PHP 360 Exam 1

what is an ACO?

"ACOs consist of providers who are jointly held accountable for achieving measured quality improvement and reductions in the rate of spending growth. Our definition emphasizes that these costs and quality improvements must achieve overall, per capita improvements in quality and cost, and that ACOs should have at least limited accountability for achieving these improvements while caring for a defined population of patients." - Mark McClellan et al., "A national strategy to put accountable care into practice," Health Affairs 2010;29:982-990 -CMS requires that an ACO must provide primary care services if providing services for Medicare beneficiaries -part of Accountable Care Act (ACA) legislation; requires service to at least 5,000 Medicare patients for at least 3 years

value of pharmacist in ACO

"Pharmaceuticals are the most common medical intervention, and their potential for both help and harm is enormous. Ensuring that the American people get the most benefit from advances in pharmacology is a critical component of improving the national health care system" -IOM u On average, $16.70 saved for every $1 invested in clinical pharmacy services (review of 104 studies) Bussey HI. Blood, sweat, and tears: Wasted by Medicare's missed opportunities. Pharmacotherapy 2004;24:1655-58. u Benefit: cost ratio ranged from 1.7:1 - 17.0:1 (literature review) Schumock GT, Butler MG, Meek PD, Vermeulen LC, Arondekar BV, Bauman JL. 2002 Task Force on Economic Evaluation of clinical Pharmacy Services of the American College of Clinical Pharmacy. Evidence of the economic benefit of clinical pharmacy services: 1996-2000. Pharmacotherapy. 2003 Jan, 23(1):113-32. -Pharmacist led interventions with best documented and published outcomes? - Diabetes - HTN - Pain Management - Anticoagulation - Polypharmacy

pediatric / neonatal PK: DISTRIBUTION

- Body water composition - Body fat composition - Plasma protein binding • Free drug fraction (active) • Drug-drug, drug-substance interactions

pediatric / neonatal PK: excretion

- Dependent on cardiac output and renal blood flow - Glomerular filtration - Tubular secretion - Tubular reabsorption

IV admixture in pediatric hospitals

- Follow USP<797> guidelines. • Quality assurance • Beyond use dating - Knowledge of: • Pediatric fluid requirements and limits • Drug administration techniques and devices • Appropriate intramuscular injection volumes • Products containing benzyl alcohol - Standardize concentrations for continuous infusions. - Determine appropriateness of drug dilution concentrations. • Maximize concentrations for fluid-sensitive patients. • Minimize hyperosmolar solutions that may lead to vascular destruction. - Employ double check systems in pharmacy, especially for drugs with low therapeutic indexes, drugs deemed to be high risk, and look-alike, sound-alike drugs.

pediatric / neonatal PK: absorption

- GI tract • Acid production • Biliary function • Gastric emptying • Intestinal motility - Rectal - Percutaneous - Intramuscular

med distribution

- Manual Process - Daily patient medication profile generated - Pharmacy technicians fill patient specific bins on each unit - All room temperature medications stored together - Additional floor stock medications available - Pharmacist verifies contents of cart -Robot-Rx - Centralized drug distribution system - Automatedstorage,dispensing, return, restocking and crediting of unit-dose, bar-coded inpatient medications. - A robotic arm operates on vertical and horizontal rails and is programmed to retrieve meds and deposit them into pt-specific cassettes.

inpt med prep

- Medication repackaging - Unit dose preparation: - Solid medications - Liquid medications - Bar-coded products - Software allows ability to track lot numbers and expiration dates - Helpful during a drug recall - Intravenous medication preparation - Automatic compounding machines - Prevents external contamination - Ability for barcode verification - Utilized primarily for compounding TPN Robotics in IV prep -Automated robotic system designed to safely prepare hazardous medication and chemotherapy - Meets all USP 797 requirements - Negative pressure - ISO class 8 -controlled clean room environment - Automated waste management-partial vials are maintained using "hold" stations to minimize waste - Barcode scanning and image technology

unit dosing in pediatric hospitals

- More labor intensive for pediatrics • Greater staffing ratios • Greater technician to pharmacist ratios - System designed to • Minimize errors • Provide drugs to the patient care areas in ready-to-administer forms - Multi-dose containers and stock medications should be avoided - Extemporaneous preparation service (compounding) • Follow USP <795> guidelines - Master formulation and batch records

pediatric / neonatal PK: metabolism

- Phase 1 metabolism • Low and variable onsets • CYP3A7→CYP3A4 • Polymorphisms - CYP2D6 • Multiple isoforms - CYP2C9, CYP2C19 - Phase 2 metabolism • Multiple isoforms - UGTs, SULTs • Excessive activity

unit dose dispenser & Bio ID scanner

- Unit dose dispenser - Eliminatesneedtocyclecount controlled substances at the end of each shift - Minimizes discrepancies - Bio ID Scanner - Uses four points from the fingertip and converts them to a numeric algorithm - Provides positive identification of user - Increases security by eliminating passwords

