‘Drug manufacturer mainly responsible for pic deaths’

Judicial inquiry critical of PIC pharmacy, Health Dept response.

LAHORE:

A judicial inquiry into the deaths of 213 cardiac patients a year ago has found Efroze Chemical Industries, the manufacturer of Isotab, “first and foremost” responsible for the tragedy, but also reported major lapses at the Punjab Institute of Cardiology and the Health Department.

The ‘Defective Drug Inquiry Tribunal’ concluded that the deaths were caused by batch number J093 of Isotab 20mg, distributed at the PIC’s free pharmacy, which contained higher than normal concentrations of pyrimenthamine.

Apart from the 213 deaths, another 1,000 patients took pills from the contaminated batch and fell ill, but survived. The inquiry was conducted by Justice Ijazul Ahsan of the Lahore High Court.

“We recommend strict legal action against the company, its management and others involved under the law,” said the 273-page inquiry report, a copy of which is available with The Express Tribune. The company had “miserably failed to fulfil its obligations”, and therefore bore “direct responsibility for the tragic loss of lives”.

The symptoms of the affected patients started occurring between the first and second week of December 2011. This was the approximate time when Isotab from the contaminated batch was dispensed. The 213 patients who had died had mostly the same symptoms: bone marrow suppression, darkening of skin, and reduction of white blood cells, causing excessive bleeding and leading to death.

The tribunal recommended that a task force of pharmaceutical experts be set up to conduct “current good-manufacturing practice compliance audits” of drug manufacturers. Companies found to be deficient in this regard should be suspended. It recommended that temporary workers should not be allowed to work in drug manufacturing and allied activities.

Distributor

The distributor of the drug, Umar Trading Co, and its partners were also held liable as they provided incorrect documentation to the PIC, omitting mention of batch number J093 in the delivery challan.

The tribunal recommended that the system of supplying medicine on the basis of delivery challans generated by the distributor and receipt of the consignment by the hospital on the basis of such challans only be stopped at once. “If at all a delivery challan is to be submitted, it must be accompanied by a detailed invoice sent by the manufacturer together with the statutory warranty,” the report read.

It also recommended that supplies and distributors be obligated to use specialised vehicles for transportation of heat-sensitive drugs. “The present system of transportation of drugs through ordinary trucks, which have no temperature control, must be discontinued,” the report read.



Institute of Cardiology

The report said that there were “major structural weakness and loopholes in the administrative process and procedures” of the PIC. “The mode and manner in which medicines are procured, received and stored, and documented and dispensed is not in consonance with the requirements of running an organised and efficient hospital,” it read.

The tribunal recommended an internal inquiry at the PIC and departmental action against those responsible for receiving, verifying and sending out batches of medicine received for testing.

It said that the free pharmacy should be separated from the hospital, an air-conditioned storage facility for medicines be set up, and the ratio of pharmacists to patients be increased to one for every 50 beds in the hospital.

Aga Khan Hospital in Karachi should act as consultants for the establishment of a model pharmacy at the PIC, as it operated a pharmacy of international standard, it said. The model should be replicated at all major hospitals in the province.

It also recommended that hospital administration be undertaken by professional administrators with no direct responsibility for clinical work.

Health Department

The report was also scathing about the Health Department’s response to the unfolding crisis, saying it was unstructured. “It was a shot in the dark,” it said. “The inquiry has brought into focus the complete absence of systems at the Health Department to handle situations like these.”

The tribunal suggested that the Punjab government set up a separate hierarchy and service structure for pharmacists and a separate pharmacy directorate.

It recommended that the government invest a substantial amount of money to acquire modern equipment, hire qualified personnel and increase the capacity of its “ill-equipped and under-staffed” drug-testing laboratory. The lab was unable to cope with its current workload, let alone its projected workload in the next few years.

The tribunal observed that drug regulation in the province had “deteriorated considerably”. It called for the reactivation of the office of chief drug inspector and provincial drug inspectors. It also recommended that workers involved in drug production be matriculates at least and able to read labels in English.

The report also spoke of deficiencies in the initial police investigations, particularly in the lack of expertise regarding drug matters. It recommended that a specialised investigation unit with expertise and training in drug-related offences be set up, along the lines of the white-collar crime unit. Until then, such investigations should be conducted with the assistance of pharmaceutical experts from outside.

Published in The Express Tribune, February 7^th, 2013.