report x contemporary issues in medicine: education in safe and

Report X

Contemporary Issues In Medicine:Education In Safe and EffectivePrescribing Practices

Medical School Objectives Project

Association ofAmerican Medical Colleges

Learn

Serve

Lead

July 2008

Report XContemporary Issues in Medicine:Education in Safe and Effective Prescribing Practices

Medical School Objectives Project

July 2008

To request additional copies of this publication, please contact:

M. Brownell AndersonAssociation of American Medical Colleges2450 N Street, NWWashington, DC 20037T 202-828-0665 F [email protected]

© 2008 by the Association of American Medical Colleges. All rights reserved.

Report XContemporary Issues in Medicine:Education in Safe and EffectivePrescribing Practices

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I. Introduction

The practicing physician in the 21st

century is faced with many challenges.Among these is the difficult task ofsafely and effectively prescribingmedications given the more specializedand powerful pharmaceuticalarmamentarium available today. Inaddition, the promise of personalizedmedicine and the growing recognitionof patient variability in preferences,risk tolerance, and response totreatment require that the modernprescriber possess a new set of skills.As newer medications have becomemore “powerful” (often more effective,and sometimes more toxic), the clinicalskills of making an accurate diagnosis,and individualizing drug treatment tofit the specific patient being treated,are becoming even more crucial.

Concern about medical studentsgraduating without adequate trainingin therapeutics is not new. In 1903, thepresident of the American TherapeuticSociety, Dr. Reynold W. Wilcox,expressed great concern aboutsuboptimal education in clinicalpharmacology and therapeutics in U.S.medical schools. During hispresidential address, he stated that“…the day had come when somethingmore is demanded of the practitioneror physician-consultant than adiagnosis…our obligation will not besatisfied until general principles havebeen fitted to the particular patient.The question is: How shall we teach themedical student so that he shall be bestfitted to become a useful practitioner?”1

During the last 30 years or so,numerous clinical pharmacologists,basic pharmacologists, and other

educators have stressed the importanceof ensuring that all medical schoolgraduates possess the attributes andqualities of a thoughtful, safe, andeffective prescriber. A variety ofsuggestions have been put forwardconcerning what a core curriculumshould contain, how such coursescould be structured, and optimal timesto teach such material to medicalstudents. 2-18

Prescribing medications for nearly anyindication is one activity that distin-guishes a physician from other healthcare professionals and is a privilegethat carries serious responsibilities topatients, society, and the profession.For these reasons, it is important thatmedical students begin to understandall that is involved in becoming a safeand effective prescriber of pharmaceu-ticals (and related substances such asbiologic vaccines or nutraceuticalagents) before they become physiciansand reach a pivotal event in theirprofessional lives: the ability toprescribe independently, on their firstday of residency training.

According to current tenets of U.S.consumer law, most consumer productmanufacturers are legally responsiblefor informing the consumer of therisks associated with the use of theirproducts. However, the pharmaceuticalcompanies that develop, manufacture,and market prescription drugs rely onphysicians to be their “learnedintermediaries” in helping patientsunderstand the risks associated withthe use of their drug products. This,too, places a large responsibility on theshoulders of the young intern whowrites his or her first prescription,without the need to have it cosigned.

The safe and effective prescribing ofmedications has been an ongoing topicof tremendous importance to thoseconcerned with physician education.The report of the Institute ofMedicine’s Committee on Quality ofHealth Care in America, To Err isHuman19, issued in 1999, detailedconcerns about the quality ofAmerican health care, including errorsin interpreting laboratory tests andprescribing and medical errors.

The Association of American MedicalColleges (AAMC) has a longstandinginterest in the quality of medicalstudent education and patient care. In2005, the AAMC and the U.S. Foodand Drug Administration (FDA)convened a conference titled, DrugDevelopment Science: Obstacles andOpportunities for Collaboration.20

Conference participants agreed thattoo few physician (and veterinary)scientists with deep understanding ofhuman diseases and drug interventionare being trained to lead necessaryresearch initiatives in both the publicand private sectors. Equally of concern,however, was a consensus thatgraduating medical students, residentsin training, and practicing physicianslacked fundamental understanding andtraining in pharmacotherapy andrational prescribing. Participants feltthat the situation would only growmore dire as the genomic revolutionmade personalized medicine a reality,and as more powerful and narrowlytargeted therapeutics reach the market.

Pharmacology faculty, clerkshipdirectors, residency program directors,and physicians in the pharmaceuticalindustry have expressed increasingconcern that medical students are not

Association of American Medical Colleges, 2008

receiving sufficient education inprescribing. Specific concerns include alack of knowledge about the process ofdrug discovery, clinical research,product development, regulation, andthe knowledge and skills involved insafely prescribing these medications.

For the past 10 years, the AAMC hasbeen engaged in the Medical SchoolObjectives Project (MSOP). The firstMSOP report, Learning Objectives forMedical Student Education, was issuedin February 1998.21 The goal of theinitiative has been to enhance therelevance and thereby improve thequality of medical student education.The specific aim of the first report wasto foster a consensus within themedical education community on thelearning objectives for the generaleducation of the physician graduate.The following principles guided thework of the advisory committee indeveloping the first report:

• The combined purposes ofundergraduate and graduatemedical education are to educatephysicians and to prepare them tomeet their individual and collectiveresponsibilities to patients and tothe society at large.

• Medical schools should provide ageneral professional education thatwill allow students to acquire theknowledge, attributes, and skillsthat they ultimately will need forpatient care responsibilitiesincluding an appreciation anddedication to continuous and life-long learning.

.

Report I is organized by physicianattributes needed to meet society’sexpectations, and each attribute isfollowed by a set of learning objectivesoutlining a blueprint for medicalstudent education. Report I is broad inscope and language and is notintended as a national curriculum.

Since publication of the first MSOPreport, subsequent MSOP reports haveeach focused on specific, important,and contemporary issues in medicaleducation, which set forth specificlearning objectives and educationalstrategies to foster the learningobjectives. These reports discusseducational issues such as medicalinformatics and population health,communication, basic science, clinicalresearch, quality of care, genetics,musculoskeletal medicine, and theprevention and treatment of obesity. Aswith the first report, these later MSOPreports have been made available tomedical schools for their consid-eration22, but any implementation ofthe objectives remains the purview ofthe faculty members of each school.The MSOP reports have been usedwidely at medical schools as blueprintsaround which to organize medicalstudent educational experiences.

Because of the ongoing importance andpublic interest in the topic, the MSOPapproach was used to develop this reporton the education of medical students ineffective and safe prescribing.

To prepare this report, the AAMCconvened a panel of academic andindustry experts in drug therapy,pharmacology education, and pharma-ceutical research and development.The panel was assembled by AAMC

staff after consulting with variousleaders in the medical education andpharmacology communities, includingindustry. The panel was charged toaddress three fundamental questions:

• What should medical studentslearn in order to becomeknowledgeable, safe, and effectiveprescribers of medications?

• What is the ideal educationalenvironment for learning about theoptimal prescribing of medications?

• What kind of educationalexperiences would allow students toachieve those learning objectives?

The panel was not charged withdeveloping a specific course in safe andeffective prescribing, but rather toconsider the knowledge, skills, andattitudes necessary for all graduatingmedical students to understand andpractice safe and effective prescribingwith the ultimate goal of improvedpatient care.