meds safe prescribing

-"Near miss" dosing error reported in Newport ED -Reviewed with the LifeChart and pediatric providers at Hasbro Children's Hospital -Modification to "pediatric context" rules in system implemented - If patient less than 18 years but ≥50 KG —provider will see "adult- based" dose buttons and frequencies

antimicrobial stewardship

-20-50% of all AB's prescribed in US acute care hospitals are inappropriate or unnecessary "Coordinated interventions designed to improve and measure the appropriate use of antimicrobials by promoting the selection of optimal antimicrobial drug regimen, dose, duration of therapy, and route of administration" Goals: -Improve patient safety and outcomes -Curb resistance -Reduce AE -Promote cost effectiveness

future direction of med ordering

-Always looking for areas of improvement! - CPOE/Lab/Pharmacyintegration. - Improve workflow. - Improves availability of data and user friendliness. - Improved medication reconciliation. - Billing - Improves capture of charges - Easy review - Drug library management: - Improves drug ordering with default route/dosage/frequency - Formulary management and drug substitution (NF/shortage) Medication administration: - Flow sheet integration - Infusion info to RNs. - Other...

metronidazole clinical pearls

-Anaerobes -Cumulative neurotoxicity

macrolides clinical pearls

-Atypical Coverage -QT prolongation -Not preferred in cardiac patients

Tetracycline clinical pearls

-Atypical coverage -CA-MRSA

key features of med ordering

-Automated Safeguards -Mix-Max dosing. -Duplicate therapy -Drug-Drug interactions - Drug-Lab interactions - Drug allergies - Integration with CPOE - Immediate access to all pertinent data from a single processing screen Pharmacy/Laboratory System Interface - Drug/Lab Rules - Automatically display a given lab when a certain medication is ordered - Example: Metformin & SCr Reports: Ability to use "rule-based" logic to generate reports -IV to PO - Age based; Geriatrics, pediatrics - Serum creatinine > 2mg/dL - Drug levels e.g Vancomycin, Gentamicin. - Multiple vendors offer a pharmacy application (i.e. Siemens, Epic, MediTech, Misys, QuadraMed)

clinda clinical pearls

-Black box warning for c. diff -CA-MRSA -DOC for necrotizing fasciitis

antibiogram

-Combines C&S data from individual pts at a particular institution to provide susceptibility patterns -Can be used to guide empiric therapy -Used to monitor resistance trends over time

drawbacks of tech systems

-Cost of hardware and software systems -Cost of training staff, Time required for training and adjusting to new technology. -Strategic barriers with new tech; unclear vision or unrealistic expectations. -Cultural barriers -informatics barriers; different skills and training required -Technical Barriers e.g new types of errors and safety concerns, downtime procedures -Privacy and security barriers

cephalosporins clinical pearls

-Cross reactivity with penicillin ~5% -Cefepime, ceftazadime: pseudomonas coverage

med error stats and numbers

-Deadly -44,000-98,000 deaths per year. -Expensive -$29 billion dollars in total costs. -Common -5% of hospital patients suffer a medication error. -30% of medication errors will cause harm -Medication technology impact: -Reduction of errors by 50-80%

carbapenems clinical pearls

-Drug of choice for ESBL -Anaerobic activity -Ertapenem: only carbapenem with no pseudomonas coverage

safe prescribing

-Grouping of insulin by time action profile to reduce risk of selecting incorrect product -"Prechecked" orders for dextrose with clear guidelines for use in the order

med safety highlights

-Improving safety of insulin prescribing -Improving safety of heparin prescribing and admin -Improving safe use of meds in the elderly -Limiting automated dispensing overrides -Medication Safety Alerts -Nationwide reporting of med safety issues -Providing feedback on medication safety improvements —Thank You for Reporting

FQ's clinical pearls

-Inc resistance rates -QT prolongation -Moxifloxacin: NOT for UTI -Levo, Moxi= "resp. quinolones"

med admin

-Manual Process -Nurse reviews MAR -Retrieves scheduled medication(s) from patient bin -Prepares medication -Verifies patient name and date-of-birth -Administers medication Barcode Medication Administration (BCMA) -Computerized system or eMAR that integrates in "real-time" patient records, med admin data, and pharmacy orders -Medication profile populates directly from the Pharmacy System -Automatic charting of medication administration when drug scanned

med inventory

-Manual process - Paper-based - Pharmacy personnel obtain medication label, restock/refill report - Retrieve from stockroom - Automated process - Integration with ADCs allow "real-time" polling of medication inventory levels - Guided light technology - Barcode scanning - Several vendors offer automated inventory systems (e.g. McKesson, Swisslog)

med overrides

-Medication override rate at all-time low (0.47%) -Annual review of list for appropriateness ̈Patient population ̈Oral vs. parenteral choices ̈High Risk -Continued follow-up monitoring ̈By unit ̈By med

where are the most ACO's geographically?

