Medication Therapy and Patient Care: Specific Practice Areas–Guidelines 487 ASHP–PPAG Guidelines for Providing Pediatric Pharmacy Services in Hospitals and Health Systems

Purpose Although the scope of pharmacy services will vary among sites depending on the needs of patients, the hospital or The purpose of these guidelines is to assist pharmacists and health system, and the resources available, these core el- pharmacy departments in meeting the special needs of pedi- ements are inextricably linked to successful outcomes. atric patients in hospitals and health systems. Pharmacists Failure to provide any of these services may compromise encounter numerous challenges when providing care to pe- the quality of pediatric patient care. diatric patients, including the limited data available on the safety and efficacy of medications; the lack of appropriate Standard I. Practice Management commercially available medication dosage forms and con- centrations; weight-based dosing; complex calculations, es- The pharmacy department should be organized under the pecially when dilutions are required; and patients’ limited direction of a qualified pharmacist competent to meet the capacity to communicate regarding symptoms, responses to needs of the institution’s pediatric patients and be provided therapy, and possible adverse drug events (ADEs).1 In addi- with sufficient physical facilities, financial resources, per- tion, pediatric pharmacy practice is associated with different sonnel, and equipment to meet the pharmacy care needs of operational demands and requirements than a practice fo- the pediatric population. cused exclusively on adults. Pediatric patients are defined as all children from neonate until adulthood. These guidelines A. Pharmacy and Pharmacist Services supplement the ASHP Minimum Standard for Pharmacies in Pharmacy Mission, Goals, and Scope of Services. The Hospitals and provide additional recommendations specific pharmacy’s mission statement shall address the specific pa- to providing pediatric pharmacy services.2 tient care needs of pediatric patients. Measured outcomes that focus on value added by pediatric pharmacy practice Organizational Models should focus on safety, productivity, efficiency, quality, education, research, and innovation. Pharmacists’ responsi- bilities for the timely, safe, and accurate order processing There are various models under which hospital or health- and medication reconciliation; medication delivery; preven- system pharmacy departments typically provide care to pe- tion of readmissions; patient education at the time of dis- diatric patients, ranging from children’s hospitals to general charge; and other specialized clinical interventions and cost hospitals or health systems providing services to pediatric avoidance associated with the prevention of ADEs are vital. patients. Depending on which model is adopted, pharmacy Implementation of lean systems management in inpatient departments will provide a different scope of services for and outpatient operations and the innovative use of health- pediatric patients. Some institutions provide acute care care technology, revenue-generating services, and special- for pediatric patients with general needs, while others will ized pediatric care should be incorporated into the pharmacy treat critically ill or specialty patients, such as oncology or practice model. transplant patients, in addition to general pediatric patients. Although the pharmacy services provided may be distinctly Hours of Pharmacy Services. Adequate hours of operation different based on the type of institution and other factors, for the provision of needed pharmacy services shall be main- there are best practices listed within these guidelines to tained; when possible, 24-hour pharmacy services should which all hospitals and health systems should aspire when be provided to the pediatric population. Essential services caring for pediatric patients. include clinical pharmacy services in specialized, high-risk units (e.g., pediatric intensive care unit [ICU], neonatal ICU, Elements of Care hematology–oncology unit, operating rooms, emergency de- partment). Satellite pharmacies in these locations are ben- The elements of pharmacy services that are critical to safe, eficial, especially if there is evidence of significant service effective, innovative, and cost-conscious medication use in failures caused by central pharmacy delays or if there are lo- hospitals and health-systems include cation-specific barriers that could affect efficiency or safety. When 24-hour pharmacy services are not feasible, a safe • Practice management and consistent alternative process shall be established, and • Medication-use policy development a pharmacist with pediatric training should be available on • Medication therapy optimization an on-call basis. Remote medication order processing may • Drug product procurement and inventory management be employed (to the extent permitted by law and regulation) • Preparing, packaging, and labeling medications to help provide pharmacy services but is not a substitute • Medication delivery for an on-call pharmacist.3 Pharmacists who participate in • Medication-use monitoring remote order processing should be trained in pediatric care • Evaluating the effectiveness of the medication-use or demonstrate competency in caring for pediatric patients. system Automated drug dispensing equipment and computer data- • Research bases are also not substitutes for the skills and knowledge of 488 Medication Therapy and Patient Care: Specific Practice Areas–Guidelines a pharmacist with pediatric training and should not be con- Adequate supplies shall be maintained for these situations, sidered alternatives to 24-hour pharmacy services.4 and the unique needs of the pediatric patient population must In the absence of 24-hour pharmacy services, access to be considered when selecting these supplies. The institu- a limited supply of medications shall be available only to au- tion’s emergency preparedness team should have pediatric thorized, licensed healthcare professionals for urgent medi- pharmacy representation and expertise. cation needs. Access to such medications shall be carefully monitored and documented, and after-hours access shall be Medical Emergencies. The pharmacy shall participate in reviewed regularly to ensure appropriate use. The list of hospital decisions about the contents of code carts, pedi- medications to be accessible and the policies and procedures atric dosing references for emergency medication kits and to be used (including subsequent review of all activities trays, and the role of pharmacists in medical emergencies. by a pharmacist) shall be developed by a multidisciplinary Pharmacists should serve on trauma and cardiopulmonary committee of physicians, pharmacists, and nurses (the phar- resuscitation committees and teams, and such pharmacists macy and therapeutics [P&T] committee or its equivalent).5 should receive appropriate training and maintain appropri- Access to medications should be limited to cases in which ate certifications. Pharmacists with pediatric training should the P&T committee (or an equivalent multidisciplinary participate in neonatal and pediatric codes and be certified committee) determines that the urgent clinical need for the in basic life support, advanced cardiovascular life support, medication outweighs the potential safety risks of making neonatal resuscitation program, or pediatric advanced life the medication accessible. Medications, quantities, dosage support. Health systems with rapid response teams should forms, and container sizes that might increase the risk for consider the inclusion of a pharmacist with pediatric training ADEs shall also be evaluated. Routine after-hours access to on such a team. the pharmacy by nonpharmacists for dispensing of medica- tions shall not be permitted. The use of well-designed and Immunization Programs. The pharmacy shall participate secured cabinets, medication carts, automated dispensing in the development of hospital and health-system policies and procedures concerning preventive and postexposure devices, and other methods precludes the need for nonphar- 4,6 immunization programs for pediatric patients and hospital macists to enter the pharmacy. employees.9 When feasible and when permitted by state law or regulations, pharmacists should participate as active im- Practice Standards and Guidelines. The standards and munizers for hospital and health-system–based preventive regulations of all relevant government bodies (e.g., state immunization programs (e.g., influenza). boards of pharmacy, departments of health, Food and Drug Administration [FDA], United States Pharmacopeia, Drug D. Human Resources Enforcement Administration) shall be met. The practice Position Descriptions. Areas of responsibility within the standards and guidelines of ASHP and appropriate ac- scope of pharmacy services shall be clearly defined. Position crediting bodies (i.e., the Joint Commission, Institute for descriptions should reflect the position’s responsibilities to Safe Medication Practices [ISMP], American Osteopathic the specific pediatric population being served (e.g., pediatric Association Healthcare Facilities Accreditation Program, ICU, neonatal ICU, emergency department). Det Norske Veritas, and Centers for Medicare and Medicaid Services [CMS]) shall be viewed as applicable, and the Director of Pharmacy. The director of pharmacy should hospital should strive to meet all applicable standards. The understand the unique needs of pediatric patients and be pharmacy department is encouraged to seek further infor- knowledgeable about and have experience in pediatric hos- mation on pediatric healthcare services from other organiza- pital pharmacy practice. An advanced management degree tions, such as the Children’s