Healthwise: The heart of the matter
Asif Chaudhry sums up the judicial commission’s conclusions regarding the PIC drug disaster last year
The three major drug scams that surfaced last year in Punjab will haunt our memories for long as nothing concrete has been done so far to revamp the poor mechanism of manufacture and supply of medicines to the government hospitals and markets.
Of these, the Punjab Institute of Cardiology scandal was far more devastating as compared to the two cough syrup-related incidents, due to the involvement of a defective drug purchased by a government-owned teaching hospital, resulting in the death of 213 patients and adversely affecting the health of over 1,000 patients.
The culprit was Isotab 20mg tablet, manufactured and distributed by Efroze Chemical Industries, and dispensed by PIC to the poor cardiac patients free of charge. Inquiries conducted in this regard point towards a major manufacturing fault — anti-malaria ingredient was mixed in the same container which was later used to prepare Isotab.
This conclusion was also seconded by the British Medicines and Healthcare Products Regulatory Agency (MHRA) — an executive agency of the Department of Health, UK — which examined the drug. The MHRA also analysed cases of 30 affected patients and found that severe overdose (1,000mg) of Pyrimethamine had caused bone marrow suppression and a terrible drop in platelet and white blood cell count, ultimately leading to death. Due to a plethora of discrepancies in the earlier inquiries — conducted at the hospital level that involved the health department, leading medical experts and later by the Punjab government — and owing to immense pressure by certain quarters a judicial commission was constituted in February 2012. Justice Ijazul Ahsan started the inquiry and finalised it in December.
The judicial commission has exposed a volume of mismanagement, criminal negligence and blunders committed by the pharmaceutical company, the distributor, and the PIC administration as well. It also identified many deficiencies and raised serious questions on the entire system of manufacturing, supplying and procurement of life-saving drugs for the poor patients who largely depend on the state-run health institutions, and suggested recommendations for amendments in the existing laws and regulations.
It has come to the fore that a large number of manufacturers may not be in compliance with the provisions of Drug Act 1976, or with the current Good Manufacturing Practices (cGMP). The judicial commission said that this is an alarming situation as the only safety net against errors, omissions, defects, contamination, etc. of the drugs and preventing such drugs from reaching the hospitals, markets and patients is at the stage of manufacturing.
Some important and salient features of the judicial commission’s report, determining elements responsible for negligence, are as follows:
Criminal negligence at the level of company: The manufacturer is first and foremost responsible for this tragedy. Only one batch was found to be contaminated that was administered by PIC in November/December, 2011, after which the patients reported adverse drug reaction symptoms. The same medicine from other batches of the same company, which were not contaminated, and prescribed in the same dosage to the patients, did not cause any adverse reactions.
The company did not fulfil its obligation to ensure that the drug supplied by them was fit for human consumption, and in strict compliance with the cGMPs. Therefore, the direct responsibility for the tragic loss of lives lies on the manufacturer, the tribunal said.
Distributor’s fault: The distributor of the drug and its partners are also equally responsible as they committed acts and omissions which resulted in incorrect documentation. The records did not reflect that the batch J093 had been received by the PIC and samples from the said batch were not sent for testing to the Drug Testing Laboratory. It was only after the recovery of medicine from some patients’ homes that the cause of drug reaction could be ascertained.
Laboratory infrastructure: The drug testing laboratory (DTL) was found to be ill-equipped, under staffed and not able to cope with current and projected workload in the next few years. Inquiries into the drugs’ reaction issue depend upon the DTL reports. The DTL needs to have professional administration in addition to separate cadre of professionals who undertake professional functions as analysts.
Drug inspectors: The role of drug inspectors is of pivotal importance in ensuring safety of manufactured drugs, yet there is much to be desired in terms of training, know how, technical education, motivation and capacity to undertake the functions that they are required to perform.
Amendment in licensing regulations: The tenure of manufacturing licenses issued by the Licensing Authority is two years, and on expiry of that period, the license could be extended if, after a proper and satisfactory inspection by a panel of inspectors/experts, the factory/manufacturing facility is found to be cGMP complaint. The Tribunal opined that after two years the license should undergo a rigorous process of inspection for cGMP compliance.
PIC administration’s fault: There are major structural weaknesses and loopholes in the administrative processes and procedures of the PIC. The mode and manner in which medicines are procured, received and stored, documented and dispensed is not in consonance with the requirements of running an organised and efficient hospital. The staff of the free dispensary, which checked and approved the consignment but missed the presence of the controversial Batch J093, should be held responsible for their actions.
Health department’s role: There is complete absence of systems at the level of health department to handle situations like these. Although the health department and the Punjab government made efforts to control the damage and prevent further loss of human lives, the response was neither structured nor based upon standard operating procedures already in place.
Investigating agencies: The investigating process was found to be lacking direction and expertise. One of the reasons was that the investigating officers were frequently changed. This practice needs to be avoided in order to ensure that issues arising out of drug related offences must be addressed swiftly, expeditiously, transparently and professionally.
General recommendations: The report makes detailed recommendations covering the areas of manufacturing, production of drugs, distribution, investigating agencies, improvement of regulatory framework and improvement of enforcement, establishment of pharmaco vigilance and poison control centres, administration of hospitals and upgrading of testing facilities.
It emphasised that compliance with cGMP requirements minimises the possibility of defective drugs reaching the hospitals, markets or patients. Once a defective or contaminated drug is out of the factory, it is extremely difficult to detect the same; even if such detection is undertaken, it takes time, effort and resources, which in most instances are not available in Pakistan.
This report should act as an eye opener for all concerned, and immediate steps must be taken to implement existing laws in their letter and spirit, introduce fresh legislation where required, frame new rules and regulations, put in place efficient, effective and modern systems and administrative structures so that the lives lost in this tragic incident would not have been lost in vain.