Process Steps And Suggestions For Creating Drug Monographs .
Process steps and suggestions for creating drug monographs and drugclass reviews in an evidence-based formulary system: Update 07/09/2008By Sheri A. Strite, Michael E. Stuart MD & Shaun Urban RPhThis is an updated version of the Feature Article originally published April 1, 2008 in —Formulary : A peer-reviewed drug management journal for managed care and hospital decision-makersAbstractGiven the high estimates of inappropriate healthcare decisions in this country and the well-documented evidenceof inappropriate variations in healthcare, a well-functioning formulary system is of great importance. Bias inresearch tends to inflate or falsely report benefit in clinical trials of interventions by up to a relative 40% to 50%.Therefore, to ensure the adoption of products with valid and clinically useful outcomes, formulary systems shouldinclude in their processes the key steps used in evidence-based medicine, including the evaluation of therapeuticstudies for bias and clinical usefulness to inform formulary decisions. This article outlines requirements andsuggestions for obtaining studies with appropriate designs and acceptable methodology and execution, andemphasizes why such studies should be the basis for developing drug monographs and class reviews andinforming decisions. (Formulary. 2008;43:135–145.)Historically, many physicians have objected to formularies because of the perception that formularies limitprescribing choices. However, it is estimated that 20% to 50% of all healthcare decisions in the United States areinappropriate.1–4 Therefore, it is reasonable to conclude that an evidence-based formulary is an important tool thatprovides users with high-quality information to aid decision making and ensure the inclusion of only agents thathave been demonstrated via research that is valid (ie, probably true) to be clinically useful.5 This paper discussesthe importance of an evidence-based formulary process and outlines the steps required for creating high-quality,evidence-based drug monographs and drug class reviews.WHY AN EVIDENCE-BASED FORMULARYSYSTEM?Clinical judgments should be informed, whenpossible, by valid and clinically useful evidence thatis likely to result in improved outcomes in the areasof morbidity, mortality, symptom relief, physical oremotional functioning, and/or health-related qualityof life. Unfortunately, many physicians, clinicalpharmacists, nurses, and other healthcareprofessionals, along with many of those providinginformation to these practitioners, such aspharmaceutical manufacturers, researchers, editors,peer reviewers, publishers, and other medicalinformation content providers, lack the skillsnecessary to adequately differentiate high-qualitystudies from poor ones; this fact has been stronglysupported by our direct experience working withnumerous groups nationwide.6,7 The problem of poorresearch and critical appraisal skills is compoundedby the weekly publication of thousands of flawed andmisleading studies and opinions, even in the bestmedical journals. Each week, approximately 12,000articles are added to the National Library ofMedicine. It is our estimate, having evaluatedthousands of published studies, that approximately 10% of published studies in the healthcareliterature are both valid and clinically useful; othershave estimated that this number is 5%.8 Indiscussions concerning the state of scientificknowledge, the Institute of Medicine concluded thatit was plausible that only 4% of interventions used inhealthcare have strong evidence to support them.9Critical appraisal matters. In a classic study,Chalmers et al10 demonstrated that a lack ofconcealment of allocation inflated the appearance ofbenefit, as did a lack of randomization, in studieswith an outcome of fatality from acute myocardialinfarction (MI). Studies that were randomized withconcealment of the allocation sequence, onaverage, reported nonsignificant findings. As studiesdiminished in quality in these 2 dimensions, benefitwas inflated as high as an absolute 10% in favor ofthe intervention. This translates into a numberneeded-to-treat (NNT) of 10, which would be highlyclinically significant if only it were true. Results ofsubsequently published studies have supported theconclusion that bias tends to favor the intervention,inflating benefits by up to a relative 40% to 50%.11–15These high rates of falsely inflated results have beendemonstrated in studies in which methods such asgeneration of the randomization sequence,concealment of allocation, blinding, and assessingoutcomes through statistical modeling are omitted ornot done correctly.11–15Although FDA is charged with ensuring the safetyand efficacy of drugs and biologic products, theagency cannot be relied on as medical decisionmakers' sole source of information about the safetyand efficacy of drugs. Skilled formulary groups canhelp solve this quality information deficit byconducting rigorous critical appraisals of the medicalliterature for validity and usefulness for all agentsbeing considered for formulary inclusion. Anevidence-based approach to the evaluation of drugs Delfini Group, LLC, 2008. All Rights Reserved WorldwideUse of this implies agreement to the legal terms and conditions on the Delfini website at www.delfini.org.Page 1 of 8
