ISMP Medication Safety Alert
February 10, 2005 Volume 10 Issue 3
The truth about hospital formularies
Survey shows many myths still exist 15 years later
Ideally, a carefully selected drug formulary guides clinicians in choosing the safest, most effective agents for treating medical problems. But, in 1990, Rucker and Schiff1 documented that full realization of this potential had been thwarted by misconceptions and myths. Fifteen years later, many of these same myths are still in existence, according to 265 respondents to our November 2004 survey.
Respondents were asked to report the frequency with which specific comments illustrative of these myths had been made during 2004 formulary deliberations at their Pharmacy and Therapeutic (P &T) Committee meetings. Interestingly, all eleven of the myths presented in the survey had been encountered by at least 19% of the respondents during 2004.
Reviewing just a few of the most frequently encountered myths reveals that formulary deliberations today may still be centered less on the critical evaluation of scientific data, and more on misconceptions about formularies.
The specialist knows best was the most common myth encountered during P&T Committee meetings. Almost three-quarters of respondents (74%) reported they'd received comments suggesting it was presumptuous for non-subspecialists to play a role in formulary decisions for specialty drugs. About one in five (19%) reported frequent comments, and 73% of all respondents who encountered this myth told us that the comments impacted formulary decisions. While specialists must be represented and consulted regarding formulary drugs within their specialty, nothing should preclude the P&T Committee from pursuing a thorough evaluation of each formulary request. Specialists are particularly adept at interpreting and presenting data on drugs in their area of interest, but a multidisciplinary peer group best evaluates clinical efficacy. Furthermore, safety is best evaluated by an interdisciplinary group of healthcare providers (physicians, pharmacists, nurses) who, collectively with specialists, may uncover otherwise unrecognized safety hazards to address before using the drug. Additionally, when research is involved, a thorough formulary review process can help avoid even the appearance of conflict of interest, and clearly separate drug prescribing for research purposes from patient therapy.
"Causal empiricism" was the basis for another frequently encountered myth. Again, three-quarters (75%) of respondents reported assertions from physicians that favorable experiences, replete with personal cases or anecdotal observations, justify the addition of a new drug to the formulary, at least for a "trial" period for the medical staff to "evaluate" the drug. Twelve percent of respondents reported hearing these types of comments often during formulary deliberations, and almost three-quarters (70%) of all respondents who encountered this myth reported that the comments impacted formulary decisions. Physicians are well aware of the importance of practicing evidence-based medicine, which fundamentally includes the need for randomized, blinded drug studies to prove efficacy and safety. But they may be unprepared to treat their own favorable experiences with skepticism, and may rely too heavily on their own abilities to evaluate the efficacy and safety of a new product. Thus, they may assume that their personal clinical impressions about the product are crucial to determine the quality of drug therapy, rather than relying on the P&T Committee's evaluation of available scientific evidence.
"Sicker patients need more drugs" was another myth heard by almost three quarters (74%) of respondents. Thirteen percent reported hearing comments related to this myth often during formulary deliberations, and two-thirds (67%) of all respondents who encountered this myth reported that the comments impacted the formulary decision. While most formularies include second-line alternatives for specified classes of medications, the assumption that sicker patients need more intensive pharmacotherapy, or more choices among available products, is only warranted if there is evidence of benefit. Some physicians may also claim that a strictly controlled formulary can cause life-threatening delays if an alternative non-formulary drug must be obtained. However, lack of therapeutic restraint and standardized protocols that carefully spell out how to handle emergencies well in advance - not the absence of a particular drug - have long been identified as major factors in iatrogenic injuries and catastrophic outcomes.
"The formulary interferes with clinical freedom" was cited as a problem by two thirds (67%) of respondents. Twelve percent reported frequent comments, many of which explicitly challenge the formulary concept. More than half (53%) of all respondents who encountered this problem reported that the comments impacted formulary decisions. Yet, the basic underlying tenets of an effective formulary include: (1) acknowledgment that each clinician prescribes a very limited subset of available products, (2) recognition that a formulary prepared by a group of experts and peers with adequate resources is likely more optimal than a clinician's personal formulary, and (3) preservation of clinical freedom by providing broad therapeutic decisionmaking guidance, not interference with prescribing.
"Widespread use equals drug of choice" was another claim encountered during formulary deliberations by almost three quarters of respondents (72%). Nine percent of respondents reported frequent comments promoting formulary addition of products due to widespread use, increased patient demand, and more subtle variations on this theme, including potential loss of competitiveness because other hospitals are using the drug. Almost two-thirds (65%) of all respondents who encountered these claims reported that they impacted formulary decisions. However, widespread use may be more a measure of marketing success than comparative benefits of the product, especially in light of the rapid acceptance of new drugs that ultimately proved to be potentially harmful, and the inappropriate prescribing of some high volume medications.
Perpetuation of these formulary myths and others initially covered by Rucker and Schiff1 can be traced back to many factors, including assertions from the pharmaceutical industry that formularies inhibit prescriber knowledge of their products and freedom to use any FDA approved medications. Non existent didactic training about using formularies as a powerful patient safety/quality tool, rather than a restrictive cost-containment strategy, during medical and pharmacy training also hinders progress and allows reinforcement of biased, negative feelings about formularies. Sadly, one thing's clear from our recent survey: tapping into the enormous potential of formularies will be a marathon in healthcare, not a sprint. Holding frank discussions about the formulary myths presented in our November 2004 survey could prove to be one giant step on this journey toward optimal care for patients. Focused attention on the theoretical foundation and operational parameters of formularies by health professional schools, the research community, and funding agencies could also result in identification of the most appropriate role of drug formularies in society today.
Reference 1: Rucker TD, Schiff G. Drug formularies: myths-in-formation. Medical Care 1990; 28:928-942. Reprinted in Hosp Pharm 1991;26:507-514.
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www.ismp.org/s/survey200411r.asp for full survey results.
