No Compromise: Ensuring Medicine Safety In Kenya
No Compromise: Ensuring Medicine Safety In Kenya
written by Daphne Northrop, video by Emily Judem
Nairobi, Kenya — Faith had been ill for months. She didn’t know what was wrong, and her visits to several Nairobi clinics were futile. No diagnosis. No relief. All she got were antihistamines.
“My health continued to deteriorate. I was weak and I did not know what I was suffering from. I could not go to work,” she says.
A friend urged her to get an HIV test. She was 31 and had two daughters. The test came back positive.
“I was traumatized. I wanted to commit suicide.”
Late one night she came perilously close. She had the poison on hand. But something stopped her.
“I looked at my kids,” she says, her eyes pained with the memory. “I felt sorry for them, because there would be no one to take care of them. They needed me more.”
That’s when the Eastern Deanery AIDS and Relief Program (EDARP), located near a crowded Nairobi slum, became her lifeline. She began taking antiretrovirals (ARVs) in 2011. Her appetite improved, and she grew stronger. Her viral load went down.
But that all changed in 2013 when one of her ARVs started to work against her, causing large misshapen fat deposits to develop on her body. The effect was so severe and disfiguring that she was embarrassed to walk outside.
“My body had changed. Before I started taking the medicine, I had small breasts. But when the medicine reacted negatively, they grew much bigger,” she says. ”My legs were so thin that you could see the bones.”
She was ashamed and hesitated to bother the doctor, she remembers.
“We receive the medicine for free. I did not want to seem like I was complaining.”
When she finally mustered the courage to speak up one year later, her doctor knew just what to do. He had seen this before. She was experiencing lipodystrophy, a side effect of the antiretroviral drug stavudine. This reaction was so common that the World Health Organization recommended in 2009 that stavudine be phased out of use. Because of its low cost, plentiful supply, and effectiveness — and despite its debilitating side effect — it was still being used in some parts of the developing world. Faith’s doctor shifted her to a different medicine.
“When my ARVs were changed, my body gradually went back to normal, and I had no worries,” she says.
Faith didn’t know it, but her report to the doctor became part of a nationwide database that tracks adverse drug reactions, and poor quality or expired medicines. Developed by MSH in 2009, with USAID support, the tracking system is the product of a long-established partnership between MSH and the Kenyan government. It is embedded in the public health system, allowing the government to track patterns and problems, develop better detection and response efforts more readily, and ultimately nip problems like Faith’s in the bud.
The system became digital in 2013 and will ultimately make paper-based records a thing of the past. The digital application can be downloaded on computers and smartphones, and reports of medicine problems can be logged on the website of Kenya’s Pharmacy and Poisons Board, the national agency overseeing medicine regulation, quality assurance, and patient safety.
With this “pharmacovigilance” system, Kenya became the first country in Africa—and in the world—to use a digital medicine quality and safety reporting tool available online and via mobile technology.
As of March 2016, all of Kenya’s 47 counties were reporting into this system, and the government had received more than 8,500 reports of suspected adverse drug reactions and more than 750 reports of suspected poor quality medicines. With this frontline data, the Pharmacy and Poisons Board has taken a variety of immediate actions: quarantining low quality or substandard medicines; recalling some medicines; changing labels; inspecting manufacturing practices; and, in one case, closing a pharmaceutical company that was not up to standards. The data has also been used in the review of treatment guidelines.
“There should be no compromise when you’re talking about drug quality,” says Joseph Mukoko, deputy project director at MSH. “Our main focus is ensuring that the patient gets maximum benefit from whatever is available.”
Kenya’s Ministry of Health credits the system with reducing suffering and saving lives.
“An ineffective medicine and an unsafe medicine can kill you. [Without] efficacy and safety of medicines, they will just do the opposite of what they are supposed to do,” says Josphat Mbuva, senior deputy chief pharmacist at the Ministry of Health.
“Giving patients poor quality medicines [is] going to affect their health. That’s why there should be no compromise when you’re talking about drug quality.”
— Joseph Mukoko
Adverse drug reactions like Faith’s are but one stubborn problem with medicine safety in Kenya. Low quality drugs, lax regulations, and smuggling are all too common. A recent study by the Kenya Association of Pharmaceutical Industry reported that counterfeit drugs account for about $130 million (USD) in sales every year.
