A Day in the Life of a Drug Utilization Review Pharmacist

My Wednesday morning routine as a drug utilization pharmacist in a managed care pharmacy started with a review of a weekly enforcement report in my inbox from the FDA.

I would review the list for drug recalls and stratify them by class. Per National Committee for Quality Assurance guidelines, we were required to notify patients according to the relative hazard risk (class I, II, or III), as well as their physicians or pharmacists within a specified number of days. This aspect of my job brought me great satisfaction because I felt I was making interventions for our patients that kept them safe.

For instance, there were recalls of a lower strength formulation of an antipsychotic medication that was found in a bottle labeled for a higher strength. The only way to differentiate whether the dose was incorrect was to have the patient or pharmacist look closely at the tablet and read the inscription on it because the high- and low-strength tablets were approximately the same size, color, and shape.

Because of the seriousness of this error, once we identified patients who may possibly have had the affected lots on the recall, we called and asked them to look at their tablets and read the inscription to us. The result was that we were able to identify several patients who had been taking half their doses for several months and didn’t realize why they weren’t feeling well.

We followed up with the physician and pharmacy and facilitated filling the correct dose for the patients. Had we not identified the error, the patients would have gone back to their physicians. Negative consequences could have included:

• Deciding that the medication wasn’t working for them and switching to an entirely different treatment.
• Worse, an increase of the incorrect current dose leading to a titration that could cause more severe adverse effects (AEs).

This example is among the types of recalls that would come through the enforcement report, and it was prevalent to find many recalls for an entirely different medication in a bottle labeled for another drug. These were particularly frightening because a patient needing a blood pressure medication could inadvertently receive an antidepressant.

The consequences of this substitution—if not caught and fixed—would be harmful because the patient wouldn’t be treated for their hypertension but would subsequently be exposed to treatment for a disease or condition that they may not have had. The result was that they would unnecessarily endure AEs that correspond to that medication.

Enforcement Report

The weekly enforcement report provides information on the affected drug, class code of the recall, the reason for recall, the recalling firm with contact information, quantity, date of initiation, whether it was voluntary or mandated, and a history of whether this recall is ongoing. Types of recalls include issues with incorrect labeling, such as the wrong dose or drug, sterility, and/or contamination.

Issues With the Enforcement Report

Timing

The severity as classified by the FDA helped to stratify the level of action that could be taken. A Class I or II recall would entail a notification. Meanwhile, a Class III recall was not considered a risk significant enough to require notification. Often, by the time of the recall alert, the medication already would have been depleted.

This is unacceptable because this practice should not be allowed based on FDA expectations for notifying the public about drug recalls to prevent patient harm. My interpretation of why lag time existed between the recall and the date it was added to the enforcement report was related directly to the complex process and several steps it takes for the manufacturer to initiate a recall with the FDA.

Recalls that were announced and executed swiftly always serve the public better than those that were delayed for many months.

Tracking

Additionally, the enforcement report provides lot number-specific information for drug recalls, but not useful information to track where those lot numbers have been distributed. To be fair this isn’t the fault of the FDA but perhaps, given the seriousness of a drug recall, a tracking mechanism should exist to enable the immediate identification of patients who received recalled medications and when.

Pharmacy claim systems are set up to record basic information with the NDC code on the bottle but currently there is no record of the specific lot number that was dispensed. With advanced technology and barcoding encoding the tablet information to the level of the lot number should be possible.

The National Council for Prescription Drug Programs (NCPDP), the organization responsible for the oversight of data transmission through pharmacy claims systems, indicated that it is not currently feasible to add functionality for pharmacists to collect lot numbers at the point of dispensing. A representative from NCPDP told me that I could join a work group to express my concerns about the need for tracking this information.

A request such as this, if deemed necessary, could take up to 10 years to be approved, update systems, and have corresponding pharmacies upgrade their own systems, too. All of this would require herculean efforts, which is discouraging to. I joined a drug safety focus group but have not participated on a group call to date.

Recalls on the Rise?

According to CNN Money, the number of recalls per year increased threefold from 2008 to 2009.¹ Recall numbers remained high at 1405 recalls in 2018. There are several theories about the cause of this phenomenon, including the poor quality of raw materials, faulty labeling and packaging, and contamination.

Poor quality of raw materials that results in drug recalls has been an issue for decades.

According to November 2018 article by WebMd.com, since the 1990s, American drug companies and the patients they serve have relied on a supply chain that starts in factories all over the globe. Specifically, the article notes that nearly 8 out of 10 medications taken by Americans have some component made abroad, largely in developing industrial powers China and India. Although globalization has aided in restraining drug costs, it has subsequently created a supply chain that’s difficult to police and is vulnerable to recalls that mitigate the lower costs, the article noted.

John Vinson, CEO of the Arkansas Pharmacists Association, said in a July 2019 interview conducted by Little Rock, Arkansas-based KTHV, that these kinds of recalls have been problematic, “because so many Americans—as many as 80 million adult patients in the United States—have high blood pressure, and many of those are treated with medication.”

The FDA inspects factories in other countries if they manufacture drugs for use in the United States. Although Vinson mentioned that most overseas facilities get passing scores in their inspection reports, he told KTHV that the massive, ongoing recall of blood pressure medications started with factories in China.

From July 2018 through November 2018, the FDA recalled 3 blood pressure medications, all known as angiotension II receptor blockers (ARBs), which prevent blood vessels from narrowing. In at least 1 case, the recall of valsartan made it harder to find.

The Government Accountability Office (GAO) refers to offshore manufacturing of drugs a “high-risk issue,” that imposes far-reaching responsibilities and increasing demand on the FDA. Congressional investigators have been keeping tabs on the issue since 1998, and especially since 2008, when contamination of the blood-thinning medication heparin from a Chinese plant caused a worldwide recall.

Conclusion

The FDA has established stringent policies for conducting inspections of pharmaceutical plants all over the world and, in recent years, has opened offices in Europe, Latin America, China, and India. According to Government Accountability Office Assistant Director for Health Care Geraldine Redican-Bigott, the FDA has “started to do many more inspections of foreign establishments, and they’ve been able to show some improvement.”

The more drugs that are manufactured with fewer controls overseas, the more there will continue to be a need for recalls. In the meantime, there has to be a better way than the potentially 10-year process it currently takes to improve the tracking of lot number-specific recalls.

To remedy this, the work and expertise of a drug utilization pharmacist should be empowered and integrated earlier into a recall process. This way, the utilization pharmacist could more easily be alerted of offending batches and lots, and develop or work an already-existing action plan to conduct the appropriate patient outreach.

This entire process also could be expedited because a higher volume of important information would be known sooner, all with an eye toward patient safety.

Reference

Drug Recalls Surge. https://money.cnn.com/2010/08/16/news/companies/drug_recall_surge/index.htm

About the Author

Nivedita Kohli earned her Bachelor of Pharmacy degree from the Bouvé College of Health Sciences at Northeastern University and is currently enrolled in the Master of Pharmacy Business Administration (MPBA) program at the University of Pittsburgh, a 12-month, executive-style graduate education program designed for working professionals striving to be tomorrow’s leaders in pharmacy business. She spent the past 20 years developing and implementing drug safety initiatives for a health plan and pharmacy benefit management provider serving Western New York. Over the past decade, she spearheaded educational programs for healthcare practitioners around appropriate opioid prescribing in addition to supporting the Erie County Opioid Epidemic Task Force with multi-faceted programs to improve the outcomes and reduce the impact of the opioid epidemic in Western New York. More recently, she is focusing on opportunities to provide high quality, sustainable healthcare in the current US market, employing her skillset in managed care and business.