pittshortagehandout - wild apricot
TRANSCRIPT
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August 18, 2018
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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/.
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…
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/.
BOOM! BOOM!
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/.
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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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/.
“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
Drug Shortage Advisory Group
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
Drug Shortage Advisory Group
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
Drug Shortage Advisory Group
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
Drug Shortage Advisory Group
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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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
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
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
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
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
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
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
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
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.
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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
American Medical Association
American Society of Anesthesiologists
American Society of Clinical Oncology (ASCO)
American Society of Health-System Pharmacists (ASHP)
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
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Top 5 Drug Classes on Shortage
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
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Top 5 Drug Classes on Shortage
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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Top 5 Drug Classes on Shortage
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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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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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.
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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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
Drug Shortage Advisory Group
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!
8/15/2018
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Systematic approach
Drug shortage advisory group
Drug shortage resources
Legislation impacting shortages
Chicka…
Systematic approach
Drug shortage advisory group
Drug shortage resources
Legislation impacting shortages
Chicka…
Systematic approach
Drug shortage advisory group
Drug shortage resources
Legislation impacting shortages
BOOM!
Systematic approach
Drug shortage advisory group
Drug shortage resources
Legislation impacting shortages
BOOM!
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/.
Questions?
Renee Pitt can be contacted at:
801-284-1149