(about 300 words)
The medical condition for which a medicine is to be used as well as the recommended dosage are printed on the container of the medicine and/or on a sheet of paper enclosed with the medicine.
The medicine manufacturers have to disclose to a government regulatory authority the contents of the medicine and for what ailment it is intended. They can market the medicines only after getting the approval.
Use of a medicine for a purpose different from the ones for which it has been approved by the regulatory authorities is known as `Off-Label use of medicines’.
Use of `off-label’ medicines is widespread. One example: Neurontin, a drug approved for epilepsy is being used for the treatment of pain.
Pharmaceutical experts have expressed several opinions on the subject. They are:
· Most doctors do not know the meaning of the term.
· Many doctors do not read the labels and prescribe medicines based on anecdotes (what they hear from unauthorised sources) rather than on clinical evidence.
· Pharma companies promote and encourage such use to promote their sales.
· Antibiotics (anti-bacterials) are used against viral diseases, even though it is well-known that they have no effect on viruses per se.
· Insurance companies in developed economies like USA do not pay for the `off label’ use of medicines.
· Many a time `off label’ use of medicine becomes an important alternative when approved medicines fail to produce medical benefits.
· There are examples of many drugs which started as `off-label’, but were approved later for clinical use.
· There are are lakhs of prescriptions coming to pharmacies all over India. It would be impossible to monitor even a fraction of them for `off-label use’.
S. Gopal
….Keying in is better than idling