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UNM College of Pharmacy from Bench to Bedside

Faculty in the College of Pharmacy’s Department of Pharmacy Practice and Administrative Science and PEPPOR, its graduate program in Pharmacoeconomics, Epidemiology, Pharmaceutical Policy and Outcomes Research, are making medicines safer by tracking severe adverse outcomes, analyzing how drug interventions can better reach the populations whose lives they intend to save, working toward earlier interventions for children exposed to drugs and alcohol in utero, carving away at health disparities in minority populations ­– even finding better ways for smokers to kick their habit.

As participants in UNM’s Clinical & Translational Science Center, one of 62 National Institutes of Health-supported research centers in the country, the college’s “bench to bedside” efforts are part of a commitment to translate basic science into better drugs, better health care practices and better public health policies.

Pharmacy Practice faculty translate science to better outcomes

Ludmila BakhirevaLudmila Bakhireva and her colleagues studying substance abuse find research questions everywhere they look around New Mexico. The state’s drug overdose death rate has been one of the highest in the nation for decades, and deaths due to opioid pain relievers have increased dramatically. New Mexico had also led the country in alcohol-related deaths for years.

“Substance abuse is such a big public health problem here,” says Bakhireva, an associate professor of pharmacy, family medicine, epidemiology and biostatistics.

Research into the use of naloxone to prevent opioid overdose deaths and on the effects of the use of opioids and alcohol during pregnancy on child development have kept Bakhireva’s plate full. Along with substance abuse research by some of her colleagues, the College of Pharmacy has carved out an important niche.

“It’s really one of our areas of excellence,” Bakhireva says.

Bakhireva is a member of the faculty in the College of Pharmacy’s Department of Pharmacy Practice and Administrative Science and PEPPOR – its graduate program in Pharmacoeconomics, Epidemiology, Pharmaceutical Policy and Outcomes Research.

While she concentrates on analyzing how drug interventions can better reach the populations whose lives they intend to save and working toward earlier interventions for children exposed to drugs and alcohol in utero, other colleagues are making medicines safer by tracking severe adverse outcomes, carving away at health disparities in minority populations ­– even finding better ways for smokers to kick their habit.

As participants in UNM’s Clinical & Translational Science Center, one of 62 National Institutes of Health-supported research centers in the country, the college’s “bench to bedside” efforts are part of a commitment to translate basic science into better drugs, better health care practices and better public health policies.

  A prime goal of Bakhireva’s research is to identify children exposed to drugs and alcohol in utero and to better understand the early cognitive effects of their exposure.

Working with UNM’s Milagro Program, which offers care to pregnant women with substance abuse issues, Bakhireva follows expectant mothers from their first prenatal care visit through pregnancy, delivery and the baby’s first 20 months. She is also leading an effort to systematically and objectively evaluate the prevalence of prenatal alcohol exposure in community-based settings.

While fetal alcohol spectrum disorder and other neurological deficits related to in utero alcohol and opioid exposure are often diagnosed when a child enters school, Bakhireva hopes her research will lead to identifying affected children earlier in life so they can benefit from early interventions.

 “One of our goals,” she says, “is to help children achieve the best possible outcomes.”

Bakhireva has expanded her inquiry to a 120 children in the ENRICH (Ethanol, Neurodevelopment, Infant and Child Health) birth cohort. The study follows the children from birth to 20 months, and compares children of mothers who used opioids and alcohol during pregnancy to mothers who only used opioids and to mothers who did neither.

Bakhireva gives the children a battery of neurodevelopmental tests and, working with the Mind Research Institute, performs brain scans to evaluate early neurocognitive deficits and atypical brain development.

Her research also focuses on why some infants born to drug-using mothers have severe withdrawal symptoms that last weeks while others normalize in a couple of days.

Bakhireva is also taking advantage of the unique ability of pharmacists in New Mexico to prescribe naloxone to study the population receiving the overdose-reversing drug. She and colleague Amy Bachyrycz are working with the New Mexico Pharmacists Association to study community pharmacists’ attitudes toward prescribing the drug and developing a database that will show which kinds of drug users in New Mexico are receiving naloxone prescriptions.

“Is it repeated use of opioids or high dose of opioids? Is it used in concurrence with other drugs? Who do we think is the prime population?” The answers to those questions might reveal overlooked populations – for example, longtime users of prescription opioids – who might benefit from having naloxone in the medicine cabinet just in case.

 “We are really pioneering this line of research in the nation,” Bakhireva says.

If Drug A is less expensive than Drug B, it must be a better deal for the health care system, right? But if Drug B is more expensive than Drug A, mustn’t it work better? And what about neither drug at all? Just sound lifestyle advice from the family doctor or neighborhood pharmacist?