The panel was aware of existingdetailed pharmacology-orientedcurricula, including The KnowledgeObjectives in Medical Pharmacologyinitiative, first issued in 1985 under theleadership of James Fisher, Ph.D., andother senior medical school pharma-cology faculty. A third edition wasissued in 2005, under the leadership ofRichard Eisenberg, Ph.D., and GaryRosenfeld, Ph.D.23 The panel was alsoaware of a number of published paperswritten by clinical pharmacologyeducators and consensus panelsrecommending various elements tocreate such a curriculum for medicalstudents and residents.4-18


2 Association of American Medical Colleges, 2008


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Panel members used the six corecompetencies recommended by theAccreditation Council for GraduateMedical Education (ACGME)24 as theorganizational structure for theobjectives in this report. Thosecompetencies include:

• Medical Knowledge

• Patient Care

• Interpersonal and CommunicationSkills

• Professionalism

• Practice-based Learning andImprovement

• Systems-based Practice

These competencies were used as amechanism to frame the discussion ofthe objectives for a strong curriculumin safe and effective prescribing inmedical student education.

II. Knowledge ObjectivesSummary

The six tables that follow contain thebroad educational objectives which, inan ideal curriculum, would be taughtand evaluated at each medical schoolto prepare all graduates to bethoughtful, effective, and safeprescribers by the time they areresidents. Each broad competencydomain, as outlined by the ACGME, isaddressed by a table, which includesnot only the broad educationalobjectives mentioned above, but alsoimportant subtopics, and a fewillustrative examples of detailedcontent to illustrate the breadth anddepth of an ideal undergraduatemedical education curriculum. Thelevel of mastery to be desired in eacharea is, in brief, the level of masterythat we would like all first-yearresidents to have attained before theywrite their very first independent drugorder or prescription on their first dayof residency.

These tables have some contentoverlap, which is unavoidable. Forexample, the ability to accurately teaseout a patient’s medication history,including an up-to-date medication listand a detailed list of previous adversedrug events and allergies, is both acommunication skill and a skillnecessary to deliver excellent patientcare. In addition, the content withinthe tables has not been prioritized.These tables also do not explicitlydescribe how student mastery of eachlearning objective might best beassessed, leaving that to the judgmentof faculty at each school, given theirinstitution’s culture and resources.

The panelists developed these six tables,after much discussion and learningfrom one another, to help all medicalschool faculty have a clearer sense of thebreadth and depth of a curriculum thatwould help all graduates become thesafe and effective prescribers that wewould hope for when we becomepatients, and that our patients have aright to expect.




III. Safe and Effective Prescribing Knowledge Objectives

Table 1 - MEDICAL KNOWLEDGE:What each student needs to learn, understand, and be able to apply to become acompetent resident prescriber. Medical students must demonstrate sufficient and appropriate knowledge about establishedand evolving biomedical, clinical, statistical, and social-behavioral sciences and apply this knowledge to patient care. Asstudents receive their M.D. degree and prepare to prescribe medications without supervision, they need to understand:

Broad topic Subtopics Detailed examples or skillsA. Factors that make each

patient uniqueAge, gender, ethnicity, weight,pregnancy and breastfeeding status,liver function, kidney function, otherconcurrent diseases, concurrentmedications, history of allergies orprevious adverse drug reactions (ADRs),relevant pharmacogenetic background,environmental exposures

• Know effects of liver disease on drug choice• Know effects of renal function on choice and

dosing of medications• Know effects of prior penicillin allergy on

choice of antibiotic• Understand pharmacotherapy of acne in pregnant

patients• Understand effects of smoking and diet on

drug action and kinetics• Know hazards of polypharmacy in the elderly

B. Principles of clinicallyimportant pharmacokinetics

Absorption, distribution, metabolism,excretion, concepts of bioavailability,AUC (area under the curve), half-life,Tmax, Cmax, clearance, maintenancedose, loading dose, potential role ofprotein binding and free drug levels insome medications, plasma vs. biologicalhalf-life, effect of inadvertent ordeliberate intermittent therapy (theissue of compliance)

• Calculate a loading dose and maintenance dose ofgentamicin

• Convert from an IV dose to an oral dose• Convert various opioids either from one route to

another, or from one drug to another• Know implications of CYP 450 genotype• Know how to instruct a patient to resume dosing

after a drug holiday

C. Drug treatment ofcommon conditions anddiseases, using frequentlyprescribed classes ofdrugs for the treatmentand prevention of disease

Drugs used to treat common conditionssuch as hypertension, asthma,pneumonia, and other commoninfections; hyperlipidemia; gastroin-testinal (GI) complaints; diabetes;obesity; arthritis and musculoskeletalconditions; acute and chronic pain;preventative drug treatment such asvaccines; role of known useful drugcombinations such as those used inhypertensive or diabetes therapies

• Select optimal antihypertensive for patients withdifferent concomitant medical problems

• Know implications of local patterns of antibioticresistance in choosing antibiotics for a patient

• Understand mechanism of action of commonlyprescribed medications

• Develop treatment plan for terminal cancer patientwith chronic pain

• Know differences in dosing children

D. Management of lesscommon but severemedical conditions andemergencies

Management of sepsis, shock,anaphylaxis, meningitis, myocardialinfarction, drug overdose, malignanthypertension

• Understand optimal management of patient withacute overdose of aspirin, acetaminophen, etc.

• Know specific steps in managing life-threateninganaphylaxis

E. Rules and regulationsthat govern prescribing

State/province board of pharmacyregulations, FDA/Health Canada, DrugEnforcement Administration (DEA),hospital formularies, hospital pharmacyand therapeutics (P&T) committees,prescribing medications for “off-label”indications

• Understand restrictions of prescribing ScheduleII-III-IV-V drugs

• Be aware of state/province rules for prescribing for selfand family

• Know that most children’s medicine is “off label”• Understand compassionate use prescribing



Broad topic Subtopics Detailed examples or skillsF. Process and regulations

governing drug discoveryand development

Discovery, non-clinical testing, investiga-tional new drug (IND) applications, PhaseI-II-III, new drug applications (NDA)/biologics license applications (BLA),approval, indications and marketing,Phase IV, postmarketing regulation, theimportance of the balance of efficacyand safety in both discovery andcommercialization of drugs

• Know limits of data about new drug at time ofregulatory approval

• Know how additional indications and warnings can beadded post approval

• Know recent changes in regulatory (e.g,. FDA in theUnited States, Health Canada in Canada) responsi-bilities and legal authority for post-approval follow-up

• Know principles of clinical research (e.g., randomization,blinding, informed consent, and good clinical practice)

G.Diagnosis andmanagement of patientswith substance abuseproblems

Alcohol abuse, smoking, opioids,cocaine, amphetamines, benzo-diazepines, etc.; related terminologyincluding tolerance, dependence,addiction, intoxication, withdrawal

• Know how to manage patient trying to quitsmoking/drinking/abusing

• Know how to manage patient acutely intoxicated with heroin• Undestand opioid maintenance therapy with

methadone or buprenorphine• Know how to manage drug/alcohol acute withdrawal• Know implications for the newborn of a

drug-addicted mother

H. How to find and use themost up-to-dateinformation about drugs,biologics, and nutraceuticals

Drug compendia; electronic databasessuch as Clinical Pharmacology Online,Lexi-Comp, Epocrates, NIH andNCCAM websites, Sanford Guide ofAntimicrobials, Micromedix, Neofax,Almedex, etc.

