Practice Management

Practice Management Jennifer L. Morris, Pharm.D., BCPS Texas Children’s Hospital Houston, Texas

Practice Management

Practice Management Jennifer L. Morris, Pharm.D., BCPS Texas Children’s Hospital Houston, Texas

ACCP Updates in Therapeutics® 2015: Pediatric Pharmacy Preparatory Review Course 2-401

Practice Management

Learning Objectives 1. Demonstrate skill in the responsibilities of a pediatric pharmacy representative to the pharmacy and therapeutics (P&T) committee to ensure appropriate formulary management for the pediatric population. 2. Design a medication use evaluation that ensures appropriate evaluation of use outcomes in a pediatric population. 3. Integrate data and unique knowledge of a pediatric pharmacist in the development of a medication use guideline or protocol for use in pediatric patients. 4. Use the American Society of Health-System Pharmacists guidelines and the Pediatric Pharmacy Advocacy Group comment to devise a plan for the provision of pharmaceutical services to pediatric patients in a health care system. 5. Develop a plan to implement optimal information technology for pediatric patients. 6. Discuss the strategies for expanding the quality and capacity of pediatric clinical pharmacists, pertinent to practice management, recommended by the joint opinion group. 7. Support the development of quality assurance plans to meet core measures.

Self-Assessment Questions Answers and explanations to these questions can be found at the end of this chapter. 1. Formulary management in pediatric patients requires an additional skill set to ensure comprehensive and safe medication use for pediatric patients. Which best reflects the responsibility of the pediatric pharmacy representative to the pharmacy and therapeutics (P&T) committee? A. Evaluate medication monographs for the inclusion of all pertinent pediatric data. B. Extrapolate a recommended dosing regimen for all medications recommended for formulary addition. C. Recommend age-based restrictions for any medication without pediatric data. D. Design workarounds for the use of medications in pediatric patients after the development of implementation plans for adults.

2. Which is most likely to ensure change in practice or processes after the completion of a medication use evaluation (MUE)? A. Adult and pediatric populations are assessed using the same outcomes. B. A multidisciplinary team of key stakeholders participates. C. High-cost medications are evaluated. D. The scope of the evaluation is expanded once data collection begins. 3. You are a pediatric clinical pharmacy specialist at a freestanding pediatric institution. You have been ask to identify a multidisciplinary team to develop, perform, and disseminate the results of a MUE for anticoagulants used for venous thromboembolism (VTE) prophylaxis after the recent implementation of a VTE risk assessment in adolescents at your institution. Which would be most essential to the team? A. Nurse. B. Operations pharmacy manager. C. Clinical nurse specialist. D. Pediatric hematologist. 4. Medication use guidelines help standardize care for specific populations or disease states. When pediatric data are not available, which might be the best strategy used by the pediatric pharmacist to develop a medication use guideline? A. Recommend against development of these guidelines when pediatric efficacy data are not available. B. Incorporate adult data when extrapolation is appropriate. C. Evaluate adherence to the guideline when adult data are extrapolated. D. Develop education and implementation plans for all disciplines. 5. Which most accurately depicts a barrier to the provision of pharmaceutical care to pediatric patients? A. Enteral medications available in both liquid and solid dosage forms. B. Standard medication dosing regimens. C. Innovative drug delivery devices. D. Interpretation of available pediatric data.


Practice Management

6. Which would be the best medication use process used by pharmacies to provide optimal inpatient medication dispensing services for pediatric patients? A. Multidose vials available in automated dispensing cabinets. B. Standardized dose nomograms for commonly used oral liquids. C. Multiple concentrations for continuous infusions. D. Individual patient-specific doses for intermittent medications.

10. Smart infusion pumps help enhance the safe delivery of intermittent and continuous-infusion parenteral medications. Pediatric pharmacists should be highly involved in developing the drug library content for these pumps. Which would best be routinely evaluated to optimize the infusion pump library? A. Unnecessary alerts. B. Needed workarounds. C. Nursing desire to use library. D. Changes to dosing in library based on new guidelines.

7. Pediatric pharmacists providing pharmacy services in an ambulatory care setting should have an understanding of the unique medication needs of patients and their caregivers. Which should be considered the most essential component in the provision of ambulatory services to pediatric patients and their caregivers? A. Education of pediatricians on poison prevention. B. Drug information education for nurses and providers. C. Medication education for caregivers on accurate medication measurement. D. Knowledge of commercially available medications.

11. A joint task force created by the American College of Clinical Pharmacy (ACCP) and the Pediatric Pharmacy Advocacy Group (PPAG) developed strategies to expand the quality and capacity of clinical pharmacy services provided to pediatric patients. Which strategy would best be used to enhance clinical pharmacy services? A. Developing minimum expectations for the training of those entering pediatric practice. B. Substituting on-the-job training for PGY2 residency experience. C. Expanding the service coverage of the currently available clinical pharmacy specialist. D. Developing expectations for the participation of clinical pharmacists in pediatric research.

8. Computerized physician order entry (CPOE) is designed to decrease the risk of medication errors at the point of the medication use process with the highest risk of error. Which best depicts the point in the medication use process when risk of error is the highest? A. Prescription. B. Transcription. C. Verification. D. Dispensing. 9. As commercial CPOE systems are designed for use in adult patients, customization is often needed to ensure optimal use in pediatric patients. Which customization would best optimize the CPOE system for use in pediatric patients? A. Weight-based dosing order sentences. B. Age-related dosing algorithms. C. Many options for route of administration for each medication. D. Extensive clinical decision support.

12. In the pediatric population, a unilateral approach to quality assessment in pediatric health care is likely to be unsuccessful. Which is most likely to complicate a unilateral approach in pediatric patients? A. Communication barriers. B. Heterogeneity of the population. C. Patient independence. D. Availability of health insurance. 13. When possible, which national strategy for health care improvement would best be integrated in pediatric health care quality? A. Engaging caregivers to seek care for patients. B. Improving safety through reduction of harm. C. Encouraging healthy eating. D. Engaging caregivers to coordinate care.

