PN Compounding Practice: The Kuwaiti Experience. Ahmed Abo-Bakr Mahmoud, R.Ph,M.Sc.,BCNSP

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1 PN Compounding Practice: The Kuwaiti Experience Ahmed Abo-Bakr Mahmoud, R.Ph,M.Sc.,BCNSP

2 Disclosure Information PN Compounding practice: The Kuwaiti Experience Ahmed Abo-Bakr Mahmoud I have no financial relationship to disclose. AND I will not discuss off label use and/or investigational use in my presentation. - List References here

3 Learning Objectives At the completion of this activity, you will be able to: Describe the challenges of sterile compounding in developing hospitals Identify solutions for issues with Parenteral Nutrition compounding with large scale production List strategies to utilize sterile compounding resources in low setting hospitals - List References here

4 What if?

5 What if? You work at low setting institution Your hospital is not following the international standards You work in a hospital with good but unequally utilized resources You want to start a new Sterile Compounding Service at your hospital

6 THINK GREY?

7 Maternity Hospital in Kuwait

8 How did we start? Tertiary care, 500+ beds, including >170 baby cots/incubators, 2 NICUs, and 2 SCBUs 8 years ago Compounder + Isolator + segregated room Initial training in 2 hospitals 2 totally different workflows Fed the machine software Established a committee of Pharmacist, Neonatologist, Consultant, and a Nurse Did the trial work found an initial workflow Went live few number of TPN bags increased gradually

9 N/11 F/12 M/12 A/12 N/12 F/13 M/13 A/13 N/13 F/14 M/14 A/14 N/14 F/15 M/15 A/15 N/15 F/16 M/16 A/16 N/16 F/17 M/17 A/17 N/17 F/18 M/18 A/18 Scale (monthly progress):

10 Scale (daily average): Average bag per day

11 Scale (daily mode): Mode of daily bags

12 Scale (maximum peak): Maximum number per day

13 Scale (Yearly output): IV Admix TPN (Aug) 2018 (pred)

14 Why do we have large scale of production? Biggest Maternity Hospital in Kuwait, 12,000 delivery/year high rate of newborn admission Referral hospital for newborn and premature higher rate of admission TPN Unit/Maternity is acting as outsourcing to surrounding hospitals, and backup workplace to other hospitals Un-optimized Enteral Nutrition service

15 Challenges

16 Staff Building Up

17 Staff building up: One Pharmacist start 3 Senior Pharmacists Core Competent Pharmacy program (2-4 weeks) trained >20 pharmacist, 14 of them are still in-service 2/3 of Pharmacy manpower Pharmacist rotation Student Program (1 week) trained >180 student and fresh graduate (over 4 years) Continued education We still have other pharmacy duties

18 Quality Vs & Time

19 Improving Quality Control/Assurance: Minimizing manual steps Barcoding Immediate labeling Double-checking Color coding for PN components Strict cleaning protocol Microbiological sampling Sterility testing

20 Reducing time: Working time = 8 hours (2 four hour shifts) Parallel jobs Fixed protocol of daily work Standardize orders Batching Minimize manual steps Running the compounder all the time Standard time needed to fill a bag 2-3 min, and lipid bag is filled in less than one min

21 Filling Gaps

22 Cover all babies all the time? 2 nd daily shift Saturdays working day Fridays 2 types starter New admissions 7 types standardized solutions Corrections No vitamins Prepared daily and stored in fridge Public Holidays Doubling orders before holidays

23 Connecting to others: Resistance at beginning Approaching key persons committee Design forms/prescriptions redesign Prescription errors Presentations, and workshops Changing practices and destructing some Taboos, e.g: early aggressive feeding

24 Calcium / Phosphate compatibility: Inorganic phosphate + Aminoven Mini-project of Ca/Phos Compatibility Now using Organic phosphate

25 Stock managing: Short-Term Store Long-Term Store Location Adjacent With pharmacy Before 2016 Items stored for 2 weeks For 3-6 months After 2016 Items stored for one week 6-12 months + a fixed list of TPN components to be prepared every morning + a maintenance list is printed daily before 2 nd shift

26 Item shortages: Being proactive Thanks to the IVPNeers for raising the shortage calls Following ASPEN shortage website recommendations Prioritizing Examples: 1- Organic Phosphate shortage 2- Vitamins/trace elements shortages 3- Lipid filter shortage

27 System down protocol: Maintenance book, with error codes and solutions in pictures Manual filling: 1-Extend working hours 2-Double check all steps 3-Creating some tools 4-Cancel adding of Lipid, or vitamins

28 New services (IV Admixture): Preparing non-stat medications Full day doses Started by one ward extend to more wards Building up databases

29 New services (IV Admixture): Adjusting software Utilizing TPN resources Follow the safe practices International resources

30 New services (Clinical Nutrition): Include Nutrition Support Pharmacist in the multidisciplinary team (grand round) Discuss the patient s Nutritional status/plan on daily basis Improve PN and EN services Change outdated practices Two wards as a start

31 THINK GREY?

32 New Sterile Compounding Unit: USP <797> Compliant No Isolators anymore 4 Laminar Flow Workbenches 3 Compounders Cover all wards PN&IV Cover PN all surrounding hospitals To go beyond

33

34 Take home messages: Identify your problems Solve by the best applicable way Prioritize Create your own path/plan Don t copy plans Utilize your resources before ordering/buying Count much on personnel, rather than the system Approach reformers in other departments teams Talk to your administration using figures/costs/statistics Large scale of production needs more cautions Persistence, persistence, persistence.

35 Additional Resources/References USP Chapter <797>, Pharmaceutical Compounding-Sterile Preparations The ASHP Discussion Guide on USP Chapter <797> ASPEN website for product shortages: nlinelibrary.wiley.com/journal/ nlinelibrary.wiley.com/journal/

36 Thank you!

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