Hospital Association, Pediatric (e.g., master of business administration, master of health Pharmacy Advocacy Group, Children’s Oncology Group, administration) or an administrative specialty residency is American Society for Parenteral and Enteral Nutrition, and desirable.10 American Academy of Pediatrics. Pharmacists. Pharmacy management shall employ an ad- B. Laws and Regulations equate number of competent, licensed pharmacists in good Applicable local, state, and federal laws and regulations shall standing with their state board to meet the specific medica- be met, and relevant documentation of compliance shall be tion-use needs of the hospital’s and health system’s pediatric maintained. The pharmacy should actively participate and patients. collaborate with local and national organizations, especially 2 those specific to pediatric patient care. Support Personnel. Sufficient support personnel (e.g., phar- macy technicians, inventory coordinators, business man- C. Policies and Procedures agers, other administrative personnel) shall be employed Policies and Procedures Manual. The institution’s policies to facilitate pharmacy services. Human resources collabo- and procedures manual shall address the care of pediatric ration and support are necessary, and additional education patients, and all pharmacy personnel shall follow those poli- for practitioners in this area may need to be considered for cies and procedures, regardless of whether a pharmacist with practice leadership. A support position shall have a written pediatric training is on duty. job description that includes a statement of the competen- cies required for that position. Support staff shall be prop- Emergency Preparedness. The facility’s business continuity erly trained and supervised, and professional development plan shall include procedures for providing safe and efficient programs for these staff are desirable. Pharmacy technicians pediatric pharmacy services to patients and their adult fam- should have completed an ASHP-accredited pharmacy tech- ily members in case of emergencies or disaster situations.7,8 nician training program, should be certified by the Pharmacy Medication Therapy and Patient Care: Specific Practice Areas–Guidelines 489

Technician Certification Board, and shall meet the require- ment required before a new hire can assume full responsibil- ments of applicable laws and regulations. Pharmacy tech- ity for the position. nicians working in advanced roles should have additional training and demonstrate competencies specific to the tasks Work Schedules and Assignments. The director of phar- to be performed for pediatric patients. macy or designee shall ensure that work schedules, proce- dures, and assignments optimize the use of personnel and re- Education and Training. All personnel shall possess the ed- sources. Internal benchmarking may be useful to determine ucation and training required to fulfill their responsibilities the best use of resources and personnel specific to pediatrics. and shall participate in relevant continuous professional de- National benchmarks may lack the understanding that work- velopment (e.g., continuing-education programs) and activi- flow and workload for pediatric pharmacy are very different ties as necessary to maintain or enhance their competence.11 than for adult pharmacy practice and are not as standardized. Pharmacists providing care to pediatric patients should pos- The specialized and customized needs of pediatric patients sess the knowledge and skills necessary to make that care require significantly more resources when compared with safe and effective for the patient population. The pharmacy adult patients. There shall be a written departmental staffing department should provide adequate training for all staff plan that addresses how pediatric patients’ needs will be met members who may be called on to provide care to pediat- during periods of staff shortages, fluctuation in workload, ric patients. Core competencies should be age based and inclement weather, or patient acuity. Remote medication or- include mastery of pharmacokinetic and pharmacodynamic der processing may be employed to help address staff short- differences, weight-based dosing and calculations, fluid ages or workload fluctuations.3 and nutrition requirements, common pediatric diseases and drugs, pharmacogenomics, drug information resources, and Performance Evaluation. There shall be procedures for reg- specialized drug preparation and administration techniques ularly scheduled evaluation of the performance of pharmacy for pediatric patients. Pharmacists’ core competence in these personnel. The evaluation format should be consistent with areas should be established initially and then periodically re- that used by the hospital or health system. The competen- assessed based on the level of care provided. cies of the position should be well defined in the position The pharmacy director or designee should be responsi- description, short- and long-term goals should be established ble for all staff development, taking into account the specific for each employee, and the employee’s competency shall needs of the department and the various pediatric popula- be assessed on a scheduled basis. Pediatric competencies tions served. Staff development programs should be current, should be routinely assessed for all pharmacists caring for frequently scheduled, and easily accessible. Online tools for pediatric patients. Pharmacists not meeting minimum stan- continuing education and staff development can also be a dards for competency should be reassigned to other areas convenient source for education and development. and not be allowed to practice until such competency is met. Pharmacists seeking positions in pediatric pharmacy The pharmacy director shall ensure that an ongoing compe- practice should complete postgraduate residency training tency assessment program is in place for all staff, and each to enhance their clinical skills and knowledge base in pe- staff member should have a continuous professional devel- diatric pharmacy practice. The knowledge, skills, and abili- opment plan. ties obtained through completion of a postgraduate year 1 (PGY1) residency are essential for new graduates seeking E. Facilities roles as pediatric pharmacists. Specialty training through Pharmacy. Adequate space, equipment, and supplies shall a postgraduate year 2 pediatric residency program offers a be available for all professional and administrative func- unique opportunity to focus on practice in a specific pedi- tions relating to pediatric inpatient and outpatient pharmacy atric population (e.g., critical care, neonatology, hematol- services. These resources shall meet all applicable laws and ogy–oncology) and is strongly recommended for pediatric regulations; shall be located in areas that facilitate the pro- pharmacists. Pharmacists, through experience, may also vision of services to patients, nurses, prescribers, and other demonstrate mastery of the knowledge, skills, attitudes, and healthcare providers; and shall be integrated with the hos- abilities to care for pediatric patients (e.g., PGY1 residency pital’s or health system’s communication and delivery or in a pediatric hospital, multiple pediatric rotations during a transportation systems. PGY1 program). Pharmacy directors should encourage staff to seek Outpatient Pharmacy Services. Outpatient pharmacy ser- competency-related certifications through the Board of vices should be attentive to the unique medication needs of Pharmacy Specialties certification (e.g., board-certified pe- the pediatric patient. Outpatient pharmacy services should diatric pharmacy specialist) or through other pediatric perti- stock pediatric dosage forms (e.g., liquids, chewable tablets) nent certifications (e.g., asthma education, immunization). and appropriate measuring devices (e.g., oral syringes) suit- Pharmacy directors should consider incentives or recogni- able for pediatric patients. All oral liquid medications for tion for pharmacists who seek additional training and cer- children should be dispensed with the appropriate measur- tifications. ing device. The pharmacy may provide flavoring services to improve the palatability of medications. In unique circum- Orientation of Personnel. There shall be an established, stances where medication preparation will need to be per- structured procedure for orienting new personnel to the formed by the patient or caregiver (e.g., short-stability medi- pharmacy, the hospital or health system, and their respec- cations, reconstitution), education should be provided by tive positions to provide care for the pediatric patient.12 the appropriate pharmacy staff member. Consideration must Evaluation of the effectiveness of orientation programs be given to the need for an extra medication supply with should be done in conjunction with the competency assess- a labeled container to be taken to school, daycare, or other 490 Medication Therapy and Patient Care: Specific Practice Areas–Guidelines places where medication may be administered. For outpa- Pharmacy computer systems should be integrated with the hos- tient medication services (e.g., ambulatory care infusion pital’s clinical, financial, and administrative information sys- centers, home infusion services, compounding services), is- tems. All computer systems shall include adequate safeguards sues, such as preparation and batching of medications, need to maintain the confidentiality and security of patient records, to be considered. If a hospital or health system outsources and a backup system should be available to continue essential for these services, selected facilities shall be able to support computerized functions (e.g., those that support patient care) the care and needs of pediatric patients. during equipment failure.

