Public trust in the State health sector is deteriorating following a string of incidents suspected to be linked to the quality control of medicines and those involving the accountability of health officials.
Many health professionals have called for the ongoing investigations into such incidents to be expedited and done transparently, in order to help rebuild waning public confidence in the health system.
The latest crisis plaguing the health sector has placed a large section of society in a desperate plight, leaving them with no choice but to continue seeking State healthcare while concerns grow around its credibility.
“We have no choice but to accept whatever free medicine offered by the hospital. Even if it kills us, we have no choice,” said H.K. Ariyadasa, a 53-year-old resident of Thammennagama, criticising the authorities for allegedly not following proper procedures to ensure the quality of medicines that are imported.
“We take whatever medicines prescribed by the doctor at the hospital. It’s up to the authorities to ensure that the medicines are safe. We know there are several reports that cast doubt on the quality of the medicines, but we can’t afford to buy from private pharmacies. Our family members rely on State hospitals,” he explained, while questioning why the authorities were unable to ensure that the country received quality medicines.
“Who should take responsibility for lives that were allegedly lost due to quality failures? Will the officer in charge of approving these medicines take responsibility or will it be the Government? Even if someone takes responsibility, what is the point after the loss of a life?” he lamented.
A.J.L. Ahammed, a 70-year-old resident from Kolonnawa, said that following the news, he had been too afraid to administer the drugs prescribed by the doctor at the National Hospital of Sri Lanka (NHSL) when he had gone for his monthly check-up.
“I’m scared to take medicine, but my daughter is forcing me to take it. I have lived all these years without any fear. I have a surgery coming up next month. I don’t know whether I should get the surgery done or not,” Ahammed lamented.
Joining the conversation, Ahammed’s daughter A. Kaleema recounted the trauma that her father was enduring, following the latest reports on medicine quality. She also explained that many mothers she was acquainted with were afraid of vaccinating their newborns due to the news.
“Some expectant mothers are afraid of opting for caesarean surgeries. I’m finding it difficult to give medicines to my father, but it’s likely that there are many other patients who have already stopped certain medicines due to this,” Kaleema stressed.
Over the past several months, various incidents of quality failures have been recorded. However, as learnt by The Sunday Morning, there have been no official records of precise numbers of the incidents that have occurred thus far, which led to several batches of different types of medicines being recalled from State hospitals.
The quality of medicines came under the spotlight following an incident reported on 2 April, where a pregnant woman who had been admitted to the Peradeniya Teaching Hospital for a caesarean surgery had allegedly died of complications after being given a certain medicine.
Following this, further incidents were reported in the mainstream media, but there has been no official statement issued by the Health Ministry clarifying such incidents, apart from statements issued by Health Minister Keheliya Rambukwella on various occasions.
Incidents accumulating
In such a backdrop, a member of the seven-member committee appointed by Minister Rambukwella to conduct a full investigation and report on the issues related to the health sector told The Sunday Morning that it was difficult to outline the precise number of incidents of quality failure, since they kept accumulating.
“It’s difficult to pinpoint the exact number of incidents being investigated by the committee, since new cases keep adding up. We will investigate all of them,” the committee member said.
The committee was appointed due to pressure mounted on the Government following the reports of a considerable number of such incidents, including several deaths allegedly attributed to quality issues.
The committee includes Medical Research Institute (MRI) Director Dr. Dedunu Dias, Professor of Allergy and Immunology Chandima Jeewandara, Professor of Pharmacology Priyadarshini Galappaththi, Consultant Emergency Physician Dr. Senitha Liyanage, Professor of Pharmacy and Pharmaceutical Sciences Nithushi Samaranayake, Professor of Nursing S.S.P. Warnakulasuriya, and Asia Pacific Association of Allergy, Asthma, and Clinical Immunology Board Director Dr. Philip Li.
Among the incidents reported during the past few weeks, a 23-year-old woman had died due to an allergic reaction from the said medicine at the Colombo North Teaching Hospital in Ragama. It is reported that when she was admitted to the hospital on 27 June due to an infection, she had been orally administered the antibiotic, but as she had shown no response, the medicine had been re-administered in the form of a vaccine. The woman had then developed complications due to an allergic reaction to the medicine, after which she had been admitted to the Intensive Care Unit (ICU) of the hospital.
