PittShortageHandout - Wild Apricot

8/15/2018

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August 18, 2018

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Poll Everywhere Audience Response

From Doom and Gloom to Chicka Chicka Boom Boom:Coping when Drug Shortages are a Hot Mess

Renee Pitt, PharmD, BCPSDrug Information Specialist, Drug Shortage Management Coordinator

Intermountain Healthcare

Disclosure

Renee Pitt has no conflicts of interest to disclose.

Renee Pitt will not be discussing off-label uses of drugs.

Learning Objectives

At the conclusion of this activity, pharmacists should be able to successfully:

1. Formulate a standardized systematic approach when implementing a mitigation plan for drug shortages.

2. Evaluate who should be represented on a drug shortage advisory group.

3. Differentiate between conservation strategies and restrictions.

4. Defend legal mitigation strategies during critical drug shortages.

Learning Objectives

At the conclusion of this activity, pharmacy technicians should be able to successfully:

1. Explain why a systematic approach is best practice when implementing a mitigation plan for drug shortages.

2. Devise specific action tasks performed by technicians that can mitigate drug shortages.

3. Compare institutional-specific internal drug shortage information versus external drug shortage information.

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Martin Jr. B, Archambault J, authors and Ehlert L, illustrator. Chicka Chicka Boom Boom. New York; Little Simon; 2012.Image accessed 25 June 2018. Available from: https://pixabay.com/en/coconut-palm-plant-tree-1297239/.


gi eh

Chicka Chicka…


BOOM! BOOM!


A Hot Mess

Martin Jr. B, Archambault J, authors and Ehlert L, illustrator. Chicka Chicka Boom Boom. New York; Little Simon; 2012. Image accessed 25 June 2018. Available from: https://pixabay.com/en/coconut-palm-plant-tree-1297239/. Image accessed 4 July 2018. Available from: http://getdrawings.com/crescent-moon-silhouette.

Martin Jr. B, Archambault J, authors and Ehlert L, illustrator. Chicka Chicka Boom Boom. New York; Little Simon; 2012. Image accessed 25 June 2018. Available from: https://pixabay.com/en/coconut-palm-plant-tree-1297239/.

Lessons Learned

1. Don’t ever give up

2. Systematic approach

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“In fact, it is uncommon to find comprehensive answers in the literature that completely and effectively address specific situations or circumstances that clinicians encounter in their daily practices.” [bold added for emphasis]

A Systematic Approach

Sheehan AH, Jordan JK. Chapter 2: Formulating an Effective Response: A Structured Approach. In: Malone PM, Malone MJ, Park SK, editors. Drug Information: A Guide for Pharmacists, 6th ed. New York: McGraw-Hill Education; 2018.

A Systematic Approach

Images accessed 25 June 2018. Available from: https://pixabay.com/en/cabin-mountains-woods-countryside-31632/, http://www.transparentpng.com/cats/fog-78.html, http://www.yosodance.com/group/black-and-white-sun-clipart/, and https://gallery.yopriceville.com/Free-Clipart-Pictures/Rainbows-PNG/Transparent_Rainbow_Free_Clipart.

Fast Facts. Intermountain Healthcare; 2018 [cited 4 July 2018]. Available from: https://intermountainhealthcare.org/about/who-we-are/fast-facts/. Image from: Intermountain Healthcare internal template documents.

22 Hospitals and nearly 200 clinics

Our mission: Helping people live the healthiest lives possible®

The Pharmacists’ Patient Care Process

Image used with permission from: Joint Commission of Pharmacy Practitioners. Pharmacists Patient Care Process. 2014. Available from: https://jcpp.net/patient-care-process/.

Drug Shortage Advisory Group

Image from: Intermountain Healthcare internal documents.

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Chair: Drug Information Specialist

Membership:

System Pharmacy Inventory Specialist

System Pharmacy Operations Director(s)

Ad Hoc Members: Clinical Specialists, Electronic Health Record Representative, Internal Process Control Representative, Medication Safety Specialist, Pharmacy Operations Director



Membership:





Generate report of historical usage data

Identify if alternative agent(s) exist, with feedback from clinical staff

Determine action steps, based on drug shortage mitigation strategies

Determine if conservation strategies or restrictions are warranted

Contact appropriate Clinical Program or Subcommittee for endorsement(eg, Antimicrobial Stewardship Subcommittee)

Contact Pharmacy and Therapeutics Executive Committee for approval of any therapeutic interchange or restrictions




