an opinion paper outlining recommendations for training - accp

An Opinion Paper Outlining Recommendations forTraining, Credentialing, and Documenting and Justifying

Critical Care Pharmacy Services

William Dager, Pharm.D., Scott Bolesta, Pharm.D., Gretchen Brophy, Pharm.D., Kamila Dell, Pharm.D.,Anthony Gerlach, Pharm.D., Judith Kristeller, Pharm.D., Scott Micek, Pharm.D., Mary Hess, Pharm.D.,

Michael Bentley, Pharm.D., Paul Juang, Pharm.D., Robert MacLaren, Pharm.D.,Sandra Kane-Gill, Pharm.D., Krystal Haase, Pharm.D., Henry Mann, Pharm.D., Colby Miller, Pharm.D.,Diane Pepe, Pharm.D., Robin Southwood, Pharm.D., Kyle Weant, Pharm.D., Jill Rebuck, Pharm.D., and

Christopher Wood, Pharm.D.

In 2000, the Society of Critical Care Medicine (SCCM) and the American Collegeof Clinical Pharmacy (ACCP) published a position paper that defined criticalcare pharmacy services as fundamental, desirable, and optimal. A task force wasdeveloped that included individuals who are members of the ACCP Critical CarePractice and Research Network, the SCCM clinical pharmacy and pharmacologysection, and the American Society of Health-System Pharmacists to develop anopinion paper with three primary objectives: to provide recommendations forthe level of preparation and training of pharmacists to practice in critical care, todevelop recommendations for the credentialing of pharmacists providing criticalcare services, and to develop mechanisms for documenting and justifyingintensive care unit (ICU) pharmacy services. Each objective was addressed toaccommodate the levels of services defined as fundamental, desirable, or optimal,and are targeted at all pharmacists providing or wanting to provide pharmacyservices to critically ill patients. The training and preparing of the pharmacistcaring for critically ill patients is discussed in the context of the knowledge andskills required to provide pharmacy services in the ICU. Credentialing of thecritical care pharmacist and the documentation of services take into account thevarious scopes of practice, and recommendations are based on current andidealistic mechanisms. A detailed outline is provided for the process of servicesjustification. This paper provides a foundation that is focused on deliveringdirect and proactive patient care services, particularly at the desirable andoptimal levels, with the ultimate goal of enhancing the level of pharmacy servicesprovided to the care of critically ill patients. This commentary should be ofinterest to numerous stakeholders including pharmacists, other pharmacydepartment staff, other ICU health care professionals, hospital and academicadministrators, accrediting agencies, government officials, and payers. The taskforce encourages the profession of pharmacy in general to incorporate keyrecommendations provided in this document with respect to specialized training,credentialing, and service justification.Key Words: critical care, intensive care, pharmacy, pharmacotherapy, services,programs, training, education, credential, competency, documentation,justification.(Pharmacotherapy 2011;31(8):135e–175e)

PHARMACOTHERAPY Volume 31, Number 8, 2011

In 2000, the Society of Critical Care Medicine(SCCM) and the American College of ClinicalPharmacy (ACCP) published a position paperthat defined the scope of critical care pharmacyservices.1 This report encompasses clinical andnonclinical pharmacy services and stratifies levelsof service as fundamental, desirable, or optimalto patient care. Fundamental activities reflectservices associated with order entry anddistribution duties that are necessary for the safeprovision of pharmaceutical care; desirableactivities add some clinical functions necessaryfor the specialized care of critically ill patients;and optimal activities reflect an integrated,specialized, and dedicated model of direct patientcare functions that aim to maximize outcomes.Various aspects of pharmacy practice areaddressed in this report including clinical,educational, administrative, and scholarly

activities. The results of a recent survey foundthat fundamental services are consistentlyprovided to the intensive care unit (ICU) butdesirable or optimal services are far less likely tooccur across all types of practice activities.2

The provision of fundamental services to ICUpatients is key to insure safe patient care.However, technological advances (e.g., provider-order entry, integrated profiles, automateddistribution systems, bar coding, etc.) and policychanges (e.g., technician-check-technician) mayshift responsibilities to possibly render the role oralter the manner in which pharmacists providethese services. Concurrently, competitivepressures and safety mandates are drivinginstitutions to focus resources on specificservices, including the care and outcomes of thecritically ill.3 Several initiatives (e.g., ability andpractice-based outcomes of the AccreditationCouncil of Pharmacy Education (ACPE),medication therapy management services,Medicare amendments recognizing pharmacistsas providers, the Joint Commission onAccreditation of Healthcare Organizations(JCAHO; now termed “The Joint Commission”or “TJC”) national patient safety goals)3-5 areempowering pharmacists to practice higher levelpharmacotherapy that necessitates direct patientcare. The Joint Commission of PharmacyPractitioners envisions that “pharmacists willhave the authority and autonomy to managemedication therapy and will be accountable forpatients’ therapeutic outcomes.”6 To achieve anoptimal model of patient care in the ICU, SCCMrecommends a collaborative approach to ICUcare with an emphasis on practitionercertification.7, 8 Pharmacy organizations havecollaboratively indicated that pharmacists willrequire credentials in the future to providevarious levels of patient care services.9

In order to meet the growing demands ofproviding, documenting, and justifying pharmacyservices in the ICU, a task force was convened todevelop an opinion paper addressing these issues.The task force included individuals who aremembers of the ACCP critical care practice andresearch network (PRN), the SCCM clinicalpharmacy and pharmacology (CPP) section, andAmerican Society of Health-System Pharmacists(ASHP). The specific objectives of the task forcewere to: 1) provide recommendations for thelevel of preparation and training of pharmaciststo practice in critical care, 2) developrecommendations for the credentialing ofpharmacists providing critical care services, and

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For questions or comments, contact Robert MacLaren,Pharm.D., FCCM, FCCP, Department of Clinical Pharmacy,University of Colorado School of Pharmacy, 12850Montview Blvd, V20-1227, Aurora, CO 80045; e-mail:[email protected] expressed in this document are endorsed by the

American College of Clinical Pharmacy critical care practiceand research network, the Society of Critical Care Medicineclinical pharmacy and pharmacology section, and theAmerican Society of Health-System Pharmacists.Writing committees:Training Pharmacists: William Dager, Pharm.D. (Universityof California Davis Medical Center, Davis, CA) (chair); ScottBolesta, Pharm.D. (Wilkes University, Wilkes Barre, PA);Gretchen Brophy, Pharm.D. (Virginia CommonwealthUniversity, Richmond, VA); Kamila Dell, Pharm.D.(University of Utah Hospital and Clinics, Salt Lake City,UT); Anthony Gerlach, Pharm.D. (Ohio State UniversityMedical Center, Columbus, OH); Judith Kristeller, Pharm.D.(Wilkes University, Wilkes Barre, PA); Scott Micek,Pharm.D. (Barnes Jewish Hospital, St. Louis, PA).Credentialing Pharmacists: Mary Hess, Pharm.D. (JeffersonUniversity, Philadelphia, PA) (chair), Michael Bentley,Pharm.D. (Carilion Clinic - Roanoke Memorial Hospital,Roanoke, VA); Paul Juang, Pharm.D. (St. Louis College ofPharmacy, St. Louis, MO).Documenting and Justifying Services: Robert MacLaren,Pharm.D. (University of Colorado, Aurora, CO) (chair);Sandra Kane-Gill, Pharm.D. (University of Pittsburgh,Pittsburgh, PA); Krystal Haase, Pharm.D. (Texas TechUniversity, Amarillo, TX); Henry Mann, Pharm.D.(University of Toronto, Toronto, ON); Colby Miller,Pharm.D. (LifeBridge Health, Baltimore, MD); Diane Pepe,Pharm.D. (The Medical Center of Aurora, Aurora, CO);Robin Southwood, Pharm.D. (University of Georgia,Athens, GA); Kyle Weant, Pharm.D. (University ofKentucky, Lexington, KY).Steering / Editing committee:William Dager, Mary Hess, Robert MacLaren (chair), JillRebuck, Pharm.D. (Lancaster General Hospital, Lancaster,PA); Christopher Wood, Pharm.D. (University of Tennessee,Memphis, TN).

CRITICAL CARE PHARMACY SERVICES ACCP

3) develop mechanisms for documenting andjustifying ICU pharmacy services. Thisdocument was developed over a two year periodwith subcommittees assigned to each objective.The subcommittees communicated electronicallyand convened several times at variousprofessional conferences. Integration andalignment of the three sections was completed bya steering / editing committee comprised of thechairs of each subcommittee and the chairs of theACCP critical care PRN and the SCCM CPP.Each objective was addressed to accommodate

the levels of services defined as fundamental,desirable, or optimal and are targeted at allpharmacists providing or wanting to providepharmacy services to critically ill patients. Therecommendations, however, are focused ondelivering direct and proactive patient careservices at the desirable and optimal levels withthe ultimate goal of enhancing the level ofpharmacy services provided to the care ofcritically ill patients. Recommendations weredeveloped according to realistic standardsalthough idealistic or speculative expectationswere also addressed. These recommendationsapply to all ICU practice sites and populations(e.g., medical, surgical, neurosurgical, trauma,burn, pediatric, neonatal, etc.) or any siteencountering ICU patients (e.g., transplant,operating room, emergency room, etc.) across alltypes of institutions (community, private,academic, government, etc.) of all sizes providingall levels of medical care (level I – III).7 Therecommendations are dynamic so that theindividual pharmacist, the department ofpharmacy, or hospital administration maydevelop, enhance, and maximize their services.Additionally, this document should be of greatinterest to the pharmacy department, other ICUhealthcare professionals, hospital and academicadministrators, accrediting agencies, governmentofficials, payers, and patients or their families.

Requirements of the ICU Pharmacist

The genesis of the ICU pharmacist typicallybegins with an individual entering or desiring toexpand their practice by developing skill sets thatallow practice advancements or transitions tohigher level activities relative to the care ofcritically ill patients. Including pharmacists inthe care of critically ill patients can lead tosuperior care by utilizing their role as the “ICUpharmacotherapy knowledge manager.”7, 8, 10–13

To be successful in such a role, pharmacists need

a strong knowledge base and diverse skill setsthat include effective communication, advancedproblem solving / critical thinking, judgment,leadership, and time management. These skillsare optimized when pharmacy services aredirectly provided in a proactive and appliedmanner. Of note, ACCP recently published anopinion paper describing the competenciesrequired by clinical pharmacists thatindependently recommended skill sets similar tothose put forth in this paper.14

Pharmacotherapy manager

ICU pharmacists must integrate pharmacology,pharmacokinetics / pharmacodynamics /pharmacogenomics, pharmacoeconomics, andpharmacotherapeutics with pathophysiologicalchanges in the management of critical illness.10,15–17 Table 1 summarizes examples of coretherapeutic topics that pharmacists providingcare to adult ICU patients with these diseases ordisorders should be knowledgeable of to theextent that they are able to be the “ICUpharmacotherapy manager.”12 Additional coretopics may apply to pharmacists providingservices to specialized patient populations (e.g.,pediatric, neonatal, burn, transplant, emergencymedicine, etc.). All pharmacists should maintaina knowledge base that incorporates currentmedical advances reported in the literatureincluding any associated controversies in a givensituation.1 Knowledge must be integrated withsound judgment and the skill of practicalapplication. This requires clinical familiarity andexperience. A commitment to life-long learning,skill development, and resource development isessential to continually delivering any level ofpharmacy service.ICU pharmacists must possess statistical

knowledge to the extent that they are able tointerpret and apply data to patient-specificscenarios. Pharmacists providing desirable oroptimal levels of care must understand andintegrate non drug interventions such asmechanical devices (e.g., ventilators, renalreplacement therapies, vascular catheterization,point-of-care testing, etc.), procedural processes(e.g., paracentesis; thorocostomy; basic surgicalinterventions; interventional radiology; fiberopticimaging such as bronchoscopy or endoscopy;radiographic imaging such as computerizedtomography, magnetic resonance imaging,fluoroscopy, radiography, etc.), measuredresponses (e.g., bedside observations;

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Table 1. Examples of Core Therapeutic Topics for Pharmacists Caring for Critically Ill Adults.

Therapeutic Area Specific Disease State, Condition, or DeviceNeurology and Psychiatry Altered mental status, encephalopathy, coma

Brain injuryCerebrovascular diseases (e.g., hemorrhage, ischemia, thromboembolic)DeliriumEncephalopthyIntracranial perfusionMovement disorders (e.g. neuroleptic malignant syndrome, seratonin syndrome, malignanthyperthermia, dystonia / dyskinesia, botulism, tetanus, etc)Neuromuscular blockadeNeuromuscular diseases (e.g., Guillain-Barre syndrome, myasthenia gravis, etc.)Neuropathies, myopathiesPain managementSedation managementSeizure management and prophylaxisSubstance abuseSpinal cord injuryWithdrawal syndromes (e.g., alcohol, opiate, nicotine, etc.)