Abbreviations CPOE Computerized physician order entry MUE Medication use evaluation P&T Pharmacy and therapeutics (committee)


Practice Management

I. INTRODUCTION A. Pharmaceutical care of pediatric patients is affected by their marked anatomical, developmental, and physiologic differences from adults. B. Pediatric pharmaceutical care requires a highly individualized approach to medication therapy. C. There is often a lack of published pharmacokinetic, safety, and outcomes data for medications used in the treatment of pediatric patients. D. Logistic difficulties may be encountered in the drug use process for pediatric patients because the dosage form and drug delivery devices are often manufactured for use in adult patients. E. These challenges require a unique practice management skill set for the pharmacists involved in the specialty care of pediatric patients in both the inpatient and outpatient settings. F. Pediatric pharmacists use their in-depth knowledge of the developmental pharmacokinetics and pharmacodynamics of pediatric pharmacotherapy, together with a specialized subset of practice management skills, to address the unique and special needs of this patient population. These skills can be used in: 1. Formulary maintenance 2. Development of evidence-based practice guidelines and policies 3. Development, assessment, and optimization of all components of the medication use process to ensure the safe administration of medications to pediatric patients 4. Continuous quality assessment of polices, guidelines, and medication use processes

II. PEDIATRIC CONSIDERATIONS FOR MAINTENANCE OF FORMULARY AND DEVELOPMENT OF MEDICATION USE GUIDELINES OR PROTOCOLS Patient Case 1. As part of your position responsibilities, you are the pediatric pharmacy representative to the P&T committee for a health system, which provides care to a combination of pediatric and adult patients. The choices of acid suppression therapy are undergoing review as a cost-saving initiative. You receive the formulary monograph for the histamine-2 receptor antagonist for review before the upcoming meeting. The recommendation is to maintain one intravenous and enteral agent for use in all age groups, but no pediatric data or assessment of available dosage forms are included. Which is the best next step to ensure that the recommendation presented in the monograph to the P&T committee is complete and accurate for the pediatric patients cared for by the health system? A. Gather input from key pediatric stakeholders regarding the recommendations for medications from this class that should be placed on the formulary for pediatric patients. B. Identify and evaluate available pediatric pharmacokinetic, safety, and outcomes data for the class of medications to make recommendations for update of the monograph. C. Evaluate the presented adult data for applicability and extrapolate to pediatric patients to make recommendations for addition to the monograph. D. Identify availability of extemporaneous preparations of pediatric friendly dosage forms for the class of medications to make recommendations for the addition to the monograph.


Practice Management

A. Pediatric patients must be considered in all formulary decisions, and special care should be taken to ensure adequate assessment in institutions where adults are the primary patient population. Failure to consider the effects of formulary decisions because of either lack of knowledge or lack of belief the medication will be used places pediatric patients at risk of adverse drug reactions and medication errors (www.ppag.org/ attachments/articles/6/ASHP_response.pdf). 1. Pediatric patients should be represented by a pediatric pharmacist on P&T committees. 2. Pediatric pharmacy representation on P&T committees should: a. Ensure the available safety and outcomes data for pediatric patients for all recommended formulary additions are included in monographs presented to the committee b. Ensure that the medications used primarily or exclusively in pediatric patients are considered for formulary addition. Once approval for addition is obtained, implementation should encourage the safe and economical use of these medications c. Recommend age-specific restrictions for medications that should not be used in pediatric patients d. Recommend adding appropriate dosage forms to ensure safe medication use in pediatric patients, and minimize the need for altering commercially available products e. Develop comprehensive plans to communicate and roll out formulary changes for use in pediatric patients to minimize the risk of error with practice change, including any changes or additions needed within in the hospital or health system information technology Patient Case 2. As a member of the residency advisory committee, you are asked to submit a plan for a MUE for resident completion. You decide that assessing the inpatient initiation/use of palivizumab would be a good option that would allow you to assess the impact of the newly updated guidelines on current practice at your institution. Which first step will best help optimize the utility of the MUE? A. Independently define the scope of the evaluation by identifying the question(s) to be answered. B. Evaluate the available data for palivizumab to identify agreement or disagreement with current guidelines. C. Identify a multidisciplinary committee of key stakeholders to provide input on the structure and desired outcomes of the evaluation. D. Identify patients who have received palivizumab in the previous year, and collect data concerning its appropriateness according to the updated guideline.

B. Medication Use Evaluation – Used to promote optimal outcomes in the medication therapy and medication use process. Evaluations may be of a medication, a class of medications, or a medication use process. The objectives, goals, processes, and key players in MUE are similar when considering pediatric patients (Am J Health Syst Pharm 1996;53:1953-5). 1. Identify medication(s) or process(es) in need of evaluation – This may occur secondary to safety concerns, availability of newly published data, or cost considerations. Within health systems servicing a broad age demographic, MUEs that span this population should include an evaluation of all groups. In addition, care should be taken to ensure that pediatric-specific evaluations do not go unnoticed because of fewer patients and perceived lesser impact. 2. Key players should consist of multidisciplinary representation. When both adult and pediatric use will be evaluated, multidisciplinary representation from both adult and pediatric service lines should be included. Failure to do so can result in poor choice of outcome assessment and lack of buy-in for implementation of results. 3. Develop scope of appropriate use to assess the medication(s) or process – Consideration of pediatric age groups to be included as well as any pediatric-specific data and outcomes that should be evaluated ACCP Updates in Therapeutics® 2015: Pediatric Pharmacy Preparatory Review Course 2-405

