drug monograph assignment

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• Am J Pharm Educ
• v.75(1); 2011 Feb 10

A Monograph Assignment as an Integrative Application of Evidence-Based Medicine and Pharmacoeconomic Principles

Anandi v. law.

a Western University of Health Sciences

Cynthia A. Jackevicius

Mark bounthavong.

b Veterans Affairs San Diego Healthcare System, California

To describe the development and assessment of monographs as an assignment to incorporate evidence-based medicine (EBM) and pharmacoeconomic principles into a third-year pharmacoeconomic course.

Eight newly FDA-approved drugs were assigned to 16 teams of students, where each drug was assigned to 2 teams. Teams had to research their drug, write a professional monograph, deliver an oral presentation, and answer questions posed by faculty judges. One team was asked to present evidence for inclusion of the drug into a formulary, while another team presented evidence against inclusion.

The teams' average score on the written report was 99.1%; on the oral presentation, 92.5%, and on the online quiz given at the end of the presentations, 77%.

Conclusions

Monographs are a successful method of incorporating and integrating learning across different concepts, as well as increasing relevance of pharmacoeconomics in the PharmD curriculum.

INTRODUCTION

Pharmacoeconomics has been taught within a mandatory, lecture-based Pharmacoeconomics and Health Outcomes course at the end of the third year of the doctor of pharmacy (PharmD) program at Western University of Health Sciences for the past 12 years. The 4-credit modular month-long (18 days, 6 hours per day) course covers a review of research methods and statistics and pharmacoepidemiology; an introduction to health outcomes and pharmacoeconomics terminology; varied pharmacoeconomics techniques, including cost-minimization, cost benefit, cost-effectiveness, cost utility analyses, decision modeling, and sensitivity analyses; the 10-14 step approach to literature evaluation of pharmacoeconomic articles; and a module on patient adherence and patient-reported outcomes, including quality of life and patient satisfaction. 1 - 3

Students traditionally have regarded the pharmacoeconomics course at our institution with anxiety and uncertainty because of its close association with research methods and statistics — an area that strikes fear in students because they feel it has limited connection to clinical practice. Further, although students are educated on the relevance of pharmacoeconomics to formulary decision making by pharmacy and therapeutics (P&T) committees, it is unclear what the processes and applications of pharmacoeconomics are, especially in regard to community pharmacy practice, which attracts more than half of PharmD graduates. 4 This uncertainty is reinforced by the lack of pharmacoeconomics material on the North American Pharmacist Licensure Examination (NAPLEX) – a factor that changed in 2010. 5 In addition, students often consider pharmacoeconomics to be an uninteresting topic. Pittenger and colleagues reported that 45% of students surveyed were uninterested in a career in managed care and that students' misunderstanding of the field may develop into negative opinions. 6

Prior to 2008, active learning in the pharmacoeconomics course consisted of discussion of cases and evaluation of published articles in each area of pharmacoeconomics (cost-minimization, cost-benefit, cost-effectiveness, cost utility analyses, and health-related quality of life). Although they found the course challenging, were engaged in the active-learning exercises, and gave the course faculty good reviews, students often commented that the material was esoteric and they were unable to see its application to pharmacy practice. Those pharmacy faculty members across the country who coordinate and/or teach this course express concern about these same challenges and an interest in methods to increase the relevance of and student interest in the course. In institutions where this course is an elective, the challenges are only compounded by lack of enrollment.

In 2005, the college of pharmacy began incorporating EBM throughout the PharmD curriculum (first through fourth year), through teaching, practicing, and evaluating EBM concepts. EBM is defined as the integration of the best research evidence with clinical expertise and the patient's unique values and circumstances. 7 , 8 The long-established McMaster EBM model has been adopted at our institution and the process is summarized in the following 5 steps 8 :

• (1) Ask: develop a focused and answerable clinical question using PICO (patient, intervention, comparison, and outcome).
• (2) Acquire: effectively and comprehensively obtain information that answers a clinical question.
• (3) Appraise: critically appraise the evidence for validity, importance, generalizability and applicability.
• (4) Apply: apply the information to a patient case/population of interest.
• (5) Assess: self-assess your ability to practice the above 4 steps and refine your skills and abilities.

Incorporation of EBM across the curriculum requires development of a breadth of activities, from individual patient case scenarios to population-based settings.

