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Million Dollar Baby: Hidden Costs and Strategies to Overcome Medication Shortages

Presented by:

Lauren Loeper PharmD, BCPS: UCHealth Memorial Hospital

Ashley Mains Espinosa, PharmD, MS, CPHIMS: SCL Health

Disclosures

�Conflicts of Interest

–Lauren Loeper PharmD, BCPS: none

–Ashley Mains Espinosa PharmD, MS, CPHIMS: none

Learning Objectives� Evaluate the structure and the fragility of the medication and fluid

supply chain

� Describe a current medication/fluid shortage situation

� Discuss ways to create structure around processes related to medication shortages

� Explain the differences between inpatient and outpatient experiences with medication shortages

� Identify hidden costs of the shortage crisis

� Other Goal:

– Interactive discussion � let’s learn from each other!

The Headlines…

https://read.bi/2zBZv8G

https://for.tn/2sltixj

https://ti.me/1AC2Jny

https://nyti.ms/2y1hv85

The Numbers…� Recent number of drug shortages (chemical entities) on American

Society of Health System Pharmacists website is 153

� Recent number of drug shortages (chemical entities) on the FDA data-base is 103

� UCHealth Memorial Hospital has 151 medications on the critical shortage list reviewed weekly

� SCL Health reviews fluid shortage situation weekly with over 20 stakeholders

� 10% of drugs produced for the US are made in Puerto Rico

� Pfizer’s injectable shortage list has over 500 line items updated dailyAmerican Society of Health System Pharmacists. Drug Shortage Website. https://www.ashp.org/Drug-Shortages/Shortage-Resources/Injectable-Opioid-Shortages-FAQ. Accessed April 2, 2018

Food and Drug Administration. Drug Shortages. https://www.accessdata.fda.gov/scripts/drugshortages. Accessed April 20, 2018.

Thomas, K. NY Times. October 23,2017. https://www.nytimes.com/2017/10/23/health/puerto-rico-hurricane-maria-drug-shortage.html. Accessed April 20, 2018.

Pfizer Hospira Injectables. http:pfizerinjectables.com. Accessed April 20, 2018

How did we get here?

�Long standing generic product conundrum

–Few Suppliers

–Poor manufacturing processes leading to interruption to production

–Low-margin profitability

–FDA can require manufactures to report drug shortages, but cannot require manufacturers to produce

P T. 2011 Nov; 36(11): 740-742, 749-757

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How did we get here?� Hospira/Pfizer merge and shortly after the medications in the Hospira

generic injectable portfolio came into short supply due to:

� Recalls

� Manufacturing delays

� Distribution delays

� Third-party supplier delays

� Prioritization of necessary product lines (i.e. sodium bicarbonate)

� Downstream effect by adding demand to secondary producers

Pfizer Injectables Customer Letter May 17, 2017. (Ellen Wetterline, US Portfolio Lead)

How did we get here?� Injectable Opioids

– Drug Enforcement Agency

� Called for 25% decrease in opioid manufacturing in 2017

� Called for an additional 20% decrease for 2018

� Effort to combat the opioid crisis

– Manufacturer issues

� Pfizer: produces 60% of the injectable opioids

� Secondary manufacturers could not keep up with increased demand

American Society of Health System Pharmacists. Drug Shortage Website. https://www.ashp.org/Drug-

Shortages/Shortage-Resources/Injectable-Opioid-Shortages-FAQ. Accessed April 2, 2018

Drug Enforcement Agency. DEA proposes reduction to amount of controlled substances to be manufactured

in 2018. https://www.dea.gov/divisions/hq/2017/hq080417.shtml. Accessed April 2, 2018.

How did we get here?� Hurricane Maria October 2017- destroyed factories and existing

inventory within the factories in Puerto Rico

– Baxter Plant

�Mini-Bag products

– Domino effect on other fluids

� Empty bags

� Tubing

– Johnson and Johnson

� HIV medication and othersThomas, K. NY Times. October 23,2017. https://www.nytimes.com/2017/10/23/health/puerto-rico-hurricane-maria-drug-shortage.html. Accessed April 20, 2018.

How did we get here?� Outsourcing Facilities

– Drug Quality and Security Act of 2013

� Under Section 503B compounding pharmacies become Outsourcing Facilities

� New legislation brought more oversight

� Shifted inspection from the individual states to the FDA

– Example from a leading outsourcing facility

� Voluntary and involuntary recalls

� Plants closed

� Short dated products with unpredictable delivery dates

� Decreased product portfolio

– Available products may not match the needs of the institution

Food and Drug Administration. Outsourcing Facilities. https://bit.ly/2xoV01R. Accessed on April 2, 2018.