-NE, East Coast, FL, some in TX/CA, very few in Western states, some in midwest

narrowing therapy from C&S

-Organism is identified and tested against different conc of AB's to determine the MIC -MIC: lowest drug conc that prevents visible growth -Specific to each AB and organism; should NOT be compared among different AB -Breakpoint: MIC at which an organism is deemed susceptible or resistant to an AB

smart pumps

-Predefined drug conc and customized libraries -Upper dosing limit (hard and soft) based on med or patient specific -Significantly reduced infusion errors -Easy to use Smart pump reports: -Pump utilization -Assess drug libraries available -Evaluate drug limits (soft, hard lower and upper limits) -Capture med admin errors and prevent future errors.

safe med use in the elderly

-Removal of zolpidem (Ambien) from order sets -Removal of infrequently used Beers Criteria meds from formulary -Disopyramide -selected Antihistamines -Reducing use of glyBURIDE in the elderly -Increased risk of hypoglycemia in elderly -System Alerts and Creation of Best Practice Alerts (BPAs)

RIPCPC

-Rhode Island Primary Care Physicians Corporation -Independent practice association (IPA) of primary care physicians located throughout the state of RI -Formed in 1994 -Over 150 family practice, internal medicine and pediatric physicians - 5 Employed pharmacists -Benefits of group contracting, shared staffing resources, networking Structure of RIPCPC - Board of Directors, Medical Directors, Committees -Requirements for active membership -Participation in monthly physician education meetings -Engage in quality patient outcomes u Commitment to progression to PCMH accreditation and use of electronic medical records

sulfonamides clinical pearls

-Risk of hyperkalemia -CA-MRSA

C.diff

-Spore forming bacterium that causes inflammation of the colon (colitis) -Use of AB's eliminates "healthy bacteria" in the GI tract allowing overgrowth of c. diff -PPI's inc risk of c. diff -Antimotility agents should NOT be used in treatment 1. mild-mod tx: flagyl 500mg PO TID x 10-14d -2nd infection: same as 1st infection tx if still mild -3rd infection: vancomycin taper / pulse therapy: 125mg PO QID x 10-14d, then BID x 7d, then QD x 7d, then 125mg Q2-3d / week for weeks 2-8 2. severe infection: vanco 125mg PO QID x 10-14d -2nd infection: same as 1st if still severe -3rd infection: vancomycin pulse taper 3. severe / complicated dz: vanco 500mg PO QID + flagyl 500mg IV q8h -2nd infection: repeat -3rd infection: vancomycin pulse / taper

daptomycin clinical pearls

-VRE, MRSA -NOT used for pneumonia: inactivated by lung surfactant

linezolid clinical pearls

-VRE, MRSA -Thrombocytopenia -Risk of serotonin syndrome -Risk of complications inc with long term use (>2 weeks)

pregnancy and lactation drug info

-drugs in pregnancy and lactation -medication and mothers' milk

pediatric / neonatal med references

-harriet lane -neonatalogy -neofax -pediatric and neonatal dosage handbook -neonatal meds and nutrition

how long should anticoagulation be held after alteplase is used?

-hold 24-48h, then restart

factors that influence ACO

-organizational infrastructure -focus on quality of care -embrace innovation -insurer collab. -pop. size -pop. composition

extemporaneous formulations references for pediatrics

-trissel's -extemporaneous formulations -pediatric injectable drugs -handbook on injectable drugs

Partner roles in ACO models

1. PCP • Provide quality preventative services • Facilitate quality chronic disease management centered on the individual patient needs • Coordinate need for additional services - specialists, etc. 2. Hospital • Coordinate patient care transition back to primary care provider • Focus on prevention of re- admissions and complications from hospital services 3. Insurer • Payment model that supports all components in ACO for optimum patient outcomes • Source of data for trending and tracking patient utilization of healthcare services 4. Specialists • Provide quality specialty services • Coordinate transition back to PCP

vancomycin dosing:

1. if TBW< IBW: Use TBW 2. if TBW =IBW: Use IBW 3. if TBW> 25% of IBW: Use ABW 4. ABW: 0.4 (TBW-IBW) +IBW

med safety closed loop

1. prescribing: -Clinical Decision Support -e-order sets 2. order review: -clinical decision report -e- CPOE interface -lab results -alerts 3. Dispensing: -interface w/ pharmacy -restricted override -guiding light tech -barcode ver. -automated dispensing 4. Transcription: -med admin profile pop. -automatic charting of admin when drug scanned 5. Admin: -right pt -right drug -right dose -right form -right time -right rate

clinical pharm services in ACO model

1.Primary Care • Medication therapy management services • Chronic disease management clinics • Medication reconciliation at care transitions 2. Hospital • Med rec at d/c • Anti-coag outpt clinic • Bedside med counseling • Meds to bed delivery services 3. Insurer • MTM services • Contracting that includes funding for additional pharmacist resources for hospitals/PCP

what is a drug?