Feedback from student pharmacists and preceptors from advanced pharmacy practice experiences (APPEs) about inadequate skills and confidence in monograph preparation prompted the college's curriculum committee to recommend inclusion of a monograph assignment in the didactic curriculum. The required pharmacoeconomics course was considered the optimal venue for introduction and practice of monographs, since the EBM and therapeutic courses taken prior to the pharmacoeconomics course prepare students for this activity.

Inclusion of the monograph assignment in the course presented a challenge for the course coordinator (AVL) in terms of incorporating clinical topic areas into the course, because like many pharmacy administration faculty members, the coordinator was not a practicing pharmacist. However, by collaborating with a clinical faculty member who led teaching of EBM in the curriculum (CJ), the monograph assignment was introduced into the course as an innovative application of both EBM and pharmacoeconomics. Our objective was to develop a monograph assignment and assess student performance across the 2 years following its incorporation.

The purpose of the monograph assignment was to locate, evaluate, and present evidence to support or deny a medication's formulary status for a fictional healthcare plan using evidence-based medicine and pharmacoeconomic methods. The monograph team assignment was introduced to the class prior to the pharmacoeconomics course to give students time to conduct the first EBM task, ie, ask a focused clinical question and acquire the evidence. The preassigned student teams (teams worked together throughout each year of the PharmD program) were asked to assume the role of formulary manager of a hypothetical health plan with 10 million covered lives who must convince the decision maker to either include or exclude a drug into the formulary. Teams had to complete both a written monograph and an oral presentation of the monograph.

The monograph assignment focused on drugs that have recently received US Food and Drug Administration (FDA) approval because: (1) monographs in actual P&T committees are usually prepared to guide decision-making on inclusion of newer drugs into the formulary; (2) our assignment was designed to simulate real-world practice, (3) since less clinical and economic outcome data are available for newer drugs, choosing only recently FDA-approved drugs ensured an equitable volume of available data for each drug, and (4) lack of widely available data forced teams to utilize data efficiently to calculate, estimate, and critically evaluate the evidence and to make decisions under conditions of uncertainty.

Eight drugs approved by the FDA within the previous 5 years were assigned to 16 teams of approximately 8-9 students each, so that each of the 8 drugs was evaluated by 2 teams. One of the 2 teams was required to present evidence for inclusion in the formulary (“for”), while the other team had to present evidence against inclusion in the formulary (“against”). Forcing teams to take a position on formulary inclusion/rejection would illustrate the various ways data could be applied/interpreted and encourage creative thinking for application to actual issues, such as strategy and business models. The pharmacoeconomics course followed completion of a course in pharmacy practice management; thus, this assignment helped to integrate some of the learning from the previous course about budget impact, contracting, and relationships between pharmacy benefit management companies and drug manufacturers.

Written Report

The data required in the written reports ranged from simple, easily available information, such as FDA-approved indications of the drug, the comparator drug of choice, and the gold standard and adverse effect profiles, to information on the pharmacology and mechanism of action of the drug, to more complicated evaluations of evidence of clinical efficacy/effectiveness of the drug from published data. The clinical evidence table required completion of the patient population, intervention, comparisons, and outcomes (PICO) for the study; study duration; and evaluation of the validity of the study design according to the previously taught EBM framework (including relative and absolute risk reduction and number needed to treat or harm, as relevant to the study). Pharmacoeconomic analyses were sometimes available for new FDA-approved drugs; however, a majority of analyses had to be calculated based on published efficacy data and estimated drug acquisition cost data to formulate a budget impact model. In addition, students were required to conduct sensitivity analyses to examine the impact of variability in their cost and efficacy data estimates. Written reports also required identification of the additional information that would be needed to make a better judgment, and questions that needed to be answered before approving the drug. Finally, the approval status recommendation (“for” or “against”) was required, with justification for the particular health plan, taking into consideration patient care, costs, ethical considerations and lack of certainty.

Oral Report

Teams presented their monographs to their classmates and faculty judges over 2 consecutive days at the end of the course. To ensure equity of team members' efforts, half of each team gave the presentation using PowerPoint, then the other half answered questions from the judges. Presentations were limited to 12 minutes; with an additional 3 minutes allowed for a question & answer session with a 4-member panel of faculty judges. To encourage creativity, students were not provided any guidance on how to deliver their presentations; however, the required content had to be presented within the allotted time.

