Monday, December 10, 2018

Never go against the recommendations of the manufacturer

All drugs/devices are accompanied with labeling or full prescribing information or the package insert, which includes directions for use, warning and precautions and dosage and administration. This package insert is for the doctor as the “learned intermediary”, who can evaluate this information and sift out that which is relevant for his patient and accordingly balance the dangers of the drug against the benefits of its use. This is because prescription drugs and devices can be obtained by patients only when prescribed by their treating doctor. So, once the doctor has been warned, the duty to use the drug properly and to warn the patient about any risks is lies upon the physician.

One should never go against manufacturer’s recommendation or DCGI approval, with regard to:

·         Dose of a drug as approved by DCGI
·         Indication/s approved by DCGI
·         Reuse of disposables or device if written “for single use only”
·         Off label use of a drug needs informed consent

If you do not do so, it will be termed as a trial and will require informed consent and approval of the institutional ethics committee.  

In the case of Balram Prasad vs Kunal Saha & Ors on 24 October, 2013 in the Supreme Court of India: Civil Appellate Jurisdiction: Civil Appeal No.2867 of 2012, the Apex Court has held as follows:

“73. He has also placed reliance upon in justification of his claim of exemplary or punitive damages. A claim of US $ 1,000,000 as punitive damages has been made against the AMRI Hospital and Dr. Sukumar Mukherjee as provided in the table. In support of this contention he placed strong reliance on Landgraf Vs. USI Film Prods [29] and this Court’s decision in Destruction of Public and Private Properties Vs. State of A.P.[30], wherein it is held that punitive or exemplary damages have been justifiably awarded as a deterrent in the future for outrageous and reprehensible act on the part of the accused. In fact punitive damages are routinely awarded in medical negligence cases in western countries for reckless and reprehensible act by the doctors or Hospitals in order to send a deterrent message to other members of the medical community. In a similar case, the Court of Appeals in South Carolina in Welch Vs. Epstein[31] held that a neurosurgeon is guilty for reckless therapy after he used a drug in clear disregard to the warning given by the drug manufacturer causing the death of a patient. This Court has categorically held that the injection Depomedrol used at the rate of 80 mg twice daily by Dr. Sukumar Mukherjee was in clear violation of the manufacturer’s warning and recommendation and admittedly, the instruction regarding direction for use of the medicine had not been followed in the instant case. This Court has also made it clear that the excessive use of the medicine by the doctor was out of sheer ignorance of basic hazards relating to the use of steroids as also lack of judgment. No doctor has the right to use the drug beyond the maximum recommended dose.

111. “159. When Dr. Mukherjee examined Anuradha, she had rashes all over her body and this being the case of dermatology, he should have referred her to a dermatologist. Instead, he prescribed “depomedrol” for the next 3 days on his assumption that it was a case of “vasculitis”. The dosage of 120 mg depomedrol per day is certainly a higher dose in case of a TEN patient or for that matter any patient suffering from any other bypass or skin disease and the maximum recommended usage by the drug manufacturer has also been exceeded by Dr. Mukherjee. On 11-5- 1998, the further prescription of depomedrol without diagnosing the nature of the disease is a wrongful act on his part.

147. Therefore, a total amount of Rs.6,08,00,550/- is the compensation awarded in this appeal to the claimant Dr. Kunal Saha by partly modifying the award granted by the National Commission under different heads with 6% interest per annum from the date of application till the date of payment.”

So, before prescribing a drug, read the manufacturer/DCGI recommendations and prescribe the dose and/or use the device as per those recommendations. Failure to do so may make you liable for medical malpractice.

Dr KK Aggarwal
Padma Shri Awardee
President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of India
Immediate Past National President IMA

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