Cardiovascular Acute coronary syndromes (unstable angina, myocardial infarction)Acute heart failure (right and left sided, diastolic and systolic)Anaphylactic shockAortic aneurysmAortic dissectionArrhythmias (atrial fibrillation and flutter, paroxysmal supraventricular tachycardia, ventriculartachycardia and fibrillation, QT prolongation, sinus bradycardia, atrioventricular bradycardia,pulseless electrical activity, asystole)Cardiac temponadeCardiac or vascular surgical proceduresCardiopulmonary resuscitationCardiovascular shockCardiac ArrhythmiasHypovolemic shockHypertensive emergencies and urgenciesMechanical assist devicesMyocardial contusionPericarditisPeripheral arterial occlusionValvular diseasesVenous thromboembolism management and prophylaxis

Pulmonary Acute respiratory distress syndromeAsthmaAspirationChronic obstructive pulmonary diseasesCystic fibrosisEtiologies of hemoptysisExtracorporeal membrane oxygenationInhalation injuryMechanical ventilationNear drowningObesity hypoventilation syndromePleural effusionsPulmonary arterial hypertensionPneumothorax, hemothoraxPulmonary embolism and other embolic syndromesSurgical resections

Hepato-gastrointestinal Acute abdomen and necrosisAscitesCholycystitisFulminant hepatic failureHepato-renal syndromeLower gastrointestinal hemorrhageMotility disorders (e.g., ileus, gastroparesis, etc.)Malabsorptive disorders (e.g., inflammatory bowel disease, short bowel syndrome, etc.)

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Table 1. (continued)

Therapeutic Area Specific Disease State, Condition, or DeviceHepato-gastrointestinal Nonvariceal upper gastrointestinal hemorrhage

PancreatitisMesenteric or splanchnic thrombosisStress-related mucosal diseaseVariceal hemorrhageViral hepatitis

Renal Acute kidney injury (prerenal, intrinsic, postrenal)Fluid and electrolytes homeostasis, abnormalities, and replacementPrevention of renal dysfunctionQuantification of renal functionRenal replacement therapiesRhabdomyolysis

Hematology AnemiasCoagulopathyHemorrhagic shockHemolytic uremic syndromeHematologic neoplasmsHypercoagulation disordersNeutropeniaSickle cell crisisThrombocytopeniaThrombotic thrombocytopenic purpuraTransfusion medicine

Endocrine Adrenal insufficiencyAlcoholic ketoacidosisAutoimmune disorders (e.g., lupus, sarcoides, rheumatic disease, vasculitis, etc.)Cushing’s syndromeDiabetic ketoacidosis, hyperosmotic nonketoacidosisGlucose controlHypothyroidism, myxedema comaPheochromocytomaThyrotoxicosisTumor lysis syndrome

Infectious Diseases Bloodstream and line infectionsBone and joint infectionsCentral nervous system infections (meningitis, encephalitis, abscess, shunt infection)EndocarditisGastrointestinal infections (e.g., E. coli hemorrhagic diarrhea, C. difficile diarrhea, “Traveler’sdiarrhea”, Yersinia, viral diarrhea, etc)Institution-specific antimicrobial susceptibility patternsIntra-abdominal infections (e.g., abscess, peritonitis, cholycystitis, etc.)Opportunistic infections (fungal, viral, bacterial, parasitic, etc.)Oropharynx (Ludwig’s angina, epiglottitis, pharyngeal space, peritonsillar or laryngeal abscess)Pneumonia (community-acquired, nosocomial, ventilator-associated, aspiration)Sepsis, severe sepsis, and septic shockSinusitisSkin and soft tissue infections (e.g., cellulitis, necrotization, diabetic, etc.)Spontaneous bacterial peritonitisSurgical prophylaxis and wound infectionsTuberculosisUrinary tract infections (e.g., pyelonephritis, catheter-related, etc.)

Other Acid / base disordersAdverse drug eventsBiohazard exposureBioterrorism exposureDermatology (e.g., decubitus ulcer, toxic epidermal necrolysis, erythema multiforme, necrosis, etc.)Drug interactionsDrug overdosesEmergency medicineEnvironmental exposuresGraft vs. hostHeat stroke


hemodynamic and cardiac monitoring;neurologic monitoring including sedation,analgesia, delirium; laboratory values; etc.). Inaddition, these pharmacists should be familiarwith pharmacoeconomic and outcomeassessments, ethical and legal considerations, riskmanagement and medication safety, ICU design,service delivery, and workforce issues. Allpharmacists need to be familiar with the health-systems processes for the delivery of medicationsand institution-specific policies or proceduresthat affect the care of ICU patients (e.g., clinicalpathways or protocols, medication reconciliation,medication safety, quality measures, pharmacyoperational processes, etc.). The ICU pharmacistmay represent a team of pharmacy personnel,each contributing unique expertise and skills. Inorder to maximize services, the pharmacist mustbe aware of the responsibilities and activities ofeach individual and may be required to integrateor lead the team.

Direct pharmacy services

While hospital-wide mortality rates decrease asthe pharmacist-to-occupied bed ratio increases,the primary factor contributing to this beneficialassociation is the involvement of pharmacists inthe direct care of patients with activities generallydeemed fundamental or desirable.18–20 Guidelinesdeveloped by SCCM determined that pharmacistsare an essential component for providing qualitycare to critically ill patients and recommend theintegration of a dedicated pharmacist into theICU team.7, 8 The provision of pharmacy servicesin a manner that is proactive and directed atpatient care decreases drug-related costs,

prevents adverse drug events, improves thequality and efficiency of care, and is associatedwith reduced mortality, shortened length of stay,and lower overall costs.13, 15, 18–26 Pharmacyservices associated with favorable healthcareoutcomes include18-21:

• Adverse drug reaction management• Drug information• Protocol management• Admission medication history• Disease state management• Participation in patient care rounds• Cardiopulmonary resuscitation

Most of these services are fundamental activities.Unfortunately, recent survey results indicate thatpharmacists are providing direct patient careservices in only 62.2% ICUs, which is similar tothe 64.8% reported nearly twenty years prior.2, 27

Skills for success

Communication

As the ICU pharmacotherapy specialist andleader, the pharmacist must effectivelycommunicate and interact with other disciplines.The development and refinement ofcommunication skills is an essential componentfor advancement of pharmacy services into andwithin ICU practice. Communication in the ICUis key to a collaborative multidisciplinaryapproach, comprehensive patient care, andoptimizing outcomes through the provision ofeffective and safe pharmacotherapy.28, 29 Effectivecommunication is built on trust and credibleclinicians are those who by their actionsdemonstrate and advocate the best interests of

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Therapeutic Area Specific Disease State, Condition, or DeviceOther Hypothermia (inadvertent and therapeutic)

ImmunizationNutrition support (enteral and parenteral)Obstetrical crisesOrgan transplant and complicationsOrthopedic injuryPain managementPharmacoeconomicsPharmacokinetics, pharmacodynamics, pharmacogenomicsSolid organ neoplasmsSurgical proceduresThermal injuriesToxicologyTrauma (blunt and penetrating)


their patients. Pharmacists must be aware of therelationships established between the pharmacydepartment and the ICU and its practitioners.Therefore, frequent pharmacist-to-pharmacist orpharmacist-to-technician communication is alsoessential.Directly providing pharmacy services is

associated with beneficial outcomes.18–20 Ideally,all pharmacists should assess patient needs at thebedside whenever possible and those providinghigher level services must be visible. A practicalapproach for the pharmacist to assess critically illpatients includes:

• Observe the patient in addition to thelaboratory, pharmacy, medical records, andinformation from other healthcare providers.

• Create a problem list, starting from the top ofthe patient and working down (e.g., head,neck, chest, abdomen, etc.) or by systems asoutlined in Appendix 1. Include all problems.Recognize that the primary pharmacyproblem may not be the reason for admission.

• Evaluate the pre-ICU medical records. Lookcarefully at the events that occurred in theambulance, prior hospital, emergency oroperating room. Evaluate the past medicalhistory and determine the need to continuetherapy in the ICU. Request additionalinformation as needed (e.g., laboratory value).

• After developing a complete problem list,begin to integrate (impact of one problem onthe others) and prioritize problems.

• Collaborate with other members of thehealthcare team, including respiratorytherapists, nurses, dieticians, and physicians.Learn how their activities impact thepharmacotherapeutic plan for the patient.Examples include:How do different ventilator settings impactthe required level of sedation?What type of intravascular access isavailable?How does nutrition support impactpharmacotherapy?How does renal replacement therapy impactdrug metabolism / elimination?

• Formulate a comprehensive therapeuticmanagement plan for each problem thatincludes:Drug regimens and devices needed.Specific monitoring regimen (what andwhen).Communicate desired and unexpected (e.g.,adverse events, lack of effect) outcomes,including the monitoring regimen and

reasons for discontinuation.Anticipate physiologic (e.g., acute kidneyinjury), pharmacologic (e.g., need for aninteracting agent), or process changes (e.g.,loss of intravenous access)

• Reassess daily the problem list and thetherapeutic plan.

Relying on information gathered and actedupon at an independent setting (e.g., pharmacyor office) may not encompass all the patient-specific clinical concerns. The presence andincreased visibility of being at the bedside createsthe opportunity to exchange patient-specificinformation and automatically engages thepharmacist in direct patient care that is oftenproactive rather than retroactive.1, 14, 15, 26, 30

Efficiently extracting patient-specific informationby asking key questions to gain a rapidunderstanding of the situation, listening to inputprovided by others, engaging in an exchange ofinformation, educating others about allpharmacotherapeutic options, and setting theexpectation for the selected drug regimens aresome of the many ways to communicate whileintegrating into the healthcare team and gainingconfidence that a pharmacotherapeutic plan willresult in expected outcomes.11, 31 A common flawof inexperienced ICU pharmacists is to consumetheir time in data collection, compiling orgathering vast amounts of available informationat the expense of analyzing it, developing atreatment plan, and effectively communicating orimplementing the plan. To provide higher levelservices and truly be the pharmacotherapyexpert, the pharmacist must efficiently interpretdata and link the data to therapeuticmanagement plans.Participating in patient care rounds is

beneficial and expected according to SCCM.7, 8

Efficient use of time and resources may limitattendance, but pharmacists should strive toattend rounds as frequently as possible. Ideallyrounds occur at the bedside but they may occurelsewhere or via automated interactive systems.Some may choose to conduct independentpharmacy-driven rounds. The established ICUpharmacist may serve as much as a consultant asa clinician. Since many therapies used in theICU are technologically demanding, highlycomplex, and costly, a desirable goal for criticalcare pharmacy services is to share clinical,pharmacoeconomic, and outcomes research withthe ICU team.1, 7, 8, 11, 15, 20, 21 Involvement inpatient care rounds also provides educationalopportunities for the pharmacist to learn from

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other ICU professionals.Written communication skills are equally

important to the care of critically ill patients.When indicated, written communication ordocumentation of pharmaceutical care activitiesshould include a concise explanation of themanagement plan. A focused pharmaceuticalcare plan should conclude with precise wordingof a recommendation that may include atherapeutic regimen and monitoring plan.Written communication, however, shouldcomplement direct verbal interactions.Actively participating on ICU committees or

hospital committees that affect the ICU providesthe pharmacist with several opportunitiesincluding establishing rapport with otherpersonnel, promoting rational and safe use ofmedications, educating other healthcareprofessionals, and learning and applying thepolicies that affect practice in the ICU.Communication during committee meetings orinvolvement with committee actions (e.g., ICUprojects, clinical pathways, policies orprocedures, quality improvement initiatives,medication safety, implementing new or revisedsystems, etc.) provide the pharmacist withadditional opportunities to exemplify theirunique knowledge of pharmacotherapy ofcritically ill patients. Similarly, informal (e.g.,inservices, pharmacy updates, project results,etc.) and formal education (e.g., lecture series,continuing education, etc.) of other healthcareprofessionals are opportunities to communicateprofessionally and demonstrate the pharmacist’srole as the pharmacotherapy expert. Similarly,the attendance of educational events conductedby other disciplines expands the pharmacist’sscope of knowledge.

Advanced problem solving / Critical thinking

Optimizing patient outcomes in the ICU isdependent upon an organized and efficientapproach to understanding and managingmedical problems or pharmacotherapy needs ofthe acutely ill. At the core of this skill is adetailed understanding of common ICU diseasestates (Table 1), patient-specific pathophysiology,drug action properties, evidence-based medicine,and patient-specific goals of therapy. Intertwinedwith didactic and experiential work is the abilityto integrate multiple sources of medicalinformation. Data assimilated from the patient orfamily interview, other healthcare professionals,medical profile, physical assessment, laboratory

examination, and other diagnostic tests providethe pathophysiologic pieces of the puzzle neededto create an acute problem list withcorresponding differential diagnoses. Once aproblem list or specific issue is established, acomprehensive and realistic care plan can bedevised and implemented. Continualreassessment and revisions of the treatment planshould be anticipated as new or adjustedinformation is common in the ICU. To ensurethe pharmaceutical care provided to the patient iseffective, safe, and appropriate given thepotentially rapid changes in their clinicalpresentation, skill in intensive monitoring mustbe developed. Key to the mastery of problemsolving in the ICU is the ability to establishmanagement plans early with therapeutic goalsand anticipated outcomes (see list above). Theplan, goals, and outcomes need to be seriallyassessed and frequently revised. Therefore,efficiency and sound clinical judgment arefundamental to critical thinking. The pharmacistshould preemptively prepare a management planfor unexpected outcomes, adverse events, or newdevelopments (e.g., acute renal dysfunction).Unexpected outcomes or adverse events shouldbe rationalized by the pharmacist in an attemptto avoid reoccurrence.Another component of critical thinking is

elucidating issues that indirectly affect patientcare. These may include workflow parameters,pharmacy or ICU structure, policies orprocedures, the actions of committees,technology, etc. Judgment and communicationare keys to effectively dealing with issues thatindirectly impact patient care. While the ICUpharmacist offers unique knowledge and skillsthat may guide interpretation or application ofthese issues, all interested parties should beconsulted since the issue may affect others.Similar to the patient care approach, the ICUpharmacist should anticipate potential indirectpatient care concerns and preemptively manageor communicate the issue.