Determine action steps, based on drug shortage mitigation strategies

Determine if conservation strategies or restrictions are warranted




1. Seek appropriate alternate channels to obtain drug

2. Borrow stock from another affiliated site

3. Consider use of therapeutic alternatives

4. Compound as a last resort

Mitigation Strategies 503B Outsourcing Facilities

EHR = Electronic Health Record

1. Drug shortages roundtable: Minimizing the impact on patient care. Am J Health Syst Pharm. 2018 Jun 1;75(11):816-820.

Positives Negatives

• Minimizes internal compounding

• Reduces labor costs• Extended dating

• Sparse product menu • High cost• 483 citations from FDA1

• 5 to 6 weeks production1

• Majority susceptible to shortages1

FDA = Food and Drug Administration

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Determine action steps, based on drug shortage mitigation strategies Determine if conservation strategies or restrictions are warranted



Drug Shortage Advisory Group Shortage TacticsConservation Strategies Restrictions

• Agreed upon by multidisciplinary collaboration at the site-level, with potential variability amongst sites

• Typically faster to implement and modify based on site-specific drug supply

• Medication should not be withheld if available, with the risk being that the medication could run out completely

• Should not be marketed as “restrictions”

• System-wide, impacting all sites• Vetted by appropriate groups on a

system-wide scale• Ratified by the system P&T Committee• Published on the Formulary Restrictions • Potential EHR changes • Medication can be withheld from a

patient if they do not meet inclusion criteria

EHR = electronic health record; P&T = Pharmacy and Therapeutics

Shortage Alerts in EHR

EHR = Electronic Health Record

1. Bogucki B, Jacobs BR, Hingle J. Computerized reminders reduce the use of medications during shortages. J Am Med Inform Assoc. 2004 11(4):278-280.2. Drug shortages roundtable: Minimizing the impact on patient care. Am J Health Syst Pharm. 2018 Jun 1;75(11):816-820.

Positives Negatives

• Communication to prescribers

• Link to shortage resources

• Reduction in orders1

• Alert fatigue• Labor-intensive entry of

new drugs in EHR2

EHR = Electronic health record

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PHARMACISTSWho is an ad hoc member of the Drug Shortage Advisory Group?

A. System Pharmacy Operations Director

B. Drug Information Specialist

C. Clinical Specialist

D. System Pharmacy Inventory Specialist

Learning Objective #2 for PHARAMCISTS

A. Conservation Strategies

B. Restrictions

PHARMACISTSA health system is experiencing a critical shortage of IV pantoprazole. Despite efforts to conserve, the system is projected to run out of drug in 2 weeks. There are multiple providers that are resistant to changing their prescribing practices. What shortage tactic would be best to implement?

Learning Objective #3 for PHARAMCISTS

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Example 1: Internal Shortage List

Image from: Froedtert & the Medical College of Wisconsin internal drug shortage list.

Example 2: Internal Shortage List

Image from: Intermountain Healthcare internal drug shortage list.

Internal Shortage List ComparisonFroedtert & the Medical College of Wisconsin Intermountain Healthcare

• SharePoint®• Drug name• Product(s) affected • Date shortage added• Manufacturer(s)• Availability status • Estimated duration of shortage• Recommendations• Severity status• Sites impacted

• Wiki site• Drug name• Product(s) affected • Date shortage added• Manufacturer(s)• Availability status • Estimated duration of shortage• Recommendations• Severity status• Sites impacted• Therapeutic area

Internal Shortage List ComparisonFroedtert & the Medical College of Wisconsin Intermountain Healthcare

• SharePoint®• Drug name• Product(s) affected • Date shortage added• Manufacturer(s)• Availability status • Estimated duration of shortage• Recommendations• Severity status• Sites impacted

• Wiki site• Drug name• Product(s) affected • Date shortage added• Manufacturer(s)• Availability status • Estimated duration of shortage• Recommendations• Severity status• Sites impacted• Therapeutic area

American Society of Health-System Pharmacists (ASHP)

U.S. Food and Drug Administration (FDA)

Centers for Disease Control and Prevention (CDC) Vaccine shortages

Group Purchasing Organizations Intalere™, Vizient™

Drug manufacturer websites

Professional organization websites

External Drug Shortage Resources








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FDA and ASHP Shortage Parameters - Contrasting the FDA (CDER) and ASHP Drug Shortage Websites: What Are the Differences? Bethesda, MD: American Society of Health-System Pharmacists; August 2014 [cited 4 July 2018]. Available from: https://www.ashp.org/Drug-Shortages/Current-Shortages/FDA-and-ASHP-Shortage-Parameters.

