News
Bug-infested nebuliser solution not linked to child deaths
The whole batch of contaminated solution meant for nebulisers sent to several state hospitals has been recalled and withheld with immediate effect, as soon as bacteria was found in it, assured a top health official, as rumour spread like wildfire that this contamination may be linked to the deaths of children affected by viral pneumonia in the South.
No link has been established between the deaths of these children and the bacteria-contaminated nebuliser-solution, Health Services Director-General Dr. Anil Jasinghe was categorical, as he explained the time-line.
Nineteen children have succumbed to viral pneumonia in the South. A majority having been transferred from peripheral hospitals, the children died at the Karapitiya Teaching Hospital.
Seventeen children, unfortunately, succumbed to illness in May, Dr. Jasinghe told the Sunday Times, adding that this batch of nebuliser-solution had been sent out to hospitals on June 2. Even though two more deaths (bringing the total to 19) occurred after June 2, these children had fallen ill and become critical before the solution was distributed to hospitals.
The Sunday Times learns that the nebuliser solution, Tropum (Ipratropium Nebulizer Solution), is an import from Pakistan.
This batch of Tropum which had been sent to the Lady Ridgeway Hospital for Children (LRH) in Colombo, the Karapitiya Teaching Hospital, the Matara Hospital, the Hambantota Hospital, the Moneragala Hospital, the Badulla Hospital and the Kegalle Hospital has been recalled forthwith, Dr. Jasinghe stressed, while assuring that there is no shortage of nebuliser-solution in the hospitals.
It was Consultant Microbiologist, Dr. Bhagya Piyasiri attached to the Karapitiya Teaching Hospital who detected the bacteria on June 7 during routine action to prevent secondary infections within the hospital’s seven Intensive Care Units (ICUs). The contamination results were later confirmed by the LRH Consultant Microbiologist, following the Karapitiya findings and subsequently by several other hospitals as well, the Sunday Times learns.
As soon as she reported the matter to the Karapitiya Teaching Hospital Director Dr. Jayampathy Senanayake, he promptly informed Health Services Director-General Dr. Jasinghe.
Thereafter, Dr. Jasinghe along with the Director-General/Chief Executive Officer of the National Medicines Regulatory Authority (NMRA), Dr. Kamal Jayasinghe got into action promptly.
Explaining that samples of this batch have been sent for testing to the National Medicines Quality Assurance Laboratory (NMQAL), Dr. Jayasinghe said the report is expected soon. Once the NMQAL report is issued, it will be put to an Expert Committee and a decision taken with regard to this product.
“There is high transparency in this process. It is not an individual decision, but the decision of experts with technical know-how after studying the NMQAL report,” said Dr. Jayasinghe.
Usually, if there are up to five batch failures of a particular product, it is the batch which is withdrawn, while if there are more than five batch failures, then the whole product is withdrawn and the licence is revoked for two years. However, going by criticality and the severity of the quality issue, the whole product may be withdrawn without considering the five-batch criterion (irrespective of whether the number of batches are fewer than five), he said, explaining the processes which are followed when quality issues arise.
Thereafter, the importing company will have to go through the full gamut of procedures to obtain the licence once again, by producing proof of Good Manufacturing Practices (GMP) etc. The NMRA audit team will also pay a visit to the manufacturing premises to determine that GMP guidelines are rigorously followed, it is learnt.
Meanwhile, the Sunday Times understands that Consultant Microbiologists conduct routine testing of samples to keep secondary infections within ICUs at bay and it was during such measures that Dr. Piyasiri of the Karapitiya Teaching Hospital came across the bacteria in the nebuliser-solution.
Samples from the Intensive Care Unit (ICU) and High Dependency Unit (HDU) as well as samples from oxygen outlets and humidifiers, suckers, IV solutions and other medications like nebuliser solutions are checked for possible contamination, it is learnt.
The viral pneumonia outbreak has been investigated and the patients were found to be having several viruses including Influenza A, sources said.