Other skills

Judgment, leadership, organization, and timemanagement are essential skills that are difficultto learn but should be developed over timethrough continual application and practice.Experienced practitioners may help the ICUpharmacist develop these skills. Becauseincreased stress is associated with the care ofcritically ill patients, the pharmacist should be

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prepared to accommodate the emotionalresponses that are common. These responses areoften natural, and planned activities to helpalleviate stress are sometimes needed (e.g.,communication, exercise, relaxation, etc.).

Project Management / Scholarship

Project management and scholarship areconsidered desirable or optimal to critical carepharmacy practice.1 Scholarship refers to theassimilation and dissemination of information inany format at any level. At the foundation of thisskill is the creation and capture of outcomemeasurements and reporting systems thatfunction in the context of each individual ICUsetting. The goal of collecting, analyzing,reporting, and ultimately implementing systemsbased on project findings is to lessen variabilityin the delivery of care, thereby optimizingoutcomes, reducing errors and enhancing safety,and improving resource utilization. Therefore, toadvance the profession of critical care pharmacy,pharmacists practicing at the fundamental levelof service should participate in the development,implementation, and data collection of protocolsand medication utilization evaluations. At thedesirable level of service, pharmacists are projectmanagers and lead the assessment of guidelines,protocols, practice changes, or performanceimprovement initiatives in the ICU. Optimally,the ICU pharmacist is the project champion ofhypothesis driven initiatives. Internal andexternal dissemination of case reports, projectresults, or pertinent review articles should beexpected of all pharmacists practicing at alllevels. In addition, all pharmacists shouldparticipate in developing ICU or institutionalpolicies, procedures, clinical pathways, and theeducation of others. Pharmacists should attemptto present their findings at local and regionalmeetings of critical care professionals and striveto disseminate their results at national andinternational conferences. These initiativesshould be supported by the institution and itsconstituents and affiliates.

Training and Preparing the ICU Pharmacist

Education

Conventional

The training and preparation of pharmacistsproviding care to critically ill patients is currentlynot standardized and may take several successful

pathways. In the United States, all professionalpharmacy programs lead to the doctor ofpharmacy degree.4 The ACPE outlines standardsand guidelines that emphasize communicationskills, curriculum content, educationalassessment and outcomes, experientialeducation, interprofessional teamwork, patientsafety, professional competency, professionalism,and scholarship amongst other key educationalcomponents.4 Several white papers prepared bythe ACCP further delineate the educationalrequirements for the didactic curriculum,17

experiential education,32 professionalism,33, 34

interprofessional networking,35 and exposure toresearch.36 Therefore, the doctor of pharmacydegree provides the core skill sets and knowledgefor graduates to function as competent clinicians.Curricula, however, should be flexible enough toaccommodate students desiring additionaltraining, either didactically or throughexperiential exposure, in particular domainsincluding but not limited to research, teaching,administration or management, and specialtypractices like critical care.Individuals desiring to practice in an ICU

environment enter residency training shortlyafter receiving their pharmacy degree.15 The firstyear resident, or postgraduate year one (PGY1),should be exposed to a variety of experiencesthat include multiple clinical subspecialties,project management and scholarly activities,teaching opportunities, and administrativefunctions.37 The individual may then choose topursue a second year of specialty training, orpostgraduate year two (PGY2). Critical care isrecognized by ASHP as a specific area for PGY2pharmacy residency training. ASHP is theorganization that accredits all pharmacyresidency programs (PGY1 and PGY2).37 As ofMay 2011, 85 critical care residency programs areeither available or in the ASHP accreditationprocess. Information on the outcomes, goals,objectives and standards of residency programsmay be found online at the ASHP website.37, 38

Individuals completing PGY1 residency programsshould have the knowledge base and skill sets toprovide desirable pharmacy services to ICUpatients with the expectation that optimalservices be easily incorporated into practice. ThePGY2 residency is directed by an experiencedcritical care pharmacist and is designed todevelop an independent practitioner withadvanced knowledge and skill sets. Therefore,these pharmacists should be capable of providingoptimal services. Only 11.1% and 5.9% of

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pharmacists providing critical care pharmacyservices have completed PGY1 and PGY2residency training, respectively.2 Pharmacyorganizations have independently and jointlyproposed that residency training for newpharmacists become mandatory before entering apatient-care practice by the year 2020.9, 39, 40

While this would standardize the training, ensureconsistent preparation of critical carepharmacists, and lead to higher levels of servicesbeing provided, pharmacy graduates substantiallyoutnumber available residency programpositions.37, 38, 41 A key challenge for thepharmacy profession as a whole is to providesufficient training programs to meet futuredemands and the growing needs of all thesubspecialties.42–44 This section of the article willfocus on developing and preparing the workingpharmacist wanting to transition to or achievehigher level pharmacy services in the ICU.

Unconventional

A common cause linked to medication errorsand adverse drug events in ICUs is the limitedknowledge related to pharmacotherapy by theprescriber.45–54 Therefore, any pharmacistwanting to practice in the ICU must havecomprehensive knowledge of key ICU topics thatare representative of their population of criticallyill patients (Table 1). Similarly, thesepharmacists must possess or be willing todevelop the skills required to providepharmacotherapy management. These may belearned through didactic lectures, active problemsolving activities, or experiential opportunitiessuch as on-the-job training, mini-sabbaticals,mentorship programs, masters or nontraditionaldoctor of pharmacy programs. Recognizing keysources of information and identifying a mentorare key to acquiring the necessary knowledge,resources, and skills.

Literature

Recognizing sources of information that canassist pharmacists in keeping current on thelatest developments in patient care or gainadditional expertise out of their daily scope ofpractice is key to professional development.Examples include peer reviewed journal articles,tertiary texts, or electronic and on-line resourcesthat are easily accessible. Table 2 providesexamples of journals that frequently publisharticles related to critical carepharmacotherapy.55–58 Unique sources of compre-

hensive information are articles that compile andbriefly summarize primary literature that areclinically relevant to a specific area of practice,including ICU pharmacotherapy.55–58 Consensusguidelines and systematic reviews may providegeneral information but the pharmacist providinghigher level services must critically evaluate andclinically interpret the primary studies.Preselected critical care abstracts from various

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Table 2. Examples of Journals Frequently PublishingCritical Care Related Articles.55–58

Type of Critical CarePharmacotherapy Articles JournalCommon Publications American Journal of Critical

CareAmerican Journal ofRespiratory and Critical CareMedicineAnesthesia and AnalgesiaAnesthesiologyChestCritical CareCritical Care ClinicsCritical Care MedicineHeart and LungIntensive Care MedicineJournal of Critical CareJournal of Trauma Injury,Infection and Critical CareSurgery

Landmark Publications Annals of Internal MedicineArchives of Internal MedicineBritish Medical JournalNew England Journal ofMedicineJournal of the AmericanMedical AssociationLancet

Subspecialty Publications American Journal of Health-System PharmacistsAnnals of Emergency MedicineAnnals of PharmacotherapyAnnals of SurgeryBurnsClinical Infectious DiseasesEmergency Medicine JournalGastroenterologyHepatologyJournal of Emergency MedicineJournal of Parenteral andEnteral NutritionNeurocritical careNeurosurgeryPediatricsPediatric Critical CareMedicinePharmacotherapyTransfusionTransplantation


journals may be purchased so the pharmacistdoes not need to regularly search each journal.Publishers may send free alerts of new issueswith article titles and abstracts. Online searchengines may offer filtered searches. A number ofresources are available in an electronic versionincluding texts, journals, and personal digitalassistants (PDA) that allow access anywhere,including the bedside.59 Over 135 additionalweb-based resources in a variety of e-learningformats are available for critical care education.60

The pharmacist desiring to provide higher levelservices must apply the available literature in amanner that takes into account the ICU-specificpatient population, practice patterns, andhospital processes and structure. In addition,several organizations such as the ACCP PRNs,SCCM CPP section, and ASHP critical care andemergency medicine network provide ICU-specific education and networking opportunitiesfor practice, education, and scholarship. Journalclubs may be available through variousinstitutional departments or the aforementionedorganizational networks.

Mentors

Mentors play vital roles in developing andadvancing the level of care provided bypharmacists.61 Mentoring may occur in multipleways including co-workers, experts in the field,other critical care practitioners, or nonICUpersonnel and may be formal or informal.Identifying and developing good mentors isimportant for facilitating the learning process.Mentors may be chosen or assigned, but ingeneral, the strongest mentorship relationshipsdevelop over time. An individual ICUpharmacist may have several mentors at any onetime or an individual mentor may lead a processthat designates preceptors to develop specificeducational components or skill sets.Ideally, an inexperienced pharmacist should

seek a mentor with insight into critical carepractice so they may provide skill developmentor enhance the understanding of approaches toassessing and managing critically ill patients andtheir disease sates.61 NonICU personnel (otherclinicians or academicians) may serve as mentorsas they may provide skill development or careerguidance applicable to the ICU. Aninexperienced pharmacist should pursue amentor who is geographically close enough thatregular meetings are easily arranged. When anearby mentor is not available, communicating

by e-mail or telephone may be feasiblealternatives to face-to-face meetings.62 A moreexperienced pharmacist may not require directmentorship or may seek mentors with expertisein a specific skill set (e.g., project management /scholarship, administration, teaching, specializedsetting, etc.). The trainee may observe variousapproaches used by practitioners to considerwhich settings to emulate as they develop theirown approach to being the pharmacotherapyspecialist providing direct care of critically illpatients. The time required to develop thetrainee into an independent pharmacist providinghigher level services will vary according to thepractice site(s), the baseline knowledge and skillsets of the trainee, and the preceptingresponsibilities of the mentor.In order for pharmacists to move toward

providing higher level services, educationalexperiences must provide opportunities to learnand apply the core therapeutic topics (Table 1).A good mentoring relationship will assist tofurther gain knowledge and skills by directlyinvolving the trainee in critical carepharmacotherapy.61, 63 A mentor / preceptorshould guide pharmacists in dealing with usualdaily ICU challenges including patient careissues, skill development, problem solving andjudgment, critical thinking, multidisciplinaryteam interactions and communication, and timemanagement and task prioritization. The processof learning through experience and caring foractual patients needs to be active and continuouswith subtle but consistent supervision. Whiletrainees should feel independence to learn andpractice as the pharmacist on themultidisciplinary team, it is equally important toprovide a safety net such that the trainee canlearn without worrying about potentialdetrimental outcomes. One major component oflearning is continuous improvement. Mentorsand preceptors need to provide trainees withopportunities to learn, make mistakes withappropriate oversight, and reflect on how toimprove their skills while encouraging them andmaintaining an excellent level of pharmaceuticalcare. A safe environment with a practice leaderwho provides guidance will assist the new ICUpharmacist to develop the skill sets andconfidence necessary to function independently.The mentor should provide feedback onsuccessful approaches and help mold the trainee’sability to represent themselves when discussingpatients and providing recommendations forimproving patient care. Collaboration in the ICU

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is essential for maximizing outcomes. Therefore,it is imperative that trainees integrate themselvesand be responsible to the multidisciplinary teamfor patient care and for the team to view thetrainee as the pharmacotherapy specialist. Aneffective ICU team will engage in all types ofinteractions, including some that may involveincorrect information, disagreements, and othercontroversial topics (e.g., social issues, religiousor cultural beliefs, etc.). Trainees need to berespectful of other members of the team and actprofessionally with ethical diligence andempathy.The mentoring relationship may extend to

issues such as guidance for policy and protocoldevelopment, administrative training,accreditation exposure, and assistance withscholarship.63-67 Whenever possible, the mentorshould involve the trainee in committees,hospital projects, and teaching opportunities thatinvolve various audiences and formats. Thepreceptor must ensure the appropriate level ofinformation is conveyed in a manner conduciveto learning for the targeted audience. Writtencommunication skills should be developedthrough practical application. In some cases, thementor may assist with professionalrelationships, guide career development, andprovide counseling for personal challenges.Eventually the pharmacist requiring mentorshipshould strive to develop into the role of thementor.

