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Urgent need for patient safety body and good watchdog, say experts
View(s):- Stress importance of meticulous data-keeping of hazardous events by the Health Ministry
By Kumudini Hettiarachchi
There was an urgent call for the holding of ‘quick and thorough’ probes into several unexpected deaths reportedly due to sub-standard medicines or severe adverse events (SAE) at state hospitals.
“It is also vital to create an independent ‘Patient Safety Body’ of technically-sound experts giving of their services voluntarily and if there is an increase in hazardous events in healthcare settings, a strong and independent watchdog is also essential,” reiterated many medical experts.
They also underscored the importance of meticulous data-keeping of such incidents by the Health Ministry, with healthcare being a hazardous field.
The practice now is that whenever such an incident takes place, while the hospital itself initiates its own internal inquiry, there is also a probe by the Health Ministry. The hospitals in which such incidents occur need to notify the National Medicines Regulatory Authority (NMRA), the drug-watchdog, so that a parallel inquiry by its Pharmacovigilance Committee is launched. However, in some instances this does not happen, the Sunday Times understands.
Human and technical errors, tragically may occur but hospitals need to have their monthly ‘Death Reviews’ to ensure such incidents do not recur, said one source.
The critical issues that people should be told are: whether a medicine linked either to a suspicious death or an SAE has been registered by the NMRA or brought under the Waiver of Registration (WOR) system. Many allege that WORs lead to the bending of strict regulatory norms like detailed dossiers, due to corruption.
Several experts made a strong request to the Health Ministry to respond to these tragic incidents promptly; temporarily withdraw any suspect medicines; hold an in-depth investigation without dragging its feet or giving excuses; after a formal inquiry, if the product is found to have bypassed ‘acceptable risk’ and been ‘incriminatory’ in the incident, then seriously consider withdrawing the product; and inform the people frankly about what is happening.
There is a need for transparency and accountability. All these incidents are making people lose faith in the government hospitals, several sources pointed out, explaining that when patients are told to undergo general anaesthesia for an operation, they plead for it to be done under local anaesthesia.
“One person to whom I recommended a surgery, questioned me closely about the safety of medicines and never came back. Most probably, he may have gone to the private sector,” said a surgeon in an outstation hospital.
Another stressed the importance of ensuring an uninterrupted supply of medications even if some medications have to be withdrawn due to failures. Otherwise when a batch is withdrawn, there could be a severe shortage. Then can arise the dangerous trend of people smuggling in drugs in suitcases which most often would be sub-standard.
“Therefore, it is vital for the Health Ministry to think out of the box and maybe, instead of giving a full tender for one type of drug to one bidder, spread it out among two or three. This would be a precautionary measure without putting ‘all eggs in one basket’,” the source said.
The Sunday Times attempted to collate the incidents in hospitals within the last four months:
Death of a 21-year-old woman who was admitted to the Peradeniya Teaching Hospital with symptoms of food poisoning. Her parents have gone on record saying that she was being administered saline and to this was added two injections after which she succumbed. The injections were reportedly Ceftriaxone, belonging to the class of third-generation cephalosporin antibiotics, used commonly in the country.
Death of an NMRA employee at the Panadura Hospital allegedly due to an infection after the insertion of a cannula.
Death of a 35-year-old woman who had undergone lens-change surgery at the National Eye Hospital of Sri Lanka reportedly due to severe co-morbidities including blocked heart vessels that she had.
Two deaths – one of an expectant mother during a Caesarian-section and another of an elderly woman who was due to undergo a hernia operation – at the Peradeniya Teaching Hospital reportedly due to the spinal anaesthesia administered to the patients.
Several people going blind after surgery at the National Eye Hospital and the Nuwara Eliya Hospital – this had been confirmed being due to the eye-drop being contaminated by the micro-bug Burkholderia cepacia (B. cepacia). The eye-drop was Prednisolone Acetate Ophthalmic Suspension USP 10-PRED-S, a common steroid and anti-inflammatory medication used after eye surgery, which had been imported from India.
Several specialists that the Sunday Times spoke to said the latest death at Peradeniya (food poisoning patient) seems to be due to anaphylaxis which is a serious allergic reaction that is rapid in onset and may cause death. It has been estimated to be fatal in 0.7 to 2% of cases.
Others pointed out that there is a need for all in the health sector to take a close look at ‘Patient Safety’ norms in the administration of medicines suggesting that intravenous medicine administrations should also be looked at in-depth, as it has been proven to have a higher risk and severity of error than other medication administrations such as taking them orally.
Another suggestion was that there should also be appreciation of those who work beyond the call of duty in the health sector, with ways and means of getting on track others not showing a similar commitment.
| Reasons leading to ‘unsafe’ care The occurrence of adverse events due to unsafe care is likely one of the 10 leading causes of death and disability in the world, according to the World Health Organization (WHO). Each year, 134 million adverse events occur in hospitals in low- and middle-income countries (LMICs), due to unsafe care, resulting in 2.6 million deaths. Here are some of the patient safety situations causing most concern, according to the WHO: Medication errors are a leading cause of injury and avoidable harm in health care systems. Health care-associated infections occur in 7 and 10 out of every 100 hospitalised patients in high-income countries and low- and middle-income countries respectively. Unsafe surgical care procedures cause complications in up to 25% of patients. Almost 7 million surgical patients suffer significant complications annually, 1 million of whom die during or immediately following surgery. Unsafe injection practices in health care settings can transmit infections and pose direct danger to patients and health care workers. Diagnostic errors occur in about 5% of adults in outpatient care settings, more than half of which have the potential to cause severe harm. Unsafe transfusion practices expose patients to the risk of adverse transfusion reactions and the transmission of infections. Radiation errors involve overexposure to radiation and cases of wrong-patient and wrong-site identification. Sepsis is frequently not diagnosed early enough to save a patient’s life – because these infections are often resistant to antibiotics, they can rapidly lead to deteriorating clinical conditions. Venous thromboembolism (blood clots) is one of the most common and preventable causes of patient harm, contributing to one third of the complications attributed to hospitalisation. | |
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