A substance intended for the... Diagnosis, Cure, mitigation, treatment, and Prevention... of disease.

JCO

Accredits and certifies hospitals Every 3-year cycle CMS: Centers for Medicare and Medicaid Services ¡ Validation survey can occur within 45 days Accreditation is important: assures patients that hospital care meets industry standards why should i care? Standards -Medication Management -Information Management -Provision of Care -Infection control -Life safety -Emergency Management, etc. National Patient Safety Goals -Use 2 identifiers -Label all meds on and off sterile field -Maintain and communicate accurate med info -Reduce harm from anticoagulants -Prevent hospital-acquired infections, etc.

med ordering in closed safety loop

Advantages -Eliminates cumbersome process of faxing orders to pharmacy. -Turnaround time reduction e.g. Fax, order sets. -Prescriber is easily identifiable if follow up is needed. -Cost reduction i.e. formulary. -Improved Safety -Elimination of illegible handwriting, interpretation errors and limiting transcription errors. - Complete orders: drug, dose, route, and frequency. - Elimination of Do Not Use abbreviations. -DUR; drug specific messages/alerts, Interactions, duplications, allergy, labs. -Pharmacy System -Computerized system that creates a pt specific medication profile including: -Allergy information -Patient demographics -Primary diagnosis -Labs

automated dispensing cabs

Automated Dispensing Cabinets (ADC) -Computerized drug storage devices or cabinets -Allow medications to be stored near point of care (i.e. inpatient care units, emergency department, operating room, etc.) -Interface directly with Pharmacy Information System - Patient specific medication profile - Allows nurse to access medication almost immediately after prescribed - Several vendors offer ADCs (e.g. Omnicell, Pyxis, McKesson) - Used by 86.7% of hospitals to dispense medications BENEFITS - Dec med delivery turn around time - first dose availability. - Limits drug diversion by limiting access - Nacrotic locked lids, user sign on l Tracking of inventory - Recalled, expired meds - Decreasing inventory cost - Formulary, overstock - Decreases dispensing errors - Decreases PRN medications over-administration - frees the pharmacist to focus on direct patient care Key features - Guiding light technology - Continuous refrigerator temperature monitoring l Secure medication storage - tamper-proof locked drawers - Drug Information - web browser - Comprehensive drug information database § Routinely updated - Provides up-to-date drug information - Saves time by eliminating searches for reference books

advantages of BCMA

BCMA Advantages -Ensures the 5 pt rights for med admin -Right patient -Right drug -Right dose -Right route -Right time -Ability to perform immediate clinical med checking e.g med messages and warnings. -Inventory control -Billing accuracy -Retrospective analysis of data e.g percentage of late admin, errors of omission.

review of pneumonia guidelines

CAP: -Resp FQ OR -B-Lactam PLUS macrolide (or doxy) -Rec duration: 5d HAP: -AB with activity against staph aureus; including MRSA if patient is at risk -AB with activity against pseudomonas and other gram negative bacilli -Rec duration: 7d

med error

Definition of a medication error: -A med error is any preventable event that may cause or lead to inappropriate med use or patient harm while the medication is in the control of the health care professional, patient or consumer. -Can happen during any step: -prescribing; communication; labeling, packaging; compounding; dispensing; distribution; administration; education and monitoring.

HMO vs. ACO

HMO: -insurer managed org. -preferred limited network of physicians /hospitals -focus on total cost of case -fee for service reimbursement model ACO: -any healthcare org. can be the manager -primary care and preventative care included -focus on qual. and cost of care -mixed reimbursement models

IBW

Males: 50 + 23 (inches >5 feet) 142 101 15 4.6 28 0.64 Females: 45.5 + 2.3 (inches >5 feet)

neonatology

Medical specialty concerned with the care, development and diseases of the newborn infant.

Integra

South County Health, RIPCPC, Care NE Medicare Blue Cross Blue Shield of Rhode Island Medicare Advantage Blue Cross & Blue Shield of Rhode Island UnitedHealthcare Community Plan of RI Neighborhood Health Plan Managed Medicaid

PCN clin pearls

Zosyn: -Pseudomonas coverage

vancomycin loading dose vs. maintenance for bacteremia

loading: 25-35mg/kg maintenance: 15-20mg/kg

NICU

• 80 beds, single room design on 2 floors • 1200+ admissions per year • including ~200 newborn transports • Average daily census of 66 patients • Average length of stay is 20 days • range, 1-200+ days