Process steps and suggestions for creating drug monographs and drugclass reviews in an evidence-based formulary system: Update 07/09/2008By Sheri A. Strite, Michael E. Stuart MD & Shaun Urban RPhis the only reliable way to know if the drug beingevaluated is likely to be responsible for the reportedoutcomes in a study (ie, the study is valid) or if theresults are likely due to bias, confounding, or chance(ie, the study is invalid). A good formulary systemcontinuously evaluates new evidence, incorporatesvalid and useful information, and monitors drugusage. Such monitoring, coupled with considerationsof value, is the hallmark of a high-quality formularysystem.The first key to an evidence-based formularysystem, therefore, is to ensure an understanding ofthe relevant science. Groups can then considerother factors, such as clinical attributes; communitystandards; risk management considerations; patient,clinician, and employer satisfaction; cost; marketingimplications; utilization; and other factors whenmaking formulary decisions.BUILDING A DRUG MONOGRAPH OR DRUGCLASS REVIEWThere are 5 general steps for building a drugmonograph or drug class review. These steps, whichare outlined in Table 1, include compilingbackground information, identifying potentially usefulscientific evidence, critically appraising that evidencefor validity and evaluating results, summarizing theevidence, and creating an overall summary for themonograph or class review and makingrecommendations.Background information. Drug monographs anddrug class reviews are the foundation of high-qualityformulary systems. These summaries of a drug'sefficacy, advantages and disadvantages, FDAstatus, and other information are a centralcomponent of the pharmacy & therapeutics (P&T)process. If monographs and class reviews arecreated using a rigorous evidence-based process,they can be used by decision-makers as trustedresources for guiding clinical care decisions,weighing alternatives, and evaluating claims madeabout drugs and users' opinions or judgments.Once it has been determined that an agent will beconsidered for formulary inclusion, the monographor class review should be created to containinformation about the current national and localstandards (eg, treatment guidelines, national andlocal expert opinions); labeling information, includingFDA-approved indications, pharmacology,warnings/precautions, adverse events (includingabuse and dependency issues), etc; interactions;therapeutic equivalents; and other therapeuticalternatives. Table 2 contains a list of resources thatcan provide much of this background informationTable 15 Steps for building a drug monograph or drug Criticallyappraise theevidence andevaluate theresults4Summarizethe evidence5Create anoverallsummaryKey Points Sources (see Table 2), nationalguidelines, and informed expertopinion Focused clinical question(include condition andintervention) Documentation of searchstrategy including sources,terms, and limits; dates ofsearches; search yield; andnumber of relevant studiesselected for further review Audit all secondary studies andsources used Evaluate for efficacy and safety Look for lethal threats to validity(see Table 3) Critically appraise (see Table 4) Summarize key threats tovalidity Assign an evidence grade (seeTable 5) Narrative statement thatincludes the quality of theevidence and the strength ofthe conclusions and/orrecommendations Include information regardingthe number of studies, numberof subjects, populationcharacteristics, andhomogeneity or heterogeneityof the included studies, etc. Limitations of the evidencereview Evidence summary grade “Roll-up” of previous steps (seeTable 6) Clearly distinguish evidencefrom recommendations Address findings regardingefficacy and safety, appropriatepatient population, importantclinical considerations, valueassessment, comparison toalternatives, implications forpractice change, andrecommendations, etc. Additional considerationsinclude the patient perspective(eg, benefits, costs, risks,harms, uncertainties, andalternatives, satisfaction) andissues that may affect treatmentadherence, and potentialproblems with issues such asdrug dependency or thepotential for abuse. Theclinician’s perspective is alsoimportant and includessatisfaction, acceptability andactionability. Describe limitationsAdapted from the Delfini Intervention Review Template. Delfini Group, LLC. 2005-2008. Delfini Group, LLC, 2008. All Rights Reserved WorldwideUse of this implies agreement to the legal terms and conditions on the Delfini website at www.delfini.org.Page 2 of 8