Medication Storage and Preparation Areas. There shall be Drug Information. Adequate space, current resources, and suitable facilities to enable and document the receipt, stor- information-handling and communication technology shall age, and preparation of medications under proper conditions be available to facilitate the provision of drug information. of sanitation, temperature, light, moisture, ventilation, segre- The pharmacy department shall select and standardize its gation, and security to ensure medication integrity and per- drug information resources, and a pharmacist with pediat- sonnel safety throughout the hospital and health system.4,13 ric training shall play a leadership role in the selection of pediatric drug information resources used by other health- Compounding Areas. There shall be suitable facilities to en- care providers in the hospital. Current objective pediatric able the compounding, preparation, and labeling of sterile and adult drug information shall be available, including and nonsterile products, including hazardous drug products, print or electronic periodicals, newsletters, best practices in accordance with national and local established quality guidelines, and recent editions of reference books in ap- assurance procedures. The work environment shall pro- propriate pediatric pharmaceutical and biomedical subject mote orderliness and efficiency and minimize the potential areas. Specifically, information on pediatric dosages, extem- for medication errors and contamination of products.14-20 poraneous formulations, drug compatibilities and stability, Resources necessary for compounding and testing alter- toxicology, drug effects, and safety during pregnancy and native doses and dosage forms of commercially available lactation should be readily obtainable. Literature support- products are essential. Preparation of pediatric doses often ing the use of drugs for unlabeled uses in pediatric patients requires more time and actions (e.g., calculation of proper should also be accessible.21 Available information sources dose, dilution, preparation of patient-specific dose in the should support research on patient care issues and facilitate most ready-to-administer form) than preparation of stan- the provision of pharmacy care and safety in the medication- dard adult doses, many of which are available in ready-to- use process. Appropriate drug information resources shall use form from manufacturers. Resources shall be allocated be readily accessible to pharmacists located in specialized to maintain the efficiency and safety of the medication-use pediatric patient care areas (e.g., neonatal intensive care). process while meeting the additional requirements of pro- This information may be accessed in conjunction with medi- viding pediatric doses. cal libraries and other available resources. Resources should have the capability to provide hard copies of drug informa- Information Technology. A comprehensive pharmacy com- tion or counseling points focused on the pediatric population puter system shall be employed and should be integrated to that the pharmacist can provide to the patient and caregiver. the fullest extent possible with other hospital information Electronic drug information databases are preferred systems and software, including computerized provider or- because they are frequently updated and can be made avail- der entry (CPOE), barcode-assisted medication administra- able to all healthcare professionals, but sufficient access to tion, electronic health record, and patient billing systems. To print information shall be available in case of equipment fail- obtain patient-specific clinical information for medication ure or downtime. Electronic databases and convenient meth- therapy monitoring and other clinical functions and to fa- ods of data dissemination (e.g., e-mail, handheld devices) cilitate the continuity of care to and from other care settings, are desirable. Electronic drug information resources shall be computer resources should be used to support the following: accessible at the point of care for all healthcare personnel.

• Access the patient medical record. F. Health Information Technology • Document patient care activities. Standards. The pharmacy director or designee shall maintain • Interface with other computerized systems. an understanding of current regulatory standards and best • Maintain patient medication profile records. practices related to the use of health information technol- • Manage clerical functions. ogy (HIT), including but not limited to the Health Insurance • Manage drug product inventories. Portability and Accountability Act, American Recovery • Manage electronic prescribing. and Reinvestment Act/Health Information Technology for • Perform necessary patient billing procedures. Economic and Clinical Health, and CMS e-reporting re- • Provide clinical decision support (CDS). quirements pertaining to medication use and pharmacy prac- • Provide drug information. tice. Staff will comply with these regulations.

Pediatric specific needs within the computer resources shall HIT Components of the Medication-Use Cycle. Pharmacy be carefully evaluated and allow for customization if war- HIT should be an integrated part of the health system’s clini- ranted. Additional informatics resources may need to be cal and financial information systems. The pharmacy execu- considered for implementation and development of sophis- tive or designee shall be an active participant in the evalua- ticated CDS. A pharmacist with pediatric training should be tion and decision to purchase any new clinical information involved in the development and maintenance of order sets, system by the health system. templates, and dose ranges used in CPOE and CDS systems. Medication Therapy and Patient Care: Specific Practice Areas–Guidelines 491

CPOE and CDS Systems. CPOE and CDS systems should Smart Infusion Pumps. The hospital shall purchase and be evaluated and customized as necessary to support age- maintain pumps that are built with a medication library (i.e., specific requirements for safe and effective medication use. smart infusion pumps). These include large-volume bag Computer systems shall report patient weight and height in pumps, small-volume syringe pumps, and patient-controlled metric units. At a minimum, these systems shall include age- analgesia pumps. Pharmacy departments should be involved specific, weight-specific, and body surface area–specific in the purchasing, implementation, and maintenance of all drug dose checking; dose capping; and drug–allergy, drug– infusion devices capable of administering medications to drug interaction, and drug–disease state checking. CPOE patients (e.g., magnetic resonance imaging compatible de- order sets and order sentences intended for use in pediatric vices, epidural pumps). The medication library shall include patients should be reviewed by the pharmacy department or standard concentrations of i.v. medications, dose limits, and by the pediatric pharmacy specialist in the case of a chil- warnings as appropriate. The medication library shall be dren’s hospital or pediatric services within an adult hospital maintained by a pharmacist with training in pediatrics. The or health system. library shall be maintained and checked on a regular basis, at least annually, and adjustments made as needed. Dosing Automation. Automation, including but not limited to dis- alerts shall be installed as appropriate to add safeguards for pensing cabinets, carousels, and robotics, should be used high-risk medications. These alerts should use hard limits and able to accommodate pediatric dosage forms, dosage wherever possible, as they have been shown to decrease er- rors to a greater extent than soft limits, which can be over- amounts, and delivery rates (e.g., neonatal i.v. syringes, 24 oral liquid dose forms). Hospitals should evaluate the use of ridden. Pump usage should be closely monitored to ensure other barcode-enabled technologies to ensure patient safety, that providers of care are appropriately using the library and such as medication tracking and i.v. workflow software. Use not overriding safeguards. of this automation should also include a continuous quality- improvement plan to optimize the effectiveness of these CDS Technology. The pharmacy department shall actively participate in the acquisition, development, and maintenance technologies for pediatric patients. of CDS systems that impact pharmacy services, including membership on any committee tasked with CDS governance. Electronic Medication Administration Record. An elec- Policies and procedures shall be developed to describe tronic medication administration record (eMAR) should