A committee appointed by the Director General of Health Services of the Ministry of Health in Sri Lanka has concluded its investigation into recent incidents of drug allergies and their aftereffects. The committee’s final report, containing both findings and recommendations, has been officially submitted to the Health Ministry.
According to Health Minister Keheliya Rambukwella, while the full report cannot be disclosed due to doctor-patient confidentiality, the conclusions and recommendations are now part of the public record and have been made available to the public.
The report highlights that the investigated deaths are attributed to anaphylactic shock. However, pending further results, the quality testing of the reported drug is being carried out through a thorough and independent examination by the National Drug Quality Laboratory (NDQL).
In summary, the report delves into a comprehensive analysis of recent cases involving patient deaths and severe harm resulting from drug allergies in Sri Lanka. Among the six cases scrutinized in detail, five met the criteria for anaphylaxis. Of these five patients, four were categorized as having probable or likely adverse drug reactions (ADRs) according to the WHO-UMC causality assessment criteria. It’s important to note that the comprehensive quality testing reports for the suspected drugs were not available at the time of compiling this report.
The report also highlights areas within the healthcare system that could benefit from improvements in preventing, identifying, and managing anaphylaxis cases. To address these issues, the committee has put forth a series of recommendations:
Recommendations.
- Revisit and establish national and institutional guidelines/protocols on anaphylaxis management/emergency management.
- Re- emphasize the practice of “Recognise early and treat immediately with adrenalin” in anaphylaxis. Authorize the registered nursing officers of institutions to use 1:1000 adrenalin in the IM route in an emergency without the directions of medical officers.
- Develop a mandatory continuous professional development mechanism or training programme for medical officers and nursing officers on emergency management of anaphylaxis.
- Institute a compulsory mechanism to conduct institutional clinical audits for all life- threatening adverse incidents reported.
- The TOR of DTCs should be revised to include the development of institutional drug management policies (ex: Institutional Antibiotic policy, ADR audit policy, etc.) and to introduce institutional mechanisms to minimize medication errors.