progress within minutes to respiratory or cardiovascular compromise and death. In fatal anaphylaxis, median times to cardiorespiratory arrest are 5 minutes in iatrogenic anaphylaxis, 15 minutes in stinging insect venom-induced anaphylaxis, and 30 minutes in food-induced anaphylaxis. The severity or the rapidity of its progression is cannot be predicted at the onset of the anaphylactic episode.

Failure to recognize the early presentation of anaphylaxis and diagnose the condition when it is most treatable is a common mistake or pitfall in clinical practice. Hypotension is an important clinical criteria to diagnose anaphylaxis. In the absence of hypotension in some cases doctors are reluctant to diagnose an anaphylactic reaction, even though this sign is not required for the diagnosis and is uncommon in children with anaphylaxis or in food-induced anaphylaxis.

Medications are a common cause of anaphylaxis and drug-induced anaphylaxis is often life-threatening.

Common medications that can cause anaphylaxis include beta-adrenergic blockers, angiotensin-converting enzyme (ACE) inhibitors, and alpha-adrenergic blockers. Administered together, these drugs interfere with the patients ability to respond to treatment as well as the compensatory physiologic responses. Ethanol, nonsteroidal anti-inflammatory drugs (NSAIDs) and opiates can exacerbate anaphylaxis symptoms by causing nonimmunologic mast cell activation.

Anaphylaxis has been reported with various NSAIDs, including most of the cyclooxygenase-1 (COX-1)-inhibiting agents as well as from celecoxib (a highly selective COX-2 inhibitor). Ibuprofen is the NSAID most commonly implicated in severe anaphylaxis in the US; diclofenac is more common in France, and the pyrazole NSAIDs (phenylbutazone, oxyphenbutazone, azapropazone) are commonly implicated in Spain. Anaphylaxis has also been reported with paracetamol.

It is notable that there are no confirmed cases of anaphylaxis to aspirin itself. This is one reason that aspirin is used in challenge procedures.

Adverse reactions to drugs such as drug allergy are unpredictable and may occur in any patient even without documented drug allergy or hypersensitivity.

This case reiterates the need for informed consent. Doctors are required to document all clinical findings including information given to the patient regarding the diagnosis and the line of treatment as part of decision making as part of their duty of care. Failure to do so exposes them to the risk of litigation.

The ruling of the UK Supreme Court on informed consent – provision of information to the patient and his/her participation in decision making – in Montgomery v Lanarkshire Health Board from Scotland in 2015 was a landmark judgement. The Montgomery judgment has made the Bolam test redundant ‘as a test to assess standard of care’. It is the court now which will review the available evidence and reach its own conclusion whether the line of treatment adopted was the required standard of care or not. Subsequently, doctors in UK are now required to provide information about all possible risks associated with a particular treatment, however rare, to the patient. The doctor has a duty “…to ensure that the patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments”.

In another incident from Pune, a homeopath was remanded in magisterial custody for 14 days in a case of alleged medical negligence resulting in the death of a 16-year-old on May 24, 2017 after the Sassoon Hospital experts committee gave a report that professional misconduct and medical negligence led to the death of the girl.

 “The 16-year-old girl, a resident of Kondhwe-Dhawade, had complained of ear and throat pain after vomiting at 11 pm on May 23, 2017. She was put on intravenous fluid. In the morning, the homeopath asked to get her screened at the pathology lab on Karvenagar Road and get her ears examined at Shashwat Hospital. After the tests she returned to the hospital at around 2.30 pm. The doctors asked the girl to eat some food.  Within half-an-hour, she started complaining of stomach ache. The homeopath told his staff, over the phone, to put her on an antibiotic drip. The girl got some relief but soon she again started complaining of severe stomach ache. Another dose was given to her. However, she fell silent and stopped moving. The doctor said he had administered a sedative and told us to take her to Mai Mangeshkar hospital. When we got there, she was declared dead on arrival” (Pune TOI).

Such incidents may become commonplace if the govt’s proposed NMC Bill is approved in its present form, which allows Homeopathy and Ayurveda doctors to practice modern medicine after completing a bridge course. They cannot diagnose and tackle emergency and critical cases such as anaphylaxis. This will only promote ‘quackery’ and put the life of the patient in danger, which happened in the case of the 16-year-old girl.

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