be the CDS request lifecycle and CDS governance process. integrated or directly interfaced with the pharmacy informa- Content and execution of CDS rules shall follow industry tion system. Information systems should populate the eMAR best practice. Opportunities for CDS should be continually with medication dose and volume for pediatric patients. The evaluated based on hospital event reports and published eMAR should include nursing notification for late doses as sources. The effectiveness of any CDS intervention should well as the ability to document a reason for any doses not be evaluated postimplementation and modified as needed. administered. Ideally, the eMAR should be integrated with The pharmacy department shall be involved in the regular assistive technology (i.e., either barcode or radio frequency review of medication-related alerts and reminders within the identification [RFID] technology) to provide electronic electronic health record to ensure that CDS content remains tracking and decision support around the 5 rights of medica- 22 current and accurate to minimize the generation of nuisance tion administration. Documentation of medication-specific alerts and to identify and correct any CDS content that may patient parameters (e.g., corresponding pain score with ad- lead to confusion or risk of medication errors.25,26 ministration of a pain medication) should be encouraged. CDS Governance. CDS rules may be locally developed or Barcode or RFID Medication Administration. A point-of- provided by the system vendor. A pediatric-specific work- care barcode or RFID medication administration system group that includes a pharmacist with pediatric training shall be employed and integrated with the eMAR and phar- should be established for consideration of pediatric-specific 23 macy information system. Point-of-care technology shall workflow and needs assessment. In either case, rules should be carefully evaluated for use in a pediatric setting, specifi- be as sensitive and specific as possible in order to minimize cally success rates for scanning labels on smaller syringe alert fatigue.26 Vendor-supplied CDS rules should be evalu- dosages and on patient armbands sized for young children ated and customized before implementation, and all CDS and infants. Careful consideration and monitoring of nursing rules shall be evaluated on an ongoing basis to ensure con- workarounds should be evaluated periodically and specific tinued relevance. At a minimum, the CDS system should barriers addressed by the medication safety team or com- provide mechanisms for drug–drug, drug–allergy, and drug– mittee. In those circumstances where barcode or RFID tags disease state interactions, as well as dose range checking are applied onsite to compounded or repackaged medica- and other dosing guidance. CDS should be utilized to col- tions, workflows and quality assurance procedures must be lect quality measures data for reporting to CMS under the in place to ensure accurate labeling. Meaningful Use of the Electronic Health Record Incentive Program. E-prescribing. E-prescribing systems shall include age- and weight-specific drug dose checking and drug–allergy, drug– CDS Development and Customization. Customization of drug interaction, and drug–disease state checking. When vendor-supplied CDS or local development of CDS solu- possible, e-prescribing systems should be integrated into the tions shall follow a defined life cycle, which shall include organization’s primary electronic medical record/CPOE sys- the following stages26: tem or, at a minimum, should be interfaced with the CPOE system in order to share allergy, drug interaction, and medi- • Requirements gathering: review of current workflow cation reconciliation history data. and identification of opportunities for CDS solutions. 492 Medication Therapy and Patient Care: Specific Practice Areas–Guidelines

• Detailed specifications for the proposed CDS solution tation, and assessment of pediatric care plans (protocols, to be developed in conjunction with a pharmacy critical pathways, disease state management programs, and informatics or information technology expert and clinical practice guidelines), standing orders, and order sets 30 approved by the affected clinical end users (e.g., that involve medication therapy. nursing, medical, and pharmacy staff representatives) as well as quality-control and regulatory department B. Formulary representatives. Formulary. A well-controlled formulary of approved medi- • Development and testing of the proposed CDS cations shall be maintained and regularly updated by the solution. P&T committee (or its equivalent). The impact of and com- • Education of the affected end users regarding the pliance with the formulary should be periodically reviewed proposed solution and any impact it may have on (e.g., through drug utilization reviews), and the P&T com- current workflow. mittee should regularly review the formulary for pediatric • Implementation of the CDS solution. efficacy and safety information. The P&T committee shall • Ongoing monitoring as described above under CDS be responsible for developing and maintaining written cri- governance to identify and correct any unintended teria for drug product selection, which shall address formu- consequences of the new CDS rule. lary requests for medications intended for use in pediatric populations. The P&T committee shall be responsible for approving and maintaining adequate product specifications G. Committee Involvement to aid in the purchase of medications and related supplies A pharmacist with pediatric training shall be a member of for pediatric patients. The pharmacy shall disseminate the and actively participate in hospital and health-system com- formulary by electronic (preferred) or other means to meet mittees responsible for establishing and implementing med- the needs of all healthcare professionals. ication-related policies and procedures for pediatric patients There shall be policies and procedures for the follow- as well as those committees responsible for the provision ing: of pediatric patient care, including the P&T, infection pre- vention and control, patient care, medication-use evaluation • Use of dietary supplements. and process, medication safety, transitions-of-care, nutrition, • Other alternative therapies. and pain management committees (or their equivalents), as • Procurement, control, and use of nonformulary medi- 5 well as the institutional review board, quality-improvement cations required for pediatric patient care. committee, and information technology committee (or their equivalents).5,27-29 Nondrug Substances. Some institutions may have non- A pharmacist with pediatric training should partici- drug substances that may be handled or distributed by the pate in or be appointed to the hospital’s P&T committee pharmacy (donor breast milk and other nutrition products). and should provide input regarding all P&T decisions and There should be policies and procedures that describe how their impact on pediatric patient populations. A pediatrics the pharmacy shall seek and obtain documented authoriza- subcommittee or other appropriate pediatric representation tion from appropriate medical staff and hospital committees should be established if the P&T committee is focused pri- before the medical use of any nondrug substance, as well as marily on adult patients. If such a subcommittee is not estab- appropriate documentation for tracking and quality-control lished, all P&T committee decisions should denote whether purposes (e.g., lot numbers). These policies and procedures they apply to pediatric patients or only adult patients. should clearly define the pharmacy procedure for storage, A pharmacist with pediatric training should be simi- preparation, and distribution of these nondrug substances. A larly involved in the development, implementation, and pharmacist with pediatric training should be involved in the assessment of care plans (medication-use processes, proto- development and approval of these policies and procedures. cols, critical pathways, disease state management programs, transitions-of-care, and clinical practice guidelines), stand- C. Drug Information ing orders, and order sets that involve medication therapy Drug Information Services. Pediatric drug information for pediatric patients. services should be provided by the pharmacist practicing in the pediatric setting by supplying information unique to the pediatric population. These services may be developed Standard II. Medication-Use as a focused service with pharmacists solely working in Policy Development this area in the health system, or drug information respon- sibilities may be incorporated