Practice Management

4. Once evaluation is complete, pediatric-specific considerations for implementing change should be proactively addressed. Patient Case 3. You recently implemented a new service line as a pediatric clinical specialist in the pediatric intensive care unit. The health system cares for both adult and pediatric patients. Several of the pediatric intensivists would like to use propofol as continuous sedation, but the health system currently limits its use in pediatric patients to those 16 years and older or for procedural sedation. Which is the best sequential process to successfully develop a medication use guideline to provide for safe and standard use of this medication in pediatric patients? A. Evaluate the available data; if sufficient data exist, develop a use guideline. Once any formal approval process required by the health system is complete, roll out the guideline to the medical staff. B. Evaluate the available data; if sufficient data exist, develop a use guideline, including a plan for routine assessment. Submit these data to the medical staff for review before submitting the use guideline to any formal review process required by the health system. C. Identify a multidisciplinary group of key stakeholders to define the need of use and any potential barriers. Evaluate the available data; if sufficient data exist, develop a use guideline. Develop this guideline, including a plan for routine assessment, and submit it to any formal review process required by the health system. D. Identify a multidisciplinary group of key stakeholders to define the need of use and any potential barriers. Evaluate the available data; if sufficient data exist, develop a use guideline. Develop this guideline, including a plan for routine assessment, and submit it to a multidisciplinary group for review before submitting to any formal review process required by the health system.

C. Medication use guidelines and protocols are helpful tools in standardizing medication therapy and medication use processes. For many medications and medication use processes, there is a paucity of data for the pediatric population. Medication use guidelines and protocols should be developed in a multidisciplinary fashion. Key stakeholders should be involved from the beginning; however, pediatric pharmacists are uniquely skilled to evaluate, develop, and safely apply medication use guidelines and protocols for pediatric patients of all ages and should take a lead role in such health-system activities. 1. Those making medication use guidelines and protocols that will be applied to pediatric patients should consider the developmental pharmacokinetic changes that pediatric patients undergo, increased risk of error in the pediatric population, logistic issues with administration, and inherent level of difficulty involved in monitoring with both subjective scales (e.g., pain scales) and objective measurements (e.g., amount of blood needed for laboratory values). When appropriate, medication use guidelines and protocols developed for adult patients should consider the potential for use in pediatric patients and include appropriate safeguards. 2. Literature should be reviewed for pharmacokinetic, safety, and efficacy data in the specific population (e.g., neonates, adolescents). In the ideal setting when data are available, these data should be assessed for outcomes to draw conclusions on the design of medication use guidelines or protocols. 3. Lack of data, especially efficacy data, may not preclude the need for medication use guidelines or protocols for the pediatric population. a. Assess the availability of pediatric data. The pharmacokinetic and safety data available should be used to devise the optimal dosing and monitoring for incorporation into the guideline or protocol. Adult efficacy data may be used to develop a plan for outcomes assessment once the guideline or protocol has been implemented. b. When pediatric data are unavailable, adult pharmacokinetic, safety, and efficacy data should be evaluated for their applicability and possibility of translation to the pediatric population. ACCP Updates in Therapeutics® 2015: Pediatric Pharmacy Preparatory Review Course 2-406

Practice Management

4. Key stakeholders should be involved in the development of appropriate education and implementation plans for their respective discipline because needs will vary between groups. At the point of implementation, super-users in the affected departments should be available to answer questions and facilitate the processes associated with the guideline or protocol. 5. Once implemented, guidelines and protocols should be routinely assessed for: a. Sustainability – After an initial implementation period, the processes associated with the guideline or protocol should be evaluated for any barriers to completion. Failure to address barriers or assess the ongoing use of the guideline or protocol may result in workarounds or a falloff in use of the process after the implementation period. b. Safety – Guidelines and protocols implementing the standard use of medications or processes in pediatric patients should be routinely evaluated for safety, especially when minimal to no safety or efficacy data are available in pediatric patients. Vigilant assessment of safety is needed to ensure that patients have not been placed at risk by either labeled or off-label uses of medications. Unique or uncommon adverse drug effects or error risks should be reported to add to the body of data in the literature for pediatric patients. c. Outcomes – Desired outcomes for the medication use guideline or protocol should be predefined in the design process. Routine evaluation of these outcomes should occur for both internal and external reporting. Reporting of standard medication use or processes in pediatric patients can help add to the body of evidence for use in pediatric patients.

III. ENSURING ADEQUATE PHARMACY SERVICES TO PEDIATRIC PATIENTS Patient Case 4. Because of the weight-based dosing regimens often used in pediatric patients, endless individualized doses can increase the risk of error, impair workflow in the dispensing process, and minimize the ability to use technology such as automated dispensing cabinets. In your daily review of patient medication profiles, you have identified that a significant number of prednisolone 15 mg/5 mL oral suspension individualized doses are being dispensed, and many are doses that may be difficult to accurately measure with the available oral syringes. Which would be the best process to enhance the medication use process for prednisolone 15 mg/5 mL? A. Develop a standardized dosing nomogram by which doses would automatically be updated. B. Round all doses to the either whole or 0.5-mL doses when orders are verified so that prepackaged products of 3 and 1.5 mg can be used for patient-specific doses. C. Educate the order verification pharmacists to contact prescribers to have the doses rounded. D. Educate the medical staff on the concentration of the formulary prednisolone liquid.

A. Pediatric Considerations in the Medication Use Process (Am J Health Syst Pharm 1994;51:1690-2) 1. Pediatric patients pose unique challenges in the delivery of pharmaceutical care for several reasons: a. Lack of published data b. Lack of commercially available products c. Need for innovative drug delivery d. Difficulty implementing standard systems to meet the special needs of these patients 2. Orientation and continuing professional development programs should be developed and maintained for pharmacists responsible for developing medication therapy plans and the medication use process for pediatric patients. Such programs should address: a. Dosage calculation, appropriate dosage form selection, preparation, and administration for the spectrum of ages. Considerations based on the age and size of patients include: ACCP Updates in Therapeutics® 2015: Pediatric Pharmacy Preparatory Review Course 2-407

Practice Management

3.

