We Need It and We Need It Now

Transcription

1 We Need It and We Need It Now Presenters: Thomas L. Grace RN, PhD, VP Emergency Preparedness, Principal Consultant, Emergency Preparedness, HAP Evolve Hospital and Health Systems Association of Pennsylvania Morten Wendelbo, Research Fellow Scowcroft Institute of International Affairs

2 FACULTY DISCLOSURE The faculty reported the following financial relationships or relationships to products or devices they or their spouse/life partner have with commercial interests related to the content of this CE activity: - Tom Grace Nothing to Disclose - Morten Wendelbo Nothing to Disclose

3 Global Supply Chains of Critical Goods Morten Wendelbo (Presenter) & Dr. Christine Crudo Blackburn Scowcroft Institute of International Affairs Bush School of Government and Public Service Texas A&M University

4 Source:

5 Australian Flu Season: H3N2 dominates The saline shortage Sept. 16: Hurricane Maria Saline shortage mentions online

6 Understanding Supply Chains

7 From ingredient to consumer

8 Ingredients/Components Ingredient A Ingredient B Ingredient C Ingredient D Ingredient E

9 Manufacturing Processing Manufacturing facility Processing

10 Distribution Center Distribution Center

11 Distribution Center Export and Import International Borders

12 Domestic Distribution Pharmacy Hospital or clinic Storage or Stockpile

13 Patient and Consumer Patient

14 Transportation Transportation

15 Source:

16 Transportation World Shipping

17 Long and Thin Supply Chains

18 Long Supply Chains

19 Thin Supply Chains Single supplier Particularly common for critical goods Single geographic area Puerto Rico China India Bottleneck transportation

20 Disruptions to the Supply Chain (Surge in demand) Natural disaster Conflict Pandemics/epidemics Terrorism

21 Planning Ahead Mapping the supply chains

22 The Many Domains Private Public Mixed

23 Big Picture Solutions Identifying the weak links in the chain Mapping the supply chains A multi stakeholder partnership A public-private partnership Developing a standard for mapping

24 What can Individual Companies or Agencies Do? Identify and map internal supply chain Understand the limitations of suppliers Diversify suppliers Multiple suppliers Pre-identified alternatives Diversify production Geographically

25 Thank you

26 Pennsylvania Healthcare Coalition RTF / Map GREENE ERIE WARREN North West PA Region 2 Emergency Response Group CRAWFORD MERCER LAWRENCE BEAVER WASHINGTON BUTLER ALLEGHENY VENANGO WESTMORELAND FAYETTE CLARION HAP STAFF South West Pennsylvania Region 13 RTF ELK HAP FOREST STAFF JEFFERSON INDIANA SOMERSET McKEAN CLEARFIELD CAMERON North West Central Emergency Response Group CAMBRIA BLAIR POTTER CLINTON CENTRE TIOGA TIOGA North Central Task Force South Central Mountain LYCOMING SNYDER Regional MIFFLINTask Force FRANKLIN JUNIATA PERRY HAP STAFF UNION ADAMS NORTHUMBERLAND DAUPHIN YORK BRADFORD SULLIVAN HAP STAFF COLUMBIA SCHUYLKILL LEBANON LANCASTER South Central Task Force WYOMING East Central Task Force SUSQUEHANNA LUZERNE WAYNE North East Pennsylvania Regional Counter Terrorism Task Force BERKS CHESTER CARBON LEHIGH MONROE NORTHAMPTON PIKE HAP STAFF BUCKS Southeastern Regional Task Force PHILADELPHIA HAP STAFF Updated 4/1/ 2018

27 The Shortage Impacts Recognition and Assessment Road map Response Community approach to problem solving Options and Alternatives Present day and the Future

28 Drug Shortages: Background Drug shortages increasing since 2010: Typically generic sterile injectable products Usually caused by manufacturing quality problems Fewer manufacturers = cascading shortages FDA authorities Help manufacturers quickly resolve quality problems Require manufacturers notify FDA in advance if aware or ASAP if sudden Request that other manufacturers make same/alternative drugs Expedite application reviews/inspections for new manufacturers Work with manufacturers for temporary importation of drug DEA For controlled substances (e.g. opioids), DEA sets amount of raw material manufacturers can get via aggregate production quotas

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30 September / October 2017 Evolving Issue: IV Fluid Shortage NaCl 0.9% 50 ml IV bag NaCl 0.9% 100 ml IV bag NaCl 0.9% 250 ml IV bag NaCl 0.9% 500 ml IV bag NaCl 0.9 % 1000 ml IV bag LR 1000 ml IV bag Some reports of LR 500 ml IV bag Do we have a Problem?

