Considerations for Sterile Compounding of Parenteral Products for Pediatric Use: Part 2 PharMEDium Lunch and Learn Series LUNCH AND LEARN

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1 LUNCH AND LEARN Considerations for Sterile Compounding of Parenteral Products for Pediatric Use: Part 2 November 10, 2017 Featured Speaker: Kirsten H. Ohler, PharmD, BCPS, BCPPS Neonatal / Pediatric Clinical Pharmacist Clinical Associate Professor, Pharmacy Practice Program Director, PGY2 Pediatric Pharmacy Residency University of Illinois at Chicago College of Pharmacy CE Activity Information & Accreditation (Pharmacist and Tech CE) 1.0 contact hour Funding: This activity is self funded through PharMEDium. It is the policy of to ensure balance, independence, objectivity and scientific rigor in all of its continuing education activities. Faculty must disclose to participants the existence of any significant financial interest or any other relationship with the manufacturer of any commercial product(s) discussed in an educational presentation. Dr. Ohler has no relevant commercial and/or financial relationships to disclose

2 Online Evaluation, Self-Assessment and CE Credit Submission of an online self assessment and evaluation is the only way to obtain CE credit for this webinar Go to Print your CE Statement online Live CE Deadline: December 8, 2017 CPE Monitor CE information automatically uploaded to NABP/CPE Monitor upon completion of the self assessment and evaluation (user must complete the claim credit step) Attendance Code Code will be provided at the end of today s activity Attendance Code not needed for On Demand 3 Ask a Question Submit your questions to your site manager. Questions will be answered at the end of the presentation. Your question...? 4 2

3 Resources Visit to access: Handouts Activity information Upcoming live webinar dates Links to receive CE credit 5 Considerations for Sterile Compounding of Parenteral Products for Pediatric Use: Part 2 Kirsten H. Ohler, PharmD, BCPS, BCPPS Clinical Associate Professor, Pharmacy Practice Clinical Pharmacy Specialist, NICU University of Illinois at Chicago 6 3

4 Disclosure The speaker, Kirsten H. Ohler, has no actual or potential conflicts of interest related to the information included in this presentation. The practice of off label medication use in pediatric patients will be discussed. 7 Objectives At the conclusion of Part 2, participants will be able to: 1. Identify considerations in drug formulation and drug delivery processes specific to the pediatric population. 2. Discuss medication safety issues specific to the pediatric population and potential methods to address them. 3. Describe the role a compounding pharmacy team can have in the care of pediatric patients

5 Drug Delivery Process Considerations Availability of a pediatric friendly formulation Need for multiple concentrations Need to make dilutions for measurable volumes Availability of appropriate drug delivery device Measurable rates Pediatric specific safety features Impact of dead space in syringe Impact of priming volume in tubing In line filters may adsorb drugs Risk of catheter occlusion 9 Considerations Drug Delivery Process Methods to manage solution overfill Simple admixture may be used if entire bag to be infused to single patient Withdrawal drug volume may be used if volume of medication to be added is large Withdrawal drug & overfill volume may be used if volume of medication to be added is large Empty container may be used when final concentration of drug must be precise Must have defined process with clear labeling

6 Drug Delivery Process Methods of intravenous administration IV push (IVP) Check compatibility Physiologic effects of rapid administration Example: Sodium bicarbonate & intraventricular hemorrhage Dead space Area between the syringe hub and needle» ~0.05mL for a 1mL syringe Example: Digoxin 100 mcg/ml» 0.5kg x 5 mcg/kg/day = 2.5 mcg/day = 1.25 mcg every 12 hr» 1.25 mcg = ml using 100 mcg/ml» 1.25 mcg = ml using 10 mcg/ml dilution 0.05 ml dead space = 40% increase in volume/dose 11 Drug Delivery Process Methods of intravenous administration IV piggyback (IVPB) / intermittent infusion Check compatibility with fluids and other drugs Fluid considerations: Mini bag vs. syringe Typical mini bag volume ml Example: 0.5 kg, total daily fluid requirement = 120 ml/kg/day = 60 ml/day including TPN, feedings, medications Priming volume of tubing

7 Drug Delivery Process Methods of intravenous administration Continuous IV infusion Check compatibility with fluids and other drugs Variability in dosing units (e.g., ml/hr, mcg/kg/hr, mg/hr) Measurable rates Example: Dopamine 0.55 kg x 5 mcg/kg/min = 0.1 ml/hr using 1600 mcg/ml 0.55 kg x 5 mcg/kg/min = 0.2 ml/hr using 800 mcg/ml 0.55 kg x 1 mcg/kg/min = 0.04 ml/hr using 800 mcg/ml Considerations for priming tubing 13 Drug Delivery Devices Buretrol Holding chamber between IV bag and infusion pump Safety mechanism to prevent accidental large fluid bolus Medications can be added to chamber Low IV flow rate affects drug delivery Not routinely used

8 Drug Delivery Devices Syringe Pump 15 Drug Delivery Devices Syringe Pump May be used for intermittent doses or continuous infusion Considerations Minimum / Maximum syringe sizes Minimum rate Usually 0.1 ml/hr Minimum rate change Usually at least 2 decimal places (e.g., 0.01 ml/hr) Microbore tubing Typically small priming volume (~1 ml) May not have smart pump features

9 Drug Delivery Devices Large Volume IV Pumps 17 Drug Delivery Devices Large Volume IV Pumps May be used for IVPB or continuous infusion Considerations Minimum rate Depends on pump, usually 0.1 ml/hr or 1 ml/hr Minimum rate change Usually only 1 decimal place (e.g., 0.1 ml/hr) Large bore tubing Typical priming volume: ml May not have smart pump features

