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Case Studies for Global Health Building relationships. Sharing knowledge. ® www.casestudiesforglobalhealth.org Alliance for Case Studies for Global Health

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Page 1: Case Studies for Global Health

Case Studies for Global HealthBuilding relationships. Sharing knowledge.

®

www.casestudiesforglobalhealth.org

Alliance for Case Studies for Global Health

Page 2: Case Studies for Global Health

www.casestudiesforglobalhealth.org

Lessons Learned:Design your health program in response to a •locally identified need.An influential in-country champion will be an •asset to your program.A chronic disease program must have a strong •monitoring component. Make sure you are cognizant of the resource •constraints of participating organizations. Build capacity to ensure your program’s •sustainability.

Saving Uzbek Hearts: A Program for Best Practices in Controlling Hyperlipidemia

30 Case Studies for Global Health(As of October 2009)

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www.casestudiesforglobalhealth.org 31Case Studies for Global Health

To say cardiovascular disease is a problem in Uzbekistan would be something of an understatement. It is, in fact, epidemic. According to the World Health Organization (WHO), more than 56 percent of all deaths in the former Soviet central Asian republic are caused by this silent yet efficient killer. Many of them are premature, the likely consequence of multiple risk factors, such as heredity, tobacco use, physical inactivity, and untreated hypertension and high blood cholesterol. It has long been clear to many Uzbek physicians that preventive interventions are urgently needed to diffuse what is clearly a ballooning health care crisis.

In 2006, Alexander Shek, the chief cardiologist at the Republic Cardiology Center in Tashkent, met with AmeriCares and Soglom

Avlod Uchun Foundation, two organizations that were working closely with the hospital on a variety of projects. AmeriCares is a U.S.-based humanitarian aid organization that specializes in medical commodity assistance, and Soglom is an Uzbek nongovernmental organization focused on health care. He asked if AmeriCares could help him address the widespread problem of hyperlipidemia (high cholesterol) in Uzbekistan as part of its aid efforts in the country. In particular, Shek wondered whether it could regularly donate the cholesterol-lowering drugs known as statins to cardiology centers to help physicians treat hyperlipidemic patients.

A series of conversations about program design and implementation culminated in June 2007 with the launch of the Central Asian Cardiovascular Disease Initiative (CACDI). To help fulfill the request for hyperlipidemia treatments for

A nurse records disbursement of simvasta-tin at the Cardiology Center in Navoi.

Photo by Jim O’Brien

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indigent patients, AmeriCares reached out to Merck & Co. and Merck/Schering-Plough Pharmaceuticals, which agreed to donate the drugs, Zocor, Vytorin and Zetia. “Our program had three primary goals,” says Ella Gudwin, director of global partnership development at AmeriCares. “One was the treatment of patients who lacked the means to pay for treatment. Another was to develop the expertise among physicians in the treatment and monitoring of cardiovascular diseases. And the third point of emphasis was patient and family education.”

The fulfillment of the last two objectives, it was hoped, would give CACDI an impact that reached beyond its small scale. Owing to the cost and spotty availability of statins in Uzbekistan, relatively few physicians had developed a working knowledge in the use of pharmaceutical agents for hyperlipidemia treatment. That, however, was slated to change. Three major cholesterol control drugs — Merck’s Zocor (simvastatin) and Mevacor (lovastatin), and Bristol-Myers Squibb’s Pravachol (pravastatin) — went off patent in 2006, and their prices had begun to drop. In 2007 the WHO put simvastatin on its Model List of Essential Medicines, which many ministries of health use as a guiding document for filling national formularies.

Setting UpCACDI is built around statin therapies, which are regarded as generally safe and effective medicines. Patients in the program are treated with simvastatin, ezetimibe — a drug that lowers cholesterol by a different mechanism of action than do the statins — or a combination of the two. Roughly 420 patients are enrolled in the initiative at any given time. They are treated by heart specialists at one of seven medical centers across Uzbekistan, though most visit the Republic Cardiology Centre in Tashkent. Enrollment is not randomized. Indeed, it has been engineered to bias the outcome positively. To be selected for the program, hyperlipidemic patients must be of sufficiently modest means to find treatment financially challenging. But, just as importantly, they must demonstrate that they and their spouses or other family members are committed to their participation. This is because the program requires lifestyle and diet changes in which family are likely to play a leading role (women, for instance, cook the meals in most traditional Uzbek households).

A nurse takes blood pressure and pulse during patient visit.

Photo by Jim O’Brien

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As a component of program monitoring, physicians must report total cholesterol levels. “We wanted the total cholesterol measurement to be used as reliable proxy for therapeutic responses to the antilipidemic therapy,” Gudwin explains. In line with best practices, physicians also take measurements of the LDL cholesterol (“bad” cholesterol) HDL cholesterol (“good” cholesterol) and triglyceride levels of patients. But these measures are only used by the physicians to monitor patients and inform them of their progress. They are not reported to the pharmaceutical donors.

Patient monitoring for safety is important to each of the donors, Merck & Co. and Merck/Schering-Plough Pharmaceuticals, which together have provided more than $8.7 million worth of medicines since mid-2007. AmeriCares manages the overall program and the supply of donated drugs, whose importation and distribution are handled within Uzbekistan by Soglom. The Republic Cardiology Center oversees the operational details of the initiative and reports patient stories and overall progress back to AmeriCares. The program also enjoys strong support from the Ministry of Health, which covers the cost of critically important laboratory tests for patient safety and monitoring. “The Ministry of Health’s contribution of resources, in terms of funding testing, creates more equality in the partnership,” says Gudwin. “But, more importantly, it creates a stronger trajectory with regard to the long-term sustainability of the best practices we’re trying to encourage through this program.” Beyond that, says Terry Conroy, the pharmacist in AmeriCares’ medical unit, the ministry’s endorsement of the program has added to its credibility. “They have validated the program,” she says, “especially for the patients.”