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i. Need for dilutions ii. Appropriate number of standard concentrations iii. Applicability of standard doses versus dose rounding b. Developmental pharmacokinetics and pharmacodynamics c. Effects of age- and disease-specific conditions on drug and dosage form selection: Focusing on both drug and excipient assessment is critical because often the excipients can pose more of a safety risk than the medication itself. d. Safety culture and risks of medications errors in pediatric patients Inpatient dispensing services – Unit dose distribution, intravenous admixture, and appropriate dose standardization will facilitate the provision of services while minimizing the risk of error. Risk of error is heightened by the lack of commercially available products and the potentially complex and enhanced number of calculations involved in dispensing medications to pediatric patients. a. Unit dose: i. Drugs should be dispensed in ready-to administer forms versus multidose products. ii. Use of extemporaneous preparation for prepackaging of medications and compounding iii. Development of standardized dosing nomograms to minimize the number of patient-specific doses and ensure the accurate measurements of medications b. Intravenous admixture: i. Parenteral preparation should meet USP 797 standards. ii. Should be able to encompass all medications administered by a parenteral route iii. Personnel require knowledge of pediatric fluid requirements and limitations as well as administration techniques and devices. (a) Need for dilutions and how to safely prepare (b) Issues with hyperosmolar solutions (c) Knowledge of excipients Ambulatory services a. In-depth understanding of unique drug needs of pediatric patients and their caregivers, including: i. Dosage forms that may require compounding for appropriate dosing and administration ii. Use of the most appropriate and accurate measuring devices as well as the risks of using household devices such as spoons iii. Medication education should include a detailed discussion of administration and reconstitution, if needed. b. Role in preventive health services, including poison prevention and immunizations Provision of drug information a. Those providing pharmaceutical care to pediatric patients should have access to pediatric-specific electronic and hard-copy drug information resources. b. Data for off-label use of specific medications for pediatric disease states should be evaluated, when available. c. Pediatric pharmacists should actively participate in educating other health care disciplines on drug therapy and the medication use process in a variety of settings. Management of medication therapy a. Therapeutic drug monitoring and pharmacokinetic services – Assessing drug therapy for both desired and adverse effects of medications. Those making changes in dosage regimens should consider the logistics of concentration obtainment, developmental pharmacokinetics and pharmacodynamics, and clinical condition. b. Need for laboratory data should be balanced with the discomfort and risk associated with obtaining blood. The minimum amount of blood needed to accurately obtain data should be sent for assessment.


Practice Management

c. Comprehensive monitoring for adverse drug reactions. Adverse reactions may be more difficult to identify because of both lack of safety data on a medication use in pediatric patients and inability of the patient to communicate owing to developmental and/or clinical status. B. Information Technology-Pediatric Interface 1. Standardization of the medication use process through optimally designed and implemented technology at the point of prescribing, preparing, dispensing, and administration should enhance the safe delivery of medications to pediatric patients. These systems are often designed for optimal use in adult patients, thus requiring customization for use in pediatric patients. Pediatric pharmacists should be intimately involved in the customization and implementation of these systems as it applies to the medication use process (Pediatric Pharmacotherapy c2013). 2. Optimizing the electronic health record for the medication use process in pediatric patients a. Content experts for specialty pediatric populations should be identified to participate in the development, assessment, and maintenance of electronic health record content for the subspecialty populations (i.e., pharmacists practicing in the neonatal intensive care unit should take the lead on neonatal medication content). These content experts should work in conjunction with both experts in pharmacy operations and multidisciplinary colleagues in structuring this content. b. CPOE is described as a means of decreasing this risk of medication errors through information technology because most medication errors occur at the point of prescribing (Pediatrics 2004;113:59-63). c. For optimal safety, the CPOE system should at a minimum interface or ideally be integrated with the pharmacy’s computer system. Both the pharmacist and the nurse should verify providerinitiated orders before the medication(s) is administered to the patient. The interface should create a computer-generated medication administration record and send appropriate orders to a profiled automated dispensing cabinet (J Pediatr Pharmacol Ther 2011;6:427-43). d. Pediatric pharmacists are key players in the customization, implementation, and maintenance of an optimal CPOE system. Pharmacists with sufficient training and experience in pediatric pharmacotherapy should participate in the development, assessment, and maintenance of the following. i. Dosing sentences should be sufficient to care for patients of the various ages and weights as seen in the pediatric population. Weight-based dosing regimens should be offered when appropriate, in addition to fixed-dose regimens, with adequate direction on the appropriate use of each. ii. Medication content should provide forcing functions for dosing units, dosage forms, routes of administration, and appropriate intervals. iii. CPOE should include useful and optimally placed clinical decision support. Needed decision support may vary between pediatric and adult patients; should be customized appropriately to prevent overuse and alert fatigue iv. Developing age-related algorithms is useful for guiding providers to the correct dosing for age; these algorithms should consider the age-related developmental changes in pediatric patients that affect the medication use process for specific medications. In addition, these algorithms are useful in preventing the use of medications outside the intended population (i.e., preventing or restricting pulmonary surfactant use outside the newborn period). v. In addition to age-based algorithms, developing and implementing order sets can help standardize care and medication therapy for specific disease states or level of acuity. These should be developed in conjunction with a multidisciplinary committee, with the pharmacist taking the lead for the medication content. e. Adequately designed CPOE systems with thoughtful implementation plans can decrease medication errors that occur during the prescribing process (Pediatrics 2004;113:59-63). ACCP Updates in Therapeutics® 2015: Pediatric Pharmacy Preparatory Review Course 2-409

