Odisha: Govt issues SOP for requisition of Tocilizumab, other drugs

BHUBANESWAR: The state government has issued a standard operating procedure (SOP) for requisition of Tocilizumab and other drugs for treating Covid-19 patients. It has recently formed an expert committee of three senior doctors of SCB Medical College and Hospital, Cuttack for taking decision on use of Tocilizumab for Covid-19 patients on a case to case basis.
Pradipta Kumar Mohapatra, additional chief secretary (health), has issued this circular to all district collectors, municipal commissioners, chief district medical and public health officers (CDMPHOs) and chief of medical colleges and hospitals.
The SOP stated that some key points should be considered before the use of this drug like presence of raised inflammatory markers (inflammatory conditions). Patients should be carefully monitored post-Tocilizumab for secondary infections and neutropenia. The drug is contraindicated in PLHIV, those with active infections (bacterial/fungal), tuberculosis and active hepatitis etc. Dose modification is essential in patients with renal impartment and hepatic impartment, said the circular.
Mohapatra in the circular mentioned that the drug controller general of India (DCGI) is the regulatory authority for granting approval for new drugs but, unfortunately, there are no clear-cut guidelines on the off-label use drugs (unapproved use of an approved drug).
“As such availability of the drugs is limited, so the treating doctors should take due diligence in prescribing new drugs/off-label drugs only if included under the government of India guidelines/the scope of Drug and Cosmetic Act. This must be done with adequate counselling of the family members/attendants and obtaining consent for the use,” said SOP.
Some hospitals are submitting the requisition for Tocilizumab without adequate information on patient’s condition, investigation reports and indications which creates problem for Expert Committee to recommend its use and supply from the government source. It has come to the notice of the committee that some hospitals have not used this drug on the patients for whom requisitions were filed.
In view of this, the government has asked the hospital authorities to submit their requisition for the patients along with the information in a prescribed proforma addressed to managing director of Odisha State Medical Corporation Limited (OSMCL) with a copy to the Expert Committee head Bidyut Das, professor of rheumatology. The committee will review and forward his recommendation/rejection to the OSMCL. The hospital with its authorised representative only will get this drug from the corporation.
The hospitals or institutions must submit the utilization certificate and will retain the empty vials for verification. The unutilized drugs must be returned to the OSMCL.
Originally a rheumatoid arthritis drug, Tocilizumab is used for moderate to severe covid cases so that the condition doesn’t worsen further. Each vial of the injection costs Rs 40,000 to Rs 50,000.

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