In the second year of the monograph assignment, an online quiz was added to ensure class attendance by non-presenting students and active listening. The quizzes counted 3% of the course grade, and were completed at the end of each day following the presentations. These quizzes were developed by the course facilitator in discussion with the judges to ensure validity of content. Overall, the monograph assignment counted 20% of the course grade (17% was the team grade and 3% was an individual grade).

EVALUATION AND ASSESSMENT

The grading rubric for the monograph assignment used a modified version of the Academy of Managed Care Pharmacy (AMCP) format for formulary submissions version 2.1. 9 The grading rubric had 16 questions, including a clinical evidence table and economic analysis (Table ​ (Table1 1 and Table ​ Table2). 2 ). Students were provided a sample dossier using the AMCP format as a reference, although they were not expected to replicate their report at the same level as the sample. Teams were asked to respond to the rubric questions in a written report due the last week of the course, 4 days prior to the oral presentations. Written reports were graded on a 100-point scale and counted 10% of the overall course grade.

Example of a Clinical Evidence Table for One Study in the Monograph Assignment

Abbreviations: R = randomized, PC = placebo-controlled, P = prospective, DB = double-blinded. Alz = Alzheimer's disease; MMSE=Mini Mental State Examination.

Pharmacoeconomic Section of Monograph Assignment

Teams were provided with the grading rubric that would be used for the oral presentation and a bank of questions the judges might ask. Presentations to the class were judged on content, delivery, and students' responses to questions. Two of the judges were pharmacy practice faculty members who focused on clinical and therapeutic questions, 1 was a pharmacy administration faculty member who focused on pharmacoeconomic questions, and 1 was a practicing pharmacoeconomic clinical specialist who asked reality-based questions. The 4 judges' scores for each team's oral presentation were averaged, and the resulting score counted for 7% of each student's course grade. At the end of the presentations each day, the judges were asked to provide overall feedback to the class and include any tips and pointers to improve the presentations or responses to questions.

The 16 teams in each year (280 students over 2 years) scored an average of 9.9/10 points (Table ​ (Table3). 3 ). Their reports were precise, accurate, and comprehensive, yet succinct in content presentation. Formative feedback was provided on the reports for improvement, as needed.

Results of Student Performance in Monograph Assignment Across 2 Years

a Scores were out of 10 points; there were no quizzes in Year 1

b Scores were out of 7 points

Oral presentation scores averaged 95% in year 1 and 90% (6.3/7 points) in year 2, with the range of scores varying widely for both years. Quiz scores averaged 77% with a range of 56%-94%. These scores were lower than expected; however, this was the first year that the students had experience with the quiz.

Students were asked to provide comments on the monograph assignment as part of their evaluation of the course. Students appeared to value the assignment and its application. Suggestions for improvement focused on logistical issues such as spacing out and timing of oral presentations, the type of questions asked by judges, and material on the quizzes rather than on completion of the assignment or the time given for it. Students also provided informal feedback indicating that they could finally see the value of pharmacoeconomics. Comments from students on APPEs noted the relevance of monographs in practice. Student feedbacks on quizzes were mixed; they recognized the need for the quizzes but believed that the questions needed improvement.

The monograph assignment focused on improving student application of EBM to evaluate the evidence in order to make a decision to include or exclude a drug to the formulary of a hypothetical health plan. It also was intended that students learn to estimate or evaluate pharmacoeconomic data on the drug and its influence on the budget if added to the formulary.

Students performed well overall on the written reports and oral presentations; however, responses to questions following oral presentations indicated the need for improvement in terms of critical and practical thinking. Students appeared to know the drug information thoroughly; but, their ability to apply this knowledge to making decisions for a patient population was weak and unsophisticated/unprofessional. Students were reluctant or uncertain on how to deny the medication under consideration or to suggest alternate possibilities, such as conditional approval. Some improvement may be achieved by adding more practical exercises to the course, but further improvement may be seen only when students gain experience in real-life settings.

Student performance on quizzes was lower than expected; student feedback indicated that they found the quantity of content overwhelming and the questions too specific. Since this was the first year that quizzes were administered following the presentations, students may not have known what to expect and may have been unprepared. Further improvement on the quality of quiz questions should be made; however, the questions must balance testing of application and synthesis that is expected of critical thinking. This is especially true in a field where clinical decisions depend on assessment of the available evidence.

From a curricular perspective, this assignment provided multiple benefits. Students were able to apply EBM and pharmacoeconomic principles to decision making for a population rather than for a single patient. Previous applications of EBM in therapeutic courses were predominantly in comparative evaluation and recommendation of drugs for an individual patient presenting with symptoms.

