Understanding medico-legal implications of adverse drug reactions

“If people understood that doctors weren’t divine, perhaps the odour of malpractice might diminish”- Richard Selzer, surgeon and author. 

Every drug has the ability to trigger some kind of adverse reaction. The Joint Commission on the Accreditation of Healthcare Organisations, United States defines an adverse drug reaction (ADR) as “an undesired effect of a medication that either increases toxicity, decreases desired therapeutic effect, or both”. 

The cause for the adverse reaction can be attributed to several factors: the patient may be allergic, incompatible components present in the drug, improper labelling, dosage of the drug prescribed, using high-risk drugs like steroids or those used for chemotherapy and the lack of a proper monitoring system. Medicines are capable of causing Spontaneous Drug Reactions which are inevitable despite taking precautions. However, spontaneous drug reactions should not be considered as Medical Negligence. 

The Indian Medical Association (IMA) conducted a webinar on 24th June, 2021 where the various Medicolegal implications of Adverse Drug Reactions were extensively discussed. Speaker Dr Subhrojyoti Bhowmick, Clinical Director for Research and Academics at Peerless Hospital and BK Roy Research Centre, spoke in detail about how many doctors were incorrectly charged with medical negligence. Another speaker, Adv. Binota Roy who specialises in the legal aspect of medical ethics cases gave some insights for doctors on how to avoid such kinds of lawsuits. Dr JA Jayalal, Chief of IMA, also provided some thoughts on forensic pharmacology and pharmacovigilance. 

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Every Doctor and Pharmacologist takes the Hippocratic Oath of “Primum non nocere” which means ‘first do no harm’. If a doctor were to deviate from this and fail at providing the most reasonable care possible that can be categorized as medical negligence.

Dr Bhowmick listed out the responsibilities that a Doctor should undertake regarding adverse drug reactions:  

  1. A doctor should be familiar with the drug including its pharmacokinetics, mode of action and possible side effects. 
  2. Adverse drug reactions should be identified and addressed with proper pharmacotherapy.
  3. A doctor should seek the help of a clinical pharmacologist in case of any doubts regarding any unknown side effects. 
  4. Data about the patient’s allergy and medical history should be available with the doctor.
  5. A doctor should properly document all the observed adverse drug reactions.
  6. A doctor should clearly communicate with the patient and listen when they complain of any unusual symptoms. 
  7. Doctors should read the fine print and the details present on the packaging of the drug that is provided by the manufacturer. 

It is essential that doctors must properly convey all the probable adverse drug reactions associated with the patients (especially the high-risk drugs) and clearly state why the benefits of the drug outweigh the risks using evidence-based medicine. Healthcare professionals should be aware of the prescribing dose and that higher dosage is always associated with higher risks. Dr Bhowmick states that the newsletters provided by the Pharmacovigilance Program of India should be made easily available to all healthcare professionals which can help them understand pharmacovigilance better. 

Adv. Binota Roy explained some of the legal aspects in such cases. In some of the older cases, the court ruled the events caused by adverse drug reactions as Medical Negligence and the concerned doctors were penalised. “Medical science is an imperfect science having its own set of ambiguities and it is impossible to have a straightjacket formula for medical negligence cases” asserts Adv. Roy. After the case of Kusum Sharma & Ors vs Batra Hospital (2010), the Supreme Court of India laid down 11 principles to be followed while determining medical negligence by medical professionals. 

Doctors and Healthcare professionals cannot be held liable for any untoward incidents and not all drug-induced reactions should be considered as medical negligence. If the doctor is able to provide a reasonable degree of care that is in accordance with the verified protocols and properly document the adverse drug reactions, lawsuits can be avoided. Adv. Roy also emphasized that the Supreme Court of India has continuously made efforts to clear the vagueness of such cases.

Dr JA Jayalal stressed on the importance of pharmacovigilance. Pharmacovigilance means assessing drug safety. He stated that there should be SOPs established on using a drug and documentation of the adverse reactions. He even mentioned that there should be a module on pharmacovigilance for medical students. A research study needs to be done to understand the pharmacovigilance of vaccines and assess the various protocols followed for pharmacovigilance.

Litigations cannot be avoided as it is the right of the citizen to go to the court of law whenever there is any kind of grievance. With proper documentation and communication with the patient, doctors can help themselves out of such kinds of lawsuits. It is also necessary to understand the unpredictable nature of adverse drug reactions and it should not be considered as negligence on behalf of healthcare professionals.

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