throughout the department with several pharmacists contributing to different services. A. Policy Development A pharmacy department may have a drug information tele- All committees that make decisions concerning pediatric phone line, e-mail address, or other mode of communication medication management and use shall have at least 1 phar- (e.g., text message, discussion board) to answer questions macist with pediatric training as a member. These include from practitioners. A pharmacist with pediatric training but are not limited to the P&T, infection control, patient should provide the pharmacy department and other health- care, medication-use evaluation, medication safety, transi- care professionals with information on new and investiga- tions-of-care, nutrition, pain management, and information tional drugs, adverse effects of and contraindications to drug technology committees (or their equivalents), as well as the therapy, compatibility and stability information, drug short- institutional review board.5,27-29 A pharmacist with pediatric ages and alternatives, dosage computations, pharmacokinet- training shall be involved in the development, implemen- ics, pharmacogenomics, and drug interactions related to the Medication Therapy and Patient Care: Specific Practice Areas–Guidelines 493 pediatric population. The drug information service should diatric patients. Hospitals should deploy additional clinical also conduct medication-use evaluations to assist the P&T pediatric pharmacy specialists to high-risk care areas (e.g., committee or its equivalent and may provide medication-use critical care, neonatology, hematology–oncology, transplant, policies specific for pediatric patients (e.g., off-label use of and emergency departments). Documentation of pharmacy medications, use of patient’s home medications). services is warranted for quality assurance. Communication of patient care recommendations is also critical for continu- Drug Information Requests. The pharmacist shall provide ity of care. Documentation in the electronic medical record pediatric patient–specific drug information and accurate, is preferred when feasible. comprehensive information about drugs and drug therapy to health professionals, patients, and patients’ caregivers A. Creating a Relationship with the Patient as appropriate. Responses to general and patient-specific Pharmacist’s Role in Direct Patient Care. Hospital and drug information requests shall be provided in an accurate pharmacy department policies should encourage pharma- and timely manner by a pharmacist, and there should be cists with pediatric training to provide direct patient care a process for documenting and ensuring the quality of re- in both inpatient and outpatient settings. Hospital and phar- 31 sponses. Documentation of drug information requests and macy department policies should encourage pharmacists other services shall be gathered and evaluated by the phar- with pediatric training to engage in medication therapy macy department. management, collaborative drug therapy management, im- munization, medication ordering and administration, and Dissemination of Drug Information. Pharmacists shall other patient care activities to the extent permitted by law, keep the hospital’s staff and healthcare providers informed regulations, and hospital requirements.33 about the use of medications in the pediatric population on an ongoing basis through appropriate publications, pre- Continuity of Care. Pharmacists should assume responsibil- sentations, and programs. Pharmacists shall ensure timely ity for continuity of care for patients’ medication therapy. dissemination of drug product information (e.g., recall no- Pharmacists and pharmacy departments should take a lead- tices, labeling changes, changes in product availability). ership role in developing and implementing policies and Electronic communications (e.g., websites, e-mail newslet- procedures for medication therapy management for admis- ters, intranet postings) are effective due to their timeliness 31 sions, discharges, transfers, and transitions across care set- and accessibility. tings and shifts (e.g., hospital unit changes, outpatient clin- ics, home care). Standard III. Optimizing Medication Therapy B. Acquiring Essential Patient Data Medication Histories. Pharmacists or their designee should An important responsibility of the pharmacist is optimizing obtain, prepare, or have immediate access to comprehen- medication use. A pharmacist with pediatric training, in col- sive medication histories for each patient, from the patient’s laboration with medical and nursing staff, shall develop poli- medical record or other databases (e.g., a medication profile) cies and procedures based on demonstrated best practices or both. It is preferred that a pharmacist with pediatric train- for ensuring the quality of medication therapy in pediatric ing conduct a medication and vaccination history for each patients. Clinical imperatives should be the primary deter- pediatric patient when feasible. The patient or caregiver may minant of medication-use decisions. be interviewed, depending on the patient’s level of commu- nication. Electronic medical records should be constructed Clinical Services. Clinical services provided by the phar- so that medication histories and other data required for med- macy department will vary, depending on the needs of pa- ication management, including medication reconciliation, tients, the resources available, the structure of the depart- are available and easily accessible to all health professionals ment, and other factors. However, the goal should be to caring for a patient. For many pediatric patients, medication provide all children with the same level of clinical exper- and vaccination histories may be obtained from caregivers tise on a consistent basis. Decentralized clinical pharmacy who may or may not provide routine care for the child (e.g., services are warranted for standalone children’s hospitals grandparents, divorced parent). If available, efforts should and other hospitals that support a large number of pediatric be made to contact caregivers who provide routine care for patients. Clinical pediatric pharmacy services shall be pri- the child and to pharmacies to gather accurate medication oritized to provide the highest level of care to populations histories. that are at highest risk, such as patients in the critical care, neonatology, hematology–oncology, and emergency depart- Standard IV. Managing Inventory ments. If perioperative or procedural services are provided in the health system, a pharmacist should also be directly Medication Storage. Medications shall be received, stored, assigned to those units.32 The clinical pharmacy services and prepared under proper conditions of sanitation, tempera- provided should include but are not limited to patient care ture, light, moisture, ventilation, segregation, and security to rounds, drug therapy monitoring, drug information, medi- ensure medication integrity and personnel safety in accor- cation profile review, medication reconciliation, ADEs dance with all federal and state laws.4 surveillance, patient education, and discharge counseling. Additional services provided by the pharmacy should in- Drug Shortages. There shall be policies and procedures for clude routine nursing and prescriber education, order set managing drug product shortages. The pharmacy’s inven- development, policy development, drug evaluation reviews, tory management system should be designed to detect and and other medication safety and quality initiatives for pe- mitigate subminimum inventory levels and alert the phar- 494 Medication Therapy and Patient Care: Specific Practice Areas–Guidelines macy to potential shortages. Pharmacy staff should moni- oral and parenteral medications where appropriate may fa- tor reliable sources of information regarding drug product cilitate the provision of these services. Every attempt shall shortages (e.g., ASHP and FDA drug shortages Web re- be made to provide patient-specific dosing, realizing that source centers).34,35 The pharmacy should develop strategies patient-specific doses are more often required in pediatric for identifying alternative therapies, working with suppliers, patients. All scheduled pediatric medications should be dis- collaborating with physicians and other healthcare provid- pensed in patient-specific unit doses. ers, and conducting an awareness campaign in the event of Manipulation of medications before administration a drug product shortage.36 Pharmacy should provide lead- (e.g., withdrawal of doses from containers, reconstitution of ership in communicating specific operational changes and