Improving Medication Safety Through the Formulary

Formularies are widely used in hospitals and across health systems to help control medication costs, but they aren’t used often enough to promote the rational and safe use of therapeutic agents, according to William Galanter, MD, PhD, an assistant professor of medicine, pharmacy practice, and pharmacy systems at the University of Illinois (Chicago, IL).

Dr. Galanter and colleagues developed the Formulary Leveraged Improved Prescribing (FLIP) evaluation tool, which health system decision-makers can use to evaluate the drugs they’re considering adding to formularies.

The checklist addresses the clinical need, efficacy, safety, misuse potential, and cost of the medications under consideration with the ultimate goal of improving prescribing practices. Dr. Galanter recently discussed the practical applications of the FLIP tool and how it supports a conservative view of medication use.

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How can a hospital's formulary be used to improve medication safety?

An ideal formulary attempts to minimize the use of medications that have safer alternatives. A formulary committee will try to limit the use of medications with inherent risks to the clinical indications for which benefits outweigh risks.

The formulary committee will also scrutinize the use of new medications backed by studies that are too small, too short, or too biased to develop real estimates of patient risk. Including a more focused group of medications within a formulary makes it possible for clinicians to learn the properties of all the drugs in use. That knowledge can minimize the risks of drug confusion, dosing errors, and drug-drug interactions. Limiting the number of medications in a formulary also prevents confusing patients with frequent switching between agents within the same medication class.

What theories are used to decide which drugs to include in a formulary?

There’s a pro-industry belief that all new drugs are beneficial and should be made available to patients. There’s also a more conservative view based on the belief that drugs can be very harmful. Some drugs are comprised of natural compounds found in the body, but most agents are basically toxins. That’s the idea behind the FLIP tool — to be very skeptical about the use of medications. Drugs must meet a higher safety threshold and have evidence of high benefit and low risk before being added to the formulary or prescribed to patients.

What role does the FLIP tool play in the decision-making process?

Formulary committees in the inpatient setting are mandated entities. Many of the physicians who sit on the committees don’t have expertise in pharmacokinetics, drug-drug interactions, the intricacies of administration, and the potential dangers posed by look-alike medication labels. The FLIP tool helps them sort through that information and can be used by formulary committee members when they’re deciding which medications to include in a formulary. It can be used to identify gaps in the evidence, to guide discussions during committee meetings, educate new committee members about issues that need to be raised, and for quality assessment and improvement of the formulary committee’s processes. Pharmacists and physicians can also use the tool when deciding on the appropriateness of prescribing new medications.

In what types of situations would the tool prove useful?

There are numerous medications — including weight-loss drugs, a variety of diabetes therapies, and some blood pressure agents — that appeared to provide clinical benefit when they were first launched, but ended up being very harmful to patients and pulled from the market. Providers who believed what the pharmaceutical industry said supported the use of the new medications, but conservative practitioners avoided prescribing the medications, because there was a lack of evidence that showed the therapies to be safe and efficacious. Many formularies added the medications based on assumptions that new therapies were beneficial. The FLIP tool is designed to inform that decision-making process moving forward.

What role do pharmacists play in improving the effectiveness of a hospital’s formulary?

Health-system pharmacists are involved in gathering and evaluating information about prospective drugs. Pharmacists who are trained to collect drug information produce the evidence formulary committee members use to make decisions about which drugs to add and which drugs to exclude. Almost all committees have pharmacists as voting members, so in addition to evidence synthesis, pharmacists help interpret and vote on the medications under consideration.

Understanding the principles of the FLIP tool can help pharmacists frame their decisions and discussions during this process. Most formularies in the hospital setting meet monthly, although they don’t necessarily have to convene that often. Pharmacists are in charge of reviewing ongoing drug utilization data and constantly review the literature and statements from the U.S. Food and Drug Administration and the Institute for Safe Medication Practices. Many formulary decisions and updates are based on that steady stream of information.