Bad reactions can have disastrous consequences for patients and consume huge portions of the health care budget. They are the cause of 10 percent of hospital admissions globally, according to the World Health Organization. Nationwide figures are not available for Kenya, but in 2015, the 1,800-bed Kenyatta National Hospital in Nairobi reported that about 10 percent of its patients had experienced adverse drug reactions.
Even if the bad reaction itself does not cause irreversible harm, it causes many to simply stop taking the medication. With an aggressive disease like HIV, stopping medicine in the middle of treatment can have deadly results.
These reactions are not inevitable consequences of taking medicine; overall, 60 percent of adverse drug reactions are preventable. And the bedrock of prevention is accurate data about the extent and nature of the problem.
Since 2003, Kenya has seen a huge increase in the availability of medicines, particularly ARVs, thanks to The Global Fund to Fight AIDS, TB, and Malaria and the US President’s Emergency Plan for AIDS Relief (PEPFAR), says Ndinda Kusu, deputy project director at MSH.
While the infusion of medicine saved hundreds of thousands of lives, it also revealed gaps in the country’s pharmaceutical system.
The problem was that “access had not been matched with a system to monitor the quality and the safety of these products in country,” Kusu says.
AIDS as Cataclysm and Catalyst
The free, steady, and effective HIV treatment that Faith has received was unimaginable in 1993, when nurse Alice Njoroge founded the EDARP Clinic, where Faith now goes for medical care. The clinic’s trajectory mirrors the evolution of Kenya’s response to AIDS.
At that time there was no HIV treatment available in Kenya; there were only antibiotics, antifungals, and painkillers to treat symptoms. Patients were feared and shunned. Njoroge said she was horrified to see what happened to patients—they were sent home to die, often abandoned by their families.
“The relatives were so scared. You would go into a home, find a patient who is very, very sick and uncared for,” she says. “Nobody would go near to feed them.”
With assistance from the Catholic Church, Njoroge founded EDARP to help families provide palliative care for their loved ones.
“We trained volunteers to give home-based care, to bathe those patients, to feed them, and to at least make sure the patients were comfortable so that, though we knew they would die, they would die in dignity,” Njoroge says.
Nearly 25 years later, the EDARP Clinic has evolved into a full-service HIV and AIDS treatment facility serving 25,000 adults and children.
By the end of 1999, about 2.1 million Kenyans were living with HIV, with 180,000 deaths that year. HIV medication was unavailable in Africa, but it was on the horizon.
In 2001, MSH was selected to take part in a USAID pilot study to determine what it would take to get the medicines distributed to Kenyans on a large scale, in huge volume, and at an unprecedented rate.
MSH proposed that existing laboratory and pharmacy systems serve as the basis for rapid start-up, be fixed where weaknesses appeared, and be improved as soon as possible.
The test run would take place in Mombasa, a coastal city with a population of about 500,000, approximately 300 miles from the capital of Nairobi. MSH began with a rapid assessment, working with three other international development organizations and local staff to understand the context and potential barriers. Together they established baseline measures, sized up the capacity of the system to manage the volume, and assessed existing pharmaceutical and laboratory services to see if they had the needed capacity.
MSH’s assessment revealed obstacles aplenty: only 13 percent of facilities had adequate storage and dispensing space, none had efficient information systems, and only 42 percent of health workers were trained to dispense ARVs. Paper-based pharmacy records didn’t provide enough information, jeopardizing patients’ ability to adhere to treatment. Staff training was inadequate and the number of health workers often was insufficient. Facilities were crowded, making confidential counseling impossible.
Pilots launched in 2002 at four sites in the city. Continual refinements improved staff abilities to manage supply, deliver treatment, and build skills. MSH created and introduced an electronic dispensing tool that eliminated cumbersome paper records, which was eventually enhanced to accurately monitor early warning signs of drug resistance.
Alice Njoroge, founder of the EDARP clinic, speaks about the impact that antiretrovirals have had on Kenya.
With resources from PEPFAR and the Global Fund in hand and successful pilots, the Mombasa clinics began officially distributing ARVs in 2003. It was the first such public program in the country, paving the way for nationwide roll-out. That year, only 6,000 people were receiving ARVs—five percent of those who needed them.