Resources Available

An established network of non-ICUpharmacists who offer practical knowledge is avaluable resource to the critical care pharmacist.These individuals may serve as advisors, provideexamples of pharmacy practice models, or offerunique knowledge of emerging or changingtherapies that potentially affect critically illpatients (e.g., oncology, neurology, nutritionsupport, transplant, infectious diseases, etc.).Another resource available to all pharmacists isthe educational offerings of critical careconferences (e.g., SCCM Annual Congress).These multidisciplinary meetings providepractice perspectives of challenging patient careissues, clinical application of emerging data, andthe opportunity to create networks of critical carecolleagues. Pharmacy specific conferences (e.g.,ASHP Midyear Clinical Meeting, ACCPmeetings) provide excellent opportunities toliaise with pharmacists practicing in critical care

or other specialties, who may offer examples ofinnovative pharmacy practice models or skillsand knowledge that may be applied to the care ofcritically ill patients. Involvement in critical careand/or pharmacy organizations offersopportunities to develop skills of effectivecommunication, leadership, organization, andtime management. The pharmacist must becommitted to continual learning and professionaldevelopment to maintain scope of knowledgeand applicable skills.The ASHP Research and Education Foundation

Critical Care Traineeship offers participantspractical experiences in designing patient-specificpharmacotherapy, solving drug therapy problems,and developing protocols / guidelines andpolicies related to the care of critically illpatients.68 The SCCM CPP section provides amentoring service for ICU pharmacists desiringassistance in various activities (practice,education, administration, or scholarship). Mini-sabbaticals may be available through variousorganizations and allow developing pharmaciststo travel to sites where an established pharmacistcan provide advanced training opportunities.Ideally these programs will be expanded andstructured to provide coordinated opportunitiesfor individuals to expand their skills and applytheir knowledge. Few pharmacy schools andsome organizations (e.g., ASHP, ACCP) havedeveloped programs designed to advanceparticular skill sets (e.g., teaching, projectmanagement / scholarship, leadership, etc.).

Support for a training environment

Administrative support for the developingpharmacist on the critical care team should beproactive. Support should come from thedepartment of pharmacy, ICU directors andmanagers, and hospital administrators but maybe required from other interested parties, such asaffiliated academic departments, governmentagencies, payers, patient advocacy groups, orother healthcare providers. In order to optimizepatient care, pharmacists, their employers, andICUs must advocate for their presence anddemonstrate their importance in the ICU.Support may involve creating and funding the

position, advancing the professional growth ofthe individual pharmacist, allowing sufficienttime to achieve successful outcomes, identifyingmentors and preceptors, or process changes thatcontinually progress pharmacy services.Networks of affiliated institutions, academic

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centers, or organizations with establishedresidency programs may create an “in-house”training program that is designed to address theneeds of the trainee. Financial support and timeallotment to foster and encourage theprofessional development of the pharmacist isessential. This may include formal mechanismsof training, mentoring, or mini-sabbaticals.Resources should be allocated that allowpharmacists to obtain the necessary training andcredentials required to practice in the ICU, joinprofessional organizations, and attend theconferences supported by those organizations.Pharmacists provided with these opportunitiescan network, advance their knowledge, andrefine approaches to managing their patients.This allows the institution to keep current onapproaches to patient care as the information isdisseminated internally to other healthcareproviders. The dissemination of institution-specific scholarship at professional conferencesmay provide recognition to the institution.Enhanced patient care associated with theprovision of training and advanced pharmacyservices must be of value to the institution,especially during times of fiscal constraint.69 Insome cases, having qualified pharmacypreceptors to create additional formal trainingopportunities for students, residents, and othertrainees may generate revenue that may partlyoffset the training and support of the critical carepharmacist.69 The opportunity for additionaltraining enhances career satisfaction and may aidindividual development and employeeretention.70 In order to maximize their return oninvestment, hospitals and/or academicinstitutions should consider the benefits ofcollaborating with experiences gained internallyor from other institutions.

Credentialing Pharmacist for Critical Care

Pharmacist credentialing is a contentious issue.Credentials are desirable for professionals, butattempting to define or clarifying the requiredcredentials for pharmacists providing variouslevels of service remain controversial. The focusof this section of the document is to project thecredential requirements for pharmacists caringfor critically ill patients. This serves as anopportunity to define the expectations of ICUpharmacists for all interested parties and isintegral to the advancement of pharmacy practicein the ICU setting, since they may be used forinstitutional privileging, eligibility for

reimbursement from governmental and privatepayers, accreditation of residency trainingprograms, and numerous other internal andexternal evaluations. For the purpose of thefollowing discussion, credentials, accreditation,certification, and related processes are thosedefined by the Council on Credentialing inPharmacy (CCP).9

Credentialing history

Credentialing, defining credentials, anddesigning processes to verify and maintaincredentials is not limited to the profession ofpharmacy. The Accreditation Council forGraduate Medical Education (ACGME) isresponsible for establishing general requirementsfor medical residencies and developing theprocess of accrediting programs.71 The AmericanBoard of Medical Specialties (ABMS) isresponsible for certifying specialists.72 Thepharmacy profession parallels medicine in thatASHP is responsible for establishing requirementsand accrediting pharmacy residency programswhile the Board of Pharmaceutical Specialties(BPS) is responsible for credentialing pharmacyspecialists.73, 74 Like medicine, recognition ofpharmacy specialty areas requires the presence ofa distinct body of scientific knowledge, appro-priate number of candidates who concentratetheir practice in the area, professional support,presence of training programs with appropriatedepth and scope, and candidate requirements.75

Characteristics of successful certificationprograms have been defined and includewidespread professional acceptance, marketpenetration beyond the profession (e.g., demanddriven by payers or employers), identification asthe major source of professional specialtyrecognition, associated beneficial outcomes andcost-effectiveness, and economicallysustainable.75

Over the past two decades, there has been anexplosion of interest in the credentialing ofhealthcare providers.75–78 In 1989, JCAHO (nowtermed TJC) required acute care institutionsseeking accreditation to confirm the credentialsof the medical staff and upon review of theinformation determine privileging status withinthe organization. The metrics for evaluatinghealthcare provision has changed to include agreater emphasis from payers on the quality ofcare provided. In addition, the general public ismuch more informed of health care quality andstandards of practice, due in part to the

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widespread dissemination of information onquality and medical errors found in variousreports including the Institute of Medicine. Thisincreased attention to healthcare quality hasspawned the creation of a number of public andpolitical advocacy and research organizationsfocused on optimizing quality of care. Whilemany organizations utilize credentials assurrogate markers of practitioner knowledge,skills, and attitudes; there are very little datacorrelating the attainment or maintenance ofparticular credentials with improved quality ofcare or cost-effective for any healthcarediscipline. This is particularly absent in theprofession of pharmacy.75

Current pharmacy credentials

The CCP was formed in 1999 and is a coalitionof 13 pharmacy organizations committed toproviding leadership, guidance, publicinformation, and coordination for credentialingprograms in or relevant to pharmacy.9 Table 3outlines current pharmacy credentials.74, 75 As ofJune 2004, the education credential awarded tothose students completing collegiate studies isthe doctor of pharmacy degree.4 Pharmacylicensure is regulated by each state’s board ofpharmacy. Upon the receipt of the doctor ofpharmacy degree and the completion of aspecified number of practice hours, theindividual may complete the licensingexamination. Additional requirements topractice may be determined by the state in whichpractice will occur. Pharmacists who wish toadvance their knowledge or skills may alsoacquire additional credentials throughpostgraduate education, training, or credentialing(Table 3). Of note, the methods used by theseorganizations to approve these credentials varyfrom knowledge-based tests to experientialpractice hours.In pharmacy, credentialing requirements by

institutions have focused on meeting TJCstandards. Most acute care institutions meetthese standards by performing a pre-employmentreview of the pharmacist’s credentials. Thispredominately involves confirmation of theappropriate degree and licensure. Someinstitutions have expanded upon this by eitherincorporating specific credentials required oroutlining a privileging process to match specificjob descriptions. In the future, it is anticipatedthat additional credentialing will be necessary toprovide higher levels of pharmacy services.

These services and associated credentials will beexpected by interested parties in order to meetexpanding accreditation benchmarks, meet theneeds of the evolving pharmacy educationalsystem, and meet institutional and payerstandards for provider status and reimbursement.Some of these changes have already started as thenewest version of the ASHP residencyaccreditation standards for PGY2 residenciesrequires program directors to obtain BPScertification when certification is offered in thatspecific advanced practice area.37

Pharmacy statements

The mission statements of both ACCP andASHP focus on support and advancement ofpharmacists and pharmacy practice.77, 78 Theirvisions suggest the practice of pharmacy shift itsfocus from managing products to patient care. Arequired element for the occurrence of this shiftis to develop credible and coordinatedcertification and credentialing processes forpharmacy practitioners. Licensure alone will beinsufficient if pharmacists are to be the experts in

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Table 3. Current Pharmacy Credentials/Certifications.74, 75

Credential / Certification Program(s)Education Doctor of Pharmacy (Pharm.D.)

Postgraduate Education MastersDoctor of Philosophy

Postgraduate Training Postgraduate Year 1 ResidencyPostgraduate Year 2 (Specialty)ResidencyFellowship

Credentials/Certifications American Academy of PainManagement Credentialed PainPractitionerAmerican Council for PharmacyEducation certificate programsa

Commission for Certification inGeriatric PharmacyDiplomat of the American Boardof Applied ToxicologyNational Institute for Standardsin Pharmacist Credentialingb

Board of PharmaceuticalSpecialtiesCredentials in nuclear,nutrition support, oncology,p h a r m a c o - t h e r a p y,psychiatry, and ambulatorycareAdded qualifications incardiology and infectiousdiseases

ano longer offeredbprogram expired December 31, 2008.


optimizing the use of medications and thesystems in which they are delivered.Recommendations related to pharmacycredentialing and to the knowledge, skills, andabilities they are meant to represent are evidentthroughout numerous pharmacy organizationaldocuments. The Task Force on ChangingDemographics encourages pharmacypractitioners to pursue a lifelong process ofmaintaining competency with respect to issuesthat have a bearing on patient outcomes andpractitioner team effectiveness.79 Otherrecommendations include a vision for entry-levelpharmacists to complete PGY1 training and forthose practicing in highly specialized areas tocomplete PGY2 training.39, 40 Additionally, mostclinical pharmacists will need to obtain anappropriate specialty certification, such as thosecurrently offered through BPS.74, 80 ASHPrecommends that by the year 2020 allpharmacists providing direct patient care mustcomplete residency training.81 Theserecommendations of advancing credentialing andtraining requirements are based on therecognition that pharmacists will be involved inall patient care settings, that pharmacists willassume responsibility and accountability formanaging drug therapy, and that pharmacists willbe recognized by payers as health careproviders.74 It is anticipated that credentialingwill be based on the application of knowledgeand the demonstration of performance.

Critical care statements

In the position paper endorsed by ACCP andSCCM, levels of service, service providers, andscope of service were outlined.1 Stratifying adultICU services by level resulted from data andoutcomes identified from the American Collegeof Surgeons (ACS) applied to trauma centers.Level 1 critical care centers providecomprehensive care and treat a wide range ofpatient populations.7 In addition to orderfulfillment, this document states that “it isessential that the pharmacist have thequalification and competency necessary toprovide pharmaceutical care in the ICU.”7

Qualifications have been described as advanceddegree, post-graduate training, or otherspecialized practice experiences. Level 2 centersprovide comprehensive care for select areas ofexpertise. The expectation for personnel andservices are the same as in Level 1 for thesepatient populations. Level 3 designation differs

primarily because institutions provide limitedcritical care services and focus on patientstabilization and coordination of patient transferto an appropriate comprehensive care center.Pharmacy services for these centers focus onmedication system processes. Recognizing thatcritical care encompasses several distinct patientpopulations, SCCM has since emphasizedpractitioner certification for optimal delivery ofcare for all critically ill patients.7, 8 Unfortunately,the specific certification requirements forpharmacists were not delineated. The scope ofcertification, however, is expected to varydepending upon the level of service and thespecific patient population.

Recommended credentials for critical carepharmacist

Recommendations for credentials of criticalcare pharmacists are based on currently availablecredentialing mechanisms.74, 75 It should benoted that considerable disparate opinionsexisted amongst those formulating theserecommendations. This likely reflects thegeneral critical care pharmacy community.75

Therefore, idealistic methods of optimizing thesecredentials are also presented in hopes that theprofession will consider similar methods ofverifying competencies in the future. Table 4outlines the recommended credentials andprovides a template for idealistic credentials.74, 75,82, 83 Purposefully absent in this document arepotential implementation strategies, time linesfor achieving change, and the identification ofthe agencies responsible for administrativeoversight as these will be determined byindependent governing, regulatory, andaccreditation entities. Several professionalorganizations, however, have vision statementswith targeted dates for their recommendations tobe implemented.77, 78 It is recognized thatachieving these credentials will vary based uponinstitutional structure, practice models, thepharmacy department, and the pharmacist.Therefore, it is highly unlikely that a single pathwill achieve the requirements for all involved inthe credentialing process.It is recommended that the process of

credentialing involve a graduated system thatprogressively develops the requirements acrossthe level of pharmacy services.82 Pharmacistsproviding fundamental services should posses thebasic licensing credentials; whereas thoseproviding desirable and optimal levels of service

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should complete additional PGY1 and PGY2,respectively. Recommendations for experienceequivalent to residency training have beenproposed; however, currently there is notconsensus on this issue. One approach describedby a recent ACCP statement recommends thatPGY1 training equivalency should be portfolio-based and incorporate a personal statement,academic credentials, valid license, feedback fromcolleagues, and documentation of at least fiveyears of experience with activities involvingdirect patient care services, practice management,medication use management and medicalinformatics, project management, andeducational services.83 Pharmacists practicing incritical care for three years or who havecompleted a PGY1 residency are eligible to sit forthe BPS Pharmacotherapy specialty examination.These requirements are advantageously perceivedby new practitioners.84 Ideally, a critical carecredential should be available that would beobtained after successful completion of the PGY2specialty residency or equivalent experience. Atthe time of writing, CCP is discussing theoptimal credentialing framework for thepharmacy profession. In addition, BPS isexploring several new specialties areas, including

critical care. The reader is encouraged tomonitor for these developments.Several limitations of these credentials exist.