Students gained experience in synthesizing scarce evidence to formulate an argument, providing a skill set that is useful in diverse practice settings. Students learned the value of appraising evidence when there were no data from head-to-head trials. They also used available resources in calculating budget impact and pharmacoeconomic ratios when there were no pharmacoeconomic studies available for the drug. Further, students learned the importance and applicability of sensitivity analyses when varied information was available for both cost and efficacy.

Students learned that data are objective but decisions have to be balanced using clinical and economic perspectives. Although decisions should be made impartially and objectively , this was not easy and required integrating best evidence with clinical expertise and the unique values and circumstances of a patient population. Some teams were unable to provide a good defense for denying a drug to the formulary. This could be attributed to the patient advocacy component of clinicians who assume that medication should be provided to patients rather than restricted. This philosophy neglects critical components of healthcare that involve economic, social, and humanistic consequences and focus on the patient rather than the population.

The students' presentation of evidence to the faculty judges and classmates simulated P&T committee meetings held in real-world pharmacy practice, and illustrated the importance of stating information succinctly. The assignment highlighted the importance of pharmacoeconomics and EBM to decision-making. An additional benefit was that this assignment helped interested students prepare for the P&T competition that is conducted by AMCP each year.

The authors are considering the following changes to the assignment based on experience and feedback:

• Reviewing and modifying the rubric as needed according to the recent AMCP format version 3.0. 10
• Adding the calculation for Cohen's d effect size to the expected results section for use with continuous outcomes. This topic was added in the P2 year of the EBM curriculum to allow students to calculate a summary measure of effect for continuous data study endpoints, which are common with newly marketed drugs.
• Enhancing evaluation of the quality of studies to be more explicit and possibly graded with levels.
• Ensuring searches for and evaluation of relevant systematic reviews and meta-analysis rather than a sole focus on individual clinical trials.
• Examining student perception of the value of the assignment by a direct survey.

One of the challenges we faced was to establish equity in the amount of work each student contributed to the assignment. We had half of the students from each team present while the other half answered questions. However, some students may not find this equitable due to the amount of stress associated with not knowing the answer to a question. Further research should investigate possible methods for developing equity in terms of workload among team members. Online quizzes allowed us to assess individual understanding of the drugs presented; but did not satisfactorily assess students' synthesis and application of clinical evidence.

CONCLUSIONS

Monographs are an innovative and useful method of integrating learning concepts in the PharmD curriculum. Incorporating monographs increased PharmD students' understanding of the relevance of a pharmacoeconomics course.

An Overview of USP Monographs

The United States Pharmacopeia – National Formulary (USP-NF) includes over 5000 quality standards for medicines, both chemical and biologic; active pharmaceutical ingredients (APIs); and excipients (inactive ingredients). It is the most comprehensive source for medicine quality standards in the world. The standards in USP-NF are used to help ensure the quality of medicines and their ingredients, and to protect the safety of patients.

USP is an official quality standard for medicines marketed in the US. In addition, USP is utilized in over 140 countries worldwide and integrated into the laws of more than 40 countries.

USP-NF includes three types of quality standards for prescription medicines:

• Monographs articulate the quality expectations for a medicine including for its identity, strength, purity, and performance. They also describe the tests to validate that a medicine and its ingredients meet these criteria.
• General Chapters provide broadly applicable information to industry on accepted processes, tests and methods to support product development and manufacturing for innovative, generic and biosimilar medicines.
• Material reference standards are used in conjunction with monographs and general chapters to verify that a medicine and its ingredients can pass tests to ensure adherence to quality requirements.

Key components

A monograph is a written document that reflects the quality attributes of medicines approved by the U.S. Food and Drug Administration (US FDA). Some of these attributes include:

Identity -  Tests to identify that a particular substance is the medicine that it claims to be.

Strength -  Testing methods and acceptable ranges for the potency of a medicine, as reflected in FDA's approvals. For example, this indicates the amount of API in a medicine.

Purity -  Information on impurities that may be present in a medicine and the amounts of these that are permitted, along with testing methods to identify and measure them. An impurity is any component in the API or finished dosage form which is not the desired product or other formulation components. Levels that exceed may present patient safety concerns.

Performance -  Laboratory tests to predict and demonstrate how a medicine will be released as it enters the human body.