Practice Management

3. As an extension of the electronic health record, smart infusion pumps can ensure the safer delivery of intermittent and continuous infusions (Pediatric Pharmacotherapy c2013). a. Pediatric pharmacists should be intimately involved in developing the drug libraries for the smart infusion pump profiles that will be used in the pediatric population. b. Considerations in drug library development for pediatric patients: i. Need for both weight-based and fixed-dosing guardrails ii. Number of standard concentrations needed to accommodate the patient variety c. Drug library parameters should be assessed on a routine basis to evaluate alerts for unsafe practices or unneeded alerts, which may result in workarounds. C. Personnel Resources 1. Strategies for expanding the quality and capacity of clinical pharmacy services provided to pediatric patients as devised by the joint opinion group of the ACCP Pediatric PRN and PPAG (Pharmacotherapy 2013;33:243-51) a. These strategies may be used to develop plans for ensuring optimal pharmacy services for clinical coverage and staffing in pediatric inpatient and outpatient care. b. Elevating the minimum expectations of those entering pediatric pharmacy practice i. PGY1 in a pediatric hospital or with several pediatric rotations – Operations: Used to provide broad experience and enhance understanding of global concepts ii. PGY2 or PGY1 with 3–4 years of clinical experience in pediatric direct patient care – Clinical pharmacist and preceptor for residency (a) Build on the PGY1 foundation and expanded pharmacotherapy knowledge base through exposure to many experiences and specialists (b) Programs focus on specialized practice to prepare trainees to enter specialist practice or academic appointment. (c) Preceptors should have a similar level of training. iii. Board certification – Participation in direct patient care and act as preceptor for APPE (advanced pharmacy practice experience) and residency and faculty appointment c. Expand the number of current clinical pharmacists – Develop a new or expand an existing PGY2, when feasible, according to clinical experiences and availability of qualified preceptors d. Sustainable methods for facilitating the involvement of pediatric clinical pharmacists in research i. Clinical pharmacist participation and support of research efforts is considered a standard of practice (www.accp.com/docs/positions/guidelines/standardsofpractice.pdf). ii. Should maintain competence in a variety of areas, including research iii. Gaps in safety and efficacy of routinely used drugs continue to exist. (a) Using practice-based research to expand the database of knowledge and as pilot data for routinely used drugs (b) Protecting time for research activities (c) Time management (d) Developing a patient care infrastructure within a pediatric hospital to allow time for research activities 2. Areas of need: a. Study to establish the projected number of pharmacists needed to provide direct patient care in the pediatric setting. Such a study should evaluate: i. Use of health care resources by pediatric patients ii. Number of practicing pediatricians iii. Settings in which pediatric pharmacy practice expertise is needed b. On the local level – Needs assessment to define the optimal number of pediatric operations and clinical pharmacists needed to provide safe and optimal care within institution ACCP Updates in Therapeutics® 2015: Pediatric Pharmacy Preparatory Review Course 2-410

Practice Management

IV. MEASURING THE QUALITY OF PHARMACEUTICAL CARE PROVIDED TO PEDIATRIC PATIENTS Patient Case 5. You have been asked to participate in a quality assessment group that has been charged with developing a plan to ensure compliance with the 2014 core measure pertaining to asthma medications in pediatric patients. Assessment of this measure will be based on the percentage of pediatric patients 5–20 years of age having a diagnosis of persistent asthma who are dispensed appropriate controller therapy. As the pediatric pulmonary clinical specialist, you have noted that many patients with asthma initiated on controller therapy during an inpatient visit are readmitted with a repeat exacerbation; also, they have not filled their inhaled corticosteroids on discharge. Which discharge process would be best to implement to enhance the patient with newly diagnosed asthma having a controller on hospital discharge? A. Encourage the use of e-prescribing. B. Counsel all patients/caregivers with new prescriptions for inhaled corticosteroids. C. Implement a process to dispense inhaled corticosteroids for home use before discharge. D. Suggest that inhaled corticosteroids be initiated on an outpatient basis.

A. A unilateral approach to pediatric quality assessment is complicated by the heterogeneity of the pediatric population. The quality assessment approach must consider the characteristics unique to this population, including developmental changes, dependency on others, epidemiology that varies from that of the adult population, risk of poverty, and racial/ethical disparities. Quality assurance for adult patients generally focuses on wellness in chronic conditions by minimizing the need for acute care for exacerbations. Because many pediatric patients require acute care with minimal association with chronic conditions, this approach may not be as useful for a global pediatric population (Pediatrics 2014;113:199-209). B. Metrics for Evaluating Quality of Services (www.medicaid.gov/Medicaid-CHIP-Program-Information/ByTopics/Quality-of-Care/Downloads/2014-Childrens-Report-to-Congress.pdf) 1. National strategy for quality improvement in health care intended to improve the delivery of health care services, patient health outcomes, and population health by implementing the following goals: a. Making care safer through reducing harm b. Engaging the patient and caregivers as partners in care c. Effective communication and coordination of care d. Effective prevention and treatment practices for leading causes of mortality (i.e., cardiovascular disease) e. Promotion of broad use of best practices to enable healthy living within communities f. Affordability of quality care to individuals, families, employers, and governments through new health care delivery models 2. When applicable, quality programs assessing the care of pediatric patients should align with these national priorities. 3. Role of the pharmacist in: a. Preventive health care – Advocacy of routine childhood vaccination; promotion of healthy community living through education to prevent tobacco, drug, and alcohol use in adolescents; education on injury prevention; pregnancy prevention in adolescent females through education and provision of contraception; and promotion of sexual health through education on abstinence and barrier contraception for adolescents b. Obesity prevention – Almost 20% of children and adolescents are obese; these patients are at risk of adverse health outcomes because of increased weight. Pharmacists can participate in obesityACCP Updates in Therapeutics® 2015: Pediatric Pharmacy Preparatory Review Course 2-411