• Find drugs indicated for treatment of UTI in pregnantpatient

• Explore potential drug interactions when patient isreceiving 6 different medications

• Know drugs contraindicated in patients with G6PDdeficiency

I. Medication errors Frequency of medication errors, contri-bution to patient morbidity andmortality, root cause analysis, qualityimprovement efforts, confusion overabbreviations, avoiding misleadingorders such as zero placed afterdecimal point

• Perform a root cause analysis on a patient who receivesthe wrong medication, or the wrong dose of a medication

• Design system changes to improve a system thatresulted in a patient receiving a potent anticancer drugvia the incorrect route

• Understand confusion between 5u of insulin and 50units of insulin

J. Adverse drug reactions Common ADRs for commonly useddrugs, pharmacoepidemiology,assessing causality, avoiding ADRs inthe first place, the role and reportingrequirements of the MedWatch system;drug-food interactions

• Download and complete a MedWatch form from theFDA Web site

• Discuss one patient you have cared for whoexperienced a serious or life-threatening ADR, anddiscuss how it might have been avoided

• Capture ADRs accurately in an electronic medical record

K. Drug-drug interactions Three common mechanisms of druginteractions (DI’s) (pharmaceutical,pharmacokinetic, pharmacodynamic);searching a list of drugs for potentialdrug-drug interactions; potentiallylife-threatening drug interactions

• Search an electronic database and be able to findwithin 3 minutes all interactions between vancomycin,gentamicin, lisinopril, naproxen, alcohol, and foods

• Identify and explain drug interaction betweenazathioprine and allopurinol

• Know effects of certain foods on drug absorption



Broad topic Subtopics Detailed examples or skillsL. Complementary and

alternative therapiesVolume of consumption of variousnutraceuticals in the generalpopulation; regulation of theproduction, sale, and advertising ofvitamins, health supplements, etc.;potential for interactions withprescription drugs; value ofacupuncture and non-pharmacologictherapies; which nutraceuticals havebeen shown to be effective;metabolism and drug-drug interactionsof commonly used nutraceuticals

• Know current limitations on how such products can beadvertised

• Know safety and efficacy of alternate products• Know when regulatory authorities can become

involved• Know why products containing ephedra were banned

from sale• Explain interaction between cyclosporine and

St. Johns wort

M. Statistical issues and trialdesign

Observational studies, interventionalstudies, Type I error, Type II error,power, advantages of blinding, utilityof meta-analysis, sensitivity andspecificity of diagnostic tests

• Know how to critically review the about clinical drugtrials literature

• Know how to eliminate bias in clinical research• Know hierarchy of evidence of clinical data

(i.e., RCTs, observational studies, case reports, etc.)• Know what factors influence sample size in an

intervention drug trial• Understand the methodological challenges in

quantitative approaches to depiction of benefitsand the balance of benefits to harm (risks)



Table 2 - CORE SKILLS FOR PATIENT CARE: What clinical skills each graduate needs to provide excellent pharma-cotherapeutic care to his/her patients. Students must possess a wide variety of clinical skills to enable them to providecompassionate, appropriate, and effective patient care to treat health problems and promote health. Many skills relatespecifically to prescribing medications. Students are expected to be able to:

Broad topic Subtopics Detailed examplesA. Communicate well with

patients and familiesabout drug-related topics

Form a therapeutic alliance, elicitpatient preferences, counsel about newdrugs and drug decisions, promoteadherence, explain risks and benefits,monitor compliance

• Assess readiness to quit smoking• Explain risks and benefits of new drug• Elicit patient preference for two possible medications

with different benefits, risks, and costs• Understand insurance coverage considerations

B. Obtain detailed andaccurate drug history

Know prior medications, current Rxmedications, over-the-counter (OTC)medications, topical medications,nutraceuticals; prior drug allergies andADRs

• Elicit detailed information from a patient who believeshe/she had a prior “allergy” to a medication (e.g.,erythromycin-induced nausea)

• Understand differences between allergic andnonallergic adverse drug reactions

• Understand best ways to elicit a detailed drug historyfrom different types of patients

C. Have a robust process fordeveloping a sound drugtherapy plan

Know the process of making accuratediagnosis, review disease pathophys-iology, generate menu of therapeuticchoices, select best choice for this patient(with consideration of patientexpectations and preferences), selectendpoints to follow, form a therapeuticalliance; elicit patient preferences, andpatient understanding of risks; knowprinciples of pharmaco-economics;understand applicable formularies(Medicare, private insurers, etc.) andexisting restriction and substitutionpolicies; understand the role of skippeddoses in compliance, and what should berecommended if dose-skipping occurs

• Know optimal treatment choice of healthy outpatientwith a UTI, vs. inpatient with urosepsis

• Incorporate evidence-based guidelines for treatment ofdiabetic patients with an ACE inhibitor or an ARB

• Select treatment for asthma

D. Use informationtechnology resources tosupport clinical pharma-cotherapeutic decisions

Know up-to-date drug information;how to access review articles,biomedical journals, electronic medicalrecords, PubMed, OVID, Google, anddrug information databases

• Find recent review article on drug management ofhypertension

• Be familiar with latest clinical trial of Angiotensin IIReceptor Blockers (ARBs) in the treatment of diabeticnephropathy

E. Prescribe thoughtfully,unambiguously, andclearly

Know eight essential parts of a writtenprescription, when to use a DEAnumber, abbreviations to be avoided,DEA restrictions on renewals

• Write a clear, complete, and unambiguous prescriptionfor an outpatient

• Perform similar task for a written drug order for aninpatient

• Keep a record (inpatient/outpatient) of written prescriptions

F. Find recent criticalpathways and evidence-based medicineinformation

Know how to access Cochranedatabase, ACP Journal, other sourcesof critical pathways, and evidence-based medicine reviews

• Find evidence-based medicine (EBM) review of thevalue of antibiotic prophylaxis in neutropenic patientsprior to development of fever

• Be familiar with WHO guidelines for most importantdrugs



Broad topic Subtopics Detailed examplesG.Read and understand

package insertsKnow information required byregulatory authorities; how differentsections are labeled; difference betweenwarning, precautions, contraindications,adverse reactions; regulatory authority-approved indications

• Prescribe for both regulatory authority approved andnonapproved indications

• Know restrictions on drug advertising and detailing• Know how updates to the official package label are

approved by regulatory authorities• Be aware of black box warnings

H. Use therapeutic drugmonitoring effectively,when needed

Know therapeutic range, targetconcentration strategy, steady-statelevel, peaks and troughs, whenphysiologic endpoints are preferable,alterations in protein binding (freefraction), understand how to correctlyperform therapeutic drug monitoring

• Know how to alter dosing of gentamicin based onpeak or trough levels

• Know effects of other drugs on steady-state levels ofcyclosporine

• Know appropriate timing for obtaining peaks andtroughs

• Know how to interpret levels that weren’t drawn at aspecific time

I. Interpret and use antibi-ograms effectively;understand principles ofantibiotic coverage

Know how to interpret sensitive, low-grade resistance, high-grade resistance;outpatient strains vs. inpatient strains;trends over time

• Know how to select antibiotic of choice for empirictreatment of meningitis based on local antibiogram

• Know how to narrow antibiotic spectrum oncesensitivity patterns of current pathogen are known

• Understand MIC’s in context of achievable drugconcentrations

J. Maintain accurate anduseful medical records

Understand how to enter and maintainmost accurate information aboutcurrent medications, prior ADRs, priorallergies

• Know how to enter crucial information in localelectronic medical record

• Confirm and validate information previously enteredby other providers

• Know how best to elicit information from patientsabout drug compliance, reasons for discontinuation



Table 3 - INTERPERSONAL AND COMMUNICATION SKILLS: Howmedical students must be able to relate to, andcommunicate with, their patients and clinical colleagues to optimize the effectiveness of their therapeutic plans.Medical students must be able to demonstrate interpersonal and communication skills that result in effective informationexchange and teaming with patients, their patients’ families, and professional associates. Students are expected to be able to:

Broad topic Subtopics Detailed examplesA. Communicate basic

information about drugtherapy to patients and theirfamilies, including purposeof medication, how itworks, possible adversedrug reactions, potentialdrug interactions, cost, andnecessary follow-up

Learn patient preferences fortreatment, understand patient concernsand goals about disease and treatment,create partnership without conflicts ofinterest, forge therapeutic alliance

• Communicate to patients that their interests areprimary

• Elicit patient preferences for palliation or cure indiseases such as cancer

B. Use effective listeningskills and elicit andprovide information usingnonverbal, explanatory,and questioning skills

Communicate well with patients whohave different levels of health literacy;use listening skills to elicit patientconcerns about delicate issues such aspalliative care, or substance abuse;note the treatment of patients withconcurrent disease and otherpotentially confounding factors forsuccessful drug therapy

• Find out drinking history in patient reluctant to discuss• Elicit history of substance abuse in patient presenting

with endocarditis or HIV

C. Work effectively withothers as a member orleader of a health careteam

Optimize relationships and communi-cation with other physicians, registerednurses, practical nurses, pharmacists,and others

• Develop relationships with pharmacists that permit apartnership for patient care, with internal safety checkson doses, etc.