In both the medical and pharmacy literature, thelack of efficiency in the documentation andverification of credentialing is a frequently citedissue. Ideally, there would be a single repositoryfor the creation and maintenance of thisinformation, allowing individuals to makeseamless workplace transitions in their careers.Such a system would also be beneficial foremployers since all verified documents wouldexist in one databank and there would bepotential to make the information available to thepublic. Another issue in the pharmacyprofession is the lack of validation of thecurrently available credentials against thecharacteristics associated with successfulprograms.75 Also, currently available credential-ing avenues may not assess the competencies ofthose with established pharmacy practices orthose practicing in subspecialties (e.g.,neuroscience, burn, etc.). Furthermore, today’scredentials may not reflect the necessity of othertypes of credentials in the future as it isanticipated that the pharmacists’ clinicalresponsibilities and accountability will increase.

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Table 4. Credentialing Recommendations for Pharmacists Providing Critical Care Services.74, 75, 82, 83

Level ofPharmacy Service Recommended Credentials Ideal CredentialsFundamental Pharmacy Degree Same as recommended credentials under desirable

Active state licensure level of pharmacy service1-2 weeks of mentored clinical exposure every 5-7years and/or focused continuing education

Desirable Pharmacy Degree Same as recommended credentials under desirableActive state licensure level of pharmacy servicePostgraduate training year 1 or similar traineeship Portfolio review every 5-7 yearsor equivalent experienceBoard of Pharmaceutical Specialist certificationin PharmacotherapyAdvanced Cardiac Life Support certification

Optimal Pharmacy Degree Same as recommended credentials under optimalActive state licensure level of pharmacy service

Portfolio review every 5-7 yearsPostgraduate training year 1 or similar Possible onsite competency assessmenttraineeship or equivalent experiencePostgraduate training year 2 in critical careor related practice (e.g. emergency medicine,transplant, etc) or equivalent experienceBoard of Pharmaceutical Specialties certificationin appropriate areaAdvanced Cardiac Life Support certification


Consideration may need to be given to assessingpractical skills and/or structuring credentialingexams differently that allow pharmacists todemonstrate higher order cognitive skills orspecific skills applicable to a specialized practice.Finally, increasing utilization of competencyassessments will likely become a focus of futurepharmacists seeking to obtain and maintain highlevel practice credentials.

Ideal credentials

Credentials should advance the level ofpractice and signify designated competencies thatreflect skills required for performance. Thecompetencies must advance knowledgeassessment to include other core skill sets. Thefollowing discussion focuses on ideal credentialsthat critical care pharmacists should posses toprovide the various levels of services. Thecritical care pharmacy community endorses thefollowing model as an example that theprofession in general should pursue whenestablishing required credentials in the future(Table 4).74, 75, 82, 83 The proposed model is acombination of currently available credentialsand the frameworks used in the United Kingdomwhere pharmacists may be assessed at levels of“general pharmacy”, “advanced”, or “consultant”after submitting a portfolio that is evaluatedbased on demonstrated competencies by acollaboration of pharmacy reviewers termed theCompetency Development and Evaluation Group(CoDEG).85, 86

The basic credentials for all levels of servicesare identical to those for recommendedcredentials except that PGY1 training (or similarexperiences) and BPS certification may becomemandatory for pharmacists providingfundamental services (Table 4).74, 75, 82, 83 This isin accordance with the recommendations ofvarious professional organizations and shouldensure the basic knowledge level and skillsrequired to provide pharmacy services tocritically ill patients and other patientpopulations. It is anticipated that manypharmacists currently providing fundamentalservices would possess experiences similar toPGY1 training.83 In order to maintain practicalskills and competency, all pharmacists providingfundamental services may periodically spend ashort period of time in a mentored direct patientcare ICU environment. Because thesepharmacists may provide fundamental pharmacyservices to various hospital units, it is anticipated

that they may have several mentored exposuresof direct patient care across various patientpopulations. Alternatively or in addition,continuing education programs may bedeveloped to maintain competencies for thesepharmacists.What also differs from the recommended

credentials is a mechanism for peer review thatincludes competency assessments forpharmacists providing desirable and optimallevels of service. These pharmacists may submita portfolio that is externally and independentlyassessed by pharmacy practice experts (bothcritical care and non critical care) through thedevelopment of a specialist board, comprisingclinical experts, academicians, and managers.Solicited appraisal from other entities (e.g., peers,professional colleagues, other ICU healthcareemployees, trainees, subordinates, state licensingbody, etc.) is recommended. This peer reviewmodel is similar to the processes used forpromotion of faculty in academia, thedesignation of fellow by critical care andpharmacy organizations, and the peer reviewprocess implemented by the Veterans HealthAdministration in 2008.87 It is also similar inphilosophy to the process of “addedqualifications” currently offered through BPS inthe areas of infectious diseases and cardiologybut differs substantially in structure and rigor. Asimilar model using competency assessment andoutcome documentation has been introduced inAlberta to facilitate pharmacist prescribingauthority in their scope of practice.88

Portfolio requirements, competenciesevaluated, and rating levels may differ accordingto the level of service. For example,competencies assessed under desirable levels ofservice may include safe and efficient drugdistribution, patient care delivery, personal traits(e.g., communication, leadership), problemsolving, management/organization, education,and project management. The portfoliorequirements for optimal services may beexpanded to also include expert professionalpractice, advanced problem solving, systems andorganizational management, education/trainingdevelopment, research/evaluation, and publichealth initiatives. Different rating scales mayexist for different levels of service; pharmacistsproviding desirable services may need to becompetent at ratings of foundational to excellentbut ratings of excellent to mastery may berequired to provide higher level services. Similarto the systems used to accredit residencies by

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ASHP,37 pharmacy schools by ACPE,4 andinstitutions by TJC,3 onsite observations of skillscould be integrated into the model as a methodof assessment, especially for determiningcompetencies of optimal service.As mentioned, the proposed competency

assessment model is conceptually similar to theframework currently being implemented in theUnited Kingdom.85, 86 The framework in theUnited Kingdom was endorsed by regionalhospital agencies and flowed to the pharmacyprofession. A key to implementing a similarsystem in the US will be institutional andgovernment support since it is the professionthat’s stimulating change. This will enhancenational acceptance and market penetration ofthe proposed model. In the United Kingdom, theposition dictates the level of competency neededto practice whereas the proposed frameworkwould allow the individual pharmacist totransition through the levels of practice as theygain experience or develop their practice. Theproposed model is also fundamentally similar tothe credentialing framework recentlyrecommended by the CPP that delineatescredentials based on practice domain (e.g.,system-wide vs. patient focused), practice focus(e.g., generalist vs. population specific), and theacquired levels of knowledge, skills, andexperiences (e.g., entry level vs. advanced).74

Both models are aligned with the ability andpractice-based outcomes used by ACPE to assesseducational curricula.4 The CPP framework,however, incorporates only currently availablecredentials, most of which are knowledge basedand limited to specific patient populations.Under the CPP model, credentials are notcurrently available for pharmacists wishing toprovide advanced services to critically illpatients. By incorporating a portfolio reviewcomponent, the proposed model provides anddefines opportunities for the demonstration andassessment of skills and experiences.The proposed model recognizes skill sets

beyond knowledge (e.g., communication,leadership, management, education/trainingdevelopment, and research / evaluationmentoring, education, committee participation,project management / scholarship). The level ofservice at which a pharmacist is assessed willdepend upon the training background andexperience of the pharmacist as well as thepractice setting and requirements of theinstitution. This method of credentialing wouldprovide opportunities for the established

pharmacist without advanced training todemonstrate competencies necessary to performhigher level services. It provides all pharmacistswith the opportunity to progress to providinghigher levels of services and credentials. This isespecially pertinent because it maximizesprofessional acceptance of the credentialingprocess, expands the market demand forcredentialing, and provides a means to limitprofessional fragmentation that occurs withvarious training and experiential backgrounds. Italso provides systematic structure to the processof credentialing that is easily interpreted byadministrators and other healthcare providers.This system would advance the concept of thecritical care pharmacy mentor so theseopportunities are available to trainees andpromote continuous learning as pharmacistswould be required to maintain or achieve variouslevels of credentials.Limitations exist to this model. Practically,

implementation would be difficult and costly.Many professional organizations, governmentalagencies, pharmacy schools, residency programs,acute care institutions, and payers would need topartner. Descriptions of competencies,submission guidelines and timeframe, panels ofexperts and mentors, and an appeals processwould need to be established. It is anticipatedthat some of the costs of administering theprogram would be supplemented by governmentor educational programs and possibly payers.However, the individual pharmacist or employerwould likely pay an assessment fee. It isenvisioned that achieving and maintainingdesirable or optimal skills in accordance with thismodel may encompass prescribing privilegesand/or establish a method for financialreimbursement for pharmacy services. Accord-ingly, a nominal fee for the purpose of acquiringthese credentials may be offset by the potential togenerate revenue. It is, therefore, incumbent onthe pharmacy profession to demonstrate thatpharmacy services are associated with positiveoutcomes and/or cost-effectiveness and thatassessment of these services may be incorporatedinto a credentialing model.75

Documenting and Justifying Critical CarePharmacy Services

The documentation of services provided bycritical care pharmacy practitioners shoulddemonstrate the diversity, effectiveness, cost, andoutcomes of the activities performed. In

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addition, documentation may demonstrate coreskill sets required for competency assessmentsand/or credentialing. Nearly 93% of ICUpharmacists document their services but most ofthese services are fundamental.2 About 75% ofdocumentation programs track clinicalsignificance but only 22% attach an economicimpact. Most documentation programs are eitherpaper-based or use a centralized computer whilefar fewer use a decentralized system (e.g., hand-held/laptop computer). It is anticipated thatdocumentation may lead to justification andincreased funding of additional and/or higherlevel activities, thereby expanding the pharmacyservices provided, matching the growth of ICUbeds, and meeting the demands of the criticalcare profession. This portion of the documentwill focus on the elements of documentation forthe various levels of pharmacy services, developtemplates for documentation, and providerecommendations for service justification.Information is presented in general terms usingcritical care pharmacy as an example that mayserve as a template for the profession.

Elements of documentation

Opportunities to document and justifypharmacy services in the ICU are vast andinclude increased patient exposure tomedications, complex therapeutic regimens,rapidly altering patient-specific variables (e.g.,organ function, pharmacokinetic profiles, etc.),costly medication regimens, therapeutic regimenswith specific use criteria, safety, constantlyemerging data, and greater interactions withother healthcare providers. The method andservices documented, however, will depend onthe levels of services provided, ICU andpharmacy structures, and available hospitalsupport systems (e.g., information technology).As the level of pharmacy services progress, thefunctions of the pharmacists evolve fromidentification and resolution to prevention andmanagement of a particular issue. As a result, theinterventional target, documented skills andoutcomes, and reasons for justification will alsoexpand as the level of services advance. Table 5outlines how the process of documentation maydiffer according to the levels of pharmacyservices.Pharmacists providing fundamental services

are involved in order processing more than directpatient care.1, 14 As a result, they act to identifyand resolve issues that are usually directed at a

particular medication or patient. Theirinterventions usually occur at the time of orderverification and tend to be retrospective relativeto when the order was written. The process ofidentification may be prospective if thesepharmacists perform patient profile reviews.These pharmacists usually resolve issues bycommunicating with other healthcareprofessionals or directing therapy under theguidance of ICU or hospital-wide protocols orpolicies (e.g., automatic substitution, IV to POconversion, medication restrictions,pharmacokinetic service, etc.). Activities thatoccur frequently and require documentation bythese pharmacists include avoidance orresolution of drug-related problems, clinicalinterventions, therapeutic monitoring, andmedication or administration relatedinformation. The most common interventionsdocumented are order verification and entry,drug distribution, and drug information.Appendix 1 provides a template of a paper-baseddocumentation form that captures theserequirements. Alternatively, some institutionsand pharmacists may use computer-baseddocumentation methods that may involve pop-upscreens incorporated into the hospitalinformation system or independentdocumentation systems. Systems that are alignedwith the hospital information system have thebenefit of synching with the pharmacy orlaboratory databases and may be accessed byothers to generate reports. Of note, users spendless time and tend to prefer computerizedsystems over paper-based manual methods. Staffpharmacists, however, document moreinterventions when using a manual method.89, 90

The physical location of these pharmacists alsoalters the activities documented. Pharmacistsworking in a centrally located area are morelikely to provide information regarding productidentification and availability whereaspharmacists practicing in an ICU-related(“satellite”) location are more likely to provideservices such as therapeutic monitoring andinterventions, education inservices, CPRparticipation, project management and clinicalresearch endeavors, and information regardingmedication administration and compatibility.89, 90

These pharmacists also receive more inquiriesand tend to interact directly with otherhealthcare professionals. The use of clinicaldecision support software (e.g., computerizedprescriber order entry) also changes the type ofinterventions as some order errors are reduced

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(e.g., incomplete orders, wrong dose or fre-quency) but other issues emerge (e.g., incon-sistent orders, unnecessary orders, orders notaligned with ICU guidelines, etc.) necessitating

intervention and documentation by thepharmacist.90–93

In order to maximize documentation, usersshould be provided an opportunity to give

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Table 5. Elements of Documentation Relative to the Level of Pharmacy Services.