Outcomes and AdjustmentsThough small as such programs go, CACDI seems to be having an impact. Between June 2007 and December 2008 it reached 642 patients, making them aware of their blood lipid levels, the need to keep cholesterol under control and the lifestyle changes essential to that end. Further, the 177 patients who had participated in the program for at least 12 months as of August 2008 saw their total serum cholesterol levels decline by an average of about 20 percent. The cardiologists treating them, meanwhile, have been trained to be focal points for the dispersal of best practices in statin pharmacotherapy for the management of hyperlipidemia. Since one of CACDI’s aims is to create centers of excellence in treating cardiovascular diseases across the country — thereby amplifying the program’s effect — it has stressed physician education. Before its official launch, the Republic Cardiology Center, a teaching hospital, hosted a training session for specialists from several regional cardiology centers that were interested in participating. The training was primarily intended to update the cardiologists on current best practices for the treatment of heart disease. At least 45 physicians have so far benefited from

the training and the opportunity to improve their qualifications, maintain high standards in patient care and follow-up, and to mitigate cardiovascular complications, such as heart attack and stroke, in their patients.

After the program started, some practices of care had to be modified, within medically acceptable limits, for the sake of affordability. Laboratory tests, especially, posed a problem. Two types of tests are essential: those used to help monitor the effectiveness of treatment and those used to identify potential serious adverse events. One of the tests — the creatine kinase (CK) assay, originally recommended as a way to monitor patients for the muscle damage occasionally associated with statin use — proved too expensive. Indeed, one hospital dropped out of the program because it could not afford the test. So the program designers chose not to require repeated CK screening. Instead, Conroy says, physicians seek to detect such problems early via clinical assessment of muscle pain. (Only those who report muscle pain during examinations need to be further tested.) If they wish to do the CK test, of course, they can, and several do establish a baseline CK reading for patients against which to compare future assays. They are just not required to report these measurements to participate in the initiative.

Reviewing patient records at the Republic Cardiology Center.

Photo by Jim O’Brien

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All physicians in the program do, however, take baseline readings of total cholesterol level and liver function, which is a means of tracking effectiveness and drug toxicity. Patients are given these tests at intervals, beginning at six to 12 weeks, and then at six months and 12 months after starting drug therapy. They are thereafter tested twice a year. The tests are not just important for monitoring the effectiveness of the treatments, says Conroy. They also demonstrate that the physicians are keeping an eye on their patients’ safety and making fact-based decisions about their therapy. Most importantly, the cholesterol test results can have a powerfully positive influence on patients. The measurements are often the only tangible signal of progress they get for their efforts. “Patients don’t feel their cholesterol level,” says Conroy, “so the disease can progress silently. This test gives it a microphone.” Watching their blood cholesterol levels slide down the chart is, Conroy notes, a powerful motivator. It helps to keep patients on the diet and exercise regimen prescribed by their physicians.

The small scope and simplicity of the program, both in terms of the testing and the enrollment, are also a plus, Gudwin and Conroy say. These aspects, they say, enhance the continuity of treatment and monitoring of patients. They do not necessarily limit the impact of the program either, they explain. Their hope is that participating institutions, dispersed as they are across the country, will act like foci from which the knowledge transferred by the program will radiate throughout the medical community.

Sustaining the EffortFrom the donor’s perspective, says Christine Funk, associate manager of Merck’s Global Health Partnerships, it is reassuring to work with an organization that has tight oversight and management procedures. AmeriCares, she says, has strong mechanisms in place to ensure that the drugs they send to recipient countries go where they’re meant to and are not diverted into the gray market. Similarly, its management at the pharmacy level is exemplary, says Funk. This eases donor concerns about expired products remaining on shelves. “We

Checking the stock of Merck-donated medicines at the Jizzak Cardiac Center.

Photo by Jim O’Brien

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require partners to tell us if anything goes wrong,” says Funk, “and AmeriCares hasn’t had to yet.”

Though Funk gives CACDI high marks, she does wonder how long a program of this sort should continue. Prices for generic statins have dropped by as much as 50 percent from the time they were initially introduced to global markets. “Generic simvastatin is available in Uzbekistan,” notes Funk. “It’s on the WHO Essential Medicines List, and the price is trending downward, though it is still expensive for poor people. But we, as donors, don’t want a forever and ever, open-ended commitment because, then, how do you get stability and sustainability within the country itself? Eventually, you want the health system to supply these needs for its patients. So [the question is] with the trend going in a positive

direction — how much longer do we maintain the donation program?”

The ministry’s support for the program is, in this context, particularly encouraging. It did, after all, underwrite the laboratory tests required by the program protocols. It recognizes that cardiovascular disease is a serious problem in Uzbekistan. And if AmeriCares has accomplished even half of what it hoped to do, a cadre of cardiologists is now well-prepared and primed to spread the word about best practices in the management of hyperlipidemia in Uzbekistan.

By Unmesh Kher

A patient prepares to have his blood drawn for routine lab tests.

Photo by Jim O’Brien