MSH worked hand-in-hand with the government to improve the system and with USAID to negotiate prices and procure ARVs, helping clinics train and retain staff, integrating ARV therapy into existing services, and creating dispensing booths with more privacy for patients. MSH created other tools, including a medication counseling checklist, pointers on the importance of treatment adherence, and information on potential drug interactions and side effects.
Njoroge’s clinic started offering ARVs in 2004. By 2006, they were made available for free in public hospitals. By 2013, the percentage of Kenyans receiving ARVs who needed them had risen to 80 percent.
“If there’s anything that has happened that was a real blessing to this country and [all of] Africa, it’s the availability of ARVs,” says Njoroge.
Adverse Drug Reactions
MSH and the Kenyan Ministry of Health soon learned that getting ARVs to patients was not enough. As more ARVs were distributed, more bad reactions to these ARVs were happening, and there was no system in place to report them.
“The ART program in Kenya started in 2003 and we were scaling up,” recalls MSH’s Kusu. “By 2006, 2007, 2008, we were already getting patients who were … experiencing adverse drug reactions. And the country did not have a national system to systematically monitor and document these undesired effects.”
“Medicines can be useful and they can be harmful. Any medicine is a potential poison.”
— Josphat Mbuva
Medicines “need to be monitored very closely,” says Mbuva of the Ministry of Health. “Medicines can be useful and they can be harmful. Any medicine is a potential poison.”
For Mbuva, a strong pharmaceutical system that monitors safety, effectiveness, and quality delivers the all-important outcome: “It translates to better service provision to the people.”
MSH and pharmacies began building the layers, slowly creating a system: a modernized set of regulations, public awareness campaigns, identification of willing participants among the country’s pharmacists, and training for medical professionals.
When the surveillance system was launched in 2009, it featured yellow and pink paper—yellow for adverse drug reactions and pink for poor quality medicines—filled out by hand. They were delivered to the pharmacovigilance office by courier.
Aiming to improve timeliness and cost and ensure sustainability, the Pharmacy and Poisons Board, assisted by MSH, worked with local software developers to build a program that would be easier to use. The Pharmacovigilance Electronic Reporting System, launched in 2013, uses a web portal that is accessible via computer or mobile device. The data links directly to the World Health Organization’s International Drug Monitoring Programme, which tracks early warning signs of trends in medicine quality and safety.
Three years later, reporting of adverse drug reactions and poor quality medicines in Kenya is 80 percent electronic. It is more cost-effective and prompt, and reporting is easier. And the system continuously is enhancing the database for future reference.
Fred Siyoi, deputy registrar at the Pharmacy and Poisons Board, explains Kenya's role as a "Center of Excellence" in pharmacovigilance.
Kenya’s advances in drug safety have been so significant that in 2014 the New Partnership for Africa’s Development, a 15-year-old African economic development program, awarded Kenya the distinction of being a Regional Center for Regulatory Excellence in Pharmacovigilance, positioning it as model in the region. Professionals from all over the world now come to Kenya to learn about the system that not only delivers the drugs, but ensures their safety, and increases the likelihood that people will stay on their medicines for as long as is needed.
The tools, standards, procedures, and training developed in Kenya have been passed along to 11 other countries: Cote D’Ivoire, Ethiopia, Haiti, Lesotho, Namibia, Rwanda, South Africa, Swaziland, Tanzania, Vietnam, and Zambia.
The interdependence of health care at the community, county and national levels will be the lifeblood of Kenya’s sweeping devolution process, which aims to replace a strong executive government concentrated in Nairobi with one that shifts power and resources closer to the communities and citizens. Launched by the new constitution in 2010 and officially underway in 2013, the initiative, which has built a new structure of county government, is one of “the most rapid and ambitious devolution processes going on in the world,” according to the World Bank.
Its impact on health is potentially momentous. Many needs are unmet among marginalized or rural populations who are not represented in the data or decisions of a highly centralized government. With more resources in the counties, advocates of devolution believe, local health care needs will drive decisions and resource allocation.
They say the same promise holds for the nation’s pharmacovigilance system. When all of the country’s pharmacies and citizens are participating, the benefits Faith experienced will be possible to all Kenyans, no matter where they live.
“I am much better now,” says Faith. “Before, I was so weak and down with no hope. But now, I hope to live more than 50 years.”
She smiles as she thinks about her children, now 18 and 13. She now has a new goal.
“I hope to live and see my grandchildren.”