October 10, 2013
October 10, 2013
The government revised a ban on medications from major pharmaceutical companies Monday and promises that a standardized grievance procedure for patients, a 2005 medication policy, and an updated registry of medical practitioners are pending implementation.
COLOMBO, SRI LANKA – Kumari took her two children, ages 7 and 11, in May to a pharmacy in Mulleriyawa, a suburb of Colombo, Sri Lanka’s commercial capital, after she discovered they both had a fever. She declined to publish the family’s surname to protect her children’s identity.
When the pharmacist prescribed paracetamol, an over-the-counter medication, to manage fever and pain, Kumari did not think much of it, she says. But when their fevers did not subside after three days, she became concerned.
Kumari took her children to the National Hospital of Sri Lanka, a government hospital in Colombo, she says. Hospital personnel immediately admitted the children after diagnosing both with dengue, a mosquito-borne virus that causes severe flu-like symptoms.
Kumari soon noticed a problem when a nurse at the hospital administered 375 milligrams of paracetamol to her son, she says. The prescription she had received from the pharmacist several days earlier had been for 750 milligrams, which indicated that the children had been taking double the dose that the nurse was now administering. Kumari told the nurse that the dose was too low.
“The nurses at the nurse station all stood up in alarm when I said this,” Kumari says.
The nurses informed the doctor that the children had been taking double the recommended dosage for the last three days, Kumari says. The attending doctor performed a liver function test on the children, which indicated increased enzyme levels in the blood. In other words, the children were already showing signs of liver damage because of an overdose of paracetamol.
A doctor on duty familiar with the case confirmed the children’s liver damage but declined to be named, citing hospital protocol to not release patient information without the approval of the director.
Around the world, paracetamol overdose in children is common, according to the National Institutes of Health, a division of the U.S. Department of Health and Human Services. But in Sri Lanka, the incidence is rising, say doctors in the National Hospital, who refused to go on record for fear of reprisal.
Kumari’s children spent the month of May in the hospital under strict medical supervision, she says. Since the children’s discharge, they have had to change their diets, and their physical activities remain minimal. Her son cannot exercise or play, and her daughter has not been able to dance.
“They suffered a lot,” Kumari says of her children. “Their whole lives have changed. My son was good in sports – he has taken part in events at [the] national level – but now he can’t do so. My daughter has had to stop her dancing lessons, and they can’t be given the food they like.”
Recovery recommendations include eating bland foods and increasing liquid intake, according to a report by the Food and Drug Administration, another division of the U.S. Department of Health and Human Services.
Despite this hardship, Kumari says she chose not to file a complaint with the Sri Lanka Medical Council, a statutory body established to protect health care seekers, or the Ministry of Health. She fears that doing so will draw discrimination when her family seeks future care.
“My kids will suffer, but then, the damage is done,” she says. “I am very disappointed, but my primary focus is on taking care of the kids.”
Although Sri Lanka often draws praise for its universal health care system, the mismanagement of already inadequate resources leads to poor patient care, say patients’ rights groups and health care unions. The lack of a formal grievance policy or an updated medical practitioner registry, which health officials promise are pending, limits oversight of procedures. Substandard and expired medicine also floods the market, as health officials say they are planning to implement a 7-year-old medication policy soon and are training students to equip pharmacies with qualified pharmacists within the next five years.
In May 2013, another patients’ rights case grabbed headlines here. A 23-year-old woman fell off a city bus while standing on the footboard to get off at the next stop and suffered a bad injury. The woman and a friend sought care at the National Hospital, where they say staff neglected them.
“No one paid any attention, although it wasn’t a busy day,” says the friend who accompanied the injured woman to the hospital. “They were just watching TV.”
Both women requested anonymity and say that because they work in the health care sector, they fear that filing a public grievance would affect their careers in the future.
“I was confused why they wouldn’t help us,” the injured woman’s friend says. “I work in health care, and I have been in many hospitals, but I have never encountered a situation like that before. We were helpless.”
The patient in this case also chose not to file a complaint. But after the case received local media coverage, the Ministry of Health ordered the removal of the television from the emergency ward.
Despite the growing discourse about a lack of patients’ rights in the health care sector in Sri Lanka, there is no available data on patient grievances or neglect because a standard process to record grievances does not exist.
Louis Benedict, spokesman for the People’s Movement for the Rights of Patients, a civil society group working for patients’ rights in Sri Lanka, confirmed the absence of data in a telephone interview. Standardized penalties for doctors or facilities providing substandard care also do not exist.
The root of problems in the government-funded public health sector is mismanagement of resources, Benedict says.