Required RequiredDocumentation Skills to be Outcomes Audience /

Level of Service Method Function Target Focus Documented Attached JustificationFundamental Paper-based or Identify Patient Avoidance or Cost Self(primarily order computer-based Resolve Medication resolution of drug- Number of Pharmacyprocessing) (pop-up screens, related problems interventions department

possible health Clinical Intervention Accrediting agenciessystem integration) interventions outcome

Therapeutic Potentiallymonitoring include:Medication or Medicationadministration safetyinformation MedicationMedication appropriatenessreconciliation ClinicalPotentially significanceinclude: TimeEducation commitmentof other Resourceprofessionals utilizationPatient profilereviewsCPR responseCommitteeparticipationResearchinvolvement

Desirable Should be Identify Patient Must include: Must include: Self(mixed order computer-based Resolve Medication Avoidance or Cost Pharmacyprocessing/clinical Solve Disease state resolution Number of departmentor clinical Prevent of drug-related interventions ICU service orbut not ICU problems Intervention departmentspecialist) Clinical outcome Pharmacy and

interventions Medication ICU peersTherapeutic safety Hospitalmonitoring Medication administrationMedication or appropriateness Affiliated universityadministration Clinical Accrediting agenciesinformation significanceMedication Timereconciliation commitmentEducation of Resourceother utilizationprofessionals PotentiallyEducation of include:patient Therapyor family outcomePatient profile (e.g. analgesia orreviews sedation levels)CPR response Cost of outcomeCommittee Patient outcomeparticipation Length of stayResearchinvolvement


feedback about the various methods and systemsprior to implementing a documentation system.The documentation program must mesh with thepharmacists’ responsibilities without creatingburdensome duties that contribute to additionalworkload. Pharmacists starting a documentationprogram should consider whether efficiency ismaximized by implementing a comprehensiveprogram (e.g., Appendix 1) or focusing theprogram so that it captures the sickest patients orcertain medications such as those highlighted byTJC as patient safety initiatives22 or those knownto cause the most serious adverse events (e.g.,vasoactive agents, sedatives/analgesics,electrolytes, anticoagulants, insulin).45–54, 93, 94

Another consideration is the method that will beused to compile the documented information.Interventions may be classified by type, targetmedication, hospital unit / patient population,time of day (or shift-based), interventionoutcome (solved vs. unresolved), patientoutcome, clinical significance, cost ofintervention, time commitment, or pharmacist.Pharmacists providing desirable services

should have substantial responsibilities forclinical services that involve direct patient care.1, 7

Many of these pharmacists are responsible forservicing several patient care populations and/orhave order processing duties incorporated as afunction of their direct patient care

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Required RequiredDocumentation Skills to be Outcomes Audience /

Level of Service Method Function Target Focus Documented Attached JustificationOptimal Computer-based Identify Patient If needed, must Must include: Self(ICU clinical or minimal Solve Medication include: Cost Pharmacyspecialist or documentation Prevent Disease state Avoidance or Number of departmentclinical as service is Manage ICU patient resolution interventions ICU service oradministrator) recognized and Guide care of drug-related Intervention department

justified Educate problems outcome Pharmacy andResearch Clinical Medication safety ICU peers

interventions Medication HospitalTherapeutic appropriateness administrationmonitoring Clinical Affiliated universityMedication or significance Accrediting agenciesadministration Time commitment Publicinformation Resource PayerMedication utilization Government agencyreconciliation Therapy outcome Licensing bodyEducation of other (e.g. analgesia or Granting agencyprofessionals sedation levels)Education of Cost of outcomepatient Patient outcomeor family Patient disposition /Patient profile length of stayreviews Patient readmissionCPR response Potentially include:Committee Satisfactionparticipation assessmentsResearch by patients,involvement families, or otherPotentially ICU professionalsinclude: Peer reviewProcess of care MentoringVerbal Process assessmentscommunication Risk reductionWritten Publicationcommunication Statistical interpretationLeadership Prescriber privilegesManagement Return on investmentSelf reflection Service reimbursement

CPR=cardiopulmonary resuscitation; ICU=intensive care unit


responsibilities in the ICU. In addition totargeting specific medications or patients, thesepharmacists tend to be involved in managingdisease states either at the bedside as part of thepatient care team or through the development ofprotocols and guidelines. These pharmacistsshould strive to identify and resolve issuesprospectively and progress toward solving andpreventing problems. Like those providingfundamental services, documentation will focuson the most common interventions but shouldinclude educational services provided to otherhealthcare professionals, patients, and familymembers; patient profile reviews; CPR response;committee participation; quality improvementinitiatives; and project management andscholarly activities. As a result, the outcomesattached to documentation will expand uponthose documented for fundamental services toinclude assessments of therapy outcome, cost ofoutcomes, patient outcomes, and possibly lengthof stay in the ICU. A computer-based system isthe preferred method of documentation. Thissystem must be shared or generate reports ofactivities and outcomes since the audience mayinclude ICU personnel, hospital administrators,affiliated university departments, or accreditingagencies. The ideal documentation systemshould be user friendly, inexpensive, efficient,adaptable or customizable, expandable,exportable to other platforms, integratable,penetrable from various ports, retrievable, andsecure. Appendix 2 provides a MicrosoftAccess®-based documentation template that maybe downloaded and modified for pharmacistsproviding desirable pharmacy services tocritically ill patients. Appendix 3 provides acomparative summary of the commerciallyavailable documentation systems.95–102

Pharmacists providing optimal services mustprovide direct patient care and are involved withdisease state management.1, 7 These pharmacistsguide pharmacotherapy and may be directlyresponsible for medication management throughestablished rapport with prescribers,collaborative practices, or ICU/hospital protocols.They shape ICU practices through theirinvolvement with policy development, education,research, resource utilization, management, andleadership. The skills and outcomes documentedmay involve those outlined for fundamental anddesirable levels of services but may also includeprocesses of assessment and care, communicationskills, leadership, management, and selfreflection demonstrated through satisfaction

assessments, peer review, mentoring, andpossibly prescriber privileges, service re-imbursement, or public health initiatives. Theylikely do not need to document to record orjustify their services as they are recognizedmembers of the ICU team and their services areexpected and valued. Documentation of theirservices likely occurs to establish additionalclinical services, expand the roles of existingservices, assess new processes or practices (e.g.,prescriber privileges or provider re-imbursement), provide data for quality assuranceor research initiatives, accreditation purposes, orpromotional reasons. Given the specializedfunctions of these pharmacists, it is implausiblethat a single, standardized documentation systemcan serve as a template. It is more likely thateach institution or pharmacist will develop asystem that meets their specific requirements.These systems most certainly will generatereports and may include statistical interpretationof their services, satisfaction surveys of theirservices, risk reduction, peer review, publication,return on investment data, or future initiatives.

Service justification

While clinical pharmacy services consistentlyprove cost-effective,19, 20, 26, 103–106 justificationserves the purpose of providing sufficientevidence to gain or maintain the political andfinancial resources for the maintenance ofexisting services or position(s) or themodification or creation of the same. This is ofparticular importance because less than a third ofall clinical pharmacists have defined criteria forcareer advancement and only 16% of institutionshave established career advancement pathwaysyet more than half of all clinical pharmacistsintend to pursue career advancementopportunites.106 Individual pharmacistsproviding fundamental services may need todocument these services for their performanceevaluations or promotion but these services willnot require justification as these are needed tosafely provide pharmaceutical care. Therefore, itis anticipated that justification will primarilyinvolve the provision of desirable or optimalservices. Table 6 describes several potentialsituations where justification of these servicesmay be required. The target audience orstakeholder of these efforts may vary but obviouspoints of convergence for justification may occur.However, it is important that the needs andconcerns of specific groups be considered and

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http://www.pharmacotherapy.org/PRN/global_intervention_4.mdb


addressed as they likely will differ betweenconstituents.107, 108 The perspectives of thesestakeholders must be serially assessed prior to,during, and after a critical care pharmacy serviceis added or modified.107–109 Therefore,justification is a continual process. In addition,current staffing structures in the pharmacydepartment and ICU must be considered and thepotential impact of the pharmacy serviceevaluated both a priori and after implementationwith the goal of maximizing efficiency.110, 111

The process of justification

Table 7 outlines the various steps requiredwhen justifying critical care pharmacy services,program(s), or position(s). Adherence to theprocess should result in identification ofperceived needs and expectations of stakeholderswhich will facilitate development of an accuratedescription of the service(s), program(s), orposition(s) with measurable outcomes thatpromote ongoing establishment of the service(s),program(s), or position(s). The resultingdescription must be individualized to the needs

of each institution and should contain achievableresponsibilities valued by the stakeholders.108, 109

Implementing and justifying a single activity(e.g., pharmacokinetic service) that serves as afoundation for additional services (e.g.,pharmacy consult service) is a common mode ofestablishing and expanding pharmacyprograms.107–109

The process must begin with an objectiveassessment and demonstration of needs related topatient-care, the ICU and pharmacy departments,and the institution or organization.109–111 Othertargets or stakeholders should also be considered(Table 6). The assessment must include thecurrent level and scope of pharmacy andinstitutional critical care services, and therecommended scope of pharmacy servicescoordinated with the level of care within theorganization. Useful reference sources forclassification of ICU type and scope of pharmacyactivities are outlined by 1) the position paperpublished by SCCM that describes ICU level ofcare and recommendations for service7, 8 and 2)the position paper published by SCCM andACCP that defines the scope of critical care

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Table 6. Situations Requiring Justification of Critical Care Pharmacy Services.a

Target of Justification Targeted Beneficiary BenefitPharmacy department, Pharmacy department, self Quality improvement, safety / risk reduction, efficiency, costpeer pharmacists effectiveness, return on investment, education, scholarship,

staff satisfaction, ICU rapport, publicity, self promotion

Hospital administration Hospital or health system Quality improvement, safety / risk reduction, efficiency, costeffectiveness, return on investment, staff satisfaction, publicity

ICU staff and department ICU healthcare providers Quality improvement, safety / risk reduction, efficiency, costeffectiveness, return on investment, education, scholarship,staff satisfaction, ICU rapport, publicity, patient or familysatisfaction

Payer Insurer, patient, government Quality improvement, safety / risk reduction, efficiency, costeffectiveness, return on investment, accreditation

Patients, family Patient, family, ICU staff and Quality improvement, safety / risk reduction,department, payer efficiency, cost effectiveness, return on investment, education,

staff satisfaction, patient or family satisfaction

Affiliated academic Affiliated academic departments, Quality improvement,departments pharmacy department, ICU safety / risk reduction, efficiency, cost effectiveness,

department return on investment, education, teaching site, scholarship,ICU or hospital rapport, publicity

Granting agency or Granting agency, accrediting Quality improvement, safety / risk reduction, efficiency, costaccrediting body body, pharmacy department, effectiveness, return on investment, staff satisfaction

ICU department, affiliatedacademic departments

aJustification is for the purposes of creation, modification, or maintenance of service(s), program(s), or position(s). ICU, intensive care unit


pharmacy services.1 Current critical carepharmacy services offered at the institution maybe compared to published literature,2 similarlystructured institutions identified throughhospital networks (e.g., health managementorganizations, the University HealthSystemConsortium, the Voluntary Hospital Association,the Department of Veterans Affairs, Institute ofMedicine), or internal or external benchmarkdata (e.g., TJC, Current Procedural Terminology(CPT) codes, Institute for HealthcareImprovement (IHI), Center for Medicare and

Medicaid Services (CMS), etc.). The baselineassessment should function as a platform todevelop goals and objectives of the pharmacyservice(s), program(s), or position(s) that willlead to a comprehensive strategy to providehigher level pharmaceutical care to critically illpatients that is aligned with the vision of theinstitution.At all steps in the process, the pharmacist must

assess potential barriers and risks ofimplementing the service(s) or program(s). Aplan to address these barriers will be needed. Athorough risk analysis should limit possible

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Table 7. Recommended Steps to Justify Critical Care Pharmacy Services.