10 Definition Medication Error Preventable event Result of system flaw or human error Occurs during ordering, preparation, administration Harm or potential harm does not have to be present Near miss Error caught before it reached the patient 19 Medication Error What s the Risk? Pediatric Medication Orders 15% Pediatric Medication Errors 31% Error No Error Harm/Death No Harm Crowley E, et al. Curr Ther Res

11 Inaccurate transcription Miscommunication Improper documentation Drug distribution system Knowledge deficit Calculation error Procedure/Protocol not followed Performance Deficit Medication Errors Computer entry error Lack of system safeguards 21 Why are Children at Higher Risk? Minimal information in the PharmD curriculum Developmental pharmacokinetics Off label medication use Metric confusion Grams vs. Kilograms vs. Pounds Prescott WA, et al. AJPE

12 Why are Children at Higher Risk? Weight based dosing mg/kg/dose vs. mg/kg/day mcg/kg/min vs. mcg/kg/hour Body weight vs. body surface area Adult dose 23 Why are Children at Higher Risk? Growth / weight gain necessitates dose recalculations Lack of dose adjustment can result in subtherapeutic effect Need for multiple concentrations / lack of standardized concentrations Less physiologic reserve than adults

13 Methods for Decreasing Errors In general Avoid abbreviations Drug names (e.g., MSO4) Units of measure (e.g., U) Instructions (e.g., QD) Always include a leading zero (e.g., 0.5 mg), never a trailing zero (e.g., 5.0 mg) 25 Methods for Decreasing Errors Utilize pharmacist consultation Preparation of medications by pharmacy staff rather than nursing staff Integrate pharmacists into patient care rounds >80% reduction in error rate Pharmacy staff should be adequately trained to care for children Provide ongoing educational system for staff Offer pediatric specific formulary with criteria for evaluation, selection, use AAP. Pediatrics Fortescue EB, et al. Pediatrics

14 Methods for Decreasing Errors Standardize units of weight (i.e. kg vs. pounds) Standardize concentrations For continuous, intermittent, and IVP medications Eliminate rule of 6 calculations for continuous infusions Example: 6 x weight (kg) = amount of drug (mg) 100 ml of solution Then 1 ml/hr = 1 mcg/kg/min ASHP Standardize 4 Safety initiative Institute for Safe Medication Practices (ISMP) standard concentrations for neonatal infusions AAP. Pediatrics Methods for Decreasing Errors Computerized prescriber order entry (CPOE) Needs to be pediatric specific Dose range checking Renal dosing alerts Clinical decision support features May prevent some errors and create others Beware of alert fatigue Not all CPOE systems have the same capabilities AAP. Pediatrics

15 Methods for Decreasing Errors Utilize technology during compounding Bar code scan Specific gravity / product weight measurement Comprehensive labeling of final product Drug name and dose Base solution Final volume Final concentration Standardize equipment (e.g., infusion pumps) Utilize double checks Rich DS, et al. Hosp Pharm Methods for Decreasing Errors Bedside bar code scanning Beware of work arounds Utilize smart pump technology Must utilize pediatric specific information Weight range limits Pressure limits Drug library Pre programmed concentrations Dose range limits Automated calculations AAP. Pediatrics

16 Smart Pump Technology Standard concentration Specific library Rate calculation automated Weight & Dose are entered manually 31 Methods for Decreasing Errors Clear communication Error tracking system Include all errors regardless of severity / potential for harm Voluntary reporting typically underestimates true error rates System flaws vs. individual fault Eliminate barriers to reporting errors Just culture AAP. Pediatrics

17 Role of the Pharmacy Team Promote a culture of safety Utilize technology Insure use of standard concentrations Conduct research on stability / compatibility Pursue additional pediatric specific education PGY2 pediatric residency training Board certified pediatric pharmacy specialist (BCPPS) 33 Conclusions Children are a vulnerable population Medication errors occur more frequently and with greater severity in children Awareness of unique safety concerns is imperative for identifying preventative strategies throughout the drug delivery process Get pediatric smart and practice in a just culture

18 References American Academy of Pediatrics, Committee on Drugs and Committee on Hospital Care. Policy statement: Prevention of medication errors in the pediatric inpatient setting. Pediatrics. 2003;112: American Academy of Pediatrics, Steering Committee on Quality Improvement and Management and Committee on Hospital Care. Policy statement: Principles of pediatric patient safety: reducing harm due to medical care. Pediatrics. 2011;127: Crowley E, Williams R, Cousins D. Medication errors in children: a descriptive summary of medication error reports submitted to the United States Pharmacopeia. Curr Ther Res. 2001;26: Fortescue EB, Kaushal R, Landrigan CP, et al. Prioritizing strategies for preventing medication errors and adverse drug events in pediatric inpatients. Pediatrics. 2003;111: Grissinger M. Understanding and managing intravenous container overfill. P & T. 2016;41:140 1 & 172. Levine SR, Cohen MR, Blanchard N, et al. Guidelines for preventing medication errors in pediatrics. J Pediatr Pharmacol Ther. 2001;6: Prescott WA, Dahl EM, Hutchinson DJ. Education in pediatrics in US colleges and schools of pharmacy. AJPE. 2014;78:1 9. Rich DS, Fricker Jr. MP, Cohen MR, et al. Guidelines for the safe preparation of sterile compounds: results of the ISMP sterile preparation compounding safety summit of October Hosp Pharm. 2013;48: Sherwin CMT, Medlicott NJ, Reith DM, et al. Intravenous drug delivery in neonates: lessons learnt. Arch Dis Child. 2014;99:

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