Two incidents were reported from the Peradeniya Teaching Hospital and the National Eye Hospital, which led to the withdrawal of two pharmaceutical items brought down to Sri Lanka from India under the Indian credit line. Questions have been raised over the quality of the remaining drugs imported to Sri Lanka recently by the State Pharmaceuticals Corporation (SPC).
Again, on 14 April, the National Eye Hospital suspended surgeries with immediate effect following the report of several incidents of infections in patients who had undergone surgeries.
Primary investigations have revealed that the infections were allegedly related to an eye drop, namely prednisolone, imported from India under the Indian line of credit. The particular batch of medicines has been withdrawn from the hospital sector.
As per the Health Ministry, investigations are underway.
Healthcare workers at the forefront
Meanwhile, health sector workers have repeatedly claimed that their lives would also be at risk should the situation continue.
Speaking to The Sunday Morning, Government Medical Officers’ Association (GMOA) Spokesman Dr. Chamil Wijesinghe said that there were certain incidents and allegations ranging from the anaesthetic drug to eye drops to various other incidents which had been proven during lab tests. He further noted that the National Medicines Regulatory Authority (NMRA) had issued a statement regarding quality failure in one such incident.
“Public trust is falling. Healthcare professionals have to provide whichever medicines that are given by the Health Ministry and the Medical Supplies Division (MSD). We are unable to check the quality of medicines within the wards; it should be done at a proper accredited lab. We have a lab which is outdated and at a primary level.
“We have doubts about the types of medicines we are being provided. Patients have emotional reactions if something goes wrong and healthcare workers are at the forefront of this. It is not the Health Minister or the Secretary or the Director General who will be facing the public should such a situation arise. This uncertainty should be cleared and clarified as soon as possible,” he asserted.
“Therefore, all these incidents should be investigated properly, impartially, and as soon as possible. Most importantly, correct information should be revealed to the public. Further, the ministry should take all measures to secure and establish the quality of medicines. The ultimate solution is establishing a national quality assurance lab,” Dr. Wijesinghe stressed.
Private sector not affected
With almost all these incidents having been reported from the State sector, the public has raised concerns about the safety of medicines available in private pharmacies and hospitals.
Speaking to The Sunday Morning, former President of the Sri Lanka Chamber of the Pharmaceutical Industry (SLCPI) Sanjiva Wijesekera assured that the medicines available in the private sector were safe.
“There have been no incidents reported from the private sector. All medicines imported to the country are properly being checked. We can assure the quality of all registered medicines. However, we are not aware of the quality of unregistered medicines,” he said, adding that he was unable to comment on the State sector.
Quality assured
In such a backdrop, when contacted by The Sunday Morning, Health Minister Keheliya Rambukwella stressed that there were a number of incidents circulating in the media and that a committee had been appointed to investigate all the issues.
When asked about the quality failures, the Minister noted that the Government was taking initial steps to establish an internationally-accepted and accredited laboratory to conduct quality tests on the medicines that were being imported to the country.
“Once the lab is established, the quality of all medicines can be tested within the country. Even now, despite several incidents being reported, the medicines that are imported to the country are safe,” the Minister said.
As medical experts allege, due to the absence of a standard drug regulatory mechanism in Sri Lanka, the market has been flooded with various lower-priced brands while high-quality brands struggle to balance quality and cost.
The medicines which are available at lower prices in the local market are not effective, the experts note.
However, a senior consultant physician who wished to remain anonymous noted that the quality of medicines could not be estimated by the price and that the best and most accurate way to check quality was through a laboratory test.
“Quality depends on raw materials and tests are needed to check whether the product has been manufactured using the correct raw materials,” he said.
Meanwhile, an official attached to the MSD confirmed that the Government had no such mechanism to check the quality of imported medicines and that companies were being asked to submit a report to the ministry.
“Companies usually hire Singaporean companies and get a report from them,” he said, adding that when the MSD imports medicines, it refers to the pedigree and whether the medicine is being used in other countries.
“If any person or a medical officer comes across low-quality products, there is a mechanism to lodge a complaint. Once such a complaint is received, the company’s registration will be cancelled after an investigation,” he said.