Practice Management

reduction strategies through involvement in screenings and educating children, adolescents, and their caregivers on healthy eating and activities. c. Maternal and infant health – Educating parents on the importance of standards of care, including routine vaccinations and vitamin K at birth, to prevent subsequent illnesses in infancy and childhood d. Pharmacists are a critical member of the team developing evidence-based medication therapy for pediatric patients and should participate in the medication education of the patient and caregiver. i. The Early and Periodic Screening, Diagnostic, and Treatment Benefit ii. Behavioral health iii. Health homes 4. CMS (Centers for Medicare & Medicaid Services) PfP (Partnership for Patients) goals of reducing adverse events, including adverse drug events, minimizing health care–associated infections, and reducing readmissions by improving transitions of care 5. Family experience with care either globally or in relationship with a specific encounter – Child Hospital Consumer Assessment of Healthcare Providers and System Survey (Child HCAHPS) Table 1. Core Set of Children’s Healthcare Quality Measures 2014 with Applicability to Pharmaceutical Care Measure

Brief Description

Follow-up care for children prescribed ADHD medications

Percentage of children with new prescriptions for ADHD medications with three follow-up visits within 10 months, one of which must be within 30 days of initial dispensing of medication

Childhood immunization status

Percentage of children who turned 2 years of age and received specified vaccines by 2 years of age

Central line–associated bloodstream infections (CLABSI) in the NICU and PICU

Rates of CLABSI during selected period of surveillance

Consumer Assessment of Healthcare Providers and Systems® CAHPS 5.0H (Child Version Including Medicaid and Children with Chronic Conditions Supplemental Items)

Assessment of caregiver experiences with child’s health care provision. Separate questionnaire for caregivers of children with chronic conditions (83-question survey) and of children without (48-question survey) used by Medicaid and CHIP for state reporting

HPV for females

Percentage of female adolescents who have received the three-dose series by their 13th birthday

Immunization status in adolescents

Percentage of adolescents who turned 13 years of age and received the specified vaccines by 13 years of age

Medication management for asthma

Percentage of children 5–20 years of age identified as having persistent asthma and dispensed appropriate controller therapy. Reported in four age cohorts for patients who persisted with appropriate asthma therapy for 50% and 75% of the treatment period

ADHD =attention deficit hyperactivity disorder; CHIP = Children’s Health Insurance Program; HPV = human papillomavirus; NICU = neonatal intensive care unit; PICU = pediatric intensive care unit. Available at www.medicaid.gov/Medicaid-CHIP-Program-Information/By-Topics/Quality-of-Care/Downloads/2014-Childrens-Report-toCongress.pdf, www.medicaid.gov/Medicaid-CHIP-Program-Information/By-Topics/Quality-of-Care/Downloads/ChildCoreMeasures.pdf, and www.medicaid.gov/Medicaid-CHIP-Program-Information/By-Topics/Quality-of-Care/Downloads/CAHPSBrief.pdf. Accessed December 23, 2014.


Practice Management

REFERENCES Pediatric Considerations for Maintenance of Formulary and Development of Medication Use Guidelines or Protocols 1. American Society of Health-System Pharmacists (ASHP). ASHP guidelines on medication use evaluation. Am J Health Syst Pharm 1996;53:1953-5. 2. Pediatric Pharmacy Advocacy Group (PPAG). Comments on ASHP Guideline on Providing Pediatric Pharmaceutical Services. Available at www.ppag. org/attachments/articles/6/ASHP_response.pdf. Accessed December 23, 2014. Ensuring Adequate Pharmacy Services to Pediatric Patients 1. American College of Clinical Pharmacy (ACCP). Standards of Practice for Clinical Pharmacists. March 2014. Available at www.accp.com/docs/positions/guidelines/standardsofpractice.pdf. Accessed December 23, 2014. 2. American Society of Health-System Pharmacists (ASHP). ASHP guideline for providing pediatric pharmaceutical services in the organized health care systems. Am J Health Syst Pharm 1994;51:1690-2.

Measuring the Quality of Pharmaceutical Care Provided to Pediatric Patients 1. 2014 Core Set of Children’s Health Care Quality Measures for Medicaid and CHIP. Available at www. medicaid.gov/Medicaid-CHIP-Program-Information/By-Topics/Quality-of-Care/Downloads/ChildCoreMeasures.pdf. Accessed December 23, 2014. 2. Beal AC, Co JP, Dougherty D, et al. Quality measures for children’s health care. Pediatrics 2014;113:199209. 3. Sebelius K. HHS Secretary’s Efforts to Improve Children Health Care Quality in Medicaid and the Children’s Health Insurance Program. 2014. Available at www.medicaid.gov/Medicaid-CHIPProgram-Information/By-Topics/Quality-of-Care/ Downloads/2014-Childrens-Report-to-Congress. pdf. Accessed December 23, 2014. 4. Technical Assistance Brief: Guidance for Conducting Consumer Assessment of Healthcare Providers and Systems (CAHPS) 5.0H child survey. Available at www.medicaid.gov/Medicaid-CHIP-ProgramInformation/By-Topics/Quality-of-Care/Downloads/ CAHPSBrief.pdf. Accessed December 23, 2014.

3. Bhatt-Mehta V, Buck ML, Chung AM, et al. Recommendations for meeting the pediatric patient’s need for clinical pharmacists: a joint opinion of the pediatric practice and research network of the American College of Clinical Pharmacy, and the Pediatric Pharmacy Advocacy Group. Pharmacotherapy 2013;33:243-51. 4. Levin SE, Cohen MR, Blanchard NR, et al. Guidelines for preventing medication errors in pediatric. J Pediatr Pharmacol Ther 2011;6:427-43. 5. Potts AL. Medication safety. In: Benavides S, Nahata MC, Chicella M, et al., eds. Pediatric Pharmacotherapy. Lenexa, KS: American College of Clinical Pharmacy, c2013:chap 4. 6. Potts AL, Barr FE, Gregory DF, et al. Computerized physician order entry and medication errors in a pediatric critical care unit. Pediatrics 2004;113:59-63.


