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Standard Procedure For Tocilizumab

Bhubaneswar: The Health & Family Welfare Department 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 injection 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.

The ACS instructed the District Collectors, Municipal Commissioners and all the Government and Private Medical Colleges and Health Care Institutions in this regard.

Issuance of SOP was necessary under the backdrop of more and more use of Tocilizumab and other new drugs for COVID Patients. It has been suggested that Tocilizumab injection 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.

In the meantime the State Government has already formed an Expert Committee chaired by Prof.Bidyut Kumar Das to recommend the use of such new drugs.

The State Government has pointed out that Long Term Safety data in COVID-19 remains largely unknown, so special considerations are to be taken care of before the use of the new drugs.

More over in the country, the Drug Controller General of India (DGCI) is the Regulatory Authority for granting approval of new drugs but unfortunately there are no clear cut guidelines on the off-label use of drugs.

As such availability of the drugs are limited, so the treating doctors should take due diligence in prescribing the new drugs, off-lable drugs, only if included under Government of India Guidelines/ the scope of Drug and Cosmetic Act.

The State Government advised that this must be done with adequate counseling of the family members, attendants and obtaining consent for their use.

The letter said that it is observed that the hospitals are submitting requisitions for provision of the Tocilizuamab for COVID patients at different hours of the day with adequate information of the patient’s condition, investigation reports, indications, which often making difficult on the part of the Expert Committee to recommend its use and supply from the Government source.

Senior officials have pointed out that after receiving Tocilizumab through Government Supply, the hospitals have not used the drugs on some patients for whom requisitions are filed.

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 authorities must submit their requisition of the patients along with detailed information for which a prescribed form has been prepared.

After the recommendation of the Expert Committee, the Odisha State Medical Corporation Limited (OSMCL) will issue the drugs to authorized representatives of the Health Care facility.

The prescribed doctors must be available over phone for any technical inputs if required by the Chairman Expert Committee, pointed out the State Government.

The Health Care Institutions receiving such drugs must submit the utilization certificate for the same through email to MD OSMCL and will retain empty vials for verification. The unutilized drugs must be  returned to the OSMCL, said the order.

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