31 IV Solution and Medication Shortage Survey 10/30/17 97 Total Responses Powered by

32 Q1: Has your facility instituted IV Solution or medication conservation actions? Answered: 97 Skipped: 0

33 Q2: Is your facility receiving decreased or limited shipments of IV Solutions? (Y or N) Answered: 97 Skipped: 0

34 Which Products have been impacted by decreased shipments? Product Yes No Not Used Total Sodium Chloride, Solution, 0.9%, 25ml 18% 10 18% 10 65% Sodium Chloride, Solution, 0.9%, 50ml 87% 52 5% 3 8% 5 60 Sodium Chloride, Solution, 0.9%, 100ml 87% 52 7% 4 7% 4 60 Sodium Chloride, Solution, 0.9%, 250ml 73% 44 20% 12 7% 4 60 Sodium Chloride, Solution, 0.9%, 500ml 69% 42 28% 17 3% 2 61 Sodium Chloride, Solution, 0.9%, 1000ml 71% 42 27% 16 2% % Sodium Chloride Injection, Solution, 1000 ml 46% 27 46% 27 8% 5 59 Lactated Ringer's Injection, Solution, 1000mL 64% 37 31% 18 5% 3 58 Lactated Ringer's Injection, Solution, 500 ml 46% 27 37% 22 17% % Dextrose in Lactated Ringer's, Solution, 1000mL 53% 31 32% 19 15% 9 59 Other (please specify - up to 3 lines) Answered 63 Skipped 23 Highlighted response > 50% of facilities using product had received decrease shipment of this product

35 % Shortfall of ordered amount in last shipment (i.e. 100 ordered - received 75 = 25% shortfall) Product # facilities not impacted # facilities impacted 10% % Shortfall experienced in last shipment 20% 30% 40% 50% 60% # facilities # facilities Significant Sodium Chloride, Solution, 0.9%, 25ml 41% 31 11% 8 3% 1 0% 0 5% 2 0% 0 5% 2 3% 1 0% 0 0% 0 0% 0 5% Sodium Chloride, Solution, 0.9%, 50ml 7% 5 80% 60 3% 2 2% 1 3% 2 2% 1 17% 11 0% 0 9% 6 8% 5 11% 7 38% Sodium Chloride, Solution, 0.9%, 100ml 8% 6 80% 60 1% 1 4% 3 3% 2 1% 1 13% 9 4% 3 9% 6 9% 6 15% 10 30% Sodium Chloride, Solution, 0.9%, 250ml 9% 7 69% 52 17% 10 8% 5 10% 6 3% 2 19% 11 2% 1 5% 3 10% 6 0% 0 14% Sodium Chloride, Solution, 0.9%, 500ml 20% 15 56% 42 7% 4 5% 3 5% 3 7% 4 25% 14 0% 0 5% 3 9% 5 2% 1 9% Sodium Chloride, Solution, 0.9%, 1000ml 19% 14 56% 42 13% 7 0% 0 13% 7 5% 3 14% 8 0% 0 11% 6 4% 2 4% 2 13% % Sodium Chloride Solution, 1000 ml 21% 16 47% 35 2% 1 6% 3 4% 2 6% 3 12% 6 0% 0 8% 4 4% 2 16% 8 12% Lactated Ringer's Solution, 1000mL 19% 14 55% 41 15% 8 2% 1 5% 3 4% 2 18% 10 2% 1 11% 6 5% 3 0% 0 13% Lactated Ringer's Solution, 500 ml 24% 18 45% 34 15% 8 2% 1 4% 2 2% 1 10% 5 0% 0 10% 5 4% 2 2% 1 17% Lactated Ringer's w/ 5% Dextrose 1000mL 23% 17 48% 36 6% 3 0% 0 2% 1 6% 3 8% 4 0% 0 2% 1 15% 8 13% 7 17% # facilities responding to survey question 97 # of facilities reporting impact 73 70% 80% 90% 100% Impact Severe Impact