Practice Management

ANSWERS AND EXPLANATIONS TO PATIENT CASES 1. Answer: B For formulary adjustments in institutions where care is provided to pediatric patients, the potential of medications for use in this population must be thoroughly considered. Therefore, those in monograph development must consider the available data in pediatric patients. The best first step is to evaluate the available pharmacokinetic, safety, and outcomes data for the recommended medication and any additional medications in the class (Answer B is correct). For the recommended medication, pediatric pharmacists should assess for age groups in which the medication has not been evaluated and compare the breadth of data with that of other medications in the class. Although each of the other processes may be used in formulary review, including that for pediatric patients in this situation, none would be the next best step. Adult data should be extrapolated only in the absence of pediatric-specific data, not as an initial means of formulating recommendations (Answer C is incorrect). Input from key stakeholders is important once data evaluation has occurred to ensure that the recommendations during the committee meeting go smoothly and the questions of other health care providers can be addressed (Answer A is incorrect). Obtaining the input of key stakeholders before data review may result in bias of formulary decision based on clinician preference and/or experience. Formulation of available products is an important consideration in the formulary management for medications that will be used in pediatric patients. Although extemporaneous preparations may be used when no commercially available product can be identified within a class of medications or potentially when the medication with the best amount of data is unavailable in pediatric-friendly dosage forms, they should not be a first-line assessment for recommending medication addition to formulary (Answer D is incorrect). 2. Answer: C Once a medication, medication class, or medication use process has been identified for evaluation using an organized process for developing the question to be answered, data collection, data use, and implementation will help ensure success. Before defining the scope of the evaluation (Answer A is incorrect), the input of key stakeholders from various disciplines should be obtained to ensure that the evaluation is structured in a manner that will meet the global needs of the health system (Answer C is correct). The responsible parties should review the

available data, including the guidelines, to ensure that the identified group is well informed. Review of data and input from the committee can then be used to identify the scope of the evaluation to ensure that the collected data will provide the most utility in identifying whether a change in practice is needed. Although a review of the data is necessary as a means of agreeing or disagreeing with the published guidelines, this should not be the sole reason for the review (Answer D is incorrect), and the guidelines should as well be evaluated in the context of the health system’s needs (Answer B is incorrect). The needs, scope, and process of the evaluation should be well defined before patient identification and data collection to ensure that appropriate but not excessive data are collected. 3. Answer: D Once you have identified the history behind the need for the guideline, the sequential process likely to be most successful is to identify a multidisciplinary group, evaluate the data, develop the guideline, and have it reviewed by the multidisciplinary group before the formal review/approval process (Answer D is correct). Evaluating the data first may fail to identify the correct data for the anticipated needs (Answers A and B are incorrect) and may fail to identify any data addressing potential barriers (Answer A is incorrect). Failure to have the multidisciplinary group review the guideline before submitting it for any formalized review/approval process may result in the need for editing after formal review/ approval (Answers A and C are incorrect). 4. Answer: A The most complete means of improving this process would be to implement a standard dosing nomogram (Answer A is correct), preferably one that electronically updates doses to the appropriate standard dose at the point of order entry. Educating order verification staff and medical staff to use appropriate doses based on the concentration of the preferred agent may be helpful, but these are not hardwire process changes, and the effects from them may wane over time (Answers C and D are incorrect). Dose rounding is a useful tool to ensure that dispensed doses of liquid medications can be accurately measured, but prepackaging a large number of dosing units to dispense specific doses can be error prone and may use an unneeded number of resources in terms of syringes (Answer B is incorrect).


Practice Management

5. Answer: C A process to ensure that inhaled corticosteroids are dispensed before discharge through either dispensing inpatient MDI (metered dose inhaler) or a fill program with an outpatient pharmacy is the most likely way to ensure that these medications are dispensed (Answer C is correct). E-prescribing ensures that the medication order is communicated to the outpatient pharmacy but does not ensure that it is dispensed to the patient (Answer A is incorrect). All patients/caregivers should be counseled on the use of new medications; however, like e-prescribing, this does not necessarily ensure that prescriptions are dispensed to families (Answer B is incorrect). Initiating controller therapy on an outpatient basis may result in extra clinic visits and a failure to meet the quality goal when the patient has a diagnosis of persistent asthma during an inpatient admission but fails to show for the clinic appointment in which inhaled corticosteroids were to be initiated (Answer D is incorrect).


Practice Management

ANSWERS AND EXPLANATIONS TO SELF-ASSESSMENT QUESTIONS 1. Answer: A Pediatric representatives should ensure that the data available are included in drug monographs for an accurate evaluation of the medications recommended for addition to the formulary (Answer A is correct). Lack of data does not preclude the use of a medication in pediatric patients; however, extrapolating a dosing regimen for all medications that may be added to the formulary is neither safe nor appropriate (Answer B is incorrect). Age-based restrictions should be implemented for medications that pose a risk to certain age groups of pediatric patients, but broad restrictions for all drugs that lack data in pediatric patients underscore the likelihood of off-label use of some medications and downplay the pediatric pharmacist’s abilities to evaluate the appropriate use of medications on a case-by-case basis (Answer C is incorrect). Often, implementation plans may need to vary from the adult population to the pediatric population. Separate implementation plans should be developed as needed to prevent workarounds that may put patients at risk experiencing medication errors (Answer D is incorrect).

for implementation of the risk assessment as well as any protocol re-work that may be appropriate, given the results of the MUE (Answer C is incorrect). A bedside nurse and operations pharmacy manager would provide expertise in implementing the plans affecting each discipline (Answers A and B are incorrect).

2. Answer: B Medication use evaluations are most effective when a multidisciplinary team of key stakeholders are involved from the development of the plan through the distribution of outcomes (Answer A is correct). Scope and outcomes of the MUE should be determined before data collection (Answer D is incorrect). However, outcomes for adult and pediatric populations may vary depending on the medication to be evaluated (Answer A is incorrect). Although high-cost medications may be evaluated, many other indicators for medications or medication use processes should be identified for evaluation, such as safety risk and adherence to protocols (Answer C is incorrect).