Although the public health system received an allocation of 125 billion rupees ($953 million) at the national and provincial level in 2013, Benedict alleges that the Ministry of Health mismanaged the resources. The result has been compromised patient care and a dearth of qualified personnel and resources in some areas.
In addition to the unequal distribution of available resources, the system does not have adequate resources, says Dr. Nalin Ariyarathne, assistant secretary of the Government Medical Officers’ Association, a trade union.
“Most health institutions, such as hospitals, do not have enough human and other resources,” he says. “We have only about 14,000 doctors and 1,300 consultants, and most of the doctors are gathered around Western province.”
On average, a resident physician treats about 200 patients per day – 10 times the recommended practice of 20 patients per day, Ariyarathne says.
“Most doctors in the government service don’t have time to talk in detail to the patients and take histories and conduct detailed investigations,” he says. “It is very difficult to do so.”
The most recent doctor-patient ratio available in Sri Lanka is one doctor per 1,500 patients, Ariyarathne says. The World Health Organization recommends one doctor per 500 patients.
But no authority or regulatory body keeps an updated database of licensed medical practitioners or patient grievances, Ariyarathne says. The combination makes it difficult to assess the current state of the health service sector.
Although the Sri Lanka Medical Council maintains a registry of all medical practitioners, it does not update it regularly, Ariyarathne says. His association has been requesting that the government regularly update a registry of practicing doctors for several years. The union renewed its formal request in July 2013.
The council has yet to update the registry.
An up-to-date database of licensed practitioners would ease the way for patients to file grievances in cases of neglect or mismanagement of care, Benedict says. Patients’ rights groups here are also calling for the establishment of a formalized procedure for patients to file grievances.
Dr. Sarath Amunugama, deputy director general of public health at the Ministry of Health, says in a phone interview that the ministry is developing a grievance procedure, which would establish steps for patients to file complaints and an authoritative body to process them. The ministry plans to implement it in the near future, but he was not able to give a specific timeframe.
When a patient files a grievance now, the ministry assesses each case on an individual basis, Amunugama says. The ministry appoints a committee of experts based on the nature of the issue under investigation, and the committee then conducts investigations. But Amunugama was unable to provide a record of any committee or subsequent investigations, citing the lack of an established grievance system.
“We don’t have an established mechanism right now,” he says. “But the patients can approach the officer in charge of the institution to make the complaint.”
Few patients lodge complaints, though, because they fear they will face further victimization if they have to return for additional health care needs in the future, Amunugama says.
“Patients are reluctant to do so, as they have to return to the same hospitals in the future, and they are afraid they would be mistreated,” Ariyarathne says. “Some are scared of the doctors and other officer[s] there, so they make no complaints, and others simply are not aware that such thing can be done.”
Medicine- and prescription-related grievances, such as what Kumari’s family faced, are among the most common, Benedict says.
Sri Lanka lacks a formal medication policy that controls the quality of medicine available, Amunugama says. As a result, fake or expired medications often make it into pharmacies, where unqualified workers sell them.
In 2006, the Ministry of Health promised implementation of the National Medicinal Drugs Policy of 2005 within weeks and even created an 18-member committee to oversee and to expedite the process.
The draft policy aims to regulate the medicinal market, which has more than 15,000 varieties of medicines, some of which have not gone through quality testing because of limitations in resources, Benedict and Ariyarathne say.
“This is one of the main reasons we have been lobbying for the implementation of NMDP, which is based on Professor Senaka Bibile’s Medicinal Drug Policy,” Benedict says.
Bibile, a pharmacologist, proposed the country’s first medicine policy in the 1970s in order to make generic pharmaceutical medication more available in the market, while reducing the larger presence of branded medication that are more expensive in the country.
The government policy legislated a reduction in the number of imported medications. It also provided that a majority of medicine would become available in generic form to allow average Sri Lankans to afford quality medication, while also saving the country billions of rupees in foreign exchange rates.
But more than seven years later, the ministry has not yet implemented the policy.
“We have even filed a fundamental rights case against the Ministry of Health against the delay of the implementation,” Benedict says. “But so far, nothing has happened. There has been no development, and there has never been a proper reason given. In Parliament, the minister [of health] stated the policy draft has disappeared.”
Ministry officials declined to comment on the delay, stating that it is a political issue. Numerous attempts to contact Maithreepala Sirisena, the minister of health, at his office, on his home phone and on his mobile phone were not successful.
In the absence of the policy, expensive, poor-quality and expired medications flood the market, Benedict says. In his years working in medical advocacy, he has seen countless medications enter the market without going through the proper quality tests.