Monographs articulate quality expectations. Compliance with a monograph does not demonstrate biosimilarity or interchangeability, nor is it a license to market a medicine. Approval, biosimilarity and interchangeability are determined by the US FDA.

The development process

Development of a monograph generally begins a few years before an originator medicine loses patent protection. In most cases, the license holder for a medicine works collaboratively with the relevant USP Expert Committee to develop the monograph in a transparent process. The monograph may be revised as follow-on products (e.g., generics, biosimilars) are approved by FDA.

USP Expert Committees are comprised of scientific experts from academia, industry, and the healthcare practitioner community. Expert committee members are not compensated. They volunteer their time and work. FDA experts participate in each of the standard-setting expert committees as government liaisons.

Publication

A USP monograph becomes publicly available after a medicine’s patent protection expires and following completion of a transparent process that includes multiple opportunities for input from stakeholders.

USP monographs are continually updated to reflect the following:

• New FDA approvals - Monographs are updated when FDA approves medicines with new or different quality specifications than those expressed in an existing monograph. For example, if FDA approves a second generic or biosimilar version of a medicine with an impurity profile that differs from that of the first approved generic or biosimilar, the USP monograph would be revised to also integrate the quality specifications approved by FDA for the second generic or biosimilar. The same revision process would be undertaken for any additional FDA approvals of that medicine. In this way, monographs evolve as FDA approves new medicines. They are a publicly available articulation of the quality expectations of medicines approved by FDA. Through the USP Pending Monograph Program (PMP), monographs are updated rapidly prior to FDA approval. Through the PMP, USP works with the sponsor of a medicine under FDA review for approval, so that the monograph reflects the medicine’s quality specifications as soon as it receives market approval from FDA. Monographs revised through the PMP process become publicly available as soon as FDA approves a medicine.
• Changes requested by FDA or others based on safety data - A monograph may be revised to reflect new data or science, subsequent to FDA product approval or monograph publication.
• Advances in technology - Monographs are revised to reflect new testing and manufacturing technologies.

Monograph revisions can be requested by any stakeholder including industry and FDA.

Monographs are utilized to help ensure patient safety

USP’s publicly available monographs are used by regulators, public health authorities, and others to confirm that the medicines provided to patients meet quality expectations for safety and effectiveness.

They help secure the global drug supply chain

USP’s monographs are used by customs and border officials and public health and law enforcement authorities to confirm the quality of medicines and their ingredients from overseas sources. Medicine manufacturers use USP’s monographs for APIs and excipients to test the quality of drug ingredients from suppliers, including ingredients produced overseas.

They accelerate product development, competition and patient access

Because USP’s publicly available monographs articulate the regulatory expectations for quality, they accelerate product development and provide more regulatory predictability. As a result, monographs support competition, which generally reduces prices and expands patient access.

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Important message

A monograph assignment as an integrative application of evidence-based medicine and pharmacoeconomic principles

Affiliation.

• 1 College of Pharmacy, Western University of Health Sciences, Pomona, CA 91766, USA. [email protected]
• PMID: 21451753
• PMCID: PMC3049646
• DOI: 10.5688/ajpe7511

Objective: To describe the development and assessment of monographs as an assignment to incorporate evidence-based medicine (EBM) and pharmacoeconomic principles into a third-year pharmacoeconomic course.

Design: Eight newly FDA-approved drugs were assigned to 16 teams of students, where each drug was assigned to 2 teams. Teams had to research their drug, write a professional monograph, deliver an oral presentation, and answer questions posed by faculty judges. One team was asked to present evidence for inclusion of the drug into a formulary, while another team presented evidence against inclusion.

Assessment: The teams' average score on the written report was 99.1%; on the oral presentation, 92.5%, and on the online quiz given at the end of the presentations, 77%.

Conclusions: Monographs are a successful method of incorporating and integrating learning across different concepts, as well as increasing relevance of pharmacoeconomics in the PharmD curriculum.

Keywords: evidence-based medicine; pharmacoeconomics; pharmacy and therapeutics committee.

• Economics, Pharmaceutical*
• Education, Pharmacy / methods*
• Educational Measurement
• Evidence-Based Medicine*
• Students, Pharmacy

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5. AMA 11th Style

Objectives:

• know how to use numeric in-text citations
• become familiar with AMA 11th style, in-text-citation and reference-list format

“AMA 11th”-style In-text Citations

The AMA 11th edition citation style like many other citation styles uses superscript numbers inserted in the text to refer to numbered entries in the reference list.