Acute coronary syndrome

• ACS encompasses the clinical conditions NSTEMI, STEMI, and unstable angina (UA) • Pts typ present with chest pain that persists for >10 min, dyspnea, diaphoresis, syncope, and/or palpitations • Pain can radiate to the arms, back, neck, and jaw • All patients presenting with acute chest pain should have a 12 lead ECG done • Additional test can include cardiac troponin, creatine kinase, and BNP

pediatric drug info

• Access to up-to-date, objective drug information unique to the pediatric population. • Standardized and available in areas where decisions are made regarding drug therapy (point of care). • References (electronic and/or text) should include: - Pediatric and neonatal medical manuals - Pediatric and neonatal drug dosing information - Extemporaneous formulations - Drug compatibilities and stability - Toxicology/Poison control - Drug effects in pregnancy and lactation • Access to literature supporting the use of drugs for unlabeled uses in pediatric patients. • Pharmacists should provide other health care professionals with information on: - New and investigational drugs - Adverse effects and contraindications to drug therapy - Dosage computations - Pharmacokinetics - Drug interactions

challenges in pharma reg

• Address the opiate crisis ▫ Increasing cost of naloxone may limit consumer access ▫ Increasing need for opioid stewardship in the health system ▫ Pharmacists may play a role in addiction management • Cancer survivorship will be a chronic disease ▫ Will require ongoing cancer care for at least 10 years Medication costs will skyrocket, current specialty pharmacy model will fragment care Tenuous status of Medicare/Medicaid • Drug shortages • 340B program faces 22% cuts in program discounts for disproportionate share hospitals

ischemic stroke

• Alteplase (Activase) • A recombinant tissue plasminogen activator that binds to fibrin in a thrombus and converts plasminogen to plasmin resulting in fibrinolysis • Only fibrinolytic used in the tx of acute ischemic stroke • FDA labeled for tx within 3h of symptom onset • Treatment may be extended to within 4.5 hours in select patients based on guideline recommendations • Door-to-needle-time should occur within 60min • Dosing: • 0.9mg/kg (max 90mg) • 10% should be given as a bolus over 1 min then the remaining 90% should be infused over 60 min

multidisciplinary approach to NICU

• Attending physicians • Fellows • Residents • Nurse practitioners • Pharmacists and Technicians • Nurses • Respiratory therapists • Occupational therapists • Nutritionists • Lactation specialists • Clinical social workers • Care management nurses

leadership in pharm

• Capable leaders of the pharmacy enterprise are scarce. • Leaders with vision can facilitate transition to an ambulatory based care provision, population health initiatives, development of collaborative practice agreements, and unlock the potential of pharmacists and technicians • Given the federal logjam, focus influence on state Board of Pharmacy, state professional associations to broaden scope of practice and expanded use of technicians

opportunities in data and tech

• Clinicians will document in discreet fields in the EHR to support data queries and analysis ▫ Will need pre-defined quality metrics for quality reporting and refining care protocols ▫ Advanced analytic will be employed to guide therapeutic decision making ▫ Data will be used to measure and compare clinician performance • Patient EHR portals, reminder systems, wearable devices will generate health data for use in real time decision making ▫ Insurance plans will likely provide incentives based on wearables • Complementary artificial intelligence can improve outcomes in a value based system • Use of ultra large data aggregates may be able to generate predicative models to improve care

drug use eval. for pediatrics

• Drug-use evaluation should be directed at drugs: - With a low therapeutic index - That are responsible for serious medication errors - With a high frequency of preventable adverse drug reactions - With cost-related issues • Antimicrobial stewardship - Up to 50% of antimicrobial use in the hospital setting is inappropriate. - National efforts have brought this issue to the forefront.

regulatory compliance

• Federal regulations that affect pharmacy practice, which emanate from several cabinet-level departments, total more than 46 different sets of requirements ▫ Not inclusive of state regulations, which may be in conflict ▫ High level of concern among pharmacy practice leaders about the burden of compliance with the growing array of complex legal requirements Timespentbypharmacypersonnelonregulatorycompliancewill increase by at least 25% in the next 5 years ▫ Centralized compliance units may jeopardize pharmacy-specific issues, failing to receive appropriate attention among the health system's many compliance priorities

formulary considerations for pediatrics

• Formulary and therapeutic substitution recommendations should take into consideration the pediatric patient. - Unilateral decisions may put pediatric patients at risk. - Exceptions may be necessary for children of certain ages. • A pediatric pharmacist should sit on P&T to address needs of the population.

elements of inpt services at W&I

• General pharmaceutical care principles. • Appropriate dosage standardization for both oral and parenteral drug distribution systems. • Utilization of appropriate commercial product if available. • If possible, 24-hour pharmaceutical services. • At least one clinical pharmacist should be available to make rounds with the health care teams. • Minimization or prevention of pain and discomfort assx with inj. meds.