“We don’t have the facilities to test all the drugs that are registered,” he says. “As a result, many medicinal drugs with substandard quality enter the market.”
Amunugama agrees and blames the lack of pharmaceutical testing on limited laboratory facilities available throughout the country. The lack of resources in the Cosmetics, Devices & Drugs Regulatory Authority, which falls under the Ministry of Health, limits medicine-testing facilities, he says.
Local laboratories are working at full capacity on testing, he says. But they approve most medications based on the information about their chemical components from the pharmaceutical companies or the local import agents, rather than through independent testing.
Dr. Hemantha Benaragama, director of the CDDRA, affirms the authority’s commitment to inspections.
On Sept. 15, the CDDRA banned four international pharmaceutical companies from Sri Lanka, according to its website. The India-based companies – Elysium Pharmaceuticals Ltd., Bafna Pharmaceuticals Ltd., Vivek Pharmachem (India) Ltd. and Laborate Pharmaceuticals (India) Ltd. – supplied 122 varieties of medicine to the Sri Lankan market.
The products of these companies failed quality tests repeatedly during the last three years, Benaragama says.
The CDDRA lifted the ban Monday on the companies, except for the six medications that failed quality tests. The authority reversed the ban on the companies because it could not get timely supplies from Bangladesh or Thailand of lifesaving medicine such as medication used to treat heart disease, Benaragama says.
The four companies producing the banned medicine did not return requests for comment.
This is not the first time in 2013 that the CDDRA has taken action against expired and low-quality medicine providers. It recalled three varieties of medication in August that failed quality tests, including one because of the presence of glass in a sealed vial, according to the authority’s online database. There also have been more than 185 reported quality test failures and recalls from mostly Indian manufacturers since database records began in December 2011.
The increased public attention around the recent quality test failures and recalls has led to a rise in related consumer complaints, Benaragama says.
“As people have noticed that we take action, the rate of complaints have gone up,” he says.
He affirms the CDDRA’s commitment to preventing low-quality medication from entering the market.
“For instance, from the end of this year, we are introducing a new process to ensure that active pharmaceutical ingredients are up to quality,” he says. “All suppliers will have to meet the WHO standards on Good Manufacturing Practices for pharmaceutical products if they are to be registered in the market.”
There is no published information available that details how the CDDRA will implement the WHO’s monitoring practices of pharmaceutical products before registration. The plan is still in the policy stage, and the authority will implement it next year, Benaragama says.
At one pharmacy near the National Hospital in Colombo, a local pharmacist, who requested anonymity for fear of reprisal from the Ministry of Health, says patients and pharmacists will benefit from a better medicine policy. Also an agent for the State Pharmaceuticals Manufacturing Corporation of Sri Lanka, which operates under the Ministry of Health, the pharmacist says expired medications are particularly problematic because of the unregulated number of medications that flood the market.
“If there was a proper policy, then we can import what is needed only,” the pharmacist says. “Some drugs have over 150 varieties of brands. Since doctors don’t prescribe some brands, they don’t move, and pharmacists lose out. The absence of such only makes patients and pharmacists helpless.”
Another local pharmacist, who requested anonymity for fear of repercussions from the regulatory bodies, says it is difficult to manage expiration dates as many importers supply her with medicine that will expire quickly.
“We don’t have proper regulations, so we are powerless to do anything,” she says. “Who are we to complain to even?”
Benaragama acknowledges that low-quality and expired medicine may pass through the current market under the CDDRA’s radar. The regulatory authority would take steps to compensate patients if one filed a grievance after becoming sick from taking such medication. It can also inform pharmacies if it becomes aware of substandard quality, but it is not possible to notify patients if they already have obtained prescriptions from government hospitals or private pharmacies.
After the latest ban of the six medications from the four Indian companies, Benaragama called for the removal of the medicine from the market, he says. But local representatives of pharmaceutical companies are directly responsible for recalling their medications in the markets.
In addition to the poor quality of available medication, nearly half of the country’s pharmacies operate without a qualified pharmacist, Benedict says. Official data names only registered pharmacists, but no data is available on the number of pharmacists who are operating without training or a license.
GPJ visited five pharmacies near the National Hospital. Only two of the pharmacies had qualified personnel on duty at the time of the visit.
The Ministry of Health is aware that a large number of pharmacies run without qualified pharmacists, Amunugama says. But the ministry is unable to remedy the situation now because of a dearth of suitable personnel in the country.
“The situation will be remedied within the next five years,” Amunugama says, “as we have been training students and holding the pharmaceutical examinations to produce the number needed in the country.”
GPJ translated some interviews from Sinhala.