|LETTER TO THE EDITOR - DOCUMENTING A CASE
|Year : 2011 | Volume
| Issue : 3 | Page : 382
Off-label use of chemotherapy drugs: Look before you leap
Milind Kumar1, Chandran K Nair2, B Satheesan3
1 Department of Radiation Oncology, Malabar Cancer Centre, Kannur, Kerala, India
2 Department of Hematology, Malabar Cancer Centre, Kannur, Kerala, India
3 Department of Surgical Oncology, Malabar Cancer Centre, Kannur, Kerala, India
|Date of Web Publication||2-Nov-2011|
Department of Radiation Oncology, Malabar Cancer Centre, P. O. Mozhikkara, Thalassery, Kannur - 670 103, Kerala
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Kumar M, Nair CK, Satheesan B. Off-label use of chemotherapy drugs: Look before you leap. J Can Res Ther 2011;7:382
We congratulate the authors on this valuable work which puts in focus an important aspect of oncology practice.  The off-label use of drugs will be important and is viewed favorably by the authors but there are certain aspects which need to be addressed especially in a developing country like ours.
There is always a concern with the use of off-label drugs that, if the patient develops unfavorable side effects or outcome, then it would be difficult for the prescriber to withstand legal process.  In our country, law is still evolving and yet to come to terms with regard to medical profession and is seen that court rulings have heterogeneous nature in alleged cases ofmedical negligence and malpractice suits. Medical Council of India, state medical councils, and Indian Medical Association or state doctors' association remains separate entities with no or little coordination or unanimity between them. The inflammatory media remains another hindrance leading to the erosion of doctors-patient trust. There remains a perpetual fluid situation regarding the medical malpractice and I wonder how difficult it would be for a sued oncologist to explain his position regarding the use of off-label drugs.
Most of the hospitals barring a few institutions fail to formulate departmental protocols and the treatment ends up being the chosen best method either by the doctor who is on duty that day or according to the specialty doctor he or she first sees. Multidisciplinary meets or clinics are yet evolving in most of the centers. Even if the protocols exist, the plea of off-label use may be misused as a defense against following departmental protocols or guidelines. It takes away the initiative to actually design protocols or include such patients in scientific trials. In such a scenario, encouraging off-label use has its own pros and cons but its overall impact will be hard to comprehend. Also the concern that off-label use is promoted by pharmaceutical companies is very much there.  The information on the basis of which the prescription of off-label drugs is made should be carefully scrutinized. It is likely that the information is mostly conflicting and sketchy and hence the interpretation according to the individual oncologist will also vary hugely. Taking a shared decision with the family is extremely important but as would be experience of many treating professionals such information sharing may lead later the families to complain that "experimentation" was done. So we would rather have departmental protocols to follow, and if we feel off-label drugs are warranted, we should rather get approval from a multidisciplinary board. We should make every effort to scientifically analyze results in such patients. If the analysis results are encouraging, an off-label drug in the present may become an approved drug in future.
| > References|| |
|1.||Gota V, Patial P. Off-label use of anti-cancer drugs in India: To be or not to be! J Cancer Res Ther 2011;7:35-9. |
|2.||Herring C, McManus A, Weeks A. Off-label prescribing during pregnancy in the UK: An analysis of 18,000 prescriptions in Liverpool Women's Hospital. Int J Pharm Pract 2010;18:226-9. |
|3.||Kesselheim AS, Mello MM, Studdert DM. Strategies and practices in off-label marketing of pharmaceuticals: A retrospective analysis of whistleblower complaints. PLoS Med 2011;8:e1000431. |