challenges in data and tech

• Information systems have not achieved improvements in safety and quality that are needed ▫ Lack of an overall, purposeful strategy to advance patient care ▫ Need systems to enable direct patient care by pharmacists, improve clinical decision support, forestall medication problems or errors • EHR's create safety concerns; must be monitored • Electronic systems across the organization must be secure from unauthorized access, are properly backed up, and have appropriately tested downtime processes • Most health systems will face an EHR redesign effort ▫ For pharmacy, this means standardization of medication ordering, distribution, monitoring, documentation, and related processes. ▫ Will be designed to enhance management of medications across continuum of care

challenges in providing pediatric pharmaceutical care

• Lack of published info on the therapeutic uses (efficacy) and monitoring (safety) of drugs. • Lack of appropriate commercially avail. dosage forms and conc. of many drugs. • The need to develop innovative ways of ensuring that the pt receives the drug in a manner that allows for the intended therapeutic effect to be realized. • Weight-based dosing. • Complex calcs, especially when dilutions are required. • Constant changes in age-related differences in PK and PD parameters. • Patients' limited capacity to communicate regarding symptoms, response to therapy, and possible adverse drug events (ADEs).

longterm mgmt for ACS

• Long term management • Everyone drives a SAAAB home!!! • Statin • Patients <75 years old, use high-intensity statin therapy • Patients >75 years old, use moderate-intensity therapy • Aspirin • 81mg Indefinitely • Antiplatelet (P2Y12) • ACE-Inhibitor • Beta Blocker -metoprolol succ pref

CHF exacerbation mgmt

• Mainstay tx includes IV loop diuretics, vasodilators, and/or inotropes • Typically IV loop diuretics are dose 2-2.5x the patients home dose as a general point of reference • Fluid restriction is rec between 1.5-2L/day • Na restriction is rec for patients with acute or chronic HF. -While the evidence to suggest specific Na restriction amounts are conflicting it is generally accepted as <2g/day

therapeutic drug monitoring in pediatrics

• Minimal expectation for clinical pharmacy services. - Perform on rounds or at least by consult - Desired and undesired effects should be documented • Person performing TDM must have an extensive understanding of the age-related differences in dosage when recommending or reviewing drug therapy. - Knowledge of age-related differences in absorption, distribution, metabolism, and elimination.

opportunities in pharma reg

• Multi-stakeholder efforts to pass provider status for pharmacists for Medicare Part B • Compliance with USP 797 regulations will require a pharmacist who specializes in sterile compounding to oversee the quality and safety of this activity • Organizational commitment to stewardship ▫ One or more pharmacists will be dedicated to appropriate control and use of pain medications, especially opioids Interprofessional collaboration (involving executive leadership, pharmacy, anesthesiology, nursing, oncology, and palliative care) is essential for preventing misuse and diversion of controlled substances ▫ Hospitals will have at least one pharmacist position devoted to inpatient and outpatient antimicrobial stewardship Progress has been made in inpatient antimicrobial stewardship, but greater effort and innovation is needed for outpatient antimicrobial stewardship

acute mgmt for ACS

• NSTEMI/UA: MONA-GAP-BA(SAAAB) +/- PCI • STEMI: MONA-GAP-BA(SAAAB) + PCI or fibrinolytic Acute management • Typ provided during EMS transport or when first arriving to the hospital • Morphine • Oxygen • NTG • ASA Prior to PCI • Glycoprotein IIb/IIIa receptor antagonists • Anticoagulants • P2Y12 Inhibitors

opportunities in drug development and therapeutics

• New molecular entities expected to double by 2022 ▫ The pharmacist will serve as precision medicine experts ▫ FDA regulatory changes will make it easier to gain approval • NOACs will replace at least 25% of warfarin use ▫ Clinical use will require increased monitoring by pharmacists • Review biosimilars for formulary inclusion • Antimicrobial resistance will continue to rise and new drugs to combat antimicrobial resistance will force formulary decisions ▫ Will need to evaluate utilization trends, and (when indicated) prescribing remediation, recognizing that near-term development of new antimicrobials may not solve the problems associated with resistance

Women & Infants hospital

• Non-profit specialty teaching hospital located in Providence, RI serving the women and infants of RI, Southeastern MA and Eastern CT. • Specialties - Obstetrics - Gynecology - Oncology - Neonatology - Assisted Reproductive Technologies (ART)

orientation / training for pediatric pharmacy

• Orientation, training, and staff development programs should be mandatory for all personnel. • All personnel should complete a standard competency exam annually to be deemed competent in pediatric pharmacy practice. - General standardized age-related competency exam - Facility specific • Policies, guidelines and protocols • Medical emergency training - BLS, PALS, NRP or NALS Topics emphasized - Dosage calcs • Dosing by age vs. weight vs. body surface area - Dosage-form selection appropriate for age and condition • Problematic drug additives/ preservatives - PK/ dynamic age-related changes - Dz-specific conditions affecting drug choice or admin - Pharmaco-genomics - Fluid and nutrition requirements - Specialized drug preparation and administration techniques - IV drug administration devices • Techniques and limitations - Appropriate references/resources for pediatric drug information - Sensitivity to the nature, frequency, and severity of medication- related errors in the pediatric pop.

