DOH guarantees sanctions for those liable in NKTI chills

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Friday, June 27, 2014

THE Department of Health (DOH) assured the public on Friday that sanctions will be meted to those responsible for the chills experienced by patients of the National Kidney and Transplant Institute (NKTI) Out-Patient Hemodialysis Center.

In a media briefing, DOH spokesperson Dr. Lyndon Lee Suy said they are already in the process of exploring their options on how to hold accountable the companies behind the Heparin Sodium 1000 IU/mL Solution for Injection with brand name Meparin 5.

"Definitely, someone will be held liable here. The mere fact that the product is contaminated, it means there was negligence… when you ask if the companies are liable, definitely there is," said Lee Suy.

He, however, said they cannot say determine yet what type of sanction will be handed to importer/distributor, Pharma-Surrey International Inc., and India-based manufacturer, MedChem International Ltd.

"Will it be the manufacturer? What about the distributor? We are not confirming any sanctions yet… One may be less liable than the one who is determined as primary responsible," said the health official.

Lee Suy said they are just awaiting recommendations of the legal officers of the DOH before they come up with a decision.

Two weeks ago, the NKTI decided to tap the Food and Drug Administration (FDA) to validate results of their investigation on what caused their patients to experience chills, prompting the Quezon City hospital to close down operations for more than one week.

On Wednesday, FDA Director General Dr. Kenneth Go said that they are focusing their investigation solely on Meparin 5 after their laboratory tests confirmed the NKTI findings.

Consequently, Go said they are already recalling all Meparin 5 products from the market in order to avoid additional cases of patient chills.

Meanwhile, the FDA has decided to include Heparin Sodium 5000 IU/mL Solution for Injection with brand name Meparin 25 in the recall order.

Based on FDA Advisory No. 2014-049, all hospitals, health facilities and the public in general, are advised to stop the use of Meparin 25.

"We included Meparin 25 because we cannot be sure the same product of different dosage strength from the same factory with suspected manufacturing problem is sterile. We cannot take the risk if patients’ fragile lives are concerned. Patients who need this product are often in intensive care," said Go in a phone interview.

Similarly, the FDA is also set to test all parenteral products manufactured by MedChem International Ltd - India that are in the Philippine market. (HDT/Sunnex)

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