5. Answer: C Use of innovative drug delivery devices for delivering medications to the pediatric population enhances the complexity of care for these patients (Answer C is correct). Standard medication-dosing regimens and commercially available liquid products help facilitate the care of pediatric patients (Answers A and B are incorrect). Medical data require adequate skills to interpret; however, the barrier in care of pediatric patients is more commonly the paucity of data than the pharmacist’s ability to interpret data (Answer D is incorrect).

3. Answer: D Although all of these disciplines would offer something unique to the MUE, a pediatric hematologist would be essential for identifying appropriate outcomes for assessment and would be key to reevaluating the assessment tool as well as disseminating information to the medical staff about the results (Answer D is correct). A clinical nurse specialist, especially whose focus is in hematology, would be useful to provide input on developing the risk assessment and developing a plan

4. Answer: B In the ideal situation, medication use guidelines for pediatric patients are developed from pediatric data; however, a lack of pediatric data may not preclude the off-label use of a medication in pediatric patients, and a medication use guideline may enhance the safety of that use (Answer A is incorrect). In these instances, appropriate adult data should be extrapolated to facilitate guideline development (Answer B is correct). The guideline and its implementation plan should be developed in a multidisciplinary fashion (Answer D is incorrect). All guidelines should be evaluated after implementation for adherence and safety, whether developed from adult or pediatric data (Answer C is incorrect).

6. Answer: B Standardization of doses and concentrations will minimize the risk of error, which is heightened in the pediatric medication use process (Answer B is correct). Some dose individualization will be necessary to meet the unique needs of pediatric patients; however, use of prepackaged doses and standardized doses help optimize the efficiency and enhance safety in the medication use process (Answer D is incorrect). Medications should be dispensed in ready-to-administer doses (Answer A is incorrect), and the number of concentrations available should be standardized and minimized (Answer C is incorrect).


Practice Management

7. Answer: C Although all of these would be included in the provision of pediatric ambulatory care pharmacy services, in-depth medication education for caregivers focusing on the accurate measurement of medications would be the most essential component to provide caregivers and patients (Answer C is correct). Knowledge of commercially available products is important in providing care, but without appropriate education of the caregivers, this will not ensure adequate care to patients (Answer D is incorrect). Providing drug information to nurses and providers and educating providers on poison prevention will affect the care provided to pediatric patients in the ambulatory setting; however, this would not be considered the most essential component to provide patients and their caregivers (Answers A and B are incorrect). 8. Answer: A When developed and implemented in an optimal fashion, CPOE systems are designed to minimize the risk of error at the point of prescribing by removing handwriting errors (Answer A is correct) and minimizing the need for transcription by secretaries, nurses, and pharmacists (Answer B is incorrect). Computerized order entry does not minimize errors in verification because this function ensures perfection of the order delivered to the pharmacist either manually or electronically (Answer C is incorrect). Dispensing as a step in the medication use process is not enhanced by CPOE because other human errors can result in inaccurate dispensing; risks of dispensing error are minimized through technologies such as bar coding or pharmacy workflow managers (Answer D is incorrect). 9. Answer: B Age-related dosing algorithms can help direct providers to dosing regimens that consider the developmental differences in pediatric patients of different ages and stratify dosing appropriately (Answer B is correct). Weight-based dosing order sentences are valuable but must be incorporated with fixed dosing and direction for patient use (Answer A is incorrect). Forcing functions such as route of administration to only acceptable routes of administration for a dosing product versus providing all routes of helps optimize the system and enhance safety (Answer C is incorrect). Clinical decision support should be thoughtfully used to provide the most useful data without creating alert fatigue (Answer D is incorrect).

10. Answer: A Nursing barriers to use and subsequent workarounds should be assessed, but workarounds should not intentionally be developed (Answer B is incorrect). One major benefit of assessing the smart pump library is to evaluate for unnecessary alerts (Answer A is correct), which can be streamlined to prevent alert fatigue and workarounds. Although optimization of the library through minimization of alerts should enhance compliance with use, desire to use technology that enhances safety is not the ideal reason for routine evaluation (Answer C is incorrect). Newly published or updated guidelines should be considered in the development of the library content; however, dosing assessment should occur more often than such guidelines would be updated, and such guidelines might not be the only source used in the development of dosing guardrails (Answer D is incorrect). 11. Answer: A Developing minimum expectations for pharmacists entering pediatric practice to include PGY1 training for operations pharmacists and PGY2 training for clinical specialists should be part of the plan to expand clinical pharmacy services (Answer A is correct). On-the-job training or experience is not likely to meet the learning experiences obtained during residency training and is not a suitable substitute (Answer B is incorrect). Adding responsibilities to those the current clinical pharmacy specialist already has without redistributing services or protecting time may diminish the clinical services (Answer C is incorrect). Participating in research certainly may be a service of clinical pharmacy, though this is more likely to be a result of implementing expectations for training to enter practice versus the best strategy to enhance service (Answer D is incorrect). 12. Answer: B A unilateral approach to quality assessment may be complicated in pediatric patients because of the heterogeneity of the population in development and pathophysiology (Answer B is correct). Although communication barriers and lack of independence result in the need to involve caregivers in quality enhancement, this does not necessarily complicate the unilateral approach to quality (Answers A and C are incorrect). Availability of health insurance is arguably better for the pediatric population, and availability of such insurance may not affect the approach to quality assessments (Answer D is incorrect).


Practice Management

13. Answer: B National strategies for improving health care include reducing harm through improved safety (Answer B is correct). Caregivers and patients should be in engaged as partners in care (Answer A is incorrect), and health care providers engage in effective communication to improve transition of care (Answer D is incorrect). Encouraging healthy eating is not currently a national strategy for health care improvement (Answer C is incorrect).