pediatric research

• Pediatric patients have long been recognized as "therapeutic orphans" because of the relative absence of therapeutic trials. • Reasons are numerous - Ethical issues - Potential adverse publicity - Possible litigation - Methodological hurdles - Inability to justify such studied for economic reasons • Best Pharmaceuticals for Children Act of 2007 (BCPA) • Pediatric research is needed on: - Safety and efficacy - PK and PD of new medications - Pharmacogenomics and prediction of ADEs - Safety, stability and efficacy of extemporaneously compounded sterile and nonsterile drug products - Safety and efficacy of administration techniques • Pediatric research is warranted because of: - The paucity of pediatric drug information - The impact of new drug delivery systems - The expansion of adult diseases into the pediatric population - The expanded application of new and established therapeutic agents • The pediatric pharmacist: - Can be directly involved in collaboration with other health care providers in conducting pediatric research. - Can serve as a member of an investigational review board. - Oversee pediatric pharmacy investigational drug services. - Administrate policies and procedures involving investigational drug studies and comparative trials involving medications in the pediatric population.

adverse drug reactions in pediatrics

• Pediatric patients may have similar types of adverse drug reactions that adults have, BUT they - May occur at a higher frequency - May have greater or lesser intensity - May be harder to recognize • Lack of literature on newly introduced drugs makes monitoring imperative when introduced to the pediatric population. • Comprehensive ADR monitoring and reporting programs are important in reducing the occurrence in pediatric patients. - FDA's Medwatch program

pediatric patient and caregiver education

• Pharmacists should counsel and educate patients and caregivers about their medication based upon their education level and general health literacy. • Every effort should be made to include the pediatric patient (age appropriate) in the education session being mindful of: - Language - Length of educational session - Barriers to communication • Provide written educational materials in appropriate language. Specific education for pediatric patients: - Which drug products for which crushing, chewing, dividing, or diluting should be avoided. - Compounding, diluting techniques, measuring (mL not teaspoon), and administration instructions. - Administration techniques should be demonstrated for all products including, ophthalmics, otics, inhalers, and injectables. - Prevention of accidental ingestion.

challenges in pharm leadership

• Pharmacy curricula do not emphasize management, operational, policy or financial issues • Need for pharmacy contingency planning related to the potential closure of inpatient units ▫ Increased use of "observation units," where patients are put in a hold status pending diagnosis and determination of need for admission Insurance coverage is variable, not considered "inpatient", therefore not covered by Medicare • Strategic plans must be crafted with an awareness of the uncertainty associated with the health care environment • Prepare for significant reductions in revenue by good stewardship of organizational resources • Remain focused on the commitment to the continuum of care and population health

general principles of pediatric pharmacy practice

• Pharmacy services should be under the direction of a competent pediatric pharmacist with adequate training • Personnel - Pediatric trained pharmacists and techs - Clinical specialists in specialized, high-risk units - (eg. NICU, PICU, Heme-Onc, OR, ED) • Postgrad training in pediatrics or extensive work experience • BPS Certification (BCPPS): first exam Fall 2015 - 798 certified (757 in the U.S.) - Annual competencies • Physical facilities - Satellite pharmacy services in patient unit • Equipment, including computer software, necessary to meet pediatric pharmaceutical care needs - Supports CPOE, CDS, eMAR, BCMA, Smart Pumps, E- prescribing - Accommodate multiple dosing strategies • Age based dosing, weight-based dosing, body surface area dosing • Resources to compound and test alternative doses and dosage forms

PT work force opportunities

• Professionalization of pharmacy technician workforce • Formal education and licensure, opportunities for supervisory, specialty or advanced roles (which may require BS degree) Medication history taking, tech-check-tech, medication teaching, etc.) • Pharmacists will practice in advanced roles that allow physicians to care for more patients ▫ Shortage of primary-care physicians ▫ Federal legislation to grant provider status to pharmacists ▫ Pharmacists have collaborative practice agreements with MDs ▫ Privileges for pharmacists with expanded patient care roles Pharmacists will routinely have prescribing authority in health systems • Pharmacy team based approach Advanced trained pharmacists as "team leaders" Supported by pharmacists with excellent clinical skills Formal responsibilities for technicians

uniquely neonatal dz

• Respiratory - Respiratory distress syndrome (RDS) - Apnea of prematurity (AOP) - Bronchopulmonary dysplasia (BPD) • Cardiac - Patent ductus arteriosus (PDA) - Persistent pulmonary hypertension of the newborn (PPHN) • ID - Congenital infections • Neurological - Intraventricular hemorrhage (IVH) - Neonatal abstinence syndrome (NAS) • GI - Necrotizing enterocolitis (NEC) • Ophthalmologic - Retinopathy of prematurity (ROP)