• Communicate clearly with nurses, and in a manner thatencourages questions and ability to spot medication errors

• Partner with other staff members to reinforce patienteducation about important aspects of medication use

D. Develop sound skills tocritically evaluate medicalinformation

Develop skills to critically evaluateevidence presented by any source,including industry; understand whatconstitutes a conflict of interest or theappearance of a conflict of interest inprofessional relationships

• Learn how to get industry representatives to focus onproviding peer-reviewed, published clinical trials

• Realize need to focus on data supporting regulatoryauthority-approved indications

• Know regulations and principles of professionalism thatgovern pharmaceutical representatives and physicians inpromotion and detailing of pharmaceuticals.

• Understand how receipt of gifts, payments, or otherrelationships can influence physician judgment anddistort prescribing practices

E. Develop the ability torecognize errors andcommunicate effectivelywith patients about them

Recognize medication errors;understand root cause analysis, conceptof team as a system, role of discussionswith risk management; need to presentinformation back to patient

• Know how to deliver news of an adverse event orerror back to patient

• Understand role of concern and apology• Obtain new information supporting more openness

with patients about medical errors

F. Explain to patients druginformation gatheredthrough direct to consumer(DTC) advertising orInternet searching

Know extent of recent DTC advertising,legal limits and reviews of ads byregulatory authorities, requirement toprovide adequate information aboutbenefits and risks

• Know how to handle patient requests for a new drugor medication

• Educate patients that “new” drugs are not necessarilymore medically effective, safer, or cost effective



Broad topic Subtopics Detailed examplesG.Understand how cultural

background can alterpatient views of drugtherapy and diseasecausation

Provide patient understanding ofpathogenesis of disease, role of drugtherapy, who must be consulted forpermission to begin drug therapy

• Elicit patient’s views about what is causing symptomsand disease

• Understand how culturally related views of medicationalter efficacy, compliance, etc.

H. Be aware of specialcommunication issuesrelated to drug research

Talk to patients about possible partici-pation as human research subjects,obtain consent that is truly informed,help patients deal with risk anduncertainty, understand specialchallenges of performing clinicalresearch in vulnerable populations

• Know essential elements for informed consent• Understand role of the IRB in approving patient

information and informed consent documents• Be familiar with past flawed studies, such as the

Tuskegee syphilis study• Understand that prisoners, children, and the mentally

challenged are considered vulnerable populations andsubject to enhanced human subject protections

• When involving pregnant women, special consid-eration must be given due to risk to the fetus

I. Avoid collusion ofanonymity

Understand need for one physician tooversee and coordinate all drugtherapy; know confusion of roles inacademic medical centers andproblems with duplicative, interactive,or conflicting drug treatment plans

• Discuss role of residents on ICU team in which patientreceives four consults from different services withdifferent drug treatment recommendations

• Understand role of resident as physician closest topatient, and often relied on by patient for advice



Table 4 - PROFESSIONALISM: Medical students must demonstrate a commitment to carrying out professionalresponsibilities, adherence to ethical principles, and sensitivity to a diverse patient population. Students are expected to:

Broad topic Subtopics Specific examplesA. Demonstrate respect for

patient, showcompassion, and modelintegrity

Put patient needs first, avoid selfinterest and personal biases, realizeimportance of follow-up

• Refrain from judging patient with substance abuseproblems

• Find balance between pedestal and therapeuticpartner

B. Commit to a habit oflifelong learning aboutdrugs, and to therapeuticexcellence

Know sources of unbiased informationabout new drugs as they are approved,how different drug compendia areassembled and organized, howchanges in regulatory authority overtime affect physician prescribing andsafety of drugs, biologics, andnutraceuticals

• Demonstrate knowledge of how to access FDA orHealth Canada Web sites

• Subscribe to objective source of information aboutnew drugs such as Medical Letter

• Able to critically review the medical literature• Subscribe to FDA Updates for Health Professionals

C. Understand accountabilityto society and theprofession

Responsible for discovering andreporting new knowledge, need tointervene when observing unethicalbehavior or substance-dependentphysician

• Know how to file a Medwatch report of suspectedserious ADR

• Know how to file a report with the source pharma-ceutical company of a suspected serious ADR

• Know how to file accurate, detailed reports of ADRsthat will be of greatest use and value

• Know how to recognize risks of substance abuse inphysicians, and how to spot and report an impairedphysician

D. Show commitment toethical principles

Provide or withhold clinical care, honorpatient confidentiality and HealthInsurance Portability and AccountabilityAct (HIPAA) provisions, employ ethicalbusiness practices, avoid real orpotential conflicts of interest, befamiliar with Declaration of Helsinkiand the Belmont Report

• Plan to develop a lifelong, ethical, and professionalrelationship with drug and device companies

• Understand how receipt of gifts, payments, or otherrelationships can influence the judgment of physiciansand can distort prescribing practices

• Know appropriate enrollment of subjects in drug trials

E. Demonstrate sensitivityand responsiveness topatients’ culture, age,gender, and disabilities

Influence of patient background andculture on beliefs about disease andtreatment; obtain true informedconsent

• Know how to provide patients’ drug information indifferent languages, written to an appropriate agelevel

• Use of translator in discussions

F. Practice behaviors thatsupport personal healthand career fulfillment,and prevent burnout

Know state/province regulations thatpertain to prescribing for self andfamily, work-related risk factors forsubstance abuse

• Know how states and provinces provide localadditional rules and regulations to national DEAguidelines

G.Understand theimportance of admittingerror, and apologizingwhen appropriate

Know concept of each prescription as atherapeutic trial, realize importance ofcatching medical errors as early aspossible, explain errors and risk topatient, act to prevent errors

• Know how to explain to patient in an understandableway the uncertainty related to making diagnosis,predicting efficacy of drug treatment, and potentialfor harm



Broad topic Subtopics Specific examplesH. Know your own personal

limitations in knowledgeor therapeutic skills, andfeel comfortable askingfor help or advice

Know importance of generalprescribing skills to the generalphysician, guidelines for seeking experthelp with difficult-to-use or especiallytoxic drugs (e.g., chemotherapy, antiar-rhythmic drugs)

• Be aware of local hospital rules about which physiciansare allowed to prescribe specific classes of drugs

• Know concept of a personal drug formulary, wherephysician has comfort level in prescribing

I. Balance commitment tothe individual patient’swelfare with societalconcerns

Understand tension between selectingbest drug for individual patient vs.needs of a larger group, overuse ofantibiotics in specific patients leadingto changes in resistance pattern for allpatients, the role of “tiering” ofprescription benefits to enable earlyuse of generics in a “fail-first”paradigm to limit drug costs, tailoredtherapeutics or personalized medicine

• Recognize changes in strains of staphylococcusresistant to methicillin over past 15 years

• Know how pharmacy budgets are developed in closedpopulations of patients (e.g., VA hospitals)



