LAHORE: The Punjab government has approved the use of injection Tocilizumab for Covid-19 patients for “investigational study” under strict protocol to prevent any misuse.
The Specialized Healthcare and Medical Education Department (SHC&MED), in a notification to the vice chancellors, principals, medical superintendents, heads of specialized medical institutions, heads of Mayo Hospital, Pakistan Kidney and Liver Institute (PKLI) and Punjab Healthcare Commission (PHC) on June 10, 2020 informed that the recent reports regarding encouraging results of use of injection Tocilizumab in management of Covid-19 patients were considered by the Corona Experts Advisory Group (CEAG).
On the recommendations of the CEAG, the competent authority has been pleased to direct as following: injection Tocilizumab is an investigational drug. It has been decided that a trial shall be conducted under strict criteria, in public hospitals duly approved/designated by the CEAG.
Detailed separate mechanisms for public hospitals and private hospitals have been devised to ensure its valid use and prevent its misuse. Only the designated public sector hospitals would procure inj Tocilizumab to be used exclusively for the patients registered for this investigational study as per the directions of the SHC&ME Department. Inj Tocilizumab shall only be used on patients admitted to ICUs. Its sale to the public is completely banned at medical stores/pharmacies of the public/private sector hospitals.
The CEAG will recommend the number of patients and the names of public sector hospitals wherein the instant investigational study is be conducted. The SHC&ME Department shall notify the same accordingly. There shall be separate monitoring arrangements for public and private hospitals for use of the drug on patients registered for the investigational study.
The SHC&ME Department shall issue certified pro-formas with unique identification numbers to the hospitals registered by the Punjab Healthcare Commission (PHC) for the investigational study. An Institutional Committee comprising the following shall be notified by each designated public and private hospital: a consultant intensivist/pulmonologist and a consultant physician.
M/S Roche and all the designated public and private hospitals will ensure 24 hours service for issuance of injections. The aforementioned shall also maintain complete record of the pro-formas and maintain all the record of injections issued.
The consultant concerned shall be responsible for video recording of opening of packed injection clearly depicting its batch number and process of its administration to the patient. The video recording shall be saved as evidence to be submitted to the “Provincial Committee to Monitor Investigational Study on the Use of Tocilizumab” or the PHC. In case any patient is discharged or he/she expires, clinical notes shall be furnished to the committee (for public hospitals) and to the PHC (for private hospitals). The PHC will conduct audit of the record of any public or private hospital or M/S Roche at random.
A copy of record of clinical notes of patients along with pro-formas maintained by the public sector hospitals and record of injections issued/maintained by Roche shall be submitted to the committee. Similarly, the private sector hospitals shall submit complete record of clinical notes along with pro-formas to the PHC. The PHC shall submit the same to the committee.
The notification also contained strict guidelines for prescription of Tocilizumab to the below and above 60 years of age patients separately. As per conditions applicable to public sector hospitals, the SHC&ME Department shall provide Tocilizumab to all designated public sector hospitals for this trial. There shall be a complete ban on public sector hospitals to purchase these injections from any funds including PLA except as explicitly allowed by the CEAG for patients being registered for investigational studies.
The instant investigational study in public hospitals shall be monitored by a committee namely “Provincial Committee to Monitor Investigational Study on the use of Tocilizumab” comprising following: Dr Javed Hayat Khan, pulmonologist, PKLI, Lahore (Convener), Prof Saqib Saeed, head of department of Chest Diseases (co-convener), Prof Kamran Cheema, head of department of Pulmonology, SIMS, Lahore (Member), and Dr Muhammad Irfan Malik, associate professor, Pulmonology, AMC/LGH, Lahore (Member). The Terms of Reference of the instant committee shall be notified separately.
The allocated number of injections shall be indicated by the SHC&ME Department to the public sector hospital concerned. These injections shall be purchased and stored under strict control by hospitals. Consultant of the public sector hospital will fill the prescribed pro-forma and submit it to the Institutional Committee for approval. The injections shall be issued by the store incharges. All the pro-formas, complete clinical record of patient and video recordings shall be forwarded to the “Provincial Committee to Monitor Investigational Study on the Use of Tocilizumab” for thorough examination and continuous monitoring. Complete record of each case would finally be submitted to the CEAG.
As per conditions applicable to private sector hospitals, M/S Roche will be responsible for provision of Tocilizumab to the designated private sector hospitals. Pharmacies within the premises of private hospitals are not allowed to sell this injection to the general public.
Meeting was chaired by Sindh Chief Minister Syed Murad Ali Shah at the CM House
Petitioner requested court to remove clauses of Anti-Terrorism Act from case
Many families left their homes and shifted to other peaceful areas after several attacks
Committee meeting was held with its convener Ramesh Lal in chair, at Parliament House here
Raja prayed court to grant him protective bail in said cases so that he could approach relevant courts for relief
Court restrained authorities from arresting petitioners