External Resource ComparisonASHP FDA

• National impact• Voluntary reports from health-systems,

prescribers, patients, etc.• Healthcare provider perspective• Shortage resolved when all

manufacturers restored to normal, market demand is met

• Estimated duration of shortage• Comprehensive list of manufacturers,

list of available products, patient safety information, therapeutic alternatives, and mitigation strategies

• National impact• Legally-mandated reports from

manufacturers and voluntary reports• Drug manufacturer perspective• Shortage resolved if at least 1

manufacturer can meet market demand• Estimated duration of shortage• Regulatory information, manufacturer

contact information, Dear Healthcare Provider Letters

ASHP = American Society of Health-System Pharmacists, FDA = U.S. Food and Drug Administration














• National impact• Voluntary reports from health-

systems, prescribers, patients, etc.• Healthcare provider perspective• Shortage resolved when all






























manufacturer can meet market demand

• Estimated duration of shortage• Regulatory information, manufacturer












manufacturer can meet market demand• Estimated duration of shortage

• Regulatory information, manufacturer contact information, Dear Healthcare Provider Letters



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American Medical Association

American Society of Anesthesiologists

American Society of Clinical Oncology (ASCO)


American Society of Parenteral and Enteral Nutrition (ASPEN)2

Institute for Safe Medication Practices (ISMP)

Society of Critical Care Medicine (SCCM)3

Professional Organizations1

1. Drug shortages roundtable: Minimizing the impact on patient care. Am J Health Syst Pharm. 2018 Jun 1;75(11):816‐820.2. Product Shortage Management. Silver Spring, MD: American Society of Parenteral and Enteral Nutrition; 2018 [cited 4 July 2018]. Available from:

http://www.nutritioncare.org/Guidelines_and_Clinical_Resources/Product_Shortages/Product_Shortage_Management/. 3. Current Issues. Mount Prospect, IL: Society of Critical Care Medicine; 2018 [cited 4 july 2018]. Available from: https://www.sccm.org/Research/Current‐Issues.

PHARMACY TECHNICIANSWhat is not an activity suited for a pharmacy technician role?

A. Provide estimated duration updates for an internal drug shortage list

B. Create a Fact Sheet with recommendations for therapeutic alternatives and other mitigation strategies

C. Physically gather inventory of a shortage drug from decentralized locations in order to centralize supply

D. Investigate alternative suppliers of a shortage drug

Learning Objective #2 for PHARMACY TECHNICIANS

PHARMACY TECHNICIANSWhich drug shortage resource is more likely to provide the most comprehensive and specific information on shortages?

A. American College of Clinical Pharmacy (ACCP)

B. American Society of Clinical Oncology (ASCO)

C. American Society of Health-System Pharmacists (ASHP)

D. U.S. Food and Drug Administration (FDA)

Learning Objective #3 for PHARAMCY TECHNICIANS

Sterile injectable products1,2

Generically available (off-patent)1,2

Few suppliers1,2

Common Characteristics of Shortage Drugs

1. Drug shortages roundtable: Minimizing the impact on patient care. Am J Health Syst Pharm. 2018 Jun 1;75(11):816-820.2. Fox ER, Tyler LS. Potential Association between Drug Shortages and High-Cost Medications. Pharmacotherapy. 2017;37(1):36-42.

Quality Manufacturing

Issues

Drug Shortage Statistics

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Drug Shortages Statistics. Bethesda, MD: American Society of Health-System Pharmacists; March 2018 [cited 4 July 2018]. Available from: https://www.ashp.org/Drug-Shortages/Shortage-Resources/Drug-Shortages-Statistics.

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Antibiotics Chemotherapy Cardiovascular Central Nervous System

Electrolytes

Top 5 Drug Classes on Shortage


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Critical shortage of etoposide

Individual importation1,2 of drug from France

Drug shortage advisory group created action plan

BEAM of Hope

1. Information on Importation of Drugs Prepared by the Division of Import Operations and Policy, FDA. Bethesda, MD; United Stated Food & Drug Administration [page last updated 09/25/2015; cited 01/29/2018]. Available from: https://www.fda.gov/ForIndustry/ImportProgram/ucm173751.htm.

2. Personal Importation. Bethesda, MD; United Stated Food & Drug Administration [page last updated 09/25/2015; cited 01/29/2018]. Available from: https://www.fda.gov/ForIndustry/ImportProgram/ImportBasics/ucm432661.htm.

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Membership:





Enacted in 20121,2

Manufacturers must notify FDA 6 months in advance, or no later than 5 days after supply disruption1,2

FDA Safety and Innovation Act (FDASIA)

The WHAT…but missing the WHEN, WHY, or HOW

1. Drug shortages roundtable: Minimizing the impact on patient care. Am J Health Syst Pharm. 2018 Jun 1;75(11):816-820.2. Food and Drug Administration Safety and Innovation Act (FDASIA). Silver Spring, MD: U.S. Food and Drug Administration; page last updated 28 March

2018 [cited 6 July 2018]. Available from: https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/FDASIA/ucm20027187.htm.

Expedite generic competition where none exists

DEA and FDA increase communication re: shortages

Tariffs on API risk increased shortages and price hikes

Legislative Efforts for Shortages

Gentile N, Schulte Wall Jillanne, Topoleski C. ASHP Government Relations June Update. Bethesda, MD: American Society of Health-System Pharmacists; June 2018 [cited 6 July 2018]. Webinar broadcast remotely on 18 June 2018.