Steps Actions1) Assessment and recognition of need Determine level of ICU care

Assess pharmacy services and programs (quantity and quality)Perform literature review and/or assess services provided at peer institutionsAppraise current resourcesDetermine potential barriers and risksDevelop service vision, goals, and objectives

2) Identification of stakeholder(s) Assess perspectives of stakeholder(s) including their needs, level of support,and concernsIdentify champions or partners to support service(s) or program(s)through political influence and/or funding

3) Describe service(s) or program(s) Develop responsibilities of the service(s) or program(s)Determine measurable outcomes of service(s) or program(s)Relate responsibilities and outcomes to stakeholder(s)Develop implementation plan, including timelineDevelop plans to address barriers and risksCommunicate service description and implementation plan to stakeholder(s)

4) Funding assessment or rationale Quality assurance/improvementCost containment or cost-effectiveResource utilizationProcess efficiencySafety, risk reduction, sentinel eventDRG outlierAccreditation requirements (e.g., TJC)External expectationsCo-funding availabilityStaff satisfactionEducational opportunitiesProjection of return on investment

5) Presentation of justification plan Tailor presentation to stakeholder(s)Modify service(s) or program(s) according to feedback

6) Evaluation Assess service(s) or program(s) according to measurable outcomesReport outcomes to stakeholder(s)Modify service(s) or program(s)Reassess service(s) or program(s)Develop expansion and exit strategies

DRG, diagnosis related grouping; ICU, intensive care unit; TJC, The Joint Commission.


threats to the proposed plan. Specific risks toconsider include lack of organizational supportor changes in organizational structure, financiallimitations, personnel or time constraints, legalor policy restrictions, and other neededresources. Potential competitors (e.g., otherclinical staff competing for funding) need to berecognized. The likelihood of implementingservice(s) is enhanced substantially when support isavailable from key individuals who serve aschampions or partners in the process.107, 108 Thesemay be pharmacy personnel, ICU physicians,ICU directors and nurse managers, other ICUpersonnel, hospital administrators, or externalentities such as academic departments, payers, oraccrediting bodies. They may offer policyinfluence or funding opportunities.A description of the service(s) or program(s)

follows the development of the service platform.Targeted responsibilities and measurableoutcomes should be detailed relative to the needsof the stakeholder(s). The goals being presentedto a particular stakeholder may be dramaticallydifferent than the internal intent of the plan orthe goals being presented to anotherstakeholder.107, 108 It is not unusual to generateseveral slightly modified proposals for differentstakeholder(s). An implementation plan shouldbe developed and include a timeline, methods toovercome barriers and risks, assessmentstrategies, and methods of communication. Theplan will need to justify the resources for theservice(s) or position(s) being introduced. Mostcommonly, the metrics of justification involveimproved quality and/or efficiency of care, costcontainment or cost-effectiveness, improvedresource utilization, risk reduction, or theexpectations of external organizations such asaccrediting bodies (TJC, IHI, CMS). Specificoutcome metrics should be identified asindicating success. The plan should be presentedin a manner tailored to each stakeholder.Typically, most stakeholder(s) prefer a shortsynopsis describing the service, implementationstrategies including acknowledgment of potentialbarriers and risks, timeline, assessment approach,likely outcomes, and budget.108–110 The budgetshould forecast various projections of potentialreturn on investment based on differentassumptions. Services or programs that are costneutral or reduce overall costs to the institutionare most likely to gain approval by thestakeholder(s). Therefore, plans that propose tohire additional pharmacists, shift staffingstructure, or require additional training of

current personnel must provide downstreameffects that show cost containment (e.g., reduceddrug usage, fewer adverse events, reduced needfor other services, etc.).107–111 Alternatively, costlyplans may provide rationale by increasing safety,improving quality of care, enhancing patient orhealthcare worker satisfaction, offeringeducational or training programs, orstrengthening external perceptions of theinstitution. Ideally, additional revenue streamsmay be identified such as affiliated academicdepartments, cost sharing between departments,educational / training programs, grants,government agencies or service re-imbursement.The plan must include methods to modify,

reassess, expand, or discontinue the service(s) orprogram(s). It is imperative that services beserially evaluated even after beneficial outcomesare demonstrated and justification is established.The perceptions will vary among stakeholders.Moreover, the service may transform and theneeds of the stakeholders may change over time.These variations require a robust justificationplan which continually addresses the individualneeds and concerns of all stakeholders. Failureto do this may result in unmet stakeholderexpectations and lead to additional barriers forfuture projects. A strategy to expand servicesdeemed successful should be tempered with exitstrategy that may be required in worst casescenarios (e.g., lack of personnel to supportextended pharmacy services).

Summary

This opinion paper, prepared by a task force ofcritical pharmacists who are members of theACCP PRN, the SCCM CPP, and the ASHP, isdesigned to provide pharmacists, pharmacydepartments, ICUs, healthcare systems, andregulatory agencies with recommendations toprepare, credential, document, and justify criticalcare pharmacy services. By utilizing therecommendations provided in this document, thepharmacist should be able to create and providehigher-level pharmacy services in the ICU thatwill benefit patients, the ICU care team, and theinstitution. Ideally the process of preparing,credentialing, and justifying services will belinked and integrated.

Acknowledgments

The following individuals were provided theopportunity to review the paper and/or offeredadditional insight to the content of the paper: Nina

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Ayrapetova, Pharm.D. (Kingsbrook Jewish MedicalCenter, Brooklyn, NY); Farooq Bandali, Pharm.D.(Saint Peter’s University Hospital / Rutgers University,Piscataway, NJ); Jeffrey Barletta, Pharm.D. (SpectrumHealth, Grand Rapids, MI); Seth Bauer, Pharm.D.(Cleveland Clinic, Cleveland, OH); Sarah Bemis,Pharm.D. (Exempla Lutheran Medical Center, WheatRidge, CO); Ryan Bickel, Pharm.D. (Denver VeteransAffairs Medical Center, Denver, CO); Bradley Boucher,Pharm.D. (University of Tennessee, Memphis, TN);Scott Chapman, Pharm.D. (North Memorial Hospital /University of Minnesota, Minneapolis, MN); BradCooper, Pharm.D. (Hamot Medical Center, Erie, PA);Joseph Dasta, M.Sc. (University of Texas, Austin, TX);Catherine Duggan, Ph.D. (University of London,London, UK); Brian Erstad, Pharm.D. (University ofArizona, Tucson, AZ); John Flanigan, Pharm.D.(Exempla Good Samaritan Medical Center, Lafayette,CO); Jeremy Flynn, Pharm.D. (University ofKentucky, Lexington, KY); Gail Gesin, Pharm.D.(Carolinas Medical Center, Charlotte, NC); CurtisHaas, Pharm.D. (University of Rochester MedicalCenter, Rochester, NY); Brian Hodges, Pharm.D.(Charleston Area Medical Center, Charleston, WV);Tyree Kiser, Pharm.D. (University of Colorado,Aurora, CO); Judith Jacobi, Pharm.D. (MethodistHospital / Clarian Health, Indianapolis, IN); StaceyKwan, Pharm.D. (North Kansas City Hospital, KansasCity, MO); Norman Kwong, Pharm.D. (Exempla SaintJoseph Hospital, Denver, CO); Stephanie MallowCorbett, Pharm.D. (University of Virginia HealthSystem, Charlottesville, VA); Steven Martin, Pharm.D.(University of Toledo, Toledo, OH); Karen McAllen,Pharm.D. (Spectrum Health, Grand Rapids, MI);William Miller, Pharm.D. (University of Iowa, IowaCity, IA); Holly Monatt, Pharm.D. (HealthOneSwedish Medical Center, Englewood, CO); EricMueller, Pharm.D. (University Hospital, Cincinnati,OH); Scott Mueller, Pharm.D. (University ofColorado, Aurora, CO); Marilee Obritsch, Pharm.D.(Hillcrest Medical Center, Tulsa, OK); Lance Oyen,Pharm.D. (Mayo Clinic, Rochester, MN); JohnPapadopoulos, Pharm.D. (Arnold and Marie SchwartzCollege of Pharmacy and Health Sciences, Brooklyn,NY); Steve Pass, Pharm.D. (University of Houston,Houston, TX); Asad Patanwala, Pharm.D. (Universityof Arizona, Tucson, AZ); Claire Swartwood, Pharm.D.(Denver Health Medical Center, Denver, CO); AnnThompson, B.Sc. (Alberta Regional Health Services,Edmonton, AB, Canada); Edwin Webb, Pharm.D.(American College of Clinical Pharmacy, Washington,DC); Eric Whittenburg, Pharm.D. (St. AnthonyCentral Hospital, Denver, CO); Peggy Yam, Pharm.D.(Methodist Health Center, Memphis, TN).

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162e


Critical Care Intervention Report Date: / /

Medication(s) involved: Time: :

Pharmacist’s Name:

Identi!able Problem Cause(s) Intervention(s)

Adverse Drug Reaction Drug / Dose Selection None Side effect (non allergic) Inappropriate drug selection No intervention Side effect (allergic) Inappropriate dose selection Prescriber Toxic effect More cost effective drug available Prescriber informed only

Dosing Problem Pharmaco-kinetic/dynamic problems Prescriber asked for informationDrug dose too low or regimen Synergistic / prophylactic drug required Intervention proposed and:

not frequent enough Deterioration / improvement of disease prescriber accepted Drug dose too high or regimen state not approved by prescriber too frequent New symptom / indication revealed outcome unknown Duration of therapy too short Manifest side effects, no other cause DrugDuration of therapy too long Additive toxicity with other medication Change: Drug Dose

Drug Choice Problem Nurse / Patient / Other Schedule Route Inappropriate: drug Nurse has concerns with drug to:

route form Nurse suspects side effect __________________________________ duplication of drug/ingredient Nurse unwilling to bother prescriber Drug stopped

duplication of therapyPatient takes food that interacts Added another drug:

______________ Con!icting orders Drug Use Process Duplicate drug discontinued No clear indication for drug Inappropriate timing of dose Illegible drug order clari"edNo drug but clear indication Drug underused / under administered Refused to dispenseNon-formulary drug ordered Drug overdosed / over administered Review

Drug Use Problem No therapeutic drug monitoring Pro"leWrong drug administered Drug abused Lab testsDrug not administered at all Unable to use drug / form as directed Drug information references

Interaction Information Other: _________________________ Drug – drug / food / disease state / Lack of awareness of prescriber Communication with healthcare lab / environment / age / gender Lack of communication between professional

Potential healthcare professionals Discussion with nurse / other healthcare Manifest Logistics professional

Drug Monitoring Prescribed drug not available Written info provided to prescriberMonitoring: Not ordered Prescribing error (slip of pen) Nurse referred to prescriber

Incorrect Dispensing error (wrong drug or dose) Spoken to family / caregiver Unnecessary Suspect wrong patient

Outcome(s)

Unknown Lack of cooperation from: Intervention not effective Problem totally solved Patient Prescriber No need or possibility to solve Problem partially solved Nurse problem

Clinical Signi!cance

None – cost savings only Signi"cant – brings care to acceptable level/standard

Low – information only High – averted potential major trauma/dysfunction

Moderate – bene"t could affect QOL Extreme – potential lifesaving

Adverse drug event Minor Intercepted error Serious error (level 2-6)_______

Appendix 1. Paper-Based Template for Documentation of Fundamental Services.

Additional Services

Drug Information or Education Other Services

< 5 minutes – oral Therapeutic drug monitoring (PK/PD)____________________

≥ 5 minutes - oral Nutrition recommendation(s) Pro!le review

Literature presented Medication reconciliation Chart documentationInformal in-service Patient or family education CPR responseFormal in-service Committee participation:_______________________________ Other:____________________________

____________ Other:______________________________________________

Resource Utilization

Time Commitment:__________________minutes Other staff involvement:______________________________________________


Guide to Critical Care Intervention Database The objectives of this database are to 1) aid critical care pharmacists (and other pharmacists) in documenting their interventions and 2) provide an integrated mechanism to run reports that document these interventions andassociated outcomes.

To begin:

a. Download the program. The icon “”Global Intervention 4” should appear. Click on this icon.b. The password is “interventions” (all lower case).c. Read the instructions below.d. Play with the database with the sample patient pro!les already provided in the database. e. Create your won database by updating your intensive care unit (ICU) information under “Table

Operations” on the Interface page. This includes physicians, pharmacists, formulary medications commonly used in the ICU, costs of medications, etc.

f. Practice entering your patients by using patients discharged prior to 2010 (otherwise patient-speci!c information WILL be counted in reports for this year).

I. The front page – The “Interface” page A. The “Stop Sign” is to exit the database entirely.

B. ANY time a form is closed, the program AUTOMATICALLY saves the information. You can either close forms by clicking the door icon, or close the form using the “X” in the top right corner of that form.

C. “Table Operations” box allows you to populate or amend variables in the lists/drop down boxes.

These items include physicians, pharmacists, ADR reactions and cost of each type of ADR, drugs/classes of drugs that cause ADRs, drugs and prices (each drug needs to be added twice – onceeach to “OLD” drugs and “New” drugs), and items to monitor with costs of monitoring. YOU WILL NEED TO CHANGE ALL OF THE COSTS/SAVINGS TO MATCH YOUR INSTITUTION PRIOR TOADDING PATIENT-SPECIFIC INTERVENTIONS.

Appendix 2. Computer-Based Template for Documentation of Desireable Services.

http://www.pharmacotherapy.org/PRN/global_intervention_4.mdb


D. “Reports” box allows you to view and print detailed reports of each activity based intervention or asummary report of all activities.

i. “Detail Reports” box allows you to view and print detailed reports for each of the following services or interventions: ADRs, Monitoring, Clari�cations, Non-patient speci�c “OtherActivities”, Encounters, and Drug Recommendations (“Cost Savings”).

ii. “Summary of Clinical Activities” box allows you to view and print the summary report for allabove reports including overall costs for a speci�c time frame.

iii. “Pending Activities” box provides a report of activities awaiting completion of their documentation. On the bottom of each tab when entering patient speci�c information you can check the “pending” box. It will show up on this report as an activity that requires follow-up.In order to delete this report from the “pending” status, you must go back to that speci�c patient report and “uncheck” the pending box.

iv. To go back to the Interface page after previewing or printing a report, click the LOWER “x” inthe upper right hand corner. The TOP “x” will close the database.

