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Ten years ago, the tragic episode of several deaths due to contaminated drug –   ISOTAB – Batch J093 – manufactured by Efroze Laboratories Karachi took place. The bigger tragedy was that the alleged manufacturer did not pay any compensation to the victim’s families whose number was well over hundred. A Judicial Inquiry Tribunal under a High Court Judge was commissioned to find out the causes of this great human loss. The JIT report is available on the WHO international website. The full report is spread on 297 pages and those interested may follow the link at the end to access the report. We shall browse through the highlights in this and few following posts.

During December 2011, many patients started reporting to various hospitals in Lahore with similar symptoms. These included bleeding, nausea, and unexplained darkening of skin. The patients reported to all major hospitals in Lahore – Mayo, Jinnah, Services, Ganga Ram etc. These patients started dying after brief illness.

Around the same time, Lahore was also under severe attack of Dengue fever which had already led to deaths of over 300 patients. Some of the symptoms presented by the above patients were quite like Dengue, but not exactly those of Dengue, which was creating confusion. An expert panel of doctors was established under Professor Dr. Faisal Masud, who was then Principal Services Institute of Medical Sciences – SIMS.

By the end of December 2011, there was a surge in deaths – over 50 were reported. The experts were baffled because the Dengue vectors were diminishing while these cases were increasing. Genius as he was, Dr. Faisal Masud tracked 16 patients privately and established that the most common symptom – fever – was missing in these patients. Further inquiry revealed that all these patients had received cardiac medicines from Punjab Institute of Cardiology Lahore – PIC. Initially, many of patients came back to PIC with their symptoms but they were referred to other hospitals because PIC specialized in Cardiology.

[Quote] On the basis of his findings that patients reporting to different hospitals with symptoms of bleeding, pigmentation of skin, low platelets count, and bone marrow suppression were not suffering from Dengue and all of them were cardiac patients, who had received free medicines from the free dispensary of PIC, Dr. Faisal Masud contacted Professor Dr. Muhammad Azhar, Chief Executive of PIC on 11.01.2012. He informed Professor Dr. Muhammad Azhar thatthe patients were probably reacting to one or more drugs dispensed to cardiac patients.

Prof. Dr. Muhammad Azhar of PIC called an urgent meeting of the Hospital Committee of PIC on 12.01.2012, which was attended by 22 doctors working at PIC. He informed the meeting that the patients were reporting with bone marrow suppression and Pancytopenia in different hospitals and these patients had been mainly taking cardiac medication issued by the Free Pharmacy of PIC. There was a high possibility of drug reaction being caused by one or more of these drugs. It was therefore, decided that the department of health may be requested to constitute a technical committee for an epidemiological study to investigate the cases admitted in different hospitals with complaints of bone marrow suppression and Pancytopenia. It was further decided to send samples of all drugs available in PIC Out Patient Department (“OPD”) to the Drug Testing Laboratory/Forensic Laboratory for report and fresh analysis. In addition, the committee recommended that all cardiac medicines in tablet form being issued to OPD patients should be stopped except Tablet Atenolol and Tablet Isotab, for the safety of cardiac patients till further orders. By way of a stop gap arrangement, the committee approved a list of medicines and recommended that the Health Department may be requested to allow purchase of the medicines/alternate medicines as an emergency.

It is significant to note that the said committee also recommended that the Government of Punjab Health Department be approached for purchase of cardiac medicines from multi-national companies for safety of patients and to avoid such drug reaction in future. Further, it was decided that the Government may be requested to devise new procurement rules in this regard. It was also decided that the firms who had supplied the medicines to PIC may be asked to submit drug testing reports with PIC. The committee also decided to inform the public through press and television about use of cardiac medicines taken from the free pharmacy of PIC.

Six dedicated phone numbers were to be provided and it was directed that a doctor and a pharmacist will be available on the helpline round the clock to provide advice and guidance.

Professor Dr. Muhammad Azhar also informed the meeting that he had talked to Secretary Health about the issue. The health department had advised to constitute a special committee including Cardiologists and 3 pharmacists from other hospitals to advise about the use of cardiac medicines. A committee headed by Dr. Nadeem Hayat Malik, Professor of Cardiology PIC, Lahore was accordingly constituted. The 9 members committee included a pharmacist from Jinnah Hospital Lahore as well as Services Hospital Lahore in addition to hospital pharmacist of PIC and senior doctors of cardiology working at PIC. A 24 hour monitoring room was set up for creating public awareness on the telephone. The said committee met the same day.

On the same day i.e. 12.01.2012, the special committee met under the chairmanship of Dr. Nadeem Hayat Malik, Professor of Cardiology, PIC Lahore at noon. The said committee reiterated the recommendations of earlier committee. However, this committee recommended that all cardiac medicines in tablet form (including Atenolol and Isotab) being issued to OPD patients be stopped for safety of cardiac patients till further orders. This committee also recommended that by way of a stop gap arrangement an approved list of medicines recommended by the hospital consultants committee be procured as an emergency case after seeking permission from the health department. This committee also reiterated the earlier recommendations that Punjab Health Department may be approached for purchase of cardiac medicines from multi-national companies. [Unquote]

To be Continued……

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