Bhubaneswar: The Health & Family Welfare Department of Odisha, on Thursday, issued the Standard Operating Procedure (SOP) for requisition of Tocilizumab and other new drugs for Covid patients in Covid treatment facilities.
Additional Chief Secretary of the Department, PK Mohapatra, in a letter to all stakeholders cited the Clinical Management Protocol: COVID-19 Version 5, issued by the Directorate General of Health Services (EMR Division) of the Union Health Ministry on July 3, 2020.
It suggested that inj. Tocilizumab /(Off Label) may be considered in patients with moderate disease with progressively increasing oxygen requirements and in mechanically ventilated patients not improving despite the use of steroids. Long-term safety data in COVID 19 remains largely unknown.
Special considerations before its use include:
• Presence of raised Inflammatory markers (e.g., CRP, Ferritin, IL-6)
• Patients should be carefully monitored post-Tocilizumab for secondary infections and neutropenia
• The drug is contraindicated in PLHIV, those with active infections (systemic bacterial/fungal), Tuberculosis, active hepatitis, ANC < 2000/mm3 and Platelet count < 1,00,000/mm,
• Dose modification is essential in patients with Renal impartment & Hepatic impartment
“Moreover, in India, 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 of drugs. As such the availability of the drugs are limited. So the treating doctors should take due diligence In prescribing new drugs/off-label drugs, only if included under Government of India guidelines / the scope of Drug & Cosmetic act. This must be done with adequate counseling of the family members/attendants and obtaining consent for their use,” stated Mohapatra.
Asserting that an expert committee has already been formed for a decision on the use of Tocilizumab and other new drugs by the Government, Mohapatra said that it is observed that the hospitals are submitting requisitions for provision of the Tocilizumab for COVID patients at different hours of the day without adequate information on the patient’s condition, investigation reports, indications, which is often making it difficult on the part of the Expert Committee to recommend its use and supply from the Government source.
“It has also come to the notice that after receiving the Tocilizumab through Government supply the hospitals have not used the drugs, on some patients for whom requisitions were filed,” he added.
So as a measure to rationalize the supply of Tocilizumab for appropriate use by needy patients and to avoid the stockpiling of these limitedly available drugs after being issued, the hospital authority (Medical Superintendent/ CMO/ Authorized Medical officer) have been asked to submit their requisition for the patients along with the information in the prescribed Proforma addressed to MD, OSMCL through e-mail and WhatsApp.
The Chairman of the Expert Committee on receipt of the copy of the requisition will review and forward his recommendation/rejection to MD, OSMCL for the issue of the drugs. The hospital with its authorized representative only will receive the drugs from OSMCL, The prescribed doctors must be available over the phone for any technical inputs if required by the Chairman of the Expert Committee.
The Hospitals or Institutions receiving such drug (intended for investigational / under emergency use authorization, off label/ repurposed drugs) must submit the utilization certificate for the same through e-mail to MD, OSMCL and will retain the empty vials for verification. The unutilized drugs must be returned to the OSMCI.
All the CDM & PHOs of the districts have been asked to widely circulate the SOP amongst all clinical establishments of the districts.