Table 5 - PRACTICE-BASED LEARNING AND IMPROVEMENT: Medical students must be able to review andevaluate their own patient care practices, appraise and assimilate scientific evidence, and find ways to improve theirpatient care outcomes. Students are expected to:

Broad topic Subtopics Specific examplesA. Analyze practice experience

and perform practice-basedimprovement activitiesusing a systematicmethodology

Analyze critical pathways, evidence-based medicine, patient safety initiatives,medication errors, quality improvementinitiatives, how patient-specificinformation (e.g., estrogen receptorstatus of tumor) can substantially altertreatment plans; participate in clinicalresearch to learn more about drug actionin the “real world” patient setting

• Perform root cause analysis of a medical error• Analyze why some practices have better compliance

for aspirin, beta-blockers, ACE inhibitors S/P MI• Understand impediments to incorporating

“best prescribing practices” in a patient practice• Understand issues and reasons for physician and

patient noncompliance with practice guidelines anddirections for use of medicines

B. Locate, appraise, andassimilate evidence fromscientific studies relatedto patients’ healthproblems

Able to read and understand primarydrug trial literature, EBM sources, meta-analyses, best Web-based sources forprimary sources and review; be familiarwith the important components of theregulatory authority-approved official“package insert”

• Find latest references dealing with vancomycin-resistant enterococcus

• Identify latest consensus guidelines for treatment ofcommunity-acquired pneumonia

• Know how to interpret and apply population-basedefficacy and/or safety data to individual patients(e.g., NSAID efficacy and safety data)

C. Obtain and useinformation about one’sown population ofpatients and the largerpopulation from whichpatients are drawn

Be familiar with community-based dataregarding cancer risk, cardiovasculardisease, obesity, and patterns ofantibiotic resistance

• Find data at local hospital of the percentage of MIpatients discharged on aspirin and a beta-blocker

• Find data at a local hospital of the percentage ofpatients with DM receiving ACE inhibitor to protectrenal function

D. Apply knowledge of studydesigns and statisticalmethods to the appraisalof clinical studies andother information ondiagnostic andtherapeutic effectiveness

Understand concepts of Type I error,Type II error, power analysis, confidenceintervals, etc., to analyze recentpublished clinical trials; managecompeting and sometimes conflictinginformation regarding the safety andefficacy of pharmaceuticals

• Read, analyze, and understand recent masked,controlled intervention trial

• Read, analyze, and understand recent case-controlobservational study

• Study related issues in the MSOP report on“Clinical Research in Medical Education”

E. Use information technologyto manage information,access online medicalinformation, and supporttheir own education

Be familiar with PubMed, OVID,UpToDate, Cochrane, ClinicalPharmacology Online, MDConsult,EBM, electrical pharmaceuticaldatabases

• Use a Web-based IT resource to access usefulinformation about a recently approved drug

• Access regulatory authority Web sites to review newinformation (indications, warnings, etc.) aboutapproved drugs

F. Understand use of criticalpathways and guidelines tostandardize and optimizepractice, using best EBM

Be familiar with Cochrane database ofsystematic reviews, Clinical Evidence,National Guideline Clearinghouse, ACPJournal Club, bmjupdates

• Find and assess a critical pathway for a commonproblem, such as management of hypertension

• Know standard-of-care treatments of common illnesses

G.Know role of hospitalpharmacy andtherapeutics (P&T)committees

Know role of closed hospital formulary,therapeutic substitution, andformularies maintained by insurancecompanies

• Understand process whereby hospital P&T committeemay select the “workhorse” drug of a given class

• Understand the principles of populations-basedcost/benefit/risk analyses

• Know possible financial and adherence implications forthe patient of a physician “blindly” prescribing newer,more expensive drugs



Table 6 - SYSTEMS-BASED PRACTICE: Medical students must demonstrate an awareness of and responsiveness tothe larger context and system of health care and the ability to effectively call on system resources to provide optimalvalue care. Students are expected to:

Broad topic Subtopics Specific examplesA. Describe how their patient

care affects other healthcare professionals, thehealth care organization,and the larger society

Prescribe drugs for approved andunapproved indications, understandnurse and pharmacist roles in drugtherapy, realize costs and contributionsof prescription and OTC drug products,be aware of implications for antibioticresistance

• Know implications of excessive antibiotic prescribingon patterns of resistance

• Understand under-prescribing of aspirin, beta-blockersfor patients with recent MI

• Realize importance of preventive care (i.e., vaccines)

B. Understand how variouselements of the systemaffect practice

Understand pharmacist availability andthe compounding of pharmaceuticals,nursing staff issues and verbal orders,insurance policies for drug coverage,prior approval for certain drugs, role ofother providers (and implications forthe supervising physician) regardingprescribing privileges

• Know why verbal orders in nonemergency situationscan be problematic

• Understand why insurance companies institutedifferent levels of copayment for different medications

• Understand scope of prescribing and limitations onprescribing by non-physician providers

C. Know how variousdelivery systems differ incontrolling health carecosts and allocatingresources

Understand the role and use offormularies and the nature of coverageprovided by appropriate insurance orgovernment health care plans

• Know why and how different insurers select differentACE inhibitors as their “workhorse” agent

• Know how to find out which drugs are on a particularformulary

D. Practice cost-effectivehealth care and resourceallocation that does notcompromise quality ofcare

Know concepts of cost-effectivenessfor diseases (such as hypertension) thathave many possible drug choices,situations in which a more “expensive”drug choice may be optimal for a co-morbid condition, etc.

• Know the usual drugs of first choice in patients withsimple essential hypertension

• Know how these choices would be modified inpatients with asthma, angina, DM, or who aremembers of various ethnic groups; or who are womenor children/adolescents

E. Advocate for qualitypatient care and helppatients deal with systemcomplexities

Understand situations when a physicianneeds to become a patient advocatewhen a specific drug is medicallynecessary, based on best evidence, butdisallowed by insurance coverage; helpenroll needy patient on a company-sponsored free drug program

• Understand when generic drugs offer a cost-effectivealternative to a brand-name product

• Understand when a more expensive branded productmay be more effective or safer than a generic product(e.g., patient allergy to excipient in a generic product,or use of a sustained-release product)

F. Understand roles ofdifferent professionals inthe prescribe-transcribe-compound-dispense-administer chain

Understand roles of nurse, LPN, unitsecretary, pharmacist, pharmacybenefits manager; confusion aboutlook-alike and sound-alike pairs

• Describe the steps and safety checks when cancerchemotherapy is ordered within your hospital

• Know the special steps and safety checks necessary foradministration of intrathecal medications by the intern(e.g., double signatures at some institutions for safety)

G.Describe how prescribingpractices can affect thehealth care system

Understand that prescription drugsaccount for about $250 billion per yearof $2 trillion total health care costs, valueto patients of avoiding surgery (e.g.,ulcers), value to patients of treatmentsfor previously untreatable diseases (e.g.,CML), concepts of cost of QALY, etc.