36 Assessment: Severe IV Fluid Shortage NaCl 0.9% 50 ml IV bag NaCl 0.9% 100 ml IV bag NaCl 0.9% 250 ml IV bag NaCl 0.9% 500 ml IV bag NaCl 0.9 % 1000 ml IV bag LR 1000 ml IV bag Growing Shortage impact of LR 500 ml IV bag

37 Assessment: Other Supply Issues Dextrose 5% - ALL SIZES - Shortage Plasmalyte - Limited Supply Empty IV Bags / Containers - Unavailable NaCl 23.4% IV vials to Compound - Unavailable Medication Delivery Systems Unavailable Mini-Bag Plus (Baxter) ADD-vantage (Hospira) addease (BBraun) Vial2Bag DC (West)

38 IV Fluids and Controlled Substance Shortages Solutions and Alternatives Exploration Call November 7, 2017 IV Fluids and Controlled Substance Shortages Solutions and Alternatives Webinar November 15, 2017 Penn State Hershey Medical Center - Lead Presenters

39 Suggested IV Fluids Conservation Methods (When Possible) Oral hydration (D/C IV fluid) Use Syringe Pumps for IV med administration to conserve fluid Use smallest bag appropriate for task; for example: Choose pre-op fluids to complement intra-op needs (instead of switching between NS and LR) Minimize KVO orders Utilize conservative intra-op IV fluid replacement Avoid reactionary micro-fluid changes Change fluid only when current bag depleted

40 Conservation Considerations Prescribe PO meds Consider IM administration IV PO Medication Substitutions Additional Education on IV Push Medications

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42 Medication Prep Changes Current Medication Ampicillin 1 gram; 1.5 gram and 2 gram / NSS 50 ml IV Mini-bag Plus (Non-refrigerated) Refrigerated Patient Specific 50 ml SYRINGE Refrigerated Patient Specific Changes Ampicillin 3 gram / NSS 100 ml IV Mini-bag Plus (Non-refrigerated) Maxipime 2 gram / NSS 50 ml IV Mini-Bag Plus (Non-refrigerated) Refrigerated SWFI 20 ml SYRINGE IV PUSH over 5 min Concentration: 100 mg / ml Pantoprazole 40 mg/ 50 ml IV Drip Refrigerated Patient Specific Pantoprazole 200 mg / 250 ml Mini-Bag Insulin 100 units / 100 ml IV Drip Product will look different

43 Decrease Usage of Small Volume IV Fluids Medication IV Push? Alternative compatibility Cordarone Yes - Per ACLS guidelines D5W (bolus doses 150mg) Dexamethasone (dose >10mg) Yes - Doses < 10mg D5W Diphenhydramine Yes if used for anaphylaxis D5W Fosphen Do not exceed 150 mg PE/minute D5W or NSS 250mL Dilute to 1.5 to 25 mg PE/mL Granisetron Yes D5W Metoclopramide HCL D5W (only if > 10mg) Yes over 1-2 minutes (doses <10mg) Metoprolol Yes - over 1 minute D5W Ondansetron > 16mg No D5W Phytonadione No D5W Prochlorperazine Yes - IV push at a rate not exceeding 5 mg/minute Not compatible with NSS or D5W

44 Controlled Substance Shortage: Severe shortage of several narcotics Morphine Methadone Hydromorphone Fentanyl HCL Meperidine HCL Guidance - Please discontinue IV narcotics & use ORAL medications whenever possible

45 Going Forward Drug Shortages: Advocacy Maintain Awareness: Monitor FDA IV & Drug Shortages webpage National Drug Shortage Summit Informal coalition involving national organizations representing health system pharmacists, oncologists, anesthesiologists, children s hospitals, safety groups, AHA active with group as well Advocated together to raise profile of drug shortages and successful in getting changes to law, e.g. (The Food and Drug Administration Safety and Innovation Act (FDASIA),

46 Going Forward Maintain Awareness: Monitor FDA IV & Drug Shortages webpage

47 Drug Shortages: What Should Congress / FDA Do? Manufacturers should provide FDA with more information on the causes of shortages and expected duration Require manufacturers to establish contingency plans and/or redundancies Manufacturers need to be more transparent Examine drug shortages as a national security initiative The FTC should include in its review of drug company merger proposals the potential risk for drug shortages.

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