In the AMA 11th style

• Superscript reference numbers are used for in-text citations (Example 1).

(Text in examples  1-4  was taken from:  Schuetz P, Chiappa V, Briel M, Greenwald JL. Procalcitonin algorithms for antibiotic therapy decisions: A systematic review of randomized controlled trials and recommendations for clinical algorithms. Arch Intern Med. 2011;171(15):1322.)

• The first resource cited is given the number 1, the second resource cited is given the number 2, etc.  Consequently, the resources (references) are listed at the end of the article in order of their citation .
• In-text citations are usually placed after punctuation marks at the end of phrases/sentences.    An exception to this rule is seen when the text mentions the resource/reference (see example below).

• Commas are used to separate numbers for two references cited in a single location (e.g. 1,2  ) or numbers for multiple discontinuous references cited in a single place (e.g. 1,2,5,7 ).

• A hyphen is used between first and last citation numbers when more than two references in sequence are cited in a single place (e.g. 1-3 ).

• Some of you may have used (author, year) in-text citations in the past. Remember, in AMA style, a number is needed even if the author and year are in the text or table.  This is because the reference list is not in alphabetic order, but rather in numeric order (according to citation number).

(Examples 5 and 6 are Iannaccone A, Kerr NC, Kinnick TR, Calzada JI, Stone EM. Autosomal recessive best vitelliform macular dystrophy: Report of a family and management of early-onset neovascular complications . Arch Ophthalmol . 2011;129(2):211.)

AMA 11th edition is not the only citation style that uses superscript numbers for in-text citations.  When superscript numbers are used, they are, virtually always, used as described above.

“AMA 11th”-style Reference List Format

If you decide to create your reference list manually, you will need to be very careful when numbering your in-text citations and formatting your reference list.  Even if you use Zotero or another citation manager (e.g. RefWorks, or EndNote) to insert  your citations and reference list, it’s important that you check the format of your reference list entries.  Rules for, and examples of, AMA 11th style reference list entries are provided below:

General rules

• If there are more than 6 authors or editors, list the first 3 authors followed by, et al.
• Authors or editors names are all shown as
• Sentence case (first letter of title capitalized) is usually used for the title an item/article/chapter that is a section of something else (book/monograph set/database).  Title case (first letter of all words longer than 2 or letters is captialized) is used for the title of the something else.  (E.g.  Fluoxetine hydrochloride.  In: PubChem .)
• Periodical titles are abbreviated using abbreviations found in PubMed (NLM title abbreviations).  Abbreviated words in the periodical titles are not followed by periods.  You can look up a journal’s NLM title abbreviation at: https://www.ncbi.nlm.nih.gov/nlmcatalog/journals/
• Periodical abbreviations and book titles are italicized.
• When you use a specific chapter and/or monograph, cite the specific chapter and/or monograph – not the entire book or compendium.
• Reference list entries for resources other than journal articles require the publisher’s name.   The previous edition of the AMA style (AMA 10th) required the publisher’s location as well, but locations are no longer required in AMA 11th.
• Reference list entries that end in a doi or web address are not followed by a period.  Periods interfere with auto-link creation.   Other reference list entries should be followed by a period.

Journal Article

Printed article or article with print-style page number range (ex. 8-16) but no doi.

• Thiesing JT, Ohno-Jones S, Kolibaba KS, Druker BJ. Efficacy of STI571, an abl tyrosine kinase inhibitor, in conjunction with other antileukemic agents against bcr-abl-positive cells. Blood. 2000 Nov 1;96(9):3195-9.

To compare the position of the pieces of information in the citation above and in a PubMed record, click here to open the PubMed record in a new tab .

Article available in print and online that has a doi.

• Capuozzo A, Montefusco S, Cacace V, et al. Fluoxetine ameliorates mucopolysaccharidosis type IIIA. Mol Ther . 2022;30(4):1432-1450. doi: 10.1016/j.ymthe.2022.01.037

Electronic-only article with doi (digital object identifier).  Include as much of the volume, issue, page number data as is available.  The sample article (cited below)  doesn’t have real page numbers but does have a volume and issue number.