• Analyze cost of years of life saved when treating MIwith tPA

• Know impacts on survival and costs of MI reperfusionwith drugs (e.g., tPA) and immediate PTCA

• Know the value of preventive care (i.e., iron deficiencyscreening, vaccines, and cholesterol screening)



Broad topic Subtopics Detailed examples or skillsH. Understand how the

system can support orhinder complexprescribing, such as forsubstance abuse,palliative care, and hometreatment with antibiotics

Know rules, regulations, and socialacceptance of treatments for substanceabuse (methadone, buprenorphine);high-dose opioids for palliative care;home-based treatment for DVT orinfection

• Know new rules and regulations enabling office-basedtreatment of opioid dependence with buprenorphine

• Know the choices of inpatient- and outpatient-basedtreatment of new onset DVT or pulmonary embolism

• Understand hospice care prescribing

I. Describe the role ofregulatory authorities andhow it could bestrengthened andimproved

Know the current process forapproving IND and NDA/BLA,regulation of marketing andadvertising, DTC advertising, reviewsand regulations of nutraceuticalproducts, postmarketing surveillance,process for requiring new warning inpackage insert, process of sharing post-marketing information betweenindustry and FDA/Health Canada,process of applying for newindications, implications of recent lawsaltering regulatory authority forreviewing drugs and nutraceuticals,laws regulating advertising of pharma-ceutical products to physicians anddirectly to consumers

• Understand process by which ephedra-containingproducts were banned by the FDA and otherregulatory authorities

• Review recent episodes of post-marketing discovery ofunexpected toxicity resulting in removal of drug frommarketing (e.g., rofecoxib, troglitazone)

• Understanding importance of regulatory agencies instudying safety of drugs for use in children andpregnant women (e.g., chloramphenicol toxicity,thalidomide tragedy) and how the FDA can encouragedrug development to include studies of drugs inchildren (through extended exclusivity)

IV. Different Models forProviding ClinicalPharmacology Education

Virtually all medical schools accreditedby the LCME offer a course in basicmedical pharmacology in Year 1 or(more commonly) in Year 2 of the M.D.curriculum. These introductory coursesusually are sequenced to coordinatewith other discipline-based basicscience courses, integrated basic sciencecourses, organ- or system-basedpathophysiology courses, or problem-based learning-based curricula. In anyof these formats, medical pharmacologycourses introduce students to the majorclasses of drugs for clinical use and theirmechanisms of action. The importanceof mastering this material during thefirst two years is currently reinforced bythe inclusion of a significant number ofquestions related to basic medicalpharmacology on Step 1 of the USMLEexam sequence.

Traditionally, medical students taketheir clinical clerkships during Year 3of medical school, and then pursuemore advanced clinical experiences(e.g., subinternships) and electivesduring Year 4. Most students are thenin the best position to study clinicalpharmacology and therapeutics aftercompletion of their introductorypharmacology courses, and afterhaving experienced the major clinicalclerkships. Some schools have attachedclinical pharmacology and therapeuticscourse material to the end of the basicmedical pharmacology course, butmany students do not have anadequate grasp of clinical medicine atthat time to fully benefit from thismaterial.

Medical schools incorporating clinicalpharmacology and therapeuticsmaterial into their curricula havefound it helpful to include thismaterial in Year 3 or Year 4 of medicalschool, after students have completedsome or all of their core clinicalclerkships. Various formats forincluding such clinical pharmacologycore material have been tried, such as:

• Clinical pharmacists participatingon team rounds to ensure thattherapeutics are discussed in apatient-centered manner, onsome or all clerkships. (Thismodel is especially common atmedical schools that have schoolsof pharmacy on the samecampus.)

• Including a clinical pharmacologycourse longitudinally throughoutYear 3, or included in intersessioncourses between clerkships duringYear 3.

• Integrating lectures or otherteaching methods into existingclerkships, often the internalmedicine clerkship. This modelhas the advantage of being“piggybacked” onto a strongexisting clerkship, but often isvery time limited and not acomprehensive curriculum inclinical pharmacology.

• Offering electives at some schoolsduring Year 4. While some ofthese electives have been of highquality, and taken by a largesegment of the senior class, suchelectives have the majordisadvantage of not reaching allgraduating seniors.

• Requiring a clinical pharma-

cology and therapeutics courseduring Year 4 is a very powerfullearning experience for seniorstudents, building on Year 2pharmacology knowledge, Year 3clinical knowledge and skills, andYear 4 student desire to preparefor internship. February of Year 4can be an especially effective timegiven what students are focusedon at that time of the year(thinking ahead to becoming agood and safe intern, and lookingahead to Match Day). However, itis difficult to “obtain” curriculumtime in Year 4, and this model isin use at very few U.S. schools,perhaps fewer than five. Also,many medical schools may nothave a core of clinical pharma-cology faculty to organize andhelp teach such a course.

• Since most allopathic U.S. andCanadian medical schools do nothave clinical pharmacologyphysician faculty on site, perhapsuse of shared teaching models orWeb-based curricular materialsmight be helpful. This model iscurrently very successful for theclinical pharmacology courseoffered for fellows within theNational Institutes of Health(NIH), and shared with fellows attraining programs across thecountry. A similar model of anational clinical pharmacologycurriculum developed specificallyfor senior medical students,offered to students at all medicalschools in a Web-based format,has been implemented recently inAustralia.16




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Just as there are several models forproviding a clinical pharmacology andtherapeutics curriculum to medicalstudents, there are several models forteaching the curriculum. Faculty atvarious schools have employedlectures, case-based large-groupinstruction (similar to the case methodused in law school or business school),small-group problem-based learningcases, small-group conferences,tutorials, clinical (patient-centered)electives, etc. Combinations of thesehave been used as well.Teaching/learning formats have oftenbeen determined by logisticallimitations of faculty availability onsite, size of the medical school class,and related factors.

Ultimately, each medical school mustdecide the minimal level of knowledgeand skill that its graduates mustpossess in these (and other)competency domains. Most schoolspursue a four-year curriculum, withmany competing demands forcurricular time and attention.Development of a robust, broad, anddeep curriculum in pharmacothera-peutics is the ideal; creation of a briefercurriculum that “covers the basics” tohelp graduates become thoughtful,safe, and effective prescribers” may be amore realistic goal for most schools.Pursuit of “great” should not preventimplementation of “good.” This isespecially important because we are ina time of important advances in drugs(i.e., monoclonal antibodies) andtechnology (i.e., online druginformation databases), overwhelmingamounts of information, and increasedtime constraints on physicians andother health care providers.

V. Summary

Recent reports from the Institute ofMedicine about the quality chasm andmedical errors, and recent post-marketing data about major health risksof several prescription drugs, remind usthat modern pharmaceuticals are morepowerful and effective than ever before,but a challenge to prescribe in a mannerthat optimizes both efficacy and safety.Every medical school is obligated toensure its graduates’ competency toprescribe medications in a manner thatmaximize drug efficacy, minimize drugtoxicity, recognize the factors that makeeach patient unique, and provide thegreatest value overall to each patientand to society. Every medical schoolgraduate will begin prescribing drugson the first day of residency, oftenwithout direct supervision of eachinpatient drug order or outpatientprescription.

For medical schools that would like tostrengthen their curricula in safe andeffective prescribing practices, thisMSOP report provides an outline ofwhat such a core curriculum mightlook like, organized by the six majorcompetency domains first proposed bythe ACGME. Curriculum time at everymedical school is precious, and findingthe optimum time to “cover” thissubject is a challenge. Assessingwhether students have adequatelymastered each learning objective to anappropriate degree likewise remains aneducational challenge with manypossible solutions. We describe severalmodels that have been successful atvarious medical schools for incorpo-rating this important material. Aparticularly effective approach to

achieving the desired competenciesmay be to offer structured instructionin clinical pharmacology/therapeuticsin Year 4 of undergraduate medicaleducation, in addition to coreinstruction in basic pharmacology inYear 1 or Year 2.

Each medical school has its own localconstraints and learning climate andwill need to find its own local solutionto help its students achieve anappropriate level of mastery of thesedifferent competencies. Because mostcurrent residents (and faculty)graduated from medical schools thatdid not emphasize training in theseareas, it becomes even clearer thatsociety expects our medical schools toensure that each graduate is ready onDay 1 of residency to prescribemedications safely and effectively, andwith appropriate skill and knowledge.