challenges in pharm staff

• Robotics will shift personnel needs ▫ When coupled with bar code technology, reduces medication distribution errors (no pharmacist verification) • Supply and demand issues in pharmacy practice ▫ Potential oversupply of pharmacists 21 states will increase graduates by 100% or more from 2001-2016 Has created need for high quality student rotations (IPPE, APPE) Must be integrated in pharmacy workload to promote productivity Potential 10% decline in salaries of entry level pharmacists ▫ Potential shortage of pharmacy technicians by 2020 Salaries of entry level techs expected to increase by 25% • Develop pharmacist privileging process to ensure competence for responsibilities ▫ Minimize "cognitive surplus" on the pharmacy team Shift responsibilities of all staff consistent with scope of practice

PK services in pediatrics

• Should ensure that the drug has been administered appropriately before samples are taken for the measurement of serum drug concentrations, for both oral and injectable drugs. • The frequency and timing of sampling should also be monitored to avoid excessive and traumatic sampling. • The collection and publication of accurate pharmacokinetic data on the pediatric population are encouraged.

challenges in pharma

• Specialty drug costs are anticipated to represent 50% of total commercially insured drug costs by 2018 ▫ Oncology drug costs will rise 7.5-10.5% annually through 2020 • Change from traditional bundled care and fee for service model to global payment model ▫ Reduce the cost of high cost disease states (oncology, MS, RA...and outpatient infusion centers) ▫ Reduce complementary service cost (radiology, lab, etc.) • Changes to 340B Drug Pricing Program ▫ Many will experience significant decline in savings ▫ More restrictive patient and prescription eligibility

challenges in drug development

• Specialty drugs, including oncology drugs, will cause economic concerns for providers and payers ▫ Therapies will be likely driven by treatment pathways (many from the payer based on institutional agreements) ▫ Implement best practice (order set development) and track pathway compliance WillpresentissuesfortheEMR Pharmacist managed service may improve adherence and provide symptom management • Use of specialty medications to treat chronic diseases will increase by 50% in 5 years ▫ Crohn's disease, multiple sclerosis, rheumatoid arthritis, cancer, hypercholesterolemia

pediatric med errors

• System for the recognition, documentation, and prevention of medication errors in pediatric population is essential. • Pharmacist participation in quality-improvement committees is important in minimizing medication errors. • Develop and enforce policies and procedures for minimizing medication errors. • Recognize pediatric patient vulnerability to errors caused by mistakes in calculations. • Recognize that some commercially available drug strengths can be potentially toxic to pediatric patients. • Recognize potential for errors during times of drug product shortages. • Refer to guidelines from: - Institute for Safe Medication Practices - Pediatric Pharmacy Advocacy Group

CHF

• Tx's that dec mortality (rec for all pts who do not have contra) • ACE or ARBs • Beta Blocker • Aldosterone receptor antagonist • Angiotensin receptor and neprilysin inhibitor • Hydralazine and nitrates • What patient pop? -african american Tx that improve sx of HF: • Loop diuretics • Digoxin • Ivabradine

challenges in pop. health mgmt

• Will result in scrutiny of staffing (redistribution vs layoff) • Develop electronic communications tools ▫ Patient education, health related reminders, encourage compliance and positive behavioral change • Improve post-acute care ▫ Quality of skilled nursing facilities, home care, etc. ▫ Utilize accurate, complete med reconciliation (transitions of care) ▫ Improve end-of life care (25% of all Medicare spending is spent on beneficiaries age 65 and older) • Integrate behavioral health ▫ Increase focus on management of mental health conditions • Develop pharmacy expertise in risk-sharing/ savings- sharing contracting (i.e. ACOs) ▫ Give special attention to strict formulary management

new opportunities in pharma

• traditionally focuses on cost containment ▫ Find novel ways to manage supply chain ▫ Demonstrate value by improving pt outcomes Strong financial incentives to keep pts healthy Embrace amb care Respond to public health challenges • Reduce variability in care (best practices) • Health systems will develop their own pharmacy benefit management services (PBMs) • Integrate value into formulary decision-making process by use of metrics ▫ number needed to treat to achieve outcomes, cost per quality adjusted life-year, cost per year of life gained, and incremental cost- effectiveness ratio

population health management

▫ Efforts of health systems to improve the health status of the population of patients they serve ▫ Reduce the cost of caring for the population they serve ▫ Providers will need discipline in deploying evidence - based strategies for managing utilization of diagnostics, procedures, and treatments and in preventing avoidable hospital readmissions Will require effective medication management • Prioritize programs aimed at achieving the highest quality at the lowest cost for specific patient populations Pharmacists will participate in wellness evaluation based on patient acuity/high risk ▫ MTM, BP checks, refill authorization... Focus on opioid abuse, drug diversion