Covid-19: Odisha Issues SOP For Use of Tocilizumab
The Odisha government has approved the standard operating procedure (SOP) for the use of Tocilizumab in the treatment of COVID-19 patients. PK Mohapatra, the Additional Chief Secretary (Health), has addressed a letter to every district collector, municipal commissioner, CDM, and PHO regarding the SOP for the use of Tocilizumab and other drugs to treat COVID-19 positives.
“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 counselling of the family members/attendants and obtaining consent for their use,” stated Mohapatra.
As per the Union Health Ministry, Tocilizumab can be given to patients who have a moderate disease with progressively increasing oxygen requirements and to mechanically ventilated patients not recovering despite the use of steroids.
Specific considerations before Tocilizumab’s use involve:
- Presence of raised Inflammatory markers (e.g., CRP, Ferritin, IL-6)
- Victims should be accurately monitored post-Tocilizumab for secondary infections and neutropenia
- The drug is contraindicated in PLHIV, those with aggressive infections (systemic bacterial/fungal), Tuberculosis, active hepatitis, ANC < 2000/mm3 and Platelet count < 1,00,000/mm
- Dosage modification is necessary for patients with Renal impartment & Hepatic impartment
To prevent stockpiling of Tocilizumab and to rationalise the supply of the drug to the patients who need it, the following steps are advised:
- The hospital authority (Medical Superintendent/ CMO/ Authorized Medical officer) has to submit their request for the patients along with the information in the prescribed Proforma directed to MD, OSMCL via e-mail and WhatsApp.
- The Chairman of the Expert Committee on the acquisition of the letter of the requisition will review and forward his recommendation/rejection to MD, OSMCL for the delivery of the drugs.
- The hospital with its commissioned representative only will receive the drugs from OSMCL. The appointed doctors must be available over the phone for any technical information if asked by the Chairman of the Expert Committee.
- The Hospitals or Institutions getting such drugs (meant for investigational / under emergency use authorisation, off label/ repurposed drugs) must put forward the utilisation certificate for the same via e-mail to MD, OSMCL and will preserve the empty vials for verification. The unutilised drugs must be returned to the OSMCI.