Matthew Borrego’s field of pharmacoeconomics uses clinical trials data and computer modeling to assess the economic efficacy of various drugs, medical devices and interventions.

“Medications, medical devices and medical interventions cost a lot,” says Borrego, an associate professor in the Department of Pharmacy Practice and Administrative Sciences. “We try to see where we’re getting the best bang for the buck. Not necessarily the cheapest drug or intervention, but the most cost effective.”

Other faculty members in the department and in PEPPOR, its graduate program in Pharmacoeconomics, Epidemiology, Pharmaceutical Policy and Outcomes Research, are making medicines safer by tracking severe adverse outcomes, analyzing how drug interventions can better reach the populations whose lives they intend to save, working toward earlier interventions for children exposed to drugs and alcohol in utero – even finding better ways for smokers to kick their habit.

As participants in UNM’s Clinical & Translational Science Center, one of 62 National Institutes of Health-supported research centers in the country, the college’s “bench to bedside” efforts are part of a commitment to translate basic science into better drugs, better health care practices and better public health policies.

Borrego’s field of pharmacoeconomics is only a couple of decades old and it is getting increased attention in light of the federal Affordable Care Act, which expands public and private insurance coverage, and tries to provide cost-effective health care delivery.

Borrego and graduate students compare the costs of certain drugs or interventions and then use the “event rate” data from clinical trials or the published literature  – how often the patients developed an adverse reaction, were hospitalized or required some other medical intervention – and plug that information into models to determine the actual cost to health care systems and the most cost-effective treatment alternative.

“We’re not in the drug discovery stage or even the bedside stage,” Borrego says. “Our work is at the very end of the translational scale. Our audience is policy makers.”

His recent study published in the journal Nephrology examined the relationship between “health literacy” and kidney function among people with stage 1-4 chronic kidney disease. Those who had greater understanding of preventive behaviors and health care providers’ recommendations had healthier kidneys. The next step of the study will look at what changes in prescription instructions or pharmacists’ and doctors’ advice might have the greatest effect on patient outcomes.

Borrego, who grew up in the village of Santa Cruz outside Española, is also interested in disparities in health outcomes between Hispanics and Native Americans and non-Hispanic whites and between lower income and higher income people.

Borrego and his graduate student, Akshay Kharat, just published the results of a large study of the disparities in treatment of asthma. Using a large national database, they looked at Hispanic and non-Hispanic white populations to determine who is being prescribed and getting access to recommended inhaled corticosteroid medications.

Among children, Borrego found no difference between the ethnic groups. Among adults the difference was significant. Twenty-one percent of Hispanic adults were prescribed corticosteroids, compared with 41 percent of non-Hispanic whites. Patients over 65 had a 2.5 greater chance of receiving an inhaled corticosteroid compared to those under 65.

Borrego believes the lack of difference among children and the elderly is because both groups have access to medical insurance while the adult populations (the study relied on pre-Affordable Health Act data from 2009) reflected disparities in health insurance coverage as well as differences in cultural beliefs and quality of care delivery.

Because the long-term health outcomes are better among asthma sufferers who use inhaled corticosteroids, Borrego believes narrowing that prescription gap between Hispanics and non-Hispanic whites could improve and save lives as well as save money for the health care system.

“You pay me now or you pay me later,” Borrego says. “They’re going to be landing up in the emergency room or worse.”

Anja HamidovicAjna Hamidovic’s application for funding from the National Institutes of Health was a little unusual, mainly because it included a budget for boxes and boxes of Girl Scout cookies.

But Hamidovic, an assistant professor in Pharmacy and Psychiatry, won the grant and is now in the early stages of a Phase II clinical trial for development of a novel therapeutic agent for smoking cessation.

Her working hypothesis?

“From the data we have available, it looks like abstinent smokers substitute one addiction for another,” Hamidovic says. “They eat and get Type II diabetes at an alarming rate. We are testing a pharmacological treatment – intranasal insulin – in hopes that, if successful, it would double its impact on public health. Not only would it reduce the incidence of Type II diabetes in abstinent smokers, but the therapy also holds the potential to increase abstinence rates because many smokers refuse to quit due to fear of gaining weight.”

People who quit smoking often gain weight­ – 5 to 10 pounds – with a sizeable portion of smoking abstainers gaining more than 15 pounds. “It’s a little-known fact,” she says. “And it’s a big problem.”