References Cited In Text

1. RW Wilcox. The teaching of therapeutics. Trans Am Ther Soc 1903;25–26.

2. H Gold. A blueprint for the expansion of human pharmacology in the medical curriculum. J Clin Pharmacol1968;8:74–78.

3. KL Melmon and HF Morrelli. The need to test the efficacy of the instructional aspects of clinical pharmacology. ClinPharmacol Ther 1969;10:431–435.

4. AH Neims and CS Watson. The need for a longitudinal plan in teaching clinical pharmacology. J Clin Pharmacol1981;21:258–259.

5. RR Spector and RJ Roberts. Commentary: physician education and drug therapy. J Clin Pharmacol 1983;23:491–493.

6. KL Melmon and TF Blaschke. The undereducated physicians’ therapeutic decisions. N Eng J Med 1983; 308:1473–1474.

7. RK Ferguson and PH Vlasses. Clinical pharmacology for fourth-year medical students. J Clin Pharmacol1984;24:271–272.

8. DW Nierenberg and TA Stukel. The effects of a required fourth-year clinical pharmacology course on student attitudesand subsequent performance. Clin Pharmacol Ther 1986;40:488–493.

9. DW Nierenberg. Clinical pharmacology instruction for all medical students. Clin Pharmacol Ther 1986;40:483–487.

10. RD Feldman, R Spector, GD Park, M Albanese, R Roberts. Clinical pharmacology and therapeutics education for seniormedical students. J Clin Pharmacol 1987;27:682–684.

11. CM Lathers and CM Smith. Teaching clinical pharmacology: coordination with medical pharmacology courses. J ClinPharmacol 1989;29:581–597.

12. AJ Ingenito, CM Lathers, HJ Burford. Instruction in clinical pharmacology: changes in the wind. J Clin PHarmacol1989;29:7–17.

13. DW Nierenberg and The Council for Medical Student Education in Clinical Pharmacology and Therapeutics. A corecurriculum for medical students in clinical pharmacology and therapeutics. Clin Pharmacol Ther 1990;48:606–610.

14. D Nierenberg: Consensus for a core curriculum in clinical pharmacology for medical students. Clin Pharmacol Ther1990:48:603–605.

15. S Maxwell, T Walley: Teaching safe and effective prescribing in UK medical schools: a core curriculum for tomorrow’sdoctors. Br J Clin Pharmacol 2003;55:496–503.

16. A Smith, T Tasioulas, N Cockayne, G Misan, G Walker, G Quick: Construction and evaluation of a web-basedinteractive prescribing curriculum for senior medical students. Br J Clin Pharmacol 2006;62:653–659.

17. C Candler, M Ihnat, G Huang: Pharmacology education in undergraduate and graduate medical education in theUnited States. Clin Pharmacol Ther 2007;82:134–136.

18. A Smith: Competency for new prescribers. Australian Prescriber 2007;30:58–59.


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19. Institute of Medicine, To Err Is Human: Building a Safer Health System. 1999. Accessible athttp://books.nap.edu/openbook.php?isbn=0309068371.

20. AAMC and the FDA, Drug Development Science: Obstacles and Opportunities for Collaboration Among Academia,Industry and Government 2005. Accessible at http://www.aamc.org/publications/.

21. AAMC. Medical School Objectives Project Report I: Learning objectives for medical student education. 1998. Accessibleat http://www.aamc.org/meded/msop/.

22. These MSOP reports are accessible at: http://www.aamc.org/meded/msop/.

23. R Eisenberg, G Rosenfeld. Knowledge Objectives in Medical Pharmacology, 2005. Accessible athttp://www.aspet.org/AMSPC/Knowledge_Objectives/default.asp.

24. ACGME Common Program Requirements: General Competencies (known as the ACGME Core Competencies).Accessible at http://www.acgme.org/outcome/.


Annotated Reference Sources

C Candler, M Ihnat, G Huang: Pharmacology education in undergraduate and graduate medical education in the UnitedStates. Clin Pharmacol Ther 2007;82:134–136.

Authors: The authors work at the AAMC (MedEdPORTAL project), and at two U.S. medical schoolsSubject: Review of pharmacology instruction in medical schools (as posted in the AAMC curriculum databaseCurrMIT) and residency training programsConclusions: Clinical pharmacology instruction in the clinical years of medical school is not well documented, andseems to be haphazard and accidental during residency. The recent movement towards competency-based teachingand assessment is likely to permeate both undergraduate (medical school) and graduate (residency) trainingprograms and, along with the driving force of the patient safety movement, lead to better and more formalinstruction in clinical pharmacology and therapeutics.

R Eisenberg, G Rosenfeld. Knowledge objectives in medical pharmacology, 2005.www.aspet.org/AMSPC/Knowledge_Objectives/default.asp.

Authors: Members of the Association for Medical School Pharmacology Chairs (AMSPC), which includes chairs ofdepartments of pharmacology at U.S. medical schoolsSubject: A description of the competencies in pharmacology that should be obtained by students completing theirbasic medical education.Conclusions: This document is a detailed description of an optimal curriculum in basic medical pharmacology, butalso includes some discussion of recommended curricular content in clinical pharmacology and therapeutics as well.

S Maxwell, TWalley: Teaching safe and effective prescribing in U.K. medical schools: a core curriculum for tomorrow’sdoctors. Br J Clin Pharmacol 2003;55:496–503.

Authors: The authors work at the University of Edinburgh and the University of Liverpool, and also hold leadershippositions in the British Pharmacological Society.Subject: Recent changes in curricular design in U.K. medical schools has made it harder to organize specific coursesin clinical pharmacology. Therefore, the general objectives related to training in clinical pharmacology andtherapeutics now need to be translated into more specific learning outcomes. Core knowledge and skills related tosafe prescribing are outlined.Conclusions: For most doctors, drug therapy is the main tool they have for influencing the health care of theirpatients. Modern drugs bring great patient benefits, but at the risk of causing great harm. Therefore, it is crucialthat medical students become competent to prescribe safely and effectively before they graduate, and that theyshould be able to assimilate new information about new drug developments throughout their professional careers.

DNierenberg, T Stukel. The effects of a required fourth-year clinical pharmacology course on student attitudes andsubsequent performance. Clin Pharmacol Ther 1986;40:488–493.

Authors: Clinical pharmacologist and biostatistician at a U.S. medical schoolSubject: Description of goals and content of a required Year 4 course in clinical pharmacology, student evaluation,and improvement in student performance on Step 2 of the national board examination.Conclusions: Eighty-nine percent of senior medical students felt that such a course was “essential” to their futurecareers as physicians. As interns, 80 percent of the graduates who responded found that the course had beenfrequently useful or essential during their internships. Average student scores on Step 2 of the NBME exams inclinical pharmacology-related questions increased from 38th percentile to 74th percentile (comparison to historicalcontrol group), compared to an increase from 48th to 52nd percentile on all topics over the same period of time.




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DNierenberg, A Atkinson, D Brater, J Drayer. The American Society for Clinical Pharmacology and Therapeutics:programs to support education in clinical pharmacology. Clin Pharmacol Ther 1990;47:262–269.

Authors: Four clinical pharmacologists, three from U.S. medical schools and one from a private clinical pharma-cology consulting company.Subject: Efforts of a national clinical pharmacology academic society to support medical student education in thefield, including conducting a survey of all U.S. medical schools in 1985 concerning their teaching of the field.Results: Sixty-nine percent of all U.S. medical schools responded to the survey. All U.S. schools offered a requiredcourse in basic medical pharmacology, usually taught in the second year (98 percent). Only 14 percent of schoolsoffered required courses in clinical pharmacology; many other schools taught clinical pharmacology material aspart of the basic pharmacology course.

DNierenberg and the Council for Medical Student Education in Clinical Pharmacology and Therapeutics. ClinPharmacol Ther 1990;48:606–610.