• Kube T, Hofmann VE, Glombiewski JA, Kirsch I. Providing open-label placebos remotely-A randomized controlled trial in allergic rhinitis. PLoS One . 2021;16(3). doi: 10.1371/journal.pone.0248367

Electronic-only article without a doi or without using a doi  – use accessed date and URL

• Patel A, Johnson J, Lee BR, Montalbano A. More timely care: effect of online queuing vs change in hours of operation on hourly arrival volumes. a practice management reflection.  J Urgent Care Med . 2021;15(9):25-30. Accessed May 10, 2022.  https://www.jucm.com/more-timely-care-effect-of-online-queuing-vs-change-in-hours-of-operation-on-hourly-arrival-volumes-a-practice-management-reflection/

Physician’s prescribing Information Package Insert

Online PPI:

• Frova – frovatriptan succinate tablet, film coated.  Package Insert. Endo Pharmaceuticals; Updated January 2018. Accessed April 4, 2021. http://dailymed.nlm.nih.gov/dailymed/getFile.cfm?id=13331&type=pdf&name=c0703630-9ce8-4259-841e-71fd2019fa66

Printed PPI:

• Frova (frovatriptan succinate) tablets.  Package Insert. Endo Pharmaceuticals; 2018.

Book Chapter, no authors

Monograph from an online drug information database – one type of ‘online book chapter’.

Treat drug monographs from a monograph database like chapters from a book, whether or not the monograph set exists in printed book form.  The following are the pieces of information you will need to cite an online drug monographs.

• monograph title = chapter title position in reference
• monograph set name   = book name position in reference
• publisher’s name – A publisher is almost always named.  The publisher for the specific dataset (like AHFS DI) may be different than the publisher for the interface that’s hosting the dataset (LexiComp).  Use the name of the dataset publisher.  The URL (web address) will acknowledge the interface provider.
• Update year = publication year position in reference.  If an update date is given for the entire monograph, as is usually the case for monographs available through the Lexi-Comp interface, use that date. If each section of a monograph has a separate update date, as is the case for Clinical Pharmacology monographs, you can either look at each section to find the most recent update date or you can use “Updated periodically” as shown in the examples below.
• Acessed Date 
• Web address (URL)
•  no authors — Online drug monograph authors are almost never named.
•   no editors — Editors of online drug datasets are almost never named.
• no page numbers — online drug monographs like most online books rarely have traditional page numbers.
• no edition numbers — online versions of drug monograph sets are rarely defined using edition numbers.

Format ( authors names, editors names, edition numbers, and page numbers may not be available in online books):

• AuthorLast F. Monograph title.   In: EditorLast F, ed. Monograph Set Title .  #rd/th ed. Publisher’s Name; yyyy:startpage-endpage. Accessed Month dd, yyyy.  webaddress
• Temazepam. In: Clinical Pharmacology .  Elsevier;  Updated periodically. Accessed  April 4, 2021. https://www.clinicalkey.com/pharmacology/monograph/589?n=Temazepam
• Cephalosporins general statement. In: AHFS DI. American Society of Health-System Pharmacists, Inc.; 2021.  Accessed April 4, 2021. https://online-lexi-com.eu1.proxy.openathens.net/lco/action/doc/retrieve/docid/complete_ashp/413862?cesid=7j2gNqI6PpV&searchUrl=%2Flco%2Faction%2Fsearch%3Fq%3Dcephalosporins%26t%3Dname%26va%3Dcephalosporins

Book chapter/monograph in print form: 

• AuthorLast F. Book chapter title.   In: EditorLast F, ed. Book Title .  #rd/th ed. Publisher’s Name; yyyy:startpage-endpage.
• Cephalosporins. In: McEvoy GK, Snow EK, Miller J, et al, eds. AHFS Drug Information 2010.  American Society of Health-System Pharmacists, Inc.; 2010:91-106.

Note that the publication year is part of this book’s title .  When this is the case, the book may be a high edition for purposes of considering the book’s authority but is a first edition for the purposes of citing the reference.  In such cases, no edition number is included in the reference list entry.

Book Chapter with Authors and Editors

Online book chapter:

Format (page numbers may not be available in online books):

• AuthorLast F (or corporate author name).  Book chapter title.   In: EditorLast F, ed. Book Title .  #rd/th ed. Publisher’s Name; yyyy:startpage-endpage. Accessed Month dd, yyyy.  webaddress
• Katz MH. Overview: HIV infection & AIDS. In: Papadakis MA, McPhee SJ, Rabow MW, eds. Current Medical Diagnosis & Treatment . 60th ed. McGraw Hill; 2021.  Accessed April 4, 2021. https://accessmedicine.mhmedical.com/content.aspx?bookid=2957&sectionid=249386982

If you are citing a  first edition or book without edition number, no edition number is shown.