powdered drug products, labeling of containers, splitting of work with appropriate medical personnel and the P&T com- tablets) by final users or providers should be minimized.15 mittee or its equivalent for specific clinical changes affect- Repackaging of oral or sterile products shall meet all appli- ing pediatric patient care due to drug shortages. cable laws, regulations, standards, and accreditation require- ments.14,18,19 Standard V. Preparing, Packaging, and Labeling Medications Barcoding of Unit Dose Packaging and Point-of-Care Administration. Unit dose packages should contain a bar- code, and that code should be used in inventory manage- ment, dose preparation and packaging, dispensing, and A. Preparing Medications administration. It is the responsibility of the pharmacy de- Compounding. Drug formulations, dosage forms, strengths, partment to ensure the quality of all aspects of barcode med- and packaging that are not available commercially but are ication administration, including scannability of barcodes needed for pediatric patient care shall be prepared by ap- 23,39 and database management. propriately trained personnel in accordance with applicable practice standards and regulations. Medications shall be ordered by the institution in standardized concentrations of Standard VI. Medication Delivery commercially available and validated master formulas—ide- ally evidence-based and referenced—as part of an effort to reduce medication errors. The pharmacy shall follow fed- A. Medication Prescribing eral and state regulations and shall provide adequate quality Prescribing. Medications shall be prescribed by individu- assurance procedures for these operations.19,20,37 Pharmacy als who have been granted appropriate clinical privileges in departments shall ensure patient safety as well as true patient the hospital and are legally permitted to order medications. need versus anticipated cost savings. Written master formu- The pharmacy shall advocate and foster practitioners’ con- lations and batch records (including product test results, as formance with standardized, approved, and safe terminology appropriate) shall be maintained, and a lot number or other and abbreviations to be used throughout the hospital when method to identify each finished product with its produc- prescribing medications and discourage use of nonstandard 4 tion and control history shall be assigned to each batch.14-20 and unapproved terminology and abbreviations. The metric Sterile and nonsterile compounding shall meet all applicable system shall be utilized for ordering oral liquid medications federal and state laws, regulations, standards, and accredita- for the pediatric population.40,41 tion requirements.14,19,20 Diagnostic or Therapeutic Purpose. Pharmacists shall have Sterile Preparations. When possible, manufactured sterile access to the patient’s diagnosis or the intended therapeu- preparations should be preferred to compounding in the tic or medical purpose of medications in a timely manner. pharmacy. All sterile medications shall be prepared and la- For many medications, pediatric labeling does not exist, and beled in a suitable environment by appropriately trained per- off-label use is common. Resources shall be available to the sonnel in accordance with established quality assurance and pharmacist to assist with identifying medication indications beyond use dating procedures.14,19 The use of sterile medica- or uses. tions compounded outside the pharmacy (e.g., nursing units) should be avoided to the extent possible; when they are used Medication Orders. All patient medication orders shall be in urgent or emergent circumstances, there shall be proce- contained in the patient’s medical record. A direct copy of dures for aseptic preparation, quality assurance, expiration the prescriber’s order, either hard copy (including facsim- dating, and ongoing competency evaluations for compound- ile) or prescriber-entered electronic transmission (preferred ing personnel.14,19,38 Sterile compounding outside the phar- method), shall be received by the pharmacist. Verbal orders macy or satellite pharmacies (e.g., on nursing units) should shall be avoided to the extent possible. When verbal orders be minimized and occur only in emergency situations.14,19 If are necessary, they shall follow the organization’s estab- outsourcing of sterile compounding services is necessary, the lished procedures for their use and documentation. Order pharmacy department shall ensure that the process provides transmittal safeguards shall be used to ensure the security of appropriate guarantees of safety and quality assurance.38 the prescriber’s order. Appropriate records of each medica- tion order and its processing in the pharmacy shall be main- B. Packaging Medications tained in accordance with applicable laws and regulations. Unit Dose Packaging. A lack of availability of commercially A system shall exist to ensure that medication orders prepared dosage forms, combined with the documented risk are not inappropriately continued.4 The pharmacy depart- of calculation errors, requires the use of comprehensive unit ment should establish, regularly review and revise, and en- dose drug distribution systems and i.v. admixture services force policies and procedures that ensure a prospective re- for pediatric patients. The use of standardized doses for both view of every medication order for a pediatric patient by a Medication Therapy and Patient Care: Specific Practice Areas–Guidelines 495 pharmacist trained in pediatrics. A standard definition should therapeutic use, method of administration, potential adverse be established for who constitutes a pediatric patient in the effects, and dosage. Caregivers and patients shall be in- institution; this definition may be based on weight, age, con- formed of these policies on admission so they do not admin- genital defects, developmental delays, or a combination of ister home medications without the healthcare provider’s these factors. All medication orders for pediatric patients knowledge and approval. shall include the patient’s allergies, the patient’s weight in Patients who are admitted to the hospital with func- kilograms, a weight-based dose designation (e.g., mg/kg), tional insulin pumps shall work with the physician, nurse, and a total dose, where applicable. Height, in centimeters, and pharmacist to ensure that the pump is set up appropri- shall also be obtained to calculate body mass index, body ately. The patient and/or parent must demonstrate compe- surface area, and renal function. Standardization for doses to tence in pump use and programming and agree to commu- be provided in milligrams or milliliters should be evaluated nicate all insulin doses with the nurse to ensure appropriate closely, and the correct process for entering orders should be administration and documentation. Hospitals shall have a standardized and communicated to providers to mitigate or- policy to address insulin pumps and their use in the hospital der errors. All elements of the medication order are required. setting. The use of abbreviations shall be limited based on specific recommendations provided by the Joint Commission on “do Standard VII. Monitoring Medication Use not use” abbreviations.41

Review of Medication Orders. Pediatric medication orders A. Reviewing Patient Responses to Medication Therapy shall be prospectively reviewed by a pharmacist with ad- Medication Therapy Monitoring. Medication therapy mon- equate pediatric training and assessed in relation to pertinent itoring shall be conducted by pharmacists. Medication ther- patient and clinical information before the first dose is dis- apy monitoring includes a proactive assessment of patient pensed or made available in an automated dispensing de- problems and an assessment of the following: vice, except in emergent situations in which the treatment of the patient would be significantly compromised by the delay • The therapeutic appropriateness of the patient’s medi- that would result from pharmacist review of the order. There cation regimen. shall be a procedure for retrospective review of these orders. • Therapeutic duplication or omissions in the patient’s Any questions regarding an order shall be resolved medication regimen. with the prescriber before dispensing or administration. • The appropriateness of the dose of the medication, as Pharmacist consultations should be documented in the pa- well as the route, method, and frequency of adminis- tient’s medical record. Information concerning changes shall tration of the medication. be communicated to the appropriate health professionals Patient adherence to the prescribed medication 4 • caring for the