Process steps and suggestions for creating drug monographs and drugclass reviews in an evidence-based formulary system: Update 07/09/2008By Sheri A. Strite, Michael E. Stuart MD & Shaun Urban RPhand conclusions from other "most trusted" secondarysources, such as groups performing high-qualitysystematic reviews.Table 2Selected secondary sources for background informationon drugsaAlthough many of the following sources can be relied upon forbackground information, they should not be used for drawingconclusions about efficacy without deeper scrutiny, because theinformation presented may not be based on valid researchstudies. We strongly recommend that any secondary sources beaudited to determine if the individual studies, upon which theconclusions are based, are in fact valid and clinically useful. Useful background information may be found on FDAwebsite. The sections of the website that are especiallyuseful include er/drugsatfda/index.cfm) and the Center for Drug and Evaluation andResearch (CDER) (http://www.fda.gov/cder/drug/default.htm). CDER is an up-to-date source for newdrug applications (NDAs) and useful backgroundinformation on new drugs. The FDA medical reviewsand statistician reviews can be of great value. It isworthwhile to search using the agent’s generic andproprietary name.The Health Technology Assessment (HTA) program,available from the British National Institute of HealthResearch (NIHR) (http://www.hta.ac.uk/) provideshealthcare technology and drug information. Thepurpose of the HTA program is to ensure that highquality research is available on the effectiveness andcost of health technologies. HTA awards funding formonographs that are produced by groups who qualifyfor grant funding. The Canadian Agency for Drugs and Technologies inHealth tspublications) provides evidence-based information ondrugs and healthcare technologies. The following websites may be of value for informationon clinical background and available alternatives, andoften provide efficacy and safety reviews: aThe Cochrane naMed (http://www.ebscohost.com/dynamed)Turning Research Into Practice (TRIP) ency for Healthcare Research and Quality(AHRQ) (http://www.ahrq.gov)British Medical Journal (BMJ) Clinical ex.jsp)At times, the introductory paragraph of randomizedcontrolled trials provides helpful backgroundinformation.Several of these sources are available by subscription only. (As ofthis writing, free access to BMJ Clinical Evidence may be obtainedthrough the United Health Foundation).Identifying potentially useful evidence. The nextstep is to create a focused clinical question and thenattempt to identify potentially useful scientificevidence. An efficient way to find high-qualityinformation is to start with the most potentiallyreliable secondary sources, such as those listed inTable 2, to obtain systematic reviews. In addition tothese sources, the Database of Abstracts ofReviews of Effects (DARE)(www.york.ac.uk/inst/crd/crddatabases.htm) can behelpful in identifying useful systematic reviews.DARE, which is maintained by University of York,identifies potential systematic reviews, assessesthem for methodological quality against a set ofinclusion criteria, and summarizes the results.At the time of publication, we are unaware of anysecondary source that is fully reliable. Therefore,critical appraisal auditing must be done for eachsystematic review being considered for inclusion inthe drug monograph or class review. When auditinga secondary source, select 1 studies determined bythe secondary source to be of the highest qualityand see if they pass the appraisal. If so, select 1studies determined to be of the lowest quality andsee if they pass the appraisal. If both the higher- andlower-quality studies pass appraisal, it is reasonableto conclude that only quality primary sources wereused in the secondary source.If a secondary source from the originally selectedsources cannot be used, the National Library ofMedicine, accessed through PubMed(www.pubmed.gov), can be useful to find othersystematic reviews, including meta-analyses orrandomized controlled trials (RCTs). The type ofarticle to search for can be specified using the "Typeof Article" variable (found under the "Limits" section).It is advisable to use the agent's generic andproprietary name when searching PubMed. It isnecessary to critically appraise all studies obtainedfrom a PubMed search. Systematic reviews obtainedfrom PubMed can be crosschecked by determiningwhether DARE has already evaluated the reviews.Editorials, comments, and related articles canprovide additional information to aid in the criticalappraisal process.If any secondary source does not pass a criticalappraisal audit, a source might still be usable as abasis for a monograph or class review if it is agreedthat the search and exclusions have been performedrigorously. In this instance, the conclusions of thereview would not be used, but rather all studiesselected for inclusion in the review should becritically appraised; any that are deemed to not be Delfini Group, LLC, 2008. All Rights Reserved WorldwideUse of this implies agreement to the legal terms and conditions on the Delfini website at www.delfini.org.Page 3 of 8
