Tuesday, December 20, 2016

United States Public Health Service Capt. Valerie Jensen, ’90 BSPh, leads efforts to prevent and address
drug shortages through the U.S. Food and Drug Administration (FDA).

Jensen, a Cedar Rapids native, has been with the FDA since 1999 and became the associate director of the agency’s Drug Shortage Program in 2007. The program works to address drug shortages and prevent new ones.

What causes drug shortages?

Shortages can happen for many reasons, including manufacturing and quality problems, delays, and discontinuations. Vital shortages already existed when Jensen started at the FDA, but in 2011-2012, the number of drugs in short supply skyrocketed to a crisis level. “That is when there were several problems all at once with many of the larger manufacturers of older generic injectable or IV drugs. They had gone along needing to make upgrades for a long time, but didn’t, and their facilities were falling apart. There were also quality issues,” Jensen explained.

The main types of badly-needed medications in shortage have involved cancer drugs, anesthetics used for patients undergoing surgery, IV nutrition for premature babies, IV saline, and others.

“Taking IV saline as an example, pretty much every patient in the hospital uses it, and we had a severe shortage,” Jensen said. “It seems silly to run out of saltwater, but during the manufacturing of any injectable drug, so many things can go wrong from start to finish. The environment and tools need to be sterile and mixed to exactly the right percentage. There can’t be any contaminants such as bacteria, fungus, or particulate matter.”

The FDA works closely with drug makers to keep vital medications in circulation. “But we don’t manufacture the drugs and can’t tell a firm how much of a drug to make or which drugs to make,” Jensen noted. “Ultimately it’s their decision whether to make drug or not.”

Some issues can take manufacturers a long time to correct. The FDA offers assistance when there are quality issues causing shortages and expedites review of anything a manufacturer needs to help increase production, such as adding a new manufacturing site or raw material supplier. The agency also notifies other manufacturers when a critical shortage is on the way to see if they are able to help prevent the shortage.

In 2012, Congress passed a new law requiring companies to tell the FDA if they foresee supply disruptions in their future. This has helped. “We needed advance notice, and this legislation has allowed us to take action early on and prevent shortages in many cases,” Jensen said.

“Multiple times in the past two years, we’ve had critical drug shortages. Manufacturers might not have the resources to ramp up production or may be at capacity. Many shortage drugs are older generics, and may not be moneymakers.”

We’re still seeing critical shortages but now there are fewer. We’re not out of the woods yet.”

When supplies would not have been available any other way, the FDA has approached in manufacturers Europe, Canada, Australia, and other countries to temporarily import their drug products. “It is not an easy fix for every drug, because there are differences in formulation and labeling, and we need to carefully evaluate these to ensure patients aren’t at risk. But it’s been a lifesaver when we need supplies to be available and we don’t have any other options,” said Jensen. “We’re still seeing critical shortages but now there are fewer. We’re not out of the woods yet,” she added.

A chance encounter

Jensen’s career path may have been something else entirely if she hadn’t volunteered to write for the University of Iowa yearbook her freshman year at the University of Iowa. An open major, she was assigned to interview Charles F. Barfknecht, a College of Pharmacy professor in what was then the Division of Medicinal Chemistry. Jensen was inspired by him and his work developing glaucoma and dry eye syndrome treatments.

She joined the college and her new mentor’s laboratory, where she was the only undergraduate student. She worked under a graduate student helping synthesize compounds. “Dr. Barfknecht encouraged his students to pursue challenging career paths that could make a difference in people’s lives,” Jensen said.

As a third-year student, Jensen studied abroad at the University of Queensland in Brisbane, Queensland, Australia. The following summer, she interned with Novartis in Summit, N.J., to learn more about the pharmaceutical industry.

After graduation, Jensen completed a PGY1 American Society of Health System Pharmacists Specialized Residency in Ambulatory Care in Whiteriver, Ariz., through the Indian Health Service (IHS). The IHS is within the Department of Health and Human Services (HHS) and provides federal health services to American Indians and Alaska Natives.

Jensen worked at hospital and ambulatory care sites providing comprehensive direct patient care as a member of a health care team, a newer concept at the time. In ambulatory care, a team of pharmacists worked under an internal medicine doctor to manage patients’ medications in anticoagulation, hypertension, diabetes and other clinics.

It was then that she joined the federal uniformed service of the U.S. Public Health Service (PHS) – one of the seven
uniformed services of the United States – as a Commissioned Corps officer. The PHS Corps is an elite team of 6,500 highly-qualified health professionals.

Service defines Jensen's career

When Jensen’s residency was over, she continued to work as a clinical pharmacist for Indian Health Service for eight more years in Arizona and New Mexico.

It was a privilege to be able to learn more about the traditions and culture as well as being able to provide excellent care for patients.”

“I worked on an Apache reservation first, then Hopi and then Navajo,” said Jensen. “All three tribes have their own ceremonies and customs and it was a privilege to be able to learn more about the traditions and culture as well as being able to provide excellent care for patients.”

By the time Jensen transferred to the FDA in 1999, she had experienced her fair share of shortages working for the Indian Health Service. “I knew the impact on patients and on the health care team. It was not ideal to need workarounds and alternative treatments in place of the drugs in shortage.”

“This is a challenging and sometimes heartbreaking job to be in at times,” said Jensen. “A shortage of a patient’s medicine can be a frightening prospect, especially if the medicine is critical to their health and there are no alternatives available. However, the knowledge that we are able to help people get the treatments they deserve is greatly rewarding.”

“She was very instrumental in the early development of the Drug Shortage Program,” said fellow Commissioned Corps Capt. Jouhayna Saliba, PharmD, a drug shortage staff member who has known Jensen for 15 years. “The program now has grown into a staff of 13 dedicated public servants and it is as a result of Captain Jensen’s outstanding leadership skills. She has been a wonderful mentor and great friend and leader. She has never lost sight of the agency’s mission.”

In addition to managing national drug shortages, Jensen’s role involves representing the FDA in national media, as well as testifying in front of Congress and speaking in front of stakeholder groups.

“It was an honor to have a rotation with such an impactful and effective leader who is just as humble,” said Sangeeta Tandon, ’11 PharmD, of the Johns Hopkins Hospital Department of Pharmacy. “You would never know she’s had spotlight interviews on CNN and other major news companies. I don’t think that it’s any coincidence that drug shortages have improved significantly while she has been serving as a leader in the drug shortages group.”

Jensen is a preceptor for College of Pharmacy students during their fourth-year Advanced Pharmacy Practice Experiences rotations. Jensen and her husband, Bob Pratt, live in Germantown, Md., and are both FDA pharmacists. They have two grown sons.