Current Shortages

Ondansetron Injection– Raise your hand if your institution:

� Restricted this medication to preserve stock

� Bartered with neighboring hospitals

� “Stocked up” in anticipation of the shortage

� Switched back and forth between concentrations/formulations to maintain stock

� Ran completely out of the medication

� Was not affected or you do not stock this medication

� “Re-centralized” this medication (i.e. pull out of ADC and dispense from Pharmacy only)

� Share other strategies!

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Ondansetron- UCHealth Approach�Utilized Alternative Selection Functionality in EHR to

steer providers to other agents

Ondansetron – UCHealth Approach� Asked pharmacists to encourage aggressive IV to PO

� Ordered the ondansetron multi-dose vial to compound syringes if necessary

� Communicated to providers through email and at various section meetings

� Decreased quantities in ADCs

� Recentralized product eventually

� Shared amongst the UCHealth system

Image: https://bit.ly/2snBP20

Ondansetron Shortage – SCL Health

� Similar actions as UCHealth, e.g. encouraged IV to PO conversions, utilized multi-dose vials, etc.

� EMR alert to suggest agents outside of class

– Broken down by indication

– Utilize non-formulary

– Secondary shortages

Ondansetron Shortage – SCL Health

� Also utilized multi-dose vials of alternative agents

� System Committee

– Not a step-wise approach

– Share best practice and new insight, but sites do what they can in that moment

– Some disbursement of medications

Current Shortage� Bupivacaine and Ropivacaine

– Raise your hand if:

� You restricted these medications to preserve stock

� You bartered with neighboring hospitals or system partners

� You “stocked up” in anticipation of the shortage

� You switched back and forth between concentrations/formulations to maintain stock

� You ran completely out of the medication

� This shortage didn’t effect your hospital or you do not stock these medications

� “Re-centralize” this medication (i.e. pull out of ADC and dispense from Pharmacy only)

� Share other strategies!

Bupivacaine and Ropivacaine Shortage-UCHealth� Ropivacaine out of stock and unavailable

� Restricted bupivacaine for elastomeric pain pumps to 0.125% maximum concentration and preservative containing product only

� Preservative free products for epidural or spinal use only

� Shared products amongst system partners and neighboring hospitals

– Other wholesalers seemed to vary in availability of product

� Decreased stock in ADCs

� Products with epinephrine compounded by anesthesia for immediate use if needed

� Considered other bupivacaine products such as liposomal bupivacaine for appropriate indications

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Bupivacaine and Ropivacaine Shortage-UCHealth

�Safety event reported- Near Miss!

–OR nurse was asked to compound bupivacaine with EPINEPHrine

–ePHEDrine was erroneously pulled from Pyxis and mixed with bupivacaine

–Second nurse noticed the incorrect vial on the table before it was used

Bupivacaine and RopivacaineShortage- SCL Health� Performed same actions

� Safety event – reached patient

–Lidocaine with EPINEPHrine stocked out in ADS

–Procedural area staff assumed main pharmacy could provide via tube

–Patient on table; biopsy performed without mixed product

–Resulted in large hematoma on patient

Fluid Shortage

–Utilize extended infusion beta lactam dosing to save bags

–Mix antibiotics in a syringe instead of bag

–Updated IV to PO interchange to allow pharmacists more freedom to interchange products

–Bring products in from Europe and Mexico

Structure

ASHP Recommendations

Drug Shortage Identified

Operational Assessment

1. Validate details of shortage

2. Determine stock on hand

3. Determine supply from predetermined alternative

sources

4. Determine purchase history and/or true use

history

5. Estimate time to impact on the health system

6. Determine supply of alternative drug products

Therapeutic assessment

1. Identify primary patient population

affected

2. Identify therapeutic alternatives

Shortage impact analysis

Estimate impact on patient care

1. Therapeutic differences

2. Prescribing processes

3. Distribution processes

4. Administration Processes

Financial Ramifications

Establish

Final Plan

Communicate

1. Information system changes

2. Technological changes

3. Inventory system changes

4. New procedures

Implement

1. Information system changes

2. Technological changes

3. Inventory system changes

4. New procedures

Fox et al. AJHP Aug 2009, 66 (15) 1399-1406;

UCHealth Drug Shortage Committee

Member Role

Pharmacy Director General Oversight

Pharmacy Managers Operational and clinical planning

Infectious Disease

Specialist

Operational and clinical planning

Clinical Coordinator Clinical planning and departmental/interdepartmental

communication

Pyxis® Specialist Usage reporting

Pharmacy purchaser Shortage identification, spreadsheet maintenance

Narcotic technician Shortage identification for narcotics, operational planning

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FDA (CDER) Drug Shortage ASHP Drug Shortage Website