patient. regimen. • Drug–drug, drug–food, drug–dietary supplement, B. Medication Delivery and Administration drug–laboratory test, and drug–disease interactions. Drug Delivery Systems, Administration Devices, and • Adverse drug reactions (ADRs) and other undesired Automated Distribution Devices. The pharmacy shall be effects.42 responsible for developing policies, procedures, and qual- • Patient medication allergies and sensitivities. ity assurance programs regarding drug delivery systems, • Clinical and pharmacokinetic laboratory data to evalu- administration devices, and automated distribution devices ate the efficacy and safety of medication therapy and to ensure safety, accuracy, security, and patient confidenti- to anticipate toxicity and adverse effects. ality in the pediatric population. Administration technology • Physical signs and clinical symptoms relevant to the consideration shall include standard concentrations, patient patient’s medication therapy. size, and administration rate. The potential for medication • Assessment of the effectiveness of the patient’s medi- errors associated with such systems and devices in the pedi- cation therapy. atric population shall be thoroughly evaluated.4,6 Pharmacy personnel shall supervise the stocking and documentation of Therapeutic Drug Monitoring. Therapeutic drug monitor- medications in automated dispensing devices.6 Whenever ing services shall be provided by the pharmacy for all pedi- possible, automated dispensing cabinets should employ atric patients for medications that include, but are not limited profile-based technology integrated with remote medication to, drugs with a narrow therapeutic window (e.g., vancomy- order-entry capabilities. cin, aminoglycosides, anticonvulsants, antirejection medica- tions, digoxin), anticoagulation medications, and other med- Medication Administration. Only personnel who are autho- ications associated with high rates of adverse events. Any rized by the hospital in accordance with applicable laws and pharmacists caring for pediatric patients must be knowl- regulations and who are appropriately trained shall be per- edgeable of the unique pharmacokinetic differences in a pe- mitted to administer medications to a patient. All adminis- diatric patient, including alterations in absorption, distribu- tered, refused, or omitted medication doses shall be recorded tion, metabolism, and excretion. The most important of these in the patient’s medical record according to an established is the larger volume of distribution for water-soluble drugs procedure, and all medications that have not been adminis- (e.g., aminoglycosides), which can significantly affect dos- tered shall be returned to the pharmacy or discarded appro- ing in younger patients. The pharmacist should ensure that priately. No medication should be administered to a patient the drug being monitored has been administered appropri- unless medical and nursing personnel have been provided ately before samples are taken for the measurement of serum with adequate information about and are familiar with its drug concentrations. The frequency and timing of sampling 496 Medication Therapy and Patient Care: Specific Practice Areas–Guidelines should also be coordinated to avoid excessive and traumatic be integrated with the hospital’s or health system’s quality sampling in pediatric patients. Documentation of pharma- assessment and quality-improvement activities. Quality- cokinetic services in a readily accessible format should be improvement activities related to the selection, prescription, completed by the clinical pharmacist with pediatric training. procurement, storage, preparation, dispensing, distribu- tion, administration, documentation, monitoring, and use of B. Educating and Counseling Patients and Family medications for the pediatric population shall be routinely Patient Education. Counseling of pediatric patients and performed in cooperation with other healthcare providers. their caregivers is an important role for the pharmacist. For Feedback shall be provided to appropriate individuals or en- younger patients or patients who lack developmental cogni- tities about the quality achieved. tion, the pharmacist may have to focus education toward the caregiver; older children and adolescents will require coun- A. Assessing Pharmacy Services and Practices seling and education provided at an age-appropriate level. Documentation of Pharmacist-Provided Patient Care When language barriers exist, interpreters may help commu- Services and Medication Therapy Outcomes. The phar- nicate with non-English-speaking patients and caregivers. macy shall have an ongoing process for consistent documen- The education level and general health literacy of the patient tation of all pharmacy interventions and the pediatric patient and caregiver may also present barriers for verbal or writ- care services provided by pharmacists and patient outcomes ten communication. Medication-related material developed from medication therapy.45 This documentation can serve as by other services and departments as well as commercial objective data supporting the need to hire a full-time phar- sources should be reviewed by the pharmacy staff for accu- macist with pediatric training in a particular area where fo- racy, currency, literacy appropriateness, and completeness. cused services may not currently exist or optimization of If necessary, interpretive language services (written or oral) pharmacy resources for the pediatric population is needed. should be made available to patients.43 Commercially avail- able, pediatric-friendly patient education handouts in mul- Workload and Financial Performance. A process shall ex- tiple languages are warranted in a pediatric health system. ist to routinely monitor and document workload and finan- Patients and caregivers should be counseled on medi- cial performance. Metrics should encompass the full scope cation use both in the inpatient and outpatient settings and of patient care, including the increased workload provided should be provided with the following information at a mini- by pharmacists and the pharmacy enterprise. This process mum: should provide for the determination and analysis of hos- pital and systemwide costs of pediatric medication therapy. • Medication’s brand and generic names A pharmacist should be an integral part of the hospital’s • Dosing instructions leadership teams (e.g., administrative, financial) and report • Methods of administration (e.g., crush, chew, apply) directly to the organization’s principal executive. • Information about potential adverse effects and drug interactions B. Improving the Medication-Use Process • Proper medication storage Medication-Use Evaluation. There shall be an ongoing pro- • Strategies to prevent accidental ingestion gram for monitoring pediatric drug utilization and costs to ensure that medications are used appropriately, safely, and Specifically, caregivers shall be instructed in the differ- effectively and to increase the probability of desired patient ences between milliliters and teaspoons for administration outcomes. The P&T committee (or its equivalent) should amounts. The recommended measurement to be used for liq- define specific parameters for evaluation (e.g., disease state, uid formulations is milliliter.40,44 Adherence shall be empha- pharmacologic category, high-use/high-cost drug products) sized for all patients and caregivers. It is helpful to provide as appropriate for the organization. Through the ongoing pediatric-specific patient care handouts with dosing instruc- evaluation of pediatric medication use, areas in need of im- tions for discharge medications and education on the proper provement in pediatric medication prescribing and manage- 46,47 use of a pediatric-friendly measuring device (e.g., not the ment can be identified and targeted for intervention. household teaspoon) and the possible options for flavoring medications. During a counseling session, the pharmacist is Medication Safety. Medication errors are common and 48 well positioned to play a role in preventive healthcare, in- costly. Pediatric patients are most vulnerable and are 3 cluding immunization and poison prevention.9 times more likely to be involved in a medication error than adults.49 Pediatric patients have unique differences in phar- macokinetic and pharmacodynamic responses to medication Standard VIII. Evaluating 49 therapy that put them at higher risk of experiencing ADEs. the Effectiveness of the In addition, there is a lack of ready-to-use medication forms Medication-Use System available from manufacturers, and commercially available products often require extensive manipulation, which may There