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Immediate withdrawal of contaminated eye-drop: MSD sends out circular
View(s):By Kumudini Hettiarachchi
A batch of a common eye-drop, confirmed as being contaminated by a bacterium, has been withdrawn but many queried as to what would happen to the patients whose vision has been impaired.
The eye-drop is Prednisolone Acetate Ophthalmic Suspension USP IO-PRED-S, a common steroid and anti-inflammatory medication used after eye surgery in the state health sector. The contaminated stock was from a manufacturer based in Gujarat, India. Earlier, after adverse reactions were reported in patients, the Health Ministry temporarily halted the use of this eye-drop.
With the analytical report finding that “the sample does not conform to USP Specifications for Sterility test”, the National Medicines Quality Assurance Laboratory (NMQAL) has recommended that Batch No. N22L16 with the manufacture date of December 2022 and expiry date of November 2024 be ‘withdrawn’.
Circular No. MSD/Q/P/2023/25 issued by the Health Ministry’s Medical Supplies Division (MSD), which is in the possession of the Sunday Times, instructs that the batch be withdrawn from use immediately.
The circular signed by MSD Director Dr. H.M.K. Wickramanayake has been sent to numerous hospitals, all provincial and regional directors of health and other health institutions and campaigns.
The Sunday Times as far back as April 23, reported the contamination of the eye drops by the bacterium Burkholderia cepacia and how patients at the premier National Eye Hospital, Colombo, had been affected by its use.
Later reports indicated that several patients at the Nuwara Eliya District General Hospital had also been affected by the use of these contaminated eye-drops.
On Friday, a National Medicines Regulatory Authority (NMRA) source told the Sunday Times that the NMQAL had found the eye-drop to be positive for the bacterium after a culture analysis.
When medicines are contaminated, the manufacturer should pay for the affected batch as well as a 25% surcharge, the source said, pointing out that the NMRA’s Recall Committee would decide whether every batch of this medicine from that particular manufacturer should be tested and recalled.
Another decision is whether the manufacturer should be blacklisted, other sources said, but an MSD source said that there may not be a need for blacklisting.
When repeatedly asked whether all the batches of this eye-drop sent to Sri Lanka should be withdrawn, the MSD source said they would have to check samples for contamination.
The MSD circular instructs that “details of all batches available of this product should be informed to the NMQAL to select samples for further testing”.
When asked about what happens to those whose vision has been impaired, the MSD source said they were being treated for the infection.
However, other sources said it would be the prerogative of the Health Ministry to file legal action against the manufacturer. Even the victims would be able to sue the manufacturer on their own.
Questioned about a substitute for this eye-drop to facilitate continuation of surgeries, the MSD source said that at the moment they do not have one and to get a new one would take some time because tender procedures have to be followed. It was also difficult to open letters of credit in view of the financial situation the country is facing.
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