Friday, 12 February 2016

Do not give drug without consent for any off label use

Do not give drug without consent for any off label use

Dr K K Aggarwal

Off label use of drugs is not allowed. Even giving doses more than the recommended dose by DCGI is also nor permitted. In   Dr. Sukumar Mukherjee    vs  Dr. Kunal Saha the apex court has observed that “  No doctor has the right to use the drug beyond the maximum recommended dose. “
Recently the DCGI has agreed to allow use of off label drug Avastin in eye disorders but after an informed consent by the patient. Any off label use ifs like a drug trial and needs both ethics committee approval and an informed consent.

All patients should be told when they are receiving a drug for off-label use and make an informed decision.

Some examples

1.            Asthma drug theophylline, shows promise in restoring the sense of smell in those who have lost that precious ability.
2.            The common epilepsy drug, phenytoin, is used to heal wounds as it causes hypertrophy of the granulation tissue.
3.            Nifedipine, a common blood pressure drug, is now used to pass out small ureteric stones smaller than 10 mm.
4.            Viagra, the erectile drug, has now been used in the treatment of pulmonary hypertension in patients with COPD.
5.            The SSRI drug sertraline is approved as an antidepressant. It is also commonly prescribed off–label to help men suffering from premature ejaculation.
6.            Methotrexate, approved for the treatment of choriocarcinoma, is frequently used for the medical treatment of an unruptured ectopic pregnancy.
7.            Gabapentin, approved for treatment of fits and post herpetic neuralgia in adults, is used off–label for bipolar disorder, essential tremors, hot flashes, migraine, neuropathic pains, phantom limb and restless leg syndrome.
8.            Avastin, the cancer drug in multi dose form, is used in retinal disorders

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