While Hamidovic concentrates on finding better ways for smokers to kick their habit, other faculty in the College of Pharmacy’s Department of Pharmacy Practice and Administrative Science and PEPPOR, its graduate program in Pharmacoeconomics, Epidemiology, Pharmaceutical Policy and Outcomes Research, are making medicines safer by tracking severe adverse outcomes, analyzing how drug interventions can better reach the populations whose lives they intend to save, working toward earlier interventions for children exposed to drugs and alcohol in utero and carving away at health disparities in minority populations.

As participants in UNM’s Clinical & Translational Science Center, one of 62 National Institutes of Health-supported research centers in the country, the college’s “bench to bedside” efforts are part of a commitment to translate basic science into better drugs, better health care practices and better public health policies.

Hamidovic was doing post-doctoral research at Northwestern University, analyzing large genetic data sets from longitudinal health studies, when she came across the link between smoking persistence and physiological levels of insulin. Hamidovic received FDA permission to use intranasal insulin – insulin that bypasses the bloodstream and is delivered directly to the brain.

“I am looking at whether a dose of this treatment is going to help curb unhealthy eating behavior,” Hamidovic says. “Simplified, when we sense there is a lot of insulin, that is one mechanism to stop eating. We feel full.”

Hamidovic recruits heavy smokers ­­– those who smoke at least 10 cigarettes a day – and puts them in the hospital for two days to study what happens to their appetite, food snacking, physiological ability to process a fatty meal, cravings, memory and mental focus as soon as they stop using nicotine. She repeats the same tests after a dose of the nasal insulin.

 “People don’t continue to abstain,” Hamidovic says, “because they don’t feel sharp. Higher insulin levels in the brain resulting from this treatment are likely to help with that.”

And those Girl Scout cookies?

Hamidovic has just started a study that puts her cold-turkey subjects in a room with three plates heaped with tempting cookies – Caramel DeLites, Shortbread and Peanut Butter Patties. Under the guise of asking them to rate the cookies on taste and texture, she tells them they can eat as much or as little as they like. The experiment is performed with an insulin dose and a placebo dose. She is testing whether the insulin will interfere with their eating behavior to regulate satiety and reduce caloric intake.

Hamidovic, who just lost a family member to lung cancer, hopes her work in the lab and the clinic could be a key to helping encourage people to quit smoking, continue their abstinence longer and be healthier ex-smokers.

The need is there: the FDA has approved three smoking cessation treatments – nicotine replacement, Chantix and Wellbutrin. “None of those,” Hamidovic says. “Helps with reducing weight gain.”

Dennis Raisch“Researchers do a lot of work in our silos, but it never really ends up in practice,” says Dennis Raisch, a professor in the Department of Pharmacy Practice and Administrative Sciences and chair of PEPPOR. “Our focus here is completely on patients by helping research findings become health care practice.”

Raisch’s personal interest is in studying serious, rare adverse reactions that occur in cancer treatments and other drugs.

Because of their relatively small patient cohorts, pre-market clinical trials of drugs turn up adverse reactions that occur in maybe one of a thousand cases. But other serious reactions are more rare, maybe occurring in one in 10,000 or 20,000 cases or more. Once a drug is out on the market and being used by more patients, those more rare adverse reactions can cause real harm to patients.

“We try to be one of the first groups that identify these reactions and increase awareness of those reactions to the physicians that are involved,” Raisch says.

But, how to identify and quantify those reactions beyond anecdotal reports?

Raisch works with a couple dozen other researchers across the country to use the FDA’s MedWatch database of adverse reactions to find patterns. The database includes millions of drug reactions reported by patients, physicians and other health care providers.

If physicians have noticed some cases of liver failure in patients using a particular drug, for example, Raisch might search the entire database for reports of liver failure and calculate the ratio of those reactions for the drug compared to other drugs. By limiting the search to only patients receiving the targeted drug, he can determine if there is a disproportionately high rate of liver failure associated with the drug.

His findings can result in a “Dear Doctor” letter being sent out to alert physicians and other health care providers of an unexpected negative reaction to a certain drug, a revision to the package insert or a boxed warning on a medication of a serious side effect.

In certain rare cases, the FDA could decide to pull a drug from the market. “We look at ourselves as an early warning system,” Raisch says. “I find it very rewarding.”

Raisch is also interested in pharmacoeconomics, especially exploring the intersection of drug efficacy, economics and quality of life in cancer treatments.

“Some of the new cancer therapies can extend your life for a few months. And during those few months where your life is extended, you probably have really low quality of life because you’re taking a drug with a lot of side effects. So,” Raisch asks, “is it worth it?

“That’s sort of my future interest,” he says. “How best to communicate to patients what their potential benefits might be versus their potential risks. To help them be more involved in decision-making.”