Authors: Clinical pharmacologists from several U.S. and Canadian medical schools who held a workshop to develop acore curriculum for medical student education in clinical pharmacology. The faculty were representing four societiesinterested in clinical pharmacology education—the American Society for Clinical Pharmacology and Therapeutics(ASCPT), the American Society for Pharmacology and Experimental Therapeutics (ASPET), the Association for MedicalSchool Pharmacology (AMSP), and the American College of Clinical Pharmacology (ACCP).Subject: Consensus guidelines for a core curriculum in clinical pharmacology and therapeutics for medical students incore information, core skills, and core attitudes, along with discussion of how such a curriculum could be implemented.Conclusions: Details of a core curriculum are presented in the “older language” of core knowledge, skills, andattitudes. These aspects of a core curriculum map fairly easily into the newer perspective of having a competency-based curriculum based on the six competency domains originally suggested by the ACGME. Implementation bydifferent medical schools has been difficult, for a variety of reasons.

DNierenberg: Consensus for a core curriculum in clinical pharmacology for medical students. Clin Pharmacol Ther1990:48:603–605.

Author: Clinical pharmacologist at a U.S. medical schoolSubject: How the consensus guidelines cited in the article above were formulated.Conclusions: Given the recent emphasis on widespread problems of mis-medication, overmedication, drug toxicity,and irrational prescribing, it is an opportune time for medical schools to consider adding required courses inclinical pharmacology. Faculty owe it to the public to make sure that medical students graduate with a firmunderstanding of how to practice rational therapeutics throughout their professional careers.

A Smith: Competency for new prescribers. Australian Prescriber 2007;30:58–59.Author: Emeritus professor of clinical pharmacology at University of Newcastle, New South Wales, AustraliaSubject: New regulations granting nurses the license to prescribe any licensed medicine for any medical condition“within their competence” has focused attention on the adequacy of training and continued professionaldevelopment of any prescriber.Conclusions: Students will prescribe medication 200,000 times during their career. Such an important task requiresadequate training (in school) and ongoing professional development.


A Smith, T Tasioulas, N Cockayne, G Misan, GWalker, G Quick: Construction and evaluation of aWeb-based interactiveprescribing curriculum for senior medical students. Br J Clin Pharmacol 2006;62:653–659.

Authors: Physicians in Australia from the National Prescribing Service and several medical schools.Subject: The development, implementation, and results of a national, voluntary, Web-based, case-based educationalprogram for helping senior medical students learn about prescribing medications optimally for common problemsto be encountered during internship year.Conclusions: Such a national curriculum designed for senior medical students, developed cooperatively fromfaculty at all medical schools and from a national prescribing resource group, was found to be very valuable bystudents and faculty at all schools who used it. High use at a school was found to be related to an enthusiasticfaculty champion at that school. Some schools felt that their curriculum time was too crowded to permit adoptionof this program. Student utilization was highest at schools that formally assessed the content of the program.




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AAMC Association of American Medical Colleges

ACCP American College of Clinical Pharmacology

ACGME Accreditation Council for Graduate Medical Education

ACP American College of Physicians

ADR Adverse drug reaction

AMSP Association for Medical School Pharmacology (now AMSPC)

AMSPC Association of Medical School Pharmacology Chairs

ARB Angiotensin Receptor Blocker (anti-hypertension drug)

ASCPT American Society for Clinical Pharmacology and Therapeutics

ASPET American Society for Pharmacology and Experimental Therapeutics

AUC Area under the curve

BLA Biologics License Application (application to the FDA)

Cmax Maximum drug concentration in plasma

CML Chronic myeloid leukemia

CurrMIT AAMC’s Curriculum Management & Information Tool

DEA Drug Enforcement Administration

DI Drug interaction

DM Diabetes mellitus

DTC Direct to consumer

EBM Evidence-based medicine

FDA Food and Drug Administration

GI Gastro-intestinal

HIPAA Health Insurance Portability and Accountability Act of 1996

HIV Human Immunodeficiency Virus

ICU Intensive care unit

IND Investigational New Drug (application to the FDA)

IRB Institutional Review Board

LCME Liaison Committee on Medical Education

MI Myocardial infarction


Abbreviations and Acronyms

This report necessarily uses a variety of abbreviations and acronyms. While most of these are well known to medical schoolfaculty, a listing is provided for the convenience of all readers.

MIC Minimum inhibitory concentration

MSOP Medical School Objectives Project

NBME National Board of Medical Examiners

NCCAM National Center for Complementary and Alternative Medicine

NDA New Drug Application (application to the FDA)

NIH National Institutes of Health

NSAID Non-Steroidal Anti-Inflammatory Drug

OTC Over the counter

P&T Pharmacy and therapeutics

PTCA Percutaneous transluminal coronary angioplasty

QALY Quality-adjusted life year

RCT Randomized clinical trial

S/P MI Status post myocardial infarction

Tmax Time to maximum plasma concentration

tPA Tissue plasminogen activator

USMLE U.S. Medical Licensing Examination

UTI Urinary tract infection

VA Department of Veterans Affairs

WHO World Health Organization




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Panel Members ChairDavid Nierenberg, M.D.Edward Tulloh KrummProfessor of Medicine andPharmacology/ToxicologySenior Associate Dean for MedicalEducationDartmouth Medical School

Vice-ChairPeter K. Honig, M.D., M.P.H.Executive Vice President, WorldwideRegulatory Affairs and Product SafetyMerck Research Laboratories

Expert Panel MembersCatherine M. Bonuccelli, M.D.Vice President, External Scientific AffairsAstraZeneca Pharmaceuticals

Nancy J. Brown, M.D.Associate Dean for Clinical andTranslational Scientist DevelopmentRobert H. WilliamsProfessor of MedicineProfessor of PharmacologyVanderbilt University School of Medicine

William W. Chin, M.D.Vice President, Discovery Research andClinical InvestigationEli Lilly and Company

Merrill J. Egorin, M.D.Professor of Medicine andPharmacologyUniversity of PittsburghSchool of Medicine

Richard M. Eisenberg, Ph.D.Professor, Department of BehavioralSciencesAdjunct Professor, Department ofPhysiology and PharmacologyUniversity of Minnesota MedicalSchool - Duluth

Jean Gray, M.D., F.R.C.P.C.Professor EmeritusDalhousie University Faculty of Medicine

Ronald L. Krall, M.D.Senior Vice Presidentand Chief Medical OfficerGlaxoSmithKline

Richard L. Schilsky, M.D.Professor of MedicineUniversity of Chicago PritzkerSchool of Medicine

Honorio Silva, M.D.Former Vice President, Science andMedical Professional Development,Pfizer Inc.Director, Project Globe Consortiumfor CPD

Hugh H. Tilson, M.D., D.P.H.Public Health Leadership ProgramSchool of Public HealthUniversity of North Carolina,Chapel Hill

StaffM. Brownell AndersonMedical EducationAssociation of American Medical Colleges

David Korn, M.D.Biomedical and Health SciencesResearchAssociation of American Medical Colleges

Anthony J. MazzaschiBiomedical and Health SciencesResearchAssociation of American Medical Colleges


Darrell Abernethy, M.D., Ph.D.

Joey V. Barnett, Ph.D.

James F. Burris, M.D.

D. Craig Brater, M.D.

Marilyn James-Kracke, Ph.D.

Jason Morrow, M.D.

Kathleen Neville, M.D.

Scott Waldman, M.D., Ph.D., F.C.P.



Reviewers

This report was distributed in draft form to various individuals, chosen for their diverse perspectives, technical expertise,and interest in the project. We thank the following individuals for their review of the draft report and for the manyinsightful comments they shared with the panel:

report x contemporary issues in medicine: education in safe and

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