Purpose Information obtained from manufacturers about

current shortages, estimated duration, and

discontinuations,

Notification of new shortages and status of ongoing

shortages; drug shortage management resources

Audience Public Healthcare providers

Scope Confirmed to be a national shortage by FDA

where demand exceeds supply

Confirmed with manufacturer that supply issues are

causing national impact

Source of Shortage Manufacturer reporting Voluntary reports by providers, patients, others. Also

receives reports from FDA

Criteria for Inclusion Supply outweighs demand in the marketplace as

reported by manufacturer

Verified shortage that is effecting pharmacies ability to

prepare medications

Criteria for Resolving

Shortage

Market demand restored All manufactures are able to make all preparations

Reason for Shortage Manufacturers required to report to FDA ASHP reports this if manufacturer is willing to disclose

Shortcomings Lower threshold to resolve the shortage, delay in

appearing on website as compared to ASHP

Manufacturers are not legally required to disclose

information

American Society of Health System Pharmacists. FDA AND ASHP Shortage Parameters. https://www.ashp.org/Drug-Shortages/Current-Shortages/FDA-and-ASHP-Shortage-Parameters. Accessed 4/2/18.

Drug Shortage ResourcesProvider Communication

� Email blasts to providers

�Directed emails to specific section groups

�Calls to medical directors

�Direct interaction with floor pharmacists at rounds, hallway, etc.

�Direct interaction at section meetings or hospital daily safety briefing

Accountability–Weekly calls with manufacturers, wholesalers, and suppliers

–Bi-weekly calls with 503B partners

–Ad hoc meetings with representatives

–Webinars from group purchasing organization (GPO)

Process

�Maximize allocations

�Diversify products

–Frozen, Mini-Bag Plus™, ADD-vantage™

–Large concentrated vials of narcotics for compounding PCA

Outpatient Concerns

� Medication unavailable at time of dispense

–Secondary choices short just like inpatient

� Affects patient experience

� Reduces clinical quality

Outpatient Concerns

�Degrades trust leading to:

– Shopping at different pharmacy

– Exacerbation of trust issues already present with the pharmaceutical industry

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Hidden Costs

Active Participation: 340B Program

�Raise your hand if your institution participates in the 340B federal drug pricing program

–Keep hands raised if utilized in the hospital mixed-use setting

–Keep hands raised if utilized in the retail pharmacy setting

Hidden Cost #1: 340B Program� Risk to compliance any time one deviates from practice

standard

� ↑Drug prices = ↓Margins

– All first purchases must utilize WAC pricing for DSH “hospital-owned” pharmacies

�Spread of NDC Accumulations

– New accumulations on each unique 11-digit NDC

– Must eventually abandon one set of accumulations

Hidden Cost #2: Cleanroom

�Labor

�Equipment

�Technician turnover due to decreased job satisfaction

Hidden Cost #3: Medication Related Errors� Products not scanning

� New concentrations

– Hydromorphone, ketamine, meperidine

– ISMP cites two deaths in similar shortage in 2010

– SCL Heparin near-misses for changing concentrations or new bag on pump, reprogramming incorrectly

� Smart pump not configured

� SCL’s P&T in April presented instance that affected patient care

Hidden Cost #4: New Contracts- 503b Facilities

�Without purchase history, new contracts are needed. Chances during shortage are low.

�Strategies

– Is this the necessary drug?

– Are there alternate agents?

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Hidden Cost #5: Expensive substitutes

�IV acetaminophen

�Liposomal bupivacaine – new indication!

�EpiPen®

Hidden Cost #6: Inventory� Stocking up on products (Cannot return products whose packages are

opened!)

� Increase in NDC variety leading to decreased optimization of 340B accumulations

� Buying shortage products on consignment

� Switching to products that are more expensive or not on contract for GPO

� Emergency shipments direct from manufacturer

� Grey market?

Hidden Cost #7: Time� Nursing

– Long push times for medications in syringe instead of bag

� Pharmacy

– Buyers spending majority of time chasing shortages

– Outpatient pharmacists phone time with prescribers to request strength, product, or other changes

� Patient

– Multiple trips to the retail pharmacy

� All parties - Discussing the situation and options

Hidden Cost #8: Money

�Decrease in outpatient volumes

�Alternative choices more expensive to the outpatient pharmacy and to the patient

Other Hidden Costs

�Labor intensive processes surrounding

–Rapid changes in EHR required

–Rapid changes in other technology

�Smart pump libraries

�Barcodes

� Inventory systems

�Automated dispensing cabinet (Pyxis®, Omnicell®)

Future Planning

�Consider becoming a 503b

�Establish and maintain stock of more diverse products to avoid allocation issues in the future

�Maintain a back stock of inventory

�Continue close surveillance of drug shortage resources

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Ethical Question:

�Etoposide shortage

–Critically low, no ETA

–What would you do?

Open Forum

�What has worked for your institution?

Questions?

Image: https://imgflip.com/i/28a99b. Accessed April 30, 2018

Million Dollar Baby: Hidden Costs and Strategies to Overcome Medication Shortages

Presented by: Lauren Loeper PharmD, BCPS and Ashley Mains Espinosa PharmD, MS,

CPHIMS