shall be an ongoing, systematic program for quality include complex calculations, to make them suitable for assessment and improvement of pharmacy services and the pediatric patients. Medication dosing is more complex, be- medication-use system. The pediatric pharmacy services cause most doses are not standardized and are dependent program should include routinely evaluating the literature on weight. Infants and children also lack the developmental for new technologies or successful practices that have been ability to recognize or describe unintended adverse effects or demonstrated to enhance safety in other organizations to ADRs should they occur. determine if such technologies or practices can improve Pharmacists shall provide leadership to and partici- the hospital’s medication-use system. This program should pate in collaborative, multidisciplinary efforts to prevent, Medication Therapy and Patient Care: Specific Practice Areas–Guidelines 497 detect, and resolve drug-related problems that can result veloping prescribing patterns to help minimize the develop- in patient harm such as root cause analysis or failure mode ment of drug resistance.27 and effects analysis. A pharmacist with pediatric training and other appropriate hospital personnel shall establish and Standard IX. Research regularly revise policies and procedures regarding pediatric medication error and adverse-event prevention and report- The pharmacist should initiate, participate in, and support ing. Monitoring, detecting, review, and analysis of the hos- clinical and practice-related research appropriate to the pital’s and health system’s medication errors and near misses goals, objectives, and resources of the specific hospital or should be an ongoing process in a just culture environment, health system. Pediatric patients have long been recognized and corresponding corrective actions should be docu- as “therapeutic orphans” because of the relative absence of 50 mented. An ongoing program for preventing, monitoring, therapeutic trials in this patient population. The pharmacist 42 resolving, and reporting ADEs shall be developed. A phar- must take into consideration that pediatric patients may not macist shall participate in appropriate organizational com- be able to provide informed consent and must have a pro- mittees and work with physicians, nurses, administrators, cedure in place to address this vulnerable population. The and others to examine and improve systems to ensure that reasons for this are numerous and include ethical issues, po- 47 medication-use processes are safe. To ensure the safety of tential adverse publicity, possible litigation, methodological pediatric patients, the pharmacy department shall establish, hurdles, and an inability to justify such studies for economic regularly review and revise, and enforce pediatric-specific reasons. The advent of the Best Pharmaceuticals for Children requirements for medication management, including consid- Act of 200753,54 and additional pediatric formulation initia- erations for look-alike/sound-alike drugs, high-alert medi- tives has greatly improved the number of resources avail- cations, ready-to-administer doses, turnaround times, over- able and the amount of research performed in children. The rides, and medication storage and labeling. pharmacist with pediatric training can be directly involved Systems shall be in place to routinely evaluate medica- in collaboration with other healthcare providers in conduct- tion errors that occur, and interventions should be made to ing pediatric research. Examples of pediatric research topics processes to prevent error recurrence. Due to the complex include, but are not limited to, the following: nature of the pediatric medication-use system, including confusing packaging and dosage forms, proactive evaluation • Safety and efficacy of drug products in pediatric of errors reported from other sources (e.g., ISMP, the Joint patients Commission, the manufacturer) shall be routinely evaluated, • Pharmacokinetics and pharmacodynamics of new and necessary process changes for error prevention should medications be made. Self-reporting systems for ADEs used in isolation • Pharmacogenomic considerations and prediction of are insufficient. An additional surveillance or trigger-based ADEs system shall also be in place to more adequately monitor for • Stability, safety, and efficacy of extemporaneously and capture events.51,52 compounded sterile and nonsterile drug products • Safety and efficacy of administration techniques ADRs. ADRs are defined as unintended responses to a • Off-label use of medications drug that poses harm or other negative patient outcomes.42 • Comparative evaluations of medications addressing Pharmacies should have a formal and comprehensive pro- treatment regimens, outcomes of therapy, and their gram to identify and report ADRs. Effective monitoring relative costs and evaluation of ADRs shall be focuses of such programs. • Behavioral and socioeconomic adherence issues in ADRs should be reported through FDA’s MedWatch pro- pediatric pharmacy care gram as a part of postmarketing data analysis in addition to • New and existing pharmacy drug distribution systems internal hospital voluntary reporting mechanisms to ensure and services for pediatric patients appropriate follow-up and evaluation. Examples of direct involvement include, but are not limited Antimicrobial Stewardship and Infection Prevention and to, the following: Control. There shall be policies and procedures to promote the optimal use of antimicrobial agents, reduce the transmis- • Serving as a member of an institutional review board. sion of infections, and educate health professionals, patients, • Maintenance, oversight, and dissemination of all and the public about these topics. Pharmacists should lead information on investigational drug studies, expanded antimicrobial stewardship and infection prevention and con- access programs, and comparative trials involving trol efforts through clinical endeavors focused on proper medications in the pediatric population. antimicrobial utilization and membership on relevant mul- • Maintenance, coordination, and oversight of policies tidisciplinary work groups and committees within the health and procedures involving investigational drug studies, system. Efforts should be made to have a specific pharmacist expanded access programs, and comparative trials with pediatric training devoted to antimicrobial stewardship involving medications in the pediatric population. and other infectious diseases programs that focus on the pe- • Primary or coinvestigator of studies or trials described diatric population. above. Pharmacists should monitor patients’ laboratory re- ports of microbial sensitivities or applicable diagnostic Conclusion markers and advise prescribers if microbial resistance is suspected, evaluate trends in microbial prescribing relative The unique challenges of the pediatric population require to changes in microbial resistance patterns, and assist in de- careful consideration for pharmacists and pharmacy depart- 498 Medication Therapy and Patient Care: Specific Practice Areas–Guidelines ments in hospitals and health systems. Pharmacists caring 15. American Society of Hospital Pharmacists. 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Johnson, Pharm.D., BCPS, BCPPS, FPAG; Julie Kasap, Pharm.D., The authors have declared no potential conflicts of interest. BCPPS; Susannah E. Koontz, Pharm.D., BCOP, FHOPA; Ken Kurek, Pharm.D.; Carlton K. K. Lee, Pharm.D., M.P.H., FASHP, At the time of writing, Dr. Pharm was affiliated with the Pew FPPAG; Nancy C. MacDonald, Pharm.D., BCPS; Shannon Manzi, Charitable Trust, Washington, DC. Pharm.D., FPPAG; Patrick McDonnell, Pharm.D., FASHP; Ju- lie Neuman, Pharm.D.; Penny Ngo, Pharm.D.; Barbara Petroff, Copyright © 2018, American Society of Health-System M.S., FASHP; James Ponto, M.S., BCNP, FASHP; Robert Poole, Pharmacists, Inc., and the Pediatric Pharmacy Advocacy Group. All Pharm.D., FPPAG, FCSHP, FASHP; James R. Rinehart, M.S., rights reserved. FASHP; LCDR Teisha A. Robertson, Pharm.D., M.B.A.; Colleen Smith, Pharm.D., BCPPS, FCCM; Christine Steffensen, Pharm.D., The bibliographic citation for this document is as follows: American M.A., BCPPS; James Stevenson, Pharm.D., FASHP; Sharon Ter- Society of Health-System Pharmacists. ASHP–PPAG guidelines nullo, Pharm.D., DABAT; Courtney Terry, Pharm.D., BCPS; Carol for providing pediatric pharmacy services in hospitals and health G. Vetterly, Pharm.D., BCPS, BCPPS; Jody Jacobson Wedret, systems. Am J Health-Syst Pharm. 2018; 75:1151–65. B.S.Pharm., FASHP, FCSHP; Wyn Wheeler, Pharm.D., BCPPS, FCCM; and Ed Wong, Pharm.D.