DEA = Drug Enforcement Administration; FDA = Food and Drug Administration

API = active pharmaceutical ingredient

Drug shortages

Off-patent drugs lacking competition

REMS program abuse

Intentional Price Hikes

Gentile N, Schulte Wall Jillanne, Topoleski C. ASHP Government Relations June Update. Bethesda, MD: American Society of Health-System Pharmacists; June 2018 [cited 6 July 2018]. Webinar broadcast remotely on 18 June 2018.

REMS= Risk Evaluation and Mitigation Strategies

Shortage drugs demonstrated a price increase of 4.3% during a shortage and 4.1% after a shortage1

Alternatives >$200 million annually2

Labor ~$216 million annually3

Cost of Shortages in the U.S.

1. Alevizakos M, Detsis M, Grigoras CA, et al. The Impact of Shortages on Medication Prices: Implications for Shortage Prevention. Drugs. 2016;76(16):1551-58.2. Ventola CL. The drug shortage crisis in the United States. PT. 2011;36(11):740-742,749-757.3. Kaakeh R, Sweet BV, Reilly C, et al. Impact of drug shortages on U.S. health systems. Am J Health Syst Pharm. 2011;68(1):1811-1819.

Dedicated drug shortage positions1,2

Purchase of alternatives1,2

Cost of Shortages

1. Baumer AM, Clark AM, Witmer DR, et al. National survey of the impact of drug shortages in acute care hospitals. Am J Health Syst Pharm. 2004;61(19):2015-2022.

2. Kaakeh R, Sweet BV, Reilly C, et al. Impact of drug shortages on U.S. health systems. Am J Health Syst Pharm. 2011;68(1):1811-1819.

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PHARMACISTS & TECHNICIANSWhich of the following are drug manufacturers mandated to disclose to the FDA according to U.S. law?

A. What drug is affected by a supply problem

B. Why drug supply was interrupted

C. An approximate date of when the supply will recover

FDA = U.S. Food and Drug Administration; U.S. = United States

Learning Objective #4 for PHARAMCISTS and #3 for PHARMACY TECHNICIANS

A. Yes

B. No

C. Maybe

PHARMACISTS & TECHNICIANSYour institution is experiencing a critical shortage of fomepizole. You notice that there are several vials in the system that will expire in 1 week. Can your site legally keep expired drug, with the rationale that some drug is better than no drug?

Learning Objective #1, #4 for PHARAMCISTS and #1 for PHARMACY TECHNICIANS

Image from: State of Utah Letter from the Utah Department of Health. February 1, 2018.

Safety and adverse effects1-4

Cost1-4

Length of stay4

Mortality5

Shortages Negatively Impact…

1. Drug shortages continue to compromise patient care. Acute Care ISMP Medication Safety Alert!®. Horsham, PA; Institute of Safe Medication Practices. 2018;23(1): 1-4. Available from: https://www.ismp.org/resources/drug-shortages-continue-compromise-patient-care.

2. Baumer AM, Clark AM, Witmer DR, et al. National survey of the impact of drug shortages in acute care hospitals. Am J Health Syst Pharm. 2004;61(19):2015-2022.

3. Kaakeh R, Sweet BV, Reilly C, et al. Impact of drug shortages on U.S. health systems. Am J Health Syst Pharm. 2011;68(1):1811-1819.4. De Weerdt E, Simoens S, Casteels M, et al. Clinical, Economic and Policy Implications of Drug Shortages in the European Union. Appl Health Econ Health

Policy. 2017;15(4):441-445.5. Vail E, Gershengorn HB, Hua M, et al. Association Between US Norepinephrine Shortage and Mortality Among Patients With Septic Shock. JAMA.

2017;317(14):1433-1442.

Contact senators regarding the impact of shortages

Participate in national surveys re: shortage experiences

Implement best practices of medications before a shortage strikes1,2

Actions YOU Can Take

1. Drug shortages roundtable: Minimizing the impact on patient care. Am J Health Syst Pharm. 2018 Jun 1;75(11):816-820.2. Kaur K, O'Connor AH, Illig SM, et al. Drug shortages as an impetus to improve parenteral nutrition practices. Am J Health Syst Pharm. 2013;70(17):1533-1537.

Systematic approach

Drug shortage advisory group

Drug shortage resources

Legislation impacting shortages

Chicka Chicka BOOM! BOOM!

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Systematic approach




Chicka…

Systematic approach




Chicka…

Systematic approach




BOOM!

Systematic approach




BOOM!


Questions?

Renee Pitt can be contacted at:

[email protected]

801-284-1149

PittShortageHandout - Wild Apricot

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