Health sector crisis: What the expert panel did not findView(s):
- Of the 15 cases, panel explains only two cases; no comment on other 13 cases
- Unpublicised terms of reference focus on allergic reactions, not on drug quality
- Doubts continue, nine undisclosed patient incidents remain without probe
By Namini Wijedasa
A Health-Ministry-appointed expert committee that inquired into recent adverse medical reactions to certain drugs administered in Government hospitals concluded that only two out of the 15 cases referred to it were deaths caused by severe allergies.
The seven-member group, set up by Health Minister Keheliya Rambukwella, did not comment publicly on the remaining 13 cases. The nature of these incidents, including whether they were caused by substandard drugs, therefore remains undisclosed.
The committee also did not investigate whether the suspect medicines which had induced these side effects were among the hundreds now being imported—on Health Ministry instructions—bypassing regulatory checks on the pretext of an “emergency” that persists well over one year.
This is because the committee’s terms of reference (ToRs), which were not publicised, strictly constrained its seven members to study allergic reactions and not drug quality.
Out of 15 cases reported to them, the experts’ initial assessment was that six were possibly due to allergies. But a detailed evaluation showed that only five cases “met the criteria for anaphylaxis” or a severe allergic reaction.
Using World Health Organisation-Uppsala Monitoring Centre (WHO-UMC) causality assessment benchmarks, the experts then categorised four out of these five adverse drug reactions (ADRs) as being “probable/likely due to the suspected drug”. Causality assessment is the finding of a relationship between a drug and a drug reaction.
Of these, only two were fatalities directly arising from drug allergy. Neither the report’s conclusion nor recommendations—the sections that were released—reveal the reasons behind problems in the remaining cases.
“The other two patients [out of four] were not patients who died as a result of drug allergy,” said Chandima Jeewandara, Professor in Allergy and Immunology, committee member, at a press conference held this week.
In the two deaths, the products concerned were two brands of ceftriaxone and one of co-amoxiclav, both antibiotics. The ceftriaxone supplies were bought from two companies—one German, the other Indian—and had passed tests by the National Medicines Regulatory Authority (NMRA) quality assurance lab, Prof. Jeewandara said.
The relevant co-amoxiclav product was manufactured in Sri Lanka. While the report on the suspect batch is pending—which indicates that tests are being carried out post-incident—particles had been found in vials of a different batch produced by the same company.
The conclusion of the expert committee report, which will not be released in full citing patient confidentiality, also said: “Comprehensive quality testing reports of the suspected drugs were not available at the time of this report”.
Prof. Jeewandara did not say how the original 15 cases were reported to them or even whether these were fatalities. Their narrow ToRs also mean nine publicly undisclosed patient incidents remain without investigation.
Consequently, nagging questions remain about the quality of drugs and devices imported and released to Government hospitals without National Medicines Regulatory Authority (NMRA) oversight or registration. And doubts continue about whether shortcomings related to quality, safety and efficacy—as clearly evidenced through concerns reported in writing by doctors—have caused several recent patient fatalities and other serious medical side effects.
“Our duty was to assess whether these reactions were due to allergy or not,” Prof. Jeewandara said, when asked by a journalist if the committee had studied drug quality. “Not to assess the….From our experience we can decide whether these reactions were due to allergy or not. In allergy investigations, usually we don’t check the drugs, especially in terms of their quality. But we did refer to all the quality reports available with regard to these drugs.”
“And we should mention also that all these suspected drugs were sent for quality testing and, you know, most of the reports were available for our assessment,” he continued, flanked by Health Ministry officials. The two fatalities attributed to severe drug allergy took place at the Kandy General Hospital and the Colombo North Teaching Hospital (Ragama).
It is now evident from information released to the media by the committee that the widely-reported deaths of a pregnant mother and a school principal at the Peradeniya Teaching Hospital were not due to drug allergies. The principal died in June from complications related to the Indian-manufactured “bupivacaine” (brand name Zupivac-H) anaesthetic injection after being in intensive care since April. The pregnant woman died in April after being administered the same injection.
Zupivac-H, imported on a controversial waiver of registration (WoR) from the NMRA, was subsequently withdrawn. And the regulator, in a press release this week, admitted that the registration for the relevant “bupivacaine hydrochloride in dextrose inj USP 5mg/ml” had expired and was not renewed. Despite this, it was imported to Sri Lanka—bypassing registration, on Health Ministry instructions—under the Indian line of credit.
The relevant vials were sent to the NMRA’s quality assurance lab after the passing of the pregnant woman, the press release says. Accordingly, two batches of the medication failed the tests while one batch was passed as matching the required criteria.
“Nevertheless, as soon as the adverse reactions were reported, the NMRA on 2023/4/4 temporarily withheld the three batches of medication and on 2023/04/10 the decision to withhold this drug was approved by the Safety and Risk Evaluation Committee (SAFRESC),” it elaborated.
After the lab report related to this medicine was received, and based on a SAFRESC directive issued on July 20, 2023, the Authority withdrew the product.
|Committee recommendations include measures on drug qualityThe Health Ministry-appointed committee made 12 recommendations. While it mostly focused on allergy-related issues, it did also prescribe the adoption of some measures on quality.One was that there should be a “stringent evaluation of the quality of medicines during registration and post-marketing quality testing of random samples is recommended to improve the quality of pharmaceuticals in the country”. |
Another was that “Appropriate and expedited reporting on quality failures is needed”.
The committee also called for “speedy remedial actions on procedural and/or financial issues that may hinder the adequate supply of safe and effective drugs of acceptable quality to healthcare institutions”.
And it proposed that there be “strict maintenance of temperature control during transportation of pharmaceuticals”. All of these topics have been widely discussed in the recent past.
The other recommendations are:
The committee members are Medical Research Institute Director Dr. Dedunu Dias (Chair); Prof. Chandima Jeewandara, Professor in Allergy and Immunology; Prof. Priyadarshani Galappaththi, Professor in Pharmacology; Dr. Senitha Liyanage, Consultant Emergency Physician; Prof. Nithushi Samaranayake, Professor in Pharmacy; Pro. S.S.P. Warnakulasuriya, Professor in Nursing; and Dr. Philip H. Li, Board Director of the Asia Pacific Association of Allergy, Asthma and Clinical Immunology.
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