Book chapter in print form:

• AuthorLast F (or corporate author name).  Book chapter title.   In: EditorLast F, ed. Book Title .  #rd/th ed. Publisher’s Name; yyyy:startpage-endpage.
• Zapadka ME, Bradbury MS, Williams DW. Brain and its coverings. In: Chen MYM, Pope TL, Ott DJ, eds. Basic Radiology. 2nd ed . McGraw Hill; 2011:325-364.

Book Chapter from a book written in it’s entirety by one group of authors with no book editors

Online book chapter :

• AuthorLast F (or corporate author name).  Book chapter title.    Book Title .  #rd/th ed. Publisher’s Name; yyyy:startpage-endpage. Accessed Month dd, yyyy.  webaddress
• Barrett KE, Barman SM, Boitano S,  Reckelhoff JF. Reflex & voluntary control of posture & movement. In: Ganong’s Medical Physiology Examination & Board Review.  26th ed . McGraw Hill; 2018. Accessed April 4, 2021. https://library1.unmc.edu/login?url=http://www.accessmedicine.com/home.aspx

Note that in entries for a  first edition or book without edition number, no edition number is shown.

Book chapter in print form :

• AuthorLast F (or corporate author name).  Book chapter title.  In: Book Title.   #rd/th ed. Publisher’s Name; yyyy:startpage-endpage.
• Barrett KE, Barman SM, Boitano S, Brooks H. Neural basis of instinctual behavior & emotions. In: Ganong’s Review of Medical Physiology. 23rd ed. McGraw Hill; 2010: 260-269.
• AuthorLast F (or corporate author name).  Webpage title.  Website Title.  Published Month dd, yyyy.  Accessed Month dd, yyyy.  web address
• Shukle P. Pharmacokinetics and pharmacodynamics.  Lecturi.  Published 2022.  Accessed May 27, 2022.  https://www.lecturio.com/medical-courses/pharmacokinetics-and-pharmacodynamics.course#/
•  Division of Cancer Prevention and Control. Breast cancer. Centers for Disease Control and Prevention. Published March 9, 2022. Accessed May 27, 2022. https://www.cdc.gov/cancer/breast/

The publication date for the first example was taken from the free first lesson.  The publication date could have been left out.

The second example above could be formatted as an author-less reference.  The “last reviewed” date has been used as a published date.  The published date could have been left out.

Questions, Problems, Text Errors?

Before you leave, …

• Do you have any questions or do you feel that clarification of some aspect of the materials would be helpful?
• Have you noticed any errors or problems with course materials that you’d like to report?
• Do you have any other comments?

If so, you can submit questions, comments, corrections, and concerns anonymously — or with your e-mail (your choice) — through this online form . Alternatively, you’re always welcome to contact Cindy Schmidt directly 402-650-5056, [email protected], or by making an appointment to meet with Cindy via Zoom.

Answers to questions or requests for clarification that are submitted anonymously will be answered in Canvas on the “Discussions” page for this course.

Introduction to Drug Information Copyright © by Cynthia M. Schmidt is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License , except where otherwise noted.

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Chapter Sixteen:  Drug Evaluation Monographs

Patrick M. Malone; Mark A. Malesker; Indrani Kar; Danial E. Baker; Sunil Kumar Jagadesh

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Disclaimer: These citations have been automatically generated based on the information we have and it may not be 100% accurate. Please consult the latest official manual style if you have any questions regarding the format accuracy.

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Learning objectives, key concepts, introduction.

• PURPOSE OF DRUG EVALUATION MONOGRAPHS
• SOURCES OF DRUG MONOGRAPHS
• CONTENTS OF THE DRUG MONOGRAPH
• IMPORTANCE OF THE DRUG MONOGRAPH
• SUMMARY PAGE
• BODY OF THE MONOGRAPH
• DISTRIBUTION OF DRUG FORMULARY
• SELF-ASSESSMENT QUESTIONS
• ACKNOWLEDGMENt
• Full Chapter
• Supplementary Content

After completing this chapter, the reader will be able to:

Describe and perform an evaluation of a drug product for a drug formulary.

List the sections included in a drug evaluation monograph.

Describe the overall highlights included in a monograph summary.

Describe the recommendations and restrictions that are made in a monograph.

Describe the purpose and format of a drug class review.

Describe and perform an evaluation of a therapeutic interchange.

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