Bero heads new WHO center studying, promoting global access to vital drugs

The office of Lisa Bero, PhD, on UCSF’s Laurel Heights campus has long been a key portal between the School of Pharmacy and the world at large, including countries where billions of people cannot get even the most vital life-saving drugs.

Now that portal has grown in significance with the September 2011 designation of Bero as director of the World Health Organization (WHO) Collaborating Center for Pharmaceutical Research and Science Policy. The new center will be based in the Department of Clinical Pharmacy where Bero is a faculty member and vice chair for research.

The center seeks to combine high-quality academic research with WHO’s political clout to remove roadblocks that prevent people in lower income countries from receiving the most crucial and effective medications.

“This center is focused on the WHO agenda around essential medicines—promoting access and use—and clinical practice guidelines development,” says Bero. “There is no other center doing that.”

The Essential Medicines List (EML) is a model formulary of the most safe and cost-effective medications for addressing public health needs, ranging from malaria to cancer and from infections to psychoses. It currently includes more than 350 drugs.

The center builds on Bero’s more than two decades of involvement with the WHO’s Department of Essential Medicines and Pharmaceutical Policy. She has been a member of WHO expert committee that selects and biennially updates the list since 2005 and is currently chair.

Meant to be adapted to local needs and budgets, the EML serves as both a spur to national formulary building and a political lever in negotiations between poorer nations and drug makers.

Making a model into a reality

But Bero notes that even when countries adopt EMLs “there are still problems with actually getting the medicines into the hands of the people who need them.”

“Getting the essential medicines list actually used in a country, meeting the supply needs and having appropriate use at the point of the patient. That’s the goal.”

The implementation of policies to overcome obstacles of availability, pricing, regulation, distribution, and appropriate use came to the fore during Bero’s 2009 sabbatical working at WHO headquarters in Geneva, Switzerland and prompted her application for collaborating center status.

Operating much as she will under the new center’s auspices, Bero focused on implementing the Children’s Essential Medicines List. This involved research on methods for conducting trials in children. It also involved advocacy—ranging from holding press conferences in Ghana to rally public support for inclusion of those child medicines in that country’s national health insurance to working with pediatricians in India to encourage appropriate use of the drugs.

Forging ahead, detailing bottlenecks

During the two-year wait for formal approval, Bero along with WHO and UCSF colleagues and student pharmacists forged ahead with studies of essential medicine bottlenecks—including studies of the availability and pricing of key drugs for preventing mortality of children under age five in Guatemala and of 60 “super-essential tracer medicines” in Haiti.

One published study that Bero co-authored with Geneva-based WHO researchers identified Zambia’s barriers to the availability and use of magnesium sulfate. The drug is an essential treatment for eclampsia seizures that are a major cause of women dying during childbirth worldwide. (The core issues were a lack of procurement by the public health system and limited demand due to a lack of training in the medication’s use.)

The latter study took an especially systematic approach, applying a fishbone-shaped process management diagram (developed to trace interacting variables causing quality defects in industry) to detail the myriad steps—including regulations, procedures, diagnostic tools, drug supplies, training and staffing—needed bring a life-saving drug into routine and appropriate use.

A fishbone (or Ishikawa) diagram can be used to assess factors facilitating or obstructing an essential medicine’s availability and use. This chart was used to identify those factors for magnesium sulfate (MgSO4) injections to treat severe pre-eclampsia and eclampsia in Zambia. (Source: Ridge AL, Bero LA, Hill SR. BMC Health Services Research 2010 10:340)

“WHO gets bombarded with people lobbying them, telling anecdotal stories, but they want to know, ‘OK, what is really happening with this drug in this place.’ The center’s research will be doing this kind of data gathering.”

What’s next if an essential medicine isn’t available? Bero ticks off key questions: “Is it on the country’s essential medicine list? Do they actually procure it? Do they have a regulatory authority that would approve it? (WHO has a program that pre-certifies regulators in low-resource settings.) Do they have local manufacturing or, if not, can they get a supply elsewhere?”

Finding solutions, applying WHO’s clout

Ultimately, studies suggest corrective policies: “Basically I see our role as telling WHO, ‘If you did this it could solve the problem,’” says Bero. “And they have some of the clout—working with governments and NGOs—to actually do that.”

While academics may not have direct leverage, Bero notes they can play a key and familiar role by documenting model cases and best practices, then publishing their findings both in peer-reviewed journals and as how-to guides for lower income countries.

“The EML is a model list, but WHO also likes to provide model processes,” she says. “We are producing a manual on how to set up a national essential medicines committee: What kind of people do you need? How many? What kind of training do they need? How do you manage their conflicts of interest?”

“We’ll also be helping WHO develop global standards for evidence-based clinical practice guidelines—covering a whole condition, including prevention and treatment—that can be adapted for local conditions.”

Under the new center’s rubric, Bero hopes to collaborate not just with the WHO but with fellow UCSF faculty working on global health, pharmaceutical policy, drug formulations for low-resource settings, and evidence-based clinical practice guidelines.