Process steps and suggestions for creating drug monographs and drugclass reviews in an evidence-based formulary system: Update 07/09/2008By Sheri A. Strite, Michael E. Stuart MD & Shaun Urban RPhboth valid and clinically useful should be discarded.In this case, it is necessary to update the review withsubsequent research published after the date of thesecondary study's search.Information from any secondary sources almostalways requires updating, which entails a search forany studies published after the search date of thesystematic review and critical appraisal of thestudies determined to be potentially valid andrelevant. To update, it is important to use the samesearch date that was used by the secondary source,rather than the publication date, which may be muchlater than the search date.When documenting your search, it is helpful toinclude information about the clinical question orfocus point of the search, sources, date of search,search terms, limits used, number of hits, number ofirrelevant studies (documented with citation), andnumber of studies selected for review (documentedwith citation). Documenting the PubMedIdentification Number (PMID number) and using it asa search variable is an efficient way to relocatestudies.Critical appraisal for validity and assessment ofresults. There are many textbooks available on thetopics of clinical epidemiology and critical appraisaltechniques.16–18 It may be helpful before starting adrug monograph to outline selected key componentsof an ideal study and use this model to compare theavailable studies. It is useful for this model study tocontain a rough benchmark for outcomes, studylength for the outcome of interest, measurementmethods, population, dosing, comparators, potencyequivalents, and washout length. Studies must beassessed for relevance to the clinical question andfor lethal threats to validity or clinical usability, whichwould exclude the study from further consideration.Transparency is an important hallmark of evidencebased clinical decision-making, and so it isrecommended to document the study reference andthe reason(s) for excluding the study. Table 3 detailssome of the common lethal threats that can bequickly identified, any of which may be sufficient toexclude a study from consideration. Table 4provides an additional checklist to further identifypotential reasons for study exclusion. The goal ofthese assessments is to summarize threats tovalidity so that an appropriate grade of evidence canbe assigned. Explicit details must be provided by theauthor, or a threat should be assumed (eg, if a paperreports that patients were randomized, but does notinclude details providing assurance of qualityrandomization methods, a threat should beTable 3Initial checklist to help identify lethal flaws inpublished clinical trials of therapeutic interventionsappropriately documented.This checklist can help to quickly identify lethal flaws within astudy. The trial could be considered invalid if any of thefollowing exist:1. Issues with study typea. Observational studies for efficacy of therapy,prevention, or screening interventions, unless theresults are all-or-none results (standards are loweredfor study quality when evaluating safety issues, butour advice is to take a net view and ensure that thewording of the conclusions is not misleading and thatthe strength of the evidence is described as beingweak if that is the case)b. Case series (including reports using comparisons withhistorical controls or “natural statistics”) unless theresults are presented as all-or-none, which isextremely rare2. Methods that increase chance findingsa. Use of post hoc analyses (ie, using study outcomes orresearch questions that are not determined inadvance) to draw conclusions regarding cause andeffectb. Subgroup analyses in which the subgroups are notdetermined in advance3. Lack of meaningful clinical benefit or other issues withoutcomesa. For clinical questions, a lack of clinical significance(end points need to address direct and meaningfulbenefit with regard to morbidity, mortality, symptomrelief, emotional or physical functioning, and/or healthrelated quality of life, or there needs to be other validevidence that demonstrates a causal link between thestudy outcomes and a clinically significant outcome)b. Effect size is not clinically meaningfulc. Nonsignificant findings are reported, but theconfidence intervals include clinically meaningfuldifferences, which would result in a lethally threatenedconclusiond. For noninferiority and equivalence trials1. Lac
Apr 01, 2008 · Drug monographs and drug class reviews are the foundation of high-quality formulary systems. These summaries of a drug's efficacy, advantages and disadvantages, FDA status, and other information are a central component of the pharmacy & therapeutics (P&T) process. If monographs and class rev
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