E. Add Date Range – This button allows you to run reports for speci�c date ranges.

F. “Other Activities” box allows you to enter and document activities not directly related to patient care, such as teaching, administration, scholarly activities, or drug information.

Appendix 2. (Continued)


D. “Reports” box allows you to view and print detailed reports of each activity based intervention or a summary report of all activities.

i. “Detail Reports” box allows you to view and print detailed reports for each of the followingservices or interventions: ADRs, Monitoring, Clari�cations, Non-patient speci�c “OtherActivities”, Encounters, and Drug Recommendations (“Cost Savings”).

ii. “Summary of Clinical Activities” box allows you to view and print the summary report for allabove reports including overall costs for a speci�c time frame.

iii. “Pending Activities” box provides a report of activities awaiting completion of their documentation. On the bottom of each tab when entering patient speci�c information you cancheck the “pending” box. It will show up on this report as an activity that requires follow-up.In order to delete this report from the “pending” status, you must go back to that speci�c patient report and “uncheck” the pending box.

iv. To go back to the Interface page after previewing or printing a report, click the LOWER “x” inthe upper right hand corner. The TOP “x” will close the database.

E. Add Date Range – This button allows you to run reports for speci�c date ranges.

F. “Other Activities” box allows you to enter and document activities not directly related to patient care, such as teaching, administration, scholarly activities, or drug information.



G. “Select Patient Report” box allows you to view all interventions for one speci�c patient. Select the appropriate patient and press “Enter”. This will bring up a report with detailed information for aspeci�c patient.

H. “Clinical Activities” box takes you to the “Patient List” - a form that provides information of allactive patients.

II. “Patient List Screen” - When adding new patients, add them to this screen �rst using the “add new patient” icon which takes you to the bottom of the list so that you do not accidentally overwrite previously added information. Populate the required information. Notice that the discharge date is blank. Once this is �lled in the patient disappears from this list. This allows you to only see activepatients; however, the data of discharged patients is not removed from the database. Even if a patient isdischarged, their information stills populates the detailed and summary reports (assuming that the daterange includes the correct time frame.)

Select the icon next to the patient’s name to save the information you added. When �nished addinginformation, select the �le icon that pops up as “open form” next to that patient's name. This will take you to the detailed interventions for this patient and allow you add patient speci�c information.

III. The “detailed intervention” screen allows you to add information about “ADRs”, “order clari�cation”,

“drug recommendations”, “drug monitoring”, “other patient encounters” and “medicationreconciliation”. Notice also that more patient demographic information may be entered at the top of eachscreen - this is optional, but may help with certain types of interventions. Below this demographicinformation are six tabs that delineate different types of interventions as listed above. When selecting thetabs remember all interventions are for this speci�c patient. If you need a different patient you must return to the Patient list.



A. For each of the speci�c tabs the �rst area of information population is the same. It records the pharmacist (add more under “Table Operations” on the Interface page if needed), date ofintervention, service and time of the intervention and the physician involved (add more under “Table Operations” on the Interface page if needed). The bottom section is also the same for every tab and includes signi�cance, known outcome, any notes/comments, and if there is anything pending for this speci�c record. The middle section is the portion that is different for each tab. Thetime spent box is to record the amount of time spent by you (or others) in minutes completing theintervention.

B. The “ADR/Prevention” tab is if for BOTH ADRs that occur and those that are prevented. Themedication drop down list can be additionally populated using the box “Add new ADR meds” on the front page. This lists common medications or classes of medications that cause reactions. TheReaction/Prevention is a drop down list of reactions that can occur. Next to these are the costs of those reactions. This cost is taken into consideration on the summary report as well as the detailedADR report. Make all of the costs in positive numbers. The reports assume that if an ADR was prevented that this would be a cost savings. The drug causing the reaction may be the same as the“Medication” however you may free text in this box. Check boxes if the answer is true.

C. The “Order clari�cations” tab may be used frequently by some users and rarely by others. This tab is for clari�cation of physician handwriting, regimens, drug lists, etc.



D. The “Drug Recommendations” tab allows you to document the addition, deletion or change of a drug regimen.

i. It takes into consideration the type of recommendation, and the reason for the recommendation.

ii. In order for the program to �gure out potential cost avoidance, there MUST be a drug in boththe “Old drug regimen” and the “New drug regimen”. If the drugs are not listed you will need to add them on the Interface page under “Table Operations”.

iii. If you are changing from IV to PO this is relatively simple, select the IV formulation in the“Old” drug drop down and the PO version in the “New” drop down. Fill in dose/day as needed.

iv. If you are adding a drug, the new drug goes in the “New” drug drop down. However you need to select “1” as the “Old” drug so that the program can complete the calculation. The opposite istrue if you delete a drug. The drug being discontinued is under the “Old” drug drop down and“1” is in the “New” drop down.

v. If you need to add 1 ½ of a vial, use the “Dose/Day” to �x this. For example: Vancomycin 1.5 GIV Q12 hours - you would select the Vancomycin 1 gram vial and change Doses/Day to 3. This �eld can use decimals.

vi. The “Number of Days of cost saving” is estimated duration of additional therapy that may have occurred if you did not intervene. For example, if the old regimen was Gentamicin 120 mg IV Q8h for 10 days and you changed the regimen on day 3 to better match the patient's current CrCl you could assume the number of days of cost savings would be 7.



E. The “Drug Monitoring” tab is for monitoring levels. The cost associated should take intoconsideration the average time spent and cost of this type of monitoring. You can add more monitoring types on the Interface page under “Table Operations”. The total for all patients is on thedetailed monitoring report and is part of the Summary Intervention report.

F. The “Patient Encounters” tab is for all other patient related encounters (e.g. response to codes,patient counseling, etc).

G. The “Medication Reconciliation” tab allows you to document the maintenance or discontinuation ofdrug therapy while the patient is hospitalized. You can add more drugs the Interface page under “Table Operations”.



Appendix 3. Characteristics of Commercially Available Documentation Systems.95–102

Unfortunately, selecting a documentation system is difficult because a comprehensive list of commercially available systemsdoes not exist.95 As a result, many pharmacists or pharmacy departments rely on the experiences of their colleagues whendetermining the appropriate documentation system to acquire. While this document provides templates of manual (appendixI) and computer-based documentation systems (appendix II), it is acknowledged that several commercial systems are availableand in use. In an attempt to aid clinicians with obtaining information on documentation systems, a search of the internet andrequested opinions of critical care pharmacists via the ACCP PRN about the various systems was conducted. The solicitedcomments were in response to the characteristics of the ideal documentation system. Product manufacturers were alsocontacted to provide information. Product demonstrations were requested when possible. The exclusion of a particular systemwas unintentional. In addition, documentation systems that are specific to one type of intervention such as pharmacokineticmonitoring were not included. In addition, several institutions have developed customized documentation systems, includingin many cases their own proprietary software.The features of the commercially available systems differ substantially. Some standardize the method of documentation with

more advanced systems having several pull down menus for ease of use while others require consumers to modify lists or enterfree-text information. While almost all systems are customizable, most systems do not provide a complete list of drugs orinterventions and thus require personnel time to modify and continually maintain the system. A key difference among systemsis the ability to integrate laboratory data with patient-specific data. This feature provides convenience and efficiency asinformation is linked and does not require additional input. The drawback of most linked systems is the inability to enteractivities in bulk since they are usually patient-based. Some systems offer an alert feature that notifies the clinician of potentialinterventions or dangerous situations. In some cases, alert features may be customized but this option may cost extra andrequire technical support. Not all systems have the capacity to generate aggregate reports of documented activities.Several documentation systems contain cost and time information to quantify the economic impact of pharmacy services.

Cost data are typically based on either acquisition cost of the drug or information from the literature. Many institutionsconsider this feature useful; however, the cost interpretation is difficult. Using drug acquisition costs as the basis for the costincurred or saved by an activity usually underestimates the overall cost. Moreover, the hospital may not visualize these costsavings since cost shifting between departments is possible. Most systems that attach costs to an outcome utilize the same costfor similar events (e.g., adverse drug events) despite potentially different outcomes (e.g., rash vs. nephrotoxicity). Somesystems include the time required to provide a specific service. Usually the magnitude of time is standardized (e.g.,pharmacokinetic consult equals 20 minutes). While this feature may be advantageous to clinicians, the standardized times maynot adequately reflect the actual time needed to perform the activity. This may be particularly troublesome for systems thatinclude personnel time as a component of cost. Therefore, it is imperative that the clinician understand the interpretation ofcost values. Some systems are capable of modifying cost data.Some systems have published data describing or supporting its clinical application which may be important, especially to

clinicians wanting to use the system for research purposes.96–102 All systems possess the ability to expand to different platforms.Handheld devices are convenient but need to be synced with the mainframe computer system before information can beaccessed by others.Lastly, the expense of existing systems varies considerably partly due to the available features. Most systems are not stand

alone and require integrated software that contributes to the acquisition cost. All systems require maintenance which may beprovided internally or from the company. The desired level of company support will contribute to the cost of the system.Purchase of a documentation system for multi-system institutions or several hospitals will result in lower pricing than if thesystem is being purchased for a single hospital. Another consideration is the company’s policy regarding support in cases ofcomputer down times or lost data and the efficiency of response for support staff to address questions or concerns.



Components of an Ideal Documentation System

CommerciallyAvailable System Manufacturer Friendly Service Inexpensive EfficientClinical Measures Gold Standard Yes: focus on Competitive Some of the previous(Clini-Doc) a,b,c,d standardization of versions of Clini-Doc

interventions making were slow with free-textentries easy entries; Clini-Doc is now

in version 3 and thisversion is faster with pulldown menus to makeentry quick

CliniTrenda,c,d American Society of Yes No longer Clinicians can enter dataHealth-System commercially available differently so reports mayPharmacists not be standardized

RxRoundsa,b,c,d MedKeeper and Yes Competitive Does not communicateNow called Rx exclusive reseller is with other informaticInterventions Gold Standard systems so patient

identifiers need to beentered

Theradoca,b,c,d Theradoc, Inc. Yes: allows patient data Costs are dependent on Communicates withto be accessible during how many alert systems other informatic systemsassessment and contains selected so patient information isan advanced alert available and containssystem multiple pull down

menus for interventionand drug selection whichminimizes free-text

Quantifi a,b,c,d PharmacyOneSource Yes: an integrated Cost is less expensive Quantifi does notSentri7 (Previously system allowing for if Quantifi is purchased contain patient specific

HealthProLink) patient data to be information but Sentri 7accessible during does contain patientassessment and contains information; bothan advanced alert contain multiple pullsystem down menus for

intervention and drugselection whichminimizes free-text

Siemens Pharmacy b,c,d Siemens Yes: sometimes difficult Competitive: cost is Yesto obtain information dependent on extent offrom the large company; Siemens systemintegrated system purchasedallowing for patientdata to be accessibleduring assessment

Pharmacy Care Epic Yes Competitive: cost is YesSystemb,c,d dependent on extent of

Epic system purchased

Patient Care Systema,c Meditech Difficult to obtain Cost is dependent on Some duplicationanswers to questions the informatics system

Pharmacy Services Healthkey Solutions Difficult to find N/A Publications supportingDocumentation Systemb,c contact information its use are available

PIDS® c RxInterventions N/A N/A Creates SOAP notes;PIDS®Enterprise can assist with billing forPIDS®Desktop services; provides alerts

for patient follow up



ExportableAdaptable or to other Penetrable fromCustomizable Expandable platforms Integratable other ports RetrievableYes Yes Yes Does not interphase Yes Yes

with other systemsbut future versionsshould

Yes Yes Yes N/A Yes Yes

Yes Yes Yes Does not interphase Yes Yeswith other systems

Yes: clinicians can Yes Yes Interphases with Yes Yesdevelop their many systemspersonal alertsystem

Yes Yes Yes Interphases with Yes Yesmany systems

Yes Yes Yes Interphases with Yes Yesproducts otherthan Siemenshowever Siemens isrecommended

Yes Yes Yes Interphases with Yes Yesproducts other thanEpic however Epicis recommended

Yes Yes Yes Interphases only Yes Yeswith Meditechsystems

Yes Yes N/A Does not interphase N/Awith other systems

Yes Yes Yes Can be integrated N/Awith dispensingsystem



Components of an Ideal Documentation System

CommerciallyAvailable System Manufacturer Friendly Service Inexpensive Efficient

CareDoc Clinical MetaCare Pharmacy Yes Cost is dependent on Laboratory results areIntervention Management System the informatics system viewed separatelyDocumentationmanagerb,ca Information from demonstrationbConversation with manufacturer representativec Information from websited Information from current userN/A not available on internet



ExportableAdaptable or to other Penetrable fromCustomizable Expandable platforms Integratable other ports Retrievable

Yes Yes Yes Interphase only with Yes YesMetaCare system

an opinion paper outlining recommendations for training - accp

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